TNF Pharmaceuticals Launches Study Series Aimed at Preserving Lean Muscle Mass During GLP-1 Weight Loss Treatment
Series of studies to observe signals of inflammation and TNF-alpha levels in patients taking GLP-1s including Wegovy® or Ozempic®
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, January 29, 2025--(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 20242 Research and Markets, GLP-1 Market: Industry Trends and Global Forecasts to 2035…., August 20243 Global Data, March 20244 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/
Contacts
Investor Contact: Robert Schatz(646) 421-9523rschatz@tnfpharma.com www.tnfpharma.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
4 hours ago
- Yahoo
Omada Health IPO signals healthier market, avoids 'down-round' trend
The IPO market is starting to feel healthier. Omada Health, a 14-year-old company providing virtual care for chronic conditions like diabetes and hypertension between office visits, closed its first trading day on Friday at $23 a share, a 21% jump from the IPO price of $19. The IPO valued the company just above $1 billion (excluding employee options), a figure that's nearly identical to Omada's last private valuation of $1 billion set in its previous VC round. The debut is one of the first among recent IPOs that was not a so-called down-round. Many of the latest public listings, including Hinge, ServiceTitan, and Reddit, priced below their private market highs, though have faired well as public companies. For founder and CEO Sean Duffy, the successful public offering validates his decision to start a company that he believed the market desperately needed. In 2011, he dropped out of Harvard Medical School after realizing that chronic illness patients required more continuous support than the existing healthcare system delivered. Before the offering, he owned 4.1% of the company, according to Omada's offering document. Other significant shareholders included Revelation Partners (10.9%), US Venture Partners (9.9%), Andreessen Horowitz (9.6%), and FMR (9.3%). Duffy told TechCrunch that over his 14-year journey as a founder, he had many harrowing moments. "I didn't think our series A was going to come together because we were working on this commercial deal that didn't materialize, and that spooked one investor," he said. "As a young business, something tries to kill you every month," he continued. "And then as the business grows, it turns into like every quarter or six months, year, two years." One of the recent challenges for many digital health businesses is navigating the "collapse" of the market post-COVID boom. Omada steered through the turbulent times by seeking new, rising markets. It recently expanded its offerings to include diet management support for GLP-1 patients.
New York Post
5 hours ago
- New York Post
Trump orders FAA to remove supersonic flight restrictions: ‘Bold new chapter in aerospace innovation'
President Trump is boosting supersonic aviation in the United States. An executive order the commander in chief signed Friday directs the Federal Aviation Administration to repeal a 1973 rule prohibiting overland supersonic flight, establish new noise standards for aircraft and remove other regulations that get in the way of the development of high-speed planes. 'The United States stands at the threshold of a bold new chapter in aerospace innovation,' the president wrote in the order. Advertisement 'For more than 50 years, outdated and overly restrictive regulations have grounded the promise of supersonic flight over land, stifling American ingenuity, weakening our global competitiveness, and ceding leadership to foreign adversaries.' 3 'President Trump is Making Aviation Great Again,' the White House said of the his executive order. AFP via Getty Images Trump argued that advances in engineering and technology have now made supersonic air travel 'not just possible, but safe, sustainable, and commercially viable.' Advertisement 'This order begins a historic national effort to reestablish the United States as the undisputed leader in high-speed aviation,' the president declared. 'By updating obsolete standards and embracing the technologies of today and tomorrow, we will empower our engineers, entrepreneurs, and visionaries to deliver the next generation of air travel, which will be faster, quieter, safer, and more efficient than ever before.' Under current FAA rules, only military aircraft – flying in specially designated areas – are allowed to break the sound barrier over land. The 1973 ban on overland supersonic flight was primarily due to the disruptive impact of the sonic booms produced when aircraft exceed the speed of sound. 3 Boom Supersonic hopes to develop a commercially viable supersonic aircraft. AP Advertisement 3 The FAA banned supersonic flights over the United States in 1973, over noise concerns. Chad Robertson – However, new technology has enabled one aircraft maker, Boom Supersonic, to develop a plane that can cruise above Mach 1 without emitting a sonic boom. 'Supersonic is back, baby!' Boom Supersonic founder and CEO Blake Scholl wrote on X, noting that in January, his company's XB-1 aircraft became the first privately developed supersonic jet to break the sound barrier. 'And today…[Trump] broke the sound barrier…permanently!' he added. Advertisement Scholl argued that the ban on supersonic flight has 'crippled progress' in aviation for half a century, but with Trump's order in place, 'The supersonic race is on and a new era of commercial flight can begin.' 'By removing decades-old regulatory barriers and promoting cutting-edge supersonic technology, President Trump is Making Aviation Great Again,' the White House said in a statement.
Yahoo
8 hours ago
- Yahoo
Aura Announces Public Filing of Registration Statement for Proposed U.S. Public Offering
ROAD TOWN, British Virgin Islands, June 06, 2025 (GLOBE NEWSWIRE) -- Aura Minerals Inc. (TSX: ORA) (B3: AURA33) (OTCQX: ORAAF) ('Aura' or the 'Company') announces that it has publicly filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed public offering of its securities in the United States. The proposed public offering includes the registration and listing of our common shares in the United States. The public offering is expected to commence after the SEC completes its review processes, subject to market and other conditions. The number of common shares to be sold and the price range for the proposed offering have not yet been determined. There will be no pre-emptive right for our shareholders and our Brazilian Depositary Receipts holders in connection with the public offering. Aura has applied to list its common shares on the Nasdaq Global Select Market under the symbol 'AUGO.' The U.S. listing is part of Aura's strategy to unlock value for our shareholders, improve stock liquidity and consolidate the liquidity in the U.S. equity market. BofA Securities and Goldman Sachs & Co. LLC are acting as Global Coordinators, BTG Pactual and Itaú BBA are acting as Joint Bookrunners and Bradesco BBI, National Bank of Canada Financial Markets, RBC Capital Markets and Scotiabank are acting as Co-Managers of the offering. The offering will be made only by means of a prospectus. Copies of the preliminary prospectus related to the offering may be obtained, when available, from BofA Securities, 201 North Tryon Street, Charlotte, NC 28255-0001, Attn: Prospectus Department. A registration statement relating to this offering has been filed with the Securities and Exchange Commission but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This communication to the market shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. The offering will not be carried out by any means that would constitute a public offering in Brazil under Law No. 6,385, dated December 7, 1976, as amended, and under Brazilian Securities Commission ('CVM') Resolution (Resolução) No. 160, dated July 13, 2022, as amended ('CVM Resolution 160'). The offering has not been and will not be registered with the CVM in Brazil. The common shares may not be offered or sold in Brazil except in circumstances which do not constitute a public offering for distribution under Brazilian securities laws and regulations. Caution Regarding Forward-Looking Information and Statements This press release includes certain statements and information that may constitute "forward-looking information" within the meaning of applicable Canadian securities laws and/or "forward-looking statements" within the meaning of applicable United States securities laws (collectively, "forward-looking statements"). Forward-looking statements relate to future events or future performance and reflect the Company's current estimates, predictions, expectations or beliefs regarding future events and include, without limitation, statements with respect to: statements relating to the public offering of the Company's common shares; the expected timing of the public offering; the registration and listing of the Company's common shares in the United States; the registration statement becoming effective; the SEC's review process; the sizing and pricing of the offering; the means by which the offering will be made; and the Company's business strategies. Often, but not always, forward-looking statements may be identified by the use of words such as "expects", "anticipates", "plans", "projects", "estimates", "assumes", "intends", "strategy", "goals", "objectives" or variations thereof or stating that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved, or the negative of any of these terms and similar expressions. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Company, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Forward-looking statements in this press release are based upon, without limitation, the following estimates and assumptions: the Company carrying out its public offering; the Company successfully completing the SEC review process; obtaining requisite regulatory approvals; and general business, economic and market conditions. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements. Important factors that may cause actual results to vary, include, without limitation, that the Company may not carry out its public offering or complete the SEC review process. Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement or forward-looking information, except in accordance with applicable securities laws. CONTACT: Investor Relations ri@
