TRAW

Over the last year, Traws has made substantial progress towards bringing a differentiated next-generation antiviral candidate for influenza to patients. Traws announced a private financing of $60 million, which positions it to advance the flu program through a human challenge study this summer. The human challenge study trial for flu prevention is important for tivoxavir marboxil as a prophylactic agent. Tivoxavir marboxil is an investigational influenza antiviral targeting a conserved bioenzyme. The company intends to initiate the human challenge study in summer once approved by MHRA. Traws also submitted an IND to FDA, but it's on clinical hold due to toxicology concerns. There's ongoing work on a bridging study in Australia and a challenge trial in the U.K. starting in June. The company is also in conversations about tivoxavir for the National Stockpile. The recent $60 million financing provides resources to drive forward the seasonal influenza prophylaxis study.

The private financing of $60 million positions Traws to advance the flu program through a human challenge study this summer. The company intends to initiate the human challenge study for flu prevention in summer once approved by MHRA. The capital from the financing allows access to additional capital as key milestones are achieved. The company believes its current cash balance is sufficient to support planned expenses into Q1 2027.

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. 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. 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. 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.

FDA has placed the IND on clinical hold due to concerns for the toxicology data package, and Traws is actively engaging to resolve it. There's uncertainty regarding MHRA's approval timeline for the human challenge study as the agency reviews the submitted package. The structural similarity to Xofluza raises some unknowns about potential immunogenicity risks, but Traws plans to address by repeating assays and using Xofluza as a control.

Q: 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?

A: 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.

Q: 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.

A: 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.

Q: 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?

A: 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.

Q: 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?

A: Yes. I'll handle that...

Q: 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.