MiNK Therapeutics, Inc. (INKT) Q1 2025 Earnings Report, Transcript and Summary

Thank you for standing by. My name is Rochelle, and I will be your conference operator today. At this time, I would like to welcome everyone to the MiNK Therapeutics First Quarter 2025 Financial Results. After the speaker remarks, there will be a question-and-answer session. [Operator Instructions] I will now turn the conference call Jennifer Buell [ph], Head of Investor Relations. 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 those related to our clinical development, regulatory and commercial plans, timelines for data release, 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; 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.

Thanks very much Zack. I appreciate it and thank you all for joining us today. This quarter, we've made meaningful progress towards our mission and that's delivering scalable, durable, off-the-shelf iNKT cell therapies to patients with solid tumors and other immune-related diseases. In the first Q of 2025, we executed across three critical areas and those include clinical progress. We presented new data in solid tumors, specifically in second-line gastric cancer at the inaugural AACR IO Conference. And we showed immune activation and very early clinical activity and responses in patients who are otherwise refractory to checkpoint modulating antibodies. On the capital side, we continue to reduce our operating cash burn and operate extremely efficiently with a further reduction of about 47% year-on-year, preserving our ability to invest in our core programs. We've been able to continue to advance their clinical trials through external financing. Those include the advancement of our second-line gastric cancer and also the development of two programs, one in ARDS and the other in GvHD, which I'll talk about in just a moment. Strategic momentum. We are advancing confidential discussions for proposals, each of which could extend our runway and accelerate our impact, and I'm going to go into those in some detail in just a moment. Partnering, as you know, is core to our strategy and it has been. It's essential to unlocking the full potential of our technology, our iNKT platform in oncology, and immunology and inflammatory diseases, and, of course, our next-generation engineered cell therapy. Our platform is really broad and deep. It allows us to take full advantage of what these cells can do, and we remain at the forefront of advanced iNKT cell biology off the shelf, in patients with immune-related conditions. And today, I'm pleased to share that we have three distinct proposals, each aligned with one of our key therapeutic areas in oncology and cancer. We're focusing on advancing 797 in solid tumor cancers, building on the momentum from our gastric and testicular cancer program. I'll highlight a little bit more about some upcoming data in testicular cancer, but in the meantime, we did just recently present data at AACR that I'll share with you in a few moments. Proposal on immunology and inflammatory conditions. This supports our development of iNKT cells in acute inflammation, such as respiratory distress, as well as inflammatory conditions such as graft versus host disease, an area of great interest to our team. And a proposal on our next generation pipeline, this encompasses our CAR-iNKT therapy, our TCR-iNKT therapy, and our proprietary neoantigen discovery platform with the aim of creating highly targeted off-the-shelf immune therapies. These transactions and proposals are not exclusive. In fact, given their distinct focus areas and complementary capabilities of these proposed partners, these proposals may be mutually reinforcing each bringing differentiated capital, infrastructure, and scientific expertise to accelerate progress within their respective domains. Taken together, these proposals reflect strong external conviction in the value of our iNKT platform and represent a rare opportunity to diversify capital, reduce dilution, and accelerate development in multiple high-impact areas for MiNK. We're engaging with focus and urgency and expect to advance one or more of these in the very near-term. We'll continue to keep you abreast and we plan to host a more formal presentation regrouping with our key stakeholders to be able to announce these in due course. Now, I'm going to turn and highlight a couple of key elements of our programs and our progress to-date. In solid tumors, we're particularly encouraged by the continued momentum in our solid tumor program. And as I mentioned, at the ASCO GI and AACR IO inaugural meetings, we presented new data from our Phase 2 investigator-sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian, the Chief of Gastrointestinal Oncology. This study is evaluating allo iNKTs or agenT-797 in combination with two differentiated checkpoint-modulating antibodies, botensilimab and balstilimab. On top of standard-of-care chemotherapy in patients with second-line advanced gastric cancer, this is a population with no effective therapies in the second line setting. The data demonstrate that iNKT cells when delivered systemically, they rapidly traffic to the tumor microenvironment where they engage both innate and adaptive immune pathways. This is different than what you see with conventional T cells and NK cell technology. This activity, what we've observed is that we were looking at tumors that effectively were an immune desert, no CD8 T cells, therefore, no ability to immunologically manage the cancer. And what we observed is upon systemic infusion of 797, we can transform a cold tumor into an immunologically active or hot tumor, promoting these very important CD8 T cell infiltration, activating dendritic cells, and reversing immune exhaustion, and these are in cancers that are resistant to PD-1 blockade. These findings support our core thesis, iNKT cells act as immunologic first responders, initiating multilayered antitumor responses through direct tumor killing or cytotoxicity and immune orchestration. We anticipate sharing additional updated clinical updates later this year and the beginning of next year. In parallel, we expect a peer-reviewed publication describing a complete response in a patient with metastatic testicular cancer. This patient was treated in our Phase 1 trial with 797, and they were treated with 797 or allo iNKTs alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and TIGIT-based regimens prior to enrolling in the trial. Following a single infusion of agenT-797, the patient achieved a durable complete clinical radiological and biochemical remission. Treatment was delivered without lymphodepletion or HLA matching and showed no evidence of cytokine release syndrome or GvHD. The post-human analysis reveals elevated interferon gamma were observing some robust tumor activity by immune effector cells, and we're also observing peripheral persistence. Our cells still continue to persist beyond six months, which gives us a large therapeutic window to continue to dose these patients. This case exemplifies the unique biology of iNKT cells, their ability to rapidly home to tumors, dismantle cell immunosuppressive barriers, and activate both NK and CD8 T cells, even in tumors previously unresponsive to immune therapy. Alongside our gastric cancer findings, this finding reinforces iNKT cells as a novel off-the-shelf immune therapy platform with the potential to deliver durable benefit and hard-to-treat solid tumors. Beyond oncology, we're continuing to advance 797 in immune-related diseases such as respiratory distress, acute respiratory distress syndrome, and graft versus host disease. Our iNKT platform showed early on and continues to show compelling promise in immune-mediated diseases where inflammation, immune dysregulation, and poor treatment options converged to create really devastating clinical realities for patients. In ARDS, a life-threatening condition with no FDA-approved therapies, agenT-797 has shown the potential to change the treatment paradigm. As we published in Nature Communications and presented at the American Thoracic Society, our data demonstrated improved survival and meaningful inflammatory control in critically ill ventilated patients, many of whom would otherwise face mortality rates exceeding 70%. We, on the other hand, observed survival rates exceeding 70%, truly path-breaking. Our signals observed in a high-risk ICU population is a powerful indication of iNKTs steroid resistance anti-inflammatory activity, and their ability to reduce secondary infections and their impact on pulmonary function and immune technology. Consistent with the new leadership and priorities at the FDA, we are working urgently to make our therapies accessible through well-designed clinical trials, compassionate use programs and accelerated development pathways that reflect the seriousness and unmet nature of these conditions. The agency's increased receptivity to novel immune-based approaches, especially in indications like ARDS, give us further confidence in our regulatory path forward. In graft versus host disease, we're prepared to initiate a Phase 1 trial of 797 in patients undergoing allogeneic bone marrow transplant. We've spoken to you about this before. And as you know, advancing this program has been in part contingent upon securing financing to be able to advance this really responsibly and inefficiently. TBAC remains one of the most severe and unpredictable complications of transplant often leaving to -- often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our iNKT approach, which requires no lymphodepletion, no genetic matching, and poses minimal to no risk of GvHD itself is uniquely suited for this setting. The trial will be supported primarily through external partnerships, allowing us to advance the high-impact program with minimal capital outlay. Further reinforcing the momentum, we were recently selected for probable funding by the National Institute of Allergy and Infectious Diseases. We expect the formal award we were recently notified just a couple of weeks ago that we expect the formal award by June. This would provide critical nondilutive funding and a strong endorsement from one of the world's most respected federal research agencies. And with this award, MiNK will launch a collaboration of preclinical and clinical research with our colleagues and scientific advisers at University of Wisconsin. Together, ARDS and TBAC represent a large underserved market where MiNK iNKT's platform can deliver outsized impact. We remain committed to advancing these programs rapidly guided by scientific conviction and a growing mandate to bring transformative immune-based therapies to patients in need. And on the operational efficiency side, we have been continuing to expand our work in the field by reducing -- and reducing operating burn. We have continued to retain our top scientific leaders. We continue to internalize operational execution of our programs, including data management and clinical research activity, which has allowed us to operate far more efficiency in a far less capital-intensive way. These actions further reflect our commitment to financial discipline and operational focus. With that, I'll turn the call over to Christine for a review of the financials.

Thank you, Jen. We ended the quarter with a cash balance of $3.2 million. Cash used in operations for the three months ended March 31, 2025, was $1.3 million. This is reduced from $2.5 million for the same period in 2024. Our net loss for the first quarter of 2025 was $2.8 million or $0.70 per share. This compares to $3.8 million or $1.10 per share for the first quarter of 2024. Thank you and operator, we are now ready to take questions.

[Operator Instructions] Your first question comes from the line of Emily Bodnar with H.C. Wainwright. Please go ahead.

Hi, good morning. Thanks for taking the questions. Just first one on the testicular patient, congrats on the CR there. Are you able to say how long after treatment was initiated that the CR was observed. If you can comment on, I guess, your overall plan in testicular cancer going forward? And if there's any other indications that you're still looking at?

Emily, thanks for the question. And this is -- this publication is expecting out somewhat imminently, and that information will be a publication. But I can share with you, this is a unique case and it exemplifies the value of immune therapy. It's not surprising that in the 12-month follow-up period, the patient actually had disease stabilization. And we were monitoring the patient and not less than a year after that -- so it's 24 months the patients came back into see the PI of the study with a complete remission in no other treatment. So, this patient had been treated by the investigator, continued its clinical treatment with the investigator clinical observations with no additional treatment put into the patient at the single infusion. And the complete response was formerly designated at month 24 after the initial treatment of 797. And in addition, the patient had multiple lesions. Disease was really widespread, and you'll see this outlined in the paper and what was really quite intriguing was disease reduction really in all of the lesions, including the liver, and that's a very important biomarker for us. We are seeing activity of iNKTs in active disease in the liver. We've observed this in our Phase 1 study, we've also observed it in our gastric cancer trial, and now we've observed it with this testicular cancer case. The patient has a lung met that appears to be indolent at this point, that he does not want to undergo a biopsy, but the disease appears that the nodule appears to have nothing but dead tissue, based on all of the scanning that has been completed. So, we're really quite enthusiastic about this. And it has encouraged us to continue to do another survival sweep in clinical interrogation of other patients on the trial. What we found to be most intriguing, when we presented the data, we presented essentially with a median of 12 months of follow-up. And we had some responses in the trial, but predominantly, we saw long-term disease stabilization, and this includes in patients with pancreatic cancer and non-small cell lung cancer, testicular cancer, appendiceal, and gastric. And those observations when we stopped -- we concluded the follow-up period of the trial, we may be underestimating the ultimate clinical benefit of iNKT cells. So, we'll be getting a further clinical sweep of these patients and updating the field on the findings.

Okay, great. And on the Phase 2 gastric trial, are you still kind of on track for initial efficacy data in the second half of this year?

That's what we're on target to do. They're continuing to enroll, and we'll be in touch with Dr. Jen [indiscernible] about the soonest presentation. So, we are -- we have been looking at some GI-specific conferences as well as some of the major oncology conferences for an update in a clinical presentation. It's ultimately within her discretion. So, it will be no later than early next year. That would be the latest, but we're still on track -- we're still targeting to get something out by the end of this year.

Okay, great. Lastly, I'm just curious in terms of the funding that you mentioned from the NIAID. If you've kind of heard of any changes or delays in government funding, just with all this new news lately? Thanks.

Well, I'm with you. We had heard of a delay we expected this at the beginning of the year. So, the six-month delay is -- the delays that we have seen globally have impacted us. However, we were reassured to get a formal notification from NIAID that we can expect to hear that we had probable funding and can expect to hear conclusively in June. NIAID has not been as heavily impacted as some of the other agencies. And so for us is a high priority for the government and for the agency graft versus host disease. And our technology presents a really novel way of addressing this problem with engraftment success and reduction in GvHD and better clinical outcomes. So, we're optimistic in the most recent correspondence from the government continues to boost our optimism.

Okay, great. Thanks for taking the questions.

Thank you.

[Operator Instructions] Your next question comes from the line of Matt Phipps with William Blair. Please go ahead.

Thanks for the update. Wondering if maybe just go over some of the details of the GvHD trial. Are you still planning on is in acute patients and maybe any just thoughts on kind of prior treatments or what type of patients you'll be looking to enroll?

Yes. Thanks so much, Matt. So, there are two places where we will ultimately be setting in GvHD. And the first with this financing support and with the priority at University of Wisconsin to bring this forward, and this is under the leadership of Jenny Gumperz, who's a Scientific Advisor and wrote the seminal paper on the mechanism of iNKTs and GvHD. The opportunity for us in steroid-refractory acute GvHD represents a very fast path forward. That's what we have identified and developed a Phase 1 program for that. We have also developed a Phase 1 program for prophylaxis and that's engraftment success and a reduction in GvHD. And in that disease setting, we have a pathway that may be even faster. Both of these will be going to the regulators for a discussion with them imminently. And then we will choose the priority program to advance. But both opportunities for us. I'm going to have Thiago Favano who has been working with the investigators in the clinical development of the -- speak just a little bit more to the enrichment that we're planning at this time.

Hi. Thanks for your question. So, for the Phase 1, we are going to explore not only GvHD, but also a few other complications of transplants that still represents an unmet need, even though we do have available treatment and drug for prevention, but the other effect they still represent an unmet need. So, based on prior robust literature and some of our own studies, we expect the iNKTs not only to prevent or combat but also to prevent infections, contributes to a better engraftment -- faster and better engraftment and also prevent maintaining graft [indiscernible] effect to prevent disease relapse. So, we all know that on the treatment of GvHD, patients get immunosuppressed, and that makes it easier for them to have relapse or infections, which is a major complication. And we -- in this Phase 1, we are going to observe the -- all these other effects on top of preventing GvHD, which paves the way for Phase 2 in the way Jen explained, we will explore in treatment of steroid-refractory GvHD and then another opportunity in prevention, which represents an even faster rate for approval.

Thanks Thiago. And Matt, I'm going to add something to this. The -- there are two things happening in parallel. One is the funding opportunity. And if the award is as we anticipated will be, which is the full committed funding then we will have an opportunity to, in our own hands, interrogate both, prophylactic as well as mitigation in steroid-refractory patients. And so that's why we've developed two programs to be able to do that. In the case that we can fund independently with the grant funding one program, there is a strategic collaborator, who's at the table right now and has shared a proposal with us to advance the other, which would be the prophylactic study.

Great, okay. Thanks.

Thank you, Matt.

That ends the Q&A session. I will now turn the call back over to Jennifer Buell for closing remarks. Please go ahead.

Thank you, operator. Thank you all for joining us today. We look forward to interacting with you in the upcoming days.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.