Exhibit 99.1 Traws Pharma Reports Second Quarter 2025 Results and Business Highlights Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation ...

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 June 30, 2025 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) Delaware 22-3627252 (State or other jurisdiction of (I.R.S. Employ ...

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 - 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 $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].