Traws Pharma, Inc.(TRAW) - 2024 Q4 - Annual Results

Traws Pharma Full Year 2024 Results and Business Highlights CEO Commentary The CEO highlighted Traws Pharma's strategic pivot to respiratory diseases, prioritizing H5N1 bird flu, with positive TXM data and successful 2024 financing - The company redefined its focus to treat critical respiratory disease threats, prioritizing bird flu[3] - Positive preclinical data for tivoxavir marboxil (TXM) showed potent resistance and robust antiviral activity in flu models, with positive Phase 1 pharmacokinetic results[3] - A successful December 2024 financing provided Traws with $20 million in gross proceeds and new institutional healthcare investors[3] - The company is pursuing a potential accelerated approval path for TXM under the FDA's Animal Rule[3] Upcoming Milestones and Recent Highlights Traws Pharma outlines key Q2 2025 milestones for bird flu and COVID programs, alongside recent positive data and management changes Upcoming Milestones (Q2 2025) For Q2 2025, the company plans FDA updates on its bird flu Animal Rule and a pre-IND meeting request for its COVID program's long COVID endpoints - Bird Flu Program: Provide an update on FDA discussions regarding the Animal Rule in Q2 2025 and finalize the development plan[6] - COVID Program: Submit a pre-IND meeting request to the FDA in Q2 2025 to understand long COVID endpoints[6] Recent Highlights Recent highlights include positive TXM data from non-human primate and ferret studies, completed Phase 1, positive ratutrelvir data, and an Interim CEO appointment - Bird Flu (TXM): Announced positive topline results from studies in non-human primates (Mar 2025), ferrets (Mar 2025), and completed Phase I studies (Jan 2025)[7][9][10] - COVID (Ratutrelvir): Positive data supporting ratutrelvir as a treatment for COVID-19 was presented at the ICAR 2025 conference[11] - Corporate: CEO Werner Cautreels retired effective March 31, 2025, with Chairman Iain D. Dukes assuming the role of Interim CEO[12] Financial Results Financial Performance Summary (FY 2024) Traws Pharma ended 2024 with $21.3 million cash, projecting funding into Q1 2026, with net loss surging to $166.5 million due to significant R&D and warrant expenses Financial Performance Metrics | Metric | FY 2024 | FY 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $21.3 million | $20.8 million | | R&D Expense | $12.8 million | $11.4 million | | G&A Expense | $12.3 million | $9.1 million | | Net Loss | $166.5 million | $18.9 million | | Net Loss per Share | $35.21 | $22.57 | - The significant increase in net loss was primarily due to a $117.5 million acquired in-process research and development expense and a $24.4 million warrant expense from the December 2024 financing[16] - The company's cash balance of $21.3 million is projected to be sufficient to support operations into the first quarter of 2026[13] - As of March 26, 2025, there were 5,073,790 shares of common stock outstanding, reflecting the issuance of 3.9 million shares from the December 2024 financing[17] Consolidated Balance Sheets As of December 31, 2024, total assets were $25.0 million, liabilities surged to $56.6 million due to $42.5 million in warrant liabilities, resulting in a $31.6 million stockholders' deficit Consolidated Balance Sheet Summary | | December 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Total current assets | $24,951,000 | $22,660,000 | | Total assets | $24,962,000 | $22,683,000 | | Total current liabilities | $11,533,000 | $9,220,000 | | Warrant liabilities | $42,494,000 | $0 | | Total liabilities | $56,592,000 | $12,011,000 | | Total stockholders' (deficit) equity | ($31,630,000) | $10,672,000 | | Total liabilities and stockholders' (deficit) equity | $24,962,000 | $22,683,000 | Consolidated Statements of Operations For FY 2024, Traws Pharma's revenues remained $226,000, with operating expenses surging to $142.6 million due to a $117.5 million acquired R&D expense, leading to a $166.5 million net loss Consolidated Statements of Operations Summary | | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Revenue | $226,000 | $226,000 | | Acquired in-process R&D | $117,464,000 | $0 | | Research and development | $12,847,000 | $11,430,000 | | General and administrative | $12,289,000 | $9,094,000 | | Total operating expenses | $142,600,000 | $20,524,000 | | Loss from operations | ($142,374,000) | ($20,298,000) | | Net loss | ($166,523,000) | ($18,948,000) | | Net loss per share of common stock | ($35.21) | ($22.57) | Product Pipeline Overview Tivoxavir Marboxil (Bird Flu) Tivoxavir marboxil (TXM) is an investigational oral, single-dose CAP-dependent endonuclease inhibitor for bird flu and seasonal influenza, demonstrating potent preclinical activity and consistent positive animal data - TXM is an investigational oral, single-dose drug designed to treat bird flu and seasonal influenza by inhibiting the CAP-dependent endonuclease[18] - Preclinical studies have shown potent in vitro activity against various influenza strains, including the highly pathogenic H5N1 bird flu[18] - The company believes the data supports further development of TXM, targeting a multi-billion dollar antiviral market with potential upside from pandemic flu outbreaks[18] Ratutrelvir (COVID-19) Ratutrelvir is an investigational oral Mpro inhibitor for COVID-19, designed without ritonavir to avoid drug interactions, with Phase 1 data suggesting reduced clinical rebound and long COVID risk - Ratutrelvir is an investigational oral Mpro inhibitor for COVID-19 that does not require co-administration with ritonavir[19] - Eliminating the need for ritonavir could avoid drug-drug interactions, making the treatment accessible to more patients[19] - Phase 1 data suggests the dosing regimen maintains target blood plasma levels that may reduce clinical rebound and the risk of long COVID[19] About Traws Pharma & Forward-Looking Statements Company Overview Traws Pharma is a clinical-stage biopharmaceutical company developing novel oral antiviral therapies for critical respiratory viral diseases, including tivoxavir marboxil and ratutrelvir - Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies for respiratory viral diseases[20] - The company's two primary antiviral programs are tivoxavir marboxil (for bird flu/seasonal influenza) and ratutrelvir (for COVID-19)[21] Forward-Looking Statements This section serves as a standard legal disclaimer, cautioning that the press release contains forward-looking statements subject to inherent risks and uncertainties, advising investors to consult SEC filings for detailed risk factors - The release contains forward-looking statements regarding the company's plans, clinical trials, and product candidates, which involve inherent risks and uncertainties[23] - Readers are directed to the "Risk Factors" section in Traws' SEC filings for a detailed discussion of potential risks that could cause actual results to differ from expectations[23]