MiNK Therapeutics, Inc. Q4 FY2025 earnings call

Mink Therapeutics is advancing an allogeneic and variant natural killer T cell platform. Clinically, it has mink cells in phase two trials for solid tumor cancers and autoimmune inflammatory conditions. Secured external funding for various trials. Demonstrated clinical activity with favorable safety profile. Strengthened financial position with cash increase and operating costs decrease. Appointed Melissa Orell as principal financial officer.

Not explicitly mentioned in detail within the provided transcript

In 2026, expect to initiate randomized Phase II trial for ARDS hypoxemic pneumonia and activate dosing in GVHD trial. Expect initial clinical data from these programs in second half. Continue to build scientific validation through data presentations and publications in first half.

Forward-looking statements are subject to risks and uncertainties. Detailed risks can be found in SEC filings.

Q: Hi, good morning. Thanks for the questions. A couple for me, maybe starting with the phase two 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 would need to be a separate trial. So maybe just talk about how you're thinking of these different indications.

A: Hi, Emily. Thanks so much for your question. Absolutely. While we have not publicly hosted 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 one slash two 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, anti-fungals, et cetera, but really physician's choice in this disease setting. So we have two 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 immune suppression 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 physician's 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. Therese Hammond is leading up our pulmonary disease programs. She's also clinically still seeing patients in the ICU. Therese is boarded in pulmonary critical care and 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 just 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, thank you. And maybe, oh, 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 the study?

A: 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 an 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 now 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 board of 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. All right. Thank you.

Q: Yes, good morning. Thanks for taking our questions and appreciate the comprehensive update. Just on the last point on IPF and even GVST, what target patient population, Jim, you have in consideration and wonder what differentiating aspects to the, you know, some of the recently approved anti-fibrotic, anti-inflammatory approaches are. you aspire to have the cell therapy you've positioned against. And then I have to ask on some of the IL-15, IMKT cell combination trial launching on cv.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 looks like the randomized control trial in the ARDS setting. If you could clarify that, that would be great.

A: Thank you for your questions. 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 the detailed eligibility criterion on ClinTrials, and this is another program where we are going to be announcing very soon, upon the announcement of the launch of the randomized phase two, 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. In ARDS, there are currently no approved therapies. 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 observe that. we see we can administer the cells, abelian cells, tolerably. We observe 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 in ventilated patients, to take samples from within the lung tissues called the bronchiolavage, which is our is the assessment that we can test in order to interrogate the immune cell, the local immune modulating capability of the cells. It gives us two opportunities. In addition to just radiologically looking at what's happening clinically within a patient's lungs, we can start to see clearance of pathology, clearance of some inflammatory markers. You could see this radiologically. But then also, When we really dig into lung tissue, we're able to see what is actually happening. In these patients, we see the substantial pro-inflammatory signatures and what we've publicly disclosed and we'll be publishing even more this year in the first half will be some of the anti-inflammatory signals that we see here in this population of patients. So we're really dampening pro-inflammatory signals We're eliminating fungal infections. We're eliminating some gram-negative bacteria, which is a major problem. And this becomes an even more substantial problem in some austere regions like war zones or places where we will be studying these cells where multidrug-resistant organisms are a substantial problem. Given that we've already been able to demonstrate not only with our clinical trial that we've published on, but also through emergency use that we've continued to help patients with, we've demonstrated that we can really do an impactful clinical activity and modulate some of these multidrug-resistant organisms, clearing them from patients with some of the most severe critical illnesses. This is such an important part of the work that we're doing right now So you'll hear more about the eligibility of these patients, and I'm going to invite you specifically to talk with some of the experts in this disease setting. So I think that was a longer way of answering the simple question on standard of care and what will be adequate controls, which would be really just physician's choice in this population. I appreciate it. Thank you, Jen. 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, you know, that trial that launched on clinicaltrial.gov, what the rationale was, and how is that different than the study that you just referenced?

A: Mike, thank you. Thank you very much. The study that I've referenced is the MINK-sponsored randomized phase 2 trial that we have not yet posted on ClinTrials. 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 superegonist, 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 during the appropriate time. Thank you, Jen. At this time, we have no further questions.

Q: Thank you, Operator, and thank you all so much for your participation today.

A: 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.