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

Rhea-AI Summary

TNF Pharmaceuticals (Nasdaq: TNFA) is advancing its lead program, MYMD-1®, through fully funded mid-stage clinical trials. MYMD-1 is a small molecule that blocks excessive TNF-alpha activity to regulate the immuno-metabolic system. The company's next clinical studies will focus on sarcopenia/frailty following statistically significant results from a Phase 2 study.

MYMD-1 met primary endpoints in reducing chronic inflammatory markers with statistical significance in sarcopenia/frailty. The company also holds FDA-cleared Phase 2 INDs for MYMD-1 in rheumatoid arthritis and Hashimoto's thyroiditis. TNFA is preparing to reveal its next steps towards value creation and long-term growth.

Positive

• MYMD-1 met primary endpoints in Phase 2 study for sarcopenia/frailty, reducing inflammatory markers significantly
• Company has fully funded mid-stage clinical trials for MYMD-1
• FDA-cleared Phase 2 INDs for MYMD-1 in rheumatoid arthritis and Hashimoto's thyroiditis
• MYMD-1 showed 47% reduction in disease severity in preclinical RA trial, outperforming Enbrel® (37% reduction)
• Potential to be the first orally administered TNF-alpha inhibitor drug and first therapy for sarcopenia

Negative

• No FDA-approved treatments currently exist for sarcopenia, indicating potential regulatory challenges
• Company may need to pursue non-dilutive partnerships for additional indications, suggesting potential resource constraints

Insights

Financial Analyst

TNF Pharmaceuticals' announcement signals promising progress in their clinical development pipeline, particularly with MYMD-1. The successful completion of a Phase 2 study for sarcopenia/frailty, meeting primary endpoints with statistically significant results, is a positive indicator. However, investors should note that while this progress is encouraging, the company is still in the clinical stage without a marketable product.

The company's fully funded mid-stage clinical trials suggest a strong financial position, which is important for biotech firms. The potential to be the first orally administered TNF-alpha inhibitor and the only therapy for sarcopenia could represent significant market opportunities if approved. The $40+ billion estimated hospitalization costs related to sarcopenia indicate a substantial potential market.

Additionally, the FDA-cleared INDs for rheumatoid arthritis and Hashimoto's thyroiditis expand the potential applications of MYMD-1, potentially diversifying revenue streams in the future. However, investors should remain cautious as clinical success does not guarantee regulatory approval or commercial success.

Medical Research Analyst

The clinical data for MYMD-1 is intriguing, particularly its ability to significantly reduce chronic inflammatory markers in sarcopenia/frailty patients. The statistical significance across three biomarkers (TNF-α, sTNFR1 and IL-6) is noteworthy, as is the absence of treatment-related adverse events. This safety profile could be a key differentiator if maintained in larger trials.

The potential application in rheumatoid arthritis is supported by preclinical data showing 47% reduction in disease severity, compared to 37% for etanercept. While promising, it's important to note that preclinical results don't always translate to human trials. The ability of MYMD-1 to cross the blood-brain barrier could offer unique therapeutic advantages, but this needs to be validated in clinical settings.

The company's pursuit of multiple indications (sarcopenia, RA, Hashimoto's thyroiditis) with a single compound is a smart strategy, potentially maximizing the return on R&D investment. However, investors should be aware that success in one indication doesn't guarantee success in others.

Market Research Analyst

TNF Pharmaceuticals is positioning itself to tackle significant market opportunities. The sarcopenia market, with its $40+ billion related hospitalization costs, represents a substantial untapped opportunity given the lack of FDA-approved treatments. Similarly, the rheumatoid arthritis market, with an estimated $40 billion annual societal cost and the thyroid disorder market, projected to reach $2.7 billion by 2025, offer considerable potential.

The company's strategy to potentially partner for non-U.S. development could accelerate commercialization and provide additional funding. This approach could be particularly beneficial for a clinical-stage company, helping to mitigate financial risks.

The secondary drug platform, Supera-CBD, targeting epilepsy, pain and anxiety/depression, provides diversification. Its potential role in treating opioid addiction could be significant given the ongoing opioid crisis. However, investors should note that this is still in early stages and faces a highly competitive CBD market.

Overall, TNF Pharmaceuticals is addressing large markets with unmet needs, which could translate to substantial revenue if their products gain approval. However, the path from clinical trials to market is long and uncertain, requiring careful investor consideration.

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.

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.

FAQ

What were the results of MYMD-1's Phase 2 study in sarcopenia/frailty for TNFA?

MYMD-1 met primary endpoints in the Phase 2 study for sarcopenia/frailty, significantly reducing chronic inflammatory markers TNF-α (P=0.008), sTNFR1 (P=0.02), and IL-6 (P=0.03) with statistical significance. No treatment-related adverse events occurred.

What other indications is TNFA pursuing for MYMD-1 besides sarcopenia?

TNFA holds FDA-cleared Phase 2 Investigational New Drug (IND) applications for MYMD-1 in rheumatoid arthritis (RA) and Hashimoto's thyroiditis, in addition to its primary focus on sarcopenia/frailty.

How did MYMD-1 perform in preclinical trials for rheumatoid arthritis compared to Enbrel?

In a preclinical trial for rheumatoid arthritis, MYMD-1 reduced disease severity by 47% compared to a 37% reduction with Enbrel® (etanercept), demonstrating superior efficacy in reducing swelling and other clinical arthritis measures.

What is the potential market size for MYMD-1 in sarcopenia treatment?

The estimated market for sarcopenia-related hospitalization costs in the U.S. is over $40 billion, representing a significant economic burden on the healthcare system and a potential market for MYMD-1 if approved.