Cuộc họp công bố kết quả kinh doanh Quý 2/2026 của MiNK Therapeutics (INKT): Thử nghiệm agenT-797 điều trị ARDS đạt tiến triển

MiNK Therapeutics (NASDAQ: INKT) đã tập trung bản cập nhật quý 2 năm 2026 vào quá trình phát triển Giai đoạn 2 ngẫu nhiên của agenT-797 trong điều trị tổn thương phổi cấp tính và hội chứng suy hô hấp cấp tính (ARDS), cùng với việc triển khai chương trình thâm nhập có trả phí dành cho bệnh nhân được chỉ định tại Brazil. Công ty kết thúc quý với 8,8 triệu USD tiền và các khoản tương đương tiền, trong khi lỗ ròng theo quý giảm so với cùng kỳ năm ngoái.

Những điểm chính cần lưu ý

• MiNK kết thúc quý 2 năm 2026 với 8,8 triệu USD tiền và các khoản tương đương tiền, so với 9,5 triệu USD vào ngày 31 tháng 3 năm 2026 và 3,4 triệu USD vào cuối năm 2025.
• Lỗ ròng theo quý giảm xuống còn 3,1 triệu USD, tương đương 0,62 USD mỗi cổ phiếu, so với 4,2 triệu USD, tương đương 1,06 USD mỗi cổ phiếu, trong quý 2 năm 2025.
• Công ty đã bắt đầu dùng liều trong C-1300-02, một nghiên cứu ngẫu nhiên Giai đoạn 2 về agenT-797 kết hợp với chăm sóc tiêu chuẩn so với giả dược kết hợp với chăm sóc tiêu chuẩn ở người trưởng thành bị tổn thương phổi cấp tính và suy hô hấp giảm oxy máu từ trung bình đến nặng đáp ứng định nghĩa ARDS toàn cầu.
• Hai bệnh nhân đầu tiên được xử lý trong giai đoạn chuẩn bị đều còn sống và không bị sốt vào ngày thứ 28. MiNK cũng báo cáo tình trạng oxy hóa cải thiện, giải quyết được ARDS, tự thở trở lại và không còn cần hỗ trợ thuốc co mạch, đồng thời nhấn mạnh rằng những quan sát này chỉ là sơ bộ, không mang tính so sánh và dựa trên một số lượng nhỏ bệnh nhân.
• MiNK dự kiến sẽ có dữ liệu sơ bộ từ phần ngẫu nhiên Giai đoạn 2 trong nửa đầu năm 2027. Ban quản lý cho biết các trung tâm tại Mỹ dự kiến sẽ bắt đầu tuyển bệnh nhân vào tháng 9 năm 2026.
• Chương trình thâm nhập có trả phí dành cho bệnh nhân được chỉ định đối với agenT-797 đang hoạt động tại Brazil. Bệnh nhân tham gia chương trình sau khi kết thúc quý, và ban quản lý có kế hoạch cung cấp thông tin tài chính liên quan trong bản cập nhật quý 3.

Dữ liệu tài chính chính

Ban quản lý cho biết công ty vẫn duy trì mô hình tinh gọn và không gia tăng hạ tầng cố định. MiNK cũng tiếp tục ưu tiên nguồn vốn không gây pha loãng cổ phiếu; thử nghiệm điều trị bệnh ghép chống chủ (GVHD) tại Đại học Wisconsin và chương trình PRAME ở trẻ em của công ty đều được tài trợ từ nguồn bên ngoài.

Hiệu quả kinh doanh và hoạt động

agenT-797 đạt tiến triển trong điều trị tổn thương phổi cấp tính và ARDS

Nghiên cứu C-1300-02 đã khởi động tại Liên minh Y tế Lãnh thổ Lviv Đầu tiên với sự hợp tác của UNBROKEN Ukraine. Nghiên cứu đang đánh giá agenT-797 kết hợp với chăm sóc tiêu chuẩn so với giả dược kết hợp với chăm sóc tiêu chuẩn ở người trưởng thành bị tổn thương phổi cấp tính và suy hô hấp giảm oxy máu từ trung bình đến nặng.

Nghiên cứu bao gồm một giai đoạn chuẩn bị dự kiến khoảng 10 bệnh nhân, tất cả đều nhận agenT-797 trước khi bước vào phần thử nghiệm ngẫu nhiên. MiNK đã trình bày kết quả từ hai bệnh nhân đầu tiên được điều trị. Cả hai đều bị viêm phổi kháng đa thuốc, và một người được xác định là người phụ nữ 41 tuổi bị tiểu đường kiểm soát kém và nhiễm trùng huyết do phế cầu khuẩn.

Vào ngày thứ 28, cả hai bệnh nhân đều còn sống và không bị sốt. Ban quản lý cũng báo cáo tình trạng oxy hóa cải thiện, giải quyết ARDS, tự thở trở lại, ngừng sử dụng thuốc co mạch và kiểm soát được tình trạng nhiễm trùng ban đầu. Kết quả xét nghiệm huyết thanh và dịch rửa phế quản phế nang cho thấy các dấu hiệu viêm thấp hơn cùng những thay đổi sinh học liên quan đến phục hồi miễn dịch, tái tạo biểu mô và phục hồi mạch máu phổi. Không có sự cố bất lợi nghiêm trọng đáng kể nào liên quan đến agenT-797 ở những bệnh nhân ban đầu này.

MiNK nhấn mạnh rằng những phát hiện này còn sớm, không ngẫu nhiên và không mang tính so sánh. Nghiên cứu ngẫu nhiên nhằm mục đích xác định xem agenT-797 có cải thiện kết quả điều trị so với chăm sóc tiêu chuẩn hay không.

Công ty mô tả agenT-797 là sản phẩm tế bào T sát thủ tự nhiên bất biến (iNKT) đồng ghép, dùng sẵn. Sản phẩm này không đòi hỏi sản xuất riêng cho từng bệnh nhân, không cần phù hợp HLA, không cần gạn tách tế bào máu hay suy giảm lympho, điều mà ban quản lý đánh giá là quan trọng để sử dụng kịp thời cho các bệnh nhân trong tình trạng nguy kịch.

Ra mắt chương trình thâm nhập có trả phí tại Brazil

MiNK đã thành lập chương trình thâm nhập có trả phí quốc tế đầu tiên dành cho bệnh nhân được chỉ định tại Brazil cùng với Orphan Drug Consultants. Chương trình cho phép các bác sĩ điều trị yêu cầu agenT-797 cho từng bệnh nhân được xác định cụ thể có nhu cầu điều trị nghiêm trọng chưa được đáp ứng, tùy thuộc vào sự phê duyệt của cơ quan quản lý theo từng trường hợp.

MiNK nhận thanh toán trên mỗi bệnh nhân đối với các sản phẩm được cung cấp, mặc dù ban quản lý nhấn mạnh rằng chương trình này không phải là một đợt ra mắt thương mại hay cấp phép lưu hành. Sáng kiến này cũng thiết lập hạ tầng cho các hồ sơ trình cơ quan quản lý địa phương, nhập khẩu, hậu cần và cảnh giác dược.

Ban quản lý cho biết Brazil được chọn vì các yêu cầu từ phía bác sĩ và tốc độ của quy trình quản lý tại địa phương. Chương trình đang hoạt động, với các bệnh nhân bắt đầu tham gia sau khi kết thúc quý 2. MiNK chưa công bố mức giá và cho biết họ dự định mở rộng sang các khu vực khác khi các quy trình quản lý hoàn tất.

Ung thư học và bằng chứng lâm sàng mở rộng

Trong bệnh ung thư dạ dày - thực quản kháng PD-1, MiNK đã dẫn chứng dữ liệu Giai đoạn 2 cho thấy tỷ lệ kiểm soát bệnh là 77% đối với agenT-797 kết hợp với botensilimab và balstilimab, với thời gian sống sót bền vững ở một nhóm bệnh nhân.

Công ty cũng nhấn mạnh các phát hiện nghiên cứu ứng dụng trước đó liên quan đến việc ức chế tác nhân gây bệnh, phục hồi miễn dịch phổi và các con đường sửa chữa mô sau khi điều trị bằng agenT-797 và chất siêu đối kháng IL-15 N-803 ở một bệnh nhân nhiễm nấm nghiêm trọng. Ngoài ra, các phân tích mô phổi người đã xác định sự sụt giảm iNKT là một đặc điểm cơ chế của xơ phổi tiến triển.

Định hướng từ Ban quản lý

MiNK dự kiến sẽ có kết quả sơ bộ từ phần ngẫu nhiên Giai đoạn 2 của C-1300-02 trong nửa đầu năm 2027, với dữ liệu bổ sung dự kiến có vào đầu năm 2027. Việc tuyển bệnh nhân đang tiếp tục diễn ra tại Ukraine, trong khi ban quản lý cho biết các trung tâm tại Mỹ dự kiến sẽ bắt đầu tuyển bệnh nhân vào tháng 9 năm 2026.

Khi tất cả các địa điểm được chọn đi vào hoạt động, ban quản lý dự kiến sẽ tuyển khoảng bốn đến tám bệnh nhân mỗi địa điểm mỗi tháng, với khả năng biến động theo mùa.

Công ty đang chuẩn bị cuộc họp với FDA về việc chuyển tiếp từ nghiên cứu ngẫu nhiên Giai đoạn 2 sang thử nghiệm xác nhận Giai đoạn 3 liền mạch. Cuộc họp chưa diễn ra vào thời điểm diễn ra cuộc gọi báo cáo, và lộ trình phát triển cuối cùng vẫn phụ thuộc vào thảo luận với cơ quan quản lý và kết quả Giai đoạn 2.

Tiêu chí đánh giá chính được đề xuất bao gồm tỷ lệ tử vong trong 28 ngày. Các thước đo thứ cấp bao gồm số ngày không cần dùng máy thở, kiểm soát tác nhân gây bệnh và tái tạo miễn dịch. Ban quản lý cho biết kết quả Giai đoạn 2 có thể hỗ trợ việc ước tính lại cỡ mẫu cho Giai đoạn 3.

Rủi ro và các điểm cần theo dõi

• Các quan sát ARDS agenT-797 được báo cáo chỉ bao gồm hai bệnh nhân đầu tiên được điều trị và không ngẫu nhiên cũng như không mang tính so sánh.
• Ban quản lý cảnh báo rằng không nên diễn giải các phát hiện lâm sàng và sinh học ban đầu vượt quá những gì bộ dữ liệu nhỏ ban đầu này thể hiện.
• agenT-797 vẫn đang trong giai đoạn thử nghiệm, và chương trình dành cho bệnh nhân được chỉ định không phải là một giấy phép lưu hành hay một sự thay thế cho việc tham gia thử nghiệm lâm sàng.
• Đặc điểm bệnh nhân có thể khác nhau giữa Ukraine và Mỹ. Bệnh nhân Ukraine bị nhiễm trùng kháng thuốc cao liên quan đến bối cảnh xung đột, trong khi ban quản lý dự kiến hồ sơ bệnh nhân ở Mỹ có thể sẽ khác.
• Việc chuyển tiếp liền mạch sang Giai đoạn 3 vẫn chưa được thống nhất với FDA và vẫn phụ thuộc vào các cuộc thảo luận quản lý trong tương lai.
• Chương trình thâm nhập có trả phí đã bắt đầu tuyển bệnh nhân, nhưng mức giá và đóng góp tài chính của chương trình vẫn chưa được công bố.

Điểm nổi bật trong phần Q&A với các chuyên gia phân tích

Các chuyên gia phân tích tập trung vào mức độ thuyết phục của bằng chứng ARDS ban đầu, việc tuyển bệnh nhân thử nghiệm, sự khác biệt giữa bệnh nhân Ukraine và Mỹ, thiết kế Giai đoạn 3 tiềm năng và chương trình thâm nhập tại Brazil.

Ban quản lý cho biết bệnh nhân mắc ARDS từ trung bình đến nặng và nhiễm trùng phức tạp có thể đối mặt với tỷ lệ tử vong tại ICU trong 28 ngày vào khoảng 30% đến 50%, nhưng nhắc lại rằng sự sống sót của hai bệnh nhân đầu tiên được điều trị bằng agenT-797 không thể khẳng định hiệu quả nếu không có bằng chứng so sánh ngẫu nhiên.

MiNK không cung cấp tổng số lượng bệnh nhân đã tuyển tính đến thời điểm hiện tại. Ban quản lý cho biết địa điểm tại Ukraine vẫn đang hoạt động và các địa điểm tại Mỹ dự kiến sẽ bắt đầu tuyển bệnh nhân vào tháng 9. Công ty cũng dự kiến quần thể bệnh nhân Giai đoạn 3 sẽ tương đương với quần thể Giai đoạn 2, với tỷ lệ tử vong trong 28 ngày là tiêu chí đánh giá then chốt.

Về thị trường Brazil, ban quản lý lý giải việc ra mắt chương trình là nhờ nhu cầu từ bác sĩ và phản hồi tích cực từ cơ quan quản lý. Công ty dự kiến sẽ thảo luận về các đóng góp tài chính ban đầu trong bản cập nhật quý 3 và có kế hoạch công bố thêm các lãnh thổ khác sau khi hoàn tất các quy trình quản lý liên quan.

Toàn văn biên bản cuộc gọi báo cáo kết quả kinh doanh

Toàn văn cuộc gọi công bố kết quả kinh doanh

Phần trình bày của ban lãnh đạo

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.

Phần hỏi đáp

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.