Medicenna Therapeutics Corp (MDNA) 2023 Q3 法說會逐字稿

Hello, and welcome to the Medicenna Therapeutics fiscal third-quarter earnings call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

您好，歡迎參加 Medicenna Therapeutics 第三季度財報電話會議。 （操作員說明）請注意，本次通話是應公司要求進行錄音的。

I would now like to turn the call over to Dan Ferry of LifeSci Advisors. Thank you, please go ahead.

我現在想將電話轉給 LifeSci Advisors 的丹·費里 (Dan Ferry)。謝謝，請繼續。

Thank you, operator, and thank you all for participating in today's conference call. This morning, Medicenna issued a press release providing financial results and corporate updates for the quarter ended December 31, 2022. If you have not seen the press release, it is available on the investor page of Medicenna's website.

謝謝接線員，也謝謝大家參加今天的電話會議。今天上午，Medicenna 發布了一份新聞稿，提供截至 2022 年 12 月 31 日的季度的財務業績和公司更新。如果您還沒有看過該新聞稿，可以在 Medicenna 網站的投資者頁面上找到。

Before we begin, I would like to remind you that certain statements and information shared during this call constitute forward-looking information within the meaning of applicable securities laws. All statements other than statements of historical facts shared during this call, and that relate to the future operations of the company, and other statements that are not historical facts including statements related to the clinical potential, development, and tolerability and safety profile of MDNA11, preliminary clinical data, the clinical potential, and development of MDNA55, partnering efforts, cash runway, the presentation of additional data and other milestones in patent protection, are forward-looking statements that are subject to risks and uncertainties.

在我們開始之前，我想提醒您，本次電話會議期間分享的某些聲明和信息構成適用證券法含義內的前瞻性信息。除本次電話會議期間分享的歷史事實陳述外，與公司未來運營相關的所有陳述，以及非歷史事實的其他陳述，包括與 MDNA11 的臨床潛力、開發、耐受性和安全性、初步臨床數據、MDNA55 的臨床潛力和開發、合作努力、現金跑道、額外數據的呈現和專利保護中的其他里程碑相關的陳述，均為前瞻性陳述，存在風險和不確定性。

There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such events. Important factors that may cause actual results to differ materially from the company's expectations include the risks detailed in the annual information form in 20-F of the company, and in other filings made by the company, with applicable securities regulators from time to time in Canada and the United States.

無法保證此類陳述將被證明是準確的，並且實際結果和未來事件可能與此類事件中的預期存在重大差異。可能導致實際結果與公司預期存在重大差異的重要因素包括公司 20-F 年度信息表以及公司不時向加拿大和美國適用的證券監管機構提交的其他文件中詳述的風險。

Listeners are cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted as a result of numerous known and unknown risks, uncertainties and other factors, many of which are beyond the control of the company. You are cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management, may prove to be incorrect, and actual results may differ materially from those anticipated.

請聽眾注意，在準備任何前瞻性信息時使用的假設可能被證明是不正確的。由於眾多已知和未知的風險、不確定性和其他因素（其中許​​多因素超出了公司的控制範圍），事件或情況可能導致實際結果與預測結果存在重大差異。請您注意不要過分依賴任何前瞻性信息。這些信息雖然被管理層認為是合理的，但可能被證明是不正確的，並且實際結果可能與預期存在重大差異。

Forward-looking statements contained in this conference call are expressly qualified by this cautionary statement. Except as required by law, the company does not intend and do not assume any obligation to update or revise publicly any of the included forward-looking statements, only as expressly required by Canadian and United States securities law.

本次電話會議中包含的前瞻性陳述明確受到本警告性聲明的限制。除法律要求外，公司不打算也不承擔任何義務公開更新或修改所包含的任何前瞻性陳述，僅根據加拿大和美國證券法的明確要求。

Speaking on today's call will be made as Medicenna's President and Chief Executive Officer, Dr. Fahar Merchant; and Chief Financial Officer, Liz Williams.

Medicenna 總裁兼首席執行官 Fahar Merchant 博士將在今天的電話會議上發表講話；和首席財務官莉茲·威廉姆斯。

I will now turn the call over to Fahar to begin. Fahar?

現在我將把電話轉給法哈爾開始。法哈爾？

Thanks, Dan. And good morning, everyone. I'll begin by discussing the most recent news out of our Phase 1/2 ABILITY study of MDNA11, our beta-only, long-acting IL-2 super-agonist. Prior this morning, we announced that the Phase 1 portion of the ABILITY trial advanced to a sixth dose escalation cohort where patients will receive a target dose of 120 micrograms per kilogram every two weeks.

謝謝，丹。大家早上好。首先，我將討論 MDNA11 的 1/2 期能力研究的最新消息，MDNA11 是我們的長效 IL-2 超級激動劑。今天早上之前，我們宣布 ABILITY 試驗的第一階段部分進入第六個劑量遞增隊列，患者將每兩週接受每公斤 120 微克的目標劑量。

This is encouraging, as it reflects that MDNA11 has a suitable tolerability profile in the end-stage case cancer patients that have enrolled in the Phase 1 study to date. The decision to advance to the sixth cohort was based on a review of the cohort five safety and preliminary pharmacodynamic data by our safety review committee, which consists of study investigators, key opinion leaders, and external advisers.

這是令人鼓舞的，因為它反映出 MDNA11 在迄今為止已參加 1 期研究的終末期癌症患者中具有合適的耐受性。進入第六隊列的決定是基於我們的安全審查委員會對第五隊列的安全性和初步藥效學數據的審查，該委員會由研究研究者、關鍵意見領袖和外部顧問組成。

With regards to safety, we are pleased to say that MDNA11 has been well tolerated with no dose-limiting toxicities, dose interruptions, dose de-escalations, or treatment discontinuations due to safety issues.

關於安全性，我們很高興地說，MDNA11 具有良好的耐受性，沒有因安全問題而出現劑量限制性毒性、劑量中斷、劑量遞減或治療中斷。

With regards to pharmacodynamics, we observed further increase in lymphocyte expansion in cohort five when compared to cohort four, which indicates that MDNA11's ability to stimulate an anti-cancer immune response had not yet plateaued. Collectively, these data suggest that we may be able to safely administer higher doses of MDNA11, which in turn could further enhance anti-cancer effects.

在藥效學方面，我們觀察到與第四組相比，第五組的淋巴細胞擴增進一步增加，這表明 MDNA11 刺激抗癌免疫反應的能力尚未達到穩定水平。總的來說，這些數據表明我們或許能夠安全地施用更高劑量的 MDNA11，這反過來又可以進一步增強抗癌效果。

To begin testing this hypothesis, cohort six is dosing regimen includes 30, 60, and 90 micrograms per kilogram priming doses of MDNA11, followed by a further step up for the fixed 120 microgram per kilogram target dose I have mentioned earlier. For comparison, participants in the fifth cohort received two 30 microgram per kilogram priming doses before stepping up to a fixed 90 microgram per kilogram dose. All doses are administered intravenously every other week.

為了開始檢驗這一假設，第六組的給藥方案包括每公斤 30 微克、60 微克和 90 微克的 MDNA11 啟動劑量，然後進一步提高我之前提到的每公斤 120 微克的固定目標劑量。為了進行比較，第五組的參與者接受了兩次每公斤 30 微克的啟動劑量，然後逐漸增加到每公斤 90 微克的固定劑量。所有劑量每隔一周靜脈注射一次。

In addition to evaluating a higher fixed dose of MDNA11, the dosing regimen in cohort six has the advantage of getting participants to the 60 micrograms per kilogram dose after only two weeks. As opposed to after four weeks, which was the case of cohorts five and four. This is important as the 60 microgram per kilogram dose of MDNA11 has already led to tumor response as presented last quarter at the SITC Annual Meeting.

除了評估較高的 MDNA11 固定劑量外，第六組的給藥方案還有一個優點，即僅兩週後參與者就達到了每公斤 60 微克的劑量。與第四周後的情況相反，第五組和第四組的情況是這樣的。這一點很重要，因為正如上季度 SITC 年會上所介紹的，每公斤 60 微克劑量的 MDNA11 已經導致了腫瘤反應。

The data presented at SITC showed tumor control in 5 of 14, or 36% of evaluable patients treated with MDNA11 monotherapy. This included a confirmed partial response in a fourth-line metastatic pancreatic cancer patient treated at 60 micrograms per kilogram, demonstrating MDNA11's single-agent potential in a notoriously difficult-to-treat cancer.

SITC 公佈的數據顯示，14 名接受 MDNA11 單一療法治療的可評估患者中有 5 名（即 36%）的腫瘤得到控制。其中包括在接受每公斤 60 微克治療的四線轉移性胰腺癌患者中確認的部分緩解，這證明了 MDNA11 在治療眾所周知的難治癌症中的單藥潛力。

We also observed encouraging signs of MDNA11's potential to drive durable clinical benefit as the patient achieving a partial response. So further deepening of tumor response on each of the two consecutive scans. While another patient with metastatic melanoma has maintained stable disease for more than a year and remains on study. These promising anti-tumor activity data were notably achieved in an extremely challenging patient population with nearly 80% of patients having failed prior immunotherapy, including the pancreatic cancer patient achieving a partial response.

我們還觀察到令人鼓舞的跡象，表明當患者獲得部分緩解時，MDNA11 具有推動持久臨床獲益的潛力。因此，兩次連續掃描的腫瘤反應進一步加深。而另一名轉移性黑色素瘤患者病情穩定已一年多，仍在接受研究。這些有希望的抗腫瘤活性數據是在極具挑戰性的患者群體中取得的，其中近 80% 的患者先前免疫治療失敗，其中包括實現部分緩解的胰腺癌患者。

The data are supported by PD results that showed dose dependent and multi-fold increases in anti-cancer immune cells with MDNA11 treatment, but not stimulation of T regs or eosinophils. This is important, as T regs are associated with pro-tumor immune pathways; while eosinophils are associated with vascular leak syndrome, a serious life-threatening side effect of the only approved IL-2 therapy Proleukin.

這些數據得到了 PD 結果的支持，PD 結果顯示，MDNA11 治療後抗癌免疫細胞呈劑量依賴性且成倍增加，但不刺激 T reg 或嗜酸性粒細胞。這很重要，因為 T reg 與促腫瘤免疫途徑相關。而嗜酸性粒細胞則與血管滲漏綜合徵相關，這是唯一獲批的 IL-2 療法 Proleukin 的一種嚴重危及生命的副作用。

Presented alongside these PD data were results demonstrating MDNA11's tolerability at escalated doses; as well as PK data that showed dose-dependent increases in exposure that remained consistent with repeat dosing, suggesting a lack of an anti-drug antibody response. Those interested in reviewing any of these data in detail can find both SITC presentations on the events section of our IR website.

與這些 PD 數據一起展示的結果證明了 MDNA11 在劑量遞增時的耐受性； PK數據顯示暴露量呈劑量依賴性增加，與重複給藥保持一致，表明缺乏抗藥物抗體反應。那些有興趣詳細查看這些數據的人可以在我們 IR 網站的活動部分找到 SITC 演示文稿。

Collectively, we believe ABILITY's early results demonstrate how MDNA11's carefully engineer design positions the Superkine as a potentially best-in-class long-acting, beta-only IL-2 therapy. We believe the key design features of MDNA11 can provide cancer patients with clinical benefit while avoiding the PK and safety shortcomings that plagued Proleukin. ABILITY's data to date supports this hypothesis, which we plan to continue exploring with several important readouts from ABILITY expected over the coming months.

總的來說，我們相信 ABILITY 的早期結果證明了 MDNA11 的精心工程設計如何將 Superkine 定位為潛在的同類最佳長效、僅 β IL-2 療法。我們相信 MDNA11 的關鍵設計特徵可以為癌症患者帶來臨床益處，同時避免困擾 Proleukin 的 PK 和安全性缺陷。迄今為止，ABILITY 的數據支持這一假設，我們計劃通過未來幾個月預期的 ABILITY 的幾個重要讀數繼續探索這一假設。

The first of these readouts is anticipated later this quarter and will include initial anti-tumor activity data and high-level PD findings from ABILITY's fifth dose escalation cohort, alongside updated data from cohorts one through four. As an earlier cohort, cohort five enrolled difficult to treat patients, unresponsive to prior treatments. The same will be true for cohort six, as each dose escalation cohort utilizes similar inclusion criteria.

預計將在本季度晚些時候首次公佈數據，其中將包括來自 ABILITY 第五劑量遞增隊列的初始抗腫瘤活性數據和高水平 PD 研究結果，以及第一至第四隊列的更新數據。作為較早的隊列，第五隊列招募了難以治療的患者，對先前的治療沒有反應。對於第六組來說也是如此，因為每個劑量遞增組都採用相似的納入標準。

We do, however, plan to take a different approach to enrollment for the Phase 2 expansion portion of the trial; where the objective will be do not only demonstrate safety in approximately 40 patients, but importantly, evaluate the efficacy of MDNA11 in patients with less advanced cancer and tumor types that are most likely to benefit from our IL-2 Superkine. Therefore, rather than enrolling patients with a dozen or more disparate tumor types which has been the case with the Phase 1 portion of the ABILITY study, the Phase 2 portion will only focus on two or three different cancer populations that better reflect MDNA11's target addressable population.

然而，我們確實計劃對試驗的第二階段擴展部分採取不同的招募方法；我們的目標不僅是在大約 40 名患者中證明安全性，更重要的是，評估 MDNA11 對最有可能受益於我們的 IL-2 Superkine 的不太晚期癌症和腫瘤類型的患者的療效。因此，與能力研究第一階段部分的情況不同，第二階段部分將只關注更好地反映 MDNA11 目標可尋址人群的兩到三個不同癌症人群，而不是招募十幾種或更多不同腫瘤類型的患者。

As we look towards the identification of MDNA11's optimal regimen and ABILITY's Phase 2 expansion phase, we are optimistic on the clients' outlook having shown an ability to achieve enduring tumor control in a challenging patient population. We expect that MDNA11's demonstrable durability of response, which is a major challenge with approved immunotherapies, could be further enhanced with optimal dosing regimen, and in a population of patients with better initial prognosis.

當我們期待確定 MDNA11 的最佳治療方案和 ABILITY 的 2 期擴展階段時，我們對客戶的前景感到樂觀，因為他們表現出了在充滿挑戰的患者群體中實現持久腫瘤控制的能力。我們預計，MDNA11 的可證明的反應持久性是已批准的免疫療法的一個主要挑戰，可以通過最佳劑量方案以及在初始預後較好的患者群體中進一步增強。

Our current projections have us reporting data from ABILITY's sixth and potentially the final dose escalation cohort, together with early anti-tumor activity data from the Phase 2 dose expansion cohort, in the third quarter of this calendar year. In addition, we anticipate reporting early data from the trial's combination arm, evaluating MDNA11 plus KEYTRUDA in the fourth quarter of this calendar year, providing us with multiple near-term opportunities to de-risk MDNA11 and demonstrate its potential as a vital component of cancer immunotherapy.

我們目前的預測是，我們將在今年第三季度報告來自 ABILITY 第六個、可能是最後一個劑量遞增隊列的數據，以及來自 2 期劑量擴展隊列的早期抗腫瘤活性數據。此外，我們預計將報告該試驗聯合組的早期數據，並在今年第四季度評估 MDNA11 加 KEYTRUDA，為我們提供多個近期機會來降低 MDNA11 的風險，並證明其作為癌症免疫治療重要組成部分的潛力。

Shifting gears, I would like to provide a brief update on MDNA55. The topline results from the single-arm Phase 2b clinical trial of MDNA55 in patients with recurrent unresectable glioblastoma, a uniformly fatal form of brain cancer, have been published in the peer-reviewed journal, Neuro-Oncology, which is the official publication of the Society for Neuro-Oncology. These results showed that the trial met its primary endpoint, with median overall survival in the primary and supportive analysis populations exceeding pre-defined success criteria and key historical benchmarks. These promising results helped us to align with the FDA on an innovative, open-label hybrid design for a potential pivotal trial.

言歸正傳，我想簡單介紹一下 MDNA55 的最新情況。 MDNA55 在復發性不可切除的膠質母細胞瘤（一種均致死的腦癌）患者中進行的單臂 2b 期臨床試驗的主要結果已發表在同行評審期刊《神經腫瘤學》上，該雜誌是神經腫瘤學會的官方出版物。這些結果表明，該試驗達到了主要終點，主要和支持性分析人群的中位總生存期超過了預先定義的成功標準和關鍵歷史基準。這些有希望的結果幫助我們與 FDA 就一項創新的、開放標籤的混合設計達成一致，以進行潛在的關鍵試驗。

I'm also happy to mention that the World Health Organization has approved the international non-proprietary name for MDNA55, which will now be referred to as bizaxofusp. Looking forward, we continue to pursue bizaxofusp's further development and potential commercialization through external partnership, as we have stated consistently in the past. This will allow us to enable bizaxo's advancement while maintaining our internal focus and resources on MDNA11 and our BiSKIT program, which was the subject of a key patent issued earlier this year.

我還很高興地提到，世界衛生組織已經批准了 MDNA55 的國際非專有名稱，現在將稱為 bizaxofusp。展望未來，正如我們過去所一貫聲明的那樣，我們將繼續通過外部合作夥伴關係尋求 bizaxofusp 的進一步發展和潛在的商業化。這將使我們能夠實現 bizaxo 的進步，同時保持我們對 MDNA11 和 BiSKIT 項目的內部關注和資源，該項目是今年早些時候發布的一項關鍵專利的主題。

This new-issued patent extends protection into at least 2039, with claims on methods of treating cancer with an IL-2 Superkine in combination with checkpoint inhibitors such as anti-PD1 inhibitor, which is being advanced in the combination arm of the ABILITY study; and for BiSKIT, such as MDNA223, which comprises an IL-2 Superkine linked to an anti-PD-1 antibody. The checkpoint inhibitor patents due to start expiring in 2028.

這項新頒發的專利將保護期延長至至少 2039 年，聲稱使用 IL-2 Superkine 與檢查點抑製劑（例如抗 PD1 抑製劑）聯合治療癌症的方法，該方法正在 ABILITY 研究的聯合組中取得進展； BiSKIT，例如 MDNA223，它包含與抗 PD-1 抗體連接的 IL-2 Superkine。檢查點抑製劑專利將於 2028 年開始到期。

We believe the data from ABILITY's combination study, as well as MDNA223's IP could be an important tool to facilitate collaborations or partnerships with leaders in this space.

我們相信來自 ABILITY 組合研究的數據以及 MDNA223 的 IP 可能成為促進與該領域領導者合作或夥伴關係的重要工具。

And with that, I have Liz review our fiscal third-quarter financial results. Liz?

接下來，我讓莉茲審查我們第三季度的財務業績。麗茲？

Thanks, Fahar. I'll begin today by reminding those listening that all references made during this section of the call are in Canadian dollar unless otherwise stated. As of December 31, 2022, Medicenna had cash and cash equivalents of $36.2 million. Based on our projections, our current cash resources are sufficient to fund our operations through the second quarter of calendar year 2024. This cash runway is expected to take us through several important clinical readouts and the completion of the ABILITY study, including both the monotherapy and combination expansion phases designed to assess MDNA11's efficacy in relevant patient population.

謝謝，法哈爾。今天開始，我將提醒聽眾，除非另有說明，否則通話這一部分中提到的所有內容均以加元為單位。截至2022年12月31日，Medicenna擁有現金和現金等價物3620萬美元。根據我們的預測，我們目前的現金資源足以為我們到 2024 年第二季度的運營提供資金。這條現金跑道預計將帶領我們完成幾個重要的臨床讀數並完成能力研究，包括旨在評估 MDNA11 在相關患者群體中的療效的單藥治療和聯合治療擴展階段。

Net loss for the quarter ended December 31, 2022, it was $1.1 million or $0.02 per share, compared to the loss of $4.8 million or $0.09 per share for the quarter ended December 31, 2021. The significant decrease of net loss for the quarter ended December 31, 2022, compared with the quarter ended December 31, 2021 was primarily a result of a non-cash gain of $3.7 million related to the change in valuation of a non-cash warrant liability associated with the August 2022 financing.

截至2022年12月31日的季度淨虧損為110萬美元，即每股0.02美元，而截至2021年12月31日的季度為虧損480萬美元，即每股0.09美元。與截至2021年12月31日的季度相比，截至2022年12月31日的季度淨虧損大幅減少，主要是由於與以下相關的非現金收益370萬美元與 2022 年 8 月融資相關的非現金認股權證負債估值發生變化。

Research and development expenses of $2.9 million were incurred during the quarter ended December 31, 2022, compared with $2.9 million incurred in the quarter ended December 31, 2021. Research and development expenses were consistent quarter over quarter. General and administrative expenses also remain consistent quarter over quarter with $2 million incurred during the quarter ended December 31, 2022, as well as during the quarter ended December 31, 2021.

截至2022年12月31日的季度發生的研發費用為290萬美元，而截至2021年12月31日的季度發生的研發費用為290萬美元。研發費用與上季度保持一致。一般和管理費用也與上一季度保持一致，截至 2022 年 12 月 31 日的季度以及截至 2021 年 12 月 31 日的季度產生了 200 萬美元。

For further details on our financials, please refer to our financial statements and management's discussion and analysis, which will be available on SEDAR and EDGAR respectively.

有關我們財務狀況的更多詳細信息，請參閱我們的財務報表以及管理層的討論和分析，這些內容將分別在 SEDAR 和 EDGAR 上發布。

With that, I'll hand the call back to Fahar for closing remarks.

至此，我會將電話轉回給法哈爾，讓其作結束語。

Thanks, Liz. Before opening up the call for Q&A, I'd like to first thank all those who have supported the progress we spoke about today, including our employees, partners, investigators, shareholders, and clinical trial participants.

謝謝，莉茲。在開始問答之前，我首先要感謝所有支持我們今天所討論進展的人，包括我們的員工、合作夥伴、研究人員、股東和臨床試驗參與者。

I would like to also emphasize how our recent progress has us set up for an exciting calendar year ahead with crucial milestones anticipated throughout 2023. The first of these milestones is expected later this quarter, which is when we anticipate reporting high-level PD findings from ABILITY's first five dose escalation cohorts and an update on anti-tumor activity. In cohorts one through four, MDNA11 displayed promising signs of monotherapy activity as well as safety PK and PD profiles that position it as a potentially best-in-class IL-2 therapy. The key objectives of cohorts five and six are to confirm if MDNA11's immunologic activity can be enhanced with higher doses, and whether these higher doses will be adequately tolerated.

我還想強調，我們最近的進展如何為未來令人興奮的一年做好準備，並預計在 2023 年實現關鍵里程碑。第一個里程碑預計將於本季度晚些時候實現，屆時我們預計將報告 ABILITY 前五個劑量遞增隊列的高水平 PD 研究結果以及抗腫瘤活性的最新情況。在第一至第四組中，MDNA11 顯示出單藥治療活性的良好跡像以及安全性 PK 和 PD 特徵，使其成為潛在的同類最佳 IL-2 療法。第 5 組和第 6 組的主要目標是確認 MDNA11 的免疫活性是否可以通過更高的劑量得到增強，以及這些更高的劑量是否能夠被充分耐受。

Based on what we see in additional readouts from the ABILITY's dose escalation phase, we will select the optimal dose and schedule for the trial's Phase 2 monotherapy expansion and combination arms. The Phase 2 component of the study will be specifically designed to assess MDNA11's efficacy in patients that are similar to its target populations. We therefore believe that the readouts anticipated from the Phase 2 portion of the trial, which are expected in the third and fourth quarter of calendar 2023, may represent significant de-risking events for the MDNA11 program.

根據我們在 ABILITY 劑量遞增階段的額外讀數中看到的情況，我們將為該試驗的 2 期單一療法擴展和聯合療法選擇最佳劑量和時間表。該研究的第二階段部分將專門設計用於評估 MDNA11 在與其目標人群相似的患者中的療效。因此，我們認為，預計在 2023 年第三和第四季度進行的第二階段試驗的結果可能代表 MDNA11 項目的重大去風險事件。

With encouraging signals of efficacy already observed in the extremely difficult-to-treat patients during the trial's dose escalation, we are optimistic about the ABILITY study's outlook. We look forward to its continued progress and providing periodic updates along the way.

在試驗劑量遞增過程中，在極難治療的患者中已經觀察到了令人鼓舞的療效信號，我們對能力研究的前景感到樂觀。我們期待它的持續進展並在此過程中提供定期更新。

And with that, we will now begin our Q&A session. Operator?

接下來，我們將開始問答環節。操作員？

Thank you. (Operator Instructions) Charles Zhu, Guggenheim Partners, LLC.

謝謝。 （操作員說明）Charles Zhu，Guggenheim Partners, LLC。

Good morning, everyone. Thanks for hosting the call and for taking the questions. First one from me, if I recall, dose cohort five was also the first when you instituted the new requirements around baseline lymphocytes. To what degree might the enhanced lymphocyte stimulation or PD markers you're observing be influenced by this higher baseline? And how do you think about that relative to the higher doses of MDNA11 you're evaluating? Thanks.

大家，早安。感謝您主持電話會議並回答問題。如果我沒記錯的話，我的第一個劑量組也是您圍繞基線淋巴細胞制定新要求時的第一個劑量組。您觀察到的增強的淋巴細胞刺激或 PD 標誌物可能會在多大程度上受到較高基線的影響？相對於您正在評估的更高劑量的 MDNA11，您如何看待這一點？謝謝。

Thank you, Charles. That's a good question. Certainly, as you know, we set a threshold for lymphocyte counts in this particular study. And we clearly are seeing that, and we've seen mostly from previous studies with Proleukin, where a high baseline lymphocyte count generally results in better patient outcomes.

謝謝你，查爾斯。這是個好問題。當然，如您所知，我們在這項特定研究中設定了淋巴細胞計數的閾值。我們清楚地看到了這一點，而且我們主要從之前的 Proleukin 研究中看到，高基線淋巴細胞計數通常會帶來更好的患者治療結果。

The key thing here is, although that's something that's been demonstrated historically, we certainly do not have as much data with our therapy and our therapeutic regimens that we use with MDNA11. Needless to say, we have -- I think, if you recall between the first three cohorts where the doses were below 60 micrograms per kilogram, we still saw patients with stable disease including a patient that continues to be treated in cohort two; who started at 10 micrograms per kilogram, where the lymphocyte count or the baseline lymphocyte count was not necessarily set at 1,000 per microliter.

這裡的關鍵是，儘管歷史上已經證明了這一點，但我們當然沒有與 MDNA11 一起使用的療法和治療方案那麼多的數據。不用說，我想，如果你還記得劑量低於每公斤 60 微克的前三個隊列，我們仍然看到疾病穩定的患者，包括在第二隊列中繼續接受治療的患者；他們以每公斤 10 微克開始，其中淋巴細胞計數或基線淋巴細胞計數不一定設定為每微升 1,000 個。

So it may be a sort of a threshold that's maybe more relevant for Proleukin or other IL-2-based agents. But certainly as far as we are concerned, although we feel that you can get to the threshold lymphocyte count or a higher lymphocyte count or expansion to occur, we certainly haven't seen any consistency in the data that we have so far. Nevertheless, we expect that as we enter into sort of the Phase 2 portion of the study where we have patients with higher -- or sort of left heavily pre-treated healthier patients, more likely that we'll have patients with a higher lymphocyte count.

因此，它可能是一種與 Proleukin 或其他基於 IL-2 的藥物更相關的閾值。但當然就我們而言，儘管我們認為可以達到淋巴細胞計數閾值或更高的淋巴細胞計數或發生擴增，但我們迄今為止所掌握的數據當然還沒有看到任何一致性。儘管如此，我們預計，當我們進入研究的第二階段部分時，我們的患者的淋巴細胞計數較高，或者是經過大量預先治療的較健康的患者，我們更有可能會遇到淋巴細胞計數較高的患者。

So it's a bit premature right now to come to any conclusions based on the data we have on only 14 patients so far. But we are encouraged to see that even a patient who started at less than 1,000 lymphocytes per microliter continues to be on study for now 15 months. So that's quite encouraging.

因此，根據迄今為止我們僅掌握的 14 名患者的數據得出任何結論還為時過早。但令我們感到鼓舞的是，即使是開始時淋巴細胞含量低於每微升 1,000 個的患者，現在仍繼續接受研究 15 個月。所以這非常令人鼓舞。

Got it. Great. Thanks for taking the question.

知道了。偉大的。感謝您提出問題。

Thank you. Matt Biegler, Oppenheimer & Co. Inc.

謝謝。馬特·比格勒，奧本海默公司

Hey, guys, thanks for the update. I'm curious, Fahar, based on the preclinical data. Do we expect to plateau out on lymphocyte count in cohort six, or I guess, another way to ask the question is how do we know when we're at the recommended Phase 2 dose? And I have a follow-up.

嘿，伙計們，感謝您的更新。法哈爾，根據臨床前數據，我很好奇。我們是否期望第六組中的淋巴細胞計數達到穩定水平，或者我猜，提出這個問題的另一種方式是我們如何知道何時達到推薦的第 2 期劑量？我有一個後續行動。

Right. Thanks, Matt. That's a good question again. And I must say that you're right on spot when you talk about the data from preclinical studies. So certainly what we have -- the way we have projected dosing regimens and selecting the different doses in different cohorts, is given mostly by extrapolating from data we have from non-human primate stats. And based on the safety windows that we saw in non-human primates, as well as where we saw the threshold occurring in non-human primates, I would say that the current dosing regimen that we are enrolling patients in, which is the cohort six, at 1.3 micrograms per kilogram, is pretty much close to where we are expecting this to plateau.

正確的。謝謝，馬特。這又是一個好問題。我必須說，當您談論臨床前研究的數據時，您是對的。因此，我們所擁有的——我們預測的給藥方案和在不同群體中選擇不同劑量的方式，主要是根據我們從非人類靈長類動物統計數據中推斷出來的。根據我們在非人類靈長類動物中看到的安全窗口，以及我們在非人類靈長類動物中看到的閾值，我想說的是，我們目前正在招募患者的劑量方案，即第六組，劑量為每公斤 1.3 微克，非常接近我們預期的穩定水平。

As you know, we saw pretty impressive results at starting at cohort four at the 60 micrograms per kilogram dose. So far, we have had, as you know, the data we have shared on the seven patients that have received more than 60 or 60 micrograms per kilogram or higher. And based on the data we have so far, it seems like we are seeing pretty impressive clinical activity, add to about the fact that we are continuing to see increases in lymphocyte count at 90 micrograms per kilogram as reported today. We believe that when we get to 120 micrograms per kilogram, we should be pretty much on par with the upper limits of dosing where we had from non-human primates.

如您所知，我們從第四組開始以每公斤 60 微克的劑量看到了相當令人印象深刻的結果。如您所知，到目前為止，我們已經分享了七名接受超過每公斤 60 或 60 微克或更高劑量的患者的數據。根據我們迄今為止掌握的數據，我們似乎看到了相當令人印象深刻的臨床活動，此外我們還繼續看到淋巴細胞計數以每公斤 90 微克的速度增加，正如今天報導的那樣。我們相信，當達到每公斤 120 微克時，我們應該與非人類靈長類動物的劑量上限基本持平。

So far, the trends from non-human primate data are predictive of what we are seeing with the lymphocyte counts with our expansion of CD8 T cells, NK cells have been consistent. And we believe that we are pretty much close to that upper limit. And we do not expect that we will necessarily have to go to a sort of next higher dose, but we already have a promising data from the 60 micrograms, and we'll have data from 90 and 120. So we have three sets of data or dosing to pick from in view of the fact that we've met the safety boarding with both the 60 and 90 micrograms. And safely meet the same safety boarding at the 120.

到目前為止，非人類靈長類動物數據的趨勢可以預測我們所看到的淋巴細胞計數與 CD8 T 細胞、NK 細胞擴增的情況是一致的。我們相信我們已經非常接近這個上限了。我們並不期望我們一定要採用下一個更高的劑量，但我們已經從 60 微克獲得了有希望的數據，並且我們將獲得 90 和 120 微克的數據。因此，鑑於我們已經通過 60 和 90 微克的安全登機，我們有三組數據或劑量可供選擇。並安全地在 120 處安全登機。

But generally across the board, we feel pretty comfortable that above 60 onwards, we should be having a therapeutic activity that's more than adequate for MDNA11. Obviously, we want to make sure that before we enter the Phase 2 portion of the trial, we need to make sure that we can confirm that by testing the higher doses as well.

但總的來說，我們覺得 60 歲以上之後，我們應該有足夠多的 MDNA11 治療活動。顯然，我們希望確保在進入試驗的第二階段部分之前，我們需要確保我們也可以通過測試更高的劑量來確認這一點。

Right, right. Makes sense. Okay. And then maybe just a quick follow up on -- I'm sure you're aware Proleukin was effectively sold to Iovance few weeks ago. I'm just kind of curious on your view of that transaction and kind of what that means for the field. And if in the future, there's any opportunities to combine with other therapeutic modalities outside of checkpoint inhibitors. Thanks.

是的是的。說得通。好的。然後也許只是快速跟進 - 我相信您知道 Proleukin 在幾週前實際上被賣給了 Iovance。我只是好奇你對這筆交易的看法以及這對該領域的意義。如果將來有機會與檢查點抑製劑之外的其他治療方式相結合。謝謝。

Again, a really good question, Matt. That really was an indication as to how large the potential opportunity is for molecules such as MDNA11. I think if you recall, the data from Iovance presented at SITC clearly indicated that in the Phase 3 setting, whether we're using Proleukin, the toxicities were clearly there. They were obviously not desirable. And it's not surprising that Iovance is also looking to develop a much safer version of IL-2.

這又是一個非常好的問題，馬特。這確實表明 MDNA11 等分子的潛在機會有多大。我想如果您還記得的話，Iovance 在 SITC 上提供的數據清楚地表明，在第 3 階段的情況下，無論我們是否使用 Proleukin，毒性都明顯存在。他們顯然是不受歡迎的。毫不奇怪，Iovance 也在尋求開發更安全的 IL-2 版本。

So I believe that the potential for IL-2, particularly MDNA11, where we have the selectivity for boosting NK cells and CD8 T cells, and not T regs, becomes really important because after going through a long process of isolating your T cells from the patient and then having to expand them through ex vivo manufacturing and then re-infusing that T cells. That itself, I think as you know, is a long process and you want to make sure that you have the best quality of T cells that you're infusing into the patient.

因此，我相信 IL-2（尤其是 MDNA11）的潛力變得非常重要，我們可以選擇性地增強 NK 細胞和 CD8 T 細胞（而不是 T reg），因為在經歷了從患者體內分離 T 細胞的漫長過程，然後必須通過離體製造來擴增它們，然後重新註入 T 細胞。我認為正如您所知，這本身是一個漫長的過程，您需要確保注入患者體內的 T 細胞質量最佳。

The good thing about a molecule such as MDNA11 is that, as you know, it does not do a good job of stimulating your immunosuppressive T regs. And this is exactly what we want, is from a manufacturing perspective, make sure that you are able to boost the population of CD8 T cells and NK cells, not T regs. Which unfortunately is not the case with Proleukin because it will boost the population of T regs.

如您所知，MDNA11 等分子的好處在於，它不能很好地刺激免疫抑制性 T 調節細胞。這正是我們想要的，從製造角度來看，確保能夠增加 CD8 T 細胞和 NK 細胞的數量，而不是 T reg 的數量。不幸的是，Proleukin 的情況並非如此，因為它會增加 T reg 的數量。

And then when you insert or re-infuse the T cells, you want to continue to expand those T cells selectively not expand your T regs and this is again where MDNA11 has its distinct selectivity and therefore distinct advantage. So we believe that this particular Iovance transaction sets the stage clearly for all other T cell-based processes or CAR-T-based processes, et cetera, where not only would a drug such as MDNA11 be ideal for manufacturing purposes or more importantly, is to then stimulate those T cells in the patient without boosting your T reg population. So that's I think an important industry of -- important opportunity to exploit. And I think MDNA11 is really well suited for that purpose.

然後，當您插入或重新輸注 T 細胞時，您希望繼續選擇性地擴增這些 T 細胞，而不是擴增您的 T reg，這又是 MDNA11 具有獨特選擇性和獨特優勢的地方。因此，我們相信，這一特定的 Iovance 交易為所有其他基於 T 細胞的工藝或基於 CAR-T 的工藝等奠定了明確的基礎，其中 MDNA11 等藥物不僅是製造目的的理想選擇，更重要的是，可以在不增加 T reg 群體的情況下刺激患者體內的 T 細胞。所以我認為這是一個重要的行業——值得利用的重要機會。我認為 MDNA11 非常適合這個目的。

Great. Cool. Thank you, guys for the question.

偉大的。涼爽的。謝謝你們的提問。

Thank you. David Martin, Bloom Burton & Co.

謝謝。大衛·馬丁，布魯姆·伯頓公司

Good morning. I've got a couple of questions. The first one is just a clarification. When you were speaking, Fahar, I think you said that we get a PK/PD and initial efficacy results for cohort five in the first calendar quarter. In the press release, it kind of indicates only PK/PD and the efficacy will be an update for cohorts one through four. Just confirming, are we getting efficacy data for cohort five in Q1?

早上好。我有幾個問題。第一個只是一個澄清。 Fahar，當您講話時，我想您說過我們在第一季度獲得了第五組的 PK/PD 和初步療效結果。在新聞稿中，它僅表示 PK/PD，療效將是第一至第四組的更新。只是確認一下，我們是否獲得了第一季度第五組的療效數據？

I did not realize. Thanks, David, for that particular question. But yes, let me sort of correct that, if the press release did not mention that then apologies. But yes, the intent is for us to release the PK/PD, but also the tumor activity data from cohort five before the end of this quarter.

我沒意識到。謝謝大衛提出這個特別的問題。但是，是的，讓我糾正一下，如果新聞稿沒有提到這一點，那麼抱歉。但是，是的，我們的目的是在本季度末之前發布 PK/PD，以及第五隊列的腫瘤活動數據。

Okay. Thanks, Fahar. Another clarification. So with the patients with higher baseline lymphocyte counts in cohort five and six, you had anticipated that by using that inclusion criteria that you would get healthier patients. And yet you're saying the cohort five, cohort six are still very sick patients and you only start getting healthier patients in the dose expansion. So is that correct, by selecting based on higher baseline lymphocyte, you didn't get healthier patients in five and six?

好的。謝謝，法哈爾。另一個澄清。因此，對於第五組和第六組中基線淋巴細胞計數較高的患者，您預計通過使用該納入標準，您將獲得更健康的患者。然而你說第五組、第六組仍然是病情很重的患者，並且在劑量擴展中才開始讓患者變得更健康。那麼，通過基於較高基線淋巴細胞的選擇，您在五六歲的時候並沒有得到更健康的患者，這是正確的嗎？

Well, it is not. As you know, healthier patients is based on the healthier immune system. Certainly, in cohorts five and six, you end up with patients with sort of a baseline lymphocyte count that is higher than what we enrolled in cohorts one, two, and three. So from that perspective, certainly what we want to try and simulate is obtain or realize that in cohorts -- in the expansion cohorts, we will be looking at patients that have gone through fewer lines of therapy. And therefore, we expect that those patients enrolled in that expansion cohort will likely have higher lymphocyte counts.

嗯，事實並非如此。如您所知，健康的患者基於更健康的免疫系統。當然，在第五組和第六組中，最終患者的基線淋巴細胞計數高於我們在第一組、第二組和第三組中登記的患者。因此，從這個角度來看，我們當然想要嘗試和模擬的是獲得或認識到，在隊列中——在擴展隊列中，我們將關注接受過較少治療的患者。因此，我們預計參加該擴展隊列的患者可能會有更高的淋巴細胞計數。

So in a sense for us to provide that information, together that information, we are better able to foresee what to expect going down the road. But remember, one thing about patients that have gone through multiple lines of therapy, is their lymphocyte count primarily from their immune health perspective. But then again, there are a host of other issues that we need to take care of or worry about. Because remember, in the dose escalation portion of the study, where we are is really treating about a dozen different type of tumors in this particular portion of the trial.

因此，從某種意義上說，我們提供這些信息，綜合這些信息，我們就能夠更好地預見未來會發生什麼。但請記住，對於經歷過多種治療的患者來說，一件事是他們的淋巴細胞計數主要是從免疫健康的角度來看的。但話又說回來，還有許多其他問題需要我們處理或擔心。因為請記住，在研究的劑量遞增部分，我們實際上正在治療大約十幾種不同類型的腫瘤。

So trying to sort of come up with some kind of homogeneity or minimizing the variability into these points here with sort of trying to stabilize and using 1,000 lymphocyte counts per se. But nonetheless, patients would have, as you know, gone through so many different type of therapies, some focused on immunotherapies, others with different kinds of chemotherapies as well. So we have a very diverse patient population in the dose escalation phase where not only are we dealing with different tumor types, but also different therapies that patients have received.

因此，試圖想出某種同質性或最大限度地減少這些點的變異性，並嘗試穩定並使用 1,000 個淋巴細胞計數本身。但儘管如此，如您所知，患者會經歷許多不同類型的治療，其中一些側重於免疫療法，另一些則採用不同類型的化療。因此，在劑量遞增階段，我們的患者群體非常多樣化，我們不僅要處理不同的腫瘤類型，還要處理患者接受的不同治療方法。

And patient health is not only determined by the immune count, but also from other prognostic factors. Age is a good example, for instance. So that also we cannot obviously restrict from that perspective. But there is a host of variations that we take into account. But the focus really now is planning for the dose expansion phase of the study and identifying two or three different tumor types that are most likely to be beneficial to the patients. These patients certainly will not be on stage patients. And therefore, we expect the patients to be more homogeneous than we were in the Phase 1 dose escalation part, where even if you have a lymphocyte count standardized, we still are dealing with 12 to 15 different tumor types.

患者的健康狀況不僅取決於免疫計數，還取決於其他預後因素。例如，年齡就是一個很好的例子。因此，我們也不能從這個角度明顯限制。但我們考慮到了許多變化。但現在真正的重點是規劃研究的劑量擴展階段，並確定最有可能對患者有益的兩種或三種不同的腫瘤類型。這些病人肯定不會是舞台上的病人。因此，我們預計患者比第一階段劑量遞增部分更加同質，即使淋巴細胞計數標準化，我們仍然要處理 12 至 15 種不同的腫瘤類型。

So it's a sort of a combination of different -- of far too many parameters in the dose escalation portion that we cannot really predict what would happen. But nevertheless --

因此，這是劑量遞增部分中太多參數的不同組合，我們無法真正預測會發生什麼。但儘管如此 -

Okay. Very encouraging to see that in cohort six, we were able to show promising data above 1,000 lymphocyte count. Okay, just one last quick question. With the new priming schedule, you say you get to the 60 dose faster. Can you remind me when -- your dose cohort, the dose at 60, did you go right to 60? Or did you start at 30 and went to 60?

好的。非常令人鼓舞的是，在第六組中，我們能夠顯示出超過 1,000 個淋巴細胞計數的有希望的數據。好的，最後一個簡單的問題。根據新的啟動時間表，您可以更快地達到 60 劑。你能提醒我什麼時候——你的劑量組，60 的劑量，你直接達到了 60 嗎？或者你是從30歲開始一直到60歲？

No. We started at 30, and there were two doses of 30 in the cohort four, and then went to 60. So it took four weeks before you got to 60. In this case, we'll get to 60 in two weeks.

不。我們從 30 歲開始，第四組中有兩劑 30 劑，然後達到 60 劑。所以花了四個星期才達到 60 劑。在這種情況下，我們將在兩週內達到 60 劑。

And you're pretty comfortable that they'll be able to tolerate getting to 60 that fast?

您對他們能夠忍受這麼快達到 60 歲感到很放心嗎？

Well, that's the objective. And that's why we had a safety review committee to make that final call.

嗯，這就是目標。這就是為什麼我們有一個安全審查委員會來做出最後決定。

Okay. Okay. That's it for me. Thanks.

好的。好的。對我來說就是這樣。謝謝。

Thank you. Swayampakula Ramakanth, H.C. Wainwright & Co., LLC

謝謝。斯瓦安帕庫拉·拉瑪坎特 (Swayampakula Ramakanth)，H.C.溫賴特有限公司

Thank you. Good morning, Fahar and Liz. A lot of my questions have been answered. When you get to Phase 2, I was just wondering among the four indications that seem to be the ones that you're looking at during this stage of development, how would you order them? Or would you consider just taking the pancreatic and melanoma as indications to go forward?

謝謝。早上好，法哈爾和莉茲。我的很多問題都得到了解答。當你進入第二階段時，我只是想知道，在你在這個開發階段所關注的四個適應症中，你會如何排列它們？或者您會考慮僅將胰腺癌和黑色素瘤作為繼續前進的適應症嗎？

Yeah. We haven't decided specifically on the tumor types so far. I think we continue to review that data. We certainly will be collecting more data in from cohort five, cohort six, as well as historical data that we've seen so far from the first four cohorts. So we are working closely as to what indications to pursue it in the dose expansion. And we will provide an update as soon as we have had received feedback and guidance from our clinical advisers, KOLs, et cetera, based on the growing body of evidence from the current study that we are conducting. So nothing has been etched in stone at this moment.

是的。到目前為止我們還沒有具體決定腫瘤類型。我認為我們會繼續審查這些數據。我們當然會從第五組、第六組以及我們迄今為止從前四個組中看到的歷史數據中收集更多數據。因此，我們正在密切合作，以確定在劑量擴展中追求哪些適應症。一旦收到臨床顧問、KOL 等的反饋和指導，我們將根據我們當前正在進行的研究中越來越多的證據提供最新信息。所以此時此刻還沒有什麼是刻在石頭上的。

Okay. And then one last question from me, any update on the BiSKIT program because we didn't hear much today.

好的。然後是我的最後一個問題，關於 BiSKIT 計劃的任何更新，因為我們今天沒有聽到太多消息。

Yeah. So the BiSKIT program. Since our last set of data we presented at a conference late last year, we continue to advance that particular program but certainly are continuing to optimize the design of the molecule and generating more in vitro, in vivo studies and characterizing that molecule further. So we will -- as we get an opportunity to present data at additional conferences or submit a publication, we will be providing more evidence and more data at that time.

是的。所以 BiSKIT 程序。自從我們在去年年底的一次會議上提交了最後一組數據以來，我們繼續推進該特定計劃，但肯定會繼續優化分子的設計，並進行更多的體外、體內研究，並進一步表徵該分子。因此，當我們有機會在其他會議上展示數據或提交出版物時，我們將在那時提供更多證據和數據。

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

好的。謝謝。感謝您提出問題。

You're welcome. Thank you.

不客氣。謝謝。

Thank you. Catherine Novack, Jones Research.

謝謝。凱瑟琳·諾瓦克，瓊斯研究中心。

Hi, good morning. Thanks for taking my question. Just a couple from me. One, in terms of the Phase 2 cohort data or Phase 2 data in the third quarter of '23. I'm curious, does that mean that you've settled on a Phase 2 dose given that I imagine that you'll have to start enrolling that before the 120 micrograms per kilogram dose cohort has finished reading out, or do you anticipate further dose finding work in the extension phase?

早上好。感謝您提出我的問題。只是我的一對。一，就 2023 年第三季度的 2 期隊列數據或 2 期數據而言。我很好奇，這是否意味著您已經確定了第 2 階段的劑量，因為我想您必須在每公斤 120 微克的劑量組完成讀出之前開始註冊，或者您預計在擴展階段會進一步尋找劑量嗎？

No. We will not be doing any further dose finding studies during expansion phase. So we will establish what we call is a provisional recommended Phase 2 dose that will be executed and implemented in the dose expansion phase of the study. So that's the plan, and we expect that we'll have some early data by the end of third quarter this year.

不會。在擴展階段，我們不會進行任何進一步的劑量探索研究。因此，我們將確定臨時推薦的第 2 期劑量，該劑量將在研究的劑量擴展階段執行和實施。這就是計劃，我們預計將在今年第三季度末獲得一些早期數據。

Okay. And then can you give any additional color maybe on the kind of efficacy data we'll see from cohort five, how many patients, what kind of follow-up? And then have you gotten any additional paired biopsies in this quarter or in this cohort?

好的。然後您能否對我們將從第五組中看到的療效數據提供任何額外的信息，有多少患者，什麼樣的隨訪？那麼您在本季度或本隊列中是否進行了任何額外的配對活檢？

Yeah. So we will be providing more data as we plan to do that at the end of this quarter. This will allow us to share with you all the patients that had been enrolled in cohort five, the type of tumors they had, the number of lines of therapy they had, as well as the PK/PD, and of course, tumor response data. So we'll be presenting all that together as a complete set of data, including data from patients in earlier cohorts that are still on the study.

是的。因此，我們計劃在本季度末提供更多數據。這將使我們能夠與您分享第五隊列中登記的所有患者、他們的腫瘤類型、他們接受的治療線數、PK/PD，當然還有腫瘤反應數據。因此，我們將把所有這些作為一組完整的數據一起呈現，包括來自仍在研究的早期隊列中的患者的數據。

Okay. And then in terms of patients that are still on the study, I believe that the last update, there were three [storm] study. Any update on that?

好的。然後就仍在研究的患者而言，我相信上次更新，有三項[風暴]研究。有更新嗎？

Yes. So that will be when we present that update at the end of this quarter on those three patients plus the patients in cohort five. So we will be able to share all that information including the data from more recent scans from not only cohort five, but also from the earlier cohorts as well.

是的。因此，我們將在本季度末介紹這三名患者以及第五組患者的最新情況。因此，我們將能夠共享所有這些信息，包括來自第五組和早期組的最新掃描數據。

All right. Thanks so much for taking my questions.

好的。非常感謝您回答我的問題。

You're welcome.

不客氣。

Thank you. David Bautz, Zacks Small Cap Research.

謝謝。大衛·鮑茨 (David Bautz)，Zacks 小盤股研究公司。

Hey. Good morning, everyone. Fahar, I'm curious why you aren't restricting the patients for cohort six to certain tumor types. I understand you haven't decided exactly what you're going to look at in the Phase 2 expansion cohort, but I'm curious why you aren't limiting it to the even the ones you're considering for Phase 2.

嘿。大家，早安。 Fahar，我很好奇為什麼你不將第六組的患者限制為某些腫瘤類型。我知道您還沒有確切地決定在第二階段擴展隊列中要關注什麼，但我很好奇為什麼您不將其限制為您正在考慮的第二階段的內容。

No. I think the key thing here is, of course, the range of tumor types we've already treated is as I said, about a dozen or so. Trying to generate data on three different tumor types in a cohort of maybe three or six patients is unlikely to provide you with certainly any trending data. But obviously what we are trying to do is try and enroll more patients that would potentially fit the profile for the dose expansion. But we're not sort of -- change the protocol right now Neither have we instructed the sites to only limit it to one or two or three different tumor types. It's too early.

當然，我認為這裡的關鍵是，我們已經治療的腫瘤類型範圍正如我所說，大約有十幾種。嘗試在三到六名患者的隊列中生成三種不同腫瘤類型的數據肯定不可能為您提供任何趨勢數據。但顯然我們正在努力做的是嘗試招募更多可能符合劑量擴展情況的患者。但我們現在並沒有改變協議，我們也沒有指示這些站點將其僅限於一種或兩種或三種不同的腫瘤類型。太早了。

I would say that the purpose of dose expansion is to do that exact same as -- the idea in the dose expansion is to really have adequate number of patients in those two or three different type of tumors, rather than having to make a decision based on three or six patients.

我想說，劑量擴展的目的是完全相同的——劑量擴展的想法是真正有足夠數量的患者治療這兩種或三種不同類型的腫瘤，而不是必鬚根據三到六名患者做出決定。

Okay. That makes sense. And then real quick, when you present this updated data later on this quarter, will that be at a scientific conference or is that going to be through the press release?

好的。這就說得通了。然後很快，當您在本季度晚些時候提供這些更新的數據時，是在科學會議上還是通過新聞稿？

Well, as we said, the data from cohort five will be presented at the end of this quarter. With additional data that comes through, it's likely that we'll present at a scientific conference. So we will at that point, depending on when the scientific conference takes place, we should have more data on cohort six, potentially even early data on the dose expansion. But that remains to be seen.

嗯，正如我們所說，第五組的數據將在本季度末公佈。有了更多的數據，我們很可能會在科學會議上展示。因此，我們屆時將根據科學會議的召開時間，獲得有關第六組的更多數據，甚至可能獲得有關劑量擴展的早期數據。但這還有待觀察。

Okay. Sounds good. Thanks for taking the questions.

好的。聽起來不錯。感謝您提出問題。

You're welcome.

不客氣。

Thank you. At this time, I turn the floor back over to Dr. Fahar Merchant for closing comments.

謝謝。此時，我將發言權轉回給 Fahar Merchant 博士以徵求結束意見。

Thank you. Thank you very much, all of you, for joining the call today. Really appreciate the support, the patients that have participated in the clinical trials, as well as the families and the investigators that have been patient with the clinical study itself. And of course, all our shareholders, employees, et cetera, that have been supporting Medicenna progress. We look forward to providing with all of you some additional updates as we said at the end of this quarter, as well as at the end of Q3. And in between, hopefully at a time when there is a conference before the end of third quarter, we report additional updates.

謝謝。非常感謝大家今天加入電話會議。非常感謝參與臨床試驗的患者以及對臨床研究本身保持耐心的家屬和研究人員的支持。當然，還有我們所有的股東、員工等，他們一直支持 Medicenna 的進步。正如我們在本季度末以及第三季度末所說的那樣，我們期待著向大家提供一些額外的更新。在此期間，希望在第三季度末之前召開會議時，我們會報告更多更新。

So look forward to providing those additional data in the coming weeks and months. And thank you all for joining today's call.

因此，期待在未來幾周和幾個月內提供這些額外數據。感謝大家參加今天的電話會議。

Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time or log off the webcast and enjoy the rest of your day.

女士們、先生們，感謝您的參與。今天的活動到此結束。此時您可以斷開線路或退出網絡廣播並享受剩下的一天。