민크 테라퓨틱스(INKT) 2026년 2분기 실적 발표 콜: agenT-797 ARDS 임상시험 진전

MiNK 테라퓨틱스(NASDAQ: INKT)는 2026년 2분기 실적 발표에서 브라질 내 유상 지정환자 접근 프로그램 출범과 함께, 급성 폐 손상 및 급성 호흡곤란 증후군(ARDS) 환자를 대상으로 한 agenT-797의 임상 2상 무작위 배정 개발에 중점을 두었다고 밝혔다. 회사는 이번 분기를 880만 달러의 현금 및 현금성 자산으로 마감했으며, 분기 순손실은 전년 동기 대비 감소했다.

핵심 요약

• MiNK는 2026년 2분기 말 기준 880만 달러의 현금 및 현금성 자산을 보유하여, 2026년 3월 31일의 950만 달러 및 2025년 말의 340만 달러 대비 변동을 보였다.
• 분기 순손실은 2025년 2분기의 420만 달러(주당 1.06달러)에서 310만 달러(주당 0.62달러)로 줄어들었다.
• 회사는 글로벌 ARDS 정의를 충족하며 중등도에서 중증의 저산소혈증성 호흡부전을 동반한 급성 폐 손상 성인 환자를 대상으로, agenT-797 및 표준 치료 병용요법과 위약 및 표준 치료 병용요법을 비교하는 무작위 배정 임상 2상 연구인 C-1300-02에서 환자 투여를 시작했다.
• 초기 런인(run-in) 단계에서 투여를 받은 첫 환자 2명은 28일 차에 생존해 있었으며 발열도 없었다. 또한 MiNK는 산소화 개선, ARDS 호전, 자발 호흡 회복 및 승압제 이탈 등을 보고했으나, 이러한 관찰 결과가 소수의 환자를 대상으로 한 예비적이고 비비교적인 관찰이라는 점을 강조했다.
• MiNK는 무작위 배정 임상 2상 부분의 예비 데이터를 2027년 상반기에 확보할 것으로 예상하고 있다. 경영진은 미국 내 연구기관들이 2026년 9월에 환자 등록을 시작할 예정이라고 밝혔다.
• 브라질에서는 agenT-797에 대한 유상 지정환자 접근 프로그램이 운영 중이다. 분기 말 이후 환자들이 이 프로그램에 참여했으며, 경영진은 3분기 실적 발표 시 관련 재무 정보를 제공할 계획이다.

주요 재무 데이터

경영진은 회사가 슬림한 운영 체제를 유지해 왔으며 고정 인프라를 추가하지 않았다고 밝혔다. 또한 MiNK는 주주 가치 희석이 없는 자금 조달을 지속적으로 우선시하고 있으며, 위스콘신 대학교에서 진행 중인 이식편대숙주질환 임상시험과 소아 PRAME 프로그램은 외부 자금 지원을 받고 있다.

사업 및 운영 성과

급성 폐 손상 및 ARDS 대상 agenT-797 임상 진전

C-1300-02 연구는 '언브로큰 우크라이나(UNBROKEN Ukraine)'와의 협력을 통해 리비우 제1연합의료원(First Lviv Territorial Medical Union)에서 개시되었다. 해당 연구는 급성 폐 손상 및 중등도에서 중증의 저산소혈증성 호흡부전을 동반한 성인 환자를 대상으로 agenT-797과 표준 치료 병용요법을 위약과 표준 치료 병용요법 대비 평가하고 있다.

해당 연구에는 무작위 배정 단계에 앞서 약 10명의 환자 전원에게 agenT-797을 투여하는 런인 단계가 계획되어 있다. MiNK는 투여를 마친 첫 환자 2명의 결과를 발표했다. 두 환자 모두 다제내성 폐렴을 앓고 있었으며, 한 환자는 조절되지 않는 당뇨병과 폐렴구균 패혈증을 앓고 있는 41세 여성으로 확인됐다.

28일 차에 두 환자는 생존해 있었고 발열이 없었다. 경영진은 또한 산소화 개선, ARDS 호전, 자발 호흡, 승압제 이탈 및 기저 감염 조절이 관찰되었다고 보고했다. 혈청 및 기관지폐포 세척액 분석 결과 염증 마커의 감소와 함께 면역 회복, 상피 복구, 폐혈관 회복에 관련된 생물학적 변화가 확인되었다. 초기 환자들에게서 agenT-797로 인한 중대한 이상반응은 귀인되지 않았다.

MiNK는 이번 결과가 초기의 비무작위 및 비비교 데이터라는 점을 강조했다. 무작위 배정 연구의 목적은 agenT-797이 표준 치료 대비 예후를 개선하는지 여부를 확인하는 것이다.

회사는 agenT-797을 동종 기성품(off-the-shelf) 불변 자연살해 T세포(iNKT) 제품으로 설명한다. 환자 맞춤형 제조, HLA 적합성 검사, 성분채집술(apheresis) 또는 림프구 제거술이 필요하지 않아 중증 환자에게 적시에 투여하는 데 중요하다고 경영진은 보고 있다.

브라질에서 유상 접근 프로그램 출범

MiNK는 오판 드럭 컨설턴츠(Orphan Drug Consultants)와 협력하여 브라질에서 첫 해외 유상 지정환자 접근 프로그램을 구축했다. 이 프로그램은 건별 규제 승인을 거쳐 미충족 의료 수요가 높은 특정 개별 환자를 위해 담당 의사가 agenT-797을 요청할 수 있도록 해준다.

MiNK는 공급된 제품에 대해 환자당 비용을 지불받지만, 경영진은 이 프로그램이 상업적 출시나 품목 허가가 아니라는 점을 강조했다. 이 이니셔티브는 현지 규제 기관 신청, 수입, 물류 및 약물 감시를 위한 인프라도 구축한다.

경영진은 의사들의 문의 및 현지 규제 절차의 신속성 때문에 브라질을 선택했다고 밝혔다. 프로그램은 활성화되었으며, 2분기 종료 이후 환자들이 참여하기 시작했다. MiNK는 가격을 공개하지 않았으며, 규제 절차가 완료됨에 따라 다른 지역으로도 확대할 계획이라고 덧붙였다.

종양학 및 광범위한 임상 증거

PD-1 불응성 위식도암에서 MiNK는 agenT-797을 보텐실리맙(botensilimab) 및 발스틸리맙(balstilimab)과 병용했을 때 77%의 질병조절률(DCR)을 보였으며 일부 환자군에서 지속적인 생존 효과가 관찰된 임상 2상 데이터를 인용했다.

회사는 또한 중증 진균 감염 환자에게 agenT-797과 IL-15 슈퍼아고니스트 N-803을 투여한 후 병원체 억제, 폐 면역 회복 및 조직 복구 경로가 작동했음을 보여준 이전의 중개연구 결과를 강조했다. 이와 별도로 인간 폐 조직 분석을 통해 iNKT 고갈이 진행성 폐섬유증의 기전적 특징임을 확인했다.

경영진 가이던스

MiNK는 C-1300-02 무작위 배정 임상 2상 부분의 예비 결과가 2027년 상반기에 나올 것으로 예상하고 있으며, 2027년 초에 추가 데이터가 나올 예정이다. 우크라이나에서는 환자 등록이 계속되고 있으며, 경영진은 미국 연구기관들이 2026년 9월에 환자 등록을 시작할 것으로 예상된다고 말했다.

선정된 모든 연구기관이 활성화되면 경영진은 계절적 변동 가능성을 감안하더라도 기관당 월 4~8명 정도의 환자가 등록될 것으로 예상하고 있다.

회사는 무작위 배정 임상 2상 연구에서 심리스(seamless) 확증 임상 3상 시험으로 전환하는 것에 대해 미국 식품의약국(FDA)과의 미팅을 준비 중이다. 실적 발표 컨퍼런스 콜 당시에는 미팅이 진행되지 않은 상태였으며, 최종 개발 경로는 규제당국과의 논의 및 임상 2상 결과에 따라 결정될 예정이다.

제안된 1차 평가변수에는 28일 사망률이 포함된다. 2차 평가변수에는 인공호흡기 이탈 일수(ventilator-free days), 병원체 조절 및 면역 재구성이 포함된다. 경영진은 임상 2상 결과가 임상 3상 표본 크기 재산정에 근거가 될 수 있다고 밝혔다.

리스크 및 관전 포인트

• 보고된 agenT-797 ARDS 관찰 결과는 투여를 마친 첫 2명의 환자만을 대상으로 하며, 비무작위 및 비비교 연구 결과이다.
• 경영진은 소규모 초기 데이터셋이 나타내는 범위를 넘어 초기 임상 및 생물학적 결과를 확대 해석해서는 안 된다고 당부했다.
• agenT-797은 여전히 연구용 약물 상태이며, 지정환자 프로그램은 품목 허가가 아니며 임상시험 참여를 대체할 수도 없다.
• 환자 특성은 우크라이나와 미국 간에 다를 수 있다. 우크라이나 환자들은 분쟁 상황과 관련된 강력한 내성 감염을 가지고 있었던 반면, 경영진은 미국 환자 프로필은 다를 수 있을 것으로 예상하고 있다.
• 임상 3상으로의 심리스 전환은 FDA와 합의되지 않았으며, 향후 규제당국과의 논의 결과에 따라 달라질 수 있다.
• 유상 접근 프로그램은 환자 등록을 시작했으나, 가격 및 재무적 기여도는 아직 공개되지 않았다.

애널리스트 Q&A 주요 내용

애널리스트들은 초기 ARDS 증거의 신뢰성, 임상시험 환자 모집, 우크라이나 및 미국 환자 간 차이점, 향후 임상 3상 설계, 브라질 접근 프로그램에 주목했다.

경영진은 중등도에서 중증의 ARDS 및 복합 감염 환자의 28일 중환자실(ICU) 사망률이 약 30%~50%에 달할 수 있지만, 무작위 비교 데이터 없이는 agenT-797을 투여받은 첫 2명 환자의 생존만으로 유효성을 입증할 수는 없다고 재차 강조했다.

MiNK는 현재 환자 모집 총수를 제공하지 않았다. 경영진은 우크라이나 연구기관이 여전히 운영 중이며 미국 연구기관은 9월에 환자 모집을 시작할 예정이라고 밝혔다. 또한 임상 3상 대상 환자군이 28일 사망률을 주요 평가변수로 하여 임상 2상 환자군과 유사할 것으로 예상하고 있다.

브라질에 대해 경영진은 의사들의 수요와 규제당국의 신속한 대응 덕분에 프로그램이 시작되었다고 설명했다. 회사는 3분기 실적 발표 시 초기 재무 기여도를 논의할 예정이며, 관련 규제 절차가 완료되는 대로 추가 지역을 발표할 계획이다.

실적 발표 컨퍼런스 콜 전문

전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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 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.