Good morning, and welcome to MiNK Therapeutics Fourth Quarter and Year-End 2025 Financial Results Conference Call. [Operator Instructions] As a reminder, this event is being recorded. If anyone has any objections, you may disconnect at this time. I would now like to turn the conference over to Stefanie Perna-Nacar, Chief Communications Officer. Please go ahead.

Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including notes related to our clinical development, regulatory and commercial plans, time lines for data releases and partnership opportunities. These statements are subject to risks and uncertainties. Please refer to our SEC filings available on our website for a detailed description of these risks. Joining me today are Dr. Jennifer Buell, President and Chief Executive Officer; Dr. Terese Hammond, Head of Development; and Melissa Orilall, Principal Financial and Accounting Officer. I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter. Dr. Buell.

Thank you, Stefanie. Good morning, everyone. For those new to MiNK Therapeutics, we are advancing a clinically validated allogeneic invariant natural killer T cell platform, one that is fundamentally differentiated in its ability to restore and coordinate immune function across diseases or even an immune failure. And unlike conventional cell therapies, our MiNK iNKT cells are off the shelf. They are administered without lymphodepletion, without HLA matching. And we've demonstrated clinical activity with a very favorable safety profile. MiNK cells are now in Phase II clinical trials in patients with solid tumor cancers and autoimmune inflammatory conditions like GvHD and severe lung disease. Clinically, in cancer, MiNK cells have demonstrated durable survival beyond 23 months with complete remission extending beyond 2 years in heavily pretreated refractory cancers. Cancer is expected with an expected survival of about 6 months. Outside of cancer, we're also seeing clinical activity in patients with hypoxemic pneumonia or otherwise called severe acute respiratory distress, reinforcing the broader applicability of our immune restoration cell product. We're excited to discuss with you today our upcoming trials. We have secured external funding to advance MiNK cells into graft-versus-host disease with the trial in the activation phase at University of Wisconsin. We have also externally funded a trial in Phase II in patients with gastric cancer with results presented last year at AACR and expected to be presented at a major conference in the first half of this year. And finally, our soon-to-be enrolling MiNK-sponsored randomized Phase II trial in patients with severe hypoxemic pneumonia or ARDS, a condition that affects approximately 200,000 to 300,000 patients per year. We'll talk more about that in just a few moments. Most importantly, we're doing this with a level of capital efficiency that's really uncommon in cell therapy. We're combining disciplined internal execution…

Thank you, Jen. During 2025, we executed an at-the-market facility in a disciplined manner, ending the year with a cash balance of $13.4 million. Since year-end, we have raised an additional $3 million through this program, extending our runway through 2026 and supporting key clinical milestones. Our net loss for the fourth quarter of 2025 was $2.6 million or $0.56 per share compared to $2.5 million or $0.62 per share for the fourth quarter of 2024. For the full year, net loss was $12.5 million or $2.93 per share compared to $10.8 million or $2.86 per share in 2024. These results reflect continued focused investment in advance in our agenT-797 clinical programs while maintaining disciplined control over our operational spend. I will now turn the call back to Jen for closing remarks.

Thank you so much, Melissa. Thank you all for being here. I think just in closing, I'll just reiterate that for us, if you just step back, the story is pretty simple. In 2025, we demonstrated durability. We showed mechanistic validation of our technology as well as human disease relevance. Those data have now set the stage for what we're doing going forward. And in 2026, we're executing on an important randomized controlled clinical trial as well as signal detection and clinical advancement in very important disease settings, including GvHD. We'll be generating clinical data and publicizing that very quickly and advancing towards potential paths for regulatory approval. We have multiple readouts planned in the first half of this year with data from our upcoming trials and preliminary readouts in the second half of this year. We're excited and I look forward to your questions. I'll now turn the call back over to the operator.

[Operator Instructions] Our first question comes from the line of Emily Bodner with H.C. Wainwright.

A couple for me. Maybe starting with the Phase II pneumonia and ARDS study. Could you kind of talk through how many patients approximately that trial is going to be? And what the appropriate control arm is here? And then you also talked about development in IPF, which sounds like it would need to be a separate trial. So maybe just talk about how you're thinking of these different indications.

Emily, thanks so much for your question. Absolutely. While we have not publicly posted the program in hypoxemic pneumonia, what I'm going to share with you is that currently in the disease population that we're pursuing, there are no approved therapies. Patients are treated with standard of care. This is the same state that we were in when we conducted our Phase I/II trial establishing the dose of these cells in this population of patients. What we've demonstrated is that patients are predominantly treated with steroid therapy with, of course, anti-infectives, antifungals, et cetera, but really physicians' choice in this disease setting. So we have 2 things that are really important. One, we've already observed and presented that these cells appear to be quite active in restoring immune functionality and clearing pathogens, independent of steroids being on board, which is unique. Many times, there's a concern about immunosuppression with steroid use, standard of care steroid use, and we're not observing that. So these cells appear to be sort of steroid-resistant. Their ability to modulate immune function, clear pathogens in the presence. We will be looking at physicians' choice as effectively standard of care. The cells will be added on top of standard of care versus the cells alone. And a critical piece of this is Dr. Terese Hammond is leading up our pulmonary disease programs. She's also clinically still seeing patients in the ICU. Terese is boarded in pulmonary critical care, neurocritical care medicine and has been treating patients with this disease profile for now decades of her life. For us to be able to have such a thoughtful leader on this program and such an informed clinician, it gives us a real opportunity to position these cells and to bring them forward into the patients who we believe they will be most effective in. And taking the cells plus or minus standard of care, gives us not only the differentiation of the cells, the added potential of the cells, but also maybe paradigm changing for these patients in the ICU.

Great. And maybe -- sorry, can I just ask one more. On the second-line gastric cancer trial, could you just remind us the status of that and when we may be able to see efficacy data from that study?

You will be seeing some efficacy data in the first half of this year at a major conference, which we'll be announcing relatively soon. And we're excited about that. But I did not answer your question about IPF, and this is, of course, a very important pulmonary fibrosis, end stage in particular, is another disease setting. It's effectively in immune-related condition. We've demonstrated that with our human data, and it's a substantial opportunity for us to develop the cells in IPF. We have some important preclinical observations as well as some new human data demonstrating that this is a pathway where we believe the cells can bring benefit. You're going to be hearing more about the design of that trial and the development path as we advance over the next couple of months. We will very likely host a special meeting in this disease setting. We have selected a scientific advisory boards, have informed clinicians in this space and have developed a program to advance. We'll be very responsible, though, about how we're going to be funding that program. So you'll hear more about that relatively soon.

Our next question comes from the line of Mayank Mamtani with B. Riley Securities.

I appreciate the comprehensive update. Just on the last point on IPF and even GvHD, what target patient population, Jen, you have in consideration? And wonder what differentiating aspects to some of the recently approved anti-fibrotic, anti-inflammatory approaches you aspire to have the cell therapy you positioned against. And then I have to ask some of the IL-15 iNKT cell combination trial launching on ct.gov. Could you help us understand how and what this 30 subject kind of total exposure would inform what you are looking to independently do with. It looks like the randomized controlled trial in the ARDS setting. I was not sure if the populations that you're exploring are overlapping across those combination and randomized trial settings. So if you could clarify that, that would be great.

Mayank, thank you for your questions. I just -- I want to make sure that I have them correct because you did cut out for just a moment. But I think on the randomized ARDS trial, the patient populations will be identified as hypoxemic pneumonia. There's a very specific global ARDS definition system that allows us to be very specific and selective about this patient population. So they will be selected and identified based on their oxygenation, so a very quantifiable way of interrogating this as well as important organ function states. So we will put a detailed eligibility criteria in clinical trials. And this is another program where we are going to be announcing very soon upon the announcement of the launch of the randomized Phase II as well as the dosing in GvHD. We'll be hosting a very special R&D meeting that will allow you to talk with our experts, our clinical development experts as well as review a deep dive of the programs and the eligibility of these patients. So in ARDS, there have been some -- there are currently no approved therapy. So this becomes standard of care, becomes really a physician's choice in this disease setting. There are no functional cell therapies in this setting. What we've been able to observe in our early stage development is that our cells really persist, and that they are not vulnerable to steroids. And that allows the cells to continue to modulate immunity in this setting. We observed that. We see we can administer the cells, 1 billion cells tolerably. We observed that the cells are in the peripheral system for some time, a number of days before they then home very specifically to lung tissue. We've been able to use a special technique that allows us, particularly…

I appreciate it. And I don't know if I missed that, or my question was cut out. If you could address the combination approach with the IL-15 agonist that trial, that launched on clinicaltrials.gov, what the rationale was? And how is that different than the study that you just referenced?

Mayank, thank you. Thank you very much. The study that I've referenced is the MiNK-sponsored randomized Phase II trial that we have not yet posted on clinicaltrials. We will be doing so. It's currently in review. The study that you're referring to, and I'm grateful that you brought it up. I've received a host of inbound inquiries about this from investors as well as from regulators. And I want to be very clear that MiNK has not formally announced any collaboration or any clinical trials with the IL-15 superagonist. And I think that's an important thing to understand. We will -- if we are to advance with these types of strategic collaborations, we will be very public about doing so. So at this time, strategic collaborations are really important to MiNK, and we have a number of discussions that are actively underway, not only for clinical trial combinations. There's a lot of excitement about 797, but also for broader strategic collaborations as well as minority financial investments in the company, none of which have we publicly disclosed at this time. We will do so when the -- during the appropriate time.

At this time, we have no further questions. I will now turn the call back over to Dr. Jennifer Buell for closing remarks.

Thank you, operator, and thank you all so much for your participation today.

Ladies and gentlemen, that concludes today's conference call. You may now disconnect your lines. Have a pleasant day.