Onconova Therapeutics(ONTX) - 2025 Q2 - Quarterly Report

Financial Position - As of June 30, 2025, Traws Pharma had cash and cash equivalents of $13.1 million and an accumulated deficit of $628.6 million, indicating significant financial challenges ahead [110]. - Traws Pharma's ability to continue as a going concern is in doubt due to insufficient cash to support operations for at least the next 12 months [110]. - The company plans to explore various dilutive and non-dilutive sources of funding to alleviate substantial doubt about its ability to continue as a going concern [151]. - The net decrease in cash and cash equivalents was $8.3 million for the six months ended June 30, 2025, compared to a decrease of $3.9 million for the same period in 2024 [154]. - The company had an accumulated deficit of $628.6 million and cash and cash equivalents of $13.1 million as of June 30, 2025 [150]. Operating Performance - Revenue for the three months ended June 30, 2025, was $2,733,000, a significant increase of $2,676,000 compared to $57,000 in the same period in 2024 [137]. - Revenues increased by $2.6 million, reaching $2.7 million for the six months ended June 30, 2025, compared to $0.1 million for the same period in 2024 [144]. - Total operating expenses for the same period were $3,982,000, down from $123,405,000 in 2024, reflecting a decrease of $119,423,000 [137]. - The net loss for the three months ended June 30, 2025, was $915,000, a reduction of $122,228,000 compared to a net loss of $123,143,000 in 2024 [137]. - Net cash used in operating activities was $11.4 million for the six months ended June 30, 2025, compared to $14.3 million for the same period in 2024 [154]. Research and Development - Traws Pharma is exploring various funding sources for development and ongoing operations, with no assurance of obtaining sufficient financing on acceptable terms [111]. - The company has four clinical programs following the acquisition of Trawsfynydd Therapeutics, including Tivoxavir marboxil, which targets influenza virus replication [112]. - A Phase 1 study of Tivoxavir marboxil showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for over 23 days [115]. - The proposed Phase 2 study for Tivoxavir marboxil will evaluate its effects on seasonal influenza and H5N1 bird flu, pending regulatory approvals [116]. - Ratutrelvir (TRX01), acquired in the merger, is designed to inhibit the main protease of SARS-CoV-2, showing non-inferiority to existing treatments in animal studies [117]. - The Phase 1 clinical trial for TRX01 included 40 participants, with no treatment-related adverse events reported up to the highest dose of 600 mg [118]. - The proposed Phase 2 study for ratutrelvir aims to enroll patients on a 10-day treatment regimen, comparing it to the approved 5-day regimen for PAXLOVID® [118]. - Narazaciclib's maximum tolerated dose was established at 160 mg once daily in combination with letrozole for women with low-grade endometrioid endometrial cancer [119]. - Rigosertib demonstrated an overall response rate of 80% in patients with RDEB-SCC, with complete responses in 50% of evaluable patients [121]. - The company expects research and development expenditures in 2025 to be higher than in 2024 due to ongoing virology programs [159]. Compliance and Financial Reporting - The company received confirmation of regained compliance with Nasdaq's minimum stockholders' equity requirements on February 25, 2025 [136]. - The financial statements are prepared in accordance with GAAP, requiring estimates and judgments that affect reported amounts of assets, liabilities, revenues, and expenses [162]. - The company evaluates estimates related to accrued expenses, revenue recognition, deferred revenue, stock-based compensation, and acquired in-process research and development [162]. - As of June 30, 2025, there have been no significant changes in the company's critical accounting policies and estimates [162]. Capital Raising Activities - The company entered into an At The Market Offering Agreement to sell shares of common stock with an aggregate sales price of up to $50,000,000 [122]. - The company sold 1,522,947 shares under the ATM Agreement for net proceeds of $3.0 million in the quarter ended June 30, 2025 [123]. - The change in fair value of warrant liability was $26.7 million during the six months ended June 30, 2025 [149].