NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) posted second-quarter 2025 results and outlined strategic progress on its antiviral drug pipeline, with a focus on COVID-19 and influenza treatments designed to address gaps left by current therapies.
The company’s lead COVID-19 candidate, ratutrelvir, is a ritonavir-free oral protease inhibitor intended for once-daily, 10-day dosing. Traws has submitted plans to Australia’s Human Research Ethics Committee for a Phase 2 study comparing ratutrelvir to Pfizer’s PAXLOVID® in newly diagnosed patients, as well as a single-arm trial in patients ineligible for PAXLOVID®. Interim CEO Iain D. Dukes said results from both trials are expected by year-end.
In influenza, the firm is continuing discussions with the Biomedical Advanced Research and Development Authority (BARDA) on stockpiling tivoxavir marboxil (TXM), a single-dose bird flu and seasonal flu therapy. While human H5N1 infections remain rare in the U.S., Traws has deferred starting a Phase 2 bird flu trial until case numbers rise, noting recent regulatory approvals in Australia and South Korea that would allow rapid study initiation.
Chief Medical Officer Dr. Robert Redfield emphasized the continuing public health burden: “With close to one million COVID and influenza hospitalizations and tens of thousands of deaths reported in the 2024–2025 virus season, we know that COVID and influenza have not ‘gone away.’” He said both ratutrelvir and TXM aim to overcome limitations of existing treatments.
Traws’ legacy oncology assets also saw movement. Clinical data for rigosertib, published in the British Journal of Dermatology, showed an 80% overall response rate in patients with ultra-rare RDEB squamous cell carcinoma, prompting the company to seek development partners.
The quarter also brought leadership changes, with Jack Stover named chairman, Dukes assuming interim CEO duties, and Charles Parker appointed interim CFO.
Traws reported that its COVID-19 and flu programs represent multi-billion-dollar market opportunities, with upcoming Phase 2 trial results expected to be key inflection points for the company’s growth trajectory.
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