MiNK Therapeutics, Inc. (INKT) Q4 2024 Earnings Report, Transcript and Summary

Hello, everyone. And welcome to MiNK Therapeutics Fourth Quarter 2024 Financial Results Call. Please note that this call is being recorded. After the speaker’s prepared remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. I’d now like to hand the call over to Zack Armen, Investor Relations. You may now begin.

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 those related to our clinical development, regulatory and commercial plan, timelines for data release and partnership opportunities. These statements are subject to risk 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; and Christine Klaskin, Principal Financial and Accounting Officer. Now I’d like to turn the call over to Dr. Buell to highlight our progress from this quarter.

Thank you very much, Zack, and thank you all for joining us today. 2024 was a defining year for MiNK Therapeutics. The year in which we executed on our strategic vision, strengthened our leadership, advanced our clinical programs and expanded partnerships that position us for significant impact in the year ahead. Our focus remains unwavering to bring the most scalable, durable and effective allogeneic iNKT cell therapy to patients with solid tumors and immune driven diseases. In the fourth quarter, we announced an important addition to our leadership team and we welcomed Dr. Robert Kadlec to our Board of Directors. This is a substantial addition for our company. Dr. Kadlec is a renowned leader in biodefense and pandemic preparedness. He’s the former head of ASPR at the Department of Health and Human Services, and he was instrumental in Operation Warp Speed Initiative. His expertise in public health strategy and medical countermeasures adds tremendous strategic depth as we explore the applications of our iNKT platform in biodefense, pandemic preparedness and infectious diseases. At the same time, we also announced the departure of our general counsel, Robert or Bob Foster. Bob has transitioned to a leading role in the Department of Health and Human Services as the Chief Counsel for Food, Research and Drugs in our new administration. We are deeply grateful for Bob’s commitment, contributions and integrity throughout his tenure at MiNK and we wish him continued success in his service to our country. On the business side, we made strong progress on multiple fronts. In addition to strengthening our leadership, we expanded our innovation toolkit. In the fourth quarter, we entered a collaboration with Autonomous Therapeutics to combine their encrypted RNA technology with our iNKT cell therapy. This collaboration is highly strategic. By integrating Autonomous’ precision encoded RNA platform with our cell therapy candidates like 797 and our FAP-CAR-iNKT, we aim to create next generation treatments for metastatic cancer. The idea is to target and eliminate metastatic tumor cells with greater precision. In preclinical models and in the clinic, we’ve already demonstrated that iNKT cells have shown that they can effectively attack tumors. And for instance, in very difficult to treat metastatic colorectal cancer models and in second-line gastric cancer, by arming these cells with encoded RNA payloads that activate only in the tumor environment, we hope to spare healthy cells while delivering potent tumor-killing signals. This partnership exemplifies how we’re leveraging external innovation to amplify the power of our iNKT platform and can open entirely new avenues for treating solid tumor cancers. In 2024, we executed across our clinical programs, expanding data of iNKT cell therapy in solid tumors, respiratory distress and immune-driven diseases. At major conferences throughout the course of this year, including the inaugural AACR IO, ASCO GI and SITC, we presented data demonstrating that 797 enhances immune activation, expands the benefit of checkpoint inhibitors and bispecific engagers, and overcomes resistance in some of the most challenging cancers, including gastric cancer. At the AACR IO Conference just this past February, we presented new translational data from our ongoing Phase 2 study, which is first of its kind in delivering an allogeneic iNKT cell therapy in refractory gastroesophageal cancer. Our data demonstrated powerful synergy between our allo-iNKT cells, important first-of-kind checkpoint inhibitors, including botensilimab and balstilimab, and standard chemotherapy. This combination led to robust immune reactivation in otherwise unresponsive tumors, essentially taking an immune desert and turning that immune desert hot, and we’ve demonstrated that pathologically and immunologically in the data we presented at AACR IO. We also reported that the addition of 797 led to higher interferon-gamma levels, increased T cell infiltration and strong antigen-presenting cell engagement. These critical biomarkers are known to correlate with better, more durable clinical responses, further validating the role of iNKT cells in driving immune reactivation. Importantly, these seminal observations revealed the importance of optimal sequencing. And in fact, the strongest responses were observed when we took our cell therapy, 797, and we combined it with checkpoint inhibitors before applying standard-of-care immunosuppressive chemotherapy. This sequencing led to the most significant immune expansion and powerful peripheral memory T cell activation, highlighting the value of early allo-iNKT induction as a key driver of therapeutic benefits. These findings underscore the unique ability of iNKT cells to intensify immune activity, reinvigorate memory T cells and reshape the tumor microenvironment, offering a scalable allogeneic solution with global patient access. We’ll be looking forward to sharing additional clinical updates later this year with the clinical outputs from this program. In addition, we’re advancing our novel pipeline, including our PRAME-TCR program and our next-gen cell therapeutics. We’ve demonstrated with our PRAME-TCR iNKTs that targeting intracellular tumor antigens previously unreachable by conventional therapies can actually demonstrate very high specificity and potent tumor killing. At the SITC 2024 Conference in November, we showed that 797 worked synergistically with checkpoint inhibitors and bispecific engagers. Basically, when used together, the anti-tumor activity was significantly enhanced beyond what either of those therapies, checkpoints or bispecific engagers can achieve alone. This builds on my earlier statement, demonstrating the clinical observations of 797 in combination with checkpoint inhibitors in gastric cancer. This is important because it suggests that allo-iNKTs can be added to existing cancer treatments to overcome resistance and boost efficacy, potentially turning non-responders into responders. At the same conference at SITC, we reported on our PRAME-targeted TCR iNKT program, which is one of our next-generation engineered products, that the PRAME tumor antigen commonly expressed in prevalent tumors like lung, ovarian, melanoma, sarcoma, has been challenging to treat and has evaded traditional T-cell therapies. Our preclinical results show that PRAME can seek and destroy PRAME-positive tumor cells with precision. This suggests a promising solution for treating a range of solid tumors that express PRAME. We’re encouraged by these data, and they showcase how adaptable and potent our platform can be. Now, there’s something that’s really quite important that these cells can deliver. We’ve shared some of this data with you previously. Beyond oncology, we continue to advance AgenT-797 in immunology and inflammatory conditions. The most advanced program is our clinical program in patients with severe acute respiratory distress. This remains a field with significant unmet need and no approved therapies. Results from our Phase 1 study published in Nature Communications and more recently presented at the American Thoracic Society annual meeting showed that 797 achieved an 80% survival rate in patients who were on the most severe form of life support, VV ECMO, and that compares to just 10% of in-hospital controls. These findings, again, underscore the potential of iNKTs in addressing high-impact health challenges. And very importantly, we also noticed that these cells prevented secondary infections, fungemia, bacteremia, that often cause mortality in the ICU setting. That’s a really critical part of the story. As we begin to continue our expansion in INI, we are looking to announce our externally supported program in acute Graft versus Host Disease or GvHD. We planned our Phase 1 trial of 797 in patients undergoing allogeneic bone marrow transplant. This trial is particularly valuable as it will be conducted predominantly with external support to offset our development costs. We have been awarded probable funding by the National Institute of Allergy and Infectious Diseases or NAIAD (sic) [NIAID], to explore the activity of 797 in acute GvHD. Now, I say probable funding and that was a specific language that was leveraged by the government agencies, and we will await the evolution of the administration and look forward to announcing more formally the funding granted by this agency. Acute GvHD is severe and potentially life-threatening complication of transplant, and current options are limited. Our goal is to use immune-modulating iNKT cells to prevent and treat GvHD by dialing down the harmful donor-derived T cell responses that cause it without compromising the graft cancer-fighting benefits. The Phase 1 study will primarily assess safety, determine an optimal dose of 797 and explore the clinical benefits in these patients. Given 797’s favorable safety profile in early trials, we’re optimistic that it will be well-tolerated in the transplant setting as well. The trial is being submitted to local and national regulators, and we expect the dose this year. Before I hand the call over to Christine, I want to emphasize how these pieces come together for MiNK. The leadership updates, the partnership with Autonomous, the clinical progress both in oncology and INI, or inflammatory and immunologic diseases like respiratory distress and GvHD, are all part of our strategy to execute efficiently while expanding the impact of our iNKT platform. We’re entering 2025 with strong momentum, a differentiated technology, provocative clinical data, and a growing network of experts and partners, and a clear plan to reach our next value inflection point. We remain committed to our mission of delivering the cell therapy to patients and we’re doing so with an eye on smart resource management and strategic growth opportunities. I’ll now turn the call over to Christine.

Thank you, Jen. We ended the year with a cash balance of $4.6 million. Cash used in operations for the three months and 12 months ended December 31, 2024, was $1.7 million and $9.6 million, respectively. This compares to $3 million and $15.8 million for the same period in 2023, reflecting our efforts to contain our spend while still advancing our programs. Our net loss for the year ended 2024 was $10.8 million or $2.86 per share. This compares to a net loss for the prior year of $22.5 million or $6.54 per share. I’ll now turn the call back to Jen for closing remarks.

Thank you, Christine. To wrap up, I’d really like to reiterate how proud I am with the MiNK team on our achievements in 2024. We built a strong foundation scientifically, clinically and operationally, and this foundation positions us for an important year ahead. In 2025, we expect to deliver on multiple milestones, additional clinical data from our gastric cancer trial, advancing our GvHD study into patient dosing and expanding our pipeline through strategic innovation. We also plan to continue forging alliances that enhance our platform and broaden the applications of iNKT cell therapy into new indications and areas of high unmet need. Our commitment to execution is really unwavering. We have the right people, now including Dr. Kadlec’s expertise on our Board, the right partners and a differentiated therapeutic approach that can create significant impacts for patients. And at the same time, we remain deeply focused on operational efficiency and excellence in fiscal responsibility, ensuring that we utilize our resources very wisely as we move forward. This balance of innovation and prudence is central as we continue to advance our company. We look forward to keeping you updated throughout the course of the next year and thank you again for your support. Operator, we’re ready to take questions.

[Operator Instructions] Your first question comes from the line of Emily Bodnar from H.C. Wainwright. Your line is now open.

Good morning. Thanks for taking the questions and congrats on the progress. Maybe, first one, if you can just provide a bit more on the status of the Phase 2 study, kind of where you are in terms of enrollment. And then, I know you said you plan to have data this year, but if there’s any kind of more granular timelines you can provide and how much data we should be expecting to see at that update. And then, in terms of focus for 2025, is your main focus on advancing 797 in both gastric cancer and in GvHD or do you expect to bring forward any of your other internally developed programs toward IND filing?

Emily, thank you very much for your question. I’m going to start with the last. So, for 797 this year, we absolutely plan to advance 797 in gastric cancer, as well as in GvHD. Those are very important, and as well as they build upon the data that we’ve generated so far. And before I go to our next-generation pipeline, which is also a key catalyst for 2025, I just want to remind you that when we presented data at the AACR IO Conference, we really focused on some of the translational biomarkers of our observation, because those has been -- that’s been a major gap. iNKT cell therapies are what we believe to be the most potent cells in immunology. We’ve generated a process and a practice that allows us to scale these, and we are educating the world as we’re advancing our science. We’re the most advanced clinical stage company bringing these cells forward. And what you see with these cells, you do not see with conventional T cells or natural killer cells, in which they’re durable and persist beyond six months, which gives us a big therapeutic window to evaluate benefits. They also have demonstrated to be tolerable, and most importantly, you can administer them without HLA matching and without lymphodepletion, and you don’t compromise that durability and persistence, which is a key differentiator. And we use the AACR IO Conference to demonstrate really those key biomarkers and the kind of bioactivity and immunologic activity of those, setting up the foundation for the clinical data that we plan to present at the end of the year, or I’ll say, in the second half of the year at a major conference. Importantly, because of the biomarker data that we’ve demonstrated, how 797 can show this broad immune activation, a hallmark of the durable response is the very high interferon-gamma signature, which is, by the way, these cells are the most productive interferon-gamma secretors. And those findings that we have been the first to describe in such depth and detail in the clinic at the AACR IO Conference set us up now to start to leverage those findings to show how they translate into the clinic. We have the majority of patients enrolled in our clinical trial, and as you know, we started enrollment in February of 2023, which gives us a very nice lengthy runway of demonstrating responses, durability of response and survival, which is an important outcome, particularly in this disease setting. So that trial continues to enroll, the majority of patients are in and we will be presenting data in the second half of the year. The other catalyst for 2025 will be our most exciting FAP-CAR-iNKT. As you might recall, this is an IL-15 armored FAP targeting CAR-iNKT that we’ve presented now in a few different occasions demonstrating the preclinical differentiation of this very valuable asset. We’re advancing through IND-enabling studies and we still plan to get that into the clinic in 2025.

Great. Thanks for all the comments.

Certainly.

Your next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is now open.

Hi. Good morning, team. Thanks for taking our questions and pleased to see the progress reported here. On the AACR IO presentation, are you able to share with us any KOL investigator feedback? And obviously, specifically interested in how you see this agent having a path following this study and do you anticipate a prospect of an accurate approval based on the data you’re generating? And then the second question, the follow-up here was around the PRAME-TCR disclosure, which seems very interesting. I would love to hear how you think the iNKT approach here differentiates versus maybe the alternative cell therapy approaches, and also, obviously, data-rich here for bispecific bispecifics we have ahead of us?

Mayank, thank you very much, and I especially appreciate your very provocative question about approval based on our randomized Phase 2 data that’s being collected. I’ll come to that in just a moment. So, for KOL feedback, this is a true opportunity for us to have, actually, the lead investigator, Dr. Yelena Janjigian, speak independently about this. I believe she will be the presenter of data for an upcoming conference, particularly the clinical data. She’s been deeply involved with our interrogation of the results, of course, the accumulation of patients as she’s leading the trial, but also the interpretation of our observations. She’s quite intrigued and very motivated to continue this trial. We have not yet expanded enrollment into the trial. We’re still accumulating the patients onto the currently estimated 40 patients into the program. She is very bullish, I’ll say, and I’ll have her speak for herself. She’ll be willing to do so, as well as her investigator, Dr. Sam Cytryn, who is also an investigator at Memorial Sloan Kettering. This is enrolling at nine centers at this time, so she expanded the program to enable greater access to patients. That essentially underscores the sentiment that she has for this program. We also have the continued support and we’re grateful for the continued support, funding-wise, from Stand Up To Cancer and so they remain really steadfast in their commitment to advancing this innovative approach for patients. As -- with respect to will this program be registrational, we’re going to continue to accumulate as much data as possible and demonstrate the clinical benefit for all patients. And then, of course, we’ll be advancing this into regulatory discussions. We are all seeking the most aggressive and efficient path to get global access to patients, particularly with second-line gastric, where there is nothing available. We’re really quite intrigued because these patients who are having -- these are patients who have not responded to Full Fox [ph] or PD-1, which, again, underscores the reactivation of what these cells can do for patients. For PRAME-TCRs, now, iNKTs, as I just mentioned in my last response to Emily is how valuable they are with respect to their delivery and their tolerability, and no HLA matching, no lymphodepletion. They’re durable. And they’re really quite selective and potent. And as you might recall, because of their invariant TCR, which is common in all of us, I can take one donor’s TCR, give them to another and they bind to an important lipid ligand, CD1d. Once they do that, they recruit T cells, conventional T cells and NK cells. So in addition to their endemic response locally, their conversion, suppression of myeloid-derived suppressor cells that we demonstrate now immunologically, they also recruit T cells, conventional T cells and NK cells. That’s highly different than what’s currently available to patients from any other PRAME targeting approach. And we’ve demonstrated that. The data are available on our website and perhaps we’ll push it out again, maybe on X, so that you’ll have rapid access to some of the data that we’ve previously presented.

Okay.

I should say, Mayank, because one last part that I did not mention, MiNK is, of course, the holder of a proprietary platform of over 4,000 phosphorylated neoantigens. We’ve created very important medicines targeting a couple of these antigens. This is an approach that is growing in interest. Of course, we’ve known how important these intracellular target approaches are. We’ve presented data on our MLL targeting TCR and on our PRAME targeting TCR. Now, of course, we’re being incredibly fiscally responsible right now, and I shall say that these programs are of active interest both to our own, in our own hands, but also in the hands of some others, given the growing interest in the neoantigen space and the personalized, individualized TCR approach. MiNK has been able to demonstrate that we could deliver on this approach really quite efficiently and it’s something you’ll be hearing more about in 2025.

Thank you. If I could squeeze one more in on the physically proven side, since you are being across different programs, is there an IND filing timeline you’re putting on any of the next-generation iNKT programs, including 215? Thanks again for taking the question.

215 IND filing is planned for 2025, so we remain on target for that IND filing and we’ll continue to update you on the planned IND filing for the TCR programs. These will be announced commensurate with other announcements related to those programs.

Got it. Thank you, again.

[Operator Instructions] Your next question comes from the line of Jack Allen from Baird. Your line is now open.

Hi. Thank you for taking the questions and congratulations on the progress made over the recent months. I wanted to start off by asking a little bit more about the Graft versus Host Disease study. You mentioned you do have this provable funding from NAIAD (sic) [NIAID]. I just wanted to ask, I guess, what is the timing? I know it’s very fluid as it relates to the funding with the federal government, but what are your thoughts on the timing around when that funding could be more solidified, and I guess, how do you think about potential backup plans as it relates to funding that study? And then beyond funding Graft versus Host, I just wanted to ask, I may have missed it on the call, but what are your latest thoughts as it relates to cash runway for the broader MiNK business right now?

First of all, Jack, you are at the top of your game and congratulations on your new baby. I’m so glad to have you back on the call. With respect to…

Thank you. Thank you.

You are welcome. With -- so with respect to Graft versus Host, for timing, we’ll just ask that you stay tuned. It is certainly a fluid time right now. We have the great luxury of having a Scientific Advisory Board member named Dr. Jenny Gumperz. Dr. Gumperz has been the individual who actually published on the seminal findings that show the mechanism as to how, in very natural killer T cells, our particular formulation is quite active in Graft versus Host, acute and chronic, actually, in her preclinical models in her most recent publication. She is our collaborator on both the preclinical work and the clinical work that is advancing, and we’re thrilled to have the opportunity to have her. Given her experience and gravitas in this space, we’re optimistic that this very important program will advance. I believe that our government, despite some of the most recent efficiencies, does see the importance of this. Patients undergoing, as you know, hematopoietic stem cell transplants, the majority of whom succumb to Graft versus Host Disease and ultimately graft failure. That is an enormous burden on our healthcare system and it’s taking young people out of the workforce. And I -- just based on our conversations with the government, they can appreciate the importance of finding approaches that are not only very tolerable, but that cannot -- can augment a successful engraftment and then also mitigate some of the subsequent complications of engraftment. This will help everyone particularly younger individuals have -- thrive following a transplant. So I’m optimistic, but I don’t want to give any predictions at this point, so we’ll keep you tuned and we will certainly announce at the moment that we hear about the funding clearing and the launch of the program. The program will be a multi-center trial and it will be led by Dr. Jenny Gumperz, as well as some of her colleagues in the clinic at University of Wisconsin. So it’s designed, it’s been submitted to the Regulatory Boards both locally at the IRBs, as well as nationally at the FDA. So once that funding clears, we should be ready to go. As far as backup strategies, this is also of great interest to partners, as well as to investors. And this is an opportunity for us to secure some very specific financing to advance the trial as a backup or even as a complement to the non-dilutive financing from the government.

Got it. Got it. Great. Thank you so much. Thanks for the congratulations on the comment there. I guess just to reiterate also, if you could provide any comments on the existing financial position of MiNK and your thoughts on the cash runway moving forward.

So, we right now, based on our financial projections and some additional efficiencies that we have internally, we have cash through the end of 2025.

Got it. Thank you so much, Jen. It’s great to connect and congratulations again on the progress.

Thank you very much, and again, congratulations to you, Jack.

That concludes our Q&A session. I’d now like to hand back over to Dr. Jennifer Buell for closing remarks.

Thank you very much, Operator, and thank you all for joining us and for your continued support. We look forward to touching base with you in the next couple of weeks.

Thank you for attending today’s call. You may now disconnect.