Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 Registrant's telephone number, including area code: (267) 759-3680 Securities registered pursuant to Section 12(b) of the Act: Or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-36020 Traws Pharma ...

Financial Performance - Revenue for the quarter ended March 31, 2025, was $57 thousand, a slight increase from $56 thousand in the same period in 2024[10] - Total revenue for the three months ended March 31, 2025, was $57,000, a slight increase from $56,000 in the same period of 2024, representing a growth of approximately 1.79%[24] - The net income for the quarter was $21.5 million, significantly improved from a net loss of $5.0 million in the same period in 2024, driven by a change in fair value of warrant liability[12] - The net income for Q1 2025 was $21,490,000, compared to a net loss of $4,983,000 in Q1 2024, indicating a significant turnaround[24] - Net income per share of common stock, basic, was $2.17 in Q1 2025, compared to a loss of $5.92 per share in Q1 2024[24] - The change in fair value of warrant liability contributed $26,513,000 to the income statement in Q1 2025, with no comparable figure in Q1 2024[24] Expenses - Research and development (R&D) expenses for the quarter totaled $2.5 million, up from $1.9 million in the comparable period in 2024, primarily due to increased expenses related to virology programs[10] - Research and development expenses increased to $2,506,000 in Q1 2025, up from $1,912,000 in Q1 2024, reflecting a rise of about 30.96%[24] - General and administrative (G&A) expenses decreased to $2.8 million from $3.4 million in the same period in 2024, mainly due to reduced consulting fees[11] - General and administrative expenses decreased to $2,754,000 in Q1 2025, down from $3,356,000 in Q1 2024, a reduction of approximately 17.91%[24] Cash and Assets - As of March 31, 2025, Traws Pharma had cash, cash equivalents, and short-term investments of approximately $15.9 million, down from $21.3 million as of December 31, 2024[9] - Total current assets decreased to $18,856,000 as of March 31, 2025, from $24,951,000 as of December 31, 2024, a decline of approximately 24.5%[22] - Stockholders' equity improved to $6,000,000 as of March 31, 2025, compared to a deficit of $31,630,000 as of December 31, 2024[22] Liabilities - Total liabilities significantly decreased to $13,063,000 as of March 31, 2025, down from $56,592,000 as of December 31, 2024, a reduction of about 76.98%[22] Product Development and Partnerships - Traws Pharma is preparing to submit a briefing package for ratutrelvir to regulatory authorities in Q2 2025, targeting acute COVID treatment and Long COVID[6] - Tivoxavir marboxil (TXM) is positioned for a multi-billion dollar market opportunity in the U.S. for bird flu and seasonal flu, with preparations underway for finalizing the development plan[7] - Phase 1 data for TXM indicated that it maintained plasma blood levels above the EC90 for approximately three weeks after a single oral dose, supporting its use as a single-dose treatment[7] - Ratutrelvir's pharmacokinetic profile showed maintenance of target blood plasma levels approximately 13 times above the EC50, indicating potential effectiveness against COVID-19[15] - Traws Pharma is seeking partnership opportunities for its legacy oncology assets, narazaciclib and rigosertib[6]

Company Focus and Clinical Programs - Traws Pharma, Inc. focuses on developing novel antiviral therapies targeting respiratory viral diseases, expanding its business after a merger with Trawsfynydd Therapeutics, Inc. on April 1, 2024[18]. - The company has four clinical programs: tivoxavir marboxil for influenza, ratutrelvir for COVID-19, narazaciclib for cancer, and rigosertib for various cancers[18]. - The merger with Trawsfynydd Therapeutics has shifted the company's focus from cancer therapies to include critical respiratory viral diseases[18]. Clinical Trial Results - Tivoxavir marboxil demonstrated a 100% protection rate in mice against H5N1 bird flu at a dose of 50 mg/kg, which is comparable to a human dose of 240 mg[26]. - In a Phase 1 clinical trial in Australia, tivoxavir marboxil maintained plasma drug levels above the EC90 for over 23 days after a single dose[22]. - Ratutrelvir showed non-inferiority to the combination of nirmatrelvir and ritonavir in an animal study, indicating its potential effectiveness against SARS-CoV-2[35]. - The Phase 1 trial for ratutrelvir included 40 participants, with a maximum dose of 600 mg showing no adverse events related to the study drug[36]. - Narazaciclib is a multi-targeted kinase inhibitor with a differentiated profile, potentially overcoming limitations of current CDK 4/6 inhibitors[38]. - Narazaciclib demonstrates a favorable kinase inhibitory profile compared to approved CDK4/6 inhibitors, potentially leading to both tumorigenic and safety benefits[45]. - In a Phase 1 study in China, 75% of enrolled patients had metastatic breast cancers, with 2 out of 3 patients at the 200 mg dose achieving stable disease[47]. - The Phase 1/2a trial of narazaciclib in combination with letrozole for recurrent metastatic endometrial cancer established a maximum tolerated dose of 160 mg[51]. - Narazaciclib inhibits CSF1R with IC50 values between 0.7 to 10 nM, indicating potential efficacy in cancers dependent on CSF1R signaling[40]. - The Phase 1 study in the US (Study 19-01) commenced in May 2021, assessing safety and pharmacokinetics of narazaciclib in patients with advanced cancer[48]. - In the Phase 1 study in China, dose-limiting toxicities were observed in 2 patients at the 200 mg dose, including Grade 4 ALT increase and Grade 3 platelet count decrease[47]. - Rigosertib has shown promising results in treating advanced squamous cell carcinoma associated with recessive dystrophic epidermolysis bullosa, with 2 complete responses observed[56]. Regulatory and Approval Processes - The company plans to meet with the FDA in the first half of 2025 to discuss accelerated approval for tivoxavir marboxil under the "Animal Rule" for H5N1 bird flu treatment[24]. - The process of obtaining regulatory marketing approvals is time-consuming and requires substantial financial resources[107]. - The FDA aims to complete its review of New Drug Applications (NDAs) for new molecular entities within 10 months of acceptance for filing[124]. - An approval letter from the FDA authorizes commercial marketing of the drug with specific prescribing information for designated indications[128]. - Post-approval requirements may include Phase 4 clinical trials and ongoing safety monitoring to assess the drug's effectiveness after commercialization[131]. - The FDA's approval process for new chemical entities (NCE) grants five years of marketing exclusivity, preventing ANDA or 505(b)(2) applications for the same active moiety during this period[143]. - The FDA allows for a patent term extension of up to five years for relevant drug patents, calculated based on the drug's testing and review phases, with a maximum total patent term of 14 years from the date of approval[145]. - The FDA's Orphan Drug Designation provides seven years of market exclusivity for drugs treating rare diseases affecting fewer than 200,000 individuals in the U.S.[159]. - The FDA's priority review designation sets a target action date of six months for drugs that provide significant improvements in treatment for serious conditions[165]. - The FDA's Fast Track designation allows for more frequent development meetings and a rolling review process for drugs addressing unmet medical needs[164]. - The Clinical Trials Regulation (EC) 536/2014 enables a single application for cross-border trials within the EU, streamlining the approval process[147]. - The FDA's regulations allow for expanded access to investigational drugs for patients with serious or life-threatening diseases under certain conditions[150]. - The FDA's Animal Rule permits approval of certain drugs based on animal studies when human efficacy studies are not ethical or feasible[154]. Financial Performance and Concerns - The company reported recurring operating losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern without obtaining adequate new financings[198]. - The independent registered accounting firm's report for the fiscal year ended December 31, 2024, contains an explanatory paragraph regarding the company's ability to continue as a going concern[200]. - The company has identified material weaknesses in its internal control over financial reporting, which could impair its ability to produce timely and accurate financial statements[200]. - The company needs to obtain additional funding to continue operations; failure to do so may require scaling back or ceasing operations[200]. - The company reported net losses of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for the year ended December 31, 2023, with an accumulated deficit of $649.2 million as of December 31, 2024[210]. - The company has incurred recurring losses from operations, leading to substantial doubt about its ability to continue as a going concern within one year after the issuance of the financial statements[205]. - The company plans to explore various financing options, including equity financings and strategic alliances, to alleviate liquidity concerns and fund ongoing clinical trials and operations[204]. - The company has not generated any revenue from product sales to date and may never become profitable, depending on the successful commercialization of its product candidates[215]. - The company anticipates continuing to incur significant expenses and operating losses for the foreseeable future, which may increase as it seeks regulatory approvals for its product candidates[211]. - The company may need to delay or pause planned clinical trials until adequate additional funding is secured, impacting its development efforts[206]. Market and Competitive Landscape - The biotechnology and pharmaceutical industries are highly competitive, with many competitors having greater financial and technical resources[96]. - The company anticipates intense competition as new drugs enter the market and advanced technologies become available[97]. - Several companies have advanced drug candidates for COVID-19, including remdesivir and oral Paxlovid, both of which have received full FDA approval[99]. - The company faces substantial competition, which may result in others discovering, developing, or commercializing products before it does[201]. - The company expects to incur substantial expenses related to the integration of Trawsfynydd[201]. Regulatory Compliance and Risks - The company is subject to extensive regulation by the FDA and other agencies, impacting research, development, and marketing of product candidates[105]. - Manufacturers must comply with stringent regulations regarding advertising and promotion, ensuring claims are consistent with FDA-approved labeling[130]. - Changes to approved applications, such as modifications in indications or manufacturing processes, require submission of a new NDA or NDA supplement[129]. - The Hatch-Waxman Amendments require applicants to list all relevant patents with the FDA upon drug approval, which are published in the Orange Book[137]. - The FDA conducts periodic inspections to ensure compliance with current Good Manufacturing Practices (cGMP) after drug approval[132]. - Compliance with regulatory requirements is critical, as failure may result in sanctions including product recalls, fines, or withdrawal of approval[152]. Economic and Geopolitical Factors - The company is currently operating in a period of economic uncertainty and capital markets disruption, which could materially adversely affect its business and financial condition[219]. - The ongoing military conflicts and geopolitical tensions may impact the company's operations and access to funding, although it has not been materially affected to date[223]. - International trade disputes may lead to tariffs and protectionist measures, adversely affecting the company's business and financial condition[224]. - Changes in U.S.-China relations and regulations could impact the company's operating results and ability to raise capital[225]. - Potential new legislation or tariffs could have negative effects on the company's financial condition and market share[227]. - Inflation may increase the company's overall cost structure, affecting liquidity and financial results[228]. - Higher interest rates and capital costs due to inflation could lead to supply shortages and increased operational costs[228].

Financial Performance - Traws Pharma reported a net loss of $166.5 million for the year ended December 31, 2024, compared to a net loss of $18.9 million for 2023, resulting in a net loss per share of $35.21[16] - Total revenue for 2024 remained unchanged at $226 million compared to 2023[28] - Operating expenses increased significantly to $142.6 million in 2024 from $20.5 million in 2023, primarily due to acquired in-process research and development costs of $117.5 million[28] - Net loss for 2024 was $166.5 million, a substantial increase from a net loss of $18.9 million in 2023[28] - Net loss attributable to common stockholders was $54.7 million, with a net loss per share of $35.21 for 2024[28] - Net loss attributable to Series C Preferred stockholders was $111.8 million, with a net loss per share of $14,085.00[28] - The company reported a loss from operations of $142.4 million in 2024, compared to a loss of $20.3 million in 2023[28] Cash and Investments - Cash, cash equivalents, and short-term investments as of December 31, 2024, were approximately $21.3 million, up from $20.8 million at the end of 2023, reflecting $20 million in gross proceeds from financing[13] Expenses - Research and development (R&D) expenses for 2024 totaled $12.8 million, an increase of $1.4 million from $11.4 million in 2023, primarily due to clinical and preclinical trials[14] - General and administrative (G&A) expenses rose to $12.3 million in 2024, up from $9.1 million in 2023, mainly due to increased consulting fees[15] - Other income decreased to $289,000 in 2024 from $1.35 million in 2023[28] Liabilities - The total liabilities of Traws Pharma increased significantly to $56.6 million as of December 31, 2024, compared to $12.0 million in 2023, largely due to warrant liabilities[26] Product Development - Traws Pharma's lead product candidate, tivoxavir marboxil, demonstrated robust antiviral activity in three validated flu models and positive Phase 1 pharmacokinetic results[3] - The company plans to provide an update on FDA discussions regarding the Animal Rule for tivoxavir marboxil in Q2 2025[6] - Traws Pharma aims to finalize the development plan for tivoxavir marboxil and move forward on the path to approval in 2025[6] - Ratutrelvir, the company's COVID-19 candidate, showed promising data at the International Conference for Antiviral Research (ICAR 2025)[11] Share Information - As of March 26, 2025, Traws had 5,073,790 shares of common stock outstanding, reflecting the issuance of 3.9 million shares related to the December 2024 financing[17] - The weighted-average shares of common stock outstanding increased to 1,552,685 in 2024 from 839,554 in 2023[28]

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]. - Other income, net, was $0.5 million for the nine months ended September 30, 2024, down from $1.1 million in the same period of 2023[150]. - The Company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[160]. Cash and Financing - As of September 30, 2024, the Company had $5.4 million in cash and cash equivalents, raising gross proceeds of $14 million through a Securities Purchase Agreement on April 1, 2024[98]. - The Company has a need for additional financing for its clinical-stage programs and ongoing operations, with no assurance of obtaining sufficient funds[99]. - 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]. - 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]. - 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]. Clinical Development - TRX100, a small molecule cap-dependent endonuclease inhibitor, is being developed for the treatment and prophylaxis of seasonal influenza and bird flu, with plans to initiate a Phase 2 study in the first half of 2025[100][104]. - TRX01, an inhibitor of the main protease of the SARS-CoV-2 virus, showed no treatment-related adverse events in a Phase 1 clinical trial, with plans to initiate a Phase 2 study in the first half of 2025[105][106]. - The first-in-man clinical study of TRX100 indicated good overall tolerability, with plasma drug levels maintained above the EC90 for more than 20 days[104]. - The Company aims to develop TRX01 without co-administration of a human cytochrome P450 inhibitor, based on preclinical studies[105]. - 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]. Mergers and Acquisitions - On April 1, 2024, the company acquired Trawsfynydd Therapeutics, Inc., issuing 141,982 shares of Common Stock and 10,359.0916 shares of Series C as part of the merger[117]. - The company incurred transaction costs of approximately $8.7 million related to the planned Merger during the nine months ended September 30, 2024[131]. - 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 filed a registration statement with the SEC on July 1, 2024, which was declared effective on August 28, 2024[126]. - The company has a contingent value rights agreement entitling holders to 43.7% of net proceeds from the sale of narazaciclib and rigosertib, or 6.24% of net sales from these drugs[124]. Regulatory and Compliance - The company received a letter from Nasdaq regarding non-compliance with minimum stockholders' equity requirements, but later regained compliance with a minimum closing price of at least $1.00 per share[114]. - A one-for-25 reverse stock split was approved by the Board, retroactively adjusting all common stock information in financial statements[113]. 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]. - The Company is exploring various sources of funding for development and regulatory approval of its research compounds, with substantial doubt regarding its ability to continue as a going concern within one year[98][99]. - 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 total operating expenses for Q3 2024 were $8.6 million, compared to $5.1 million in Q3 2023, reflecting a significant increase in R&D and G&A costs[15] - The company reported total liabilities of approximately $10.97 million as of September 30, 2024, down from $12.01 million at the end of 2023[14] - 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] Research and Development - Research and development (R&D) expenses for Q3 2024 totaled $5.1 million, an increase of 104% compared to $2.5 million for the same period in 2023[7] - Phase 1 data for ratutrelvir indicates potential for once-a-day dosing without ritonavir, showing no treatment-related adverse events and consistent plasma drug levels[3] - Tivoxavir marboxil demonstrated good tolerability in Phase 1 studies, maintaining plasma drug levels above the EC90 for over five days, supporting its potential as a single-dose treatment for influenza[4] - Traws Pharma plans to initiate Phase 2 clinical proof of concept studies for both tivoxavir marboxil and ratutrelvir in community-acquired settings in 2025[3] General and Administrative 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 a $1.2 million increase in professional and consulting fees[8]

Financial Performance - Traws Pharma reported a net loss of $123.1 million for Q2 2024, equating to $4.87 per basic and diluted common share, significantly higher than the net loss of $4.3 million or $0.20 per share in Q2 2023[9]. - Revenue for Q2 2024 was $57,000, consistent with Q2 2023[16]. - Total operating expenses for Q2 2024 were $123,405,000, compared to $4,667,000 in Q2 2023[16]. - Net loss for Q2 2024 was $123,143,000, compared to a net loss of $4,250,000 in Q2 2023[16]. - Loss from operations for Q2 2024 was $(123,348,000), significantly higher than $(4,610,000) in Q2 2023[16]. - Basic and diluted net loss per share for Q2 2024 was $(4.87), compared to $(0.20) in Q2 2023[16]. - Acquired in-process research and development expenses were $117,464,000 for Q2 2024, with no prior year comparison[16]. - Research and development expenses increased to $3,964,000 in Q2 2024 from $2,456,000 in Q2 2023[16]. - General and administrative expenses decreased to $1,977,000 in Q2 2024 from $2,211,000 in Q2 2023[16]. - Other income for Q2 2024 was $205,000, down from $360,000 in Q2 2023[16]. Cash and Liabilities - The company had cash, cash equivalents, and short-term investments of approximately $16.9 million as of June 30, 2024, down from $20.8 million at the end of 2023, which is expected to support operations through year-end 2024[7]. - Traws Pharma's total liabilities as of June 30, 2024, were approximately $12.6 million, compared to $12.0 million at the end of 2023[15]. Research and Development - Research and development (R&D) expenses for Q2 2024 totaled $4.0 million, an increase from $2.5 million in the same period of 2023, primarily due to costs associated with ongoing clinical studies[8]. - Traws Pharma completed a merger with Trawsfynydd Therapeutics and a concurrent private placement of $14 million, expanding its clinical portfolio to include two oral small molecule programs for influenza and COVID-19[5]. - The company is advancing its antiviral program, with Phase 1 results for tivoxavir marboxil expected in Q4 2024 and initiation of Phase 2 studies planned for Q4 2024/Q1 2025[3]. - Ratutrelvir, targeting COVID-19, completed Phase 1 studies in Australia, with topline results expected in Q4 2024 and Phase 2 studies to follow[4]. - The oncology strategy includes investigator-sponsored trials for narazaciclib, with topline results from Phase 1/2 studies anticipated in H2 2024[3]. - The company plans to announce the recommended Phase 2 dose for narazaciclib and initiate ISTs in multiple myeloma and breast cancer in H2 2024[3]. Corporate Communication - A corporate update call is scheduled for August 15, 2024, to discuss recent business progress and financial results[1].

Financial Performance - The Company reported net losses of $128.1 million for the six months ended June 30, 2024, compared to $10.0 million for the same period in 2023, resulting in an accumulated deficit of $610.8 million as of June 30, 2024[81]. - Revenue for the three months ended June 30, 2024, was $57 million, consistent with the same period in 2023, attributed to the recognition of deferred revenue from collaboration with SymBio[117]. - Total operating expenses for the three months ended June 30, 2024, were $123.4 million, a decrease of $118.7 million compared to $4.7 million in the same period in 2023[117]. - The net loss for the three months ended June 30, 2024, was $123.1 million, compared to a net loss of $4.3 million for the same period in 2023, reflecting an increase of $118.9 million[117]. - For the six months ended June 30, 2024, the company incurred a net loss of $128.1 million, with $117.5 million attributed to non-cash expenses from the acquisition[126]. - Net cash used in operating activities was $14.3 million for the six months ended June 30, 2024, primarily due to a net loss of $128.1 million[133]. - The company has not achieved profitability since inception and expects to continue incurring net losses for the foreseeable future[138]. Cash and Funding - As of June 30, 2024, the Company had $16.9 million in cash and cash equivalents, raising gross proceeds of $14 million from a Securities Purchase Agreement on April 1, 2024, related to the Merger[82]. - The company plans to explore various funding sources to alleviate substantial doubt about its ability to continue as a going concern[127]. - The company is exploring various funding sources for continued development of product candidates and ongoing operations[139]. - Cash and cash equivalents as of June 30, 2024, were $16.9 million, with an accumulated deficit of $610.8 million[126]. - Net cash expended in 2024 is expected to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs from the Merger[138]. Clinical Development - The first-in-man clinical study of TRX100 was conducted from May to September 2023, enrolling 28 healthy males, with a primary endpoint of safety and tolerability[85]. - TRX100 is intended to inhibit influenza virus replication and is being advanced in a Phase 1 randomized study in Australia, expected to commence dosing in mid-August 2024[88]. - Ratutrelvir (TRX01), an inhibitor of the main protease of SARS-CoV-2, is currently in a Phase 1 clinical trial initiated in May 2024, with 40 participants enrolled in the single ascending dose phase[90]. - Narazaciclib, a CDK4-plus inhibitor, is being evaluated in a multi-center Phase 1/2a trial for low-grade endometrioid endometrial cancer, with ongoing analysis of safety and tolerability[91]. - The Company is pursuing orphan drug designation for rigosertib for epidermolysis bullosa-associated squamous cell carcinoma with the FDA[94]. - Significant expenses and operating losses are expected as the company continues development and seeks regulatory approval for product candidates[139]. - If regulatory approval is obtained, the company anticipates incurring significant NDA preparation and commercialization expenses[139]. Merger and Acquisition - The Company acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, issuing 3,549,538 shares of Common Stock and 10,359.0916 shares of Series C Preferred Stock as part of the merger[95]. - The Company incurred transaction costs of approximately $8.7 million related to the merger, which were expensed as in-process research and development[112]. - A total of 496,935 shares of Common Stock and 1,578.2120 shares of Series C Preferred Stock were sold for approximately $14 million under a Securities Purchase Agreement[104]. - The Company appointed three new directors and made significant management changes effective as of the merger closing[98]. - The Company terminated 11 of its 17 employees post-merger, incurring severance costs of $0.9 million[113]. - The Company changed its name to Traws Pharma, Inc. and began trading under the ticker symbol "TRAW" on April 3, 2024[111]. - The Company agreed to hold a stockholders' meeting to approve the conversion of Series C Preferred Stock into Common Stock[96]. - The Company filed a registration statement with the SEC for the resale of shares related to the PIPE Securities within 90 days of the merger closing[105]. 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[81]. - Substantial doubt exists regarding the Company's ability to continue as a going concern within one year after the issuance of these financial statements[82]. - The company currently lacks a sales, marketing, and distribution organization for pharmaceutical products and may rely on licensing and co-promotion agreements[139]. - Building a commercial infrastructure in the U.S. for approved product candidates would require significant financial and management resources[139]. - The company expects to incur additional costs associated with operating as a public company and fulfilling obligations under the Merger Agreement[139]. - For additional risks, the company refers to the "Risk Factors" section in its Annual Report[140].

Financial Performance - The Company reported net losses of $5.0 million for the three months ended March 31, 2024, compared to $5.8 million for the same period in 2023, with an accumulated deficit of $487.6 million as of March 31, 2024[88]. - Revenue for the three months ended March 31, 2024, was $56,000, consistent with the same period in 2023[123]. - The Company’s net loss for the three months ended March 31, 2024, was $4,983,000, a decrease of $792,000 compared to the net loss of $5,775,000 for the same period in 2023[123]. - Operating activities used $4.4 million of net cash during the three months ended March 31, 2024, slightly lower than the $4.5 million used in the same period of 2023[137]. - Cash flows from operating activities resulted in a net decrease of $4.4 million in cash and cash equivalents for the three months ended March 31, 2024[137]. - The company had an accumulated deficit of $487.6 million and cash and cash equivalents of $16.4 million as of March 31, 2024[131]. - The company expects net cash expenditures in 2024 to be higher than in 2023 due to advancements in clinical trials and significant transaction-related costs associated with the merger[140]. Corporate Developments - The Company acquired Trawsfynydd Therapeutics, Inc. on April 1, 2024, as part of a merger agreement, which is intended to qualify as a tax-free reorganization[94]. - Upon the merger's consummation, the Company issued 3,549,538 shares of common stock and 10,359.0916 shares of Series C Preferred Stock to Trawsfynydd's stockholders[95]. - The Company plans to hold a stockholders' meeting to approve the conversion of Series C Preferred Stock into Common Stock and potentially amend its certificate of incorporation[95]. - The Board of Directors appointed new executives, including Werner Cautreels as CEO, Iain Dukes as Executive Chairman, and Nikolay Savchuk as COO, effective as of the merger closing[98]. - The Company incurred approximately $1 million in cash compensation to Tungsten Partners LLC for services rendered in connection with the Merger[115]. Research and Development - The Company plans to advance the development of four clinical programs, including Viroxavir (TRX100) for influenza, Travatrelvir (TRX01) for COVID-19, narazaciclib for solid tumors, and Rigosertib for epidermolysis bullosa-associated squamous cell carcinoma[91]. - Viroxavir has completed a Phase 1 study demonstrating positive safety and tolerability data, with plans for a Phase 1 dose extension in the second half of 2024[91]. - Travatrelvir is expected to be more potent than Pfizer's Mpro inhibitor and does not require co-administration with a CYP inhibitor, potentially allowing for wider use[91]. - The Company entered into a contingent value rights agreement, entitling holders to 43.7% of net proceeds from the sale of its two leading cancer drug candidates, Narazaciclib and Rigosertib, during the CVR Term[104]. Expenses and Financial Management - General and administrative expenses increased by $1.2 million, or 59%, to $3.4 million for the three months ended March 31, 2024, primarily due to higher legal and professional fees related to the Trawsfynydd acquisition[125]. - Research and development expenses decreased by $2.2 million, or 53%, to $1.9 million for the three months ended March 31, 2024, mainly due to a reduction in manufacturing costs[127]. - The Company incurred transaction costs of approximately $1.7 million during the three months ended March 31, 2024, included as general and administrative expenses[114]. - The Company issued and sold an aggregate of 496,935 shares of Common Stock and 1,578.2120 shares of Series C Preferred Stock for approximately $14 million as part of a Securities Purchase Agreement[106]. - The Company is exploring various funding sources for development and regulatory approval of its research compounds, indicating potential challenges in obtaining sufficient financing[90]. - 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[132]. Going Concern - Substantial doubt exists regarding the company's ability to continue as a going concern within one year after the date these financial statements are issued[132]. - The company does not currently have a commercial infrastructure for sales and marketing of pharmaceutical products and may rely on licensing agreements for commercialization[143]. - The Company terminated 11 of its 17 employees on April 8, 2024, with estimated severance costs of approximately $1 million to be expensed in the second quarter of 2024[118]. Stock Market Activity - The company’s Common Stock began trading on the Nasdaq Stock Market under the ticker symbol "TRAW" effective April 3, 2024, following a name change to Traws Pharma, Inc.[113].