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NEWTOWN, Pa. - Traws Pharma, Inc. (NASDAQ: TRAW), a biopharmaceutical company with a market capitalization of $10.5 million, presented data at the International Society for Antiviral Research (ICAR 2025) that supports the potential of its drug candidate, tivoxavir marboxil (TXM), as a treatment for bird flu. According to InvestingPro analysis, while the company maintains more cash than debt on its balance sheet, it’s currently experiencing rapid cash burn, with a negative free cash flow of $30.2 million in the last twelve months. The presentation, which took place in Las Vegas, Nevada, highlighted TXM’s effectiveness in laboratory and preclinical studies, as well as its safety and tolerability in Phase 1 trials.
The company’s Chief Science Officer, C. David Pauza, PhD, emphasized the need for an effective antiviral agent against bird flu, especially given the increased risk of exposure among agricultural workers due to widespread infection in poultry and dairy farms. Despite the stock’s significant decline of over 86% in the past year, analysts maintain a strong buy recommendation with a price target of $6, according to InvestingPro data. According to Pauza, TXM has shown potent suppression of both native and resistant strains of the virus while also providing protection against mortality and viral disease.
Preclinical studies demonstrated that TXM could suppress various subtypes of the influenza virus, including baloxavir-resistant strains. In a rodent challenge model, all mice treated with TXM survived without virus-induced weight loss and showed significant reductions in lung viremia, whereas untreated animals succumbed by the sixth day of the study.
Phase 1 trial data indicated that a single dose of TXM could maintain plasma blood levels at effective concentrations for approximately three weeks, suggesting potential for a single treatment regimen. The study included a broad range of doses in anticipation of bird flu’s virulence.
Traws Pharma plans to discuss the drug’s development path with the FDA, including the possibility of an accelerated approval process. The company will provide further updates on its antiviral programs during a virtual investor event on March 31, 2025.
TXM, which targets the influenza cap-dependent endonuclease, is being developed as a single-dose treatment for both bird flu and seasonal influenza. Traws Pharma also has an investigational oral small molecule in development for COVID-19.
The company’s forward-looking statements reflect their current expectations regarding TXM’s potential and their plans for regulatory engagement. However, these statements are subject to risks and uncertainties that could cause actual results to differ materially.
This article is based on a press release statement from Traws Pharma. While the company faces current challenges with profitability, InvestingPro analysis reveals that net income is expected to grow this year, with analysts forecasting positive earnings. Discover 12 additional exclusive ProTips and comprehensive financial metrics for Traws Pharma by subscribing to InvestingPro.
In other recent news, Traws Pharma, Inc. announced positive preliminary results from a preclinical study involving ferrets treated with its drug candidate, tivoxavir marboxil, for the H5N1 bird flu virus. This development highlights the potential for tivoxavir marboxil to address urgent health challenges posed by bird flu, especially as human exposures increase. Additionally, the company has regained compliance with Nasdaq’s stockholders’ equity requirement after a successful financing round that raised $20 million, ensuring its continued listing on the Nasdaq Capital Market. Traws Pharma has also amended the terms of its Series A Warrants, affecting the control change threshold and volatility rate, as detailed in a recent SEC filing.
Furthermore, Traws Pharma secured stockholder approval for the issuance of a significant number of shares upon the exercise of warrants, aligning with its financing strategy to increase common stock. The company announced agreements for up to $72.6 million in funding to support its drug development programs, with an initial $20 million to be received upon closing. This funding is expected to extend Traws Pharma’s financial runway into the first half of 2026, supported by investors such as Perceptive Advisors and OrbiMed. The company plans to provide further updates on tivoxavir marboxil in the first quarter of 2025.
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