NEWTOWN, Pa. - Traws Pharma Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company currently valued at $15.2 million, reported on Monday that it has completed Phase 1 dosing of its investigational oral treatment, tivoxavir marboxil, for H5N1 bird flu. According to InvestingPro analysis, while the company maintains a healthy cash position relative to debt, it faces significant challenges with rapid cash burn and negative earnings of -$141.78 per share in the last twelve months. The clinical-stage company announced that its Phase 1 trial in healthy volunteers showed the drug was safe and maintained effective drug levels in the blood for over 23 days.
The study, which was randomized, double-blind, and placebo-controlled, did not report any treatment-related adverse events. The company's Chief Medical (TASE:PMCN) Officer, Robert R. Redfield, MD, emphasized the growing risk of bird flu adapting to humans with the spread of avian influenza among animal populations. InvestingPro subscribers can access detailed financial health metrics and 8 additional key insights about Traws Pharma's development pipeline and market position. He stated that bird flu is an occupational hazard for poultry and dairy workers, and with increasing human infections, vigilance against a potential epidemic is crucial.
In vitro studies have shown that tivoxavir marboxil effectively inhibits drug-resistant and highly pathogenic avian influenza viruses. An in vivo study in mice also demonstrated potent protection and suppression of virus replication in the lungs when the mice were treated with the drug after exposure to H5N1.
Traws Pharma expects to begin a Phase 2 study in the first half of 2025 as it expands its influenza program in response to the bird flu threat. The virus has been detected in dairy cattle in the U.S. since March 2024, resulting in infections in over 60 people across eight states.
The investigational therapy, designed to inhibit a key influenza protein, has shown promising results in preclinical studies against a range of influenza strains. The Phase 1 pharmacokinetic profile suggests that a single dose could potentially offer a prophylaxis regimen.
The company's antiviral program also includes another Phase 1 drug candidate targeting COVID-19. Traws Pharma is dedicated to developing therapies for respiratory viral diseases and addressing unmet medical needs with novel compounds. Despite trading near its 52-week low of $4.06, analysts maintain a strong buy recommendation with a $6 price target. Get comprehensive valuation metrics and expert analysis with InvestingPro's advanced tools and real-time updates.
This announcement is based on a press release statement from Traws Pharma and contains forward-looking statements that involve risks and uncertainties. The company has made these forward-looking statements regarding its business and product candidates, including the regulatory plans for tivoxavir marboxil. However, actual results may differ materially from those projected in the forward-looking statements.
In other recent news, Traws Pharma has announced several key developments. The company has reported positive results from Phase 1 trials for two potential treatments: tivoxavir marboxil, an oral treatment for influenza, and ratutrelvir, an oral treatment for COVID-19. Despite facing potential delisting from the Nasdaq Capital Market due to not meeting the minimum stockholders’ equity requirement, a merger with Onconova Therapeutics (NASDAQ:TRAW) and Trawsfynydd Therapeutics is expected to improve Traws Pharma's financial position.
Within the company, board member Luba Greenwood has resigned, a decision that was voluntary and not due to any disagreement with the company's operations, policies, or practices. In addition, the company has seen the departure of Steven M. Fruchtman, the President and Chief Scientific Officer, Oncology.
To maintain robust financial practices, Traws Pharma has engaged KPMG LLP as its new independent registered public accounting firm and has amended its corporate bylaws, lowering the quorum requirement for stockholder meetings. These recent developments highlight Traws Pharma's ongoing activities and strategic adjustments.
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