MiNK Therapeutics（INKT）2026年第2四半期決算説明会：agenT-797のARDS治験が進展

MiNK Therapeutics（NASDAQ: INKT）は、2026年第2四半期の業績アップデートにおいて、急性肺障害および急性呼吸窮迫症候群（ARDS）を対象としたagenT-797のランダム化第2相治験の開発状況と、ブラジルにおける有償の患者指名アクセスプログラムの開始に焦点を当てました。同四半期末時点の現金および現金同等物は880万ドルとなり、四半期純損失は前年同期比で縮小しました。

要点

• MiNKの2026年第2四半期末時点の現金および現金同等物は880万ドル（2026年3月31日時点は950万ドル、2025年末時点は340万ドル）となりました。
• 四半期純損失は、2025年第2四半期の420万ドル（1株当たり1.06ドル）から310万ドル（1株当たり0.62ドル）に縮小しました。
• 同社は、C-1300-02での投与を開始しました。同試験は、グローバルなARDSの定義を満たす急性肺障害および中等症から重症の低酸素血症性呼吸不全の成人患者を対象とし、標準治療＋agenT-797と標準治療＋プラセボを比較評価するランダム化第2相試験です。
• ランイン（導入）期に治療を受けた最初の2名の患者は、28日時点で生存しており、発熱も見られませんでした。MiNKはまた、酸素化の改善、ARDSの消失、自発呼吸への復帰、および昇圧薬サポートからの離脱を報告しましたが、これらの観察結果は予備的かつ非対照的なものであり、少数の患者に基づいていることを強調しました。
• MiNKは、ランダム化第2相部分からの予備データ発表を2027年前半と見込んでいます。経営陣によると、米国の治験施設では2026年9月に症例登録が開始される見通しです。
• ブラジルでは、agenT-797の有償患者指名アクセスプログラムが実施されています。患者は第2四半期末以降に同プログラムに参加しており、経営陣は第3四半期の業績アップデートで関連する財務情報を開示する予定です。

主要財務データ

経営陣は、同社が効率的な事業規模を維持しており、固定インフラを追加していないと述べました。また、MiNKは株式希薄化を伴わない資金調達を引き続き優先しており、ウィスコンシン大学での移植片対宿主病（GVHD）治験および小児PRAMEプログラムは外部から資金提供を受けています。

事業および業績ハイライト

agenT-797、急性肺障害およびARDSで進展

試験C-1300-02は、UNBROKEN Ukraineとの提携のもと、リヴィウ第1地域医療連合（First Lviv Territorial Medical Union）で開始されました。本試験では、急性肺障害および中等症から重症の低酸素血症性呼吸不全の成人患者を対象に、標準治療＋agenT-797の有効性を標準治療＋プラセボと比較評価しています。

本試験には、ランダム化部分の前に約10名の患者全員にagenT-797を投与するランイン期が計画されています。MiNKは、治療を受けた最初の2名の患者の知見を発表しました。2名とも多剤耐性肺炎を患っており、うち1名はコントロール不良の糖尿病と肺炎球菌性敗血症を併発した41歳の女性でした。

投与28日時点で、2名の患者は生存しており発熱も認められませんでした。経営陣はさらに、酸素化の改善、ARDSの消失、自発呼吸の再開、昇圧薬サポートからの離脱、および初回感染のコントロールを報告しました。血清および気管支肺胞洗浄液の検査結果からは、炎症マーカーの低下とともに、免疫回復、上皮修復、肺血管回復に関連する生物学的変化が示されました。これら初期の患者において、agenT-797に起因する主な重篤な副反応は認められませんでした。

MiNKは、これらの結果が初期段階のものであり、非ランダム化かつ非対照的なものであると強調しました。ランダム化試験は、agenT-797が標準治療と比較して予後を改善するかどうかを検証することを目的としています。

同社はagenT-797を、他家（同種）既製品のインバリアント・ナチュラルキラーT（iNKT）細胞製品と説明しています。患者ごとの個別製造、HLA適合試験、アフェレーシス（成分採血）、リンパ球除去を必要としないため、経営陣は重症患者への迅速な使用において重要であると捉えています。

ブラジルで有償アクセスプログラムを開始

MiNKは、Orphan Drug Consultantsとともに、ブラジルで初となる国際的な有償患者指名アクセスプログラムを確立しました。このプログラムにより、個別の規制承認を条件として、主治医が深刻な未充足の医療ニーズを持つ特定の個別患者に対してagenT-797を要請できるようになります。

MiNKは供給された製品に対して患者ごとに支払いを受け取りますが、経営陣はこのプログラムが商業的発売や製造販売承認を意味するものではないと強調しました。また、この取り組みにより、現地の規制申請、輸入、物流、および安全性監視（ファーマコビジランス）のためのインフラが整備されます。

経営陣は、医師からの問い合わせや現地規制プロセスの迅速さを理由にブラジルが選定されたと述べました。プログラムは稼働中であり、第2四半期末以降に患者が参加しています。MiNKは価格を開示しておらず、規制手続きが完了次第、他の地域にも拡大する計画だと説明しています。

がん領域および広範な臨床エビデンス

PD-1抵抗性の食道胃がんにおいて、MiNKはagenT-797とボテンシリマブおよびバルスチリマブの併用療法が77%の病勢コントロール率を示し、一部の患者群で持続的な生存効果が得られた第2相データを引用しました。

同社はまた、重篤な真菌感染症患者に対してagenT-797とIL-15スーパーアゴニストN-803による治療を行った後の病原体抑制、肺の免疫回復、組織修復経路に関する以前のトランスレーショナル研究の知見を強調しました。これとは別に、ヒト肺組織の解析により、iNKT細胞の枯渇が進行性肺線維症のメカニズム上の特徴であることが特定されました。

経営陣の見通し（ガイダンス）

MiNKは、C-1300-02試験のランダム化第2相部分からの予備データ発表を2027年前半に見込んでおり、追加データは2027年初頭に予想されています。ウクライナでの症例登録は継続中であり、経営陣は米国の治験施設で2026年9月に登録が開始される見通しであると述べました。

選定されたすべての施設が稼働すると、経営陣は1施設当たり月間約4〜8名の患者の登録を見込んでいますが、季節的な変動が生じる可能性もあります。

同社は、ランダム化第2相試験からシームレスな検証的第3相試験への移行についてFDAと協議する準備を進めています。決算電話会議の時点ではこの協議は行われておらず、最終的な開発パスは規制当局との協議および第2相試験の結果に依存します。

提案されている主要評価項目には28日死亡率が含まれています。副次評価項目には、人工呼吸器離脱日数、病原体抑制、および免疫再構築が含まれます。経営陣は、第2相試験の結果が第3相試験のサンプルサイズ再計算を裏付ける可能性があると述べました。

リスクおよび注視すべきポイント

• 報告されたagenT-797のARDSに関する観察結果は、最初の投与患者2名のみを対象としたものであり、非ランダム化かつ非対照的なものです。
• 経営陣は、初期の臨床的および生物学的知見について、小規模な初期データセットが示す範囲を超えて解釈すべきではないと注意を促しました。
• agenT-797は開発中の治験薬段階にとどまっており、患者指名プログラムは製造販売承認や臨床試験参加の代替となるものではありません。
• 患者の背景特性はウクライナと米国で異なる可能性があります。ウクライナの患者は紛争背景に関連した高度耐性菌感染症を有していましたが、経営陣は米国の患者プロファイルが異なる可能性があると考えています。
• 第3相へのシームレスな移行についてはFDAと合意に達しておらず、今後の規制当局との協議に依存します。
• 有償アクセスプログラムへの患者の参加は開始されていますが、価格および財務面への貢献度はまだ開示されていません。

アナリスト質疑応答の要点

アナリストは、初期のARDSに関するエビデンスの強さ、治験の患者登録状況、ウクライナと米国の患者の差異、想定される第3相試験のデザイン、およびブラジルでのアクセスプログラムに注目しました。

経営陣は、中等症から重症のARDSと複雑な感染症を併発した患者の28日ICU死亡率は約30%〜50%に達する可能性があると述べた一方で、agenT-797の投与を受けた最初の2名の患者の生存実績は、ランダム化比較によるエビデンスなしに有効性を証明するものではないと改めて強調しました。

MiNKは現時点での登録人数の合計を開示しませんでした。経営陣は、ウクライナの治験施設は稼働を続けており、米国の施設では9月に登録が開始される予定であると説明しました。また、第3相試験の対象患者群は第2相試験と同等になり、28日死亡率が主要な評価項目になると見込んでいます。

ブラジルでの展開について、経営陣は医師からの需要と現地規制当局の迅速な対応が要因であると説明しました。同社は第3四半期の業績アップデートで初期の財務的寄与について言及する予定であり、関連する規制手続きが完了した後にさらなる対象地域を発表する計画です。

業績説明会トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

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.

質疑応答

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.