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].

Exhibit 99.1 Traws Pharma Reports Full Year 2024 Results and Business Highlights Tivoxavir marboxil's potential as a single dose therapeutic agent for bird flu supported by significant antiviral activity in three well accepted animal models and positive Phase 1 data Ongoing FDA interaction to align on path forward for tivoxavir marboxil, including potential for accelerated approval utilizing the "Animal Rule" Cash Runway to support planned operations into Q1 2026 Investor Update call today, March 31, 2025 a ...

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]

Exhibit 99.1 Traws Pharma Reports Q2 2024 Financial Results, Provides Recent Business Highlights Merger with Trawsfynydd Therapeutics, Inc ("Trawsfynydd") and concurrent private placement of $14 million (cash runway to support planned operations through year end), with recently achieved clinical milestones, put Traws on track to achieve key readouts for the clinical pipeline in H2 2024 and beyond · Lead antiviral program, tivoxavir marboxil, for influenza, including avian flu, is dosing the first cohort in ...

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].