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Date
Thursday, August 14, 2025 at 8:30 a.m. ET
Call participants
Chief Executive Officer — Dr. Jennifer Buell
Chief Financial Officer — Christine Klaskin
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Takeaways
Operating Cash Burn-- Reduced Q2 operating cash burn by over 30% year-over-year, reflecting operational efficiencies.
Cash Balance-- $1.7 million cash balance at Q2 2025 quarter end, plus an additional $13 million raised post-Q2 2025 through equity sales, extending runway beyond mid‑2026.
Net Loss-- $4.2 million, or $1.06 per share, for the second quarter of fiscal 2025, compared to $2.7 million, or $0.73 per share, in the same period of fiscal 2024.
Phase 2 Clinical Data-- Published results include a complete clinical response in a 49-year-old man with metastatic testicular cancer following a single dose of AGENT-797, with sustained remission beyond two years and no cytokine release syndrome or graft-versus-host disease.
Gastric Cancer Case-- Greater than 40% tumor shrinkage and durable response lasting over ten months in a patient receiving a single administration of AGENT-797.
Partnership Discussions-- "Momentum in late-stage strategic partnership discussions continues." with structural refinements aimed at maximizing shareholder and scientific value.
GVHD Prophylactic Trial-- Phase 1 trial set to launch with external grant funding, investigating two dose levels in approximately 20‑25 patients in the first part of the trial, assessing safety, engraftment, infection mitigation, and GVHD prevention.
Funding for Trials-- GVHD and ARDS programs "are fully funded" via Department of Defense and University of Wisconsin grants, minimizing capital impact for these efforts.
ARDS Study Outcomes-- Early pandemic data showed survival exceeding 80% in patients on VV ECMO and 75% in those mechanically ventilated, as well as reduced secondary infections.
MINC215 Program-- Engineered CAR INKT program data published in Frontiers in Immunology; preclinical progress supports further advancement, with partnering interest cited.
Clinical and Regulatory Catalysts-- Top-line Phase 2 gastric cancer data, initiation of the GVHD Phase I trial, and progress on MINC215 are expected by the end of 2025, with additional external funding and potential new partnerships highlighted.
Summary
MiNK Therapeutics(INKT -16.36%) reported clinically pivotal patient case data, showing AGENT-797's durable impact in oncology and new traction in immune-mediated disease applications. The company reduced its Q2 operating cash burn by over 30% year over year and further enhanced liquidity through a $13 million equity raise completed after Q2 2025, ensuring a cash runway through mid-2026. Management confirmed that its upcoming GVHD and ARDS trials are fully funded through grants, allowing these pivotal studies to proceed without a need for company capital infusion.
CEO Buell stated, "A single dose of 797 infusion without lymphodepletion and without HLA matching achieved a sustained remission for now more than two years with no cytokine release syndrome or GVHD" in a refractory metastatic testicular cancer patient.
Christine Klaskin noted, "Our net loss year to date reflects the continued investment in the progression of our Agent 797 program and increased non-cash expenses compared to the prior year."
Initial focus for the new GVHD study population will be prevention of GVHD, engraftment optimization, and infection reduction, not treatment of existing GVHD.
ARDS trial endpoints will include 28-day mortality, secondary infection rates, ventilator-free days, and oxygenation improvements, as aligned with FDA conventions for registration paths.
The strategic intent to secure one or more partnerships remains active, with "strong interest" and refinement in deal terms identified by management as value levers.
Industry glossary
AGENT-797: Allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapy under clinical investigation for cancer and inflammatory diseases.
GVHD (Graft-versus-host disease): Complication following allogeneic tissue transplant, where donor cells attack the recipient’s tissues.
ARDS (Acute Respiratory Distress Syndrome): Severe lung condition with high mortality, often requiring mechanical ventilation, and currently lacking approved disease-modifying therapies.
VV ECMO (Veno-venous extracorporeal membrane oxygenation): Advanced life-support for patients with severe respiratory failure, referenced for patient outcomes in clinical reporting.
CAR INKT: Genetically engineered invariant natural killer T cells expressing a chimeric antigen receptor, designed to enhance anti-tumor activity against solid tumors.
MINC215: MiNK’s proprietary CAR INKT clinical program in preclinical or early translational stages.
Full Conference Call Transcript
Dr. Jennifer Buell: Thank you, Zack, and thank you all for joining us today. At MiNK Therapeutics, Inc., we continue to be the most clinically advanced company industrializing off-the-shelf invariant natural killer T cells. Based on our observations and experience with these cells, we continue to believe that these are the most important cells for immune reconstitution and disease elimination. We'll talk about a little bit of that today. We're pioneering the science and as you can see from all our financials, we have some of the most disciplined operations and efficient use of capital in this space.
In the first half of this year, we've made meaningful clinical progress scientifically and operationally with important financial actions that now extend our runway beyond mid-2026. This position is the result of deliberate burn rate reduction, streamlined operations, and the strategic integration of high-impact funding. In this quarter, we achieved significant milestones. We published important observations from our clinical trials, including a complete clinical response in a 49-year-old man with metastatic testicular cancer. This patient had failed all standard therapies and multiple investigational therapies as we reported in Nature's Oncogene just last month. I'll go into more of the details shortly.
This durable response underscores the potential of our INKT platform, particularly allo INKTs, agent 797, to address unmet needs in cancer and other immune-related diseases. Additionally, we also reduced our Q2 operating cash burn by over 30% year over year, reflecting our operational efficiencies. Momentum in late-stage strategic partnership discussions continues. With increased market capitalization following the oncogene publication signaling growing investor confidence in INKT therapies. This visibility has led us to refine the structure in terms of the potential partnerships that were under discussion to maximize value for science, operations, and our shareholders.
We remain in active dialogue with multiple parties and continue to see strong interest in our science and our platform with the goal of securing partnerships that can expand our capabilities, extend our runway, and accelerate our program execution. To summarize the landmark clinical cases that I just highlighted a moment ago, the data that we published in 2025 demonstrates how INKT therapy can address some very challenging and refractory cancers. And in July, Nature's Oncogene publication, our report of a durable complete remission in a 49-year-old man with metastatic testicular cancer unresponsive to platinum-based chemotherapy, high-dose chemotherapy with stem cell rescue, checkpoint inhibitors, and anti-TIGIT based therapies shows the potential.
A single dose of 797 infusion without lymphodepletion and without HLA matching achieved a sustained remission for now more than two years with no cytokine release syndrome or GVHD. These findings were led by oncology experts, Drs. Benjamin Garmese and Tony Greco. And earlier in the same Nature Oncogene journal, we presented a refractory gastric cancer case also resistant to chemotherapy, immunotherapy, and checkpoint inhibition. This patient, after a single administration of AGENT 797, experienced greater than 40% tumor shrinkage that was durable beyond the ten months in the monitoring period. These data spurred our currently ongoing Phase II trial in collaboration with Memorial Sloan Kettering Cancer Center, Dr. Yelena Janjigi and Dr. Sam Saturn.
These data were presented at ASCO GI and at AACR IO showing that 797's ability not only to rapidly traffic the tumor turning immunologically cold tumors hot even in PD-one resistant cancers. Our INKT cells are a rare immune subset with intrinsic tumor homing capability. The capacity to infiltrate disease tissue and with the unique immune regulatory function that can both activate anti-tumor immunity and temper harmful inflammation is unusual and very unique to this cell type. Unlike conventional T or NK cells, INKTs recognize glycolipid antigens presented by CD1D molecules enabling them to engage targets that are not accessible to most other immune effector cells.
This dual capacity to kill directly and to orchestrate other immune components positions INKTs as an important element in the therapeutic armamentarium in both oncology and immune-mediated diseases. Now, our exciting frontier beyond oncology, we are applying INKTs to immune complications or hematopoietic stem cell transplantation and to severe inflammatory syndromes such as acute respiratory distress syndrome. The opportunity here is substantial. In stem cell transplantations each year, thousands of patients with advanced hematologic malignancies, including AML, CML, MDS, and ALL undergo allogeneic transplantation. These patients, more than half of them, face risks of graft versus host disease, failed engraftment, and disease relapse.
Our upcoming phase one trial of 797 will specifically evaluate the prophylaxis of acute GVHD in adults more than 18 years of age undergoing allo hematopoietic stem cell transplantation from any donor type, matched sibling, matched or one allele, unmatched or haploidentical following essentially standard treatment, which is myoablative, reduced intensity or non-myoablative conditioning with post-transplant cyclophosphamide. Eligible patients will have a KPS greater than 70 and meet standard allo indications. The commercial opportunity is substantial. In the U.S. and Europe alone, we see an estimated more than 20,000 patients eligible, in this setting. The preliminary data published by Dr.
Jenny Gumpers, one of our leading scientific advisors, have demonstrated early in preclinical settings the mechanism of action that we believe underlie the ability of these cells to not only prevent GVHD but also to enable successful, more successful engraftment success is substantial. If AGEN 797 is effective in this indication, this could represent alone a first-in-class high-value opportunity to transform transplant outcomes while meaningfully expanding our commercial reach. In respiratory distress, 797's immune modulating properties reducing hyper-inflammation while preserving anti-pathogen immunity have already shown very encouraging survival signals and clinical experience, including virally associated ARDS. The global respiratory distress incidence is over three million cases per year with no approved modifying therapies.
Even a targeted subset, such as mechanically ventilated patients with moderate to severe ARDS could represent a substantial market opportunity. We expect to announce relatively soon the advancement of a randomized phase two-three study with external funding to advance INKT cells in patients with respiratory distress, building on our published data in Nature's Communication. Now these programs, the GBHC program and the ARDS program are going to be advanced through some substantial support externally. With DOD funding for the STTR grant and supportive funding from University of Wisconsin Cancer Center grant to Dr. Jenny Gumpers and Dr. Hongtao Li, our HSCT trial is expected to begin enrollment this year. Dr.
Gumpers and Lee's early work suggests that INKTs can enhance donor stem cell engraftment, limit GVHD, and potentially obviate the need for cytotoxic lymphodepletion ultimately. This would be a paradigm shift. This program will use a dose escalation design with two different doses to evaluate safety, GVHD incidence, time to engraftment, relapse rates, early immune reconstitution, and prevention of infections. Importantly, this trial and associated translational research are funded to proceed with minimal capital impact. Finally, our engineered INKT programs. While our lead focus remains on our native allo INKT program, we're also developing engineered approaches that appear to be best in class based on our preclinical observations.
Our CAR INKT program, MINC215 was featured most recently in Frontiers and Immunology and what our lead Scientific Advisory Board Chair, Dr. Mark Exley called one of the world's foremost experts in INKT biology has called an INKT manifesto. These data were published just three weeks ago and this work outlines a framework for applying engineered INKTs to solid tumors, potentially overcoming some of the trafficking and persistence limitations seen with conventional T and engineered NK therapies. So looking ahead, we anticipate several important catalysts.
We expect top-line data from our Phase II gastric cancer trial by the end of 2025, the initiation of our GVHD Phase I trial in the same time period, and further advancements of our MINC215 program, including the potential addition of a strategic partner or more than one strategic partner. With a lean cost structure, a strong balance sheet, and multiple value-creating milestones ahead, MiNK Therapeutics, Inc. is well-positioned to advance multiple programs in parallel while preserving shareholder value. I'll turn the call over to Christine Klaskin to review the financials.
Christine Klaskin: Thank you, Jen. We ended the quarter with a cash balance of $1.7 million. And since quarter end, we've strengthened our financial position by raising an additional $13 million through equity sales. This reinforces our resources and extends our cash runway through the middle of next year, providing a solid foundation to advance our programs and execute on the upcoming milestones Jen just highlighted. Our net loss year to date reflects the continued investment in the progression of our Agent 797 program and increased non-cash expenses compared to the prior year. Net loss for the second quarter of 2025 was $4.2 million or $1.06 per share compared to $2.7 million or $0.73 per share for 2024.
For the six months ended June 2025, our net loss was $7 million or $1.76 per share compared to $6.5 million or $1.82 per share for the same period in 2024. I'll now turn the call back to the operator for questions.
Operator: And our first question comes from the line of Mayank Mamtani with B. Riley Securities.
Mayank Mamtani: Congrats on a strong quarter. Could you talk a bit more about this preventative GVHD trial design, number of patients, endpoints you're looking at? Looks like you're looking at two dose levels. And also would be helpful to put this in context with what, you know, we have as approved different mechanisms, I believe, post-transplant in the late-line GVHD setting. And then I have a couple of follow-up.
Dr. Jennifer Buell: Thanks, Mayank. Great to hear from you. So this trial is going to be it's designed currently as a phase one. We'll do a couple of patients as a run-in for safety with a lower dose, just a handful of patients. And then we'll move a higher dose which has been our target dose which is a billion cells per patient which we believe is going to be the target dose here as well. That will expand for signal seeking in about twenty to 25 patients for the first part of the trial.
We have an opportunity to expand this and we believe based on the preclinical evidence and when you look head to head with some of the commercially available agents right now in preclinical models, the INKTs not only appear to be more tolerable but also more effective. And, there are a couple of areas where these cells can be more effective because they don't just mitigate GVHD, they can enable engraftment success which will also mitigate GVHD. So getting these cells in early, enhancing engraftment success and then preventing infections which we've seen both in virally induced lung conditions, as well as in some of our oncology programs is going to be an important part of this.
GVHD, mitigating GVHD of course is additional to that. So a more tolerable regimen that could be more effective not only in engraftment success, infection reduction and GVHD mitigation.
Mayank Mamtani: Thank you. And then on the July gastric cancer study, it looks like you are going to have some updates before year-end. Could you maybe give a little bit more color on what that could be and if any medical conferences you're targeting? And then lastly, I didn't see, you know, in press release about the targeted INKT program that you have with the cash balance that you have now, is there plans to maybe fast track that or are you trying to be more focused on the autoimmune side of things? Thanks for taking the questions.
Dr. Jennifer Buell: Thank you very much. Well, so there are a couple I think I'll start with your first. Gastric cancer, we started enrolling now over eighteen months ago and therefore we have some mature clinical follow-up. We presented data at AACR IO and it was a plenary session and a poster presentation by Dr. Satirin. What we have been able to show is that in a disease setting that is essentially an immune desert when we administer 797 we essentially see CD8 T cell infiltration across the stroma into the tumor and then disease elimination. The biomarker data are publicly available on our website. They'll also be published in a formal peer-reviewed journal.
And what we did not present at AACR IO was the clinical follow-up on these patients. So we look forward to getting the survival follow-up and seeing some of the immune modifying properties of these cells deliver something that we believe is not only clinically valuable but presents a substantial survival benefit for patients with this very difficult to treat disease. With respect to the Fab Car INT, so our focus right now is advance these cells in some of these immune-mediated diseases we see.
This has been on our hot list for a substantial amount of time and we're thrilled to be able to advance this in partnership with the University of Wisconsin as well as the DoD to get these cells into this very important disease setting. We think that there's a way to interrogate the biology and the disease setting that we'll launch in that we're going to test in first and then ultimately changing the paradigm of how patients are currently undergoing stem cell transplantation, which is an incredibly difficult regimen. And it's also difficult for the patient, they spend many, many weeks alone in a hospital. So I think that these cells can make a substantial change here.
That said, our Fab Car iNKT, you've seen the data that we presented at AACR and at SITC and at the cell therapy meeting. The differentiation of this product is very impressive. We have essentially developed the viral vectors in a GMP environment and we've conducted a substantial amount of the IND preclinical activity. So we've done quite a bit of work and we've been able to do so very efficiently. And now in our own hands, we have the capability to start to do small-scale manufacture of that at very limited cost. Therefore, we do believe that we can advance this program to an IND with limited expense.
We also have quite a bit of partnering interest on this program and so there may be a collaborator that will work with us to advance this that will further accelerate our ability to do so and also minimize the financial impact on the company in doing so. So it is our highest priority and our capital will be focused on getting the immune-related disease settings underway very aggressively. And our SAPCAR I and KT will move in parallel but with a far less financial
Mayank Mamtani: Understood, I'll hop back in the queue. Thank you, Jen.
Dr. Jennifer Buell: Of course.
Operator: Our next question comes from the line of Matt Phipps with William Blair. Your line is open.
Eric (for Matt Phipps): Hi. Thanks for taking the question. This is Eric on for Matt Phipps. Just one question. So I know you guys have previously mentioned that you're running two potential studies in graft versus host disease. Maybe one more focused on the prophylactic setting and another more focused on acute steroid refractory patients. I was just wondering if you could find any updated thoughts on this development plan.
Dr. Jennifer Buell: So this program that's now funded and advancing is essentially in the prophylactic setting. So patients will be engrafted, They'll be and I'll share with you in follow-up, Eric, some of the details that I outlined on the call earlier. But effectively patients will receive their engraftment, their treatment, their engraftment, and they'll be dosed with the cells to interrogate engraftment success, minimizing infections, graft-related infections, transplant-related infections, and mitigating GVHD. So the trial will incorporate our ability to do so. We will not be administering right now in patients who are actively experiencing GVHD, we'll be preventing it.
Eric (for Matt Phipps): Got it, thanks.
Operator: Our next question comes from the line of Emily Bodnar with H. C. Wainwright. Your line is open.
Emily Bodnar: Hi. Good morning. Thanks for taking the questions. I'm curious if you can give us more info on how much these two grants are. I guess what percent of the clinical trial costs for the GVHD program would you expect those to fund? And then curious if you could give more color on the Phase two-three trial you mentioned in ARDS and what the registrational path could look like there.
Dr. Jennifer Buell: Thanks, Emily. So for the first, these are fully funded. Now, does retain the ability with the partnership that we have with the university as well as the PIs, to provide support if there are specific questions that we want to ask. Biomarker questions, translational data, things that are not currently drafted into the program that are ancillary and may strengthen some of the scientific literature with this. So it's at our discretion. So the trials are going to be going without our capital infusion but infusion at our discretion. So it gives us quite a bit of flexibility to interrogate more biomarkers and expand the trial or support acceleration of the program in some capacity.
Respiratory distress, this is near and dear to us. We have some announcements that we are planning to come out relatively soon. Our observations, just as a quick reminder, is that we saw patients who were elderly, mechanically ventilated, and some on VV ECMO. And we not only saw substantial improvements over what's best available care for patients right now in the ICU, with survival exceeding eighty percent in patients on VV ECMO and seventy-five percent on those mechanically ventilated. Which particularly at the time that we studied and this was in the early time during the pandemic when patients were dying at very rapid rates.
The comparable controls from a control group in the same centers that we were testing the cells, the survival was between ten and twenty-two percent. So these data have excited us quite a bit. And importantly, we've also had the opportunity to interrogate some of the cytokines, the local immune modulation of these cells, and we published the anti-inflammatory signal. Secondly, we also observed a reduction in secondary infections including no bacteremia, fungemia, etcetera. We also had a couple of emergency use cases, some of which we just dosed the cells and others we had the opportunity to dose the cells plus commercially available cytokines.
And what we've observed is that these cells are the most critically important component of the regimen for these patients. You'll be seeing some data coming out relatively soon showing that upon administering, these cells within twenty-four to forty hours, we could see complete elimination of fungemia, particularly cocci, which is a problem and it's causing atypical pneumonia which is growing in prevalence in our country and worldwide. So that is really quite concerning. We believe that this trial will address a few things. One, that the FDA has clear guidance on outcomes of respiratory distress despite the fact that there are currently no approved trials, no approved products to treat respiratory distress in patients right now.
This therapy appears to be in the words of Dr. Therese Hammond, our lead investigator, the most broadly acting therapy that she has had her hands on in the ICU. We will look at twenty-eight day mortality. That's the FDA's convention and what they've suggested to us. We will also look at prevention of secondary infections. We will look at ventilator-free days. So getting patients off of a ventilator to also help prevent some comorbidities associated with the ventilator use. And we will look at oxygenation as well as an important part of this. And in our clinical trial, we observed that we very quickly enhanced pulmonary function and also oxygenation in the lungs upon administration of the cells.
So this trial will be designed to give us the full scope of what these cells can do with primary endpoints designed for FDA registration. And that is something that we will certainly do in partnership with the FDA.
Emily Bodnar: Great, thank you.
Operator: There are no further questions at this time, and this concludes the Q&A session. I now turn the call back to Dr. Jennifer Buell for closing remarks.
Dr. Jennifer Buell: Thanks, operator. Thank you all for joining us and for being with us today. We're eager to share further updates on our clinical and strategic progress which will be forthcoming. Thanks again.
Operator: This concludes today's call. A replay will be available in the Events and Presentations section of our investor website at https://investor.minktherapeutics.com/eventsandpresentations. Thank you for participating. You may now disconnect.