Yahoo Finance

Participants

Jennifer Buell; Independent Director; Mink Therapeutics Inc

Christine Klaskin; Independent Director; Mink Therapeutics Inc

Presentation

Operator

Thank you for standing by. My name is Rosell, 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 start, followed by the number one on your telephone keypad. If you would like to withdraw your question, press start one again. I will now turn the conference call to Jack Jennifer Ball, 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 Doctor Bell to highlight our progress from this quarter.

Jennifer Buell

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 Q1 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 were 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 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. 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, just a moment.
Partnering, as 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.
And today I'm pleased to share that we have 3 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, but in the meantime, we did just recently present data at ACR 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 neo antigen discovery platforms 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 reinforced 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 pollution, 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 HLA NKTs 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 in 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 cells infiltration, activating dendritic cells and reversing immune exhaustion, and these are in cancers that are resistant to PD1 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 in 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 1 trial with 797, and they were treated with 797, or alloy iNKTs alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and idget-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 lymph depletion or HLA matching and showed no evidence of cytokine relief 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 6 months, which give us a large therapeutic window to continue to dose these patients. This case exemplifies the unique biology of iNKT cells, their ability to rapidly ho 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 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 INKP 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 is 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 and 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, give us further confidence in our regulatory path forward.
In graft versus host disease, we're prepared to initiate a phase 1 trial, a 797 of patients undergoing allergenic bone marrow transplant. We've spoken to you about this before, and as advancing this program has been in part contingent upon securing financing to be able to advance this really responsibly and efficiently. TBHC remains one of the most severe and unpredictable complications of transplants. Often leading to often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our iNKT approach, which requires no lymph depletion, 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 and with this award, MIC will launch a collaboration of pre-clinical and clinical research with our colleagues and scientific advisors at the University of Wisconsin.
Together, ARDS and TVVHC represent a large underserved market where MP 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 activities 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.