TRAW

Advancing tivoxavir marboxil toward MHRA resubmission in Q3 2026 with a revised toxicology package, supporting initiation of the Phase 2a human influenza Challenge study Completed the April 2026 private placement and received shareholder approval of the Series B and Series C tranches, enabling access to up to $50 million in potential additional financing, subject to achievement of program milestones and investor participation NEWTOWN, Pa., Aug. 14, 2026 (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 reported financial results and provided recent business highlights for the quarter ended June 30, 2026, including updates on its lead clinical programs and April 2026 financing. "Following the MHRA's review, we are moving quickly to generate the revised toxicology package the agency identified, and we expect to resubmit by the end of the third quarter of this year. Our conviction in tivoxavir marboxil’s potential as a prophylactic agent for seasonal influenza is unchanged. We look forward to progressing the program towards the initiation of the Phase 2a human influenza Challenge pending MHRA approval," commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. "As we approach respiratory virus season, seasonal influenza remains a significant public health threat, particularly for vulnerable populations such as the elderly and immunocompromised," commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. "Tivoxavir marboxil has the potential to provide an important new option for influenza prophylaxis in these vulnerable populations." Recent Highlights and Anticipated Milestones: Investigational Programs: Tivoxavir marboxil (TXM, influenza)Intended Indication and Market Potential: Potential as a best-in-class oral prophylactic for seasonal flu and potential inclusion in pandemic preparedness initiatives, all-together, estimated to be a multi-billion-dollar opportunity1. Next Steps: Updated Preclinical Data Package to Support MHRA Resubmission — Following feedback from the MHRA on the Company's planned Phase 2a human influenza Challenge study, Traws is preparing an updated toxicology data package. The Company expects to resubmit this package at the end of the third quarter of 2026. If accepted by the MHRA, the study is planned to be conducted in healthy volunteers at hVIVO, a global leader in the conduct of human Challenge studies for infectious diseases and respiratory viruses, in the UK. Efforts Ongoing to Resolve the Clinical Hold — The U.S. Food and Drug Administration (FDA) placed the U.S. IND for TXM on clinical hold due to concerns with the toxicology data package. The Company is preparing a comprehensive response to address the FDA's concerns, with the goal of resolving the hold and advancing the program in the US by the end of 2026. Emerging Viral Threats: Platform BreadthBeyond its lead influenza and COVID-19 programs, Traws' platform has generated early leads with potential applicability to other emerging viral threats, including hantavirus, Ebola virus disease, and Lassa fever, reflecting the breadth of the Company's antiviral capabilities. Financing Update: In April 2026, the Company completed a financing that delivered $10.0 million in upfront proceeds and provides the potential to raise up to an additional $50.0 million through three tranches of warrants, each structured to align capital with key clinical and regulatory milestones: Series A warrant ($10.0 million): exercisable upon MHRA approval of the Company's planned human influenza Challenge study. Series B warrant ($10.0 million): approved by shareholders and exercisable upon announcement of data from the Challenge study. Series C warrant (up to $30.0 million): approved by shareholders. On July 8, 2026, the Company's shareholders approved the Series B and Series C tranches, satisfying a necessary condition for the milestone-based financing structure established in the April 2026 private placement. Access to capital under these tranches remains subject to achievement of the applicable program milestones, the sequential exercise of the earlier tranches, and investor participation. The Series A tranche is exercisable upon MHRA approval of the Company's planned Phase 2a human influenza Challenge study, while the Series B warrant is positioned to become exercisable upon announcement of data from the Challenge study. Together with the Series A warrant, this structure gives Traws Pharma the potential to access up to $50.0 million in additional capital as it advances its influenza program, reinforcing the Company's financial position and its ability to drive its pipeline toward key value-creating milestones. Financial Results: Cash and cash equivalents: As of June 30, 2026, the Company had cash and cash equivalents of $5.0 million, compared to $3.8 million as of December 31, 2025. The increase primarily reflects proceeds from the Company's April 2026 private placement and sales under its at-the-market (ATM) equity program, partially offset by cash used in operations. The Company believes that its existing cash and cash equivalents, together with anticipated proceeds from its at-the-market equity program, will be sufficient to fund planned operations into the first quarter of 2027. However, based on current projections, the Company may not have sufficient cash and cash equivalents to support its operations subsequent to the first quarter of 2027, and may require additional financing. Revenue: The Company recognized no revenue for the three months ended June 30, 2026, compared to $2.7 million for the same period in 2025. For the six months ended June 30, 2026, the Company recognized no revenue, compared to $2.8 million for the same period in 2025. The decrease in both periods was primarily attributable to non-recurring deferred revenue recognized in the second quarter of 2025 in connection with the mutual termination of a licensing agreement related to the Company's legacy oncology program. Research and Development (R&D) Expenses: R&D expenses were $1.1 million for the three months ended June 30, 2026, compared to $2.3 million for the same period in 2025. The decrease of $1.2 million was primarily attributable to lower spending on the Company's tivoxavir marboxil program. For the six months ended June 30, 2026, R&D expenses were $6.0 million, compared to $4.8 million for the same period in 2025. The increase of $1.2 million was primarily attributable to ongoing development activities for ratutrelvir and tivoxavir marboxil, including completion of the Phase 2a clinical trial for ratutrelvir and initiation of a bridging study for tivoxavir marboxil in March 2026. General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the three months ended June 30, 2026, compared to $1.7 million for the same period in 2025. The increase of $1.8 million was primarily attributable to higher professional and consulting fees and non-cash stock-based compensation expense. For the six months ended June 30, 2026, G&A expenses were $5.5 million, compared to $4.4 million for the same period in 2025. Other operating income for the three and six months ended June 30, 2026, consists of the removal of a legacy accrued research and development obligation carried on the Company's balance sheet of $1.4 million, which was initially recognized in a prior reporting period. During the second quarter of 2026, in connection with a review of its legacy accrued balances, the Company determined that the obligation is no longer subject to enforcement and that no future outflow of economic benefits is expected. Because the amount was originally recorded as research and development expense, its removal is presented within operating expenses rather than as non-operating income. Net Loss: Net loss for the three months ended June 30, 2026, was $3.0 million, or $0.16 per basic and diluted common share, compared to a net loss of $0.9 million, or $0.11 per basic and diluted common share, for the same period in 2025. Net loss for the six months ended June 30, 2026, was $10.2 million, or $0.64 per basic and diluted common share, compared to net income of $20.6 million, or $2.02 per basic and $1.95 per diluted common share, for the same period in 2025. Net income for the six months ended June 30, 2025 included a $26.7 million non-cash gain from the change in fair value of warrant liabilities. Shares Outstanding: Traws had 15,368,277 shares of common stock outstanding as of August 13, 2026. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose prophylactic agent for seasonal influenza and treatment of pandemic/bird flu. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion-dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. Source information Per link Traws data on file Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. The Company is advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health including seasonal influenza and H5N1 bird flu, negative-strand RNA viruses including Hantavirus, Ebola Virus Disease, Lassa Fever and COVID-19/Long COVID. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing of Traws’ clinical trials; the potential for tivoxavir marboxil to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the extent of the spread and threat of the bird flu; seasonal flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Charles ParkerTraws Pharma, [email protected] www.trawspharma.com Investor Contact:John Fraunces LifeSci Advisors, [email protected]

Private financing of up to $60M offering of common stock (with $10M upfront) and milestone-based warrants expected to support operations into Q1 2027 Tivoxavir marboxil advancing towards a human influenza challenge trial as a once-monthly prophylactic agent Advancing clinical candidates for the treatment of hantavirus infections NEWTOWN, Pa., May 15, 2026 (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 provided recent business highlights and reported financial results for the quarter ended March 31, 2026. The highlights include updates on the Company's lead program, tivoxavir marboxil (TXM), in development for influenza prophylaxis, and its hantavirus drug development efforts. “Q1 2026 was a period of meaningful progress for Traws. The recently announced private financing of up to $60 million in gross proceeds provides us with a clear runway into Q1 2027 and supports our ability to execute on our key programs. We are advancing TXM toward a human challenge trial as a once-monthly prophylactic agent against seasonal influenza, which is scheduled to be initiated in Q2 2026. Separately, we will be actively engaging with the FDA to resolve the clinical hold and enable initiation of global studies by year end,” commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. “Our pipeline now also includes a potential antiviral therapy for hantavirus. The recent outbreak1 brought new attention to a disease with no approved treatments.” Recent Highlights and Anticipated Milestones: $60 Million Private Financing On April 15, 2026, TRAW announced an up to $60 million private investment in a public equity (PIPE) financing, including $10 million in gross proceeds at closing, with up to approximately $50 million of additional potential gross proceeds from milestone-based and three-year warrants. As described in the Company’s 8K issued on April 15, 2026, the financing consists of the sale of 5,982,919 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $1.6730 per share. The upfront gross proceeds and milestone-based warrants, along with the current cash and cash equivalents, are estimated to provide sufficient resources to fund company operations into Q1 2027 including completion of a human challenge trial to evaluate TXM as a once-monthly prophylactic agent for influenza prevention. Investigational Programs: Tivoxavir Marboxil (TXM, influenza): Intended Indication and Market Potential: Potential as a best-in-class once-monthly prophylactic for seasonal flu and potential inclusion in pandemic preparedness initiatives,2,3   all-together, estimated to be a multi-billion-dollar opportunity. Next Steps: Completion of Phase 1 Bridging Study – The ongoing Phase 1 Bridging Study, conducted under an open IND in Australia, is intended to evaluate if the compressed tablet formulation provides 28-days of coverage. MHRA Approval and Initiation of Challenge trial – Following completion of the Phase 1 Bridging Study and receipt of MHRA approval, TRAW will conduct a single-dose influenza virus challenge trial of TXM at hVIVO, a global leader in the conduct of human challenge studies for infectious diseases and respiratory viruses, in the UK. Efforts Ongoing to Resolve the Clinical Hold – FDA placed the U.S. IND for TXM on clinical hold due to concerns with the toxicology data package. The Company is preparing a comprehensive response, with the goal of resolving the hold and enabling initiation of global clinical studies by year end. Hantavirus Program: Intended Indication and Market Potential: Hantavirus, a rodent-borne negative-strand RNA virus that typically results in a 30-50% fatality rate when transmitted to humans and which has been implicated as the cause of several cruise ship fatalities and serious illnesses in recent days1. Next Steps: Traws plans to move rapidly to advance a clinical candidate for hantavirus treatment. Financial Results: Cash and cash equivalents: As of March 31, 2026, the Company had cash and cash equivalents of approximately $3.1 million, compared to approximately $3.8 million as of December 31, 2025, excluding gross proceeds of up to approximately $60 million for a PIPE financing and milestone-based and three-year warrants which the Company completed on April 15, 2026. Based on current plans, the Company believes that its current cash balance, including net proceeds from the offering and milestone-based warrants, is sufficient to support planned expenses, including completion of the Challenge Study, into Q1 2027. Revenue for the quarter ended March 31, 2026, was $0.0 million, compared to $0.06 million for the comparable period in 2025. Research and development (R&D) expense for the quarter ended March 31, 2026, totaled $4.9 million, compared to $2.5 million for the comparable period in 2025. This increase of $2.4 million primarily relates to an increase in expenses related to completion of antiviral clinical trial milestones. General and administrative (G&A) expense for the quarter ended March 31, 2026, totaled $2.0 million, compared to $2.8 million for the comparable period in 2025. This decrease of $0.7 million was primarily attributable to a decrease in professional and consulting fees. Change in fair value of warrant liability for the quarter ended March 31, 2026, was an expense of $0.2 million, compared to other income of $26.5 million for the comparable period in 2025. The change for the three months ended March 31, 2025 is primarily attributable to remeasurement of the warrant liability upon amendment and partial exercise of the Pre-Funded Warrants and Series A Warrants, and the fair value of remaining Series A Warrants as of March 31, 2025. Net Income (loss): The net loss for the quarter ended March 31, 2026 was $7.1 million, or a net loss of $0.53 per basic and diluted common share. This compares to net income of $21.5 million, or net income of $2.17 per basic and $2.09 per diluted common share, for the quarter ended March 31, 2025. Shares Outstanding: Traws had 15,150,669 shares of common stock outstanding as of May 12, 2026. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose prophylactic agent for seasonal influenza and treatment of pandemic/bird flu. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion-dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives 2,3, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. Source information About Traws Pharma, Inc. Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health including seasonal influenza and H5N1 bird flu, negative-strand RNA viruses including hantavirus and COVID-19/Long COVID. Lead program, tivoxavir marboxil, is in development as a once-monthly oral prophylactic agent for influenza prevention, with additional potential as a single-dose therapy for seasonal flu or H5N1 bird flu, targeting the influenza cap-dependent endonuclease (CEN). For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing of Traws’ clinical trials; Traws’ ability to identify and advance potential clinical candidates for the treatment of hantavirus infections, the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for tivoxavir marboxil and ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of pandemic flu including H5N1 bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact:Charles ParkerTraws Pharma, [email protected] www.trawspharma.com Investor Contact:John Fraunces LifeSci Advisors, [email protected]

This article first appeared on GuruFocus. Revenue: $2.8 million for the year ended December 31, 2025, compared to $226,000 in 2024. Net Income: $9.2 million for the year ended December 31, 2025, compared to a net loss of $166.5 million in 2024. Cash and Cash Equivalents: Approximately $3.8 million as of December 31, 2025, compared to $21.3 million as of December 31, 2024. Research and Development Expense: $12.1 million for the year ended December 31, 2025, compared to $12.8 million in 2024. General and Administrative Expense: $8.5 million for the year ended December 31, 2025, compared to $12.3 million in 2024. Private Financing: $60 million, including $10 million upfront and potential additional proceeds from milestone-based warrants. Warning! GuruFocus has detected 6 Warning Signs with TRAW. Is TRAW fairly valued? Test your thesis with our free DCF calculator. Release Date: April 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Traws Pharma Inc (NASDAQ:TRAW) announced a $60 million private financing, positioning the company to advance its flu program through the Human Challenge Study this summer. The company's lead candidate, tavoxivir, is positioned as a potential best-in-class prophylactic agent for influenza, with a once-monthly oral formulation. Preclinical studies showed robust antiviral activity of tavoxivir against a wide range of influenza strains, including all influenza A and B strains. Phase I data indicated that tavoxivir maintained plasma blood levels well above the EC90 for over three weeks, with good overall safety. The company reported a significant increase in revenue for 2025, reaching $2.8 million compared to $226,000 in 2024, primarily due to deferred revenue recognition from a terminated licensing agreement. The US FDA placed a clinical hold on Traws Pharma Inc's Investigational New Drug application due to concerns with the toxicology data package. The company's cash, cash equivalents, and short-term investments decreased significantly from $21.3 million in 2024 to $3.8 million in 2025. Research and development expenses remained high at $12.1 million for 2025, despite a slight decrease from the previous year. The company faces potential regulatory challenges with the MHRA in the UK regarding the initiation of the Human Challenge Study. There is uncertainty regarding the optimal dosing frequency for tavoxivir, which could impact its commercial viability and competitive positioning. Q: Can you clarify the FDA's concerns regarding the toxicology data package and any potential mutagenicity risks for tavoxivir? A: The structural similarity of tavoxivir to Zofluza, which has a clean mutagenicity label, gives us confidence. We plan to repeat some assays and submit new ones, using Zofluza as a control. We believe the initial data suggesting mutagenic risk can be explained by other mechanisms. Q: Are there any risks or potential delays with the MHRA regarding the start of the study in the UK this summer? A: Our package is under review by the MHRA, which has a 30-day review period. Different regulatory agencies can reach different conclusions on the same data. For instance, Australia approved our studies with the same toxicology data. We remain optimistic about the MHRA's approval. Q: If the challenge study data suggests a different dosing frequency, such as twice monthly or weekly, would you consider it commercially viable? A: Yes, we are open to different dosing frequencies. We will evaluate the challenge study results to determine the optimal dosing frequency for Phase 2b/3 trials, considering both efficacy and market research insights. Q: What triggers the final $30 million tranche of the financing, and how can it be accessed? A: The final Series C warrant includes an acceleration feature. If our stock trades at twice the deal price for 30 consecutive days, we can force exercise the warrant within a 10-day window. Otherwise, it has a three-year term. Q: What is the commercial strategy for tavoxivir as a prophylactic agent for influenza? A: We aim to position tavoxivir as a best-in-class, once-monthly oral prophylactic agent for flu prevention. It has shown robust antiviral activity and a favorable safety profile, making it suitable for seasonal flu and pandemic preparedness. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Management is prioritizing tivoxavir marboxil as a potential best-in-class once-monthly oral prophylactic for seasonal influenza, targeting the highly conserved CAP-dependent endonuclease. The strategic focus on prophylaxis aims to address unmet needs in vulnerable populations and secure inclusion in the U.S. National Stockpile for pandemic preparedness, including H5N1 bird flu. A next-generation compressed tablet formulation has been developed, showing a 30% increase in exposure in preclinical studies compared to the first-generation powder formulation. The company attributes its confidence in a 28-day dosing window to Phase I data showing plasma levels remaining above EC90 for over three weeks with the initial formulation. Operational progress is currently centered on a bridging study in Australia to confirm the optimized pharmacokinetic profile of the new tablet formulation. Management noted that while they are engaging with the FDA regarding a clinical hold, they are proceeding with U.K. and Australian clinical activities where regulatory agencies have not flagged similar concerns. Traws intends to initiate a Phase IIa human challenge study in the U.K. this summer, contingent on MHRA approval, to establish proof-of-concept for viral protection. The company is actively working to resolve an FDA clinical hold on its IND application related to the toxicology data package, with a goal of advancing U.S. development in late 2026. Management plans to share positive bridging data from the Australian study with the MHRA to support the upcoming seasonal flu prophylaxis challenge trial. Future Phase IIb/III study designs and dosing frequency (ranging from once-weekly to once-monthly) will be determined by the specific duration of protection observed in the human challenge study. Current cash reserves, including potential milestone-based warrant proceeds, are projected to support planned operations into Q1 2027. The FDA placed a clinical hold on the tivoxavir IND in January 2026 due to concerns regarding the toxicology data package. A $60 million private financing was structured with $10 million upfront and $50 million tied to milestone-based warrants and stock price performance. 2025 revenue of $2.8 million was primarily driven by a one-time $2.7 million deferred revenue recognition following the termination of a legacy oncology licensing agreement. The Series C warrant for $30 million includes an acceleration feature if the stock trades at 2x the deal price ($1.67) for 30 consecutive days. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management believes the toxicology concerns may be due to flaws in initial assays rather than the drug itself, noting that the structurally similar Xofluza has a clean immunogenicity label. The company plans to repeat assays using Xofluza as a control to demonstrate a similar safety profile to the FDA. CEO Iain Dukes noted that regulatory agencies often reach different conclusions on identical data, highlighting that Australian regulators approved two studies despite having access to the same toxicology package. The company remains optimistic about the MHRA's 30-day review clock for the U.K. challenge study. While targeting a once-monthly regimen, management stated that a once-weekly oral dose would still be commercially attractive compared to injectable alternatives. The final dosing strategy will be optimized based on the degree of protection measured at 1, 2, 3, and 4-week intervals during the challenge trial. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

Tivoxavir marboxil advancing towards a human influenza challenge trial as a once-monthly prophylactic agent, building on broad preclinical antiviral activity, Ratutrelvir topline Phase 2a data show a differentiated profile versus PAXLOVID® in COVID patients, with good overall safety; final study analysis underway Private financing of up to $60M (with $10M of such amount upfront) offering of common stock and milestone-based and three-year warrants completed on April 15, 2026 supporting operations into Q1 2027 Investor Update call today, April 15, 2026 at 4:30 PM ET NEWTOWN, Pa., April 15, 2026 (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 reported financial results for the year ended December 31, 2025 and provided recent business highlights including updates for the Company’s lead investigational program: tivoxavir marboxil (TXM) in development for influenza prophylaxis and treatment, and completion of a private investment in public equity (PIPE) financing providing up to $60 million in gross proceeds, including $10 million in gross proceeds at closing. The financing, plus current cash and cash equivalents, is expected to provide sufficient resources to support Company operations into Q1 2027, including completion of the planned Phase 2a single-dose human Challenge Trial for TXM as a once-monthly oral prophylactic agent for influenza prevention (“Challenge Trial”). “Traws has made substantial progress over the last year, towards our goal of advancing our potential best-in-class influenza program as a prophylactic agent. The bridging study for the new compressed tablet formulation is currently underway in Australia. In parallel, the Company expects the planned Challenge Trial to proceed as scheduled in the second quarter of 2026, subject to formal approval from the United Kingdom Medicines and Healthcare products Regulatory Agency (“MHRA”). Additionally, we are actively engaging with the U.S. Food and Drug Administration to resolve the clinical hold and support advancement of the TXM program in the U.S.,” commented Iain Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. “The capital from the recent private financing, supported by a group of new and existing investors, positions Traws to complete the Challenge Trial, while preserving access to substantial additional capital as key milestones are achieved.” Conference Call and Webcast Information Date: Wednesday, April 15, 2026, at 4:30 PM ET Participant Dial-in (U.S.): 1-877-407-0789 Participant Dial-in (International): 1-201-689-8562 Webcast Access: Click Here A replay of the webcast will be available on the Investors section of the Traws website at https://www.trawspharma.com/corporate-events-presentations. Recent Highlights and Anticipated Milestones: $60 Million Private Financing On April 15, 2026, TRAW announced an up to $60 million PIPE financing including initial funding of $10 million in gross proceeds at closing, with up to approximately $50 million of additional potential gross proceeds from milestone-based and three-year warrants. The financing consists of the sale of 5,982,919 shares of common stock (or pre-funded warrants in lieu thereof) at a purchase price of $1.6730 per share, with the warrant exercise price equal to the deal price, as follows: Series A milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable upon receipt of approval from MHRA to conduct the challenge trial. Series B milestone-based warrant with an aggregate exercise price of $10.0 million that becomes exercisable following both shareholder approval and the announcement of data from the challenge trial. Series C common warrants with a three-year term to purchase shares of our common stock and providing potential additional gross proceeds of $30.0 million if fully exercised following shareholder approval. The upfront gross proceeds and milestone-based warrants, along with the current cash and cash equivalents, are estimated to provide sufficient resources to fund company operations into Q1 2027 including completion of a human challenge trial for TXM as a once-monthly prophylactic agent for influenza prevention. The terms of the financing are described in more detail in the Company’s current report on Form 8-K filed in connection with the financing on April 15, 2026. Investigational Programs: Tivoxavir Marboxil (TXM, influenza): Intended Indication and Market Potential: Potential as a best-in-class once-monthly prophylactic or treatment for seasonal flu and pandemic/bird flu, estimated to be a multi-billion dollar opportunity, including potential for stockpiling and pandemic preparedness initiatives.1,2 Recent Developments: New Formulation Supports Planned Prophylactic Treatment Study Recently completed preclinical studies show that the new TXM compressed tablet formulation provides longer exposure and extended coverage against influenza. This new formulation, coupled with broad preclinical activity previously demonstrated against a wide range of influenza strains, including all influenza A and B strains, supports TXM’s potential use as a once-monthly prophylactic treatment for seasonal flu. Traws also continues to advance the program for TXM as a single-dose oral therapy for seasonal flu or H5N1 bird flu, including efforts to secure formal consideration by the Biomedical Advanced Research and Development Authority (BARDA) for inclusion in the U.S. stockpile, with a focus on resolving the clinical hold by the U.S. FDA. Next Steps: Completion of Phase 1 Bridging Study – The ongoing Phase 1 bridging study, being conducted under an open IND in Australia, is intended to recapitulate the preclinical data and confirm that the new compressed tablet formulation can provide 28-days of coverage, enabling TXM’s use as a once-monthly prophylactic treatment. MHRA Approval and Initiation of Challenge trial – TRAW will conduct a single-dose influenza virus challenge trial of TXM at hVIVO, in the UK, following completion of the Phase 1 Bridging study and receipt of MHRA approval. hVIVO is global leader in the conduct of human challenge studies for infectious diseases and respiratory viruses. Efforts Ongoing to Resolve the Clinical Hold – FDA informed the Company that its U.S. IND for TXM has been placed on clinical hold due to concerns with the toxicology data package. The Company plans to engage with the FDA to address the clinical hold and is working to develop and submit a comprehensive response, with the goal of resolving the hold and advancing the program in the U.S. during 2026. Ratutrelvir (COVID): Intended Indication and Market Potential: Potential as a once-daily, ritonavir-independent oral Main protease (Mpro) inhibitor for the treatment of acute COVID infection in a broad range of patients, including those who are PAXLOVID®-ineligible, with potential to reduce the risk of COVID rebound and Long COVID, estimated to be a multi-billion dollar opportunity.3 Recent Developments: Positive Phase 2a Results Traws is completing final analysis of the 90-patient Phase 2a study. Topline data demonstrated safety and proof-of-concept efficacy for ratutrelvir in PAXLOVID®-eligible and PAXLOVID®-ineligible patients. Patients ineligible to receive PAXLOVID® are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option. The Phase 2a study was designed as an active-controlled comparator trial versus PAXLOVID® (nirmatrelvir/ritonavir), evaluating patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications or clinically significant drug–drug interactions. Topline data showed: Efficacy: Ratutrelvir demonstrated equivalent time to sustained treatment resolution with no viral rebounds in PAXLOVID® eligible subjects. The study also showed that treatment with ratutrelvir produced faster symptom resolution in PAXLOVID®-ineligible patients (HR, 1.31; 95% CI, 0.78-2.20, p=0.018). Safety: Ratutrelvir demonstrated favorable overall safety, with fewer treatment related adverse events compared to PAXLOVID®. Next Steps: Phase 2 Data Support Further Development of Ratutrelvir – Traws plans to use the resulting data from the final analysis of the Phase 2a study to inform next steps for its clinical and regulatory strategy. Corporate Updates: John Leaman, MD, named Independent Board Director on October 6, 2025, bringing significant expertise in finance, M&A and corporate strategy. Appointment of Iain Dukes, MA, D Phil, as CEO, and Charles Parker, as CFO, confirmed by the Board on October 6, 2025. Financial Results: Cash and cash equivalents: As of December 31, 2025, the Company had cash and cash equivalents of approximately $3.8 million, compared to approximately $21.3 million as of December 31, 2024, excluding gross proceeds of up to approximately $60 million for a PIPE financing and milestone-based and three-year warrants which the Company completed on April 15, 2026, with funding thereunder expected April 16, 2026. Based on current plans, the Company believes that its current cash balance, including net proceeds from the offering and milestone-based warrants, is sufficient to support planned expenses, including completion of the Challenge Study, into Q1 2027. Revenue for the year ended December 31, 2025, was $2.8 million, compared to $0.2 million for the comparable period in 2024. The increase in 2025 revenue was due to the recognition of deferred revenue as a result of the termination of the Symbio license agreement. Acquired in-process research and development expense for the year ended December 31, 2025 was zero compared to $117.5 million for the comparable period in 2024, recognized related to virology programs acquired in connection with the acquisition of Trawsfynydd through a merger. Research and development (R&D) expense for the year ended December 31, 2025, totaled $12.1 million, compared to $12.8 million for the comparable period in 2024. This decrease of $0.7 million primarily relates to a decrease in expenses related to the oncology programs, partially offset by an increase in expenses related to the virology programs. General and administrative (G&A) expense for the year ended December 31, 2025, totaled $8.5 million, compared to $12.3 million for the comparable period in 2024. This decrease of $3.8 million was primarily attributable to a decrease in professional and consulting fees. Net Income (loss): The net income for the year ended December 31, 2025 was $9.2 million, or net income of $0.83 per basic common and $0.82 per diluted common share. This compares to net loss of $166.5 million, or a net loss of $35.21 per basic and diluted common share, for the year ended December 31, 2024. Shares Outstanding: Traws had 10,157,257 shares of common stock outstanding as of April 14, 2026. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose agent for prophylactic use or treatment of seasonal influenza and pandemic/bird flu. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives1,2, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions4, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID5. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3. Source information Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: seasonal influenza and H5N1 bird flu, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a once-monthly oral prophylactic agent for influenza prevention, with additional potential as a single-dose therapy for seasonal flu or H5N1 bird flu, targeting the influenza cap-dependent endonuclease (CEN). Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing of Traws’ clinical trials; the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-355-2395 [email protected]

IND filing of tivoxavir marboxil represents final step for formal consideration by the Center for the Biomedical Advanced Research and Development Authority (BARDA) for inclusion in strategic stockpile Updated clinical results with ratutrelvir confirm a differentiated profile versus PAXLOVID® with fewer adverse events, no viral rebounds and faster time to sustained symptom resolution Ratutrelvir’s safety and efficacy advantage recapitulated in PAXLOVID®-ineligible patients, representing a significant population with few effective treatment options Full study enrollment expected in January 2026 NEWTOWN, Pa., Jan. 13, 2026 (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 filing of a U.S. IND application with the U.S. Food and Drug Administration (FDA) for tivoxavir marboxil (TXM), a potential best in class CAP-dependent endonuclease inhibitor as a single oral tablet administered for the treatment of influenza. “This filing represents an important step towards formal consideration of TXM for influenza therapy and inclusion in the strategic national stockpile,” commented C. David Pauza, PhD, Chief Scientific Officer of Traws Pharma. “Coupled with our ongoing positive interactions with the U.S. Department of Health and Human Services (HHS) regarding the unique properties of TXM as a broad pan-influenza strain therapeutic, we remain optimistic about the potential inclusion of this agent in the nation’s armamentarium against potential future disease outbreaks.” Updated ratutrelvir interim clinical results from the Phase 2 COVID study Separately, the Company announced updated analysis of its ongoing study of ratutrelvir, an investigational oral, ritonavir-free Mpro/3CL protease inhibitor, confirming a differentiated clinical profile in a prespecified interim analysis of an ongoing randomized, open-label Phase 2 clinical study versus PAXLOVID® in patients with mild-to-moderate COVID-19, together with a single arm in PAXLOVID®-ineligible subjects. Patients ineligible to receive PAXLOVID® are frequently at elevated risk for severe disease and require suitable, safe and effective treatment options. Ratutrelvir has the potential to address this gap in care and may be a valuable therapeutic option. The study, designed as an active-controlled comparator trial versus PAXLOVID® (nirmatrelvir/ritonavir), evaluated patient-reported symptom outcomes, safety, and real-world usability. A separate treatment arm was comprised of patients ineligible for ritonavir-boosted regimens due to contraindications or clinically significant drug–drug interactions. To date, 50 patients have been included in the interim analysis, with 32 patients treated with ratutrelvir and 18 patients treated with PAXLOVID®. Of the planned 90-patient population, 95% has been enrolled. Patients in the ratutrelvir arm received ratutrelvir 600 mg orally once daily for 10 days, while patients in the comparator arm received PAXLOVID®, administered as nirmatrelvir 300 mg twice daily plus 100mg ritonavir twice daily for 5 days, consistent with approved prescribing information. “From a clinical perspective, these interim data confirm that ratutrelvir may provide a meaningful benefit across a broader range of patients, including those who are unable to receive ritonavir-boosted therapy,” commented Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “The favorable tolerability profile, together with a shortened time to symptom resolution and the absence of viral rebound events in ratutrelvir-treated patients, encourages and supports the continued clinical evaluation of ratutrelvir in both acute COVID-19 and in studies designed to better understand its potential impact on longer-term outcomes.” Across the analysis, ratutrelvir-treated patients demonstrated time-to-sustained symptom alleviation and resolution that was numerically superior to PAXLOVID® -treated patients, as assessed using the InFLUenza Patient-Reported Outcome Plus (FLU-PRO Plus)/ COVID-19 Symptoms Diary (12 days versus 14 days, respectively (p<0.014)). Sustained alleviation was defined as self-reported alleviation of all COVID-19 symptoms for four consecutive days. No COVID-19 symptom or virologic rebound events have been observed to date in ratutrelvir-treated patients. One rebound event was observed in the PAXLOVID® comparator arm, occurring shortly after completion of the standard 5-day dosing regimen. Thirteen patients treated with ratutrelvir were ineligible for PAXLOVID® due to contraindications or drug–drug interaction risk. These patients demonstrated patient-reported symptom improvement dynamics and safety, consistent with those observed in the broader ratutrelvir-treated cohort. Ratutrelvir was well tolerated in the interim analysis, with fewer reported adverse events compared with the PAXLOVID®-treated cohort. Evaluating only subjects that had completed the 28 day period of assessment, the most commonly reported adverse event among ratutrelvir-treated patients was mild dyspepsia, reported in 2 patients (7.6%). No dysgeusia or ritonavir-associated adverse effects were reported, and no treatment discontinuations due to adverse events were observed. In contrast, adverse events commonly associated with PAXLOVID®, including dysgeusia, dizziness, and dyspepsia, were reported in 4 patients (30%) in the comparator arm, consistent with prior clinical trial and real-world experience. “The combination of early and sustained symptom improvement, extended dosing duration, absence of viral rebound observed to date, and favorable tolerability supports the strategic hypothesis that ratutrelvir may have utility in reducing post-acute sequelae of SARS-CoV-2 infection (Long COVID),” commented Dr. Redfield. “By enabling earlier and potentially more complete viral clearance, without the limitations associated with ritonavir boosting, ratutrelvir may offer a differentiated approach to both acute COVID-19 treatment and prevention of longer-term complications, pending confirmation in dedicated clinical studies.” “Collectively, the interim data position ratutrelvir as a next-generation oral 3CL protease inhibitor with ritonavir-free administration, once-daily oral dosing, an improved time to symptom resolution and tolerability profile, with applicability to PAXLOVID®-ineligible populations, and potential relevance to long-COVID prevention strategies,” commented Iain Dukes MA DPhil, Chief Executive Officer of Traws Pharma. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions1, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID2. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives4,5, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. Source information Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of Traws’ IND filing with the FDA; the success and timing of Traws’ clinical trials, including when Traws will report the final analysis of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-355-2395 [email protected]

Progressing Phase 2 studies for ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID with expected top line data by year end Significant intellectual property and other assets acquired Significant cost reductions quarter over quarter NEWTOWN, Pa., Nov. 13, 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 reported financial results for the quarter ended September 30, 2025 and provided recent business highlights for its antiviral programs. Recent Highlights and Anticipated Milestones: Product Development Ratutrelvir (COVID): Potential best-in-class therapy to minimize the risk of viral rebound and Long COVID A ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed to be administered as a single dose, with potential for once-daily, 10-day dosing Intended Indication: Treatment of acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVID, including in currently PAXLOVID® -ineligible patients U.S. Market Opportunity: Estimated to be a multi-billion dollar opportunity1 Recent Updates: Phase 2 initiation: Dosing initiated in a Phase 2 non-inferiority study to evaluate the effects of ratutrelvir, compared to PAXLOVID®, in newly diagnosed COVID patients. The program also includes a separate single arm study to evaluate the safety and efficacy of ratutrelvir in patients who are ineligible for treatment with PAXLOVID®. Prior Phase 1 studies showed ratutrelvir maintained plasma drug levels four times above the EC90 over a 10-day treatment period in healthy volunteers, with no drug-induced metabolism and no treatment-related adverse events. Next Steps: Topline data expected by year-end 2025 from both the Phase 2 non-inferiority study and the single-arm study in PAXLOVID®-ineligible subjects Tivoxavir Marboxil (TXM, Bird flu and seasonal flu): Potential best-in-class single-dose treatment for bird flu and seasonal flu A single-dose, investigational CAP-dependent endonuclease inhibitor Intended Indication: Treatment or prevention of H5N1 bird flu and seasonal flu U.S. Market: Estimated to be a multi-billion dollar opportunity, including potential government stockpiling2,3 for pandemic preparedness in the short- to medium-term. Recent Updates: Prior Phase 1 studies showed that a single dose-maintained plasma blood levels above the EC90 for approximately three weeks, with good overall tolerability. Preclinical data support evaluation of TXM in bird flu and seasonal flu based on compelling protection against mortality and disease in three well accepted flu “challenge” models (mice, ferrets and non-human primates) using an H5N1 virus isolated from a dairy worker. Next Steps: Stockpiling readiness: Filing of IND to enable advancement of discussions with BARDA regarding the inclusion of TXM in the drug stock piling initiative for pandemic preparedness. Legacy Programs: Traws’ strategic objective for its legacy oncology assets (rigosertib and narazaciclib) is to establish additional partnerships for further development. Rigosertib Intended Indication: Treatment of recessive dystrophic epidermolysis bullosa associated locally advanced or metastatic squamous cell carcinoma (RDEB SCC) U.S. Market: RDEB SCC is an ultra rare, complicated monogenic disease with a highly aggressive, early metastasizing course, and a cumulative risk of death of ~70-79% by 45-55 years of age4,5 Recent Updates: Publication of key clinical efficacy data for rigosertib in RDEB SCC in the British Journal of Dermatology6 showing a compelling overall response rate of 80%, with complete responses in 50% of evaluable patients and good overall tolerability. These data suggest that rigosertib has the potential to address the substantial unmet need for approved therapies to treat RDEB SCC. Next Steps: Exploring pathways to advance this important potential medicine: Traws is seeking partnership opportunities to support further development of rigosertib Management Updates: John Leaman, MD, named Independent Board Director on October 6, 2025, bringing significant expertise in finance, M&A and corporate strategy. Permanent appointment of Iain Dukes, MA, D Phil, as CEO, and Charles Parker, as CFO, confirmed by the Board on October 6, 2025. Financial Results: Cash and cash equivalents: As of September 30, 2025, the Company had cash and cash equivalents of approximately $6.4 million, compared to approximately $21.3 million as of December 31, 2024. Intangible Assets for the quarter ended September 30, 2025 were $2.6 million compared to zero for the comparable period in 2024. On September 9, 2025, the Company announced that it had entered into an Asset Purchase Agreement with Viriom, Inc., a related party. The transaction includes the Company’s purchase of key intellectual property and other assets associated with a pyrrolidine antiviral compound. Total consideration paid for the assets was $2.6 million, which includes legal costs incurred in consummating the Asset Purchase Agreement of $0.2 million. The purchased patent has a useful life of 15 years and will be amortized on a straight-line basis over this period, as the economic benefits are expected to be realized evenly over the patent’s useful life. Revenue for the quarter ended September 30, 2025, was zero, compared to $57 thousand for the comparable period in 2024. Research and development (R&D) expense for the quarter ended September 30, 2025, totaled $2.3 million, compared to $5.1 million for the comparable period in 2024. This decrease of $2.8 million primarily relates to decrease in expenses related to the virology and oncology programs. General and administrative (G&A) expense for the quarter ended September 30, 2025, totaled $1.7 million, compared to $3.5 million for the comparable period in 2024. This decrease of $1.8 million was primarily attributable to a decrease in professional and consulting fees. Net Income (loss): The net loss for the quarter ended September 30, 2025 was $4.0 million, or a net loss of $0.34 per basic common and diluted common share. This compares to a net loss of $8.5 million, or a net loss of $1.49 per basic and diluted common share, for the quarter ended September 30, 2024. Shares Outstanding: Traws had 7,990,867 shares of common stock outstanding as of November 10, 2025. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions7, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID8. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity1. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives2,3, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. Source information Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, including when Traws will report results of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-355-2395 [email protected]

Non-inferiority trial versus PAXLOVID® assessing safety and efficacy, including rates of disease rebound and incidence of Long COVID development, of ratutrelvir, a ritonavir-free anti-viral treatment Separate single-arm trial assessing safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant, vulnerable population with few available treatment options Top-line data from both trials expected by year-end 2025 NEWTOWN, Pa., Oct. 14, 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 dosing of the first subject in a Phase 2 study to evaluate ratutrelvir, a ritonavir-free anti-viral treatment in newly diagnosed COVID subjects. “The first trial will enable Traws to compare ratutrelvir, a potential best in class ritonavir-free agent, against the current gold standard, PAXLOVID®,” said Iain D. Dukes, MA, DPhil, Chief Executive Officer of Traws Pharma. “This study will evaluate safety, as well as rates of infection, COVID symptoms, disease rebound and incidence of Long COVID. In addition, we will initiate a second trial to evaluate the safety and efficacy of ratutrelvir in PAXLOVID®-ineligible patients, a population at risk for poor outcomes from COVID infection with few available treatment options. Our expectation is to be able to report the results of both Phase 2 studies by year-end 2025.” “Across the US, we see multiple signs that COVID continues to threaten public health, especially among elderly and vulnerable individuals,” said Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “We believe that Traws’ ritonavir-free COVID therapeutic candidate, ratutrelvir, has the potential to overcome the shortcomings of current treatments and become the new standard of care. Ratutrelvir’s good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and the risk of Long COVID. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program.” About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions1, and potentially enable wider patient use. Phase 1 data also showed that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID2. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity3. Source information: Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “potential”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, including when Traws will report results of the Phase 2 studies of ratutrelvir; the potential efficacy of ratutrelvir for the treatment of COVID-19; the potential for ratutrelvir to gain market acceptance, if and when regulatory approval is obtained, or become the new standard of care; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-335-2395 [email protected]

Non-inferiority trial to assess safety and efficacy, including rates of disease rebound and incidence of Long COVID development of ratutrelvir, a ritonavir-free treatment, compared to PAXLOVID® Separate single-arm trial will assess safety and efficacy in PAXLOVID®-ineligible subjects, who represent a significant vulnerable population with few available treatment options Top-line data from both trials expected by year-end 2025 NEWTOWN, Pa., Aug. 18, 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 receipt from the Human Research Ethics Committee (HREC) of approval to proceed with a Phase 2 study to evaluate ratutrelvir, a ritonavir-free treatment in newly diagnosed COVID subjects. “The first trial will enable Traws to compare ratutrelvir, a potential best in class ritonavir-free agent, against the current gold standard, PAXLOVID®. Importantly, in second quarter 2025, Pfizer reported $427 million in sales for PAXLOVID®, representing a 70% increase compared to the same period in the prior year1,” said Iain D. Dukes, MA, DPhil, Interim Chief Executive Officer of Traws Pharma. “This study will evaluate safety, as well as rates of infection, COVID symptoms, disease rebound and incidence of Long COVID. In addition, we will initiate a second trial to evaluate the safety and efficacy of ratutrelvir in PAXLOVID®-ineligible patients, a population at risk for poor outcomes from COVID infection with few available treatment options. Our expectation is to be able to report the results of both these Phase 2 studies by year-end 2025.” “Across the U.S., we see multiple signs that COVID-19 continues to threaten public health, especially among elderly and vulnerable individuals,” said Robert R. Redfield, MD, Chief Medical Officer of Traws Pharma. “Current treatments do not fully control the virus, and require booster agents that often result in unfavorable drug interactions. Current therapies fail to prevent either the short-term rebound of symptoms or the onset of Long COVID. We believe that Traws’ ritonavir-free COVID therapeutic candidate, ratutrelvir, has the potential to overcome shortcomings of current treatments and become the new standard of care. Ratutrelvir’s good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and the risk of Long COVID. We are pleased to initiate these two Phase 2 trials in the Southern Hemisphere. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program.” “The rapid spread of new viral variants and rising rates of test positivity indicate that a new COVID surge is ongoing in the U.S. In just four months, the new variant NB.1.8.1 appeared and increased to now represent 40% of all COVID cases2, showing the speed of virus spread in the population. With waning COVID immunity and declining vaccination rates, antiviral drugs are increasingly important for reducing symptoms of disease and possibly protecting family members from infection. However, approved therapies do not control all outcomes of COVID, especially among vulnerable populations, which include elderly and immunosuppressed individuals who are often excluded from treatment due to the presence of ritonavir in PAXLOVID®,” said C. David Pauza, PhD, Chief Science Officer of Traws. “Ratutrelvir is ritonavir-free, highly potent and has a pharmacokinetic profile that could position it for wide adoption, especially among elderly and vulnerable individuals, based on its broad activity against a range of viruses including drug-resistant strains.” About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions, and potentially enable wider patient use. Phase 1 data also showed that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID3. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity4. Source information: Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, including when Traws will report results of the Phase 2 studies of ratutrelvir; Traws’ interactions with the FDA, BARDA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of the bird flu; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-335-2395 [email protected]

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 of Phase 2 studies of ratutrelvir in newly diagnosed COVID patients, with extensions to assess rebound and Long COVID, as well as evaluation in PAXLOVID®-ineligible subjects TXM program to emphasize focus on stockpiling readiness Traws to host a Q2 2025 business update call today, August 14th at 8:30 AM ET NEWTOWN, Pa., Aug. 14, 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 reported financial results for the quarter ended June 30, 2025 and provided recent business highlights for its antiviral programs. Importantly, unlike vaccines, antivirals are both therapeutic, eliminating viral infections, as well as prophylactic, preventing viral infections or spreading of infection to others. “Traws has made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. We have reprioritized our clinical trial plans to reflect potential short and medium-term shareholder value with the following actions”, said Iain D. Dukes, MA, DPhil, Interim Chief Executive Officer of Traws Pharma: “In our COVID program, we have submitted to Human Research Ethics Committee (HREC) a Phase 2 study of ratutrelvir, a potential best in class ritonavir-free agent, in newly-diagnosed COVID patients versus PAXLOVID® to evaluate safety and efficacy, as well as rates of disease rebound and incidence of Long COVID development. Separately, we have proposed to evaluate ratutrelvir in a single-arm study in PAXLOVID®-ineligible patients, who represent a significant vulnerable population with few treatment options. Our expectation is to be able to report the results of these Phase 2 studies by year-end 2025. Importantly, in second quarter 2025, Pfizer reported $427 million in sales for PAXLOVID®, representing a 70% increase compared to the same period in the prior year1. For the influenza program, we will continue our constructive discussions with the Biomedical Advanced Research and Development Authority (BARDA) regarding the inclusion of TXM in the drug stockpiling initiative for influenza, including bird flu. We believe that this represents the major short-to- medium-term commercial potential for this program. While H5N1 influenza is widespread in poultry and dairy herds, with several recent human cases in farm workers, it has not progressed to date in the U.S. at rates feared for a near-term potential pandemic. The current health risk has been determined to be low by the Centers for Disease Control and Prevention (CDC), which continues to monitor for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase 2 study incorporating bird flu-infected subjects would be low and initiation of this study has been deferred. During a Type D meeting, the FDA reaffirmed its position that clinical trial data, rather than reliance on the Animal Rule, is the registrational path for bird flu therapeutics. Recent approval of our Phase 2 bird flu/seasonal flu phase 2 protocol by Australian and South Korean regulatory authorities will allow us to quickly initiate a clinical study in either the Southern or Northern Hemispheres, respectively, should the incidence rate of bird flu increase.” “As the end of summer draws near, we are acutely aware that autumn is a time of heightened COVID and influenza awareness and vulnerability for many people across the country, as both viruses continue to mutate and pose critical threats to human health,” said Robert Redfield, MD, Chief Medical Officer of Traws Pharma. “Furthermore, with close to one million COVID and influenza hospitalizations and tens of thousands of deaths reported in the 2024-2025 virus season2,3, we know that COVID and influenza have not “gone away”. We also know from experience that each COVID and influenza hospitalization touches multiple lives and is a source of medical costs, lost time and lost wages for families and caregivers. Current treatments do not provide full antiviral coverage, and in the case of COVID, require accompanying agents that can result in drug-drug interactions, or enable rebound infections and long-term viral syndromes. We believe that Traws’ ritonavir-free COVID and once-daily flu candidates each have the potential to overcome the shortcomings of current treatments and become the new standard of care.” “COVID is now established as a long-term public health challenge, with an increasing burden of disease for people suffering from post-acute sequelae of COVID, also known as Long COVID4. The current approved antiviral, PAXLOVID®, is frequently contra-indicated in vulnerable populations, including the elderly and immunocompromised individuals, due to ritonavir-based drug-drug interactions5. Ratutrelvir has an emerging profile that could position it for wide adoption, especially in vulnerable individuals, based on its broad activity against a range of resistant strains,” said C. David Pauza, Chief Science Officer of Traws. “In addition, ratutrelvir’s good overall tolerability allows once-daily, single tablet dosing for 10 days, which could reduce the rate of rebound and, consequently, the risk of Long COVID. We intend to progress the development of ratutrelvir in the coming months, starting with a Phase 2 study planned to begin soon in the Southern Hemisphere. Positive results could provide important proof-of-concept data and represent a valuable inflection point for the program.” Recent Highlights and Anticipated Milestones: Product Development Ratutrelvir (COVID) A ritonavir-independent investigational oral Main protease (Mpro) inhibitor designed to be administered as a single dose, with potential for once-daily, 10-day dosing Intended Indication: Treatment of acute COVID infection, with potential to reduce the risk of COVID rebound and Long COVID including in currently PAXLOVID® -ineligible patients U.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity6,7 Recent Updates: Phase 1 studies have shown that ratutrelvir maintained plasma drug levels four times above the EC90 over a 10-day treatment period in healthy volunteers, with no drug-induced metabolism and no treatment-related adverse events. These data, combined with preclinical studies showing potent suppression of resistant virus, suggest that ratutrelvir could represent a novel, best-in-class therapy for acute COVID that could minimize the risk of viral rebound and Long COVID, supporting further development Next Steps: Phase 2 initiation: Initiate dosing in a Phase 2 non-inferiority study in Australia that will evaluate the effects of ratutrelvir, a potential best in class protease inhibitor that does not require ritonavir administration, compared to PAXLOVID®, in newly diagnosed COVID patients. The study plan also includes a single arm to evaluate the safety and efficacy of ratutrelvir in patients who are ineligible for treatment with PAXLOVID®. Tivoxavir Marboxil (TXM, Bird flu and seasonal flu) A single-dose, investigational CAP-dependent endonuclease inhibitor Intended Indication: Treatment or prevention of H5N1 bird flu and seasonal flu U.S. Market Opportunity: Estimated to be a multi-billion dollar market opportunity, including, in the short- to medium-term, potential stockpiling8,9 Recent Updates: Phase 1 data showed that TXM maintained plasma blood levels above the EC90 for approximately three weeks after a single oral dose, with good overall tolerability; these data support the use of TXM as a single-dose treatment TXM has demonstrated compelling protection against mortality and disease in three well accepted flu models (mice, ferrets and non-human primates) that evaluated a single, oral dose of TXM in a virus challenge study using H5N1 virus isolated from a dairy worker. TXM treatment reduced viral burden (all species) and increased survival (mice and ferrets), with improved lung pathology (all species), with good overall safety. These data provide a strong foundation for evaluating TXM in both seasonal flu and H5N1 bird flu Next Steps: Stockpiling readiness: Advance discussions with BARDA and other regulatory agencies regarding the inclusion of TXM in the drug stock piling initiative for pandemic preparedness, including bird flu. Carefully watch the CDC monitoring system for bird flu transmissions to humans during the upcoming months. Legacy Programs: Traws’ strategic objective for its legacy oncology assets (rigosertib and narazaciclib) is to establish additional partnerships for further development. Rigosertib Intended Indication: Treatment of recessive dystrophic epidermolysis bullosa associated locally advanced or metastatic squamous cell carcinoma (RDEB SCC) U.S. Market Opportunity: RDEB SCC is an ultra rare, complicated monogenic disease with a highly aggressive and early metastasizing course, with a cumulative risk of death of approximately 70-79% by 45-55 years of age10,11 Recent Updates: Publication of key clinical efficacy data for rigosertib in RDEB SCC in the British Journal of Dermatology12 showing a compelling overall response rate of 80%, with complete responses in 50% of evaluable patients and good overall tolerability. These data suggest that rigosertib is a potential treatment for RDEB SCC, where there is a substantial unmet need and no approved therapies. Next Steps: Exploring pathways to advance this important potential medicine: Traws is seeking partnership opportunities to support further development of rigosertib Corporate Updates Management Updates: Jack Stover was named Chairman of the Board on April 15, 2025, with the transition of Iain D. Dukes, MA, D. Phil to Board Member, with his expanded responsibilities as Interim Chief Executive Officer (announced March 31, 2025). Charles Parker was named Interim Chief Financial Officer (CFO) on July 5, 2025, succeeding former Interim CFO Nora Brennan. Conference Call and Webcast Information Traws will host a conference call today, August 14, 2025, at 8:30 AM ET to discuss its Q2 results and pipeline progress. Dial-in (U.S.): 1-877-407-0789 Dial-in (International): 1-201-689-8562 Conference ID: 13754425 Webcast Access: Click Here A replay of the webcast will be available on the Investors section of the Traws website at https://www.trawspharma.com/corporate-events-presentations. Financial Results: Cash, cash equivalents and short-term investments: As of June 30, 2025, the Company had cash, cash equivalents, and short-term investments of approximately $13.1 million, compared to approximately $21.3 million as of December 31, 2024. Revenue for the quarter ended June 30, 2025, was $2.7 million, compared to $57 thousand for the comparable period in 2024. This increase of $2.7 million is attributable to $2.7 million in deferred revenue, recognized as revenue in the second quarter 2025, related to the mutual termination in April 2025 of a licensing agreement associated with our legacy oncology program. Research and development (R&D) expense for the quarter ended June 30, 2025, totaled $2.3 million, compared to $4.0 million for the comparable period in 2024. This decrease of $1.7 million primarily relates to a decrease in expenses related to the oncology program and personnel expenses, partially offset by an increase in expenses related to our virology programs. General and administrative (G&A) expense for the quarter ended June 30, 2025, totaled $1.7 million, compared to $2.0 million for the comparable period in 2024. This decrease of $0.3 million was primarily attributable to a decrease in personnel related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees Net Income (loss): The net loss for the quarter ended June 30, 2025 was $0.9 million, or a net loss of $0.11 per basic common and diluted common share. This compares to a net loss of $123.1 million, or a net loss of $20.52 per basic and diluted common share, for the quarter ended June 30, 2024, which included a one-time charge of $117.5 million for acquired in-process research and development related to Onconova’s April 2024 acquisition of Trawsfynydd. Shares Outstanding: Traws had 7,063,829 shares of common stock outstanding as of August 13, 2025. About Ratutrelvir Ratutrelvir is an investigational oral, small molecule Mpro (3CL protease) inhibitor designed to be a broadly acting treatment for SARS-CoV-2/COVID-19 that is used without ritonavir. It has demonstrated in vitro activity against a range of virus strains. Preclinical and Phase 1 studies show that ratutrelvir does not require co-administration with a metabolic inhibitor, such as ritonavir, which could avoid ritonavir-associated drug-drug interactions5, and potentially enable wider patient use. Phase 1 data also show that ratutrelvir’s pharmacokinetic (PK) profile demonstrated maintenance of target blood plasma levels approximately 13 times above the EC50 using the target Phase 2 dosing regimen of 600 mg/day for ten days, which may also reduce the likelihood of clinical rebound and, consequently, reduce the risk for Long COVID4. Industry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity6,7. About Tivoxavir Marboxil Tivoxavir marboxil (TXM) is an investigational oral, small molecule CAP-dependent endonuclease inhibitor designed to be administered as a single-dose for the treatment of bird flu and seasonal influenza. It has shown potent in vitro activity against a range of influenza strains in preclinical studies, including a human isolate of the highly pathogenic avian flu H5N1 (bird flu). Consistent, positive preclinical data from three animal species indicate that a single dose of TXM demonstrated a therapeutic effect against H5N1 bird flu. Seasonal influenza represents an estimated multi-billion dollar antiviral market opportunity, largely driven by global health organizations, practice guidelines and government tenders and inclusion in drug stock piling initiatives8,9, with upside potential from potential pandemic flu outbreaks including H5N1 bird flu. We believe that these data support further development of TXM as a treatment for bird flu. Source information: Third-party products mentioned herein are the trademarks of their respective owners. About Traws Pharma, Inc. Traws Pharma is a clinical stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. We are advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health: COVID-19/Long COVID and bird flu and seasonal influenza. Ratutrelvir is in development as a ritonavir-independent COVID treatment, targeting the Main protease (Mpro or 3CL protease). Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, targeting the influenza cap-dependent endonuclease (CEN). Traws is actively seeking development and commercialization partners for its legacy clinical oncology programs, rigosertib and narazaciclib. More details can be found on Traws’ website at https://www.ir.trawspharma.com/partnering. For more information, please visit www.trawspharma.com and follow us on LinkedIn. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for ratutrelvir and tivoxavir marboxil, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, Traws’ interactions with the FDA, BARDA and similar foreign regulators, collaborations, market conditions, regulatory requirements and pathways for approval, the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID, the extent of the spread and threat of the bird flu, Traws’ ability to raise additional capital when needed, and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law. Traws Pharma Contact: Charles Parker Traws Pharma, Inc. [email protected] www.trawspharma.com Investor Contact: John Fraunces LifeSci Advisors, LLC 917-335-2395 [email protected]