Earnings Call Transcript - INKT Q4 2024

Operator, Operator

Hello, everyone. 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. Thank you. I’d now like to hand the call over to Zack Armen, Investor Relations. You may now begin.

Zack Armen, Investor Relations

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.

Dr. Jennifer Buell, President and CEO

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 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 the 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 can effectively attack tumors. 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 the 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. The strongest responses were observed when we took our cell therapy, 797, and 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 look 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. 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. The PRAME tumor antigen, commonly expressed in prevalent tumors like lung, ovarian, melanoma, and 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, which showcase how adaptable and potent our platform can be. 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, compared to just 10% of in-hospital controls. These findings underscore the potential of iNKTs in addressing high-impact health challenges. Very importantly, we also noted that these cells prevented secondary infections, fungemia, and bacteremia, which often cause mortality in the ICU setting. As we 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 NIAID, to explore the activity of 797 in acute GvHD. Now, I say probable funding, and that was specific language 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 a 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 to 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 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, 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 cell therapy to patients while managing resources wisely as we move forward.

Christine Klaskin, Principal Financial and Accounting Officer

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.

Dr. Jennifer Buell, President and CEO

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, which 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 truly unwavering. We have the right people, including Dr. Kadlec’s expertise on our Board, the right partners, and a differentiated therapeutic approach that can create significant impacts for patients. At the same time, we remain deeply focused on operational efficiency and excellence in fiscal responsibility, ensuring that we utilize our resources 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, Operator

Your first question comes from Emily Bodnar from H.C. Wainwright. You may now ask your question.

Emily Bodnar, Analyst

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?

Dr. Jennifer Buell, President and CEO

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 they also build upon the data that we’ve generated so far. I just want to remind you, when we presented data at the AACR IO Conference, we focused on some of the translational biomarkers of our observation, because that has 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. With these cells, you do not see the same activity with conventional T cells or natural killer cells, in which they’re durable and persist beyond six months, which gives us a large 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. We used the AACR IO Conference to demonstrate those key biomarkers and the kind of bioactivity and immunologic activity, establishing the foundation for the clinical data 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 we’ve demonstrated, how 797 shows broad immune activation, a hallmark of durable response is the very high interferon-gamma signature. Moreover, these cells are the most productive interferon-gamma secretors. Those findings we have been the first to describe in such detail and depth in the clinic at the AACR IO Conference set us up now 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, providing a lengthy runway to demonstrate responses, durability of response, and survival, which is an important outcome, particularly in this disease setting. The trial continues to enroll, and we will present data in the second half of the year. Another 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 previously presented, demonstrating the preclinical differentiation of this valuable asset. We’re advancing through IND-enabling studies, and we plan to get that into the clinic in 2025.

Emily Bodnar, Analyst

Great. Thanks for all the comments.

Operator, Operator

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

Mayank Mamtani, Analyst

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 accurate approval based on the data you’re generating? 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 bispecifics we have ahead of us?

Dr. Jennifer Buell, President and CEO

Mayank, thank you very much. I especially appreciate your provocative question about approval based on our randomized Phase 2 data that we’re collecting. For KOL feedback, this is truly an opportunity for us to have 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 into the currently estimated 40 patients in the program. She is very bullish, 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 at Memorial Sloan Kettering. This is enrolling at nine centers right now, so she expanded the program to enable greater access to patients. That underscores her positive sentiment for this program. We also continue to receive funding from Stand Up To Cancer, and they remain steadfast in their commitment to advancing this innovative approach for patients. With respect to whether this program will be registrational, we will continue to accumulate as much data as possible and demonstrate clinical benefit for all patients. Of course, we’ll be advancing this into regulatory discussions. We are 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 intrigued because these patients have not responded to Full Fox or PD-1, which underscores the reactivation of what these cells can do for patients. Regarding PRAME-TCRs, as I just mentioned, iNKTs are valuable with respect to delivery and tolerability, with no HLA matching and no lymphodepletion. They’re durable and quite selective and potent. As you might recall, due to their invariant TCR, which is common in everyone, I can take one donor’s TCR and give it to another; they bind to important lipid ligands, CD1d. Once they do that, they recruit T cells and conventional T cells as well as NK cells. Thus, in addition to their endogenous response locally, their conversion and suppression of myeloid-derived suppressor cells that we demonstrate now immunologically, they also recruit T cells and conventional T cells and NK cells. That differs significantly from the other available PRAME targeting approaches. The data are on our website, and we may push it out again, maybe on X, for rapid access to previously presented data.

Mayank Mamtani, Analyst

Okay.

Dr. Jennifer Buell, President and CEO

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

Mayank Mamtani, Analyst

Thank you. If I could squeeze one more in on the physically proven side, since you are 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.

Dr. Jennifer Buell, President and CEO

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 alongside other announcements related to those programs.

Mayank Mamtani, Analyst

Got it. Thank you, again.

Operator, Operator

Your next question comes from the line of Jack Allen from Baird. Your line is now open.

Jack Allen, Analyst

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 probable funding from 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?

Dr. Jennifer Buell, President and CEO

First of all, Jack, you are at the top of your game, and congratulations on your new baby. I’m glad to have you back on the call. With respect to Graft versus Host, for timing, we 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 published seminal findings that show the mechanism by which our particular formulation is quite active in Graft versus Host, both acute and chronic, actually, in her preclinical models in her latest publication. She is our collaborator on both the preclinical and clinical work that is advancing, and we’re thrilled to have her. Given her experience in this space, we’re optimistic that this very important program will advance. I believe our government, despite some recent efficiencies, sees the importance of this. Patients undergoing hematopoietic stem cell transplants, the majority of whom succumb to Graft versus Host Disease and graft failure, is a significant burden on our healthcare system and takes young people out of the workforce. Based on our conversations with the government, they appreciate the importance of finding approaches that are not only tolerable but can augment successful engraftment and mitigate some subsequent complications of engraftment. This will help particularly younger individuals thrive after a transplant. So, I’m optimistic but don’t want to make predictions at this point; we’ll keep you updated and certainly announce when we hear about the funding clearance and the launch of the program. The program will be a multi-center trial led by Dr. Jenny Gumperz and some of her colleagues at the University of Wisconsin. It’s designed, and has been submitted to both local IRBs and nationally at the FDA. Once that funding clears, we should be ready to go. As for backup strategies, this is of great interest to partners and investors alike. We have an opportunity to secure specific financing to advance the trial as backup or as a complement to the non-dilutive financing from the government.

Jack Allen, Analyst

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.

Dr. Jennifer Buell, President and CEO

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

Jack Allen, Analyst

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

Dr. Jennifer Buell, President and CEO

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

Operator, Operator

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

Dr. Jennifer Buell, President and CEO

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.

Operator, Operator

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