TNF Pharmaceuticals and Renova Health Report Positive Results in Identifying Targets for Treating TNF-Driven Inflammation in Patients Receiving GLP-1 Agonists

Use of AI and machine learning accelerates identification of patient groups whose care can be improved

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

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

[email protected]

www.tnfpharma.com