NASDAQ:INKT MiNK Therapeutics Q2 2026 Earnings Report $12.20 +0.58 (+4.99%) As of 08/21/2026 04:00 PM Eastern ProfileEarnings HistoryForecast MiNK Therapeutics EPS ResultsActual EPS-$0.62Consensus EPS -$0.60Beat/MissMissed by -$0.02One Year Ago EPSN/AMiNK Therapeutics Revenue ResultsActual RevenueN/AExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AMiNK Therapeutics Announcement DetailsQuarterQ2 2026Date8/13/2026TimeBefore Market OpensConference Call DateThursday, August 13, 2026Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by MiNK Therapeutics Q2 2026 Earnings Call TranscriptProvided by QuartrAugust 13, 2026ShareShareShare This ReportLink copied to clipboard.Key Takeaways Positive Sentiment: MiNK advanced agenT-797 into a randomized Phase II ARDS study, with enrollment continuing in Ukraine and U.S. sites expected to begin enrolling in September. The company expects preliminary randomized data in the first half of 2027 and is preparing to discuss a potential seamless Phase III design with the FDA. Positive Sentiment: Initial observations from two treated patients showed survival without fever at day 28, improved oxygenation, ARDS resolution, spontaneous breathing, vasopressor liberation, infection control, and no major treatment-related serious adverse events. However, management emphasized that the data are early, non-comparative, and based on a small run-in cohort. Positive Sentiment: MiNK launched its first international paid named-patient access program in Brazil, generating physician-directed access and payments while building cross-border logistics and regulatory infrastructure. The company said additional patients were treated after quarter-end and that further financial details are expected with its third-quarter update. Negative Sentiment: MiNK ended the quarter with $8.8 million in cash, down from $9.5 million at the end of the first quarter, while quarterly operating cash use increased to $2.1 million as the Phase II trial was operationalized. The company continues to report losses and did not provide explicit cash-runway guidance. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallMiNK Therapeutics Q2 202600:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipantsPresentationSkip to Participants Operator00:00:00Good 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 Stephanie Pernicaro from MiNK Therapeutics, MiNK investor relations. Stephanie, please go ahead. Stephanie PernicaroChief Communications Officer at MiNK Therapeutics00:00:27Thank 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 BuellPresident and CEO at MiNK Therapeutics00:01:23Thank 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 II study in patients with acute lung injury and ARDS. We presented initial day 28 observations from treated patients and established our first 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 remains no approved pharmacologic therapy shown to reduce mortality in patients with ARDS or to restore coordinated immune function after severe lung injury. Jennifer BuellPresident and CEO at MiNK Therapeutics00:02:35More 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 response 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. agenT-797 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:03:55It does not require apheresis, does not require patient-specific manufacturing, HLA matching, or lymphodepletion. That last point is biology rather than logistics. iNKT cells are restricted by an important TCR that is 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 C-1300-02. This is our randomized phase II 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 Medical Union in collaboration with Unbroken Ukraine. Jennifer BuellPresident and CEO at MiNK Therapeutics00:05:08We dosed the first patient within days of Ministry of Health authorization during an active conflict in 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. Terese Hammond presented the initial data from our observations from the first patients treated with agenT-797. MHSRS, the symposium, is the Department of War's 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:06:13agenT-797 acts on the host response rather than on the specific organism. It is pathogen agnostic, which is directly relevant where multi-drug-resistant infections are common and antibiotics fail. 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 infections. The 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 in these initial patients. Jennifer BuellPresident and CEO at MiNK Therapeutics00:07:24These are early patients, and these patients were part of the run-in. They are 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 whether 797 improves outcomes in these patients on top of standard of care. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:08:17Enrollment continues in Lviv, Ukraine, and activation of U.S. 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 named patient access program. This program launched in Brazil and in collaboration with our colleagues at Orphan Drug Consulting, a local team on the ground in Brazil and South America. This program is important for three reasons. First, it enables a treating physician to request agenT-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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:09:24Third, 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. MiNK does not identify or solicit patients. Requests must originate with the treating physician and receive the required per-patient authorization. Jennifer BuellPresident and CEO at MiNK Therapeutics00:10:31Now, 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 in 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 superagonist N-803 in a patient with severe fungal infection. In Boston earlier this year at the American Society of Gene & 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:11:36At the Keystone Symposia 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. In cancer, our phase II 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 longer 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 antitumor response. 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 OrilallPrincipal Financial Officer at MiNK Therapeutics00:12:48Thank you, Jen. We ended the second quarter with $8.8 million in cash and cash equivalents, compared with $9.5 million at March 31st, 2026, and $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. Melissa OrilallPrincipal Financial Officer at MiNK Therapeutics00:13:55This modest increase was specific and deliberate, reflecting the cost of operationalizing our randomized phase II study, activating and initiating the Lviv site, completing the regulatory work supporting Ministry of Health authorization, dosing 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 BuellPresident and CEO at MiNK Therapeutics00:14:34Thank you, Melissa. As Melissa noted, the modest increase in operating cash use reflects the launch and execution of a randomized phase II study. Outside of that targeted investment, our financial discipline remains unchanged. We have not added fixed infrastructure, our footprint and head count remain deliberately lean, and our manufacturing model is inventory-based rather than 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 prime 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:15:28At 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 our 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 in acute lung injury and ARDS while preserving a responsible pathway for patients to access the therapy outside of our ongoing clinical trials. This quarter, we advanced the essential elements of that strategy, a randomized phase II study designed to generate rigorous evidence, an 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:16:28Our 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:17:21Continue enrollment in Study C-1300-02, activate our U.S. sites, expand the comparative clinical and biologic data set, and execute our named 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. Operator00:18:03Thank you. To ask a question, press star then one. To withdraw, press star then one again. Our first question comes from the line of Emily Bodnar with H.C. Wainwright. Your line is open. Emily BodnarAnalyst at H.C. Wainwright00:18:22Hi. Good morning. Thanks for taking the questions, and congrats on the progress. I guess maybe to start with the hypoxemic pneumonia and ARDS data that you mentioned, can you confirm how many patients were included in this run-in that you discussed? Along with that, it would be great if you 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. I guess your confidence that the day 28 survival that you have observed is due to agenT-797. Thank you. Jennifer BuellPresident and CEO at MiNK Therapeutics00:19:04Hi, Emily. Thanks so much for the question. I will share with you the data that we have presented publicly, and those slides will be available on our website as well. These are patients with hypoxemic pneumonia, and they meet effectively, and I will have Dr. Hammond go through some of the profile elements of these specific patients that we presented. But they meet the global definition of acute respiratory distress syndrome. 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. In this study, we have a run-in scheduled for about 10 patients, where all patients receive the cell therapy. Then we launched the randomized portion of the study. Jennifer BuellPresident and CEO at MiNK Therapeutics00:19:58We presented data in those patients that did receive the cell therapy, and these were patients. We presented data on our first two patients treated in the study. The first was a 41-year-old female, and she had poorly controlled diabetes and pneumococcal sepsis. At its submission, I could have Dr. Hammond, if you are 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 HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:20:35Yeah. No, of course, Jen, and thank you for the question, Emily. As Jen said, these are adults. We are trying to decrease the amount of exclusion criteria. So they are folks with moderate to severe hypoxemic pneumonia, and they can also have coexisting trauma, so we are 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 U.S. in the sense that both of these patients had multidrug-resistant pneumonia, multidrug-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. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:21:43To 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 are purporting the results of this just in a preliminary manner. But I think that we feel confident that going into the randomized portion of this clinical trial, agenT-797, at its 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 is 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. Emily BodnarAnalyst at H.C. Wainwright00:22:50Great. Thank you for the details. Operator00:22:56Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Your line is open. Mayank MamtaniAnalyst at B. Riley Securities00:23:04Yes, good morning. Thanks for taking our questions and appreciate the level of detail on pipeline progress. 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 if you can comment on the enrollment rate as you see in both Ukraine but also as FDA sites come on board, 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 BuellPresident and CEO at MiNK Therapeutics00:23:46Mayank, thank you for the question. The study is currently underway in Ukraine and expanding into the U.S. 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 II portion of the study in the first half of 2027. We're expecting to continue enrollment at a rate that is consistent with the sites that are selected for this study. Particularly with seasonality, we do see upticks in enrollment as well for obvious reasons in this program. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:24:50I 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. 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. That will allow us to generate data from the randomized phase II, and then move directly into the confirmatory phase III in a very rapid fashion. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:25:53As patients traverse from one destination to the next, they generally succumb to multi-drug resistant organisms. In Ukraine, there are some recent publications showing that about 100% of these individuals are succumbing to multi-drug resistant pathogens. It is an opportunity for us and our colleagues that have quite a bit of interest from the military to evaluate what these cells can do in that setting as well. Essentially respiratory distress coming from multi-drug resistant pathogens in addition to some other complications, as Dr. Hammond mentioned. Will that be the same in the U.S.? 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 U.S. Terese? Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:27:00Yeah, no, absolutely, and thank you for the question. I think that what struck me at the MHSRS meeting that we recently attended was just the fact that these very virulent multi-drug 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. 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. They're gram-negative Klebsiella, which is pan-resistant to all antibiotics, Acinetobacter, Pseudomonas. Those are the big three that are really affecting conflict zones in Ukraine and beyond, and also infiltrating tertiary hospitals in Europe. This is a really big problem. I treat patients in Central California. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:28:03We 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 Klebsiella, for example, a year in these patients that have been ill for a long time, usually on chronic ventilator therapy. I am not used to having young people come in from the community and acquiring these very virulent infections even before they have been in a heart burn, 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. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:29:03I hope that we don't see them to the same extent that we're seeing in the Ukraine as we open up the U.S. 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 MamtaniAnalyst at B. Riley Securities00:29:31Thank you for all that color. Would you expect phase III population focus to be very comparable, this pan-resistant that you're talking about? I was also wondering, the acute endpoints used here, at some point would make placebo control unethical. Is there a randomization ratio you could look differently in phase III than phase II? Lastly, if you could comment on any process-wide data sharing practices with DoD, BARDA. I know you mentioned FDA, but was just curious how DoD is involved here. Jennifer BuellPresident and CEO at MiNK Therapeutics00:30:11Thanks, Mayank. I'll start here. The population we would expect to be comparable to our phase II population. The results from the phase II will also give us an opportunity to conduct a sample size re-estimation. We're looking at primary endpoints 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 at this point. It would be premature to speak about some of our government interactions. But I could share with you that we have a newly appointed board member, Dr. John Holcomb, who's a trauma surgeon and also essentially very actively involved in driving improvements in medical care specific to conflict zones, military personnel, and of course, the bridge to civilians. Jennifer BuellPresident and CEO at MiNK Therapeutics00:31:23His work has recently led to the approval of plasma as a product for resuscitation in patients. He's an incredible scientist and very thoughtful strategic leader and partner for us. The work that we're doing, as Terese mentioned, because of the increase in the number of conflict zones that we have internationally and 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 of major interest for all of us. Mayank MamtaniAnalyst at B. Riley Securities00:32:17Got it. If I may just ask about the Brazil paid program, maybe just the rationale for choosing that geography and if you could, to the extent possible, comment on pricing, how you're seeing demand both locally and I'm sure other regions are also interested in this. Any thoughts on that, Jen? Jennifer BuellPresident and CEO at MiNK Therapeutics00:32:41Thanks, Mayank. Absolutely. 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. 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 convey some of those efficiencies to patients that have broad requests are pretty broad for patients who are coming in. Jennifer BuellPresident and CEO at MiNK Therapeutics00:33:49Some patients are requesting this, patients with cancer as well as patients with other indications. As the program expands, we'll speak more to the detail of it. The regions will be expanding, and we'll announce those expansions as we get through the regulatory processes in different territories. Mayank MamtaniAnalyst at B. Riley Securities00:34:11Thank you so much. Looking forward to the call. Jennifer BuellPresident and CEO at MiNK Therapeutics00:34:13Of course. Thanks, Mayank. Operator00:34:18Again, if you would like to ask a question, press star then one. To withdraw, press star then one again. 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 BuellPresident and CEO at MiNK Therapeutics00:34:39Thank you, operator. Thank you all for participating. I appreciate your support. We look forward to keeping you in the loop with upcoming developments on the program. Thank you. Operator00:34:51This concludes today's call. A 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.Read moreParticipantsExecutivesStephanie PernicaroChief Communications OfficerJennifer BuellPresident and CEOMelissa OrilallPrincipal Financial OfficerTerese HammondHead of Inflammatory and Pulmonary DiseasesAnalystsEmily BodnarAnalyst at H.C. WainwrightMayank MamtaniAnalyst at B. Riley SecuritiesPowered by Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) MiNK Therapeutics Earnings HeadlinesQ3 EPS Forecast for MiNK Therapeutics Boosted by AnalystAugust 20 at 1:29 AM | americanbankingnews.comMiNK outlines 4-8 patients per site per month as U.S. ARDS enrollment starts in SeptemberAugust 14, 2026 | seekingalpha.comA letter from Shannon StansberryPorter Stansberry nearly canceled the entire project. When he first saw the claimed returns - only one down year in nearly two decades and total gains of almost 2,000% - his immediate reaction was disbelief. It took a trusted friend's personal vouching for Emmet Savage and a face-to-face trip to Ireland to change his mind. The full documentary, Investigating Project Prophet, is now live.August 23 at 1:00 AM | Porter & Company (Ad)MiNK Therapeutics Inc (INKT) (Q2 2026) Earnings Call Highlights: AGENT-797 Shows Early Promise ...August 14, 2026 | uk.finance.yahoo.comMiNK Therapeutics, Inc. Q2 2026 Earnings Call SummaryAugust 14, 2026 | finance.yahoo.comMiNK Therapeutics Q2 2026 Earnings Call: Complete TranscriptAugust 14, 2026 | benzinga.comSee More MiNK Therapeutics Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like MiNK Therapeutics? Sign up for Earnings360's daily newsletter to receive timely earnings updates on MiNK Therapeutics and other key companies, straight to your email. Email Address About MiNK TherapeuticsMiNK Therapeutics (NASDAQ:INKT) 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. The company has established scalable, GMP‐compatible manufacturing processes to produce engineered exosomes at clinically relevant volumes. Research efforts focus on optimizing biodistribution, payload loading efficiency and safety profiles in animal models, with the goal of advancing IND‐enabling studies for first‐in‐human trials. Headquartered in Cambridge, Massachusetts, MiNK collaborates with academic institutions and contract development organizations across North America and Europe to accelerate its research and development programs. The company’s integrated operations encompass discovery, preclinical testing and process development, supported by a team of experts in exosome biology, translational immunology and biomanufacturing. Through these partnerships and internal capabilities, MiNK aims to bring novel, precision immunotherapies to patients with high‐unmet‐need solid tumors.View MiNK Therapeutics ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Latest Articles MarketBeat Week in Review – 08/17 - 08/21Flash in the Pan or Sustained Rally Contender? 3 Momentum Stocks to Watch$27 Billion in Buybacks: 3 Stocks Betting Their Strong Runs Aren’t OverRoss Stores Just Flipped the Off-Price Retail Story After TJX's Marmaxx Miss3 Stocks Came Roaring Back—Now They’re Flashing Warning SignsMicrosoft's Sell-Off May Be a Gift, Not a WarningIs Palo Alto Networks Priced for Perfection Again as AI Security Demand Accelerates? 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PresentationSkip to Participants Operator00:00:00Good 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 Stephanie Pernicaro from MiNK Therapeutics, MiNK investor relations. Stephanie, please go ahead. Stephanie PernicaroChief Communications Officer at MiNK Therapeutics00:00:27Thank 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 BuellPresident and CEO at MiNK Therapeutics00:01:23Thank 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 II study in patients with acute lung injury and ARDS. We presented initial day 28 observations from treated patients and established our first 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 remains no approved pharmacologic therapy shown to reduce mortality in patients with ARDS or to restore coordinated immune function after severe lung injury. Jennifer BuellPresident and CEO at MiNK Therapeutics00:02:35More 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 response 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. agenT-797 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:03:55It does not require apheresis, does not require patient-specific manufacturing, HLA matching, or lymphodepletion. That last point is biology rather than logistics. iNKT cells are restricted by an important TCR that is 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 C-1300-02. This is our randomized phase II 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 Medical Union in collaboration with Unbroken Ukraine. Jennifer BuellPresident and CEO at MiNK Therapeutics00:05:08We dosed the first patient within days of Ministry of Health authorization during an active conflict in 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. Terese Hammond presented the initial data from our observations from the first patients treated with agenT-797. MHSRS, the symposium, is the Department of War's 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:06:13agenT-797 acts on the host response rather than on the specific organism. It is pathogen agnostic, which is directly relevant where multi-drug-resistant infections are common and antibiotics fail. 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 infections. The 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 in these initial patients. Jennifer BuellPresident and CEO at MiNK Therapeutics00:07:24These are early patients, and these patients were part of the run-in. They are 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 whether 797 improves outcomes in these patients on top of standard of care. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:08:17Enrollment continues in Lviv, Ukraine, and activation of U.S. 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 named patient access program. This program launched in Brazil and in collaboration with our colleagues at Orphan Drug Consulting, a local team on the ground in Brazil and South America. This program is important for three reasons. First, it enables a treating physician to request agenT-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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:09:24Third, 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. MiNK does not identify or solicit patients. Requests must originate with the treating physician and receive the required per-patient authorization. Jennifer BuellPresident and CEO at MiNK Therapeutics00:10:31Now, 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 in 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 superagonist N-803 in a patient with severe fungal infection. In Boston earlier this year at the American Society of Gene & 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:11:36At the Keystone Symposia 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. In cancer, our phase II 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 longer 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 antitumor response. 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 OrilallPrincipal Financial Officer at MiNK Therapeutics00:12:48Thank you, Jen. We ended the second quarter with $8.8 million in cash and cash equivalents, compared with $9.5 million at March 31st, 2026, and $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. Melissa OrilallPrincipal Financial Officer at MiNK Therapeutics00:13:55This modest increase was specific and deliberate, reflecting the cost of operationalizing our randomized phase II study, activating and initiating the Lviv site, completing the regulatory work supporting Ministry of Health authorization, dosing 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 BuellPresident and CEO at MiNK Therapeutics00:14:34Thank you, Melissa. As Melissa noted, the modest increase in operating cash use reflects the launch and execution of a randomized phase II study. Outside of that targeted investment, our financial discipline remains unchanged. We have not added fixed infrastructure, our footprint and head count remain deliberately lean, and our manufacturing model is inventory-based rather than 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 prime 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:15:28At 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 our 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 in acute lung injury and ARDS while preserving a responsible pathway for patients to access the therapy outside of our ongoing clinical trials. This quarter, we advanced the essential elements of that strategy, a randomized phase II study designed to generate rigorous evidence, an 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:16:28Our 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:17:21Continue enrollment in Study C-1300-02, activate our U.S. sites, expand the comparative clinical and biologic data set, and execute our named 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. Operator00:18:03Thank you. To ask a question, press star then one. To withdraw, press star then one again. Our first question comes from the line of Emily Bodnar with H.C. Wainwright. Your line is open. Emily BodnarAnalyst at H.C. Wainwright00:18:22Hi. Good morning. Thanks for taking the questions, and congrats on the progress. I guess maybe to start with the hypoxemic pneumonia and ARDS data that you mentioned, can you confirm how many patients were included in this run-in that you discussed? Along with that, it would be great if you 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. I guess your confidence that the day 28 survival that you have observed is due to agenT-797. Thank you. Jennifer BuellPresident and CEO at MiNK Therapeutics00:19:04Hi, Emily. Thanks so much for the question. I will share with you the data that we have presented publicly, and those slides will be available on our website as well. These are patients with hypoxemic pneumonia, and they meet effectively, and I will have Dr. Hammond go through some of the profile elements of these specific patients that we presented. But they meet the global definition of acute respiratory distress syndrome. 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. In this study, we have a run-in scheduled for about 10 patients, where all patients receive the cell therapy. Then we launched the randomized portion of the study. Jennifer BuellPresident and CEO at MiNK Therapeutics00:19:58We presented data in those patients that did receive the cell therapy, and these were patients. We presented data on our first two patients treated in the study. The first was a 41-year-old female, and she had poorly controlled diabetes and pneumococcal sepsis. At its submission, I could have Dr. Hammond, if you are 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 HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:20:35Yeah. No, of course, Jen, and thank you for the question, Emily. As Jen said, these are adults. We are trying to decrease the amount of exclusion criteria. So they are folks with moderate to severe hypoxemic pneumonia, and they can also have coexisting trauma, so we are 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 U.S. in the sense that both of these patients had multidrug-resistant pneumonia, multidrug-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. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:21:43To 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 are purporting the results of this just in a preliminary manner. But I think that we feel confident that going into the randomized portion of this clinical trial, agenT-797, at its 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 is 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. Emily BodnarAnalyst at H.C. Wainwright00:22:50Great. Thank you for the details. Operator00:22:56Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Your line is open. Mayank MamtaniAnalyst at B. Riley Securities00:23:04Yes, good morning. Thanks for taking our questions and appreciate the level of detail on pipeline progress. 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 if you can comment on the enrollment rate as you see in both Ukraine but also as FDA sites come on board, 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 BuellPresident and CEO at MiNK Therapeutics00:23:46Mayank, thank you for the question. The study is currently underway in Ukraine and expanding into the U.S. 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 II portion of the study in the first half of 2027. We're expecting to continue enrollment at a rate that is consistent with the sites that are selected for this study. Particularly with seasonality, we do see upticks in enrollment as well for obvious reasons in this program. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:24:50I 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. 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. That will allow us to generate data from the randomized phase II, and then move directly into the confirmatory phase III in a very rapid fashion. 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. Jennifer BuellPresident and CEO at MiNK Therapeutics00:25:53As patients traverse from one destination to the next, they generally succumb to multi-drug resistant organisms. In Ukraine, there are some recent publications showing that about 100% of these individuals are succumbing to multi-drug resistant pathogens. It is an opportunity for us and our colleagues that have quite a bit of interest from the military to evaluate what these cells can do in that setting as well. Essentially respiratory distress coming from multi-drug resistant pathogens in addition to some other complications, as Dr. Hammond mentioned. Will that be the same in the U.S.? 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 U.S. Terese? Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:27:00Yeah, no, absolutely, and thank you for the question. I think that what struck me at the MHSRS meeting that we recently attended was just the fact that these very virulent multi-drug 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. 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. They're gram-negative Klebsiella, which is pan-resistant to all antibiotics, Acinetobacter, Pseudomonas. Those are the big three that are really affecting conflict zones in Ukraine and beyond, and also infiltrating tertiary hospitals in Europe. This is a really big problem. I treat patients in Central California. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:28:03We 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 Klebsiella, for example, a year in these patients that have been ill for a long time, usually on chronic ventilator therapy. I am not used to having young people come in from the community and acquiring these very virulent infections even before they have been in a heart burn, 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. Terese HammondHead of Inflammatory and Pulmonary Diseases at MiNK Therapeutics00:29:03I hope that we don't see them to the same extent that we're seeing in the Ukraine as we open up the U.S. 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 MamtaniAnalyst at B. Riley Securities00:29:31Thank you for all that color. Would you expect phase III population focus to be very comparable, this pan-resistant that you're talking about? I was also wondering, the acute endpoints used here, at some point would make placebo control unethical. Is there a randomization ratio you could look differently in phase III than phase II? Lastly, if you could comment on any process-wide data sharing practices with DoD, BARDA. I know you mentioned FDA, but was just curious how DoD is involved here. Jennifer BuellPresident and CEO at MiNK Therapeutics00:30:11Thanks, Mayank. I'll start here. The population we would expect to be comparable to our phase II population. The results from the phase II will also give us an opportunity to conduct a sample size re-estimation. We're looking at primary endpoints 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 at this point. It would be premature to speak about some of our government interactions. But I could share with you that we have a newly appointed board member, Dr. John Holcomb, who's a trauma surgeon and also essentially very actively involved in driving improvements in medical care specific to conflict zones, military personnel, and of course, the bridge to civilians. Jennifer BuellPresident and CEO at MiNK Therapeutics00:31:23His work has recently led to the approval of plasma as a product for resuscitation in patients. He's an incredible scientist and very thoughtful strategic leader and partner for us. The work that we're doing, as Terese mentioned, because of the increase in the number of conflict zones that we have internationally and 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 of major interest for all of us. Mayank MamtaniAnalyst at B. Riley Securities00:32:17Got it. If I may just ask about the Brazil paid program, maybe just the rationale for choosing that geography and if you could, to the extent possible, comment on pricing, how you're seeing demand both locally and I'm sure other regions are also interested in this. Any thoughts on that, Jen? Jennifer BuellPresident and CEO at MiNK Therapeutics00:32:41Thanks, Mayank. Absolutely. 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. 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 convey some of those efficiencies to patients that have broad requests are pretty broad for patients who are coming in. Jennifer BuellPresident and CEO at MiNK Therapeutics00:33:49Some patients are requesting this, patients with cancer as well as patients with other indications. As the program expands, we'll speak more to the detail of it. The regions will be expanding, and we'll announce those expansions as we get through the regulatory processes in different territories. Mayank MamtaniAnalyst at B. Riley Securities00:34:11Thank you so much. Looking forward to the call. Jennifer BuellPresident and CEO at MiNK Therapeutics00:34:13Of course. Thanks, Mayank. Operator00:34:18Again, if you would like to ask a question, press star then one. To withdraw, press star then one again. 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 BuellPresident and CEO at MiNK Therapeutics00:34:39Thank you, operator. Thank you all for participating. I appreciate your support. We look forward to keeping you in the loop with upcoming developments on the program. Thank you. Operator00:34:51This concludes today's call. A 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.Read moreParticipantsExecutivesStephanie PernicaroChief Communications OfficerJennifer BuellPresident and CEOMelissa OrilallPrincipal Financial OfficerTerese HammondHead of Inflammatory and Pulmonary DiseasesAnalystsEmily BodnarAnalyst at H.C. WainwrightMayank MamtaniAnalyst at B. Riley SecuritiesPowered by