NEWTOWN, Pa. – Traws Pharma, Inc. (NASDAQ: TRAW), a clinical-stage biopharmaceutical company, today announced the successful outcome of its Phase 1 trial for tivoxavir marboxil, an investigational oral treatment for influenza. The study, involving healthy volunteers, indicated favorable tolerability and pharmacokinetic profiles, suggesting the drug's potential as a one-time treatment for various flu viruses, including pandemic strains.
The trial was a randomized, double-blind, placebo-controlled study assessing the safety, tolerability, and pharmacokinetics of tivoxavir marboxil. According to the company's Chief Executive Officer, Werner Cautreels, PhD, the drug maintained plasma levels above the effective concentration for over five days, indicating its potential as a best-in-class flu therapy. The Phase 2 study is anticipated to commence in the first half of 2025.
Tivoxavir marboxil targets the CAP-dependent endonuclease (CEN), a protein consistent across human and avian influenza viruses. This characteristic potentially allows the drug to combat a wide range of flu viruses, including drug-resistant and highly pathogenic strains. Preclinical studies demonstrated the drug's potent inhibition of these viruses, with a preferential uptake in the lungs, a desirable feature for respiratory treatments.
Influenza remains a significant public health challenge, particularly affecting older adults and vulnerable populations. Robert R. Redfield, MD, Chief Medical Officer at Traws Pharma and former Director of the CDC, highlighted the urgency for novel therapeutics, especially given the recent bird flu outbreaks and the risk they pose for pandemics.
The seasonal influenza market, driven by health organizations, practice guidelines, and government tenders, represents a multi-billion-dollar opportunity, which may expand with pandemic occurrences. Traws Pharma's development of tivoxavir marboxil aims to address this market by offering a potentially more efficient treatment option.
Traws Pharma specializes in developing oral small molecule therapies for respiratory viral diseases and cancer. The company's commitment to safety and addressing unmet medical needs is central to its mission to provide solutions for viral infections.
The information in this article is based on a press release statement from Traws Pharma, Inc.
In other recent news, Traws Pharma has reported positive results from its Phase 1 clinical trial for ratutrelvir, a potential oral treatment for COVID-19. The company has also announced a merger with Onconova Therapeutics (NASDAQ:TRAW) and Trawsfynydd Therapeutics, which is expected to bolster Traws Pharma's financial position with an estimated cash balance of $28 million. However, Traws Pharma is facing potential Nasdaq delisting due to an equity shortfall of approximately $105.5 million.
In personnel changes, Traws Pharma welcomed Luba Greenwood to its Board of Directors, following the departure of long-serving Director James J. Marino. The company also reported the immediate resignation of Steven M. Fruchtman, its President and Chief Scientific Officer, Oncology.
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 are some of the recent developments at Traws Pharma.
InvestingPro Insights
As Traws Pharma, Inc. (NASDAQ: TRAW) advances its promising influenza treatment, investors should consider some key financial metrics and insights from InvestingPro. The company's market capitalization stands at a modest $9.57 million, reflecting its early-stage status in the biopharmaceutical industry.
InvestingPro Tips highlight that Traws Pharma holds more cash than debt on its balance sheet, which is crucial for a clinical-stage company funding expensive drug trials. This financial cushion could support the upcoming Phase 2 study of tivoxavir marboxil scheduled for early 2025.
However, it's important to note that the company is currently not profitable, with a negative P/E ratio of -0.27 over the last twelve months as of Q2 2024. This is not unusual for biotech firms in the development phase, but it underscores the importance of successful clinical trials for the company's future.
The stock has faced significant headwinds, with InvestingPro Data showing a one-year price total return of -70.28% as of the latest data. This performance aligns with the InvestingPro Tip indicating that the stock has fared poorly over the last month and has fallen significantly over the past year.
Despite these challenges, analysts predict that Traws Pharma will be profitable this year, which could be a turning point if the company's influenza treatment continues to show promise. Investors looking for a deeper dive into Traws Pharma's potential can access 13 additional InvestingPro Tips, offering a more comprehensive analysis of the company's financial health and market position.
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