NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) reported third quarter 2025 financial results and highlighted steady momentum across its antiviral programs, including Phase 2 progress for its COVID candidate ratutrelvir and readiness steps for its single-dose flu antiviral tivoxavir marboxil. The company also posted sharply reduced operating costs and formalized key leadership appointments as it prepares for several data catalysts by year-end.
Traws is positioning ratutrelvir, a ritonavir-free oral Mpro inhibitor, as a potential best-in-class therapy for acute COVID with the added aim of reducing viral rebound and the long-term complications associated with infection. The once-daily, 10-day regimen is now being evaluated in a Phase 2 non-inferiority study against Paxlovid as well as in a separate cohort of patients ineligible for Paxlovid treatment. Top-line data from both studies are expected before the end of 2025.
Earlier Phase 1 data showed ratutrelvir maintained plasma levels well above the antiviral threshold for the full 10-day course, with no treatment-related adverse events. The company estimates the U.S. opportunity for an effective oral antiviral addressing rebound risk and Long COVID could reach into the multi-billion-dollar range.
Tivoxavir marboxil (TXM), Traws’ single-dose candidate for H5N1 bird flu and seasonal influenza, is also progressing toward further development. Prior human data demonstrated drug exposure above the EC90 for roughly three weeks after a single dose. Preclinical results across mouse, ferret, and non-human primate models showed robust protection against H5N1 using a recent virus isolated from a U.S. dairy worker. Traws plans to file an IND to support discussions with BARDA on potential inclusion of TXM in government stockpiling initiatives.
For its legacy oncology assets, the company reported encouraging clinical data for rigosertib in treating RDEB-associated squamous cell carcinoma, an ultra-rare and aggressive disease with high mortality. Recent published results showed an 80% overall response rate, including 50% complete responses. Traws is seeking development partners to advance the program.
Leadership changes this quarter included the appointment of John Leaman, M.D., as an independent board director and the confirmation of Iain Dukes, MA, D Phil, as CEO and Charles Parker as CFO.
Financials reflected the company’s cost-cutting efforts. Cash and cash equivalents totaled $6.4 million as of September 30, down from $21.3 million at year-end due to strategic asset purchases, including a key antiviral patent acquired for $2.6 million. R&D spending fell to $2.3 million from $5.1 million a year earlier, and G&A expenses decreased by roughly half. Net loss narrowed to $4.0 million from $8.5 million in the prior-year period.
Traws ended the quarter with 7,990,867 shares outstanding and said it expects its reduced operating footprint, combined with upcoming clinical readouts, to position the company for a data-driven 2026.
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