Coherus Oncology Inc (CHRS) 2025 Q2 法說會逐字稿

Thank you for standing by. My name is Jordan, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the Coherus Oncology earnings conference call. (Operator Instructions)

感謝您的支持。我叫喬丹，今天我將擔任您的會議主持人。現在，我歡迎大家參加 Coherus Oncology 收益電話會議。（操作員指示）

I'd now like to turn the conference over to Jodi Sievers, Head of Investor Relations for Coherus Oncology. You may begin.

現在，我想將會議交給 Coherus Oncology 投資者關係主管 Jodi Sievers。你可以開始了。

Thank you, Jordan. Good afternoon, and welcome to Coherus Oncology's second-quarter 2025 earnings conference call. Joining me today to discuss our results are Denny Lanfear, Chief Executive Officer of Coherus; Bryan McMichael, Chief Financial Officer; Dr. Rosh Dias, Chief Medical Officer; Dr. Theresa Lavallee, Chief Scientific and Development Officer; and Sameer Goregaoker, Executive Vice President, Commercial.

謝謝你，喬丹。下午好，歡迎參加 Coherus Oncology 2025 年第二季財報電話會議。今天與我一起討論我們業績的有 Coherus 執行長 Denny Lanfear、財務長 Bryan McMichael、首席醫療官 Rosh Dias 博士、首席科學與開發官 Theresa Lavallee 博士和商業執行副總裁 Sameer Goregaoker。

Before we get started, I would like to remind you that today's call includes forward-looking statements regarding Coherus's current expectations about future events. Actual results may vary significantly, and we undertake no duty to update or revise any forward-looking statement. Please see the press release that we issued today and our quarterly report on Form 10-Q for more information on risks and uncertainties. And now I'll turn the call over to Denny.

在我們開始之前，我想提醒您，今天的電話會議包括有關 Coherus 對未來事件的當前預期的前瞻性陳述。實際結果可能有很大差異，我們不承擔更新或修改任何前瞻性聲明的義務。有關風險和不確定性的更多信息，請參閱我們今天發布的新聞稿和 10-Q 表季度報告。現在我將把電話轉給丹尼。

Thank you, Jodi, and welcome all. In Q2 2025, we completed our strategic repositioning and renamed our company Coherus Oncology, to better reflect our mission. Today, in addition to reviewing the progress we made in growing our commercial revenue and advancing our clinical oncology programs ahead of key data rate outs in the first half of '26. I want to take the opportunity to introduce you to our new company and highlight what sets us apart.

謝謝你，喬迪，歡迎大家。2025 年第二季度，我們完成了策略重新定位，並將公司更名為 Coherus Oncology，以更好地反映我們的使命。今天，除了回顧我們在增加商業收入和推進臨床腫瘤學計畫方面的進展，以及在 26 年上半年關鍵數據率出爐之前的進展之外。我想藉此機會向您介紹我們的新公司並強調我們的與眾不同之處。

Today, I'll be focusing for you on three main points of Coherus Oncology. First, who we are as a company in terms of science, products and mission. Second, what we are doing clinically and strategically to advance that mission through combinations of products and collaborations with partners. And third, while our proven track record in deals and partnerships and in development gives us confidence we will successfully execute globally on our plans, creating significant value for our US focused business.

今天，我將為大家重點講一下Coherus Oncology的三個重點。首先，從科學、產品和使命的角度來看，我們是一家甚麼樣的公司。其次，我們正在臨床和策略上開展工作，透過產品組合和與合作夥伴的合作來推進這項使命。第三，我們在交易、合作和發展方面的良好記錄讓我們有信心在全球範圍內成功執行我們的計劃，為我們以美國為中心的業務創造巨大的價值。

First, let's talk about who we are. Coherus Oncology is a commercial stage innovative company built on deep science, focused on developing cutting-edge cancer therapies. Our goal is to deliver a step change in survival for cancer patients using new generation, first-in-class and best-in-class therapeutics.

首先，讓我們談談我們是誰。Coherus Oncology 是一家基於深度科學的商業階段創新公司，專注於開發尖端癌症療法。我們的目標是利用新一代、一流和最佳的治療方法顯著提高癌症患者的存活率。

Our science is reading through the clinical results and patient benefit. For example, our next-generation PD-1 inhibitor, toripalimab has a unique FG loop binding site and significantly higher potency compared to standard of care PD-1s and this has translated to demonstrated efficacy in low PD-L1 cancers.

我們的科學正在解讀臨床結果和病人利益。例如，我們的下一代 PD-1 抑制劑特瑞普利單抗具有獨特的 FG 環結合位點，與標準治療 PD-1 相比效力明顯更高，這已證明其對低 PD-L1 癌症有效。

While other standard of care PD-1 treatments have lost approval for low PD-L1 esophageal cancer in the US toripalimab has been accrued across all PD-L1 levels for first-line esophageal in the EU, validating its genuine mechanistic and clinical differentiation.

儘管其他標準 PD-1 療法在美國已失去對低 PD-L1 食道癌的批准，但特瑞普利單抗已在歐盟所有 PD-L1 水平的食道癌一線治療中累積，證實了其真正的機制和臨床差異。

Approved for use in recurrent or metastatic nasopharyngeal cancer, LOQTORZI, which is the brand name for toripalimab demonstrated in a pivotal study a compelling 37% improvement in overall survival versus standard of care, earning top ranking on NCCN guidelines.

LOQTORZI 是特瑞普利單抗的品牌名，已獲批用於治療復發性或轉移性鼻咽癌，在一項關鍵研究中，該藥物與標準治療相比，總體生存率提高了 37%，在 NCCN 指南中名列前茅。

We translated this to increased adoption by physicians and patients fueling commercial growth. LOQTORZI net revenue in the second quarter grew 36% over Q1 2025 to $10 million. Nasopharyngeal cancer represents a $150 million to $200 million market opportunity for us. However, the larger commercial case for LOQTORZI lies in combination therapy with both our own pipeline product candidates as well as other companies products.

我們將其轉化為醫生和患者的更多採用，從而推動商業成長。LOQTORZI 第二季淨收入較 2025 年第一季成長 36%，達到 1,000 萬美元。鼻咽癌對我們來說代表著1.5億至2億美元的市場機會。然而，LOQTORZI 更大的商業案例在於與我們自己的候選產品以及其他公司產品的聯合治療。

In the latter case, we supply the drug but do not fund the trials, potentially expanding the LOQTORZI label very cost effectively. Now let me move on to the development strategy for the pipeline assets for just a moment. The step change in cancer patient survival we seek requires multiple mechanism of action working in concert to attack tumors.

在後一種情況下，我們提供藥物但不資助試驗，從而有可能以非常經濟的方式擴大 LOQTORZI 標籤。現在，我稍微談談管道資產的發展策略。我們尋求的癌症患者存活的顯著改變需要多種作用機制協同作用來攻擊腫瘤。

Our pipeline assets have complementary MOAs to LOQTORZI, and we are actively advancing combination studies across prioritized indications. Collaborations are key to combinations as we don't want to overlook any potential significant therapeutic benefit in combining any of our assets with another company's approved or experimental agents.

我們的管道資產與 LOQTORZI 具有互補的 MOA，並且我們正在積極推進針對優先適應症的組合研究。合作是組合的關鍵，因為我們不想忽視將我們的任何資產與其他公司批准或實驗的藥物相結合所產生的任何潛在的顯著治療益處。

Thus, developing strategic partnerships is an integral part of our overarching development strategy and dovetails with our efforts to license the pipeline ex US, as I will describe later. This results in a very capital-efficient indication expansion strategy for our products and sets us apart from other companies as we do not constrain ourselves to just using our own portfolio.

因此，發展策略夥伴關係是我們整體發展策略的一個組成部分，並且與我們在美國以外地區授權管道的努力相吻合，我稍後將進行描述。這使得我們的產品擁有非常資本高效的適應症擴展策略，並且使我們有別於其他公司，因為我們不局限於僅使用我們自己的產品組合。

Let me now briefly review each of our pipeline product candidates. First, CHS 114, our anti-CCR8 Treg depleter, and then Kasdozoquito, our anti-IL-27 antagonist, in terms of first, how they were scientifically brought forward. Second, why they are so promising. And third, rationale for the development path we've chosen. Then Dr. Dias, our Chief Medical Officer, will review the ongoing studies and the upcoming data readouts expected in the first half of '26.

現在讓我簡要回顧一下我們的每個候選產品管道。首先是我們的抗 CCR8 Treg 耗竭劑 CHS 114，然後是我們的抗 IL-27 拮抗劑 Kasdozoquito，首先就它們是如何科學地提出的。第二，為什麼它們如此有前途。第三，我們所選擇的發展道路的合理性。然後，我們的首席醫療官迪亞斯博士將回顧正在進行的研究以及預計在 26 年上半年發布的數據讀數。

First, CHS-114, our potential best-in-class CCR8 Treg depleter. Now normally, T regulatory cells act as brakes on the body's immune response, preventing autoimmune disease. In cancer, particularly with solid tumors, Tregs help tumors evade the immune system, allowing them to grow unchecked.

首先是 CHS-114，我們潛在的同類最佳 CCR8 Treg 耗竭劑。正常情況下，T 調節細胞會抑制人體的免疫反應，進而預防自體免疫疾病。對於癌症，特別是實體腫瘤，Treg 幫助腫瘤逃避免疫系統，使其不受抑制地生長。

While the existence and role of Tregs as known years before, in 2016, researchers found that Treg cells in the tumor microenvironment had a unique receptor CCRA, on their surface. This sparked a rush to create antibodies that target CCRA with the objective to eliminate these specific Tregs and not others and boost the immune system's response against tumors.

儘管 Treg 的存在和作用多年前就為人所知，但在 2016 年，研究人員發現腫瘤微環境中的 Treg 細胞表面有一個獨特的受體 CCRA。這引發了研發針對 CCRA 的抗體的熱潮，目的是消除這些特定的 Treg 而不是其他 Treg，並增強免疫系統對腫瘤的反應。

This was viewed as a potential major breakthrough goal in the year's long battle against cancer. CHS-114 was developed with great care to specifically target only CCR8, ensuring it doesn't bind to other receptors outside the tumor microenvironment, which would cause side effects and limit its use.

這被視為今年長期抗癌鬥爭中潛在的重大突破目標。CHS-114 經過精心研發，專門針對 CCR8，確保它不會與腫瘤微環境以外的其他受體結合，從而避免引起副作用並限制其使用。

However, CCR rate is a GPCR receptor, and targeting such receptors is notoriously difficult as there's so little protein on the cell surface for binding, making antibody development very challenging. The development process for CHS-114 was rigorous and candidate agents were screened against over 5,200 known off-target sites to ensure selectivity.

然而，CCR 率是 GPCR 受體，而針對此類受體非常困難，因為細胞表面可供結合的蛋白質太少，這使得抗體開發非常具有挑戰性。CHS-114 的開發過程非常嚴格，候選藥物針對超過 5,200 個已知的脫靶位點進行篩選，以確保選擇性。

The result of this effort is the only known anti-CCR8 Treg depleting agent with no off-target binding, which may avoid unexpected toxicity.

這項努力的成果是，我們找到了唯一已知的沒有脫靶結合的抗 CCR8 Treg 耗竭劑，這可以避免意外的毒性。

Two key points here. First, some CCR8 competitors are accounting off-target binding in their development programs and some are finding dose-limiting toxicities. Secondly, CHS-114's high selectivity makes it potentially best-in-class, giving us competitive advantage in terms of development timing and market entry.

這裡有兩個關鍵點。首先，一些 CCR8 競爭對手在其開發計劃中考慮了脫靶結合，一些競爭對手發現了劑量限制性毒性。其次，CHS-114 的高選擇性使其成為同類產品中的佼佼者，為我們在開發時機和市場進入方面提供了競爭優勢。

It's important to note that we are the only independent US biotech developing a CCR8 and the US FDA approval is highly valuable ex US in terms of partnering, which is a key focus for us. We are working efficiently and aggressively, of course, to bring CHS-114 to market for key indications in the US as quickly as possible. And we're making good progress.

值得注意的是，我們是唯一一家開發 CCR8 的美國獨立生物技術公司，美國 FDA 的批准對於美國以外的合作非常有價值，這是我們關注的重點。當然，我們正在積極且有效率地開展工作，以盡快將 CHS-114 推向美國市場，用於治療關鍵適應症。我們正在取得良好進展。

With our head and neck trial, Coherus Oncology is the first US company to demonstrate that anti-CCR8 treatment can deplete Tregs in tumors. 114 treatment also led to increased CD8-positive T cell infiltration in the head and neck cancer patient tumors. I would also note that in combination with LOQTORZI in the same study, we saw a partial response and significant reduction of target and nontarget lesions in a fourth-line patient. Of course, given the promise of the mechanism of action, targeting CCR8 has become very competitive.

透過我們的頭頸部試驗，Coherus Oncology 成為第一家證明抗 CCR8 治療可以消耗腫瘤中的 Treg 的美國公司。 114 治療也導致頭頸癌患者腫瘤中的 CD8 陽性 T 細胞浸潤增加。我還要指出的是，在同一項研究中，與 LOQTORZI 聯合使用時，我們觀察到四線患者的部分反應以及靶病變和非靶病變的顯著減少。當然，鑑於作用機制的前景，針對 CCR8 的競爭已經變得非常激烈。

However, the upside is that this class of treatments is gaining broad validation across various tumors and settings, particularly in combination with a PD-1. Importantly, given the MOA, there is also the potential for broad combinability of anti-CCR8 across other efficacious modalities such as T cell engagers, ADCs and so on.

然而，好處是這類治療方法正在各種腫瘤和環境中獲得廣泛驗證，特別是與 PD-1 結合使用時。重要的是，考慮到 MOA，抗 CCR8 也可能與其他有效方式（如 T 細胞接合劑、ADC 等）進行廣泛的結合。

This is the subject of our partnering efforts, both in the US and ex US. We currently have clinical studies in head and neck, gastric and esophageal cancer, which we will review directly. However, I wish to point out that Dr. Alexander Redinski, Chairman of Immunology at Memorial Sloan Kettering and key member of our Coherus Oncology Scientific Advisory Board, recently published two important preclinical papers characterizing the immunosuppressive role of Tregs in colorectal cancer, an area of burgeoning unmet need.

這是我們在美國國內和美國以外地區合作努力的主題。我們目前正在進行頭頸癌、胃癌和食道癌的臨床研究，我們將直接審查這些研究。然而，我想指出的是，紀念斯隆凱特琳癌症中心免疫學主席兼 Coherus 腫瘤科學顧問委員會核心成員 Alexander Redinski 博士最近發表了兩篇重要的臨床前論文，描述了 Tregs 在結直腸癌中的免疫抑製作用，而結直腸癌是一個新興的未滿足需求領域。

We are currently developing clinical plans to address this increasingly common disease, affecting younger patients as recently reported by the Journal of American Medical Association. We believe that in 2026, anti-CCR8 will start to realize their therapeutic promise and become a new treatment backbone used broadly across many solid tumor types.

我們目前正在製定臨床計劃來應對這種日益常見的疾病，正如《美國醫學會雜誌》最近報導的那樣，這種疾病影響著更年輕的患者。我們相信，到 2026 年，抗 CCR8 將開始實現其治療前景，並成為廣泛應用於多種實體腫瘤類型的新治療支柱。

Let me now refresh you on casdozokitug, a unique first-in-class opportunity in our pipeline. Casdozokitug is the only known anti-IL-27 treatment currently in development, and IL-27 plays a key role in the immune responses within barrier tissues such as liver and lung. It is well known that cytokines in the immune system are tightly linked to cancer, and it has been demonstrated that IL-27's role in mediating the immune response is the basis for its mechanism of action.

現在讓我重新向您介紹 casdozokitug，這是我們管道中獨一無二的一流機會。Casdozokitug 是目前正在開發的唯一已知的抗 IL-27 治療方法，IL-27 在肝臟和肺部等屏障組織內的免疫反應中起著關鍵作用。眾所周知，免疫系統中的細胞激素與癌症緊密相關，並且已證明IL-27在介導免疫反應中的作用是其作用機制的基礎。

Mechanistically, within the tumor microenvironment, IL-27 facilitates tumor growth in three ways: first, by inducing checkpoint expression, such as PD-1s, LAG-3 and others on the surface of T cells, inhibiting the immune response. Secondly, by reducing pro-inflammatory cytokines, weakening the immune response. And lastly, affecting natural killer cells, preventing them from attacking tumors.

從機制上講，在腫瘤微環境中，IL-27 以三種方式促進腫瘤生長：首先，透過誘導 T 細胞表面的檢查點表達，例如 PD-1、LAG-3 等，抑制免疫反應。其次，透過減少促發炎細胞因子，削弱免疫反應。最後，影響自然殺手細胞，阻止它們攻擊腫瘤。

This makes IL-27 a novel and distinctive target with immunomodulatory mechanism that is synergistic with checkpoints, attacking immune resistance from a complementary direction. What's important for you to think about here is that the translation of the data from our model systems to the human clinical trials is impressive, giving us a clear path forward for development.

這使得 IL-27 成為一個具有免疫調節機制的新穎而獨特的靶點，該機制與檢查點具有協同作用，可以從互補的方向攻擊免疫抵抗。這裡需要您思考的重要一點是，從我們的模型系統到人體臨床試驗的數據轉換令人印象深刻，為我們提供了明確的發展道路。

Across preclinical mouse models, IL-27 was shown to have an important role in turning off T cells and NK cells in lung and liver. These are the two key tissue types we have chosen to investigate for therapeutic effect and compelling efficacy has been demonstrated in first-line liver cancer patients as previously disclosed.

在臨床前小鼠模型中，IL-27 被證明在關閉肺和肝中的 T 細胞和 NK 細胞方面發揮重要作用。這是我們選擇研究治療效果的兩種關鍵組織類型，如前所述，其在一線肝癌患者中已顯示出令人信服的療效。

Coherus Oncology has global rights to casdozokitug, and hepatocellular carcinoma is a global disease with particular incidents in Asia and other regions, including Europe and MENA. This makes the ex-US licensing efforts of casdozokitug a priority for us, and we believe the success of such efforts will follow from strong clinical data.

Coherus Oncology 擁有 casdozokitug 的全球權利，肝細胞癌是一種全球性疾病，在亞洲和其他地區（包括歐洲和中東和北非）尤其常見。這使得 casdozokitug 在美國以外的授權工作成為我們的首要任務，我們相信此類努力的成功將源自於強大的臨床數據。

Such partnering across regions can be expected to provide three things: first, validation of the value of our pipeline; second, nondilutive financing for ongoing clinical development; and third, cost offsets for larger pivotal clinical trials to come later.

預計這種跨地區合作將帶來三方面的結果：第一，驗證我們產品線的價值；第二，為正在進行的臨床開發提供非稀釋性融資；第三，為後期更大規模的關鍵臨床試驗提供成本補償。

Dr. Dias will now provide clinical development rationale and update, letting you know what you can expect next year as the data reads out. Then Sameer Goregaoker, our Executive Vice President, Commercial, will provide MPC market color as well as a summary of the large market opportunity of the pipeline product candidates. Rosh?

Dias 博士現在將提供臨床開發原理和最新進展，讓您了解明年數據公佈後可以期待什麼。然後，我們的商業執行副總裁 Sameer Goregaoker 將提供 MPC 市場概況以及管道產品候選的巨大市場機會摘要。羅什？

Thank you, Denny, and good afternoon, everyone. I'll start with a review of our clinical program for CHS-114 before moving on to casdozokitug. Given the biology, CHS-114 has potential utility in multiple areas, and we have active trials across several tumor types. Firstly, in second-line head and neck squamous cell carcinoma, where the rationale for exploration is several fold.

謝謝你，丹尼，大家下午好。我將首先回顧 CHS-114 的臨床計劃，然後再討論 casdozokitug。鑑於生物學特性，CHS-114 在多個領域具有潛在效用，我們正在針對多種腫瘤類型進行積極試驗。首先，在二線頭頸部鱗狀細胞癌中，探索的理由有很多。

First, this is a tumor type that is well supported by high target expression in terms of the prevalence and density of CCR8-positive Tregs in the tumor. Additionally, this is an indication synergistic with the current indication for LOQTORZI in NPC, a subtype of head and neck cancer.

首先，就腫瘤中 CCR8 陽性 Treg 的盛行率和密度而言，這是一種得到高標靶表達良好支持的腫瘤類型。此外，此適應症與 LOQTORZI 目前在治療頭頸癌亞型 NPC 方面的適應症具有協同作用。

And furthermore, clinically, we've been very encouraged by the confirmed partial response demonstrated earlier in the head and neck program in a very late-line patient previously refractory to prior PD-1 inhibition with this data being presented at AACR a few months ago and which firmly supports continued development in head and neck.

此外，從臨床角度來看，我們非常高興地看到，在頭頸部治療項目中，一位先前對 PD-1 抑制有抵抗力的極晚期患者獲得了確認的部分緩解，該數據幾個月前在 AACR 上公佈，有力地支持了頭頸部治療的持續發展。

Our head and neck squamous cell trial explores two biologically active doses of CHS-114 in combination with toripalimab in the second-line setting, which is currently an area of very high unmet medical need with the goal of declaring a dose for continued development, whilst at the same time, developing further efficacy and safety data and aiming to address FDA's Project Optimus.

我們的頭頸部鱗狀細胞試驗探索了兩種生物活性劑量的 CHS-114 與特瑞普利單抗在二線治療中的聯合應用，目前這是一個非常未滿足的醫療需求領域，目的是宣布繼續開發的劑量，同時開發進一步的功效和安全性數據，並旨在解決 FDA 的 Optimus 項目。

This trial is active and ongoing, and we remain on track to develop efficacy -- to deliver efficacy and safety data in the first half of 2026 previously communicated. The second priority tumor type for CHS-114 is second-line gastric cancer, which again is supported by the biology and has demonstrated proof of principle of the CCR8 class in combination with toripalimab specifically as communicated in data presented at ASCO '24.

這項試驗正在積極進行中，我們仍在按計劃開發療效——將在先前傳達的 2026 年上半年提供療效和安全性數據。CHS-114 的第二優先腫瘤類型是二線胃癌，這再次得到了生物學的支持，並且已經證明了 CCR8 類與特瑞普利單抗聯合使用的原理證明，具體如 ASCO '24 上展示的數據所示。

The approach here is to include patients with gastric, GEJ and esophageal adenocarcinoma and again, to explore two biologically active doses in combination with toripalimab in 40 second-line patients. This trial is active and ongoing in US and Asia Pacific sites, and we anticipate safety and efficacy results over the course of next year, as previously discussed.

這裡的方法包括患有胃癌、GEJ 和食道腺癌的患者，並再次在 40 名二線患者中探索兩種生物活性劑量與特瑞普利單抗的聯合治療。該試驗正在美國和亞太地區進行，我們預計明年將獲得安全性和有效性結果，正如之前所討論的。

The third tumor type we're pursuing is in esophageal squamous cell carcinoma, where we're looking at both a first-line and a second-line population. As a reminder, LOQTORZI has demonstrated activity irrespective of PD-L1 levels in the first-line setting, and we're exploring TORI-114 combination with chemo in first-line ESCC.

我們正在研究的第三種腫瘤類型是食道鱗狀細胞癌，我們正在研究第一線和二線人群。提醒一下，LOQTORZI 已證明在一線治療中無論 PD-L1 水平如何均具有活性，我們正在探索 TORI-114 與化療在一線 ESCC 中的聯合應用。

Concurrently, we're also pursuing second-line esophageal squamous cell with the TORI-114 combination as a fast-to-market strategy as the current standard of care constitutes a large area of unmet medical need. Both cohorts are active and ongoing in the US and Asia Pacific sites, and we anticipate safety and efficacy results over the course of next year.

同時，我們也正在推行 TORI-114 組合療法治療二線食道鱗狀細胞癌的快速上市策略，因為目前的標準治療方案仍有很大未滿足的醫療需求。這兩個研究隊列均在美國和亞太地區積極進行並持續進行，我們預計明年將獲得安全性和有效性結果。

Casdozokitug, our first-in-class IL-27 targeting antibody is progressing in our first-line hepatocellular carcinoma study. As a reminder, the current ongoing Phase 2 study is a 3-arm, 72-patient study exploring two biologically active doses of casdozo in combination with toripalimab and bevacizumab compared toripalimab, which, in addition to generating further efficacy and safety data, aims to address FDA's Project Optimus dose optimization requirement whilst at the same time, addressing contribution of components as we move through the development pathway.

Casdozokitug 是我們一流的 IL-27 標靶抗體，正在我們的第一線肝細胞癌研究中取得進展。提醒一下，目前正在進行的 2 期研究是一項 3 組、72 名患者的研究，探索兩種生物活性劑量的 casdozo 與特瑞普利單抗和貝伐單抗的組合與特瑞普利單抗的比較，除了生成進一步的功效和安全性數據外，還旨在滿足 FDA 的 Project Optimus 劑量優化要求，同時解決我們在開發路徑中移動時的成分。

As a reminder, this ongoing study builds upon the very encouraging data presented at ASCO GI in January this year, demonstrating a 38% overall response rate and a 17% complete response rate with the addition of casdozo to the current standard of care atezo and bev, where historically, the overall response rate has been around 30% and the complete response rate around [80%]. In our study, we've shown a deepening of responses over time and responses irrespective of viral or non-viral etiology.

需要提醒的是，這項正在進行的研究建立在今年 1 月 ASCO GI 上公佈的非常令人鼓舞的數據基礎之上，該數據表明，在目前的標準治療方案阿特唑和貝伐單抗的基礎上添加卡多唑，總體反應率為 38%，完全反應率為 17%，而歷史上，總體反應率約為 30%，完全反應率約為 30%，完全反應率約為 30%，完全反應率約為 30%，完全反應率約為 30%，完全反應率約為 30%，完全反應率約為 30%[80%]。在我們的研究中，我們發現反應會隨著時間的推移而加深，並且與病毒或非病毒病因無關。

This trial is currently active and ongoing in the US and the Asia Pacific region, and we anticipate safety and efficacy data in the first half of '26 as previously communicated. Finally, building upon the monotherapy activity previously demonstrated in late-line non-small cell lung cancer with squamous histology, casdozo is also under development in squamous non-small cell. With a randomized Phase 2 study sponsored by Prominent investigational group currently in the planning stages and expected to commence next year. With that, I will hand things over to Sameer. Sameer?

該試驗目前正在美國和亞太地區進行，我們預計將在 26 年上半年獲得安全性和有效性數據，正如之前所傳達的那樣。最後，基於先前在鱗狀組織學晚期非小細胞肺癌中證實的單一療法活性，casdozo 也在鱗狀非小細胞肺癌中處於開發階段。由著名研究小組贊助的隨機 2 期研究目前正處於規劃階段，預計明年開始。說完這些，我就會把事情交給薩米爾。薩米爾？

Thank you, Rosh. Q2 marked the first quarter when we operated as a dedicated innovative oncology company. This enabled us to maintain a singular focus on educating physicians on LOQTORZI as a differentiated and highly efficacious PD-1 for NPC patients.

謝謝你，羅什。第二季是我們作為一家專注於創新的腫瘤學公司運作的第一個季度。這使我們能夠專注於教育醫生了解 LOQTORZI 作為針對 NPC 患者的差異化、高效 PD-1。

Our goal is to establish LOQTORZI as the standard of care and preferred regimen for all eligible NPC patients. We are happy to report strong progress towards that goal. Net revenue in Q2 was $10 million, a 36% increase quarter-over-quarter and a 65% increase year-over-year.

我們的目標是將 LOQTORZI 確立為所有符合條件的 NPC 患者的治療標準和首選方案。我們很高興地報告，我們在實現這一目標方面取得了巨大進展。第二季淨收入為 1,000 萬美元，季增 36%，年增 65%。

Q2 performance was driven primarily by strong demand from new patients and some positive impact from wholesaler inventory rebuild following a drawdown in Q1. Our execution in Q2 was driven by a LOQTORZI-only sales force supplemented by robust digital marketing efforts. We were focused on educating physicians on the updated NCCN guidelines, and we are pleased with the reactions that we have seen.

第二季度的業績主要受到新患者的強勁需求以及批發商庫存在第一季減少之後重建的一些積極影響的推動。我們在第二季的執行是由 LOQTORZI 獨家銷售團隊以及強大的數位行銷努力推動的。我們致力於向醫生普及最新的 NCCN 指南，我們對所看到的反應感到滿意。

Over 90% of the 33 NCCN institutions have now used LOQTORZI in their NPC patients. The number of new purchasing accounts has grown by 20%, an indicator of the increasing breadth of use. And we saw a 22% increase in accounts using LOQTORZI in a subsequent patient after initial trial, indicating greater depth of use.

目前，33 家 NCCN 機構中超過 90% 已在其 NPC 患者中使用 LOQTORZI。新採購帳戶數量增加了20%，使用範圍不斷擴大。我們發現，在初次試驗後，後續患者使用 LOQTORZI 的帳戶增加了 22%，這表明使用深度有所提高。

Among academic KOLs and head and neck specialists, we have seen a significant move towards adopting LOQTORZI in both the first-line and the second-line plus setting. This adoption comes at the expense of off-label IOs and chemo-only use, both of which are nonpreferred in the updated NCCN guidelines.

在學術 KOL 和頭頸部專家中，我們看到在一線和二線以上環境中採用 LOQTORZI 的趨勢顯著。這種採用是以犧牲未列入說明書的IOs和僅使用化療為代價的，而這兩者都不是更新後的NCCN指南中的首選。

Feedback from KOLs have been very positive, and we hear a strong preference for the brand over nonpreferred regimens. While we are pleased with the results of our promotional efforts, significant growth opportunity remains primarily in the community setting.

來自關鍵意見領袖 (KOL) 的回饋非常積極，我們聽到了人們對該品牌的強烈偏好，而不是非首選方案。雖然我們對推廣工作的成果感到滿意，但巨大的成長機會仍然主要存在於社區環境中。

Over half of the addressable patients are managed in this segment, but adoption is generally slower in community oncology than in the academic centers. There are more than 3 times as many target community oncologists versus academic HCPs, but these physicians typically see a much smaller number of NPC patients each year.

超過一半的可尋址患者在此領域進行管理，但社區腫瘤科的採用速度通常比學術中心慢。目標社區腫瘤科醫生的數量是學術型 HCP 的 3 倍多，但這些醫生每年接診的鼻咽癌患者數量通常要少得多。

As a result, advances in NPC treatment and NCCN guidelines are not top of mind for these physicians. So in second half 2025, we are using a combination of sales force, digital and data to unlock the community opportunity. First, we are launching a refreshed messaging platform this month that clearly articulates our strong efficacy and superiority versus chemo only.

因此，NPC 治療的進展和 NCCN 指南並不是這些醫生最關心的問題。因此，在 2025 年下半年，我們將結合銷售力量、數字和數據來釋放社區機會。首先，本月我們將推出一個更新的訊息平台，清楚地表達我們相對於單純化療的強大功效和優勢。

Second, we're developing highly engaging KOL-driven digital content to help educate community oncologists. And third, we are doubling down on our investment in real-time data to drive intelligent targeting of HCPs and patients at the time of diagnosis.

其次，我們正在開發極具吸引力的 KOL 驅動的數位內容，以幫助教育社區腫瘤學家。第三，我們正在加倍投資即時數據，以推動診斷時對 HCP 和患者的智慧定位。

With our strong focus on commercial execution, we expect that LOQTORZI revenue will follow typical rare disease dynamics with a steady ramp fueled by new patient acquisition and broad adoption in the community setting.

由於我們高度重視商業執行，我們預計 LOQTORZI 的收入將遵循典型的罕見疾病動態，並隨著新患者的獲得和社區環境中的廣泛採用而穩步增長。

I'd like to end this section by saying that we remain on track to achieve our 2025 revenue goals of between $40 million and $50 million and to achieve a dominant share in the NPC market, which is estimated to be in the range of $150 million to $200 million. While LOQTORZI will fuel our near-term growth, we are excited about the impressive commercial potential of our two pipeline assets.

最後，我想說，我們仍有望實現 2025 年 4,000 萬美元至 5,000 萬美元之間的收入目標，並在 NPC 市場中佔據主導地位，預計市場份額在 1.5 億美元至 2 億美元之間。雖然 LOQTORZI 將推動我們的近期成長，但我們對兩條管道資產的巨大商業潛力感到興奮。

A key point I want to note at this point is that all of our clinical trials for both CHS-114 and Casdozo are paired with LOQTORZI. As a result, each new indication approval would represent a label expansion for LOQTORZI, and we would realize revenues from both the novel agent and LOQTORZI.

此時我想指出的一點是，我們針對 CHS-114 和 Casdozo 的所有臨床試驗都與 LOQTORZI 配對。因此，每項新適應症的批准都代表著 LOQTORZI 的標籤擴展，我們將從新藥和 LOQTORZI 中獲得收入。

Through our LOQTROZI commercialization efforts, we continue to build a best-in-class oncology organization with proven launch capabilities. At the time of potential approval of our pipeline indications, we will be well positioned to benefit from this commercial expertise as well as our relationships across the oncology community.

透過我們的 LOQTROZI 商業化努力，我們將繼續打造具有成熟上市能力的一流腫瘤學組織。當我們的管線適應症可能獲得批准時，我們將能夠從這種商業專業知識以及我們與腫瘤學界的關係中受益。

For casdozo, HCC represents a US market opportunity of about $4 billion and the potential for significant improvement in patient care. If the data readouts continue to be positive for casdozo, the commercial organization will be well positioned to support the potential for a new standard of care for patients in this area of high unmet medical need.

對 casdozo 而言，HCC 代表著約 40 億美元的美國市場機遇，以及顯著改善病患照護的潛力。如果 casdozo 的數據讀數繼續呈陽性，那麼該商業組織將能夠為這一醫療需求尚未滿足的領域的患者提供新的護理標準。

For CHS-114, as Denny mentioned, we believe we may have a best-in-class non-partnered US asset. Second-line head and neck cancer for this molecule is a market of about $4.5 billion, while second-line gastric cancer represents $3.5 billion and esophageal cancer comes in at just under $1 billion. In isolation, any of these potential indications for our pipeline assets represent a significantly large US commercial opportunity.

對於 CHS-114，正如丹尼所提到的，我們相信我們可能擁有一流的非合作美國資產。該分子在二線頭頸癌治療的市場規模約為 45 億美元，在二線胃癌治療的市場規模為 35 億美元，在食道癌治療的市場規模略低於 10 億美元。單獨來看，我們的管道資產的任何這些潛在跡像都代表著美國巨大的商業機會。

With the potential for multiple indications compounded by incremental ex US markets, we are very excited about our innovative immuno-oncology portfolio. While we remain in the near term focused on maximizing the NPC indication, our commercial organization stands ready to support the next phase of our growth in the coming years.

由於多種適應症的潛力以及美國以外市場的增量，我們對創新的免疫腫瘤學產品組合感到非常興奮。雖然我們近期仍將重點放在最大限度地發揮 NPC 的適應症，但我們的商業組織已準備好在未來幾年支持我們下一階段的成長。

With that, I'll now pass the call to our CFO, Bryan McMichael.

說完這些，我現在將電話轉給我們的財務長布萊恩麥克邁克爾 (Bryan McMichael)。

Thank you, Sameer, and good afternoon, everyone. Today, I will limit my discussion to key financial updates and refer you to our earnings press release for the second quarter and year-to-date 2025 figures and detailed results.

謝謝你，薩米爾，大家下午好。今天，我將把討論限制在關鍵的財務更新上，並請您參閱我們關於第二季度和 2025 年年初至今的收益新聞稿以及詳細結果。

I'm happy to report that Coherus has made strong progress on its operational and financial transition, fully consistent with our plans outlined in last quarter's call. Following the close of the divestiture in April, we used a portion of the $483 million in upfront cash proceeds to complete the payoff of substantially all the $230 million convertible notes as well as buy down the UDENYCA royalty obligation.

我很高興地報告，Coherus 在營運和財務轉型方面取得了重大進展，與我們在上個季度電話會議上概述的計劃完全一致。在四月份資產剝離結束後，我們使用了 4.83 億美元預付現金收益的一部分，完成了 2.3 億美元可轉換票據的絕大部分償還，並買下了 UDENYCA 的特許權使用費義務。

We ended Q2 with $238 million in cash and investments, and we project sufficient cash to provide runway through 2026 beyond key data readouts. Cash burn continues to moderate as per plan quarter-to-quarter in 2025 as we wind down the transition service agreement activities associated with the divestiture and settle pre-close remaining liabilities. The majority of the $97 million in accrued rebates, fees and reserves of the balance sheet, down from $148 million last year, will be settled over the coming quarters through 2025 and 2026.

我們在第二季結束時擁有 2.38 億美元的現金和投資，我們預計除了關鍵數據讀數之外，我們還有足夠的現金為 2026 年提供跑道。隨著我們逐步結束與資產剝離相關的過渡服務協議活動並清償交易前剩餘債務，2025 年現金消耗將繼續按計劃逐季度減緩。資產負債表中累積回扣、費用和儲備金為 9,700 萬美元，低於去年的 1.48 億美元，大部分將在未來幾季（2025 年和 2026 年）結算。

I'm also pleased to report in Q2, we achieved additional progress on our managing of our cost and cost structure and expenditures. We now expect to save approximately $30 million on an annualized basis from Q2 headcount reductions, up from $25 million communicated in Q1. This includes the employees transitioned in the divestiture and other reductions initiated during Q2.

我也很高興地報告，在第二季度，我們在成本、成本結構和支出管理方面取得了進一步的進展。我們現在預計，第二季裁員將節省約 3,000 萬美元的年度成本，高於第一季的 2,500 萬美元。其中包括在第二季度剝離和啟動的其他裁員中過渡的員工。

We remain on track per plan to be at 150 FTEs or less by year-end, which will yield an additional approximate $5 million in annualized savings over the Q1 guidance. Existing the legacy business has allowed us to simplify our operations and reduce operating costs, particularly as they relate to supply chain and commercial activities.

我們仍按計劃在年底前將全職員工人數控制在 150 人或以下，這將比第一季的指導金額額外帶來約 500 萬美元的年度節省。現有的傳統業務使我們能夠簡化營運並降低營運成本，特別是與供應鏈和商業活動相關的成本。

Net of non-reimbursed transition service costs, SG&A incurred solely for Coherus programs and expenses for the full year 2025 is projected to be between $90 million and $100 million. R&D expenses will be a function of data readouts in our ongoing portfolio prioritization process, and we'll be able to provide more detail on that later in the year.

在扣除未報銷的過渡服務成本後，預計 2025 年全年僅為 Coherus 項目和費用產生的銷售、一般和行政費用 (SG&A) 將在 9,000 萬美元至 1 億美元之間。研發費用將取決於我們正在進行的投資組合優先排序過程中的數據讀數，我們將在今年稍後提供更多詳細資訊。

With that, I'll hand it over to Denny.

說完這些，我就把它交給丹尼。

Thank you, Bryan. Let me close with a few key points that reflect the strength of our company, our focus on our drugs, our data and our deals with effective execution making it happen. The science behind our drugs is first rate, next-generation, first-in-class and arguably best-in-class, addressing very large markets. Our data, our science is already and continues to translate strong clinical data, step change survival benefit to patients.

謝謝你，布萊恩。最後，我想談幾個關鍵點，它們反映了我們公司的實力、我們對藥品的關注、我們的數據以及我們透過有效執行實現的目標。我們的藥物所採用的科學是一流的、新一代的、同類首創的、甚至可以說是同類最佳的，可以滿足非常大的市場需求。我們的數據、我們的科學已經並將繼續轉化為強有力的臨床數據，為患者帶來顯著的生存益處。

Strong clinical execution is keeping us on track to turn over key data cards in the first half of next year, meeting your expectations. And then there's our deals. Excellent deal execution defined our strategic transformation into a focused innovative oncology company, and it will now unlock significant pipeline value through ex US licensing deals, which will do three things over the next 6, 12 and 18 months.

強大的臨床執行力使我們能夠在明年上半年交付關鍵數據卡，滿足您的期望。然後就是我們的交易。出色的交易執行定義了我們向專注於創新的腫瘤學公司的策略轉型，現在它將透過美國以外的許可交易釋放巨大的管道價值，這將在未來 6、12 和 18 個月內完成三件事。

First, validate our science and our products; secondly, monetize our global rights with upfront; and third, offset our global development cost for the future. And in the US, we will seek collaborations that expand our labels cost efficiently through combinations with development partners. Strong execution across all three of these dimensions will deliver value to shareholders and is enabled by world-class advisers and Board members working integrally with our team.

首先，驗證我們的科學和產品；其次，透過預付款將我們的全球權利貨幣化；第三，抵消我們未來的全球開發成本。在美國，我們將尋求與開發夥伴的合作，以經濟高效的方式擴大我們的品牌。在這三個維度上的強有力執行將為股東帶來價值，並且得益於世界一流的顧問和董事會成員與我們團隊的緊密合作。

We expect our strong balance sheet to support operations through '26, well beyond our key clinical catalysts.

我們預計強勁的資產負債表將支持我們到26年的運營，遠遠超出我們的主要臨床催化劑。

Operator, we're happy now for you to open the line for questions.

接線員，我們很高興您現在可以開通熱線來回答問題。

(Operator Instructions)

（操作員指示）

Brian Cheng, JPMorgan.

摩根大通的 Brian Cheng。

Hey guys, thanks for taking our question this afternoon. Maybe let's start off with the pipeline. As you think through your CCRA program, your 114 program in your overall approach in the near term, can you just talk about how important it is to identify a partner to perhaps regional partners to accelerate some of the progress that you have made in the near term? And if there is interest in that, when do you think it will be a good time to look for a partner here? Thanks. And then I have a follow-up.

嘿夥計們，感謝您今天下午回答我們的問題。也許我們可以從管道開始。當您考慮您的 CCRA 計劃、您的 114 計劃以及您近期的整體方針時，您能否談談確定合作夥伴（也許是區域合作夥伴）對於加速您近期取得的一些進展有多麼重要？如果對此有興趣，您認為什麼時候是在這裡尋找合作夥伴的最佳時機？謝謝。然後我有一個後續問題。

Yeah. Thanks, Brian, for that. First of all, Rosh, do you want to recap for us when we will see the data cards turned over for 114?

是的。謝謝 Brian。首先，Rosh，你能為我們回顧一下我們什麼時候會看到翻開 114 張數據卡嗎？

Yes, absolutely. Thanks, Brian, for the question. So we will -- for both molecules, actually, we anticipate seeing both efficacy and safety data in the first half of next year. But specifically for CHS-114 for our head and neck program, we -- again, we will see efficacy and safety data in the first half of the year, building, of course, on the data sets that I've -- the very encouraging data sets actually that I've previously communicated. For gastric and esophageal for 114, we anticipate safety in the first half of the year and then efficacy in the second half of the year.

是的，絕對是。謝謝 Brian 提出的問題。因此，實際上，對於這兩種分子，我們預計將在明年上半年看到療效和安全性數據。但具體到我們頭頸部項目的 CHS-114，我們將在今年上半年看到療效和安全性數據，當然，這些數據是基於我之前傳達的非常令人鼓舞的數據集。對於114種胃癌和食道癌，我們預期上半年可檢驗安全性，下半年可檢驗療效。

Thanks. So Brian, we're funded through those studies with the product. But as I indicated in my prepared remarks, we expect partners to work collaboratively with us and help us offset these development costs. And I think the issue of the timing really strikes also to the development of others. Theresa, do you want to add a comment?

謝謝。布萊恩，我們透過對該產品的研究獲得了資金。但正如我在準備好的演講中所指出的，我們希望合作夥伴與我們合作，幫助我們抵消這些開發成本。我認為時機問題也確實對其他人的發展產生影響。特蕾莎，你想添加評論嗎？

Yeah. Thanks, Brian. I think there's a couple of key data sets as we look as we -- Rosh outlined that we'll be getting to a recommended Phase 2 dose. So that simplifies the development and I think makes it more attractive for partners in other regional areas. Additionally, what we showed at AACR and besides just Treg depletion and clinical response, we showed a marked infiltration of CD8 T cells, which really has caught the attention of several folks because that clearly lends itself to combinations with other modalities outside of toripalimab, such as T cell engagers.

是的。謝謝，布萊恩。我認為，正如我們所看到的，有幾個關鍵數據集——羅什概述了我們將達到建議的第二階段劑量。因此，這簡化了開發過程，並且我認為它對其他地區的合作夥伴更有吸引力。此外，我們在 AACR 上展示的結果，除了 Treg 耗竭和臨床反應之外，還顯示了明顯的 CD8 T 細胞浸潤，這確實引起了一些人的注意，因為這顯然適合與特瑞普利單抗以外的其他方式相結合，例如 T 細胞接合劑。

And so I think what we're having is active conversations with people to look for the right partner, both to test other tumor types as well as other combinations and then folks that are prioritized are tumor types where we expect to see efficacy and look at other regions. So all of those conversations are ongoing, but I think it will be really important for us to find a partner that can run with us and not complicate the speed at which we want to move this program.

因此，我認為我們正在與人們積極對話，尋找合適的合作夥伴，既要測試其他腫瘤類型，也要測試其他組合，然後優先考慮那些我們期望看到療效的腫瘤類型，並關注其他區域。所以所有這些對話都在進行中，但我認為對我們來說，找到一個可以與我們一起運行並且不會影響我們推進該計劃的速度的合作夥伴非常重要。

And I would add two other points for you, Brian. First of all, the CCR8 Treg depleter class is under vigorous development, as you know, globally. And there are data sets being put forward at various meetings. And we would expect that, and we would expect those data sets sometime over the next 6 to 12 months, say, to accelerate. We think 2026 will be the year that CCREs come to the fore.

布萊恩，我還想為你補充另外兩點。首先，如您所知，CCR8 Treg 耗竭類在全球正處於蓬勃發展之中。各種會議上都有數據集被提出。我們預計，我們預計這些數據集在未來 6 到 12 個月內會加速成長。我們認為 2026 年將是 CCRE 脫穎而出的一年。

The second point, as Theresa indicated, is that we're very open-minded with respect to combining our CCR8 with others drugs. we're not constraining ourselves just to our own portfolio. We think there's broad applicability for the mechanism of action here, and we intend to take advantage of that.

第二點，正如 Theresa 所指出的，我們對將 CCR8 與其他藥物結合持非常開放的態度。我們不會將自己僅限於自己的產品組合。我們認為這裡的作用機制具有廣泛的適用性，我們打算利用這一點。

Great. And then maybe just one quick one on LOQTORZI. Just based on the trajectory and also some of the dynamics you're hearing from doctors, how confident are you on your path towards the $150 million to $200 million goal for the franchise? Are there any indicators that you're now seeing that get -- that gets you confident in yourself moving towards that goal? Thanks.

偉大的。然後也許我們再快速談談 LOQTORZI。僅根據發展軌跡以及您從醫生那裡聽到的一些動態，您對該系列電影實現 1.5 億至 2 億美元的目標有多大信心？現在您看到的哪些指標讓您對自己朝著這個目標前進充滿信心？謝謝。

Thanks, Brian. Sameer, do you want to handle that?

謝謝，布萊恩。Sameer，你想處理這個嗎？

Yes. Thank you, Brian. First of all, let me just kind of answer that. So we feel pretty confident. We expect that we'll get to peak revenues by 2028. And just one piece of anecdotal evidence that gives us confidence. After the NCCN guidelines were updated, we saw a pretty strong uptake in the academic setting in the hospitals and the head and neck specialists. They're the ones who are waiting for the guidelines updates. And once the guidelines got updated, we communicated the data to them. They really jumped on the bandwagon.

是的。謝謝你，布萊恩。首先，讓我來回答這個問題。所以我們非常有信心。我們預計到 2028 年我們的收入將達到高峰。光是一個軼事證據就給了我們信心。NCCN 指南更新後，我們看到醫院學術環境和頭頸部專家的接受度相當高。他們正在等待指南更新。一旦指南更新，我們就會將數據傳達給他們。他們確實加入了這股潮流。

So what we need to do now is do the same thing and educate the community on our data sets. So we feel pretty confident, Brian.

所以我們現在需要做的是做同樣的事情並向社群宣傳我們的資料集。所以我們感到非常有信心，布萊恩。

Thanks Brian.

謝謝布萊恩。

Michael Nedelcovych, TD Cowen.

邁克爾·內德爾科維奇，TD·考恩。

Hi, thank you for the question. I have two. My first question is on the anti-CCR8 program. You mentioned competitor readouts that could serve as sort of stocking horses for your molecule. Are you aware of any as you survey the competitive landscape that would -- that you would consider proof of concept for the mechanism, so perhaps a randomized trial? That's my first question.

你好，謝謝你的提問。我有兩個。我的第一個問題是關於抗 CCR8 計劃的。您提到了競爭對手的讀數，它可以作為您分子的儲備馬。您在調查競爭格局時是否意識到—您會考慮對該機制進行概念驗證，也許是進行隨機試驗？這是我的第一個問題。

And then my second question is actually on the competitive landscape for your anti-IL-27. I know you have the potential here to be first-in-class. Have you seen any follow-on molecule -- any follow-on programs from competitors? Are there other anti-IL-27 molecules in development that perhaps we don't know about?

我的第二個問題其實是關於抗 IL-27 的競爭格局。我知道你有潛力成為一流的人才。您是否看到任何後續分子—任何來自競爭對手的後續計劃？是否還有其他我們可能不知道的抗 IL-27 分子正在開發中？

Thank you, Michael. Thoughtful and very pertinent questions. Theresa, do you want to address the competitive profile, both on the two molecules, CCR8 and casdozo?

謝謝你，麥可。深思熟慮且非常中肯的問題。特蕾莎，您想談談 CCR8 和 casdozo 這兩種分子的競爭情況嗎？

Yeah. I'll start with the second line first for casdozokitug. We are not aware of anyone else going into clinical development with an IL-27 antagonist. And we have garnered a lot of interest from partners with the HCC CR rate to continue those discussions. For the CCR8, what I find compelling is every time we see a data card turned over, we're seeing efficacy.

是的。我將首先從 casdozokitug 的第二行開始。我們不知道是否有其他人正在使用 IL-27 拮抗劑進行臨床開發。並且我們已經獲得了大量合作夥伴對 HCC CR 率繼續進行討論的興趣。對於 CCR8，我發現引人注目的是，每當我們看到翻轉的數據卡時，我們都會看到功效。

We saw at ASCO this year that (inaudible) presented data in pancreatic cancer showing a 22% overall response rate, I believe, in combination with toripalimab, which is quite impressive in refractory pancreatic cancer. Additionally, (inaudible) with their IgG1 wild-type antibody, so a less potent molecule than ours, showed a complete response and a PR in colorectal cancer, a tumor type that really MSS colorectal cancer has been underserved.

我們在今年的 ASCO 上看到 (聽不清楚) 展示的胰臟癌數據顯示，與特瑞普利單抗聯合使用時，整體反應率為 22%，這對於難治性胰臟癌來說相當令人印象深刻。此外，（聽不清楚）他們的 IgG1 野生型抗體（因此比我們的抗體效力更低的分子）在結直腸癌中表現出完全緩解和 PR，而結直腸癌是一種真正未充分治療的腫瘤類型。

So as we see each data readout come, it's looking quite interesting. The only randomized study that has been reported publicly is [Lenova] advancing in MSI-high colorectal cancer. So we actively (inaudible) clinicaltrials.gov and the reporting of these molecules as we've heard a lot of buzz in the community and expect to see updates in the next year from other folks as well as our own programs.

因此，當我們看到每個數據讀數時，它看起來非常有趣。唯一公開報導的隨機研究是[聯想]在 MSI 高結腸直腸癌方面取得進展。因此，我們積極（聽不清楚）clinicaltrials.gov 和這些分子的報告，因為我們聽到了社區中的許多嗡嗡聲，並期望在明年看到其他人以及我們自己的專案的更新。

Yes. I just dovetail on Theresa's remarks, Michael, there is, of course, robust development activity across a number of big pharmas. No one's talking very much right now. But we suspect over the next 6 or 12 months, there's going to be quite a bit of data come to the fore, certainly maybe next year by ASCO.

是的。邁克爾，我完全同意特蕾莎的言論，當然，許多大型製藥公司都在大力進行開發活動。現在沒人說話。但我們懷疑，在未來 6 到 12 個月內，將會有相當多的數據浮出水面，也許明年 ASCO 就會公佈這些數據。

Okay, thank you so much.

好的，非常感謝。

Colleen Kusy, Baird.

科琳·庫西，貝爾德。

Great, good afternoon. Thanks for taking our questions. A few from us. You spoke about on the commercial side, making some investments into the community that's largely untapped right now. Can you just walk us through those? And when you expect those might bear out into the sales trajectory? And then I have a couple of follow-ups, please.

太好了，下午好。感謝您回答我們的問題。我們中的一些人。您談到了商業方面，對目前尚未開發的社區進行一些投資。能簡單介紹一下這些嗎？您預計這些因素何時會影響銷售軌跡？然後我還有一些後續問題。

Sameer, do you want to handle that?

Sameer，你想處理這個嗎？

Yes. Thank you, Colleen. So the community -- one of the dynamics of the community is that there's -- we have to target at least 3 times as many physicians in the community as the academic setting. And the number of patients in the community is very dispersed. So each physician sees maybe one or two patients a year.

是的。謝謝你，科琳。因此，社區——社區的動態之一是——我們必須將社區中的醫生數量設定為學術環境中的至少三倍。而且社區內患者人數非常分散。因此，每位醫生每年可能只看一到兩名病人。

So -- but at the same time, we can't ignore the community because half the patients are in the community. So what's going to happen is we're focusing -- now refocusing our efforts on the community, both from the sales force standpoint, digital standpoint.

所以——但同時，我們不能忽視社區，因為一半的患者都在社區中。因此，我們將把重點重新放在社區上，包括從銷售團隊的角度和數位角度。

And we're also purchasing a lot of data to identify the physicians with the patients at the time of diagnosis. So that whole multipronged approach is underway. But I think because of those dynamics, the time for us to really get to peak sale is going to be about those three to four years because making a difference in the community is going to be an ongoing process.

我們還購買了大量數據，以便在診斷時識別與患者在一起的醫生。因此，整個多管齊下的措施正在進行中。但我認為，由於這些動態，我們真正達到銷售高峰的時間將是大約三到四年，因為為社區做出貢獻將是一個持續的過程。

Great, that's helpful. Thank you.

太好了，很有幫助。謝謝。

Do you have a follow-on question, Colleen?

科琳，你還有其他問題嗎？

Yeah. I know historically, you -- and you spoke to, you out-licensed LOQTORZI in a capital-efficient way to potentially expand the indications there. Is there anything on the horizon from any partners we should be aware of in terms of potential data readouts? And then on the strategy, what sort of deals do you think you'd prioritize for LOQTORZI licensing in the future?

是的。我知道，從歷史上看，您——並且您說過，您以資本高效的方式獲得了 LOQTORZI 的許可，以便有可能擴大那裡的適應症。就潛在資料讀取而言，我們是否應該了解合作夥伴即將推出的任何新措施？那麼在策略上，您認為未來您會優先考慮哪些類型的 LOQTORZI 授權交易？

I'll handle the first one, and I'll let Theresa handle the second one. To be clear, we have not out-licensed LOQTORZI. What we have done is we have entered into collaborative strategic arrangements whereby we supply LOQTORZI for other clinical trials.

我來處理第一個，然後讓 Theresa 處理第二個。需要明確的是，我們並沒有獲得 LOQTORZI 的授權。我們所做的是，我們已經達成了合作策略協議，根據該協議，我們為其他臨床試驗提供 LOQTORZI。

The strategy being that as they develop those products, we will eventually get a label that we can promote against. And we do that, we just -- the only cost to us really is just supply of the drug, which is not very significant. So this is very cost effective.

我們的策略是，隨著他們開發這些產品，我們最終將獲得一個可以推廣的標籤。我們這樣做，我們唯一的成本實際上就是藥品供應，這並不算多。所以這是非常划算的。

Yes. On the last call, we talked about STORM Therapeutics having those study ongoing and enrolling in both head and neck cancer and lung cancer, two tumor types that complement the data sets we have in hand for tori. I mean, I can't speak for how they would disclose data, but knowing that team, I would anticipate some update next year. The other studies are on track to start. And additionally, we would look towards more announcements later this year.

是的。在上次電話會議上，我們談到了 STORM Therapeutics 正在進行的研究，並招募了頭頸癌和肺癌患者，這兩種腫瘤類型補充了我們掌握的 tori 數據集。我的意思是，我無法說出他們將如何披露數據，但了解那個團隊後，我預計明年會有一些更新。其餘研究也正按計畫啟動。此外，我們期待今年稍後發布更多公告。

We're now only announcing them when first patient is dosed. So we don't have to wait a long time for data. So hopefully, next year, we'll see some data readouts.

我們現在只在第一位患者服藥時才宣布這項消息。所以我們不必等待很長時間才能獲得數據。所以希望明年我們能看到一些數據讀數。

The other point I would make pursuant to your question is a point though that Theresa makes frequently is that if you are a company developing a new therapeutic, you want to make sure that you have a highly active next-generation PD-1. We're not constrained to using the standard of care, which will go biosimilar in a few years in 2020 or whatever. So the interest that we have had in terms of partnering and co-development, I think, is driven from that is LOQTORZI's outstanding efficacy and safety profile.

根據您的問題，我想提出的另一點也是 Theresa 經常提出的觀點，那就是如果您是一家開發新療法的公司，那麼您就希望確保您擁有高度活躍的下一代 PD-1。我們並不局限於使用標準治療，該治療將在 2020 年或以後幾年內實現生物相似藥。因此，我認為，我們在合作和共同開發方面的興趣源於 LOQTORZI 出色的功效和安全性。

Great. That's really helpful. And then last one for us. Just on the randomized Phase 2 for casdozo, tori, bev in frontline HCC. Can you just comment on how enrollment is going there?

偉大的。這真的很有幫助。這是我們的最後一個。剛進入 casdozo、tori、bev 在一線 HCC 治療中的隨機第 2 階段。您能評論一下那裡的招生情況嗎？

Rosh, how is enrollment going?

Rosh，招生進行得怎麼樣？

Yes. Thanks for the question, Colleen. So yeah, so recruitment is going well. We are recruiting in the US and in the Far East. So these are active trials that, again, we're on track to report data for in the first half of next year, both for efficacy and safety.

是的。謝謝你的提問，科琳。是的，招募進展順利。我們正在美國和遠東地區招募。因此，這些都是積極的試驗，我們將在明年上半年報告其功效和安全性的數據。

Just recall, though, that with HCC in particular, responses can take a little bit of time to mature and become more kind of deeper as well, which is what we saw in our earlier trials. So bear that in mind as well, but we're on track with improvement.

不過，請記住，對於 HCC 來說，反應可能需要一點時間才能成熟並變得更深入，這正是我們在早期試驗中所看到的。所以也請記住這一點，但我們正在改進。

Great, thanks for taking our questions.

太好了，感謝您回答我們的問題。

Thanks, Colleen.

謝謝，科琳。

Li Chen, H.C. Wainwright.

李晨，H.C.溫賴特。

This is Li Chen for Dr. Doug Tsao. Thanks for taking our questions and congratulations on the quarter. So maybe to start with, I'm curious to know if you still follow the first-line HCC patients treated with the triplet of tori and bev. And if there's any insight into the durability there? Or maybe when should we expect those data to be presented? And then I have a follow-up.

我是李晨，代表Doug Tsao 博士。感謝您回答我們的問題，並祝賀本季取得的成績。因此，首先，我很好奇您是否仍關注使用 tori 和 bev 三合一療法治療的第一線 HCC 患者。對其耐用性有什麼見解嗎？或者我們應該什麼時候期待這些數據被呈現？然後我有一個後續問題。

So the data set that you referred to is with the atezo triplet data, and we did present the final data in January of this year at ASCO GI. And that was the data that I referred to in my prepared remarks with an overall response rate of 38%, a CR rate of 17%, which compares obviously favorably with current benchmarks. So that trial is the atezo trial. The trial that we report -- that's ongoing right now and that we will report out next year, early next year initial -- in terms of initial data is the toripalimab casdozo, bevacizumab triplet, right? So we've switched obviously to our own PD-1, and that's the patient study that I described.

因此，您提到的數據集是阿替洛芬三聯體數據，我們確實在今年 1 月的 ASCO GI 上展示了最終數據。這就是我在準備好的發言中提到的數據，整體回覆率為 38%，CR 率為 17%，與目前基準相比顯然更為有利。所以那項試驗就是阿替佐米試驗。我們報告的試驗 - 目前正在進行中，我們將在明年，也就是明年初報告初步數據 - 就初步數據而言，是特瑞普利單抗卡多佐和貝伐單抗三聯體，對嗎？因此，我們顯然已經轉向我們自己的 PD-1，這就是我所描述的患者研究。

I see. So I guess I'm asking for PFS and OS data from the initial triplet results. So it sounds like you don't plan to report.

我懂了。所以我想我要求的是初始三聯體結果中的 PFS 和 OS 資料。聽起來你不打算報告。

Yeah. So the data was reported in January. And in terms of durability, a couple of things I'll mention. Number one, there was a deepening of response over time and also obviously an increase in response rate. And secondly, for those responses, there was durability.

是的。因此，該數據是在一月份報告的。關於耐用性，我想提幾點。首先，隨著時間的推移，反應不斷加深，反應率也明顯提高。其次，這些回應具有持久性。

The majority of those responses were six months or more.

大多數回覆的時間間隔為六個月或更長時間。

But the PFS was reported at [8.9] -- so higher than the (technical difficulty) [150] and the OS data is still maturing.

但據報道，PFS 為 [8.9]，高於（技術難度）[150]，且 OS 資料仍在成熟中。

Great, thanks for the clarification. And my second question is regarding the next phase in the next phase of development in first-line SCC. How do you think about the comparator arms for the Phase 3? Do you think the data in first half '26 will be enough for decision-making?

太好了，謝謝你的澄清。我的第二個問題是關於第一線鱗狀細胞癌的下一階段發展。您如何看待第三階段的比較組？您認為 26 年上半年的數據足以做出決策嗎？

Well, I think we'll have -- so we'll have initial data in terms of efficacy and safety, as I've mentioned, in the first half of the year. But again, in HCC, it can take a little bit of time for the data to mature, meaning it can take a little bit of time for the data -- the full effect to be realized, right, in terms of depth of response.

嗯，我認為我們將會有——正如我所提到的，我們將在今年上半年獲得功效和安全性的初步數據。但是，在 HCC 中，資料可能需要一點時間才能成熟，這意味著資料可能需要一點時間才能達到全部效果，就反應深度而言。

So once we have that, the next stage will -- we anticipate will be a next stage trial, Phase 2, Phase 3 with -- compared to the current standard of care, the majority of -- in the majority of countries worldwide, the current standard of care is [atezo-bev].

因此，一旦我們有了這些，我們預計將進行下一階段的試驗，即第二階段、第三階段，與目前的治療標準相比，世界上大多數國家的治療標準是[atezo-bev]。

So that's what we anticipate will be the comparator. And again, some of those benchmarks that I mentioned earlier of 38% for us for overall response rate compared to 30% for atezo-bev and also 17% CR rate for our combination versus around 8% for the CR rate. That gives us confidence at this stage.

這就是我們預期的比較器。再次重申，我之前提到的一些基準是，我們的整體反應率為 38%，而阿替洛爾為 30%，我們的組合療法的 CR 率為 17%，而阿替洛爾的 CR 率約為 8%。這給了我們現階段的信心。

Right. Thanks again for the questions and con congratulations.

正確的。再次感謝您的提問並表示祝賀。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

So yeah, thanks for the question. So thinking longer term, given your extensive knowledge of biosimilars, do you foresee any risk of off-label competition when KEYTRUDA comes off patent and begins to face pricing pressure from biosimilars?

是的，謝謝你的提問。因此，從長遠來看，鑑於您對生物相似藥的廣泛了解，當 KEYTRUDA 專利到期並開始面臨來自生物相似藥的價格壓力時，您是否預見到任何標籤外競爭的風險？

Thank you for your question, Jason. I'll let Rosh take a look at that. Rosh?

謝謝你的提問，傑森。我會讓羅什看看這個。羅什？

So yeah, thanks for the question. So in NPC specifically, a few points I'll mention. First of all, I think it's very well appreciated that toripalimab is a differentiated PD-1 on its molecular characteristics as well as on some of its clinical characteristics as well.

是的，謝謝你的提問。因此，具體到 NPC，我會提到幾點。首先，我認為，特瑞普利單抗在分子特性和一些臨床特性上都是差異化的 PD-1。

For NPC specifically, we remain the only approved and available therapy within the US. So the approval is with us. Secondly, we have really the only positive data compared to pembro and nivo do not have positive data in NPC.

具體來說，對於 NPC 來說，我們仍然是美國境內唯一獲得批准並可用的治療方法。因此我們同意。其次，與 pembro 和 nivo 在 NPC 中沒有陽性數據相比，我們確實只有陽性數據。

And thirdly, we are the only preferred therapy on NCCN guidelines with first-line categorization for -- with essentially Category 1 designation in first-line specifically. So yes, we do not anticipate any effect from that perspective.

第三，我們是 NCCN 指南中唯一被列為一線治療的首選療法——基本上被指定為第一線治療中的 1 類。所以是的，從這個角度來看我們預計不會有任何影響。

I would say unequivocally none. There's a failed Phase 2 study. We are the only labeled PD-1. And I think that there is a good appreciation by physicians of the power of strong data, and our data is very, very strong for nasopharyngeal cancer.

我可以毫不含糊地說，沒有。第二階段研究失敗了。我們是唯一被標記為PD-1的。我認為醫生們非常重視強有力數據的力量，而我們的數據對於鼻咽癌來說非常非常有力。

And you have to remember that biosimilars only get the label for the reference product. So it would be --

您必須記住，生物相似藥只能獲得參考產品的標籤。所以它會--

They would not have a label.

他們沒有標籤。

Yes.

是的。

But thanks for the question.

但感謝您的提問。

Got it. Thanks.

知道了。謝謝。

Douglas Tsao, H.C. Wainwright.

Douglas Tsao、H.C. Wainwright。

Hi, good afternoon. Thanks for taking the questions. Can you hear me?

嗨，下午好。感謝您回答這些問題。你聽得到我嗎？

Yeah.

是的。

Yes, we hear you, Doug. Hey.

是的，我們聽到了，道格。嘿。

Hey, great, thanks for squeezing me in and I hope I didn't miss it. But I did want to ask about the impact of the guidelines. I think you touched on sort of the difference between the centers of excellence as well as in the community setting. And I'm just curious, are the guidelines sort of permeating or the impact of the guidelines permeating out into the community and it's just taking a little bit longer? Or is it really they are not necessarily following them as closely as what you're seeing in the major academic centers?

嘿，太好了，謝謝你擠時間給我，希望我沒有錯過。但我確實想問一下該指南的影響。我認為您談到了卓越中心和社區環境之間的差異。我只是好奇，這些指導方針是否已經滲透到社區中，或者說，這些指導方針的影響是否已經滲透到社區中，只是需要更長的時間？或者他們確實不一定像你在主要學術中心看到的那樣密切關注這些變化？

That's a good question on the guidelines. Sameer, can you just recap the guidelines for Doug just briefly and how we do it?

這是關於指導方針的一個好問題。Sameer，您能否簡單回顧一下 Doug 的指導方針以及我們是如何做到的？

Yes. I mean we're very excited about the guidelines. The guidelines put us in a category one preferred position, LOQTORZI plus chemotherapy. So we're the only ones in that preferred position. So after the guidelines were put in place, we did a lot of work with the hospital setting, KOLs and head and neck specialists, and we were able to really move the needle.

是的。我的意思是我們對這些指導方針感到非常興奮。指南將我們置於第一類優先地位，即LOQTORZI加化療。所以我們是唯一處於這優先地位的人。因此，在指導方針出台後，我們與醫院、KOL 和頭頸部專家做了很多工作，並且我們能夠真正取得進展。

And we've gotten a lot of hospital specialists and head and neck specialists using LOQTORZI because they're the ones who see a lot of patient, patient volume. The issue in the community is it's not so much that they don't follow the guidelines. They only see a very small number of patients every year, and they just go by what they remember from last time.

我們已經有很多醫院專家和頭頸專家使用 LOQTORZI，因為他們會診大量病患。社區中的問題並不是他們不遵守指導方針。他們每年只看很少一部分病人，而且只是根據上次的記憶來判斷。

And it takes a while for them to head and neck basically or nasopharyngeal carcinoma is not top of mind for them. So it's our job to keep detailing them and educating them until those guidelines get really established in their practice.

他們需要一段時間才能基本治癒頭頸部腫瘤，而鼻咽癌則不再是他們最關心的問題。因此，我們的工作就是不斷向他們詳細說明並教育他們，直到這些指導方針在他們的實踐中真正確立。

So it's going to be a process, but we're really focused on executing that process, and we believe that we will make an impact to the community as well.

所以這將是一個過程，但我們真正專注於執行這個過程，我們相信我們也會對社區產生影響。

Okay, great. Thank you so much and congrats on the progress.

好的，太好了。非常感謝，並祝賀你的進展。

Thanks, Doug.

謝謝，道格。

There are no questions. That concludes the Q&A session. I'll turn the call back over to Denny Lanfear for closing remarks.

沒有問題。問答環節到此結束。我將把電話轉回給丹尼·蘭菲爾 (Denny Lanfear) 做最後發言。

Thank you. Thank you all for joining us on our call. I think as you can see in today's call, we've really hit our stride with regards to the execution, both clinically and commercially and otherwise with the company. Strong balance sheet will keep us moving through next year while we turn over the data cards, and we look forward to seeing you guys at the Baird and the HCW conferences the second week of New York. Thank you.

謝謝。感謝大家參加我們的電話會議。我認為，正如您在今天的電話會議中所看到的，我們在執行方面確實取得了進展，無論是在臨床、商業還是公司的其他方面。強勁的資產負債表將使我們在明年繼續前進，同時我們也會交出數據卡，我們期待在紐約第二週的貝爾德和 HCW 會議上見到你們。謝謝。

This concludes today's conference 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。