Traws Pharma Q4 2025 Earnings Report

Traws Pharma EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.51
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Traws Pharma Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $0.06 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Traws Pharma Announcement Details

• Quarter: Q4 2025
• Date: 5/18/2026
• Time: N/A
• Conference Call Date: N/A
• Conference Call Time: N/A

Traws Pharma (NASDAQ:TRAW), a clinical stage biopharmaceutical company, focuses on developing small molecule oral product candidates for respiratory viral diseases and cancer. The company is developing investigational novel therapies for influenza and COVID19 that are designed to address treatment resistance, such as TRX01 (travatrelvir), a Mpro/3CL inhibitor in development for the treatment of COVID19; and TRX100 (viroxavir), an endonuclease inhibitor in development for the treatment of pandemic influenza. It is also developing narazaciclib, a multi-kinase CDK4/6 inhibitor, which is in Phase 1/2 clinical trials in patients with cancer, with or without co-administration of letrozole to define the recommended phase 2 dose for further development in endometrial cancer; and oral rigosertib, which is administered alone or in combination for investigation in various cancers. The company was formerly known as Onconova Therapeutics, Inc. and changed its name to Traws Pharma, Inc. in April 2024. Traws Pharma, Inc. was incorporated in 1998 and is headquartered in Newtown, Pennsylvania.

Traws Pharma Q4 2025 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Traws completed a private financing providing up to $60 million (including $10M upfront and milestone/stock-based warrants), which management says funds planned activities through the human challenge study and into Q1 2027 if milestones/warrants are realized.
• Positive Sentiment: Management highlighted Tivoxavir marboxil as a potential once‑monthly oral prophylactic with broad activity against influenza A/B, preclinical protection in multiple species (including non‑human primates vs H5N1), and a new tablet that showed ~30% higher exposure in preclinical studies.
• Neutral Sentiment: The company plans a Phase IIa human challenge prophylaxis trial in the U.K. this summer (at hVIVO) pending MHRA approval and is running a Phase I bridge study in Australia to confirm the tablet formulation’s extended exposure.
• Negative Sentiment: The FDA placed Traws’ IND on clinical hold citing concerns with the toxicology data package; management expects to repeat assays and engage the agency, targeting U.S. program advancement in late 2026 but with regulatory risk and potential delays.
• Negative Sentiment: Cash was only about $3.8 million at year‑end 2025 (down from $21.3M), and the company’s funding runway depends on milestone‑based warrants and future exercises, making near‑term financing certainty conditional.

Presentation

[Operator]

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.

[John Fraunces, IR at LifeSci Advisors]

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.

[John Fraunces, IR at LifeSci Advisors]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Charles Parker, CFO at Traws Pharma]

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.

[Charles Parker, CFO at Traws Pharma]

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.

[Charles Parker, CFO at Traws Pharma]

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.

[Charles Parker, CFO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Operator]

Also the line of Alethia Young with Cantor Fitzgerald. Please proceed.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

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?

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

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.?

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

Okay, terrific. Just forecasting this out, thinking about sort of the value proposition for Tivoxavir in flu prevention.

[Iain D. Dukes, CEO at Traws Pharma]

Mm-hmm.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

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?

[Iain D. Dukes, CEO at Traws Pharma]

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.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

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.

[Iain D. Dukes, CEO at Traws Pharma]

Yeah.

[Charles Parker, CFO at Traws Pharma]

I'll handle that one.

[Iain D. Dukes, CEO at Traws Pharma]

Charles, can you take that please?

[Charles Parker, CFO at Traws Pharma]

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.

[Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald]

Perfect. Thanks so much.

[Charles Parker, CFO at Traws Pharma]

Mm-hmm.

[Iain D. Dukes, CEO at Traws Pharma]

Thank you.

[Operator]

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.

Participants

Executives

• Charles Parker, CFO
• Iain D. Dukes, CEO

Analysts

• Alethia Young, Large Cap Biotech Analyst and Head of Healthcare Research at Cantor Fitzgerald
• John Fraunces, IR at LifeSci Advisors