Traws Pharma, Inc.

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.

As a reminder, I would now like to turn the call over to Science Advisors.

Thank you, Operator, and welcome everyone to Trust Pharma's full year 2025 financial results and business update conference call. This afternoon, TRAS 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 TRAS Chief Executive Officer, Dr. Ian 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 Form Act of 1995, which involved 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, TROS 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 Trous' CEO, Dr. Ian Dukes.

Thanks, John, and thanks to everyone for joining us today. Over the last year, Trous has made substantial progress toward our objective of bringing our differentiated next-generation antiviral candidate for influenza to patients. This morning, Trous announced a private financing of $60 million. The private financing was supported by new and existing healthcare-focused investors. The capital from this financing positions trials 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, spying 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 Tivoxir and Roboxyl as a potential best-in-class prophylactic agent for flu prevention. We intend to initiate the study this summer once we have approved proceeds from the Medicines, Health Care Products and Regulatory Agency, or MRHA, in the UK. During today's call, we'll provide an overview of development of our lead candidate, Tivoxir and Roboxyl, or Tivoxir for short, for influenza. Tuvoxibir or Voxel is an exciting next-generation investigational influenza antiviral that targets the highly-conserved viral enzyme cap-dependent endonuclease. We believe Tuvoxibir 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 have prioritized development of Tuvoxibir 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 market need, unmet medical need for improved prophylactic agents and therapies for flu. We envisage Sivoxavir's potential use in two 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 Tavoxivir 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 Tavoxivir 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 Zotoxibir 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 and healthy volunteers showed that the first-generation powder and capsule formulation, Tovoxavir, maintained plants at 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, Tovoxavir, 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 1 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 prophylaxis program, the Phase 2A Seasonal Flu Prophylaxis Challenge Trial. The challenge trial will be conducted at H-VIVO in the UK. Starting in June, positive results demonstrating protection from viral infection will be a landmark proof of concept for the program, supporting to Voxivir's unique value proposition as a safe and effective prophylactic agent. In the meantime, we continue to continue our conversations around Trevoxavir 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. meeting stockpile, we submitted our Investigational New Drug Application, or IND, in January. FDA recently informed us that our IND findings have been placed on clinical hold due to concerns of 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 the goal of advancing the program in the U.S. in late 2026. We are optimistic about the ongoing British 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. Thank you, Ian, for the summary of the financial results.

Thank you, Ian. This morning, Charles 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 view of the full financial statements. You can also access the press release in the 10K on our website. First, the recently completed financing. The private placement transaction includes funding of $10 million up front 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, and a Series C common warrant with a three-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, Toronto's 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 trans-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 83 cents per basic common and 82 cents 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, Josh. Before we open the line for questions, I'll briefly summarize the topics we've covered on the call. Trous 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 Trous' future growth. For influenza, we are poised to advance the evaluation of Devoxerum voxel as a prophylactic agent, supported by completion of a bridging study to the compressed tablet formulation and initiation of a trial in the UK 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 is, please proceed.

Yes, I hope that you can hear me.

Thanks so much for taking the questions. Great, 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 Zofluza, is there any plausible concern or risk around mutagenicity? in the prophylaxis setting for taboxivir, just given it's, you know, structurally similar, or are you pretty confident that this can be fully resolved?

Thanks for your question. So, the structural similarity of taboxivir to Zofluza is an important point that you bring up because, Biloxivir has a clean mutagenicity label with negative in aims and has shown no mutagenic 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 Zoflu as an additional control in the assays that we submit to the FDA. So there's no reason a priori why we should be any different to Zofluza. 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. And then just on the UK side, so the, I was hoping you could just characterize if there's any potential risk or what the various scenarios might be with 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 UK?

Yes, thanks for that.

We actually don't really answer that question today. Our package has been submitted to MHRA. 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, HVAC 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.

Okay, terrific. And just forecasting this out, thinking about sort of the value proposition for divoxavir and flu prevention, it sounds like, you know, 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, you know, 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. So, we will obviously very carefully evaluate the results from a challenge study, and we will be assessing the degree of protection at one week, two week, three week, as well as four weeks in this study. And we'll make a decision based on what we see in terms of how we want to proceed forward into a phase 2b3 in terms of the optimal dosing frequency that we would adopt.

Okay, thank you. Last question for 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 like at your request for shareholder approval, you can access that capital within that three-year window? Thanks so much.

Yes. I'll handle that one.

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 three-year term.

Perfect. Thanks so much. 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.