CHECK OUT THE INVESTOR PRESENTATION HERE‍

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Hello Everyone,

That last one was another quick double digit mover. The markets got beat up pretty bad today but there were a few bright spots. We are alway hoping to profile the next double digit mover and there is no doubt we had quite the success recently with two back to back TRIPLE DIGIT MOVERS (150% & 180%) that we had the good fortune to profile these companies well before those explosions took place. It has been a tremendous way to close out the year thus-far.

We want you to turn your attention to something sitting at 1.44 right now that got a huge pop, closing up to the tune of 13% on some key news.

Turn your attention to TNFA for Tuesdays session. You are going to want to research this one right away.

As a clinical stage biopharma company, TNF Pharmaceuticals is developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases. Our lead clinical candidate, MYMD-1® is an orally available, next-generation TNF-alpha inhibitor with the potential to transform the way TNF-alpha based diseases are treated.  

With its small molecule design, selective mechanism of action, and ability to cross the blood brain barrier, MYMD-1® has the potential to disrupt the TNF-alpha inhibitor market and provide meaningful therapeutic solutions to patients not served by current therapies.

MYMD-1® has demonstrated the potential to slow the aging process and extend healthy lifespan. The product is being evaluated 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.

A second therapeutic candidate, Supera-CBD, is a novel, synthetic, non-toxic cannabidiol (CBD) analog that is 8,000 times more potent as a CB2 agonist (activator) than plant-based CBD. In addition to its potential role in managing anxiety, chronic pain and seizures, Supera-CBD has been shown to have anti-inflammatory effects.

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Drug Candidates

TNF Pharmaceuticals is commercializing two broad drug platforms, each with its own distinct indications. MYMD-1^® is a novel therapeutic shown to positively impact multiple conditions related to immunometabolic dysregulation. Supera-CBD is a synthetic cannabidiol that offers better bioavailability and potency than botanicals. Both are protected by a robust, worldwide patent portfolio.

TNF Pharmaceuticals Presents Statistically Significant Phase 2a Trial Results for Novel Sarcopenia/Frailty Treatment at Prestigious International Conference

PUBLISHED

DEC 9, 2024 9:00AM EST

Based on successful Phase 2a data, Company set to initiate Phase 2b sarcopenia study in early 2025; currently securing centers of excellence to begin enrollment

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.

TNF Pharmaceuticals Prepares to Advance Lead Clinical Program Targeting Age-Related Decline

MYMD-1® development to continue through fully funded mid-stage clinical trials

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.

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NEWS

MANAGEMENT

Mitchell Glass, M.D.

President and Chief Medical Officer, Director

Dr. Glass brings a 35-year career in life sciences, with multiple drug approvals including Accolate ®, Avandia ® and Coreg®, to TNF Pharmaceuticals. 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.

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).

Ian Rhodes

Chief Financial Officer

Ian Rhodes was appointed as Interim Chief Financial Officer on February 1, 2021. Mr. Rhodes joined Brio Financial Group (“Brio”) in January 2021. From March 2020 to December 2020, Mr. Rhodes served as the Interim CFO of Roadway Moving and Storage. From November 2018 to July 2019, he served as Interim CFO of Greyston Bakery and Foundation. From December 2016 to September 2018, Mr. Rhodes served as President, CEO and Director of GlyEco, Inc., and served as CFO of GlyEco, Inc. from February 2016 to December 2016. From May 2014 to January 2016, he served as CFO of Calmare Therapeutics. Mr. Rhodes began his career at PricewaterhouseCoopers, where he worked for 15 years. Mr. Rhodes holds a Bachelor of Science degree in Business Administration with a concentration in Accounting from Seton Hall University and is a licensed CPA in New York.

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