Bicara Therapeutics Inc (BCAX) 2026 Q2 法說會逐字稿

Good day and thank you for standing by.

大家好，感謝您稍候。

Welcome to the Bakara.

歡迎參加 Bakara。

Therapeutics Second Quarter 2026 Earnings Conference Call.

Therapeutics 2026 年第二季財報電話會議。

(Operator Instructions)

（接線員指示）

At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you need to press *11 on your telephone. You will then hear an automated message advising your hand is raised.

目前所有與會者皆為僅收聽模式。在講者簡報結束後，將進行問答環節。若要在問答環節提問，請在電話上按 *11。之後您將聽到自動語音訊息，告知您的舉手已提出。

To infer your question, please press *11 again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker for today. Rachel Frank, please go ahead.

若要取消提問，請再按一次 *11。提醒您，今日會議將被錄音。現在我將把會議交給今天的講者。Rachel Frank，請開始。

Thank you, and good morning, everyone. It's a pleasure to welcome you to Bycara Therapeutics' second quarter 2026 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter and provided a business update, including strategic leadership transitions marking the company's next era of growth and execution. You can access the press release as well as the slides that we'll be reviewing today by going to the Investors section of our company website.

謝謝，各位早安。很高興歡迎各位參加 Bycara Therapeutics 2026 年第二季財報電話會議。今天稍早，我們發布新聞稿，重點說明本季業績並提供業務更新，包括策略性領導層交接，標誌公司邁向下一個成長與執行的新時代。您可前往公司網站的投資人專區，取得新聞稿以及我們今天將檢視的簡報投影片。

Before we begin, please note that this call will include forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1,995. Please refer to our most recent SEC filings for important risk factors that could cause our actual performance and results to materially differ from those expressed or implied in these forward-looking statements. Any forward-looking statement made on this call represents our views only as of today, and we disclaim any obligation to update any forward-looking statements.

在開始之前，請注意本次電話會議將包含前瞻性陳述，並受 1995 年《私人證券訴訟改革法》安全港條款之保障。請參閱我們最新的 SEC 申報文件，其中載有重要風險因素，可能導致實際表現與結果與這些前瞻性陳述所明示或暗示者有重大差異。本次電話會議中所作的任何前瞻性陳述僅代表截至今日的觀點，我們不承擔更新任何前瞻性陳述之義務。

Joining us on the call today are Claire Mazindar, Chief Executive Officer Ryan Colgate, President and Chief Operating Officer and Ivan Hyatt, Chief Financial Officer. I'll now turn the call over to Claire.

今天與會的還有：執行長 Claire Mazindar、總裁兼營運長 Ryan Colgate，以及財務長 Ivan Hyatt。接下來我把電話交給 Claire。

Before we get into today's announcements, I want to begin by acknowledging what has been another important quarter for Bicara.

在進入今天的公告之前，我想先指出，這又是 Bicara 一個重要的季度。

Across the organization, our team has continued to execute with focus and discipline as we advance the pivotal Phase III Fortify HNO1 study of Physera-alpha or Physera and frontline recurrent and metastatic HPV-negative head and neck squamous cell cancer.

在整個組織中，我們的團隊持續以專注與紀律推進關鍵性的第三期 Fortify HNO1 研究，評估 Physera-alpha（或稱 Physera）用於一線復發與轉移性 HPV 陰性頭頸部鱗狀細胞癌。

We also have strengthened our operational capabilities as we prepare the company for an exciting next chapter as we near a top-line interim analysis of our pivotal study and potential commercialization.

隨著我們接近關鍵性研究的主要期中分析以及潛在商業化，我們也強化了營運能力，為公司令人振奮的下一篇章做好準備。

Part of that momentum was our ASCO 2026 update, where we presented three-year follow-up data showing that TGF beta inhibition leading to direct tumor penetration translates to unprecedented depth and duration of response. At three years, Physera nearly doubled overall survival versus standard of care while maintaining a consistent safety profile, all driven by TGF beta inhibition.

這股動能的一部分來自我們在 ASCO 2026 的更新，我們發表了三年追蹤資料，顯示 TGF beta 抑制所帶來的直接腫瘤滲透，可轉化為前所未有的反應深度與持續時間。在三年時點，Physera 在維持一致安全性概況的同時，整體存活期幾乎較標準治療翻倍，而這一切皆由 TGF beta 抑制所驅動。

I'm incredibly proud of everything our employees have accomplished and grateful for their continued commitment to our mission.

我為員工所完成的一切感到無比自豪，也感謝他們持續投入我們的使命。

Today's leadership announcements reflect that same philosophy of thoughtful planning that has governed our approach to the development of Physera. Since founding Bycara, our goal has never been simply to build a successful development stage biotech company. It has been to build an enduring organization, one with the leadership, culture, and capabilities to create lasting value for patients and shareholders for many years to come.

今天的領導層公告，反映了同樣的理念：以審慎規劃來推動我們對 Physera 的開發策略。自創立 Bycara 以來，我們的目標從來不只是打造一家成功的研發階段生技公司。我們的目標是建立一個可長可久的組織，具備領導力、文化與能力，能在未來多年持續為病患與股東創造長期價值。

The leadership changes we are announcing today represent the next step in that evolution. Today, I am thrilled to announce that at the beginning of next year, Ryan will become President and Chief Executive Officer, while I transition to the role of Vice Chair of the Board and Strategic Advisor.

我們今天宣布的領導層變動，代表這段演進的下一步。我很高興宣布，從明年年初起，Ryan 將出任總裁兼執行長，而我將轉任董事會副主席與策略顧問。

When Ryan joined me in launching Bicara more than five years ago, we always discussed this moment as being the time at which I would hand him the torch. And it's a reflection of our collective accomplishment that we're here today with a clear line of sight to top-line interim analysis of our pivotal study that we believe may lead to an accelerated approval and subsequent launch. As we look toward that potential launch, Ryan's experience makes him exceptionally well suited to lead the organization.

當 Ryan 在五年多前與我一同創立 Bicara 時，我們一直把這一刻視為我將火炬交給他的時點。而我們今天能站在這裡，清楚看見關鍵性研究主要期中分析的進展，我們相信這可能帶來加速核准並在其後上市，這也反映了我們共同的成果。展望潛在上市，Ryan 的經驗使他特別適合帶領組織前行。

As many of he has over two decades of life science leadership from early stage R&D all the way through global commercial execution, including running Takeda's U.S. Oncology portfolio and launching multiple approved drugs for solid and hematologic tumors.

如同許多人所知，他在生命科學領域擁有逾二十年的領導經驗，從早期研發一路到全球商業化執行，包括負責武田（Takeda）美國腫瘤產品組合，並成功上市多項已核准、用於實體瘤與血液腫瘤的藥物。

My own training is as a cancer biologist, and that background has shaped how I have led by Kara from the beginning. Staying close to the science and building the company around it. But commercialization calls for something different.

我本身受訓背景是癌症生物學家，而這樣的背景也形塑了我自一開始帶領 Bycara 的方式：緊貼科學，並以科學為核心打造公司。但商業化需要的是不同的能力。

Real hands-on experience launching drugs and building commercial organizations. And that is precisely Ryan's experience. Both I and the entire Bicara Board of Directors have complete confidence that he is the right leader to guide us to our next chapter as we prepare for the potential commercialization of Bicera and the next phase of growth at Bicara.

需要真正親身參與藥品上市與建立商業組織的實務經驗。而這正是 Ryan 的專長。我本人以及整個 Bicara 董事會都完全相信，他是帶領我們邁向下一篇章的最佳領導者，因應 Bicera 的潛在商業化以及 Bicara 下一階段的成長。

As I step into my new role as Vice Chair and Strategic Advisor, I look forward to continuing our partnership closely, supporting Ryan and this leadership team to our next phase.

當我轉任董事會副主席與策略顧問的新角色時，我期待能持續緊密合作，支持 Ryan 與這個領導團隊邁向下一階段。

I'm also pleased to announce that Jen Larson will join Bicara as our Chief Financial Officer, succeeding Ivan effective tomorrow. You'll hear from Ivan in a few minutes on our financials for the quarter, but first I'd like to thank him for everything he has contributed to Bicara.

我也很高興宣布，Jen Larson 將加入 Bicara 擔任財務長，自明日起接任 Ivan。稍後您將聽到 Ivan 針對本季財務狀況的說明，但在此之前，我想先感謝他對 Bicara 的所有貢獻。

As one of our early executives, he played a critical role in helping establish our finance organization, leading by car through more than $800 million in capital raises, stewarding our transition to the public markets, and building the financial foundation that has positioned us for where we are today.

作為我們早期的高階主管之一，他在建立財務組織方面扮演關鍵角色，帶領 Bycara 完成超過 8 億美元的募資，推動我們轉進公開市場，並建立財務基礎，使我們得以走到今天的位置。

We are sincerely grateful for his leadership. At the same time, we're excited to welcome Jen to the leadership team.

我們由衷感謝他的領導。同時，我們也很高興歡迎 Jen 加入領導團隊。

Jen brings extensive experience leading finance organizations at commercial stage biotech companies and has a strong track record of helping organizations navigate growth and commercialization.

Jen 在商業化階段的生技公司領導財務組織方面擁有豐富經驗，並具備協助組織因應成長與商業化的優異實績。

Her expertise will be an important addition as we head into this important stage ahead.

在我們邁入這個重要階段之際，她的專業將是關鍵的補強。

I also want to highlight that we recently announced the appointments of Jeremy Bender and Christy Olinger to our board directors.

我也想強調，我們近期宣布任命 Jeremy Bender 與 Christy Olinger 擔任董事會董事。

Both new board members bring a strong track record of guiding biopharmaceutical companies through critical stages of growth, including pipeline development, corporate strategy, and commercialization. And their experience and guidance will strengthen our board as we look toward the future of Bicara.

兩位新任董事都具備在關鍵成長階段引導生物製藥公司前進的卓越實績，包括產品線開發、公司策略與商業化。他們的經驗與指導，將在我們展望 Bicara 未來之際強化董事會的力量。

Personally, this transition is a meaningful moment for me. Looking back, I'm incredibly proud of what we've accomplished together, from advancing bold science to building an exceptional team and culture that I believe will continue to differentiate BICARA well into the future.

就我個人而言，這次交接對我意義重大。回顧過去，我對我們共同完成的一切感到無比自豪——從推進大膽的科學，到打造一支卓越的團隊與文化；我相信這些將在未來很長一段時間持續讓 BICARA 脫穎而出。

While my role at BICARA is evolving, my commitment to its success is unwavering. I look forward to continuing to support Ryan, our leadership team, and our board as BICARA enters this exciting next phase.

雖然我在 BICARA 的職務正在演變，但我對其成功的承諾始終堅定不移。我期待在 BICARA 進入這個令人振奮的下一階段之際，持續支持 Ryan、我們的領導團隊以及董事會。

With that, let me turn the call over to Ryan for a few remarks.

接下來，讓我把電話會議交給 Ryan，請他說幾句。

Thank you, Claire.

謝謝你，Claire。

I first want to acknowledge your extraordinary leadership and partnership. Since ICARA's founding, you've established not only a compelling scientific vision, but also a culture centered on excellence, collaboration, and unwavering commitment to patients. It has been a privilege to work alongside you, and I'm grateful for your continued partnership as you transition into your new role.

我首先想肯定你卓越的領導力與夥伴關係。自 ICARA 成立以來，你不僅建立了引人入勝的科學願景，也打造了以卓越、協作以及對病患堅定承諾為核心的文化。能與你並肩合作是我的榮幸，也感謝你在轉任新職務之際仍持續與我們合作。

I'm honored by the confidence the Board has placed in me and energized that lies ahead. As Claire mentioned, this transition is not about changing our direction. It's about building upon a foundation that has been intentionally created over many years and bringing my own background in oncology drug launches and pipeline expansions there as I step up to succeed Claire.

我很榮幸獲得董事會對我的信任，也對未來充滿幹勁。如 Claire 所提到，這次交接並不是要改變我們的方向。而是要在多年來有意打造的基礎之上繼續建構，並在我接任 Claire 之際，帶入我在腫瘤藥物上市與產品線擴充方面的背景與經驗。

I had a clear vision for how we will build our commercial capabilities. Just precisely like Claire and the Board asked me with brain on a Chief Commercial Officer earlier this year, and Chris Sarkey is exactly the right leader to help realize it.

我對我們將如何建立商業化能力有清晰的願景。就如同今年稍早 Claire 與董事會在我擔任首席商務長時所要求我思考的一樣，而 Chris Sarkey 正是協助實現該願景的最佳領導人選。

Today, by car is in a very different position than when we started. We have a promising late-stage development program. Highly capable organization and a leadership team with the experience necessary to support the next phase of the company's evolution.

今天，Bicara 所處的位置已與我們起步時大不相同。我們擁有具前景的後期開發計畫。也有高度勝任的組織，以及具備支持公司演進下一階段所需經驗的領導團隊。

Our focus now is on executing against the opportunity with the same discipline and long-term perspective that is defined by CARA from the beginning. Looking ahead, our priorities are clear. We will continue preparing the organization for the potential commercialization of Picera while maintaining excellence and execution across every function.

我們目前的重點，是以自 CARA 一開始就定義的同樣紀律與長期視角，來把握並落實這個機會。展望未來，我們的優先事項很明確。我們將在維持各項職能卓越執行的同時，持續為 Picera 的潛在商業化做好組織準備。

At the same time, we'll continue to advance MICERA's development program thoughtfully and strategically, ensuring that we allocate capital and resources in ways that maximize long-term value creation. And just as important, we'll continue investing in the people and culture that become one of ICARA's greatest strengths, because building an enduring biotech company requires more than outstanding science. It also takes exceptional people working together with clarity, accountability, and shared purpose.

同時，我們也將以審慎且具策略性的方式持續推進 MICERA 的開發計畫，確保我們以能最大化長期價值創造的方式配置資本與資源。同樣重要的是，我們將持續投資於人才與文化——這已成為 ICARA 最重要的優勢之一，因為打造一家能長久經營的生技公司，所需的不僅是卓越的科學。還需要傑出的人才以清晰目標、責任承擔與共同使命協同合作。

I'm also excited about the strength and depth of the leadership team that will help guide BICARA through this next chapter, including two additional leadership transitions that will become effective in January as well. Tanya Green, currently our Chief Development Officer, will succeed me as Chief Operating Officer. And Jenna Cohen, currently our Chief Corporate Affairs Officer, will be promoted to Chief Business Officer.

我也對將協助引領 BICARA 進入下一篇章的領導團隊之實力與深度感到振奮，其中也包括兩項將於一月生效的額外高階主管交接。現任首席開發長 Tanya Green 將接任我擔任首席營運長。而現任首席企業事務長 Jenna Cohen 將晉升為首席商務長。

When Tanya joined us last year, it was immediately clear that she was suited to take on the COOC when the time came. Her appointment to the role reflects the strength of operational and executional excellence that has become an immediate hallmark of her leadership at Bicara.

Tanya 去年加入我們時，我們立刻就清楚她在時機成熟時非常適合接任 COO 一職。她的任命反映出她在 Bicara 的領導下，營運與執行卓越已迅速成為其領導風格的鮮明標誌。

Likewise, Jenna has made immediate strategic impact since joining Bicara. Her expanded role positions us well as we continue to strengthen our corporate strategy, corporate development, and long-term growth initiatives. Finally, we are pleased to welcome Greg Schiferman as Chief Legal Officer. Effective at the end of the month, Greg brings deep biotech legal experience to Vicara. He'll be a key partner to the team as we move through our pivotal milestones and toward a potential commercial launch of Vicera.

同樣地，Jenna 自加入 Bicara 以來也立即帶來策略層面的影響。她擴大的職責將使我們在持續強化公司策略、企業發展以及長期成長計畫方面更具優勢。最後，我們很高興歡迎 Greg Schiferman 出任首席法務長。Greg 將於本月底生效加入，為 Vicara 帶來深厚的生技法務經驗。在我們推進關鍵里程碑並邁向 Vicera 潛在商業上市的過程中，他將成為團隊的重要夥伴。

As we approach what we believe will be a transformational period for Vicara, our mission remains unchanged. Bring Vicera to patients who need it most urgently, starting with people living with HPV negative head and neck cancer. Continue advancing innovative science, execute with discipline, and create long-term value for all of our stakeholders, starting with the patients we serve.

在我們邁向我們相信將為 Vicara 帶來轉型的時期之際，我們的使命不變。將 Vicera 帶給最迫切需要的病患，首先是罹患 HPV 陰性頭頸癌的人。持續推進創新科學、以紀律執行，並為所有利害關係人創造長期價值——首先是我們所服務的病患。

With that in mind, I want to highlight some of the important recent progress that we have made. First, as Claire mentioned previously, this past May at ASCO, we presented the most comprehensive and mature clinical data set assembled for Feisera and first-line recurrent or metastatic HPV-negative head and neck cancer.

基於此，我想重點說明我們近期取得的一些重要進展。首先，如 Claire 先前提到，今年五月在 ASCO 上，我們發表了針對 Feisera 以及一線復發或轉移性 HPV 陰性頭頸癌所彙整的最完整、最成熟的臨床資料集。

These data span approximately 90 patients across three dose cohorts, with up to three years of follow-up in our 1,500-milligram weekly pivotal dose. The longest follow-up presented of any investigational agent in the HPV-negative head and neck cancer space. Visera continued to deliver deep, durable responses, reinforcing its best-in-class potential in this setting.

這些資料涵蓋約 90 名病患、橫跨三個劑量隊列；在我們每週 1,500 毫克的關鍵劑量下，最長追蹤時間可達三年。這也是 HPV 陰性頭頸癌領域中，任何研究中藥物所呈現的最長追蹤資料。Visera 持續帶來深度且持久的反應，進一步強化其在此適應症中具同級最佳（best-in-class）潛力。

At our pivotal study dose of 1,500 milligrams weekly, an estimated one in three patients was alive at three years. Approximately doubling the survival rate observed in retrospective analyses with standard of care pembrolizumab and HPV-negative patients. Importantly, EGF-8 inhibition was observed to be the mechanistic foundation of this clinical benefit, driving tumor penetration, enabling immune cell infiltration, and translating depth of response into durable long-term survival, a clinical profile no other EGFR-directed therapy in head and neck cancer has demonstrated.

在我們關鍵性研究的每週 1,500 毫克劑量下，估計約每三位病患就有一位在三年時仍存活。相較於回溯性分析中，使用標準治療 pembrolizumab 的 HPV 陰性病患所觀察到的存活率，約提升至兩倍。重要的是，觀察到 EGFR-8 抑制是此臨床效益的機制基礎，能促進腫瘤滲透、使免疫細胞得以浸潤，並將反應深度轉化為持久的長期存活；這樣的臨床特徵，是其他任何針對 EGFR 的頭頸癌療法所未曾展現的。

Second.

第二。

The execution of Fortify HN01 remains a top priority. We are on track for substantial enrollment by year end, keeping us positioned for an interim analysis in mid-2027 and a potential path to accelerated approval.

Fortify HN01 的執行仍是最優先事項。我們正按計畫在年底前達成可觀的收案進度，使我們仍有望在 2027 年年中進行期中分析，並具備走向加速核准的潛在路徑。

We continue to see strong momentum across the study with over 200 sites now active and sustained engagement from our investigator base more broadly.

我們持續看到該研究的強勁動能，目前已有超過 200 個試驗中心啟動，且研究者群體的參與度也持續維持在高水準。

Third, we are excited to announce we have initiated Fortify FLEX. Our alternative dosing study to support our loading and every three-maintenance dose. The speed in which we designed and activated the study on the heels of strong clinical data from our exploratory every two-week cohort presented earlier this year is a hallmark of the BiCARA way, following the science and executing with speed and precision that best serve the needs of patients. Our goal with Fortify Flex is to have the data in hand by the time of our central U.S. Approval, supporting a compelling path for earlier adoption of this streamlined regimen.

第三，我們很高興宣布已啟動 Fortify FLEX。這是我們的替代給藥研究，用以支持我們的負荷劑量以及每三週一次的維持劑量。在今年稍早我們發表探索性每兩週一次隊列的強勁臨床資料之後，我們能以如此速度完成研究設計並啟動，正是 BiCARA 方式的體現：遵循科學，並以速度與精準執行，以最能滿足病患需求。我們對 Fortify Flex 的目標，是在我們於美國取得核心核准之時即可掌握相關資料，以支持這一更精簡療程能更早被採用的具說服力路徑。

Finally, beyond our pivotal trial population, we continue to build out by Sarah's broad development strategy, both within head and neck cancer and beyond, where we have already established proof of concept and additional indications, including cutaneous squamous cell carcinoma and canal cancer.

最後，除了我們的關鍵性試驗族群之外，我們也持續依循 Sarah 的廣泛開發策略擴展布局，涵蓋頭頸癌領域內以及其他領域；在其他適應症方面，我們已建立概念驗證並拓展更多適應症，包括皮膚鱗狀細胞癌與肛管癌。

Building on this foundation, there's a lot of momentum right now.

在這個基礎之上，目前動能十足。

I couldn't be more optimistic about the future, and I look forward to leading this outstanding organization into its next chapter. I'll now turn the call over to Ivan to discuss our financials.

我對未來再樂觀不過，也期待帶領這個傑出的組織邁入下一篇章。接下來我將把電話會議交給 Ivan，請他說明我們的財務狀況。

Thanks, Ryan. Earlier this morning, we reported detailed second quarter 2026 financial results in our press release, and I'll summarize a few highlights here.

謝謝你，Ryan。今天稍早，我們已在新聞稿中公布了2026年第二季的詳細財務結果，我在此摘要幾項重點。

Our total operating expenses for the second quarter of 2026 increased compared to the second quarter of 2025, driven by clinical operations and development expenses associated with our ongoing pivotal Fortify H101 study, including increased manufacturing and development costs.

我們2026年第二季的總營運費用較2025年第二季增加，主要受臨床營運以及與我們正在進行的關鍵性Fortify H101研究相關的研發費用所帶動，其中包含製造與開發成本的增加。

We also saw an increase in personnel-related costs, including stock-based compensation, as we have grown our workforce, primarily in support of clinical operations and development functions.

隨著我們擴編人力（主要用於支援臨床營運與開發職能），人員相關成本亦有所上升，包括以股份為基礎的薪酬。

We expect quarter-over-quarter operating expenses to increase for the remainder of the year, driven by continued investment in clinical operations, technical operations and workforce growth in support of those functions.

我們預期今年剩餘期間的營運費用將呈現季對季增加，主因為持續投資於臨床營運、技術營運，以及為支援上述職能而進行的人力擴增。

We anticipate increased spend within clinical operations to support our pivotal study, Fortify HNL1, particularly as we expect to be substantially enrolled by the end of this year to enable a top-line interim analysis in the middle of 2027, as well as new investment in Fortify Flex, our alternative dosing study, which was recently initiated.

我們預期臨床營運支出將增加，以支援我們的關鍵性研究Fortify HNL1；特別是我們預計在今年底前達到大致完成收案，以便於2027年年中進行主要指標的期中頂線分析；此外，對於近期已啟動、作為替代給藥研究的Fortify Flex，我們也將投入新的投資。

Given the strength of a maturing Phase 1B data for Physara in head and neck cancer and consistent with today's leadership announcements that positions us well for our next phase of growth and execution, we also anticipate increased investment in key functions to enable launch readiness, including medical affairs and our commercial organization, to position us for launch success upon potential U.S. Regulatory approval.

鑑於Physara在頭頸癌的第一期B（Phase 1B）數據日趨成熟且表現強勁，並與今日的領導團隊任命一致、使我們在下一階段的成長與執行上具備良好定位，我們也預期將加大對關鍵職能的投資，以提升上市準備度，包括醫藥事務與商業組織，讓我們在潛在取得美國監管核准後能成功上市。

We ended the second quarter of 2026 with approximately $497 million in cash equivalents, and marketable securities, which provides cash runway into the first half of 2029.

截至2026年第二季末，我們持有約4.97億美元的現金約當物與有價證券，可支應營運資金至2029年上半年。

That runway is expected to take us through several important milestones, including advancing the pivotal FORTIFY-H101 study in Physera in frontline recurrent metastatic HPV-negative head and neck cancer through to a primary overall survival analysis, supporting a planned regulatory filing for Physera, providing initial investment into medical and commercial infrastructure ahead of a potential U.S. Approval and launch. Clinical development costs for Fortify Flex, and funding manufacturing costs for Physera for existing drug development efforts.

預期該資金可支應我們達成數項重要里程碑，包括推進Physera在一線復發／轉移性HPV陰性頭頸癌的關鍵性FORTIFY-H101研究，直至主要整體存活期（OS）分析；支援Physera的規劃監管申請；在潛在取得美國核准與上市之前，對醫療與商業基礎建設進行初期投資並為上市做準備。Fortify Flex的臨床開發成本，以及為現有藥物開發工作提供Physera的製造成本資金。

Before we begin our Q&A section, I want to close by saying that it has been an incredible privilege to help build Vicara's finance organization from the ground up and to be a part of this team as we have grown from a private company to where we stand today. It has been an honor to work alongside Claire and Ryan for all these years. I am proud of what we have built together.

在開始Q&A之前，我想以一句話作結：能夠從零開始協助建立Vicara的財務組織，並在公司從私人企業一路成長到今天的過程中成為團隊一員，是一項無比的榮幸。多年來能與Claire與Ryan並肩合作，是我的榮幸。我為我們共同打造的一切感到自豪。

As I have gotten to know Jen, I am credibly confident that she is the right person with the right commercial experience set to lead the finance organization from here.

在與Jen相處並更了解她之後，我非常有信心她是合適的人選，具備正確的商業經驗組合，能從此刻起帶領財務組織向前。

Thank you.

謝謝。

With that, I'll now turn the call back over to the operator for questions. Operator.

接下來，我把電話交回給接線員進行提問。接線員。

Thank you.

謝謝。

(Operator Instructions) As a reminder, if you would like to ask a question, please press *11 on your telephone. If you would like to remove yourself, please press *11 again. We also ask that you wait for your name and company to be announced before proceeding with your question. One moment while we compile the Q&A roster.

(接線員指示) 提醒各位，如欲提問，請在電話上按*11。如欲取消排隊，請再按一次*11。我們也請您在姓名與公司被宣布後再開始提問。我們正在整理Q&A名單，請稍候。

First question will be coming from the line of Eric Smith of Cancer. Please go ahead.

第一個問題來自Cancer的Eric Smith。請發言。

Thanks for taking my question.

謝謝讓我提問。

Just let me start by saying congrats to Ryan and the team on the new appointments. And of course, Claire and Ivan, we'll miss you going forward.

我先說，恭喜Ryan和團隊的新任命。當然，Claire和Ivan，接下來我們會想念你們。

And maybe a question on the transition for you, Claire, when you did discuss years ago with Ryan that this was the right moment for the transition. Why is this the right moment for the transition? Why say in advance of data as opposed to following the Phase 3 readout?

也許我想問一下交接的問題，Claire，你多年前與Ryan討論過，這是交接的適當時機。為什麼現在是交接的正確時點？為什麼選擇在數據出來之前宣布，而不是等到第三期（Phase 3）讀出之後？

Thank you.

謝謝。

Thanks for your question, Eric.

謝謝你的問題，Eric。

And when Ryan and I actually met six years ago to talk about BICARA, we always knew there would be a time when we would need to establish our commercial infrastructure and get ready for launch readiness in advance of top-line data.

Ryan和我其實在六年前首次會面討論BICARA時，我們就一直知道，未來會有一個時間點需要建立商業化基礎建設，並在頂線數據出來之前就開始為上市做準備。

As we entered this year building on very strong momentum for Fortify Channel 1, I started to really see the light at that end of the tunnel and knew that we needed to elevate a new executive team to build that foundation. And so we saw this as an intentional succession planning from the position of strength that allowed us to set the groundwork for what's to come. I'm very excited about the momentum we have. Have, and I look forward to supporting as a strategic advisor and vice chair. I'm not planning to disappear in any way. This is just to elevate a team of experienced executives who have significant commercial experience.

今年我們在Fortify Channel 1的強勁動能之上持續推進時，我開始真正看到隧道盡頭的曙光，也知道我們需要提升一個新的高階管理團隊來打下這個基礎。因此，我們將此視為在優勢基礎上進行的、有意識的接班規劃，使我們能為未來鋪路。我對我們目前的動能感到非常振奮。我也期待以策略顧問與副董事長的身分持續支持。我完全沒有要消失的打算。這只是為了提升一支具備豐富商業經驗的資深主管團隊。

And Claire, can I ask if you've got a full-time opportunity that you're thinking about or lined up?

Claire，我可以問你是否有在考慮或已安排其他全職機會嗎？

No, BICAR is my full-time opportunity from that perspective. I'm not taking on any additional operational roles.

沒有，從那個角度來看，BICAR就是我的全職機會。我不會再承擔任何額外的營運職務。

Thank you very much.

非常感謝。

Thank you. One moment for the next question.

謝謝。請稍候，下一個問題。

Tyler Van Buren of TD Cowen, your line is open.

TD Cowen的Tyler Van Buren，您的線路已開通。

Hey guys, good morning. Claire and Ivan, I too want to thank you and congratulate you for all of your accomplishments. You both will be missed and I'd also like to congratulate Ryan, Tanya, Jen, Jenna, and Greg on the promotions. Look forward to continuing to work together.

各位早安。Claire和Ivan，我也想向你們致謝並恭喜你們所有的成就。你們兩位都會被想念；我也要恭喜Ryan、Tanya、Jen、Jenna與Greg升任。期待繼續合作。

Maybe you guys could discuss how you'll manage enrollment of the Fortify Flex study so that it's not disruptive.

也許你們可以談談，將如何管理Fortify Flex研究的收案，以避免造成干擾。

To completing enrollment for the primary ongoing Fortify trial.

以完成主要、正在進行中的Fortify試驗收案。

And then the second question would just be, as you continue to evaluate the competitive head and neck cancer landscape, are there any presentations, ESMO, that you believe are important to note and that you'll be paying close attention to?

第二個問題是，當你們持續評估頭頸癌競爭態勢時，是否有任何你們認為值得注意、並會密切關注的發表（例如ESMO）？

Hey, Tyler, thank you for the question. I'll start and then pass it over to Tanya to speak a little bit about more about Fortify Flux. As you can imagine, we have been very deliberate and thoughtful in terms of the footprint around Fortify Flux in order to make sure that it does nothing to, impede the continued progress that we have on Fortify. But, I'll let Tanya speak to that a bit more. As far as, again, what we've seen thus far, we are aware of.

Tyler，謝謝你的問題。我先回答，接著再請Tanya多談一些Fortify Flux。如你所想像，我們在Fortify Flux的佈局上一直非常審慎且深思熟慮，以確保它不會對我們在Fortify上的持續進展造成任何阻礙。不過，我會讓Tanya再多補充一些。至於目前我們所看到的，我們也已注意到。

Abstracts that are going to be out there from J&J with Annie.

來自 J&J 與 Annie 的摘要將會對外發布。

And it also appears as if there will be some additional data on something that is not quite clear exactly what we'll see there. But obviously, we will monitor that, very closely. Over that, Tanya, do you want to speak a little bit more to what we've done with Fortify Flux?

而且看起來似乎還會有一些額外數據，但目前還不太清楚我們究竟會在那裡看到什麼。不過很明顯地，我們會非常密切地關注。接下來，Tanya，你要不要再多談一點我們在 Fortify Flux 上做了什麼？

Sure. Hi, this is Tanya Green, Chief Development Officer. Thanks for the question, Tyler. So, we are, thoughtfully thinking about the potential overlap of sites. As it stands, there's only about a third of sites that will overlap with our Fortify HNO1 study, and we'll be looking at different regions across Europe. Latin America, Asia Pacific, and the U.S. And ensure that we're stage dating enrollment so that four to five remains our top priority in terms of enrollment.

當然。大家好，我是 Tanya Green，首席開發長。謝謝你的提問，Tyler。所以，我們正在審慎地思考研究中心可能重疊的情況。就目前而言，只有大約三分之一的研究中心會與我們的 Fortify HNO1 研究重疊，而我們也會在歐洲不同地區進行。拉丁美洲、亞太地區以及美國，並確保我們分階段安排入組，使得第 4 至第 5 階段仍然是我們在入組方面的首要優先事項。

One moment for the next question.

請稍候，進行下一個問題。

And our next question is coming from the line of Steven Willey of Stifel.

下一個問題來自 Stifel 的 Steven Willey。

Please go ahead.

請開始提問。

Yeah, good morning. I would just like to echo my appreciation to declare an item and congrats to everyone on the new appointments.

是的，早安。我也想呼應一下我的感謝，並恭喜大家的新任命。

Maybe just a couple of questions. So I guess as we get closer to a year-end colorectal disclosure, just curious if you have a better sense of the number of patients and duration of follow-up we should expect to see. And I guess now that you have...

我這邊可能有兩個問題。我想隨著我們接近年底的大腸直腸癌數據揭露，想請教你們是否更清楚我們應該預期看到的病患人數以及隨訪時間長度。另外我想，既然你們已經……

Initiated the 45 flex study should be anticipated any additional development steps in colorectal or additional tumor types to also leverage induction and maintenance, and I just have a follow-up.

啟動了 45 flex 研究，是否預期在大腸直腸癌方面還會有任何額外的開發步驟，或是其他腫瘤類型也會利用誘導與維持治療策略？我還有一個追問。

Thank you for your question, Steve. So to speak to the third-line CRC studies that we are pursuing, as you may remember, we have two open-label signal-seeking cohorts we're looking at, both are third-line plus MSS. Colorectal cancer, KRAS and BRAS wild-type patients, one as a monotherapy with Physera, the other in combination with Pembro. We anticipate having approximately 20 patients in each of these cohorts with short-term follow-up. So it will be really a look at early safety and efficacy from those cohorts at the time of the disclosure.

謝謝你的問題，Steve。就我們正在推進的第三線 CRC 研究而言，如你所記得的，我們有兩個開放標籤、尋找訊號的隊列正在觀察，兩者皆為第三線以上且為 MSS。大腸直腸癌、KRAS 與 BRAS 野生型患者；其中一個是 Physera 單藥治療，另一個則與 Pembro 聯合。我們預期每個隊列約有 20 位患者，且為短期隨訪。因此，在揭露時點，將主要呈現這些隊列的早期安全性與療效觀察。

To your second question around other types of focus, you will see us really develop a strategy around other indications outside of our Fortify Gen01 study. We have already demonstrated proof of concept in cutaneous plain cell carcinoma and **** canal cancer and do believe that there is a lot of biology and combination approaches in CRC as well that we have been exploring.

至於你第二個問題、關於其他聚焦的腫瘤類型，你會看到我們確實會在 Fortify Gen01 研究之外，制定其他適應症的策略。我們已在皮膚鱗狀細胞癌以及****管癌中展示概念驗證，也相信在 CRC 方面有許多生物學與聯合治療策略值得探索，我們也一直在研究。

And that will be pursued with induction and maintenance.

而這將會以誘導與維持治療的方式來推進。

Sorry, in colorectal cancer or?

抱歉，是在大腸直腸癌，還是？

Yeah, just colorectal and other tumor types.

對，就是大腸直腸癌以及其他腫瘤類型。

Correct. We've been looking both at, late line tumors as well as earlier in the case of head and neck in the locally advanced setting as well, as where we have...

沒錯。我們同時也在看後線腫瘤；另外在頭頸癌方面，也在局部晚期的情境下更早期地評估，並且在那裡我們也有……

Okay.

好的。

Curious, how do you think a potential approval of ambient second-line patients might impact post-progression treatment dynamics of Fortify? And can you just remind us what percentage of sites that you've enrolled and activated in Fortify are based in the U.S.?

我想了解，若第二線患者可能獲得 emivantamab 的核准，會如何影響 Fortify 在疾病進展後的治療動態？另外也請提醒一下，在 Fortify 中你們已入組並啟動的研究中心，有多少比例位於美國？

Thank you.

謝謝。

I believe about 20% of our sites are. In the U.S. Today in terms of our frontline FORTIFIA channel 1 study.

我相信大約有 20% 的研究中心位於。就我們目前的第一線 FORTIFIA channel 1 研究而言，在美國。

And to your question around the potential accelerated approval of emivantamab in second line, we don't anticipate seeing significant changes to our enrollment study, given we do plan to be substantially enrolled for the interim analysis by end of year and remain on track to do so.

至於你提到 emivantamab 在第二線可能加速核准的問題，我們不預期會對我們的研究入組造成顯著變化，因為我們計畫在年底前為期中分析達到相當程度的入組，且目前仍按計畫進行。

All right.

好的。

Thanks for taking the questions.

謝謝回答我的問題。

Thank you. One moment for the next question, please.

謝謝。請稍候進行下一個問題。

Next question is coming from the line of Bradley Canino of Guggenheim. Please go ahead.

下一個問題來自 Guggenheim 的 Bradley Canino。請開始提問。

Well, it's definitely rare. You get to congratulate so many people at once. So it's great to see the continuity for the company as well.

這確實很少見。可以一次恭喜這麼多人。所以也很高興看到公司的人事延續性。

Two check-in questions for me. First, in head and neck, I'm wondering, given it's been about two, three months since ASCO, what has been the physician reaction to the TGF data and core of biology work presented there? And have you noticed that impact enrollment in a positive way at all? And then second, maybe following up on Steve's question, just more of a pointed question colorectal, now that we have two EGF. Bispecifics moving into Phase 3s.

我有兩個確認問題。第一個，在頭頸癌方面，我想請教，距離 ASCO 大概已過了兩三個月，醫師對於當時呈現的 TGF 數據與核心生物學研究的反應如何？你們是否注意到這對入組有任何正面影響？第二個，延續 Steve 的問題，但更聚焦在大腸直腸癌：現在我們看到有兩個 EGF。雙特異性抗體正在進入第三期試驗。

Why are you not following that and how are you thinking about that balance against the opportunities you've called out in skin and rectal cancer?

你們為什麼不跟進這個方向？以及你們如何看待這與你們在皮膚癌與直腸癌所提到的機會之間的取捨平衡？

Thank you.

謝謝。

Thank you for your questions, Brad. So, to your first question, I do believe that ASCO was a very good -- we did get very good feedback from investigators at ASCO based off the data set. We shared the maturity of our data when it came to depth and durability of response, but also the tolerability profile that has now been seen with three years' worth of follow-up.

謝謝你的問題，Brad。就第一個問題而言，我確實認為 ASCO 是一次非常好的——我們確實根據該數據集在 ASCO 上從研究者那裡獲得非常好的回饋。我們分享了數據在反應深度與持久性方面的成熟度，同時也分享了在三年隨訪中所觀察到的耐受性特徵。

I think as we see the development strategies of our competitors, the feedback has continued to be extremely positive for BICARA and has led to, building significant momentum in geographies where both emivantamab and pdosimtamab were also enrolling patients. So we do think it was an important inflection point for us as well from a momentum standpoint with Fortify HN01. I think to your questions around colorectal cancer, while both Genmab and J&J have very different resources than by car, our intention has really been to follow the science. And go where we believe that not only there is a hypothesis for EGFR, but as well for TGF-beta. And that took us initially into, the third-line setting where we believed that TGF-beta expression played a significant role in EGFR resistance and beyond.

我認為，隨著競品的開發策略逐步明朗，對 BICARA 的回饋仍持續非常正面，並且在 emivantamab 與 pdosimtamab 也在入組患者的地區，帶動了顯著的動能累積。因此，我們確實認為，從 Fortify HN01 的動能角度來看，那也是我們的一個重要轉折點。至於你關於大腸直腸癌的問題，雖然 Genmab 與 J&J 的資源與 by car 非常不同，我們的意圖一直是跟隨科學。並前往我們相信不僅對 EGFR 有假說、同時也對 TGF-beta 有假說的領域。這最初帶領我們進入第三線情境，因為我們認為 TGF-beta 表現量在 EGFR 抗藥性及其後續中扮演重要角色。

We have already demonstrated that TGF-beta hypothesis in both cutaneous and **** canal cancer and believe that there is a strong rationale in the locally advanced setting of head and. That's not to say that there isn't a strategy in colorectal cancer, but we do believe that there are combination approaches that will make us a first-in-class approach rather than following our competitors into the frontline setting of MSS patients.

我們已在皮膚以及****管癌中驗證了這個 TGF-beta 假說，並相信在頭頸癌的局部晚期情境中也有強而有力的理據。這並不是說在大腸直腸癌沒有策略，但我們確實相信，透過聯合治療策略，我們可以成為同類首創（first-in-class）的做法，而不是跟隨競品進入 MSS 患者的第一線治療情境。

Thank you. One moment for the next question.

謝謝。請稍等，我們進行下一個問題。

The next question is coming to the line of Tavid Ahmad of Bank of America. Please go ahead.

下一個問題來自美國銀行（Bank of America）的 Tavid Ahmad。請開始提問。

Hi, good morning. Congratulations for me as well on all of the new roles for everyone.

嗨，早安。也恭喜大家在新職務上的任命。

I maybe just wanted to ask your thoughts about your competitors' update that they are still going to be presenting data from Frontline 10 and next by the end of this year.

我想請教你們對競爭對手最新更新的看法：他們仍計畫在今年底前公布 Frontline 10 及後續研究的數據。

When they do, what should we be thinking about in terms of readout or retrow rather for Ficera? Thanks.

當他們公布時，就 Ficera 而言，我們在解讀（readout）或更確切地說「讀穿」（read-through）方面應該如何思考？謝謝。

Thanks for your question, Taveen. So, what we do know just from the update from Genmab's earnings last week is that they do plan -- the only new information we have is the timelines are now slated for Q4 of this year for Library General 1 to read out. Our anticipation is at that top-line readout, we will likely get overall response rates data and not much more than that.

謝謝你的問題，Taveen。所以，我們目前從 Genmab 上週的財報更新中得知的是：他們確實有計畫——我們掌握到的唯一新資訊是時程已排定在今年第四季，Library General 1 將會讀出結果。我們預期在那次頂線（top-line）讀出時，可能會提供整體反應率（ORR）數據，而不會有太多其他資訊。

I think in many ways, the read-through is really around speaking to the potential profile of eGFRs, changing the treatment landscape as a standard of care in the frontline setting. And it will very much depend on how that data is. Out by HPV status and the like.

我認為在很多方面，所謂的讀穿重點其實在於：這些 eGFR 的潛在特徵輪廓，是否能在第一線治療情境下改變治療版圖、成為標準治療。而這將非常取決於數據表現如何。例如是否會依 HPV 狀態等進行分層呈現。

Thank you.

謝謝。

Thank you. One moment for the next question.

謝謝。請稍等，我們進行下一個問題。

Next question is coming from the line of Judah Frommer of Morgan Stanley. Please go ahead.

下一個問題來自摩根士丹利（Morgan Stanley）的 Judah Frommer。請開始提問。

Yeah, hi guys. Thanks for taking my question, Claire and Ivan. It's been a pleasure to work with you guys and congrats to the rest of the team. Maybe just a couple more on the competitive landscape with some more clarity on competitor timing.

是的，嗨，各位好。謝謝你們回答我的問題，Claire 和 Ivan。很高興能與你們合作，也恭喜團隊其他成員。我想再追問幾個關於競爭態勢的問題，現在對競爭對手的時程也更清楚了。

And, potentially, Peto and Amy being there in second line ahead of eGFR bispecifics in first. What's kind of the latest feedback from docs on utilizing an eGFR-directed therapy in first line if they are approved in second line and how those dynamics could play out? And where can you differentiate on safety versus the other eGFR bispecifics? Thanks.

另外，假設 Peto 和 Amy 在第二線先於第一線的 eGFR 雙特異性抗體之前上市。醫師對於在第一線使用 eGFR 導向療法（若其已在第二線獲批）的最新回饋是什麼？這些動態可能會如何發展？以及在安全性方面，你們相較其他 eGFR 雙特異性抗體可以如何做出差異化？謝謝。

Thanks for your question, Judah.

謝謝你的問題，Judah。

So what I will say to your first question around both frontline and second line usage of ETFR, what we're hearing from investigators is in general there is.

關於你第一個問題——ETFR 在第一線與第二線的使用——我們從研究者那邊聽到的整體看法是，一般而言確實存在。

A hope and want that eGFRs will be used in the frontline setting, which is, the largest majority of patients. And we anticipate that to really become the de facto standard of care. But the question then becomes a little bit around sequencing of potential eGFR bispecifics. What we do know is the proposed mechanism of action of pedocimptomab does speak to.

大家希望也想要在第一線使用 eGFR，因為那是涵蓋最多數病人的治療情境。我們預期這將真正成為事實上的標準治療。但接下來的問題就會變成：潛在的 eGFR 雙特異性抗體要如何排序使用（sequencing）。我們已知的是，pedocimptomab 的擬議作用機轉確實涉及。

The degradation of the EGFR receptor. And so you're starting to hear investigators think through what makes the most sense in terms of, sequencing and what to use in the frontline setting, if you wanted to also use a different EGFR in the second-line setting. What I will also say is you are seeing additional ADCs outside of EGFRs testing their molecules in an EGFR. Post-EGFR setting, knowing that EGFRs will likely be the standard of care. So I think there is a very clear recognition around EGFRs moving into the frontline setting.

EGFR 受體的降解。因此你開始聽到研究者在思考：在排序與第一線用藥選擇上，什麼最合理——如果你也希望在第二線使用另一個 EGFR 相關療法。另外我們也看到，除了 EGFR 之外，還有其他 ADC 正在測試其分子於 EGFR。後 EGFR（post-EGFR）的治療情境，因為大家認為 EGFR 很可能會成為標準治療。所以我認為，對於 EGFR 走向第一線這件事，市場已有非常明確的共識。

And our belief is that the EGFR-naive second-line setting will be a diminishing patient population.

而我們的看法是：在第二線、尚未使用過 EGFR（EGFR-naive）的病人族群將會逐漸縮小。

To your question around tolerability, we continue to hear excellent feedback.

至於你問到的耐受性，我們持續收到非常正面的回饋。

The tolerability of fisera in combination with Pembro, as we've expanded in a pivotal study, which does seem to differentiate from the other combinations that are being studied in the frontline setting. What we do know, of course, is that emivantamab is being studied in combination with chemotherapy. And today, investigators are really looking for a chemosparing regimen.

隨著我們在一項關鍵性研究中擴大收案，fisera 與 Pembro 併用的耐受性看起來確實能與目前在第一線研究的其他併用方案做出區隔。當然，我們也知道 emivantamab 正在與化療併用進行研究。而目前研究者真正想要的是一個可減少化療使用（chemosparing）的治療方案。

Thank you for your question.

謝謝你的問題。

Thank you. One moment for the next question.

謝謝。請稍等，我們進行下一個問題。

Next question is coming from the line of Kelsey Goodwin of Piper Sandler. Please go ahead.

下一個問題來自 Piper Sandler 的 Kelsey Goodwin。請開始提問。

Okay, good morning. Thanks for taking our questions. And congrats again on all the appointments.

好的，早安。謝謝你們回答我們的問題。也再次恭喜各項任命。

For my first question, building on, I think, a prior question, just given Ficera's unique profile is very much durability-focused, as we head into this initial wave of the ORR interim updates for you and for your competitor, how are you thinking about these first looks and potential areas of differentiation before we get that longer-term follow-up?

我的第一個問題是延續先前的提問：鑑於 Ficera 的獨特特徵非常著重於持久性（durability），當我們即將迎來你們與競爭對手第一波 ORR 期中更新時，你們如何看待這些初步結果？在取得更長期追蹤之前，可能有哪些差異化的面向？

And then, second, just quickly on 4 to 5 Flex. Mentioned you aim to have data in hand at the time of approval. When might that be included in the eventual label? Thanks so much.

第二個問題，快速問一下 4 到 5 Flex。你們提到目標是在核准時就能把數據握在手上。那這可能會在什麼時候納入最終標籤（label）？非常感謝。

Thanks for your question, Kelsey. So, to speak to your first question, a large part of the data set we put out at ASCO this.

謝謝你的問題，Kelsey。針對第一個問題，我們今年在 ASCO 公布的數據集很大一部分。

This year was around connecting our depth of response up to ultimately durability and overall survival benefit. We do believe that at the time of the interim analysis for both ourselves. And Genmab, depth of response will be an important indicator for what's to come in terms of durability and overall survival. We will, of course, as you may know, a six-month durability is an important aspect of the data set that will be used to support a potential accelerated approval as well. And so, I really do believe it will be the totality of the data beyond just response rates that will be important in distinguishing these two data sets.

是在於把反應深度（depth of response）與最終的持久性以及整體存活（overall survival）獲益連結起來。我們確實相信，在我們與 Genmab 的期中分析時點，反應深度將會是預示後續持久性與整體存活的重要指標。當然，如你所知，六個月的持久性是用來支持潛在加速核准的重要數據面向之一。因此我確實認為，重要的是超越單純反應率、看整體數據的全貌，才能區分這兩套數據集。

To your question on four to five flexes by being able to start this study while in advance of what we had initially anticipated at the beginning of the year, we do anticipate having the data set in hand for the first approval.

至於你問到的 4 到 5 flex，由於我們能夠比年初原先預期更早啟動這項研究，我們預期在第一次核准時就能把這套數據握在手上。

Okay, great.

好的，很棒。

Thank you so much.

非常感謝。

Thank you. One moment for the next question.

謝謝。請稍等，我們進行下一個問題。

Our next question comes from the line of Renee Benjamin of Citizens. Please go ahead.

下一個問題來自 Citizens 的 Renee Benjamin。請開始提問。

Hey, good morning, guys. Thanks for taking the questions and let me echo my congratulations as well to the entire team.

嗨，各位早安。謝謝你們回答問題，也讓我再次向整個團隊表達恭喜。

Maybe two quick ones for us. One of our KOL calls mentioned left-sided CRC might benefit more with certain combinations versus, let's say, right-sided CRC, which kind of leads us to ask, as you think about the underlying factors and potential stratifications, you might be looking at, what are you kind of focusing on to ensure that you're getting a true kind of go-forward signal for Visera?

我們這邊可能有兩個簡短的問題。我們的一通KOL電話提到，相較於例如右側CRC，左側CRC在某些組合療法下可能受益更大；這也讓我們想問，當你們思考其背後因素與可能的分層時，你們目前聚焦在什麼，以確保你們為Visera取得一個真正可作為後續推進依據的訊號？

As a second question, I'd be remiss not to ask Ivan something. Ivan, during your prepared remarks, you mentioned the burn rate increase that we should be factoring as 45 flex starts and some of these other programs move forward. Can you talk a little bit about how we should be thinking about the burn? How much of a burn increase should we be thinking about and any preliminary sales force metrics you might be able to talk about? Thanks.

第二個問題，我若不問Ivan一些事情就說不過去了。Ivan，在你準備好的發言中，你提到隨著45 flex啟動以及其他一些專案往前推進，我們應該把燒錢率（burn rate）增加納入考量。你能否談談我們應該如何看待燒錢？我們應該預期燒錢增加多少？以及你是否能分享任何初步的銷售團隊指標？謝謝。

Thank you for your question, Reni. So, I'll start with the question on colorectal cancer and then pass it over to Ivan to answer your question around burn.

謝謝你的提問，Reni。我先回答結直腸癌的問題，接著再請Ivan回答你關於燒錢的問題。

So, to your point, there is a history of EGFR usage in left-sided colorectal cancer, which is why that's where the approval is for EGFR monoclonal antibodies today, and where both, I believe, J&J and Genmab are going with their phase 3s. Left-sided CRC. Part of our attempt from a signal-seeking perspective to also look at right-sided colorectal cancer was given the role that VEGF inhibitors, including bevacizumab, play from an anti-angiogenic standpoint in the right-sided CRC. We know that TGF beta plays a role in angiogenesis and wanted to determine whether there was an opportunity to have a similar impact with our EGFR. Beta by functional. We do anticipate that given the small signal-seeking size of the 20-plus patient study, we will need to tease out left-sided, right-sided, and other potential biomarkers to help determine what is the right patient population. But that was the intent of our signal-seeking cohorts.

如你所說，EGFR在左側結直腸癌的使用有其歷史背景，這也是為什麼目前EGFR單株抗體的核准適應症是在左側結直腸癌；而且我相信J&J和Genmab的三期試驗也都是往左側CRC走。左側CRC。我們從尋找訊號（signal-seeking）的角度也嘗試納入右側結直腸癌，部分原因是VEGF抑制劑（包括bevacizumab）在右側CRC中從抗血管新生的角度扮演的角色。我們知道TGF beta在血管新生中也扮演角色，因此想確認是否有機會透過我們的EGFR。Beta（功能性）。我們確實預期，鑑於這項20多位病人的小型尋找訊號研究，我們需要進一步釐清左側、右側以及其他潛在生物標記，以協助判定正確的病人族群。但這就是我們設計尋找訊號隊列的初衷。

And with that, I'll pass it over to Ivan.

接下來我把問題交給Ivan。

And with your question on burn, we anticipate a fairly consistent burn rate quarter over quarter as we continue to get deeper into this pivotal study. With these Fortify Flex as well, as we continue with enrollment, what we'll end up seeing is consistency as we are eventually sunset some of the spend on the Fortify study in the '27 timeframe and as we continue to ramp up commercial spend and the build around the FTEs.

關於你問到的燒錢，我們預期隨著我們在這項關鍵性研究（pivotal study）中持續深入，季度對季度的燒錢率會相當一致。另外在這些Fortify Flex方面，隨著我們持續收案，最終你會看到支出趨於一致：我們預計在27年左右逐步結束（sunset）Fortify研究的部分支出，同時我們也會持續拉升商業化支出，以及圍繞FTE的人力建置。

I think you're up.

我想輪到你了。

Yeah, that was it. So probably it's for you, Ryan, regarding the Salesforce metrics.

對，就這些。所以可能是給你，Ryan，關於銷售團隊指標的問題。

Yeah, absolutely. I think at this point, we're not prepared to start speaking to that. And certainly, as we get closer to commercialization, we'll be prepared to guide some of those metrics.

對，當然。我想在這個時間點，我們還沒準備好開始談這些。當然，隨著我們更接近商業化，我們會準備好提供其中一些指標的指引。

Got it. Thanks very much.

了解。非常感謝。

Thank you. One moment for the next question.

謝謝。請稍候，下一個問題。

Next question is coming from the line.

下一個問題來自以下線路。

Of Zeit Mukherjee of U.S. Bancorp BTIG. Please go ahead.

U.S. Bancorp BTIG的Zeit Mukherjee。請發問。

Great. Good morning, and thanks for taking the question, and congratulations to you, Ryan, and best wishes to you, Claire and Ivan, on your next step. So, two quick questions from us. I believe you had previously said Fortify Flex will not be a non-inferiority study. So, could you just specify again, what supports approval of this regimen? And the second question was just related to colorectal cancer. Are. Thinking potentially about combining Cisera with mutant selective KRAS or PanRAS inhibitor combinations. Thanks.

很好。早安，謝謝讓我提問；也恭喜你，Ryan，並祝福你，Claire和Ivan，在下一步一切順利。我們有兩個簡短問題。我記得你們之前說過Fortify Flex不會是一項非劣性（non-inferiority）研究。所以你能否再具體說明一次，什麼因素支持這個療程的核准？第二個問題與結直腸癌相關。是否。你們是否在考慮把Cisera與突變選擇性KRAS或PanRAS抑制劑的組合併用？謝謝。

Thanks for your question, Jeet. So, to that point on the Fortify Flex, the intent of the study is really to compare the two regimens between our weekly dosing of 1,500 milligrams weekly to our loading and maintenance dose. And so, what we're looking for is a comparability around durability of response and ensuring that we can maintain the same durability of response post the loading portion, which is the same for both studies. Which is why the FDA was comfortable in the sizing of the study and the data set that we plan to submit to include it in the label. I apologize; I missed the second part of your question.

謝謝你的提問，Jeet。關於Fortify Flex，這項研究的目的主要是比較兩種療程：我們每週1,500毫克的每週給藥，對比我們的負荷劑量加維持劑量方案。因此我們要看的，是反應持久性（durability of response）的可比性，並確保在負荷期之後（兩個研究的負荷期相同），我們仍能維持相同的反應持久性。這也是為什麼FDA對研究規模以及我們計畫提交、並納入標籤的資料集感到放心。抱歉，我漏掉了你問題的第二部分。

About whether or not working.

關於是否正在進行。

RAS combos and CRC.

RAS組合與CRC。

Yeah, so we have been thinking quite a bit about it. As you may be aware, we've presented quite a bit of data at ACR and CITC around our work in combination with RAS inhibitors that shows that the TGS beta arm of our molecule is able to address many of the resistance mechanisms to those RAS inhibitors and so ensure improved durability.

是的，我們確實思考了很多。如你可能知道的，我們在ACR和CITC上已經發表了不少與RAS抑制劑聯合使用的數據，顯示我們分子中的TGS beta臂能夠處理那些RAS抑制劑的多種抗藥機制，從而確保更好的持久性。

Of effect, part of our strategy is to determine what is the best area to go into and to ensure that we can also combine with RAS inhibitors and ensure that there are no synergistic toxicities.

效果方面，我們策略的一部分是判定最適合切入的領域，同時也要確保我們能與RAS抑制劑併用，並確認不會出現協同毒性（synergistic toxicities）。

And with that, thank you for your question.

以上，謝謝你的提問。

Thank you. And this does conclude today's Q&A session. I would like to turn the call over to Claire for closing remarks.

謝謝。今天的問答環節到此結束。我想把電話交給Claire做結語。

Please go ahead.

請繼續。

I want to thank you all for joining today. I can say I'm very energized by whereby Cara stands and confident in the team that is going to lead us forward. We look forward to updating you on our progress very soon.

感謝各位今天參與。我可以說，我對Cara目前的狀況感到非常振奮，也對將帶領我們向前的團隊充滿信心。我們期待很快向各位更新我們的進展。

Thank you all.

謝謝各位。

This concludes today's program.

今天的節目到此結束。

Thank you for joining. You may now disconnect.

感謝加入。您現在可以掛線。