NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) expects its existing cash and anticipated at-the-market equity proceeds to fund operations only into the first quarter of 2027, leaving the clinical-stage biotechnology company dependent on additional financing as its lead influenza program remains subject to regulatory review in the U.S. and U.K.
Traws ended the second quarter with $5 million in cash and cash equivalents, up from $3.8 million at Dec. 31, 2025, primarily reflecting proceeds from an April private placement and sales through its at-the-market equity program, partially offset by operating expenditures.
The company cautioned that, based on current projections, it may not have sufficient cash to continue operations beyond the first quarter of 2027 and could require additional capital.
Traws has access to as much as $50 million in potential additional financing under warrants issued as part of its April private placement, but those proceeds are contingent on regulatory and clinical milestones as well as investor participation.
The April financing generated $10 million upfront. A Series A warrant could provide another $10 million following U.K. Medicines and Healthcare products Regulatory Agency approval of the company’s planned Phase 2a human influenza Challenge study.
A second $10 million Series B warrant would become exercisable following release of data from that study, while Series C warrants could provide as much as $30 million. Shareholders approved the Series B and Series C tranches July 8.
Access to the later tranches remains dependent on achievement of the relevant milestones, sequential exercise of earlier warrants and participation by investors.
The financing structure puts added significance on the regulatory path for tivoxavir marboxil, Traws’ investigational oral influenza antiviral.
The company plans to resubmit a revised toxicology package to the MHRA by the end of the third quarter after the regulator requested additional information related to the planned Phase 2a study.
If cleared, the human Challenge study would be conducted in healthy volunteers at hVIVO in the U.K.
Tivoxavir marboxil also remains under a U.S. Food and Drug Administration clinical hold because of concerns involving the toxicology package supporting its investigational new drug application.
Traws is preparing a response to the FDA and is targeting resolution of the hold by the end of 2026.
“Following the MHRA’s review, we are moving quickly to generate the revised toxicology package the agency identified,” Chief Executive Officer Iain Dukes stated. The company expects to resubmit the package by the end of the third quarter.
Traws is developing tivoxavir marboxil as a potential prophylactic treatment for seasonal influenza and has also positioned the program for possible pandemic-preparedness applications. The company characterizes the combined opportunity as a multibillion-dollar market.
Its antiviral research platform has also produced early-stage leads targeting hantavirus, Ebola virus disease and Lassa fever, though the release did not identify clinical development timelines for those programs.
Financially, Traws recorded no revenue in either the second quarter or first half of 2026. That compared with $2.7 million of revenue in the second quarter of 2025 and $2.8 million during the first six months of that year, primarily stemming from nonrecurring deferred revenue associated with termination of a legacy oncology licensing agreement.
Second-quarter research and development spending declined to $1.1 million from $2.3 million a year earlier, largely because of lower spending on tivoxavir marboxil during the period.
For the first six months, however, R&D expenses increased to $6 million from $4.8 million as Traws funded development of tivoxavir marboxil and ratutrelvir, including completion of a Phase 2a ratutrelvir trial and initiation of a tivoxavir marboxil bridging study in March.
General and administrative expenses more than doubled to $3.5 million in the second quarter from $1.7 million, driven primarily by higher professional and consulting fees and stock-based compensation.
The company also recognized $1.4 million of other operating income after removing a legacy accrued R&D obligation that it determined was no longer enforceable and would not require a future cash outflow.
Traws posted a second-quarter net loss of $3 million, or 16 cents per basic and diluted share, compared with a $900,000 loss, or 11 cents per share, a year earlier.
For the first half, the net loss totaled $10.2 million, or 64 cents per share, compared with net income of $20.6 million in the first six months of 2025. The prior-year result included a $26.7 million noncash gain from changes in the fair value of warrant liabilities.
Traws had 15,368,277 common shares outstanding as of Aug. 13.
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