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Dec 31, 2024
Onconova Q4 2024 Earnings Report
Traws Pharma reported full year 2024 results and business highlights.
Key Takeaways
Traws Pharma reported a net loss of $166.5 million for the full year 2024, driven by acquired in-process research and development expense and warrant expense. The company ended the year with $21.3 million in cash and cash equivalents, stating it has sufficient cash runway into Q1 2026. Key developments include positive data for tivoxavir marboxil in bird flu models and completion of Phase 1 studies, as well as positive data for ratutrelvir in COVID-19.
Traws Pharma reported a full-year 2024 net loss of $166.5 million, compared to a net loss of $18.9 million in 2023.
The company's cash, cash equivalents, and short-term investments totaled $21.3 million as of December 31, 2024, providing cash runway into Q1 2026.
Tivoxavir marboxil, the lead product candidate for bird flu, showed positive data in non-human primates and ferrets, and completed Phase 1 clinical studies.
Ratutrelvir, the COVID-19 candidate, presented positive data at ICAR 2025, supporting its potential as a main protease inhibitor.
Forward Guidance
Traws Pharma plans to provide an update on FDA discussions regarding the Animal Rule for bird flu in Q2 2025, finalize formulation and CMC scale-up, and move forward on the path to approval. For COVID, they plan to submit a pre-IND meeting request to engage with the FDA to understand long COVID endpoints in Q2 2025. The company believes its cash and cash equivalents will be sufficient to support ongoing operations into Q1 2026.
Positive Outlook
- Ongoing FDA interaction to align on path forward for tivoxavir marboxil, including potential for accelerated approval utilizing the "Animal Rule" in Q2 2025.
- Finalizing formulation and CMC scale up for tivoxavir marboxil.
- Finalizing the development plan and moving forward on the path to approval for tivoxavir marboxil.
- Submitting a pre-IND meeting request to engage with the FDA to understand long COVID endpoints for COVID in Q2 2025.
- Cash runway expected to support planned operations into Q1 2026.
Challenges Ahead
- The company's ability to achieve accelerated approval for tivoxavir marboxil is subject to regulatory requirements and pathways.
- The extent of the spread and threat of bird flu could impact the market opportunity.
Historical Earnings Impact
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