Iovance Biotherapeutics Inc (IOVA) 2025 Q3 法說會逐字稿

Welcome to the Iovance Biotherapeutics third quarter and year-to-date 2025 conference call. My name is Daniel, and I will be your operator for today's call. (Operator Instructions) Please note that this conference call is being recorded. I will now turn the call over to Sara Pellegrino, Senior Vice President Investor Relations, and Corporate Communications at Iovance. Sara, you may begin.

歡迎參加 Iovance Biotherapeutics 2025 年第三季及年初至今的電話會議。我叫丹尼爾，我將擔任您今天通話的接線生。（操作員說明）請注意，本次電話會議正在錄音。現在我將把電話轉交給 Iovance 的高級副總裁兼投資者關係和企業傳播負責人 Sara Pellegrino。薩拉，你可以開始了。

Thank you, Operator. Good morning, and welcome to the Iovance webcast to discuss our business achievements, pipeline milestones, and third quarter 2025 results. Members of our executive leadership team speaking on today's call include Dr. Fred Vogt, Interim CEO and President; Corleen Roche, Chief Financial Officer; Dan Kirby, Chief Commercial Officer; Dr. Igor Balinski, Chief Operating Officer; and Friedrich Finckenstein, Chief Medical Officer. During the question-and-answer session, we will also welcome Dr. Raj Puri and Marc Theoret from our Regulatory Affairs Executive Leadership Team; and Dr. Brian Gassman, Executive Vice President of Translational Medicine and Research.

謝謝接線生。早安，歡迎參加 Iovance 網路直播，我們將在此討論我們的業務成就、專案里程碑以及 2025 年第三季業績。今天參加電話會議的執行領導團隊成員包括：臨時執行長兼總裁 Fred Vogt 博士；財務長 Corleen Roche；首席商務官 Dan Kirby；營運長 Igor Balinski 博士；以及首席醫療官 Friedrich Finckenstein。在問答環節，我們也將歡迎監管事務執行領導團隊的 Raj Puri 博士和 Marc Theoret；以及轉化醫學和研究執行副總裁 Brian Gassman 博士。

This morning, we issued a press release that is available on our corporate website at iovance.com. I would like to remind everyone that 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 interaction, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interaction, restructuring, licenses and collaborations, cash position and expense guidance, and future updates.

今天上午，我們發布了一份新聞稿，可在公司網站 iovance.com 上查閱。我想提醒大家，本次電話會議將包含有關 Iovance 的目標、業務重點、業務計劃和交易、收入及收入預期、商業活動、臨床試驗及結果、監管審批及互動、計劃和戰略、研究和臨床前活動、我們技術的潛在未來應用、生產能力、監管反饋和指導、與支付方的互動、重組、許可和合作、現金狀況和支出

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 filing. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statements.

前瞻性陳述受多種風險和不確定因素的影響，其中許多風險和不確定因素是我們無法控制的，包括我們不時在提交給美國證券交易委員會的文件中描述的風險和不確定因素。我們的實際結果可能與今天電話會議上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。

I will now like to turn the call over to Fred.

現在我將把通話交給弗雷德。

Thank you, Sara. I will start by sharing our continued progress to increase revenue and margins, advance our pipeline, reduce expenses, and improve operational execution. Third quarter revenue grew 13% over the prior quarter, and notably, gross margin improved and was 43% following the initial results of our strategic restructuring and cost optimization. More improvements are coming, including today's announcement of our centralization of manufacturing at our internal manufacturing facility.

謝謝你，薩拉。首先，我將分享我們在提高收入和利潤率、推進產品線、降低成本和改善營運執行方面取得的持續進展。第三季營收比上一季成長了 13%，值得注意的是，在我們的策略重組和成本優化取得初步成果後，毛利率有所提高，達到 43%。更多改進措施即將推出，包括今天宣布的將生產集中到我們內部製造工廠的計劃。

Our highest priority is to accelerate revenue growth to increase the impact of the adoption across our network of academic and community authorized treatment centers, or ATCs. We've expanded to include new academic ATCs and multiple community ATCs. Initial patients are being treated in the community and are generally earlier in their melanoma treatment journey. As we educate community oncologists across our ATCs, including the major academic centers, we are seeing earlier, more frequent patient referrals that drive growth.

我們最重要的任務是加快收入成長，以擴大我們學術和社區授權治療中心（ATC）網路的採用率。我們擴大了規模，新增了學術型空中交通管制中心和多個社區型空中交通管制中心。首批患者在社區接受治療，通常處於黑色素瘤治療的早期階段。隨著我們對包括主要學術中心在內的所有 ATC 的社區腫瘤醫生進行培訓，我們看到患者轉診越來越早、越來越頻繁，從而推動了成長。

Real-world data showed response rates of 60% in the second line treatment setting, which has provided a strong foundation to amplify our compelling story to the melanoma community for the power of TIL therapy in melanoma. We are on track to achieve our revenue guidance range of $250 million to $300 million for the full year of 2025. With robust current demand, we expect a strong fourth quarter of Amtagvi alongside increasing Proleukin sales as we saw in late 2024.

真實世界的數據顯示，在二線治療中，反應率為 60%，這為我們向黑色素瘤患者群體宣傳 TIL 療法在黑色素瘤治療中的強大作用奠定了堅實的基礎。我們預計將實現 2025 年全年 2.5 億美元至 3 億美元的營收目標。鑑於目前強勁的需求，我們預計 Amtagvi 第四季將表現強勁，同時 Proleukin 的銷售額也將像我們在 2024 年底看到的那樣成長。

We continue to project Amtagvi peak sales of more than $1 billion in the US in melanoma, with larger additional opportunities in international markets and in future indications.

我們繼續預測 Amtagvi 在美國黑色素瘤領域的銷售高峰將超過 10 億美元，並在國際市場和未來的適應症方面有更大的額外機會。

For example, our interim clinical data and previously treated non-squamous, non-small lung cancer showed a best-in-class profile and unprecedented durability compared to standard of care in this population, including an objective response rate of 26% and a median duration of response not reached at more than 25 months of follow-up. There is a significant market opportunity in this lung cancer indication, which is about seven times greater than our current advanced melanoma indication.

例如，我們的中期臨床數據和先前治療的非鱗狀、非小細胞肺癌顯示，與該族群的標準治療相比，該療法具有同類最佳的療效和前所未有的持久性，包括 26% 的客觀緩解率和超過 25 個月隨訪後仍未達到的中位緩解持續時間。肺癌這一適應症蘊藏著巨大的市場機遇，其市場規模約是我們目前晚期黑色素瘤適應症的七倍。

We expect to quickly complete enrollment in our LUN-202 Registrational Trial in 2026 with approximately 80 patients. This sample size will support an accelerated approval given the unmet need in non-small cell lung cancer, precedent of the Amtagvi approval in 73 melanoma patients, and recent accelerated approvals based on 70 to 80 patients with defined non-small cell lung cancer population.

我們預計將於 2026 年迅速完成 LUN-202 註冊試驗的招募工作，屆時將招募約 80 名患者。鑑於非小細胞肺癌領域尚未滿足的需求、Amtagvi 在 73 名黑色素瘤患者中獲批的先例，以及最近基於 70 至 80 名特定非小細胞肺癌患者的加速批准，該樣本量將支持加速批准。

The US FDA previously provided positive feedback on our trial design which aligns with FDA guidance for single arm trials to support accelerated approvals for single agents in conditions with unmet medical need. We look forward to advancing toward a supplemental biologics license application in non-squamous non-small cell lung cancer and a potential launch in the second half of 2027.

美國 FDA 先前對我們的試驗設計給予了積極的回饋，該設計符合 FDA 關於單臂試驗的指導方針，以支持加速批准用於治療未滿足醫療需求的單一藥物。我們期待推動非鱗狀非小細胞肺癌的補充生物製品許可申請，​​並預計在 2027 年下半年推出該產品。

As we increase revenue and advance our pipeline, we are laser focused on expense management profitability. Following our third quarter reorganization, we are finding our operating plan to ensure we are appropriately investing in our commercial launch and high value programs. Again, cost of sales and gross margin will improve significantly as we transition manufacturing to our internal facility in early 2026. During this call and our future quarterly updates, we will highlight our ongoing efforts toward further expense reductions and resource allocation.

隨著收入的成長和業務的推進，我們將重點放在費用管理和獲利能力上。在第三季重組之後，我們正在尋找合適的營運計劃，以確保我們對商業發布和高價值項目進行適當的投資。再次強調，隨著我們在 2026 年初將生產轉移到我們自己的內部工廠，銷售成本和毛利率將顯著改善。在本次電話會議以及我們未來的季度更新中，我們將重點介紹我們為進一步降低成本和優化資源分配所做的持續努力。

Corleen will now highlight our third quarter financials in further detail.

接下來，Corleen將更詳細地介紹我們第三季的財務狀況。

Thanks, Fred. Good morning everyone. During my first quarter as Chief Financial Officer, I want to emphasize our focus on driving the company towards sustained profitability. Our strategy includes prioritizing topline growth, significantly improving margin, and controlling costs with a disciplined approach.

謝謝你，弗雷德。大家早安。在我擔任財務長的第一個季度，我想強調我們將致力於推動公司實現持續獲利。我們的策略包括優先提升營收、大幅提高利潤率，並透過嚴謹的方法控製成本。

In the third quarter, our top-line revenue remained strong. Total product revenue increased approximately 13% over the prior quarter to about $68 million. This included Amtagvi sales of approximately $58 million and global Proleukin revenue of nearly $10 million. As expected and consistent with prior quarters, overall gross to net was less than 2% and is expected to remain minimal. As Fred mentioned, we are on track to achieve our revenue guidance in the first full calendar year of Amtagvi sales.

第三季度，我們的營收依然強勁。產品總收入較上一季成長約 13%，達到約 6,800 萬美元。其中包括 Amtagvi 約 5800 萬美元的銷售額和 Proleukin 的全球收入近 1000 萬美元。如預期，與前幾季一致，毛利淨利比率低於 2%，預計將維持在較低水準。正如弗雷德所提到的，我們有望在 Amtagvi 銷售的第一個完整日曆年內實現我們的收入目標。

Next, I am pleased to highlight initial improvements in expenses and gross margin from the corporate restructuring and continued cost optimization initiatives implemented in the third quarter. We reduced total costs and expenses by approximately 10% over the prior quarter, excluding restructuring charges of approximately $5 million. We lowered cost of sales by approximately 21% over the prior quarter, resulting in improved gross margin of approximately 43%.

其次，我很高興地強調，第三季實施的公司重組和持續成本優化措施，在費用和毛利率方面取得了初步改善。與上一季相比，我們總成本和費用減少了約 10%，不包括約 500 萬美元的重組費用。與上一季相比，我們的銷售成本降低了約 21%，使毛利率提高了約 43%。

Importantly, costs associated with patient drop off and manufacturing results continue to decline as our revenue continues to grow. Gross margin will improve over time as we accrue benefits from our recent restructuring, implement additional cost savings initiatives, and centralize manufacturing at our internal facility. Our cash position of approximately $307 million as of September 30 was bolstered by expense reductions and is expected to fund operations into the second quarter of 2027.

重要的是，隨著我們收入的持續成長，與病患流失和生產結果相關的成本也持續下降。隨著我們從最近的重組中獲益，實施額外的成本節約措施，並將生產集中在我們的內部工廠，毛利率將隨著時間的推移而提高。截至 9 月 30 日，我們的現金儲備約為 3.07 億美元，這得益於開支削減，預計足以維持營運至 2027 年第二季。

I will now turn the call to Dan Kirby, our Chief Commercial Officer.

現在我將把電話轉給我們的商務長丹‧柯比。

Thanks, Corleen. Our ultimate goal is to establish Amtagvi as the preferred option for all eligible patients. Patients deserve a one-time cell therapy with curative intent, and we are steadfast in delivering on that promise. My conversations with patients and caregivers remind us of the commitment to the Iovance mission, pioneering a new treatment paradigm for patients with solid tumor cancers.

謝謝你，科琳。我們的最終目標是使Amtagvi成為所有符合條件的患者的首選方案。患者理應獲得一次性治癒性細胞療法，我們將堅定不移地兌現這項承諾。我與患者和照護者的交談提醒我們，Iovance 始終致力於實現其使命，為實體腫瘤癌症患者開創一種新的治療模式。

At the recent Melanoma Research Foundation gala in Denver, Iovance received the Corporate Leadership Award in recognition of our efforts to advance care for melanoma patients. In my first 8 months at Iovance, we have made notable progress to lay the foundation for revenue growth by driving adoption across our ATCs. I'll highlight three key areas of focus.

在最近於丹佛舉行的黑色素瘤研究基金會晚宴上，Iovance 榮獲企業領導力獎，以表彰我們在推動黑色素瘤患者護理方面所做的努力。在 Iovance 的頭 8 個月裡，我們透過推動 ATC 的採用，為營收成長奠定了基礎，取得了顯著進展。我將重點介紹三個關鍵領域。

First, new ATCs are driving growth. In the third quarter we added community ATCs alongside new high volume academic ATCs. These new ATCs contributed to the highest number of patient starts with better capture in the third quarter. Our first community ATCs are beginning to treat patients with Amtagvi in this setting. New ATCs continue to come online and will drive further growth in the fourth quarter and beyond.

首先，新的空中交通管制中心正在推動成長。第三季度，我們新增了社區航空運輸中心，以及新的高流量學術航空運輸中心。這些新的 ATC 為第三季患者開診量達到最高水平，且患者接診率更高。我們的首批社區抗病毒治療中心已開始在這種環境下使用安塔格維治療患者。新的空中交通管制中心持續投入使用，並將推動第四季及以後的進一步成長。

Second, penetrating the community market is key to unlocking Amtagvi's tremendous potential as we increase the frequency, speed, and efficiency of community referrals to ATC. Healthcare professional and patient-focused campaigns are having a positive impact. Under our specialty pharmacy agreement with Biologics by McKesson, patients have broader access to Amtagvi. Hospitals now have flexibility to obtain Amtagvi directly or through a specialty pharmacy, giving their finance teams competence to place more orders.

其次，打入社區市場是釋放 Amtagvi 巨大潛力的關鍵，因為我們需要提高社區向 ATC 轉診的頻率、速度和效率。以醫療專業人員和患者為中心的宣傳活動正在產生積極影響。根據我們與 McKesson 生物製劑公司達成的特藥藥房協議，患者可以更廣泛地獲得 Amtagvi。現在醫院可以靈活地直接或透過專科藥局獲得Amtagvi，這使得醫院的財務團隊能夠下更多訂單。

Our third focus area is to drive earlier treatment with Amtagvi. This will increase penetration in our academic centers. We are educating medical oncologists on the advantages of cell treatment with Amtagvi when it has the greatest benefit. Earlier shifts in referral patterns are supported by our first real world data that shows 60% of patients respond in the second line setting.

我們的第三個重點領域是推動使用Amtagvi進行更早的治療。這將提高其在我們學術中心的滲透率。我們正在向腫瘤內科醫生講解何時使用 Amtagvi 進行細胞治療才能發揮最大益處。我們首個真實世界數據支持了早期轉診模式的轉變，數據顯示 60% 的患者在二線治療中有效。

In addition, new initiatives in academic ATCs will address earlier tissue procurement for patient types, such as BRAF mutations, so they can be treated before their health status declines. Proleukin revenue also grew in the third quarter. Our main revenue channel for Proleukin is used with Amtagvi. Two US wholesalers ordered in the third quarter and all three wholesalers are expected to order significant volume in the fourth quarter. Prolekan will continue to grow through this main revenue channel in addition to the two other revenue channels for clinical and manufacturing use.

此外，學術 ATC 的新舉措將著眼於更早地獲取 BRAF 突變等患者類型的組織，以便在他們的健康狀況惡化之前對其進行治療。Proleukin 的營收在第三季也實現了成長。Proleukin 的主要收入管道是與 Amtagvi 一起使用。兩家美國批發商在第三季下了訂單，預計這三家批發商在第四季都會有大量訂單。除了臨床和生產用途這兩個其他收入管道外，Prolekan 還將繼續透過這個主要收入管道實現成長。

Like other companies, we are evaluating our Proleukin pricing strategy outside of the United States based on the current environment, which may help drive future revenue growth. Amtagvi has the potential to reach more than 30,000 patients with advanced melanoma globally. Canada became the first new market to approve Amtagvi, and approvals are pending in three additional markets, the United Kingdom and Australia in the first half of 2026, and Switzerland in early 2027.

與其他公司一樣，我們正在根據當前環境評估我們在美國以外地區的 Proleukin 定價策略，這可能有助於推動未來的收入成長。Amtagvi 有潛力惠及全球超過 3 萬名晚期黑色素瘤患者。加拿大成為第一個批准Amtagvi的新市場，另外三個市場正在等待批准，分別是2026年上半年的英國和澳大利亞，以及2027年初的瑞士。

In the European Union, we are confident in our planned strategy. We are seeking scientific advice from the European Medicines Agency and intend to resubmit for regulatory approval shortly thereafter. Looking at the broader potential of lung cancer, our IDR data demonstrates that one-time treatment with lifileucel represents a true game changer and potential cure for patients with non-squamous advanced non-small cell lung cancer.

在歐盟，我們對已製定的戰略充滿信心。我們正在向歐洲藥品管理局尋求科學建議，並打算在此之後不久重新提交監管部門的批准申請。從更廣泛的肺癌治療潛力來看，我們的IDR數據顯示，一次性使用lifileucel治療對於非鱗狀晚期非小細胞肺癌患者來說，代表著真正的變革和潛在的治癒。

With approximately 50,000 addressable patients in the US alone, the market opportunity is about seven times larger than our current melanoma opportunity and represents potential US peak sales of $10 billion. US academic and community practices are enthusiastic about our lung cancer program. All of our current and future ATCs are expected to launch in non-small cell lung cancer.

光在美國就有約5萬名潛在患者，市場機會比我們目前黑色素瘤市場的機會大七倍左右，美國市場的潛在高峰銷售額可達100億美元。學術界和社區醫療機構都對我們的肺癌計畫充滿熱情。我們目前和未來所有的ATC都預計將在非小細胞肺癌領域推出。

A significant portion of them already treat patients in our LUN-202 trial. The ATC footprint for lung cancer is essentially the same as our melanoma treatment network. ATCs are eager to leverage their current pill infrastructure to quickly adopt lifileucel in lung cancer upon approval.

其中很大一部分人已經在我們 LUN-202 試驗中治療患者。ATC肺癌治療網絡與我們的黑色素瘤治療網絡基本相同。ATC 渴望利用其現有的藥物基礎設施，在 lifileucel 獲得批准後迅速將其應用於肺癌治療。

I will now pass the call to Igor.

現在我將把電話轉給伊戈爾。

Thank you, Dan. I will provide a brief manufacturing update. We have streamlined our manufacturing organization while reducing costs and improving our manufacturing success rate, as reflected in our third quarter gross margin. Importantly, we're finalizing an expansion at our internal facility, the IOM Cell Therapy Center or ICTC, that will enable us to support anticipated demand without the need for a contract manufacturer.

謝謝你，丹。我將簡要匯報一下生產方面的最新情況。我們精簡了生產組織，降低了成本，提高了生產成功率，這體現在我們第三季的毛利率上。重要的是，我們正在完成內部設施 IOM 細胞治療中心 (ICTC) 的擴建，這將使我們能夠在無需合約製造商的情況下滿足預期需求。

All Amtagvi and clinical manufacturing will transition to ICTC in early 2026 to maximize capacity utilization, lower cost of sales, and drive future cross margin growth. We will complete a key step in this facility extension during routine annual maintenance around the end of this year. During this time, our contract manufacturer will provide continued access for patients to meet demand before we transition from manufacturing to ICTC. We will also boost capacity immediately prior and following the maintenance period to provide additional manufacturing slots for patients, allowing smooth supply through the next two quarters.

2026 年初，所有 Amtagvi 和臨床生產都將過渡到 ICTC，以最大限度地提高產能利用率、降低銷售成本並推動未來的交叉利潤成長。我們將在今年年底的例行年度維護期間完成該設施擴建的關鍵步驟。在此期間，我們的合約製造商將繼續為患者提供產品以滿足需求，之後我們將從生產過渡到 ICTC。我們也將在維護期前後立即提高產能，為患者提供額外的生產名額，從而確保未來兩季的平穩供應。

Bringing all manufacturing internally will be an important milestone for us as a company. In addition to the cost benefits, we will maintain uninterrupted supply during routine maintenance in the future using internal capabilities. We can also scale up within the existing facility to support future markets globally and indications including (inaudible).

將所有生產環節轉移到公司內部，對我們公司來說將是一個重要的里程碑。除了成本效益之外，我們將利用內部能力，在未來的例行維護期間保持不間斷供應。我們還可以利用現有設施擴大規模，以支持未來的全球市場和適應症，包括（聽不清楚）

I will now pass the call to Frederick.

現在我將把電話轉給弗雷德里克。

Earlier this week, we reported interim data from our registrational IOV-LUN-202 clinical trial of lifileucel. The data demonstrated a potentially best in class clinical profile. And meaningful improvement over current standard of care in previously treated patients with non-squamous, non-small cell lung cancer.

本週早些時候，我們公佈了 lifileucel 註冊臨床試驗 IOV-LUN-202 的中期數據。數據顯示，該產品具有同類最佳的臨床性能。對於先前接受過治療的非鱗狀非小細胞肺癌患者，與目前的標準治療相比，療效有了顯著提高。

Following one-time treatment with lifileucel monotherapy, the objective response rate was an impressive 26%. An objective response was observed in 10 out of 39 patients, which included two complete responses. The disease control rate was 72%, showing a meaningful benefit for many patients with stable disease. Importantly, median duration of response was not reached at more than 25 months of follow-up, which is unprecedented durability for non-small cell lung cancer therapy in the post-chemo and immune checkpoint inhibitor setting.

經過一次利菲魯塞爾單藥治療後，客觀緩解率達到了令人矚目的 26%。39 名患者中有 10 名觀察到客觀緩解，其中 2 名完全緩解。疾病控制率為 72%，對許多病情穩定的患者來說，這表明該疾病具有顯著療效。重要的是，在超過 25 個月的追蹤期內，中位緩解持續時間仍未達到，這對於化療和免疫檢查點抑制劑治療後的非小細胞肺癌而言，是前所未有的持久性。

Standard of care docetaxel monotherapy recently showed an objective response rate of only 13% and a median duration of response of only 5.6 months without any complete responses in the same patient population. We are on track to quickly complete enrollment of approximately 80 patients in 2026. We have seen a strong increase in enrollment this year driven by the positive reception of the efficacy data among trial investigators.

最近，標準治療方案多西他賽單一療法在同一患者群體中顯示的客觀緩解率僅為 13%，中位緩解持續時間僅為 5.6 個月，且未出現完全緩解。我們預計在 2026 年迅速完成約 80 名患者的招募工作。今年，由於試驗研究人員對療效數據給予了正面評價，我們看到入組人數大幅增加。

In addition to the 39 patients in the data set, a double-digit number of patients are awaiting or have recently received pill infusions, and more patients have entered the trial as of today. We plan to share more data from LUN-202 at a medical meeting next year, including a meaningful number of additional patients and longer follow-up.

除了資料集中的 39 名患者外，還有兩位數的患者正在等待或最近接受了藥丸輸注，截至今天，又有更多患者加入了試驗。我們計劃在明年的醫學會議上分享更多 LUN-202 的數據，包括更多患者和更長的追蹤時間。

We also look forward to advancing towards a supplemental biologic license application for lifileucel in non-squamous, non-small cell lung cancer and a potential launch in the second half of 2027. We also continue to make progress across the rest of our pipeline, which I am happy to discuss during the Q&A session. Thank you.

我們也期待推進 lifileucel 用於非鱗狀非小細胞肺癌的補充生物製品許可申請，​​並預計在 2027 年下半年推出該產品。我們在其他產品線方面也持續取得進展，我很樂意在問答環節中與大家討論這些進展。謝謝。

(Operator Instructions) Andrew Tsai, Jefferies.

（操作說明）Andrew Tsai，傑富瑞集團。

Nice execution this quarter. Great to see various dynamics improving. Good job. So my question this quarter is on the lung cancer data update that you had. It's interesting that the signal did not necessarily degrade compared to the prior data cut, in fact, maybe the efficacy on DR seemed to get better. So for the remaining batch of patients, would you expect the third data cut to be also similar or even better than what we're seeing in this interim that you just had, or would you expect some kind of efficacy degradation on a larger sample size? Thank you.

本季表現不錯。很高興看到各方面都在改善。好工作。所以我本季的問題是關於你們更新的肺癌數據。有趣的是，與先前的數據相比，訊號並沒有明顯下降，事實上，對 DR 的療效似乎有所提高。那麼對於剩下的患者，您認為第三次資料篩選的結果會與我們剛剛看到的這個中期結果相似，甚至更好嗎？還是您認為在更大的樣本量下會出現某種療效下降？謝謝。

Thanks Andrew. I can start and maybe Friedrich can chime in here. I don't -- we don't expect any degradation in the efficacy signal. We're getting very good within the LUN-202 trial at making sure our investigators identify the right patients for the trial. And we are obviously going to be cutting the data with longer and longer follow-ups and with ongoing responders, as you can see in the swimmer's plot from that data cut, we would expect to see that durability improve even beyond what we have today. I'll let Friedrich comment a little bit on the details of how we think that study is going to play out, but that's the big picture view.

謝謝你，安德魯。我可以先開始，也許弗里德里希可以插幾句。我不認為－我們預期療效訊號不會有任何下降。在 LUN-202 試驗中，我們越來越擅長確保研究人員能夠為試驗找到合適的患者。顯然，我們將透過越來越長的追蹤時間和持續的回應者來分析數據，正如你從該數據分析的游泳選手圖表中看到的那樣，我們預計持久性甚至會比我們今天所擁有的還要好。我會讓弗里德里希對我們認為這項研究將如何進行的細節做一些評論，但這就是大局觀。

Yeah, I agree with Fred. Not much to add there. I think the study now has reached the -- that phase where folks know what they're doing. They're familiar with the therapy. They know how to identify patients. We are able to communicate best practices. So I think this is all in a very stable place. What is noticeable is that we saw a true uptick in enrollment, which is really driven by the positive data that we were able to share with the investigators lately. That's also fairly typical. It's kind of an inflection point where then things just take off because folks see and believe in the therapy and things are working really well.

是的，我同意弗雷德的看法。沒什麼好補充的了。我認為這項研究現在已經到了——人們知道自己在做什麼的階段。他們熟悉這種療法。他們知道如何辨識病人。我們能夠交流最佳實踐。所以我覺得一切都非常穩定。值得注意的是，我們看到入學人數確實有所增加，這主要是由於我們最近能夠與研究人員分享的積極數據所推動的。這也相當常見。這算是一個轉捩點，之後事情就開始起飛，因為人們看到了這種療法並相信它，而且效果非常好。

Yanan Zu, Wells Fargo.

Yanan Zu，富國銀行。

Great. Thanks for taking our questions and congrats on the quarter. Just a quick one on the lung cancer. Can you talk about when -- did you touch base with FDA regarding the path and -- the regulation path and you did mention 80 patients. I wanted to see -- hear your confidence that 80 patients is enough for the lung cancer, filing.

偉大的。感謝您回答我們的問題，並祝賀您本季取得佳績。簡單介紹一下肺癌。您能否談談何時與 FDA 聯繫，以了解監管路徑？您曾提及 80 名患者。我想親眼看看——親耳聽聽你對80名肺癌患者是否足夠進行申報的信心。

Then on Amtagvi in melanoma, can you talk about infusion growth into fourth quarter and into 2026, your confidence for inflection point in the patient infused. And lastly, sorry, if I may, on the improved gross margin. Great to see that result. Can you comment on how much of it is coming from patient dropout and manufacturing success rate improvements versus how much is coming from cost reduction measures.

那麼關於 Amtagvi 在黑色素瘤中的應用，您能否談談到第四季度和 2026 年的輸注增長情況，您對輸注患者人數拐點的信心如何？最後，恕我冒昧，關於毛利率的提高，我想說幾句。很高興看到這個結果。您能否評論一下，其中有多少是由於病患流失和生產成功率提高所造成的，又有多少是由於成本降低措施造成的？

Why don't I start on the FDA point and then Igor will jump in and I'll ask Dan and Corleen to help out with the Amtagvi inflection point as well, the gross margin questions here. We -- we've engaged heavily with FDA on the LUN-202 trial. I've gotten guidance from them, feedback on the trial design, patient population. CMC things like the potency ISA, we feel very comfortable that we're on the right track here.

我先從 FDA 的問題開始，然後 Igor 會加入討論，我也會請 Dan 和 Corleen 幫忙解答 Amtagvi 的轉折點問題，以及這裡的毛利率問題。我們—我們與 FDA 就 LUN-202 試驗進行了深入的溝通。我從他們那裡獲得了指導，以及關於試驗設計和患者群體的回饋。對於 CMC 相關事項，例如效價 ISA，我們感覺我們走在正確的道路上，這一點我們很有信心。

Obviously engagement with FDA is a continuous process during a trial, as I'm sure investors know, we have to engage frequently and we do engage frequently. A lot of it doesn't get talked about, so we'll continue to do that on this trial. But we're very comfortable with where we stand right now on the trial design and on what we need to do to get a supplemental BLA submitted on time.

顯然，在試驗過程中與FDA的溝通是一個持續的過程，我相信投資人也知道這一點，我們必須經常溝通，而且我們也確實經常溝通。很多事情都沒有人談論，所以我們會在這次審判中繼續談論這些。但是，我們對目前的試驗設計以及為按時提交補充生物製品許可申請所需採取的措施感到非常滿意。

On the sample size for the patient, for the 80 patients, we pointed out during a lot of our calls earlier this week as well as during our prepared remarks here that we think 80 patients will be sufficient based on the precedent of Amtagvi with 73 patients, which led to the approvals on label on melanoma, as well as a lot of recent FDA, meaning the last couple of months, FDA approvals and non-small cell lungs. So I'll let Raj and maybe Marc comment on that, on what they've seen at the FDA and why they think that's reasonable.

關於患者樣本量，對於 80 名患者，我們在本週早些時候的多次電話會議以及我們在此準備的發言中都指出，我們認為 80 名患者就足夠了，這是基於 Amtagvi 的先例，該藥物有 73 名患者，並獲得了黑色素瘤的適應症批准，以及最近幾個月 FDA 批准的許多非小細胞肺癌適應症。所以，我會讓 Raj 和 Marc 來評論一下，說說他們在 FDA 看到了什麼，以及為什麼他們認為這是合理的。

In addition to what Fred said that we have continuous interaction with the FDA, we plan to apply for many different priority designations such as fast track designation, (inaudible) designation, et cetera. And I mentioned that 80 patients, also based on the 73 melanoma patients that we got them tag the approval on. And recently, Marc will elaborate further that, the FDA has approved about four non small cell lung cancer trials that are based on a approval of patients between 70 to 80 patients.

除了 Fred 所說的我們與 FDA 的持續互動之外，我們還計劃申請許多不同的優先資格認定，例如快速通道資格認定、（聽不清楚）資格認定等等。我還提到，這 80 名患者也是基於我們為他們爭取到批准的 73 名黑色素瘤患者。最近，馬克進一步闡述道，FDA已經批准了大約四項非小細胞肺癌試驗，這些試驗基於對70至80名患者的批准。

Yeah, I agree with what you had said, Raj. I think there's recent precedent for this number of patients, inpatients with non-small cell lung cancer and very high unmet medical needs, with the response rate and particularly this unprecedented duration of response. We feel based on the precedents and the data thus far, a patient, data set, would be sufficient and compelling.

是的，我同意你的說法，拉傑。我認為最近有先例，對於如此多的非小細胞肺癌住院患者，以及如此高的未滿足醫療需求，治療反應率，尤其是這種前所未有的反應持續時間，都是如此。根據以往的先例和目前的數據，我們認為，一個病患資料集就足以作為有力的佐證。

All right, so on the inflection question and fourth quarter growth, obviously we feel very confident in having a strong fourth quarter, but I'll let Dan talk about some of the details there.

好的，關於拐點問題和第四季度增長，顯然我們對第四季度的強勁增長非常有信心，但我會讓丹來談談其中的一些細節。

Thank you and thanks, Fred. Thanks, Yanan for the question. First, the answer is yes. We expect continued growth in the fourth quarter and beyond into 2026. The reasons behind that are I'm going to separate this from academic and community. In the academic setting, we've launched field efforts including a disease awareness campaign in Q3 to educate medical oncologists for earlier referral into those centers.

謝謝，也謝謝你，弗雷德。謝謝亞楠的提問。首先，答案是肯定的。我們預計第四季及以後到2026年將繼續保持成長。原因在於，我要將此事與學術界和社群分開來。在學術領域，我們已在第三季度啟動了實地工作，包括進行疾病意識宣傳活動，以教育腫瘤內科醫生儘早將患者轉診至這些中心。

We're seeing some results from that right now that will continue moving forward. We also are launching in the academic setting initiatives to increase penetration, which would have to do with addressing certain patient types that we haven't been able to capture such as BRAF mutations I mentioned where we have opportunities to get tissue earlier. So we do see growth in the academic setting.

我們現在已經看到了一些成果，而且這種勢頭還會繼續下去。我們也在學術界推出了一些措施來提高滲透率，這與解決我們尚未能夠接觸到的某些患者類型有關，例如我提到的 BRAF 突變，我們有機會更早獲得組織樣本。因此，我們確實看到了學術領域的成長。

Moving to community, I mentioned that we're onboarding now and we've started to treat at the first community site. We have several large ones that are coming on in this quarter that will drive significant growth in Q4 and beyond in the 2026 and that also sets the table for months.

談到社群方面，我提到我們現在正在進行新用戶註冊，並且已經在第一個社群網站開始提供服務。本季我們將迎來幾個大型項目，這些項目將在第四季度及以後（2026 年）推動顯著成長，並為未來幾個月奠定基礎。

For gross margin, let me just focus you on two areas, and I think you mentioned them. One, which is patient drop off and manufacturing results. So if you think about the dollars that are written off from out of spec since the beginning of the year, they have decreased by 40%. They're about $9 million this quarter, and we are now seeing the initial benefit of the restructuring that we announced in Q3. So those are two key areas that are driving revenue improvements or margin improvement.

關於毛利率，我只重點介紹兩個方面，我想你已經提到過了。一是病人下車和生產結果。因此，如果你考慮自年初以來因不符合規格而被註銷的美元金額，它們已經減少了 40%。本季約為 900 萬美元，我們現在看到了我們在第三季宣布的重組帶來的初步好處。所以，這兩方面是推動營收成長或利潤率提升的關鍵因素。

Salim Syed, Mizuho.

Salim Syed，瑞穗銀行。

Congrats on the progress. I guess one for me on the guidance here. I know you're reiterating the guidance, Corleen, I guess is there any scenario here in your mind where you're going to actually hit the closer to the top end here? I'm just curious why this 0.2 months left in the year, why we haven't narrowed it down the top end of the range to a lower number that seems more reasonable.

恭喜你取得進展。我覺得這裡面有一個指導意見。我知道你是在重申指導意見，科琳，我想問的是，在你看來，有沒有哪一種情況能讓你們真正接近最高目標？我只是好奇為什麼今年還剩下 0.2 個月，為什麼我們不把範圍的上限縮小到一個更合理的較低數字呢？

Yes, so we reiterated our guidance range of 250 to 300, which is a pretty narrow range to begin with. It's our first full calendar year on the market as you know and we're on track right now towards that guidance. Fourth quarter, as Dan was just mentioning a minute ago, we have a large influx of new ATCs. We've got pro LUC and sales to contend with, which we think will be very strong in the quarter, especially based on fourth quarter last year. You can go back and look at those numbers, and we have got this ATC growth both in the community and in the academic setting. So I think at this point we're just comfortable with the guy that we put out 250 to 300 and we'll be in that range and that's that's what we're comfortable saying right now.

是的，所以我們重申了 250 至 300 的指導範圍，這本身就是一個相當窄的範圍。如你所知，這是我們上市的第一個完整日曆年，目前我們正朝著既定目標穩步前進。正如丹剛才所提到的，第四季我們將迎來大量新的空中交通管制員。我們需要應對 LUC 和銷售方面的挑戰，我們認為這兩項指標在本季都會非常強勁，尤其是基於去年第四季的表現。您可以回顧這些數字，我們在社區和學術界都實現了ATC的成長。所以我覺得目前我們對推出的球員比較滿意，他的薪資在 250 到 300 之間，我們會在這個範圍內，這就是我們現在可以接受的說法。

Tyler Van Buren, TD Cowen.

泰勒·範·布倫，TD·考恩。

This is Nick for Tyler. Just one for me. Can you let us know how many Amtagvi patients were treated this quarter? And then also how will the ICTC maintenance -- this quarter impact Amtagvi infusions and sales? Thanks very much.

這是尼克給泰勒的。我只留一個。請問本季有多少名Amtagvi患者接受了治療？此外，本季 ICTC 的維護將如何影響 Amtagvi 的輸液和銷售？非常感謝。

Yeah, Nick, we're not going to -- we're not talking about infusions anymore. We're just going to use revenue going forward as you can see from our press release. We think that's the ultimate story here and we hope investors appreciate that we're focusing on the dollars, and that's what matters at the end of the day. On the ICTC maintenance, I'll pass the Igor for that question. I think he had covered it in his prepared remarks. Maybe you can highlight it -- highlight that again, Igor.

是的，尼克，我們不會——我們不再談論輸液了。正如您從我們的新聞稿中看到的那樣，我們今後將只使用收入作為衡量標準。我們認為這就是事情的最終結果，我們希望投資者能夠理解我們關注的是美元，而這才是最終重要的。關於 ICTC 的維護問題，我會把這個問題交給 Igor 回答。我認為他在準備好的發言稿中已經談到了這一點。或許你可以把它標出來──再標出來一次，伊戈爾。

Yeah, of course. Thanks for the question. So as I mentioned, as part of the routine maintenance this year, we'll complete the extension, part of the facility that's important for centralizing manufacturing at ICTC and also kind of continue providing uninterrupted capacity from ICTC during future maintenance periods. And this year we've learned from our experience in Q1 2025, so we made several improvements.

當然。謝謝你的提問。正如我之前提到的，作為今年例行維護的一部分，我們將完成擴建工程，這是 ICTC 集中生產的重要設施的一部分，同時也能在未來維護期間繼續為 ICTC 提供不間斷的產能。今年，我們從 2025 年第一季的經驗中吸取了教訓，並做出了一些改進。

We will boost manufacturing capacity immediately and prior to the ICTC maintenance that will provide additional manufacturing slots for patients, and that will allow essentially smooth supply through the next two quarters.

我們將立即提高生產能力，並在 ICTC 維護之前進行，這將為患者提供額外的生產名額，並在接下來的兩個季度內基本實現平穩供應。

David Dye, UBS.

David Dye，瑞銀集團。

A couple of questions for me. So just on the ATC ramp, we're seeing early community initiatives in there. I'm just curious in terms of what are the timeline for the community activation to actually see patients treated. That's the first question.

我有幾個問題想問一下。僅在空中交通管制停機坪上，我們就看到了早期的社區倡議。我只是好奇，從社區動員到真正看到患者接受治療，需要多長時間。這是第一個問題。

And the second question just around the marginal improvement, you said you're planning to have more marginal improvement over the next few quarters. So I'm curious, what is sort of like the -- of the margin we should be expecting over the next quarters, essentially, one should be expecting the plateauing of the margin over time.

第二個問題是關於邊際改進的，您說您計劃在接下來的幾個季度實現更大的邊際改進。所以我很好奇，在接下來的幾個季度裡，我們應該預期利潤率會是多少？基本上，我們應該預期利潤率會隨著時間的推移而趨於平穩。

So I'll take the ATC work first and look at the ramp for that. So you mentioned specifically community, our first community centers are starting to treat now. Typically with centers they treat a few patients. They make sure the insurance goes through, they get comfortable with it and they start ramping patients after that. That is expected to continue with our community ones that are just starting to treat now.

所以我先做空中交通管制的工作，然後看看停機坪的狀況。所以你特別提到了社區，我們的第一批社區中心現在已經開始提供服務了。通常情況下，這些中心只會治療少數病人。他們確保保險順利通過，熟悉流程後，就開始逐步增加病患數量。預計這種情況還會繼續發生在我們社區那些剛開始接受治療的機構。

The newer ones coming on with the volume will start slow in -- with a few patients and therefore, but then we'll start to ramp up. The key with the community is that the referral patterns are already there to get those patients in earlier. So as we discussed with those larger entities opening them, we also have robust discussions regarding referral patterns and patients lining up. So we will see a ramp there, a little faster than you'll see with the academics, but, it should be coming over in the next quarter or two, and then we'll get to full peak probably by mid next year.

新加入的團隊會慢慢開始，一開始只會接診少數患者，但之後我們會逐步擴大規模。社區的關鍵在於，轉診模式已經建立，可以更早讓患者得到治療。因此，正如我們與那些開設這些診所的大型機構討論的那樣，我們也就轉診模式和患者排隊情況進行了深入的討論。所以我們會看到這方面的成長速度會比學術方面的成長速度快一些，但應該會在接下來的一兩個季度內有所改善，然後我們可能會在明年年中達到頂峰。

David, on the gross margin, yes, we mentioned it will continue to improve. So that will be a further benefit from the restructuring, but also a number of initiatives across operational efficiency in the manufacturing plant, as well as cost savings initiatives to run the organization as efficiently as possible.

大衛，關於毛利率，是的，我們說過它會繼續改善。因此，重組將帶來進一步的好處，同時也將帶來製造工廠營運效率的多項舉措，以及旨在盡可能高效地營運組織的成本節約舉措。

And just to finish off, we did announce one of those things today, David, by transitioning all manufacturing to internal, as Igor and Corleen and others discussed, we expect this to have additional margin improvements on the back of that. That's not something that's reflected in the 43% that we reported today.

最後，David，我們今天確實宣布了其中一件事，那就是將所有生產轉移到內部，正如Igor、Corleen和其他人討論的那樣，我們預計這將帶來額外的利潤率提升。這一點並沒有反映在我們今天公佈的 43% 的數據中。

Colleen Cusy, Baird.

科琳·庫西，貝爾德。

Great, good morning. Thanks for taking our questions and congrats on the progress. On the community ATCs that you're seeing come online, can you just speak to the capacity that you see at those centers versus what the capacity is that you're seeing at the academic centers?

太好了，早安。感謝您解答我們的問題，並祝賀您的進展。對於您看到的正在上線的社區航空運輸中心 (ATC)，您能否談談您看到的這些中心的容量與您在學術中心看到的容量相比如何？

Sure, so thank you very much, Colleen, for the question. The capacity of the community centers, they are hospitals, they do have the bed space comparable to the academics. What we do see with them though is less of a clinical trial allocation and other competing priorities for those beds and more of a priority in the solid tumor space than we see in the academics for it because they do split beds in the academics with the hematology space where the CRTs are, et cetera. So we do see an opportunity to have a larger percent of their capacity in the community setting. `

當然，非常感謝Colleen的提問。社區中心的容量，它們就像醫院一樣，它們的床位數量可以與學術機構相媲美。不過，我們看到的是，與學術界相比，實體瘤領域的臨床試驗分配和其他競爭性優先事項較少，因為學術界會將床位與血液疾病領域（包括 CRT 等）分開。因此，我們看到了一個機會，讓他們在社區環境中發揮更大的作用。`

Reni Benjamin, Citizens.

雷尼‧班傑明，《公民》。

I'm sorry I jumped on the call a little late, so you may have answered this already, so just indulge me. I'd like to understand a little bit more about the global expansion that you highlighted. How do you envision these programs or the expansion without a partner. Should we really be -- should we be thinking about any sort of a meaningful contribution in terms of revenues going forward or at least in 2026, or is this something that goes out much further?

很抱歉我接電話晚了一點，您可能已經回答過了，請您見諒。我想更深入地了解您提到的全球擴張情況。如果沒有合作夥伴，您如何設想這些項目或擴張計劃？我們真的應該——我們真的應該考慮在未來或至少在 2026 年，在收入方面做出任何有意義的貢獻嗎？還是說這是更長遠的事？

And just a follow-up question, regarding both Tilvan and the LUN-202 study. It seems like enrollment will slow at least from the 202 study. Can you just give us a better sense as to how enrollment is progressing in each of those studies? That would be great. Thank you.

還有一個後續問題，是關於 Tilvan 和 LUN-202 的研究。至少從 202 年的研究開始，招募人數似乎會放緩。能否更詳細地介紹一下每項研究的招募進度？那太好了。謝謝。

Yeah, Reni. So first on the global expansion, we're not thinking right now really about partnership tool technology and the science of delivering pills to patients, the medicine behind it is complicated. We're not really sure there's a partner out there that would give us any kind of advantage, and we're always really cautious about asset pollution, giving anybody rights to anything that we do because we think that pills are going to be extremely powerful in the future, and we would like to own all that.

是的，雷尼。所以首先，關於全球擴張，我們現在還沒有真正考慮合作工具技術和向病人輸送藥丸的科學，背後的醫學原理很複雜。我們不太確定是否有合作夥伴能給我們帶來任何優勢，而且我們一直非常謹慎地避免資產污染，不會把我們所做的任何事情的權利授予任何人，因為我們認為藥丸在未來會非常強大，我們希望擁有所有這些權利。

That said, we may work with distributors in certain markets. We may work with people that can help enter markets for us. We tend to stay very light and lean in those markets while we wait for revenue to appear. In 2026, I don't expect a significant amount of revenue from those markets. However, we'll start to see that business grow, and then over time I think it will become a major component of our business in the future.

也就是說，我們可能會在某些市場與經銷商合作。我們可以與能夠幫助我們進入市場的人合作。在等待收入出現期間，我們傾向於在這些市場中保持非常輕盈和精簡的狀態。2026年，我預期這些市場不會帶來可觀的收入。但是，我們將會看到這項業務逐漸發展壯大，隨著時間的推移，我認為它將來會成為我們業務的重要組成部分。

And since Dan heads those teams, I'll let him give some color and maybe just highlight the markets that we're going to go back into, including the UK, and we're going to be entering for the first time, the UK and Australia and other places where there's a significant number of melanoma patients in need.

既然丹是這些團隊的負責人，那就讓他來介紹一下情況，重點說說我們將要重返的市場，包括英國，以及我們將首次進入的英國、澳大利亞和其他有大量黑色素瘤患者需要治療的地方。

And so Reni, one of the things we've always said about our global expansion, if you look at the history of cell therapies globally. This has been more of a long-term strategy to produce revenue in 2027 and beyond, but you needed to get the filing and approvals in place because reimbursement does take a while in those regions you want to make sure you do it in the proper sequence. So where we are right now with it, we are ramping up in Canada, with our first ATC.

所以，Reni，關於我們的全球擴張，我們一直以來都強調一點，那就是，如果你看看全球細胞療法的歷史。這更多的是一項著眼於 2027 年及以後產生收入的長期策略，但你需要提前完成備案和審批，因為在這些地區報銷需要一段時間，所以你要確保按正確的順序進行。所以，就我們目前的情況而言，我們正在加拿大加大力度，推出我們的第一個空中交通管制員。

We have pending approvals in the UK as well as Australia. We're in discussion right now in the UK about getting NHS support on which ATCs will go up and running there. So we're getting the process in place as well as within Switzerland and the refiling in the EU. So this has been a long-term strategy with it and something that. We will see if you look at kte who did a great job with Yara globally. It took them several years for the approvals to get revenue in there, so we followed that model, knowing it would take 2027, would be our first year to have any appreciable revenues, not saying we won't get any next year, but really appreciable revenues in 2027 for next year.

我們在英國和澳洲都有待審批的申請。我們目前正在英國討論如何獲得英國國家醫療服務體系 (NHS) 的支持，以確定哪些空中交通管制中心將在英國投入運作。所以我們正在落實瑞士境內的流程，以及在歐盟重新提交申請的流程。所以這是一項長期戰略，也是…我們看看kte就知道了，他們在全球範圍內為Yara做出了巨大貢獻。他們花了幾年時間才獲得批准並開始盈利，所以我們也遵循了這種模式，知道要到 2027 年才會有可觀的收入，並不是說我們明年不會有任何收入，而是說明年要到 2027 年才能有真正可觀的收入。

And then on the enrollment question, I'll focus on 1,202, Reni because Tovan we really haven't said anything publicly about the enrollment there beyond that it's going well, and we think, that that that's on track right now, but on 1 202, enrollment has really picked up lately. And if you heard on the calls earlier this week, we have double-digit patients right now waiting for infusions, and we have a lot of activity there. I'll let Friedrich comment in a second here, but we think we can easily hit the timeline that we gave for the launch of, Lielluo and non-small cell lung in the second half of 2027 based on our current enroll enrollment timings in the lung 202 trial. Friedrich, do you want to add to that?

關於招生問題，我將重點關注 1,202 Reni，因為 Tovan，除了招生進展順利之外，我們還沒有公開談論過那裡的招生情況，我們認為，目前一切都在按計劃進行，但是 1,202 的招生最近確實有所增加。如果你在本週早些時候的電話會議上聽到了，我們現在有兩位數的患者正在等待輸液，我們那邊非常忙碌。我稍後會讓 Friedrich 對此發表評論，但根據我們目前在肺 202 試驗中的入組時間，我們認為我們可以輕鬆實現我們給出的在 2027 年下半年推出 Lielluo 和非小細胞肺癌的時間表。弗里德里希，你還有什麼要補充的嗎？

Yeah, just really quick, Reni, since I don't know when you joined, I, I've described that before, earlier in the call. I think in the lung study, we've now reached this point where, number one, we have stability and familiarity of the investigators at the sites with the therapy. They know how to pick patients and important, we have a data set that has the size and the quality and the data that are driving investigator engagement.

是的，Reni，就簡單說一下，因為我不知道你是什麼時候加入的，我之前在通話中已經解釋過了。我認為在肺部研究中，我們現在已經達到了這樣的階段：首先，各研究中心的研究人員對這種療法已經非常熟悉，病情也比較穩定。他們知道如何挑選患者，重要的是，我們擁有一個規模和品質都足夠大的數據集，這些數據正在推動研究人員的參與。

They see the potential for this therapy. They see the benefit in the patients, and they now are enrolling at the speed of what's typical for a trial that has shown data like this. So I share Fred's confidence in us being on track here with our goals.

他們看到了這種療法的潛力。他們看到了患者從中受益，現在正以與此類已顯示數據的試驗通常速度一樣的速度招募患者。所以，我和佛瑞德一樣，對我們朝著目標穩步前進充滿信心。

Got it. And just as a quick follow-up, maybe, Fred, to your comments about Tovan that enrollment's going well and things are on schedule. Can you just remind me when do you think ultimately enrollment would be complete or when you might be filing the DLA? Have you provided any of that guidance before?

知道了。弗雷德，我想就你之前關於托萬的評論做個簡短的補充，你說招生工作進展順利，一切都在按計劃進行。您能否提醒我一下，您認為最終的註冊流程何時完成，或者您何時會提交殘障生活津貼申請（DLA）？您之前有提供過這方面的指導嗎？

Not yet. We're still pretty early in this trial here. This is a longer-term study. We do have the ability to read at an interim time point for ORR and seek an accelerated approval in first line melanoma in this study, and that's not too far off. We have not guided anything publicly, and there's obviously for 670 patient trial, at least 600 patients on the main population. That's tough to predict accurately right now, but we should be in touch pretty soon with some more updates on that as that starts to crystallize for us.

還沒有。我們現在還處於試驗的早期階段。這是一項長期研究。我們有能力在中期時間點讀取 ORR 數據，並在本研究中尋求一線黑色素瘤治療的加速批准，而且這一天也不會太遠。我們沒有公開任何指導意見，而且很明顯，對於一項 670 名患者的試驗來說，主要人群中至少有 600 名患者。現在很難準確預測，但隨著情況逐漸明朗，我們會盡快與您聯繫，提供更多最新消息。

Thank you. This concludes the question-and-answer session. I would now like to turn it back to Fred Vogt for closing remarks.

謝謝。問答環節到此結束。現在我謹將發言權交還給弗雷德·沃格特，請他作總結發言。

Thank you again for joining the Iovance Biotherapeutics third quarter of 2025 conference call. We look forward to providing future updates on our commercial launch and pipeline as well as our cost optimization initiatives to drive towards profitability. We are motivated by the stories we continue to hear about the patients who benefit from Iovance pill cell therapies.

再次感謝您參加 Iovance Biotherapeutics 2025 年第三季電話會議。我們期待在未來提供有關我們商業化發布和產品線以及我們為實現盈利而採取的成本優化措施的最新資訊。我們不斷聽到患者因 Iovance 藥丸細胞療法而受益的故事，這激勵著我們不斷前進。

I'm confident that Iovance will remain the global leader in innovating, developing, and delivering current and future generations of pill cell therapies for patients with cancer. As always, we are thankful to our patients, the healthcare and advocacy communities, our partners, and our exceptional Iovance team. I would also like to thank our dedicated shareholders and covering analysts for their support. Thank you.

我相信 Iovance 將繼續保持其在創新、開發和提供當前及未來幾代癌症患者的膠囊細胞療法方面的全球領先地位。一如既往，我們感謝我們的患者、醫療保健和倡導團體、我們的合作夥伴以及我們傑出的 Iovance 團隊。我還要感謝我們忠實的股東和分析師們的支持。謝謝。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。