NEWTOWN, PA — Traws Pharma, Inc. (NASDAQ: TRAW) has released its financial results for the year ending December 31, 2024, alongside significant updates to its investigational programs. The company has made substantial progress in developing tivoxavir marboxil (TXM), its lead antiviral candidate for bird flu, as well as ratutrelvir, a protease inhibitor aimed at combating COVID-19.
Promising Headway in Antiviral Research
Tivoxavir marboxil, prioritized as Traws Pharma’s lead program, continues to demonstrate its potential as a single-dose treatment for bird flu. The therapy has shown robust results in multiple validated animal models, including ferrets and non-human primates, with significant antiviral activity. These findings, paired with positive pharmacokinetic data from Phase 1 clinical trials, suggest that TXM could address the rising pandemic threat of H5N1 bird flu.
The company is actively engaging with the FDA to explore an accelerated approval pathway for TXM under the “Animal Rule.” This pathway allows approval based on well-defined efficacy studies in animals when human trials are not feasible. An update on these discussions is expected in the second quarter of 2025.
CEO Werner Cautreels highlighted these achievements, stating, “We re-defined our focus to address critical threats to human health from respiratory diseases, with bird flu as our top priority. The encouraging results from tivoxavir marboxil reinforce its potential to be a game-changer in tackling a possible pandemic risk.”
Meanwhile, Traws Pharma’s COVID-19 candidate, ratutrelvir, has also gained traction, with promising data presented at the International Conference for Antiviral Research (ICAR 2025). The therapy employs protease inhibitor technology to target SARS-CoV-2, further expanding the company’s antiviral pipeline.
Financial Position and Strategic Progress
Traws Pharma closed 2024 with $21.3 million in cash and short-term investments, boosted by a $20 million financing round completed in December. This funding is expected to support operations into the first quarter of 2026 as the company advances its pipeline and prepares for clinical milestones.
Research and development expenses for 2024 totaled $12.8 million, up from $11.4 million in 2023, driven by ongoing clinical and preclinical trials for the company’s antiviral programs. General and administrative costs also rose, increasing to $12.3 million from $9.1 million.
The company reported a net loss of $166.5 million for the year, attributed to expenses related to acquired in-process R&D and warrant expenses linked to the December financing. Despite this, the strategic pivot to infectious disease programs and successful fundraising reflect Traws Pharma’s long-term commitment to delivering impactful therapies.
Leadership Transition
A key corporate highlight for 2024 includes the upcoming retirement of CEO Werner Cautreels, PhD. Effective March 31, 2025, Iain D. Dukes, D Phil, will step in as interim CEO while continuing his role as Chairman of the Board. Dr. Dukes brings extensive leadership experience, ensuring continuity as the company navigates its next phase of growth.
Upcoming Milestones in 2025
Key objectives for the year ahead include finalizing the regulatory pathway with the FDA for TXM approval, scaling up formulation and manufacturing processes, and advancing clinical development plans for both bird flu and COVID-19 candidates. Additionally, a meeting request with the FDA to establish endpoints for long COVID is expected in the second quarter of 2025.
A Future Focused on Public Health
Traws Pharma’s commitment to addressing respiratory health threats positions it at the forefront of pandemic preparedness. With a focused pipeline, strategic financial planning, and leadership transitions aimed at strengthening its operations, the company looks set to make meaningful impacts on global health challenges.
The continued development of tivoxavir marboxil and ratutrelvir spotlights Traws Pharma’s effort to target unmet medical needs in infectious disease, offering hope against emerging and existing threats alike.
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