Traws Pharma Reports Full Year 2024 Results and Business Highlights

Core Insights - Traws Pharma is advancing tivoxavir marboxil (TXM) as a single-dose therapeutic for bird flu, supported by strong antiviral activity in animal models and positive Phase 1 clinical data [1][2][3] - The company is in discussions with the FDA regarding an accelerated approval pathway under the "Animal Rule" [1][2] - Traws Pharma has a cash runway that is expected to support operations into Q1 2026, following a successful financing round that raised $20 million [1][12] Recent Developments - Traws Pharma has declared bird flu as its top priority, with ongoing concerns about farm infections and mutated viruses posing a pandemic risk [2] - Positive preclinical data for TXM has been demonstrated in three validated flu models, showing robust antiviral activity [2][6][8] - The company completed Phase 1 studies for TXM, indicating its potential as a single-dose oral treatment for H5N1 bird flu [9] Financial Performance - As of December 31, 2024, Traws Pharma reported cash and cash equivalents of approximately $21.3 million, an increase from $20.8 million in 2023 [12] - Research and development expenses for 2024 totaled $12.8 million, up from $11.4 million in 2023, primarily due to clinical and preclinical trials [13] - The net loss for 2024 was $166.5 million, significantly higher than the $18.9 million loss in 2023, largely due to acquired in-process research and development expenses [15][28] Product Pipeline - Traws Pharma's lead product candidate, TXM, is designed to be a single-dose treatment for bird flu and has shown potent in vitro activity against various influenza strains [17][18] - The company is also developing ratutrelvir, a COVID-19 treatment that does not require co-administration with ritonavir, potentially broadening its patient use [19][21] - Upcoming milestones include finalizing the development plan for TXM and submitting a pre-IND meeting request for ratutrelvir to engage with the FDA [7][10]