NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has reported its first-quarter financial results and provided updates on its investigational antiviral programs, underscoring advancements toward regulatory approval and potential breakthroughs in the treatment of viral infections.
The company’s lead candidates, tivoxavir marboxil (TXM) and ratutrelvir, are designed to address critical unmet needs in treating bird flu, seasonal flu, and COVID-19. Traws has submitted an FDA briefing document for TXM’s accelerated approval under the Animal Rule and is preparing regulatory discussions for ratutrelvir, focusing on acute COVID treatment, rebound prevention, and Long COVID.
“Traws continues to make excellent progress this year with its two proprietary antiviral candidates,” said Iain D. Dukes, D.Phil, Interim CEO. “Identifying opportunities to accelerate the path to approval is core to Traws’ strategy. We are excited to engage with regulatory authorities in the coming months to advance these programs and their potential to address significant global health challenges.”
Preclinical studies of TXM have shown its promise as a single-dose treatment for H5N1 bird flu and seasonal flu. Data from animal models demonstrated significant reductions in viral burden and lung pathology. Its Phase 1 results further highlighted sustained plasma drug levels for approximately three weeks post-dose, indicating a long-lasting therapeutic window.
Ratutrelvir, an investigational protease inhibitor targeting COVID-19, also showed strong preclinical activity, including suppression of resistant virus strains. Phase 1 trials reported favorable tolerability and pharmacokinetic outcomes, supporting its potential as a once-daily treatment for 10 days.
“Viral diseases are a significant medical challenge, with high morbidity and mortality,” said Dr. Robert Redfield, Chief Medical Officer and former CDC Director. “Vaccines face hurdles like resistance and insufficient coverage, but antivirals show promise for treating and preventing viral spread. Traws’ programs are advancing with potent activity in preclinical studies and promising Phase 1 profiles that could differentiate them significantly.”
On the financial front, Traws reported cash, equivalents, and short-term investments totaling $15.9 million as of March 31, 2025. Net income for the quarter was $21.5 million, primarily attributable to changes in warrant liability valuation. Operating expenses reflected increased investments in virology programs, offset partially by streamlined consulting costs.
Looking ahead, Traws plans to finalize regulatory discussions and development plans for TXM and ratutrelvir later this year, while exploring partnership opportunities for its legacy oncology assets. With antiviral treatments aimed at addressing urgent global needs, the company is well-positioned to deliver significant contributions to public health.
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