Mink Therapeutics Inc (INKT) 2025 Q1 法說會逐字稿

Thank you for standing by. My name is Rosell, and I will be your conference operator today. At this time, I would like to welcome everyone to the MiNK Therapeutics first quarter 2025 financial results. After the speaker remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press start, followed by the number one on your telephone keypad. If you would like to withdraw your question, press start one again. I will now turn the conference call to Jack Jennifer Ball, head of investor relations, please go ahead.

感謝您的支持。我叫羅塞爾，今天我將擔任您的會議主持人。現在，我歡迎大家閱讀 MiNK Therapeutics 2025 年第一季財務業績。演講者發言後，將進行問答環節。如果您想在此期間提問，只需按下開始鍵，然後按下電話鍵盤上的數字 1。如果您想撤回您的問題，請再次按下「開始」。我現在將電話會議轉給投資者關係主管傑克珍妮佛鮑爾 (Jack Jennifer Ball)，請繼續。

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 release 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, and Christine Klaskin, principal Financial and Accounting Officer. Now, I'd like to turn the call over to Doctor Bell to highlight our progress from this quarter.

謝謝接線員，也謝謝大家今天加入我們。今天的電話會議正在進行網路直播，您可以在我們的網站上重播。我想提醒您，本次電話會議將包括前瞻性陳述，包括與我們的臨床開發、監管和商業計劃、數據發佈時間表和合作機會相關的陳述。這些聲明受風險和不確定性的影響。請參閱我們網站上的 SEC 文件，以了解這些風險的詳細描述。今天與我一起出席的還有總裁兼執行長 Jennifer Buell 博士和財務會計長 Christine Klaskin。現在，我想將電話轉給貝爾博士，以強調我們本季的進展。

Thanks very much, Jack. I appreciate it and thank you all for joining us today. This quarter we've made meaningful progress towards our mission, and that's delivering scalable, durable, off the shelf iNKT cell therapies to patients with solid tumors and other immune-related diseases. In the Q1 of 2025 we executed across three critical areas, and those include clinical progress. We presented new data in solid tumors, specifically in second line gastric cancer, at the inaugural AACR IO conference, and we showed immune activation and very early clinical activity and responses in patients who were otherwise refractory to checkpoint modulating antibodies.

非常感謝，傑克。我對此表示感謝，並感謝大家今天的參與。本季度，我們在實現我們的使命方面取得了有意義的進展，那就是為實體瘤和其他免疫相關疾病患者提供可擴展、持久、現成的 iNKT 細胞療法。2025 年第一季度，我們在三個關鍵領域取得了進展，其中包括臨床進展。我們在首屆 AACR IO 會議上展示了實體瘤（特別是二線胃癌）的新數據，並且展示了對檢查點調節抗體有抵抗力的患者的免疫活化和非常早期的臨床活動和反應。

On the capital side, we continue to reduce our operating cash burn and operate extremely efficiently with a further reduction of about 47% year on year, preserving our ability to invest in our core programs. We've been able to continue to advance our clinical trials through external financing, and those include the advancement of our second line gastric cancer and also the development of two programs, one in ARDS and the other in GvHD, which I'll talk about in just a moment. We are advancing confidential discussions for proposals, each of which could extend our runway and accelerate our impact, and I'm going to go into those in some detail, just a moment.

在資本方面，我們繼續減少營運現金消耗，並極其高效地運營，年比進一步減少約 47%，保持了我們投資核心項目的能力。透過外部融資，我們能夠繼續推進臨床試驗，其中包括推進二線胃癌治療，以及開發兩個項目，一個是 ARDS 項目，另一個是 GvHD 項目，我稍後會談到。我們正在就提案進行秘密討論，每項提案都可以延長我們的跑道並加速我們的影響力，我將稍後詳細介紹這些提案。

Partnering, as is core to our strategy, and it has been. It's essential to unlocking the full potential of our technology, our iNKT platform in oncology, in immunology, inflammatory diseases, and of course our next generation engineered cell therapy. Our platform is really broad and deep. It allows us to take full advantage of what these cells can do, and we remain at the forefront of advancing iNKT cell biology off the shelf in patients with immune-related conditions.

合作是我們策略的核心，而且一直都是如此。這對於充分發揮我們的技術、iNKT 平台在腫瘤學、免疫學、發炎疾病以及下一代工程細胞療法方面的潛力至關重要。我們的平台確實廣泛而深入。它使我們能夠充分利用這些細胞的功能，並且我們仍然處於推動免疫相關疾病患者 iNKT 細胞生物學發展的前沿。

And today I'm pleased to share that we have 3 distinct proposals, each aligned with one of our key therapeutic areas in oncology and cancer. We're focusing on advancing 797 and solid tumor cancers, building on the momentum from our gastric and testicular cancer programs. I'll highlight a little bit more about some upcoming data in testicular cancer, but in the meantime, we did just recently present data at ACR that I'll share with you in a few moments.

今天我很高興地告訴大家，我們有三個不同的提案，每個提案都與我們在腫瘤學和癌症領域的一個關鍵治療領域一致。我們正致力於推動 797 和實體瘤癌症的治療，並藉助胃癌和睪丸癌計畫的進展。我將重點介紹一些有關睪丸癌的最新數據，但同時，我們最近確實在 ACR 上展示了一些數據，稍後我將與大家分享。

Proposal on immunology and inflammatory conditions. This supports our development of iNKT cells in acute inflammation such as respiratory distress, as well as inflammatory conditions such as graft versus host disease, an area of great interest to our team. And a proposal on our next generation pipeline. This encompasses our car iNKT therapy, our TCR iNKT therapy, and our proprietary neo antigen discovery platforms with the aim of creating highly targeted off the shelf immune therapies. These transactions and proposals are not exclusive, in fact, given their distinct focus areas and complementary capabilities of these proposed partners. These proposals may be mutually reinforced reinforcing, each bringing differentiated capital, infrastructure, and scientific expertise to accelerate progress within their respective domains.

關於免疫學和發炎狀況的提案。這支持了我們在急性發炎（例如呼吸窘迫）以及發炎狀態（例如移植物抗宿主疾病）中開發 iNKT 細胞，這是我們團隊非常感興趣的領域。以及有關我們下一代管道的提案。這包括我們的汽車 iNKT 療法、我們的 TCR iNKT 療法以及我們專有的新抗原發現平台，旨在創造高度針對性的現成免疫療法。事實上，這些交易和提議並不是排他性的，因為這些擬議合作夥伴的重點領域不同，而且能力互補。這些提案可以相互加強，各自帶來不同的資本、基礎設施和科學專業知識，以加速各自領域的進步。

Taken together, these proposals reflect strong external conviction in the value of our iNKT platform and represent a rare opportunity to diversify capital, reduce pollution, and accelerate development in multiple high impact areas for MiNK. We're engaging with focus and urgency and expect to advance one or more of these in the very near term. We'll continue to keep you abreast, and we plan to host a more formal presentation regrouping with our key stakeholders to be able to announce these in due course.

綜合起來，這些提議反映了外界對我們 iNKT 平台價值的強烈信念，也為 MiNK 提供了一個難得的機會，可以實現資本多元化、減少污染，並加速多個高影響領域的發展。我們正在集中精力、緊急行動，並期望在短期內推進其中一項或多項工作。我們將繼續向您通報最新情況，並計劃與我們的主要利益相關者重新召開一次更正式的演講，以便能夠在適當的時候宣布這些消息。

Now I'm going to turn and highlight a couple of key elements of our programs and our progress to date. In solid tumors, we're particularly encouraged by the continued momentum in our solid tumor program, and as I mentioned at the ASCO GI and AACR IO inaugural meetings, we presented new data from our phase 2 investigator sponsored trial that's being housed at Memorial Sloan Kettering under the leadership of Dr. Yelena Janjigian, the chief of gastrointestinal oncology.

現在我將重點介紹我們計劃的幾個關鍵要素以及迄今為止的進展。在實體瘤方面，我們對實體瘤計畫的持續發展勢頭感到特別鼓舞，正如我在 ASCO GI 和 AACR IO 成立大會上提到的那樣，我們展示了由研究者發起的第二階段試驗的新數據，該試驗在紀念斯隆凱特琳癌症中心進行，由胃腸腫瘤科主任 Yelena Janjigian 博士領導。

This study is evaluating HLA NKTs or agenT-797, in combination with two differentiated checkpoint modulating antibodies, botensilimab and balstilimab. On top of standard of care chemotherapy in patients with second line advanced gastric cancer. This is a population with no effective therapies in the second line setting. The data demonstrate that iNKT cells when delivered systemically, they rapidly traffic to the tumor microenvironment where they engage both innate and adaptive immune pathways. This is different than what you see with conventional T cells and NK cell technology.

這項研究正在評估 HLA NKT 或 agenT-797 與兩種分化檢查點調節抗體 botensilimab 和 balstilimab 的聯合作用。在二線晚期胃癌患者標準治療的基礎上進行化療。這群人在二線治療中尚無有效療法。數據表明，iNKT 細胞在系統性傳輸時會迅速轉移到腫瘤微環境，並在那裡參與先天性和適應性免疫途徑。這與傳統 T 細胞和 NK 細胞技術不同。

This activity, what we've observed is that we were looking at tumors that effectively were in immune desert. No CD8 T cells, therefore no ability to immunologically manage the cancer. And what we observed is upon systemic infusion of 797, we can transform a cold tumor into an immunologically active or hot tumor, promoting these very important CD8 T cells infiltration, activating dendritic cells and reversing immune exhaustion, and these are in cancers that are resistant to PD1 blockade. These findings support our core thesis. iNKT cells act as immunologic first responders, initiating multi-layered anti-tumor responses through direct tumor killing or cytotoxicity and immune orchestration. We anticipate sharing additional updated clinical updates later this year in the beginning of next year.

在這項活動中，我們觀察到的是，我們正在觀察實際上處於免疫沙漠中的腫瘤。沒有 CD8 T 細胞，因此沒有免疫控制癌症的能力。我們觀察到，在系統性輸注 797 後，我們可以將冷腫瘤轉變為免疫活性或熱腫瘤，促進這些非常重要的 CD8 T 細胞浸潤，活化樹突狀細胞並逆轉免疫衰竭，而這些都是對 PD1 阻斷有抗性的癌症。這些發現支持了我們的核心論點：iNKT 細胞作為免疫第一反應者，透過直接殺死腫瘤或細胞毒性和免疫協調啟動多層次的抗腫瘤反應。我們預計將於今年稍後和明年年初分享更多更新的臨床資訊。

In parallel, we expect a peer reviewed publication describing a complete response in a patient with metastatic testicular cancer. This patient was treated on our phase 1 trial with 797, and they were treated with 797, or alloy iNKTs alone in this setting. The patient had progressed through platinum-based chemotherapy, autologous stem cell transplantation, radiation, and checkpoint and idget-based regimens prior to enrolling in the trial. Following a single infusion of agenT-797, the patient achieved a durable, complete clinical, radiological and biochemical remission. Treatment was delivered without lymph depletion or HLA matching and showed no evidence of cytokine relief syndrome or GvHD.

同時，我們期待一篇同行評審的出版物，描述轉移性睪丸癌患者的完全緩解情況。該患者在我們的 1 期試驗中接受了 797 治療，並且在這種情況下單獨接受了 797 或合金 iNKT 治療。在參加試驗之前，患者已經接受了鉑類化療、自體幹細胞移植、放射治療以及檢查點和基於idget的方案治療。在一次輸注 agenT-797 後，患者獲得了持久、完全的臨床、放射學和生化緩解。治療無需淋巴耗竭或 HLA 匹配，並且沒有細胞激素緩解綜合徵或 GvHD 的跡象。

The post treatment analysis reveals elevated interferon gamma. We're observing some robust tumor activity by immune effector cells, and we're also observing peripheral persistence. Our cells still continue to persist beyond 6 months, which give us a large therapeutic window to continue to dose these patients. This case exemplifies the unique biology of iNKT cells, their ability to rapidly ho to tumors, dismantle immunosuppressive barriers, and activate both NK and CD8 T cells. Even in tumors previously unresponsive to immune therapy.

治療後分析顯示幹擾素γ升高。我們觀察到免疫效應細胞的一些強烈的腫瘤活動，我們也觀察到週邊持久性。我們的細胞仍能存活超過 6 個月，這為我們繼續為這些患者提供更大的治療窗口。此案例體現了 iNKT 細胞獨特的生物學特性、其快速到達腫瘤、消除免疫抑制屏障以及激活 NK 和 CD8 T 細胞的能力。即使是以前對免疫療法沒有反應的腫瘤。

Alongside our gastric cancer findings, this finding reinforces iNKT cells as a novel, off the shelf immune therapy platform with the potential to deliver durable benefit and hard to treat solid tumors. Beyond oncology, we're continuing to advance 797 in immune-related diseases such as respiratory distress, acute respiratory distress syndrome, and graft versus host disease. Our INKP platform showed early on and continues to show compelling promise in immune-mediated diseases where inflammation, immune dysregulation, and poor treatment options converge to create really devastating clinical realities for patients.

結合我們在胃癌方面的研究結果，這項發現進一步證實了 iNKT 細胞作為一種新型、現成的免疫治療平台，具有為難以治療的實體腫瘤帶來持久益處的潛力。除了腫瘤學之外，我們也持續進行 797 在免疫相關疾病的研究，例如呼吸窘迫、急性呼吸窘迫症候群和移植物抗宿主疾病。我們的 INKP 平台很早就顯示出並繼續在免疫介導疾病中顯示出令人信服的前景，在免疫介導疾病中，炎症、免疫失調和不良的治療選擇共同給患者帶來了真正毀滅性的臨床現實。

In ARDS, a life-threatening condition with no FDA approved therapies, AgenT-797 is shown the potential to change the treatment paradigm. As we published in Nature Communications and presented at the American Thoracic Society, our data demonstrated improved survival and meaningful inflammatory control and critically ill ventilated patients, many of whom would otherwise face mortality rates exceeding 70%. We, on the other hand, observed survival rates exceeding 70%, truly pathbreaking.

對於 ARDS 這種危及生命的疾病（目前尚無 FDA 批准的治療方法），AgenT-797 顯示出改變治療模式的潛力。正如我們在《自然通訊》上發表的文章和在美國胸腔科學會上所展示的那樣，我們的數據表明，危重呼吸機患者的生存率和發炎控制得到了改善，否則其中許多人的死亡率將超過 70%。另一方面，我們觀察到存活率超過 70%，這確實具有開創性。

Our signals observed in a high-risk ICU population is a powerful indication of iNKT's steroid resistant anti-inflammatory activity and their ability to reduce secondary infections and their impact on pulmonary function and immune tonology. Consistent with the new leadership and priorities at the FDA, we are working urgently to make our therapies accessible through well-designed clinical trials, compassionate use programs, and accelerated development pathways that reflect the seriousness and unmet nature of these conditions. The agency's increased receptivity to novel immune-based approaches, especially in indications like ARDS, give us further confidence in our regulatory path forward.

我們在高風險 ICU 族群中觀察到的訊號有力地表明了 iNKT 的類固醇抗發炎活性及其減少繼發性感染的能力以及它們對肺功能和免疫張力的影響。與 FDA 的新領導層和優先事項一致，我們正在緊急努力透過精心設計的臨床試驗、同情用藥計劃和加速開發途徑使我們的治療方法可及，這些都反映了這些疾病的嚴重性和未滿足的性質。該機構對新型免疫療法的接受度不斷提高，尤其是在 ARDS 等適應症方面，這使我們對未來的監管道路更有信心。

In graft versus host disease, we're prepared to initiate a phase 1 trial, a 797 of patients undergoing allergenic bone marrow transplant. We've spoken to you about this before, and as advancing this program has been in part contingent upon securing financing to be able to advance this really responsibly and efficiently. TBHC remains one of the most severe and unpredictable complications of transplants. Often leading to often leading to multi-organ damage, prolonged hospitalization, poor quality of life, and disease progression. Our iNKT approach, which requires no lymph depletion, no genetic matching, and poses minimal to no risk of GvHD itself, is uniquely suited for this setting. The trial will be supported primarily through external partnerships, allowing us to advance this high impact program with minimal capital outlay.

在移植物抗宿主疾病方面，我們準備啟動第一階段試驗，對 797 名患者進行過敏性骨髓移植。我們之前已經和你們談過這個問題，推進這個計畫在某種程度上取決於能否獲得融資，以便能夠真正負責任和有效地推進這個計畫。TBHC 仍然是移植中最嚴重且最難預測的併發症之一。通常會導致多重器官損傷、延長住院時間、生活品質不佳和病情進展。我們的 iNKT 方法不需要淋巴耗竭、不需要基因匹配，並且對 GvHD 本身的風險極小甚至沒有風險，因此特別適合這種情況。該試驗將主要透過外部合作夥伴獲得支持，使我們能夠以最少的資本支出推進這項高影響力的項目。

Further reinforcing the momentum, we were recently selected for probable funding by the National Institute of Allergy and Infectious Diseases. We expect the formal award. We were recently notified just a couple of weeks ago that we expect the formal award by June. This would provide critical, non-dilutive funding and a strong endorsement from one of the world's most respected federal research agencies and with this award, MIC will launch a collaboration of pre-clinical and clinical research with our colleagues and scientific advisors at the University of Wisconsin.

為了進一步增強這一勢頭，我們最近被國家過敏和傳染病研究所選中獲得資助。我們期待正式的裁決。就在幾週前，我們收到通知，預計六月頒發正式獎項。這將提供關鍵的、非稀釋性的資金和來自世界上最受尊敬的聯邦研究機構之一的強有力支持，憑藉該獎項，MIC 將與威斯康辛大學的同事和科學顧問進行臨床前和臨床研究的合作。

Together, ARDS and TVVHC represent a large underserved market where MP platform can deliver outsized impact. We remain committed to advancing these programs rapidly, guided by scientific conviction and a growing mandate to bring transformative immune-based therapies to patients in need. And on the operational efficiency side, we have been continuing to expand our work in the field by reducing and reducing operating burn. We have continued to retain our top scientific leaders. We continue to internalize operational execution of our programs, including data management and clinical research activities which has allowed us to operate far more efficiency in a far less capital-intensive way.

總而言之，ARDS 和 TVVHC 代表著一個巨大的服務不足的市場，其中 MP 平台可以產生巨大的影響。我們將繼續致力於快速推進這些項目，以科學信念和日益增長的使命為指導，為有需要的患者提供變革性的免疫療法。在營運效率方面，我們一直在透過減少營運消耗來繼續擴大我們在該領域的工作。我們繼續留住我們的頂尖科學領袖。我們繼續將我們的專案的營運執行內部化，包括資料管理和臨床研究活動，這使我們能夠以更少的資本密集型方式更有效率地運作。

These actions further reflect our commitment to financial discipline and operational focus. With that, I'll turn the call over to Christine for a review of the financials.

這些行動進一步體現了我們對財務紀律和營運重點的承諾。說完這些，我會把電話轉給克莉絲汀，讓她審查一下財務狀況。

Thank you, Jen. We ended the quarter with a cash balance of USD3.2 million cash used in operations for the three months ended March 31, 2025, was USD1.3 million. This is reduced from USD2.5 million for the same period in 2024. Our net loss for the first quarter of 2025 was USD2.8 million or USD0.70 per share. This compares to USD3.8 million or USD1.10 per share for the first quarter of 2024. Thank you. And operator, we are now ready to take questions.

謝謝你，Jen。本季末，我們的現金餘額為 320 萬美元，截至 2025 年 3 月 31 日的三個月的營運現金使用量為 130 萬美元。這一數字比 2024 年同期的 250 萬美元有所減少。我們 2025 年第一季的淨虧損為 280 萬美元，即每股 0.70 美元。相比之下，2024 年第一季的利潤為 380 萬美元，即每股 1.10 美元。謝謝。接線員，我們現在可以回答問題了。

At this time, I would like to remind everyone in order to ask a question, press star, then the number one in your telephone keypad. We will pause for just a moment to compile the roster. Your first question comes from the line of Emily Bodnar with HC Wainwright. Please go ahead.

此時，我想提醒大家，要想提問，請按電話鍵盤上的星號，然後按數字 1。我們將暫停片刻來編制名冊。您的第一個問題來自 HC Wainwright 的 Emily Bodnar。請繼續。

Hi, good morning. Thanks for taking my questions. This first one on the testicular patient. Congrats on the CR there. Are you able to say how long after treatment was initiated that the CR was observed and if you can comment on, I guess your overall plan in testicular cancer going forward and if there's any other indication that you're still looking at.

嗨，早安。感謝您回答我的問題。這是第一個關於睪丸患者的例子。恭喜你獲得 CR。您能否說說在開始治療後多久觀察到 CR，以及您是否可以評論一下，我猜您未來在睾丸癌治療方面的總體計劃，以及是否還有其他跡象表明您仍在關注。

Emily, thanks for the question, and this is this publication is expecting out somewhat imminently, and that information will be in the publication, but I can share with you this is a unique case and it exemplifies the value of immune therapy. It's not surprising that in the 12 month follow up period, the patient actually had disease stabilization, and we were monitoring the patient and not less than a year after that, so 24 months, the patients came back in to see the PI of the study with a complete remission and no other treatment. So this patient had been treated by the investigator, continued his clinical treatment with the investigator clinical observations, with no additional treatment put into the patient after the single infusion. And the complete response was formally designated at month 24 after the initial treatment of 797.

艾米麗，謝謝你的提問，這份出版物即將出版，這些資訊也會在出版物中，但我可以與你分享，這是一個獨特的案例，它體現了免疫療法的價值。毫不奇怪，在 12 個月的追蹤期內，患者的病情實際上已經穩定下來，並且我們一直在監測患者，此後不少於一年，即 24 個月，患者回來查看研究的 PI，病情完全緩解，無需其他治療。因此，該患者已接受研究者的治療，並在研究者的臨床觀察下繼續進行臨床治療，單次輸注後無需對患者進行其他治療。在接受 797 初始治療後的第 24 個月，正式指定為完全緩解。

And in addition, the patient had multiple lesions. The disease was really quite widespread, and you'll see this outlined in the paper and what was really quite intriguing was disease reduction really in all of the lesions, including the liver, and that's a very important biomarker for us. We are seeing activity by NKTs in active disease in the liver. We've observed this in our phase one study, we've also observed it in our gastric cancer trial, and now we've observed it with this testicular cancer case.

此外，患者身上有多處病變。這種疾病確實非常普遍，您會在論文中看到這一點，真正令人感興趣的是所有病變（包括肝臟）的疾病都有所減少，這對我們來說是一個非常重要的生物標記。我們發現 NKT 在肝臟活動性疾病中表現出活性。我們在第一階段的研究中觀察到了這一點，在胃癌試驗中也觀察到了這一點，現在我們又在睪丸癌病例中觀察到了這一點。

The patient has a lung mat that appears to be indolent at this point, that he does not want to undergo a biopsy, but the disease appears to the nodule appears to have nothing but dead tissue. Based on all of the scanning that has been completed. So we're really quite enthusiastic about this, and it has encouraged us to continue to do another survival sweep and clinical interrogation of other patients on the trial. What we found to be most intriguing when we presented the data, we presented essentially with a median of 12 months of follow up and we had some responses in the trial, but predominantly we saw long-term disease stabilization and this includes in patients with pancreatic cancer, non-small cell lung cancer.

患者的肺結節目前看起來已經不活躍，患者不想接受活檢，但疾病似乎使結節只剩下死組織。基於已完成的所有掃描。因此，我們對此非常熱衷，這鼓勵我們繼續對試驗中的其他患者進行生存調查和臨床詢問。當我們展示數據時，我們發現最有趣的是，我們基本上展示了中位數為 12 個月的隨訪，並且在試驗中得到了一些反應，但主要是我們看到了長期疾病穩定，這包括胰腺癌、非小細胞肺癌患者。

Testicular cancer appendiceal and gastric. But in those observations when we stopped the, we concluded the follow up period of the trial, we may be underestimating the ultimate clinical benefit of iNKT cells. So, we'll be getting a further clinical sweep of these patients and updating the field on the findings.

睪丸癌、闌尾癌和胃癌。但在我們停止試驗並結束後續觀察時，我們可能低估了 iNKT 細胞的最終臨床益處。因此，我們將對這些患者進行進一步的臨床檢查，並更新研究結果。

Okay, great. And on the phase two gastric trial, are you still kind of on track for initial efficacy data in the second half of this year?

好的，太好了。關於第二階段胃部試驗，您是否仍有望在今年下半年獲得初步療效數據？

That's what we're on target to do. They're continuing to enroll, and we'll be in touch with Dr. Janjigian about the soonest presentation. So we are, we have been looking at some GI specific conferences as well as some of the major oncology conferences for an update and a clinical presentation. It's ultimately within her discretion, so it will be no later than early next year. That would be the latest, but we're still on track. We're still targeting to get something out by the end of this year.

這就是我們的目標。他們正在繼續報名，我們將與 Janjigian 博士聯繫，盡快安排演示。因此，我們一直在關註一些胃腸道專門會議以及一些主要的腫瘤學會議，以獲取最新資訊和臨床介紹。這最終由她自行決定，因此最晚不會晚於明年年初。這將是最新的，但我們仍在按計劃進行。我們仍計劃在今年年底前推出一些成果。

Okay, great. Lastly, I'm just curious in terms of the funding that you mentioned from the NAYA if you've kind of heard of any changes or delays in government funding just with all this new news lately.

好的，太好了。最後，我只是對您提到的 NAYA 的資金感到好奇，您是否聽說過最近這些新消息導致政府資金有任何變化或延遲。

Well, I'm with you. We, so we had heard of a delay. We expected this at the beginning of the year. So, the 6-month delay is, the delays that we have seen globally have impacted us. However, we're, we were reassured to get a formal notification from NAYA that we can expect to hear that we had probable funding and can expect to hear conclusively in June. NAYA has not been as heavily impacted as some of the other agencies, and so this for us is a high priority for the government and for the agency graft versus host disease, and our technology presents a really novel way of addressing this problem with engraftment success and reduction in GvHD and better clinical outcomes. So, we're optimistic and the most recent correspondence from the government continues to boost our optimism.

好吧，我同意你的看法。我們，所以我們聽說了延遲的情況。我們年初就預料到了這一點。所以，6 個月的延遲，我們在全球範圍內看到的延遲已經對我們產生了影響。然而，我們很高興收到 NAYA 的正式通知，告知我們有可能獲得資金，並預計在 6 月得到最終答复。NAYA 受到的影響不像其他一些機構那麼嚴重，因此對我們來說，這是政府和機構移植物抗宿主疾病的首要任務，我們的技術提供了一種解決這一問題的真正新穎的方法，可以實現植入成功、減少 GvHD 並取得更好的臨床結果。因此，我們很樂觀，政府最近的信件繼續增強我們的樂觀情緒。

Okay great. Thanks for taking the questions. Thank you.

好的，太好了。感謝您回答這些問題。謝謝。

Again, if you would like to ask a question, press star one in your telephone cable. Your next question comes from the line of Max with William Blair. Please go ahead.

再次強調，如果您想提問，請按電話線上的星號 1。您的下一個問題來自威廉布萊爾的馬克斯。請繼續。

And, one, thanks for the update, wondering if, maybe just go over some of the details of the GVAC trial. Are you still planning on booking acute patients and maybe any thoughts on kind of prior treatments or what type of patients you'll be looking to enroll.

首先，感謝您的更新，我想知道是否可以簡單介紹 GVAC 試驗的一些細節。您是否仍計劃預約急性患者？您是否對先前的治療方法或您希望接收的患者類型有什麼想法？

Yeah. Thanks so much, Matt. So, there are two places where we will ultimately be setting into GvHD, and the first with this financing support and with the priority at University of Wisconsin to bring this forward, and this is under the leadership of Jenny Gumpers, who's a scientific advisor and wrote the seminal paper on the mechanism of iNKTs and GvHD. The opportunity for us in steroid refractory acute GvHD represents a very fast path forward. That's what we have identified and developed a phase one program for that. We have also developed a phase one program for prophylaxis, and that's engraftment success and a reduction in GvHD. And in that disease setting, we have a pathway that may be even faster. Both of these will be going to the regulators for a discussion with them imminently. And then we will choose the priority program to advance, but both opportunities for us, I'm going to have Tiago Favano, who's been working with the investigators in the clinical development of this speak just a little bit more to the enrichment that we're planning at this time.

是的。非常感謝，馬特。因此，我們最終將在兩個地方進行 GvHD 研究，第一個是在資金支持下，在威斯康辛大學的優先推動下，該計畫由 Jenny Gumpers 領導，她是一位科學顧問，撰寫了關於 iNKT 和 GvHD 機制的開創性論文。對我們來說，類固醇難治性急性移植物抗宿主疾病 (GvHD) 治療的機會代表著一條非常快速的前進道路。這就是我們為此確定並制定的第一階段計劃。我們也制定了第一階段的預防計劃，以確保植入成功並減少移植物抗宿主疾病 (GvHD)。在這種疾病環境下，我們有一個可能更快的途徑。這兩個問題都將很快提交給監管機構進行討論。然後，我們將選擇優先推進的項目，但對我們來說，這兩個機會都是相同的，我將請一直與該臨床開發研究人員合作的蒂亞戈·法瓦諾 (Tiago Favano) 稍微談談我們目前正在計劃的充實工作。

Hi, thanks for your question. So, for the phase one, we're going to explore not only the GvHD but also a few other complications of transplants that still represent an unmet need even though we do have available treatment. And drugs for prevention, but the other effects, they still represent unmet needs. So based on prior robot literature and some of our own studies, we expect the Ng not only to prevent or combat GvHD, but also to prevent infections, contribute to a better engraftment, faster and better engraftment. And and also prevent maintaining leukemia effects to prevent disease relapse. So we all know that on the treatment of GvHD patients get immunosuppressed and that makes it easier for them to have relapse or infections, which is a major complication.

你好，謝謝你的提問。因此，在第一階段，我們不僅要探索 GvHD，還要探索一些其他移植併發症，儘管我們有可用的治療方法，但這些併發症仍然是未滿足的需求。以及用於預防的藥物，但其他作用，它們仍然代表未滿足的需求。因此，基於先前的機器人文獻和我們自己的一些研究，我們預期 Ng 不僅能夠預防或對抗 GvHD，還能預防感染，有助於更好、更快、更好地植入。並且還能防止維持白血病的效果，防止病情復發。因此，我們都知道，在接受 GvHD 治療時，患者會產生免疫抑制，這使得他們更容易復發或感染，這是一個嚴重的併發症。

And we in this phase one, we are going to observe all these other effects on top of preventing the GvHD. Which paved the way for phase 2 that Jen explained, we will explore in treatment of steroid refractor GvHD and then another opportunity in prevention which represents an even faster way for approval.

在第一階段，我們將觀察除了預防移植物抗宿主疾病 (GvHD) 之外的所有其他影響。這為 Jen 解釋的第二階段鋪平了道路，我們將探索類固醇難治性移植物抗宿主疾病的治療，然後探索預防的另一個機會，這代表著更快的批准方式。

Thanks. And then, I'm going to add something to this. The, there are two things happening in parallel. One is the funding opportunity and if the award is as we anticipate it will be, which is the full committed funding, then we will have an opportunity to in our own hands, interrogate both prophylaxis, as well as mitigation in steroid refractory patients. And so that's why we've developed two programs to be able to do that. In the case that we can fund independently with the grant funding one program, there's a strategic collaborator who's at the table right now and has shared a proposal with us to advance the other, which is the prophylactic study.

謝謝。然後，我要添加一些內容。然後，有兩件事同時發生。一是資金機會，如果獎項如我們預期的那樣，即全額承諾的資金，那麼我們將有機會親自研究類固醇難治性患者的預防和緩解方法。這就是我們開發兩個程式來實現這一目標的原因。如果我們能夠透過撥款獨立資助一個項目，那麼現在就有一位策略合作夥伴與我們分享了一份提案，以推進另一個項目，即預防性研究。

Okay, thanks for your please, Jen.

好的，謝謝你，Jen。

Thank you, Matt.

謝謝你，馬特。

That ends the session. I will now turn the call back over to Jennifer Buell for closing remark. Please go ahead.

會議結束。現在我將把電話轉回給詹妮弗·布埃爾 (Jennifer Buell) 做結束演講。請繼續。

Thank you, operator. Thank you all for joining us today. We look forward to interacting with you in the upcoming days.

謝謝您，接線生。感謝大家今天的參與。我們期待在接下來的日子裡與您互動。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。