Investor Event March 31, 2025 Targeting Critical Threats to Human Health Forward-looking statements This presentation contains, and certain oral statements made by management from time to time may contain, "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include ...

Company Overview - 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]. Clinical Programs and Trials - 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]. - Traws Pharma 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 company has conducted extensive pre-clinical studies on tivoxavir marboxil, demonstrating significant antiviral effects in multiple animal models[25]. - Ratutrelvir maintained plasma drug levels within the therapeutic window for 12 days, with 24-hour trough levels constant at approximately 110 nM[37]. - 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 treated at the 200mg dose achieving stable disease[47]. - The maximum tolerated dose for narazaciclib in combination with letrozole was established at 160mg once daily, with no dose limiting toxicities observed in the initial cohort[51]. - The IND submission for narazaciclib to the US FDA was completed in November 2020, with enrollment for the US Phase 1 study commencing in May 2021[48]. - Narazaciclib inhibits CSF1R with IC50 values between 0.7 to 10 nM, indicating potential impact on cancers dependent on CSF1R signaling[40]. - The combination of CDK and ARK5 inhibitors in narazaciclib is proposed to have a differentiated effect on cancer cells by inhibiting both cytostatic and cytotoxic pathways[39]. - The Phase 1 study of narazaciclib in the US involved escalating daily doses starting at 40mg, with the highest tested dose being 280mg[50]. - The clinical experience with rigosertib in RDEB-associated SCC showed 2 complete cutaneous responses in 4 evaluable patients, with durable responses lasting 15 and 16 months[56]. - Rigosertib's safety profile appears acceptable, with preliminary data supporting its activity against PLK1 in RDEB-associated SCC[57]. Financial Overview - Research and development expenses amounted to $12.8 million and $11.4 million for the years ended December 31, 2024 and 2023, respectively, indicating a focus on clinical-stage product candidates[61]. - 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 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 significant losses since its inception in 1998 and anticipates continuing to incur losses in the future due to ongoing research and development expenses[210]. - The company has not generated any revenue from product sales to date and may never become profitable[215]. - The company plans to explore various financing options, including equity financings and strategic alliances, to alleviate concerns about its ability to continue operations[204]. - As of December 31, 2024, the company had cash and cash equivalents of $21.3 million and current liabilities of $11.5 million, raising substantial doubt about its ability to continue as a going concern for the next twelve months[203]. Regulatory Environment - The regulatory process for obtaining marketing approvals is extensive and costly, requiring significant time and financial resources[105][107]. - The FDA is the main regulatory body for biopharmaceuticals in the United States, and non-compliance can lead to severe sanctions[108]. - The FDA has a goal of completing its review of New Drug Applications (NDAs) for new molecular entities within 10 months of acceptance for filing[124]. - The FDA may require a substantial user fee for NDA submissions, which can be waived in certain instances[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 FDA's Animal Rule permits approval of certain drugs based on animal studies when human efficacy studies are not ethical or feasible[154]. - The FDA's Breakthrough Therapy designation allows for expedited development and review of drugs that show substantial improvement over existing therapies for serious conditions[168]. - The Clinical Trials Regulation (EC) 536/2014 enables a single application for cross-border trials within the EU, streamlining the approval process[147]. Competitive Landscape - The biotechnology and pharmaceutical industries are highly competitive, with many competitors having greater financial and technical resources, leading to intense competition for product development and FDA approvals[96][97]. - The company is aware of various approved drugs for influenza treatment, including oseltamivir phosphate (Tamiflu) and baloxavir marboxil (Xofluza), highlighting the competitive landscape[98]. - Several companies have advanced drug candidates for COVID-19, including remdesivir and oral Paxlovid, which have received full FDA approval[99]. - The company faces substantial competition, which may result in others commercializing products before it does[201]. Operational Risks - The company relies on third parties for conducting preclinical and clinical trials, and any failure by these parties could delay regulatory approval[202]. - The company has limited experience in large-scale manufacturing and is dependent on third-party manufacturers, which could lead to delays[202]. - The company may face significant liabilities from product liability lawsuits, which could limit commercialization of its products[201]. - The company may be subject to securities litigation, which could divert management attention and incur expenses[202]. Economic and Market Conditions - The company is currently operating in a period of economic uncertainty and capital markets disruption, which could adversely affect its financial condition and results of operations[219]. - The ongoing military conflicts and geopolitical tensions could negatively impact the global economy and financial markets, potentially affecting the company's ability to obtain additional funding[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 may 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 ...

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 at 10:00 AM ET NEWTOWN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. ...

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 at 10:00 AM ET NEWTOWN, Pa., March 31, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. ...

Werner Cautreels, PhD, to retire as CEO, while continuing as a Board MemberIain D. Dukes, D Phil, Executive Board Chairman, to become Interim CEO NEWTOWN, Pa., March 28, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced the retirement of Werner Cautreels, PhD, Chief Executive Officer (CEO), effec ...

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ:TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respir ...

Event to highlight the differentiated features of Traws oral small molecule product candidates: Tivoxavir Marboxil, a single dose, CAP-dependent endonuclease inhibitor for Bird FluRatutrelvir, a main protease inhibitor, to be used without ritonavir, for COVID-19 NEWTON, Pa., March 26, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respi ...

Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimenPreparations are underway for FDA interactions and initiation of Phase 2 studiesData presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharma ...

Preclinical and Phase 1 data suggest that ratutrelvir can be used without ritonavir and may reduce the likelihood of COVID rebound and the risk of long COVID due to a longer treatment regimenPreparations are underway for FDA interactions and initiation of Phase 2 studiesData presentation to be provided at the Investor Event on March 31, 2025 at 10:00 AM ET NEWTOWN, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ:TRAW) ("Traws Pharma", "Traws" or "the Company"), a clinical-stage biopharmac ...