Conferencia de resultados del T2 de 2026 de MiNK Therapeutics (INKT): avanza el ensayo de agenT-797 para el SDRA

MiNK Therapeutics (NASDAQ: INKT) centró la actualización del segundo trimestre de 2026 en el desarrollo de la Fase 2 aleatorizada de agenT-797 para la lesión pulmonar aguda y el síndrome de dificultad respiratoria aguda (SDRA), junto con el lanzamiento de un programa de acceso pagado para pacientes identificados en Brasil. La empresa cerró el trimestre con 8,8 millones de dólares en efectivo y equivalentes de efectivo, mientras que su pérdida neta trimestral se redujo en comparación con el mismo periodo del año anterior.

Puntos clave

• MiNK cerró el T2 de 2026 con 8,8 millones de dólares en efectivo y equivalentes de efectivo, frente a los 9,5 millones de dólares al 31 de marzo de 2026 y los 3,4 millones de dólares al cierre de 2025.
• La pérdida neta trimestral se redujo a 3,1 millones de dólares, o 0,62 dólares por acción, frente a los 4,2 millones de dólares, o 1,06 dólares por acción, del T2 de 2025.
• La empresa inició la dosificación en el estudio C-1300-02, un ensayo aleatorizado de Fase 2 de agenT-797 más la atención estándar frente a placebo más la atención estándar en adultos con lesión pulmonar aguda e insuficiencia respiratoria hipoxémica de moderada a grave que cumplen con la definición global de SDRA.
• Los dos primeros pacientes tratados en la fase de rodaje estaban vivos y sin fiebre en el día 28. MiNK también informó de una mejora en la oxigenación, resolución del SDRA, retorno a la respiración espontánea y retiro del soporte vasopresor, al tiempo que enfatizó que estas observaciones eran preliminares, no comparativas y basadas en un número reducido de pacientes.
• MiNK espera datos preliminares de la parte aleatorizada de Fase 2 en la primera mitad de 2027. La dirección afirmó que se prevé que los centros de Estados Unidos comiencen la inclusión de pacientes en septiembre de 2026.
• En Brasil está activo un programa de acceso pagado para pacientes identificados para agenT-797. Los pacientes ingresaron al programa tras el cierre del trimestre y la directiva tiene previsto ofrecer la información financiera correspondiente en la actualización del T3.

Datos financieros clave

La dirección afirmó que la empresa ha mantenido una estructura ligera y no ha añadido infraestructura fija. MiNK también sigue priorizando la financiación no dilutiva; su ensayo de la enfermedad contra el injerto frente al huésped en la Universidad de Wisconsin y el programa pediátrico PRAME cuentan con financiación externa.

Rendimiento empresarial y operativo

agenT-797 avanza en lesión pulmonar aguda y SDRA

El estudio C-1300-02 se inició en First Lviv Territorial Medical Union en colaboración con UNBROKEN Ucrania. Evalúa agenT-797 más la atención estándar frente a placebo más la atención estándar en adultos con lesión pulmonar aguda e insuficiencia respiratoria hipoxémica de moderada a grave.

El estudio incluye una fase preliminar prevista de aproximadamente 10 pacientes que reciben agenT-797 antes de la parte aleatorizada. MiNK presentó los resultados de los dos primeros pacientes tratados. Ambos padecían neumonía multirresistente, y uno de ellos se identificó como una mujer de 41 años con diabetes mal controlada y sepsis neumocócica.

En el día 28, los dos pacientes estaban vivos y sin fiebre. La directiva también informó de una mejor oxigenación, resolución del SDRA, respiración espontánea, retirada del soporte vasopresor y control de la infección basal. Los hallazgos en suero y lavado broncoalveolar mostraron marcadores inflamatorios más bajos y cambios biológicos asociados con la recuperación inmunitaria, la reparación epitelial y la recuperación vascular pulmonar. No se atribuyeron acontecimientos adversos graves de importancia a agenT-797 en estos primeros pacientes.

MiNK subrayó que los resultados son preliminares, no aleatorizados y no comparativos. El estudio aleatorizado tiene como objetivo determinar si agenT-797 mejora los resultados frente a la atención estándar.

La empresa describe agenT-797 como un producto alogénico y listo para usar de células T asesinas naturales invariantes. No requiere fabricación específica para el paciente, compatibilidad HLA, aféresis ni linfodepleción, lo que la dirección considera crucial para un uso oportuno en pacientes en estado crítico.

Se lanza en Brasil el programa de acceso pagado

MiNK estableció su primer programa internacional de acceso pagado para pacientes identificados en Brasil con Orphan Drug Consultants. El programa permite a los médicos tratantes solicitar agenT-797 para pacientes identificados individualmente con necesidades médicas no cubiertas graves, sujeto a la autorización regulatoria caso por caso.

MiNK recibe el pago por paciente de los productos suministrados, aunque la dirección enfatizó que el programa no constituye un lanzamiento comercial ni una autorización de comercialización. La iniciativa también establece la infraestructura para las solicitudes regulatorias locales, importación, logística y farmacovigilancia.

La dirección afirmó que Brasil fue seleccionado debido a las consultas de los médicos y la rapidez del proceso regulatorio local. El programa está activo y la incorporación de pacientes comenzó tras el cierre del T2. MiNK no ha revelado los precios y señaló que prevé expandirse a otras regiones a medida que concluyan los trámites regulatorios.

Oncología y evidencia clínica más amplia

En el cáncer gastroesofágico refractario a PD-1, MiNK citó datos de Fase 2 que muestran una tasa de control de la enfermedad del 77% para agenT-797 combinado con botensilimab y balstilimab, con una supervivencia duradera en un subgrupo de pacientes.

La empresa también destacó hallazgos traduccionales previos relacionados con la supresión de patógenos, la restauración inmunitaria pulmonar y las vías de reparación tisular tras el tratamiento con agenT-797 y el superagonista de IL-15 N-803 en un paciente con infección fúngica grave. Por otra parte, los análisis de tejido pulmonar humano identificaron la depleción de células iNKT como una característica mecanicista de la fibrosis pulmonar avanzada.

Orientación de la dirección

MiNK prevé obtener lecturas preliminares de la parte aleatorizada de Fase 2 del estudio C-1300-02 en la primera mitad de 2027, y se esperan datos adicionales a principios de 2027. La selección de pacientes continúa en Ucrania, mientras que la dirección indicó que se prevé que los centros de Estados Unidos comiencen el reclutamiento en septiembre de 2026.

Una vez activados todos los centros seleccionados, la directiva prevé el reclutamiento de aproximadamente de cuatro a ocho pacientes por centro al mes, con posible variación estacional.

La empresa se está preparando para reunirse con la FDA con el fin de abordar la transición del estudio aleatorizado de Fase 2 a un ensayo confirmatorio continuo de Fase 3. La reunión aún no se había celebrado en el momento de la llamada, y la vía de desarrollo final sigue sujeta a la discusión regulatoria y a los resultados de la Fase 2.

El criterio de valoración principal propuesto incluye la mortalidad a los 28 días. Las medidas secundarias incluyen días libres de ventilador, control de patógenos y reconstitución inmunitaria. La dirección afirmó que los resultados de la Fase 2 podrían respaldar una reestimación del tamaño de la muestra de la Fase 3.

Riesgos y aspectos a tener en cuenta

• Las observaciones notificadas sobre agenT-797 en SDRA abarcan únicamente a los dos primeros pacientes tratados y no son aleatorizadas ni comparativas.
• La directiva advirtió que los hallazgos clínicos y biológicos iniciales no deben interpretarse más allá de lo que muestra el reducido conjunto de datos iniciales.
• agenT-797 sigue estando en fase de investigación, y el programa para pacientes identificados no es una autorización de comercialización ni un sustituto de la participación en ensayos clínicos.
• Las características de los pacientes pueden diferir entre Ucrania y Estados Unidos. Los pacientes ucranianos presentaban infecciones altamente resistentes asociadas al entorno del conflicto, mientras que la directiva prevé que el perfil del paciente en Estados Unidos sea diferente.
• Una transición continua a la Fase 3 no ha sido acordada con la FDA y sigue dependiendo de futuras conversaciones regulatorias.
• El programa de acceso pagado ha comenzado a inscribir pacientes, pero los precios y su contribución financiera aún no se han revelado.

Lo más destacado del turno de preguntas y respuestas de los analistas

Los analistas se centraron en la solidez de las pruebas iniciales en SDRA, el reclutamiento del ensayo, las diferencias entre los pacientes ucranianos y estadounidenses, el diseño potencial de la Fase 3 y el programa de acceso en Brasil.

La dirección indicó que los pacientes con SDRA de moderado a grave e infecciones complejas pueden afrontar una mortalidad en la UCI a los 28 días de aproximadamente el 30% al 50%, pero reiteró que la supervivencia en los dos primeros pacientes tratados con agenT-797 no puede establecer la eficacia sin pruebas comparativas aleatorizadas.

MiNK no ofreció una cifra total actual de reclutamiento. La dirección afirmó que el centro de Ucrania permanece activo y se prevé que los centros de Estados Unidos comiencen la inclusión de pacientes en septiembre. También prevé que la población de la Fase 3 sea comparable a la de la Fase 2, con la mortalidad a los 28 días como criterio de valoración clave.

Con respecto a Brasil, la directiva atribuyó el lanzamiento a la demanda médica y la agilidad regulatoria. La empresa espera abordar las contribuciones financieras iniciales en su actualización del T3 y planea anunciar nuevos territorios tras completar los procesos regulatorios correspondientes.

Transcripción completa de la llamada de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

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.

Preguntas y respuestas

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.