Mink Therapeutics Inc (INKT) 2024 Q2 法說會逐字稿

Good morning and welcome to MiNK Therapeutics second quarter 2024 conference call and webcast.

早安，歡迎來到 MiNK Therapeutics 2024 年第二季電話會議和網路廣播。

(Operator Instructions) Please note this event is being recorded.

（操作員說明）請注意此事件正在被記錄。

If anyone has any objection, you may now disconnect at this time.

如果有人有任何異議，您現在可以斷開連接。

I would now like to turn the conference (technical difficulty) Zack Armen, Investor Relations.

我現在想把會議（技術難度）轉向扎克·阿門（Zack Armen），投資者關係。

Thank you all for joining us today.

感謝大家今天加入我們。

Today's call is being webcast and will be available on our website for replay.

今天的電話會議正在進行網路直播，並將在我們的網站上重播。

I'd like to remind (technical difficulty) including statements regarding our clinical development, regulatory and commercial plans and timelines, as well as timelines for data release and partnership opportunities, among other updates.

我想提醒一下（技術困難），包括有關我們的臨床開發、監管和商業計劃和時間表的聲明，以及數據發布和合作機會的時間表以及其他更新。

These statements are subject to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks.

這些聲明存在風險和不確定性，我們建議您參閱我們網站上提供的 SEC 文件，以了解有關這些風險的更多詳細資訊。

Joining me today are Dr. Jen Buell, President and Chief Executive Officer; Dr. Marc Van Dijk, Chief Scientific Officer; Dr. Joy Zhou, Head of CMC; and Christine Klaskin, Principal Financial and Accounting Officer.

今天與我一起出席的有總裁兼執行長 Jen Buell 博士； Marc Van Dijk 博士，首席科學官； Joy Zhou博士，CMC主任；首席財務和會計官 Christine Klaskin。

Now I'd like to turn the call over to Dr. Buell to highlight our progress on this quarter.

現在我想將電話轉給布爾博士，以強調我們在本季的進展。

Thank you, Zach.

謝謝你，扎克。

Good morning, and thanks for joining us today.

早安，感謝您今天加入我們。

I'm excited to share the strides we've made in the first half of 2024 as we continue to align our achievements with our long-term strategic goals.

我很高興與大家分享我們在 2024 年上半年的進步，因為我們將繼續將我們的成就與我們的長期策略目標保持一致。

And for those of you who are new to the story at MiNK, our mission is focused on delivering the immune potent potential of invariant natural killer T-cells to tackle diseases of the immune system and cancer.

對於那些剛接觸 MiNK 故事的人來說，我們的使命是提供恆定自然殺手 T 細胞的免疫潛力，以應對免疫系統疾病和癌症。

Today I'll be highlighting our latest clinical developments, particularly in our lead programs, AgenT-797.

今天，我將重點介紹我們最新的臨床進展，特別是我們的主導計畫 AgenT-797。

These are native, unmodified iNKT cells, and MiNK-215, our armored FAP CAR-iNKT.

這些是天然的、未經修飾的 iNKT 細胞，以及 MiNK-215，我們的裝甲 FAP CAR-iNKT。

Additionally, I'll discuss how we've fortified our financial foundation, setting the stage for sustained innovation and growth.

此外，我還將討論我們如何鞏固財務基礎，為持續創新和成長奠定基礎。

We've made substantial progress in streamlining our operations to optimize our financials in this market.

我們在簡化營運以優化該市場的財務狀況方面取得了實質進展。

In this quarter, we continue to generate critical data from our ongoing clinical programs.

在本季度，我們繼續從正在進行的臨床項目中產生關鍵數據。

We continue to advance our R&D efforts and ensure efficient in-house manufacturing all the while appreciating further reductions to our operating burn.

我們持續推動研發工作，確保高效率的內部製造，同時進一步減少營運消耗。

Now reduced more than 50% from this time last year, mainly from the internalization of key activities.

現在比去年這個時候減少了50%以上，主要來自關鍵活動的內部化。

These reductions have been a result of the internalization of our efforts and continued external financial support to advance our exciting programs.

這些減少是我們內部努力和持續外部財政支持的結果，以推進我們令人興奮的計劃。

I'll walk you through these developments and illustrate how we're taking the way remains success.

我將向您介紹這些進展，並說明我們如何繼續取得成功。

We'll begin with our operational and financial progress.

我們將從我們的營運和財務進展開始。

Our lead program, 797, is an allogeneic unmodified iNKT cell therapy currently advancing in a Phase 2 trial for second-line gastric cancer and acute respiratory disease syndrome, or ARDS.

我們的主導計畫 797 是一種同種異體的未經修飾的 iNKT 細胞療法，目前正在進行二線胃癌和急性呼吸系統疾病症候群 (ARDS) 的 2 期試驗。

On gastric cancer, second-line gastric cancer is a challenging condition with a poor prognosis and a high mortality rate.

在胃癌方面，二線胃癌是一種具有挑戰性的疾病，預後差，死亡率高。

Patients undergoing second-line therapy for advanced gastric or gastroesophageal junction cancer typically have a median overall survival of only 4 to 10 months, depending on factors, such as performance status and treatment regimen.

接受二線治療的晚期胃癌或胃食道交界癌患者的中位總存活期通常僅為 4 至 10 個月，取決於體能狀態和治療方案等因素。

In parallel, 797 is also being evaluated for ARDS.

同時，797 也正在接受 ARDS 評估。

This is a rapidly progressive and life-threatening condition with a mortality rate of approximately 40%.

這是一種進展迅速、危及生命的疾病，死亡率約 40%。

Our commitment to addressing these critical unmet medical needs underscores the potential of 797 to provide meaningful therapeutic benefit in both oncology and respiratory care.

我們致力於解決這些未滿足的關鍵醫療需求，這突顯了 797 在腫瘤學和呼吸護理領域提供有意義的治療益處的潛力。

Let me begin with our program in ARDS.

讓我從 ARDS 中的程式開始。

This is a rapidly progressive form of respiratory failure with alarmingly high mortality rates.

這是一種快速進展的呼吸衰竭，死亡率高得驚人。

The prevalence of ARDS has been growing, particularly in younger populations, and this is likely exacerbated by the aftermath of the COVID-19 pandemic.

ARDS 的盛行率一直在上升，特別是在年輕人中，這種情況可能因 COVID-19 大流行的後果而加劇。

This condition represents a significant burden on healthcare systems globally given its high incidence and severe outcomes.

鑑於其高發病率和嚴重後果，這種情況給全球醫療保健系統帶來了沉重負擔。

The urgency to address ARDS has been underscored by the most recent announcement from the Biomedical Advanced Research and Development Authority, or BARDA, which has committed almost $120 million to a randomized Phase 2 program focused on critical outcomes such as survival and ventilator-free days.

生物醫學高級研究與發展管理局(BARDA) 最近的聲明強調了解決ARDS 的緊迫性，該機構已承諾投入近1.2 億美元用於一項隨機的第二階段計劃，重點關註生存和無​​呼吸機天數等關鍵結果。

This substantial investment highlights the critical need for innovative and effective treatment in this challenging disease setting.

這項巨額投資凸顯了在這種具有挑戰性的疾病環境中對創新和有效治療的迫切需求。

The BARDA program is expected to evaluate three therapeutic options, two of which are monoclonal antibodies and have already been disclosed with the third agent not yet announced.

BARDA 計劃預計將評估三種治療方案，其中兩種是單株抗體，並且已經公開，第三種藥物尚未發表。

Our published data from the Phase 1/2 trial of 797 demonstrates a 75% survival rate and significant improvement in ventilator-free days for patients with ARDS, suggesting that iNKT cells could play a typical role in ARDS management.

我們發表的 797 期 1/2 期試驗數據表明，ARDS 患者的生存率為 75%，且無呼吸機天數顯著改善，表明 iNKT 細胞可以在 ARDS 管理中發揮典型作用。

These promising results indicate that 797 can be seamlessly incorporated into standard treatment protocols and provide potential for substantial clinical benefit.

這些有希望的結果表明 797 可以無縫納入標準治療方案，並提供潛在的實質臨床益處。

At the recent American Thoracic Society or ATS Annual Meeting, we presented additional compelling data.

在最近舉行的美國胸腔科學會或 ATS 年會上，我們提供了更多令人信服的數據。

This is from our expanded access program, building on our findings from our Phase 1 and 2 clinical trials, showing the clinical efficacy of 797 in a critically ill immunocompromised transplant patients with severe COVID-19-induced respiratory distress.

這是我們的擴大准入計劃的一部分，該計劃以我們的1 期和2 期臨床試驗的結果為基礎，顯示了797 對患有嚴重COVID-19 引起的呼吸窘迫的免疫功能低下移植患者的臨床療效。

Following a single administration of 797, similar to the dosing in our clinical trial, this patient experienced a rapid reduction in inflammatory cytokines, leading to successful excavation and rapid discharge from the hospital.

在單次服用 797 後，與我們臨床試驗中的劑量相似，該患者的發炎細胞因子迅速減少，導致成功挖掘並迅速出院。

With nearly 600,000 individuals in the United States alone affected by acute respiratory distress, about 30% to 40% of those patients with severe key respiratory conditions, annually the burden on our healthcare system is unmet.

光是在美國就有近 60 萬人受到急性呼吸窘迫的影響，其中約 30% 至 40% 的患者患有嚴重的關鍵呼吸系統疾病，每年我們的醫療保健系統的負擔都無法得到滿足。

The promising results of 797 growth potential is an important therapy to contribute to eliminating or mitigating ARDS, and this has broader regulatory in healthcare implications.

797 生長潛力的令人鼓舞的結果是一種有助於消除或減輕 ARDS 的重要療法，這對醫療保健具有更廣泛的監管影響。

MiNK Therapeutics is among the select group of a few companies advancing therapies in this challenging disease setting, and our early data suggests that 797 could be one of the most promising candidates in the field.

MiNK Therapeutics 是少數在這一具有挑戰性的疾病環境中推進治療的公司之一，我們的早期數據表明 797 可能是該領域最有前途的候選藥物之一。

Now I'm going to be transitioning to another disease setting that we feel is a significant priority for us and for patients and building on the promising findings and immune optimization with our therapy.

現在，我將轉向另一種疾病治療，我們認為這對我們和患者來說都是一個重要的優先事項，並以我們的治療的有希望的發現和免疫優化為基礎。

We're excited to announce the upcoming launch of a Phase 1 trial in steroid-refractory acute graft versus host disease and improved outcomes in allogeneic hematopoietic stem cell transplantation.

我們很高興地宣布即將啟動類固醇難治性急性移植物抗宿主疾病的第一期試驗，並改善同種異體造血幹細胞移植的結果。

Our investigator-sponsored trial will include two leading hematology centers, one in the US and one in Europe, and represents a critical step in broadening the therapeutic applications of our iNKT sub-platform in regions where patients have limited effective treatment options.

我們由研究者資助的試驗將包括兩個領先的血液學中心，一個在美國，一個在歐洲，這代表著在患者有效治療選擇有限的地區擴大 iNKT 子平台治療應用的關鍵一步。

GvHD is a serious and potentially life-threatening complication of bone marrow transplants, where donor immune cells attack the recipient's body.

GvHD 是骨髓移植的一種嚴重且可能危及生命的併發症，其中供體免疫細胞攻擊受體的身體。

Our iNKT cell therapy is designed to modulate this immune response, aiming to reduce the incidence and severity of GvHD, while preserving the graft versus tumor or disease effect.

我們的 iNKT 細胞療法旨在調節這種免疫反應，旨在降低 GvHD 的發生率和嚴重程度，同時保留移植物抗腫瘤或疾病的效果。

The trial also explore other important endpoints such as disease recurrence, infections and improved engraftment which iNKT cells may positively influence.

該試驗也探討了 iNKT 細胞可能產生正面影響的其他重要終點，例如疾病復發、感染和改善植入。

We are currently collaborating with our partnering institutions and investigators to finalize the study design with plans to activate the sites to readiness this year with first dosing by late year or very early in 2025.

我們目前正在與我們的合作機構和研究人員合作，最終確定研究設計，並計劃在今年啟動這些站點，使其做好準備，並在年底或 2025 年初進行首次給藥。

Now another important initiative we have ongoing in oncology is our program of 797 advancing in a Phase 2 trial in second-line gastric cancer.

現在，我們在腫瘤學領域正在進行的另一項重要措施是我們的 797 計畫正在進行二線胃癌的 2 期試驗。

This trial is currently underway in Memorial Sloan Kettering Cancer Center Hospital under the leadership of Dr. Yelena Janjigian, She's a Chief of Gastrointestinal Oncology and internationally recognized expert in gastric cancer.

該試驗目前正在紀念斯隆凱特琳癌症中心醫院進行，由胃腸腫瘤科主任、國際公認的胃癌專家 Yelena Janjigian 博士領導。

Our study is evaluating the potential of 797 in combination with the Genesis next-generation checkpoint inhibitors, botensilimab and balstilimab, which has shown very promising antitumor responses in a number of disease settings.

我們的研究正在評估 797 與 Genesis 下一代檢查點抑制劑 botensilimab 和 balstilimab 聯合使用的潛力，該藥物在多種疾病環境中顯示出非常有希望的抗腫瘤反應。

Our collaboration represents a critical opportunity to explore the synergistic benefit of iNKT cell therapy with advanced checkpoint inhibitors, potentially offering a powerful new treatment modality for patients with advanced gastric cancer.

我們的合作代表了探索 iNKT 細胞療法與先進檢查點抑制劑協同效益的關鍵機會，有可能為晚期胃癌患者提供強大的新治療方式。

This is a condition with historically limited therapeutic options, and as I mentioned earlier, survival between 4 and 10 months in these patients.

這種疾病歷來治療選擇有限，正如我之前提到的，這些患者的存活期為 4 到 10 個月。

Enrollment is actively underway, and the first cohort of patients are now exceeding three months to six months of follow-up in the trial and showing very exciting signals of clinical activity, where the majority of patients have already demonstrated some semblance of benefit in this population.

入組工作正在積極進行中，第一批患者現已在試驗中進行超過三個月至六個月的隨訪，並顯示出非常令人興奮的臨床活動信號，其中大多數患者已經在該人群中表現出一些表面上的益處。

We're very optimistic about the balance of clinical activity and tolerability of these combinations.

我們對這些組合的臨床活性和耐受性的平衡非常樂觀。

We expect to see data presentation at a major oncology conference this year or very early in 2025.

我們預計將在今年或 2025 年初的大型腫瘤學會議上看到數據顯示。

Now I will turn the call over to Dr. Marc Van Dijk, our Chief Scientific Officer, and he'll review our earlier stage programs that are advancing.

現在我將把電話轉給我們的首席科學官 Marc Van Dijk 博士，他將審查我們正在推進的早期階段項目。

Marc?

馬克？

Thank you, Jen.

謝謝你，珍。

Turning to our preclinical pipeline.

轉向我們的臨床前管道。

We are rapidly advancing MiNK-215 and IL-15 armored FAP-targeting CAR invariant natural killer T-cell therapy, that's a mouthful, but it's targeting tumor stroma.

我們正在快速推進 MiNK-215 和 IL-15 裝甲 FAP 靶向 CAR 不變自然殺手 T 細胞療法，雖然很拗口，但它針對的是腫瘤基質。

This therapy has demonstrated very promising preclinical activity against solid tumors, including microsatellite stable colorectal cancer and liver metastases and non-small cell lung cancer.

該療法已證明對實體瘤具有非常有前景的臨床前活性，包括微衛星穩定結直腸癌、肝轉移瘤和非小細胞肺癌。

The strategic focus on targeting FAP expressing tumors stems from the overexpression of FAP in the tumor microenvironment, which plays a key role in supporting tumor growth and suppressing immune responses.

針對錶達 FAP 的腫瘤的策略重點源於腫瘤微環境中 FAP 的過度表達，它在支持腫瘤生長和抑制免疫反應方面發揮關鍵作用。

By disrupting this environment, MiNK-215 is designed to enhance immune-mediated tumor destruction, offering a novel approach to combating these resistant cancers.

透過破壞這種環境，MiNK-215 旨在增強免疫介導的腫瘤破壞，從而提供一種對抗這些抗藥性癌症的新方法。

Our team is dedicated in bringing this innovative therapy into the clinical arena, with plans to file an IND in 2025.

我們的團隊致力於將這種創新療法帶入臨床領域，並計劃於 2025 年提交 IND。

We are developing a robust preclinical package that will allow us to identify and enrich a biomarker-based patient population, facilitating more rapid signals and signal detection and development.

我們正在開發一個強大的臨床前包，使我們能夠識別和豐富基於生物標記的患者群體，促進更快速的信號和信號檢測和開發。

The potential for MiNK-215 to disrupt the treatment landscape in solid tumors is significant, particularly as we continue to see breakthroughs in CAR T therapies.

MiNK-215 顛覆實體瘤治療模式的潛力是巨大的，特別是當我們繼續看到 CAR T 療法的突破時。

Our manufacturing is led by Joy Zhou, who is driving our efforts to fully develop MiNK-215 manufacturing in-house.

我們的製造由 Joy Zhou 領導，他正在推動我們在內部全面開發​​ MiNK-215 製造。

By leveraging our state-of-the-art facilities, we aim to maximize scaling performance, ensuring the efficient production of high-quality allogeneic cell therapies.

透過利用我們最先進的設施，我們的目標是最大限度地提高擴展性能，確保高效生產高品質的同種異體細胞療法。

Our partnership with a leading lentiviral-vector producer, utilizing their novel technology ensures a seamless and efficient production process for our antiviral vectors, critical for the development of MiNK-215.

我們與一家領先的慢病毒載體生產商合作，利用他們的新技術確保我們的抗病毒載體的生產過程無縫且高效，這對於 MiNK-215 的開發至關重要。

The recent approval of an allogeneic cell therapy in solid cancer marks a significant milestone in the field and serves as a relevant benchmark for MiNK.

最近批准的實體癌症同種異體細胞療法標誌著該領域的一個重要里程碑，並成為 MiNK 的相關基準。

This approval highlights the growing acceptance and potential of allogeneic therapies, reinforcing our confidence in the regulatory pathway for MiNK-215.

這項批准凸顯了同種異體療法日益增長的接受度和潛力，增強了我們對 MiNK-215 監管途徑的信心。

Additionally, the anticipated success in CAR-T treatments for solid tumor malignancies emphasizing the potential from MiNK's iNKT cell therapy that contribute to significant treatment advances.

此外，實體腫瘤惡性腫瘤 CAR-T 治療的預期成功強調了 MiNK 的 iNKT 細胞療法的潛力，有助於顯著的治療進展。

Our research and development teams continue to push forward our pipeline of next-generation cell therapies.

我們的研發團隊繼續推動我們的下一代細胞療法的研發。

These include T-cell receptor-based therapies and bispecific cell engagers, which have the potential to address gaps in traditional therapies and can be combined with more advanced assets, such as AgenT-797.

其中包括基於 T 細胞受體的療法和雙特異性細胞接合劑，它們有可能彌補傳統療法的空白，並且可以與更先進的資產（例如 AgenT-797）相結合。

Our partnership with ImmunoScape is now well underway and centers around the discovery and development of T-cell receptors to a specific class of pan-tumor neoantigens.

我們與ImmunoScape 的合作目前正在順利進行，重點是針對特定類別的泛腫瘤新抗原的T 細胞受體的發現和開發。

We believe that our invariant NKT cells are ideal allogeneic hosts for these pan-tumor neoantigen TCRs and offer the potential to develop cost-effective, off-the-shelf allogeneic TCR-based cell therapies.

我們相信，我們的不變 NKT 細胞是這些泛腫瘤新抗原 TCR 的理想同種異體宿主，並提供開發具有成本效益、現成的基於同種異體 TCR 的細胞療法的潛力。

In parallel, we are continuing to advance our proprietary PRAME TCR-iNKT program.

同時，我們正在繼續推進我們專有的 PRAME TCR-iNKT 計劃。

We've also investigated combining AgenT-797 with bispecific cell engagers.

我們也研究了 AgenT-797 與雙特異性細胞接合器的結合。

AgenT-797 is administered without lymphodepletion, has shown activity in solid tumor settings, and we have detected circulating AgenT-797 in non-HLA-matched patients for up to six months.

AgenT-797 無需進行淋巴細胞清除，在實體瘤環境中顯示出活性，並且我們已在非 HLA 匹配患者中檢測到循環 AgenT-797 長達六個月。

We have compelling in vitro data on the combination of AgenT-797 with cell engagers, our own as well as third-party engagers.

我們擁有關於 AgenT-797 與細胞接合器（我們自己的以及第三方接合器）結合的令人信服的體外數據。

And we believe that the combination of AgenT-797 and cell engagers, specifically in absence of lymphodepletion, will significantly enhance tumor penetration, counteract local immune suppression and improve overall efficacy.

我們相信，AgenT-797 和細胞接合劑的組合，特別是在沒有淋巴細胞清除的情況下，將顯著增強腫瘤滲透，抵消局部免疫抑制並提高整體療效。

We plan to present preclinical data from some of these programs as a key meeting later this year.

我們計劃在今年稍後的重要會議上展示其中一些項目的臨床前數據。

I'll now turn it back to Jen for some closing remarks.

現在我將把它轉回給 Jen，讓其做一些結束語。

Jen?

珍？

Thank you very much Marc, appreciate it.

非常感謝馬克，非常感謝。

And this is, as you can see we have an incredibly efficient platform in which we've been able to not only advance clinical programs, but also some highly innovative, next-generation technologies.

正如您所看到的，我們擁有一個非常有效率的平台，我們不僅能夠推進臨床項目，而且能夠推進一些高度創新的下一代技術。

And as we advance these programs, which you can see, we are also very committed to fiscal conservatism ensuring that we leverage every mechanism available to advance our therapies highly efficiently.

正如您所看到的，在我們推動這些計劃的同時，我們也非常致力於財政保守主義，確保我們利用一切可用的機制來高效地推進我們的治療。

Our strategy includes pursuing nondilutive funding sources, and these include some of the grant funding programs that are currently underway as well as strategic partnerships to maintain our financial health, while bringing these deserving therapies to the forefront of treatment options.

我們的策略包括尋求非稀釋性資金來源，其中包括目前正在進行的一些贈款資助計劃以及維持我們財務健康的策略合作夥伴關係，同時將這些值得的治療方法帶到治療選擇的最前沿。

Our approach will not only accelerate the development of iNKT cell therapies, but also preserve value during this unusual time in biotech.

我們的方法不僅將加速 iNKT 細胞療法的開發，而且還能在生物技術的這個不尋常時期保持價值。

So I want to thank you for your continued support.

因此，我要感謝您一直以來的支持。

And I'm going to turn the call over to Christine to review our financials.

我將把電話轉給克里斯汀，讓她審查我們的財務狀況。

Christine?

克里斯汀？

Thank you, Jen.

謝謝你，珍。

We ended the quarter with a cash balance of $9.3 million, which reflects cash used in operations for the quarter of $2.3 million.

本季結束時，我們的現金餘額為 930 萬美元，這反映了本季營運中使用的現金為 230 萬美元。

This is a reduction from the $2.6 million used for the first quarter of this year.

這比今年第一季使用的 260 萬美元有所減少。

And as Jen mentioned earlier, an almost 50% reduction from prior year.

正如 Jen 之前提到的，比去年減少了近 50%。

Our net loss for the three months and six months ended June 30, 2024, was $2.7 million or $0.07 per share and $6.5 million or $0.18 per share.

截至 2024 年 6 月 30 日止的三個月和六個月，我們的淨虧損為 270 萬美元或每股 0.07 美元，以及 650 萬美元或每股 0.18 美元。

This compares to $6.2 million or $0.18 per share and $11.9 million or $0.35 per share for the same period in 2023.

相比之下，2023 年同期為 620 萬美元或每股 0.18 美元，以及 1,190 萬美元或每股 0.35 美元。

I will now turn the call back to the operator for questions.

我現在將把電話轉回給接線員詢問問題。

(Operator Instructions) Emily Bodnar, H.C. Wainwright.

（操作員說明）Emily Bodnar，H.C.溫賴特。

Hi, good morning.

嗨，早安。

Thanks for taking my questions.

感謝您回答我的問題。

Jen, just to confirm, so the GvHD study that you're planning to initiate, it sounds like that's going to be funded with external capital.

Jen，只是為了確認一下，您計劃啟動的 GvHD 研究，聽起來像是將由外部資本資助。

Is that correct?

這是正確的嗎？

And then second question, when you say you are seeing early signs of activity in the gastric cancer study, can you provide any more context to what you're kind of seeing and how that might compare to just standard of care chemo alone?

然後第二個問題，當您說您在胃癌研究中看到活動的早期跡象時，您能否提供更多背景資訊來說明您所看到的情況以及這與單獨的標準護理化療相比如何？

Thanks.

謝謝。

Thank you very much for your questions, Emily.

非常感謝您的提問，艾蜜莉。

Your first for the GvHD program, yes this will be supported by external funding to advance the program.

您的第一個 GvHD 計劃，是的，這將得到外部資金的支持以推進該計劃。

And secondly, in gastric now I -- given that Dr. Janjigian is planning to present these results at a conference, I'm hesitant to say any more than at least in the cohort that we have now observed and fully enrolled that's beyond three months to six months of follow-up, we are seeing some very exciting signals of clinical benefit that do exceed what our expectations are with [ram tax] on its own.

其次，在胃病方面，鑑於 Janjigian 博士計劃在一次會議上展示這些結果，我猶豫是否要說更多，至少在我們現在觀察到並完全入組的隊列中超過三個月在六個月的隨訪中，我們看到了一些非常令人興奮的臨床益處訊號，這些訊號確實超出了我們對[公羊稅]本身的預期。

And as you can imagine, given the number of patients, thousands of patients have been dosed with the chemotherapy, we have a strong sense of what that arm, how it will perform.

正如你可以想像的那樣，考慮到患者的數量，成千上萬的患者已經接受了化療，我們對那隻手臂的作用以及它將如何發揮作用有著強烈的認識。

And we're seeing performance far beyond that at this point in the trial.

我們在試驗中看到的性能遠遠超出了此時的水平。

Jack Allen, Baird.

傑克艾倫、貝爾德。

Hi, thanks so much for taking the questions and congratulations on the progress.

您好，非常感謝您提出問題並祝賀取得的進展。

I wanted to dive a little bit more deeply into the gastric update that we expect.

我想更深入地了解我們期望的胃更新。

I guess I understand you don't want to make too many comments ahead of the scientific presentation.

我想我理解您不想在科學演示之前發表太多評論。

But can you just remind us about the different cohorts in the study?

但您能提醒我們一下這項研究中的不同群體嗎？

And any comments on where patients were enrolled as it relates to those cohorts to date?

對於迄今為止與這些隊列相關的患者入組地點有何評論？

And then on the graft versus host disease trial, very exciting news to see that got underway.

然後，關於移植物抗宿主疾病試驗，非常令人興奮的消息正在發生。

I just wanted to see if you had any more comments as it relates to the size of that study and when we can expect initial data from that trial.

我只是想看看您是否還有更多意見，因為這與該研究的規模以及我們何時可以從該試驗中獲得初始數據有關。

Certainly.

當然。

Thanks, Jack, for your questions.

謝謝傑克的提問。

On the gastric program, this is a program in which we have a very heavy translational component as well as clinical component.

在胃治療計畫中，我們有非常重要的轉化成分和臨床成分。

So looking at very traditional endpoints, response rate, tumor reduction overall survival in this population as well as some of the translational markers.

因此，我們著眼於非常傳統的終點、緩解率、該族群的腫瘤減少總體存活率以及一些轉化標記。

And to do so, what we have embarked on is a trial that allows us to interrogate iNKT as an induction and iNKT on top of standard of care chemo, ram tax, as well as iNKTs in combination with BOT/BAL and chemo.

為此，我們開始進行一項試驗，使我們能夠將 iNKT 作為誘導劑，在標準護理化療、公羊稅之上，以及 iNKT 與 BOT/BAL 和化療相結合。

And we have representative patients in each of those treatment considerations.

我們在每個治療考慮因素中都有代表性的患者。

So the data that you will see will give some semblance not only of translational mechanisms that are happening, but also clinical outcomes in those populations.

因此，您將看到的數據不僅會提供正在發生的轉換機制的一些外觀，還會提供這些人群的臨床結果。

GvHD, so this is a program that we are as excited as you are, Jack, to get this underway.

GvHD，所以這是一個項目，我們和你一樣興奮，傑克，能夠啟動這個項目。

Our preclinical data has really supported the importance of iNKT in this particular disease setting.

我們的臨床前數據確實支持了 iNKT 在這種特定疾病環境中的重要性。

And what we've observed is that preclinically, we know that iNKT may uniquely transform the landscape that will enable engraftment success and also mitigate and prevent GvHD.

我們觀察到，在臨床前，我們知道 iNKT 可能會獨特地改變環境，從而實現植入成功，並減輕和預防 GvHD。

This is such a growing problem, impacting over 50% of patients that are undergoing stem cell transplantation.

這是一個日益嚴重的問題，影響超過 50% 接受幹細胞移植的患者。

But we believe that these cells can deliver benefit both in adult patients, as well as in pediatric patients.

但我們相信這些細胞可以為成年患者和兒科患者帶來益處。

And you may know that there is a mesenchymal stem cell approved in Europe and not yet in the US that has demonstrated that an important benefit, particularly in pediatric population, specifically where GvHD is organ-based.

您可能知道，有一種間質幹細胞已在歐洲獲得批准，但在美國尚未獲得批准，該幹細胞已證明具有重要的益處，特別是在兒童群體中，特別是在以器官為基礎的 GvHD 中。

And we think that ourselves may even be able to expand benefit beyond the observation today, certainly beyond ruxolitinib, as well as beyond some of the available cell approaches given the mechanism of action.

我們認為，我們甚至可能能夠將益處擴大到今天的觀察範圍之外，當然也超出了魯索替尼的範圍，也超出了一些現有的細胞方法（考慮到作用機制）。

We will be activating the trial.

我們將啟動試用。

We're working aggressively to do so this year.

今年我們正在積極努力做到這一點。

Ideally, we will have some patients who can start enrolling in this calendar year.

理想情況下，我們將有一些患者可以在本日曆年開始註冊。

Otherwise, it will be very early next year.

不然明年就很早了。

The endpoints are rapid in this with response rates and for protection and mitigation within about a 28-day window.

端點的反應速度很快，並且在大約 28 天的時間內提供保護和緩解。

So we would expect to have data from the trial in 2025, probably in the second half of the year.

因此，我們預計將在 2025 年（可能是今年下半年）獲得試驗數據。

Got it.

知道了。

Great.

偉大的。

Thank you so much for that update.

非常感謝您的更新。

And then maybe just one last question, more broad, but as it relates to securing additional non-dilutive funds to the capital, I just wanted to hear any comments you have around appetite of partnerships and things of that nature.

也許只是最後一個問題，更廣泛，但由於它涉及確保資本獲得額外的非稀釋性資金，我只是想听聽您對夥伴關係和此類性質的興趣的任何評論。

Yes.

是的。

Partnering is actually really core to our strategy, and it will be important not only to expand our bandwidth, but also our global presence.

合作實際上是我們策略的核心，不僅擴大我們的頻寬，而且擴大我們的全球影響力也很重要。

So we continue to have very active interactions with potential partners who share our vision and also have the bandwidth to do -- to deliver in regions of the world where we do not yet have a footprint, but also to help us accelerate the development of these cells.

因此，我們繼續與潛在的合作夥伴進行非常積極的互動，他們與我們有共同的願景，並且有足夠的能力去做——在世界上我們尚未涉足的地區提供服務，同時也幫助我們加速這些領域的發展。

Mayank Mamtani, B. Riley.

Mayank Mamtani，B.Riley。

Hi, good morning team.

嗨，早上好，團隊。

Thanks for taking our questions and congrats on the progress.

感謝您提出我們的問題並祝賀我們的進展。

So in regards to the 797 combination work with BOT/BAL sort of informing also your future combination work you may pursue with T-cell engagers, could you maybe just talk a little bit more about that?

因此，關於 797 與 BOT/BAL 的組合工作，這也為您未來可能與 T 細胞參與者進行的組合工作提供了信息，您能否再多談談這一點？

And if there are any specific tumor service antigen modalities, T-cell engagers that you have in mind?

您是否想到了任何特定的腫瘤服務抗原模式、T 細胞接合劑？

And then the second question about the 215 IND filing plans actually to early 2025.

然後第二個問題是關於 215 IND 申請實際上計劃到 2025 年初。

I would love to hear the initial Phase I protocol plan you're looking to submit with your IND filing.

我很想聽聽您希望與 IND 備案一起提交的初始第一階段方案計劃。

And any color on what dose levels you're looking to produce?

您希望產生什麼劑量水平的任何顏色？

And how much you be thinking of manufacturing given you've invested in-house in developing this modality?

鑑於您已經在內部投資開發這種模式，您對製造的考慮有多少？

Excellent.

出色的。

Okay.

好的。

Mayank, I'm going to start with the second question, and I'll turn it over to Marc, and we also have Dr. Joy Zhou here on manufacturing for 215.

Mayank，我將從第二個問題開始，我將把它交給 Marc，我們還有 Joy Zhou 博士在這裡討論 215 的製造。

So on the latter, so 215.

所以對於後者，所以 215。

This is a program, as you know, we now have a new investor who has joined us and partnered with us and accelerated the development of this program we're doing so actively.

這是一個項目，如您所知，我們現在有一位新投資者加入我們並與我們合作，並加速了我們正在積極開展的該項目的開發。

We had already generated quite a bit of preclinical work to support our IND filing.

我們已經進行了大量臨床前工作來支持我們的 IND 申請。

We are expanding that to bolster our initial clinical protocol, which will allow us to identify patients most likely to respond and deliver therapy at an effective starting dose.

我們正在擴大這一範圍，以支持我們的初始臨床方案，這將使我們能夠識別最有可能做出反應的患者，並以有效的起始劑量提供治療。

That's really our highest priority at this moment in order to accelerate the development of this important therapy.

為了加速這項重要療法的開發，這確實是我們目前的首要任務。

Our preclinical data, which we've now presented publicly in a number of locations as it is continued to build and evolve and what we've most recently demonstrated is that the 215 program not only can benefit in organoid models, colorectal cancer, but also penetrate metastatic liver disease in those human-like models.

我們的臨床前數據，隨著它的不斷建立和發展，我們現在已經在許多地方公開展示，我們最近證明的是 215 項目不僅可以在類器官模型、結直腸癌中受益，而且還可以在那些類人模型中滲透轉移性肝病。

This has increased our imperative for identifying patients most likely to benefit, and those will be very likely to be patients with FAP-expressing tumors.

這增加了我們識別最有可能受益的患者的必要性，這些患者很可能是表達 FAP 的腫瘤患者。

Now we will be somewhat in a Phase 1 trial, somewhat inclusive to identify exploratory signals.

現在我們將進入第一階段試驗，包括識別探索性訊號。

But we will be really focused in order to identify patients where we believe that we can measure some of the biomarkers, elimination of the FAP-expressing tumor cells and the immune-enhancing potential of this therapy to really deliver the benefit that we think is possible.

但我們將真正專注於識別患者，我們相信我們可以測量一些生物標記、消除表達 FAP 的腫瘤細胞以及這種療法的免疫增強潛力，以真正帶來我們認為可能的益處。

We will be manufacturing this program in-house and Dr. Zhou and her team are working very aggressively to do so.

我們將在內部製作這個程序，週博士和她的團隊正在非常積極地努力做到這一點。

Our process development analytics development work is actively underway for release that criterion.

我們的流程開發分析開發工作正在積極進行，以發布該標準。

And we are just now in the process of finalizing some of the work that's necessary for the transaction, and that we'll be transferring it in-house to produce the material.

我們現在正在完成交易所需的一些工作，我們將把它轉移到內部來生產材料。

Importantly, we have been delivering 797 in our own hands, and we've optimized the protocol to be able to deliver really robust billions of cells per donor.

重要的是，我們一直在自己手中提供 797，並且我們已經優化了協議，以便能夠為每個捐贈者提供真正強大的數十億個細胞。

We are able to scale the cells, and we've publicly talked about this, where we can scale the cells without exhaustion, really capitalizing on the possibility.

我們能夠擴展單元格，並且我們已經公開討論過這一點，我們可以在不耗盡精力的情況下擴展單元格，真正利用這種可能性。

We will plan to leverage that platform in order to now deliver our engineered CAR iNKT platform.

我們將計劃利用該平台來交付我們設計的 CAR iNKT 平台。

So that's the 215 program.

這就是215計劃。

We are looking forward to getting that into the clinic.

我們期待著將其帶入診所。

We're going to be wrapping up some of the preclinical data that will allow us to get there at a dose that we think will be quite impactful and in a population that we believe will benefit.

我們將完成一些臨床前數據，這些數據將使我們能夠以我們認為相當有影響力的劑量達到目標，並在我們認為將受益的人群中實現。

Now on the engagers, I'm really glad that you asked this.

關於訂婚者，我真的很高興你問這個問題。

We have done a lot of work in our own hands with engagers with the concept that engagers need more and more seeing that in the landscape.

我們自己與參與者一起做了很多工作，我們的理念是參與者需要越來越多地看到這一點。

And I think, we may have a very important recipe for success here for T-cell engagers, and I'm going to turn it over to Marc Van Dijk to tell you a bit more.

我認為，對於 T 細胞參與者來說，我們可能有一個非常重要的成功秘訣，我將把它交給 Marc Van Dijk，讓他告訴你更多。

Yes.

是的。

Thanks, Jen.

謝謝，珍。

So engagers are interesting.

所以參與者很有趣。

I mean, there is quite a lot of development in the cell engager space, more and more so also in the solid tumor space.

我的意思是，細胞接合器領域有相當多的發展，實體腫瘤領域也越來越多。

We've seen some success with one approval.

我們已經看到了一次批准就取得了一些成功。

And I think we can increase the efficacy enormously by adding an allogeneic cell therapy component in the form of iNKT cells.

我認為我們可以透過添加 iNKT 細胞形式的同種異體細胞治療成分來大幅提高療效。

And I say this specifically because engagers are sort of they induce the local -- the central immune response and they are -- they need to pull T-cells into the tumor, but there is a lot of resistance in the tumor.

我之所以這麼說，是因為接觸者會誘導局部——中樞免疫反應，他們需要將 T 細胞拉入腫瘤，但腫瘤中有很多抵抗力。

And iNKT cells, they are very good entering sites where T-cells cannot easily go, as well as overcoming local immune suppression.

而 iNKT 細胞，它們可以很好地進入 T 細胞無法輕易到達的部位，並克服局部免疫抑制。

That's the reason to build 215.

這就是建造215的原因。

That's the reason why 797 has shown activity in gastric cancer.

這就是 797 對胃癌表現出活性的原因。

And we believe that combining bispecific cell engagers for solid tumors with AgenT-797 or later with 215 really starts to add those two efficacy mechanisms together to have a much higher impact than either one or cell engagers alone can achieve.

我們相信，將實體瘤雙特異性細胞接合劑與AgenT-797 或後來的215 結合，確實開始將這兩種功效機制結合在一起，產生比單獨一種或細胞接合劑所能達到的更大的影響。

And the other really differentiating component is that 797 is applied without lymphodepletion.

另一個真正與眾不同的部分是 797 的應用無需進行淋巴細胞清除。

And that's essential for maximizing the immune response of the patient's own immune system.

這對於最大化患者自體免疫系統的免疫反應至關重要。

So that combination and non-lymphodepleting iNKT cells plus cell engagers, we believe, has an enormous potential for solid tumor treatment.

因此，我們相信，非淋巴細胞清除 iNKT 細胞與細胞接合劑的組合在實體腫瘤治療方面具有巨大潛力。

But that's what we're exploring with both our own cell engager program, but also looking at cell engagers that are out there.

但這就是我們正在透過自己的細胞參與計畫所探索的內容，同時也關注現有的細胞參與者。

And we have quite a lot of preclinical data that we hope to share at the conference later this year.

我們有相當多的臨床前數據，希望在今年稍後的會議上分享。

Got it.

知道了。

Thank you for that comprehensive answer.

感謝您的全面回答。

And then just if I could squeeze one more in, Jen, on the couple of options for non-dilutive financing, Are you able to talk to the scale and scope and in terms of what remains to kind of get that through the finish-line, that would be helpful.

然後，Jen，如果我能再補充一點關於非稀釋性融資的幾種選擇，您能否談談規模和範圍，以及如何才能完成這項工作？ ，那會有幫助的。

And thanks again for taking my question.

再次感謝您提出我的問題。

Thanks, Mayank.

謝謝，瑪雅克。

With respect -- as you're seeing with some of the non-dilutive grant funding support that we have been able to garner to support our trials in immune-related diseases as well as in oncology, you can see how the excitement of these cells and their potential is shared with a number of groups, a diverse set of groups who are very intrigued by advancing the technology.

恕我直言，正如您所看到的，我們已經獲得了一些非稀釋性贈款資金支持，以支持我們在免疫相關疾病和腫瘤學方面的試驗，您可以看到這些細胞的興奮程度他們的潛力與許多團體分享，這些團體對推進技術非常感興趣。

That has allowed us to continue to really prioritize the development of data that will help us to continue to advance some of the discussions that are actively underway.

這使我們能夠繼續真正優先考慮數據的開發，這將有助於我們繼續推進一些正在積極進行的討論。

So I hesitate to give any additional color, except to say that the interest of what these cells can do have been coming inbound from pharma groups who are interested in expanding the footprint of their cell therapy programs, as well as those looking to get into the space.

因此，我不願給出任何額外的顏色，只是說，對這些細胞的作用的興趣來自那些有興趣擴大其細胞治療項目足蹟的製藥集團，以及那些希望進入該領域的製藥集團。

There is quite a bit of interest in the autoimmunity, the GvHD data, as well as on the engineered portfolio with the preponderance of additional interest in respiratory diseases coming from a very focused group of pharma companies.

人們對自體免疫、GvHD 數據以及工程組合非常感興趣，其中對呼吸系統疾病的額外興趣主要來自一群非常專注的製藥公司。

So I'm going to leave it at that, just to simply say for us, the most important thing is regional infrastructure and global footprint that can allow us to accelerate the development of these important therapies.

因此，我只想簡單地說，對我們來說，最重要的是區域基礎設施和全球足跡，它們可以讓我們加速這些重要療法的發展。

And that's been driving our prioritization of the conversations that we're having now and some of which we'll expand on in the next couple of weeks.

這推動了我們對現在正在進行的對話以及其中一些對話的優先順序進行排序，我們將在接下來的幾週內擴展其中一些對話。

And ideally, we will be able to have some of these advanced far enough by the end of this year or early next year.

理想情況下，我們將能夠在今年年底或明年初將其中一些技術取得足夠的進展。

Matthew Phipps, William Blair.

馬修·菲普斯，威廉·布萊爾。

Hi, thanks for taking my questions.

您好，感謝您回答我的問題。

Jen, glad to see the GvHD trial getting started.

Jen，很高興看到 GvHD 試驗開始。

Just wondering if you could give some details, steroid-refractory, but will you allow for other lines of prior therapy.

只是想知道您是否可以提供一些細節，類固醇難治性的，但您是否會允許其他先前的治療方案。

And is this going to be a single ascending dose, multiple ascending dose?

這會是單次遞增劑量還是多次遞增劑量？

Can you give us any details on the dosing schemes?

您能為我們提供有關劑量方案的任何詳細資訊嗎？

Yeah.

是的。

Thanks so much, Matt.

非常感謝，馬特。

On the dosing scheme, at this point we have been able to administer the cells beyond one dose, and we are very pleased that we can do so tolerably in populations of patients that we wanted to monitor really quite closely.

在劑量方案上，目前我們已經能夠給予超過一劑量的細胞，我們非常高興我們能夠在我們想要密切監測的患者群體中做到這一點。

So if we can administer the cells, we do not see any enhanced reactivity or rejection and administering beyond one dose.

因此，如果我們能夠施用這些細胞，我們不會看到任何增強的反應性或排斥反應以及施用超過一劑的情況。

We would look at this -- from a target dosing standpoint, we have generated quite a bit of data now beyond 80 patients in dose finding.

我們會考慮這一點——從目標劑量的角度來看，我們現在已經在劑量發現方面產生了超過 80 名患者的大量數據。

And I think we have quite a bit of confidence that 1 billion cells is our target dose.

我認為我們對 10 億個細胞是我們的目標劑量很有信心。

We wouldn't want to start very much lower than that.

我們不希望起點比這低很多。

We may do a step-down dose in the GvHD trial.

我們可能會在 GvHD 試驗中逐步降低劑量。

However, we may not need to.

然而，我們可能不需要這樣做。

So we're negotiating that currently and we would look at about 1 billion cells.

所以我們目前正在就此進行談判，我們將研究大約 10 億個細胞。

We would do a single dose, as well as we would explore if a second dose or a third dose is necessary.

我們將進行單次劑量，並探討是否需要第二次或第三次劑量。

I'm not sure that it will be.

我不確定會是這樣。

We will be open, and we are finalizing those design elements right now with some regulatory interactions.

我們將保持開放，我們現在正在透過一些監管互動來最終確定這些設計元素。

We are open to other lines of therapy, we want to be sure to have the right reference so that in our trial, which even in the Phase 1, that we're contemplating right now a reference group that would allow us to accelerate the development by demonstrating if we are looking at 40% to 50% or higher and response rates compared to what we are seeing is 30% with some of the available therapeutic approaches.

我們對其他療法持開放態度，我們希望確保有正確的參考，以便在我們的試驗中，即使在第一階段，我們現在正在考慮一個參考組，這將使我們能夠加速開發通過證明我們是否看到40% 至50% 或更高，以及與我們所看到的一些可用治療方法的30% 相比，反應率。

We want to keep the prior lines of therapy relatively clear so that we have a homogeneous population even in a Phase 1 setting that will allow us to advance very quickly into a randomized Phase 2.

我們希望保持先前的治療方案相對清晰，以便即使在第一階段的情況下我們也能擁有同質的人群，這將使我們能夠非常快速地進入隨機的第二階段。

There are no further questions.

沒有其他問題了。

So I'll turn the call back over to Dr. Jennifer Buell.

所以我會把電話轉回詹妮弗·布爾博士。

Thank you very much, everyone.

非常感謝大家。

I want to thank my team as well as for those on the line for your continued support, appreciate it.

我要感謝我的團隊以及線上人員的持續支持，非常感謝。

That concludes today's call.

今天的電話會議到此結束。

You may now disconnect.

您現在可以斷開連線。