Traws Pharma, Inc. (NASDAQ:TRAW) Q4 2025 Earnings Call Transcript

Traws Pharma, Inc. (NASDAQ:TRAW) Q4 2025 Earnings Call Transcript April 16, 2026

Operator: Ladies and gentlemen, thank you for standing by. Welcome to the Traws [Technical Difficulty]. [Operator Instructions] As a reminder, this call is recorded. I would now like to turn the call over to John Fraunces, LifeSci Advisors.

John Fraunces: 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 will hear from Traw’s Chief Executive Officer, Dr. Iain 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 Dukes.

Iain 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 private financing was supported by new and existing health care-focused investors. The capital from this financing positions Traws to advance the flu program through a human challenge study this summer while providing access to additional capital as we achieve further key milestones. Influenza is estimated to be a multibillion-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 received from the Medicines and Healthcare Products and Regulatory Agency, or MRHA (sic) [ MHRA ] in the U.K. During today’s call, we will 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 bioenzyme 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.

Q&A Session

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 2 settings: prophylaxis, where it might be used on a monthly basis to prevent infection, especially during the flu season; and secondly, as an element of the 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 3 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 a single dose of tivoxavir provided protection against lethal bird flu challenge in 3 species with significant reductions in lung virus burden and pathology in nonhuman primates. Third, Phase I data in normal volunteer and healthy volunteers showed that the first-generation power and capsule formulation of tivoxavir maintained plasma blood levels well above the EC90 for over 3 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 a 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 bridging 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 prophylaxic program, the Phase IIa seasonal flu prophylaxis challenge trial. The Traws 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 continue 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. leading 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 for the toxicology data package. We are actively engaging with the FDA to address its concerns and resolve the clinical hold as expeditious as possible with the 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 the year.

At this point, I am going to hand this over to Charles.

John Fraunces: Thanks, Iain [indiscernible] summary of the financial results.

Charles Parker: 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 a 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 3 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. And 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 and 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, 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 $2.7 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 of 2025. 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 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 Iain.

Iain Dukes: 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 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: Comes from the line [indiscernible] with Cantor Fitzgerald.

Unknown Analyst: Hopefully, you can hear me. Great. I 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 immunogenicity in the prophylaxis setting for tivoxavir, just given it’s structurally similar? Or are you pretty confident that this can be fully resolved?

Iain Dukes: Thanks for your question. So the structural similarity of tivoxavir to Xofluza is an important point that you bring up because baloxavir has a clean immunogenicity label. It was negative in [indiscernible] and has shown no immunogenic potential since it’s been approved several years ago. So 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. So 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. So there’s no reason a priority why we should be any different to Xofluza. And so that gives us quite a lot of confidence that the in vitro data suggests immunogenic risk are probably explainable through other mechanisms of action of the drug.

Unknown Analyst: Okay. Nice. And then just on the U.K. side. So the — I 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 Dukes: Yes. Thanks for that. We actually don’t — we can’t really answer that question today. Our package has been submitted to MHRA. They are 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. So for instance, in Australia, which — 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. And again, [ HRAS ] had access to exactly the same toxicology information that the FDA has today. And then secondly, when we recently got approved to run the bridging study in Australia, again, no concerns have been flagged. So we remain hopeful and optimistic that the MHRA will indeed approve the study as submitted.

Unknown Analyst: Okay. Terrific. And just forecasting this out, thinking about sort of the value proposition for tivoxavir and flu prevention. 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 Dukes: 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. So 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, and we’ll make a decision based on what we see in terms of how we want to proceed forward into a Phase IIb/III in terms of the optimal dosing frequency that we would adopt.

Unknown Analyst: Okay. Last question for me, just a 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 like at your request for shareholder approval, you can access that capital within that 3-year window?

Charles Parker: Yes. I’ll handle that…

Iain Dukes: Charles, do you think…

Charles Parker: 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, then for 30 days consecutively, then we can — there will be a 10-day window to force exercise that warrant. So that is the accelerated feature within the warrant. Otherwise, it’s a 3-year term.

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.