Coherus Oncology Inc (CHRS) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good day, and thank you for standing by. Welcome to the Q1 2026 Coherus Oncology Inc earnings conference call.

    大家好,感謝您撥冗等候。歡迎參加 Coherus Oncology Inc 2026 年第一季(Q1 2026)財報電話會議。

  • (Operator Instructions)

    (接線員指示)

  • Please be advised that today's conference is being recorded.

    敬請注意,今天的會議將被錄音。

  • I would now like to hand the conference over to your speaker today, Carrie Graham. Please go ahead.

    現在我想把會議交給今天的發言人 Carrie Graham。請開始。

  • Carrie Graham - Vice President, Investor Relations and Advocacy

    Carrie Graham - Vice President, Investor Relations and Advocacy

  • Thank you, Heidi. Good afternoon, and welcome to Coherus Oncology's first quarter 2026 earnings conference call.

    謝謝你,Heidi。各位下午好,歡迎參加 Coherus Oncology 2026 年第一季財報電話會議。

  • Joining me today to discuss our results are Dennis Lanfear, Chief Executive Officer of Coherus; Dr. Rosh Dias, Chief Medical Officer; Dr. Theresa LaVallee, Chief Scientific and Development Officer; Sameer Goregaoker, Chief Commercial Officer; and Bryan McMichael, Chief Financial Officer.

    今天與我一同討論業績的有:Coherus 執行長 Dennis Lanfear;首席醫務長 Rosh Dias 醫師;首席科學與開發長 Theresa LaVallee 醫師;首席商務長 Sameer Goregaoker;以及財務長 Bryan McMichael。

  • 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 statements. Please see the press release that we issued today and our quarterly report on Form 10-Q for more information on risks and uncertainties.

    在開始之前,我想提醒各位,今天的電話會議包含前瞻性陳述,涉及 Coherus 對未來事件的目前預期。實際結果可能有重大差異,我們不承擔更新或修訂任何前瞻性陳述之義務。有關風險與不確定性的更多資訊,請參閱我們今天發布的新聞稿以及 Form 10-Q 季度報告。

  • And now I'll turn the call over to Denny.

    接下來我把電話交給 Denny。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Well, thank you, Carrie, and thank you all for joining us this afternoon on our Q1 2026 quarterly call.

    謝謝你,Carrie,也謝謝各位今天下午參加我們 2026 年第一季的季度電話會議。

  • Let me first give you a quick fly-by of the company's strategy to make sure we level-set everyone, including our new investors.

    我先快速概述一下公司的策略,確保大家(包括我們的新投資人)對齊認知。

  • That strategy starts with LOQTORZI, our next-generation differentiated PD-1 inhibitor which is both a revenue generator in the context of nasopharyngeal cancer and a revenue multiplier in the context of its combination with the novel molecules in our pipeline such as Casdozokitug, which we are exploring in liver cancer and Tagmokitug, which we are exploring across a number of cancer indications, including gastrointestinal, head and neck, and most recently, prostate cancer.

    這項策略始於 LOQTORZI——我們新一代、具差異化的 PD-1 抑制劑;它在鼻咽癌領域既是營收來源,同時在與我們研發管線中的新分子(例如 Casdozokitug,我們正在肝癌中探索;以及 Tagmokitug,我們正在多個癌症適應症中探索,包括腸胃道、頭頸部,以及最近的前列腺癌)聯合使用時,亦可成為營收倍增器。

  • We are executing a well-integrated financial, commercial, and development strategy that maximizes LOQTORZI's potential across both these dimensions while moving the pipeline forward efficiently. NPC is large enough to cover the core cash burn at a projected $175 million a year peak share, which does not include clinical trial costs, something which we view separately.

    我們正在執行一套高度整合的財務、商業與開發策略,在有效推進管線的同時,最大化 LOQTORZI 在這兩個面向的潛力。鼻咽癌(NPC)的市場規模足以在預估峰值市占下、以每年 1.75 億美元的水準覆蓋核心現金消耗(不包含臨床試驗成本;我們將其視為另一項獨立項目)。

  • Proprietary combinations of LOQTORZI with the pipeline asset translates to a two-for-one win. Label expansion for LOQTORZI included upon any approval. This will, of course, also translate to commercial synergies. This is how we can target $33 billion in market opportunity with our current efforts.

    將 LOQTORZI 與管線資產進行自有(專有)聯合用藥,等同於「一舉兩得」。任何獲批都將包含 LOQTORZI 的標籤擴增。這當然也會帶來商業協同效益。這就是我們如何以目前的努力鎖定 330 億美元的市場機會。

  • The third leg of the strategic triad is a Treg depletion with Tagmokitug across cancers and across non-proprietary combinations, which we view as a foundational Treg depletion platform and not merely another checkpoint adjunct. We further wish to explore Treg depletion as a potential new scaffold across cancer therapies.

    策略三角的第三個支柱,是以 Tagmokitug 在各類癌症以及非專有聯合療法中進行 Treg(調節性 T 細胞)耗竭;我們將其視為一個基礎性的 Treg 耗竭平台,而不僅僅是另一種檢查點療法的輔助。我們也希望進一步探索 Treg 耗竭,作為癌症治療中潛在的新骨架(scaffold)。

  • Tregs broadly mediate immune response, and cancer hijacks immune mediation to grow and proliferate. Many cancer therapies either result in or are limited by Tregs gone awry. Our strategic objective then is to broadly deploy Tagmokitug across cancers and non-proprietary therapies.

    Treg 在廣泛層面調控免疫反應,而癌症會挾持這種免疫調控以促進生長與增殖。許多癌症療法要麼會導致 Treg 失衡,要麼其療效會受失衡的 Treg 所限制。因此,我們的策略目標是將 Tagmokitug 廣泛部署於各類癌症以及非專有療法之中。

  • Last quarter, we concluded the first such arrangement with J&J in prostate with [Pasritamig], a T-cell engager. We are currently exploring other partnering opportunities, which include not just T-cell engagers, but ADCs, radiotherapy, and various bispecifics.

    上一季,我們與 J&J 在前列腺癌領域達成了第一項此類合作,搭配 [Pasritamig](一種 T 細胞接合器)。我們目前也在探索其他合作機會,不僅包括 T 細胞接合器,亦包括 ADC、放射治療,以及各種雙特異性抗體。

  • Now, as we have been saying for some time across all of our presentations, CCR8-based Treg depletion could be challenging for a lot of reasons. You need to have the right molecule and the right target. The right molecule translates to a number of things across, selectivity, affinity, pharmacology, and all the rest. And the right target translates to immune context and the nuances of the biology.

    如同我們一段時間以來在所有簡報中所提到的,以 CCR8 為基礎的 Treg 耗竭可能因多種原因而具挑戰性。你需要正確的分子與正確的標的。所謂正確的分子,涵蓋選擇性、親和力、藥理特性等多個面向。而正確的標的,則涉及免疫情境以及生物學上的細微差異。

  • Recently, it's become clear that the therapeutic promise of Treg depletion notwithstanding, some market participants are pausing or stopping the programs, while others are accelerating and expanding the programs. It's essential for all of us to understand the nuances playing out. Accordingly, I've asked my Chief Scientific Officer, Theresa LaVallee, to spend a few minutes with you today and provide a lens through which to view the field's evolution. I hope you find it useful. Also today, Rosh Dias, our Chief Medical Officer, will update you on the trials, the enrollment, and the timing results. Sameer Goregaoker will review the Q1 revenues, as well as provide an update on our commercial execution.

    近期已逐漸明朗的是:儘管 Treg 耗竭具有治療潛力,但部分市場參與者正在暫停或停止相關計畫,而另一些則在加速並擴大計畫。對我們所有人而言,理解其中正在發生的細微差異至關重要。因此,我請我們的首席科學長 Theresa LaVallee 今天花幾分鐘時間,提供一個觀察視角,協助大家理解該領域的演進。希望各位覺得有幫助。此外,今天我們的首席醫務長 Rosh Dias 也將更新試驗進展、收案情況與結果時程。Sameer Goregaoker 將回顧第一季營收,並更新我們的商業執行情況。

  • We continue to project that we will head some $15 million per quarter sometime this year in 2026 and $30 million to $35 million per quarter sometime in 2027 and a market share peak of about $44 million per quarter sometime in 2028, which translates to about $175 million a year.

    我們仍預期:在 2026 年的某個時間點,本年度每季可達約 1,500 萬美元;在 2027 年的某個時間點,每季可達 3,000 萬至 3,500 萬美元;並在 2028 年的某個時間點達到約每季 4,400 萬美元的市占峰值,折合約每年 1.75 億美元。

  • After Sameer, Bryan McMichael will review for you our financials.

    在 Sameer 之後,Bryan McMichael 將為各位說明我們的財務狀況。

  • And with that, now let me turn the call over to Rosh.

    那麼,接下來我把電話交給 Rosh。

  • Dr. Dias?

    Dias 醫師?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Thank you, Denny, and good afternoon, everyone.

    謝謝你,Denny,各位下午好。

  • We continued to advance our highly focused clinical development program for our pipeline molecules, Casdozokitug and Tagmokitug through the Q1, and we're pleased with our progress with both molecules, with accrual progressing well and we are tracking to plan.

    在第一季期間,我們持續推進針對管線分子 Casdozokitug 與 Tagmokitug 的高度聚焦臨床開發計畫;我們對兩項分子的進展感到滿意,收案進度良好,並且符合既定計畫。

  • Recently, we announced that we had completed our target accrual to our CATALYST-202 randomized study in first-line hepatocellular carcinoma. As a reminder, this is a 72-patient pre-armed study investigating two active doses of Casdozokitug in combination with toripalimab and bevacizumab versus [tori-bev], and is designed to further characterize the efficacy and safety of this triplet as well as address FDA's Project Optimus and contribution of components.

    近期我們宣布,已完成 CATALYST-202 隨機研究在一線肝細胞癌中的目標收案。提醒各位,這是一項 72 名患者的預先分組(pre-armed)研究,比較 Casdozokitug 兩個有效劑量與 toripalimab 及 bevacizumab 的聯合療法,對照 [tori-bev];其設計旨在進一步刻畫此三聯療法的療效與安全性,並回應 FDA 的 Project Optimus 以及各組成成分的貢獻度(contribution of components)要求。

  • This study builds upon the previous data we presented last year at ASCO GI, where the combination of Casdozo on top of the current standard of care of atezo and bev demonstrated an overall response rate of 38% and a very encouraging complete response rate of 17%, both of which are greater than the historical data for atezo-bev alone of 30% and 7.7%, respectively.

    本研究建立在我們去年於 ASCO GI 發表的既有數據之上:在現行標準治療 atezo 與 bev 的基礎上加入 Casdozo 的組合,顯示總反應率為 38%,且完全反應率達到非常令人鼓舞的 17%;兩者皆高於 atezo-bev 單獨治療的歷史數據(分別為 30% 與 7.7%)。

  • Patient accrual has gone well, and we anticipate having initial data available around the mid-year time frame as projected. Given what we observed in the prior Casdozo HCC trial, we expect the response data to mature overtime time after that, perhaps quarter-to-quarter.

    患者收案進展順利,我們預期可如先前所估,在年中左右取得初步數據。基於我們在先前 Casdozo 肝細胞癌(HCC)試驗中的觀察,我們預期其反應數據在此之後會隨時間逐步成熟,可能以季度為單位持續更新。

  • Moving to Tagmokitug, our CCR8 cytolytic antibody, we're currently running two active protocols in a targeted clinical program in tumor types where CCR8 intratumoral expression levels and the demonstration of activity previously in the CCR8 field provide rationale for investigation.

    接著談 Tagmokitug——我們的 CCR8 細胞溶解型抗體;目前我們在一個聚焦的臨床計畫中執行兩項進行中的試驗方案,鎖定 CCR8 腫瘤內表現量較高的腫瘤類型,且在 CCR8 領域先前已有活性證據,因而具備研究的合理性。

  • Our first protocol expands our approach in head and neck squamous cell carcinoma and builds upon the late-line head and neck squamous cell data we presented at AACR 2025, where we demonstrated tumor immune cell remodeling to a more cytotoxic state with tagmo monotherapy and a partial response in the fourth-line patients with the tagmo-tori combination.

    我們的第一項試驗方案擴展了我們在頭頸部鱗狀細胞癌的策略,並建立在我們於 AACR 2025 發表的後線頭頸部鱗狀細胞癌數據之上;當時我們顯示 tagmo 單藥可使腫瘤免疫細胞重塑為更具細胞毒性的狀態,且在第四線治療患者中,tagmo-tori 聯合療法出現部分反應。

  • Our current 40-patient expansion explores two active doses of tagmo in combination with tori, specifically in a second-line population. Accrual has progressed well, and we anticipate having data for 40 patients with a variable number of scans around the mid-year frame.

    我們目前的40名患者擴增研究,正在第二線治療族群中,評估tagmo與tori併用的兩個有效劑量。收案進展良好,我們預期在年中左右的時間點,將取得40名患者的數據,並包含數量不一的影像掃描結果。

  • Our second protocol looks at multiple cohorts under an umbrella protocol as previously discussed. Cohort A investigates the tagmo-tori combination in 40 patients with a second-line upper GI adenocarcinoma, which includes a gastric adeno -- gastroesophageal junction adeno and esophageal adenocarcinoma in two doses of tagmo in combination with tori. This cohort is ongoing and continues to accrue well. We anticipate having initial data available mid-year as projected.

    我們的第二項試驗方案,如先前所述,是在一個傘式試驗方案下評估多個隊列。A隊列在40名第二線上消化道腺癌患者中研究tagmo-tori併用;此類別包含胃腺癌、胃食道交界處腺癌以及食道腺癌,並以兩個tagmo劑量與tori併用。此隊列仍在進行中,且持續收案良好。我們預期如先前規劃,將於年中取得初步數據。

  • Cohorts B, C, and D are all active and accruing, and we remain on track to show initial data through the second half of this year, as previously communicated. Cohorts B and C of this protocol are in esophageal squamous cell carcinoma, where the activity of tori irrespective of PD-L1 status is particularly marked and forms the basis of tori's approval in Europe as the only PD-1 approved across all PD-L1 levels in this tumor type. We're investigating the tagmo-tori combination in second-line ESCC, and in first-line ESCC, we're exploring tagmo and tori in combination with chemotherapy as a safety cohort.

    B、C與D隊列皆已啟動並正在收案,我們仍按計畫在今年下半年提供初步數據,如先前所溝通。本試驗方案的B與C隊列聚焦於食道鱗狀細胞癌(ESCC),在此腫瘤類型中,tori不受PD-L1狀態影響的活性特別顯著,並構成tori在歐洲獲批的基礎:其為此腫瘤類型中唯一在所有PD-L1表達水準皆獲核准的PD-1藥物。我們正在第二線ESCC中研究tagmo-tori併用;同時在第一線ESCC中,作為安全性隊列,我們探索tagmo與tori再加上化療的併用。

  • Cohort D is exploring tagmo and tori in fourth-line plus microsatellite-stable colorectal carcinoma without liver mets, an area of increasing incidence, particularly in younger age groups, and where there is a large unmet medical need, as the current standard of care demonstrates very limited benefit.

    D隊列正在探索tagmo與tori用於第四線以上、微衛星穩定型(MSS)的結直腸癌且無肝轉移的患者;此領域發生率正上升,尤其在較年輕族群中更為明顯,且存在龐大的未被滿足醫療需求,因為現行標準治療的效益非常有限。

  • Lastly, we've made excellent progress on the J&J pasritamig T-cell engager combination cohort of tagmo in prostate cancer which will be the first of a new multi-cohort protocol, which is an approach that will enable us to add additional tagmo combination cohorts with other novel mechanisms under a single protocol efficiently. We continue to anticipate the first patient in this fall.

    最後,我們在前列腺癌中,針對tagmo與J&J的pasritamig T細胞接合器(T-cell engager)之併用隊列已取得極佳進展;這將是新的多隊列試驗方案中的第一個隊列。此一作法將使我們能在單一試驗方案下,更有效率地加入其他具新穎機轉的tagmo併用隊列。我們仍預期今年秋季納入首位患者。

  • With that, I will hand it over to Theresa. Theresa?

    接下來,我把時間交給Theresa。Theresa?

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • Thank you, Rosh, and good afternoon.

    謝謝你,Rosh,各位下午好。

  • Today, I will cover three topics.

    今天我將涵蓋三個主題。

  • Two aspects for Tagmokitug. As the CCR8 competitive field is evolving, I will briefly review the importance of pharmacology in drug development. And then I will review our own Tagmokitug pharmacology data to date. These data have supported the opportunity to expand Tagmokitug development with J&J T-cell engager pasritamig, a novel combination with CCR8-depleting antibodies and a potentially complementary anti-cancer therapy. We are excited this is our first non-proprietary combination to advance the clinical development.

    其中兩個面向與Tagmokitug相關。隨著CCR8競爭格局持續演變,我將簡要回顧藥理學在藥物開發中的重要性。接著我會回顧我們目前為止的Tagmokitug藥理數據。這些數據支持我們有機會,將Tagmokitug的開發擴展至與J&J的T細胞接合器pasritamig併用;這是一種與CCR8耗竭型抗體搭配、且可能具互補性的抗癌新型組合療法。我們對於這是我們第一個非自有(non-proprietary)的併用方案、並將推進臨床開發感到振奮。

  • So, let me start with reviewing some of our analysis plans for the [casdo/ketug] (sic - see press release, " Casdozokitug") randomized CATALYST-202 study.

    那麼,我先從回顧我們針對[casdo/ketug](原文如此—請參見新聞稿,「Casdozokitug」)隨機分派的CATALYST-202研究之部分分析規劃開始。

  • Having the Casdozokitug HCC study fully enrolled now allows for the biomarker analysis to be done. We have prioritized two aspects for data readouts: biomarkers associated with response and pharmacodynamic biomarkers to support contribution of effect for Casdozokitug. The previous Casdozokitug HCC study provided a small dataset suggesting that higher levels of IL-27 expression in tumors were associated with response. However, we had just seven tumor samples, which is only 25% of the evaluable patients.

    Casdozokitug的肝細胞癌(HCC)研究目前已完成全數收案,這使得生物標記分析得以進行。我們將數據揭露優先聚焦於兩個面向:與反應相關的生物標記,以及用以支持Casdozokitug作用貢獻的藥效學(pharmacodynamic)生物標記。先前的Casdozokitug HCC研究提供了一個小型資料集,顯示腫瘤中較高的IL-27表達水準與治療反應相關。然而,我們當時只有7個腫瘤樣本,僅占可評估患者的25%。

  • Despite that, the analysis showed the tumors from the four patients with response had a higher level of IL-27 protein compared to the three progressive disease patients. In the current CATALYST-202 study, we have trained pre-treatment tumor samples for almost all of the patients and expect to have IL-27 expression data when we read out the study.

    儘管如此,分析顯示:有反應的4名患者之腫瘤,其IL-27蛋白水準高於3名疾病進展患者。在目前的CATALYST-202研究中,我們已取得幾乎所有患者的治療前腫瘤樣本,並預期在研究讀出時可取得IL-27表達數據。

  • We also plan to perform circulating tumor DNA analysis. Circulating tumor DNA is emerging as an important biomarker to evaluate tumor burden and treatment response. As tumor cells grow, they shed DNA into the patient's blood, and many studies show a decrease in circulating tumor DNA levels following treatment correlates with better survival outcomes. Circulating tumor DNA already serves as a marker for minimal residual disease and hematological malignancies, and there is a large effort in the field to have the same for solid tumors. Given the delayed responses in HCC, we are interested in exploring this as an earlier surrogate marker for efficacy.

    我們也計畫進行循環腫瘤DNA(ctDNA)分析。循環腫瘤DNA正逐漸成為評估腫瘤負荷與治療反應的重要生物標記。隨著腫瘤細胞生長,它們會將DNA釋放到患者血液中;多項研究顯示,治療後循環腫瘤DNA水準下降與較佳的存活結局相關。循環腫瘤DNA已可作為微小殘存病灶(MRD)與血液惡性腫瘤的指標,而領域內也正投入大量努力,期望在實體腫瘤中達到同樣應用。鑑於HCC的反應可能延遲,我們有興趣探索其作為更早期療效替代指標的可能性。

  • Let me shift now to our Cytolytic CCR8 antibody, Tagmokitug, which we are investigating across a number of indications. As the competitive field is evolving, with some teams causing or stopping their programs, while others are advancing their programs into late-stage development, these disparate outcomes may be explained by the basics of drug development. Early-phase clinical studies must answer two questions: right drug, right target.

    接著我轉到我們的細胞溶解型(cytolytic)CCR8抗體Tagmokitug,我們正在多個適應症中進行研究。隨著競爭格局演變,有些團隊啟動或停止其計畫,另一些則將計畫推進至後期開發;這些不同結果,可能可由藥物開發的基本原則來解釋。早期臨床研究必須回答兩個問題:藥是否正確、靶點是否正確(right drug, right target)。

  • To have the right drug requires four critical pharmacological elements, good PK and potency, showing you can deliver the drug at the needed exposure, and thirdly, dose-dependent effects on the intended target, showing the drug has hit the target and affected the target as related to dose.

    要稱得上是「正確的藥」,需要四個關鍵藥理要素:良好的藥物動力學(PK)與效力(potency),證明能在所需暴露量下給藥;第三,對預期靶點呈現劑量依賴性的作用,顯示藥物確實命中靶點,且其對靶點的影響與劑量相關。

  • And fourthly, an acceptable safety profile alone in combination. The majority of the CCR8 antibodies aim for a bind-and-kill MOA to deplete intratumoral Tregs. However, as we have consistently stated, the CCR8 receptor is a GPCR. It is well-known GPCRs are challenging to make selective and potent antibodies against. This is now being reinforced with the CCR8 class.

    第四,無論單藥或併用皆需具可接受的安全性概況。多數CCR8抗體的目標是透過「結合並殺死」(bind-and-kill)的作用機轉(MOA),以耗竭腫瘤內的Treg。然而,正如我們一再強調,CCR8受體屬於GPCR。眾所周知,GPCR是難以製作出具選擇性且高效力抗體的靶點。CCR8這一類別目前也再次印證了這點。

  • In April, at the AACR meeting, Amgen and Gilead presented on their CCR8 programs. The data show mixed results, and these antibodies show a toxicity profile that is not seen by some other CCR8 programs. Amgen halted enrollment in their program after presenting data showing only 2 responses in 77 patients treated. About a third of the patients were treated with a combination of AMG-355 and pembrolizumab.

    在4月的AACR年會上,Amgen與Gilead發表了其CCR8計畫。數據顯示結果好壞參半,且這些抗體呈現出某些其他CCR8計畫未見的毒性概況。Amgen在發表數據後停止其計畫收案;該數據顯示在77名接受治療的患者中僅觀察到2例反應。約三分之一的患者接受AMG-355與pembrolizumab的併用治療。

  • From the 12 with gastric cancer, 1 partial response was observed. These results contrast with the gastric cancer data from Lanova, now Sino Biopharma, where LM-108, in combination with PD-1 inhibitors, demonstrated a 36% overall response rate. Gilead, in contrast, showed anti-tumor activity, including single-agent activity and tumor types known to have a high degree of CCR8-positive Tregs. Gilead is now advancing their Denikitug into Phase 2 development in multiple studies and we await additional data sets.

    在12名胃癌患者中,觀察到1例部分反應。這些結果與Lanova(現為中國生物製藥)在胃癌的數據形成對比:LM-108與PD-1抑制劑併用時,顯示36%的總反應率。相較之下,Gilead顯示出抗腫瘤活性,包括單藥活性,以及在已知CCR8陽性Treg比例較高的腫瘤類型中的活性。Gilead目前正推進其Denikitug進入多項第二期研究,我們也在等待更多數據集。

  • In summary, it would seem that many CCR8 programs that are stopping are doing so due to drug-like properties falling short and failing the right drug criteria. In contrast, Tagmokitug has shown good pharmacology and has met all the criteria for right drug, excellent linear dose and dose-dependent PK, potency for both binding and killing the target, dose-dependent immune effects, and acceptable safety profile both with and without toripalimab.

    總結而言,許多停止的CCR8計畫似乎是因為藥物樣特性不足,未能符合「正確的藥」之標準。相較之下,Tagmokitug展現了良好的藥理特性,並符合「正確的藥」的所有標準:優異且線性的劑量—PK關係、對靶點具結合與殺傷兩方面的效力、劑量依賴性的免疫效應,以及在有或沒有toripalimab併用時皆具可接受的安全性概況。

  • With the right drug under investigation, we have now turned our attention to answering the question of hitting the right target. As you have seen, we are aggressively pursuing data to support right combination for the best efficacy across cancers, lines of therapy, and immune context. We are evaluating Tagmokitug in combination with either toripalimab, a PD-1 inhibitor or pasritamig, a T-cell engager.

    在有合適的候選藥物正在研究的前提下,我們現在把重點轉向回答「是否打到正確標的」這個問題。如各位所見,我們正積極推進數據,以支持在不同癌種、不同治療線別以及不同免疫情境下,採用正確的聯合用藥以達到最佳療效。我們正在評估 Tagmokitug 與 toripalimab(PD-1 抑制劑)或 pasritamig(T 細胞接合器)聯合使用。

  • We plan to evaluate Tagmokitug and other combination where Tregs are associated with therapy resistance, such as ADCs or radiotherapy. We believe this will inform our development broadly across anti-cancer therapies on the best way to overcome Treg-driven resistance in cancer patients.

    我們計畫評估 Tagmokitug 以及其他在 Tregs 與治療抗性相關的聯合方案,例如 ADC 或放射治療。我們相信,這將為我們在各類抗癌療法的開發上提供更廣泛的指引,找出在癌症患者中克服 Treg 驅動抗性的最佳方式。

  • With that, I'll turn the call over to our Chief Commercial Officer. Sameer?

    接下來,我把電話會議交給我們的首席商務長。Sameer?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Thank you, Theresa. And good afternoon, everyone.

    謝謝你,Theresa。各位下午好。

  • Today, let me offer you some color on our Q1 results, what we saw with respect to demand signal, and our focus going forward to drive growth.

    今天,我想就我們 2026 年第一季的結果、我們在需求訊號方面的觀察,以及接下來推動成長的重點,提供各位一些補充說明。

  • In Q1 2026, LOQTORZI net sales were up 61% versus Q1 2025. On a quarter-over-quarter basis, net sales were $11.8 million versus $12.4 million in Q4 '25. This result was consistent with typical first-quarter seasonal trends, but this year it was impacted by the severe weather across large parts of the country as others have also seen.

    在 2026 年第一季,LOQTORZI 淨銷售額較 2025 年第一季成長 61%。以季對季來看,淨銷售額為 1,180 萬美元,相較於 2025 年第四季的 1,240 萬美元。這個結果符合第一季常見的季節性趨勢,但今年也受到全國多地嚴峻天氣的影響,其他公司也有類似情況。

  • To better understand this year's seasonal impact, we assessed a basket of 85 oncology products. We found an average of 5% decline from Q4 to Q1 over the past four years. However, in 2026, the decline for this basket was more pronounced at 10%, likely driven by the severe winter storms that hit most of the country. With the seasonal impact now behind us, we expect LOQTORZI revenue growth to build through the remainder of 2026, given a closer analysis of our growth drivers. We are pleased to report that LOQTORZI new starts reached an all-time high in Q1. This was driven by, one, broader prescribing in new accounts and, two, deeper use through repeat ordering in existing accounts. Overall, breadth and depth of ordering accounts increased 21% and treatment duration continues to increase quarter-over-quarter.

    為了更了解今年的季節性影響,我們評估了一籃子共 85 項腫瘤產品。我們發現,過去四年從第四季到第一季平均下滑 5%。然而在 2026 年,這一籃子產品的下滑更明顯,達到 10%,很可能是因為嚴重冬季風暴影響了全國大部分地區。隨著季節性影響已經過去,基於我們對成長驅動因素更深入的分析,我們預期 LOQTORZI 的營收成長將在 2026 年剩餘期間逐步加速。我們很高興報告,LOQTORZI 在第一季的新啟用治療(new starts)創下歷史新高。這主要由兩個因素帶動:第一,在新客戶帳戶中更廣泛的處方;第二,在既有帳戶中透過重複訂購帶來更深度的使用。整體而言,訂購帳戶的廣度與深度提升了 21%,且治療持續時間持續呈現季對季增加。

  • Looking ahead, we see two clear levers to drive continued demand growth.

    展望未來,我們看到兩個明確的槓桿可用來推動需求持續成長。

  • First, we're focusing on reducing chemo-only use, particularly in the community setting, through continued education on NCCN guidelines and our Phase 3 data, including the six-year long-term survival benefit analysis.

    第一,我們將聚焦降低僅使用化療(chemo-only)的比例,特別是在社區醫療場域,透過持續教育 NCCN 指南與我們的第三期數據,包括六年長期存活效益分析。

  • Secondly, we're working to curb off-label PD-1 use in NPC that is mainly driven by guideline and indication misperceptions. On both fronts, our efforts reinforced LOQTORZI's position as the only approved and available immune therapy in NPC, offering a superior survival benefit over chemotherapy alone. We are moving this plan forward, utilizing targeted investments to enhance our execution.

    第二,我們正致力於抑制在 NPC 中的超適應症(off-label)PD-1 使用,這主要是由於對指南與適應症的誤解所致。在這兩方面,我們的努力都強化了 LOQTORZI 作為 NPC 唯一獲核准且可取得的免疫療法之地位,並且相較單純化療提供更優越的存活效益。我們正推進此計畫,並透過有針對性的投資來提升執行力。

  • Importantly, new claims data purchases have expanded our visibility into chemo-only and off-label IOUs across up to 70% of addressable patients. This expanded visibility is being incorporated into patient alerts to enable earlier, more precise field targeting, and multi-channel execution. Our insight sales team is now fully operational, significantly expanding our reach into the community setting, a key growth driver.

    重要的是,新購買的理賠資料已擴大我們對僅化療與超適應症免疫腫瘤用藥(IOU)使用情況的可視性,涵蓋最多達 70% 的可觸及患者。這種更高的可視性正被納入患者警示機制,以便更早、更精準地進行前線團隊目標鎖定與多通路執行。我們的洞察銷售團隊目前已全面運作,顯著擴大我們在社區醫療場域的觸及範圍,而這正是關鍵的成長驅動因素。

  • We're also scaling digital education through KOL video programs, targeted EMR initiatives, and pilots on emerging ACP AI platforms. These AI platforms are seeing rapid growth -- rapid adoption by oncologists and are increasingly used to drive treatment decisions.

    我們也正透過 KOL 影片專案、鎖定式 EMR 計畫,以及在新興 ACP AI 平台上的試點,擴大數位教育規模。這些 AI 平台正快速成長——腫瘤科醫師採用速度很快,且越來越常被用來推動治療決策。

  • Regarding our guidance, we continue to expect 10% to 15% demand growth per quarter, averaged across 2026 quarters. Our focus will continue to be on driving broader and deeper adoption across the community and academic setting, supported by growing duration of treatment.

    關於我們的指引,我們仍預期 2026 年各季度平均每季需求成長 10% 至 15%。我們將持續聚焦推動在社區與學術醫療場域更廣泛且更深度的採用,並由治療持續時間的增加所支持。

  • With that, I'll now turn the call over to Bryan McMichael, our Chief Financial Officer.

    接下來,我把電話會議交給我們的首席財務長 Bryan McMichael。

  • Bryan Mcmichael - Chief Financial Officer

    Bryan Mcmichael - Chief Financial Officer

  • Thank you, Sameer, and good afternoon, everyone.

    謝謝你,Sameer,各位下午好。

  • I'll start with notable financial and operational updates, then run through the company's financial position at the end of the quarter and results for Q1 2026.

    我將先說明幾項重要的財務與營運更新,接著回顧公司在季末的財務狀況,以及 2026 年第一季的業績表現。

  • The key financial event this quarter was the follow-on equity offering, which we mentioned on last earnings call. As an update, total net proceeds were $54 million and include the full exercise of the underwriters' over-allotment option. These funds have strengthened our liquidity position and are supporting the new Tagmokitug, CRC, and prostate studies; enhanced investments in LOQTORZI commercialization capabilities to reach revenue targets faster; and general corporate purposes.

    本季最重要的財務事件是後續增發(follow-on)股權發行,我們在上次法說會中曾提及。更新一下:淨募集資金總額為 5,400 萬美元,並包含承銷商超額配售選擇權的全數行使。這些資金強化了我們的流動性,並支持新的 Tagmokitug、CRC 與前列腺研究;加大對 LOQTORZI 商業化能力的投資,以更快達成營收目標;以及一般公司用途。

  • Regarding sales, in addition to the color on LOQTORZI net revenues provided by Sameer, I will add that we expect to provide full-year 2026 revenue guidance on the earnings call in August as indicated on our last call.

    關於銷售,除了 Sameer 對 LOQTORZI 淨營收所提供的補充說明之外,我再補充一點:如同我們上次會議所提到的,我們預期將在 8 月的法說會上提供 2026 全年營收指引。

  • Let me turn to operating expenses.

    接著我談營運費用。

  • R&D expenses from continuing operations for Q1 2026 were $21.5 million, down from $24.4 million in the first quarter of the prior year. The decrease was primarily due to savings from reduced headcount and infrastructure costs, reflecting tight spending discipline, partially offset by increased investments in the pipeline.

    2026 年第一季持續營運的研發費用為 2,150 萬美元,低於去年同期第一季的 2,440 萬美元。下降主要來自人力與基礎設施成本降低所帶來的節省,反映嚴格的支出紀律;但部分被對研發管線增加投資所抵銷。

  • SG&A expenses from continuing operations were $23.1 million in the first quarter, down from $26 million in Q1 2025. The decrease reflects continued savings from Coherus' complete exit from the biosimilar business, which, as we talked to you today, was completed more than one year ago.

    2026 年第一季持續營運的銷售、一般及行政(SG&A)費用為 2,310 萬美元,低於 2025 年第一季的 2,600 萬美元。下降反映 Coherus 完全退出生物相似藥業務所帶來的持續節省;如同我們今天所談,該退出已在一年多前完成。

  • Now turning to the balance sheet.

    接著看資產負債表。

  • Total cash, cash equivalents, and investments at the end of the quarter was $167 million, down slightly from $172.1 million at year-end. Given the recent raise in our financial plans, we believe we are sufficiently funded through key data readouts in 2026 and 2027.

    截至季末,現金、約當現金及投資總額為 1.67 億美元,較年末的 1.721 億美元略為下降。考量近期募資以及我們的財務規劃,我們認為資金足以支應至 2026 年與 2027 年的關鍵數據讀出。

  • With that, I'll hand the call back over to Dennis.

    接下來,我把電話會議交回 Dennis。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Bryan.

    謝謝你,Bryan。

  • Operator, we're ready to go to the questions.

    接線員,我們準備開始問答。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Jay Olson, Oppenheimer..

    Oppenheimer 的 Jay Olson。.

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • On LOQTORZI, can you talk about the dynamics driving the average duration of treatment among existing patients, which continues to grow? Is the growing duration driven by first-line patients?

    關於 LOQTORZI,你們能談談推動既有患者平均治療持續時間(仍在增加)的動態因素嗎?治療持續時間的增加是否由第一線患者所帶動?

  • And then related to that, congrats on the new patient stars in the first quarter. Can you maybe share some color on how the patients split between first and second line and where should we eventually expect a percentage of patients on LOQTORZI in the first line setting?

    另外也相關地,恭喜第一季新患者啟用治療創新高。你們能否補充一些細節,患者在第一線與第二線之間的分布如何?以及最終我們應該預期在第一線治療情境中,使用 LOQTORZI 的患者比例會到多少?

  • And then if I could, I have a follow-up on tagmo, please?

    另外如果可以的話,我想再追問一題關於 tagmo。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Jay. I'll let Sameer unpack that for you.

    謝謝你,Jay。我請 Sameer 為你詳細說明。

  • Sameer, would you like to address Jay's question about the treatment duration and so on?

    Sameer,你想回應 Jay 關於治療持續時間等問題嗎?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Thank you, Jay. Thanks for the question.

    謝謝你,Jay。謝謝你的提問。

  • And you had a couple of points to that question, so just make sure I got your question correctly.

    而且你對那個問題有幾個要點,所以我只是想確認我正確理解了你的問題。

  • The first question will be average duration of treatment and how that's split between new and existing patients. Is that correct, Jay?

    第一個問題是平均治療持續時間,以及新病患與既有病患之間如何分布。是這樣嗎,Jay?

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Yes. And then, yeah.

    是的。然後,對。

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • So, in terms of the duration of treatment, what I can say is our duration of treatment depends on the type of patients. We have two types of patients. One type of patient is the first-line locally advanced and first-line metastatic patients. And the second type of patient is a monotherapy patient, which is the later-line metastatic patients. We, in the clinical trials in the real world, oversee higher duration of therapy for the first-line patients than the second-line monotherapy patients.

    所以,就治療持續時間而言,我能說的是,我們的治療持續時間取決於病患類型。我們有兩種類型的病患。一種是第一線局部晚期與第一線轉移性病患。第二種是單藥治療病患,也就是後線的轉移性病患。在臨床試驗與真實世界中,我們觀察到第一線病患的治療持續時間高於第二線單藥治療病患。

  • In terms of new and existing patients, I think it's the same dynamic playing out for both the new and existing patients. So across the board, we're seeing that the duration continues to grow as we get further away from launch and eventually, hopefully, we'll get close to the clinical trial duration.

    至於新病患與既有病患,我認為兩者呈現的是相同的動態。因此整體而言,我們看到隨著距離上市時間越久,治療持續時間持續增加,最終希望能接近臨床試驗中的治療持續時間。

  • And the next question was about new patient starts in first-line and second-line.

    下一個問題是關於第一線與第二線的新病患起始治療人數。

  • So currently, we're seeing about 75% to 80% of our patients are coming from the metastatic setting, both the front-line metastatic setting and the second-line metastatic setting and a smaller percentage of patients coming from the locally advanced recurrent setting. And that's in line with physicians initially at launch, putting patients on a later line patients and then moving the use of therapy to an early line setting. As we get further into the launch, we would expect that we get more locally advanced recurrent patients.

    目前我們看到大約75%到80%的病患來自轉移性情境,包括第一線轉移性與第二線轉移性情境;另有較小比例的病患來自局部晚期復發情境。這與醫師在上市初期先將病患放在較後線治療,之後再把治療使用往較前線移動的情況一致。隨著上市推進,我們預期會有更多局部晚期復發病患。

  • And last thing I'll say is, we also now have visibility into where these patients are. We've purchased a lot of claims data, so we know which physicians are managing these locally advanced recurrent patients, and we're going after those accounts and physicians to educate them on LOQTORZI.

    最後我想補充的是,我們現在也能掌握這些病患在哪裡。我們購買了大量理賠資料,因此我們知道哪些醫師在管理這些局部晚期復發病患,我們正針對那些帳戶與醫師進行拜訪,教育他們了解LOQTORZI。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Jay, and thank you, Sameer.

    謝謝你,Jay,也謝謝你,Sameer。

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • Thank you. That's super helpful.

    謝謝。這非常有幫助。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • (multiple speakers) -- next question.

    (多位講者)——下一個問題。

  • I'm sorry.

    不好意思。

  • Jay Olson - Analyst

    Jay Olson - Analyst

  • That was super helpful and extremely comprehensive. Thanks for the detailed explanation.

    那真的非常有幫助,而且非常全面。謝謝你詳細的說明。

  • Just on tagmo, given that the second-line head and neck and gastric cancer readout is expected mid-year, could you just talk about what investors should expect to learn from those two updates, and will you be providing next steps in the clinical development for those two programs?

    關於tagmo,鑑於第二線頭頸癌與胃癌的數據讀出預計在年中公布,你能否談談投資人應該從這兩次更新中期待了解什麼?以及你們是否會提供這兩個計畫在臨床開發上的下一步?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Rosh, do you want to take that one about the data and then, Theresa, you can take next steps.

    Rosh,你要先回答關於數據的部分嗎?然後Theresa,你可以談下一步。

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yeah, thank you, Jay, for the question.

    好的,謝謝你,Jay,提出這個問題。

  • So in terms of data readouts, yeah, so we anticipate initial data for the second-line head and neck and the second-line upper GI adeno around the mid-year timeframe.

    就數據讀出而言,是的,我們預期在年中左右會有第二線頭頸癌以及第二線上消化道腺癌(upper GI adeno)的初步數據。

  • A couple of things I'll say, first of all, we anticipate at least 50% of the patients to be reported. As you think about the data and timing, there are probably two key determinants, right? One is the number of patients. Number two is the number of scans that may be needed to show activity. So again, for the number of patients, I anticipate more than 50% or more of patients.

    我想說幾點:首先,我們預期至少會報告50%的病患。當你思考數據與時程時,可能有兩個關鍵決定因素,對吧?第一是病患人數。第二是可能需要的掃描次數,以顯示活性。所以同樣地,就病患人數而言,我預期會是50%以上的病患。

  • In terms of the numbers of scans, that's a little bit more variable. We'll be looking at overall response rate. We'll be looking at clinical benefit rate. We'll be looking at safety, but duration will take a little bit longer to really mature. And as you know the real benefit of IO has been in extending that tail. So I'd look out for those key metrics to start with.

    至於掃描次數,變動性會更大一些。我們會看整體反應率(ORR)。我們會看臨床獲益率。我們會看安全性,但持續時間(duration)需要更久才會真正成熟。而且如你所知,免疫腫瘤(IO)的真正效益在於延長那個長尾。所以一開始我會先關注那些關鍵指標。

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • Yeah, I think to add to that, Jay, thanks because we're super excited to think about next steps. And so, as we look at the data, particularly with durability, I mean, ORR is nice, it's 30% or greater tumor shrinkage. Durability is what matters, though, because the regulatory endpoints are survival.

    是的,我想補充一下,Jay,謝謝,因為我們對下一步非常興奮。因此,當我們看數據時,特別是持久性(durability),我的意思是,ORR不錯,它代表腫瘤縮小30%或以上。但真正重要的是持久性,因為法規端點是存活。

  • So, thinking about, is there sufficient efficacy to support favorable regulatory strategies which all of these studies are designed, if the signal's there, to have sufficient patients to do that. Additionally, is there a patient population or a way of enriching patients? Is another output that we're really looking at for what's the immune context and is there a way then to advance into a study to look more towards later-stage development?

    所以我們會思考:是否有足夠的療效來支持有利的法規策略?這些研究的設計都是在訊號存在時,納入足夠病患以支撐那樣的策略。此外,是否存在某個病患族群或某種方式可以富集病患?這也是我們非常關注的另一個產出:免疫微環境(immune context)是什麼?是否有方法進一步推進到一項研究,更朝向後期開發?

  • So, we'll be looking for both of those outputs and directions from the studies as they read out.

    因此,隨著研究讀出,我們會同時尋找這兩個面向的產出與方向。

  • Operator

    Operator

  • Paul Jeng, Guggenheim.

    Paul Jeng,Guggenheim。

  • Paul Jeng - Equity Analyst

    Paul Jeng - Equity Analyst

  • For tagmo, I have a follow-up question on the head and neck cancer data that you'll be reporting, mostly on patient demographics. Can you speak to what proportion of patients you would expect to be PD-1 experienced? And do you plan to break out responses by HPV status?

    關於tagmo,我對你們將要報告的頭頸癌數據有個追問,主要是病患人口學特徵。你能談談你預期有多少比例的病患會是曾接受PD-1治療(PD-1 experienced)嗎?以及你們是否計畫依HPV狀態拆分反應?

  • And then how do you think about okay (multiple speakers) --

    然後你們如何看待,好吧(多位講者)——

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Paul, let's stop there and just do one question. Let's answer that, and then we can follow in.

    Paul,我們先停在這裡,一次先問一個問題。我們先回答這個,然後再接著問。

  • Theresa or Rosh, do you want to take that?

    Theresa或Rosh,你們要回答這題嗎?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yeah, I can take that. So thanks, Paul, for the question. So yes, all of the patients in the second line head and neck study will be PD-1 or PDL-1 experienced. And yes, one of the key sonification factors is the HPV status.

    好的,我可以回答。所以謝謝你,Paul,提出這個問題。是的,第二線頭頸癌研究中的所有病患都會是PD-1或PDL-1治療經驗者。而且是的,其中一個關鍵分層因素就是HPV狀態。

  • (multiple speakers)

    (多位講者)

  • Paul Jeng - Equity Analyst

    Paul Jeng - Equity Analyst

  • I did, yeah. So, I just wanted to ask about how you're thinking about the bar for response rates in light of what some of the investigational eGFRs and even ADCs have shown in the setting?

    對,是的。所以,我只是想問,在這個治療情境下,考量到一些研究中的eGFR甚至ADC所顯示的結果,你們如何看待反應率門檻?

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yeah, I can take that one as well. So, first of all, the current standard of care is pretty dismal in terms of the overall response rate, it is cetuximab and that overall response rate tends to be in the 13% to 15% ORR range. You're absolutely right, we do see the environment changing and evolving with the eGFR.

    好的,我也可以回答這題。首先,目前的標準治療在整體反應率方面相當不理想,是cetuximab,而其整體反應率通常落在13%到15%的ORR區間。你說得完全正確,我們確實看到隨著eGFR,環境正在改變並演進。

  • And a couple of points I'll mention, so first of all, there is positive data in the first line as well as the second-line setting, which I think better position these agents in the first-line setting.

    我提幾點:首先,在第一線以及第二線情境都有正向數據,我認為這讓這些藥物在第一線情境中的定位更好。

  • And secondly, I think the majority of the benefit is really driven by HPV negative status. And so, I think that also leaves the HPV positive patients, which accounts for roughly about 40% of subjects overall pretty wide open. So, I think that's the way we kind of look at the current benchmarks and the evolving datasets.

    第二,我認為大部分的獲益其實是由HPV陰性狀態所驅動。因此,我認為這也讓HPV陽性病患——約占整體受試者約40%——仍有相當大的未滿足空間。所以,我們大致是用這樣的方式來看目前的基準以及正在演進的數據集。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Theresa, you have additional comments?

    Theresa,你還有補充嗎?

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • Yes, and we're actively watching it, obviously, with announcements from the [Nectin ADC] data that's super exciting shows a rapid development path in the head and neck space, then [Hibrix] data coming out really showing a non-eGFR approach in the frontline setting shows room and interest for novel agents.

    是的,而且我們顯然也在積極關注;隨著[Nectin ADC]數據的公布,這些非常令人振奮,顯示在頭頸癌領域有快速的開發路徑;接著[Hibrix]數據的釋出也確實顯示,在一線治療情境中採取非eGFR的策略,對新型藥物仍有空間與興趣。

  • What we find particularly interesting about this mechanism, obviously, our initial output is with PD-1 and tagmo. And to your question, the first study is only asking, can we rescue PD-1 resistance? Since they're all PD-1 failures.

    我們認為這個機制特別有趣的地方在於,顯然我們最初的輸出是與PD-1以及tagmo搭配。回到你的問題,第一個研究只是在問:我們能否逆轉PD-1抗藥性?因為受試者全部都是PD-1治療失敗的患者。

  • Moving into combination with any and all of these agents could make a lot of sense. So, in addition to streamlining our development with a way to advance the later stage, we also see ways to broaden and improve on durability of a lot of these responses, particularly with ADCs, as we do combinations.

    進一步與任何以及所有這些藥物做聯合治療都可能非常合理。因此,除了以一種方式精簡我們的開發、推進到後期階段之外,我們也看到透過聯合治療(特別是與ADC)來擴大並提升許多反應的持久性的方法。

  • Operator

    Operator

  • Brian Cheng, J.P. Morgan.

    Brian Cheng,J.P. Morgan。

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Maybe just first look towards the -- can you provide a little bit more about this weather impact to the top-line here, are patients not able to get another round of LOQTORZI, is there access issue because of weather?

    也許先看一下——你能否再多說一點天氣對這裡營收(top-line)的影響?是病人無法再接受一個療程的LOQTORZI,還是因為天氣造成可近性(access)問題?

  • And just on top of that, how do we reconcile that dynamic with the record new patient start that you're seeing this quarter, and we have a follow-up.

    另外,在此之上,我們要如何把這個動態與你們本季看到的新病人啟動數創新高相互對照理解?我們還有一個追問。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Okay, thanks, Brian. Sameer, you want to take that?

    好的,謝謝,Brian。Sameer,你要回答這題嗎?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • Yes, thank you, Brian, for the question.

    是的,謝謝你,Brian,提出這個問題。

  • So we're now into the third year of our launch. So we're getting a better sense of the seasonality patterns. We saw some seasonality last year. It was kind of early to understand that. So this year, again, we saw the seasonality. And that's why we dug into an analysis of what's really happening in the oncology setting. And we took a basket of 85 oncology molecules and really interestingly, for the last four years, this basket, we saw very consistent 5% decline from Q4 to Q1.

    我們現在已進入上市的第三年。因此我們對季節性型態有更好的掌握。去年我們看到一些季節性。當時還有點早,難以完全理解。所以今年我們再次看到季節性。這也是為什麼我們深入做了分析,看看腫瘤治療情境中到底發生了什麼。我們取了85個腫瘤藥物作為一個樣本籃(basket),很有意思的是,在過去四年中,這個樣本籃從Q4到Q1都非常一致地下降5%。

  • And what we didn't expect is a larger magnitude of the decline in 2026, where we saw a 10% decline for that basket from Q4 to Q1. So it's like as we expected, it's a pretty consistent decline pattern in Q1, and then most products go back to growth in Q2. So we're following a similar pattern it looks like, right?

    而我們沒預期的是,2026年的降幅更大:這個樣本籃從Q4到Q1下降了10%。所以就像我們預期的,Q1出現相當一致的下滑型態,然後大多數產品在Q2會回到成長。看起來我們也在走類似的型態,對吧?

  • That being said, in terms of reconciling the new patients and the existing patients, so we believe what happened is we had, I think, about two major winter storms, which affected about two to three weeks throughout the first quarter and I think what happened is a lot of patients who are on either three-week cycles or two-week cycles missed their cycles and as a result, we lost that entire cycle for a big chunk of patients, and they reset their cycle clock.

    話雖如此,關於如何把新病人與既有病人這兩者對起來看,我們認為發生的情況是:第一季大概有兩場主要的冬季風暴,影響了約兩到三週;我想結果是,許多採三週或兩週給藥週期的病人錯過了他們的療程,因此我們對一大部分病人而言少掉了整個一個週期,且他們的週期時鐘被重置。

  • So we lost these individual cycles for a chunk of patients. That is totally separate from the new patient starts, right, because new patients are really important for us to drive future growth, and we're pretty excited that we saw robust new patient growth, which is going to become the existing patients for future quarters. So those are the two dynamics at play we saw.

    所以我們對一部分病人流失了這些個別週期。這與新病人啟動是完全分開的動態,對吧?因為新病人對我們推動未來成長非常重要;我們也很振奮看到新病人強勁成長,而這些新病人會在未來季度轉化為既有病人。所以我們看到的就是這兩個動態同時在發生。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • The other point that I'd say, Brian, is I think Q4 to Q1 last year, we went down, I think, about 3%. So this year, I think it's like 5%. So given the storms, it's pretty much in line. But also, given these starts, I think that we should go back on the growth curve here directly this quarter.

    另外一點我想說,Brian,去年Q4到Q1我們下降大概是3%。今年大概是5%。所以考量到風暴影響,基本上是符合預期。但同時,考量到這些新啟動,我認為我們本季應該會直接回到成長軌道。

  • Did you have a follow-up question, Brian?

    Brian,你有追問嗎?

  • Brian Cheng - Analyst

    Brian Cheng - Analyst

  • Yeah, we do. Maybe just on the 202 study, Theresa, you talked about how, the importance of circulating tumor DNA and also IL-27 expression in the upcoming data, in terms of figuring out the association of those expressions to tumor reduction. Do you have a sense -- based on preclinical model, do you have a sense of how correlated they are in terms of the magnitude of IL-27 reduction to tumor reduction in preclinical model?

    有的。也許就202研究來問,Theresa,你提到循環腫瘤DNA以及IL-27表達在即將公布的數據中的重要性,用來釐清這些表達與腫瘤縮小之間的關聯。你是否有概念——基於臨床前模型,你是否有概念IL-27下降幅度與腫瘤縮小在臨床前模型中有多相關?

  • Thank you.

    謝謝。

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • Yeah, the preclinical models don't have a good readout there. I mean, what we have seen in the mouse is that it's very tissue specific. So the tumors have to be in the lung or the liver and given the amount of IL-27 that's expressed there, that comes through. And the two things that we're really looking for, I think, just to set expectations for the mid-year readout, we've talked about this at several times is that it's an initial readout.

    是的,臨床前模型在那方面沒有很好的讀出(readout)。我的意思是,我們在小鼠中看到的是它非常具有組織特異性。所以腫瘤必須在肺或肝臟,且取決於那裡表達的IL-27量,才會反映出來。而我們真正要看的兩件事——我想先為年中讀出設定一下預期——我們已多次談過:這會是一個初步讀出。

  • The first readout in the CATALYST-201, the previous atezo and bev study, the overall response rate was only 27%. But a lot of patients were unsteady and we saw tumor shrinkage deepening. And that's where we think that the initial readout with trends in circulating tumor DNA as well as looking at are there differences in the outcomes based on IL-27 levels will really give us a look-see about the probability of it being a positive study as the data matured.

    在CATALYST-201(先前的atezo加bev研究)的第一次讀出中,整體反應率只有27%。但很多病人的狀態並不穩定,而我們看到腫瘤縮小的程度在加深。因此我們認為,這次初步讀出若能看到循環腫瘤DNA的趨勢,以及觀察不同IL-27水準是否會帶來結局差異,將能讓我們先行判斷:隨著數據成熟,這項研究成為正向研究的機率如何。

  • Operator

    Operator

  • (Operator Instructions)

    (接線員指示)

  • Colleen Kusy, Baird.

    Colleen Kusy,Baird。

  • Nicholas Quartapella - Analyst

    Nicholas Quartapella - Analyst

  • _____

    _____

  • Hey, everyone, it's Nick on for Colleen. Thanks for taking the question.

    各位好,我是Nick,代Colleen提問。謝謝讓我提問。

  • I just had a quick one on the Casdozo program. So between atezo and bev and tori and bev as the backbone in combination there, do you expect to see any differences in the efficacy or safety profile?

    我有一個關於Casdozo計畫的簡短問題。在聯合治療中,以atezo加bev與以tori加bev作為骨幹(backbone)之間,你們預期在療效或安全性特徵上會看到任何差異嗎?

  • Thank you.

    謝謝。

  • Rosh Dias - Chief Medical Officer

    Rosh Dias - Chief Medical Officer

  • Yeah, thanks, Nick, for the question. So I think you'll recall that we talked about HEPATORCH, which is the study of toripalimab and bevacizumab versus sorafenib. And that really showed very similar, if not slightly higher, overall survival compared to atezo and bev, obviously, not a head-to-head.

    是的,謝謝你,Nick,這個問題。我想你會記得我們談過HEPATORCH,這是一項toripalimab加bevacizumab對比sorafenib的研究。該研究顯示其整體存活期與atezo加bev非常相近,甚至略高一些;當然這不是頭對頭比較。

  • So I think we have confidence in that and the other thing I'll say is that the ADA rate for atezo tends to be a lot higher than the toripalimab. So I think those two points really give us some confidence that the tori and bev is a good backbone on which to add Casdozokitug.

    所以我們對此有信心;另外我想說的是,atezo的ADA(抗藥抗體)發生率通常比toripalimab高很多。因此我認為這兩點讓我們更有信心:tori加bev是一個很好的骨幹,可以在其上加入Casdozokitug。

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • And the safety profile has been quite good. That's actually one of the standouts, particularly in this disease and the frontline HCC study. And Casdozo across the board really hasn't added any additional or new toxicities to any treatment, whether it be atezo, whether it be tori, whether it be pembro that has been evaluated to date.

    而且安全性特徵一直相當不錯。這其實是其中一個亮點,特別是在這個疾病與一線HCC研究中。而Casdozo整體而言並未在任何治療上增加額外或新的毒性,不論是atezo、不論是tori、或是不論是目前評估過的pembro。

  • Operator

    Operator

  • Michael Nedelcovych, TD Cowen.

    Michael Nedelcovych,TD Cowen。

  • Michael Nedelcovych - Equity Analyst

    Michael Nedelcovych - Equity Analyst

  • I have two. I'll start with my first on Tagmokitug.

    我有兩個問題。我先從第一個、關於Tagmokitug的問題開始。

  • Theresa, you alluded to this in your remarks, but I believe Lanova has initiated a Phase 3 trial for its CCR8 antibody. Can you elaborate a bit on your previous remarks? How important is this development from the point of view both of validating the mechanism, but also in terms of what it means for the competitive landscape and to the extent that you can speak to specific similarities or differences between their molecule and approach to Tagmokitug that would be super helpful. Thanks.

    Theresa,你在發言中提到這點,但我相信Lanova已為其CCR8抗體啟動了一項第三期試驗。你能否再多闡述一下你先前的評論?從驗證機制的角度來看,這項進展有多重要?另外就競爭格局而言,它意味著什麼?在你能談的範圍內,如果能說明他們的分子與其方法相對於Tagmokitug在具體相似處或差異處,將非常有幫助。謝謝。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thanks for that, Mike. Theresa?

    謝謝你,Mike。Theresa?

  • Theresa Lavallee - Chief Scientific & Development Officer

    Theresa Lavallee - Chief Scientific & Development Officer

  • Yeah, I love this question. And I think this is really important because we see programs advancing and programs stopping. Sino Biopharma with LM-108, or Cafelkibart, has started two Phase 3s. In fact, last week, they announced dosing the first patient in the gastric cancer Phase 3. They also have MSI high CRC study as a pivotal study ongoing. So they really have confidence and are doubling down on this program and the molecule, and they also will be reporting at ESMO this year.

    是的,我很喜歡這個問題。我認為這非常重要,因為我們看到有些計畫在推進,也有些計畫在停止。中國生物製藥的 LM-108(或 Cafelkibart)已啟動兩項第 3 期試驗。事實上,上週他們宣布在胃癌第 3 期試驗中完成首位受試者給藥。他們也有 MSI 高表現的 CRC 研究作為關鍵性試驗正在進行中。因此他們對這個計畫與這個分子非常有信心,並且加碼投入;此外,他們也將在今年的 ESMO 上報告。

  • Additionally, we see players like Gilead opening to Phase 2 randomized study, gastric cancer, colorectal study, advocate advancing in colorectal cancer. And VMS continuing to add patients to their study. So we think that the differences from the programs that are being parked or the negative data that the lack of activity that Amgen showed comes down to pharmacology. So we're super excited about seeing programs advancing and seeing the properties of our molecule really making it exciting to now look at the data readouts later this year.

    另外,我們也看到像吉利德這樣的參與者啟動第 2 期隨機試驗(胃癌、結直腸癌研究),並主張在結直腸癌上推進。VMS 也持續在其研究中納入病人。因此我們認為,與那些被擱置的計畫或負面數據相比,安進所顯示的缺乏活性差異主要來自藥理學。所以我們對看到各項計畫持續推進感到非常興奮,也看到我們分子的特性讓人更期待,接下來在今年稍晚看到數據讀出。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Mike, did you have a follow-on question for us?

    Mike,你有後續問題要問我們嗎?

  • Michael Nedelcovych - Equity Analyst

    Michael Nedelcovych - Equity Analyst

  • I have another one on LOQTORZI, if that's okay.

    如果可以的話,我還有一個關於 LOQTORZI 的問題。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Sure.

    當然。

  • Michael Nedelcovych - Equity Analyst

    Michael Nedelcovych - Equity Analyst

  • I'm just curious, given that you now have a better sense of seasonality, do you still think LOQTORZI can get to that roughly $30 million to $35 million in quarterly sales in 2027, or might it take a bit longer than that?

    我只是好奇,鑑於你們現在對季節性有更好的掌握,你們是否仍認為 LOQTORZI 能在 2027 年達到每季約 3,000 萬到 3,500 萬美元的銷售額,還是可能需要更久一些?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • We are confident in doing so, in my prepared remarks, I reiterated guidance on three key issues with respect to the revenues. First being reaching $15 million per quarter sometime this year in '26 second, reaching $30 million to $35 million per quarter sometime in '27, and then thirdly, reaching what would be an annualized $175 million per year, which is about $44 million a quarter sometime in 2028. And I think that our data purchases and our knowledge now of the therapeutic area gives us confidence we'll be able to do that.

    我們有信心做到。在我事先準備的發言中,我重申了關於營收的三個關鍵指引。第一,今年某個時間點在 2026 年達到每季 1,500 萬美元;第二,在 2027 年某個時間點達到每季 3,000 萬到 3,500 萬美元;第三,在 2028 年某個時間點達到年化 1.75 億美元,也就是每季約 4,400 萬美元。我認為,我們的數據採購以及目前對治療領域的理解,讓我們有信心能夠達成。

  • Operator

    Operator

  • Doug Tsao, H.C. Wainwright.

    Doug Tsao,H.C. Wainwright。

  • Douglas Tsao - Equity Analyst

    Douglas Tsao - Equity Analyst

  • Just thanks for taking the questions. I guess just maybe on the lot towards the issue in terms of the impact on storms, was this something that affected largely new patient starts or was it just simply a function of patients' ongoing therapy? And should we think of this as just sort of purely deferred revenue that eventually should catch up for the rest of the year?

    謝謝讓我提問。我想就 LOQTORZI 這個問題,關於暴風雨的影響:這主要影響的是新病人開始用藥,還是只是病人持續治療的因素?我們是否應把這視為單純的遞延營收,之後在今年剩餘時間應該會追上?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Yeah, Sameer, you want to take that one for Doug?

    Sameer,你要替 Doug 回答這題嗎?

  • Sameer Goregaoker - Chief Commercial Officer

    Sameer Goregaoker - Chief Commercial Officer

  • I'll take a shot at that. Thank you, Doug, for the question.

    我來試著回答。謝謝你,Doug,這個問題。

  • So I think the first part of that question is it did affect our -- I believe it affected our existing patients. New patients, as I mentioned in my prepared remarks, we had more new accounts either starting or restarting new patients than we had in the past. So, our new patient growth seems robust. I believe what happened is the existing patients because of seasonality, insurance changes, plus the weather, there were some hiccups in ongoing treatment.

    我想這個問題的第一部分是:它確實影響了我們——我相信它影響的是我們既有病人。至於新病人,如我在事先準備的發言中提到,我們新增帳戶(不論是開始或重新開始新病人治療)的數量比過去更多。所以,我們的新病人成長看起來相當強勁。我認為發生的情況是:既有病人因為季節性、保險變更,再加上天氣因素,導致持續治療出現一些小插曲。

  • So that's where we lost some cycles. I don't think we're going to get those cycles back because if you're on a three-week cycle and you miss your cycle this week, you basically go back in a new three-week cycle. So that one cycle is lost basically forever.

    所以我們在那裡少了一些療程週期。我不認為我們能把那些週期補回來,因為如果你是三週一個週期,而你這週錯過了,那基本上就會回到新的三週週期。所以那一個週期基本上就永遠失去了。

  • But again, let me just kind of go back to what we said earlier, right? So that's Q1, right? So we're pretty excited about the new patient starts continuing on track and ability to drive demand growth for the rest of this year.

    不過,再讓我回到我們先前說的,對吧?那是第一季,對吧?所以我們對新病人開始用藥持續按計畫推進、以及在今年剩餘時間推動需求成長的能力,感到相當振奮。

  • Douglas Tsao - Equity Analyst

    Douglas Tsao - Equity Analyst

  • Can I jump in with the follow-up, Dennis?

    Dennis,我可以接著問一個追問嗎?

  • Just maybe on tagmo, obviously, we have a significant number of readouts through beginning in the middle part of the year and into the second-half of the year. I guess just when you think about where you are from the balance sheet, Dennis, are you able to -- and I think you would certainly play to succeed or assume that you're going to succeed with these studies. Do you think that you're in a position to continue to sort of prosecute all these opportunities or is there some prioritization that might need to happen?

    就 tagmo 而言,很明顯我們從年中開始到下半年初會有相當多的讀出。我想問的是,Dennis,從資產負債表的角度來看,你們是否能夠——而且我想你們當然會以成功為目標,或假設這些研究會成功——你認為你們有能力持續推進並把握所有這些機會嗎?還是可能需要做一些優先順序的取捨?

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • I would direct you back to my prepared remarks at the beginning of the call, but we are certainly funded through the ‘26 and all the ‘27 turning over of all the data cards.

    我會請你回到我在電話會議一開始的事先準備發言,但我們確實有資金可支應到 2026 年,以及 2027 年所有數據讀出。

  • One thing that we do is if we have an unfunded clinical trial or we have something that we believe is worthwhile, we take it to our investors. And currently, all of our clinical trials are funded. We just raised, as you know and that really addressed the issues of the CRC studies which were not funded, as well as the prostate study with J&J, both of which, I think you'd agree, are very worthwhile. So that's pretty much our approach to it. We don't foresee any additional trials right now. I think that we've done a very good job with a very broad development program across Tagmokitug and a very highly focused program with respect to Casdozokitug. So I think we're set.

    我們做的一件事是:如果有未獲資金支持的臨床試驗,或有我們認為值得做的事情,我們會把它帶給投資人。而目前,我們所有臨床試驗都有資金支持。如你所知,我們剛完成募資,這確實解決了先前未獲資金支持的 CRC 研究,以及與 J&J 合作的前列腺研究;我想你也會同意,這兩項都非常值得投入。所以這大致就是我們的做法。我們目前不預期會有額外的試驗。我認為我們在 Tagmokitug 上做了一個非常廣泛的開發計畫,同時在 Casdozokitug 方面則是非常聚焦的計畫。所以我認為我們已經就緒。

  • Thank you, Doug.

    謝謝你,Doug。

  • Operator

    Operator

  • Thank you. There seems to be no further questions. I would like to hand back for closing remarks.

    謝謝。看起來沒有進一步的問題。我想把時間交回去做結語。

  • Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

    Dennis Lanfear - Chairman of the Board, President, Chief Executive Officer

  • Thank you, Heidi. Thank you all for joining us today in our Q1 2026 call. We look forward to seeing you again on our August call, which will be very exciting. In the interim, we'll see you at Jefferies, where we'll be presenting, and we'll also be at ASCO.

    謝謝你,Heidi。謝謝各位今天參加我們 2026 年第一季的電話會議。我們期待在八月的電話會議再與各位見面,屆時會非常令人振奮。在此期間,我們會在 Jefferies 與會並進行簡報,也會參加 ASCO。

  • Thank you. Bye-bye.

    謝謝。再見。

  • Operator

    Operator

  • 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。感謝各位參與。您現在可以掛線。