Iovance Biotherapeutics Inc (IOVA) 2024 Q3 法說會逐字稿

Thank you for standby. My name is Mandeep, and I'll be your operator today. I'd like to welcome everyone to the Iovance Third Quarter 2024 Financial results call. I would now like turn the call over to Sara.

謝謝你的等待。我叫 Mandeep，今天我將擔任您的接線生。歡迎大家參加 Iovance 2024 年第三季財務業績電話會議。我現在想把電話轉給薩拉。

Thank you, operator. Good afternoon, and thank you for joining this conference call and webcast to discuss our third quarter and year-to-date 2024 financial results as well as recent corporate and development program updates.

謝謝你，接線生。下午好，感謝您參加本次電話會議和網路廣播，討論我們第三季度和 2024 年年初至今的財務業績以及最近的公司和發展計劃更新。

Dr. Fred Vogt, our Interim Chief Executive Officer and President, will provide an introduction and summarize the latest progress with our US commercial launch of Amtagvi including revenue and revenue guidance, patient demand and market access, an update on our global regulatory submissions at a high-level summary of our key pipeline. Dr. Brian Gastman, our Executive Vice President, Medical Affairs, will highlight adoption and demand at authorized treatment centers or ATC as well as our community outreach initiatives to drive additional growth for the US commercial launch of Amtagvi in advanced melanoma.

我們的臨時執行長兼總裁 Fred Vogt 博士將介紹並總結我們在美國商業推出 Amtagvi 的最新進展，包括收入和收入指導、患者需求和市場准入、我們全球監管提交的最新情況我們的關鍵管道的高級摘要。我們的醫療事務執行副總裁 Brian Gastman 博士將重點介紹授權治療中心或 ATC 的採用和需求，以及我們的社區外展計劃，以推動 Amtagvi 在美國商業上市治療晚期黑色素瘤的進一步增長。

Dr. Igor Bilinsky, our Chief Operating Officer will cover our commercial manufacturing experience and the status of our ongoing capacity expansion. Jean-Marc Bellemin, our Chief Financial Officer, will review our financial results, including revenue and revenue guidance, gross margin, and the strength of our balance sheet; and Dr. Friedrich Graf Finckenstein, our Chief Medical Officer will review key pipeline highlights including recent updates related to our clinical program in frontline non-small cell lung cancer. Dr. Raj Perry, our EVP of Regulatory Affairs and (technical difficulty) Senior Vice President, Commercial are also on the call and available for the Q&A session.

我們的營運長 Igor Bilinsky 博士將介紹我們的商業製造經驗以及我們正在進行的產能擴張的狀況。我們的財務長 Jean-Marc Bellemin 將審查我們的財務業績，包括收入和收入指導、毛利率以及資產負債表的實力；我們的首席醫療官 Friedrich Graf Finckenstein 博士將回顧關鍵的產品線亮點，包括與我們一線非小細胞肺癌臨床計畫相關的最新更新。我們的監管事務執行副總裁和（技術難題）商業高級副總裁 Raj Perry 博士也將參加電話會議並參加問答環節。

Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans and transactions, revenue and revenue guidance, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, cash position and expense guidance and future updates.

今天下午早些時候，我們發布了一份新聞稿，您可以在我們的公司網站 iovance.com 上找到該新聞稿。在開始之前，我想提醒大家，本次電話會議期間發表的聲明將包括有關Iovance 的目標、業務重點、業務計劃和交易、收入和收入指導、商業活動、臨床試驗和結果、監管批准的前瞻性陳述和互動、計劃和策略、研究和臨床前活動、我們技術的潛在未來應用、製造能力、監管反饋和指導、付款人互動、許可和協作、現金狀況和費用指導以及未來更新。

Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements. With that introduction, I will hand the call to Fred.

前瞻性陳述受到眾多風險和不確定性的影響，其中許多風險和不確定性超出了我們的控制範圍，包括我們在 SEC 文件中不時描述的風險和不確定性。我們的結果可能與今天電話會議期間預測的結果有重大差異。我們不承擔公開更新任何前瞻性聲明的義務。介紹完畢後，我會將電話轉給弗雷德。

Thank you, Sara. I'm pleased to host this afternoon's conference call to discuss our financial results for the third quarter and year-to-date of 2024 as well as our recent corporate highlights.

謝謝你，薩拉。我很高興主持今天下午的電話會議，討論我們 2024 年第三季和年初至今的財務業績以及我們最近的企業亮點。

Iovance is nearing the end of a successful year following our first FDA approval and a strong start to the US commercial launch of Amtagvi for patients with advanced melanoma. We are rapidly advancing our robust pipeline of current future generation T-cell therapies across all stages development to expand our commercial opportunities.

在我們首次獲得 FDA 批准以及針對晚期黑色素瘤患者的 Amtagvi 在美國商業上市的良好開端之後，Iovance 即將迎來成功的一年。我們正在各個開發階段快速推進當前下一代 T 細胞療法的強大產品線，以擴大我們的商業機會。

I would like to begin by highlighting the exceptional continued demand for Amtagvi. Our third quarter total product revenue was $58.6 million, surpassing the top end of our third quarter total product revenue guidance of $53 million to $55 million. Total product revenue in the third quarter included $41 million for Amtagvi and $16.5 million for Proleukin.

首先，我想強調對 Amtagvi 的特殊持續需求。我們第三季的產品總收入為 5,860 萬美元，超過了第三季產品總收入指引值 5,300 萬至 5,500 萬美元的上限。第三季的產品總收入包括 Amtagvi 的 4,100 萬美元和 Proleukin 的 1,650 萬美元。

As a reminder, Amtagvi revenue is recognized upon infusion to the patient. Proleukin revenue is recognized upon delivery to distributors or hospitals typically a few months prior to Amtagvi infusion. Year-to-date, total product revenue was $90.4 million to September 30 including $54.9 million for Amtagvi and $35.5 million for Proleukin.

提醒一下，Amtagvi 收入在向患者輸注時確認。Proleukin 收入通常在 Amtagvi 輸注前幾個月交付給經銷商或醫院時確認。年初至今，截至 9 月 30 日，產品總收入為 9,040 萬美元，其中 Amtagvi 為 5,490 萬美元，Proleukin 為 3,550 萬美元。

Third quarter and year-to-date revenue reflects robust initial uptake and increasing strong demand and adoption of Amtagvi as well as sales of Proleukin used with Amtagvi. Since the first infusion in April through today, 126 patients have been infused with Amtagvi keeping us on track towards our 2024 guidance at representing about $75 million 2024 revenue from Amtagvi alone with more to come. Infusions over time also reflects an increasing rate of adoption with 25 in the second quarter, 82 in the third quarter and 39 in the fourth quarter to date.

第三季和年初至今的收入反映了 Amtagvi 的強勁初始吸收和不斷增長的強勁需求和採用，以及與 Amtagvi 一起使用的 Proleukin 的銷售。自4 月首次輸注至今，已有126 名患者接受了Amtagvi 輸注，這使我們能夠朝著2024 年的指導方向前進，僅Amtagvi 一項就意味著2024 年的收入約為7500 萬美元，而且未來還會有更多收入。隨著時間的推移，注入也反映出採用率不斷上升，迄今為止，第二季為 25 個，第三季為 82 個，第四季為 39 個。

Our team's successful execution as well as the unmet medical need in advanced melanoma, high awareness broad patient access and a motivated and expanding network of authorized treatment centers or ATCs, continue to drive strong adoption and uptake of Amtagvi and Proleukin. With 56 current ATCs, we remain focused on our goal of onboarding approximately 70 total ATCs by year-end. Our community referral initiatives are also driving additional demand as our ATCs continue to scale up to treat more patients.

我們團隊的成功執行以及晚期黑色素瘤中未滿足的醫療需求、廣泛患者的高認知度以及積極且不斷擴大的授權治療中心或 ATC 網絡，繼續推動 Amtagvi 和 Proleukin 的強勁採用和吸收。目前我們有 56 個 ATC，我們仍然致力於實現到年底總共加入約 70 個 ATC 的目標。隨著我們的 ATC 不斷擴大規模以治療更多患者，我們的社區轉診計畫也推動了額外的需求。

In addition to robust demand, favourable medical coverage policies and reimbursement are facilitating broad access to Amtagvi. Approximately 75% of Amtagvi patients are covered by private payers. More than 250 million lives or more than 95% of US covered lives currently have access to reimbursement through positive medical coverage policies for pharmacy benefit plans.

除了強勁的需求之外，有利的醫療保險政策和報銷也促進了 Amtagvi 的廣泛普及。大約 75% 的 Amtagvi 患者由私人付款人承保。目前，超過 2.5 億人（即超過 95% 的美國受保人）可以透過藥物福利計劃的積極醫療保險政策獲得報銷。

And positive payer coverage has been consistent with the label of clinical trials and National Comprehensive Cancer Network or NCCN guidelines. As Igor will further summarize, we are manufacturing and delivering Amtagvi to patients at an increasing pace. We can meet current demand while increasing capacity and head count each month to match ongoing growth.

積極的付款人保險與臨床試驗和國家綜合癌症網絡或 NCCN 指南的標籤一致。正如 Igor 將進一步總結的那樣，我們正在以越來越快的速度為患者製造和提供 Amtagvi。我們可以滿足當前的需求，同時每月增加產能和人員數量，以適應持續的成長。

As the launch continues, the treatment journey is also speeding up for patients. Financial clearance currently averages approximately three weeks, representing a significant reduction from four to six weeks of initial launch. ATCs are saving additional time by scheduling in parallel with financial clearance and/or initiating the preconditioning regimen in conjunction with (technical difficulty) several days prior to product arrival. We are consistently delivering on our turnaround time of 34 days for manufacturing and release testing and expect this turnaround time to decrease as the launch continues.

隨著啟動的繼續，患者的治療之旅也在加速。目前財務清算平均約三週，比最初啟動時的四周大幅縮短至六週。ATC 透過與財務清算並行安排和/或在產品到達前幾天（技術難度）啟動預處理方案，節省了額外的時間。我們始終如一地實現 34 天的製造和發布測試週轉時間，並預計隨著發布的繼續，該週轉時間會縮短。

Looking ahead, we are reaffirming our full year 2024 total product revenue guidance of $160 million to $165 million. We also reiterate our full year 2025 guidance of $450 million to $475 million in total product revenue. We expect a significant increase in year-over-year growth as ATC's broaden utilization and new ATCs as well as community referral networks contribute to additional demand.

展望未來，我們重申 2024 年全年產品總收入指引為 1.6 億至 1.65 億美元。我們也重申 2025 年全年產品總收入指引為 4.5 億至 4.75 億美元。我們預計，隨著 ATC 利用率的擴大、新的 ATC 以及社區轉介網絡將帶來額外的需求，同比增長將顯著增加。

We anticipate significant additional revenue growth in 2026 and beyond. In the currently approved advanced melanoma education alone, Amtagvi and Proleukin represent more than $1 billion peak opportunity in the US market.

我們預計 2026 年及以後收入將大幅成長。僅在目前批准的高級黑色素瘤教育中，Amtagvi 和 Proleukin 就代表了美國市場超過 10 億美元的高峰機會。

Globally, Amtagvi represents a multibillion-dollar opportunity to address more than 20,000 previously treated advanced melanoma patients annually in the US and in our initial ex US markets. Gross margin, which Jean-Marc will highlight in a few minutes, is also expected to increase to greater than 70% over the next several years. And our third quarter gross margin is more than halfway towards that target.

在全球範圍內，Amtagvi 代表了一個價值數十億美元的機會，每年可以在美國和我們最初的美國以外市場治療超過 20,000 名既往接受過治療的晚期黑色素瘤患者。Jean-Marc 將在幾分鐘內重點介紹毛利率，預計未來幾年將增加至 70% 以上。我們第三季的毛利率已達到該目標的一半以上。

With a fully integrated infrastructure and (technical difficulty) interest in Amtagvi outside the US, Iovance is well positioned to continue scaling globally. Our ex US teams are being built and regulatory dossiers are under review, submitted our plans across multiple international markets with potential for our first ex US approval in the first half of 2025.

憑藉完全整合的基礎設施以及對美國以外 Amtagvi 的興趣（技術難度），Iovance 處於有利地位，可以繼續在全球擴展。我們的美國前團隊正在組建，監管檔案正在審查中，我們在多個國際市場提交了計劃，有可能在 2025 年上半年獲得首次美國前批准。

European Medicines Agency validated and accepted our marketing authorization application, or MAA, for a review for all EU member states with potential approval in the second half of 2025. The Medicines and Healthcare Products Regulatory Agency in the United Kingdom is reviewing a separate MAA submission for potential approval in the first half of 2025.

歐洲藥品管理局驗證並接受了我們的行銷授權申請 (MAA)，以便對所有歐盟成員國進行審查，並可能在 2025 年下半年獲得批准。英國藥品和保健品監管機構正在審查單獨的 MAA 申請，以便可能在 2025 年上半年獲得批准。

Our new drug submission is also underway for near-term submission in Canada and will include a prioritized review process for potential approval in mid-2025. Additional regulatory (technical difficulty) remain on track for submission in Australia and Switzerland in 2025, and we'll target additional markets with highly concentrated populations of advanced melanoma patients in the future.

我們的新藥提交工作也正在進行中，近期將在加拿大提交，並將包括優先審查流程，以便在 2025 年中期獲得批准。其他監管（技術難度）仍有望於 2025 年在澳洲和瑞士提交，我們未來將瞄準晚期黑色素瘤患者群體高度集中的其他市場。

Iovance is poised to remain the global leader in innovating, developing, and delivering current and future generations of TIL cell therapies for patients with cancer. The first approval, launch in large-scale manufacturing with TIL cell therapy together with our intellectual property position and deep pipeline provide us with distinct competitive advantages. Future growth drivers include global label expansions in the frontline advanced melanoma, other tumor types and next-generation programs that we'll discuss in more detail today.

Iovance 準備繼續在創新、開發和提供當前和未來幾代癌症患者 TIL 細胞療法方面保持全球領先地位。TIL 細胞療法的首次批准、大規模生產以及我們的智慧財產權地位和深厚的產品線為我們提供了獨特的競爭優勢。未來的成長動力包括一線晚期黑色素瘤、其他腫瘤類型和下一代計畫的全球標籤擴張，我們今天將更詳細地討論這些。

I'll hand over now to Brian, our Executive Vice President of Medical Affairs, who will summarize our ATC network in US field activities. Brian?

現在我將把工作交給我們的醫療事務執行副總裁 Brian，他將總結我們在美國現場活動的 ATC 網路。布萊恩？

Thank you, Fred. We're excited about the potential for Amtagvi to improve the lives of thousands of patients with advanced melanoma. Our ATCs continue to share positive feedback and stories about their patients who have benefited from Amtagvi since approval. My objectives today are to highlight: one, demand and adoption and utilization across our expanding ATC network; and two, our field support for ATCs as well as targeted community oncologists.

謝謝你，弗雷德。我們對 Amtagvi 改善數千名晚期黑色素瘤患者生活的潛力感到興奮。我們的 ATC 繼續分享自 Amtagvi 獲批以來受益於 Amtagvi 的患者的正面回饋和故事。我今天的目標是強調：第一，我們不斷擴大的 ATC 網路的需求、採用和利用；第二，我們對 ATC 以及目標社區腫瘤學家的現場支持。

First, our ATC network is scaling and expanding as planned, and we expect robust demand growth to continue. Amtagvi's early inclusion in the NCCN guidelines, combined with strong clinical data, has supported broad and successful market access. Today, Amtagvi is available at 56 United States ATCs, and our goal is to reach approximately 70 total ATCs by the end of 2024 with more to come in 2025.

首先，我們的 ATC 網路正在按計劃擴大規模，我們預計需求將持續強勁成長。Amtagvi 早期納入 NCCN 指南，結合強大的臨床數據，支持了廣泛且成功的市場准入。目前，Amtagvi 在 56 個美國 ATC 中可用，我們的目標是到 2024 年底達到約 70 個 ATC，並在 2025 年增加更多。

Our field medical team is composed of highly experienced medical science liaisons and former health care providers, including oncologists and surgeons. They understand the unique needs of each ATC and proactively provide support, training and peer-to-peer conversations around patient selection and surgical resection to maximize successful outcomes with the Amtagvi treatment regimen.

我們的現場醫療團隊由經驗豐富的醫學科學聯絡員和前醫療保健提供者組成，包括腫瘤科醫生和外科醫生。他們了解每個 ATC 的獨特需求，並圍繞患者選擇和手術切除主動提供支援、培訓和同儕對話，以最大限度地提高 Amtagvi 治療方案的成功結果。

As we expand our ATC network to bring treatment closer to patients, more than 90% of treat patients are located within 200 miles of an ATC today. Nearly all melanoma patients will be within a two-hour drive to the closest center by year-end.

隨著我們擴大 ATC 網路以使治療更接近患者，如今超過 90% 的治療患者位於 ATC 200 英里範圍內。到年底，幾乎所有黑色素瘤患者都將在兩小時車程內到達最近的中心。

Community referrals are also driving patient volume and demand growth across our networks of ATCs. Iovance field teams are currently targeting top community practices and large community-focused professional organizations. The primary objective is to drive early referrals by identifying patients with advanced melanoma who are currently receiving frontline treatment and may be eligible for Amtagvi upon disease progression.

社區轉診也推動了我們 ATC 網路的患者數量和需求成長。Iovance 現場團隊目前的目標是頂級社區實踐和大型以社區為中心的專業組織。主要目標是透過識別目前正在接受一線治療並且在疾病進展後可能有資格接受 Amtagvi 的晚期黑色素瘤患者來推動早期轉診。

In summary, we are extremely pleased with the early launch performance as our ATCs successfully adopt and broadened utilization of Amtagvi. I will now pass the call to Igor Bilinsky, our Chief Operating Officer, to highlight our manufacturing progress.

總之，我們對早期的發布表現非常滿意，因為我們的 ATC 成功採用並擴大了 Amtagvi 的利用率。現在，我將致電我們的營運長伊戈爾·比林斯基 (Igor Bilinsky)，強調我們的製造進度。

Thank you, Brian. Today, I'd like to highlight our commercial and clinical manufacturing capabilities the progress of our commercial launch and the status of our ongoing capacity and facility expansion.

謝謝你，布萊恩。今天，我想重點介紹我們的商業和臨床製造能力、商業啟動的進展以及我們正在進行的產能和設施擴張的狀況。

Our manufacturing capacity continues its steady ramp up month-over-month to support the growing Amtagvi commercial demand. We continue to actively hire manufacturing and quality control staff as well as supporting functions and have significantly increased our staff capacity at (technical difficulty) Therapy Center, or ICTC since launch in February.

我們的製造能力逐月持續穩定成長，以支援不斷成長的 Amtagvi 商業需求。自 2 月成立以來，我們繼續積極僱用製造和品質控制人員以及支援職能人員，並顯著提高了（技術難度）治療中心 (ICTC) 的員工能力。

We have too many sectoring facilities approved by the FDA for commercial manufacturing of Amtagvi. One is our internal manufacturing facility, Iovance Cell Therapy Center located from the Navy Yard in Philadelphia. It is one of the largest cell therapy manufacturing facilities in the world. In addition, our contract manufacturers facility provides us with further capacity and scheduling flexibility to serve Amtagvi patients.

我們有太多經 FDA 批准用於 Amtagvi 商業生產的部門設施。其中之一是我們的內部製造工廠，位於費城海軍造船廠的 Iovance 細胞治療中心。它是世界上最大的細胞療法生產設施之一。此外，我們的合約製造商設施為我們提供了更大的產能和調度靈活性，為 Amtagvi 患者提供服務。

We are pleased with our commercial manufacturing experience to date, which remains consistent with prior clinical experience. The medical affairs team is doing a tremendous job sharing best practices among ATCs such as optimal tumor selection and sample procurement for manufacturing, which contributed to improving manufacturing success rates.

我們對迄今為止的商業製造經驗感到滿意，這與先前的臨床經驗保持一致。醫療事務團隊正在做大量工作，在 ATC 之間分享最佳實踐，例如最佳腫瘤選擇和製造樣本採購，這有助於提高製造成功率。

The turnaround time has been consistent at 34 days from receiving cells at the manufacturing facility to Amtagvi being ready for return shipment to the ATC. As Fred mentioned, we are working on optimizing our processes to further shorten the turnaround time.

從製造廠接收電池到 Amtagvi 準備好返回至 ATC，週轉時間始終為 34 天。正如 Fred 所提到的，我們正在努力優化流程，以進一步縮短週轉時間。

As we scale up, we also expect to improve the cost of goods over time through economies of scale and operational efficiencies as well as by leveraging our competitive advantage and unique position as the leader in the TIL cell therapy space. Our manufacturing network is currently running at high capacity utilization while ensuring small availability for our ATCs.

隨著我們規模的擴大，我們也希望透過規模經濟和營運效率，以及利用我們作為 TIL 細胞治療領域領導者的競爭優勢和獨特地位，隨著時間的推移，提高商品成本。我們的製造網路目前以高產能利用率運行，同時確保我們的 ATC 的可用性較小。

In anticipation of potential regulatory approvals of Amtagvi outside the US, we are establishing logistics and distribution to support a successful commercial launch in new markets such as the EU, UK, and Canada. The ICTC already serves patients in our clinical trials in Europe, Australia, and other geographies, and we intend to manufacture global commercial product from our Philadelphia sites as well.

預計 Amtagvi 可能會在美國以外的監管部門獲得批准，我們正在建立物流和分銷，以支持在歐盟、英國和加拿大等新市場的成功商業發布。ICTC 已經在歐洲、澳洲和其他地區的臨床試驗中為患者提供服務，我們也打算在費城工廠生產全球商業產品。

In anticipation of the longer-term growth of global commercial demand in melanoma and other indications, we are expanding our manufacturing network. ICTC is built today has the capacity to provide TIL products for more than 2,000 patients annually.

預計黑色素瘤和其他適應症的全球商業需求將長期成長，我們正在擴大我們的製造網絡。目前建成的ICTC已具備每年為2,000多名病患提供TIL產品的能力。

Building out the existing shelf space at ICTC is expected to bring that capacity to over 5,000 patients annually upon completion, which we expect within a couple of years. Further expansion of our manufacturing campus in Philadelphia, along with process optimization and automation is expected to bring the capacity to over 10,000 patients annually.

ICTC 現有貨架空間的擴建預計將在幾年內完成，每年可容納 5,000 多名患者。我們在費城的製造園區的進一步擴建以及流程優化和自動化預計每年將為超過 10,000 名患者帶來產能。

The Iovance manufacturing supply chain and quality team is committed to operational excellence in providing Amtagvi to patients in the spirit of doing everything right first time every time. I'd like to thank them for their continued dedication, 24/7, 365 in serving out patients who meet this paradigm-changing and potential life-saving therapy.

Iovance 製造供應鏈和品質團隊致力於卓越運營，本著每次第一次就做好每件事的精神，為患者提供 Amtagvi。我要感謝他們 24/7、365 持續不斷的奉獻精神，為接受這種改變範式且可能挽救生命的療法的患者提供服務。

Importantly, our expertise in TIL cell therapy as well as manufacturing capabilities are protected by a robust intellectual property portfolio. Iovance currently owns more than 230 granted or allowed US and international patents and patent rights for Amtagvi and other TIL-related technologies that are expected to provide exclusivity through at least 2042.

重要的是，我們在 TIL 細胞治療方面的專業知識以及製造能力受到強大的智慧財產權組合的保護。Iovance 目前擁有超過 230 項授權或允許的美國和國際專利以及 Amtagvi 和其他 TIL 相關技術的專利權，預計至少到 2042 年將提供排他性。

I'm available to answer additional questions during the Q&A, and I will now hand the call to Jean-Marc, our Chief Financial Officer.

我可以在問答期間回答其他問題，現在我將把電話轉給我們的財務長 Jean-Marc。

Thank you, Igor. Today, I will review our current cash position as well as our results for the third quarter and nine months ended September 30, 2024. I will also highlight our financial outlook, including revenue and expense guidance as well as our gross margin.

謝謝你，伊戈爾。今天，我將回顧我們目前的現金狀況以及截至 2024 年 9 月 30 日的第三季和九個月的業績。我還將強調我們的財務前景，包括收入和支出指導以及毛利率。

As of September 30, 2024, our unaudited cash position was approximately $403.8 million, including approximately $200 million in net proceeds (technical difficulty) the market equity financing facility during the second and early third quarters of 2024. We expect the current cash position and anticipated product revenue to be sufficient to fund current and planned operation into 2026.

截至 2024 年 9 月 30 日，我們未經審計的現金部位約為 4.038 億美元，其中包括 2024 年第二季和第三季初市場股權融資工具的淨收益（技術難度）約 2 億美元。我們預計目前的現金狀況和預期的產品收入足以為目前和計劃到 2026 年的營運提供資金。

I will now transition to our financial results. Net loss for the third quarter of 2024 was $83.5 million or $0.28 per share compared to a net loss of $113.8 million or $0.46 per share for the third quarter ended September 30, 2023. Net loss for the first nine months of 2024 was $293.6 million or $1.03 per share compared to a net loss of $327.7 million or $1.44 per share for the nine-month period ended September 30, 2023.

我現在將轉向我們的財務表現。2024 年第三季的淨虧損為 8,350 萬美元，即每股 0.28 美元，而截至 2023 年 9 月 30 日的第三季淨虧損為 1.138 億美元，即每股 0.46 美元。2024 年前 9 個月的淨虧損為 2.936 億美元，即每股 1.03 美元，而截至 2023 年 9 月 30 日的 9 個月期間，淨虧損為 3.277 億美元，即每股 1.44 美元。

Transitioning to revenue, which Fred previously summarized, our total product revenue includes Amtagvi infusion in the US and global sales of Proleukin primarily used in the Amtagvi treatment regimen and other commercial and clinical settings. As previously discussed, Proleukin revenue is recognized upon delivery to distributors and hospitals and generally purchased several months in advance of anticipated infusions and Amtagvi revenue recognition.

轉向收入，正如 Fred 之前總結的那樣，我們的總產品收入包括美國的 Amtagvi 輸液以及主要用於 Amtagvi 治療方案和其他商業和臨床環境的 Proleukin 的全球銷售。如前所述，Proleukin 收入在交付給分銷商和醫院時確認，並且通常在預期輸注和 Amtagvi 收入確認之前幾個月購買。

Total product revenue was $58.6 million for the third quarter of 2024, including $42.1 million for Amtagvi and $16.5 million for Proleukin. Total product revenue for the first nine months of 2024 was $90.4 million and consisted of $54.9 million for Amtagvi and $35.5 million for Proleukin. Revenue for the first three and nine months of 2023 was $0.5 million and $0.7 million, respectively, for global sales of Proleukin.

2024 年第三季產品總收入為 5,860 萬美元，其中 Amtagvi 為 4,210 萬美元，Proleukin 為 1,650 萬美元。2024 年前 9 個月的產品總收入為 9,040 萬美元，其中 Amtagvi 為 5,490 萬美元，Proleukin 為 3,550 萬美元。2023 年頭三個月和九個月 Proleukin 的全球銷售額分別為 50 萬美元和 70 萬美元。

Revenue increases in both periods of 2024 over the prior year period were primarily attributable to the US commercial launch of Amtagvi and the related strong demand for Proleukin for use with Amtagvi beginning in the second quarter of 2024.

2024 年兩個時期的營收均較上年同期成長，主要歸因於 Amtagvi 在美國的商業上市以及從 2024 年第二季開始與 Amtagvi 一起使用的 Proleukin 的相關強勁需求。

I will now highlight our cost of sales, which includes cost of inventory, overhead and related cash and noncash expenses that are directly associated with sales of Amtagvi and Proleukin as well as manufacturing cost of Amtagvi.

我現在將重點介紹我們的銷售成本，其中包括庫存成本、管理費用以及與 Amtagvi 和 Proleukin 的銷售直接相關的相關現金和非現金費用以及 Amtagvi 的製造成本。

Cost of sales for the three months ended September 30, 2024, was $39.8 million primarily attributed to $8.3 million in period costs associated with patient drop-off and manufacturing success rates, $6.9 million for noncash expenses including fair market value step-up and intangible asset amortization and $3.9 million in royalties payable on product sales.

截至2024 年9 月30 日的三個月銷售成本為3,980 萬美元，主要歸因於與患者流失和製造成功率相關的期間成本830 萬美元，非現金費用690 萬美元，包括公平市場價值增值和無形資產攤銷和產品銷售應付的 390 萬美元特許權使用費。

Notably, our third quarter cost associated with patient drop-off and manufacturing success rate has decreased over previous quarters report of $8.7 million even though volume and activity greatly increased. In the prior year three-month period, cost of sales was $4.3 million, primarily related to noncash amortization for intangible assets.

值得注意的是，儘管數量和活動大幅增加，但與前幾季報告的 870 萬美元相比，我們第三季與病患流失和製造成功率相關的成本有所下降。去年三個月期間，銷售成本為 430 萬美元，主要與無形資產的非現金攤提有關。

Cost of sales for the nine months ended September 30, 2024, was $78.5 million primarily related to $17.2 million in certain costs associated with patient drop-off and manufacturing success rates, $20.3 million in noncash expenses including fair market value step-up and intangible assets amortization and $8.2 million in royalty payable on product sales.

截至2024 年9 月30 日的九個月銷售成本為7,850 萬美元，主要與與患者流失和製造成功率相關的某些成本1,720 萬美元、2,030 萬美元的非現金費用（包括公平市場價值增值和無形資產）有關攤銷和產品銷售應付的 820 萬美元特許權使用費。

In the prior year nine-month period, cost of sales was $6.4 million, primarily related to noncash amortization for intangible assets. The increase in cost of sales in the third quarter and year-to-date 2024 over the prior year period were primarily attributable to the US commercialization of Amtagvi beginning in the first quarter of 2024 as well as related increased sales of Proleukin, including the initiation of product sales, commercial manufacturing and related cash and noncash expenses tied to Amtagvi and Proleukin.

去年 9 個月期間，銷售成本為 640 萬美元，主要與無形資產的非現金攤提有關。2024 年第三季和年初至今銷售成本較上年同期增加的主要原因是 Amtagvi 從 2024 年第一季開始在美國商業化，以及 Proleukin 的相關銷售額增加，包括啟動與Amtagvi 和Proleukin 相關的產品銷售、商業製造及相關現金及非現金支出。

Since the initial launch of Amtagvi, cost of sales is improving as we increase volume and capacity utilization due to continued strong demand and launch ramp up. In addition, as Brian and Igor mentioned, the ongoing support, education, and training with ATCs as well as continued focus on operational efficiencies in manufacturing and release testing can further optimize our cost of sales and translate to a higher gross margin over time.

自 Amtagvi 首次推出以來，由於持續強勁的需求和推出量的增加，我們增加了銷售和產能利用率，銷售成本正在改善。此外，正如Brian 和Igor 所提到的，ATC 的持續支援、教育和培訓以及對製造和發布測試營運效率的持續關注可以進一步優化我們的銷售成本，並隨著時間的推移轉化為更高的毛利率。

I will briefly comment on our third quarter gross margin. Our cost of sales in the third quarter includes $6.9 million of noncash expenses such as fair market value and amortization related to the Proleukin acquisition, resulting in the third quarter gross margin of $25.6 million against a revenue of $58.6 million. The improvement in gross margin over the second quarter reflects our ongoing focus on profitability and positions us more than (technical difficulty) towards our target of a gross margin above 70% in the coming years.

我將簡要評論我們第三季的毛利率。我們第三季的銷售成本包括 690 萬美元的非現金費用，例如與 Proleukin 收購相關的公平市價和攤銷，導致第三季毛利率為 2,560 萬美元，而收入為 5,860 萬美元。第二季毛利率的改善反映了我們對獲利能力的持續關注，並使我們能夠超越（技術難度）實現未來幾年毛利率超過 70% 的目標。

I will now shift to our operating expenses. Research and development expenses were $68.2 million for the third quarter of 2024, a decrease of $19.3 million compared to $87.5 million for the same period ended September 30, 2023. Research and development expense were $210.1 million for the nine months ended September 30, 2024, a decrease of $46.5 million compared to $256 million for the same period ended September 30, 2023.

我現在將轉向我們的營運費用。2024年第三季的研發費用為6,820萬美元，比截至2023年9月30日同期的8,750萬美元減少了1,930萬美元。截至2024年9月30日止九個月的研發費用為2.101億美元，較截至2023年9月30日止同期的2.56億美元減少4,650萬美元。

The decrease in research and development expenses in the third quarter and first nine months of 2024 over the prior year period were primarily attributable to the transition of Amtagvi to commercial manufacturing and lower clinical costs and lower costs resulting from the completion of pre-commercial qualification activities in 2023. This decrease in research and development were partially offset by increase in head count and related costs, including stock-based compensation.

2024年第三季和前9個月研發費用較上年同期減少的主要原因是Amtagvi向商業化生產轉型以及完成商業化前資格活動帶來的臨床成本和成本降低2023年。研發的減少被員工數量和相關成本（包括股票薪酬）的增加部分抵消。

Selling, general and administrative expenses were $39.6 million for the third quarter of 2024, an increase of $12.6 million compared to $27 million for the same period ended September 30, 2023. Selling, general and administrative expenses were $110.5 million for the first nine months of 2024, an increase of $33.5 million compared to $77 million for the same nine-month period ended September 30, 2023.

2024 年第三季的銷售、一般和管理費用為 3,960 萬美元，比截至 2023 年 9 月 30 日止同期的 2,700 萬美元增加了 1,260 萬美元。2024 年前 9 個月的銷售、一般和管理費用為 1.105 億美元，比截至 2023 年 9 月 30 日的同期 9 個月的 7,700 萬美元增加了 3,350 萬美元。

The increase in selling, general and administrative expenses in the third quarter and first 9 months of 2024 compared to the prior year period was primarily attributable to increase in head count and related costs, including stock-based compensation to support our overall business and related infrastructure growth as well as legal cost and commercial-related costs.

與去年同期相比，2024 年第三季和前 9 個月的銷售、一般和管理費用增加，主要是由於員工人數和相關成本的增加，包括支持我們整體業務和相關基礎設施的股票薪酬增長以及法律成本和商業相關成本。

Looking ahead, I would like to briefly summarize our financial outlook. As Fred mentioned, we reiterate our guidance for total product revenue within the range of $160 million to $165 million for the full year of 2024 and $450 million to $475 million for the full year 2025.

展望未來，我想簡要地總結我們的財務前景。正如 Fred 所提到的，我們重申 2024 年全年產品總收入在 1.6 億至 1.65 億美元範圍內的指導，2025 年全年產品總收入在 4.5 億至 4.75 億美元範圍內。

Regarding our operating expenses, we reiterate full year 2024 cash burn guidance in the range of $320 million to $340 million, excluding onetime expense. We will also keep leveraging opportunities to optimize spending in the coming quarters.

關於我們的營運支出，我們重申 2024 年全年現金消耗指引為 3.2 億至 3.4 億美元，不包括一次性支出。我們也將繼續利用機會優化未來幾季的支出。

For additional information, please see the company's selected consolidated balance sheet and statement of operations in this afternoon's press release and our Form 10-Q to be filed later today. I will now hand the call to Frederick, our Chief Medical Officer, to discuss our clinical pipeline.

欲了解更多信息，請參閱今天下午的新聞稿中公司選定的合併資產負債表和運營報表以及今天晚些時候提交的 10-Q 表格。我現在將電話轉給我們的首席醫療官弗雷德里克，討論我們的臨床管道。

Thank you, Jean-Marc. As my colleagues have conveyed Amtagvi is only the tip of the iceberg for the potential of TIL cell therapy in solid tumors, which represent more than 90% of all diagnosed cancers in the US. Today, I will focus on our clinical programs in lung, frontline melanoma, and endometrial cancer as well as our exciting next-generation pipeline.

謝謝你，讓-馬克。正如我的同事所傳達的，Amtagvi 只是 TIL 細胞療法治療實體腫瘤潛力的冰山一角，實體瘤占美國所有診斷癌症的 90% 以上。今天，我將重點介紹我們在肺癌、一線黑色素瘤和子宮內膜癌方面的臨床項目，以及我們令人興奮的下一代產品線。

This week, we are attending the Society for Immunotherapy and Cancer Conference, or SITC Annual Meeting in Houston. Here, we have a number of invited presentations focused on Amtagvi and our pipeline. In the late-breaking poster, we are presenting updated preliminary results from Cohort 3A and the IOV-COM-202 trial, including additional patients and longer-term follow-up. Cohort 3A is investigating lifileucel plus pembrolizumab in patients with advanced non-small cell lung cancer who are naive to checkpoint inhibitor therapy.

本週，我們將參加在休士頓舉行的免疫治療和癌症協會年會，或 SITC 年會。在這裡，我們有一些受邀演講，重點是 Amtagvi 和我們的管道。在最新發布的海報中，我們展示了 Cohort 3A 和 IOV-COM-202 試驗的最新初步結果，包括更多患者和長期追蹤。隊列 3A 正在研究 lifileucel 加派姆單抗治療未接受過檢查點抑制劑治療的晚期非小細胞肺癌患者。

I'll review and analysis of Cohort 3A patients with EGFR wild-type disease regardless of PD-L1 status, who represent the majority of patients in the frontline non-small cell lung cancer setting. The confirmed objective response rate, or ORR, was 64.3% among these patients, including 54.5% ORR in patients who have difficult-to-treat PD-L1 negative disease, which is higher than reported responses in these patients to currently approved therapy.

我將回顧和分析 3A 組患有 EGFR 野生型疾病的患者，無論 PD-L1 狀態如何，他們代表了一線非小細胞肺癌治療中的大多數患者。這些患者中確認的客觀緩解率 (ORR) 為 64.3%，其中患有難以治療的 PD-L1 陰性疾病的患者的 ORR 為 54.5%，高於這些患者對目前批准的治療報告的緩解率。

Remarkably, five of the six responses in EGFR wild-type tumors were ongoing as of the last follow-up visit, with four ongoing for more than 20 months from TIL infusion. In addition, median duration of response was not reached at a median study follow-up of 26.5 months.

值得注意的是，截至上次追蹤時，EGFR 野生型腫瘤的 6 種反應中有 5 種仍在持續，其中 4 種在 TIL 輸注後持續了 20 個多月。此外，中位研究追蹤時間為 26.5 個月，但尚未達到中位緩解持續時間。

The robust response rates and meaningful durability for Cohort 3A demonstrate the potential for the lysines regimen to drive meaningful benefit when added to standard of care frontline non-small cell lung cancer treatment. The results are available in the late-breaking poster as well as in our corporate deck at iovance.com.

隊列 3A 的強勁響應率和有意義的持久性表明，賴氨酸療法在添加到一線非小細胞肺癌治療標準護理中時有可能帶來有意義的益處。結果可在最新海報以及 iovance.com 的公司資料中查看。

Based on Cohort 3A data, we plan to open a new Cohort 3D in the IOV-COM-202 clinical trial. Cohort 3D will investigate a regimen that adds lifileucel to the frontline standard of care of chemotherapy and pembrolizumab for patients with EGFR wild-type non-small cell lung cancer. Cohort 3D results will inform the design of a planned confirmatory trial in frontline non-small cell lung cancer.

基於Cohort 3A數據，我們計劃在IOV-COM-202臨床試驗中開設新的Cohort 3D。Cohort 3D 將研究一種方案，將 lifileucel 添加到 EGFR 野生型非小細胞肺癌患者化療和 pembrolizumab 的一線治療標準中。隊列 3D 結果將為計畫中的非小細胞肺癌一線驗證性試驗的設計提供資訊。

We expect that the integration of the lifileucel regimen into current frontline standard of care with chemo and pembrolizumab will further augment the strong efficacy seen in Cohort 3A and has the potential to establish a new frontline regimen in non-small cell lung cancer.

我們預計，將 lifileucel 方案整合到目前化療和派姆單抗的一線治療標準中將進一步增強隊列 3A 中所見的強大療效，並有可能在非小細胞肺癌中建立新的一線方案。

To address unmet medical need among patients with advanced non-small cell lung cancer in the post anti-PD-1 setting, we're investigating lifileucel monotherapy in the single-arm registrational Phase II IOV-LUN-202 clinical trial.

為了解決晚期非小細胞肺癌患者在抗 PD-1 治療後未滿足的醫療需求，我們正在單臂註冊 II 期 IOV-LUN-202 臨床試驗中研究 lifileucel 單藥療法。

Single-agent chemotherapy, the current standard of care in this setting provides limited rate and duration of responses. Investigators are excited about the opportunity to advance the first cell therapy for patients with non-small lung cancer and the IOV-LUN-202 trial. (technical difficulty) and enrolment continue to accelerate. We are also confident in our approval strategy based on the positive preliminary data and prior FDA feedback for IOV-LUN-202.

單藥化療是目前這種情況下的護理標準，其反應率和持續時間有限。研究人員對有機會推進針對非小細胞肺癌患者的首個細胞療法和 IOV-LUN-202 試驗感到興奮。 （技術難度）和招生繼續加快。基於積極的初步數據和 FDA 先前對 IOV-LUN-202 的回饋，我們對我們的批准策略也充滿信心。

We expect to report additional data for the registrational cohorts in 2025, and achieve a potential accelerated US approval for lifileucel in non-small cell lung cancer in 2027.

我們預計將在 2025 年報告註冊隊列的更多數據，並可能在 2027 年在美國加速批准 lifileucel 用於治療非小細胞肺癌。

Expanding the commercial opportunity for Amtagvi into frontline advanced melanoma is also a top priority at Iovance. Our global registrational Phase III trial TILVANCE-301 remains on track to support accelerated and full approvals of Amtagvi in combination with pembrolizumab in frontline advanced melanoma as well as regular approval of Amtagvi and post anti-PD-1 melanoma.

將 Amtagvi 的商業機會擴展到一線晚期黑色素瘤也是 Iovance 的首要任務。我們的全球註冊 III 期試驗 TILVANCE-301 仍在按計劃進行，以支持 Amtagvi 與 pembrolizumab 聯合治療一線晚期黑色素瘤的加速和全面批准，以及 Amtagvi 和抗 PD-1 黑色素瘤的定期批准。

We continue to see strong momentum with enrolment and high enthusiasm among clinical sites. Nearly 50 sites are currently active across 11 countries in North America, Europe, and Australia. And more than 50 sites -- across 50 new sites across 15 additional countries are lined up to join TILVANCE-302. As a reminder, TILVANCE-301 is supported by results from IOV-COM-202 Cohort 1A in patients with advanced melanoma naive to immune checkpoint inhibitors.

我們繼續看到臨床中心註冊人數和熱情高漲的強勁勢頭。目前，北美、歐洲和澳洲 11 個國家有近 50 個活躍站點。超過 50 個站點（來自另外 15 個國家的 50 個新站點）正在排隊加入 TILVANCE-302。提醒一下，TILVANCE-301 得到了 IOV-COM-202 隊列 1A 在未接受過免疫檢查點抑制劑治療的晚期黑色素瘤患者中的結果的支持。

In the most recent Cohort 1a data presentation at ASCO, lifileucel plus pembrolizumab demonstrated an unprecedented rate, depth and durability of responses, including a 30% confirmed complete response rate as well as a safety profile that is differentiated from combination checkpoint inhibitor therapies.

在 ASCO 最近發布的隊列 1a 數據中，lifileucel 聯合 pembrolizumab 表現出了前所未有的緩解速度、深度和持久性，包括 30% 的確認完全緩解率以及與聯合檢查點抑製劑療法不同的安全性。

In addition, we are exploring a potential best-in-class frontline alternative for physicians and patients in the US Cohort 1D in the IOV-COM-202 trial will investigate lifileucel in combination with nivolumab and relatlimab in patients with frontline advanced melanoma.

此外，我們正在為 IOV-COM-202 試驗中美國隊列 1D 的醫生和患者探索一種潛在的同類最佳一線替代方案，該試驗將研究 lifileucel 與 nivolumab 和 relatlimab 聯合治療一線晚期黑色素瘤患者。

Moving along the pipeline, we are excited about our first clinical trial in advanced endometrial cancer. Recent approvals of immune checkpoint inhibitors in combination with chemotherapy for frontline endometrial cancer have created an unmet need for patients who progress. There are no currently approved therapies after anti-PD-1, which represents a significant new opportunity for TIL cell therapy.

沿著管道前進，我們對晚期子宮內膜癌的首次臨床試驗感到興奮。最近批准的免疫檢查點抑制劑與化療聯合治療一線子宮內膜癌，為進展的患者帶來了未滿足的需求。目前尚無繼抗 PD-1 之後批准的療法，這為 TIL 細胞療法帶來了重大的新機會。

Patient enrolment has commenced in our IOV-END-201 Phase II trial to investigate lifileucel after frontline standard of care of chemotherapy and anti-PD-1 therapy in patients with both mismatch repair or MMR-deficient and proficient tumors. This trial is supported by published preclinical and manufacturing success data as well as positive feedback from gynaecological oncology experts.

我們的 IOV-END-201 II 期試驗已開始患者入組，以在錯配修復或 MMR 缺陷和充分的腫瘤患者中進行化療和抗 PD-1 治療的一線標準護理後研究 lifileucel。該試驗得到了已發表的臨床前和製造成功數據以及婦科腫瘤學專家的積極回饋的支持。

As the leader in TIL cell therapy, Iovance is also at the forefront of next-generation approaches to optimize TIL until treatment regimen. We are investigating a next-generation PD-1 inactivated TIL cell therapy, IOV-4001 in the IOV-GM1-201 clinical trial.

作為 TIL 細胞療法的領導者，Iovance 也處於優化 TIL 直至治療方案的下一代方法的前沿。我們正在 IOV-GM1-201 臨床試驗中研究下一代 PD-1 滅活 TIL 細胞療法 IOV-4001。

Genetic modification using the talent technology to inactivate PD-1 may enhance the efficacy of IOV-4001 in place of systemic anti-PD-1 therapy, which is associated with short- and long-term systemic adverse events or AEs. IOV-GM1-201 has cleared the Phase I safety reason and is currently enrolling two Phase II cohorts of patients with previously treated advanced melanoma or non-small cell lung cancer with high interest by investigators to contribute to this trial. The pace of enrolment is increasing, and this trend is expected to continue through 2025.

使用天賦技術滅活 PD-1 的基因改造可能會增強 IOV-4001 取代全身抗 PD-1 治療的療效，後者與短期和長期系統性不良事件或 AE 相關。IOV-GM1-201 已清除了I 期安全原因，目前正在招募研究人員高度感興趣的兩個II 期患者隊列，這些患者曾接受過治療，晚期黑色素瘤或非小細胞肺癌患者對此試驗做出貢獻。入學速度正在加快，預計這一趨勢將持續到 2025 年。

Building on our successful Proleukin franchise, IOV-3001 as a second-generation modified IL-2 analog designed to enhance TIL survival and cellular proliferation. IOV-3001 favourable pharmacodynamic and pharmacokinetic characteristics may result in a better safety profile and may support less frequent dosing compared to Proleukin. An investigation on new drug or IND application was allowed to proceed for a Phase I/II clinical trial of IOV-3001 for use in the TIL therapy treatment regimen and clinical enrolment is expected to begin soon.

IOV-3001 以我們成功的 Proleukin 系列產品為基礎，作為第二代修飾的 IL-2 類似物，旨在增強 TIL 存活和細胞增殖。與 Proleukin 相比，IOV-3001 有利的藥效學和藥物動力學特徵可能會帶來更好的安全性，並且可能支持較低的給藥頻率。IOV-3001用於TIL治療方案的I/II期臨床試驗已獲準進行新藥調查或IND申請，預計很快將開始臨床入組。

Lastly, IND-enabling studies are proceeding for IOV-5001, a genetically engineered inducible and tethered IL-12 TIL cell therapy. The prior generation IL-12 TIL product demonstrated an impressive ORR of 63% in advanced melanoma patients at doses 10 to 100-fold lower than conventional TIL products.

最後，IOV-5001 的 IND 研究正在進行中，這是一種基因工程誘導型和束縛型 IL-12 TIL 細胞療法。上一代 IL-12 TIL 產品在晚期黑色素瘤患者的 ORR 高達 63%，劑量比傳統 TIL 產品低 10 至 100 倍。

However, the product secreted IL-12, which resulted in adverse events. IOV-5001 design includes inducible IL-12 expression restricted to the tumor and tethering of IL-12 to the cell surface, which prevents IL-12 secretion. (technical difficulty) IOV-5001 to allow higher cell doses over the prior generation product and improve TIL efficacy while ensuring safety, potentially allowing for expansion into a wide range of common solid tumor cancers beyond our current pipeline with significant market opportunity.

然而，該產品會分泌IL-12，導致不良事件。IOV-5001 設計包括限制在腫瘤內的誘導型 IL-12 表達以及將 IL-12 束縛在細胞表面，從而防止 IL-12 分泌。（技術困難）IOV-5001允許比上一代產品更高的細胞劑量，並在確保安全性的同時提高TIL療效，有可能擴展到我們當前管道之外的廣泛常見實體瘤癌症，並具有巨大的市場機會。

Preclinical results supporting IOV-5001 will be featured in a poster at SITC on Saturday, November 9. We plan to submit a pre-IND meeting request to FDA this year to support clinical development of IOV-5001 in many common solid tumor cancers with large populations and unmet need in 2025. Preclinical results for IOV-5001 will be featured in a post-trade SITC on Saturday, November 9.

支持 IOV-5001 的臨床前結果將於 11 月 9 日星期六在 SITC 上發布海報。我們計劃今年向 FDA 提交 IND 前會議請求，以支持 IOV-5001 在 2025 年針對許多人口眾多且需求未得到滿足的常見實體瘤癌症的臨床開發。IOV-5001 的臨床前結果將於 11 月 9 日星期六在交易後 SITC 中公佈。

Additional details about our development programs are included in today's press release as well as the corporate slide deck, and the data presentations I mentioned are currently available to view on the scientific presentations and publications page on our website. I'm happy to address questions about these programs and additional trials during the Q&A session.

有關我們開發計劃的更多詳細資訊包含在今天的新聞稿和公司幻燈片中，我提到的數據演示目前可以在我們網站上的科學演示和出版物頁面上查看。我很高興在問答環節中解答有關這些計劃和其他試驗的問題。

I would like to acknowledge the significant progress we have made in advancing our clinical and preclinical pipelines this year and thank our talented multidisciplinary team and research partners. I'm excited to see what's next as we continue to develop and deliver TIL cell therapy to cancer patients in additional therapeutic settings and with additional tumor types. I'll now turn the call over to the operator to begin the question-and-answer session.

我要感謝我們今年在推動臨床和臨床前管道方面取得的重大進展，並感謝我們才華橫溢的多學科團隊和研究合作夥伴。我很高興看到接下來會發生什麼，因為我們將繼續在其他治療環境和其他腫瘤類型中為癌症患者開發和提供 TIL 細胞療法。我現在將把電話轉給接線員以開始問答環節。

(Operator Instructions) Tyler Van Buren, TD Cowen.

（操作員說明）Tyler Van Buren，TD Cowen。

Congratulations on the quarter and all the progress. So the 39 patients treated to date are 30% above the 30 infusions reported at the same time point last quarter. And so if you just simply apply that to Q3 sales to Q4 and Proleukin sales are stable, you should obviously meet your annual guidance. However, there are significant holidays coming up next quarter. So can you talk about the potential impact of the holidays? And have you seen any infusion scheduled around those holidays yet?

恭喜本季和所有進展。因此，迄今為止接受治療的 39 名患者比上季度同一時間點報告的 30 名輸注患者多了 30%。因此，如果您只是將其應用於第三季至第四季度的銷售額，並且 Proleukin 銷售額穩定，那麼您顯然應該滿足您的年度指導。然而，下個季度將有重要的假期。那麼您能談談假期的潛在影響嗎？您是否看過在這些假期前後安排的輸液？

Yes, Tyler, we can talk about that a bit. We actually project infusions out over to the entire quarter, and we can see them far in advance. And yes, of course, during the holidays, there's going to be some patients that either put their -- try to get their infusion or carryovers to try to get to infusion ahead of the holidays or after the holidays for family reasons as well as the physicians wanting to take time off.

是的，泰勒，我們可以討論一下。實際上，我們將輸注計劃擴展到整個季度，我們可以提前很長時間看到它們。是的，當然，在假期期間，會有一些患者出於家庭原因以及其他原因，要么嘗試在假期前或假期後進行輸液，要么嘗試在假期後進行輸液。

So there is a bit of a lull during that period, but I think what you've calculated there is a fair estimate regardless of any law. I think we'll still perform quite well in the quarter. We've accounted for that when we do our projections.

因此，在那段時期有一點平靜，但我認為無論任何法律如何，您的計算結果都是一個公平的估計。我認為我們本季的表現仍然很好。我們在進行預測時已經考慮到了這一點。

Peter Lawson, Barclays.

彼得·勞森，巴克萊銀行。

I guess just a question around the IL-2 stocking level. Kind of how does that change over time? I assume there's kind of going to be less stocking each quarter, but just if you can kind of walk through the dynamics of what you think IL-2 number will look like for both use and then the stocking level?

我想只是關於 IL-2 庫存水準的問題。隨著時間的推移，這種情況會發生怎樣的變化？我假設每個季度的庫存都會減少，但如果您能大致了解一下您認為 IL-2 數量在使用和庫存水準方面的動態變化呢？

Thanks, Peter. The level -- we're currently stocking of three specialty distributors, which represent the 3 large distributors in the United States, (technical difficulty) we primarily focused on one in Q2, another one in Q3, and there'll be another one we expect in Q4.

謝謝，彼得。水平－我們目前庫存了三個專業分銷商，代表了美國的3個大型分銷商，（技術難度）我們主要關注第二季度的一個，第三季度的另一個，我們還會有另一個。預計在第四季。

I think, as I said before, the numbers will be steady. They could go down, up 10% or so. You see we did more last quarter, we did less this quarter. I would strongly advising anyone thinking we can't do more. We can do more for Proleukin in the fourth quarter, and that may be the case, we'll see. But after that, we'll have all the main distributors stocked up. And as I've said on the last earnings call, we expect after that, growth to then start in 2025 and go up more traditionally quarter-over-quarter.

我認為，正如我之前所說，數字將會穩定。它們可能會下跌，也可能上漲 10% 左右。你看我們上個季度做得更多，本季做得更少。我強烈建議任何認為我們不能做得更多的人。我們可以在第四季度為 Proleukin 做更多的事情，情況可能就是這樣，我們拭目以待。但在那之後，我們會讓所有主要經銷商備貨。正如我在上次財報電話會議上所說，我們預計此後，成長將從 2025 年開始，並以傳統方式實現季度環比增長。

Andrea Newkirk, Goldman Sachs.

安德里亞·紐柯克，高盛。

Fred, I was wondering if you could provide more color on your comment that preconditioning is happening sometimes in parallel or before Amtagvi actually arrives at the ATC. Just curious how common this is. And does this suggest that your manufacturing out of spec rates are improving sufficiently such that ATCs are willing to do this at risk?

Fred，我想知道您是否可以在您的評論中提供更多信息，即預處理有時會同時發生或在 Amtagvi 實際到達 ATC 之前發生。只是好奇這種情況有多常見。這是否表明你們的製造不合格率已經得到充分改善，以至於 ATC 願意冒著風險這樣做？

Yes, that's right, Andrea. The ATCs that have a lot of experience with both our manufacturing process and are out of specs as well as if their patients are getting more and more comfortable doing this. So yes, I think you're correct that does reflect that kind of confidence. I can't tell you exactly how common it is.

是的，沒錯，安德里亞。ATC 對我們的製造工藝有豐富的經驗，並且不符合規格，以及他們的患者是否越來越習慣這樣做。所以是的，我認為你是對的，這確實反映了這種信心。我無法確切地告訴你它有多常見。

What I can tell you is that it's more common at the larger ATCs that are more sophisticated that have more experience, I think many quarters in the launch, we'll probably see that for a good number of patients. I don't know.

我可以告訴你的是，這種情況在較大的ATC 中更為常見，這些ATC 更複雜，擁有更多的經驗，我認為在推出的許多季度中，我們可能會在許多患者中看到這種情況。我不知道。

I can't really guess, but either a majority are significant minority as we go out of time because what we know is that everybody is getting the message (technical difficulty) this product into the patients better. So I think there's a lot of the full confidence they'll want to do this more generally.

我真的無法猜測，但隨著時間的推移，大多數都是少數，因為我們知道每個人都在更好地向患者傳達該產品的訊息（技術難度）。所以我認為他們有充分的信心想要更廣泛地這樣做。

Yanan Zhu, Wells Fargo.

朱亞楠，富國銀行。

Congrats on the quarter. I was wondering about the 82 infusions in the last quarter. How are they -- how are they distributed across the months? And is there a clear trajectory of growth and going into fourth quarter, -- how do you feel about the month-to-month prospects?

恭喜本季。我想知道上個季度 82 次輸液的情況。它們怎麼樣——它們在幾個月中是如何分佈的？進入第四季是否有明確的成長軌跡—您對逐月前景有何看法？

And if I may, also wondering like the month-to-month growth, is that mainly from demand growth and ATC center number increase? Or are there any elements of improved manufacturing and logistics that makes you comfortable about forecasting growth?

我也想知道逐月成長是否主要來自需求成長和 ATC 中心數量增加？或者是否有任何改進的製造和物流因素使您能夠放心地預測成長？

(technical difficulty) infusions in the third quarter, there was month-over-month growth that basically (technical difficulty) up month-over-month, and we expect that to continue through Q4 with the [ 39 ] we've already reported. With respect to your question about whether that's driven by ATC growth, meaning growth in demand of the ATCs or adding new ATCs, yes, that's a big factor in driving that, and the availability of slots above all, what drives that.

在第三季度（技術難度）注入中，環比成長基本上是（技術難度）逐月上升，我們預計這種情況將持續到第四季度，與我們已經報告的[39]一樣。關於您提出的問題，即這是否是由ATC 增長推動的，即ATC 需求的增長或增加新的ATC，是的，這是推動這一趨勢的一個重要因素，而最重要的是，插槽的可用性是推動這一趨勢的因素。

So the fact that we're scaling up manufacturing is really what's driving that growth, it links up with the manufacturing capacity.

因此，我們擴大製造規模確實是推動成長的因素，它與製造能力有關。

Now I can add since you asked, yes, I think we're getting better and better with our out-of-spec rate. I can't say it's a month over month, but quarter-over-quarter, I think that's what's happening. And I expect that to continue into 2025 and beyond. So yes, month-over-month, you see growth, and we expect it to continue. It's largely driven by capacity, but I'm sure there's an element of -- element of approved out of spec rate and stuff like that also adding some wins to the sales.

現在我可以補充一下，既然你問了，是的，我認為我們的不合格率正在變得越來越好。我不能說這是逐月變化，而是逐季度變化，我認為這就是正在發生的事情。我預計這種情況將持續到 2025 年及以後。所以，是的，你會看到逐月成長，我們預計這種成長將持續下去。這很大程度上是由產能驅動的，但我確信有一個因素——批准的不合格率因素以及類似的因素也為銷售增加了一些勝利。

Ben Burnett , Stifel.

本·伯內特，斯蒂菲爾。

Just a question on just the profitability and kind of the gross margin goals, where you think you mentioned getting to 70%. It sounds like you're halfway there. How are you realizing that? And I guess what are the operational levers that will get you to that 70% goal?

只是一個關於盈利能力和毛利率目標類型的問題，您認為您提到了達到 70%。聽起來你已經成功一半了。你是如何意識到這一點的？我猜想有哪些操作手段可以幫助您實現 70% 的目標？

Maybe I can start, Ben, and then Jean-Marc can jump in and help here a little bit. So as we scale up the launch, especially using our ICTC facility, COGS goes down very quickly just on the capacity utilization. So that's a big factor in improving gross margin at the end of the day because that's a major component of cost, a major component of cost of sales and that will drive margins up from where they are right now, which is in the mid-40s to somewhere up closer to 70%.

也許我可以開始，本，然後讓-馬克可以介入並提供一些幫助。因此，當我們擴大發射規模時，特別是使用我們的 ICTC 設施，COGS 僅在產能利用率上就會迅速下降。因此，這最終是提高毛利率的一個重要因素，因為這是成本的主要組成部分，是銷售成本的主要組成部分，這將推動利潤率從目前的水平（40 多歲）上升。

We've got all sorts of other initiatives, including operational excellence, type work that we use to conduct projects to also improve margins. This includes some things that are quite confidential, obviously, the things that we do to improve our manufacturing process things that we do scale things up. A lot of those things have to be filed with the FDA and takes some time to go through, but they're all in progress right now.

我們還有各種各樣的其他舉措，包括卓越營運、我們用來開展專案以提高利潤率的工作類型。這包括一些非常機密的事情，顯然，我們為改進製造流程所做的事情以及我們所做的擴大規模的事情。其中很多事情都必須向 FDA 備案，並且需要一些時間才能完成，但現在都在進行中。

And then I think we have pretty good management of our expenses, too. We try to bring those down and keep those steady at least even as we expand our clinical portfolio. Jean-Marc, may be able to add a little bit more on the accounting side of that as well.

我認為我們對開支的管理也相當好。即使我們擴大了我們的臨床產品組合，我們也會盡力將其降低並保持穩定。讓-馬克（Jean-Marc）也許還可以在會計方面添加更多內容。

Yes. Thank you, Fred. No, I think you said it all. And then if you think about the margin, I mean, we do expect the cost of sales -- I mean the cost of goods sold in general to improve over time. We are only in the second quarter of launches. So obviously, there is a lot of optimization, which is currently happening.

是的。謝謝你，弗雷德。不，我想你都說了。然後，如果你考慮利潤率，我的意思是，我們確實預計銷售成本 - 我的意思是銷售商品的成本總體上會隨著時間的推移而改善。我們剛剛推出第二季。顯然，目前正在進行大量優化。

And as you have seen in terms of the significant jump of our improved gross margin between Q3 and Q2, we know that in the future by -- as mentioned by Fred, with automation, optimization, also working on some of the costs even related to raw materials, the cost of goods sold from -- (technical difficulty), that's the beauty of having our own ICTC and being in charge and control of the cost.

正如您所看到的，我們在第三季和第二季之間毛利率的大幅提高，我們知道，正如弗雷德所提到的，未來，透過自動化、最佳化，甚至致力於解決一些與以下相關的成本原料、銷售商品的成本——（技術難度），這就是擁有我們自己的 ICTC 並負責和控製成本的美妙之處。

So that's why we are confident and expect the gross margin to go into the 70% -- above 70% in the future years.

這就是為什麼我們有信心並預計未來幾年毛利率將達到 70%——70% 以上。

David Dai, UBS.

戴大衛，瑞銀。

(technical difficulty) improve drop our rate?

（技術難度）提高掉率？

We got -- we only caught part of that, David. Could you please repeat that question? .

我們得到了——我們只捕捉了其中的一部分，大衛。您能重複一下這個問題嗎？。

My apologies. So just curious about the dropout rate. What are some of the activities you did to improve the dropout rate that you saw this quarter compared to last quarter?

我很抱歉。所以只是好奇輟學率。與上季相比，本季您採取了哪些活動來提高輟學率？

I don't think we really did anything in particular. We are optimizing the launch as we go. We're teaching ATCs how to get patients through better. We're teaching them how to do better quality surgical resections. You heard a lot of that in the script from all of us include Brian's part of the script.

我不認為我們真的做了什麼特別的事。我們正在不斷優化發布。我們正在教 ATC 如何讓患者更好地度過難關。我們正在教他們如何進行更好品質的手術切除。你在劇本中從我們所有人那裡聽到了很多這樣的內容，包括布萊恩在劇本中的部分。

But we are, I think, just seeing the benefits of the launch that's ongoing. It's only really only two quarters in the launch. So I think you can expect to see this improve quarter-over-quarter, and we'll eventually get up to what we think will be the manufacturing success rate that we had or at least manufacturing experience that we had during the clinical studies.

但我認為，我們只是看到了正在進行的發布的好處。距離發布實際上只有兩個季度。因此，我認為您可以期望看到這種情況逐季度改善，我們最終將達到我們認為的製造成功率，或至少達到我們在臨床研究期間擁有的製造經驗。

So no, there's nothing I can really point to that we did specifically. We're just optimizing across the board.

所以不，我沒有什麼可以真正指出我們具體做了什麼。我們只是全面優化。

Michael Yee, Jefferies.

麥可葉，杰弗里斯。

Fred, can you remind us about reimbursement. I know that since launch, it's been sort of coverage by patient in single case deals. Can you remind how does it work for commercial if you wanted a more broad-based contract where you can get approval very quickly days or weeks rather than a month. I'm just wondering how that's going and if that's -- it could be a significant accelerator of the business?

弗雷德，你能提醒我們有關報銷的事情嗎？我知道自推出以來，它一直是患者在單一案例交易中的承保。您能否提醒一下，如果您想要一份基礎更廣泛的合同，您可以在幾天或幾週而不是一個月的時間內很快獲得批准，那麼商業合同是如何運作的呢？我只是想知道進展如何，如果是的話，它可能會成為業務的重要加速器嗎？

The second question relates to the lung cancer. Can you just remind us draw ongoing pivotal study in second line, is that something that could possibly read out next year, maybe just right size my expectations?

第二個問題與肺癌有關。您能否提醒我們在第二行畫出正在進行的關鍵研究，這是明年可能讀出的東西，也許正好符合我的期望？

Yes. So on the point of reimbursement, like we did -- we noted during the prepared remarks there that we have cut the average reimbursement time for four to six weeks, down to three weeks. That's the financial clearance time that includes prior authorization as well as a single case agreements. That's probably, we think, the sweet spot going forward. That's really realistically what the ATCs can do.

是的。因此，在報銷方面，就像我們所做的那樣，我們在準備好的發言中指出，我們已將四到六週的平均報銷時間縮短至三週。這是財務清算時間，包括事先授權以及單一案例協議。我們認為，這可能是未來的最佳點。這確實是 ATC 可以做的事情。

The good news is they can select the manufacturing site parallel schedule the operating room time and bring the patient pack back in, which takes typically about 3 weeks, even at high speed, given their operating room capacity and stuff like that.

好消息是，他們可以選擇製造地點，並行安排手術室時間並將患者包帶回，考慮到手術室容量和類似的情況，即使在高速情況下，這通常也需要大約 3 週的時間。

So it really -- I don't think it's a drag at all. We don't anticipate really needing to further optimize that. If you take a look at our corporate deck that we posted today, you'll see a new slide that summarizes this I think that really helps highlight where we're going and where other areas we can optimize, but that's not really (technical difficulty).

所以，我認為這根本不是一個拖累。我們預計並不需要進一步優化它。如果您看一下我們今天發布的公司投影片，您會看到一張總結這一點的新投影片，我認為這確實有助於突出我們的發展方向以及我們可以優化的其他領域，但這並不是真正的（技術難度）。

We're already there, I think, on that one. (technical difficulty). Our press release today talked about us having data out next year 2025 and us getting approval in 2027, that's what we think can happen baseline data based on the study as it's running right now.

我想，我們已經做到了這一點。（技術難度）。我們今天的新聞稿談到，我們將在明年 2025 年發布數據，並在 2027 年獲得批准，這就是我們認為基於目前正在進行的研究的基線數據可能發生的情況。

Asthika Goonewardene, Truist Securities.

Asthika Goonewardene，Truist 證券公司。

(technical difficulty) I wanted to double quick on to the improvement of the out-of-spec rate. And now that you've had several centers treat a good number of patients, are you seeing that there -- any trends or factors that influence (technical difficulty), I'm particularly wondering is it just a factor of centers having more experience? Or are you now getting new centers coming online that are just getting better and just much better outperforming the resections and producing the product right out the case?

（技術難度）我想加倍快速地提高不合格率。現在您已經有幾個中心治療了大量患者，您是否看到任何影響（技術難度）的趨勢或因素，我特別想知道這是否只是中心擁有更多經驗的一個因素？或者您現在是否有新的中心上線，這些中心正在變得越來越好，遠遠優於切除術並立即生產產品？

Well, it's both. We're trying -- at the beginning, we had centers come along that were good and some that struggle to do resections and select patients. We help them out. They got better. And now we learned from that as well and are teaching the new ATCs as they come on the benefits of all that early learning so that they don't make the same mistakes.

嗯，兩者都是。我們正在努力——一開始，我們有一些很好的中心，也有一些在進行切除和選擇患者方面遇到困難。我們幫助他們。他們變得更好了。現在我們也從中吸取了教訓，並正在教導新的 ATC，因為他們從早期學習中受益，這樣他們就不會犯下同樣的錯誤。

We plan out actual run charge for each ATC to see what they did. -- look patient-by-patient for ATC, give them a scorecard as to how they're performing, and help them with our peer-to-peer team that Brian's team oversee -- Brian oversees the team, the Fred's team that does that and others, they go out and they talk to the surgeons, and they make sure the patient selection is correct and they work with them on resection quality. And now I think -- I would just say that we're just gaining momentum and building momentum here. It's been a big rush and is stepping up and up and going faster and faster.

我們規劃了每個 ATC 的實際運作費用，看看他們做了什麼。 - 逐一查看 ATC 的患者，給他們一張關於他們表現的記分卡，並透過 Brian 團隊監督的點對點團隊幫助他們 - Brian 監督這個團隊，Fred 的團隊負責他們出去與外科醫生交談，確保患者選擇正確的，並與他們一起研究切除品質。現在我想——我只想說，我們正在這裡獲得動力並建立動力。這是一次大的衝刺，而且速度越來越快。

There's nothing really magical to it. It's hard work. But once it's (technical difficulty) get the experience, and I think what we're seeing is that any ATC can really get these skills to do Amtagvi therapy.

它並沒有什麼真正神奇的地方。這很辛苦。但是一旦（技術難度）獲得經驗，我認為我們看到的是任何 ATC 都可以真正獲得這些技能來進行 Amtagvi 療法。

Thank you. That does conclude today's Q&A session. I would now like to turn the call over to Fred Vogt, Interim CEO, for closing remarks.

謝謝。今天的問答環節到此結束。現在我想將電話轉交給臨時執行長 Fred Vogt，他將發表結束語。

Thank you again for joining the Iovance Biotherapeutics Third quarter and year-to-date 2024 financial results and corporate update conference call. We're pleased to provide an update on our launch of the first commercial TIL cell therapy and look forward to providing further Amtagvi launch updates as well as continued developments in our pipeline in the near future.

再次感謝您參加 Iovance Biotherapeutics 第三季和年初至今的 2024 年財務表現和公司更新電話會議。我們很高興提供有關我們推出首個商業 TIL 細胞療法的最新信息，並期待在不久的將來提供進一步的 Amtagvi 上市更新以及我們管道的持續開發。

It's already been a transformative year for Iovance, and we continue to be motivated as we hear frequent feedback from ATCs about advanced melanoma patients benefiting and finding hope with Amtagvi in the commercial setting.

對於 Iovance 來說，今年已經是變革的一年，當我們經常聽到 ATC 的反饋，稱晚期黑色素瘤患者在商業環境中受益於 Amtagvi 並找到希望時，我們繼續受到激勵。

As always, we're thankful to the patients, health care and advocacy communities, our partners and our exceptional Iovance team. I would also like to thank our shareholders and covering analyst for their support. Thank you.

一如既往，我們感謝患者、醫療保健和倡導團體、我們的合作夥伴以及我們出色的 Iovance 團隊。我還要感謝我們的股東和分析師的支持。謝謝。

This does conclude today's call. You may now disconnect.

今天的電話會議到此結束。您現在可以斷開連線。