Bicara Therapeutics Inc (BCAX) 2026 Q1 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Bicara Therapeutics first quarter 2026 earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Rachel Frank, Vice President of Investor Relations and Corporate Communications. Please go ahead.

各位好，感謝您稍候。歡迎參加 Bicara Therapeutics 2026 年第一季財報電話會議。（接線員指示）請注意，今天的會議將被錄音。我現在要把會議交給今天的第一位講者，投資人關係與企業傳播副總裁 Rachel Frank。請開始。

Thank you, and good morning, everyone. It's a pleasure to welcome you to Bicara Therapeutics first quarter 2026 earnings call. Earlier this morning, we issued a press release highlighting results from the quarter and recent business progress. 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 website.

謝謝，各位早安。很高興歡迎各位參加 Bicara Therapeutics 2026 年第一季財報電話會議。今天稍早，我們發布新聞稿，重點說明本季業績結果與近期業務進展。您可前往我們網站的「投資人」專區取得新聞稿以及我們今天將一同檢視的簡報投影片。

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 1995. 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.

在開始之前，請注意本次電話會議將包含依據 1995 年《私人證券訴訟改革法》安全港條款所定義的前瞻性陳述。請參閱我們最新的 SEC 申報文件，其中載有重要風險因素，可能導致我們的實際表現與結果與這些前瞻性陳述所明示或暗示者出現重大差異。

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. Joining us on the call today are Claire Mazumdar, Chief Executive Officer; Bill Schelman, Chief Medical Officer; Ryan Cohlhepp, President and Chief Operating Officer; and Ivan Hyep, Chief Financial Officer. I'll now turn the call over to Claire.

本次電話會議中所作的任何前瞻性陳述僅代表我們截至今日的觀點，我們不承擔更新任何前瞻性陳述的義務。今天與會者包括：執行長 Claire Mazumdar；醫務長 Bill Schelman；總裁兼營運長 Ryan Cohlhepp；以及財務長 Ivan Hyep。我現在把電話交給 Claire。

Good morning, and thank you for joining us today. The first quarter of 2026 set a strong foundation for the year ahead. We made measurable progress on the strategy we outlined earlier this year with continued momentum behind our lead asset, ficerafusp alfa or ficera, which we believe is a potentially best and first-in-class bifunctional EGFR-directed antibody combined with the TGF-beta ligand trap for the treatment of HPV-negative first-line head and neck cancer.

各位早安，感謝今天加入我們。2026 年第一季為接下來一年的發展奠定了堅實基礎。我們在今年稍早所提出的策略上取得了可衡量的進展，並持續推動我們的主力資產 ficerafusp alfa（或稱 ficera）。我們相信，ficera 可能成為同類最佳且同類首創的雙功能 EGFR 標靶抗體，並結合 TGF-β 配體捕捉（ligand trap）機制，用於治療 HPV 陰性的一線頭頸癌。

Our priorities remain focused on executing a strategic development plan for ficera, preparing for commercial success by laying the foundation to capture a large and growing global market in head and neck cancer and expanding ficera's potential beyond our lead indication, while maintaining financial discipline. To deliver on those priorities, we are building the team to match our ambitions as we transition from a clinical stage to a commercial stage organization.

我們的優先事項仍聚焦於：執行 ficera 的策略性開發計畫；透過奠定基礎以掌握頭頸癌這個龐大且持續成長的全球市場，為商業成功做好準備；在維持財務紀律的同時，將 ficera 的潛力拓展至主要適應症之外。為了落實這些優先事項，隨著我們從臨床階段組織轉型為商業化階段組織，我們正在打造與我們企圖心相匹配的團隊。

With that in mind, I want to share a few updates this morning. After several years as our Chief Medical Officer, Dave Raben has transitioned to a Senior Executive Adviser role and Bill Schelman, previously Executive Vice President of Clinical Development, has stepped into the CMO role.

基於此，我想在今天早上分享幾項更新。擔任我們醫務長多年的 Dave Raben 已轉任資深執行顧問一職，而先前擔任臨床開發執行副總裁的 Bill Schelman 已接任醫務長（CMO）。

Dave has been instrumental in shaping Bicara into the company it is today, guiding ficera into pivotal Phase III development and building the foundation of our clinical and medical organization. We are deeply grateful for his contributions and look forward to his continued partnership in his advisory capacity. Bill is well positioned to build on that foundation.

Dave 在塑造今日的 Bicara 方面扮演了關鍵角色，帶領 ficera 進入關鍵性第三期（Phase III）開發，並建立我們臨床與醫療組織的基礎。我們對他的貢獻深表感謝，也期待他以顧問身分持續與我們合作。Bill 也具備在此基礎上再接再厲的良好條件。

He joined us last fall as an experienced development and commercial stage leader and has quickly made an impact across our development programs. And as we build toward commercial launch, we are thrilled to have brought on a proven leader to guide that work. Chris Sarchi joined last week as our Chief Commercial Officer, bringing extensive oncology, commercialization and leadership experience.

他於去年秋天加入我們，具備豐富的開發與商業化階段領導經驗，並迅速在我們各項開發計畫中產生影響。隨著我們邁向商業上市，我們很高興延攬到一位經驗證的領導者來引領相關工作。Chris Sarchi 於上週加入，擔任我們的商務長（CCO），帶來深厚的腫瘤學、商業化與領導經驗。

Chris will continue building out the team with additional hires across market access and commercial operations in the months ahead. In addition, we made a number of key updates in the first quarter. First, our continued execution has us on track to achieve substantial enrollment in FORTIFI-HN01 by the end of the year, positioning us for an interim analysis in mid-2027 for potential accelerated approval.

Chris 將在未來數月持續擴編團隊，並在市場准入與商業營運等領域進行更多招募。此外，我們在第一季也完成多項關鍵更新。首先，憑藉我們持續的執行力，我們正按計畫在今年年底前於 FORTIFI-HN01 達成可觀的收案進度，使我們有望在 2027 年年中進行期中分析，以爭取潛在的加速核准。

With that progress, our belief in ficera's potential to be both best and first-in-class in frontline recurrent and metastatic HPV-negative head and neck cancer has only strengthened. That conviction is grounded in ficera's differentiated mechanism, the depth and durability of response we have observed and our development approach. Recent developments in the competitive landscape are reinforcing this view.

隨著這些進展，我們對 ficera 在一線復發與轉移性 HPV 陰性頭頸癌中同時成為同類最佳與同類首創的潛力之信心更加堅定。這份信念建立在 ficera 差異化的作用機轉、我們觀察到的反應深度與持久性，以及我們的開發策略之上。競爭格局的近期發展也進一步強化了這個觀點。

While the market has at times viewed peer time lines as ahead of ours, that picture is changing, driven by our own continued progress as well as the significant upsizing of a peers pivotal trial. Together, these dynamics support our potential path to first-in-class. They also validate the strategic choice we made to develop ficera specifically for HPV-negative patients, where the science, the unmet need and the commercial opportunity align.

市場有時認為同業的時程領先於我們，但這個情勢正在改變，原因包括我們自身持續的進展，以及某同業關鍵性試驗的大幅擴增收案規模。綜合而言，這些動態支持我們邁向同類首創的潛在路徑，也驗證了我們選擇專注於為 HPV 陰性患者開發 ficera 的策略決策，因為在此族群中，科學依據、未被滿足的醫療需求與商業機會彼此一致。

Second, and Bill will speak to this in more detail, based on discussions with the FDA, we plan to initiate a study that will evaluate ficera in combination with pembrolizumab as a loading and every three-week maintenance dosing regimen. This is an advancement that we believe has the potential to expand optionality for patients and providers and enhances the long-term commercial profile of ficera.

第二點，Bill 將更詳細說明：根據與 FDA 的討論，我們計畫啟動一項研究，評估 ficera 與 pembrolizumab 併用，採用負荷劑量（loading）加上每三週一次維持給藥的劑量方案。我們相信，這項進展有潛力為患者與醫療提供者擴大治療選擇，並提升 ficera 的長期商業化特性。

Third, just last Friday, a peer-reviewed manuscript was published in the Journal of Clinical Oncology, detailing results from our Phase Ib expansion cohort, evaluating 1,500 milligrams of ficera weekly in combination with pembrolizumab in frontline recurrent metastatic head and neck cancer, data most recently presented at ASCO 2025.

第三點，就在上週五，《臨床腫瘤學期刊》（Journal of Clinical Oncology）刊登了一篇經同儕審查的論文，詳述我們第一期 Ib（Phase Ib）擴增隊列的結果；該隊列評估每週 1,500 毫克 ficera 與 pembrolizumab 併用於一線復發轉移性頭頸癌，相關數據最近於 ASCO 2025 發表。

This publication is an important milestone that validates and adds to the growing body of scientific evidence supporting ficera's differentiated mechanism of action and clinical benefit. It also provides the broader oncology community with a peer-reviewed view of the data underpinning our pivotal program.

這篇論文的發表是一項重要里程碑，驗證並補強了日益累積的科學證據，支持 ficera 差異化的作用機轉與臨床效益。同時也讓更廣泛的腫瘤學社群得以透過同儕審查的形式，檢視支撐我們關鍵性計畫的數據。

And lastly, with the completion of an oversubscribed public offering in February, built on an already strong cash position, we are well positioned to invest in the opportunities ahead of us. As we look ahead to the next quarter and the remainder of the year, we're excited to share meaningful long-term follow-up data at ASCO in a few weeks. The data will further characterize ficera's safety profile, along with the depth and durability of response driven by TGF-beta inhibition.

最後，隨著我們在 2 月完成超額認購的公開發行，並建立在原本已相當強勁的現金部位之上，我們已具備良好條件投資於未來的機會。展望下一季與今年其餘時間，我們很期待在幾週後的 ASCO 分享具意義的長期追蹤數據。這些數據將進一步刻畫 ficera 的安全性概況，以及由 TGF-β 抑制所帶來的反應深度與持久性。

These data span all three clinical doses tested in expansion cohorts, including the dose we're advancing in our pivotal trial. We are also continuing to enroll multiple Phase Ib expansion cohorts to identify early proof-of-concept signals and inform ficera's development strategy, both within head and neck cancer and across solid tumors.

這些數據涵蓋擴增隊列中測試的三種臨床劑量，包括我們正在關鍵性試驗中推進的劑量。我們也持續招募多個 Phase Ib 擴增隊列，以辨識早期概念驗證（proof-of-concept）訊號，並為 ficera 的開發策略提供資訊，涵蓋頭頸癌內部以及各類實體腫瘤。

With that, I'll turn it to Bill to walk through our recent clinical updates and what to expect from us at ASCO this year.

接下來我把時間交給 Bill，請他說明我們近期的臨床更新，以及今年在 ASCO 我們將帶來哪些內容。

Thanks, Claire, and good morning, everyone. We have taken a deliberate and thoughtful approach to evaluating ficera in patient populations with high unmet need and with the strongest biological rationale. This has included development in head and neck cancer as well as other solid tumors, including metastatic colorectal cancer, cutaneous squamous cell carcinoma and anal cancer.

謝謝 Claire，各位早安。我們以審慎且周延的方式評估 ficera，聚焦於未被滿足需求高、且具最強生物學合理性的患者族群。這包括頭頸癌，以及其他實體腫瘤的開發，例如轉移性大腸直腸癌、皮膚鱗狀細胞癌與肛門癌。

In that context, our recent disclosures have focused on clinical data from approximately 90 patients across 3 cohorts from our Phase Ib study evaluating ficera in combination with pembrolizumab in frontline recurrent or metastatic HPV-negative head and neck cancer. This patient population has particularly poor outcomes with limited treatment options and represents the vast majority of patients in this setting.

在此背景下，我們近期揭露的重點，聚焦於我們 Phase Ib 研究中約 90 名患者的臨床數據，涵蓋 3 個隊列；該研究評估 ficera 與 pembrolizumab 併用於一線復發或轉移性 HPV 陰性頭頸癌。此患者族群的預後特別不佳、治療選項有限，且在此臨床情境中占絕大多數。

The 1,500-milligram weekly plus pembrolizumab cohort, which is the dose we are currently evaluating in the Phase III portion of the FORTIFI-HN01 pivotal trial was presented at ASCO last year and represents our most mature data set. With two years of follow-up, deep and durable responses were observed with a median duration of response of 21.7 months and a median overall survival of 21.3 months, more than doubling the overall survival observed with the standard of care of pembrolizumab in HPV-negative patients.

每週 1,500 毫克加上 pembrolizumab 的隊列，是我們目前在 FORTIFI-HN01 關鍵性試驗第三期（Phase III）部分所評估的劑量，已於去年 ASCO 發表，並且是我們最成熟的數據集。經兩年追蹤後，觀察到深度且持久的反應；反應持續時間（DoR）中位數為 21.7 個月，整體存活期（OS）中位數為 21.3 個月，較 HPV 陰性患者以 pembrolizumab 作為標準治療所觀察到的整體存活期增加逾一倍。

The 750-milligram weekly plus pembrolizumab cohort supported the evaluation of the optimal biological dose of ficera in the Phase II portion of our ongoing FORTIFI trial and helped to inform selection of the 1,500-milligram weekly as the OBD that is currently being evaluated in the Phase III portion of the study.

每週 750 毫克加上 pembrolizumab 的隊列，支持我們在進行中的 FORTIFI 試驗第二期（Phase II）部分評估 ficera 的最佳生物劑量（OBD），並協助我們選定每週 1,500 毫克作為 OBD，目前正於研究的第三期（Phase III）部分進行評估。

The data from these cohorts also reinforces our confidence in the interim analysis of overall response rate as the foundation for pursuing accelerated approval. The cohort evaluating 2,000 milligrams every other week plus pembrolizumab demonstrated that even at a less frequent dose, we see rapid and deep responses that are the hallmark of the ficera clinical profile.

這些隊列的數據也進一步強化我們對整體反應率（ORR）期中分析的信心，並將其作為推進加速核准的基礎。評估每兩週 2,000 毫克加上 pembrolizumab 的隊列顯示，即使給藥頻率較低，我們仍可看到快速且深度的反應，這正是 ficera 臨床特徵的標誌。

The data from this cohort also helped inform our alternative dosing regimen study. Across all 3 Phase Ib cohorts, the depth and durability of response observed underscore the central role of TGF-beta inhibition in ficera's mechanism. By enabling tumor penetration, TGF-beta inhibition drives the kind of deep and durable responses that translate to long-term survival benefit.

此隊列的數據也協助我們制定替代給藥方案研究。在所有 3 個 Ib 期隊列中，所觀察到的反應深度與持久性凸顯了 TGF-beta 抑制在 ficera 作用機轉中的核心角色。透過促進腫瘤滲透，TGF-beta 抑制可驅動深且持久的反應，進而轉化為長期存活獲益。

Taken together, the data presented to date affirm that ficera has the potential to be a well-tolerated chemotherapy-free treatment option across the spectrum of disease burden, including in patients with large bulky tumors and low CPS scores, where rapid and deep responses are particularly critical. As we look towards ASCO 2026, we will be presenting updated data across all three of these cohorts from the Phase Ib study.

綜合目前所呈現的數據可確認，ficera 具有成為耐受性良好、無化療治療選項的潛力，適用於不同疾病負荷的患者範圍，包括腫瘤體積龐大且 CPS 分數偏低的患者；在這些患者中，快速且深度的反應尤為關鍵。展望 ASCO 2026，我們將呈現 Ib 期研究中這三個隊列的更新數據。

We will provide three-year follow-up data from the 1,500-milligram cohort, which will allow us to characterize the long-term efficacy from this dose compared to the standard of care. We will also share long-term endpoints from the 750-milligram weekly and the 2,000-milligram every other week data sets.

我們將提供 1,500 毫克隊列的三年追蹤數據，使我們能夠將此劑量的長期療效與標準治療進行比較。我們也將分享 750 毫克每週一次以及 2,000 毫克每兩週一次兩個數據集的長期終點。

These data will provide the most comprehensive look at ficera in frontline recurrent and metastatic HPV-negative head and neck cancer to date, including durability of outcomes not seen with other investigational agents targeting EGFR in this setting, a key differentiator and the signal of ficera's best-in-class potential.

這些數據將提供迄今為止對 ficera 在一線復發與轉移性 HPV 陰性頭頸癌中最全面的觀察，包括其他在此情境下針對 EGFR 的研究性藥物所未見的結果持久性；這是關鍵差異化因素，也是 ficera 具備同類最佳（best-in-class）潛力的訊號。

Additionally, the strength and consistency of these results across cohorts further derisk our pivotal FORTIFI-HN01 trial. Another key aspect of our ASCO update is that we'll further characterize the role of TGF-beta in head and neck cancer. TGF-beta inhibition is the defining feature of ficera and what sets it apart from other EGFR-directed therapies.

此外，這些結果在各隊列間的強度與一致性也進一步降低我們關鍵性 FORTIFI-HN01 樞紐試驗的風險。我們 ASCO 更新的另一個重點是，將更進一步闡明 TGF-beta 在頭頸癌中的角色。TGF-beta 抑制是 ficera 的定義性特徵，也是其有別於其他 EGFR 導向療法之處。

Our translational data has shown consistent TGF-beta inhibition across all ficera doses, confirming the mechanism behind tumor penetration and immune activation with the strongest inhibition at the 1,500-milligram weekly dose and the 2,000-milligram every other week dose. We'll also look to show how tumor penetration driven by TGF-beta inhibition translates into depth and durability of response that leads to long-term outcomes for patients.

我們的轉譯研究數據顯示，在所有 ficera 劑量下皆可見一致的 TGF-beta 抑制，證實其背後促進腫瘤滲透與免疫活化的機轉；其中以每週 1,500 毫克與每兩週 2,000 毫克的抑制效果最強。我們也將展示由 TGF-beta 抑制所驅動的腫瘤滲透，如何轉化為反應的深度與持久性，並進一步帶來患者的長期結局。

Alongside the clinical story, we'll continue to build at ASCO, we're also focused on optimizing how ficera is delivered to patients. As previously mentioned, based on discussions with the FDA, we plan to initiate an alternative dosing study in the third quarter of this year. This study will enroll approximately 150 to 200 patients and will evaluate the efficacy of ficera on a 12-week loading phase followed by an every 3-week maintenance phase regimen.

在我們持續於 ASCO 建構臨床論述的同時，我們也專注於優化 ficera 的給藥方式以提供給患者。如先前所述，基於與 FDA 的討論，我們計畫於今年第三季啟動一項替代給藥研究。該研究將納入約 150 至 200 名患者，並評估 ficera 以 12 週負荷期（loading phase）後接每 3 週一次維持期（maintenance phase）的療程之療效。

All patients will receive 1,500 milligrams weekly of ficera plus pembrolizumab for 12 weeks and will then be randomized to either continue 1,500 milligrams weekly of ficera plus pembrolizumab or transition to 2,250 milligrams every three weeks plus pembrolizumab. The primary endpoint will evaluate progression-free survival. In designing an alternative dosing regimen, our priority is to preserve ficera's potential best-in-class profile while creating practical options for patients and providers.

所有患者將先接受 ficera 每週 1,500 毫克加上 pembrolizumab 共 12 週，之後將被隨機分派為：持續 ficera 每週 1,500 毫克加上 pembrolizumab，或轉換為每三週 2,250 毫克加上 pembrolizumab。主要終點將評估無惡化存活期（PFS）。在設計替代給藥方案時，我們的首要目標是在保留 ficera 潛在同類最佳特徵的同時，為患者與醫療提供者創造更具實務性的選項。

Since we expect to seek accelerated approval for ficera with the 1,500-milligram weekly dose from the FORTIFI-HN01 study, running this randomized study in parallel will allow us to potentially have results from this study in time for a potential approval, creating a compelling path for early adoption of the streamline regimen.

由於我們預期將以 FORTIFI-HN01 研究中的每週 1,500 毫克劑量為基礎，為 ficera 申請加速核准，因此同步進行這項隨機研究，將使我們有機會在潛在核准時點前取得研究結果，為精簡療程的早期採用建立一條具吸引力的路徑。

Additionally, this addresses an important need for patients, providers and payers, specifically by providing treatment options that will reduce clinic burden, improve quality of life and support long-term adherence. And critically, this dosing strategy is shaping how we are thinking about life cycle management and ficera's opportunity beyond frontline recurrent or metastatic head and neck cancer. With that, I'll turn it over to Ryan to discuss the potential market opportunity and what's ahead for the rest of the year.

此外，這也回應了患者、醫療提供者與支付方的重要需求，具體而言是提供可降低門診負擔、提升生活品質並支持長期依從性的治療選項。更關鍵的是，這項給藥策略也正在形塑我們對產品生命週期管理的思考，以及 ficera 在一線復發或轉移性頭頸癌之外的機會。接下來我把時間交給 Ryan，請他談談潛在的市場機會以及今年剩餘時間的規劃。

Thank you, Bill. Turning to the broader opportunity, we have strong conviction in the differentiated profile ficera has shown across our clinical program compared to other investigational agents in head and neck and the development strategy we built around that profile designed to deliver against the full opportunity ahead.

謝謝你，Bill。談到更廣泛的機會，我們對 ficera 在整個臨床計畫中相較於其他頭頸癌研究性藥物所展現的差異化特徵深具信心，也對我們圍繞該特徵所建立、旨在充分實現未來整體機會的開發策略充滿信念。

Head and neck cancer is a significant and fast-growing global market projected to reach more than $5 billion in global sales into the 2030s. HPV-negative patients represent a large majority of patients in the frontline recurrent metastatic setting and HPV status is known at the time of diagnosis, which means that HPV testing is not a barrier to care.

頭頸癌是一個重要且快速成長的全球市場，預計在 2030 年代全球銷售額將超過 50 億美元。HPV 陰性患者在一線復發轉移性情境中占大多數，且 HPV 狀態在診斷時即可得知，這表示 HPV 檢測不會成為就醫的障礙。

Across major markets, there are roughly 50,000 annually incident patients, including approximately 18,000 in the US where we plan to launch initially. The unmet need in this population for a therapy that drives deep, durable and clinically significant benefit while sparing chemotherapy and improving quality of life is what makes the rigor of our clinical data and the discipline of our development strategy matter.

在主要市場中，每年約有 50,000 名新發患者，其中美國約 18,000 名，而我們計畫先在美國上市。此族群對於能帶來深度、持久且具臨床意義獲益，同時避免化療並改善生活品質的療法存在高度未被滿足的需求；這正是我們臨床數據的嚴謹性與開發策略的紀律性之所以重要的原因。

It is also why we continue to invest in the medical and commercial infrastructure required to deliver ficera to patients. This includes the commercial leadership team we have been building with Chris now leading our commercial efforts, including the prelaunch evidence generation and field readiness work required for a successful oncology launch, and we look forward to having him on the road with us at ASCO and beyond.

這也是我們持續投資於將 ficera 交付給患者所需的醫療與商業基礎建設的原因。其中包括我們正在建置的商業領導團隊，目前由 Chris 領導商業工作，涵蓋上市前證據生成以及成功腫瘤產品上市所需的前線準備工作；我們也期待在 ASCO 及其後續活動中與他一同出行。

While the frontline recurrent metastatic setting is our initial focus, the opportunity for ficera in head and neck cancer is much larger. Given our conviction in ficera's potential to be both first and best-in-class, we see clear space to own and lead a broader segment of the head and neck cancer landscape.

雖然一線復發轉移性情境是我們的初始重點，但 ficera 在頭頸癌的機會要大得多。基於我們對 ficera 可能同時成為同類首創（first-in-class）與同類最佳（best-in-class）的信心，我們看到在更廣泛的頭頸癌版圖中具備明確的空間可由我們主導並引領。

The locally advanced setting, in particular, represents another large market with clear biologic rationale for ficera and a meaningful opportunity for expansion. As we think about that opportunity, we have initiated two investigator-initiated sponsored studies in the locally advanced setting and continue to enroll additional cohorts that will inform our expansion strategy. including a cohort of patients in frontline recurrent metastatic HPV-negative head and neck cancer with CPS less than or equal to one as well as a cohort of patients with frontline recurrent metastatic HPV-positive head and neck cancer with heavy history of smoking.

尤其是局部晚期（locally advanced）情境，代表另一個龐大市場，對 ficera 亦有明確的生物學理據，並提供具意義的擴展機會。針對該機會，我們已在局部晚期情境啟動兩項研究者發起的贊助研究（investigator-initiated sponsored studies），並持續招募其他隊列以支持我們的擴展策略，包括：一線復發轉移性 HPV 陰性頭頸癌且 CPS 小於或等於 1 的患者隊列，以及一線復發轉移性 HPV 陽性頭頸癌且具有重度吸菸史的患者隊列。

Beyond head and neck, we believe there is a strong biologic rationale to expand ficera's pipeline and the potential into solid tumor types with significant unmet need. We have already shown proof of concept in indications such as cutaneous squamous cell carcinoma and anal canal cancer, reinforcing our conviction in ficera's broad applicability across TGF-beta-driven tumors.

除頭頸癌之外，我們相信亦有強而有力的生物學理據可擴展 ficera 的研發管線與潛力至具有重大未被滿足需求的實體腫瘤類型。我們已在皮膚鱗狀細胞癌與肛管癌等適應症中展示概念驗證（proof of concept），進一步強化我們對 ficera 可廣泛適用於 TGF-beta 驅動腫瘤的信念。

Building on that foundation, we are currently enrolling patients in a Phase Ib expansion cohort evaluating ficera, both as a monotherapy and in combination with pembrolizumab in patients with third-line plus metastatic colorectal cancer. TGF-beta is implicated in metastatic disease and resistance to current treatments, providing a biologic rationale for evaluating ficera in this setting.

在此基礎上，我們目前正在招募患者進入一項 Ib 期擴展隊列，評估 ficera 作為單藥治療以及與 pembrolizumab 併用，適用於三線以上轉移性大腸直腸癌患者。TGF-beta 與轉移性疾病及對現有治療的抗藥性相關，為在此情境下評估 ficera 提供了生物學理據。

This is also a challenging setting. Patients are very sick, often progressing rapidly through prior lines of therapy. And with the treatment landscape in CRC continuing to evolve, we are taking a measured approach with a high bar for what would warrant further investment. As the data mature across these cohorts, we will continue to make thoughtful decisions about where ficera can deliver the most differentiated value and how we allocate our resources accordingly. With that, I'll turn it to Ivan to review the financials.

這同時也是一個具挑戰性的情境。患者病情非常嚴重，且常在既往治療線數後快速惡化。隨著大腸直腸癌（CRC）的治療版圖持續演進，我們採取審慎的策略，並以高門檻判斷何種情況值得進一步投資。隨著各隊列數據逐步成熟，我們將持續審慎決策，聚焦 ficera 能提供最具差異化價值的領域，並相應配置資源。接下來我把時間交給 Ivan，請他回顧財務表現。

Thanks, Ryan. Earlier this morning, we reported detailed first quarter 2026 financial results in our press release, and I'll summarize a few highlights here. Our total operating expenses for the first quarter of 2026 increased compared to our first quarter of 2025, driven by clinical operations and development expenses associated with our ongoing pivotal FORTIFI-HN01 study, including increased manufacturing and development costs.

謝謝你，Ryan。今天稍早，我們已在新聞稿中公布 2026 年第一季的詳細財務結果，我在此摘要幾項重點。2026 年第一季的總營運費用較 2025 年第一季增加，主要由臨床營運與開發費用所帶動，與我們正在進行的關鍵性 FORTIFI-HN01 樞紐研究相關，包括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. Consistent with the first quarter, we anticipate continued increases in operating expenses for 2026, reflecting increased investment in our clinical operations, particularly for the pivotal FORTIFI-HN01 study, with the interim analysis expected in mid-2027 and parallel study as well as an increase in SG&A, as we invest in early commercial and medical infrastructure to support the potential launch of ficera.

我們也看到與人員相關的成本增加，包括隨著我們擴編人力（主要用於支援臨床營運與研發職能）而增加的以股份為基礎的薪酬。與第一季一致，我們預期 2026 年營運費用將持續上升，反映我們對臨床營運的投資增加，特別是針對關鍵性 FORTIFI-HN01 研究（期中分析預計於 2027 年年中進行）及其平行研究；同時，隨著我們投資於早期商業化與醫療基礎設施以支援 ficera 的潛在上市，SG&A 也將增加。

We ended the first quarter of 2026 with $539.8 million in cash, cash equivalents and marketable securities, bolstered by an oversubscribed public offering in February that generated $161.8 million net proceeds and meaningfully strengthened our balance sheet, which provides cash runway into the first half of 2029 and allows us to invest thoughtfully in areas we believe will deliver future clinical and commercial success. With that, I'll now turn the call back over to the operator for questions. Operator?

我們在 2026 年第一季末持有 5.398 億美元的現金、約當現金及有價證券；2 月份一項超額認購的公開發行帶來 1.618 億美元的淨募資款，進一步強化了我們的資產負債表，提供可延伸至 2029 年上半年的現金跑道，並使我們能夠審慎投資於我們相信將帶來未來臨床與商業成功的領域。接下來我把電話交回給接線員進行提問。接線員？

(Operator Instructions)

（接線員指示）

Eric Schmidt, Cantor.

Eric Schmidt，Cantor。

Good morning, and thanks for taking my question. Maybe one in terms of what to expect at ASCO in a couple of weeks' time. Can you provide us with any benchmarks for 3-year outcomes data, landmark data in HPV-negative head and neck? And then you mentioned looking at the role of TGF-beta as well. Does that mean that we're going to see some correlations between PD and response rates?

早安，謝謝讓我提問。也許先問一個關於幾週後 ASCO 會議上可期待看到什麼的問題。你們能否提供任何 3 年結局數據的基準（benchmarks），例如 HPV 陰性頭頸癌的里程碑（landmark）數據？另外你們也提到會看 TGF-beta 的角色。這是否表示我們將看到 PD 與反應率之間的一些相關性？

Thank you for your question, Eric. So the question was relating to a preview of the ASCO 2026 data sets. So as we highlighted during the call, there are two separate abstracts that were accepted at behalf of ASCO. One is focused on long-term follow-up in terms of the three expansion cohorts in frontline recurrent and metastatic HPV-negative head and neck with the most mature data set being the 1,500-milligram one you were alluding to, which will have three years' worth of median follow-up. In that one, we really hope to speak to the so-called immunotherapy tail driven by the TGF-beta durability.

謝謝你的問題，Eric。你的問題是關於 ASCO 2026 數據集的預覽。如同我們在電話會議中強調的，我們有兩篇摘要獲 ASCO 接受。一篇聚焦於一線復發與轉移性 HPV 陰性頭頸癌三個擴增隊列的長期追蹤，其中最成熟的數據集是你提到的 1,500 毫克劑量，將有三年的中位追蹤時間。在那個數據集中，我們希望能談到所謂由 TGF-beta 持久性所驅動的免疫治療長尾效應（immunotherapy tail）。

And so in there, if you look at prior precedents, pembrolizumab in all-comers delivers about a 20% to 25% three-year overall survival, while it's believed to be about 15% to 20% in the HPV-negative subsets of real-world data sets. The other abstract is focused on looking at depth and durability of response from the TGF-beta inhibition, and we'll continue to speak to what we believe is ficera's defining hallmark that TGF-beta inhibition is driving this depth and response that's ultimately leading to far superior durability than other investigational agents and leading to outsized overall survival benefit.

因此，如果你看先前的先例，pembrolizumab 在全體受試者（all-comers）中約可達到 20% 至 25% 的三年總存活率，而在 HPV 陰性亞組的真實世界數據集中一般被認為約為 15% 至 20%。另一篇摘要則聚焦於評估 TGF-beta 抑制所帶來的反應深度與持久性；我們也將持續闡述我們認為 ficera 的關鍵特徵：TGF-beta 抑制正在驅動這種反應深度與反應，最終帶來遠優於其他研究中藥物的持久性，並帶來顯著更高的總存活獲益。

Tyler Van Buren, TD Cowen.

Tyler Van Buren，TD Cowen。

Hey, guys. Good morning. Congrats on the progress. Just wanted to ask a quick follow-up before my question, if you don't mind. A follow-up on Eric's question related to the ASCO data. I guess it's clear that we'll have three years of follow-up with the 1,500 mg dose. But since investors are asking, it would be helpful if you could just clarify how much follow-up we should expect with the 2,000 and 750 dose cohorts.

嗨，各位。早安。恭喜進展。我想在我的主要問題之前先快速追問一下，如果你們不介意。延續 Eric 關於 ASCO 數據的問題。我想很清楚 1,500 mg 劑量會有三年的追蹤。但因為投資人一直在問，如果你們能釐清 2,000 與 750 劑量隊列大概會有多少追蹤時間，會很有幫助。

We can obviously guess, but just clarity there would be helpful. And then I guess my main question is related to the alternate dosing regimen of the 1,500 mg induction with the 2,250 mg maintenance. Do you think it's possible that, that regimen could have improved durability than either 1,500 or 2,250 alone based upon exposure and the data that you've produced to date?

我們當然可以猜，但如果能更明確會更好。然後我的主要問題是關於替代給藥方案：1,500 mg 誘導期搭配 2,250 mg 維持期。基於暴露量以及你們目前產出的數據，你們是否認為該方案有可能比單獨使用 1,500 或 2,250 具有更好的持久性？

Thanks for your questions, Tyler. So I'll answer the first question first, which is a question around the other 2 cohorts being presented at ASCO, which are the 750-milligram weekly cohort as well as the 2,000-milligram every two-week cohort. Both of those have approximately 12 to 18 months worth of median follow-up.

謝謝你的問題，Tyler。我先回答第一個問題，也就是 ASCO 將呈現的另外兩個隊列：每週 750 毫克隊列，以及每兩週 2,000 毫克隊列。這兩個隊列的中位追蹤時間約為 12 到 18 個月。

And so we do plan to share longer-term follow-up data sets for both of those at ASCO in a few weeks. And to help answer your question around durability of response in the maintenance setting, I'll pass that question over to Ryan.

因此，我們確實計畫在幾週後的 ASCO 分享這兩個隊列更長期的追蹤數據。至於你關於維持治療情境下反應持久性的問題，我會把這個問題交給 Ryan。

Thanks, Tyler, for the question. In terms of the regimen, again, the overall approach that we are taking there, as you mentioned, is we're initiating with the 1,500 milligrams weekly and then transitioning to a maintenance phase of 2,250. A couple of, I think, key tenets of that approach.

謝謝你的問題，Tyler。就這個方案而言，如你所提，我們的整體作法是先以每週 1,500 毫克開始，之後轉入 2,250 的維持期。我認為這個作法有幾個關鍵原則。

One, as you recognize in the data that we presented thus far, we see deep rapid responses, which are enabled by the 1,500-milligram dose. And really being able to get a depth of response, more than 80% of our patients are getting depth of response of 80% or greater, which we really believe is contributing to that durability.

第一，如你在我們目前呈現的數據中所看到的，我們觀察到深且快速的反應，而這是由 1,500 毫克劑量所促成。真正能達到反應深度——我們有超過 80% 的患者反應深度達到 80% 或以上——我們相信這確實有助於持久性。

One of the things that the 2,250 every three weeks enables is an exposure profile that allows us to, I think, maintain that durability after we received -- or achieved very meaningful reductions in tumor reductions and keeping patients on from a tolerability perspective, I think being able to bring people into clinic every three weeks rather than every week while maintaining exposures that maintain that durable response. We absolutely believe that this regimen potentially enables both a more durable as well as a better -- a more tolerable profile.

而每三週一次的 2,250 其中一個優點，是它提供一種暴露量（exposure）曲線，使我們在已經——或達成——非常顯著的腫瘤縮小後，能夠維持這種持久性；同時從耐受性角度來看，讓病人每三週而不是每週回診，並在維持足以支撐持久反應的暴露量之下持續治療。我們確實相信這個方案可能同時帶來更持久、以及更——更可耐受的特徵。

Stephen Willey, Stifel.

Stephen Willey，Stifel。

Yeah, good morning. Thanks for taking the questions. Maybe just some color around the use of PFS as a primary endpoint in the dose optimization trial, just given that this is obviously an event-driven endpoint, there's no control arm. And then is there a formal non-inferiority margin that you need to hit? I guess just any color you can provide around kind of this formal notion of comparability would be helpful.

是的，早安。謝謝讓我提問。想請你們多談一些在劑量最佳化試驗中使用 PFS 作為主要終點的考量，因為這顯然是事件驅動的終點，而且沒有對照組。另外，你們是否需要達到某個正式的非劣性（non-inferiority）界值？我想任何你們能提供的、關於這種正式「可比性」概念的說明都會很有幫助。

Thanks for your question, Steve. So I'll actually answer the second part of your question first around non-inferiority. This is actually not designed as a noninferiority study. We got positive feedback from the FDA based off of our discussions based off of the sizing of the study, which we alluded to being approximately 150, 200 patients, it does not -- it would have required far more patients as a non-inferiority study.

謝謝你的問題，Steve。我先回答你第二個部分，也就是非劣性。這項研究其實不是以非劣性設計。我們與 FDA 討論後得到正面回饋；以我們提到的研究規模約 150 到 200 名患者來看——如果要做成非劣性研究，將需要更多的患者。

The other focus, again, going back to Tyler's question, the other focus of looking at this dosing regimen is really, again, to ensure that we're maintaining the efficacy profile focused on depth and durability of response with the induction into maintenance dosing. And so the focus of the PFS endpoint was really to look at that ensuring the durability is consistent between the two arms. And the FDA was comfortable with PFS being that endpoint for that reason.

另一個重點——回到 Tyler 的問題——在於評估這個給藥方案，主要是為了確保在從誘導期進入維持期給藥時，仍能維持以反應深度與持久性為核心的療效特徵。因此，PFS 終點的重點是用來確認兩個組別之間的持久性是否一致。基於這個原因，FDA 也接受以 PFS 作為該終點。

Kelsey Goodwin, Piper Sandler.

Kelsey Goodwin，Piper Sandler。

Hey, good morning. Thanks for taking my questions. I think you alluded to it in the prepared remarks, but for your competitors' frontline trial where they increased target enrollment by about 200 patients, I just first wanted to confirm, is there any read-through to FORTIFI in its trial size? And then secondly, how do you think about the gap in timing now between ficera and [Pido].

嗨，早安。謝謝讓我提問。我想你們在事先準備的講稿中有提到，但關於競品的一線試驗，他們把目標收案增加了大約 200 名患者。我首先想確認，這對 FORTIFI 的試驗規模是否有任何可推論（read-through）？其次，你們如何看待 ficera 與 [Pido] 之間現在的時間差距？

Thank you for question, Kelsey. So just to highlight, we were alluding to the LiGeR-1 study, and you may have not seen on clinicaltrials.gov that the page is updated to reflect enrollment of 700 patients, up from the original 500 in an all-comers study. I think that's consistent with feedback we've been hearing from investigators that they were planning to add additional HPV-negative patients.

謝謝你的問題，Kelsey。先強調一下，我們指的是 LiGeR-1 研究；你可能已在 clinicaltrials.gov 上看到該頁面更新，顯示收案人數為 700 名，較原先全體受試者（all-comers）研究的 500 名有所增加。我認為這與我們從研究者那裡聽到的回饋一致：他們原本就計畫納入更多 HPV 陰性患者。

From what we have heard today that there was potentially an imbalance in terms of HPV-positive versus HPV-negative patients in that particular study given that -- there are no other HPV-positive studies in Phase III. We haven't seen any read-through other than the fact that it continues to highlight what we've always highlighted that ficera has the potential to be both best and first-in-class.

根據我們今天聽到的資訊，在那項特定研究中，HPV 陽性與 HPV 陰性患者的比例可能存在失衡，因為——在第三期試驗中並沒有其他 HPV 陽性研究。我們目前看到的解讀，除了它持續凸顯我們一直強調的觀點之外，沒有其他更多內容：ficera 具有成為同類最佳且同類首創（best- and first-in-class）的潛力。

We've seen very strong execution of the FORTIFI-HN01 study, and those dynamics continue to speak to what we believe is a significant narrowing of the perception around ficera and FORTIFI being second to market. In fact, we continue to believe in our potential first in class.

我們看到 FORTIFI-HN01 研究的執行非常強勁，而這些動態持續印證我們的看法：市場對於 ficera 與 FORTIFI「第二個上市」的認知正在顯著收斂。事實上，我們仍然相信我們有潛力成為同類首創。

Brad Canino, Guggenheim.

Brad Canino，Guggenheim。

Hey, good morning. Thanks, team. It's nice to be on the call. At ASCO, maybe just to drill into one of the doses, the lower 750 mg, which wasn't selected for the Phase III. So how do you look at that as really being able to support the TGF-beta hypothesis given the exposure and coverage that it provides?

嗨，早安。謝謝各位團隊。很高興參與這通電話。在 ASCO 上，或許想更深入問其中一個劑量：較低的 750 mg，這個劑量並未被選入第三期試驗。所以你們如何看待它在其所提供的暴露量與覆蓋度之下，是否真的能支持 TGF-beta 的假說？

And will that view only be in a subset of patients such as the responders? And then just a quick second, given we're talking about the competitor trial and the upsize, where do you sit with expected timing of OS analysis for your Phase III study today?

而這個觀點是否只會適用於某個病人子集，例如反應者？另外再快速問第二個問題：既然我們在談競品試驗與擴大規模，你們目前對自家第三期研究的 OS 分析預期時點是怎麼看？

Thanks, Brad, for your question, and welcome to the team. So to the first question around the 750-milligram dose, so that was, as you highlighted, a dose that we did not take forward in the pivotal Phase III study. However, we do see a significant TGF-beta inhibition. And we know that from an EGFR receptor occupancy, we are fully saturating the EGFR locus. So we've always thought of it as still superior than EGFR monoclonal antibody while showing slightly less TGF-beta inhibition.

謝謝你的問題，Brad，也歡迎加入團隊。先回答關於 750 毫克劑量的第一個問題：如你所指出，這個劑量我們沒有推進到關鍵性第三期試驗。不過，我們確實看到顯著的 TGF-beta 抑制。而且我們知道，從 EGFR 受體佔有率來看，我們已經完全飽和 EGFR 位點。因此我們一直認為，即便 TGF-beta 抑制略低一些，它仍然優於 EGFR 單株抗體。

What you will continue to see at ASCO is that even in this patient population, the hypothesis that TGF-beta inhibition is driving improved depth and durability will continue to speak to another strong data set that will reinforce the notion now in a total of 90 patients that we have strong depth and durability data that will speak to that overall survival benefit.

你們在 ASCO 會持續看到的是：即使在這個病人族群中，「TGF-beta 抑制正在驅動更佳的反應深度與持久性」這個假說，仍會由另一組強勁數據來支持；而這也將強化一個觀點——目前合計 90 位患者的資料顯示，我們有很強的反應深度與持久性數據，能夠支持整體存活（overall survival）獲益。

And your second question was related -- I apologize, timing of OS analysis. As we continue to guide to the interim analysis for potential accelerated approval is slated for mid-2027, which is a look at overall response rates with six months of durability and likely a look at qualitative overall survival at that time. We do anticipate being focused on HPV-negative patients only that our event rates will happen more rapidly than those of our peers and that the OS endpoint will come again more rapidly than anticipated.

你的第二個問題是關於——抱歉——OS 分析的時點。依我們目前的指引，用於潛在加速核准的期中分析預計在 2027 年年中進行，屆時會看整體反應率（ORR）以及 6 個月的持久性，並且很可能也會在那個時間點對整體存活做定性（qualitative）的觀察。我們預期將只聚焦 HPV 陰性患者，因此事件發生率會比同業更快，OS 端點也會比預期更快到來。

Judah Frommer, Morgan Stanley.

Judah Frommer，Morgan Stanley。

Yeah. Hi, good morning. Thanks for taking the questions, guys. Maybe just broadening out the competitor conversation a bit. We saw some data from an OX40 targeting asset this morning, but I believe in CPS greater than 20. So maybe can you just remind us of kind of the breakdown of the epidemiology by CPS score and kind of what the advantages of a broader targeting asset in ficera could be? And again, what time lines could look like versus this asset?

是的，嗨，早安。謝謝各位回答問題。或許把競品的討論再拉大一點：我們今天早上看到一個針對 OX40 的資產數據，但我相信是在 CPS 大於 20 的族群。所以能否請你們提醒一下，依 CPS 分數來看流行病學的分布大概如何？以及 ficera 這種更廣泛靶向的資產可能有哪些優勢？另外，相較於該資產，時間線可能會是什麼樣子？

Thanks for your question, Judah. I do believe you're referring to an InhibRx presentation that actually I believe is happening at the same time as our call. So while we haven't had a chance to significantly look at the data set, I can speak at a high level to those results. So as you alluded to, the data set from, I believe, a randomized Phase II is focused on CPS greater than or equal to 20.

謝謝你的問題，Judah。我想你指的是 InhibRx 的發表，我相信它其實正在與我們的電話會議同時進行。因此我們還沒有機會深入檢視那組數據，但我可以在高層次上談談結果。如你所提到的，那組數據（我相信是隨機分派的第二期試驗）聚焦在 CPS 大於或等於 20。

So these are considered the CPS high patients who typically do respond to pembro monotherapy. What we do know is that ficera is being and the FORTIFI study is being looked at in the CPS greater than or equal to one as well, we have shown some strong results from our late-line patients in CPS 0 and are currently looking at an open-label CPS zero cohort.

因此這些被視為 CPS 高的患者，通常會對 pembro 單藥治療有反應。我們所知道的是，ficera 以及 FORTIFI 研究也在 CPS 大於或等於 1 的族群中評估；同時，我們在 CPS 0 的後線患者中也已顯示一些強勁結果，並且目前正在評估一個開放標籤的 CPS 0 隊列。

In the CPS 1 to 19 category, we see stronger response rates across all three of our cohorts between 50% to 70%, really speaking to the TGF-beta inhibition going after the more so-called immunosuppressive patients for the CPS low. From an epidemiological standpoint, it's believed to be about 50-50 CPS 1 to 19 versus CPS 20 to greater and 15% of the frontline market being the CPS zero.

在 CPS 1 到 19 的類別中，我們看到三個隊列的反應率都更強，約在 50% 到 70% 之間，這確實反映出 TGF-beta 抑制對於較「免疫抑制」的 CPS 低患者更具作用。從流行病學角度來看，一般認為 CPS 1 到 19 與 CPS 20 以上大約各占 50%，而一線市場中約有 15% 為 CPS 0。

I think your other question was around just the competitive threat. What we believe we are hearing is that they are slating to start enrollment in the pivotal study later this year with full enrollment scheduled to be 2029. So significantly later than our interim analysis for potential accelerated approval coming mid-2027. So we do not see this as a competitive threat in terms of timing.

我想你另一個問題是關於競爭威脅。我們聽到的資訊是，他們預計在今年稍晚啟動關鍵性研究的收案，並且完整收案預計要到 2029 年。因此相較於我們預計在 2027 年年中進行、用於潛在加速核准的期中分析，時間上明顯更晚。所以我們不認為在時程上構成競爭威脅。

Reni Benjamin, Citizens.

Reni Benjamin，Citizens。

Hey, great. Thanks for taking the questions, and congrats on the progress. As my question is mainly focused around the Phase Ib expansion cohorts and the early proof-of-concept signals. Can you just maybe provide more color on each of those expansion cohorts, kind of why we're going after CPS less than one and those patients with heavy smoking. And then same thing with the CRC, what is that high bar that you're hoping to achieve when those results come out in the second half?

嗨，很好。謝謝回答問題，也恭喜進展。我的問題主要聚焦在 Ib 期擴展隊列與早期概念驗證訊號。你們能否更具體說明各個擴展隊列：為什麼要針對 CPS 小於 1，以及重度吸菸的患者？另外 CRC 也是同樣問題：當下半年結果出來時，你們希望達到的「高門檻」是什麼？

Thank you for the question. So I'll start with the other cohorts. You mentioned CPS less than one and also the heavy smokers. So I think what we saw in dose escalation is we actually saw some pretty significant responses in those patients who had CPS 0. In fact, one patient in particular had a complete response there.

謝謝你的問題。我先從其他隊列開始。你提到 CPS 小於 1，以及重度吸菸者。我想我們在劑量遞增中看到的是：在 CPS 0 的患者中其實出現了一些相當顯著的反應。事實上，其中有一位患者達到完全反應。

As you go back to kind of the fundamental biology of our molecule of EGFR and TGF-beta, there's a lot of biological support for the synergy associated with those two mechanisms being given together and also in combination with a PD-1. And so that was a biology that we wanted to probe and again, exploring a population. As Claire had alluded to in the last response, in terms of an epidemiological perspective, about 15% of patients are CPS less than one.

回到我們分子機制的基礎生物學——EGFR 與 TGF-beta——有大量生物學證據支持這兩種機制同時給藥的協同作用，並且也支持與 PD-1 聯合使用。因此這是我們想要探究的生物學方向，同時也再次探索一個族群。正如 Claire 在上一個回答中提到的，從流行病學角度來看，大約有 15% 的患者是 CPS 小於 1。

So it's a meaningful population. And again, a biology that's supported by our molecule. In the heavy smokers, I think it goes back to our view when we looked at our dose escalation data retrospectively, there was a responder population with an HPV positive. All of those patients who responded were heavy smokers. In that case, we saw people who had a history of smoking of 20 pack a year or greater who responded.

所以這是一個具意義的族群，而且其生物學也與我們的分子相符。至於重度吸菸者，我想要回到我們對劑量遞增資料做回溯性分析時的觀點：在 HPV 陽性的反應者族群中，所有有反應的患者都是重度吸菸者。在那個情況下，我們看到吸菸史達到每年 20 包（20 pack-year）或以上的人有反應。

And again, of our three responders there, two out of the three of them were complete responses. So our view is that there's likely a component of smoking that's driving the biology there, even more so than the HPV positive infection. And again, an area that we wanted to probe as we think about those expansion opportunities within the head and neck population. CRC, I think, honestly, it's an evolving target.

而且在那三位反應者中，有兩位達到完全反應。因此我們的看法是：吸菸可能是驅動該生物學的因素，甚至比 HPV 陽性感染更為關鍵。這也是我們在思考頭頸癌族群的擴展機會時，想要進一步探究的領域。至於 CRC，我想坦白說，這是一個仍在演進中的目標。

We continue to look at the landscape. We've seen data sets out from other agents of recent. And I think the other thing not only is relative to the competitive landscape, but also our own internal. We had mentioned activity in cutaneous anal canal. There's good opportunities for this molecule in the locally advanced setting of head and neck.

我們持續觀察整體版圖。近期也看到其他藥物的數據集。另外一點不僅與競爭環境相關，也與我們內部的評估相關。我們曾提到在皮膚與肛管方面的活性。在頭頸癌的局部晚期（locally advanced）治療情境中，這個分子也有很好的機會。

So as we evaluate the various opportunities, there are, I think, are ample opportunities to develop ficera across a range of different tumors and more broadly in head and neck cancer. And that really is the bar is, where we think we're going to have the most meaningful impact, and that's where we're going to end up investing our capital.

因此，當我們評估各種機會時，我認為 ficera 在多種不同腫瘤、以及更廣泛的頭頸癌領域都有充足的開發機會。而所謂的「門檻」其實就是：我們認為在哪裡能帶來最有意義的影響，我們就會把資本投入到那裡。

And can I just follow up with when we might see some of the data for -- we know when the CRC data is coming out, but maybe from these other cohorts, when might we see those data?

我可以再追問一下，我們大概什麼時候能看到一些資料——我們知道 CRC 的資料何時會公布，但其他這些隊列的資料，大概什麼時候會看到？

Again, we've not provided specific guidance on that. And again, we'll provide greater clarity in terms of timing for that in future updates.

再次說明，我們尚未就此提供具體指引。我們也會在未來的更新中，就時間點提供更清楚的說明。

Great. Thank you very much for taking the questions.

很好。非常感謝回答問題。

Jeet Mukherjee, BTIG.

Jeet Mukherjee，BTIG。

Great. Thanks for taking the question. Just looking ahead to your loading and maintenance regimen, just as you talk to your investigators, how do they think about a 12-week weekly regimen followed by once every three weeks versus just a pure once every two-week regimen from Pido there?

很好，謝謝讓我提問。展望你們的負荷劑量與維持治療方案，當你們與研究者交流時，他們如何看待先每週給藥 12 週、之後改為每三週一次，與從 Pido 那邊採用純粹每兩週一次方案之間的差異？

Is there any preference that they have generally between one or the other? Obviously, safety and efficacy being the primary point there. But just was curious if there's any preference there between the two regimens. And then just coming back to ASCO, are we looking to have updated data be a part of the abstract? Or will they be reserved for the conference presentation?

他們一般在這兩種方案之間有偏好嗎？當然安全性與有效性是首要考量。但我只是好奇兩種方案之間是否有偏好。另外回到 ASCO，我們會在摘要中納入更新後的資料嗎？還是會保留到會議現場報告時再公布？

So I'll take your first question there. As we have talked with investigators and the broader community, I think there's a real focus on that initial therapy and the rapidity and the depth of that initial therapy. I think even if you look at the historical treatment paradigm, we continue to see a fair amount of chemotherapy used, and that is largely being driven by the desire to have very rapid responses.

我先回答第一個問題。當我們與研究者及更廣泛的社群交流時，我認為大家非常聚焦在初始治療，以及初始治療反應的速度與深度。即使你回顧歷史上的治療模式，我們仍看到相當比例使用化療，而這主要是出於希望獲得非常快速反應的需求所驅動。

And so in terms of that trade-off of being able to go to every two weeks at the outset versus being able to get rapid deep responses, the preference continues to be that rapid deep response, which the weekly regimen gives. Again, I think as you think about the overall administration schedule transitioning to every three weeks at the 12-week mark, I think the view there is a willingness to get faster, better efficacy quick and then be able to go to a more convenient maintenance regimen over time.

因此，就一開始就能改為每兩週一次，與能夠獲得快速且深度反應之間的取捨而言，偏好仍然是快速且深度的反應，而每週方案能提供這點。再者，當你考量整體給藥時程在第 12 週轉為每三週一次時，我認為大家的看法是：願意先以更快、更好的療效迅速起效，之後再隨時間轉為更便利的維持治療方案。

And to your second question, Jeet, which I believe was about whether the abstracts -- whether the data presentation will have more mature data than the abstracts, that is correct. There will be more data provided during our presentation than what was provided in the abstracts. Thank you for your question.

至於你的第二個問題，Jeet，我理解是關於摘要——也就是現場資料呈現是否會比摘要更成熟，答案是肯定的。我們在報告時提供的資料會比摘要中提供的更多。謝謝你的提問。

Boris Peaker, Jones Trading.

Boris Peaker，Jones Trading。

Great. Thanks for squeezing me in. Just a follow-up on a prior question when we're talking about every 2-week dosing, every three-week maintenance dosing. In addition to potentially satisfying FDA's Project Optimus requirements, how important do you see this dosing from the commercial perspective and kind of competitive perspective?

很好，謝謝讓我插個問題。針對先前關於每兩週給藥、以及每三週一次維持給藥的追問：除了可能滿足 FDA 的 Project Optimus 要求之外，從商業化與競爭的角度來看，你們認為這種給藥方式有多重要？

I'll answer your first question around Project Optimus and then pass it over to Ryan. So just to highlight for us, we have satisfied Project Optimus by choosing the 1,500-milligram dose weekly as opposed to the 750-milligram dose weekly within the FORTIFI-HN01 study. So this is a separate parallel clinical study that is looking at moving this new alternative dosing regimen into a potential ultimate label. To your second question around the commercial uptake, I'll pass it over to Ryan.

我先回答你關於 Project Optimus 的問題，然後交給 Ryan。先強調一下：我們在 FORTIFI-HN01 研究中選擇每週 1,500 毫克劑量，而不是每週 750 毫克劑量，已滿足 Project Optimus。這是一項獨立、平行的臨床研究，旨在將這個新的替代給藥方案推進，最終可能納入標籤。至於你第二個關於商業採用的問題，我交給 Ryan。

Yes. In terms of -- from a differentiation perspective, efficacy remains the key parameter for differentiation, consistent, I think, with most oncology molecules. Again, that's why we continue to initiate with 12 weeks of weekly therapy to maximize efficacy, deep durable, rapid responses. And again, we think that, that will be the key that's going to drive differentiation and the initial share uptake between ourselves and competitor molecules.

是的。就差異化而言，療效仍是差異化的關鍵參數，我想這也符合大多數腫瘤藥物的情況。也因此我們持續以每週治療 12 週作為起始，以最大化療效，取得深度、持久且快速的反應。我們也認為，這將是推動我們與競品之間差異化、以及初期市占提升的關鍵。

Being able to then also maximize and optimize for schedule once you get out to that 12-week maintenance phase, we believe that we have -- we'll be creating a regimen that has the ability to not only compete but to differentiate and be best-in-class from an efficacy, tolerability and from a convenience perspective, really being able to fully optimize the profile across all three dimensions.

在進入 12 週後的維持期時，若也能在給藥時程上做到最大化與最佳化，我們相信我們將打造出一個不僅能競爭、且能在同類最佳（best-in-class）上脫穎而出的方案——在療效、耐受性與便利性三個面向都能真正把整體特性最佳化。

Great. Thanks for taking my question.

很好，謝謝回答我的問題。

Joe Catanzaro, Mizuho.

Joe Catanzaro，Mizuho。

Hey, everybody. Thanks so much for taking my questions. I actually had one as well on this maintenance trial that you've sort of, I think, touched on. But wondering if you could speak to the quantitative difference in exposure at steady state, if any, between 1,500 weekly and 2,250 every three weeks.

各位好，非常感謝讓我提問。我也有一個關於你們這項維持治療試驗的問題，我想你們多少已經提到一些。不過我想請你們談談：在穩態時，若有的話，每週 1,500 與每三週 2,250 之間的暴露量（exposure）在量化上有何差異？

It sounds like you need those longer-term efficacy metrics, but wondering if the argument can be made on sort of equivalent PK and safety between those two regimens.

聽起來你們需要更長期的療效指標，但我想知道是否可以主張這兩種方案在藥物動力學（PK）與安全性上大致等效。

Yes. I mean, again, from an overall exposure perspective, what we are looking to accomplish there, the 2,250, essentially, we're looking for exposures that are comparable to what you've seen at 750. And again, why we look across the various data sets to really get, I think, the regimen that we have gotten to, we're looking at the strength of the data across all of our various cohorts.

是的。我的意思是，從整體暴露量角度來看，我們希望達成的是：2,250 這個方案，本質上我們是在尋求與你在 750 劑量下所看到的暴露量相當。也因此我們會橫跨各種資料集來評估，我想我們之所以能走到目前這個方案，是因為我們檢視了各個不同隊列中資料的整體強度。

So again, I mean, I think the key here is starting the 1,500 milligrams, getting that rapid deep response and then being able to maintain the exposure levels to maintain the durability of response.

所以我認為關鍵在於：以 1,500 毫克起始，取得快速且深度的反應，然後能維持暴露水準，以維持反應的持久性。

Richard Law, Goldman Sachs.

Richard Law，高盛。

Hey guys, good morning. So based on that accelerated approval time line, I believe you mentioned in the past that only a small clinical team will be unblinded to review the interim Phase III results and management will still be blinded. So when will management team become unblinded? And when should we expect to see the data as well? And also, does it mean that the unblinded clinical team will file the BLA without management seeing what's in there initially when filed?

各位早安。基於加速核准的時間線，我記得你們之前提到，只有一個小型臨床團隊會解盲以審閱第三期期中結果，而管理團隊仍會維持盲態。那麼管理團隊何時會解盲？我們又何時應該預期看到資料？另外，這是否意味著解盲的臨床團隊會在管理層一開始尚未看到內容的情況下就提交 BLA？

Richard, I think you're -- just to understand your question, the study is a blinded study. We have an interim for potential accelerated approval in mid-2027 that will be based on response rates with 6 months' worth of follow-up as well as qualitative overall survival. Like any company, there will be -- the data cut will be done, the data lock will be done and then our team within Bicara will submit the BLA. There are no oddities to that process.

Richard，我想你——我先確認一下你的問題。本研究是一項盲態研究。我們在 2027 年年中會有一次期中分析，可能用於加速核准，將以反應率、6 個月追蹤資料，以及整體存活期的質性評估為基礎。和任何公司一樣，會進行資料截點（data cut）、資料鎖定（data lock），然後我們 Bicara 團隊會提交 BLA。這個流程沒有任何特殊之處。

So there's no separate unblinding with a different team and then we're -- I thought that was the case before, if not.

所以不會有由不同團隊進行的單獨解盲，然後我們——我之前以為是那樣，如果不是的話。

No, there is an IDMC like in many cases that will allow us to submit and then we will move to the Bicara team.

不會。會有一個 IDMC，就像許多情況一樣，讓我們能夠提交，之後我們會交由 Bicara 團隊推進。

Thank you. I'm showing no further questions at this time. I'd like to turn it back to Claire Mazumdar for closing remarks.

謝謝。目前顯示沒有其他問題。我想把電話交回給 Claire Mazumdar 做結語。

Thank you for joining us today and for your continued support of Bicara. We're focused on the work ahead for the program and most importantly, for the patients we're working to serve. And we look forward to seeing many of you at ASCO in a couple of weeks.

感謝各位今天加入，也感謝各位持續支持 Bicara。我們專注於推進這個計畫接下來的工作，更重要的是，為我們致力服務的病患。我們也期待在幾週後的 ASCO 與許多各位見面。

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

今天的電話會議到此結束。感謝各位參與，現在可以掛線。