Mink Therapeutics - Earnings Call - Q1 2025

Executive Summary

• MiNK’s Q1 2025 print was steady operationally with materially lower opex YoY, while EPS missed consensus by ~$0.09 as the quarter included a $0.17M non‑cash fair value adjustment on a related party note and no revenue; cash used in operations fell to $1.34M (vs $2.54M YoY) and cash ended at $3.24M. EPS was -$0.70 vs S&P Global consensus -$0.61 (two estimates)*; revenue was expected at $0 and remained pre‑revenue.
• Strategy progressed: management is in late‑stage discussions on three distinct partnering transactions (oncology, immunology/GvHD/ARDS, next‑gen engineered iNKT) intended to extend runway with lower dilution; management guided “very near term” potential to advance one or more.
• Clinical momentum continued: Phase 2 2L gastric trial is actively enrolling with plans for an efficacy update in 2H25 (or early next year at the latest); new translational data show iNKT + BOT/BAL + chemo reprograms PD‑1–resistant tumors; a testicular cancer complete remission after one 797 infusion will be published and supports solid tumor potential.
• Non-dilutive funding: NIAID selected MiNK for probable grant funding for allogeneic iNKT in GvHD with a formal award expected by June 2025 (a key near‑term stock catalyst), aligning with plans to initiate a Phase 1 in steroid‑refractory and/or prophylaxis settings supported primarily by external capital.

What Went Well and What Went Wrong

What Went Well

• Operating discipline: R&D expense fell 51% YoY to $1.26M with flat G&A ($1.27M), reducing operating cash burn to $1.34M vs $2.54M YoY, and net loss narrowed to $2.77M (vs $3.81M YoY).
• Clinical/biologic validation: Q1 highlighted PD‑1–refractory gastroesophageal cancer translational data showing early iNKT induction boosted IFNγ, CD8 infiltration, and APC engagement; a complete remission case in metastatic testicular cancer after a single 797 infusion (no lymphodepletion/HLA match) reinforces platform differentiation.
• Strategic optionality: CEO emphasized three late‑stage partnership proposals across oncology, immunology, and next‑gen engineered iNKT that could extend runway and accelerate programs with less dilution: “expect to advance one or more… in the very near term”.

Quote: “These proposals reflect strong external conviction in the value of our iNKT platform… a rare opportunity to diversify capital, reduce dilution and accelerate development”.

What Went Wrong

• EPS miss vs consensus: Q1 EPS of -$0.70 was below S&P Global consensus of -$0.61 (two estimates), driven in part by a non‑cash $0.17M fair value change on a related‑party note and no revenue contribution*.
• Liquidity still tight: Cash declined to $3.24M with going‑concern disclosure noting “substantial doubt” absent anticipated funding, despite management’s belief that cash plus anticipated funding covers >1 year; external funding remains a key execution risk.
• Listing risk resurfaced post‑quarter: Company received a Nasdaq MVLS deficiency notice on May 13 with 180 days to regain compliance, creating headline risk (note: they had previously reported regaining compliance on Feb 20).

Transcript

Operator (participant)

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. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. I will now turn the conference call to Zack Armen, Head of Investor Relations. Please go ahead.

Zack Armen (Head of 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 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.

Jennifer Buell (President and CEO)

Thanks very much, Jack. 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 I/O conference, and we showed immune activation and very early clinical activity and responses in patients who were otherwise refractory to checkpoint modulating antibodies. On the capital side, we've continued 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 our clinical trials through external financing, and 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, in immunology, 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 advancing 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 and solid tumor cancers, building on the momentum from our gastric and testicular cancer programs. I'll highlight a little bit more about some upcoming data in testicular cancer. 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 neoantigens 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. As I mentioned, at the ASCO GI and AACR I/O inaugural meetings, we presented new data from our phase two investigator-sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian and the Chief of Gastrointestinal Oncology. This study is evaluating allo-iNKTs, or AGENT-797, in combination with two differentiated checkpoint modulating antibodies, both enzalutamide and valsartan, 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 demonstrates 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 in immune desert, no CD8 T cells, therefore no ability to immunologically manage the cancer. 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 cells infiltration, activating dendritic cells, and reversing immune exhaustion. 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 multi-layered anti-tumor 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 on our phase one trial with AGENT-797, and they were treated with AGENT-797, our allo-iNKT cells, alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and pigment-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-treatment analysis reveals elevated interferon gamma.

We're 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 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 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 pathbreaking. Our signals observed in a high-risk ICU population is a powerful indication of iNKT's steroid-resistant anti-inflammatory activity and their ability to reduce secondary infections and their impact on pulmonary function and immune tonology.

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 I 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 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. We were recently notified just a couple of weeks ago that we expect the formal award by June. This would provide critical, non-dilutive 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 advisors 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 activities, which has allowed us to operate far more efficiently 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 review of the financials.

Christine Klaskin (Principal Financial and Accounting Officer)

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. Operator, we are now ready to take questions.

Operator (participant)

At this time, I would like to remind everyone in order to ask a question, press star, then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. Your first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead.

Emily Bodnar (Biotech Equity Research Analyst)

Hi, good morning. Thanks for taking my questions. I guess 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?

Jennifer Buell (President and CEO)

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, thank you for the question. This publication is expecting out somewhat imminently, and that information will be in the publication. 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. We were monitoring the patient and not less than a year after that, so in 24 months, the patient came back in to see the PI of the study with a complete remission and no other treatment.

This patient had been treated by the investigator, continued his clinical treatment with the investigator, clinical observations with no additional treatment put into the patient after the single infusion. The complete response was formally designated at month 24 after the initial treatment of 797. In addition, the patient had multiple lesions. Disease was really quite widespread, and you'll see this outlined in the paper. What was really quite intriguing was disease reduction really in all of the lesions, including the liver. That's a very important biomarker for us. We are seeing activity of INKTs and active disease in the liver. We've observed this in our phase I 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.

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. We are really quite enthusiastic about this. It has encouraged us to continue to do another survival sweep and 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. We had some responses in the trial, but predominantly we saw long-term disease stabilization. This includes in patients with pancreatic cancer, non-small cell lung cancer, testicular cancer, appendiceal, and gastric. In those observations, when we stopped the, we concluded the follow-up period of the trial, we may be underestimating the ultimate clinical benefit of iNKT cells.

We'll be getting a further clinical sweep of these patients and updating the field on the findings.

Emily Bodnar (Biotech Equity Research Analyst)

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

Jennifer Buell (President and CEO)

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

Emily Bodnar (Biotech Equity Research Analyst)

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.

Jennifer Buell (President and CEO)

I'm with you. We had heard of a delay. We expected this at the beginning of the year. 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. This, for us, is a high priority for the government and for the agency, graft versus host disease.

Our technology presents a really novel way of addressing this problem with engraftment success and reduction in GVHD and better clinical outcomes. We are optimistic, and the most recent correspondence from the government continues to boost our optimism.

Emily Bodnar (Biotech Equity Research Analyst)

Okay, great. Thanks for taking the questions.

Operator (participant)

Thank you. Again, if you would like to ask a question, press star one on your telephone keypad. Your next question comes from the line of Max Phipps with William Blair. Please go ahead.

Max Phipps (Equity Research Analyst)

Hi, Jen. Thanks for the update. Wondering if maybe just go over some of the details of the GVHD trial. Are you still planning on focusing on acute patients and maybe any just thoughts on kind of prior treatments or what type of patients you will be looking to enroll?

Christine Klaskin (Principal Financial and Accounting Officer)

Yeah. Thanks so much, Max. There are two places where we will ultimately be studying in GVHD.

The first with this financing support and with the priority at University of Wisconsin to bring this forward. This is under the leadership of Jennifer Buell, who's a scientific advisor and wrote the seminal paper on the mechanism of iNKT cells and GVHD. The opportunity for us in steroid refractory acute GVHD represents a very fast path forward. We have identified and developed a phase I program for that. We have also developed a phase I program for prophylaxis, and that's engraftment success and a 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. We will choose the priority program to advance.

Both opportunities for us, I'm going to have Thiago Favano, who has been working with the investigators in the clinical development of this, speak just a little bit more to the enrichment that we're planning at this time.

Thiago Favano (Senior Director of Program Operations)

Hi, thanks for your question. For the phase one, we are going to explore not only GVHD, but also a few other complications of transplants that still represent an unmet need, even though we do have available treatment and drugs for prevention. The other effects, they still represent an unmet need. Based on prior robust literature and some of our own studies, we expect the iNKTs not only to prevent or combat GVHD, but also to prevent infections, contribute to a better engraftment, faster and better engraftment, and also maintaining graft versus leukemia effect to prevent disease relapse.

We all know that under treatment of GVHD, patients get immunosuppressed, and that makes it easier for them to have relapse or infections, which is a major complication. In this phase one, we are going to observe all these other effects on top of preventing GVHD, which paves the way for phase two into the setting that Jen explained. We will explore in treatment of steroid refractory GVHD and then another opportunity in prevention, which represents an even faster way for approval.

Christine Klaskin (Principal Financial and Accounting Officer)

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 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.

That is why we have 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 is at the table right now and has shared a proposal with us to advance the other, which would be the prophylactic setting.

Thiago Favano (Senior Director of Program Operations)

Okay, thanks.

Operator (participant)

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.

Jennifer Buell (President and CEO)

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