Replimune Group Inc (REPL) 2025 Q4 法說會逐字稿

Good morning, and welcome to the Replimune fiscal year fourth quarter 2025 financial results and corporate update conference call. (Operator Instructions) This call is being webcast live on the Investors & Media section of Replimune's website at replimmune.com, and a recording will be available after the call. I would like to introduce Arleen Goldenberg from Replimune. Please go ahead.

早安，歡迎參加 Replimune 2025 財年第四季財務業績和公司更新電話會議。（操作員指示）本次電話會議將在 Replimune 網站 repliimmune.com 的投資者與媒體部分進行網路直播，會議結束後將提供錄音。我想介紹來自 Replimune 的 Arleen Goldenberg。請繼續。

Thank you, operator, and good morning, everyone. Thank you for joining us today for a discussion of Replimune's fiscal year fourth quarter 2025 business highlights and financial results. Leading the call today will be Sushil Patel, our Chief Executive Officer. He will be joined by Chris Sarchi, our Chief Commercial Officer; and Emily Hill, our Chief Financial Officer.

謝謝接線員，大家早安。感謝您今天加入我們討論 Replimune 2025 財年第四季的業務亮點和財務業績。今天的電話會議主持人將是我們的執行長 Sushil Patel。他將與我們的首席商務官 Chris Sarchi 和財務長 Emily Hill 一起出席。

After our prepared remarks, we will open the call for Q&A. An audio recording and webcast replay for today's conference call will also be available online as detailed in the press release announcement for this call.

在我們準備好發言之後，我們將開始問答環節。今天電話會議的錄音和網路直播重播也將在網路上提供，詳情請參閱本次電話會議的新聞稿公告。

During today's call, we will be making certain forward-looking statements, including, without limitation, statements about the potential safety, efficacy and regulatory and clinical progress of our product candidates, our anticipated cash runway and our future expectations, plans, partnerships and prospects.

在今天的電話會議中，我們將做出某些前瞻性陳述，包括但不限於有關我們候選產品的潛在安全性、有效性和監管及臨床進展、我們預期的現金流以及我們未來的期望、計劃、合作夥伴關係和前景的陳述。

These statements are subject to various risks such as changes in market conditions and difficulties associated with research and development and regulatory approval processes. These and other risk factors are described in the filings made with the SEC, including our Annual Report on Form 10-K and our Form 10-Q filed today.

這些聲明受到各種風險的影響，例如市場條件的變化以及與研發和監管審批流程相關的困難。這些和其他風險因素在提交給美國證券交易委員會的文件中有所描述，包括我們今天提交的 10-K 表年度報告和 10-Q 表年度報告。

Forward-looking statements are based on the assumptions, opinions and estimates of management at the date the statements are made, including the non-occurrence of the risks and uncertainties that are described in the filings made with the SEC or other significant events occurring outside of Replimune's normal course of business.

前瞻性陳述是基於陳述作出之日管理層的假設、意見和估計，包括向美國證券交易委員會提交的文件中所描述的風險和不確定性的未發生或在 Replimune 正常業務範圍之外發生的其他重大事件。

You are cautioned not to place undue reliance on these forward-looking statements, which are made as of today, May 22, 2025. Replimune disclaims any obligation to update such statements even if management's views change, except as required by law.

請注意不要過度依賴這些前瞻性陳述，這些陳述是截至 2025 年 5 月 22 日做出的。即使管理層的觀點發生變化，Replimune 也不承擔更新此類聲明的任何義務，除非法律要求。

With that, let me turn the call over to Sushil Patel, Replimune's Chief Executive Officer.

說完這些，讓我把電話轉給 Replimune 的執行長 Sushil Patel。

Thank you, Arleen, and welcome, everyone, to today's earnings call. We appreciate you joining us as we review our fiscal fourth quarter and full year 2025 results. Today, we'll highlight the significant progress we've made across regulatory, clinical and commercial as we approach the potential approval and launch of RP1.

謝謝你，阿琳，歡迎大家參加今天的收益電話會議。感謝您與我們一起回顧我們的第四季和 2025 年全年業績。今天，我們將重點介紹在 RP1 獲得批准和推出之際，我們在監管、臨床和商業方面取得的重大進展。

You'll also hear updates on our confirmatory IGNYTE trial, pipeline developments for RP2 and our financial position as we prepare for commercial readiness. I'll begin with a strategic overview before turning the call over to Chris to walk through launch preparation, and Emily to cover our financials.

您還將聽到有關我們的確認性 IGNYTE 試驗、RP2 的管道開發以及我們為商業化做準備時的財務狀況的最新消息。我將首先進行策略概述，然後將電話轉給克里斯 (Chris) 介紹發布準備工作，並讓艾米麗 (Emily) 負責我們的財務事宜。

Replimune was founded to pioneer the next generation of oncolytic immunotherapy and is now poised to realize that promise with a substantial body of evidence supporting our mission. In particular, data from the IGNYTE study, shows that roughly one third of patients are able to achieve durable response in a high unmet need setting with few options. I am delighted with the tremendous organizational advances we've made, allowing us, if approved, to be ready for a strong commercial launch of our first therapy in anti-PD1 failed melanoma. This would not have been possible without the efforts of the entire Replimune team.

Replimune 成立的初衷是開拓下一代溶瘤免疫療法，現在我們已準備好透過大量證據支持我們的使命來實現這項承諾。特別是，IGNYTE 研究的數據顯示，大約三分之一的患者能夠在未滿足需求較高且選擇較少的情況下獲得持久的反應。我很高興看到我們在組織上取得了巨大的進步，如果獲得批准，我們將準備好大力商業化推出我們針對抗 PD1 失敗黑色素瘤的首個療法。如果沒有整個 Replimune 團隊的努力，這是不可能的。

Over the past year, we have made significant regulatory progress resulting in a recognition of RP1 as a breakthrough therapy with priority review and a PDUFA date of July 22, 2025. We remain actively engaged with the FDA and recently completed the late cycle meeting and manufacturing inspections. The IGNYTE3 confirmatory study is underway and has a priory endpoint overall survival. Enrollment in the US is on track with over 100 sites planned globally.

在過去的一年裡，我們在監管方面取得了重大進展，RP1 被認定為具有優先審查權的突破性療法，PDUFA 日期為 2025 年 7 月 22 日。我們一直積極與 FDA 合作，最近完成了後期週期會議和製造檢查。IGNYTE3 驗證性研究正在進行中，並且具有先前的終點總體存活率。美國的招生工作正在按計劃進行，全球計劃開設 100 多個地點。

While we have seen important advances in the melanoma treatment landscape, the unmet need remains significant. We believe, upon FDA approval, RP1 will be well positioned to be the first choice for advanced melanoma patients who have previously received an anti-PD1 containing regimen. This is based on a combination of compelling safety and efficacy data, a comprehensive understanding of the patient population and prescriber base and a launch model optimized to unlock the potential intratumoral injections.

雖然我們已經看到黑色素瘤治療領域取得了重要進展，但未滿足的需求仍然很大。我們相信，一旦獲得 FDA 批准，RP1 將成為先前接受過含抗 PD1 方案的晚期黑色素瘤患者的首選。這是基於令人信服的安全性和有效性數據、對患者群體和處方者基礎的全面了解以及為釋放潛在的腫瘤內注射而優化的啟動模型。

Building upon the strong systemic and visceral activity we've seen with RP1 in advanced melanoma, we are equally excited about our pipeline development, which are focused on the potential of deep lesion injections with RPx to benefit patients beyond skin cancer. We look forward to establishing our RPx platform as a new interventional immuno-oncology treatment paradigm, which we believe will be enabled through the collaboration between oncologists and interventional radiologists.

基於我們在晚期黑色素瘤中觀察到的 RP1 強大的全身和內臟活性，我們對我們的管道開發同樣感到興奮，該管道開發專注於使用 RPx 進行深部病變注射的潛力，以使皮膚癌以外的患者受益。我們期待將我們的 RPx 平台確立為一種新的介入性免疫腫瘤治療模式，我們相信這將透過腫瘤學家和介入放射科醫生之間的合作實現。

Our US manufacturing facility has produced commercial inventory to support the RP1 launch, with capacity to support long-term global demand. We are well capitalized to execute on our commercialization plans and have recently completed the build-out of our customer-facing organization.

我們的美國製造工廠已經生產了商業庫存以支援 RP1 的發布，並有能力滿足長期全球需求。我們擁有充足的資金來執行我們的商業化計劃，並且最近完成了面向客戶的組織的建設。

Now let me turn the call over to Chris Sarchi, Chief Commercial Officer of Replimune, to discuss the RP1 launch in more detail. Chris?

現在，讓我將電話轉給 Replimune 首席商務長 Chris Sarchi，更詳細地討論 RP1 的發布。克里斯？

Thanks, Sush. Before I get into our commercial plans, perhaps a brief introduction for those of you on the call who I haven't yet had the opportunity to meet. I joined Replimune about two and a half years ago to help lead our commercial organization. Prior to joining Replimune, I helped spearhead the launch of Libtayo as a new standard of care for the treatment of cutaneous squamous cell carcinoma. Upon approval, the successful launch of RP1 will be my tenth oncology product launch that I've had the opportunity to be a part of. And now I look forward to helping to build Replimune into a leading oncology company.

謝謝，Sush。在介紹我們的商業計劃之前，我想先向那些我還沒有機會見面的與會者做一個簡短的介紹。大約兩年半前，我加入 Replimune，幫助領導我們的商業組織。在加入 Replimune 之前，我曾幫忙帶頭推出 Libtayo，作為治療皮膚鱗狀細胞癌的新標準護理。獲得批准後，RP1 的成功推出將成為我有幸參與的第十次腫瘤產品發布。現在我期待著幫助 Replimune 成為一家領先的腫瘤學公司。

Our team is really excited and ready to launch RP1 for a broad range of patients upon approval. We believe RP1 to be well positioned for most patients to progress on a PD1 containing regimen based on the deep and durable response rates as well as the safety profile demonstrated in our IGNYTE registrational trial.

我們的團隊非常興奮，並準備在獲得批准後向廣大患者推出 RP1。我們相信，根據我們在 IGNYTE 註冊試驗中證明的深度和持久的反應率以及安全性，RP1 非常適合大多數患者採用含 PD1 的方案取得進展。

With our PDUFA date fast approaching, our primary focus has been on the commercial preparations. We have a deep understanding of the market landscape, prescriber adoption and referral patterns and an established launch plan that's optimized for intratumoral delivery across all customer segments.

隨著 PDUFA 日期的臨近，我們的主要精力集中在商業準備上。我們對市場格局、處方採用和轉診模式有著深入的了解，並制定了針對所有客戶群的腫瘤內給藥進行優化的發布計劃。

The commercial opportunity for RP1 to help improve the lives of those with advanced melanoma is considerable. We estimate approximately 13,000 patients progress on or after PD1 treatment annual in the US and about 80% of these patients will be eligible for RP1 distributed evenly across hospital and nonhospital settings. Importantly, RP1 is administered in the outpatient setting and doesn't require hospitalization.

RP1 在幫助改善晚期黑色素瘤患者生活方面具有巨大的商業機會。我們估計，美國每年約有 13,000 名患者在接受 PD1 治療或治療後病情出現進展，其中約 80% 的患者將有資格接受 RP1 治療，這些患者在醫院和非醫院環境中均等分佈。重要的是，RP1 是在門診進行的，不需要住院。

For community-based oncology, we believe the introduction of RP1 will allow providers to maintain treatment continuity for the patients within their practice for the full course of RP1 as well as nivolumab for up to two years.

對於社區腫瘤學，我們相信引入 RP1 將允許提供者在其實踐中為患者保持長達兩年的 RP1 和 nivolumab 全程治療的連續性。

For superficial injections, we anticipate administration will most often take place in the patient exam room. And while medical oncologists may be some of the early injectors, the primary injector over time will likely be advanced practice providers. We expect that this approach will help support the broad and rapid adoption of RP1 in the clinical practice.

對於淺表注射，我們預計給藥通常會在患者檢查室進行。雖然腫瘤內科醫生可能是早期注射者之一，但隨著時間的推移，主要注射者可能會是高級執業提供者。我們希望這種方法將有助於支持 RP1 在臨床實踐中的廣泛和快速應用。

From our research, we know that for patients in the advanced melanoma setting, who would be candidates for RP1, about 8 in 10 will have deep lesions or a combination of both superficial and deep. In these cases, interventional radiologists will work closely with the oncologist and play a key role using image guidance.

根據我們的研究，我們知道對於適合 RP1 治療的晚期黑色素瘤患者來說，大約有 80% 的患者會有深部病變或表淺和深部病變的組合。在這些情況下，介入放射科醫師將與腫瘤科醫師密切合作，並在影像引導下發揮關鍵作用。

Interventional radiologists are excited that RP1 may afford them the opportunity to play an even greater role in actively treating patients. Both oncologists as well as interventional radiologists are impressed with the data showing the systemic activity of RP1 plus nivolumab in non-injected visceral lesions, which provides them with added confidence in selecting tumors for injections.

介入性放射科醫師很高興 RP1 可以讓他們有機會在積極治療患者方面發揮更大的作用。腫瘤學家和介入放射科醫生都對 RP1 加 nivolumab 在非注射內臟病變中的全身活性數據印象深刻，這為他們選擇注射腫瘤提供了更大的信心。

Interventional radiologists have also expressed that administering RP1 is straightforward and can be readily adopted into practice upon approval. Importantly, procedural codes already exist to support RP1 deep and superficial injections, with a routine RP1 drug buy-and-bill reimbursement process that further minimizes barriers to access across all settings.

介入性放射科醫師也表示，RP1 的管理很簡單，經批准後即可輕鬆投入實務。重要的是，已經存在支持 RP1 深層和淺層注射的程序代碼，並且具有常規的 RP1 藥品購買和賬單報銷流程，進一步最大限度地減少了所有環境中的獲取障礙。

The geographic distribution of patients with advanced melanoma allows us to be very focused in targeting our launch efforts. Even more importantly, there's a high and overlapping concentration of providers, primarily interventional radiologists and medical oncologists, to treat most melanoma patients.

晚期黑色素瘤患者的地理分佈使我們能夠非常集中地進行我們的產品發布工作。更重要的是，治療大多數黑色素瘤患者的醫療服務提供者（主要是介入性放射科醫師和腫瘤內科醫師）的集中度較高且重疊。

We've identified roughly 350 key accounts that we believe treat half of the melanoma population. Beyond that, we know that nearly all of these patients are being treated in healthcare settings that have interventional radiology on site or rather accessible through existing referral processes, further supporting our belief in the broad and rapid adoption of RP1.

我們已確定了大約 350 個重點客戶，我們認為這些客戶可以治療一半的黑色素瘤患者。除此之外，我們知道，幾乎所有這些患者都在擁有介入放射學的醫療機構中接受治療，或者可以透過現有的轉診流程接受治療，這進一步支持了我們對 RP1 得到廣泛和快速採用的信念。

Our comprehensive understanding of the market drove how we built our commercial organization, which we believe will accelerate the launch of RP1. We recently completed the build-out of our commercial infrastructure. The customer-facing team has been trained and comprised of approximately 60 people with half focused on demand generation and the remainder on supporting pull-through.

我們對市場的全面了解推動了我們建立商業組織，我們相信這將加速 RP1 的推出。我們最近完成了商業基礎設施的建設。面向客戶的團隊已經過培訓，由大約 60 名成員組成，其中一半專注於需求生成，其餘成員專注於支援拉動。

A new and differentiated role we've created is the Interventional Radiology Oncology Coordinator, or IROC. This team has a significant level of experience working in the interventional radiology space. Their focus will be coordination between medical oncology and interventional radiology, ensuring that we're able to connect the dots between these functions while supporting our RP1 image-guided administration.

我們創建的一個全新且獨特的角色是介入性放射腫瘤學協調員（IROC）。該團隊在介入放射學領域擁有豐富的經驗。他們的重點是協調腫瘤內科和介入放射學，確保我們能夠連接這些功能，同時支援我們的 RP1 影像引導管理。

We also have a team of oncology nurse educators who provide guidance on superficial administration, drive positive early experiences with RP1 and work across the medical oncology multidisciplinary team. Our national accounts team is actively engaged with payers, and our field reimbursement specialists, regional marketers and strategic account managers round out our customer-facing teams.

我們還有一支腫瘤科護理教育者團隊，他們提供表面管理的指導，推動 RP1 的正面早期體驗，並與腫瘤內科多學科團隊合作。我們的國家客戶團隊積極與付款人合作，我們的現場報銷專家、區域行銷人員和策略客戶經理完善了我們的客戶服務團隊。

Our distribution model is now complete with specialty distributor agreements and key state licenses in place, which will support next-day delivery to accounts across the country. At launch, our patient support hub, Replimune Connect Plus, will provide critical services to patients and caregivers to ensure a positive treatment experience.

我們的分銷模式現已完善，擁有專業經銷商協議和主要國家許可證，可支援隔天向全國各地的客戶交付產品。在啟動時，我們的患者支援中心 Replimune Connect Plus 將為患者和照護者提供關鍵服務，以確保積極的治療體驗。

You may have noticed several programs already in market. Our HCP unbranded awareness effort, the Oncolytic Frontier, which highlights the importance of collaboration across multidisciplinary treatment team is live online now. A few months ago, we also launched a program called Melanoma Path focused on unbranded disease education featuring real advanced melanoma patients and caregivers. Much of this content was created with the support of our advanced melanoma patient steering committee.

您可能已經注意到市場上已經有幾個程序。我們的 HCP 無品牌宣傳活動「溶瘤前沿」現已在線上線，該活動強調了多學科治療團隊合作的重要性。幾個月前，我們還啟動了一項名為「黑色素瘤之路」的項目，重點關注非品牌疾病教育，以真實的晚期黑色素瘤患者和護理人員為對象。其中大部分內容是在我們的晚期黑色素瘤患者指導委員會的支持下創建的。

We've been actively engaged with the melanoma community for the support of many key organizations, including the Melanoma Research Foundation. We're excited to be one of two presenting sponsors at their Annual Breakthrough Consortium meeting later this year at ASCO, the consortium of 30 cancer centers of excellence collaborating to develop the most promising therapies in melanoma.

我們一直積極與黑色素瘤社群合作，為包括黑色素瘤研究基金會在內的許多重要組織提供支援。我們很高興成為今年稍後在 ASCO 舉行的年度突破聯盟會議的兩家贊助商之一，該聯盟由 30 個癌症卓越中心組成，致力於合作開發最有前景的黑色素瘤治療方法。

As you can hear, we're excited with our progress to date and looking forward to hitting the ground running. Of course, ultimately, our goal is to ensure that no patient is left behind and all appropriate patients for RP1 are offered this valuable treatment once available. Our team is confident in the plans we put in place to help deliver on this important goal.

正如您所聽到的，我們對迄今為止的進展感到非常興奮，並期待著立即開始行動。當然，我們的最終目標是確保不漏掉任何患者，並且所有適合 RP1 的患者都能獲得這種寶貴的治療。我們的團隊對我們制定的有助於實現這一重要目標的計劃充滿信心。

With that update, I'll turn the call over to Emily to discuss our financial results. Emily?

有了這項更新，我將把電話轉給艾米麗，討論我們的財務結果。艾米麗？

Thank you, Chris. I'm going to start today with an update on the Investor Relations front. We are excited to be in the process of planning an upcoming Investor Day for June 24. During Investor Day, you will be able to hear from our management team and leading key opinion leaders on the current melanoma landscape, and the opportunity to deliver oncolytic immunotherapy to patients, and our RP1 road map for commercial success upon approval in anti-PD1 failed melanoma.

謝謝你，克里斯。今天我將先介紹一下投資者關係的最新情況。我們很高興正在籌劃即將於 6 月 24 日舉行的投資者日。在投資者日期間，您將能夠聽到我們的管理團隊和主要意見領袖對當前黑色素瘤情況的看法，以及為患者提供溶瘤免疫療法的機會，以及我們在抗 PD1 失敗黑色素瘤獲得批准後實現商業成功的 RP1 路線圖。

Our KOL panel includes expert interventional radiologists, medical oncologists and pharmacists in the melanoma space. We will also share more about our future development of RP2, including our registration-directed trial REVEAL in uveal melanoma and our study in hepatocellular carcinoma. Finally, we will discuss our strategy for RPx long-term pipeline development.

我們的 KOL 小組包括黑色素瘤領域的專家介入放射科醫生、腫瘤內科醫生和藥劑師。我們還將分享更多有關 RP2 未來發展的信息，包括我們在葡萄膜黑色素瘤中的註冊導向試驗 REVEAL 以及我們在肝細胞癌中的研究。最後，我們將討論 RPx 長期管道開發策略。

Now turning to our financial results for the fiscal year and quarter ended March 31, 2025. We ended the fiscal year with cash and cash equivalents totaling $483.8 million as compared to $420.7 million as of fiscal year ended March 31, 2024.

現在來看看截至 2025 年 3 月 31 日的財政年度和季度的財務表現。在本財政年度結束時，我們的現金和現金等價物總額為 4.838 億美元，而截至 2024 年 3 月 31 日的財政年度為 4.207 億美元。

Based on the current operating plan, the company believes that existing cash, cash equivalents and short-term investments as of March 31, 2025, will enable the company to fund operations into the fourth quarter of 2026, which includes scale-up for the potential commercialization of RP1 in skin cancers and for working capital and general corporate purposes. This current cash runway excludes any potential revenue expected.

根據目前的營運計劃，該公司認為，截至 2025 年 3 月 31 日的現有現金、現金等價物和短期投資將使公司能夠為 2026 年第四季度的運營提供資金，其中包括擴大 RP1 在皮膚癌領域的潛在商業化規模以及營運資金和一般公司用途。目前的現金流不包括任何預期的潛在收入。

Research and development expenses were $54 million for the fiscal fourth quarter and $189.4 million for the fiscal year ended March 31, 2025, as compared to $42.6 million for the fiscal fourth quarter and $175 million for the fiscal year ended March 31, 2024. This increase is primarily due to an increase in personnel-related costs as we scaled operations in preparation for commercial launch as well as consulting and facility-related costs. Research and development expenses included $4.5 million in stock-based compensation expenses for the fiscal fourth quarter and $18.4 million for the fiscal year ended March 31, 2025.

第四財季研發費用為 5,400 萬美元，截至 2025 年 3 月 31 日的財年研發費用為 1.894 億美元，而第四財季研發費用為 4,260 萬美元，截至 2024 年 3 月 31 日的財年研發費用為 1.75 億美元。這一成長主要是由於我們擴大營運規模以準備商業發布，導致人員相關成本增加，以及諮詢和設施相關成本增加。研發費用包括第四財季的 450 萬美元股票薪酬費用和截至 2025 年 3 月 31 日的財年的 1,840 萬美元。

Selling, general and administrative expenses were $25.4 million for the fiscal fourth quarter and $72.2 million for the fiscal year ended March 31, 2025, as compared to $16.2 million for the fiscal fourth quarter and $59.8 million for the fiscal year ended March 31, 2024.

第四財季銷售、一般及行政開支為 2,540 萬美元，截至 2025 年 3 月 31 日的財年為 7,220 萬美元，而第四財季銷售、一般及行政開支為 1,620 萬美元，截至 2024 年 3 月 31 日的財年為 5,980 萬美元。

Selling, general and administrative expenses included $3.8 million in stock-based compensation expenses for the fiscal fourth quarter and $16.6 million for the fiscal year ended March 31, 2025.

銷售、一般及行政費用包括第四財季的 380 萬美元股票薪酬費用及截至 2025 年 3 月 31 日的財年的 1,660 萬美元。

The company's net loss was $74.1 million for the fiscal fourth quarter and $247.3 million for the fiscal year ended March 31, 2025, as compared to a net loss of $55.1 million for the fiscal fourth quarter and $215.8 million for the fiscal year ended March 31, 2024.

該公司第四財季淨虧損為 7,410 萬美元，截至 2025 年 3 月 31 日的財年淨虧損為 2.473 億美元，而第四財季淨虧損為 5,510 萬美元，截至 2024 年 3 月 31 日的財年淨虧損為 2.158 億美元。

I will now turn the call over to the operator to open our question-and-answer session. Operator?

現在我將把電話轉給接線員，開始我們的問答環節。操作員？

(Operator Instructions) Anupam Rama, JPMorgan.

（操作員指示） Anupam Rama，摩根大通。

With the PDUFA around the corner, what sort of medical education work are you going to be doing at ASCO ahead of the launch of RP1? I noticed that you guys had a couple of posters at the conference.

隨著 PDUFA 即將出台，在 RP1 推出之前，您將在 ASCO 進行哪些醫學教育工作？我注意到你們在會議上張貼了幾張海報。

Anupam, thanks for the question. Yeah, we've got a busy ASCO coming up. We had a couple of important posters. As you mentioned, we build the data that we presented previously on IGNYTE showing systemic and visceral activity, including a non-injected liver and lung metastases. What we'll be doing at ASCO is actually sharing what the response rate looks like when you inject superficial lesions versus a combination of superficial and visceral lesions versus visceral-only lesions such as lung and liver metastases. And I think that data is going to show that there's going to be a strong rationale for physicians to want to inject deeper lesions to maximize outcomes for patients.

Anupam，謝謝你的提問。是的，我們即將迎來一場繁忙的 ASCO。我們有幾張重要的海報。正如您所提到的，我們建立了先前在 IGNYTE 上展示的數據，顯示了全身和內臟活動，包括非注射的肝臟和肺轉移。我們在 ASCO 上要做的實際上是分享注射表淺病變、表淺和內臟病變組合以及僅內臟病變（如肺和肝轉移）時的反應率。我認為數據將表明，醫生有充分的理由希望在更深的病變部位注射藥物，以最大限度地提高患者的治療效果。

We also have a biomarker biodistribution and safety poster, which is going to show that you can use routine cleaning using disinfectants that are routinely available for physicians in their practices and that RP1 is neutralized very rapidly. And then also that patients don't see infections or their close contacts. So we're excited about that data. And I think it's going to build on the evidence of the data we previously presented with the IGNYTE data.

我們還有一張生物標誌物生物分佈和安全海報，它將展示您可以使用醫生在實踐中常用的消毒劑進行常規清潔，並且 RP1 會被非常迅速地中和。而且患者也看不到感染者或他們的密切接觸者。所以我們對這些數據感到非常興奮。我認為這將以我們先前透過 IGNYTE 數據提供的數據證據為基礎。

Roger Song, Jefferies.

傑富瑞 (Jefferies) 的羅傑宋 (Roger Song)。

Great. So maybe given the dynamic for the launch between the oncologists and, as you mentioned, on radiologists, can you just give us some color around your expectations for the launch trajectory, considering some of them are superficial only lesion and then some of them are mix and then some of them are visceral only?

偉大的。因此，也許考慮到腫瘤學家和放射科醫生之間的啟動動態，正如您所提到的，您能否給我們一些關於啟動軌蹟的預期，考慮到其中一些只是表皮病變，然後其中一些是混合的，然後其中一些只是內臟的？

Roger, this is Chris. So we are anticipating a broad and rapid adoption across hospitals and communities really with a heavier lift initially within the hospital setting, we've identified, as you heard, around 350 of our top accounts across the country.

羅傑，這是克里斯。因此，我們預計該技術將在醫院和社區中廣泛和快速的應用，最初在醫院環境中的應用將更為廣泛，正如您所聽到的，我們已經確定了全國約 350 個頂級客戶。

We, by the time of the launch, expect roughly 150 of these accounts will have experience with intratumoral injections or have been trained on that by the time we get approved. The vast majority of these accounts will have access to interventional radiology within their centers.

我們預計，到推出時，其中大約 150 個帳戶將具有腫瘤內註射經驗，或在我們獲得批准時接受過相關培訓。其中絕大多數帳戶將能夠在其中心內進行介入放射學治療。

We've done a lot of research, as you can imagine, across the space between medical oncologists and interventional radiologists and over 90% of the folks we've spoken to are willing to utilize RP1 routinely upon approval. And so when you think about this level of excitement, the familiarity and experience, this really does support broad and rapid adoption of RP1 post approval.

正如您所想的，我們在腫瘤內科醫生和介入放射科醫生領域進行了大量的研究，我們採訪過的 90% 以上的人都願意在獲得批准後定期使用 RP1。因此，當您考慮到這種程度的興奮、熟悉和體驗時，這確實支援廣泛且快速地採用 RP1 後批准。

Got it. If I can have a follow-up question. Assuming you will get approval for the PD1-failed melanoma in upcoming PDUFA date, what would be your NCCN listing strategy to maybe potentially expand to some other subgroup and then also maybe beyond the melanoma like CSCC?

知道了。如果我可以有一個後續問題。假設您將在即將到來的 PDUFA 日期獲得 PD1 失敗黑色素瘤的批准，您的 NCCN 上市策略是什麼，可能擴展到其他亞組，然後可能超越黑色素瘤，例如 CSCC？

Roger, in terms of the IGNYTE data, obviously, we'll be able to get an approval straight away when we get the FDA approval for anti-PD1 failed melanoma. And yeag, we would though still submit that data once we have the publication, which we're hoping to have around the time of the PDUFA date, which will again just further sort of solidify our position in NCCN, although it's not necessary as we will have FDA approval.

羅傑，就 IGNYTE 數據而言，顯然，當我們獲得 FDA 對抗 PD1 失敗黑色素瘤的批准時，我們將能夠立即獲得批准。是的，我們仍然會在出版物發布後提交這些數據，我們希望在 PDUFA 日期前後提交，這將進一步鞏固我們在 NCCN 中的地位，儘管這不是必需的，因為我們將獲得 FDA 的批准。

As we think about future indications, I think what we're going to do is obviously see what the data looks like for those different indications, whether that's non-melanoma skin cancers such as CERPASS or the [article] stature in solid organ transplant, we'll be publishing the data and then determining the best path to provide access to patients, Roger.

當我們考慮未來的適應症時，我認為我們顯然要做的就是看看這些不同適應症的數據是什麼樣的，無論是非黑色素瘤皮膚癌（如 CERPASS）還是實體器官移植中的地位，我們都會發布數據，然後確定為患者提供治療的最佳途徑，羅傑。

Yeah. In addition to that, Roger, upon approval, we'll be immediately submitting our information to the drug compendia that hospitals can download this into the system. What we've done is making -- is to make sure that we have rapid adoption within the electronic medical record systems as quick as we can.

是的。除此之外，羅傑，一旦獲得批准，我們將立即將我們的資訊提交給藥品彙編，醫院可以將其下載到系統中。我們所做的就是確保盡快在電子病歷系統中迅速採用。

On day one, we'll be submitting a package to the companies that represent roughly 85% of all the electronic medical records databases in the country. And we put in place sort of a reactive mode as well, so that for those that don't readily adopt into the EMR system, our customer-facing teams will have an app they can go to right away, reach out and let the third-party group we're working with now where those haven't taken place yet and we'll resolve those issues very, very quickly to ensure we minimize barriers to access, as Sush was saying.

第一天，我們將向代表全國約 85% 電子病歷資料庫的公司提交一份文件。我們還建立了一種反應模式，這樣對於那些不容易採用 EMR 系統的客戶，我們的面向客戶的團隊將有一個可以立即使用的應用程序，聯繫並讓我們現在正在合作的第三方團體解決這些問題，如果這些問題還沒有發生，我們會非常非常快地解決這些問題，以確保最大限度地減少訪問障礙，正如 Sush 所說的那樣。

Jonathan Chang, Leerink Partners.

Jonathan Chang，Leerink Partners。

Congrats on the progress and for hosting what I believe is your first earnings call. First question, can you discuss the impact you're seeing from the recent regulatory changes, provide any color on recent FDA interactions?

恭喜您的進展，並祝賀您主持了我認為是您的第一次收益電話會議。第一個問題，您能否討論一下您從最近的監管變化中看到的影響，並提供一些關於最近 FDA 互動的資訊？

And then on second question on IGNYTE, can you discuss the translation of response rate into metrics like PFS and OS? And what benchmarks are you pointing to for PFS and OS in the anti-PD1 failed melanoma setting?

然後關於 IGNYTE 的第二個問題，您能討論一下將回應率轉換為 PFS 和 OS 等指標嗎？在抗 PD1 治療失敗的黑色素瘤中，您對 PFS 和 OS 的基準是什麼？

Thanks, Jonathan. This is Emily. I'll take the first segment of your question. So just as a reminder, for those on the call, we received breakthrough designation late last year and then submitted our BLA for RP1 in PD1 failed melanoma.

謝謝，喬納森。這是艾米麗。我來回答你問題的第一部分。因此，提醒一下，對於參加電話會議的人來說，我們在去年年底獲得了突破性進展，然後提交了針對 PD1 失敗黑色素瘤的 RP1 的 BLA。

Our BLA was accepted in January with a priority review. And since that -- since January, we've been responding to information requests from the FDA in a timely and thorough manner. We're very grateful to have seen committed and consistent engagement from our review team, and we haven't seen any changes to the cadence of that commitment.

我們的 BLA 於一月份獲得優先審查。自那時起——自一月份以來，我們一直在及時、全面地回應 FDA 的資訊請求。我們非常高興看到我們的審核團隊始終如一地投入，而且我們也沒有看到這項承諾的節奏有任何變化。

Having recently completed both our late-cycle meeting with the FDA and our manufacturing inspections, we're very pleased with the outcome of those interactions, and we believe there are no impediments. We're on track for our July 22 PDUFA.

我們最近完成了與 FDA 的後期會議和製造檢查，我們對這些互動的結果非常滿意，我們相信沒有任何障礙。我們正在按計劃執行 7 月 22 日的 PDUFA。

And Jonathan, just to address your second question -- and yeah, you're right, it's the first call, which we're very excited about. So in terms of the data that we've seen for IGNYTE, just as a reminder, we've seen around a third of patients achieve durable responses, which you look at median duration response of more than 20 months. This is a single-arm study, as you're aware. And so obviously, there are some limitations of PFS and OS in this study.

喬納森，我來回答你的第二個問題——是的，你是對的，這是第一次通話，我們對此感到非常興奮。因此，就我們看到的 IGNYTE 數據而言，提醒一下，我們看到大約三分之一的患者獲得了持久反應，平均持續時間反應超過 20 個月。如您所知，這是一項單臂研究。顯然，本研究中的 PFS 和 OS 存在一些限制。

However, we've seen a PFS of around four months and the overall survival, which I think is actually very impressive where we've seen more than about 55% of patients still alive at three years. And so we think that's going to be very meaningful relative to other options in this space.

然而，我們看到 PFS 約為四個月，整體存活率也很高，我認為這實際上非常令人印象深刻，因為我們看到超過 55% 的患者在三年後仍然存活。因此我們認為，相對於該領域的其他選擇，這將非常有意義。

You asked about the benchmarks we should be using. And I think it is important to remember that the IGNYTE did use a very strict criteria for anti-PD1 failure and there is an exact apples-to-apples comparisons. But if you think about some of the other studies and assets or molecules used in this space, such as Ipi-Nivo or opdualag having failed either Ipi-Nivo or opdualag in the frontline setting, you see about a 12% response rate.

您詢問我們應該使用的基準。我認為重要的是要記住，IGNYTE 確實使用了非常嚴格的抗 PD1 失敗標準，並且進行了精確的同類比較。但是，如果您考慮該領域中使用的一些其他研究和資產或分子，例如 Ipi-Nivo 或 opdualag 在前線環境中失敗了，您會看到大約 12% 的回應率。

And typically, there are physicians and KOLs who tell you we do not expect to see median overall survival of more than 12 months. So I think that's a reasonable benchmark that most people use further checkpoint inhibition after failure of prior checkpoint inhibition really only results in a response rate of 6% or 7% with very modest overall survival benefits.

通常，醫生和關鍵意見領袖會告訴你，我們預期中位總存活期不會超過 12 個月。因此我認為這是一個合理的基準，即大多數人在先前的檢查點抑制失敗後使用進一步的檢查點抑制實際上只能產生 6% 或 7% 的反應率，總體生存效益非常適中。

Allison Bratzel, Piper Sandler.

艾莉森‧布拉澤爾，派珀‧桑德勒。

Just on the confirmatory IGNYTE-3 trial, I think you initiated dosing of patients last summer. So could you just talk to your experience to date with that trial and what you're seeing in terms of enrollment, opening of trial sites and things like that? And just expectations on a time line for completing enrollment. Any color there would be helpful.

僅在確認性 IGNYTE-3 試驗中，我認為您在去年夏天就開始對患者進行給藥。那麼，您能否談談迄今為止您在該試驗中的經歷，以及您在招募、試驗地點開放等方面所看到的情況？並且只是對完成註冊的時間軸有所期待。任何顏色都會有幫助。

And second, could you -- you talked to your expectations on the potential label or label discussions for RP1 and just what gives you confidence in a broad label and achieving broad access?

其次，您能否談談您對 RP1 潛在標籤或標籤討論的期望，以及是什麼讓您對廣泛的標籤和實現廣泛的訪問充滿信心？

So just in terms of IGNYTE or (technical difficulty) just as a reminder for people, this is a large randomized study, a confirmatory Phase 3 trial with 400 patients where we're combining RP1 with nivolumab versus limited dealers' choice, which includes opdualag chemotherapy or single-agent checkpoint inhibition.

因此，就 IGNYTE 或（技術難度）而言，只是提醒大家，這是一項大型隨機研究，一項有 400 名患者參與的確認性 3 期試驗，我們將 RP1 與 nivolumab 相結合，而不是有限的經銷商選擇，其中包括 opdualag 化療或單藥檢查點抑制。

This is a trial that's going to have more than 100 sites globally. And as you can imagine, we've been providing the agency the updates on the timelines for the overall study and enrollment updates on a regular basis. We expect the trial to take a couple of years to complete enrollment given the study population and size of the study. But -- and as you can imagine, right now, we're intentionally focusing on enrolling in US sites given the upcoming PDUFA and when we realize that at approval patients will not want to be randomized into the control arm.

此次試驗將在全球 100 多個站點進行。正如您所想像的，我們一直在定期向該機構提供整體研究時間表和招生更新的資訊。考慮到研究族群和研究規模，我們預計試驗將需要幾年時間才能完成招募。但是 — — 正如您所想像的，鑑於即將出台的 PDUFA，並且我們意識到在獲得批准時患者不會希望被隨機分配到對照組，因此現在我們有意專注於在美國站點進行註冊。

So given that we're really focusing our efforts and driving enrollment in the US, it's going very well. There's a lot of excitement around the trial. And what we're actually now doing is spending a lot of time on the rest of world expansion so that at PDUFA, we would continue to see enrollment in that study in countries such as the UK, Australia and Europe.

因此，鑑於我們確實集中精力推動美國的招生，一切進展順利。這次審判引起了很大的轟動。而我們現在實際上正在做的是花費大量時間在世界其他地區擴張，以便在 PDUFA 上，我們能夠繼續看到英國、澳洲和歐洲等國家參與這項研究。

And again, there's equally a high-level excitement from ex-US investigators around the trial. We look forward to speaking to many of them at the upcoming ASCO meeting. And then you asked the second question, I believe, on the broad label, is that correct?

前美國調查人員對這次審判也同樣表現出高度的興奮。我們期待在即將召開的 ASCO 會議上與他們中的許多人進行交談。然後你問了第二個問題，我相信，關於廣義的標籤，這是正確的嗎？

Yeah.

是的。

Just as a reminder, IGNYTE really enrolled a real-world population which included really pretty much every type of anti-PD1 failed presentation, and we saw a consistent benefit across all the subgroups. So we would expect the label and as you know, now that we finished the late-cycle meeting we'll be going into labeling discussions, to very much reflect the study population that we investigated in the IGNYTE trial and would expect a label to reflect that broad population.

提醒一下，IGNYTE 確實招募了現實世界的人群，其中包括幾乎所有類型的抗 PD1 失敗表現，並且我們在所有亞組中都看到了一致的好處。因此，我們期望標籤能夠很好地反映我們在 IGNYTE 試驗中調查的研究人群，並且如您所知，現在我們完成了後期週期會議，我們將進入標籤討論階段，並期望標籤能夠反映廣泛的人群。

Evan Seigerman, BMO Capital Markets.

埃文·塞格曼 (Evan Seigerman)，BMO 資本市場。

This is Conrad on for Evan. Ahead of the potential commercial launch, can you maybe talk a little bit about how you're planning for manufacturing resiliency, including second sites to provide RP1 product? And then I also believe you have an attractive cost of goods profile with RP1. Can you maybe remind us what the drivers are there?

這是康拉德 (Conrad) 代替埃文 (Evan) 上場的。在可能的商業發布之前，您能否談談您如何規劃製造彈性，包括提供 RP1 產品的第二個網站？然後我還相信 RP1 的商品成本狀況很有吸引力。您能否提醒我們有哪些驅動程式？

Yeah. So just in terms of the manufacturing, and again, as a reminder, we're manufacturing our own product at that facility that was designed specifically for the manufacturer of RPx and framing them in the US.

是的。因此，就製造而言，再次提醒一下，我們正在專門為 RPx 製造商設計的工廠生產我們自己的產品，並在美國進行組裝。

And yeah, you're right, we have attractive cost of goods. It was one of the strategic reasons that we actually invested in the manufacturing early. And we do anticipate to have a off-the-shelf product that physicians will utilize order and use the next day. We'll have sufficient inventory for rapid and broad support at launch and also have sufficient supply to ensure that we have mid to long-term supply for expansion of RP1.

是的，您說得對，我們的商品成本很有吸引力。這是我們早期投資製造業的策略性原因之一。我們確實期望能有現成的產品，醫生可以在第二天訂購併使用。我們將擁有充足的庫存，以便在產品發佈時提供快速而廣泛的支持，同時也將擁有充足的供應，以確保我們擁有用於 RP1 擴展的中長期供應。

In terms of the capacity, we -- again, we have a lot of redundancy within the facility to produce sufficient supply way beyond the initial launch, and we're also looking to produce other product, including RP2 and RP3 at the facility in the future.

就產能而言，我們——同樣，我們的工廠內部有很多冗餘，可以在首次推出之後提供足夠的供應，我們還希望將來在該工廠生產其他產品，包括 RP2 和 RP3。

(Operator Instructions) Peter Lawson, Barclays.

（操作員指示）巴克萊銀行的彼得·勞森。

I wonder if you could just talk through any of the gating factors that exist between now and the PDUFA date, especially around CMC? And then kind of your thoughts around kind of IGNYTE learnings from [fewer] launches? How you're thinking about giving revenue guidance and thinking about market penetration?

我想知道您是否可以談談從現在到 PDUFA 日期之間存在的任何限制因素，尤其是圍繞 CMC 的因素？那麼，您對 IGNYTE 從 [更少的] 發射中學到的教訓有何看法？您如何考慮提供收入指導和市場滲透率？

Yeah. So I'll just take the first question. As I mentioned earlier, we did complete our late-cycle meeting, and we did complete our factoring inspections, both the [Ternian] and Park facility, which does our process validation in analytical methods and then the main manufacturing facility in Framingham. So we feel we're well positioned there. And as you would imagine, there was discussions on CMC and other clinical questions at the late cycle meeting and we remain on track.

是的。所以我只想回答第一個問題。正如我之前提到的，我們確實完成了後期週期會議，也完成了保理檢查，包括[Ternian]和Park工廠，這兩個工廠負責分析方法的流程驗證，然後是位於Framingham的主要製造工廠。因此，我們覺得我們在那裡處於有利地位。正如您所想像的，在後期週期會議上討論了 CMC 和其他臨床問題，我們仍在按計劃進行。

In terms of revenue guidance, I anticipate that we'll be providing metrics for you to track the success of the launch, including ultimately, patient numbers and payers, and we'll hold off on revenue guidance until further into the launch.

在收入指導方面，我預計我們將為您提供指標來追蹤發布的成功情況，最終包括患者數量和付款人，並且我們將推遲發布收入指導，直到發布進一步進行。

Is there any kind of formal or informal feedback you've got from the FDA regarding, I guess, manufacturing or any other components there?

我想，您是否從 FDA 那裡得到有關製造或任何其他組件的任何正式或非正式的反饋？

Yeah. I mean, of course, we are under an active BLA review. We have completed the inspections and so there is formal feedback associated with those inspections. And none of that formal feedback should provide a bottleneck towards our July 22 PDUFA.

是的。我的意思是，當然，我們正在接受積極的 BLA 審查。我們已經完成了檢查，因此有與這些檢查相關的正式回饋。所有這些正式回饋都不應成為我們 7 月 22 日 PDUFA 的瓶頸。

Peter, thank you for the second question. While there's been significant advances in the treatment of advanced melanoma in recent years, there still remains a pretty significant unmet need when it comes to either deep responses, durable responses or safety profiles.

彼得，謝謝你的第二個問題。儘管近年來晚期黑色素瘤的治療取得了重大進展，但在深度反應、持久反應或安全性方面仍存在相當大的未滿足需求。

And so we know that today, when patients progress on a PD1, they started on PD1 here in the front-line setting, half of them are going to progress within six months. And so for these patients, they don't have oftentimes 6, 8 or 10 weeks for the next treatment option to be employed.

因此我們知道，今天，當患者在 PD1 治療上出現進展時，他們在前線環境中開始使用 PD1，其中一半將在六個月內出現進展。因此對於這些患者來說，他們通常沒有 6、8 或 10 週的時間來選擇下一個治療方案。

When we talk to physicians in the community, melanoma experts around the country, when they start a patient on a treatment and it's working well and it's tolerated well, they will rarely remove that patient from treatment.

當我們與社區醫生、全國各地的黑色素瘤專家交談時，當他們開始對患者進行治療並且效果良好且耐受性良好時，他們很少會讓患者停止治療。

And so our position is that RP1 will be positioned as a first-line option for patients who progress on PD1 therapy based upon our deep and durable response rates, our safety profile and our next-day distribution and off-the-shelf use of convenience, which again, really helps to support broad and rapid adoption once approved.

因此，我們的立場是，RP1 將被定位為 PD1 治療進展患者的一線選擇，這基於我們深度和持久的反應率、我們的安全性以及我們的次日分發和現成的便利性，這再次真正有助於支持一旦獲得批准後廣泛而快速的採用。

I'm showing no further questions at this time. I'd like to turn the call back over to Sushil Patel for closing remarks.

我目前沒有其他問題。我想將電話轉回給 Sushil Patel 做最後發言。

Thank you. So in summary, it's been a productive few months and with a very exciting inflection point as we prepare for our first approval and commercial launch with RP1. We look forward to our upcoming milestones, including data updates on our deep and visceral activity in safety at ASCO and our upcoming Investor Day and potential approval announcement.

謝謝。總而言之，這幾個月是富有成效的，在我們為 RP1 的首次批准和商業發布做準備時，我們迎來了一個非常令人興奮的轉折點。我們期待即將到來的里程碑，包括在 ASCO 安全方面的深入和內在活動的數據更新以及即將到來的投資者日和潛在的批准公告。

Finally, I just want to acknowledge everyone at Replimune. I'm proud of the efforts of our team and want to thank them for their dedication as we work to deliver important treatment options to patients in need. Thank you for joining our call today.

最後，我只想感謝 Replimune 的所有人。我為我們團隊的努力感到自豪，並感謝他們的奉獻精神，我們致力於為有需要的患者提供重要的治療選擇。感謝您今天參加我們的電話會議。

Thank you for your participation. This does conclude the program, and you may now disconnect. Everyone, have a great day.

感謝您的參與。這確實結束了程序，您現在可以斷開連接了。祝大家有個愉快的一天。