Study evaluates novel small molecule TNF-alpha inhibitor as potential alternative to biologic treatments

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

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rschatz@tnfpharma.com

www.tnfpharma.com

TNF Pharmaceuticals Collaborates with DADA2 Foundation for Compassionate Use Study of Isomyosamine in Rare Pediatric Autoinflammatory Disease