Oncolytics Biotech Inc (ONCY) 2025 Q1 法說會逐字稿

Good afternoon and welcome to Oncolytics Biotech's first-quarter conference call. (Operator Instructions) Please be advised that this call is being recorded at the company's request.

下午好，歡迎參加 Oncolytics Biotech 第一季電話會議。（操作員指示）請注意，此通話是應公司要求錄音的。

I would like to turn a call over to Jon Patton, Director of Investor Relations and Communication. Please go ahead.

我想將電話轉給投資者關係和溝通總監喬恩·巴頓 (Jon Patton)。請繼續。

Thank you, operator. Today we'll provide an update on the quarter and a review of our financials. As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of pelareorep, including statements regarding the company's ongoing CEO search, our mission, strategies, and milestones; the company's belief as to the potential and mechanism of action of pelareorep as a cancer therapeutic; our potential registrational opportunities for pelareorep and our plans and strategies related there too; our plans to continue enrollment in GOBLET Cohort 5; our ongoing business development initiatives; and other statements related to anticipated developments in the company's business.

謝謝您，接線生。今天我們將提供本季的最新情況和財務狀況的回顧。提醒一下，本次電話會議中的各種言論包含與公司業務前景以及 pelareorep 的開發和商業化有關的某些前瞻性陳述，包括有關公司正在進行的 CEO 搜索、我們的使命、戰略和里程碑的陳述；公司對 pelareorep 作為癌症治療的潛力和作用機制的信念；我們對 pelarehororep 的潛在註冊計劃以及我們與我們繼續參加戰略和戰略；的計劃；我們正在進行的業務發展計劃；以及與公司業務預期發展相關的其他聲明。

These statements are based on management's current expectations and beliefs. And they're subject to a number of factors, which involve none and non-rest delays, uncertainties, and other factors not under the company's control. They may cause actual results, performance, or achievements of the company to be materially different from the results, performance, expectations implied by these for statements. In any forward-looking statement, in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith, our beliefs have a reasonable basis, but there can be no assurance that the statement of expectation or belief will be achieved.

這些聲明是基於管理層當前的期望和信念。而且它們受到許多因素的影響，包括無延誤和非延誤、不確定性以及其他公司無法控制的因素。它們可能導致公司的實際結果、業績或成就與這些陳述所暗示的結果、業績或預期有重大差異。在任何前瞻性聲明中，Oncolytics 都會表達對未來結果的期望或信念，這種期望或信念是真誠表達的，我們的信念有合理的基礎，但不能保證該期望或信念的陳述會實現。

These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and those other factors detailed in the company's filings with SEDAR and the SEC. Oncolytics does not undertake any obligation to update these overlooking statements, except as required by applicable laws.

這些因素包括目前或正在進行的臨床試驗的結果、與智慧財產權保護相關的風險、財務預測、監管機構的行動以及公司向 SEDAR 和 SEC 提交的文件中詳述的其他因素。Oncolytics 不承擔更新這些忽略聲明的任何義務，除非適用法律要求。

On today's call, I'm joined by Chair of Oncolytics' Board of Directors and interim CEO, Wayne Piisano; Chief Medical Officer, Dr. Tom Heineman; VP of Business Development, Christophe Decois; and Chief Financial Officer, Kirk Look. The team will be available for Q&A at the end of this call.

在今天的電話會議上，與我一起參加會議的還有 Oncolytics 董事會主席兼臨時首席執行官 Wayne Piisano、首席醫療官 Tom Heineman 博士、業務發展副總裁 Christophe Decois 和首席財務官 Kirk Look。本次通話結束後，團隊將參與問答環節。

And with that, I'll hand it over to Wayne.

說完這些，我就把麥克風交給韋恩。

Good afternoon, everyone, and thank you, Jon. I know it's only been a short time since we last provided a corporate update, so today's call will be relatively brief. I'll run through the important developments from the quarter, and then ask Tom to discuss our critical progress, and Chris off to share a business development update. Then Kirk will say a few words about our financials.

大家下午好，謝謝你，喬恩。我知道距離我們上次提供公司最新情況才過去不久，所以今天的電話會議會相對簡短。我將介紹本季的重要發展，然後請湯姆討論我們的關鍵進展，並請克里斯分享業務發展最新情況。然後柯克會講幾句關於我們財務狀況的話。

To start, I want to let you know that our CEO search is active, and we've met several excellent candidates. With an asset like pelareorep, which has potential and numerous consequential indications, we are aiming to find a leader who can steward pela with a laser focus on clinical trial execution. Our clinical data continues to exceed expectations, and we believe the further development of pela will allow it to fulfill its potential as a valuable treatment option for patients with several difficult to treat malignancies, including pancreatic cancer, breast cancer, and anal carcinoma, all of which have a high unmet medical need.

首先，我想告訴大家，我們正在積極尋找首席執行官，並且已經遇到了幾位優秀的候選人。憑藉像 pelareorep 這樣具有潛力和眾多重要適應症的資產，我們的目標是找到一位能夠專注於臨床試驗執行的領導者。我們的臨床數據繼續超越預期，我們相信 pela 的進一步發展將使其發揮其潛力，成為多種難以治療的惡性腫瘤患者的寶貴治療選擇，包括胰腺癌、乳腺癌和肛門癌，這些疾病都有很高的未滿足的醫療需求。

Additionally, the new CEO will provide invaluable leadership and strategic decision making surrounding our planned registration enabling study, evaluating pela and paclitaxel in advanced or metastatic HR positive, HR2 negative breast cancer. And I hope to be able to announce our new CEO in the near future.

此外，新任執行長將圍繞我們計劃的註冊授權研究提供寶貴的領導力和策略決策，評估 pela 和紫杉醇在晚期或轉移性 HR 陽性、HR2 陰性乳癌中的作用。我希望能夠在不久的將來宣布我們的新執行長。

Pelareorep or pela, as we often call it, is a unique and versatile immunotherapeutic agent that we believe has tremendous potential to help a wide range of cancer patients. As discussed during a key opinion leader event in March, Professor Alexander Eggermont described pela's benefits, including intravenous administration. The ability to be taken to tumor sites via monocytes and lymphocytes, and that it doesn't create anti-aging antibodies, allowing T cells to reach the tumor for long lasting responses, all without infecting normal healthy cells.

Pelareorep 或我們常說的 pela 是一種獨特且用途廣泛的免疫治療劑，我們相信它具有幫助廣大癌症患者的巨大潛力。正如 3 月在一次關鍵意見領袖活動中討論的那樣，Alexander Eggermont 教授描述了 pela 的益處，包括靜脈注射。它能夠透過單核細胞和淋巴細胞被帶到腫瘤部位，並且不會產生抗衰老抗體，使 T 細胞到達腫瘤進行持久反應，而不會感染正常健康細胞。

During the same call, Professor Martine Piccard, a leading expert in breast cancer, shared her experience in the clinic and confirmed intravenous administration is much preferred to any intra-tumoral interventions. She also discussed pela's opportunity in breast cancer and the multitude of registrational opportunities for an asset like pela. She confirmed support for the continued advancement of pela based on two randomized studies confirming its ability to provide an overall survival benefit in breast cancer. She also discussed her belief that there could be an opportunity for pela to benefit patients at an earlier stage of treatment, possibly in a curative setting.

在同一次電話會議中，乳癌領域的頂尖專家 Martine Piccard 教授分享了她的臨床經驗，並確認靜脈給藥比任何腫瘤內幹預都更可取。她也討論了 pela 在乳癌領域的機會以及 pela 等資產的眾多註冊機會。她支持繼續推進 pela 療法，理由是兩項隨機研究證實了 pela 療法能夠為乳癌患者提供整體存活益處。她還討論了她的信念，即 pela 可能有機會在治療的早期階段使患者受益，甚至可能在治癒環境中受益。

Additionally, in the first quarter, we were able to showcase the versatility of pela and gastrointestinal cancers when we presented data at ASCO GI in both pancreatic and anal cancers. Tom will lead the discussion of that clinical data shortly. Looking forward, we'll be sharing pancreatic cancer data at this year's ASCO meeting, highlighting pela's unique mechanism of action, which stimulates both innate and adaptive immune responses.

此外，在第一季度，當我們在 ASCO GI 上展示胰臟癌和肛門癌的數據時，我們能夠展示胰臟癌和胃腸道癌的多功能性。湯姆將很快主持有關該臨床數據的討論。展望未來，我們將在今年的 ASCO 會議上分享胰臟癌數據，重點介紹 pela 獨特的作用機制，即刺激先天性和適應性免疫反應。

I'd now like to turn the call over to Tom for an update on our clinical progress and plans. Tom?

現在我想將電話轉給湯姆，讓他介紹我們的臨床進展和計劃。湯姆？

Thanks, Wayne, and thanks for teeing up the data that we have shared and will be sharing this year at medical conferences, such as ASCO and ASCO GI. The impactful data that Wayne mentioned was presented in January of this year at the ASCO GI conference.

謝謝，韋恩，也感謝您整理我們已經分享過的數據以及今年將在 ASCO 和 ASCO GI 等醫學會議上分享的數據。韋恩提到的有影響力的數據是在今年 1 月的 ASCO GI 會議上提出的。

Interim results from GOBLET Cohort 4, which investigates pela and atezolizumab in relapsed anal carcinoma, showed a 33% objective response rate, including one patient with a complete response that lasted more than 15 months. We have expanded this cohort to Stage 2 in which an additional 18 patients will be enrolled. If the efficacy signal in this cohort persists, we will engage in discussions with our scientific advisory board and key opinion leaders to optimize the development of pela in this indication.

GOBLET Cohort 4 研究了 pela 和 atezolizumab 治療復發性肛門癌的中期結果，結果顯示客觀緩解率為 33%，其中一名患者的完全緩解持續超過 15 個月。我們已將該隊列擴展至第 2 階段，將招募另外 18 名患者。如果該群體的療效訊號持續存在，我們將與我們的科學顧問委員會和關鍵意見領袖進行討論，以優化 pela 在該適應症中的發展。

While anal carcinoma is not as large a commercial opportunity as breast or pancreatic cancer, achieving regulatory approval in this indication would serve as an important validation of pela's potential in gastrointestinal cancers and could greatly benefit patients with a very high unmet medical need. In addition, GOLBET Cohort 5, which is funded by a $5 million grant from the Pancreatic Cancer Action Network, or PanCAN, is currently enrolling newly diagnosed metastatic pancreatic cancer patients.

雖然肛門癌的商業機會不如乳癌或胰臟癌那麼大，但獲得該適應症的監管批准將成為 pela 在胃腸道癌症治療中潛力的重要驗證，並可極大地造福未滿足醫療需求的患者。此外，由胰腺癌行動網絡（PanCAN）提供的 500 萬美元資助的 GOLBET Cohort 5 目前正在招募新診斷的轉移性胰腺癌患者。

This cohort is evaluating pela combined with modified FOLFIRINOX, with or without a atezolizumab. Enrollment into the safety run-in phase of this cohort was recently completed. After a review of the safety data by an independent data safety monitoring board and the German regulatory authorities, we received all necessary permissions to proceed with full enrollment, which is ongoing. This cohort has enrolled more than half of the patients required to complete Stage 1 of the study, which requires a total of 30 valuable patients, 15 each in the arm with atezolizumab and the arm without atezolizumab.

該隊列正在評估 pela 與改良 FOLFIRINOX 的聯合治療，聯合或不聯合阿特珠單抗。該隊列的安全磨合階段的招募工作最近已完成。在獨立資料安全監測委員會和德國監管機構對安全資料進行審查後，我們獲得了進行全面註冊所需的所有必要許可，目前該註冊工作正在進行中。此隊列已招募完成研究第一階段所需患者的一半以上，第一階段研究共需要 30 名有價值的患者，使用阿替利珠單抗的組別和非阿替利珠單抗的組別各 15 名。

Upon completion of Stage 1 enrollment, a decision will be made whether to advance either one or both arms to Stage 2 enrollment. If the efficacy data are encouraging, this study could lead to yet another registrational opportunity. We expect to review initial efficacy data from this cohort later this year and share it publicly next year.

完成第一階段招生後，將決定是否將一個或兩個科室推進到第二階段招生。如果療效數據令人鼓舞，這項研究可能會帶來另一個註冊機會。我們預計將在今年稍後審查該群體的初步療效數據，並在明年公開分享。

In addition to the exciting progress in our gastrointestinal cancer studies, I'd also like to remind you of the compelling breast cancer results from two randomized Phase 2 studies in which pela-based combination therapy substantially outperformed standard-of-care treatment.

除了我們在胃腸道癌症研究方面取得的令人興奮的進展之外，我還想提醒大家注意兩項隨機 2 期研究的令人信服的乳癌結果，其中基於 pela 的聯合療法大大優於標準治療。

The first of these was the IND-213 study in metastatic breast cancer, in which median overall survival in the pela group was nearly double that in the control arm. We followed IND-213 with the BRACELET-1 study to confirm the efficacy signal. In BRACELET-1, we evaluated patients with advanced or metastatic HR positive HER2 negative breast cancer who had progressed on hormonal therapy, including a CDK4/6 inhibitor.

其中第一項是針對轉移性乳癌的 IND-213 研究，其中 pela 組的中位總存活期幾乎是對照組的兩倍。我們追蹤了 IND-213 並進行了 BRACELET-1 研究以確認功效訊號。在 BRACELET-1 中，我們評估了接受荷爾蒙治療（包括 CDK4/6 抑制劑）後病情進展的晚期或轉移性 HR 陽性 HER2 陰性乳癌患者。

The BRACELET-1 data became available last fall and showed a substantial clinical benefit for pela combined with paclitaxel compared to paclitaxel monotherapy. This was based on a near doubling of both the median progression-free survival and the two-year survival rate, a near tripling of the confirmed objective response rate, and the median overall survival more than a year longer than that in the control arm.

BRACELET-1 數據於去年秋季公佈，顯示與紫杉醇單藥治療相比，pela 與紫杉醇聯合治療具有顯著的臨床益處。這是基於中位無惡化存活期和兩年存活率幾乎翻倍、確認的客觀反應率幾乎增加三倍以及中位總體生存期比對照組長一年多。

With two randomized Phase 2 studies pointing to a meaningful clinical benefit, as well as supportive mechanism of action data from several studies, including the AWARE-1breast cancer trial, we believe we have largely de-risked this program, setting the stage for continued development of pela and breast cancer. In the evolving breast cancer treatment landscape, we have a number of attractive options for the continued development of pela. These include a potential registration enabling study designed to take advantage of the accelerated approval pathway, which was successfully utilized by breast cancer drugs such as Pfizer's, IBRANCE, and Daiichi's and Enhertu.

兩項隨機 2 期研究顯示其具有顯著的臨床益處，而且包括 AWARE-1 乳癌試驗在內的多項研究也提供了支持性的作用機制數據，我們相信我們已經在很大程度上降低了該計劃的風險，為子宮頸癌和乳癌的持續發展奠定了基礎。在不斷發展的乳癌治療領域，我們為 pela 的持續發展提供了許多有吸引力的選擇。其中包括一項潛在的註冊授權研究，旨在利用加速審批途徑，輝瑞公司的 IBRANCE、第一製藥公司的 Enhertu 等乳癌藥物已成功利用該途徑。

We also have the option to conduct studies in patients at different stages in the breast cancer treatment path, including patients with an operable disease who have failed antibody drug conjugate therapy and early stage patients utilizing a neoadjuvant approach. This latter is one of the pathways suggested by key opinion leaders, including Professor Martine Piccard, who spoke at the KOL event Wayne mentioned at the start of this call.

我們也可以選擇對乳癌治療過程中不同階段的患者進行研究，包括抗體藥物偶聯療法失敗的可手術患者和採用新輔助療法的早期患者。後者是關鍵意見領袖建議的途徑之一，其中包括在韋恩在本次電話會議開始時提到的 KOL 活動上發言的 Martine Piccard 教授。

Next, I would like to introduce Christophe, who will comment on our ongoing business development activities.

接下來，我想介紹克里斯托夫，他將對我們正在進行的業務發展活動發表評論。

Thanks, Tom. I'm happy to share an update on our BD activities in addition to development involving our current collaboration. As we discussed, the data presented at ASCO GI continued to show the versatility of pela in multiple indications, specifically pancreatic or anal cancer.

謝謝，湯姆。除了涉及我們目前合作的發展之外，我很高興分享我們的 BD 活動的最新進展。正如我們所討論的，ASCO GI 上展示的數據繼續顯示了 pela 在多種適應症中的多功能性，特別是胰腺癌或肛門癌。

One underappreciated aspect is a remarkable safety profile of pela. Pela has been administered to over 1,100 patients over the course of its development. While we are encouraged to see there remain no safety concern in anal cancer, where pela has being evaluated with the checkpoint inhibitors, atezolizumab, is now being tested in munition with modified FOLFIRINOX in pancreatic cancer.

一個被低估的方面是 pela 的卓越安全性。在 Pela 的研發過程中，已有超過 1,100 名患者接受了該藥物治療。雖然我們很高興看到肛門癌中不再存在安全問題，但該藥物已與檢查點抑製劑阿特珠單抗一起進行評估，目前正在與改良的 FOLFIRINOX 一起在胰腺癌中進行試驗。

This chemotherapy regimen has a different safety profile than gemcitabine plus paclitaxel, the chemotherapy regimen from Cohort 1 of the GOBLET study. The fact that we are able to combine pela with multiple chemotherapies and checkpoint inhibitors while maintaining a favorable safety profile in pancreatic cancer, makes it easier to engage in productive BD conversation. We had encouraging business development interaction in January at the JPMorgan Conference and will continue to meet with potential biopharma partners at ASCO in Chicago and BIO in Boston.

此化療方案的安全性與 GOBLET 研究第 1 組化療方案吉西他濱加紫杉醇不同。事實上，我們能夠將 pela 與多種化療和檢查點抑制劑相結合，同時保持胰腺癌的良好安全性，這使得開展富有成效的 BD 對話變得更加容易。我們在一月份的摩根大通會議上進行了令人鼓舞的業務發展互動，並將繼續在芝加哥的 ASCO 和波士頓的 BIO 與潛在的生物製藥合作夥伴會面。

We're also supported by key opinion leaders like Professor Martine Piccard and Professor Alex Eggermont, will continue to be enthusiastic supporters of pela's potential. During the previously discussed KOL event organized by the [Henri], both Professor Piccard and Professor Eggermont, I like the need for new treatment innovations such as pela that work to activate the immune system to recognize and kill cancer. Furthermore, we already have support from advocacy groups like PanCAN while funding Cohort 5 as a GOBLET study.

我們也得到了 Martine Piccard 教授和 Alex Eggermont 教授等關鍵意見領袖的支持，他們將繼續熱情支持 pela 的潛力。在之前討論過的由 [Henri]、Piccard 教授和 Eggermont 教授組織的 KOL 活動中，我都喜歡看到對諸如 pela 之類的新治療創新的需求，這些創新可以激活免疫系統來識別和殺死癌症。此外，我們已經得到了 PanCAN 等倡導團體的支持，同時資助第 5 組作為 GOBLET 研究。

As I mentioned on our previous calls, the companying data pillars generated multiple indication serves us well. We have two randomized Phase 2 studies, showing pela's benefits in HR positive HER2 negative metastatic breast cancer. Multiple pancreatic studies pointing to pela's meaningful impact and an emerging efficacy signal that's continued to persist in anal cancer.

正如我在之前的電話會議中提到的那樣，公司資料支柱產生的多重指示對我們很有幫助。我們有兩項隨機 2 期研究，顯示 pela 對 HR 陽性 HER2 陰性轉移性乳癌的益處。多項胰臟研究表明，pela 具有顯著影響，並且正在出現的療效訊號在肛門癌中持續存在。

In summary, this continues to be an exciting time for pela as we evaluate the most efficient way to pursue regulatory approval and further demonstrate the potential of our unique immune therapeutic asset as in helping improve the lives of cancer patients. I look forward to our next chance to update you on our BD opportunities and activities.

總而言之，對於 pela 來說，這仍然是一個激動人心的時刻，因為我們正在評估尋求監管部門批准的最有效方式，並進一步展示我們獨特的免疫療法資產在幫助改善癌症患者生活方面的潛力。我期待下次有機會向您介紹我們的 BD 機會和活動。

I'll now turn the presentation over to Kirk, who will discuss our financials for the quarter. Kirk?

現在我將演講交給柯克，他將討論我們本季的財務狀況。柯克？

Thanks, Christophe, and good afternoon, everyone. I'd like to discuss our financial results for the first quarter of 2025, which will be provided in Canadian dollars unless otherwise noted. A full summary of our financial results can be found on the Investors section of our website on their filings and reports or in the press release issued earlier this afternoon.

謝謝，克里斯托夫，大家下午好。我想討論我們 2025 年第一季的財務業績，除非另有說明，否則將以加幣提供。您可在我們網站的「投資者」部分的文件和報告或今天下午早些時候發布的新聞稿中找到我們財務業績的完整摘要。

Turning to our financial results for the first quarter. As of March 31, 2025, we reported cash and cash equivalents of $15.3 million, providing runway through key value-driving milestones and through the third quarter of 2025. Net cash operating activities for the quarter were $6.5 million, compared to $7.5 million in the same period last year. The decrease reflects lower net operating expenditures, partially offset by changes in noncash working capital.

談談我們第一季的財務表現。截至 2025 年 3 月 31 日，我們報告的現金和現金等價物為 1530 萬美元，為實現關鍵價值驅動里程碑和到 2025 年第三季提供了支撐。本季淨現金經營活動為 650 萬美元，去年同期為 750 萬美元。這一下降反映了淨營運支出的下降，但被非現金營運資本的變化部分抵消。

General and administrative expenses were $3 million for the first quarter, consistent with the prior year. Research and development expenses totaled $4.1 million, down from $5.7 million in Q1 of 2024. This decrease is primarily driven by reduced manufacturing and clinical trial costs, partially offset by increased personal-related and share-based compensation expenses associated with leadership transition activities. The net loss for the quarter was $6.7 million or $0.08 per basic and diluted share compared to a net loss of $6.9 million, $0.09 per share in Q1 of 2024.

第一季的一般及行政開支為 300 萬美元，與上年持平。研發費用總計 410 萬美元，低於 2024 年第一季的 570 萬美元。這一下降主要歸因於製造和臨床試驗成本的降低，但與領導層過渡活動相關的個人相關和股份薪酬費用的增加部分抵消了這一下降。本季淨虧損為 670 萬美元，即每股基本虧損和稀釋虧損均為 0.08 美元，而 2024 年第一季淨虧損為 690 萬美元，即每股 0.09 美元。

Finally, following the end of our quarter, we were pleased to announce a USD20 million share purchase agreement with Alumni Capital. This agreement provides the company with access to capital solely at our discretion, helping us extend our financial runway.

最後，在本季結束後，我們很高興地宣布與 Alumni Capital 達成了一項價值 2000 萬美元的股票購買協議。該協議為公司提供了完全由我們自行決定的資本獲取管道，幫助我們延長財務跑道。

This concludes our financial review. We look forward to providing further updates throughout the year and encourage you to watch for our upcoming poster presentation on pela's mechanism election at ASCO. On behalf of the entire Oncolytics team, I'd like to thank our patients, caregivers, health care providers, employees and shareholders for their ongoing support.

我們的財務審查到此結束。我們期待全年提供進一步的更新，並鼓勵您關注我們即將在 ASCO 上進行的 pela 機制選舉的海報展示。我謹代表整個 Oncolytics 團隊感謝我們的病患、照護人員、醫療保健提供者、員工和股東的持續支持。

Now I would like to open the call for Q&A. Operator?

現在我想開始問答環節。操作員？

(Operator Instructions) Patrick Trucchio, H.C. Wainwright.

（操作員指示）Patrick Trucchio，H.C. Wainwright。

Thanks. Good afternoon and congrats on all the progress. Just first, regarding the anticipated start of the registrational trial in HR positive HER2 negative metastatic breast cancer. What can you share about the potential trial design for the study. Will PFS be a primary endpoint? And how are you incorporating feedback from regulatory agencies?

謝謝。下午好，祝賀你取得的所有進展。首先，關於預計開始 HR 陽性 HER2 陰性轉移性乳癌註冊試驗。能分享一下該研究的潛在試驗設計嗎？PFS 會成為主要終點嗎？您如何採納監管機構的回饋意見？

And then separately, have there been any recent interactions with the FDA or other regulatory bodies regarding the pancreatic cancer program? And what feedback, if any, of you received concerning potential registrational pathways?

另外，最近是否與 FDA 或其他監管機構就胰臟癌計畫進行過任何互動？關於潛在的註冊途徑，你們收到了什麼回饋（如果有的話）？

Yeah, hi, Patrick. Tom Heineman here. Maybe I can answer those and others can step in if there's more to say. Regarding on the breast cancer side, we, as you know, have discussed the study with the FDA at a Type C meeting in second or third quarter of last year, right?

是的，你好，派崔克。這裡是湯姆·海涅曼。也許我可以回答這些問題，如果還有更多要說的話，其他人也可以介入。關於乳癌方面，如您所知，我們在去年第二季或第三季的 C 類會議上與 FDA 討論過這項研究，對嗎？

We continue to -- beg your pardon, we continue to work towards the initiation of our next study in breast cancer. At the time that we discussed this with the FDA, we obviously discussed many elements of the study design, including the primary endpoint, which we do anticipate will be progression-free survival in our next breast cancer study. So that's on the breast cancer side.

我們將繼續——請原諒，我們將繼續努力啟動下一項乳癌研究。在我們與 FDA 討論此事時，我們顯然討論了研究設計的許多要素，包括主要終點，我們預計在下一次乳癌研究中，該終點將是無惡化存活期。這就是乳癌方面的情況。

On the pancreatic cancer side, we have not had, I mean, we have -- the FDA is aware of our pancreatic cancer program, including having granted as Fast Track approval in pancreatic cancer. We have been working with GCA, as you may be aware, to develop a protocol in pancreatic cancer and those -- that activity is ongoing.

在胰腺癌方面，我們還沒有，我的意思是，我們有——FDA 知道我們的胰腺癌計劃，包括授予胰腺癌快速通道批准。您可能知道，我們一直在與 GCA 合作制定胰腺癌治療方案，而且該活動仍在進行中。

Of course, we're talking to key opinion leaders and exploring all the best options in our pancreatic cancer program forward, but we have not had any additional discussions with the FDA recently, if we were to move forward with the registrational study through any means that would require an FDA meeting before we initiated that study, however.

當然，我們正在與關鍵意見領袖交談，探索我們胰腺癌計劃中所有最好的選擇，但是，如果我們要通過任何需要在啟動該研究之前召開 FDA 會議的方式推進註冊研究，我們最近沒有與 FDA 進行任何額外的討論。

I hope that answered your question. Maybe if I forgot anything, let me know.

我希望這回答了你的問題。如果我忘了什麼，請告訴我。

Yes, that's helpful. And then just a follow-up, if I may, on the business development activities. I'm wondering if there are specific areas like regional rights or co-development opportunities or other areas that are being prioritized?

是的，這很有幫助。如果可以的話，接下來我將跟進業務發展活動。我想知道是否有特定領域，例如區域權利或共同開發機會或其他領域被優先考慮？

And then just given pelareorep's mechanism of action, are there plans to explore additional combination approaches maybe with immune checkpoint inhibitors or in other tumor types?

那麼，考慮到 pelareorep 的作用機制，是否有計劃探索其他組合方法，例如與免疫檢查點抑制劑或其他腫瘤類型？

Hi Patrick, this is Christophe. Yes, I'm happy to answer the first question. I think Tom can comment on the second part of the question because we're already doing that. Yes. What we're doing right now, as we mentioned, we've been busy at JPMorgan, we'll be at ASCO, we'll be at BIO.

你好，派崔克，我是克里斯托夫。是的，我很樂意回答第一個問題。我認為湯姆可以對問題的第二部分發表評論，因為我們已經這樣做了。是的。正如我們所提到的，我們現在正在做的事情是，我們在摩根大通很忙，我們會在 ASCO，我們會在 BIO。

We are looking at potential different partnership for us, what's very important is, as we discussed during this call, pela has a potential multiple indications. So we'd like to have obviously, breast and pancreatic being our top priorities. So we'd like a partner that could help us maximize the value of the asset in this multiple indication. And that could be done either through a global partnership or more regional like European partnership. So we are looking at both post-avenues right now. Does that answer your question?

我們正在尋找潛在的不同合作夥伴關係，非常重要的是，正如我們在這次電話會議中所討論的那樣，pela 具有多種潛在的適應症。因此，我們顯然希望將乳房和胰臟疾病作為我們的首要任務。因此，我們希望找到一個合作夥伴，幫助我們在這種多重跡像下實現資產價值的最大化。這可以透過全球夥伴關係或更具區域性的夥伴關係（如歐洲夥伴關係）來實現。因此，我們現在正在研究這兩條途徑。這回答了你的問題嗎？

Yes, that's helpful.

是的，這很有幫助。

Tom do you want to comment -- do you want to comment on the combination?

湯姆，你想評論一下——你想對這個組合發表評論嗎？

Yes. Yeah, sure. If you don't mind, Patrick, I'll just mention the combination with checkpoint inhibitors specifically. So we've done a lot of work, translational work based on samples from clinical trials in a number of different indications, including breast and pancreatic cancer and have shown particularly in pancreatic cancer, but also in breast cancer, the pela clearly potentiates the activity of checkpoint inhibitors, right?

是的。是的，當然。派崔克，如果你不介意的話，我只想特別提一下與檢查點抑制劑的結合。因此，我們做了很多工作，基於來自多種不同適應症的臨床試驗樣本的轉化工作，包括乳腺癌和胰腺癌，並且已經證明特別是在胰腺癌中，而且在乳腺癌中，pela 明顯增強了檢查點抑製劑的活性，對嗎？

Now in breast cancer, we have seen very strong efficacy data with pela without a checkpoint inhibitor. So it's not necessarily essential in every context. But in pancreatic cancer, specifically, we have really solid clinical and translational data indicating a synergy with checkpoint inhibitors. So this is something that we will continue to explore and leverage on an indication-by-indication basis.

現在在乳癌方面，我們已經看到了不使用檢查點抑制劑的 pela 的非常強大的療效數據。因此它並非在任何情況下都是必需的。但具體來說，在胰臟癌方面，我們有非常可靠的臨床和轉化數據表明其與檢查點抑制劑具有協同作用。因此，我們將繼續根據具體情況進行探索和利用。

Okay. Thanks so much.

好的。非常感謝。

(Operator Instructions) Michael Freeman, Raymond James.

（操作員指示）麥可·弗里曼、雷蒙德·詹姆斯。

Hey, good afternoon, Wayne, Kurt, Tom, Christophe. So a few questions here. You mentioned on the metastatic breast program. You've previously discussed a registration path that accelerated approval. And then I think I'm hearing for the first time discussion of treatment of patients at different stages of the journey and leaning towards earlier-stage patients, if I'm hearing it, if I heard it right.

嘿，下午好，韋恩、庫爾特、湯姆、克里斯托夫。這裡有幾個問題。您提到了轉移性乳腺腫瘤計畫。您之前討論過加速審批的註冊途徑。然後我想這是我第一次聽到關於治療處於不同階段的患者的討論，並且傾向於治療早期患者，如果我沒聽錯的話。

I wonder if you could discuss -- just like to dive into that a little more. Is this -- would this be an alternative to do a registration-enabling trial? Or would this be like a separate cohort along the treatment journey? Please discuss the rationale and different potential registration paths.

我想知道您是否可以討論一下——只是想更深入地探討一下這個問題。這是－這是進行註冊試驗的替代方案嗎？或者這會是治療過程中的單獨群體嗎？請討論其基本原理和不同的潛在註冊途徑。

Yes, Tom here. So just to be clear, we're not trying to imply that we would be shifting towards earlier stage necessarily.

是的，我是湯姆。因此需要明確的是，我們並不是暗示我們必然會轉向早期階段。

I'm just trying to indicate that there are a lot of different populations in the breast cancer [ payment ] path that could provide valuable information and advanced overall program and one of those may be an earlier stage study in neoadjuvant patients.

我只是想表明，乳癌[支付]途徑中有很多不同的人群可以提供有價值的資訊和先進的整體計劃，其中之一可能是針對新輔助患者的早期研究。

But the other thing to consider is that the antibody drug conjugates, as you're certainly aware, are changing the landscape in breast cancer. This provides us with a real opportunity because following antibody-drug conjugate therapy, the treatment for these patients is much less clear and is wide open for agents like pela-based combination therapy to step in.

但另一件需要考慮的事情是，正如您所知，抗體藥物偶聯物正在改變乳癌的模式。這為我們提供了真正的機會，因為在抗體藥物偶聯療法之後，這些患者的治療方法不太明確，並且為基於 pela 的聯合療法等藥物的介入提供了廣闊的空間。

And so they're in some discussing with key opinion leaders, there is a sense that one potential way to advance the program and derisk it and move it forward efficiently would be to specifically generate in patients who have who are -- these are not earlier-stage patients, but these are patients who have failed hormonal therapy and then also failed at antidrug conjugate.

因此，他們正在與一些關鍵意見領袖進行討論，他們認為，推進該計劃、降低風險並有效推進該計劃的一種潛在方法是專門針對那些已經接受過激素治療且抗藥物結合療法也失敗的患者。

We have every reason to believe that pela would be a successful agent in that patient population and generating direct data in that population could be a very nice way to further derisk the program and also stimulate additional interest by potential partners, investors and so forth who are looking to understand as well as possible where pela could fit into the overall treatment path.

我們完全有理由相信，pela 將成為該患者群體的成功藥物，並且在該群體中產生直接數據可能是進一步降低專案風險的一種非常好的方式，同時也能激發潛在合作夥伴、投資者等的額外興趣，他們希望盡可能了解 pela 在整個治療過程中的位置。

I hope that answers your question, and I don't know if anyone else on the call may want to contribute to that answer.

我希望這能回答你的問題，我不知道電話中是否有其他人願意對此做出貢獻。

Yes. That's helpful. Just a little more on that. I'm curious, like was that not similar to the what you had contemplated for the original registration-enabling trial like that it would line up after ADCs? Or are you now sort of considering a smaller cohort study that would exclusively look at post like patient failed hormonal therapy and the ADCs.

是的。這很有幫助。關於這一點我再說一點。我很好奇，這與您對最初的註冊啟用試驗的設想是否不太相似，例如它會在 ADC 之後排隊？或者您現在是否正在考慮進行一項規模較小的隊列研究，專門研究患者激素治療失敗後的情況和 ADC。

Yeah. We had anticipated that before. The -- the reality of the matter is that at that time, it was more hypothetical because the ADCs had been approved as the first line therapy immediately following failure on hormonal therapy, right?

是的。我們之前就已經預料到了這一點。事實是，當時這更具假設性，因為 ADC 已被批准為激素治療失敗後立即使用的一線療法，對嗎？

Now with that approval, I don't remember when that was the first quarter of this year with that approval now on the books, that opens up a slightly different population and leads us to expect that the ADCs are going to be used even earlier in the treatment path than had been obvious before, right?

現在有了這項批准，我不記得是在今年第一季度，現在已經有了這項批准，這開闢了一個略有不同的人群，並使我們預期 ADC 將比以前更早地用於治療途徑，對嗎？

And so provides us with some additional opportunity and motivation to further solidify that pela's efficacy in that population. You see what I'm saying, and if we were to go down that path, we certainly would do it in a smaller study, but we wouldn't do it in a tiny study. We definitely want to make sure that the data that we've generated there are robust enough to really move the program for us rapidly and with this little risk as possible.

這為我們提供了額外的機會和動力，以進一步鞏固該療法在該族群中的功效。你明白我的意思，如果我們要沿著這條路走下去，我們肯定會在規模較小的研究中這樣做，但我們不會在微型研究中這樣做。我們當然希望確保我們產生的數據足夠可靠，能夠真正快速地為我們推進該計劃，並且盡可能降低風險。

Okay. All right. Great. I appreciate you guys being a dynamic of the landscape.

好的。好的。偉大的。我很欣賞你們為景觀帶來活力。

Now I have a question for Kirk. On the share purchase agreement. Congratulations on finding that access to capital. I wonder if you could describe just like the basic structure of this agreement, any terms, conditions, benefits to alumni capital? And just like the flexibility that offers [ you ]?

現在我有一個問題要問柯克。關於股份購買協議。恭喜您找到了取得資金的途徑。我想知道您是否可以描述一下該協議的基本結構、條款、條件以及對校友資本的益處？就像提供的靈活性一樣[ 你 ]？

Yeah, for sure, Michael. I think essentially, the share purchase agreement does provide us with access to capital at our discretion. Importantly, the minimum purchase notice is set at the [ 750,000 ] often what we see are smaller purchase notices moving forward.

是的，當然，邁克爾。我認為從本質上來說，股份購買協議確實為我們提供了自行取得資本的途徑。重要的是，最低購買通知設定為 [ 750,000 ] 我們經常看到的是較小的購買通知。

So we felt that, that was important. The structure in terms of commitment fees. There was an upfront commitment fee that was granted and then there is an additional fee that's attached on a pro rata basis. As well in an effort to reduce the cost of capital, which we were pleased with. And so it really allows us to -- based on kind of the market dynamics at the time allows us a source of capital that we can at our discretion, take advantage of and allows us to move the programs forward.

因此我們認為這很重要。承諾費的結構。首先要支付一筆預付承諾費，然後還要再按比例收取一筆額外費用。我們也努力降低資本成本，對此我們感到滿意。因此，它確實使我們能夠——根據當時的市場動態，獲得我們可以自行決定利用的資金來源，並使我們能夠推動專案向前發展。

Get us through our milestones, especially around the GOBLET study that's coming up here and get through this CEO transition and importantly, move the runway forward.

幫助我們實現里程碑，特別是圍繞即將進行的 GOBLET 研究，並度過這次 CEO 過渡，更重要的是，推動跑道向前發展。

Okay. All right. That's helpful. Have you tapped that since announcing it?

好的。好的。這很有幫助。自從宣布這個消息之後，您有沒有利用過這個消息？

We are -- yes, we've tapped it a little bit. But again, we're just making sure that it works as described, and we're doing it in a in a strategic manner.

是的，我們已經利用了一點。但再次強調，我們只是確保它按照描述的方式運行，並且我們以戰略性的方式進行。

Okay, thank you, that's all for me. Congratulations.

好的，謝謝，我的就這些了。恭喜。

Thank you. There are no further questions at this time. I would now hand the call back to Mr. Kirk Look for any closing remarks.

謝謝。目前沒有其他問題。現在我將把電話交還給柯克·盧克先生，請他做最後發言。

Well, thanks, operator. Once again, I would like to thank everyone for taking the time to hear about our recent progress and plans for the future. We continue to be excited about 2025 and how pela is positioned to positively impact [ the lives of ] cancer patients wish everyone a great day. Thanks very much.

好的，謝謝，接線生。我再次感謝大家抽出時間來了解我們最近的進展和未來的計劃。我們繼續對 2025 年充滿期待，並期待 pela 將如何對癌症患者的生活產生積極影響，並祝大家度過美好的一天。非常感謝。

And this concludes today's call. Thank you for participating. You may all disconnect.

今天的電話會議到此結束。感謝您的參與。你們都可以斷開連線。