INKT - NASDAQ

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

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.