Group 1 - Traws Pharma, Inc. has announced a financing agreement to raise up to $72.6 million, which includes an initial tranche of $20 million and a subsequent tranche of up to $52.6 million, aimed at extending its cash runway into the first half of 2026 and beyond [1][2] - The financing will support the development of Tivoxavir Marboxil, a drug candidate designed to treat respiratory viral diseases, including bird flu, with significant potential in the antiviral market [2][9] - The initial tranche will be funded through the issuance of 3,919,249 shares of common stock and pre-paid warrants, with additional funds available upon the exercise of non-prepaid warrants [1] Group 2 - The company is expecting key data readouts in early 2025 related to Ferret Bird Flu and Non-Human Primate Bird Flu, as well as Phase 2A data anticipated in the second half of 2025 [1] - Traws Pharma has received support from notable institutional investors, indicating strong confidence in the company's potential and the transformative nature of this financing [2] - The company plans to host an update call regarding Tivoxavir Marboxil in the first quarter of 2025, providing further insights into its development [14] Group 3 - The H5N1 bird flu virus has been confirmed in at least 866 herds across 16 states in the U.S., with over 60 human infections reported, highlighting the urgency for effective treatments [8][13] - Tivoxavir Marboxil has shown potent in vitro activity against various influenza strains, including highly pathogenic avian flu, and may enable a single-dose prophylaxis regimen [9][13] - The financing and ongoing development efforts are crucial as health officials warn of the rising potential for epidemic or pandemic spread of bird flu [13]

Core Insights - Traws Pharma is developing tivoxavir marboxil as a potential treatment for H5N1 bird flu, demonstrating safety and tolerability in Phase 1 trials, with drug levels maintained above the effective concentration for over 23 days [3][5][15] - The company plans to initiate a Phase 2 study in the first half of 2025, responding to the increasing risk of avian influenza adapting to humans [4][10] - The emergence of H5N1 in U.S. dairy cattle has raised concerns, with over 60 human infections reported, highlighting the urgency for effective treatments [10] Company Overview - Traws Pharma, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases, including influenza and COVID-19 [11] - The company is committed to addressing unmet medical needs through innovative drug development technologies [11] Product Development - Tivoxavir marboxil has shown potent inhibition of drug-resistant influenza viruses and highly pathogenic avian flu viruses in both in vitro and in vivo studies [5][15] - The drug's pharmacokinetic profile supports the potential for a single-dose treatment regimen, which could be significant for pandemic preparedness [15] Market Opportunity - The seasonal influenza market represents a multi-billion dollar opportunity, driven by global health initiatives and government tenders, with additional potential from pandemic flu scenarios [6]

Financial Performance - The Company reported net losses of $136.6 million for the nine months ended September 30, 2024, compared to $14.8 million for the same period in 2023, resulting in an accumulated deficit of $619.2 million as of September 30, 2024[97]. - Revenues for the three months ended September 30, 2024 were $57,000, consistent with the same period in 2023[139]. - Total operating expenses for the nine months ended September 30, 2024 were $137.3 million, significantly higher than $16.0 million in the same period of 2023[146]. - The Company incurred transaction costs of approximately $8.7 million related to the planned Merger during the nine months ended September 30, 2024[131]. - Net cash used in operating activities was $25.8 million for the nine months ended September 30, 2024, primarily due to a net loss of $136.6 million and a $7.7 million change in operating assets and liabilities[156]. - Significant non-cash charges of $118.5 million were recorded, mainly from the immediate expensing of in-process research and development related to the acquisition of Trawsfynydd, totaling $117.5 million[156]. - The company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[160]. - Projected net cash expenditures in 2024 are expected to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the Merger[160]. Cash Position and Funding - As of September 30, 2024, the Company had $5.4 million in cash and cash equivalents and raised gross proceeds of $14 million through a Securities Purchase Agreement on April 1, 2024[98]. - The company believes its cash and cash equivalents will fund ongoing trials and operations into the first quarter of 2025, but raises substantial doubt about its ability to continue as a going concern beyond that period[160]. - The Company is exploring various sources of funding for development and ongoing operations, with substantial doubt regarding its ability to continue as a going concern[98][99]. - The Company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[152]. - Net cash provided by financing activities was $14.0 million for the nine months ended September 30, 2024, from the private placement of Common Stock[159]. Clinical Development - TRX100, a small molecule cap-dependent endonuclease inhibitor, is being developed for the treatment and prophylaxis of seasonal influenza and bird flu[100]. - The Phase 1 clinical study of TRX100 showed good overall tolerability, with a single dose maintaining plasma drug levels above the EC90 for more than 20 days[104]. - TRX01, an inhibitor of the main protease of the SARS-CoV-2 virus, demonstrated inhibition of viral replication in preclinical studies and is planned for further development[105]. - The Phase 1 trial of TRX01 included 40 participants and showed no treatment-related adverse events, with plasma drug levels maintained within the therapeutic window for 12 days[106]. - The Company plans to initiate a Phase 2 study for both TRX100 and TRX01 in the first half of 2025[104][106]. - Narazaciclib is being evaluated in a multi-center Phase 1/2a trial for recurrent metastatic low-grade endometrioid endometrial cancer, with approximately 30 patients expected to enroll in the Phase 2 expansion cohort[107]. - A Phase 1 study of narazaciclib as a monotherapy is ongoing to assess safety and tolerability in patients with relapsed and/or refractory advanced cancer[108]. - The company plans to initiate two investigator-initiated studies in the USA for narazaciclib, targeting patients with refractory breast cancer and multiple myeloma[109]. - Rigosertib is being studied for epidermolysis bullosa-associated squamous cell carcinoma, with the company pursuing orphan drug designation from the FDA[111]. Corporate Actions - On April 1, 2024, the company completed a merger with Trawsfynydd Therapeutics, issuing 141,982 shares of Common Stock and 10,359.0916 shares of Series C[117]. - The merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes[116]. - The company raised approximately $14 million through a private placement, issuing 19,879 shares of Common Stock and 1,578.2120 shares of Series C[125]. - The company has filed a registration statement with the SEC for the resale of shares related to the merger, which was declared effective on August 28, 2024[126]. - A reverse stock split of one-for-25 was approved by the Board in September 2024, retroactively adjusting all related share information[113]. - The company regained compliance with Nasdaq's minimum bid price requirement after its common stock closed at least $1.00 per share for ten consecutive business days[114]. - The Company was notified of non-compliance with Nasdaq's minimum stockholders' equity requirement and attended a hearing to present its compliance plan[153]. Operational Challenges - The Company expects to incur significant expenses and operating losses for the foreseeable future as it continues the development of its product candidates[97]. - There is currently no organization for sales, marketing, and distribution of pharmaceutical products, and the company may rely on licensing and co-promotion agreements for commercialization[161]. - Additional costs are expected to be incurred associated with operating as a public company and fulfilling obligations under the Merger Agreement and related agreements[161].

Financial Performance - As of September 30, 2024, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $5.4 million, down from $20.8 million at December 31, 2023[6]. - The net loss for Q3 2024 was $8.5 million, or $8.81 per share, compared to a net loss of $4.7 million, or $5.64 per share, for the same period in 2023[9]. - Traws Pharma's accumulated deficit increased to approximately $619.2 million as of September 30, 2024, compared to $482.6 million at the end of 2023[14]. - The company reported total liabilities of $10.97 million as of September 30, 2024, down from $12.01 million at the end of 2023[14]. Research and Development - Research and development (R&D) expenses for Q3 2024 totaled $5.1 million, compared to $2.5 million for the same period in 2023, reflecting a significant increase due to the initiation of Phase 1 studies[7]. - Traws Pharma is advancing its antiviral programs, with Phase 2 studies for ratutrelvir and tivoxavir marboxil expected to commence in 2025[2]. - Phase 1 data for ratutrelvir indicates it can be dosed without ritonavir, showing no treatment-related adverse events and consistent plasma drug levels[3]. - Phase 1 data for tivoxavir marboxil supports its potential as a single-dose treatment for influenza, maintaining plasma drug levels above the EC90 for over five days[4]. Operating Expenses - General and administrative (G&A) expenses for Q3 2024 were $3.5 million, up from $2.7 million in Q3 2023, primarily due to increased professional and consulting fees[8]. - Traws Pharma's total operating expenses for Q3 2024 were $8.6 million, compared to $5.1 million for the same period in 2023[15].

Core Insights - Traws Pharma is advancing its clinical pipeline with promising Phase 1 data for its antiviral programs targeting COVID-19 and influenza, indicating potential for best-in-class treatments [2][3] Clinical Development - Ratutrelvir shows potential as a once-a-day, single-drug, 10-day treatment for COVID-19 without the need for ritonavir, demonstrating lower likelihood of clinical rebound and good tolerability [1][3] - Tivoxavir marboxil is positioned as a one-time treatment for influenza, including pandemic strains, with favorable pharmacokinetic profiles and tolerability [1][3] Upcoming Milestones - Phase 2 clinical proof of concept studies for both ratutrelvir and tivoxavir marboxil are expected to commence in 2025 [2][3] Financial Performance - As of September 30, 2024, Traws Pharma reported cash and cash equivalents of approximately $5.4 million, a decrease from $20.8 million at December 31, 2023 [5] - Research and development expenses for Q3 2024 totaled $5.1 million, up from $2.5 million in Q3 2023, primarily due to Phase 1 study costs [6] - General and administrative expenses increased to $3.5 million in Q3 2024 from $2.7 million in Q3 2023, driven by higher professional fees [7] - The net loss for Q3 2024 was $8.5 million, compared to a net loss of $4.7 million in the same period of 2023 [8] Company Overview - Traws Pharma is a clinical stage biopharmaceutical company focused on developing oral small molecule therapies for respiratory viral diseases and cancer [9][10]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |--------------------------------------------------- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma, Inc. (Exact name of registrant as specified in its charter) | --- | --- | |-------------------------------------------------- ...

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Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) (I.R.S. Employer Identification No.) 18940 Registran ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Mark One) FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Onconova Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 22-3627252 (State or other jurisdiction of incor ...