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NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ: TRAW), a biopharmaceutical company focusing on respiratory viral diseases with a market capitalization of $10.4 million, announced significant findings from a recent study of tivoxavir marboxil (TXM) in non-human primates. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it’s currently burning through cash reserves at a notable rate. TXM, a single-dose oral treatment for bird flu, demonstrated a substantial reduction in lung viremia and prevention of weight loss in subjects exposed to the H5N1 bird flu virus.
The study involved ten non-human primates split into two groups: five treated with TXM and five as controls. The TXM group showed consistently lower levels of lung viremia compared to controls, with virus levels undetectable in some cases. Additionally, while control subjects lost an average of 4.2% body weight, TXM-treated animals maintained or slightly increased their weight.
These results complement earlier TXM studies in ferrets and mice, which also showed increased survival rates and decreased viral burden. The consistency of TXM’s therapeutic effects across different animal models is noteworthy, as ferrets and mice are established models for influenza research.
Given the ongoing threat of bird flu to human health, with recent mutations observed in a Texas dairy worker, Traws Pharma is seeking FDA feedback on an expedited approval pathway. The company plans to meet with the FDA in the first half of 2025 to discuss the potential for accelerated approval under the "Animal Rule," which allows for drug approval based on safety data from human volunteers and efficacy data from animal studies. While the company’s stock has faced challenges, declining over 86% in the past year, analysts maintain a strong buy recommendation with a $6 price target, suggesting significant potential upside from current levels.
Robert R. Redfield, MD, Chief Medical Officer at Traws Pharma and former CDC Director, emphasized the importance of addressing the substantial risk to human health posed by bird flu. C. David Pauza, PhD, Chief Science Officer, highlighted the success of TXM in suppressing bird flu disease in preclinical studies using the virus that mutated in the Texas case.
Traws Pharma is set to present a comprehensive overview of TXM’s preclinical and human data at an Investor Event on Monday, March 31, 2025, at 10:00 AM ET. The session will outline the next steps towards potential approval. InvestingPro subscribers can access detailed financial health metrics and additional insights about Traws Pharma’s development pipeline and market position, with over 10 exclusive ProTips available.
TXM has shown potent activity against various influenza strains, including the highly pathogenic H5N1, and aims to address both the seasonal influenza market and potential pandemic outbreaks. The company’s product pipeline also includes ratutrelvir, a COVID-19 treatment candidate. Based on InvestingPro’s Fair Value analysis, the stock appears slightly undervalued at current levels, with analysts projecting profitability this year despite current negative earnings of -$141.78 per share.
This article is based on a press release statement from Traws Pharma, Inc.
In other recent news, Traws Pharma has made significant strides in its antiviral drug development programs. The company presented promising data at the International Society for Antiviral Research, showcasing the potential of its drug candidate, tivoxavir marboxil, as a treatment for bird flu. The drug demonstrated efficacy in preclinical studies, including ferret and rodent models, and showed safety in Phase 1 trials. Traws Pharma is in discussions with the FDA about an accelerated approval process for the drug, highlighting its potential as a single-dose treatment.
In other developments, Traws Pharma has regained compliance with Nasdaq’s stockholders’ equity requirement following a successful equity financing round. The company raised $20 million, ensuring its continued listing on the Nasdaq Capital Market. Additionally, Traws Pharma has amended the terms of its Series A Warrants, adjusting provisions related to control change thresholds and volatility rates. This amendment was detailed in a recent SEC filing, although the financial impact remains undisclosed.
Furthermore, Traws Pharma received stockholder approval for the issuance of shares upon the exercise of warrants issued in a private placement. This approval enables the issuance of more than 19.99% of the company’s outstanding common stock, supporting its financing strategy. These developments reflect Traws Pharma’s ongoing efforts to advance its antiviral programs and strengthen its financial position.
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