Oncolytics Biotech Inc (ONCY) 2024 Q3 法說會逐字稿

Good afternoon and welcome to Oncolytics Biotech's third quarter 2024 conference call.

下午好，歡迎參加 Oncolytics Biotech 的 2024 年第三季電話會議。

(Operator Instructions) Please be advised that this call is being recorded at the company's request.

（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 Jon Patton, Director of Investor Relations and Communication.

我現在想將電話轉給投資者關係和溝通總監喬恩·帕頓 (Jon Patton)。

Please go ahead.

請繼續。

Thank you, operator and thank you all for joining us.

謝謝運營商，也謝謝大家加入我們。

After remarks from company management, we will open the call for Q&A.

在公司管理階層發表演說後，我們將開始問答環節。

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 mission, strategy, 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 thereto, our plan to continue enrollment in GOBLET Cohort 5, our ongoing business development initiatives and other statements related to anticipated developments in the company's business.

謹此提醒，本次電話會議期間發表的各種言論包含與公司業務前景以及pelareorep 的開發和商業化相關的某些前瞻性陳述，包括有關公司使命、戰略和里程碑的陳述、公司對潛力和潛力的信念。發展相關的其他聲明。

These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties and other factors not under the company's control that may cause actual results, performance or achievements of the company to be materially different from the results, performance, or expectations implied by these forward-looking statements.

這些陳述是基於管理層當前的期望和信念，並受到許多因素的影響，其中涉及已知和未知的風險、延誤、不確定性以及其他不受公司控制的因素，這些因素可能導致公司的實際結果、業績或成就與這些前瞻性陳述所暗示的結果、績效或預期有重大差異。

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 and are believed to have a reasonable basis, but there can be no assurance that these statements or expectation or belief will be achieved.

在 Oncolytics 表達對未來結果的期望或信念的任何前瞻性聲明中，此類期望或信念是善意表達的，並被認為具有合理的基礎，但不能保證這些陳述或期望或信念將會實現。

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.

這些因素包括目前或即將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 提交的文件中詳細說明的其他因素。

Oncolytics does not undertake any obligation to update these forward-looking statements, except as required by applicable laws.

除適用法律要求外，Oncolytics 不承擔更新這些前瞻性聲明的任何義務。

Now I'm pleased to introduce the members of our management team who are joining me to discuss the important progress we made during the third quarter.

現在我很高興介紹我們的管理團隊成員，他們將與我一起討論我們在第三季的重要進展。

These are Chair of Oncolytics Board of Directors and Interim CEO, Wayne Pisano; Chief Medical Officer, Dr. Tom Heineman; Chief Financial Officer, Kirk Look; and Vice President of Business Development, Christophe DeGois.

他們是 Oncolytics 董事會主席兼臨時執行長 Wayne Pisano；首席醫療官 Tom Heineman 博士；首席財務官，Kirk Look；和業務開發副總裁 Christophe DeGois。

Wayne will start the conversation this morning, so I'll hand it off to him.

韋恩今天早上將開始談話，所以我會把它交給他。

Wayne?

韋恩？

Thank you, Jon.

謝謝你，喬恩。

Good morning.

早安.

Also thanks to everyone who's joining our call today, especially because we've had several meaningful news events since our last update.

也要感謝今天加入我們電話會議的所有人，特別是因為自上次更新以來我們已經發生了幾起有意義的新聞事件。

Following my brief introduction, Tom will provide a recap of the BRACELET-1 data and our plans for a clinical trial design to support the accelerated approval of pelareorep in metastatic breast cancer.

在我的簡短介紹之後，Tom 將回顧 BRACELET-1 數據以及我們的臨床試驗設計計劃，以支持加速批准 pelareorep 用於治療轉移性乳癌。

He will also expand upon our plans for pelareorep in gastrointestinal cancers.

他還將詳細闡述我們的 pelareorep 治療胃腸道癌症的計劃。

Christophe will discuss our large addressable market opportunities and partnership efforts.

Christophe 將討論我們巨大的潛在市場機會和合作夥伴關係。

Kirk will review the financials.

柯克將審查財務狀況。

And finally, we will end by taking your questions.

最後，我們將回答大家的問題。

In the third quarter of 2024, we reached a critical milestone in our development of pelareorep or pela, as we often call it, our leading immunotherapeutic agent.

2024 年第三季度，我們在 pelareorep 或 pela（我們常稱其為我們領先的免疫療法藥物）的開發過程中達到了一個重要里程碑。

The BRACELET-1 breast cancer study reported its final data and the combination of pela plus paclitaxel showed substantial improvement compared to paclitaxel monotherapy in critical metrics like progression-free survival, overall survival, and 24-month overall survival rate.

BRACELET-1 乳癌研究報告了其最終數據，與紫杉醇單藥治療相比，pela 加紫杉醇的組合在無進展生存期、總生存期和24 個月總生存率等關鍵指標方面顯示出顯著改善。

Progression-free survival and the 24-month overall survival rate nearly doubled, while overall survival showed an approximate 14-month benefit.

無惡化存活期和 24 個月總存活率幾乎翻倍，而總存活期顯示出約 14 個月的益處。

We believe these data provide us the opportunity to significantly impact the lives of patients with HR positive/HER2 negative metastatic breast cancer and we believe the next appropriate step is a registration-enabling study utilizing BRACELET-1 outcomes as the basis for an accelerated approval development path.

我們相信這些數據為我們提供了顯著影響 HR 陽性/HER2 陰性轉移性乳癌患者生活的機會，我們相信下一步適當的步驟是利用 BRACELET-1 結果作為加速批准開發的基礎進行註冊研究小路。

Now before Tom provides a more comprehensive update, I would also like to highlight that we are continuing enrollment in the safety run-in phase of GOBLET Cohort 5 in newly diagnosed patients with metastatic pancreatic ductal adenocarcinoma, supported by the Pancreatic Cancer Action Network.

現在，在 Tom 提供更全面的更新之前，我還想強調一下，在胰腺癌行動網絡的支持下，我們將繼續在 GOBLET Cohort 5 的安全磨合階段招募新診斷的轉移性胰腺導管腺癌患者。

Additionally, we continue to work with GCAR on finalizing the master protocol and seeking FDA feedback for the registration-enabling study in pancreatic cancer.

此外，我們將繼續與 GCAR 合作，最終確定主協議，並尋求 FDA 對胰臟癌註冊研究的回饋。

With the potential for two registrational studies ahead, we believe 2025 will be an exciting year for pela and for Oncolytics.

鑑於未來兩項註冊研究的潛力，我們相信 2025 年對 pela 和 Oncolytics 來說將是令人興奮的一年。

Now I'd like to turn the call over to Tom to provide a more detailed update.

現在我想將電話轉給 Tom，以提供更詳細的更新資訊。

Tom?

湯姆？

Thank you, Wayne.

謝謝你，韋恩。

Just to quickly refresh anyone who hasn't heard our story for a while or is new to what we're doing, pela is an intravenously delivered immunotherapeutic that acts systemically.

為了讓那些已經有一段時間沒有聽過我們的故事或對我們正在做的事情不熟悉的人快速了解一下，pela 是一種靜脈注射的免疫治療藥物，可以發揮全身作用。

It introduces double-stranded RNA into the tumor, which promotes an inflammatory response that makes the tumor visible to the immune system.

它將雙股 RNA 引入腫瘤，從而促進發炎反應，使腫瘤對免疫系統可見。

At the same time, it stimulates antitumor cellular immune responses that can attack the now visible tumor.

同時，它刺激抗腫瘤細胞免疫反應，可以攻擊現在可見的腫瘤。

Our main priorities are to advance our planned registrational studies in breast and pancreatic cancer.

我們的主要優先事項是推進我們計劃的乳腺癌和胰腺癌註冊研究。

So that is where we will focus our discussion today.

這就是我們今天要討論的重點。

Starting with our breast cancer program, we recently shared efficacy results from the BRACELET-1 study, which exceeded our expectations across the board, including both progression-free survival, PFS, and overall survival, OS.

從我們的乳癌計畫開始，我們最近分享了 BRACELET-1 研究的療效結果，該研究全面超出了我們的預期，包括無惡化存活期 (PFS) 和總存活期 (OS)。

The median PFS nearly doubled from 6.4 months in the control arm to 12.1 months in the pela arm.

中位無惡化存活期 (PFS) 幾乎翻倍，從對照組的 6.4 個月增至 Pela 組的 12.1 個月。

Similarly, while median OS was 18.2 months in the control arm, it could not even be calculated in the pela arm because more than half the patients were still alive at the end of the study.

同樣，雖然對照組的中位 OS 為 18.2 個月，但在 Pela 組中甚至無法計算，因為在研究結束時超過一半的患者仍然活著。

Nonetheless, using the conservative assumption that all the pela patients would have passed away at the time of their next clinic visit, the median OS would have been 32.1 months, well more than one year longer than the control patients.

儘管如此，如果使用所有 Pela 患者在下次就診時都已去世的保守假設，中位 OS 將為 32.1 個月，比對照患者長一年多。

Perhaps even more telling, the proportion of patients who live two years or longer nearly doubled from 33% in the control arm to 64% in the pela arm.

也許更能說明問題的是，壽命兩年或更長的患者比例幾乎翻了一番，從對照組的 33% 增加到 Pela 組的 64%。

It's important to note that the patient populations were well balanced across the study groups with no substantial differences that would be expected to bias results in favor of pela.

值得注意的是，研究組的患者群體非常平衡，沒有顯著差異，預期結果會偏向 Pela。

Safety results from the BRACELET-1 study were in line with pela's well-understood and favorable safety profile based on more than 1,100 treated patients.

BRACELET-1 研究的安全性結果與 Pela 基於 1,100 多名接受治療的患者得出的廣為人知且有利的安全性狀況一致。

The next question is, where we go from here?

下一個問題是，我們下一步該去哪裡？

After discussions with key opinion leaders, our biopharma collaborators and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment.

在與關鍵意見領袖、我們的生物製藥合作者和 FDA 討論後，我們確定了一種可以在患者入組開始後兩年內產生主要終點結果的方法。

Accordingly, our next planned breast cancer study is anticipated to be a registration-enabling large Phase 2 study of around 180 HR positive/HER2 negative metastatic breast cancer patients.

因此，我們計劃的下一項乳癌研究預計將是一項可註冊的大型 2 期研究，涉及約 180 名 HR 陽性/HER2 陰性轉移性乳癌患者。

We would use progression-free survival as the primary endpoint and would power the study to achieve a Phase 3 level of success if the expected clinical benefit is achieved.

我們將使用無惡化存活期作為主要終點，如果達到預期的臨床效益，我們將推動研究取得 3 期成功。

If pela-based therapy demonstrates a progression-free survival benefit comparable to that seen in BRACELET-1, we anticipate seeking licensure potentially through the accelerated approval pathway.

如果基於 Pela 的療法顯示出與 BRACELET-1 中所見的無進展生存獲益相當，我們預計可能會透過加速審批途徑尋求許可。

This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's IBRANCE and Daiichi's in HER2.

這種方法已用於獲得其他乳癌治療的初步批准，包括輝瑞的 IBRANCE 和 Daiichi 的 HER2 治療。

We believe this is a cost-effective and efficient strategy for the development of pela in breast cancer.

我們相信，這是開發 pela 治療乳癌的一種經濟有效的策略。

I would now like to move to the GOBLET study and our opportunity in gastrointestinal cancers.

我現在想談談 GOBLET 研究以及我們在胃腸道癌症方面的機會。

So far, we have evaluated pela-based therapies in first-line metastatic pancreatic ductal adenocarcinoma, or PDAC, third-line metastatic colorectal cancer and second line or later anal cancer.

到目前為止，我們已經評估了基於 Pela 的治療一線轉移性胰腺導管腺癌 (PDAC)、三線轉移性結直腸癌和二線或以後的肛門癌。

Despite the difficulty of treating these specific cancers, pela-based combination therapy met the initial predefined efficacy success criteria for each of these indications.

儘管治療這些特定癌症存在困難，但基於 Pela 的聯合療法滿足了每種適應症的最初預定療效成功標準。

Our highest priority in GI cancers is pancreatic cancer.

我們在胃腸道癌症中最優先考慮的是胰臟癌。

We've seen exciting efficacy signals in previous studies and the objective response rate we reported in the pancreatic cancer cohort of the GOBLET study was more than double historical objective response rates.

我們在先前的研究中看到了令人興奮的療效訊號，並且我們在 GOBLET 研究的胰腺癌隊列中報告的客觀緩解率是歷史客觀緩解率的兩倍以上。

The strength of these results attracted the attention of multiple potential partners.

這些成果的優勢吸引了多個潛在合作夥伴的注意。

One of these collaborators is the Global Coalition for Adaptive Research or GCAR, which specializes in the design and conduct of cost-effective innovative adaptive clinical trials intended to support licensure.

這些合作者之一是全球適應性研究聯盟（GCAR），該聯盟專門設計和進行具有成本效益的創新適應性臨床試驗，旨在支持許可。

We are currently collaborating with GCAR to develop an adaptive registrational-enabling study to evaluate pela-based combination therapy in metastatic PDAC and we expect to seek with GCAR, FDA guidance on the study design.

我們目前正在與 GCAR 合作開發一項適應性註冊支援研究，以評估轉移性 PDAC 中基於 Pela 的聯合療法，我們希望尋求 GCAR、FDA 對研究設計的指導。

We look forward to continuing our collaboration with GCAR on this exciting opportunity and we will provide an update as this program advances.

我們期待在這個令人興奮的機會上繼續與 GCAR 合作，隨著該計劃的進展，我們將提供最新資訊。

As a complement to our work with GCAR, we also received a $5 million grant from the Pancreatic Cancer Action Network, also known as PanCAN, to evaluate a different pela-based combination therapy in PDAC.

作為 GCAR 合作的補充，我們還從胰腺癌行動網絡（也稱為 PanCAN）獲得了 500 萬美元的資助，用於評估 PDAC 中基於 pela 的不同聯合療法。

Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine, nab-paclitaxel, or modified FOLFIRINOX.

從歷史上看，轉移性胰臟癌最常見的兩種治療標準是吉西他濱、白蛋白結合型紫杉醇或改良 FOLFIRINOX 化療方案。

The gemcitabine-nab-paclitaxel regimen is the focus of our work with GCAR, while the PanCAN grant is funding the evaluation of pela combined with modified FOLFIRINOX.

吉西他濱-白蛋白結合型紫杉醇療法是我們與 GCAR 合作的重點，而 PanCAN 則撥款資助 pela 與改良 FOLFIRINOX 聯合的評估。

This is an attractive opportunity because if pela-based therapy demonstrates benefit when combined with both commonly used chemotherapy regimens, it may lead to improved therapeutic options for nearly all metastatic pancreatic cancer patients.

這是一個有吸引力的機會，因為如果基於 Pela 的療法與兩種常用的化療方案相結合時顯示出益處，則可能會為幾乎所有轉移性胰腺癌患者帶來改善的治療選擇。

Earlier this year, we announced the dosing of the first patient in the new GOBLET cohort evaluating pela, combined with modified FOLFIRINOX.

今年早些時候，我們宣布對評估 pela 的新 GOBLET 隊列中第一位患者與改良的 FOLFIRINOX 聯合用藥。

Enrollment into this cohort of the GOBLET study is ongoing and we will provide additional updates when they become available.

GOBLET 研究隊列的招募工作正在進行中，我們將在有更多更新資訊時提供。

Should the combination of pela and modified FOLFIRINOX produce a positive outcome, it would result in another registrational opportunity for pela in this challenging indication.

如果 pela 和改良版 FOLFIRINOX 的組合產生積極的結果，這將為 pela 在這一具有挑戰性的適應症中帶來另一個註冊機會。

Before I turn the call over to Christophe to expand on our business development efforts as well as our most recent commercial assessments, I would like to briefly summarize our immediate priorities.

在我將電話轉給克里斯托夫以擴大我們的業務發展工作以及我們最近的商業評估之前，我想簡要總結一下我們當前的優先事項。

First, we plan to pursue an accelerated approval pathway for pela in HR positive/HER2 negative metastatic breast cancer through a large registration-enabling study that compares paclitaxel plus pela to paclitaxel alone.

首先，我們計劃透過一項大型註冊研究對紫杉醇加 pela 與單獨紫杉醇進行比較，以尋求加速批准 pela 治療 HR 陽性/HER2 陰性轉移性乳癌的途徑。

Since we've already demonstrated pela's clinical benefit in two prior randomized studies, we are confident in this approach.

由於我們已經在先前的兩項隨機研究中證明了 pela 的臨床益處，因此我們對這種方法充滿信心。

Secondly, we are working with GCAR to finalize the protocol for the metastatic pancreatic cancer trial evaluating pela, gemcitabine, nab-paclitaxel, and atezolizumab, and we will seek guidance from the FDA on this approach, which we believe will open another registrational pathway for pela.

其次，我們正在與GCAR 合作，最終確定評估pela、吉西他濱、白蛋白結合型紫杉醇和atezolizumab 的轉移性胰腺癌試驗方案，我們將就這一方法尋求FDA 的指導，我們相信這將為藥物開闢另一條註冊途徑。

And finally, we continue to enroll patients into the GOBLET study cohort evaluating pela combined with modified FOLFIRINOX, which is in newly diagnosed pancreatic cancer patients.

最後，我們繼續將患者納入 GOBLET 研究隊列，評估 pela 與改良 FOLFIRINOX 的聯合治療，該研究在新診斷的胰腺癌患者中進行。

Our conviction in pela's broad therapeutic benefits grow stronger with each positive dataset as does our belief in pela's potential to improve the lives of cancer patients.

隨著每一個積極的數據集的出現，我們對 Pela 廣泛的治療益處的信念越來越堅定，我們對 Pela 改善癌症患者生活的潛力的信念也越來越堅定。

With that, I will turn the call over to Christophe to discuss pela's market opportunity, our ongoing collaborations, and future partnership opportunities.

接下來，我將把電話轉給 Christophe，討論 Pela 的市場機會、我們正在進行的合作以及未來的合作機會。

Christophe?

克里斯托夫？

Thanks, Tom.

謝謝，湯姆。

Since joining Oncolytics, I've focused on facilitating business development opportunities as well as working to articulate the broad opportunity we have with pela to potential strategic industry partners.

自從加入 Oncolytics 以來，我一直專注於促進業務發展機會，並努力向潛在的策略產業合作夥伴闡明我們與 Pela 合作所擁有的廣泛機會。

We continue to have conversation with our current collaborators, Pfizer and Roche, in addition to potential biopharma partners.

除了潛在的生物製藥合作夥伴之外，我們還將繼續與目前的合作夥伴輝瑞（Pfizer）和羅氏（Roche）進行對話。

With the announcement of the final data from BRACELET-1, including a 5.7 months progression-free survival benefit and nearly 14 months overall survival benefit, I anticipate we'll be able to have enhanced discussion about pela going forward as this is an asset that is clearly ready to move to registrational setting.

隨著 BRACELET-1 最終數據的公佈，包括 5.7 個月的無進展生存獲益和近 14 個月的總體生存獲益，我預計我們將能夠加強關於 pela 的討論，因為這是一項資產，顯然已準備好進入註冊設定。

There are numbers of potential partner who could be interested in the progress we're making and in our plans for the future.

許多潛在合作夥伴可能對我們正在取得的進展和未來的計劃感興趣。

We just completed a robust analysis of the HR positive/HER2 negative metastatic breast cancer population and are encouraged by the potential pela may have in this indication.

我們剛完成了 HR 陽性/HER2 陰性轉移性乳癌族群的穩健分析，並對 Pela 在該適應症中可能具有的潛力感到鼓舞。

Using the assumption that pela could be ready for an accelerated approval in 2027, we anticipate an addressable population of around 55,000 patients in the US at that time.

假設 Pela 可以在 2027 年加速批准，我們預計屆時美國的目標族群約為 55,000 名患者。

We derived these numbers by factoring in patients who would have progressed on endocrine therapy and who are ineligible for, not responsive to, or progress on Enhertu, which is an antibody conjugate is becoming part of the breast cancer treatment paradigm.

我們透過考慮在內分泌治療中可能取得進展的患者以及不符合Enhertu 治療、對Enhertu 治療無反應或取得進展的患者得出這些數字，Enhertu 是一種抗體偶聯物，正在成為乳癌治療範例的一部分。

If we then project sales going forward for the US and Europe, assuming a 15% to 20% market penetration by the year 2033, we see the potential for $2.4 billion in annual sales for US plus EU5.

如果我們預測美國和歐洲的未來銷售額，假設到 2033 年市場滲透率為 15% 至 20%，我們預期美國和歐盟 5 國的年銷售額潛力為 24 億美元。

This would create a meaningful breast cancer drug franchise to just about any biopharma partners.

這將為幾乎所有生物製藥合作夥伴創造有意義的乳癌藥物特許經營權。

And that is what we are offering in our discussion going forward, a multibillion-dollar potential drug with the potential for accelerated approval in a few years.

這就是我們在未來的討論中提供的，一種價值數十億美元的潛在藥物，有可能在幾年內加速批准。

While we are obviously very excited about the breast cancer data and opportunity, pela has shown exciting efficacy in multiple cancer indications.

雖然我們顯然對乳癌數據和機會感到非常興奮，但 Pela 在多種癌症適應症中表現出了令人興奮的功效。

The pancreatic cancer data has been reported is very compelling as well.

已通報的胰臟癌數據也非常引人注目。

In the second quarter, we entered into a collaboration with GCAR and last year received funding from PanCAN via the Therapeutic Accelerator Award.

第二季度，我們與 GCAR 建立了合作，並在去年透過治療加速器獎獲得了 PanCAN 的資助。

Both of these strategic relationships provide external validation of the potential of pela-based combination therapy.

這兩種策略關係都為基於 Pela 的聯合療法的潛力提供了外部驗證。

GCAR selected the combination of pela, gemcitabine, nab-paclitaxel, and atezolizumab for investigation in the inaugural pancreatic cancer program after a thorough vetting process, which included meetings with key opinion leaders and multiple committees.

經過徹底的審查過程（包括與關鍵意見領袖和多個委員會舉行會議）後，GCAR 選擇了 pela、吉西他濱、白蛋白結合型紫杉醇和 atezolizumab 的組合用於首個胰腺癌項目的研究。

We're working with them to finalize the master protocol and have GCAR submitted to the FDA for guidance.

我們正在與他們合作最終確定主協議，並將 GCAR 提交給 FDA 尋求指導。

Importantly, the GCAR alliance will provide access to trial sites, rapid patient enrollment, and control arm drug supply.

重要的是，GCAR 聯盟將提供試驗地點、快速患者登記和對照藥物供應。

PanCAN is a non-profit organization dedicated to fighting pancreatic cancer in a comprehensive way by advancing scientific research, building community, sharing knowledge and advocating for patients.

PanCAN 是一個非營利組織，致力於透過推動科學研究、建立社區、分享知識和為患者辯​​護來全面對抗胰臟癌。

PanCAN Therapeutic Accelerator Grant is funding Cohort 5 of the GOBLET study, which is pela plus modified FOLFIRINOX with and without atezolizumab.

PanCAN 治療加速器補助金正在資助 GOBLET 研究的第 5 組，該研究是 pela 加改良的 FOLFIRINOX 聯合或不聯合 atezolizumab。

As Tom mentioned earlier, modified FOLFIRINOX is the other chemotherapy backbone that is most often used besides gemcitabine plus nab-paclitaxel, so a meaningful response with the FOLFIRINOX combination would create significant opportunity to improve the treatment outcomes for a large number of patients.

正如 Tom 之前提到的，改良的 FOLFIRINOX 是吉西他濱加白蛋白結合型紫杉醇之外最常用的另一種化療骨幹，因此 FOLFIRINOX 組合的有意義的反應將為改善大量患者的治療結果創造重要機會。

With that, I'll bring on Kirk to cover our Q3 2024 financial highlights.

接下來，我將請柯克來報道我們 2024 年第三季的財務亮點。

Kirk?

柯克？

Thanks, Christophe, and good morning, everyone.

謝謝克里斯托夫，大家早安。

I'd like to discuss our financial results for the third quarter of 2024, which will be provided in Canadian dollars, unless otherwise noted.

我想討論我們 2024 年第三季的財務業績，除非另有說明，否則將以加幣提供。

A full summary of our financial results can be found on the Investors section of our website under Filings and Reports or in the press release issued earlier this morning.

我們的財務表現的完整摘要可以在我們網站的投資者部分的文件和報告下或在今天早上發布的新聞稿中找到。

As we start to ramp up our efforts to put pela on the path to registration, we continue to be efficient with our cash resources and keep our critical milestones in mind.

當我們開始加強讓 Pela 走上註冊之路時，我們將繼續有效利用我們的現金資源，並牢記我們的關鍵里程碑。

As of September 30, 2024, the company reported $19.6 million in cash and cash equivalents.

截至2024年9月30日，該公司報告的現金和現金等價物為1,960萬美元。

Net cash used in operating activities for the nine months ended September 30, 2024, was $19.1 million compared to $22.3 million for the nine months ended September 30, 2023.

截至2024年9月30日的九個月經營活動所使用的現金淨額為1,910萬美元，而截至2023年9月30日的九個月為2,230萬美元。

The decrease reflects non-cash working capital changes, partly offset by higher net operating activities in 2024.

這一減少反映了非現金營運資本變化，但部分被 2024 年淨經營活動增加所抵銷。

Our general and administrative expenses for the third quarter of 2024 were $3.1 million compared to $5.2 million for the third quarter of 2023.

我們 2024 年第三季的一般及管理費用為 310 萬美元，而 2023 年第三季為 520 萬美元。

The decrease was primarily due to lower investor relations activities and transaction costs that were part of our 2023 public offering.

減少的主要原因是我們 2023 年公開發行的一部分的投資者關係活動和交易成本減少。

Research and development expenses for the third quarter of 2024 were $6.8 million compared to $5.8 million for the third quarter of 2023.

2024 年第三季的研發費用為 680 萬美元，而 2023 年第三季的研發費用為 580 萬美元。

The increase was primarily due to higher manufacturing expenses and clinical trial expenses.

這一增長主要是由於製造費用和臨床試驗費用增加。

Increased manufacturing expenses were related to completing a cGMP production run in the quarter, increased clinical trial expenses that were associated with our GCAR collaboration, BRACELET-1 study closeout costs, and the clinical data management of legacy studies.

製造費用的增加與本季完成 cGMP 生產運作、與我們的 GCAR 合作相關的臨床試驗費用、BRACELET-1 研究收尾成本以及遺留研究的臨床資料管理相關。

This increase was partly offset by lower GOBLET study costs as we focus on enrolling Cohort 5, which is supported by the PanCAN grant.

這一增長部分被 GOBLET 研究成本降低所抵消，因為我們專注於招收第 5 組，該組由 PanCAN 撥款支持。

The net loss for the third quarter of 2024 was $9.5 million compared to a net loss of $9.9 million for the third quarter of 2023.

2024 年第三季的淨虧損為 950 萬美元，而 2023 年第三季的淨虧損為 990 萬美元。

The basic and diluted loss per share was $0.12 in the third quarter of 2024 compared to a basic and diluted loss per share of $0.14 in the third quarter of 2023.

2024 年第三季的基本和稀釋每股虧損為 0.12 美元，而 2023 年第三季的基本和稀釋每股虧損為 0.14 美元。

Now we are very excited to move pela further along the path to registration and we are looking at multiple upcoming milestones.

現在，我們非常高興能夠讓 Pela 在註冊之路上走得更遠，我們正在尋找即將到來的多個里程碑。

We are moving forward with our registration-enabling study in HR positive/HER2 negative metastatic breast cancer based on the clinical benefits observed in IND-213 BRACELET-1 in addition to the feedback we received from the FDA.

我們正在根據 IND-213 BRACELET-1 中觀察到的臨床益處以及從 FDA 收到的回饋，推進我們針對 HR 陽性/HER2 陰性轉移性乳癌的註冊研究。

Our collaboration with GCAR is continuing to progress and we are nearing the finalization of the master protocol.

我們與 GCAR 的合作正在不斷取得進展，我們即將完成主協議。

Cohort 5 of the GOBLET study, the combination of pela and modified FOLFIRINOX with and without atezolizumab continues to enroll and we expect safety data in early 2025, followed by efficacy data later next year.

GOBLET 研究的第 5 組，即 pela 和改良 FOLFIRINOX 聯合或不聯合 atezolizumab 的組合繼續入組，我們預計將在 2025 年初獲得安全性數據，隨後在明年晚些時候獲得療效數據。

We are also looking for updated efficacy data from Cohort 4 of GOBLET next year.

我們也正在尋找明年 GOBLET 第 4 組的更新療效數據。

That is the cohort evaluating pela and atezolizumab in second-line or later anal cancer.

這是評估 pela 和 atezolizumab 在二線或後期肛門癌中的隊列。

So we always try to end our calls by expressing our gratitude to the people who are instrumental in helping us continue our mission of giving cancer patients the opportunity to live longer, better lives.

因此，在結束通話時，我們總是試圖向那些幫助我們繼續實現讓癌症患者有機會活得更長久、更美好生活的使命的人們表示感謝。

This includes the entire Oncolytics team, our investors, our patients, and their families.

這包括整個 Oncolytics 團隊、我們的投資者、我們的患者及其家人。

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

現在我想開始問答環節。

Operator?

操作員？

(Operator Instructions) Soumit Roy, Jones Trading.

（操作員指示）Soumit Roy，Jones Trading。

Congratulations on all the progress.

祝賀所有的進展。

And wanted to check on the upcoming San Antonio Breast Cancer update.

並想查看即將發布的聖安東尼奧乳腺癌更新。

Should we expect any closer data cut?

我們是否應該期待更近距離的數據削減？

Or what kind of detail should we expect there?

或者我們應該期待什麼樣的細節？

Soumit, Tom Heineman here, Chief Medical Officer.

蘇米特，湯姆·海涅曼（Tom Heineman），首席醫療官。

The data that we presented in this call are, in fact, the final results.

我們在這次電話會議中提供的數據實際上是最終結果。

Because of the timing and of the meeting, we will not have anything, any update at San Antonio.

由於時間和會議的原因，我們在聖安東尼奧不會有任何更新。

But the results presented are, in fact, the final results.

但所呈現的結果其實是最終結果。

So there is no more updated cut expected.

因此預計不會再有更新的削減。

Got it.

知道了。

And a quick one on the HER2 negative status is, could you remind us, they were IHC 2 and below or

關於 HER2 陰性狀態的快速說明是，您能否提醒我們，它們的 IHC 2 及以下或

--

--

Well, when this study was started, the antibody drug conjugates were not on the market and they were not being used, right?

那麼，當這項研究開始時，抗體藥物偶聯物還沒有上市，也沒有被使用，對嗎？

So there was no reason to test specifically the HER2 status.

因此沒有理由專門測試 HER2 狀態。

All of the patients in the study fell into the classic characterization, however, of HER2 low.

然而，該研究中的所有患者均屬於 HER2 低水平的典型特徵。

So they were all 2 or lower according to the standard definition.

所以根據標準定義，它們都是 2 或更低。

Louise Chen, Cantor.

路易絲·陳，康托爾。

First, on your breast cancer registration-enabling study, can you provide additional color on the potential to achieve accelerated approval?

首先，關於您的乳癌註冊研究，您能否提供有關實現加速批准的潛力的更多資訊？

How early will you able to achieve this?

您多久能實現這個目標？

Or do we have to wait until the trial completion for regulatory action?

還是必須等到審判結束後才採取監管行動？

And I do have a follow-up.

我確實有後續行動。

Okay.

好的。

Well, I'll start.

好吧，我要開始了。

It's Tom Heineman again.

又是湯姆·海涅曼。

So the path for regulatory approval and accelerated approval is based on our prior feedback with the FDA and on precedent, right?

因此，監管批准和加速批准的路徑是基於我們先前向 FDA 提供的回饋和先例，對嗎？

And so we think that the study, as designed, will provide a clinically meaningful benefit.

因此，我們認為這項研究按照設計將提供具有臨床意義的益處。

And if it does provide a clinically meaningful benefit comparable or even anywhere close to what we saw in the BRACELET study, that would result in a statistical level of p-value of less than 0.05, okay?

如果它確實提供了與我們在 BRACELET 研究中看到的相當甚至接近的具有臨床意義的益處，那麼這將導致 p 值的統計水平小於 0.05，好嗎？

And so in other words, with that study, we would hit all the main points that the FDA is looking for when they consider an approval.

換句話說，透過這項研究，我們將觸及 FDA 在考慮批准時正在尋找的所有要點。

So one, we would have a clinically meaningful benefit.

因此，我們將獲得具有臨床意義的益處。

Two, we would have statistical -- a highly statistically significant study, and three, if it performs as it has in all our previous studies, we would have a solid safety profile, which are the three main things the FDA is looking for, okay?

第二，我們將有統計數據——一項具有高度統計意義的研究，第三，如果它的表現與我們之前所有研究一樣，我們將擁有可靠的安全性概況，這是FDA 正在尋找的三個主要內容，好吧？

So the FDA, of course, will never tell you in advance that they will approve anything before they see the data.

因此，FDA 當然不會提前告訴你他們會在看到數據之前批准任何事情。

But if this study performs as we expect it to, we would hit on all the points that we think would be compelling for the FDA to support a regulatory approval following in the precedent set by such -- by many drugs but including such drugs as IBRANCE in HER2.

但如果這項研究如我們預期的那樣進行，我們將觸及所有我們認為有說服力的要點，以便 FDA 支持監管部門的批准，遵循許多藥物的先例，但包括 IBRANCE 等藥物在 HER2 中。

And with regard to the timing, perhaps I can hand that off to Kirk to discuss the timing explicitly.

至於時間安排，也許我可以交給柯克明確討論時間安排。

If you don't mind, Kirk.

如果你不介意的話，柯克。

Yeah.

是的。

In terms of timing, we would -- once we can get the study up and running and enrolling, we expect enrollment to happen over an 18-month period and then data maturity is expected to be six months after the last patient is on.

就時間安排而言，一旦我們能夠啟動、運行和招募研究，我們預計招募將在 18 個月內進行，然後數據成熟期預計為最後一名患者入組後的 6 個月。

And then we would expect to be in a -- subject to the data, of course, we expect to be in a filing position after that point in time.

然後我們預計會處於——根據數據，當然，我們預計會在該時間點之後處於備案狀態。

Great.

偉大的。

My follow-up question is on your first upcoming major milestone, which is finalizing the master protocol for your adaptive registration-enabling trial.

我的後續問題是關於您即將到來的第一個重大里程碑，即最終確定您的自適應註冊啟用試驗的主協議。

Given this is for first-line PDAC patients, we're wondering how quickly will you be able to complete patient enrollment?

鑑於這是針對第一線 PDAC 患者，我們想知道您能夠多快完成患者登記？

Well, once the -- so we need to finalize the protocol, as we mentioned, it will need to be discussed with the FDA.

嗯，一旦——所以我們需要最終確定協議，正如我們所提到的，需要與 FDA 進行討論。

In other words, there are some upstream steps.

換句話說，還有一些上游步驟。

Once that study starts enrolling, we would have to map out the time lines precisely based on the parameters of the study at that time.

一旦研究開始招募，我們就必須根據當時的研究參數精確地制定時間表。

But we expect it to enroll quickly because this is a -- this is not a rare disease.

但我們預計它會很快註冊，因為這不是一種罕見的疾病。

This is a, unfortunately, relatively common cancer and we would be expecting to work with all of -- well, or many of the best, highest potential recruiting potential sites in the US and maybe even elsewhere.

不幸的是，這是一種相對常見的癌症，我們希望與美國甚至其他地方的所有、或許多最好、最具潛力的招聘網站合作。

So while I hesitate to put a precise time line on it, we expect the study to enroll very efficiently.

因此，雖然我猶豫是否要給出一個精確的時間表，但我們希望這項研究能非常有效地招募。

And Kirk, maybe you'd like to expand on that, I don't know.

柯克，也許你想進一步闡述這一點，我不知道。

No, I think that's exactly right.

不，我認為這是完全正確的。

Michael Freeman, Raymond James.

麥可·弗里曼，雷蒙德·詹姆斯。

First of all, congratulations on the sensational metastatic breast data.

首先，恭喜您獲得了令人震驚的乳房轉移數據。

It's truly impressive.

這確實令人印象深刻。

So my question is, on the back of this overall survival data, I wonder, perhaps, Christophe, if you could describe your partnering and business development approach and algorithm as you have this powerful data in hand?

所以我的問題是，在這個整體生存數據的支持下，我想知道，克里斯托夫，你是否可以描述一下你的合作和業務開發方法和演算法，因為你手頭上有這些強大的數據？

And if you could describe -- maybe just summarize how progress is going?

如果你能描述一下──也許只是總結一下進展如何？

And for instance, like have you seen an accumulation of pharmas in your data room?

例如，您是否在數據室中看到大量的藥品？

And then I'll have a follow-up after this.

之後我會進行後續跟進。

Yes, sure.

是的，當然。

This is Christophe DeGois.

我是克里斯托夫·德戈伊斯。

Yes, we last year -- I mean, before I joined the company, last year, we had -- when we presented the interim data, the PFS data, we had some interest from pharma companies but obviously, they wanted to see the final data.

是的，我們去年 - 我的意思是，在我加入公司之前，去年，當我們提供中期數據、PFS 數據時，我們對製藥公司產生了一些興趣，但顯然，他們希望看到最終結果數據。

As explained during this call, we got this data very recently.

正如本次電話會議中所解釋的，我們最近獲得了這些數據。

So we are putting our duck in orders and starting to reengage pharma companies.

因此，我們正在下訂單，並開始重新與製藥公司合作。

Obviously, we've been talking, as mentioned before, we've been talking to our current partners but we're also expanding to other companies.

顯然，我們一直在討論，正如之前提到的，我們一直在與當前的合作夥伴進行討論，但我們也在擴展到其他公司。

I think the end of the year coming and JPMorgan, I think where we're really now preparing for a big outreach and a large outreach.

我認為年底即將到來，摩根大通，我認為我們現在正在為大規模的外展活動做準備。

And that will be with your typical big pharma partners that are interested in the solid tumor market, but also potentially European or Asian companies for more regional partnership.

這將是與對實體瘤市場感興趣的典型大型製藥合作夥伴的合作，但也可能是與歐洲或亞洲公司建立更多區域合作夥伴關係。

We haven't decided yet of the best options.

我們還沒有決定最好的選擇。

We are looking at the different options right now.

我們現在正在考慮不同的選擇。

So obviously, in the coming months, I think we will be very active.

顯然，在接下來的幾個月裡，我認為我們將非常積極。

Yeah, that's helpful.

是的，這很有幫助。

I guess when you think about a partnership, how would you contemplate structuring that sort of a partnering deal or sort of business development deals, like the type of outreach you've just described, how do you expect the structure of an ultimate deal might be?

我想當您考慮合作夥伴關係時，您會如何考慮建立此類合作交易或業務開發交易，例如您剛剛描述的外展類型，您預計最終交易的結構可能會如何？

Again, this is a little early but we have definitely -- if you look at what we've done so far, we've had the capacity to run the Phase 2 trial that Tom described in breast cancer.

再說一次，現在還為時過早，但我們確實——如果你看看我們迄今為止所做的事情，我們已經有能力進行湯姆所描述的乳癌第二階段試驗。

But there are also other opportunities, as we explained.

但正如我們所解釋的，還有其他機會。

Obviously, pancreatic cancer, even in breast, there may be other opportunities, early on opportunities.

顯然，胰腺癌，即使是乳腺癌，也可能有其他的機會，早期的機會。

So I think our objective is going to bring a partner that's going to help us accelerate the development of the drug in breast, I mean, in metastatic breast cancer but potentially also in the other indication.

因此，我認為我們的目標是找到一個合作夥伴，幫助我們加速乳癌藥物的開發，我的意思是，在轉移性乳癌中，但也可能在其他適應症中。

We are a fairly small company.

我們是一家相當小的公司。

Our focus right now is definitely on bringing pela approved for breast cancer.

我們現在的重點肯定是讓 Pela 獲得批准用於乳癌治療。

But we cannot neglect the other opportunities in other solid tumors.

但我們不能忽視其他實體瘤的其他機會。

So for us, I think the ideal partner is somebody who is going to get committed to help us accelerate that and also prepare for the launch of the drug.

因此，對我們來說，我認為理想的合作夥伴是致力於幫助我們加速這一進程並為藥物上市做好準備的人。

If we get accelerated approval, we want someone who is going to help, especially on the commercial side preparing the market for the drug.

如果我們獲得加速批准，我們需要有人提供幫助，特別是在商業方面為藥物市場做準備。

And that's where the big pharma or large biotech can really bring value.

這就是大型製藥公司或大型生技公司真正能夠帶來價值的地方。

Absolutely.

絕對地。

And just very quickly, just one more.

很快，又一個。

What pricing are you using in your -- as you size these markets as you just did very well?

當你評估這些市場時，你使用什麼定價，因為你剛剛做得很好？

Yeah, that's a very good question.

是的，這是一個很好的問題。

We've made some assumption on that.

我們對此做了一些假設。

And the pricing we're using is the pricing similar to Enhertu, with a slight premium since we'll be coming post-Enhertu for most of the patients.

我們使用的定價與 Enhertu 類似，但略有溢價，因為我們將在 Enhertu 之後為大多數患者提供定價。

And we've looked at the pricing of Enhertu in the US and outside the US as you can imagine, the pricing outside the US is slightly different.

我們研究了 Enhertu 在美國和美國以外的定價，你可以想像，美國以外的定價略有不同。

There are no further questions ahead.

沒有其他問題了。

Please continue.

請繼續。

Well, that concludes our call today.

好了，我們今天的通話就到此結束。

Again, I'd like to thank everyone who took the time to join us this morning and learn more about our recent progress in BRACELET-1 and our plans for registration in this indication.

再次，我要感謝今天早上抽出時間加入我們並詳細了解我們 BRACELET-1 的最新進展以及我們在該適應症中的註冊計劃的所有人。

I hope everyone has a wonderful day.

我希望每個人都有美好的一天。

Again, thanks very much.

再次非常感謝。

Have a great day.

祝你有美好的一天。

Bye.

再見。

Ladies and gentlemen, this concludes today's conference call.

女士們、先生們，今天的電話會議到此結束。

Thank you for your participation.

感謝您的參與。

You may now disconnect.

您現在可以斷開連線。