TRAW
TrawsFDocument history
Earnings documents stored for TRAW.
Investor releaseQuarter not tagged2026-05-15Traws Pharma Provides Business Highlights and Reports Q1 2026 Financial Results
GlobeNewswire
Traws Pharma Provides Business Highlights and Reports Q1 2026 Financial Results
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...
Investor releaseQuarter not tagged2026-04-16Traws Pharma Inc (TRAW) Q4 2025 Earnings Call Highlights: A Turnaround Year with Significant ...
GuruFocus.com
Traws Pharma Inc (TRAW) Q4 2025 Earnings Call Highlights: A Turnaround Year with Significant ...
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 optima...
Investor releaseQuarter not tagged2026-04-16Traws Pharma, Inc. Q4 2025 Earnings Call Summary
Moby
Traws Pharma, Inc. Q4 2025 Earnings Call Summary
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 wa...
Investor releaseQuarter not tagged2026-04-16Traws Pharma Reports Full Year 2025 Results and Provides Business Highlights
GlobeNewswire
Traws Pharma Reports Full Year 2025 Results and Provides Business Highlights
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 exi...
TranscriptFY2025 Q42026-04-15FY2025 Q4 earnings call transcript
Earnings source - 33 paragraphs
FY2025 Q4 earnings call transcript
Gentlemen, thank you for standing by. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. I would now like to turn the call over to LifeSci Advisors. Please.
Thank you, operator, and welcome everyone to Traws Pharma's full year 2025 financial results and business update conference call. This afternoon, Traws issued a press release reporting its 2025 financial results and provided a business update. If you have not yet seen this press release, it is available in the investor relations section of the company's website. Following my introduction, we'll hear from Traws Chief Executive Officer, Iain D. Dukes, and Chief Financial Officer, Charles Parker. Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change.
Except as required by law, Traws disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances. For more information on forward-looking statements, please review the disclaimer in this morning's press release and the risk factors in the company's SEC filings. With that, I will now turn the call over to Traws's CEO, Dr. Iain D. Dukes.
Thanks, John, and thanks to everyone for joining us today. Over the last year, Traws has made substantial progress towards our objective of bringing our differentiated next generation antiviral candidate for influenza to patients. This morning, Traws announced a private financing of $60 million. The PIPE financing was supported by new and existing healthcare-focused investors. The capital from this financing positions Traws to advance the flu program through the human challenge study this summer, while providing access to additional capital as we achieve further key milestones. Influenza is estimated to be a multi-billion-dollar opportunity, spanning prophylactic and therapeutic applications, including strategic government stockpiling and pandemic preparedness incentives. The human challenge study trial focused on flu prevention is an important step towards establishing the potential for Tivoxavir marboxil as a potential best-in-class prophylactic agent for flu prevention.
We intend to initiate the study this summer once we have approval to proceed from the Medicines and Healthcare products Regulatory Agency, or MHRA, in the U.K. During today's call, we'll provide an overview of development of our lead candidate Tivoxavir marboxil, or Tivoxavir for short, for influenza. Tivoxavir marboxil is an exciting next generation investigational influenza antiviral that targets the highly conserved viral enzyme Cap-dependent endonuclease. We believe Tivoxavir is well-positioned to become a best-in-class once monthly oral prophylactic agent with additional potential for pandemic flu, including H5N1 bird flu. We will prioritize development of Tivoxavir as a once monthly prophylactic agent for influenza prevention. Seasonal influenza continues to have a severe public health impact in the U.S., particularly in vulnerable populations.
While there are approved therapies and vaccines for flu, with such a number of infections, hospitalizations, and deaths, there's still an incredible unmet medical need for improved prophylactic agents and therapies for flu. We envisage Tivoxavir's potential use in two settings. Prophylaxis, where it might be used on a monthly basis to prevent infection, especially during the flu season. Secondly, as an element of a national stockpile for pandemic preparedness. We believe Tivoxavir is well-suited to be a first-in-class prophylactic agent for seasonal flu based on its emerging profile as an oral once-a-month agent with a favorable tolerability profile and broad activity generally across influenza A and B strains. Cornerstone of our thesis for Tivoxavir anchors on three items. First, previously reported preclinical studies showed robust antiviral activity against a wide range of influenza strains, including all influenza A and B strains.
Second, positive preclinical data reported last year showed that a single dose of Tivoxavir provided protection against lethal bird flu challenge in three species, with significant reductions in lung virus burden and pathology in non-human primates. Third, phase I data in normal volunteer and healthy volunteers showed that the first generation powder and capsule formulation of Tivoxavir maintained plasma blood levels well above the EC90 for over three weeks with good overall safety. Coupled to this, we have developed a next generation compressed tablet formulation of Tivoxavir with an optimized pharmacokinetic profile. Data from preclinical studies show 30% increase in exposure with this new formulation. These results have given us confidence that the new tablet can provide 28-day coverage against influenza and be an effective once-a-month agent.
We are in the process of conducting a phase I bridge study in Australia to confirm the extended exposure we saw in preclinical studies. The positive bridging data will be shared with the MHRA in addition to the initial filings that we've already made with this agency, and hopefully this will be used to advance ourselves to the next step in our prophylaxis program, the phase IIa seasonal flu prophylaxis challenge trial. The challenge trial will be conducted at hVIVO in the U.K. starting in June. Positive results demonstrating protection from viral infection will be a landmark proof of concept for the program, supporting Tivoxavir's unique value proposition as a safe and effective prophylactic agent. In the meantime, we continue to our conversations around Tivoxavir in terms of it being included in the national stockpile for pandemic preparedness.
To support our intention to secure formal consideration by the Biomedical Advanced Research and Development Authority, or BARDA, for inclusion in the U.S. strategic stockpile, we submitted our Investigational New Drug application, or IND, in January. FDA recently informed us that our IND filing has been placed on clinical hold due to concerns with the toxicology data package. We are actively engaging with the FDA to address its concerns and resolve the clinical hold as expeditiously as possible, with a goal of advancing the program in the U.S. in late 2026. We are optimistic about the ongoing bridging study and challenge study and look forward to reporting back on our progress through via. At this point, I am going to hand this over to Charles. Thank you. To provide a summary of the financial results.
Thank you, Iain. This morning, Traws announced the completion of a private financing that provides up to $60 million in potential gross proceeds. We also issued a press release this afternoon covering our results for the year ended December 31, 2025. I'll refer you to our recent 10-K filing for review of the full financial statements. You can also access the press release and the 10-K on our website. First, the recently completed financing. The private placement transaction includes funding of $10 million upfront and three warrants, which consist of a Series A milestone-based warrant with an aggregate exercise price of $10 million that becomes exercisable upon receipt of approval from MHRA to conduct the challenge trial. A Series B milestone-based warrant with an aggregate exercise price of $10 million that becomes exercisable following both shareholder approval and the announcement of data from the challenge trial.
A Series C common warrant with a 3-year term to purchase shares of our common stock and providing potential additional gross proceeds of $30 million if fully exercised following shareholder approval. Based on our current plans, the company believes that its current cash balance, including net proceeds from the offering in milestone-based warrants, if fully exercised, is sufficient to support planned expenses into Q1 2027. Turning to our financials. As of December 31, 2025, Traws had cash equivalents and short-term investments of approximately $3.8 million, compared to $21.3 million as of December 31, 2024. Revenue for the year ended December 31, 2025 was $2.8 million, compared to $226,000 for the same period in 2024.
The increase is attributable to $0.7 million in deferred revenue recognized as revenue in the second quarter related to the mutual termination of a licensing agreement associated with our legacy oncology program in April 2025. Acquired in-process research and development expense for the year ended December 31, 2025 was 0, compared to $117.5 million for the comparable period in 2024, recognized related to virology programs acquired in connection with the acquisition of Traws funded through a merger. Research and development expense for the year ended December 31, 2025 totaled $12.1 million, compared to $12.8 million for the comparable period in 2024. The decrease of $0.7 million primarily relates to a decrease in expenses related to the oncology program, partially offset by an increase in expenses related to the virology programs.
General and administrative 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 is primarily attributable to a decrease in professional and consulting fees. 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 a 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. Now I'd like to turn the call back to Ian.
Thanks, Charles. Before we open the line for questions, I'll briefly summarize the topics we've covered on the call. Over the last year, Traws has made substantial progress towards our goal of advancing our differentiated next generation potential best-in-class antiviral candidate for influenza. The recent $60 million financing provides us with the resources to drive forward the planned seasonal influenza prophylaxis study for TXM and supports Traws's future growth. For influenza, we are poised to advance the evaluation of Tivoxavir marboxil as a prophylactic agent, supported by completion of a bridging study for the compressed tablet formulation and initiation of a challenge trial in the U.K. this summer. As we begin the Q&A session, I want to thank everyone for joining us today. Now we'll open up the call for questions. Operator, please go ahead.
Also the line of Alethia Young with Cantor Fitzgerald. Please proceed.
Yes, hi, hopefully you can hear me. Thanks so much for taking the questions. Great. Wanted to just work through a few points of clarification here, if I could. Just first on the FDA's questions, do you have a sense of what, if any, new experiments you might need to conduct to satisfy their questions on the toxicology data package? And also, based on sort of what we know from Xofluza, is there any plausible concern or risk around mutagenicity in the prophylaxis setting for Tivoxavir, just given it's structurally similar? Or are you pretty confident that this can be fully resolved?
Thanks for your question. The structural similarity of Tivoxavir to Xofluza is an important point that you bring up, because Tivoxavir has a clean mutagenicity label, it was negative in Ames, and has shown no mutagenic potential since it's been approved several years ago. We think this is very strong evidence that the data that was generated in our initial package of information submitted to the FDA could have some flaws associated with it. Our plan is actually to repeat some of these assays and submit new assays as well, and using Xofluza as an additional control in the assays that we submit to the FDA.
There's no reason a priori why we should be any different to Xofluza, and so that gives us quite a lot of confidence that the in vitro data suggesting mutagenic risk are probably explainable through other mechanisms of action of the drug.
Okay, nice. Just on the U.K. side, was hoping you could just characterize if there's any potential risk or what the various scenarios might be with the MHRA regarding starting that study on time in the summer with the prevailing toxicology data package, or if there could be any sort of delays or need for submission of additional data in the U.K.?
Yes, thanks for that. We can't really answer that question today. Our package has been submitted to MHRA. They're now under a 30-day clock to review the package that we have sent. It is frequently the case that these regulatory agents come to different conclusions based on identical toxicology packages submitted. For instance, in Australia, where the regulatory agency saw exactly the same data that was seen by the FDA, we were obviously allowed to proceed with the healthy volunteer studies now twice, because initially our studies were approved and moved forward. Again, HREC had access to exactly the same toxicology information that the FDA has today. Then secondly, when we recently got approved to run the bridging study in Australia, again, no concerns have been flagged. We remain hopeful and optimistic that the MHRA will indeed approve the study as submitted.
Okay, terrific. Just forecasting this out, thinking about sort of the value proposition for Tivoxavir in flu prevention.
Mm-hmm.
It sounds like, given the pharmacokinetic profile, like once monthly is possible here, but, once you do the challenge study and you have the data in hand, if it turns out that twice monthly or even once weekly sort of optimizes efficacy, do you think that's just as viable commercially and something you would contemplate testing in a subsequent study, or are you sort of committed to a once monthly prophylaxis regimen here, just from a commercial adoption and sort of competitive standpoint?
No, not at all. We've done some initial market research on this point, and to your point, once weekly could still be a very attractive formulation for an oral compared to an injectable. We will obviously very carefully evaluate the results from a challenge study, and we will be assessing the degree of protection at 1 week, 2 week, 3 week, as well as 4 weeks in the study. We'll make a decision based on what we see in terms of how we want to proceed forward into a phase IIb/3 in terms of the optimal dosing frequency that we would adopt.
Okay, thank you. Last question from me, just quick clarification on the final $30 million tranche of the financing announced today. Is there any event that triggers that or is that sort of at your request for shareholder approval, you can access that capital within that 3-year window? Thanks so much.
Yeah.
I'll handle that one.
Charles, can you take that please?
Yep. Yes. Thanks for the question. The final warrant C, 30 million, has an accelerated feature. If our stock trades at 2x the deal price, which was $1.67 for 30 days consecutively, there'll be a 10-day window to force exercise that warrant. That is the accelerated feature within the warrant, otherwise, it's a 3-year term.
Perfect. Thanks so much.
Mm-hmm.
Thank you.
I'm showing no further questions in the queue. Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.
Investor releaseQuarter not tagged2026-01-13Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID®-Eligible and Ineligible COVID-19 Patients
GlobeNewswire
Traws Pharma Files Tivoxavir Marboxil Investigational New Drug (IND) Application for Influenza Therapy, and Provides Updated Results from the Ongoing Clinical Study of Ratutrelvir in PAXLOVID®-Eligible and Ineligible COVID-19 Patients
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...
Investor releaseQuarter not tagged2025-11-13Traws Pharma Reports Third Quarter 2025 Results and Business Highlights
GlobeNewswire
Traws Pharma Reports Third Quarter 2025 Results and Business Highlights
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...
Investor releaseQuarter not tagged2025-10-14Traws Pharma Doses First Patient with Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025
GlobeNewswire
Traws Pharma Doses First Patient with Ratutrelvir in Phase 2 COVID Studies, Expects Results by Year-End 2025
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 i...
Investor releaseQuarter not tagged2025-08-18Traws Pharma Receives Approval to Proceed with Phase 2 COVID Studies with Ratutrelvir, Expects Results by Year-End 2025
GlobeNewswire
Traws Pharma Receives Approval to Proceed with Phase 2 COVID Studies with Ratutrelvir, Expects Results by Year-End 2025
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. Ratutrelvi...
Investor releaseQuarter not tagged2025-08-14Traws Pharma Reports Second Quarter 2025 Results and Business Highlights
GlobeNewswire
Traws Pharma Reports Second Quarter 2025 Results and Business Highlights
Advancing novel programs for respiratory viruses that pose pandemic threats or risk of serious illness, including SARS CoV2 (ratutrelvir) and influenza (Tivoxavir marboxil, TXM) Prioritization of ratutrelvir, a ritonavir-free, protease inhibitor regimen in development for Acute and Long COVID, reflects the ongoing infection risk and greater need, with waning vaccine utilization A submitted HREC study will enable initiation 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 compa...
TranscriptFY2025 Q22025-08-14FY2025 Q2 earnings call transcript
Earnings source - 12 paragraphs
FY2025 Q2 earnings call transcript
Ladies and gentlemen, thank you for standing by. Welcome to the Traws Pharma, Inc. Second Quarter 2025 Financial Results and Business Update Call. [Operator Instructions] As a reminder, this call is being recorded today, August 14, 2025. At this time, I'd like to turn the call over to John Fraunces of Lifesci Advisors.
Thank you, operator, and welcome, everyone, to Traws Pharma's Second Quarter 2025 Financial Results and Business Update Conference Call. This morning, Traws issued a press release reporting its second quarter 2025 financial results and provided a business update. If you have not yet seen this press release, it is available on the Investor Relations section of the company's website. Following my introduction, we will hear from Traw's Interim Chief Executive Officer, Dr. Iain Dukes; Chief Science Officer, Dr. David Pauza; Chief Medical Officer, Dr. Robert Redfield; and Interim Chief Financial Officer, Charles Parker. Before we begin, I would like to remind everyone that statements made during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made as the underlying facts and circumstances may change. Except as required by law, Traws disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. For more information on forward-looking statements, please review the disclaimer in this morning's press release and the risk factors in the company's SEC filings. With that, I will now turn the call over to Traw's Interim CEO, Dr. Iain Dukes.
Thanks, John, and thanks to everyone for joining us today. Traws has made good progress this year towards our goal of bringing our antiviral candidates to patients as soon as possible. This morning, we announced that we have reprioritized our clinical trial plans to reflect potential short- and medium-term shareholder value with the following actions. In our COVID program, we have submitted to Human Research Ethics Committee, HREC, a Phase II 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 instance of Long COVID development. Separately, we proposed to evaluate in a single-arm study, the effects of ratutrelvir in PAXLOVID-ineligible patients who represent a significant vulnerable population with few treatment options. Our expectation is to be able to report results from these Phase II studies by year-end 2025. Importantly, in second quarter of 2025, Pfizer reported $427 million in sales of PAXLOVID, representing a 70% increase compared to the same period in the prior year. For the influenza program, we'll continue our constructive discussions with the Biomedical Advanced Research and Development Authority, or BARDA, regarding the inclusion of tivoxavir marboxil, or TXM, in the drug stockpiling initiative for influenza, including bird flu. We believe that this represents a major short- and 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 CDC, which continues to monitor for bird flu transmission in humans. Accordingly, the immediate likelihood of successfully recruiting a Phase II 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 II bird flu/ seasonal flu protocol by both 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 rates of bird flu increase. I'll now hand over the call to our Chief Scientific Officer, Dr. David Pauza Porter; and our Chief Medical Officer, Dr. Robert Redfield, for more detailed comments on our COVID program. David?
Thank you, Iain. COVID-19 continues to be a major public health threat due to the evolution and rapid spread of new viral variants. Today, 6 major variants are spreading in the United States and the NB.1.8.1 variant, first appearing in April of this year, is already responsible for more than 40% of infections nationwide. The speed at which new variants arise and increase within the population tells us that the virus is spreading at a high rate and retains potential for causing severe disease. As vaccine immunity declines overall, increases in the rate of virus spread are increasingly likely. Effective antiviral drugs may now be the best option for managing COVID-19. Ratutrelvir is an investigational main protease inhibitor, developed and tested by Traws Pharma, has proven to be effective against all viral variants tested so far in preclinical studies and is expected to retain potency against existing and anticipated viral variants. We are now advancing ratutrelvir into Phase II clinical studies to accelerate its entry into the marketplace. Ratutrelvir is designed for use without ritonavir, a booster compound used to increase the effectiveness of PAXLOVID because ritonavir interferes with a number of commonly prescribed medications. Consequently, many patients seeking treatment for COVID-19 are ineligible to take PAXLOVID and need a safe alternative. Ratutrelvir was well tolerated in Phase I clinical studies, where we evaluated a once-daily oral dose for 10 consecutive days. The longer treatment interval is intended to eliminate the virus and prevent rebound, which is experienced by many individuals with or without treatment for COVID-19. We've applied for permission to conduct a Phase II clinical trial in patients with COVID-19, including those people eligible for PAXLOVID and people who are ineligible for PAXLOVID. By demonstrating ratutrelvir's benefit in COVID-19 patients, we expect to address the estimated $1.5 billion annual market opportunity of individuals who are seeking treatment but are ineligible for PAXLOVID and to demonstrate the multiple benefits of ratutrelvir therapy. Dr. Redfield, would you like to add comments?
Thanks, Dave. COVID-19 has become a nearly year-round public health problem with multiple peaks of infection throughout the year. Current treatments have significant limitations. For example, PAXLOVID includes the addition of ritonavir, a pharmacokinetic enhancer that can result in significant drug-drug interactions, limiting its use in many elderly patients on certain anticoagulants. Treatment is also complicated by the high rate of COVID rebound and the development of a prolonged post-infection symptoms known as Long COVID. Unfortunately, COVID vaccines do not effectively prevent infection. As a consequence, viral transmission continues unchecked in the community, whether or not vaccines are used. Many infected individuals do not seek treatment because they've heard of the unpleasant or only partially effective PAXLOVID and they're not able to take PAXLOVID due to drug-drug interactions caused by ritonavir. Traws Pharma answer is ratutrelvir, a new investigational drug that does not require ritonavir to reach its therapeutic levels and can be taken for 10 days instead of the 5 days recommend for PAXLOVID. Ratutrelvir treatment may expand access for all patients to receive COVID-19 therapy. We are hopeful that the longer duration will result in more complete elimination of the virus and will prevent vial rebounds and hopefully reduce the incidence of Long COVID. Traws Pharma is committed to providing broader access to COVID therapeutics that include the treatment and the prevention of Long COVID. Long COVID currently affects more than 15 million people in the United States. It can cause or reduce significant disability and reduce the quality of life. Ratutrelvir was designed specifically to address these factors that may contribute to Long COVID. Therefore, including the possibility for the virus to linger in the body after current treatments are completed. Our overall goal is to provide the best COVID-19 therapy for the greatest number of people while reducing the threat of Long COVID. Iain?
Thank you, Bob. Turning to our influenza program. Dr. Pauza and Dr. Redfield have the following observations. David?
Well, thank you, Iain. Seasonal influenza has a severe public health impact in the U.S. However, looking behind the risk for seasonal disease is a larger problem of influenza spreading in wild birds and mammals where the virus is evolving rapidly and in unpredictable ways. The current global outbreak of avian influenza or bird flu caused massive die-offs of birds and marine mammals throughout the world, impacted milk production in dairies and wiped out many poultry operations. Bird flu also poses an extreme risk to human beings. The history of human bird flu dating back 3 decades or more showed more than 50% of reported infections were fatal. Thus, bird flu is a very high-risk agent and only a few changes in the virus already present in animals are needed to allow for more efficient spread within the human population. In response to this threat, Traws Pharma developed and tested tivoxavir marboxil, an investigational oral drug intended to be taken once after infection for treatment and prevention of bird flu. The bird flu virus, circulating currently in wild and domestic animals, is rewriting the books on lethal influenza. This virus grows faster than seasonal influenzas and has extraordinary capacity to kill all animal species where it has been tested. The high viral growth rate renders it less susceptible to common influenza therapies and requires the specific development of treatments targeting this bird flu threat. Tivoxavir marboxil was evaluated in human clinical studies using dose levels that are predicted based on our animal studies to be effective for treating bird flu. Tivoxavir marboxil is safe and produce blood drug levels that might control virus for 21 days or longer after a single dose. Traws Pharma believes that tivoxavir marboxil is the first influenza therapy developed specifically for bird flu and it was designed to overcome the extraordinary challenges of a highly virulent influenza virus. Dr. Redfield?
As the former Director for the United States Center for Disease Control and Prevention and a lifelong infectious disease physician, I understand the need to promote health measures for the current threats and to be prepared for high-risk emerging diseases. We believe that avian H5N1 virus is one of the great threats to public health and must be addressed with serious preparedness measures, including stockpiling effective treatments. A highly infectious influenza that cannot be effectively treated with current medications poses an extreme risk to the U.S. population. We strongly believe that new measures are required to prepare for an H5N1 outbreak and that Traws Pharma is advancing tivoxavir marboxil as a valuable option. Imagine how much suffering could have been prevented if we had had a national drug stockpile that could contain the right kind of COVID-19 drugs and enough of it to prevent the spread in death within the United States. While COVID-19 was unexpected, the global spread of H5N1 virus among animals presents a clear risk for viral adaptation and efficient human-to-human transmission. With the known potential -- lethal potential of H5N1 in humans, a human adapted H5N1 outbreak could be catastrophic. Traws Pharma is advancing tivoxavir marboxil to support a national strategy for preparing to confront an outbreak of H5N1 influenza. Importantly, the target of tivoxavir marboxil, a viral protein called cap-dependent endonuclease is an essential component of the influenza virus replication and is highly conserved among all influenza virus types. Whether pandemic threats arise from H5N1 or almost any other type of influenza virus, it is likely that tivoxavir marboxil will retain activity and be effective in treating and possibly preventing the threat of pandemic influenza. Traws Pharma is engaged with the U.S. Food and Drug Administration, or the FDA, and the Biomedical Advanced Research and Development Authority, or BARDA, regarding the development of tivoxavir marboxil as a national -- for the national stockpile. The FDA has commented on the design of the clinical trials for proceeding with tivoxavir marboxil development and BARDA has provided advice regarding drug development for pandemic preparedness. We continue our interactions with these agencies as part of our overall effort to provide an effective countermeasure to the risk of pandemic influenza. Iain?
Thank you, Bob. Before we review our financial results, I will make a few remarks on our legacy on quality assets comprised of 2 unique kinase inhibitors, rigosertib and narazaciclib. Traws' strategic objectives for these programs is to establish value-creating partnerships. In the second quarter, we published compelling efficacy data for rigosertib in a rare disease called recessive dystrophic epidermolysis bullosa associated local advanced or metastatic squamous cell carcinoma, or RDEB. In the study, rigosertib demonstrated a compelling overall response rate of 80% with complete responses in 50% of evaluable patients and good overall tolerability. These data suggest rigosertib as a potential treatment for RDEB SCC where there's substantial unmet need and no approved therapies. We're excited by the compelling efficacy and tolerability of rigosertib in this rare disease, and we're committed to finding an appropriate partner to advance this important potential medicine to approval. I will now ask our Interim CFO, Charles Parker, to review our financial results. Charles?
Thanks, Iain. This morning, Traws issued a press release for the quarter ended June 30, 2025. I'll refer you to our recent 10-Q filing for a review of the full financial statements. You can also access the press release and the 10-Q on our website. Turning to our financials. As of June 30, 2025, Traws had cash, cash equivalents and short-term investments of approximately $13.1 million compared to $21.3 million as of December 31, 2024. Moving through our second quarter 2025 financial results. Revenue for the quarter ended June 30, 2025, was $2.7 million compared to $57,000 for the same period in 2024. The increase is attributable to $2.7 million in deferred revenue, recognized as revenue in the second quarter, related to mutual termination of a licensing agreement associated with our legacy oncology program in April of this year. Research and development expense for the second quarter in 2025 totaled $2.3 million compared to $4 million for the comparable period in 2024. The decrease of $1.7 million primarily relates to a decrease in expenses of our oncology program and a decrease in personnel expenses. This was partially offset by an increase in expenses related to our virology programs. General and administrative expense for the second quarter in 2025 totaled $1.7 million compared to $2 million for the comparable period in 2024. This decrease of $0.3 million is primarily attributable to a decrease in personnel-related expenses and stock-based compensation, partially offset by an increase in professional and consulting fees. The net loss for the second quarter of 2025 was $0.9 million. This was driven by the recognition of the licensing revenue of $2.7 million. As a result, the net loss for the second quarter in 2025 was $0.11 per basic 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 comparable period in 2024. Traws' second quarter 2024 net loss reflects a noncash charge of $117.5 million related to in-process R&D from Onconova's April 2024 acquisition of Trawsfynydd. Now I'd like to turn the call back to Iain.
Thanks, Charles. Before we open the line for questions, I will briefly summarize the topics we've covered on today's call. We're excited about our 2 potential best-in-class antiviral product candidates for 2 multibillion-dollar markets. Ratutrelvir in development as a potential ritonavir-free treatment for COVID and tivoxavir marboxil in development as a single-dose treatment for influenza, including bird flu. We reprioritized our programs to maximize the opportunity to provide investors with the short- and medium-term value with acceleration of ratutrelvir, our potential treatment for COVID. In regard to our influenza program, with the waning cases of birth flu in the United States, we intend to focus our efforts on inclusion of tivoxavir marboxil in the drug stockpiling initiative to help ensure pandemic readiness and continue our constructive discussions with BARDA. And lastly, we remain committed to finding an appropriate partner to assist in developing and commercializing our legacy oncology assets. As we begin the Q&A session, I want to thank everyone for joining us today. Now we will open up the call for questions. Operator, please go ahead.
[Operator Instructions] Thank you. Ladies and gentlemen, thank you for your participation on today's conference call. This concludes today's event. You may now disconnect.
Investor releaseQuarter not tagged2025-08-08Traws Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 14, 2025
GlobeNewswire
Traws Pharma to Report Second Quarter 2025 Financial Results on Thursday, August 14, 2025
NEWTOWN, Pa., Aug. 08, 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 plans to host a conference call and webcast on Thursday, August 14, 2025 at 8:30 AM ET to discuss financial results for the second quarter ended June 30, 2025 and recent business progress. Conference Call and Webcast Information Date: Thursday, August 14, 2025, at 8:30 AM ET Participant Dial-in (U.S.): 1-877-407-0789 Participant 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. 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: bird flu and seasonal influenza, and COVID-19/Long COVID. Tivoxavir marboxil is in development as a single dose treatment for bird flu and seasonal influenza, 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. 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]

