New York, NY, March 18, 2026 (GLOBE NEWSWIRE) -- Q/C Technologies, Inc. (Nasdaq: QCLS) (“Q/C” or “the Company”), today announced the launch of a new initiative to design and prototype a proprietary optical processing unit (OPU) aimed at tackling the growing performance and energy constraints in artificial intelligence inference infrastructure.

Optical computing overcomes challenges posed by electronic GPUs. Artificial intelligence is dominated by one operation: the matrix multiplication. Photons can be configured to perform matrix multiplication naturally via interference achieving O(n) or even O(1) propagation latency, while most electronic devices used today, including GPUs, require O(n³) operations of work per matrix. Energy requirements of passive photonic components are minimal, addressing a key concern of electronic GPUs today. Photonic computing adds other advantages, including orders of magnitude faster clock speed and bandwidth. Q/C aims to overcome the three key limitations of optical computing: analog resolution, nonlinearity and storage via patentable proprietary technology and partnerships.

“Q/C believes the future of artificial intelligence hardware is optical. With AI driving the next inflection point in computing architecture, we plan to develop our own optical chip that we believe can address key bottlenecks in bandwidth, energy efficiency, and scalability,” said Q/C Executive Chairman Joshua Silverman. “We are encouraged by the caliber of AI, photonics and computing talent already engaged with Q/C including our newest director Chelsea Voss and strategic advisors Martin Shkreli and James Altucher. Together, they will spearhead a best-in-class solution for powering the future of AI.”

“We have begun assembling a specialized engineering team to advance our new program and we expect development to proceed through defined milestones including the introduction of optical, semiconductor, and systems engineers, filing foundational patent applications, and validating architectural designs and core computational functionality. We look forward to sharing our progress throughout the year,” added Q/C Director Chelsea Voss.

About Q/C Technologies, Inc.

Q/C Technologies is pioneering the next generation of energy-efficient quantum class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light in the crypto domain. Q/C believes that LightSolver’s technology bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation crypto applications. qctechnologies.com

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the development, performance and scalability of its qc-LPU100™ product and related technologies, unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
800-507-9010

Ms. Voss is a computer scientist and Member of Technical Staff at OpenAI, where she has played a key role in the development, evaluation, and launch of some of the most advanced, widely used artificial intelligence systems. Her expertise spans machine learning infrastructure, model evaluation, hardware reliability, and published research contributions including results across image generation, ML interpretability, and reinforcement learning. In her current position, Ms. Voss has served in senior technical roles supporting the training and deployment of frontier AI models, including leading evaluation efforts used to present new capabilities to the public and press, contributing to large-scale training runs, and supporting infrastructure and reliability systems critical to production AI platforms. She previously worked as a software engineer at Pilot.com and Sendwave.com, building scalable systems across financial and payments platforms. Ms. Voss earned her M.Eng. and S.B. degrees in computer science from MIT, giving her a technical grounding in formal verification, compiler theory, and quantum algorithms.

“We are pleased to welcome Chelsea to the Q/C Technologies Board,” said Joshua Silverman, Executive Chairman. “We believe her deep technical experience, particularly in the intersection of advanced computation, large-scale systems, and real-world deployment, will be invaluable as we advance our quantum-class computing strategy. Chelsea strengthens our Board with a perspective grounded in both cutting-edge research and operational execution.”

“Q/C Technologies is tackling fundamental challenges in computation, efficiency, and scalability,” said Voss. “I’m excited to join the Board and contribute my expertise in computer systems engineering as the Company works to bring photonic computing into real-world applications.”

Q/C Technologies is developing a new generation of quantum-class laser processing units (qc-LPU^™) designed to solve complex computational problems using the physical properties of light rather than traditional electrical signals. Through its partnership with LightSolver, the Company aims to advance photonic computing platforms intended to deliver significant improvements in speed, energy efficiency, and scalability for blockchain and other compute-intensive applications.

For more information, visit Chelsea Voss’s LinkedIn profile: linkedin.com/in/csvoss.

About Q/C Technologies, Inc.
Q/C Technologies is pioneering the next generation of energy-efficient quantum class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light in the crypto domain. Q/C believes that LightSolver’s technology bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation crypto applications. qctechnologies.com

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the development, performance and scalability of its qc-LPU100™ product and related technologies, unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
800-507-9010

Q/C Technologies welcomes Martin as part of its expanding advisory team alongside James Altucher, further strengthening the Company’s depth of expertise across computing, AI, and blockchain technologies.

“I'm convinced that the next leap in frontier computing is optical, not purely quantum. Q/C’s ‘quantum class’ technology approach bridges frameworks, offering the potential for extraordinary performance and efficiency gains,” said Shkreli.

Executive Chairman Josh Silverman added, “We’re pleased to welcome Martin to Q/C Technologies as an advisor. With Martin joining James on our advisory team, Q/C is well-resourced with visionary thought leaders who understand where computing and digital infrastructure are heading. Their combined insight supports our mission to lead in the development and commercialization of quantum class computing. Martin will also be working with us to identify additional industry experts to assist the Company at the executive and board level.”

Q/C’s qc-LPU100^™ brand of quantum-class laser processing units is a high-performance computing infrastructure that is powered by the properties of light instead of electrical signals for optimal energy efficiency. Through its partnership with Lightsolver, the Company is working to adapt its groundbreaking technology to real world use cases in blockchain. For fast-growing number of computational problems, Q/C’s LPU has demonstrated speeds up to 100x faster than state-of-the-art GPUs and quantum computers with 1/100th the energy usage.

For additional information, please see the Company’s Current Report on Form 8-K to be filed with the SEC on or about December 9, 2025.

About Q/C Technologies, Inc.

Q/C Technologies (Nasdaq: QCLS) is pioneering the next generation of energy-efficient quantum-class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light in the crypto domain. Q/C believes that LightSolver’s technology bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation crypto applications. qctechnologies.com

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the development, performance and scalability of its qc-LPU100™ product and related technologies, unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
800-507-9010

Set to outpace GPUs and QPUs (quantum processing units) with higher speed, efficiency, scale and sustainability

New York, NY, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Q/C Technologies, Inc. (Nasdaq: QCLS) (“Q/C” or “the Company”), a pioneer of quantum-class computing at the speed of light, today announced its collaboration with LightSolver, the inventor and owner of the quantum-class laser processing unit (LPU) technology. Through this collaboration, Q/C becomes the first client to adapt LightSolver's proprietary LPU technology for quantum-class applications in the crypto domain, introducing the qc-LPU100™—a Q/C-branded implementation that harnesses the natural properties of light with the goal of achieving first-in-class computational speed and energy.

Joshua Silverman, Executive Chairman of Q/C Technologies, commented, “By working with LightSolver and leveraging their breakthrough LPU technology, our qc-LPUs will be designed to tackle critical challenges such as high energy consumption, scalability, and rising operational costs that impact profitability. For an ever-growing number of problems, we have demonstrated speeds up to 100x faster than state-of-the-art GPUs and even quantum computers with 1/100 the energy usage.

“We believe this disruptive technology can transform crypto mining for Decentralized Physical Instructure (DePin) tokens, and burgeoning AI companies that require high performance computing and use these DePin tokens for their computing needs, enhancing scalability, efficiency, and security. We are excited about the opportunities ahead and believe this quantum-class technology has the potential to drive long-term shareholder value.”

“LightSolver, the inventor and owner of the LPU, has demonstrated speeds up to 100x faster than GPUs in solving partial differential equations (PDEs), bridging the gap between today’s GPUs and not-yet-developed quantum computers,” said Q/C Senior Quantum Adviser, Steven Frankel.

LightSolver’s quantum-class LPUs are being developed to unlock what Q/C believes is an unprecedented modeling capacity to solve partial differential equations (PDEs)—the math that models how things change over time and space—at light speed. Traditional computers struggle with these problems because they take too much time and power. Traditional quantum models offer promise but still face major practical limitations. In contrast, LightSolver’s system uses light-powered lasers to both compute and store data in an effort to remove input/output bottlenecks and lowering memory bandwidth usage while enabling large-scale simulations.

“We are thrilled to be working with Q/C to adapt our groundbreaking technology to real world use cases in blockchain,” said Ruti Ben-Shlomi, PhD, CEO and co-founder of LightSolver. “Previously, standard LPUs were limited to optimization problems, but with our new approach, our system can handle larger, more complex simulations, with plans to scale to 100,000 variables by 2027 and one million by 2029. We believe that the Q/C-branded qc-LPU100s could become a game-changing model for many practical blockchain applications.”

About Q/C Technologies, Inc.

Q/C Technologies is pioneering the next generation of energy-efficient quantum class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light in the crypto domain. Q/C believes that LightSolver’s technology bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation crypto applications. ir.qctechnologies.com

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the development, performance and scalability of its qc-LPU100™ product and related technologies, unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
800-507-9010

New York, NY, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Q/C Technologies, Inc. (Nasdaq: QCLS) (“Q/C” or the “Company”), a pioneer of quantum-class computing at the speed of light, today announced the appointment of Steven Frankel, Ph.D. as Senior Quantum Advisor. Dr. Frankel will help guide the Company’s ongoing efforts in quantum-class photonic computing to advance the development and commercialization of Q/C’s innovative Laser Processing Unit (LPU). Developed by LightSolver, Q/C’s LPU is the world’s first light and laser-based computing system designed to solve complex optimization and combinatorial problems at the speed of light.

Dr. Frankel is currently the Rosenblatt Professor of Mechanical Engineering at the Technion – Israel Institute of Technology and previously served for more than three decades as a professor at Purdue University. His research spans computational fluid dynamics, turbulence, combustion, and multiphase systems, with recent work focused on machine learning and quantum computing hardware. During a research fellowship at Quantum Machines in Tel Aviv, Dr. Frankel contributed to projects involving superconducting qubits, trapped ions, and physics-informed neural networks, bringing deep domain expertise that bridges advanced physics and quantum technologies.

“We are honored to welcome Dr. Frankel to Q/C Technologies,” said Joshua Silverman, Executive Chairman. “His distinguished academic background and applied research in quantum computational systems and physics-based neural networks bring exceptional insight to our collaboration with LightSolver. Dr. Frankel’s expertise will be instrumental as we pursue first-mover advantages in quantum-class photonic computing, helping translate this breakthrough from development to commercialization across the high-performance computing sector.”

Dr. Frankel added, “Q/C Technologies is at the forefront of merging photonic and quantum computing to tackle some of the most complex computational challenges. I’m excited to help the Company accelerate its path toward commercialization and deliver computing solutions that redefine speed, scalability, and sustainability.”

About Q/C Technologies, Inc.

Q/C Technologies is pioneering the next generation of energy-efficient quantum class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light. Q/C bridges a disruptive computing paradigm for high-speed photonic computing at scale, unlocking unprecedented performance and sustainability for next generation applications and post quantum security. ir.qctechnologies.com

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
800-507-9010

NEW YORK--(BUSINESS WIRE)-- Q/C Technologies, Inc. (Nasdaq: QCLS), formerly TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), (“Q/C” or “the Company”), today announced that its common stock will begin trading under the new ticker symbol “QCLS” beginning today at the market open.

The Company’s new name Q/C Technologies represents its recent strategic pivot into quantum-class computing with exclusive global rights to LightSolver’s light-speed laser processing unit (LPU), the world’s first light and laser-based computing system, for application in quantum class cryptocurrency verticals.

“The official transition to Q/C Technologies and our new Nasdaq ticker is an important milestone in aligning our public identity with the Company’s transformation,” said Joshua Silverman, Executive Chairman of Q/C Technologies. “With our focus on quantum-class photonic computing and exclusive rights to LightSolver’s platform for cryptocurrency applications, we are well positioned to advance our first-mover strategy and build sustainable value for shareholders. We look forward to sharing additional updates as we continue to execute on our plan.”

In connection with the name change and stock symbol change, no action is required from current shareholders, and the Company’s CUSIP number will remain the same.

About Q/C Technologies, Inc.

Q/C Technologies is pioneering the next generation of energy-efficient quantum class, high-performance computing infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light. Q/C bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation applications and post quantum security.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Source: Q/C Technologies, Inc.

Licensed technology positions Company at forefront of new quantum-class computing paradigm

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“Q/C” or the “Company”) today announced that it has changed its corporate name to Q/C Technologies, Inc. and will begin trading under the new ticker symbol “QCLS” on the Nasdaq Capital Market, effective as of the market open on Thursday, September 25, 2025. Until then, the Company’s common stock will continue to trade under its current ticker symbol “TNFA.”

The new name Q/C Technologies represents the Company’s recent strategic pivot into quantum-class computing with exclusive global rights to LightSolver’s light-speed laser processing unit (LPU), the world’s first light and laser-based computing system, for application in the cryptocurrency vertical.

By harnessing the unique physical properties of light in an innovative computing paradigm, the LPUs can reduce energy consumption by up to 90% while outperforming traditional GPUs and even quantum computing in both speed and efficiency. In addition to these performance gains, Lightsolver’s architecture is designed to improve security for blockchain operations, offering a more sustainable and resilient foundation for the cryptocurrency industry. Together, these advantages are expected to position the Company to be at the forefront of innovation in blockchain infrastructure.

“Our new name and identity better reflect the Company’s future,” said Joshua Silverman, Chairman of Q/C Technologies. “With exclusive rights to LightSolver’s innovative computing platform for the crypto vertical, we are advancing a first-mover strategy in a trillion-dollar industry under immense pressure to evolve profitably and at scale. We believe that this transformation will position us to create significant value for our shareholders.”

In connection with the name change and stock symbol change, no action is required from current shareholders and the Company’s CUSIP number will remain the same.

The Company also noted that it continues to evaluate strategic options for its legacy therapeutic programs, isomyosamine and Supera-CBD, with the goal of maximizing value from these assets as it pivots into next-generation computing and blockchain infrastructure.

About Q/C Technologies (formerly TNF Pharmaceuticals)

Q/C Technologies is pioneering the next generation of energy-efficient blockchain infrastructure. Through a licensing agreement with LightSolver, Q/C holds exclusive rights to the use of innovative quantum-inspired laser-based processing units (LPUs) that solve compute-intensive combinatorial and physical problems at the speed of light. Q/C bridges a disruptive computing paradigm for high-speed photonic computing with cryptocurrency infrastructure development at scale, unlocking unprecedented performance and sustainability for next generation blockchain applications.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements and include statements related to the expected benefits from the licensing agreement with LightSolver and performance of LightSolver’s technology. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact our liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the Company’s ability to create value from its pharmaceutical candidates; the amount of funds the Company requires for the commercial development of its licensed technology and maintenance of its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Source: Q/C Technologies, Inc.

"We are pleased to have regained compliance with Nasdaq’s listing standards. This milestone comes as we work to build a strong strategic platform for growth and shareholder value. We will be updating shareholders on our progress in the weeks ahead,” said Joshua Silverman, Executive Chairman.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: any setbacks in the expected benefits from the licensing agreement with LightSolver Ltd. or the performance or marketability of LightSolver’s technology; unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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tnfpharma.com/contact

Source: TNF Pharmaceuticals Inc.

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”) today announced its participation in the H.C. Wainwright & Co. 27th Annual Global Investment Conference taking place September 8–10, 2025, at the Lotte New York Palace Hotel in New York City. TNF’s presentation is scheduled for Wednesday, September 10, 2025, at 8:00 a.m. ET.

Presentation Details:

In addition to the formal presentation, management will participate in one-on-one investor meetings on site during the day of their presentation and virtual meetings throughout the conference dates. Meetings may be scheduled on the conference website.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact its liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; and the Company’s ability to quickly and effectively respond to new technological developments. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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tnfpharma.com/contact

Source: TNF Pharmaceuticals, Inc.

Led by a top strategic investor with significant participation from existing stockholders

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”) today announced the closing of a $7.0 million private placement financing of convertible preferred stock with the Company’s largest strategic stockholder and other existing stockholders.

The private placement involved the sale of 7,000 shares of preferred stock, with a stated value of $1,000 per share, convertible into 1,400,000 million shares of the Company’s common stock at an initial conversion price of $5.00, and accompanying warrants to purchase up to 1,400,000 shares of the Company’s common stock at a conversion price of $5.00. The shares of preferred stock and the warrants will not be convertible or exercisable, respectively, until receipt of the requisite stockholder approval. Aggregate gross proceeds from the private placement totaled $7 million.

“We appreciate the vote of confidence in TNF’s value proposition and execution of our newest strategies,” said Joshua Silverman, TNF’s Executive Chairman. “We believe the $7 million in new capital positions TNF to complete key development milestones planned for our newly licensed innovative technology, which we believe is the first light-based computing accelerator for blockchain.”

As of September 3, 2025, TNF’s shares of common stock outstanding totaled 1,846,930.

“We are actively engaging strategic opportunities to continue the development of isomyosamine and Supera-CBD,” said Mitchell Glass, Chief Medical Officer. “Our goal is to ensure these assets continue to create value for shareholders.”

The securities in the private placement were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Rodman & Renshaw, LLC, H.C. Wainwright & Co. and GP Nurmenkari Inc. (GPN) acted as placement agents on the transaction.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements and include statements related to the expected benefits from the licensing agreement with LightSolver and performance of LightSolver’s technology. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact our liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Investor Contact:
tnfpharma.com/contact

Source: TNF Pharmaceuticals, Inc.

Strategic partner LightSolver named a 2025 World Economic Forum Technology Pioneer and recognized in Gartner’s 2025 Hype Cycle for Data Center Infrastructure Technologies

Supported by strategic investment from TNF’s largest stockholder; TNF to pursue name change reflecting new direction

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”) today announced that it has entered into a licensing agreement for an innovative processing accelerator designed to expedite compute-intensive computations In partnership with LightSolver Ltd. (“LightSolver”), a company recognized by Gartner and the World Economic Forum for its breakthrough innovation. TNF holds exclusive rights to the use of its computing technology in cryptocurrency and blockchain applications. TNF intends to change its name in accordance with its new venture.

LightSolver is the creator of the first laser-based processing unit (“LPU”) to harness light for computation, offering an accelerated computation method designed to outpace conventional GPUs, quantum computing, and high-performance computing (HPC) with greater speed and efficiency. Applied to cryptocurrency, this scalable technology will be designed to reduce energy costs by up to 90% and offer a potential pathway to fully sustainable infrastructure.

“With LightSolver’s LPUs, we believe compute-intensive combinatorial and physical problems can be solved at the speed of light—orders of magnitude faster than other methods. At the same time, crypto infrastructure is still using outdated tools that aren’t tailored for crypto applications. We are excited to partner with TNF to develop what we believe to be the first light-based computing system to blockchain,” said Dr. Ruti Ben-Shlomi, Chief Executive Officer of LightSolver.

“We believe LightSolver has created a disruptive computing paradigm that opens a new world of light speed computation,” said Joshua Silverman, TNF’s Executive Chairman. “Our new partnership with LightSolver gives us exclusive access to quantum-inspired LPU-based systems capable of unlocking unprecedented performance and sustainability for the cryptocurrency industry. Alongside our new partnership, TNF is in late-stage discussions with a tech infrastructure and crypto mining expert to lead the development and commercialization strategy for our licensed technology.

“Our recent significant improvements in TNF’s financial position enable us to be opportunistic in our business developments,” Silverman added. “With LightSolver, we believe we are positioned to capitalize on the strong momentum behind both photonic computing and the future of cryptocurrency infrastructure. We believe we now have first mover advantages in a burgeoning industry—a strategy that we believe best positions TNF for growth and value creation.”

LightSolver has secured grants from the European Innovation Council (EIC), an organization that promotes breakthrough innovation with scale-up potential at the global level. LightSolver’s computing technology innovation has drawn world-class early adopters including a top-tier bank and aerospace companies, along with numerous prestigious accolades. LightSolver was recently named a 2025 World Economic Forum Technology Pioneer and was recognized as a sample vendor in Gartner’s 2025 Hype Cycle for Data Center Infrastructure Technologies. LightSolver was cofounded by PhD physicists Ruti Ben-Shlomi and Chene Tradonsky from the Weizmann Institute of Science, one of the world’s leading multidisciplinary basic research institutions in the natural and exact sciences.

“We believe LightSolver’s computing leap is similar in significance to technology’s upgrade from slow form dial-up internet to high-speed fiber internet,” Dr. Ruti Ben-Shlomi continued. “Our LPUs tackle problems that are unfeasible for classical supercomputers due to their memory bottlenecks and energy inefficiency. For cryptocurrency applications, laser-based computing is intended to reduce heat and power waste with the speed and efficiency of light—transforming how mining, proof-of-work, and decentralized computing scale.”

LightSolver’s IP-protected LPU offers distinct advantages over quantum computing. It operates in a highly parallel mode within an optical resonator with a clock-time of a few nanoseconds to execute complex computations. It is less demanding in terms of environmental conditions, with no vacuum or ultracold temperatures required. Second, LightSolver’s LPU is only the size of a rack unit. Further, it is less demanding in terms of environmental conditions with no vacuum or ultracold temperatures required.

TNF also announced today that it has entered into a securities purchase agreement for a $7.0 million private placement financing, including the Company’s largest strategic stockholder and other existing stockholders, involving the sale of 7,000 shares of its newly created Series H convertible preferred stock (“preferred stock”), with a stated value of $1,000 per share, convertible into shares of its common stock following receipt of the requisite stockholder approval and accompanying common stock purchase warrants, which is expected to close on or about September 4, 2025, subject to the satisfaction of customary closing conditions.

The shares of preferred stock have an initial conversion price of $5.00 per share. The warrants are exercisable following the receipt of the requisite stockholder approval, have an initial exercise price of $5.00 per share and expire five years from the date of stockholder approval.

The securities in the private placement were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

TNF continues to evaluate strategic, value-enhancing options for its legacy therapeutic platforms, including its oral TNF-alpha inhibitor (isomyosamine) and Supera-CBD, as part of its ongoing commitment to maximizing shareholder value.

Rodman & Renshaw, LLC, H.C. Wainwright & Co. and GP Nurmenkari Inc. (GPN) are acting as placement agents on the transaction.

About LightSolver

LightSolver is the inventor of an all-optical computing technology capable of solving complex and large computational problems at the speed of light. Utilizing the interference patterns of lasers, the Laser Processing Unit™ (LPU) can tackle challenges that were previously constrained by the limits of electronics, while fitting into a rack unit and operating at room temperature. Dr. Ruti Ben-Shlomi and Dr. Chene Tradonsky, physicists from the world-renowned Weizmann Institute, founded the company in 2020.

lightsolver.com

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements and include statements related to the completion of the private placement and the satisfaction of customary closing conditions related to the private placement, the expected benefits from the licensing agreement with LightSolver and performance of LightSolver’s technology. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact our liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Investor Contact:
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Source: TNF Pharmaceuticals, Inc.

The Company’s common stock will begin trading on a split-adjusted basis upon market open on Tuesday, September 2, 2025. The Company expects to provide operational business updates coinciding with the completion of the reverse stock split.

The new CUSIP number for the Company’s common stock following the reverse stock split is 62856X300. At the effective time of the reverse stock split, every 100 issued and outstanding shares of the Company's common stock will be combined automatically into 1 share of the Company's common stock without any change in the par value per share. No fractional shares will be issued in connection with the reverse stock split, and fractional shares resulting from the reverse stock split will be rounded up to the nearest whole share. There will be no change in the par value of $0.001 per share of the common stock as a result of the reverse stock split.

The reverse stock split will reduce the number of shares of the Company’s common stock outstanding as of August 27, 2025, from 178,615,658 shares to 1,786,157 shares. Proportional adjustments will be made to the number of shares of the Company’s common stock issuable upon exercise or conversion of the Company’s equity awards, convertible preferred stock, warrants and other convertible securities as well as the applicable exercise or conversion price.

Stockholders holding their shares in book-entry form or through a bank, broker, or other nominee do not need to take any action in connection with the reverse stock split. Their accounts will be automatically adjusted to reflect the number of shares owned. Beneficial holders are encouraged to contact their bank, broker, or other nominee with any procedural questions. All other stockholders may direct questions to the Company’s transfer agent, Securities Transfer Corporation, 2901 Dallas Pkwy Suite 380, Plano, TX 75093.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the intended effects of the reverse stock split. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250828785479/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Largest shareholder is long-term strategic investor

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that is has significantly improved its financial position over the past 5 months through a material reduction in liabilities, while maintaining total assets of over $17 million as of June 30, 2025.

“The recent significant improvement in our financial position gives TNF a stronger platform for growth opportunities and taking advantage of shareholder value creation opportunities,” said TNF President and Chief Medical Officer, Mitchell Glass, M.D. “We are pleased to have the continued support of our largest investors, and look forward to updating investors on TNF’s business developments in the near future, including our ongoing collaboration with Renova on GLP-induced inflammation and muscle damage.”

The improvements in the Company’s financial position will be reflected in future financial statements of the Company.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: unanticipated financial setbacks, the Company needing to pursue financing options that could adversely impact our liabilities due to adverse market conditions, the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Investor Contact:
tnfpharma.com/contact

Source: TNF Pharmaceuticals, Inc.

NEW YORK--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that it has formed a philanthropic collaboration with the DADA2 Foundation, a nonprofit organization seeking innovative ways to accelerate research into the rare inflammatory disease DADA2 (Deficiency of Adenosine Deaminase 2). Together, the parties are expected to initiate a Compassionate Use (Expanded Access) study evaluating TNF’s lead candidate isomyosamine as a potential treatment.

The DADA2 Foundation describes DADA2 as a rare, monogenic recessively inherited autoinflammatory disease characterized by systemic inflammation, vasculitis, early-onset stroke, immunodeficiency, and bone marrow failure. The condition can lead to recurring childhood strokes at a young age and a high risk of premature death before adulthood. Early diagnosis is critical to minimize systemic organ damage.

TNF President and Chief Medical Officer, Mitchell Glass, M.D. commented, “The body of evidence surrounding DADA2 has shown that TNF inhibition is a most effective treatment for the hyperinflammatory and vasculitic aspects of this disease—a potentially fatal condition that primarily affects children. Compared with standard-of-care biological treatments, our TNF-alpha inhibitor, isomyosamine, is an orally administered small molecule with comparable potency, easier titration to the intended effect and, most importantly, anti-inflammatory action with minimal or no immunosuppression. We believe it could be a superior alternative for treating this devastating disease.”

DADA2 Foundation Founder and President, Chip Chambers, M.D. commented, “Biological TNF inhibitors have shown to be the only safe and effective treatment for DADA2 patients with autoinflammatory/vasculitic forms of DADA2, but have many limitations including route of administration, cost, and the potential to lose efficacy over time. We are excited to explore isomyosamine as a potential new treatment to improve the lives of DADA2 patients and their families.”

Approximately 25% of DADA2 patients are diagnosed before one year of age and 77% by 10 years of age. Patients who have bone marrow failure tend to present during early infancy, whereas delayed presentation is common in patients with vasculitis affecting medium- and small-sized vessels and systemic inflammation. There are more than 600 DADA2 patients today, but research suggests that 35,000 patients could be affected and undiagnosed globally.¹

About the DADA2 Foundation

The DADA2 Foundation is building a global network of patients, researchers and clinicians who are collaborating together to find treatments and a cure for the disease, DADA2. DADA2, deficiency of adenosine deaminase 2, affects more than 600 patients globally. Our goal is to find every patient not yet found, connect them with the care they need, and continue to pursue a cure. dada2.org

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s goals and expectations related to the Company’s partnership with the DADA2 Foundation. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ DADA2 Foundation website

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Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

First study examines pro-inflammatory TNF-α levels in patients receiving GLP-1 agonists including Wegovy® or Ozempic®

Initial findings support opportunities to improve diagnosis and treatment and demonstrate isomyosamine’s potential to impact quality of life in a general practice population

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health, a company committed to focusing on outpatient care to minimize costs, impact and the need for hospitalization, today announced positive results from the first stage of a general practice population study focusing on patients receiving GLP-1 agonists. The study series is expected to evaluate the impact of the Company’s novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management in patients who are a) on GLP-1 agonists, b) candidates for treatment with GLP-1 agonists, or c) probably not suitable for treatment with weight loss therapy.

In coordination with Renova Health, the purpose of this first stage was to analyze 30,000 patients already under the care of primary care physicians and identify convergences between the use of GLP-1 agonists and chronic disorders linked with increased risk of inflammation. The data were parsed into three cohorts depending on prespecified criteria. TNF plans to use these data to optimize appropriate patient recruitment and accelerate isomyosamine drug development.

TNF’s President and Chief Medical Officer, Mitchell Glass, M.D., commented, “Our goal for our GLP-1 study series is to identify patients who are taking GLP-1 agonists to test whether isomyosamine can decrease inflammation and prevent or ameliorate the risk of adverse outcomes such as muscle wasting in patients who have baseline TNF-derived inflammatory signals. In our initial review of the data, we have already noted that sarcopenia and frailty are both underreported, which we believe provides evidence that at-risk populations could suffer adverse events from GLP-1 treatment without adequate surveillance to detect and treat drug-induced muscle wasting.”

“The prevalence of certain disorders such as sarcopenia were well below the Centers for Disease Control and Prevention’s estimates in community dwelling adults,” said Dave Jacobs, Chief Executive Officer of Renova Health. “Identifying patients in the community who are at increased risk of fall may enable us to use non-invasive monitoring to identify these patients earlier and more accurately and to provide support. We believe early and ongoing evaluation of sarcopenic and frail patients could enable us to impact quality of life in thousands of patients once identified and followed with straightforward and validated tests of balance and cognition.”

About Renova Health

Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health’s success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit www.renovahealth.care.

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s goals and expectations related to the Company’s partnership with Renova Health. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250507647046/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, and Renova Health announce the application of AI and machine learning technologies to identify high-risk patient groups that may benefit the most from interventions that preserve lean muscle mass during GLP-1 treatment for diabetes, weight loss, and chronic weight management. In keeping with FDA’s recent draft Guidance on using Artificial Intelligence, the TNF-Renova partnership is analyzing data from 30,000 patients to identify high-risk patients. TNF plans to use these data to optimize appropriate patient recruitment, accelerating isomyosamine drug development.

“Our collaboration partner, Renova Health has used its AI and machine learning technology platform to analyze and identify optimal patient pools and study sites, enabling a swift and efficient progression of our study series over the coming months,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. “This technology has allowed us to look at the constellation of underlying conditions, symptoms, acute events, and medications being taken across thousands of patients to identify specific patient subsets for which isomyosamine treatment may be most beneficial.”

Renova Health’s proprietary AI and machine learning technology—including a cutting-edge natural language processing (NLP) and large language model (LLM) platform—offers key benefits to TNF Pharmaceuticals including the ability to quickly review thousands of patient records to identify a target population that may benefit from isomyosamine. This target population consists of patients who have underlying chronic diseases, such as diabetes, COPD, chronic kidney disease, or sarcopenia/frailty, have suffered an acute medical event associated with inflammation (such as a fall or bone fracture), and are taking GLP-1 medications.

“We are thrilled to collaborate with TNF Pharmaceuticals to advance precision medicine through our cutting-edge NLP, LLM, and AI platform,” said David Jacobs, CEO of Renova Health. “Our technology transcends traditional big data analytics by creating highly specific patient personas, identifying optimal cohorts for isomyosamine based on underlying conditions, acute events, and medication profiles. Furthermore, our platform uncovers the nuanced impact of individual physician practices—such as varying diagnosis codes for GLP-1 prescriptions, like BMI versus diabetes—which can significantly influence cohort selection and study outcomes. This unparalleled precision enables TNF Pharmaceuticals to target patients who stand to benefit most, accelerating study timelines and enhancing therapeutic impact.”

About Renova Health

Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health’s success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit www.renovahealth.care.

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s goals and expectations related to TNF-Renova partnership. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250422412441/en/

Investor Contact:

Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Drug shown to decrease biomarkers associated with TNF-alpha activation in elderly patients with sarcopenia

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, announced today that a platform presentation of an abstract titled “Isomyosamine for the Treatment of Sarcopenia in Older Adults” was delivered by Mitchell Glass, M.D., President and Chief Medical Officer of TNF, at the British Geriatrics Society (BGB) Spring Meeting 2025, held April 9-11, 2025, in Belfast, Ireland and online.

During his presentation, Dr. Glass spoke about the Company’s small-molecule TNF-alpha (TNF-α) inhibitor, isomyosamine, which has shown potential for regulating pro-inflammatory cytokines associated with sarcopenia. In response to a question, he emphasized the Company's commitment to sarcopenia as an initial indication, including muscle wasting as an effect of treatment with GLP-1 agonists. He also commented on the Company's plans to extend Phase 3 into the UK and Europe.

“An earlier Phase 2 study of isomyosamine demonstrated its safety and tolerability in elderly patients with sarcopenia, with significant reductions in inflammatory biomarkers such as TNF-α, IL-6, and soluble TNF receptor 1 (sTNFR1). We are currently enrolling patients in a larger Phase 2b clinical trial that will investigate isomyosamine’s effect on cellular inflammation and recovery of ambulation speed in elderly patients post-hip fracture. An increased sample size and more frequent dosing in the follow-up trial will enable us to better evaluate the drug's potential to improve both clinical and biochemical outcomes in sarcopenic patients,” Dr. Glass explained.

The British Geriatrics Society is the membership association for professionals specializing in the healthcare of older people across the UK. Founded in 1947, BGS has over 5,000 members, and it is the only Society in the UK offering specialist expertise in the wide range of healthcare needs of older people.

About Isomyosamine

Isomyosamine (ICD-10-CM code M62.84) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNFα plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch and the timing of the Company’s planned trial of isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, filed by the Company on April 11, 2025, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250416886460/en/

Investor Contact:

Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, announced that data from the Phase 2a clinical trial of its oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine was presented last week in a podium session at the peer-reviewed 15th International Conference on Frailty and Sarcopenia Research (ICFSR) held March 12-14, 2025, in Toulouse, France.

The presentation included positive Phase 2a clinical data showing decreases of biomarkers associated with TNF-α activation in elderly patients with sarcopenia. The Company’s recently initiated Phase 2b clinical trial will further evaluate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

“We were proud to speak about our compelling clinical data for isomyosamine at ICFSR’s premier annual conference on sarcopenia. The data presented showcases the rationale for our current Phase 2b study in elderly sarcopenia patients and the optimal oral dosing regimen going forward,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “We are further exploring isomyosamine’s potential for regulating pro-inflammatory cytokines associated with sarcopenia with an assessment of the drug’s impact on the recovery of mobility and independence for these elderly patients.”

The ICFSR conference was created with the objective to speed the development of high-quality clinical trials in frail older adults by sharing experiences, success and failure alike, to accelerate the discovery of treatments, prevention methods for healthy aging and prevention of disabilities and dependency in older adults.

About Isomyosamine

Isomyosamine (ICD-10-CM code M62.84) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNFα plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch and the timing of the Company’s planned trial of isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250317910784/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Investors invited to submit questions prior to the event

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that it will host an investor conference call and webcast on Thursday, March 6, 2025, at 4:30 pm ET. Mitchell Glass, M.D., President and Chief Medical Officer of TNF, will provide a clinical scientific update on the Company’s lead candidate isomyosamine, a novel oral TNF-alpha (TNF-α) inhibitor drug shown to positively impact conditions related to immunometabolic dysregulation.

A Phase 2b clinical trial is currently underway to evaluate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery. Concurrently, TNF recently launched the first in a series of studies to evaluate the impact of isomyosamine for preserving lean muscle mass during and after GLP-1 obesity treatments for weight loss.

Conference Call and Webcast Access:

• Date and Time: Thursday, March 6, 2025, at 4:30pm ET
• Participant Dial-In: 877-407-0832 / +1 201-689-8433
• Live Webcast: Join here.
• Q&A Submit questions to rschatz@tnfpharma.com prior to the event
• 30-day phone replay: 877-660-6853 / 201-612-7415; Access ID: 13752199
• 30-day webcast replay: Same link above.

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch, the success and timing of, the Company’s planned trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250305398073/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Study builds on positive results achieved in earlier Phase 2a trial

TNF-alpha inhibitor market estimated at $40+ billion with no FDA-approved oral treatments

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

“The initiation of our Phase 2b isomyosamine trial marks an important milestone in our mission to develop a novel science for immuno-metabolic regulation and increased longevity,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF. “A deeper exploration of isomyosamine’s efficacy will be studied in patients with acute post-surgical inflammation and complications from hip or femur fractures. In addition to further functional decline, these patients face a higher likelihood of complications that can compromise or delay recovery and are associated with higher healthcare costs.”

According to Jay Magaziner, Ph.D., Director of the Center for Research on Aging at the University of Maryland and founder of the Baltimore Hip Studies project that evaluates outcomes after hip fractures in older patients, “After hip fracture, older patients can precipitously lose bone, muscle, and function, which is associated with a systemic inflammatory response. If we can block this inflammatory response, we have a chance to reduce the amount of muscle loss and the associated functional loss, leading to better outcomes in hip fracture among older persons.”

The upcoming Phase 2b trial to be initiated at the University of Florida is a randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of isomyosamine in reducing inflammation in patients with sarcopenia undergoing fracture repair. Sixty patients will be treated with isomyosamine or placebo for up to 90 days after surgery. The study will measure the extent and time course of recovery to evaluate functional improvement, comparing active dosing to placebo.

The site’s principal investigator is Porter Young, M.D., an assistant professor of orthopaedic surgery and rehabilitation at the University of Florida. His research centers on acetabulum fractures, pelvis fractures, periarticular fractures and management of polytrauma patients.

Isomyosamine is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. Isomyosamine has also been shown to selectively block TNF-α action where it is overactivated without preventing it from doing its normal job of responding to routine infection. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.

Burden of Sarcopenia

Sarcopenia (ICD-10-CM code M62.84) affects approximately 10% to 16% of the elderly worldwide.¹ It is also estimated to affect more than 1 in every 10 young adults of most ethnicities.² Based on conservative calculations, at least 50 million people were affected by sarcopenia in 2018, and the disease is projected to affect over 200 million over the next four decades due to the growing elderly population.³

The sarcopenia treatment market is estimated to be $3.07 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 4.5% to $4.0 billion by 2029.⁴ With no FDA-approved treatments for sarcopenia, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system.⁵

The global market value for TNF inhibitor drugs was estimated to be $39.7 billion in 2024. Growing at an expected CAGR of 3.6% for the next five years, the TNF inhibitor market is expected to reach $47.3 billion by 2029.⁶

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

________________

¹ Metabolism journal, Epidemiology of sarcopenia: Prevalence, risk factors, and consequences (2023)
² Metabolism journal, Sarcopenia in youth (2023)
³ Biology, Sarcopenia Is Associated with an Increased Risk of Postoperative Complications… (2023)
⁴ Mordor Intelligence, Sarcopenia Treatment Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)
⁵ Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019)
⁶ Mordor Intelligence, TNF Inhibitors Market Size (2024 - 2029)

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

About the University of Florida

The University of Florida is a premier academic institution that has repeatedly ranked as one of the top five public universities in the country, according to U.S. News & World Report. With campuses in Gainesville and Jacksonville, UF’s health sciences centers and colleges attract the brightest students, scholars, scientists and health care providers from across the country and abroad.

UF faculty conducted a record $1.26 billion in research in fiscal year 2024.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch, the success and timing of, the Company’s planned trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250225405912/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Lean body mass accounts for up to 40% of weight loss from GLP-1 treatments

Potential entry into high growth GLP-1 market of nearly $50 billion in 2024, projected value of $100 billion by 2029

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNF” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that it has initiated the first in a series of studies to evaluate the impact of its novel oral TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in preserving lean muscle mass during and after GLP-1 treatment for weight loss and chronic weight management.

“The body of evidence for the GLP-1 drug class shows that up to 40% of total weight loss in GLP-1 patients is lean body mass including skeletal muscle mass,¹” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF. “The purpose of our clinical study series is to assess isomyosamine’s potential to preserve lean muscle mass during and following GLP-1 weight loss in chronic overweight and obese patients of all age groups.”

The first study examines TNF-α levels in patients receiving the GLP-1 agonist Wegovy® or Ozempic® who show signs of increased inflammation associated with sarcopenia, which is the progressive loss of muscle mass. Isomyosamine targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia.

“Findings from the initial observational study will inform our forward move into multiple planned clinical studies designed to evaluate isomyosamine’s effects in our target population of GLP-1 patients,” Dr. Glass continued. “Our collaboration partner, Renova Health, is using its proprietary AI and machine learning technology to analyze and identify optimal patient pools and study sites, enabling an efficient progression of our study series over the coming months.”

"We are proud to partner with TNF to tackle the critical challenges faced by patients using GLP-1 medications,” said David Jacobs, Chief Executive Officer of Renova Health. “This collaboration is expected to allow us to leverage our advanced AI and machine learning capabilities for precise cohort selection and patient engagement, enabling us to uncover deeper, more meaningful patient insights that will enhance the study’s impact.”

Valued at $49.3 billion in 2024,² the GLP-1 receptor agonist market is projected to reach $105 billion in 2029, growing at a projected compound annual growth rate (CAGR) of 19.2% from 2023 to 2029.³ According to the Centers for Disease Control and Prevention, obesity costs the U.S. healthcare system nearly $173 billion annually.⁴

About Isomyosamine

Isomyosamine is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch, the success and timing of, the Company’s planned trial of isomyosamine (MYMD-1®) as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

____________________________
¹ Drug Discovery and Development, March 2024
² Research and Markets, GLP-1 Market: Industry Trends and Global Forecasts to 2035…., August 2024
³ Global Data, March 2024
⁴ Centers for Disease Control and Prevention (CDC), About Obesity, January 2024

View source version on businesswire.com: https://www.businesswire.com/news/home/20250129231553/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Transformative potential for novel TNF-alpha inhibitor drug:
Estimated $40 billion TNF inhibitor market and $50 billion GLP-1 agonist market

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, today announced that it has achieved a key safety data milestone supporting expanded and longer-term clinical studies of its novel TNF-alpha (TNF-α) inhibitor drug, isomyosamine, in multiple indications.

The Company successfully completed an FDA-recommended study of isomyosamine that demonstrated clinical safety throughout 13 weeks of treatment at all dose levels evaluated.

“Positive data from this milestone study confirms isomyosamine’s historically strong safety profile and enables us to extend the duration of future clinical trials,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “We believe we are fully equipped to advance our comprehensive isomyosamine platform in a longer-term clinical trial in sarcopenia and future studies in multiple conditions associated with immunometabolic dysregulation.”

Trials, Indications, and Markets

Sarcopenia/frailty: TNFA plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025. The study will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier Phase 2 clinical study. The sarcopenia treatment market is estimated to be $3.07 billion in 2024 and is expected to grow at a compound annual growth rate (CAGR) of 4.48% and is estimated to reach $4.02 billion by 2029.¹

GLP-1 muscle loss: the Company recently announced a planned trial of isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty. The fully funded study is expected to evaluate TNF-α levels in patients receiving GLP-1 agonist Wegovy or Ozempic who show signals for increased inflammation associated with sarcopenia. Currently valued at $49.3 billion, the GLP-1 agonist market is projected to reach $105 billion by 2029, growing at an expected CAGR of 19.2% from 2023 to 2029.² According to the Centers for Disease Control and Prevention, obesity costs the U.S. healthcare system nearly $173 billion annually.³

TNF inhibitor drug category: the global market value for TNF inhibitors was estimated to be $39.7 billion in 2024. Growing at an expected CAGR of 3.6% for the next five years, the TNF inhibitor market is expected to reach $47.3 billion by 2029.⁴

About Isomyosamine

Isomyosamine (MYMD-1®) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNF-α plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch and the timing of the Company’s planned trial of MYMD-1 as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250115095685/en/

Investor Contact:

Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Collaboration partner to use AI and machine learning to identify targeted patient pool

Potential entry into high growth GLP-1 market valued at nearly $50 billion in 2024 and projected to surpass $100 billion by 2029

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, today announced that it has entered into a collaborative agreement with Renova Health for a planned trial of its TNF-alpha (TNF-α) inhibitor drug isomyosamine (MYMD-1) as a treatment for GLP-1-induced sarcopenia and frailty. The fully funded study is expected to evaluate TNF-α levels in patients receiving GLP-1 agonist Wegovy or Ozempic who show signals for increased inflammation associated with sarcopenia.

“The GLP-1 drug class has transformed the pharmaceutical landscape in recent years as the prevalence of obesity surges to record numbers. While GLP-1 receptor agonists are highly effective in treating overweight and obesity, rapid and extensive weight loss can bring a range of dangerous complications including sarcopenic loss of muscle mass and bone density,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “Since our lead drug targets excess pro-inflammatory TNF-alpha, a primary cause of sarcopenia, we believe it could provide a much-needed solution for preserving muscle mass in GLP-1-induced weight loss.

“We look forward to collaborating with Renova Health, a leading innovator supporting superior healthcare outcomes. Together we will work to identify the optimal patient pool, sample size, dosing regimen, and other key objectives for a successful open label trial,” Dr. Glass added.

Studies have shown that up to 40% of the total weight lost by GLP-1 patients is lean body mass, which includes skeletal muscle mass.¹ If proven effective in preserving lean muscle mass during GLP-1 weight loss, isomyosamine could become a first-in-class therapy for a massive population of younger and middle-aged overweight and obese patients globally.

“Renova Health is excited to partner with TNF Pharmaceuticals,” said David Jacobs, CEO of Renova Health. “Together, we share a commitment to putting patients first and exploring innovative ways to achieve better outcomes at lower costs. This collaboration reflects our dedication to treating patients as real people, not just data points.”

Dr. Juliet Daniel, Medical Director of Renova Health, added, “This partnership combines Renova’s ‘Hyper-Personalized’ patient engagement expertise with TNFA’s promising research. Together, we aim to address key challenges in GLP-1 therapies and advance care for patients affected by inflammation and muscle loss.”

Currently valued at $49.3 billion, GLP-1 agonists are expected to be the top selling drug class in 2024.² The GLP-1 agonist market is projected to reach $105 billion in 2029, growing at an expected 19.2% CAGR from 2023 to 2029.³

According to the CDC, obesity costs the U.S. healthcare system nearly $173 billion annually.⁴

TNFA is currently conducting a Phase 2 clinical trial of isomyosamine as a treatment for aging-related sarcopenia. Based on statistically significant positive results from the smaller Phase 2a study, the Company plans to launch a Phase 2b study early in the first quarter of 2025.

About Isomyosamine

Isomyosamine (MYMD-1®) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNFα plays a causative role in the pathogenesis of various age-related diseases.

About Renova Health

Renova Health partners with large clinic practices, hospital systems, and accountable care organizations to help deliver better patient outcomes at a lower cost. The key to Renova Health’s success is its highly skilled, caring, and passionate Personal Health Advocates that create and nurture a personal, trusting relationship with patients that helps to uncover deeper insights and ultimately leads to superior healthcare outcomes. For more information, visit www.renovahealth.care

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. Isomyosamine is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. Isomyosamine is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

___________________________

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the Company’s ability to launch and the timing of the Company’s planned trial of MYMD-1 as a treatment for GLP-1-induced sarcopenia and frailty. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241219070411/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

First oral TNF-α inhibitor, if approved, would offer potential patient benefit in an approximate $40 billion TNF inhibitor market

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, today announced that significant positive topline results from a Phase 2a study of its lead drug candidate MYMD-1® (isomyosamine) was presented at a prestigious international congress of global experts in sarcopenia and related disorders held December 6–8, 2024 in Washington, D.C.

“In our view, MYMD-1 could become a consequential therapeutic solution for patients not served by current TNF-alpha inhibitors,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNFA. “With no FDA-approved treatments available to sarcopenia/frailty patients that target this disease itself, there is a large unmet medical need for effective therapies. Plus, the estimated $3 billion sarcopenia treatment market is just a subset of the broader TNF inhibitor market which was estimated to be $40 billion in 2024.

“Based on the positive results from our MYMD-1 Phase 2a study, we are set to launch a Phase 2b study in sarcopenia/frailty early in the first quarter of 2025,” Dr. Glass added.

The presentation, ‘Isomyosamine for the Treatment of Sarcopenia in Elderly Population,’ describes the results of a double-blind, placebo-controlled study in patients aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. Subjects in the trial who were given once daily oral doses of MYMD-1 showed significant decreases in several biomarkers attributed to chronic inflammation, including tumor necrosis factor-alpha (TNF-α) (P=0.008), Interleukin-6 (IL-6) (P=0.03) and soluble TNF-α receptor 1 (sTNFR1) (P=0.02) at several timepoints throughout the 28 days of treatment. No serious adverse events were reported.

The global market value for TNF inhibitors was estimated to be $39.7 billion for 2024. Growing at an expected 3.6% CAGR for the next five years, the TNF inhibitor market is expected to reach $47.3 billion by 2029.¹

Sarcopenia is the progressive loss of muscle mass and strength primarily due to aging. Based on conservative calculations, at least 50 million people were affected by sarcopenia in 2018, and the disease is projected to affect over 200 million over the next four decades due to the growing elderly population.² The sarcopenia treatment market is estimated to be $3.07 billion in 2024 and is expected to grow at a CAGR of 4.48% to $4.02 billion by 2029.³

Approximately 10% to 16% of the elderly worldwide suffer from sarcopenia.⁴ In addition to the elderly, sarcopenia is estimated to affect more than 1 in every 10 young adults of most ethnicities.⁵ With no FDA-approved treatments for sarcopenia itself, as opposed to its symptoms, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system.⁶

The 17th International Conference of the Society on Sarcopenia, Cachexia, & Wasting Disorders joins researchers, clinicians, academic experts, investigators and industry leaders from around the world. SCWD is a non-profit scientific organization comprised of an international and multidisciplinary group of healthcare professionals primarily active in these fields.

About MYMD-1^®

MYMD-1® (isomyosamine) is a novel plant alkaloid small molecule shown to regulate the immuno-metabolic system through the modulation of numerous pro-inflammatory cytokines including TNF-alpha (TNF-α), an immune cell signaling protein and inflammatory cytokine responsible for inducing and maintaining the inflammatory process. TNF-α is located upstream of a cascade of molecular signals that induces inflammation and helps activate the process of aging. Many in vivo and in vitro studies have shown that TNFα plays a causative role in the pathogenesis of various age-related diseases.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ Mordor Intelligence, TNF Inhibitors Market Size (2024 - 2029)

² Biology, Sarcopenia Is Associated with an Increased Risk of Postoperative Complications… (2023)

³ Mordor Intelligence, Sarcopenia Treatment Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

⁴ Metabolism journal, Epidemiology of sarcopenia: Prevalence, risk factors, and consequences (2023)

⁵ Metabolism journal, Sarcopenia in youth (2023)

⁶ Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019)

View source version on businesswire.com: https://www.businesswire.com/news/home/20241209916402/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Prevail InfoWorks, Inc. to act as Clinical Research Organization partner; global full service CRO with hundreds of clinical trials over a decade

TNF Pharmaceuticals fully funded for clinical trials for next two years

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel oral therapies for autoimmune and inflammatory conditions, today announced that it has secured a strategic equity investment, priced at a 20% premium to a 30-trading days volume weighted average price (VWAP), from Prevail Partners, LLC, a U.S. investment fund focused on life sciences companies. The Company has engaged global full-service Clinical Research Organization (CRO) Prevail InfoWorks, Inc., an affiliate of Prevail Partners, to provide clinical services for the next Phase 2 clinical study using our proprietary drug in sarcopenia/frailty.

“Prevail Partners, a corporate strategic evergreen fund, selects life sciences companies developing novel and breakthrough therapeutics. The fund’s investment in TNFA points to their confidence in our potent oral synthetic TNF-alpha (TNFα-inhibitor MYMD-1’s potential to transform how TNFα-based diseases are treated,” said Mitchell Glass, M.D., President and Chief Medical Officer of the Company. “Prevail InfoWorks recently received industry recognition as the most advanced tech-enabled CRO, and our study will benefit from their unique experience and expertise. We are excited about our new partners and our close alignment of interests in executing our upcoming clinical studies efficiently and effectively.”

Prevail Partners has agreed to purchase 283,019 shares of TNFA common stock at a price of $2.12 per share, representing a 20% premium to the Company’s 30-trading days VWAP as of the closing date of October 1, 2024.

TNFA lead drug candidate, presently designated MYMD-1, is a novel, orally dosed TNFα inhibitor drug for treating multiple conditions related to immune-metabolic dysregulation. MYMD-1 blocks the activity of excess TNFα which supports restoration of control and regulation of the immune system. A successful small Phase 2 study evaluating the safety and efficacy of MYMD-1 as a treatment for sarcopenia was completed in 2023. The statistically significant positive results of the study met primary endpoints for significantly reducing chronic inflammatory markers.

Sarcopenia is the progressive loss of muscle mass and strength, commonly affecting the elderly population due to aging. Sarcopenia affects approximate 10% to 16% of the elderly worldwide.¹

Sarcopenia can also affect people with a high body mass index (BMI) in a condition called sarcopenic obesity. Sarcopenia is estimated to affect more than 1 in every 10 young adults of most ethnicities.²

The sarcopenia treatment market is estimated to be $3.07 billion in 2024 and is expected to grow at a CAGR of 4.48% to $4.02 billion by 2029.³ With no FDA-approved treatments for sarcopenia, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system.⁴

About Prevail Partners, LLC

Prevail Partners (www.prevailpartners.com) is an investment fund focused on life sciences companies. The fund is designed to take advantage of the attractive returns possible in promising scientific advances in the life science fields of therapeutics, preventive treatments and medical devices. A uniquely favorable feature of the fund is that Prevail InfoWorks applies proprietary technologies and services to equip companies in which the fund invests, giving investors and strategic licensing partners the comfort that the clinical trials have a higher likelihood of success.

About Prevail InfoWorks, Inc.

For over a decade, Prevail InfoWorks (www.prevailinfoworks.com) has been dedicated to providing life science companies with the most innovative and complete technology and service solutions for their clinical development. The company delivers unique products and services that accelerate and de-risk drug development and clinical regulatory process more rapidly and cost effectively, including through real-time actionable intelligence of evolving topline trends and metrics to patient specific data derived from aggregating all clinical, diagnostic, operational and project accounting data. Prevail InfoWorks is an affiliate of Prevail Partners LLC.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), a clinical stage pharmaceutical company, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ Metabolism journal, Epidemiology of sarcopenia: Prevalence, risk factors, and consequences (2023)

² Metabolism journal, Sarcopenia in youth (2023)

³ Mordor Intelligence, Sarcopenia Treatment Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

⁴ Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019)

View source version on businesswire.com: https://www.businesswire.com/news/home/20241002229933/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Clinical study of MYMD-1 in sarcopenia/frailty met primary endpoints for significantly reducing chronic inflammatory markers with statistical significance

MYMD-1 shown to inhibit excessive activity of TNF-alpha to regulate the immuno-metabolic system

Company holds FDA-cleared Phase 2 INDs for MYMD-1 in two additional chronic inflammatory conditions, rheumatoid arthritis and Hashimoto’s thyroiditis

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (“TNFA” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, and autoimmune and inflammatory conditions, today announced that it is preparing to advance its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule shown to block excessive activity of TNF-alpha (TNF-α) in the blood to regulate the immuno-metabolic system. The next clinical studies of MYMD-1 will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier Phase 2 clinical study.

“In our view, MYMD-1, if approved, could be the first orally administered TNF-alpha inhibitor drug and the first and only therapy for sarcopenia, a common age-related disorder that causes a prolonged decline in physical function. The success of our clinical strategy and regulatory pathway to date supports MYMD-1’s potential to disrupt the TNF-alpha inhibitor market,” said Mitchell Glass, M.D., President and Chief Medical Officer of TNF Pharmaceuticals. “As we prepare for our next fully funded clinical studies in sarcopenia/frailty, we also have open INDs for Phase 2 trials of MYMD-1 in two additional chronic inflammatory conditions, rheumatoid arthritis (RA) and Hashimoto’s thyroiditis, which we could pursue with the support of non-dilutive domestic and/or international development partnerships. A partner outside of the U.S. could potentially help us accelerate the timeline to commercialization of our lead asset.

“Each of MYMD-1’s indications provide solid measures of Company value,” Dr. Glass continued. “We are excited about the positive data we have gathered so far for our lead asset. Our next steps, to be revealed soon, will extend our reach toward significant and sustainable value creation, and long-term Company growth.”

MYMD-1 Phase 2 Clinical Development

MYMD-1 targets TNF-alpha (TNF-alpha tumor necrosis factor-alpha, or TNF-α), a protein in the body that plays a key role in inflammation and autoimmunity.

Sarcopenia. A small Phase 2 study, completed in 2023, investigated the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of participants with chronic inflammation associated with sarcopenia/frailty. The study met its primary endpoints for significantly reducing chronic inflammatory markers with statistically significant results.

• MYMD-1 significantly reduced serum levels of chronic inflammatory markers and met all primary pharmacokinetic and secondary safety and tolerability endpoints.
• MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03).
• No treatment-related adverse events (AEs) or serious adverse events (SAEs) occurred over the course of the study.

Sarcopenia, the aging-related progressive loss of muscle mass and strength in older people and in a growing population of younger people, is a condition which leads to greater risk of hospitalization, disability, and death. With no FDA-approved treatments for sarcopenia, the estimated $40+ billion in related hospitalization costs is a considerable economic burden on the U.S. healthcare system.¹

Rheumatoid arthritis (RA). An Investigational New Drug (IND) application for a Phase 2 study of MYMD-1 in RA was reviewed and approved by the FDA in August 2023.

MYMD-1’s small molecule design enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to the widely used RA therapy Enbrel® (etanercept).² Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection).

RA is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually.³

Hashimoto’s thyroiditis. MYMD holds an FDA-cleared IND for a Phase 2 pilot study of MYMD-1 for Hashimoto’s thyroiditis, a condition in which the immune system stops recognizing the thyroid as part of the body and begins attacking it.

Hashimoto’s thyroiditis is the most common cause of hypothyroidism in the United States.⁴ According to an American Thyroid Association report, approximately 12% of the U.S. population will develop a thyroid condition during their lifetime and an approximate amount of 20 million Americans are diagnosed with some form of thyroid disease during their lifetime.⁵ The global thyroid gland disorder market was valued at $2.1 billion in 2017, and is estimated to reach $2.7 billion by 2025 at a CAGR of 3.8% from 2018 to 2025.⁶

Secondary Drug Platform — Supera-CBD™

TNFA’s secondary drug platform, Supera-CBD™, is a synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times more potent CB2 agonist than plant-based CBD.⁷ Supera-CBD is targeted for the treatment of epilepsy, pain and anxiety/depression. Based on an in vitro binding analysis of Supera-CBD with three types of opioid receptors, the profile suggests that Supera-CBD could play a role in treating opioid addiction.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly known as MyMD Pharmaceuticals, Inc.), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ Journal of Frailty & Aging, Economic Impact of Hospitalizations in US Adults with Sarcopenia (2019)
² ENBREL ETANERCEPT is a registered trademark of Immunex Corporation
³ https://reporter.nih.gov/project-details/10080141
⁴ Taylor N Peter et al. Global epidemiology of hyperthyroidism and hypothyroidism. Nature: Endocrinology. 2018 May; 14:301-316.
⁵ American Thyroid Association. General Information/Press Room. Available in: https://www.thyroid.org/media-main/press-room/
⁶ KUNSEL, Tenzin. Thyroid Gland Disorder Treatment Market. Allied Market Search, 2018. Available in: < https://www.alliedmarketresearch.com/thyroid-gland-disorder-treatment-market >
⁷ Company reports; study conducted by Eurofins Discovery, a Eurofins Scientific (EUFI.PA) company

View source version on businesswire.com: https://www.businesswire.com/news/home/20240821460281/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- TNF Pharmaceuticals, Inc. (Nasdaq: TNFA) (formerly MyMD Pharmaceuticals, Inc.) (the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases and autoimmune and inflammatory conditions, today announced that its common stock, listed on the Nasdaq Capital Market, begins trading under the new ticker symbol, “TNFA,” effective before the market open today, July 24, 2024.

The new trading symbol “TNFA” replaces the Company’s previous trading symbol “MYMD” and coincides with the Company’s previously announced corporate name change to TNF Pharmaceuticals, Inc. The new corporate identity more accurately aligns with the Company’s scientific focus on TNF-alpha (TNF-alpha tumor necrosis factor-alpha, or TNF-α), a protein in the body that plays a key role in inflammation and autoimmunity. The Company’s lead clinical candidate, MYMD-1®, blocks the activity of excess TNF-α, which supports restoration of control and regulation of the immune system.

“Our Company’s new name and stock identity comes at an important time in our clinical development of MYMD-1, illuminating both our core science and our clinical candidate’s strong potential to be the first TNF-α inhibitor in this indication,” said the Company’s President, Chief Medical Officer and Director, Mitchell Glass, M.D.

Effective today, all stock trading, Securities and Exchange Commission filings and market-related information will be reported under the new trading symbol “TNFA.” The CUSIP for the Company's common stock is unchanged. There is no action required by the Company’s current stockholders with respect to the trading symbol change.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc. (Nasdaq: TNFA), formerly known as MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.tnfpharma.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240724213342/en/

Robert Schatz
(646) 421-9523
rschatz@tnfpharma.com
www.tnfpharma.com

Source: TNF Pharmaceuticals, Inc.

Company plans mid-stage clinical trials of TNF-alpha inhibitor drug MYMD-1® following statistically significant Phase 2 studies

TNF Pharmaceuticals will begin trading on Nasdaq under the new trading symbol "TNFA" effective July 24, 2024

BALTIMORE--(BUSINESS WIRE)--

TNF Pharmaceuticals, Inc., formerly MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases and autoimmune and inflammatory conditions, today announced a rebranding to the new name “TNF Pharmaceuticals, Inc.,” effective today. The Company’s common stock, listed on the Nasdaq Capital Market, will begin trading under the new stock symbol “TNFA,” effective before the market open on Wednesday, July 24, 2024.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240722253499/en/

“Our new name, TNF Pharmaceuticals, is more closely aligned with our scientific focus on TNF-alpha, a protein in the body that plays a key role in inflammation and autoimmunity,” said the Company’s President and Chief Medical Officer Mitchell Glass, M.D. “Excess TNF-α in the blood or tissue can lead to diseases and disorders marked by acute or chronic inflammation, including age-related disorders. Our lead clinical candidate, MYMD-1®, blocks the activity of excess TNF-alpha which supports restoration of control and regulation of the immune system.”

MYMD-1 is a novel, orally dosed TNF-alpha (TNF-α) inhibitor drug for treating multiple conditions related to immune-metabolic dysregulation. A successful and statistically significant small Phase 2 study was completed in 2023, evaluating the safety and efficacy of MYMD-1 as a treatment for sarcopenia, the progressive loss of muscle mass and strength associated with aging.

“We are moving forward with mid-stage clinical trials of MYMD-1 in sarcopenia based on positive clinical data from our Phase 2 trial and previous research findings,” Dr. Glass continued. “We believe MYMD-1 could become a transformative treatment for TNF-alpha-based autoimmune and inflammatory diseases including age-related conditions.”

MYMD-1 is distinguished from currently marketed TNF-α blockers in multiple ways. It is a first-in-class oral treatment shown to reduce TNF-α and inflammation without infusion or injection. The drug’s ease of oral dosing is a strong advantage over currently available TNF-α blockers, none of which are dosed orally. Unlike systemic therapies, our oral TNF alpha inhibitor can be dose adjusted acutely and chronically for maximal safety and efficacy depending on the patient’s need.

TNF Pharmaceuticals retains the registered trademark MYMD-1® for its lead drug program. The Company’s new Investors website address is ir.tnfpharma.com.

About TNF Pharmaceuticals, Inc.

TNF Pharmaceuticals, Inc., formerly known as MyMD Pharmaceuticals, Inc., a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1® is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and neither the Company nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the Company’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and the Company’s ability to, obtain and maintain regulatory approvals for clinical trials of the Company’s pharmaceutical candidates; the timing and results of the Company’s planned clinical trials for its pharmaceutical candidates; the amount of funds the Company requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which the Company operates; the Company’s ability to retain and attract senior management and other key employees; the Company’s ability to quickly and effectively respond to new technological developments; and the Company’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on the Company’s proprietary rights. A discussion of these and other factors with respect to the Company is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by the Company on April 1, 2024, and subsequent reports that the Company files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and the Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240722253499/en/

Investor Contact:
Robert Schatz
(646) 421-9523

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or the “Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases and autoimmune and inflammatory conditions, today announced the appointment of Mitchell Glass, M.D., a member of the board of directors of the Company, as president and chief medical officer. The Company also announced the appointment of Mr. Stephen Friscia, a veteran investor, to the board of directors.

Appointment of Mitchell Glass, M.D.

“Through his many years of biopharma leadership, Dr. Glass has established a successful and productive track record of executing successful early- to mid-stage clinical development and regulatory strategies and bringing numerous companies to market entry and commercialization,” said Josh Silverman, chairman of the board of MyMD. “After completing a successful and statistically significant small Phase 2 study of MYMD-1® in sarcopenia/frailty last year, now is the right time for the Company to bring in a highly experienced leader to guide the Company through further mid-stage clinical development. We believe Dr. Glass has the right expertise and ingenuity necessary to drive continued value creation for the benefit of all stakeholders.”

"This is an exciting time to join MyMD. MyMD’s initial Phase 2 data provides guidance to perform larger studies of MYMD-1 focused on patient outcomes. Our team looks forward to providing near-term updates on the path forward for our novel TNF-α inhibitor,” said Dr. Glass.

Dr. Glass is board certified in internal medicine, pulmonary and critical care medicine, with a focus in inflammatory diseases and immunopathology. His biopharmaceutical career spans 35 years across diverse life sciences industries and fields, from broad-ranging executive positions at top ten pharmaceutical companies, to founding, leading and funding start-ups and early-stage biopharma companies. As a long-term investor in the healthcare sector, Dr. Glass is a founder and principal of Medpro Investors, a New York-based venture capital firm focused on the healthcare sector. He is a long-term consultant and regulatory representative for company and university engagement with the FDA and international regulatory counterparts, and he currently serves on the American Lung Association’s Scientific Advisory Committee.

Dr. Glass holds an extensive and successful track record in leading companies through FDA regulatory pathways from early research and development to late-stage trials and market commercialization. His career highlights include 5 new drug applications (NDAs) and marketing authorization applications (MAAs), 7 pre-NDA meetings including international counterparts, 12 End of Phase 2 (EOP2) meetings with FDA, and more than 80 investigational new drug applications (INDs).

Appointment of Stephen Friscia

“Stephen Friscia is the newest addition to our board of directors, bringing two decades of equity research and portfolio management experience. His broad perspective and knowledge of the healthcare sector will be key assets as we proceed with strategic value creation,” Silverman concluded.

Mr. Friscia is the manager and co-founder of Kipps Capital, a family office established in 2016. Previously, Mr. Friscia was a managing director and portfolio manager for multiple institutional investment and asset management firms, with several focused in small and mid-cap value equities, including Iridian Asset Management LLC, MacKay Shields LLC, Bear Stearns Asset Management Inc., John A. Levin & Co., Inc., and Evergreen Investments LLC (Wachovia Corporation).

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to treat diseases and disorders marked by acute or chronic inflammation. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: MyMD’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; and MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by MyMD on April 1, 2024, and subsequent reports that MyMD files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240617357457/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, and autoimmune and inflammatory conditions, today announced that it has secured $7 million in commitments in two private placement funding rounds led by a strategic investor, PharmaCyte Biotech, Inc. (Nasdaq: PMCB), a clinical-stage biotechnology company developing cellular therapies for cancer and diabetes. An additional $7 million was raised from existing MyMD shareholders participating in the offerings. The closings of the two private placements are each subject to customary closing conditions and are both expected to occur on or around May 22, 2024.

“We are excited to welcome PharmaCyte as a new strategic investment partner in our continuing development of MYMD-1 in sarcopenia, as well as the evaluation of our other approved INDs in rheumatoid arthritis (RA) and Hashimoto’s thyroiditis,” said Chris Chapman, M.D., President, Chief Medical Officer, and Director of MyMD. “Likewise, we appreciate the participation of many of our valued existing shareholders who share strong conviction in our potentially groundbreaking drug candidates for combatting aging and treating autoimmune diseases. We believe that this capital infusion will fund us through our next clinical studies of MYMD-1 in sarcopenia for the next two years.”

Under the terms of the purchase agreement for MyMD’s Series G Preferred Stock financing round, PharmaCyte will receive 7,000 shares of Series G Preferred Stock with a stated value of $1,000 per share, convertible into shares of MYMD common stock, and warrants to purchase up to an aggregate amount of 7,709,252 additional shares of common stock, for a total consideration of approximately $7,000,000. In addition, existing shareholders will receive 1,950 aggregate shares of Series G Preferred Stock with a stated value of $1,000 per share, convertible into shares of MYMD common stock, and warrants to purchase up to an aggregate amount of 2,147,580 additional shares of common stock, for a total consideration of $1,950,000. The shares of Series G Preferred Stock have an initial conversion price of $1.816 per share. The warrants issued in the Series G Preferred Stock offering are immediately exercisable at an initial exercise price of $1.816 per share, and (i) certain of the warrants expire five years from the date of issuance, and (ii) certain of the warrants expire 18 months from the date of issuance.

Under the terms of the purchase agreement for MyMD’s Series F-1 Preferred Stock financing round, existing shareholders will receive 5,050 aggregate shares of Series F-1 Preferred Stock with a stated value of $1,000 per share, convertible into shares of MYMD common stock, and warrants to purchase up to an aggregate amount of 5,561,678 additional shares of common stock, for a total consideration of $5,050,000. The shares of Series F-1 Preferred Stock have an initial conversion price of $1.816 per share. The warrants issued in the Series F-1 Preferred Stock offering are exercisable immediately at an initial exercise price of $1.816 per share, and (i) certain of the warrants expire five years from the date of issuance, and (ii) certain of the warrants expire 18 months from the date of issuance.

The full conversion of the Series F-1 and Series G preferred stock and the full exercise of the accompanying warrants are subject to stockholder approval. For a full description of the terms of these financings, please see the Company’s Current Report on Form 8-K that was filed with the U.S. Securities and Exchange Commission today, including the attached exhibits.

The securities in each offering were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About MYMD-1

MyMD has reported statistically significant positive topline Phase 2 results for its next generation oral TNF-α Inhibitor MYMD-1® in sarcopenia/age-related frailty. The Phase 2 study met its primary endpoints of significantly reducing chronic inflammatory markers in patients treated with MYMD-1. MYMD-1 holds potential to be the first drug approved by the FDA for sarcopenia, an age-related decline in physical function which leads to greater risk of hospitalization, disability, and death.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the completion of the private placements and the satisfaction of customary closing conditions related to the private placements, the anticipated use of proceeds therefrom, the effect that the reverse stock split may have on the price of MyMD’s common stock; MyMD’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; and MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights.. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, filed by MyMD on April 1, 2024 and subsequent reports that MyMD files with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240521024499/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Source: MyMD Pharmaceuticals, Inc.

On October 11, 2023, MyMD received notice from the Listing Qualifications Department of Nasdaq indicating that the Company was not in compliance with the Listing Rule, as its common shares had failed to meet a closing bid price of $1.00 or more for 30 consecutive business days. The Company conducted a 1-for-30 reverse split of its common stock on February 14, 2024, with the goal of increasing the trading price of the common stock. The common stock began trading on a split-adjusted basis on February 15, 2024, under the new CUSIP number 62856X201.

For the Company to regain compliance with the Listing Rule, the Company’s common stock was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days. This requirement was met on March 1, 2024.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the effect that the reverse stock split may have on the price of MyMD’s common stock; MyMD’s ability to maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240305851820/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Media Contact:
media@mymd.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that it intends to effect a reverse stock split of its common stock at a ratio of 1 post-split share for every 30 pre-split shares. The reverse stock split will become effective at 4:05 p.m. Eastern Standard Time on Wednesday, February 14, 2024. MyMD’s common stock will continue to be traded on the Nasdaq Capital Market under the symbol MYMD and will begin trading on a split-adjusted basis when the market opens on Thursday, February 15, 2024. The new CUSIP number for MyMD’s common stock following the reverse stock split will be 62856X201.

At the effective time of the reverse stock split, every 30 shares of MyMD’s issued and outstanding common stock will be converted automatically into one issued and outstanding share of common stock without any change in the par value per share. Simultaneously therewith, the number of shares of common stock that the Company shall have authority to issue will be reduced by a factor of 30 from 500,000,000 shares to 16,666,666 shares. Stockholders holding shares through a brokerage account will have their shares automatically adjusted to reflect the 1‑for-30 reverse stock split. It is not necessary for stockholders holding shares of the Company’s common stock in certificated form to exchange their existing stock certificates for new stock certificates of the Company in connection with the reverse stock split, although stockholders may do so if they wish.

The reverse stock split will affect all stockholders uniformly and will not alter any stockholder’s percentage interest in the Company’s equity, except to the extent that the reverse stock split would result in a stockholder owning a fractional share. Any fractional share of a stockholder resulting from the reverse stock split will be rounded up to the nearest whole number of shares. The reverse stock split will reduce the number of shares of MyMD’s common stock outstanding from 62,749,125 shares to approximately 2,091,638 shares, subject to adjustment for the rounding up of fractional shares. Proportional adjustments will be made to the number of shares of MyMD’s common stock issuable upon exercise or conversion of MyMD’s equity awards, convertible preferred stock and warrants, as well as the applicable exercise or conversion price. Stockholders with shares in brokerage accounts should direct any questions concerning the reverse stock split to their broker; all other stockholders may direct questions to the Company’s transfer agent, Securities Transfer Corporation, via email at issuerservices@stctransfer.com or phone at (469) 633-0101.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the effect that the reverse stock split may have on the price of MyMD’s common stock; MyMD’s ability to regain and maintain compliance with the Nasdaq Stock Market’s listing standards; the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240213384915/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Media Contact:
media@mymd.com

Source: MyMD Pharmaceuticals, Inc.

Potential to be first orally-administered TNF-α inhibitor treatment for RA

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that its Investigational New Drug (IND) application for a Phase 2 clinical trial of oral MYMD-1® as a treatment for rheumatoid arthritis (RA) was recently cleared by the U.S. Food and Drug Administration (FDA), and plans are underway for trial launch in the first quarter of 2024.

“With the FDA’s recent clearance of our IND in RA, we are moving forward with plans to initiate a Phase 2 trial within the next several months. Results from preclinical studies have demonstrated MYMD-1’s potential to treat RA, and we believe this drug could one day be a disruptor in the massive market for similar treatments,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD.

Differentiated by its ease of oral dosing and selectivity, MYMD-1 is a TNF-α inhibitor with a small molecule design that enables the drug to cross the blood brain barrier for entry into the central nervous system. In a preclinical trial, MYMD-1 was shown to significantly reduce swelling and other clinical arthritis measures compared to widely used RA therapy Enbrel® (etanercept).¹ Disease severity (total composite score) was reduced by 47% with MYMD-1 (450 mg/kg/day orally) versus a 37% reduction with etanercept (10 mg/kg by subcutaneous injection).

Under this IND, the Phase 2 clinical trial of MYMD-1 will be a randomized placebo-controlled study that is expected to enroll approximately 60 patients with active rheumatoid arthritis. Patients will receive oral MYMD-1 dosing of 1050 mg.

Market Opportunity

Rheumatoid arthritis is a chronic, systemic inflammatory disorder that causes chronic inflammation of the joints and affects approximately 1.5 million Americans. RA’s cost to society, including healthcare costs; loss of employment; costs to employers, government, and caregivers; and costs associated with a deterioration of quality of life, is estimated to be over $40 billion annually.²

About MYMD-1

Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

MYMD-1 has shown effectiveness in preclinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ ENBREL ETANERCEPT is a registered trademark of Immunex Corporation

² https://reporter.nih.gov/project-details/10080141

View source version on businesswire.com: https://www.businesswire.com/news/home/20231206611024/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Media Contact:
media@mymd.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced that it plans to share information on the Company and its product pipeline, including an update on recent positive phase 2 study results for MYMD-1 in sarcopenia, at the upcoming BioFuture 2023 Meeting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231004139695/en/

(Graphic: Business Wire)

Chris Chapman, MD, president, director, and chief medical officer at MyMD Pharmaceuticals, is scheduled to present at the conference on October 6^th, 2023, at 9:30am EST. Jenna Brager, PhD, executive vice president of drug development at MyMD Pharmaceuticals, is scheduled to participate in a panel discussion, Longevity: Stopping Age-Related Disease at the Cellular Level on October 5^th, 2023, at 11:45am EST.

MyMD recently announced positive topline Phase 2 study results in participants with sarcopenia/frailty which showed MYMD-1 demonstrated statistical significance in reducing serum levels of TNF-α, IL-6 and sTNFR1, biomarkers common to a number of chronic inflammatory diseases, and met all primary pharmacokinetic and secondary safety and tolerability endpoints across multiple doses over 28 days of treatment. New key findings from the Phase 2 study showed that cohort 4 (1050mg) showed a reduction in TNF-α, a key cytokine, across 28 days versus placebo (p=0.002 to 0.008).

“The scientific data clearly indicate statistical significance across 28 days at the high dose group and we are extremely excited about the completion of the phase 2 clinical trial,” said Dr. Chris Chapman, MD, president, director, and chief medical officer at MyMD Pharmaceuticals.

Continued Dr. Chapman, “We are pleased to share information about our company and pipeline at BioFuture 2023, particularly related to our lead candidate and next generation TNF-α inhibitor, MYMD-1, which we believe is showing tremendous promise in inflammatory diseases. Its potential to ease the burden of these diseases, which affect millions of patients, caregivers and their healthcare professionals, is what compels us to continue this important research.”

The Company will present the clinical safety report to the FDA with plans to seek future guidance for a Phase 3 clinical trial in sarcopenia. If approved, MYMD-1 has the potential to be the first drug approved by FDA for the condition, an age-related decline in muscle mass and physical function which leads to greater risk of hospitalization, disability, and death.

MyMD also recently announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1^® in patients with active rheumatoid arthritis (RA). Phase 2 trials are planned in RA.

MYMD-1 is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. MYMD-1 has also been shown to selectively block TNF-α action where it is overactivated without preventing it from doing its normal job of responding to routine infection. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. The company has completed Phase 2 studies of MYMD-1® for sarcopenia/frailty, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. The U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics, and pharmacokinetics of oral TNF-α inhibitor MYMD-1® in patients with active rheumatoid arthritis (RA).

MyMD’s second therapeutic candidate is Supera-CBD™, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA)’s scientific review concluded Supera-CBD will not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the COVID-19 pandemic or similar public health emergencies on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231004139695/en/

Investors:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
andreacohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

- Acceptance follows statistically significant Phase 2 data in sarcopenia showing MYMD-1 reduced TNF-α and other inflammatory markers common to RA, while demonstrating safety and tolerability

- MyMD now advancing 3 clinical programs for MyMD-1 in chronic inflammatory conditions including Sarcopenia, RA and Hashimoto’s Thyroiditis

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1^® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept).¹ The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication.

MYMD-1 is an oral, next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. MYMD-1 has also been shown to selectively block TNF-α action where it is overactivated without preventing it from doing its normal job of responding to routine infection. MYMD-1 is doubly effective at inhibiting inflammation by blocking both TNF-a and IL-6 activity, whereas currently approved anti-TNF and anti-IL-6 treatments for RA can only target one or the other. In addition, in early clinical studies it has not been associated with serious side effects known to occur with traditional immunosuppressive therapies that treat inflammation.

“FDA acceptance of an IND in RA for our next-generation oral TNF-α inhibitor, MYMD-1, is our most significant milestone as it adds substantial momentum to our clinical program with sufficient funding and targets one of the largest potential market opportunities,” said Chris Chapman, M.D., president, director, and chief medical officer of MyMD. “We are excited to initiate discussions with our CRO regarding a Phase 2 clinical trial in RA and believe the statistically significant biomarker data from the Phase 2 study in sarcopenia show MYMD-1 has the potential to disrupt the TNF-α inhibitor market and offer therapeutic benefit to patients with a range of chronic inflammatory conditions.”

Recently, MyMD announced positive, statistically significant Phase 2 study results in participants with sarcopenia/frailty which showed MYMD-1 reduced TNF-α, IL-6 and sTNFR1, biomarkers which are common to a number of chronic inflammatory diseases, and met all safety and tolerability endpoints. The Company plans to initiate Phase 3 trials. If approved, MYMD-1 has the potential to be the first drug approved by FDA for the sarcopenia, an age-related decline in muscle mass and physical function which leads to greater risk of hospitalization, disability, and death.

“This is significant news and suggests MYMD-1 may hold promise to be the first oral TNF-α inhibitor and a potential future treatment for rheumatoid arthritis,” said clinical researcher, rheumatologist and past President of the Florida Society of Rheumatology, Robert W. Levin, MD. “There remains a need for new oral therapies with novel mechanism of action for patients not served by current options and I look forward to leading upcoming Phase 2 studies of MYMD-1 to determine its full potential in RA. I look forward to reviewing the study outcomes.”

About Rheumatoid Arthritis

Rheumatoid arthritis, an autoimmune disorder characterized by inflammation (painful swelling) and bone erosion, affects nearly 14 million people worldwide, including 1.5 million Americans.² Although typically associated with older adults, RA can occur at any age, and it is three times more likely to affect women than men.³ TNF-α has played a central role in treatments for RA since 1998, all of which are administered via injection or infusion.

Furthermore, the burden to patients, care providers and society is striking, with an estimated annual cost of $39.2 billion.⁴ The price tag includes healthcare costs, loss of employment, costs to employers, government and caregivers as well as costs associated with a deterioration of quality of life, among other societal costs.

About MYMD-1

MYMD-1, a next generation, oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, and this drug is being studied to slow the aging process, prevent sarcopenia and frailty, extend healthy lifespan, as well as treat rheumatoid arthritis. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1^®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. The company has completed Phase 2 studies of MYMD-1^® for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA)’s scientific review concluded Supera-CBD will not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the COVID-19 pandemic or similar public health emergencies on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

References:

¹ENBREL ETANERCEPT is a registered trademark of Immunex Corporation
²https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8352468/
³https://www.arthritis.org/diseases/rheumatoid-arthritis
⁴https://pubmed.ncbi.nlm.nih.gov/19908947/

View source version on businesswire.com: https://www.businesswire.com/news/home/20230814042365/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media Contact:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
andreacohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

To participate in the conference call, please register here. A webcast can also be accessed under the ‘Events & Presentations’ section on the Investors page at www.MYMD.com. A replay of the webcast will be archived on the MyMD website for 30 days.

About MYMD-1

MYMD-1, a next generation, oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1^®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. The company has completed Phase 2 studies of MYMD-1^® for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA)’s scientific review concluded Supera-CBD will not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the COVID-19 pandemic or similar public health emergencies on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230802047601/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Christy Curran
Sam Brown, Inc.
(615) 414-8668
christycurran@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

- MYMD-1 demonstrated statistical significance across three biomarkers: TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03)

- First Oral TNF-α inhibitor, if approved, would offer potential patient benefit in large markets

- Company to present the data to FDA and intends to advance the clinical program for MYMD-1; will hold conference call on August 2, 2023, at 4:30 PM Eastern Time

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or the “Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, today announced statistically significant positive topline results from its randomized Phase 2 study of oral TNF-α inhibitor, MYMD-1^® in patients with chronic inflammation associated with sarcopenia, or age-related frailty. The study met its primary endpoints of significantly reducing chronic inflammatory markers in participants treated with MYMD-1. MYMD-1 has the potential to be the first drug approved by the United States Food and Drug Administration (FDA) for sarcopenia, an age-related decline in physical function which leads to greater risk of hospitalization, disability, and death.

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The study met both of its primary endpoints, significantly reducing serum levels of three biomarkers, TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) and maintaining appropriate plasma concentrations and parameters in pharmacokinetic evaluations. The study also achieved all secondary endpoints related to safety and tolerability. There were no treatment-related adverse events (AEs) or serious adverse events (SAEs) over the course of the study.

“We are very excited about these results indicating MYMD-1 demonstrated statistically significant reductions in all three inflammatory markers and met all additional pharmacokinetic and safety endpoints needed to advance our sarcopenia clinical program, with guidance from the FDA,” said Chris Chapman, M.D., President, Director, and Chief Medical Officer at MyMD. “These results support the unique advantages of MYMD-1 as the first oral, selective TNF-α inhibitor candidate and potential future treatment option for sarcopenia and other autoimmune conditions such as rheumatoid arthritis.”

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) was designed to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines. Patients in the study were dosed weekly with MYMD-1 or placebo over a 28-day period. The study consisted of four dosing cohorts versus placebo (600mg, 750mg, 900mg and 1050mg).

“We are encouraged by the reduction of inflammatory markers along with the favorable safety profile demonstrated in this study of an oral TNF-α inhibitor,” continued Dr. Chapman. “Sarcopenia can significantly affect people as they age, and there are currently no approved treatments for the condition. A selective, oral treatment that reduces TNF-α and inflammation and does not require infusion or injection would be a welcome advance for this population.”

Full results from the study will be presented or published at a later date to be determined. The company plans to initiate discussions with the FDA regarding a Phase 3 study of MYMD-1 in sarcopenia.

Conference Call Information
MyMD management will host a conference call on Wednesday, August 2, 2023, at 4:30 PM ET. The webcast can be accessed under the ‘Events & Presentations’ section on the Investors page at www.MYMD.com. A replay of the webcast will be archived on the MyMD website for 30 days. Dial-in information for conference participants may be obtained by registering for the event here.

About MYMD-1
MYMD-1, a next generation, oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1^®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. The company has completed Phase 2 studies of MYMD-1^® for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA)’s scientific review concluded Supera-CBD will not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the COVID-19 pandemic or similar public health emergencies on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed by MyMD on March 31, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230731983609/en/

Investors:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Christy Curran
Sam Brown, Inc.
(615) 414-8668
christycurran@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

- MyMD is only 3 patients away from dosing its final patient in its first Phase 2 clinical trial of lead drug candidate MYMD-1^® -

BALTIMORE, MD--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, today announced a dosing update on its fully-funded Phase 2 clinical trial of lead drug candidate MYMD-1^®, an orally available next-generation TNF-alpha inhibitor, as a therapy for chronic inflammation associated with sarcopenia and frailty (NCT05283486).

The Safety Review Committee has confirmed no safety or toxicity issues with the first 30 patients enrolled in this study and has voted unanimously to escalate to the final dose level. Thirty patients enrolled in Cohorts 1, 2, and 3 have completed dosing and end of study visits. To date, three subjects from Cohort 4 have completed end of study visits. There are no outstanding study visits and all 30 patients have officially completed all study parameters and been discharged from the study.

“We are proud of the notable progress that we have made thus far on our first Phase 2 study of MYMD-1,” said Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “As we move into the final cohort of this study, we remain hopeful in MYMD-1’s potential to transform future treatment of sarcopenia/frailty in the aging population.”

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) is currently ongoing to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty inpatients aged 65 years or older. The study’s primary objective is to demonstrate reduction of chronic inflammatory markers in patients treated with MYMD-1^® versus placebo. To qualify for the clinical trial, patients’ biomarkers during the screening period must be within the following criteria: IL-6 ≥ 2.5pg/mL; and/or sTNFR-1 ≥ 1500pg/mL. To date, MyMD has randomized and dosed 37 of 40 total patients across Cohorts 1 (n=10; 600mg), 2 (n=10; 750mg), 3 (n=10; 900mg) and 4 (n=7; 1050mg).

On average, it is estimated that 5 to 13% of elderly people between the ages of 60 and 70 are affected by sarcopenia. These numbers increase to 11 to 50% for those aged 80 or above.¹ Currently, there are no FDA approved treatments for chronic inflammation associated with sarcopenia/frailty for those aged 65 years or older.

“The aging disorders market is expected to be at least $600 billion by 2025²,” continued Dr. Chapman. “TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately $40 billion per year.³ Studies have shown that a slowdown in aging that increases life expectancy by one year is worth $38 trillion and by 10 years is worth $367 trillion.⁴”

MYMD-1^® is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. MyMD is planning early-stage trials for rheumatoid arthritis and will provide guidance as the program develops.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1^®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1^® has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1^® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA)’s scientific review concluded Supera-CBD will not be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

References:
1. von Haehling S, Morley JE, Anker SD. An overview of sarcopenia: facts and numbers on prevalence and clinical impact. J Cachexia Sarcopenia Muscle. 2010 Dec;1(2):129-133. doi: 10.1007/s13539-010-0014-2. Epub 2010 Dec 17. PMID: 21475695; PMCID: PMC3060646.
2. https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html
3. October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market, Acumen Research and Consulting
4. Nature Aging | VOL 1 | July 2021 | p. 616–623

View source version on businesswire.com: https://www.businesswire.com/news/home/20230412005218/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, is presenting data from a preclinical study of investigational, oral TNF-α inhibitor MYMD-1® at the 2023 Society of Toxicology Annual Meeting (SOT) in Nashville, TN. Study results comparing MYMD-1 to placebo were very highly significant and showed MYMD-1 reduced histopathological changes and the severity of standard arthritis clinical trial measures.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230320005115/en/

The study was designed to investigate the anti-inflammatory effects of MYMD-1^® in a rheumatoid arthritis (RA) model that mimics features of arthritis in humans and included commonly used clinical arthritis endpoints. Histopathology parameters were very highly significant vs placebo for composite score (p<0.0001), bone resorption (p<0.0001), periosteal/exostatic change (p<0.001), inflammation (p<0.001), pannus/synovial hyperplasia (p<0.001), and in life pawn volume (p<0.001). Disease severity (total composite score) was reduced by 47% with MYMD-1^® at 450 mg/kg/day orally versus a 37% reduction for etanercept 10 mg/kg by subcutaneous injection (see attached graphs).

“These results demonstrate the potential of MYMD-1^® to inhibit arthritis development as shown in this research model,” said Sonia Edaye, Lead Investigator and Pharmacology/Discovery Scientist at Charles River Laboratories. “Unlike current TNF-α inhibitors, MYMD-1^® can be given orally and is a promising investigational new drug for rheumatoid arthritis.”

“These very highly significant results are exciting and pave the way for our plans to develop MYMD-1 as a potential treatment for rheumatoid arthritis,” said Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “With its differentiated oral administration and selectivity, MYMD-1^® has strong potential as a next-generation TNF-α inhibitor that may one day offer a new and meaningful therapeutic solution for the more than 1 million people affected by RA in the US¹, many of whom are not served by current options.”

Poster #3046/P148 entitled “A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNF-α, MYMD-1^® (Isomyosamine) Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis,” is scheduled for poster presentation today March 20, 2023, at 9:00 AM CT.

MYMD-1^® is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. MyMD is planning early-stage trials for rheumatoid arthritis and will provide guidance as the program develops.

Study Design

The research model was induced by an intravenous injection of a monoclonal antibodies cocktail that directed to collagen type II on Day 1 (sensitization), followed by an intraperitoneal injection of the endotoxin LPS on Day 6 (boost immunization). Three doses of MYMD-1^® (50, 250 and 450 mg/kg/day) were tested, and the dose formulations were administered by oral gavage, twice daily, starting at the onset of the disease (Day 8 in this study). Etanercept (a biologic TNF-α inhibitor) and Dexamethasone (a glucocorticoid) were also administered respectively twice weekly by subcutaneous injection (10 mg/kg) and daily by oral gavage (3 mg/kg) as positive controls.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an orally available next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated. MYMD-1^®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1^® has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1^® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. The U.S. Drug Enforcement Administration (DEA) has determined that Supera-CBD will not be classified as a regulated chemical or require scheduling during development. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7085464/

View source version on businesswire.com: https://www.businesswire.com/news/home/20230320005115/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

The LOT Network community is committed to protecting members against frivolous PAE litigation. Members agree that if, and only if, a member’s patent asset falls into the hands of a PAE, other members are granted a license to that patent – rendering them immune to a PAE lawsuit using that patent. With a total of 2,289 patent troll cases in 2022 alone,¹ the average lawsuit costing $4 million to defend,² and 87% of patent assets used in PAE lawsuits originating from operating companies,³ LOT Network’s coverage of nearly 4 million patent assets globally provides broad protection and peace of mind to member companies.

“Biotech companies are increasingly finding themselves defending costly patent-troll lawsuits,” said Christopher Chapman, MD, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “MyMD joins a growing number of life science companies leveraging LOT Network as a layer of protection against troll litigation, so that we can continue to focus our resources on our clinical development programs and protect our expansive IP portfolio and the interests of our shareholders.”

“We are pleased to welcome MyMD into LOT Network,” said Ken Seddon, CEO of LOT Network. “Joining the community demonstrates their commitment to preserving their resources for innovation and protecting their ecosystem against unwanted litigation.”

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD™, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

About LOT Network
LOT Network is an international community of the world’s leading high-tech companies committed to protecting its members from costly litigation from patent assertion entities (PAEs). LOT Network currently protects more than 2,800 members in 56 countries from litigation from over 3.8 million worldwide patents and counting. Members include market leaders such as IBM, Toyota, JP Morgan Chase, Canon, Google, Tesla, Disney, Cisco, Amazon, Microsoft, BP, Alibaba, and Dow, as well as innovative companies across all high-tech industries.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ https://www.unifiedpatents.com/insights/2023/1/4/2022-patent-dispute-report?rq=2022
² https://finance.yahoo.com/news/current-patent-litigation-costs-between-120200165.html
³ https://www.unifiedpatents.com/insights/2019/12/30/q4-2019-patent-dispute-report

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Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, today announced that the U.S. Drug Enforcement Administration (DEA) has conducted a scientific review and determined that investigational cannabinoid Supera-CBD™ is not currently considered a controlled substance or listed chemical. The scientific review of the chemical structure of Supera-CBD was conducted in accordance with the Controlled Substances Act (CSA) and its governing regulations.

“Currently, all FDA-approved cannabinoid products are considered controlled substances, with the exception of Epidiolex, and although plant-derived cannabidiol (CBD) is unscheduled, its use by military and federal civilian employees currently is prohibited without a valid prescription. This decision by the DEA is tremendous news for Supera-CBD and we are very pleased that our product candidate will not require DEA scheduling during development,” said Christopher Chapman, MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “We look forward to studying Supera-CBD’s potential to improve upon the benefits of CBD while retaining its safety and tolerability without intoxicating effects.”

“It is a tremendous benefit to be able to conduct drug development without the burden of dealing with a scheduled product,” said Dr. Jack Henningfield, Vice President, Research, Health Policy, and Abuse Liability at Pinney Associates, Inc. “We look forward to continuing our support of MyMD Pharmaceuticals as Supera-CBD advances through development.”

Supera-CBD™ is a synthetic, non-toxic cannabidiol (CBD) analog that is an 8000-times more potent CB2 agonist than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown in preclinical studies to have anti-inflammatory effects. Supera-CBD is a unique synthetic analog of CBD whose structure has been modified to be CB2-receptor selective. Studies to investigate Supera-CBD’s binding and affinity to CB1 and CB2 receptors show that the compound had very low affinity to CB1 and had a four-fold increase in binding to the CB2 receptor in comparison to CBD. Supera-CBD has completed genotoxicity studies and the company has initiated preclinical pain studies in partnership with Johns Hopkins Medicine.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230302005256/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, announced that preclinical data from a study, conducted in partnership with Charles River Laboratories International, Inc., has been accepted for presentation at the upcoming Society of Toxicology (SOT) 2023 Annual Meeting.

Poster #3046/P148 “A Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNF-α, MYMD-1 (Isomyosamine) Significantly Reduced the Inflammation and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis,” is scheduled for poster presentation on March 20, 2023, at 9:00 AM CT.

“We look forward to presenting these exciting results with Charles River Laboratories and are very pleased that Society of Toxicology has chosen to highlight them at their annual meeting,” said Chris Chapman, MD, president, director, and chief medical officer at MyMD Pharmaceuticals. “Rheumatoid arthritis affects as many as 1.5 million people in the United States alone and we look forward to studying MYMD-1 further in this condition.” ¹

MYMD-1 is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. MyMD plans to give guidance on the early-stage trials for rheumatoid arthritis (RA) as it develops. MyMD-1 is currently being evaluated in a Phase 2 study for sarcopenia/frailty, a result of the aging process. It has the potential to become the first drug approved by FDA for that condition. The company plans to complete the Phase 2 sarcopenia trial and share data in the near future.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an oral next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its small molecule design and selectivity. MYMD-1 has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ https://www.arthritis.org/diseases/rheumatoid-arthritis

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Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

“This successful financing will support the continued development of MYMD-1 for sarcopenia, an aging indication for which there is currently no FDA-approved products, and we look forward to completing our Phase 2 trial and sharing data in the near future,” said Christopher Chapman, MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “We are also excited to continue developing MYMD-1 as a next generation oral TNF-alpha inhibitor for rheumatoid arthritis and look forward to sharing upcoming guidance on the timing of our rheumatoid arthritis program.”

Preferred Stock and Warrants

In a transaction with expected gross proceeds of $15 million, the Company has executed a securities purchase agreement for a registered direct offering of preferred stock with a conversion price of $2.255 per share, subject to adjustment, and warrants to acquire up to an aggregate amount of 6,651,885 additional shares of the Company’s common stock. The warrants are exercisable immediately at an exercise price of $2.255 per share and expire five years from the date of issuance. The preferred stock conversion price and warrant exercise price of $2.255 per share represents an approximately 10% premium to the closing share price on Friday, February 17.

The Company engaged Katalyst Securities LLC to serve as placement agent to the Company in connection with the offering.

The securities described above are being offered and sold by MyMD in a registered direct offering pursuant to a “shelf” registration statement on Form S-3 (Registration No. 333-254698), including a base prospectus previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on May 11, 2021. The offering of such securities is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting Katalyst Securities LLC at 630 Third Avenue, 5th Floor, New York, NY 10017, by phone at 212-400-6993.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would’’ and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230221005277/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, is presenting data today at the 2022 British Society for Immunology (BSI) Congress in Liverpool, England. Results from preclinical and clinical studies showed that MYMD-1 was safe and well-tolerated in healthy subjects and significantly reduced inflammation in a mouse model compared to the widely used arthritis treatment etanercept (Enbrel^®). These findings support the continued evaluation of MYMD-1^® for autoimmune and inflammatory disorders.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221206005205/en/

The studies were designed to investigate the safety and pharmacology profile of MYMD-1. In a preclinical study, repeat oral administration to mice in a collagen antibody induced arthritis (CAIA) model at 450 mg/kg/day significantly reduced the clinical score and paw swelling when compared to the CAIA disease control. In-life results showed percent change of inflammation relative to control was reduced by 37% with MYMD-1 while reduction was 29% with etanercept at 10 mg/kg/day. In a clinical study of healthy adults, single daily oral doses each of 150 mg, 300 mg, and 450 mg for 3 days and multiple daily doses of 600 mg for 6 days were safe and well-tolerated.

“These data are exciting and suggest that, with its differentiated oral administration and selectivity, MYMD-1 holds promise as a potentially new and meaningful therapeutic solution for patients with rheumatoid arthritis who are not served by current TNF-α inhibitors,” said Christopher Chapman, MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “We look forward to continuing to explore MYMD-1 in upcoming studies to determine its full potential in RA and other autoimmune and inflammatory disorders.”

Late-breaking abstract P-639 entitled “Pharmacology and clinical profile of MYMD-1^® (isomyosamine), an oral, selective, next-generation, tumor necrosis factor-alpha (TNF- α) inhibitor that crosses the blood brain barrier,” is scheduled for poster presentation on December 6, 2022, at 6pm GMT.

MYMD-1 is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α-based diseases are treated due to its selectivity and ability to cross the blood brain barrier. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. MYMD-1 has also been shown to selectively block TNF-α where it is overactivated without preventing it from doing its normal job of responding to routine infection. It has not been associated with serious side effects common with traditional immunosuppressive therapies that treat inflammation.

“We are encouraged by the reduction of TNF-α along with the favorable safety profile demonstrated in these studies,” said Dr. Leonard Dunn, Poster Coauthor and MYMD-1 Investigator. “An oral treatment that selectively reduces TNF-α and inflammation would be a welcomed advance.”

In addition to early-stage trials for rheumatoid arthritis, MyMD-1 is currently being evaluating in Phase 2 studies for sarcopenia/frailty, a result of the aging process, and has the potential to be the first drug approved by the FDA for the condition.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221206005205/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, has been invited to present late-breaking data at the 2022 British Society for Immunology (BSI) Congress in Liverpool, England.

Late-breaking abstract entitled “Pharmacology and clinical profile of MYMD-1^® (isomyosamine), an oral, selective, next-generation, tumor necrosis factor alpha (TNF-α) inhibitor that crosses the blood brain barrier,” is scheduled for poster presentation on December 6, 2022, at 6pm GMT. In addition to safety and pharmacology data, the presentation will include information on the anti-inflammatory effects of MYMD-1 in a collagen antibody induced arthritis (CAIA) model, which mimics features of arthritis in humans.

“We look forward to presenting these results at BSI and are very pleased that they have been chosen to be shared at this prestigious international gathering of immunology experts,” said Chris Chapman MD, president, director, and chief medical officer at MyMD Pharmaceuticals. “We believe strongly in the potential of MYMD-1 as a next-generation TNF-α inhibitor. With its differentiated oral administration and selectivity, it may one day offer a meaningful therapeutic solution for patients with conditions such as rheumatoid arthritis who are not served by current TNF-α inhibitors.”

MYMD-1 is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based diseases are treated due to its selectivity and ability to cross the blood brain barrier. MyMD-1 is currently being evaluated in Phase 2 studies for sarcopenia/frailty, a result of the aging process, and has the potential to become the first drug approved by FDA for the condition. MyMD Pharmaceuticals is planning to study MYMD-1^® in early-stage trials for rheumatoid arthritis (RA),

About MYMD-1

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.

MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No FDA-approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. Because it can cross the blood brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

About MyMD Pharmaceuticals

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1^®, is an oral next-generation TNF-α inhibitor with the potential to transform the way TNF-α based diseases are treated due to its small molecule design and selectivity. MYMD-1 has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-α inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1^® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, and is currently planning for early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications.

MyMD’s second therapeutic candidate is Supera-CBD™, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance, or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221117005091/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media Contact:
Andrea Cohen
Sam Brown, Inc.
(917) 209-7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, today announced the publication of results from a Phase 1 study of oral tumor necrosis factor-alpha (TNF-α) inhibitor, MYMD-1^® (Isomyosamine), in peer-reviewed journal, Drug Research. The randomized, double-blind, placebo-controlled study, intended to evaluate the safety, tolerability, and pharmacokinetic profile of MYMD-1 in healthy adults, found that single daily doses for 3 days and multiple daily doses for 6 days were safe and well tolerated in healthy subjects. The study used single daily doses of 150 mg, 300 mg, and 450 mg, respectively, and multiple daily doses of 600 mg. There were no new or unexpected safety findings and no clinically relevant or severe adverse events reported.

MYMD-1 is an oral next-generation TNF-α inhibitor with the potential to transform the way that TNF-α based autoimmune diseases are treated. Its ease of oral dosing is a significant differentiator compared to currently available TNF-α inhibitors, all of which require delivery by injection or infusion. MYMD-1 has also been shown to selectively block TNF-α where it is overactivated without preventing it from doing its normal job of responding to routine infection. In addition, it has not been shown to cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.

“As the first TNF-α inhibitor to be dosed orally, publication of these data confirm our belief that MYMD-1 may one day offer a new treatment option for patients not served by currently available therapies,” said Chris Chapman MD, President, Director, and Chief Medical Officer at MyMD Pharmaceuticals. “We look forward to upcoming Phase 2 results in sarcopenia and to advancing our MYMD-1 programs in other autoimmune disorders including rheumatoid arthritis and Hashimoto’s thyroiditis.”

MYMD-1 is currently being evaluated in Phase 2 studies for sarcopenia/frailty, a result of the aging process, with data expected in 4Q 2022. MYMD-1 has the potential to be the first drug approved by FDA for the condition. The company also expects to initiate a clinical program in rheumatoid arthritis (RA), which affects more than 1.3 million Americans.¹ Along with the growing aging population, autoimmune diseases like RA are becoming more prevalent. The National Institutes of Health estimates that autoimmune diseases overall may affect as many as 24 million Americans.²

About MYMD-1
MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.

MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No FDA-approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. Because it can cross the blood brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “may,” “plan,” “will,” “would” and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis
² https://www.niehs.nih.gov/health/topics/conditions/autoimmune/index.cfm

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Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Andrea Cohen
Sam Brown, Inc.
(917) 209 7163
AndreaCohen@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE, Md.--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, announced a dosing update on its fully-funded Phase 2 clinical trial of lead drug candidate MYMD-1^®, an orally available next-generation TNF-alpha inhibitor, as a therapy for chronic inflammation associated with sarcopenia and frailty.

To date, the trial has completed dosing for the second patient cohort. The Safety Review Committee has confirmed no safety or toxicity issues and has voted unanimously to escalate to the next higher dose and begin enrolling the next cohort.

“We are pleased with the good news that we will be progressing our Phase 2 trial into the next dosing cohort, given that MYMD-1 has been well-tolerated by participants to date,” said Chris Chapman, MD, President, Director and Chief Medical Officer of MyMD. “We continue to anticipate efficacy data later this year.”

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) is currently ongoing to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty in participants aged 65 years or older.

About MyMD Pharmaceuticals
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), is a clinical stage biopharma company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. MyMD’s lead clinical candidate, MYMD-1®, is an orally available next-generation TNF-alpha inhibitor with the potential to transform the way that TNF-alpha based diseases are treated. MYMD-1®, with its small molecule design, improved safety profile and ability to cross the blood brain barrier, has the promise to provide meaningful therapeutic solutions to patients not served by current TNF-alpha inhibitors and as a potential therapy for CNS-based inflammatory and autoimmune diseases. MYMD-1 has demonstrated the potential to slow the aging process and extend healthy lifespan. The company is evaluating MYMD-1® in Phase 2 studies for sarcopenia/frailty, a result of the aging process, as well as early-stage trials for rheumatoid arthritis (RA), with the potential to expand into other applications. MyMD’s second therapeutic candidate is Supera-CBD, a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8000 times more potent a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing addiction, anxiety, chronic pain and seizures, Supera-CBD has also been shown to have anti-inflammatory effects. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220920005338/en/

Investor Contact:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media Contact:
Mike Beyer
Sam Brown, Inc.
(312) 961-2502
MikeBeyer@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that it received a decision to grant from the European Patent Office in its application no. EP 3755318 A1. The allowed claims cover MyMD’s Supera-CBD™ compound as a new molecular entity and pharmaceutical formulations containing the compound.

“We are excited that another major patent office has acknowledged the superior ability of Supera-CBD™ to selectively bind with the CB2 receptor, which could potentially offer a breakthrough drug for the treatment of indications such as pain and anxiety,” commented Chris Chapman, M.D., President, Director, and Chief Medical Officer. “This news, along with the ongoing clinical development of lead compound, MYMD-1, demonstrates the continued progress MyMD has made this year in advancing these two products.”

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), that drives chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. A Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty is currently ongoing. The company’s scientific review committee met recently and agreed to move to the next higher dose in the study.

The upcoming patent grant adds to the company’s growing portfolio that already includes patents in the US, Australia, Canada, Israel, and South Korea for Supera-CBD™ and its therapeutic uses.

About MYMD-1
MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.

MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

About MyMD Pharmaceuticals, Inc.
MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220830005186/en/

Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Mike Beyer
Sam Brown, Inc.
(312) 961-2502
MikeBeyer@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today the publication of data in the Journal of Gerontology: Biological Sciences (JGBS) from a pre-clinical study of MYMD-1^® demonstrating four-fold greater improvements than rapamycin in delaying aging and extending the life of mice who began treatment at the human equivalent of 60 years of age. The study was led by principal study investigator Patrizio P. Caturegli, MD, MPH, a professor of pathology at the Johns Hopkins University School of Medicine.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220803005056/en/

“We are very excited that this important early data with our lead product MYMD-1 has been published in a prestigious medical journal,” said Chris Chapman, MD, President, Director, and CMO of MyMD Pharmaceuticals. “These results further validate the potential of MYMD-1 in delaying aging. Our ongoing Phase 2 study of MYMD-1 in sarcopenia/frailty, a result of a pathological aging process, is going well. Since TNF-alpha is a key player in the aging process, we also believe MYMD-1 has real potential to address autoimmune and inflammatory conditions by modulating inflammation, even when begun at an advanced age.”

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), that drives chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. A Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) to investigate the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty is currently ongoing. The company’s scientific advisory board met recently and agreed to move to the next higher dose in the study.

Aging is closely linked to multi-morbidities, frailty, and death due to conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic, or autoimmune diseases.ⁱ Similarly, frailty, or a decline in physical function leading to greater risk of hospitalization, disability, and death, increases with age independent of underlying conditions or demographical characteristics.ⁱⁱ

Results from the JGBS Study

The study compared MYMD-1, an oral inhibitor of TNF-α, to rapamycin, the best characterized drug endowed with anti-aging properties. In vivo, a longitudinal cohort of C57BL/6 mice, was randomized to receive either MYMD-1, high-dose rapamycin, or low-dose rapamycin plus metformin. Each of these three treatment arms of 18 mice (10 females and 8 males) was followed for 13 months or until death. Lifespan was significantly longer in the MYMD-1 group compared to rapamycin (P=0.019 versus high-dose and P=0.01 versus low-dose) in a Cox survival model that accounted for sex and serum levels of IL-6, TNF-α, and IL-17A (see figure above). MyMD-1 also improved several health span characteristics in the study, resulting in milder body weight loss, maintenance of greater muscle strength, and amelioration of progression to frailty.

Additionally, using a panel of 12 human primary cell systems (BioMAP Diversity PLUSTM) where a total of 148 biomarkers were measured, MYMD-1 possessed anti-proliferative, anti-inflammatory, and anti-fibrotic properties. Many were shared with rapamycin, but MYMD-1 was more active in the inhibition of pro-inflammatory cytokines and pro-fibrotic biomarkers.

About MYMD-1

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.

MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

ⁱ St Sauver JL, Boyd CM, Grossardt BR, Bobo WV, Finney Rutten LJ, Roger VL, et al. Risk of developing multimorbidity across all ages in an historical cohort study: differences by sex and ethnicity. BMJ Open. 2015;5:e006413.

ⁱⁱ Kochanek KD, Murphy SL, Xu J, Arias E. Deaths: Final Data for 2017. Natl Vital Stat Rep. 2019;68:1-77.

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Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Mike Beyer
Sam Brown, Inc.
(312) 961-2502
MikeBeyer@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced further advancement of its fully funded Phase 2 clinical trial of lead drug candidate MYMD-1^® as a therapy for delaying aging and expanding healthy lifespan. To date, the trial has completed dosing for the first patient cohort and dosing has been initiated in the next higher dose cohort. The trial’s Safety Review Committee has confirmed no safety issues and no toxicity in the prior cohort and has voted unanimously to escalate to the next higher dose and begin enrolling the next cohort.

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) investigates the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of chronic inflammation associated with sarcopenia/frailty in participants aged 65 years or older.

“As agreed upon with the FDA, the primary endpoint of our Phase 2 multi-center study is to demonstrate reduced levels of TNF-alpha (TNF-α), a key player in associated pathological aging, in the blood of patients,” said Chris Chapman, MD, President, Director and Chief Medical Officer of MyMD. “Having already demonstrated the drug’s mechanism of action and efficacy in Phase 1, achieving the same primary endpoint as our current trial, we are pleased with the progress in Phase 2 to date. We continue to advance the trial and expect efficacy data in the second half of 2022.”

In the Phase 1 dose-ranging study of MYMD-1 for delaying aging, subjects were treated with MYMD-1 or placebo and TNF-α levels were measured pre- and post-treatment. The data demonstrated a statistically significant decrease in TNF-alpha levels (p-value <0.05) found in MYMD-1 treated subjects, but no change in the participants given placebo. This data was consistent with outcomes from pre-clinical models pointing to the drug’s potential role in reducing both frailty and inflammatory cytokines.

Market Opportunity

MyMD has not identified any other FDA-approved drugs for treating aging disorders and extending healthy lifespan humans, a market expected to be at least $600 billion by 2025¹ according to a major investment bank. TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately $40 billion per year.² Aging is closely linked to multi-morbidities, frailty, and death due to conditions such as neoplastic, cardiovascular, neurodegenerative, metabolic, or autoimmune diseases.³ Similarly, frailty, or a decline in physical function leading to greater risk of hospitalization, disability, and death, increases with age independent of underlying conditions or demographical characteristics.⁴

About MYMD-1

MYMD-1, an oral selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation, is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection.

MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No FDA-approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

_________________________________
¹ https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html
² October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market, Acumen Research and Consulting
³ St Sauver JL, Boyd CM, Grossardt BR, Bobo WV, Finney Rutten LJ, Roger VL, et al. Risk of developing multimorbidity across all ages in an historical cohort study: differences by sex and ethnicity. BMJ Open. 2015;5:e006413.
⁴ Kochanek KD, Murphy SL, Xu J, Arias E. Deaths: Final Data for 2017. Natl Vital Stat Rep. 2019;68:1-77.

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Investors:
Robert Schatz
(646) 421-9523
rschatz@mymd.com

Media:
Mike Beyer
Sam Brown, Inc.
(312) 961-2502
MikeBeyer@sambrown.com

Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.^® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, announced today that it has entered into a material transfer agreement (MTA) with Bascom Palmer Eye Institute of Miami, Florida to collaborate on a pre-clinical study using MYMD-1^® as a potential treatment for traumatic optic neuropathy (TON). The project is fully funded by Bascom Palmer Eye Institute.

TON is a condition caused by injury to the optic nerve, resulting in partial or complete vision loss. Visual impairment is usually caused by blunt force trauma to the head. The reported incidence of TON ranges from 1.5% to 4% following head trauma¹, and each year an estimated 2.8 million Americans sustain a traumatic brain injury².

Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD, commented, “We are excited about this agreement with our country’s top eye institute to test our lead drug candidate MYMD-1 in ophthalmology. Bascom Palmer is virtually unmatched as a world leader in vision research and care and their interest in MYMD-1 validates our belief in the potential of the drug for autoimmune and inflammatory conditions.”

Dr. David Tse, M.D., FACS, Professor of Ophthalmology and the Dr. Nasser Ibrahim Al-Rashid Chair in Ophthalmology at Bascom Palmer Eye Institute commented, “Through this partnership with MYMD, we look forward to investigating the potential utility of an oral TNF-alpha inhibitor in animal models of eye-related diseases.”

“Following this initial pre-clinical study, the potential exists to collaborate with Bascom Palmer on large patient studies in the future,” Dr. Chapman continued. “This collaboration reiterates MyMD’s dedication to partnering with top-tier academic institutions to study MYMD-1 as a treatment for various high-impact conditions and diseases.”

About Bascom Palmer Eye Institute

With its 60-year history, Bascom Palmer has become a global leader in vision research, education, and clinical care. Bascom Palmer Eye Institute serves as the Department of Ophthalmology for the University of Miami Miller School of Medicine in Miami, Florida. Its mission is to enhance the quality of life by improving sight, preventing blindness, and advancing ophthalmic knowledge through compassionate patient care and innovative research.

Bascom Palmer Eye Institute is ranked the #1 eye hospital in the United States by U.S. News & World Report, an honor it has received 20 times. The Institute’s ophthalmology residency program is ranked best in the U.S. by Doximity, an online professional network for U.S. physicians. Ophthalmology Times ranked Bascom Palmer the best overall ophthalmology program in the nation with the best eye hospital and the best clinical and residency programs. Additionally, many of Bascom Palmer’s doctors are listed in Castle Connolly’s America’s Top Doctors.

About MYMD-1

Originally developed for autoimmune diseases, MYMD-1 is being studied to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic analog of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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Investor Contact:
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rschatz@mymd.com
www.mymd.com

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Source: MyMD Pharmaceuticals, Inc.

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced further advancement in its fully-funded, multi-center Phase 2 clinical trial of lead drug candidate MYMD-1® as a therapy for delaying aging and expanding healthy lifespan. All clinical trial sites, including a world leading academic institution, are now enrolling patients.

The Phase 2 multi-center double-blind, placebo controlled, randomized study (NCT05283486) investigates the efficacy, tolerability and pharmacokinetics of MYMD-1 in the treatment of participants aged 65 years or older with chronic inflammation associated with sarcopenia/frailty.

“As agreed upon with the FDA, the main goal, or primary endpoint, of our Phase 2 multi-center study is to demonstrate reduced levels of TNF-alpha (TNF-α), a key player in associated pathological aging, in the blood of patients,” said Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD. “Having already demonstrated the drug’s mechanism of action and efficacy in Phase 1 where we achieved the same primary endpoint as our current trial, we are pleased with the progress in Phase 2 to date.

“With all trial sites now enrolling patients, we expect the pace of enrollment to speed up over the next several months. As we continue to advance our trial, we currently expect efficacy data in the second half of 2022. This trial remains our number one priority in our product development strategy.”

In the Phase 1 dose-ranging study of MYMD-1 for delaying aging, subjects were treated with MYMD-1 or placebo and TNF-α levels were measured pre- and post-treatment. The data demonstrated a statistically significant decrease in TNF-α levels (p-value <0.05) found in MYMD-1 treated subjects, but no change in the participants given placebo. This data was consistent with outcomes from pre-clinical models pointing to the drug’s potential role in reducing both frailty and inflammatory cytokines.

Market Opportunity

MyMD has not identified any other FDA-approved drugs for treating aging disorders and extending healthy lifespan humans, a market expected to be at least $600 billion by 2025¹ according to a major investment bank. TNF-α blockers are the most prescribed drugs by revenue, a global market of approximately $40 billion per year,² and, according to Nature Aging journal,³ a slowdown in aging that would increase life expectancy by one year is worth $38 trillion and by 10 years is worth $367 trillion.

About MYMD-1

Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ https://www.cnbc.com/2019/05/08/techs-next-big-disruption-could-be-delaying-death.html
² October 9, 2019, Tumor Necrosis Factor (TNF) Inhibitor Drugs Market, Acumen Research and Consulting
³ Nature Aging | VOL 1 | July 2021 | p. 616–623

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Investor:
Robert Schatz
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rschatz@mymd.com
www.mymd.com

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media@mymd.com

Source: MyMD Pharmaceuticals, Inc.

Submission of Investigational New Drug (IND) application and protocols for a Phase 2 RA study planned for second half of 2022

BALTIMORE--(BUSINESS WIRE)-- MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage pharmaceutical company committed to extending healthy lifespan, today announced positive new preclinical study data demonstrating the potential effectiveness of MYMD-1 for the treatment of rheumatoid arthritis (RA). MYMD-1 demonstrated a significantly greater anti-inflammatory effect than current TNF-alpha inhibitors on the market, the top three of which represent an estimated $31 billion market (based on 2020 revenues)¹.

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Inhibition of Inflammation in Preclinical Model of Rheumatoid Arthritis (3) (Graphic: Business Wire)

The comparative study of arthritis, using the CAIA model², was conducted and analyzed by Charles River Laboratories International, a full-service contract research organization for drug discovery and development. Study results showed that MYMD-1 inhibited inflammation more effectively in the RA model by 30% and 70% of the top two marketed drugs, respectively.

“We are excited about the impressive new data we are announcing today that shows a highly favorable comparison of our lead drug candidate MYMD-1 to the gold standard rheumatoid arthritis drug therapies currently on the market today. A small fraction of this enormous $31 billion market represents a highly attractive opportunity for MyMD,” said Chris Chapman, M.D., President, Director and Chief Medical Officer of MyMD.

“Utilizing the strong proof-of-concept and efficacy data from our pre-clinical model, we are preparing to submit to the FDA an Investigational New Drug (IND) application for MYMD-1 as treatment for RA, along with protocols for a Phase 2 study, in the second half of this year.”

In addition to the greater efficacy shown in the preclinical model of RA, we believe that MYMD-1 holds significant advantages over current anti-TNF-alpha therapies:

• Smaller molecular size with easy access throughout the body, including the brain;
• Selective inhibition of TNF-alpha production by lymphocytes involved in autoimmune disease, but not macrophages involved in front line immune protection against bacteria and viral infections;
• Not shown to cause serious side effects in preclinical studies that is common with traditional therapies that treat inflammation;
• Simultaneous inhibition of pro-inflammatory cytokines TNF-alpha, IL-6 and IL-17; and
• Ease of oral dosing rather than by needle injection. Drug candidate MYMD-1 is the only TNF-alpha inhibitor that is dosed orally.

MyMD is currently conducting a Phase 2 clinical trial of MYMD-1 as a therapy for delaying aging and expanding healthy lifespan. The primary endpoint for the Phase 2 double-blind, placebo-controlled clinical trial is to achieve a reduction in circulating levels of TNF-alpha within 28 days of therapy.

In addition to aging and rheumatoid arthritis, MYMD-1’s distinct action in regulating the immune system and treating chronic inflammation is being developed for the treatment of multiple sclerosis (MS), diabetes, and inflammatory bowel disease.

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic autoimmune disease and an inflammatory form of arthritis. The disorder preferentially attacks the joints and is characterized by inflammation and bone erosion. In the progression of RA, joints are infiltrated by white blood cells that produce the pro-inflammatory cytokines TNF-alpha, IL-6 and IL-17. Rheumatoid arthritis is the most common form of autoimmune arthritis, affecting more than 1.3 million Americans⁴ and occuring at any age. Studies have determined that the number of people suffering from rheumatoid arthritis may rise to over 78 million by 2040⁵.

About MYMD-1

Originally developed for autoimmune diseases, MYMD-1’s primary purpose is to slow the aging process, prevent sarcopenia and frailty, and extend healthy lifespan. Because it can cross the blood-brain barrier and gain access to the central nervous system (CNS), MYMD-1 is also positioned to be a possible treatment for brain-related disorders. Its mechanism of action and efficacy in diseases including multiple sclerosis (MS) and thyroiditis have been studied through collaborations with several academic institutions.

MYMD-1 has shown effectiveness in pre-clinical and clinical studies in regulating the immune system by performing as a selective inhibitor of tumor necrosis factor-alpha (TNF-α), a driver of chronic inflammation. Unlike other therapies, MYMD-1 has been shown in these studies to selectively block TNF-α when it becomes overactivated in autoimmune diseases and cytokine storms, but not block it from doing its normal job of being a first responder to any routine type of moderate infection. MYMD-1’s ease of oral dosing is another differentiator compared to currently available TNF-α blockers, all of which require delivery by injection or infusion. No approved TNF inhibitor has ever been dosed orally. In addition, the drug is not immunosuppressive and has not been shown to cause the serious side effects common with traditional therapies that treat inflammation.

About MyMD Pharmaceuticals, Inc.

MyMD Pharmaceuticals, Inc. (Nasdaq: MYMD), a clinical stage pharmaceutical company committed to extending healthy lifespan, is focused on developing two novel therapeutic platforms that treat the causes of disease rather than only addressing the symptoms. MYMD-1 is a drug platform based on a clinical stage small molecule that regulates the immune system to control TNF-α, which drives chronic inflammation, and other pro-inflammatory cell signaling cytokines. MYMD-1 is being developed to delay aging, increase longevity, and treat autoimmune diseases and COVID-19- associated depression. The Company’s second drug platform, Supera-CBD, is being developed to treat chronic pain, addiction and epilepsy. Supera-CBD is a novel synthetic derivative of cannabidiol (CBD) and is being developed to address and improve upon the rapidly growing CBD market, which includes both FDA approved drugs and CBD products not currently regulated as drugs. For more information, visit www.mymd.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Forward-looking statements speak only as of the date they are made and none of MyMD nor its affiliates assume any duty to update forward-looking statements. Words such as "anticipate," "believe," "could," "estimate," "expect," "may," "plan," "will," "would'' and other similar expressions are intended to identify these forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the timing of, and MyMD’s ability to, obtain and maintain regulatory approvals for clinical trials of MyMD’s pharmaceutical candidates; the timing and results of MyMD’s planned clinical trials for its pharmaceutical candidates; the amount of funds MyMD requires for its pharmaceutical candidates; increased levels of competition; changes in political, economic or regulatory conditions generally and in the markets in which MyMD operates; MyMD’s ability to retain and attract senior management and other key employees; MyMD’s ability to quickly and effectively respond to new technological developments; MyMD’s ability to protect its trade secrets or other proprietary rights, operate without infringing upon the proprietary rights of others and prevent others from infringing on MyMD’s proprietary rights; and the impact of the ongoing COVID-19 pandemic on MyMD’s results of operations, business plan and the global economy. A discussion of these and other factors with respect to MyMD is set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021, filed by MyMD on March 31, 2022. Forward-looking statements speak only as of the date they are made and MyMD disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise.

¹ https://www.yahoo.com/now/abbvies-humira-still-number-1-224014673.html

² Animal models of arthritis mimic many of the features of arthritis in humans and have been used successfully in establishing proof of concept for new treatment compounds. Of the animal models available, the murine Collagen Antibody-Induced Arthritis (CAIA) model is modeled after RA, and is widely used because of the similar putative etiology to human disease. Moreover, microscopic changes associated with rheumatoid arthritis (e.g., inflammation, bone erosion, and bone degeneration) are observed in CAIA control animals.

³ Predicted Humira response was calculated based on previous comparisons of Enbrel vs. Humira in the same CAIA model during a previous experiment by Charles River.

⁴ https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Rheumatoid-Arthritis

⁵ Data published by Research and Markets, March 16, 2018

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Investor:
Robert Schatz
(646) 421-9523
rschatz@mymd.com
www.mymd.com

Media:
media@mymd.com

Source: MyMD Pharmaceuticals, Inc.