INKT

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 8:30 a.m. ET Investor Relations - Stefanie Perna-Nacar President and Chief Executive Officer - Jennifer Buell Head of Development - Terese Hammond Principal Financial Officer - Melissa Orilall Operator: Good morning and welcome to MiNK Therapeutics' second quarter 2026 conference call and webcast. All participants will be in a listen-only mode until the question and answer session. Please note this event is being recorded. I would now like to turn the conference over to Stefanie Perna-Nacar from MiNK Therapeutics, MiNK Investor Relations. Stephanie, please go ahead. Stefanie Perna-Nacar: 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 releases, 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, Dr. Terese Hammond, Head of Development, and Melissa Orilall, Principal Financial Officer. I'd like to turn the call over to Dr. Buell to highlight our progress from this quarter. Dr. Buell? Jennifer Buell: Thank you, Stephanie. Good morning, and thank you for joining us. The second quarter was an important period of execution for MiNK. We moved agenT-797 into a randomized phase two study in patients with acute lung injury and ARDS. We presented initial day 28 observations from treated patients and establish our 1st, international paid named patient access program. Together, these reflect the model we are building, rigorous clinical development, rapid delivery of an off-the-shelf cell therapy, and responsible access for patients with urgent unmet needs. Critical illness is still treated largely by supporting failing organs while clinicians wait for the underlying injury to resolve. Ventilators support the lungs. Vasopressors support the circulation. Antibiotics address infection. There remained no approved pharmacologic therapy shown to reduce mortality in patients with ARDS or to restore coordinated immune function after severe lung injury. More than half of the patients with ARDS succumb to their disease and die. Our thesis is that this is fundamentally a problem of immune regulation. Patients with severe hypoxemic respiratory failure die because the host responds to the insult destroys the lungs, the epithelium, the endothelium, the barrier. What has been tried in this indication has largely either suppressed immunity globally, such as corticosteroids do, or stimulated it, but neither restores regulation. Invariant natural killer T cells are a regulatory T cell population. They sit at the interface of innate and adaptive immunity and they read the tissue environment that they are placed into and they direct the responses accordingly. HN797 is an allogeneic off-the-shelf invariant natural killer T cell product, it's designed to address several linked features of critical illness, uncontrolled infection, dysregulated inflammation, and impaired tissue repair. Just as important, it is available from inventory in real time. It does not require apheresis, does not require patient-specific manufacturing, HLA matching, or lymphodepletion. And that last point is biology rather than logistics. iNKT cells are restricted by an important TCR that's common in all of us. This TCR is named CD1d, which is essentially non-polymorphic. So these cells can be given from a healthy donor to any patient without matching and without the graft-versus-host risk that constrains conventional allogeneic T cell development. That combination, biologic activity and practical deployability, is central to our strategy. During this quarter, we initiated dosing into study C1300O2. This is our randomized phase 2 study of agenT-797 plus standard of care versus placebo plus standard of care in adult patients with acute lung injury and moderate to severe hypoxemic respiratory failure, meeting the global ARDS definition. The study opened at First Lviv Territorial Medical Union in collaboration with UNBROKEN Ukraine. We doseed the first patient within days of Ministry of Health authorization during an active conflict and critically ill mechanically ventilated patients that setting places extraordinary demands on patients clinicians and the health system. It also demonstrates why the logistics of a therapy matter. A cell therapy cannot change critical care if it cannot reach the patients in time. Last week at the military health system research symposium Dr. Therese Hammond presented the initial data from our observations from the first patients treated with agenT-797. MHSRS symposium is the Department of Wars principal medical research meeting focused on bringing effective therapies to areas of war and to patients who are in need, both civilian populations injured as well as those heroes fighting. They address very important questions on access to medicines that can help patients with immune restoration, agenT-797 acts on the host response rather than on the specific organism. It's pathogen agnostic, which is directly relevant where multi drug resistant infections are common and antibiotics fail and importantly in war and specifically in the Ukraine more than 100% of those injured, are infected with multi-drug resistant pathogens and those patients are treated both locally as well as in other hospitals in Europe which is accelerating the spread of these pathogens. In our trial, we reported that our patients were alive and without fever at day 28. Importantly, they showed improved oxygenation, resolution of ARDS with return to spontaneous breathing, and liberation from vasopressor support. The microbiologic findings indicated control of baseline infection. The serum and bronchoalveolar lavages showed lower inflammatory markers and biologic changes associated with immune recovery, epithelial repair and pulmonary vascular recovery. No major serious adverse events were attributed to agenT-797 in these initial patients. Now, these are early patients, and these patients are part of the run in their non comparative observations from a small number of patients and we should not over interpret these results beyond what they show. The purpose of the randomized study is actually to generate the comparative evidence needed to determine by the 797 improves outcomes in these patients on top of standard of care. And we believe that as this trial continues to enroll and the randomized portion is actively activated, then we expect to be able to demonstrate this activity in this program. What we have shown is an early view of the clinical and biologic patterns. We designed the study to evaluate and notably the clinical course and the mechanistic readouts moved in the same direction over the same interval, which is the pattern. You would predict if the mechanism is host directed immune regulation. Enrollment continues in Lviv, Ukraine, and activation of US centers is actively underway. We expect to report additional data in early 2027. Our second advance to report this quarter was the establishment of MiNK's first international name patient access program. This program launched in Brazil and in collaboration with our colleagues at Orphan Drug Consultants, a local team on the ground in Brazil and South America. This program is important for three reasons. First, it establishes a treating physician. It enables a treating physician to request 797 for an individually identified patient with serious unmet needs subject to case by case regulatory authorization. Second, this is a paid program. MiNK receives payment for products supplied on a per patient basis. While this is not a commercial launch, it is an important step in demonstrating that our existing inventory can support both clinical development and responsible physician directed access. Third, the program establishes the operational infrastructure required to deliver an off-the-shelf cell therapy across borders. That includes local regulatory submissions, importation, logistics, and pharmacovigilance. Moving a cell therapy product reliably from inventory to an individual patient is where cell therapy programs typically fail, and it is not a capability that can be acquired at the point of approval. Our capabilities established now globally in Ukraine, in Brazil, and expanding in the U.S. can inform responsible access in other markets over time. To be clear agenT-797 remains investigational. This program is not a marketing authorization and it is not a substitute for participation in a clinical trial. Patients eligible for C-1300-02 will be directed to the study. Link does not identify or solicit patients. Requests must originate with the treating physician and receive the required per patient authorization. Now, our work in critical illness is supported by a growing body of translational and clinical evidence. Earlier this year at the American Thoracic Society International Conference with concurrent publication and clinical immunology communications, we reported evidence of a pathogen suppression, lung immune restoration and activation of tissue repair pathways. Following treatment of agenT-797 and the IL-15 super agonist N-803 in a patient with severe fungal infection. In Boston earlier this year at the American Society of Gene and Cell Therapy, we presented evidence that the same off-the-shelf iNKT product manufactured from the same donor batch produces a different and context-dependent immune response depending on the disease environment. We observed immune activation in cancer and inflammation regulating activity in patients with ARDS without genetic engineering. And at the Keystone Symposium earlier this year, human lung tissue analyses identified iNKT depletion as a mechanistic feature of advanced pulmonary fibrosis, extending the same immune restoration logic from acute injury into chronic fibrotic disease. And in cancer, our phase 2 data in patients with PD-1 refractory gastroesophageal cancer showed a 77% disease control rate and durable survival in a subset of patients treated with agenT-797 in combination with botensilimab and balstilimab with an induction strategy associated with long-term progression free and overall survival. Across these programs, the consistent scientific question is whether iNKT cells can restore coordinated immune function when the immune system can no longer adequately control infection, regulate inflammation, repair tissue, or mount an effective anti-tumor response. And our trials and ongoing programs are designed to answer these questions. I will now turn the call over to Melissa to discuss our financials. Melissa Orilall: Thank you, Jen. We ended the second quarter with $8.8 million in cash and cash equivalents, compared with $9.5 million at March 31, 2026, $3.4 million at year-end 2025. Our net loss for the quarter narrowed to $3.1 million or $0.62 per share, compared with $4.2 million or $1.06 per share for the second quarter of 2025. For the first six months of 2026, net loss was $5.9 million or $1.20 per share compared with $7 million or $1.76 per share for the same period last year. Our cash used in operations was $2.1 million for the quarter compared with $1.6 million a year ago. Now, this modest increase was specific and deliberate, reflecting the cost of operationalizing our randomized phase two study, Activated and initiated in the Lviv site. Completed the regulatory work supporting Ministry of Health authorization, the first patients and laying the groundwork for the U.S. sites which are now coming online. This investment directly supports the randomized evidence needed to evaluate the potential of this program. I will now turn the call back to Jen for closing remarks. Jennifer Buell: Thank you, Melissa. As Melissa noted, the modest increase in operating cash use reflects the launch and execution of a randomized phase two study. Outside of that targeted investment, our financial discipline remains unchanged. We have not added fixed infrastructure. Our footprint and headcount remain deliberately lean, and our manufacturing model is inventory-based rather than and patient by patient. We also continue to prioritize non-dilutive funding, both the graft-versus-host disease trial at University of Wisconsin and the pediatric PRAME program are externally funded. And importantly, our paid named patient access program allows us to continue enabling responsible access to agenT-797 for patients with cancer, and others with critical illness when requested by their treating physician and authorized by local regulators. At the same time, this program establishes the international infrastructure needed to deliver our off-the-shelf cell therapy across borders, and it also provides some resource support for ongoing clinical trials. An important part of our advancement is based on the clinical experience and scientific understanding established through our oncology programs, which created the foundation for evaluating agenT-797 in critical illness. We are now advancing this important initiative and acute lung injury and while preserving a responsible, pathway for patients to access the therapy outside of our ongoing clinical trials. This quarter, we advanceed the essential elements of that strategy, a randomized phase II study designed to generate rigorous evidence and off the shelf. Product that can reach critically ill patients without patient specific manufacturing and a paid name patient program that broadens responsible access and begins to establish an international delivery pathway. Our ambition is to change the role of cell therapy from a complex intervention confined largely to specialized cancer centers to a readily available therapy that can be delivered when and where patients need it. The broader opportunity is significant. In cancer and critical illness, the underlying challenge is a loss of coordinated immune function. In critical illness, the initial infection, injury, or other insult may begin the crisis, but the subsequent loss of immune regulation can determine whether the patient recovers or progresses to prolonged organ failure and untimely death. If the earlier clinical and biologic patterns we are observing are confirmed through randomized evidence, this approach could have relevance beyond severe pneumonia and ARDS, including trauma, transplantation, cancer, and fibrotic diseases. Our priorities are clear. Continue enrollment in study C-1300-02, activate our US sites, expand the comparative clinical and biologic data set, and execute our name patient program responsibly. We are encouraged by our progress, disciplined about what remains to be proven, and focused on generating the evidence required to determine whether agenT-797 can meaningfully change outcomes for patients with critical illness, while continuing to enable access for patients as our broader clinical programs advance. Thank you for joining us today. Operator, we will now open the call for questions. Operator: Thank you. [Operator Instructions] And our first 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 and congrats on the progress. I guess maybe to start with the hypoxia, pneumonia, and ARDS data that you mentioned, can you confirm how many patients were included in this run-in that you discussed? And then along with that, it'd be great if you kind of walk through the baseline, characteristics of these patients that they presented with and how you would expect these patients to have performed on standard of care had they been on that instead and I guess your confidence that the day 28 survival that you've observed is due to agenT-797 thank you. Jennifer Buell: Hi, Emily. Thanks so much for the question. And I'll share with you the data that we've presented publicly, and those slides will be available on our website as well. These are patients with hypoxia and pneumonia, and they meet effectively. And I'll have Dr. Hammond go through some of the profile, of these specific patients that we presented, but they meet the global definition of acute respiratory distress syndrome. So this is all cause pneumonia. These patients could have a virus or a trauma or any other complications that may succumb them to having hypoxemic pneumonia. And in this study, we have a run-in scheduled for about 10 patients. Where all patients received the cell therapy. And then we launched the randomized portion of the study. We presented data in those patients that did receive the cell therapy, and these were patients and we presented data on our first two patients treated in the study. And the first was a 41-year-old female and she had poorly controlled diabetes and pneumococcal sepsis. And so at its submission, actually, I can have Dr. Hammond, if you're available to share the case, and you could speak both to the profile of the patients, but then also to your expectations on what, They would have succumbed to without the cells? Terese Hammond: Yes, no, of course, Jen, and thank you for the question, Emily. So as Jen said, these are adults. They're, we're trying to decrease the amount of exclusion criteria. So they're folks with moderate to severe hypoxemic pneumonia, and they can also, who have coexisting trauma. So we're not excluding trauma patients from enrollment. Essentially the first two patients that we treated in Lviv were somewhat different than the patients that I treat in the US in the sense that both of these patients had multi drug resistant pneumonia, multi drug-resistant organisms, from the very moment that they were intubated, so before they were even treated, In sort of the most simplistic terms, patients with moderate to severe ARDS, especially when they have complex infections, have somewhere between a 30% and 50% chance of mortality during the course of their first 28 days in an ICU, to be able to survive 28 days, especially in the setting of very severe pan-resistant organisms, I think is provocative. As Jen said, these are just unrandomized patients. We're reporting the results of this just as a... preliminary in a preliminary manner. But I think that we feel confident that going into the randomized portion of this clinical trial, agenT-797 added the very best standard of care has certainly established already a suggestion that the modification of the immune system, the restoration of barrier protection, the reinvigoration of an immune response in a patient who's critically ill, may have some really distinct benefits over and above what we do every day to try to get these patients through their critical illness. Operator: Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Your line is open. Mayank Mamtani: Yes, good morning. Thanks for taking your questions and appreciate the level of detail on pipeline progress. So on the same ARDS lung injury trial, if you could maybe comment on how many patients have been dosed and randomized in this randomized portion to date. I believe you have a 90 patient target and maybe she can comment on the enrollment rate as you see in both Ukraine, but also as FDA sites come on board, you know, your expectation for U.S. enrollment? And are there any phenotype inflammation pattern differences you expect in ex-U.S. versus U.S. patients, if you could comment on that?. Jennifer Buell: Thank you for the question. So the study is currently underway in Ukraine and expanding into the United States. We haven't spoken to specific numbers of patients enrolled at this time. Enrollment's continuing. We expect to have our preliminary readouts from the randomized phase two portion of the study in the first half of 2027. So we're expecting to continue enrollment at a rate that is consistent with the sites that are selected for this study. And particularly with seasonality, we do see upticks in enrollment as well, for obvious reasons in this program. So we would expect to have between four to eight patients per site per month when all of the sites are actively enrolling. We have our center in Ukraine that's actively enrolling and our centers in the U.S. that will start enrollment in September. I think you had asked, so I should also mention for this program, we are intending and seeking a meeting with the FDA in order to move the trial from our randomized phase II into a seamless phase III study. So we'll be able to share an update on that in subsequent calls. We have not had the meeting yet, but we are preparing to do so within the impending weeks. And that will allow us to generate data from the Phase I -- I'm sorry, from the randomized Phase II and then move directly into the confirmatory Phase III in a very rapid fashion. And from the immune, I think you had asked about the differences in the patient population. What Terese had mentioned is the patients who have been treated in Ukraine have multi-drug resistant pathogens. And these are pretty severe and it's a major problem in areas of war as patients traverse from one destination to the next, they generally succumb to multi drug resistant organisms. And in Ukraine, there are some recent publications showing that about 100% of these individuals are succumbing to multi drug resistant pathogens. So it is an opportunity for us and our colleagues within the, that have quite a bit of interest from the military to evaluate what these cells can do in that setting as well. So essentially respiratory distress coming from multi-drug resistant pathogens in addition to some other complications as Dr. Hammond mentioned, that will that be the same in the United States? We, I believe that the profile may be a little bit different and I'll ask Dr. Hammond to weigh in on her perspective. She's treated a number of patients with agenT-797 in her ICU. So she could speak to the profile of patients that she's expecting to see in the United States. Terese? Terese Hammond: Yes, no, absolutely. And thank you for the question. I think that what struck me at the MHSRS meeting that we were in, that we recently attended, was just the fact that these very virulent, multidrug-resistant organisms are traveling from sort of point of injury across the evacuation path for both combatants and non-combatants in conflict zones and now spreading across Europe. And I think all of us feel like it's only a matter of time, especially as conflicts escalate, before we start to see emergence of more of these really, really virulent organisms and their Gram-negative Klebsiella, , which is pan-resistant to all antibiotics. Acinetobacter, Pseudomonas. Those are the big three that are that are really affecting conflict zones in Ukraine and beyond, and also infiltrating tertiary hospitals in Europe. So this is a really big problem. I treat patients in Central California. We do see resistances to antibiotics in patients that have been in the hospital for long periods of time that are coming to us from nursing homes. I may see one or two cases of pan resistant for example, a year. And these patients that have been ill for a long time, usually on chronic ventilator therapy, I'm not used to having young people come in from the community and acquiring these very virulent infections, even before they have been in the hospital. By the time they've been in the hospital for 24 or 48 hours or been intubated for 24 or 48 hours. It's a very different pattern that we're seeing in Ukraine. As Jen said, I think this is an opportunity for us to look deeply at the immunology of the host when they're exposed to these virulent antibiotic or antibiotic resistant organisms. I hope that we don't see them to the same extent that we're seeing in the Ukraine, as we open up the US sites. But I think that this is on the horizon for all of us and something that we have to take very seriously. The more science we can put behind the management of these pan-resistant infections, the better off we are as a medical society, whether it's here in the U.S. or abroad. Mayank Mamtani: And would you expect phase three population focus to be very comparable to pan-resistant that you're talking about? And I was also wondering the acute endpoints used here, you know, at some point would make placebo control unethical, so is there like a randomization ratio, you could look differently in phase III than phase. And lastly, if you could comment on any, you know, process by data sharing practices with DoD, BARDA. I know you mentioned FDA, but was just curious how DOD is involved here? Jennifer Buell: Thanks, Mayank. I'll start here. So the population we would expect to be comparable to our Phase II population, so the results in the Phase II will also give us an opportunity to conduct a sample size re-estimation. So with the – we're looking at a primary endpoint that include 28-day mortality, and that's an FDA-driven endpoint. We're also, of course, looking at other secondary endpoints, ventilator-free days, pathogen control, immune reconstitution, et cetera. I won't speak too much to some of at this point it would be premature to speak about some of our government interactions, but I could share with you that our appoint, we have a newly appointed board member, Dr. John Holcomb, who's a trauma surgeon and also a, essentially very actively involved in driving improvements in medical care specific to conflict zones, military personnel, and of course, the bridge to civilians. His work has recently led to the approval of plasma for, is a product for resuscitation in patients. He's an incredible scientist and very thoughtful strategic leader and partner for us. And in this, the work that we're doing as Terese mentioned, because of the increase in the number of conflict zones that we have internationally and then also the exposure as we move patients from different regions. We're seeing a spread of these multi-drug resistant pathogens and that includes patients traversing from Ukraine into hospitals in Europe, and beyond. So improving outcomes for these patients will help to strengthen our national security overall, and that's a major interest for all of us. Mayank Mamtani: Got it. And if I may just ask about the Brazil paid program, you know, maybe just the rationale for choosing that geography and if you could, to the extent possible, comment on, you know, of pricing, how you're seeing demand both locally and I'm sure other regions are also interested in this and any thoughts on that, Jen? Jennifer Buell: Thanks, Mayank. Absolutely. So this program launched in Brazil due to a number of physician inquiries and the speed with which the regulators moved there. We're expanding the program as we do see increasing demand during this time. So we won't yet speak to pricing, but I'll share with you that we have launched the program, it's active and we have patients in and we will be reporting that those patients were brought in just after the close of the quarter. So we'll be announcing some of the financials in our Q3 update. In the meantime, I would say we're enabling access. We have an incredibly efficient manufacturing process and it does allow us to have, um, to convey some of those efficiencies to patients that have a broad, requests are pretty broad for patients who are coming in, some patients are requesting those patients with cancer, as well as patients with other, so as the program expands, we'll speak more to the detail of it. The regions will be expanding and will announce those expansions as we get through the regulatory processes in different territories. Operator: [Operator Instructions] There are no further questions at this time. This concludes the Q&A session. I will now turn the call back to Dr. Jennifer Buell for closing remarks. Jennifer Buell: Thank you, operator. Thank you all for participating. I appreciate your support. We look forward to keeping you in the loop and with upcoming developments on the program. Thank you. Operator: This concludes today's call. Our replay will be available in the events and presentation section of our investor website at https://investor.minktherapeutics.com/events-and-presentations. Thank you for participating. You may now disconnect. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Initiated a randomized Phase 2 study of agenT-797 for ARDS, focusing on restoring immune regulation rather than global immune suppression or stimulation. Leveraged the non-polymorphic nature of the CD1d receptor to deliver an off-the-shelf therapy that requires no HLA matching or lymphodepletion, enabling rapid deployment in critical care settings. Demonstrated the feasibility of delivering cell therapy in active conflict zones by dosing the first patient in Ukraine within days of regulatory authorization. Observed early clinical patterns in run-in patients showing improved oxygenation, resolution of ARDS, and control of multi-drug resistant infections. Established a context-dependent immune response model where the same iNKT product acts as an activator in cancer and a regulator in inflammatory lung disease. Maintained a lean operational footprint by utilizing inventory-based manufacturing and securing non-dilutive funding for specific clinical programs. Expect to report additional data from the randomized Phase 2 portion of the ARDS study in early 2027. Planning a meeting with the FDA in the coming weeks to discuss transitioning the current trial into a seamless Phase 3 confirmatory study. Anticipate U.S. site enrollment to begin in September 2026, with projected enrollment rates of four to eight patients per site per month. Intend to expand the international Named Patient Access Program to additional territories following the initial launch in Brazil. Aim to validate the host-directed immune regulation mechanism to support potential expansion into trauma, transplantation, and fibrotic diseases. Launched a paid Named Patient Access Program in Brazil, establishing the cross-border logistics and pharmacovigilance required for future commercialization. Recent publications show that approximately 100% of individuals in Ukraine are succumbing to multi-drug resistant pathogens, presenting an opportunity for the company to evaluate its cells in that setting., presenting a unique challenge and research opportunity. Reported a narrowed net loss of $3.1 million for the quarter, with cash reserves of $8.8 million supported by disciplined spending and inventory-based manufacturing. Cautioned that early run-in data is non-comparative and based on a small number of patients, requiring randomized evidence for definitive proof of efficacy. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management noted that the first two patients treated in Ukraine had multi-drug resistant organisms at the time of intubation, a population with a 30% to 50% mortality risk. Observed that both patients survived to day 28 with improved oxygenation and liberation from vasopressors, which management described as provocative given the severity of their infections. Management expects U.S. enrollment to start in September 2026, noting that while Ukraine sees high rates of pan-resistant pathogens, U.S. cases may show different resistance patterns. The Phase 2 study (C-1300-02) is currently enrolling patients in Ukraine and activating sites in the U.S., with additional data expected in early 2027., with enrollment rates expected to fluctuate based on seasonal upticks in respiratory illness. The program was launched in Brazil due to high physician inquiry and rapid regulatory response; it provides a pathway for patients with cancer or critical illness to access therapy outside trials. Management confirmed the program is paid and will contribute to financials starting in Q3, helping to offset clinical trial costs while testing international delivery infrastructure. Management declined to detail specific government interactions but highlighted the appointment of Dr. John Holcomb to the board to bridge military and civilian trauma care. Emphasized that addressing multi-drug resistant pathogens in conflict zones is a matter of national security, attracting significant interest from military research entities.

Interested in MiNK Therapeutics, Inc.? Here are five stocks we like better. MiNK initiated a randomized Phase II trial of off-the-shelf agenT-797 plus standard care for acute lung injury and moderate-to-severe ARDS in Ukraine, with U.S. sites expected to begin enrolling in September. Preliminary randomized data are anticipated in the first half of 2027, while early results from two patients were encouraging but remain preliminary and non-comparative. The company launched its first international paid named-patient access program in Brazil, allowing physicians to request agenT-797 for individual patients with serious unmet needs, subject to regulatory approval. MiNK said the program is not a commercial launch and expects to expand it to additional territories. Second-quarter net loss narrowed to $3.1 million from $4.2 million a year earlier, while cash and equivalents stood at $8.8 million at quarter-end. Quarterly operating cash use increased to $2.1 million as MiNK advanced the ARDS trial and prepared U.S. sites. MiNK Therapeutics (NASDAQ:INKT) said it initiated dosing in a randomized Phase II trial of its allogeneic invariant natural killer T-cell therapy, agenT-797, for patients with acute lung injury and acute respiratory distress syndrome, or ARDS, during the second quarter of 2026. The company also launched its first international paid named-patient access program in Brazil and reported a second-quarter net loss of $3.1 million, narrower than the $4.2 million loss reported a year earlier. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be President and Chief Executive Officer Jennifer Buell said MiNK opened Study C-1300-02 at First Lviv Medical Union in collaboration with Unbroken Ukraine. The trial is evaluating agenT-797 plus standard of care against placebo plus standard of care in adults with acute lung injury and moderate-to-severe hypoxemic respiratory failure meeting the global ARDS definition. Buell said the first patient was dosed within days of authorization from Ukraine’s Ministry of Health. The program is designed around an off-the-shelf cell therapy that does not require patient-specific manufacturing, HLA matching, apheresis or lymphodepletion. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand “A cell therapy cannot change critical care if it cannot reach the patients in time,” Buell said, pointing to the logistical challenges of treating critically ill, mechanically ventilated patients in an active conflict zone. MiNK presented early day-28 observations from the first two treated patients at the Military Health System Research Symposium. According to the company, both patients were alive and fever-free at day 28, with improved oxygenation, resolution of ARDS, return to spontaneous breathing and liberation from vasopressor support. MiNK also reported microbiologic control of baseline infections, lower inflammatory markers in serum and bronchial lavage samples, and biological changes associated with immune recovery, epithelial repair and pulmonary vascular recovery. → On Holding's Price Stumble May Be an Opening for a Company Built to Run No major serious adverse events were attributed to agenT-797 in the initial patients, according to MiNK. However, Buell emphasized that the observations came from a small, non-comparative run-in cohort and should not be overinterpreted. The company plans for roughly 10 patients in the run-in phase before advancing the randomized portion of the study. Terese Hammond, MiNK’s head of inflammatory and pulmonary diseases, said the first two patients had multidrug-resistant pneumonia at or shortly after intubation. She said patients with moderate-to-severe ARDS and complex infections can face 28-day mortality rates of about 30% to 50%, but noted that the company’s findings remain preliminary and unrandomized. Enrollment is continuing in Lviv, while MiNK expects U.S. sites to begin enrolling in September. Buell said the company has not disclosed the number of patients enrolled or randomized to date. It expects preliminary data from the randomized Phase II portion in the first half of 2027. The company expects enrollment rates of four to eight patients per site per month when all selected sites are active, according to Buell. She also said MiNK is preparing to seek a meeting with the Food and Drug Administration in the coming weeks to discuss potentially transitioning from the randomized Phase II trial into a seamless Phase III study. MiNK said the Phase II trial’s primary endpoint includes 28-day mortality, with secondary measures including ventilator-free days, pathogen control and immune reconstitution. Buell said Phase II results could support a sample-size re-estimation for a later-stage study. Management said the patient population in Ukraine may differ from that expected at U.S. sites because of the prevalence of multidrug-resistant organisms in conflict zones. Hammond cited pan-resistant Klebsiella, Acinetobacter and Pseudomonas among the organisms affecting patients in Ukraine and European hospitals. MiNK also established a paid named-patient access program in Brazil, working with Orphan Drug Consulting and local partners. The program permits physicians to request agenT-797 for individually identified patients with serious unmet medical needs, subject to case-by-case regulatory authorization. Buell said Brazil was selected following physician inquiries and the pace of local regulatory processes. She said the program is active and has enrolled patients after the quarter’s close, with financial details expected in the company’s third-quarter update. MiNK did not disclose pricing. The company said the program is not a commercial launch or marketing authorization, and is not intended to replace clinical trial participation. Patients eligible for Study C-1300-02 will be directed to the trial, while named-patient requests must originate with treating physicians and receive local regulatory authorization. MiNK said the initiative provides payment on a per-patient basis and helps establish infrastructure for regulatory submissions, importation, product logistics and pharmacovigilance across borders. Management said it expects the program to expand into additional territories as regulatory processes are completed. Principal Financial Officer Melissa Orilall said MiNK ended the second quarter with $8.8 million in cash and cash equivalents, compared with $9.5 million at March 31, 2026, and $3.4 million at year-end 2025. Second-quarter net loss was $3.1 million, or $0.62 per share, compared with a $4.2 million loss, or $1.06 per share, in the prior-year period. Net loss for the first six months of 2026 was $5.9 million, or $1.20 per share, compared with $7 million, or $1.76 per share, a year earlier. Cash used in operations was $2.1 million during the quarter, compared with $1.6 million in the second quarter of 2025. Orilall attributed the increase in operating cash use to launching the randomized trial, activating the Lviv site, completing regulatory work in Ukraine, dosing initial patients and preparing U.S. sites. Buell said the company has maintained a lean operating footprint and continues to prioritize non-dilutive funding, including externally funded graft-versus-host disease and pediatric programs. MiNK Therapeutics, Inc is a clinical-stage biotechnology company developing exosome-based immunotherapies for the treatment of solid tumors. The company's proprietary platform isolates and engineers naturally occurring extracellular vesicles, or exosomes, to deliver therapeutic payloads—such as mRNA, proteins and modulatory factors—directly into the tumor microenvironment. By leveraging the innate cell‐to‐cell communication properties of exosomes, MiNK aims to reprogram immune cells and overcome immune suppression within solid tumors. MiNK's preclinical pipeline features multiple lead candidates designed to repolarize tumor‐associated macrophages and boost T cell–mediated tumor clearance. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "MiNK Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

First patients treated in randomized Phase 2 trial C-1300-02 were alive at Day 28, with improved oxygenation, resolution of ARDS with return to spontaneous breathing and liberation from vasopressor support Clinical recovery and biologic readouts moved in the same direction; serum and bronchoalveolar lavage analyses showed reduced inflammatory markers and biologic changes associated with immune recovery and tissue repair; no major serious adverse events were attributed to agenT-797 Launched international paid named-patient access program established for physicians to request access to agenT-797, subject to per-patient regulatory authorization; building cross-border infrastructure and access NEW YORK, Aug. 13, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering off-the-shelf allogeneic invariant natural killer T (iNKT) cell therapies for cancer and immune disorders, today reported financial results for the second quarter ended June 30, 2026, and provided an update on the clinical advancement of its lead candidate, agenT-797. The second quarter marked MiNK's advancement to randomized clinical validation. The Company dosed its first patient in C-1300-02 within days of Ministry of Health authorization in Ukraine, and has since reported Day 28 observations in ventilated, critically ill patients treated in an active conflict environment — a pace made possible by a therapy that ships from inventory and requires no apheresis, patient-specific manufacturing, HLA matching, or lymphodepletion. “We are building cell therapy for the real world—off the shelf, available from inventory, and deployable where patients receive care,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “This quarter, we put that mission into action. We moved agenT-797 into randomized Phase 2 evaluation and delivered it to mechanically ventilated patients within days of regulatory authorization—even in an active conflict environment. The initial clinical course and mechanistic readouts moved in the same direction over the same interval, consistent with the host-directed immune regulation our study was designed to evaluate. These observations are early, and we look forward to sharing additional data from the randomized trial in 2027.” “In parallel, we are building a new model for responsible access,” Buell continued. “Our paid named-patient program enables physician-directed access, generates program support from product supplied, and establishes the cross-border infrastructure required to deliver agenT-797 beyond clinical trials. Together, these advances are moving cell therapy beyond specialized cancer centers and toward a readily available treatment that can reach patients when and where it is needed.” Second Quarter 2026 and Recent Highlights Randomized Phase 2 Trial in Acute Lung Injury and ARDS Targets a high-mortality unmet need in critical care. Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care, with mortality exceeding 40-50% and no approved therapies shown to reduce mortality.i Critically ill patients often deteriorate because severe lung injury can trigger broader immune dysfunction, including impaired pathogen control, infection susceptibility, and organ dysfunction. Randomized Phase 2 dosing initiated in May 2026. MiNK began dosing at First Lviv Territorial Medical Union in Lviv, Ukraine, in collaboration with UNBROKEN Ukraine, within days of receiving Ministry of Health authorization. C-1300-02 (NCT07615010) is evaluating agenT-797 plus standard of care versus placebo plus standard of care in adults with acute lung injury and moderate-to-severe hypoxemic respiratory failure meeting Global ARDS Definition criteria. The study is being conducted under an active U.S. IND. Initial Day 28 observations presented at the Military Health System Research Symposium (MHSRS). Dr. Terese C. Hammond, M.D., Head of Inflammatory and Pulmonary Diseases at MiNK, presented initial observations with co-authors from First Lviv Territorial Medical Union. The initial agenT-797–treated patients were alive and afebrile at Day 28, with improved oxygenation, resolution of ARDS with return to spontaneous breathing and liberation from vasopressor support. Microbiologic findings indicated control of baseline infections. Serum and bronchoalveolar lavage analyses showed reduced inflammatory markers and biologic changes associated with immune recovery, epithelial repair and pulmonary vascular recovery. No major serious adverse events were attributed to agenT-797 in these initial patients. U.S. expansion in progress. Enrollment continues in Lviv, and activation of U.S. clinical centers is underway. Additional data are expected in early 2027. Paid International Named-Patient Access First paid international access program established. MiNK is collaborating with Orphan Drug Consulting (ODC) to support physician-initiated requests for agenT-797 for individually identified patients. The program expands access for patients with serious unmet medical need and provides MiNK with program revenue for product supplied. Each request is initiated by the treating physician and remains subject to case-by-case Brazilian regulatory authorization. The program does not represent a commercial launch or marketing authorization. Access, revenue and scalable international infrastructure. ODC supports local regulatory submissions, importation, logistics and pharmacovigilance. Product will be supplied on a paid, per-patient basis in accordance with applicable Brazilian access regulations. The program may result in non-promotional income to MiNK while establishing the operational infrastructure needed to support responsible access to agenT-797 in additional international markets. Translational and Scientific Progress ATS 2026 and peer-reviewed publication (May 2026). Data presented at the American Thoracic Society International Conference and published concurrently in Clinical Immunology Communications showed pathogen suppression, lung immune restoration and activation of tissue-repair pathways following administration of agenT-797 and an IL-15 super agonist (N-803), in Coccidioides infection. ASGCT 2026 (May 2026). MiNK presented clinical evidence at the American Society for Gene and Cell Therapy Meeting that a single off-the-shelf iNKT-cell product manufactured from the same donor batch produced context-dependent immune activity—immune activation in cancer and anti-inflammatory activity in ARDS—without genetic engineering. Financial Results Cash and cash equivalents were $8.8 million as of June 30, 2026, compared with $9.5 million as of March 31, 2026, and $13.4 million as of December 31, 2025. Net loss for the second quarter of 2026 was $3.1 million, or $0.62 per share, compared with $4.2 million, or $1.06 per share, for the second quarter of 2025. For the six months ended June 30, 2026, net loss was $5.9 million, or $1.20 per share, compared with $7.0 million, or $1.76 per share, for the same period in 2025. The year-over-year improvement reflects continued expense discipline. Second Quarter 2026 Financial Results Conference Call and Webcast MiNK will host a conference call and webcast today at 8:30 a.m. ET to discuss its financial results, provide clinical updates on agenT-797 in lung injury and highlight important business updates. Webcast & Replay InformationLive event link: https://edge.media-server.com/mmc/p/zkuebhpcWebcast Replay: https://investor.minktherapeutics.com/events-and-presentations About Mink Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company developing off-the-shelf allogeneic iNKT cell therapies for life-threatening conditions driven by immune dysfunction. The company's lead program, agenT-797, is being evaluated in acute lung injury and critical illness, with a pipeline that extends across immuno-oncology, transplant medicine, and other settings where dysregulated immunity is a driver of morbidity and mortality. MiNK believes that iNKT cell biology, because of its regulatory role across innate and adaptive immunity, may represent a foundational approach to immune restoration applicable across a broad range of conditions. For more information, visit www.minktherapeutics.com. About the Paid Named-Patient Access Program in Brazil Named-patient access refers to a physician-initiated request for an unregistered medicine for an individually identified patient, subject to authorization by the competent health authority. MiNK's program launched in Brazil and is administered in collaboration with Orphan Drug Consulting (ODC), which acts as MiNK's local partner for per-patient regulatory submissions, importation, cold-chain handling, and adverse event reporting. Access under the program is initiated only by a treating physician, who is responsible for determining whether use is medically appropriate for a particular patient, for obtaining informed consent, and for the clinical management and monitoring of that patient. MiNK does not identify, recruit, solicit, or select patients, does not compensate physicians for requesting the product, and does not conduct promotional activity with respect to agenT-797 in Brazil or in any other jurisdiction. agenT-797 has not been approved for marketing by the Brazilian Health Regulatory Agency (ANVISA), the U.S. Food and Drug Administration, or any other regulatory authority, and its safety and efficacy have not been established. Availability under the program does not imply that agenT-797 is safe or effective for any use, and the program is not a commercial launch. The program is separate from, and is not a substitute for, participation in MiNK's clinical trials; patients who may be eligible for C-1300-02 or another MiNK-sponsored study will be directed to those studies. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the therapeutic potential, safety, clinical benefit, and development plans for agenT-797 and MiNK's other iNKT-based programs; the design, enrollment, site activation, and timing of data from the C-1300-02 trial; the establishment, scope, operation, regulatory basis, and continuation of the Company's named-patient access program in Brazil, including whether per-patient authorizations will be granted and whether the program will generate any receipts; the sufficiency of the Company's cash resources and expected operating runway; and anticipated milestones. Initial observations from a small number of patients in an ongoing, blinded randomized trial are preliminary, are not controlled comparisons, and may not be predictive of results in additional patients or of the trial's ultimate outcome. Observations from patients treated outside of a controlled clinical trial, including under a named-patient program, are uncontrolled and are not evidence of safety or efficacy. Actual results may differ materially from those expressed or implied. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK's most recent Annual Report on Form 10-K and subsequent filings with the Securities and Exchange Commission. MiNK undertakes no obligation to update these statements except as required by law. References iBellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788–800. Contacts Investor Contact: 917-362-1370 | [email protected] Contact: 781-674-4428 | [email protected] Source: MiNK Therapeutics

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MiNK Therapeutics Inc (NASDAQ:INKT) initiated a randomized Phase 2 study for AGENT-797 in acute lung injury/ARDS, with first patient dosed in Ukraine and US sites expected to start enrollment in September. Initial data from the first two treated patients showed survival to day 28, improved oxygenation, resolution of ARDS, and no serious adverse events attributed to AGENT-797. The company established its first international paid named patient access program in Brazil, providing a new revenue stream and demonstrating the ability to deliver off-the-shelf cell therapy across borders. AGENT-797 is an off-the-shelf allogeneic cell therapy that does not require HLA matching, apheresis, or lymphodepletion, making it logistically feasible for critical care settings. The company reported a 77% disease control rate in PD-1 refractory gastroesophageal cancer patients treated with AGENT-797 in combination with other agents, supporting broader oncology potential. Net loss narrowed to $3.1 million in Q2 2026 from $4.2 million in Q2 2025, reflecting improved financial discipline. The company is planning a seamless Phase 3 study with FDA, aiming to accelerate regulatory path for AGENT-797 in ARDS. The initial ARDS data is from only two patients in a non-comparative run-in, and the company cautions against overinterpreting these early results. Cash position remains low at $8.8 million, which may not be sufficient to fund the full Phase 2/3 program without additional financing. The company has not disclosed specific enrollment numbers or rates for the randomized Phase 2 study, creating uncertainty about timelines. The paid named patient access program is not a commercial launch and may face regulatory hurdles in different countries, limiting its revenue potential. The Phase 2 study is being conducted in Ukraine during an active conflict, which poses operational risks and could affect patient enrollment and data quality. The company has not yet had the FDA meeting for the Phase 3 design, and the outcome could impact the development timeline. The therapy is still investigational, and there is no approved pharmacologic therapy for ARDS, meaning the regulatory path is uncertain. Warning! GuruFocus has detected 2 Warning Sign with INKT. Is INKT fairly valued? Test your thesis with our free DCF calculator. Q: Can you confirm how many patients were included in the run-in portion of the hypoxic pneumonia and ARDS study, and walk through the baseline characteristics of these patients? How would they have performed on standard of care, and what gives you confidence that the day 28 survival observed is due to Agent 797? A: Dr. Jennifer Buell (President and CEO) and Dr. Therese Hammond (Head of Development) confirmed that the run-in is scheduled for about 10 patients, all receiving the cell therapy. They presented data on the first two patients treated in Lviv, Ukraine. The first was a 41-year-old female with poorly controlled diabetes and pneumococcal sepsis. Both patients had multi-drug resistant pneumonia from the moment of intubation. Dr. Hammond noted that patients with moderate to severe ARDS and complex infections have a 30-50% mortality risk in the first 28 days in the ICU. Surviving 28 days, especially with pan-resistant organisms, is provocative. While these are unrandomized, preliminary observations, the company believes the data suggests Agent 797's immune-modifying effects may offer distinct benefits over standard of care alone. Q: How many patients have been dosed and randomized in the randomized portion of the ARDS trial to date? What is the expected enrollment rate in Ukraine and the US, and are there phenotype differences expected between ex-US and US patients? A: Dr. Buell stated the company has not disclosed specific enrollment numbers but expects preliminary readouts from the randomized Phase 2 portion in the first half of 2027. Enrollment is expected to be 4-8 patients per site per month when all sites are active. The Ukraine center is actively enrolling, and US centers will start in September. The company is also seeking an FDA meeting to move from the randomized Phase 2 into a seamless Phase 3 study. Dr. Hammond added that Ukrainian patients present with extremely virulent, pan-resistant organisms (e.g., Klebsiella, Acinetobacter, Pseudomonas) from the moment of intubation, a pattern she does not typically see in her US practice in Central California, where resistant infections are usually seen in chronically ill, long-term ventilator patients. This difference highlights the severity of the conflict-zone patient population. Q: Would the Phase 3 population focus be comparable to the pan-resistant population discussed? At what point would placebo control become unethical, and could the randomization ratio change in Phase 3? Also, can you comment on data-sharing practices with the DOD? A: Dr. Buell responded that the Phase 3 population is expected to be comparable to the Phase 2 population, with results allowing for sample size re-estimation. The primary endpoint is 28-day mortality, an FDA-driven endpoint, with secondary endpoints including ventilator-free days, pathogen control, and immune reconstitution. Regarding government interactions, she noted it is premature to discuss specifics but highlighted the newly appointed board member, Dr. John Holcomb, a trauma surgeon instrumental in driving medical care improvements for conflict zones. The spread of multidrug-resistant pathogens from Ukraine into European hospitals is a national security concern, and improving outcomes for these patients is a major interest for the military. Q: What was the rationale for choosing Brazil for the first international paid named patient access program? Can you comment on pricing and demand? A: Dr. Buell explained that the program launched in Brazil due to a number of physician inquiries and the speed of local regulators. The program is active, and patients were brought in just after the close of the quarter, with financials to be announced in the Q3 update. While not disclosing pricing, she noted the company's efficient manufacturing process allows it to convey efficiencies to patients. Demand is broad, including requests from patients with cancer and other indications. The program is expected to expand to other regions as regulatory processes are completed. Q: What were the key financial results for the second quarter of 2026? A: Melissa Borilal (Principal Financial Officer) reported that the company ended Q2 2026 with $8.8 million in cash and cash equivalents, compared to $9.5 million at March 31, 2026, and $3.4 million at year-end 2025. The net loss for the quarter narrowed to $3.1 million, or $0.62 per share, compared to $4.2 million, or $1.06 per share, in Q2 2025. For the first six months of 2026, the net loss was $5.9 million, or $1.20 per share, versus $7 million, or $1.76 per share, in the prior year period. Cash used in operations was $2.1 million for the quarter, up from $1.6 million a year ago, reflecting the deliberate investment in operationalizing the randomized Phase 2 study, activating the Lviv site, and laying groundwork for US sites. Q: What is the company's strategy regarding non-dilutive funding and financial discipline? A: Dr. Buell emphasized that the modest increase in operating cash use is directly tied to the randomized Phase 2 study launch. Outside of that targeted investment, financial discipline remains unchanged. The company has not added fixed infrastructure, and its footprint and headcount remain lean. Manufacturing is inventory-based rather than patient-by-patient. The company continues to prioritize non-dilutive funding, with the graft-versus-host disease trial at University of Wisconsin and the pediatric PRGN program both externally funded. The paid named patient access program also provides resource support for ongoing clinical trials. Q: What were the initial clinical and biologic observations from the first patients treated with Agent 797 in the ARDS study? A: Dr. Buell reported that the first patients treated were alive and without fever at day 28. They showed improved oxygenation, resolution of ARDS with return to spontaneous breathing, and liberation from vasopressor support. Microbiologic findings indicated control of baseline infections. Serum and bronchial lavages showed lower inflammatory markers and biologic changes associated with immune recovery, epithelial repair, and pulmonary vascular recovery. No major serious adverse events were attributed to Agent 797. Dr. Buell cautioned that these are early, non-comparative observations from a small number of patients and should not be overinterpreted, but the clinical course and mechanistic readouts moved in the same direction, consistent with host-directed immune regulation. Q: What is the broader scientific thesis behind Agent 797, and what evidence supports its potential in critical illness? A: Dr. Buell explained that critical illness is fundamentally a problem of immune regulation. Agent 797 is an allogeneic, off-the-shelf invariant natural killer T (iNKT) cell product designed to address uncontrolled infection, dysregulated inflammation, and impaired tissue For the complete transcript of the earnings call, please refer to the full earnings call transcript.

NEW YORK, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering allogeneic invariant natural killer T (iNKT) cell therapies to treat cancer and immune disorders, today announced that it will report financial results for the second quarter ended June 30, 2026, before the market opens on Thursday, August 13, 2026. The Company will host a conference call and webcast at 8:30 AM ET that morning to review financial results and provide a corporate update focused on the clinical advancement of agenT-797, MiNK’s off-the-shelf allogeneic iNKT cell therapy, in acute lung injury. The update will include new clinical data on the progress of agenT-797 in patients with pulmonary injury, as well as details regarding the launch of MiNK’s named-patient program. Webcast & Replay InformationA live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website following the event. Live event link: https://edge.media-server.com/mmc/p/zkuebhpcWebcast Replay: https://investor.minktherapeutics.com/events-and-presentations About MiNK TherapeuticsMiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse. Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for agenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law. Contacts Investor Contact: 917-362-1370 | [email protected] Contact: 781-674-4428 | [email protected] Source: MiNK Therapeutics

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management is pivoting the agenT-797 platform toward acute care settings like ARDS and severe lung injury, where the 'off-the-shelf' nature of the therapy bypasses the manufacturing delays and lymphodepletion requirements that limit conventional cell therapies. Performance attribution for the platform is driven by the 'context-dependent' nature of iNKT cells, which management claims can switch between pro-inflammatory tumor-killing in cancer and anti-inflammatory healing in lung injury using the same unmodified product. Strategic positioning in oncology has shifted toward high-unmet-need, refractory populations; Phase II gastric cancer data showed a median overall survival exceeding 23 months, which management describes as highly unusual for checkpoint-refractory patients. The company is utilizing a capital-efficient operational strategy, leveraging internal capabilities and local support to maintain a disciplined cash burn profile., leveraging internal manufacturing and global partnerships, such as the collaboration in Ukraine, to execute clinical trials with a disciplined cash burn profile. Operational scalability is supported by a proprietary manufacturing process that generates billions of cells per donor, addressing historical barriers related to complexity and cost in cell therapy. Management emphasizes that their iNKT cells 'read the room' of the immune environment, offering a fundamentally different biologic approach than failed MSC therapies by simultaneously modulating inflammation and preserving pathogen clearance. The newly initiated randomized Phase II ARDS trial is designed as a seamless Phase II/III pathway, allowing for rapid transition to registrational development based on effect estimates observed in the initial 90-patient cohort. Management expects to present preliminary findings from the randomized ARDS trial in the second half of 2026, with endpoints focused on overall survival and ventilator-free days. Current cash runway is projected to last at least 12 months, covering the launch and continued execution of the randomized trial through early 2027. Future strategic growth is tied to non-dilutive support from partnerships, such as the pediatric cancer collaboration mentioned in the first quarter., which provides IND-enabling support and commercial participation rights. Upcoming interactions with the FDA in the 'impending weeks' will finalize the total patient numbers and specific statistical frameworks for the expansion into Phase III. The company completed the repayment of approximately $5.2 million in convertible notes in Q1 2026 to simplify the balance sheet ahead of randomized clinical execution. Clinical operations in Ukraine have been cleared by both the Ukrainian Ministry of Health and the U.S. FDA, providing a unique real-world environment to study trauma-associated respiratory failure and multidrug-resistant infections. Management identified fungal pneumonia as a growing 'biologic threat' with no current treatments, positioning their IL-15 superagonist combination as a potential novel solution. A net loss of approximately $2.7 million for Q1 2026 reflects a focused investment strategy on the agenT-797 clinical programs while maintaining tight control over operating expenses. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The randomized Phase II trial will enroll 90 patients with a 1:1 randomization of agenT-797 plus standard of care versus placebo plus standard of care. Primary endpoints include overall survival, ventilator-free days, and ICU duration, with early readouts expected by the second half of the year due to the acute nature of the disease. Management is prospectively interrogating biomarkers to identify the 'hyperinflammatory' 1/3 of ARDS patients who have significantly higher mortality and may respond more effectively to iNKT therapy. The statistical plan is designed to stratify for these inflammatory profiles to potentially accelerate development timelines. The company has mastered proprietary shipping logistics, demonstrated by the ability to deliver cryopreserved cells to active war zones in Ukraine without specialized local manufacturing. Commercial rationale is built on reducing the high cost of ICU stays (often exceeding $100,000 per day) by accelerating patient extubation and discharge. Unlike iPSC or cell-line derived products, MiNK uses 'thymic educated' donor-derived cells that retain the ability to respond dynamically to different disease environments. Management claims this 'groundbreaking' adaptability allows the same product to treat both cancer and inflammatory lung disease effectively.

This article first appeared on GuruFocus. Release Date: May 15, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. MiNK Therapeutics Inc (NASDAQ:INKT) presented data at four major international scientific meetings, showcasing their progress in pulmonary fibrosis, refractory gastric cancer, and severe lung injury. The company has initiated a randomized Phase II clinical trial for their Agent 797 in combination with standard care for severe acute lung injury and respiratory distress, with plans for a seamless Phase 2/3 pathway. MiNK Therapeutics Inc (NASDAQ:INKT) has developed a scalable manufacturing process for their INKT cell therapies, allowing for efficient production and distribution, even under challenging conditions like wartime in Ukraine. The collaboration with SeeFurther to advance PRAME-targeted INKT cell therapy for pediatric cancers provides non-dilutive support and potential commercial benefits. The company maintains a strong cash position, providing operational runway for at least the next 12 months, supporting ongoing clinical trials and development programs. Despite promising data, the development of medicines for conditions like ARDS has historically been challenging due to biologic heterogeneity and complexity. The company faces significant risks and uncertainties related to clinical development, regulatory approvals, and commercial plans, as highlighted in their forward-looking statements. MiNK Therapeutics Inc (NASDAQ:INKT) reported a net loss of approximately $2.7 million for the first quarter of 2026, reflecting ongoing financial challenges. The success of their INKT cell therapies is contingent on the ability to demonstrate efficacy in diverse and complex disease environments, which remains a significant hurdle. The company's reliance on partnerships and collaborations, such as with SeeFurther and Immunity Bio, introduces potential dependency risks on external entities for successful program advancement. Warning! GuruFocus has detected 6 Warning Signs with PAVM. Is INKT fairly valued? Test your thesis with our free DCF calculator. Q: Can you disclose how many patients you're enrolling in each arm of the ARDS trial, and what endpoints you expect to have by the second half of this year? A: We are designing the randomized Phase II trial to include about 90 patients, with a one-to-one randomization. The endpoints will include overall survival, ventilator-free days, and the number of days in the ICU. We expect to have early readouts and plan to present these data in the second half of this year. Dr. Jennifer Buell, CEO Q: Can you elaborate on the collaboration with Immunity Bio and the trials involving their Antiva? A: The collaboration with Immunity Bio involves combining our INKT therapy with their IL-15 super agonist, Antiva, to address fungal pneumonia, which is a growing problem. We will present more detailed data at the ATS conference, highlighting the potential of this combination to modulate the immune system effectively. Dr. Therese Hammond, Head of Development Q: How does the reprogramming of INKT cells occur, and are there biomarkers to predict patient response? A: We are investigating biomarkers that differentiate the inflammatory state in ARDS patients, which may predict response to our therapy. Our INKT cells are donor-derived and have shown the ability to adapt to different disease environments, demonstrating distinct immune responses without disease-specific modifications. Dr. Jennifer Buell, CEO Q: What are your thoughts on the commercial potential and distribution model for your therapies, especially in acute care settings? A: We have demonstrated the ability to distribute our cells internationally, even under challenging conditions like wartime in Ukraine. ARDS affects over 200,000 individuals annually in the U.S. and more than 3 million globally, presenting a substantial commercial opportunity. We plan to share more details on our commercial strategy alongside data from our randomized Phase II trial later this year. Dr. Jennifer Buell, CEO Q: Are there any differences in CMC requirements for ARDS compared to oncology indications? A: The CMC requirements for ARDS involve scaling donor-derived INKT cells to billions per donor, maintaining a standardized manufacturing process. This allows us to deliver the same cells across different disease settings, showing varied immunologic and clinical activity, which is a significant advancement in IMKT development. Dr. Jennifer Buell, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Randomized Phase 2 trial initiated for agenT-797 in severe acute lung injury and respiratory distress, with preliminary data expected in the second half of 2026 AACR and ASGCT presentations showcase durable survival and context-dependent iNKT activity in cancer and inflammatory lung disease Non-dilutive collaborations expand MiNK’s platform and potentiate meaningful commercial revenue potential, while preserving focus on lead clinical programs Company continues disciplined execution with reduced operating burn and focused advancement of high-priority programs New clinical data to be presented at the ATS conference on May 20, 2026 NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company developing allogeneic invariant natural killer T (allo-iNKT) cell therapies to restore immune balance and treat immune-mediated diseases and cancer, today reported financial results for the first quarter ending March 31, 2026, and provided a corporate update. “MiNK entered 2026 focused on converting a growing body of clinical and translational evidence into prospective validation,” said Jennifer Buell, Ph.D., President and Chief Executive Officer of MiNK Therapeutics. “During the first quarter and subsequent period, we advanced agenT-797 into a randomized Phase 2 study in acute lung injury and critical illness, presented data that further support the context-dependent biology of iNKT cells, and continued to expand the platform through selective, non-dilutive collaborations. This is the next phase of MiNK’s strategy: disciplined clinical execution, rigorous translational validation, and capital-efficient expansion of a broadly deployable cell therapy platform.” Dr. Buell continued, “What continues to distinguish agenT-797 is both its biology and its practicality. As an off-the-shelf iNKT cell therapy administered without lymphodepletion or HLA matching, agenT-797 is designed for settings where immune dysfunction drives poor outcomes and where speed, tolerability and deployability matter. We believe this is particularly relevant in severe acute lung injury and critical illness, where patients often face a cascade of respiratory failure, secondary infection and organ dysfunction with limited therapeutic options.” Recent Business and Development Highlights agenT-797 Advanced into Randomized Phase 2 Clinical Evaluation in Acute Lung Injury and Critical Illness MiNK initiated a randomized Phase 2 clinical trial evaluating agenT-797 plus standard of care compared with placebo plus standard of care in adults with severe acute lung injury and critical illness, including moderate to severe acute hypoxemic respiratory failure due to severe pneumonia, who meet Global ARDS criteria and are admitted to the ICU. The study is being designed with a seamless Phase 2/3 operational framework intended to support efficient transition into later-stage development if findings from the randomized Phase 2 portion are prospectively confirmed. The trial has received authorization from the Ukraine Ministry of Health, is supported by an active U.S. IND, and remains subject to FDA clearance for planned U.S. site activation. Preliminary data are expected in the second half of 2026. Acute lung injury and ARDS remain among the most serious unresolved conditions in critical care. ARDS affects an estimated 3 million patients globally and approximately 200,000 patients annually in the United States, accounting for nearly 25% of mechanically ventilated ICU patients.i Mortality remains high, approximately 40% to 50%, and there are currently no approved pharmacologic therapies shown to reduce mortality in ARDS.ii The trial is designed to prospectively evaluate agenT-797 in a clearly defined, critical care population where ventilator-free days, secondary infection, respiratory recovery and survival can be assessed within clinically meaningful and regulatory-aligned endpoints. Recent Data at AACR and ASGCT Strengthen the Biologic Rationale for Context-Dependent iNKT Activity Recent clinical and translational presentations at the American Association for Clinical Research (AACR) Annual Meeting and the American Society of Gene and Cell Therapy Meeting (ASGCT) reinforced the potential of MiNK’s iNKT platform to generate disease-relevant immune activity across distinct clinical settings. In PD-1 refractory gastroesophageal cancer, investigator-sponsored Phase 2 data showed disease control and longer-term survival in a subset of heavily pretreated patients, supported by evidence of immune activation and tumor microenvironment remodeling. The study achieved a 77% disease control rate, with long-term survival beyond 20 months observed in a subset of patients with immune-induction prior to chemotherapy. These patients also had longer progression-free survival compared with those treated without induction, with median PFS of 6.9 months versus 3.5 months. At ASGCT, translational analyses showed that the same off-the-shelf agenT-797 product generated distinct immune outputs in solid tumor and ARDS patients. In solid tumor patients, agenT-797 was associated with a TH1 pro-inflammatory signature consistent with anti-tumor immune activation. In ARDS patients, the same product was associated with a TH2 anti-inflammatory signature consistent with immune restoration and lung injury recovery. Together, these findings support MiNK’s broader development strategy: advancing agenT-797 in settings where immune dysfunction contributes to poor outcomes, while using translational data to define patient populations, biologic mechanisms and future development pathways. Non-Dilutive Collaborations Support Capital-Efficient Platform Expansion MiNK continued to advance its strategy of expanding the iNKT platform through selective collaborations that provide external support and potential downstream economics while preserving focus on lead clinical programs. In the first quarter, MiNK announced a collaboration with C-Further, an international pediatric oncology therapeutics consortium enabled by Cancer Research Horizons, LifeArc and Great Ormond Street Hospital Charity, to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers. The collaboration provides up to approximately $1.1 million in non-dilutive aggregate funding to support IND-enabling development, with potential meaningful double-digit downstream commercial revenue participation. The C-Further program applies MiNK’s off-the-shelf iNKT platform to a validated tumor antigen strategy in pediatric oncology and reflects the company’s broader approach to platform expansion through externally supported, capital-efficient development. MiNK is also advancing additional externally supported programs, including its graft-versus-host disease program supported by NIH STTR funding and the Mary Gooze philanthropic award. These collaborations and funding sources are intended to support pipeline progress while reducing the capital burden typically associated with multi-program cell therapy development. Upcoming ATS Presentation Extends Platform Discussion into Persistent Pulmonary Infection and Immune Dysfunction MiNK will present clinical data featuring agenT-797 at the American Thoracic Society (ATS) International Conference 2026. The presentation, titled “Novel Interleukin-15 Superagonist (N-803) and Invariant Natural Killer T Cell (agenT-797) Combination Immunotherapy for Unresolving Coccidioides immitis Infection,” will be presented by Terese Hammond, M.D., and in collaboration with ImmunityBio (NASDAQ: IBRX) on May 20, 2026. In accordance with ATS guidelines, no data or results have been disclosed prior to the conference. The presentation is expected to expand the platform discussion beyond oncology and acute inflammatory lung injury into persistent infection, immune dysfunction and pathogen control, areas where MiNK believes immune restoration may have broader therapeutic relevance. Financial Results MiNK ended the first quarter of 2026 with approximately $9.5 million in cash and cash equivalents, compared with approximately $13.4 million as of December 31, 2025. During the quarter, the company completed repayment of approximately $5.2 million associated with the Agenus convertible note, further simplifying its balance sheet. Following this repayment, MiNK raised approximately $3.0 million through its at-the-market sales agreement during the three months ended March 31, 2026. Net loss for the first quarter of 2026 was approximately $2.7 million, or $0.57 per share, compared with approximately $2.8 million, or $0.70 per share, for the same period in 2025. First Quarter 2026 Financial Results Conference Call and Webcast MiNK will host a conference call and webcast today at 8:30 a.m. ET to discuss its financial results and corporate update. Conference Call and Webcast Information Webcast & Replay Information A live webcast and replay of the conference call will be accessible from the Events & Presentations page of the Company’s website following the event. Live event link: https://edge.media-server.com/mmc/p/n4ak2xfn Webcast Replay: https://investor.minktherapeutics.com/events-and-presentations About MiNK Therapeutics MiNK Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of allogeneic invariant natural killer T (iNKT) cell therapies and precision immune modulators designed to restore immune balance and drive durable cytotoxic responses. MiNK’s proprietary iNKT platform bridges innate and adaptive immunity to address cancer, autoimmune disease, and immune collapse. Its lead candidate, agenT-797, is an off-the-shelf, cryopreserved iNKT cell therapy currently in clinical trials for solid tumors, graft-versus-host disease (GvHD), and critical pulmonary immune failure. MiNK’s pipeline also includes TCR-based and neoantigen-targeted iNKT programs that enable tissue-specific immune activation. With a scalable manufacturing process and broad therapeutic potential, MiNK is advancing a new class of immune reconstitution therapies designed to deliver durable, accessible, and globally deployable treatments. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws, including statements regarding the potential, safety, clinical benefit, and development plans for agenT-797 and other iNKT-based therapies. These statements involve risks and uncertainties, including those described under “Risk Factors” in MiNK’s most recent SEC filings. MiNK undertakes no obligation to update these statements except as required by law. Contacts Investor Contact: 917-362-1370 | [email protected] Media Contact: 781-674-4428 | [email protected] Source: MiNK Therapeutics _________________________ References i Cleveland Clinic. Acute Respiratory Distress Syndrome (ARDS). ii Bellani G, Laffey JG, Pham T, et al. Epidemiology, Patterns of Care, and Mortality for Patients with Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016;315(8):788–800.

Interested in MiNK Therapeutics, Inc.? Here are five stocks we like better. MiNK launched a randomized phase II trial of AGENT-797 for severe acute lung injury and ARDS, with about 90 patients expected and a potential seamless phase II/III path. The company plans to discuss the design with the FDA soon and expects preliminary data in the second half of 2026. Management said AGENT-797 has now been used in roughly 100 patients with a favorable safety profile, and highlighted data suggesting the same allogeneic cell therapy may act differently depending on disease context. In cancer, it showed Th1-like cytotoxic activation, while in lung injury it appeared to support immune restoration and pathogen control. MiNK ended the quarter with about $9.5 million in cash and said its current plan provides at least 12 months of runway, even after repaying a convertible note and funding the ARDS study. The quarter’s net loss was about $2.7 million, slightly better than a year ago. MiNK Therapeutics (NASDAQ:INKT) said it is advancing its off-the-shelf invariant natural killer T cell therapy platform into a randomized clinical program for severe acute lung injury and acute respiratory distress syndrome, while also reporting first-quarter 2026 financial results that management said support at least 12 months of operating runway. On the company’s first-quarter conference call, President and Chief Executive Officer Dr. Jennifer Buell said MiNK has recently presented data across multiple scientific meetings, including findings in pulmonary fibrosis, refractory gastric cancer and mechanistic work involving its lead iNKT cell therapy candidate, AGENT-797. → Micron Investors Face a High-Stakes Moment After the Latest Rally Buell said the company’s broader focus is developing off-the-shelf iNKT cell therapies for diseases involving “immune failure, inflammatory injury, and impaired pathogen control.” She noted that AGENT-797 has been administered without lymphodepletion or HLA matching, and said approximately 100 patients have been treated to date with what the company has observed as a favorable safety profile. MiNK announced the initiation of a randomized phase II clinical trial evaluating AGENT-797 in combination with standard of care versus placebo plus standard of care in patients with severe acute lung injury and respiratory distress identified using globally recognized ARDS criteria. → How Bad Could Tesla’s Cybertruck Recall Be for Shares? Buell said the trial has been designed with endpoints and infrastructure that could support a “seamless phase II/III pathway” if early findings are prospectively confirmed. She said MiNK expects to speak with the U.S. Food and Drug Administration in the coming weeks regarding the trial design and development plans. During the question-and-answer session, Buell said the randomized phase II portion is expected to enroll about 90 patients, randomized one-to-one between AGENT-797 plus standard of care and placebo plus standard of care. She said the phase III portion would be informed by effect estimates observed in the randomized part of the trial. → How Berkshire’s New York Times Bet Looks Today The company identified endpoints including overall survival, ventilator-free days, number of ventilator days and days in the ICU. Buell said MiNK expects early readouts relatively quickly in this setting and anticipates presenting preliminary findings in the second half of 2026. Buell said ARDS affects an estimated 3 million people globally and about 200,000 people annually in the U.S., accounting for about 25% of mechanically ventilated ICU patients. She said mortality remains high, with approximately 40% to 50% of patients dying from the disease. MiNK is conducting work through a partnership with First Kyiv Territorial Medical Union in Ukraine. Buell said the study has been approved by the Ministry of Health of Ukraine and has cleared the FDA for dosing. Buell said the collaboration provides an opportunity to evaluate iNKT-based cell therapies in patients with critical illness, including trauma-associated respiratory failure, multi-drug resistant pathogens, chronic inflammatory issues and downstream fibrosis. She said the ability to deliver a cryopreserved allogeneic therapy rapidly without lymphodepletion or HLA matching is “operationally important” in acute-care settings. Dr. Terese Hammond, MiNK’s head of development and a practicing pulmonary critical care physician, said the patients targeted in the trial include those requiring high-flow oxygen, non-invasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation. She said these patients can present with hyperinflammatory disease or later evolve into immunologically exhausted states involving impaired pathogen clearance, secondary infection, prolonged ventilator dependence, fibrosis and multi-organ dysfunction. Hammond said AGENT-797 appeared in earlier observations to function across both inflammatory and immune-exhausted scenarios. “It’s not simply inflammatory improvement that we see through using these cells,” she said, describing the observations as a combination of inflammatory modulation, immune recovery and pathogen control. Buell reviewed data presented at the American Association for Cancer Research meeting from a phase II investigator-sponsored study in gastroesophageal cancer led by Memorial Sloan Kettering investigators Dr. Yelena Janjigian and Dr. Sam Spiteri. The patient population was described as heavily pretreated and checkpoint refractory. Buell said the company observed prolonged survival in patients who received induction immune therapy prior to chemotherapy. She said median overall survival extended beyond 23 months in the immune-primed cohort, and several patients remained alive years after dosing. She characterized that outcome as unusual in refractory gastric cancer, while noting that follow-up continues to mature. MiNK also highlighted translational findings presented at the American Society for Gene & Cell Therapy. Buell said Dr. Yan Sun from the company’s team presented analyses showing different immune outputs from the same donor-derived AGENT-797 product depending on disease context. In cancer, Buell said the biology showed Th1-oriented cytotoxic immune activation, while in severe lung injury it shifted toward restoration-associated immune signaling. Hammond said ARDS patients treated with the same donor-derived AGENT-797 product showed restoration-oriented anti-inflammatory cytokine signaling, including interleukin-4 and interleukin-13. In oncology patients, she said the cytokine profile differed, with pro-inflammatory Th1-associated interferon gamma activation and cytotoxic immune engagement. MiNK also discussed findings to be presented at the American Thoracic Society conference involving AGENT-797 in combination with N-803, also known as ANKTIVA, an IL-15 superagonist associated with ImmunityBio. Hammond said she will present a case involving persistent Coccidioides immitis infection treated with AGENT-797 and ANKTIVA. She said the case involved immune dysfunction and persistent inflammatory injury where conventional antifungal therapy and corticosteroids had not been sufficient. Following treatment, she said MiNK observed evidence of inflammatory stabilization and progressive fungal pathogen clearance. In response to an analyst question, Buell said the ATS presentation would provide more detail on the company’s work with ImmunityBio and the rationale for the combination. Hammond described fungal pneumonia, including Valley fever, as an increasing threat and said antifungal treatments do not work for all patients. Principal Financial Officer Melissa Orilall said MiNK ended 2025 with approximately $13.4 million in cash and cash equivalents and completed repayment of approximately $5.2 million associated with the Agenus convertible note during the first quarter of 2026. She said the company raised approximately $3 million through its at-the-market sales agreement during the quarter, ending March 31, 2026, with approximately $9.5 million in cash. Orilall said the company’s current operating plan provides runway for at least the next 12 months, including initiation and continued execution of the randomized ARDS clinical trial. MiNK reported a first-quarter net loss of approximately $2.7 million, or $0.57 per share, compared with a net loss of approximately $2.8 million, or $0.70 per share, in the same period of 2025. Buell said MiNK has generated material needed for the majority of its clinical program and does not expect “substantial manufacturing burn” prospectively. She also pointed to a first-quarter collaboration with C-Further to advance a PRAME-targeted TCR-engineered iNKT cell therapy for pediatric cancers, which she said provides non-dilutive support for IND-enabling activities and potential downstream commercial participation. MiNK Therapeutics, Inc is a clinical-stage biotechnology company developing exosome-based immunotherapies for the treatment of solid tumors. The company's proprietary platform isolates and engineers naturally occurring extracellular vesicles, or exosomes, to deliver therapeutic payloads—such as mRNA, proteins and modulatory factors—directly into the tumor microenvironment. By leveraging the innate cell‐to‐cell communication properties of exosomes, MiNK aims to reprogram immune cells and overcome immune suppression within solid tumors. MiNK's preclinical pipeline features multiple lead candidates designed to repolarize tumor‐associated macrophages and boost T cell–mediated tumor clearance. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "MiNK Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

Image source: The Motley Fool. Tuesday, March 31, 2026 at 5:30 a.m. ET President & CEO — Jennifer Buell Principal Financial Officer — Melissa Orilall Need a quote from a Motley Fool analyst? Email [email protected] Jennifer Buell: Thank you, Stefanie. Good morning, everyone. For those new to MiNK Therapeutics, we are advancing a clinically validated allogeneic invariant natural killer T cell platform, one that is fundamentally differentiated in its ability to restore and coordinate immune function across diseases or even an immune failure. And unlike conventional cell therapies, our MiNK iNKT cells are off the shelf. They are administered without lymphodepletion, without HLA matching. And we've demonstrated clinical activity with a very favorable safety profile. MiNK cells are now in Phase II clinical trials in patients with solid tumor cancers and autoimmune inflammatory conditions like GvHD and severe lung disease. Clinically, in cancer, MiNK cells have demonstrated durable survival beyond 23 months with complete remission extending beyond 2 years in heavily pretreated refractory cancers. Cancer is expected with an expected survival of about 6 months. Outside of cancer, we're also seeing clinical activity in patients with hypoxemic pneumonia or otherwise called severe acute respiratory distress, reinforcing the broader applicability of our immune restoration cell product. We're excited to discuss with you today our upcoming trials. We have secured external funding to advance MiNK cells into graft-versus-host disease with the trial in the activation phase at University of Wisconsin. We have also externally funded a trial in Phase II in patients with gastric cancer with results presented last year at AACR and expected to be presented at a major conference in the first half of this year. And finally, our soon-to-be enrolling MiNK-sponsored randomized Phase II trial in patients with severe hypoxemic pneumonia or ARDS, a condition that affects approximately 200,000 to 300,000 patients per year. We'll talk more about that in just a few moments. Most importantly, we're doing this with a level of capital efficiency that's really uncommon in cell therapy. We're combining disciplined internal execution with non-dilutive funding through government and institutional partnerships, and we're manufacturing at a scale that appears to be the most efficient in cell therapy at this time. At the same time, we continue to build scientific validation through multiple data presentations and peer-review publications, many of which will be out in the first half of this year. Now history tells an important story here on execution. And looking back at 2025. It was a year that we moved really from promise to proof, establishing durability, validating our mechanism, demonstrating that this platform can be advanced with both rigor and efficiency. In 2022, we demonstrated that our results were really quite durable clinically and biologically. And at the Society for Immunotherapy of Cancer Annual Meeting in late 2025, just a couple of months ago, we presented updated clinical data in heavily pretreated checkpoint refractory solid tumor cancers. This is a substantial and growing population of patients. These were patients who had exhausted standard options. What we observed was meaningful. Median overall survival exceeding 23 months in combination with commercially available PD-1 therapies, complete remissions extending beyond 2 years, long-term survival across multiple solid tumor cancers, including gastric, thymoma, renal, adenoid cystic cancers and lung cancer. These outcomes matter, particularly in this patient population and importantly, because they have persisted over time. At the same time, we've deepened our understanding of how this is working. We saw activation and expansion of important immune cell populations, dendritic cell supporting antigen presentation, repolarization of macrophages towards pro-inflammatory antitumor states and reinvigorated or exhausted T cells with restored function. We also observed controlled increases in cytokines, such as interferon gamma, IL-2, TNF alpha, consistent with a productive immune response without systemic toxicity. The takeaway for us is very straightforward. The durability we're seeing clinically is supported by a coordinated immune activation state. This is not a single pathway effect, and it's what defines MiNK iNKT cells as our platform. In scientific validation beyond oncology, we asked how this biology goes beyond cancer. This year at the Keystone Symposia, Dr. Terese Hammond, our Head of Pulmonary Critical Care Medicine, presented human data showing significant depletion of iNKT cells in patients with end-stage idiopathic pulmonary fibrosis. This is important evidence of immune deficiency in patients with immune dysfunction. And when you see that forward, the path becomes really clear. Restore what's missing. This is how we're approaching expansion, follow the biology, validate in humans and then move into clinical execution. And we've taken this approach in patients with hypoxemic pneumonia or ARDS. This is a very serious condition. It's growing in prevalence and incidents and is affecting currently approximately 200,000 to 300,000 patients annually with a mortality rate of 30% to 40%, and no approved disease-modifying therapies. In our Phase I/II trial in this particular population, we dosed critically ill patients with respiratory distress. These patients were on mechanical ventilation and/or VV-ECMO. These patients are consuming substantial resources in our ICUs, and our results showed that we can get the cells into patients in community hospitals. We can dose to 1 billion cells without deleterious tox. As a matter of fact, the cells were tolerated quite well. We not only did not see cytokine release. We, in fact, dampened pro-inflammatory signals or harmful inflammation. We observed prolonged survival. 70% of patients alive compared to 10% of patients within hospital controls. We observed that these cells could locally modulate immune function in the lung, and they can restore function of lung tissue, specifically endothelial function and improved oxygenation in these patients. We saw rapid activation. We saw patients coming off of the most severe life support, VV-ECMO. We saw that these cells also not only cleared infectious pathogens, but also we saw a reduction in the onset of secondary infections. This is important because secondary infections are often the cause of death for patients in the ICU. As a result of these findings, we are now well on our way to announcing the first dosing of patients in our randomized Phase II study that's designed to expand to a Phase II/III study. This is a global program. It's designed very efficiently, and it's planned to launch with our colleagues at top centers in Ukraine and in the U.S. These are real-world environments that we are able to reach because of the practicality of our approach. We have an off-the-shelf therapy with a favorable safety profile and no requirement for complex infrastructure. We're working very closely with the Ministry of Health in Ukraine and the U.S. FDA to advance this program. With dosing starting imminently, we expect an initial clinical data in the second half of this year. These are very rapid trials. This will be our first randomized controlled study in pulmonary diseases designed for clinically meaningful and regulatory aligned end points. We believe this will enable MiNK to pursue rapid development pathways. Now in other disease settings, we've spoken to you about our graft-versus-host disease program already. We've shared more detailed foundation of this program and the study design, in fact, and our intent is to help patients undergoing hematopoietic stem cell transplantation, where more than half of the patients have graft failure and GvHD. We plan to not only improve engraftment success but prevent acute GvHD. The study is important. It's garnered the support of 2 distinct sources of nondilutive funding. The NIH NIAID STTR Award supports the development of preclinical and translational work while the Mary Gooze Clinical Trial Award directly funds the clinical trial execution at the University of Wisconsin, including patient enrollment and trial operations. The clinical trial is in final review with the university with clinical initiation targeted for the first half of this year. We believe we'll be dosing very soon. This structure allows us to advance into immune-mediated diseases in immune-tolerant settings without incremental capital burden. It's disciplined expansion. It's funded, targeted and aligned with our platform. Nondilutive funding is part of how we operate. In 2025, we secured multiple sources of nondilutive capital funding, including NIH funding, philanthropic support and consortium funding through C-Further most recently, which includes approximately over $1 million to get into our IND-enabling studies and meaningful double-digit downstream economics. The C-Further collaboration is particularly important, not just for the nondilutive funding to support IND-enabling development of a really important target, a PRAME-targeting iNKT TCR, but for what it represents strategically. This program was selected as one of the first within the C-Further consortium, an international pediatric oncology initiatives supported by Cancer Research Horizons, LifeArc and Great Ormond Street Hospital, reflecting external validation of both the maturity of our platform and its potential in high-need setting such as pediatric cancer. The collaboration advances our PRAME-targeted TCR-engineered iNKT program combining a well-characterized tumor antigen with our iNKT platform, which is designed to bridge innate and adaptive immunity and coordinate broader immune responses within the tumor microenvironment. And importantly, the program is structured to generate rigorous comparative preclinical data across multiple pediatric tumor models to support data-driven candidate selection and advance to first-in-human studies. From a strategic standpoint, the model allows us to advance the next-gen program in a high-need indication with nondilutive capital. It also allows us to leverage leading academic and translational experts without building that infrastructure or expanding it internally. MiNK gets to retain meaningful double-digit downstream commercial participation, and we preserve the platform flexibility through a nonexclusive structure. This is simply not a funding mechanism. It's really a way to expand the platform, derisk early innovation and create long-term value while maintaining capital discipline. So taken together, these sources of capital have enabled us to advance clinical programs and expand the pipeline and generate translational data while preserving shareholder equity. It's deliberate, and it's a repeatable part of how we're building MiNK. And on the financial discipline front, we're doing more with less. We strengthened our financial position over the year with our cash increasing to about $13.4 million from $4.6 million and our operating cost decreasing nearly 40% over the course of the year. The key takeaway is that we've increased cash while reducing burn and continuing to execute on important programs. With the scale and complexity of the work we're now undertaking, including randomized clinical trial execution, multi-program advancement and increasing external engagement, we've strengthened our financial leadership. We recently appointed Melissa Orilall as Principal Financial Officer. Melissa brings deep experience in financial operations planning and disciplined execution, including her work at the Whitehead Institute and in corporate banking. Her focus is on ensuring that our capital allocation, reporting and operational execution is tightly aligned as we advance through this next phase. Now on our expanded pipeline. As I've mentioned, we continue to advance our PRAME TCR NKT program by non-dilutive funding. Further, our MiNK-215, which is our CAR iNKT program targeting stromal resistance is very important. We've continued to build our translational data set on this asset as we responsibly bring it into IND enablement. These currently do not have a specific near-term catalyst, but we would expect to be announcing some within the next 3 to 5 months on our 215 program. And as our data set has strengthened, we have seen increased external interest in 797 and iNKT biology. Some of you have actually reached out to me specifically about third parties who have announced the combination of 797 in their clinical trials. And as I've mentioned now publicly, MiNK has not formally announced any of our strategic collaborations yet. We -- strategic partnering does remain core to our strategy, and we plan to continue to keep you apprised as these developments ensue. What to watch for in 2026? This year, we are focused on some substantial and measurable milestones which are really quite exciting. In the first half of 2026, as I mentioned, we expect to initiate our randomized Phase II, Phase II/III ARDS hypoxemic pneumonia study and the activation and dosing in our GvHD trial. In the second half of the year, we do expect to have initial clinical data from both of those programs, not only representing our first randomized data set in pulmonary diseases, but also early immune and translational readouts in GvHD as well as in lung disorders. In parallel, during the first half of '26, we'll continue to build scientific validation through multiple data presentations and peer-reviewed publications, extending the data sets presented at SITC and Keystone. And taken together, these milestones are designed to generate clear interpretable data that informs our next steps, both in development and in potential regulatory and strategic pathways. Now I'd like to turn the call over to Melissa to review our financials. Melissa? Melissa Orilall: Thank you, Jen. During 2025, we executed an at-the-market facility in a disciplined manner, ending the year with a cash balance of $13.4 million. Since year-end, we have raised an additional $3 million through this program, extending our runway through 2026 and supporting key clinical milestones. Our net loss for the fourth quarter of 2025 was $2.6 million or $0.56 per share compared to $2.5 million or $0.62 per share for the fourth quarter of 2024. For the full year, net loss was $12.5 million or $2.93 per share compared to $10.8 million or $2.86 per share in 2024. These results reflect continued focused investment in advance in our agenT-797 clinical programs while maintaining disciplined control over our operational spend. I will now turn the call back to Jen for closing remarks. Jennifer Buell: Thank you so much, Melissa. Thank you all for being here. I think just in closing, I'll just reiterate that for us, if you just step back, the story is pretty simple. In 2025, we demonstrated durability. We showed mechanistic validation of our technology as well as human disease relevance. Those data have now set the stage for what we're doing going forward. And in 2026, we're executing on an important randomized controlled clinical trial as well as signal detection and clinical advancement in very important disease settings, including GvHD. We'll be generating clinical data and publicizing that very quickly and advancing towards potential paths for regulatory approval. We have multiple readouts planned in the first half of this year with data from our upcoming trials and preliminary readouts in the second half of this year. We're excited and I look forward to your questions. I'll now turn the call back over to the operator. Operator: [Operator Instructions] Our first question comes from the line of Emily Bodner with H.C. Wainwright. Emily Bodnar: A couple for me. Maybe starting with the Phase II pneumonia and ARDS study. Could you kind of talk through how many patients approximately that trial is going to be? And what the appropriate control arm is here? And then you also talked about development in IPF, which sounds like it would need to be a separate trial. So maybe just talk about how you're thinking of these different indications. Jennifer Buell: Emily, thanks so much for your question. Absolutely. While we have not publicly posted the program in hypoxemic pneumonia, what I'm going to share with you is that currently in the disease population that we're pursuing, there are no approved therapies. Patients are treated with standard of care. This is the same state that we were in when we conducted our Phase I/II trial establishing the dose of these cells in this population of patients. What we've demonstrated is that patients are predominantly treated with steroid therapy with, of course, anti-infectives, antifungals, et cetera, but really physicians' choice in this disease setting. So we have 2 things that are really important. One, we've already observed and presented that these cells appear to be quite active in restoring immune functionality and clearing pathogens, independent of steroids being on board, which is unique. Many times, there's a concern about immunosuppression with steroid use, standard of care steroid use, and we're not observing that. So these cells appear to be sort of steroid-resistant. Their ability to modulate immune function, clear pathogens in the presence. We will be looking at physicians' choice as effectively standard of care. The cells will be added on top of standard of care versus the cells alone. And a critical piece of this is Dr. Terese Hammond is leading up our pulmonary disease programs. She's also clinically still seeing patients in the ICU. Terese is boarded in pulmonary critical care, neurocritical care medicine and has been treating patients with this disease profile for now decades of her life. For us to be able to have such a thoughtful leader on this program and such an informed clinician, it gives us a real opportunity to position these cells and to bring them forward into the patients who we believe they will be most effective in. And taking the cells plus or minus standard of care, gives us not only the differentiation of the cells, the added potential of the cells, but also maybe paradigm changing for these patients in the ICU. Emily Bodnar: Great. And maybe -- sorry, can I just ask one more. On the second-line gastric cancer trial, could you just remind us the status of that and when we may be able to see efficacy data from that study? Jennifer Buell: You will be seeing some efficacy data in the first half of this year at a major conference, which we'll be announcing relatively soon. And we're excited about that. But I did not answer your question about IPF, and this is, of course, a very important pulmonary fibrosis, end stage in particular, is another disease setting. It's effectively in immune-related condition. We've demonstrated that with our human data, and it's a substantial opportunity for us to develop the cells in IPF. We have some important preclinical observations as well as some new human data demonstrating that this is a pathway where we believe the cells can bring benefit. You're going to be hearing more about the design of that trial and the development path as we advance over the next couple of months. We will very likely host a special meeting in this disease setting. We have selected a scientific advisory boards, have informed clinicians in this space and have developed a program to advance. We'll be very responsible, though, about how we're going to be funding that program. So you'll hear more about that relatively soon. Operator: Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Mayank Mamtani: I appreciate the comprehensive update. Just on the last point on IPF and even GvHD, what target patient population, Jen, you have in consideration? And wonder what differentiating aspects to some of the recently approved anti-fibrotic, anti-inflammatory approaches you aspire to have the cell therapy you positioned against. And then I have to ask some of the IL-15 iNKT cell combination trial launching on ct.gov. Could you help us understand how and what this 30 subject kind of total exposure would inform what you are looking to independently do with. It looks like the randomized controlled trial in the ARDS setting. I was not sure if the populations that you're exploring are overlapping across those combination and randomized trial settings. So if you could clarify that, that would be great. Jennifer Buell: Mayank, thank you for your questions. I just -- I want to make sure that I have them correct because you did cut out for just a moment. But I think on the randomized ARDS trial, the patient populations will be identified as hypoxemic pneumonia. There's a very specific global ARDS definition system that allows us to be very specific and selective about this patient population. So they will be selected and identified based on their oxygenation, so a very quantifiable way of interrogating this as well as important organ function states. So we will put a detailed eligibility criteria in clinical trials. And this is another program where we are going to be announcing very soon upon the announcement of the launch of the randomized Phase II as well as the dosing in GvHD. We'll be hosting a very special R&D meeting that will allow you to talk with our experts, our clinical development experts as well as review a deep dive of the programs and the eligibility of these patients. So in ARDS, there have been some -- there are currently no approved therapy. So this becomes standard of care, becomes really a physician's choice in this disease setting. There are no functional cell therapies in this setting. What we've been able to observe in our early stage development is that our cells really persist, and that they are not vulnerable to steroids. And that allows the cells to continue to modulate immunity in this setting. We observed that. We see we can administer the cells, 1 billion cells tolerably. We observed that the cells are in the peripheral system for some time, a number of days before they then home very specifically to lung tissue. We've been able to use a special technique that allows us, particularly in ventilated patients to take samples from the -- within the lung tissues called the bronchial lavage. This is the assessment that we can test in order to interrogate the immune cell, the local immune modulating capability of the cells. It gives us 2 opportunities. In addition to just radiologically looking at what's happening clinically for within a patient's lungs, we can start to see clearance of pathology, clearance of some inflammatory markers on, you could see this radiologically. But then also when we really dig into lung tissue, we're able to see what is actually happening. In these patients, we see the substantial pro-inflammatory signatures. And what we've publicly disclosed, and we'll be publishing even more this year in the first half will be some of the anti-inflammatory signals that we see here in this population of patients. So we're really dampening pro-inflammatory signals. We're eliminating fungal infections. We're eliminating some gram-negative bacteria, which is a major problem. And this becomes an even more substantial problem in some austere regions like war zones or places where we will be studying these cells where multidrug-resistant organisms are a substantial problem. Given that we've already been able to demonstrate, not only with our clinical trial that we published on, but also through emergency use that we've continued to help patients with, we've demonstrated that we can really do an impactful clinical activity and modulate some of these multidrug-resistant organisms, clearing them from patients with some of the most severe critical illnesses. This is such an important part of the work that we're doing right now. So you'll hear more about the eligibility of these patients, and I'm going to invite you specifically to talk with some of the experts in this disease setting. So I think that was a longer way of answering the simple question on standard of care and what will be adequate controls, which would be really just physician's choice in this population. Mayank Mamtani: I appreciate it. And I don't know if I missed that, or my question was cut out. If you could address the combination approach with the IL-15 agonist that trial, that launched on clinicaltrials.gov, what the rationale was? And how is that different than the study that you just referenced? Jennifer Buell: Mayank, thank you. Thank you very much. The study that I've referenced is the MiNK-sponsored randomized Phase II trial that we have not yet posted on clinicaltrials. We will be doing so. It's currently in review. The study that you're referring to, and I'm grateful that you brought it up. I've received a host of inbound inquiries about this from investors as well as from regulators. And I want to be very clear that MiNK has not formally announced any collaboration or any clinical trials with the IL-15 superagonist. And I think that's an important thing to understand. We will -- if we are to advance with these types of strategic collaborations, we will be very public about doing so. So at this time, strategic collaborations are really important to MiNK, and we have a number of discussions that are actively underway, not only for clinical trial combinations. There's a lot of excitement about 797, but also for broader strategic collaborations as well as minority financial investments in the company, none of which have we publicly disclosed at this time. We will do so when the -- during the appropriate time. Operator: At this time, we have no further questions. I will now turn the call back over to Dr. Jennifer Buell for closing remarks. Jennifer Buell: Thank you, operator, and thank you all so much for your participation today. Operator: Ladies and gentlemen, that concludes today's conference call. You may now disconnect your lines. Have a pleasant day. 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