MiNK Therapeutics, Inc. Q1 FY2025 Earnings Call

Thank you for your patience. My name is Rochelle, and I will be your conference operator today. 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. I will now turn the call over to Jennifer Buell, Head of Investor Relations. Please proceed.

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 quarter 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. 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 advance our 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 has been essential to unlocking the full potential of our technology, our iNKT platform in oncology, 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. 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. A proposal on our next-generation pipeline 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 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. As I mentioned, at the ASCO GI and AACR IO inaugural meetings, we presented new data from our Phase 2 investigator-sponsored trial being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian, the Chief of Gastrointestinal Oncology. This study evaluates 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, a population with no effective therapies in the second line setting. The data demonstrate that iNKT cells, when delivered systemically, can rapidly traffic to the tumor microenvironment where they engage both innate and adaptive immune pathways. This is different from what is observed 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, with no CD8 T cells, therefore, no ability to immunologically manage the cancer. 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, even 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 was 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, indicating some robust tumor activity by immune effector cells, and we're also observing peripheral persistence. Our cells continue to persist beyond six months, which provides 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 in 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 converge to create 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 indicate the anti-inflammatory activity of iNKTs and their ability to reduce secondary infections and impact on pulmonary function and immune response. 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, gives 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. As you know, advancing this program has been contingent upon securing financing to advance this responsibly and efficiently. GvHD remains one of the most severe and unpredictable complications of transplant, 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 this 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 by June. This would provide critical nondilutive funding and a strong endorsement from one of the world's most respected federal research agencies. With this award, MiNK will launch a collaboration of preclinical and clinical research with our colleagues and scientific advisers at the University of Wisconsin. Together, ARDS and GvHD represent a large underserved market where MiNK's iNKT 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. On the operational efficiency side, we have been continuing to expand our work in the field by 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 efficiently in a 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.

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 are any other indications that you're still looking at?

Thank you for the question, Emily. The publication we anticipate releasing soon will contain that information. However, I can tell you that this case is unique and demonstrates the effectiveness of immune therapy. It’s notable that during the 12-month follow-up, the patient experienced disease stabilization. We monitored the patient, and less than a year later—after 24 months—he returned to see the principal investigator of the study and achieved a complete remission without any additional treatment. The investigator had been continuing clinical observations without further treatment following the single infusion. The complete response was officially noted at month 24 post the initial treatment with 797. The patient had multiple lesions, reflecting widespread disease, which will be detailed in the paper. Particularly interesting was the reduction in all lesions, including those in the liver, which is a key biomarker for us. We are observing iNKTs' activity in the liver during active disease. This has been noted in our Phase 1 study and our gastric cancer trial, and now with this case of testicular cancer. The patient also has a lung metastasis that currently seems inactive. He has chosen not to undergo a biopsy, but scans suggest that the nodule may be just dead tissue. We are quite encouraged by this and plan to conduct further clinical evaluations of other patients in the trial. Notably, when we shared our data, we presented it with a median follow-up of 12 months. Although we observed some responses during the trial, the majority of cases achieved long-term disease stabilization, including patients with pancreatic cancer, non-small cell lung cancer, testicular cancer, appendiceal cancer, and gastric cancers. These findings at the end of the follow-up period might have led us to underestimate the full clinical benefits of iNKT cells. We will conduct further evaluations of these patients and provide updates on our findings.

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

That's what we're targeting to do. They're continuing to enroll, and we'll be in touch with Dr. Jen about the soonest presentation. We have been looking at some GI-specific conferences as well as some major oncology conferences for an update in a clinical presentation. It's ultimately within her discretion. It will be no later than early next year; that would be the latest, but we're still on track and 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. Have you heard of any changes or delays in government funding, just with all this new news lately? Thanks.

We had heard of a delay expected at the beginning of the year. The six-month delay we have seen globally has 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. For us, this is a high priority for the government and for the agency regarding graft versus host disease. Our technology presents a really novel way of addressing this problem with engraftment success, reduction in GvHD, and improved clinical outcomes. So, we're optimistic based on the most recent correspondence from the government and it continues to boost our optimism.

Okay, great. Thanks for taking the questions.

Thank you.

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

Thanks for the update. I wonder if you could go over some of the details of the GvHD trial. Are you still planning it in acute patients, and any thoughts on prior treatments or what type of patients you'll be looking to enroll?

Yes. Thanks so much, Matt. There are two places where we will ultimately be setting in GvHD. The first with this financing support, and with the priority at the University of Wisconsin to bring this forward, is under the leadership of Jenny Gumperz, a Scientific Advisor who 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 we've developed a Phase 1 program for that. We have also developed a Phase 1 program for prophylaxis, which is engraftment success and reduction in GvHD. 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 are viable for us. I'm going to have Thiago Favano speak just a little bit more about the enrichment we're planning at this time.

Hi. Thank you for your question. In Phase 1, we will investigate not only GvHD but also several other transplant complications that need addressing. Although there are treatments and drugs available for prevention, these other effects still represent a gap. Drawing from previous strong literature and some of our own research, we believe that iNKTs can not only fight GvHD but also help prevent infections, leading to improved engraftment, which will be faster and of better quality, as well as reducing disease relapse. It is well-known that treating GvHD often leads to immunosuppression in patients, raising the risk of relapse or infections, which are significant complications. In this Phase 1 study, we will evaluate these additional effects while also preventing GvHD, setting the stage for Phase 2 focused on treating steroid-refractory GvHD and further opportunities in prevention, which could expedite the approval process.

Thanks, Thiago. Matt, I'm going to add something to this. There are two things happening in parallel. One is the funding opportunity. If the award is as we anticipate it to be, which is the full committed funding, then we will have an opportunity to interrogate both, prophylactic and mitigation in steroid-refractory patients. That's why we've developed two programs to handle that. In the case that we can fund independently with the grant funding one program, there is a strategic collaborator who is 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.