使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good afternoon, and welcome to AbCellera's Q2 2026 business update conference call. My name is Jonathan, and I will facilitate the audio portion of today's interactive broadcast. (Operator Instructions)
下午好,歡迎參加 AbCellera 2026 年第二季業務更新電話會議。我叫 Jonathan,將負責主持今天互動式廣播的音訊部分。(接線員指示)
At this time, I would like to turn the call over to Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. You may proceed.
此刻,我想把電話會議交給 AbCellera 首席法務與合規長 Tryn Stimart。請開始。
Tryn Stimart - Chief Legal Officer, Chief Compliance Officer, Corporate Secretary and Privacy Officer
Tryn Stimart - Chief Legal Officer, Chief Compliance Officer, Corporate Secretary and Privacy Officer
Thank you. Hello, everyone. Thank you for joining us for AbCellera's second quarter 2026 earnings call. I'm Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. Dr. Carl Hansen, AbCellera's President and CEO; and Andrew Booth, AbCellera's Chief Financial Officer, are speaking on today's call.
謝謝。各位好。感謝各位參加 AbCellera 2026 年第二季財報電話會議。我是 AbCellera 首席法務與合規長 Tryn Stimart。AbCellera 總裁暨執行長 Carl Hansen 博士,以及 AbCellera 財務長 Andrew Booth,也將在今天的電話會議中發言。
During this call, we may make statements about our strategic priorities and financial outlook based on our current expectations and in accordance with the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
在本次電話會議中,我們可能會根據目前的預期,並依據 1995 年《私人證券訴訟改革法案》的安全港條款,就我們的策略重點與財務展望發表聲明。
Our statements are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from those described. Please review the Risk Factors section of our most recent Form 10-K and subsequent 10-Q filings with the SEC for a more detailed discussion of these risks.
我們的聲明受到多項風險、不確定性及其他因素影響,可能導致實際結果與所述內容出現重大差異。請查閱我們最近一期 Form 10-K 以及其後向美國證券交易委員會(SEC)提交的 10-Q 文件中的「風險因素」章節,以取得更詳細的風險討論。
AbCellera assumes no obligation to update any forward-looking statements to reflect events or circumstances after today's date. Our presentation today, our earnings press release and our SEC filings are available on our Investor Relations website. The information we provide about our pipeline is intended for the investment community and is not promotional.
AbCellera 不承擔更新任何前瞻性聲明以反映今日之後事件或情況的義務。我們今天的簡報、財報新聞稿以及向 SEC 提交的文件,均可在我們的投資人關係網站取得。我們所提供的管線資訊係供投資社群參考,並非宣傳用途。
As we transition to our prepared remarks, please note that this call is being recorded and will be available for replay on our Investor Relations website and that all dollars referred to during the call are US dollars. After our prepared remarks, we will open the lines for questions and answers. Now I'll turn the call over to Carl.
在進入預先準備的發言前,請注意本次電話會議將被錄音,並會在我們的投資人關係網站提供重播;此外,會議中提及的所有金額均為美元。在我們的準備發言結束後,我們將開放電話線進行問答。現在我把電話交給 Carl。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Thanks, Tyrn, and thank you, everyone, for joining us today. The most important data readout this year is the top line results for ABCL635 in the treatment of moderate to severe hot flashes associated with menopause. Last quarter, we shared our interim Phase I data that showed robust and sustained target engagement in healthy male volunteers and supported quickly advancing into a Phase II study in postmenopausal women experiencing moderate to severe hot flashes.
謝謝你,Tyrn,也謝謝各位今天加入我們。今年最重要的資料讀出,是 ABCL635 用於治療與更年期相關之中度至重度熱潮紅的主要結果。上一季我們分享了第一期的期中數據,顯示在健康男性受試者中具有強勁且持續的靶點結合(target engagement),並支持我們快速推進至在停經後、出現中度至重度熱潮紅的女性中進行第二期研究。
Recruitment in this study accelerated through H1, and we completed enrollment and initial dosing of patients in June, well ahead of schedule. Based on this, we expect a top line data readout very soon. If the data is positive, we believe ABCL635 will be highly derisked.
本研究在上半年招募加速,我們已於 6 月完成受試者入組與初始給藥,進度大幅超前原定時程。基於此,我們預期很快就會有主要數據讀出。若數據為正面,我們相信 ABCL635 的風險將大幅降低。
As noted in our last call, we've been preparing for next steps, which would include late-stage clinical development in moderate to severe VMS associated with menopause and clinical studies to evaluate ABCL635 in treating VMS associated with cancer treatment. Turning to our broader portfolio. ABCL-688 and ABCL386 continue to progress through IND-enabling activities, and we expect both to enter Phase I/II studies in 2027. We will disclose more information on these programs when they enter clinical studies.
如同我們在上次電話會議中提到的,我們一直在為後續步驟做準備,其中包括:針對與更年期相關之中度至重度血管舒縮症狀(VMS)的後期臨床開發,以及評估 ABCL635 用於治療與癌症治療相關之 VMS 的臨床研究。接著談我們更廣泛的產品組合。ABCL-688 與 ABCL386 持續推進至 IND 申請前(IND-enabling)相關工作,我們預期兩者皆將於 2027 年進入第一/二期研究。待這些計畫進入臨床研究時,我們將揭露更多資訊。
Our Phase I trial for ABCL575 completed dosing and is on track for a readout in Q4. As previously discussed, we intend to complete Phase I studies, and we currently have no plans to develop it past Phase I. Finally, I had previously communicated a goal of moving another program into IND-enabling activities in the first half of this year. Although we missed this time line, we are making good progress, and I'm confident in the productivity and innovation of discovery.
我們針對 ABCL575 的第一期試驗已完成給藥,並按計畫於第四季進行數據讀出。如先前所述,我們打算完成第一期研究,目前沒有計畫將其開發推進至第一期之後。最後,我先前曾表示目標是在今年上半年再推進另一個計畫進入 IND 申請前相關工作。雖然我們未能達成該時程,但進展良好,我對研發探索(discovery)的生產力與創新能力充滿信心。
The most significant public disclosures since our last earnings call are related to business development associated with our T cell engager platform. As a reminder, it was five years ago that we started working on TCEs. And since then, we have invested heavily in the platform. Our efforts began with the hypothesis that more diverse CD3 binders would be important for engineering TCEs with improved therapeutic properties. Our internal work to date has proven this to be true, but it's also revealed that diversity of CD3 binders alone is not sufficient.
自上次財報電話會議以來,最重要的公開揭露與我們 T 細胞接合器(T cell engager,TCE)平台相關的商務拓展有關。提醒各位,五年前我們開始投入 TCE。自那時起,我們已在該平台上大幅投資。我們的工作起點是假設:更具多樣性的 CD3 結合分子,對於工程化具更佳治療特性的 TCE 將很重要。迄今我們的內部研究證實此假設為真,但也揭示僅有 CD3 結合分子的多樣性仍不足夠。
Today, we know that repeated success in generating optimal TCEs requires a comprehensive toolkit of binders, technologies, assays, models and biological insights. Accordingly, our platform now includes diverse panels of CD3 targeting antibodies, along with proprietary panels of co-stimulatory antibodies to enhance and fine-tune TCE function, scalable protein engineering workflows to create a large diversity of binder combinations and formats, scalable in vitro assays to assess TCE function and development properties, experience in the translation between in vitro assays and in vivo models across multiple targets and increasingly, a connection between TCE properties and third-party clinical data.
如今我們知道,要能反覆成功地產生最佳化的 TCE,需要一套完整工具組合,包括結合分子、技術、檢測方法、模型與生物學洞見。因此,我們的平台目前包含多樣化的 CD3 靶向抗體面板,以及用於增強並微調 TCE 功能的專有共刺激抗體面板、可擴展的蛋白工程工作流程以建立大量多樣的結合分子組合與格式、可擴展的體外(in vitro)檢測以評估 TCE 功能與開發特性、跨多個靶點在體外檢測與體內(in vivo)模型之間轉譯的經驗,以及日益重要的——將 TCE 特性與第三方臨床數據連結起來的能力。
Together, we believe this creates a highly enabled platform for developing multi-specific TCEs with broad applications across oncology and autoimmunity. While we are leveraging this capability to advance internal programs, we also view it as a key platform for strategic partnerships.
綜合而言,我們相信這打造出一個高度完備的平台,可開發具廣泛應用的多特異性 TCE,涵蓋腫瘤學與自體免疫領域。在運用此能力推進內部計畫的同時,我們也將其視為策略合作夥伴關係的關鍵平台。
Last year, we announced our first significant TCE collaboration with AbbVie. Adding to this, we have recently entered into two new TCE collaborations with Vertex and with Jazz. These 2 deals are adding over $110 million in upfront cash to our balance sheet and have the potential for larger value in downstream payments and tiered royalties on net sales.
去年,我們宣布與 AbbVie 的首個重要 TCE 合作。在此基礎上,我們近期又與 Vertex 以及 Jazz 達成兩項新的 TCE 合作。這兩筆交易將為我們的資產負債表增加超過 1.10 億美元的預付款現金,並有機會在後續里程碑款項以及依淨銷售額計算的分級權利金方面帶來更大的價值。
Last week, we announced our most recent collaboration, which is with Vertex, focused on TCEs for autoimmune diseases and other conditions. Under the terms of the deal, AbCellera will receive $28 million in upfront payments, is eligible for potential downstream payments and tiered royalties on net sales and has a potential option to conduct process development and clinical manufacturing.
上週,我們宣布最新的合作夥伴關係,與 Vertex 合作,聚焦於用於自體免疫疾病及其他病症的 TCE。依據交易條款,AbCellera 將獲得 2,800 萬美元的預付款,並有資格取得潛在的後續里程碑款項與依淨銷售額計算的分級權利金,且可能擁有進行製程開發與臨床製造的選擇權。
In June, we also announced a collaboration with Jazz Pharmaceuticals that includes three confirmed discovery programs with $84 million in total near-term upfront payments. We have received $56 million in upfront payments for the first two programs, and we will receive another $28 million for the third program, which will be initiated within the next 12 months.
6 月,我們也宣布與 Jazz Pharmaceuticals 的合作,其中包含三個已確認的探索計畫,近期預付款合計 8,400 萬美元。我們已就前兩個計畫收到 5,600 萬美元的預付款;第三個計畫將在未來 12 個月內啟動,屆時我們將再收到 2,800 萬美元。
Under the agreement, AbCellera is also eligible to receive over $2 billion in potential downstream payments, along with mid-single-digit to low double-digit tiered royalties on net sales. The deal also includes a mutual option for two additional discovery programs under the same financial terms and a mutual option for AbCellera to undertake certain IND-enabling activities and clinical manufacturing. The total potential deal value with all five programs included would be over $4 billion. We believe that this is one of the largest TCE discovery deals reported to date.
依據協議,AbCellera 亦有資格獲得超過 20 億美元的潛在後續里程碑款項,並取得依淨銷售額計算的分級權利金,比例約為中個位數至低雙位數百分比。該交易亦包含在相同財務條款下,雙方可共同選擇再新增兩個探索計畫的選擇權,以及 AbCellera 可共同選擇承擔特定 IND 申請前相關工作與臨床製造的選擇權。若五個計畫全數納入,交易總潛在價值將超過 40 億美元。我們相信這是迄今公開報導中規模最大的 TCE 探索交易之一。
Before handing over to Andrew, I'm pleased to welcome Dr. Victor Stander and Dr. Lynn Sealy as new Independent Directors on AbCellera's Board. Dr. Stander and Dr. Sealy are experienced biopharmaceutical executives with proven and complementary expertise in development across oncology, women's health, immunology and endocrinology. Lynn and Victor bring deep expertise and development experience that will serve us well as we build our portfolio and our company.
在交給 Andrew 之前,我很高興歡迎 Victor Stander 博士與 Lynn Sealy 博士加入 AbCellera 董事會,擔任新的獨立董事。Stander 博士與 Sealy 博士皆為資深生物製藥產業高階主管,並在腫瘤學、女性健康、免疫學與內分泌領域的開發方面具備經驗豐富、且相互互補的專業能力。Lynn 與 Victor 帶來深厚的專業與開發經驗,將在我們打造產品組合與公司之際提供重要助力。
And with that, I will hand it over to Andrew to discuss our financials. Andrew?
那麼,接下來我把時間交給 Andrew 來說明我們的財務狀況。Andrew?
Andrew Booth - Chief Financial Officer
Andrew Booth - Chief Financial Officer
Thanks, Carl. As Carl pointed out, AbCellera continues to be in a strong liquidity position with over $565 million in cash and equivalents and with roughly $110 million in available committed government funding to execute on our strategy. We are continuing to execute on our plans with a focus on internal programs and leveraging our process development and clinical manufacturing investments.
謝謝,Carl。如 Carl 所指出的,AbCellera 仍維持強勁的流動性部位,擁有超過 5.65 億美元的現金及約當現金,並且約有 1.10 億美元可動用的已承諾政府資金,以執行我們的策略。我們持續推進既定計畫,聚焦內部專案,並運用我們在製程開發與臨床製造方面的投資。
Looking at revenue and expenses. Revenue for the quarter was around $4 million compared to total revenue of approximately $17 million in the same quarter of 2025. Revenue this quarter is consisted mostly of research fees. Our research and development expenses for the quarter were approximately $46 million, approximately $7 million more than last year.
接著看營收與費用。本季營收約為 400 萬美元,相較於 2025 年同季總營收約 1,700 萬美元。本季營收主要由研究費用構成。本季研發費用約為 4,600 萬美元,較去年增加約 700 萬美元。
This expense reflects the focus on investment in our internal programs. In sales, general and administration, expenses were approximately $14 million compared to $22 million last year. The large decrease in SG&A expenses relates to the conclusion of our intellectual property litigation case and to changes in the teams following the focus on our internal pipeline.
這項費用反映我們對內部專案投資的重點。在銷售、一般及行政費用方面,本季約為 1,400 萬美元,去年為 2,200 萬美元。SG&A 費用大幅下降,主要與我們智慧財產權訴訟案件的結束,以及在聚焦內部產品線後團隊調整有關。
Looking at earnings, we are reporting a net loss of roughly $55 million for the second quarter of 2026 compared to a loss of about $35 million a year earlier. In terms of earnings per share, this result works out to a loss of $0.18 per share on a basic and diluted basis.
就獲利而言,我們報告 2026 年第二季淨損約 5,500 萬美元,較一年前約 3,500 萬美元的虧損增加。以每股盈餘來看,基本及稀釋後每股虧損為 0.18 美元。
Turning to cash. Altogether, we finished the quarter with $567 million of total cash and marketable securities. That's a $6 million increase in total cash for the first half of 2026. Operating activities for the first half of the year used approximately $8 million in cash and included in the operating cash flow is the receipt of $56 million from the upfront payments under our TCE deal with Jazz.
接著談現金。整體而言,我們在季末的現金及有價證券總額為 5.67 億美元。這代表 2026 年上半年總現金增加 600 萬美元。今年上半年營運活動約使用 800 萬美元現金;營運現金流中包含我們與 Jazz 的 TCE 交易所收取的 5,600 萬美元預付款。
This portion of the upfront payments from the Jazz partnership was received in the quarter. Excluding marketable securities, investment activities year-to-date included approximately $6 million of capital expenditures, offset by $7 million in government grants received. As a part of our treasury strategy, we have $420 million invested in short-term marketable securities, and our investment activities for the quarter included a $15 million investment in these holdings.
這部分來自 Jazz 合作的預付款是在本季收到。若排除有價證券,今年迄今投資活動包含約 600 萬美元的資本支出,並由收到的 700 萬美元政府補助所抵銷。作為我們的資金管理策略之一,我們有 4.20 億美元投資於短期有價證券,而本季投資活動包含對這些持有部位新增 1,500 萬美元投資。
As a reminder, we have received committed commitments for funding the advancement of our internal pipeline from the Government of Canada's Strategic Innovation Fund and the Government of British Columbia. This available capital does not show up on our balance sheet.
提醒一下,我們已獲得加拿大政府「策略創新基金」以及卑詩省政府所承諾的資金,用於推進我們的內部產品線。這些可用資本不會反映在我們的資產負債表上。
And with over $565 million in cash and equivalents and the unused portion of our secured government funding, we have over $675 million in available liquidity to execute on our strategy. In addition, we have further available liquidity from our ownership of the other Vancouver lab-based office building as well as our GMP facility.
因此,憑藉超過 5.65 億美元的現金及約當現金,以及已取得但尚未動用的政府擔保資金部分,我們可用流動性超過 6.75 億美元,以執行我們的策略。此外,我們持有另一棟位於溫哥華、以實驗室為主的辦公大樓,以及我們的 GMP 設施,也提供進一步的可用流動性。
With respect to overall company expenditures, our capital needs are very manageable, and we continue to believe that we have sufficient liquidity to fund at least the next three years of pipeline investments. And with that, we'll be happy to take your questions. Operator?
就公司整體支出而言,我們的資本需求非常可控,我們仍相信具備充足流動性,足以支應至少未來三年的產品線投資。那麼,我們很樂意回答各位的提問。接線員?
Operator
Operator
(Operator Instructions)
(接線員指示)
Steve Seedhouse, Cantor.
Steve Seedhouse,Cantor。
Steve Seedhouse - Analyst
Steve Seedhouse - Analyst
Just wanted to ask first on the upcoming -- on the forthcoming VMS data. What, in your view, is a clinically meaningful improvement in the VMS severity just in the context of that, I think, three-point ordinal scale that's used for assessing severity?
我想先問一下即將公布的——關於即將出爐的 VMS 數據。在您看來,就用於評估嚴重程度的三點序位量表而言,VMS 嚴重度在臨床上具有意義的改善幅度應該是什麼?
And then also, will you have threshold analyses for the VMS frequency data available with top line, something like a proportion of patients with 90% or 100% reduction in frequency. Just curious if that's something that will be with the top line. And then I have a follow-up as well.
另外,你們是否會在主要結果(top line)中提供 VMS 頻率數據的門檻分析,例如頻率降低 90% 或 100% 的患者比例?我只是好奇這是否會包含在主要結果裡。我也還有一個追問。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Steve, Carl here. Thanks for the question. So first, in terms of the upcoming readout that obviously we're very excited about, our view is that success is a clean safety profile, which so far, everything that we've seen through Phase I has been entirely consistent with that and efficacy that tracks in a way that is comparable to the two small molecules that are approved.
Steve,我是 Carl。謝謝你的問題。首先,對於即將公布的讀出結果,我們當然非常期待;我們認為成功的標準是清楚的安全性概況,而截至目前,我們在第一期所看到的一切都完全一致地支持這一點;同時,療效表現要能以可比的方式追蹤到已獲核准的兩款小分子藥物。
So on the frequency side, we are obviously looking for a response relative to placebo that's on the order of 20% at least, which is about what you see with the small molecules. And there's an additional requirement that you have at least two -- a reduction in frequency of at least two hot flashes per day, which is something that we expect to meet under the same criteria.
在頻率方面,我們顯然希望看到相對於安慰劑至少約 20% 的反應幅度,這大致就是小分子藥物所呈現的水準。此外還有一項要求是——每日熱潮紅頻率至少降低 2 次,我們預期在相同標準下也能達成。
On the severity side, we're expecting that if we get the frequency, we're going to track with severity and have numbers that are very comparable to the small molecules. I don't think we've communicated a definitive bar on that one. But historically, the severity has been easier to hit than the frequency. And so we are really more focused on the frequency side right now.
在嚴重度方面,我們預期只要頻率達標,嚴重度也會同步改善,數值會與小分子藥物非常相近。我不認為我們曾對這一項傳達過明確的門檻。但從歷史經驗來看,嚴重度通常比頻率更容易達標。因此我們目前更聚焦在頻率端。
Steve Seedhouse - Analyst
Steve Seedhouse - Analyst
And just I wanted to ask about the -- you made some comments, and you've mentioned this before about potential application in cancer. So I guess this would be certainly women with breast cancer, but maybe also men on androgen deprivation therapy.
另外我想問一下——你們提到過一些評論,而且之前也提過關於在癌症上的潛在應用。所以我想這當然會包括乳癌女性,但也可能包括接受雄激素剝奪治療的男性。
And it sounded like you were going to look into opening some Phase II studies along with the late-stage program in menopause. But I'm curious why -- like why not move directly into Phase III label-enabling studies in those cancer indications, just given what we've seen from OASIS-4 with [LinkQuit] and assuming you'll have positive Phase II data in hand yourself and dose selection would be facilitated by that. Would love to get your thoughts on that.
聽起來你們打算在更年期的後期計畫之外,同步開展一些第二期研究。但我好奇的是,為什麼——為什麼不直接在那些癌症適應症上推進到第三期、可支持標籤核准(label-enabling)的研究?考量到我們從 OASIS-4 與 [LinkQuit] 看到的結果,而且假設你們自己也會有正向的第二期數據在手,劑量選擇也會因此更容易。很想聽聽你們的想法。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Thanks, Steve. It's a great question. Probably it's a question that would be best directed to Sarah, our Chief Medical Officer, since she has been obviously leading point on the regulatory strategy. My understanding is that moving it first into this patient population, which is obviously going to be significantly different given that you're dealing with patients that have oncology is the first step before moving into later-stage trials.
謝謝,Steve。這是個很好的問題。這個問題可能更適合請我們的首席醫療官 Sarah 來回答,因為她顯然一直在主導法規策略。我的理解是,先把它推進到這個患者族群——由於面對的是腫瘤科患者,顯然會有顯著差異——是進入後期試驗之前的第一步。
And we expect to initiate that relatively soon as we get ready for the larger study on BMS associated with menopause. And of course, there's going to be some gap between a readout and getting the final trial closed up and getting all set up for that. So we're sequencing that as quickly as possible.
我們預期在準備與更年期相關的 BMS 大型研究之際,會相對很快啟動這項工作。當然,從讀出到最終結案、以及完成所有後續設置之間會有一些時間差。因此我們會盡可能快速地安排這個順序。
Operator
Operator
Srikripa Devarakonda.
Srikripa Devarakonda。
Srikripa Devarakonda - Analyst
Srikripa Devarakonda - Analyst
I want to ask a little bit about safety differentiation. The small molecules have liver monitoring requirements. If the upcoming data from 635 confirms -- reconfirms, I should say, a clean liver profile, can you talk a little bit about what you plan to do in Phase III in terms of liver monitoring to help establish a definitive differentiation on this aspect? And also, do you think a clear differentiation on safety would help capture the first-line non-hormonal market? And I have a follow-up question.
我想問一下關於安全性差異化。小分子藥物需要肝功能監測。如果 635 即將公布的數據確認——應該說再次確認——肝臟安全性概況乾淨,你們能否談談在第三期中,針對肝功能監測你們打算怎麼做,以協助在這個面向建立明確的差異化?另外,你們是否認為在安全性上有清楚差異化,將有助於拿下第一線的非荷爾蒙市場?我還有一個追問。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Sure. I'm probably going to not go too deep into this since we are expecting data relatively soon, and then we'll have ample opportunity to vet all those questions. But just briefly, as you mentioned, we have been very focused on safety as a key differentiator.
當然。我可能不會在這裡講得太深入,因為我們預期相對很快就會有數據出來,屆時我們將有充足的機會去審視所有這些問題。但簡單說,正如你提到的,我們一直非常聚焦於把安全性作為關鍵差異化因素。
Both the two small molecules have liver monitoring. That is inconvenient, both in practice and for patients. And we believe that it is a property associated with metabolism of small molecules and one that an antibody should not have. And of course, as reported last earnings call, the data so far shows no perceptible increase in liver enzymes across any of the patients. And so that thesis is sound, and we expect that, that will continue.
這兩個小分子都需要進行肝功能監測。這在實務操作上以及對病患而言都不方便。我們認為這是與小分子代謝相關的特性,而抗體理論上不應該有這樣的問題。當然,如同上次財報電話會議所報告的,截至目前的數據顯示,在任何病患身上都沒有觀察到肝酵素有可感知的上升。因此這個論點是成立的,我們也預期這種情況會持續。
In terms of how we look at that going forward, that will be on Sarah's docket, but my expectation is that we will continue to do some monitoring of enzyme levels. And make sure that, that holds going forward. But frankly, from a scientific perspective, I see no reason why that wouldn't.
至於未來我們如何看待這件事,這會列在 Sarah 的工作項目中,但我的預期是我們會持續監測一些酵素水準。並確保未來仍然維持這樣的結果。但坦白說,從科學角度來看,我看不出有任何理由會不是如此。
The other thing that you didn't mention on the safety side is there has been a somnolence side effect associated with the Bayer molecule. That's a somnolence side effect that we believe is associated with binding of that molecule, not just to NK3R but NK1R. We have an antibody that is specific, entirely specific to NK3R. So we do not expect to see that come up.
另外一個你在安全性方面沒有提到的是,拜耳那個分子曾與嗜睡(somnolence)的副作用相關。我們認為這種嗜睡副作用與該分子不僅結合 NK3R、也結合 NK1R 有關。我們的抗體具有特異性,且完全特異於 NK3R。因此我們不預期會出現那樣的情況。
And obviously, we haven't seen any of that in the data that we looked at so far, but that's another point that we'll be pushing. We do think that in addition to the convenience of a once-monthly dosing, improved safety for a product like this is paramount, and we are so far very encouraged by the data we've seen.
而且很明顯地,截至目前我們所檢視的數據也沒有看到任何這類訊號,但這也是我們會強調的另一個重點。我們確實認為,除了每月一次給藥的便利性之外,對於這類產品而言,更佳的安全性至關重要;而就目前看到的數據,我們非常受到鼓舞。
Srikripa Devarakonda - Analyst
Srikripa Devarakonda - Analyst
Great. Just a quick question on the partnerships that you have signed with Vertex, Jazz -- it seems like the focus is on multi-specific T cell engagers. Just wondering if you can talk a little bit about the percentage of internal resources that are dedicated to this TCE platform versus the others, especially the GPTR ion channel platform?
很好。關於你們與 Vertex、Jazz 簽署的合作夥伴關係,我有個快速問題——看起來重點是在多特異性 T 細胞接合器(T cell engagers)。想請你談談內部資源有多少比例投入在這個 TCE 平台,相較於其他平台,特別是 GPTR 離子通道平台?
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Great question. As I mentioned in my prepared remarks, our work in TCE is now a long-standing effort. So we have spent the last five years putting in place some of the very important building blocks to execute on these types of therapies. And along the way, have learned a lot about what it takes to succeed in this space. So much of that is now in the bank. So we're operating now from an established platform. We have extra bandwidth because that work is done to take on additional programs.
問得很好。如同我在事先準備的發言中提到的,我們在 TCE 上的工作如今已是長期投入。因此過去五年,我們建立了執行這類療法所需的一些非常重要的基礎要素。在這個過程中,我們也學到很多關於要在這個領域成功所需的條件。所以其中很大一部分現在已經累積完成。因此我們目前是在一個既有的平台上運作。由於那些工作已完成,我們也有額外的產能可以承接更多專案。
And so I expect there will not be a big change in our allocation of resources to TCE, but it will be directed from putting the foundation in place, building the expertise and the capabilities to executing on those capabilities, both for internal programs and for partner programs. And we are very pleased to see that come to fruition and to have attracted to stellar partners in Vertex and Jazz who prioritize high innovation and are serious about bringing forward to the clinic.
因此我預期我們在 TCE 的資源配置不會有很大的變化,但重心會從打地基、建立專業與能力,轉向運用這些能力來推進執行,包含內部專案與合作夥伴專案。我們很高興看到這些成果落地,也很高興能吸引到 Vertex 與 Jazz 這樣卓越的合作夥伴;他們重視高度創新,並且認真要把產品推進到臨床。
Just the last point, with respect to the balance between TCEs and, let's say, GPCRs and ion channels, I don't have a hard number, but I'd say that there's significantly more effort on the GPCR and ion channel side, but TCE has been one of the strong pillars of the pipeline, and we expect it will stay that way for the coming future.
最後一點,關於 TCE 與(例如)GPCR 與離子通道之間的平衡,我沒有一個硬性的數字,但我會說在 GPCR 與離子通道這一側投入的努力明顯更多;不過 TCE 一直是產品線的強力支柱之一,我們預期在可預見的未來也會維持如此。
Operator
Operator
Stephen Willey, Stifel.
Stephen Willey,Stifel。
Stephen Willey - Equity Analyst
Stephen Willey - Equity Analyst
This is Josh on for Steve. Congrats on the progress. Maybe just as a follow-up to the first question asked specifically on severity. And looking at some of the historical fezolinetant elinzenetant data, it sort of seems that -- it doesn't appear that fezolinetant actually maybe shows a statistically significant difference on severity at certain time points.
我是 Josh,代 Steve 提問。恭喜你們的進展。也許作為對第一個問題、特別是關於嚴重程度(severity)的追問。回頭看一些歷史上的 fezolinetant、elinzenetant 數據,似乎——看起來 fezolinetant 在某些時間點對嚴重程度可能並沒有呈現統計上顯著的差異。
And it looks like elinzenetant specifically at later time points and at higher doses has kind of shown this and wanted to get your thoughts on maybe severity being something that's maybe exposure driven and how you're thinking about that with maybe CL635's differentiation with the extended pathway.
而 elinzenetant 似乎是在較後期時間點、以及較高劑量時,才比較有顯示出這點;想聽聽你對於嚴重程度是否可能是由暴露量(exposure)所驅動的看法,以及你們如何看待 CL635 透過延長作用途徑所帶來的差異化。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
It's a great question. I don't know exactly the data that you're looking at. Both severity and frequency are important regulatory endpoints that need to be hit. That's the understanding that we're moving on. And we do think that they correlate very well. There's -- at the very least, there's well-reported data on dose escalation for fezolinetant, where a dose escalation of fezolinetant showed improved efficacy both in frequency and in severity.
這是個很好的問題。我不確定你正在看的具體是哪一組數據。嚴重程度與頻率都是重要的法規端點,必須達標。這是我們目前推進工作的理解基礎。我們也確實認為兩者的相關性很高。至少,關於 fezolinetant 的劑量遞增有相當多已報導的數據:提高 fezolinetant 劑量可在頻率與嚴重程度兩方面都帶來更佳療效。
And on the severity case, it did look as though that dose response lasted longer or plateaued later than it did on frequency. So I think that would be consistent with what you're saying, but I would be cautious to speculate too much with exactly how that's going to play out. And in any event, we are anxiously awaiting the data that's coming. So we're going to have that answer pretty quick, and then we'll be digging deeper into it.
而在嚴重程度方面,看起來那個劑量反應維持得更久,或是比頻率更晚才進入平台期。所以我認為這與你所說的方向一致,但我會謹慎,不想對它將如何具體發展做過多推測。無論如何,我們都非常期待即將出爐的數據。所以我們很快就會得到答案,接著也會更深入地去分析。
Operator
Operator
Evan Seigerman, BMO Capital Markets.
Evan Seigerman,BMO Capital Markets。
Unidentified Participant
Unidentified Participant
Mc (inaudible) on for Evan. The Vertex collaboration applies T cell engagers to autoimmune diseases. And without disclosing the targets, can you discuss what technical features are required to create an acceptable therapeutic profile in these autoimmune diseases, particularly around depth and duration of cell depletion, cytokine release and repeat dosing? Appreciate it.
我是 Mc(聽不清),代 Evan 提問。Vertex 的合作是將 T 細胞接合器應用於自體免疫疾病。在不揭露標的的前提下,你能否談談在這些自體免疫疾病中,要建立可接受的治療特性(therapeutic profile)需要哪些技術特徵,特別是細胞清除的深度與持續時間、細胞激素釋放,以及重複給藥?謝謝。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Yes. It's a great question. I think you highlighted the important things for cell depleters that are used in autoimmunity. And what you want is deep depletion, something that is safe, something that is tolerable. All of that is in play. But it also depends on the target and the exact application. And so without getting into the details of that, I don't think I could give you a very detailed answer on that particular question.
可以。這是個很好的問題。我認為你點出了在自體免疫領域使用的細胞清除型療法(cell depleters)的關鍵要素。你希望有深度清除,同時要安全、要可耐受。這些都在考量範圍內。但這也取決於標的以及具體的應用情境。因此在不談細節的情況下,我想我無法就這個問題給出非常具體的回答。
Operator
Operator
Allison Bratzel, Piper Sandler.
Allison Bratzel,Piper Sandler。
Allison Bratzel - Analyst
Allison Bratzel - Analyst
One for me on 635. Could you just talk to your expectations for the placebo arm in the Phase II? Are the small molecule trials a good benchmark of what to expect from the placebo? And could you just talk to aspects of the Phase II trial design that are designed to mitigate placebo responses?
我有一個關於 635 的問題。你能談談你們對第二期(Phase II)安慰劑組的預期嗎?小分子試驗是否是預估安慰劑表現的良好基準?另外也請談談第二期試驗設計中,哪些面向是用來降低安慰劑反應的?
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Yes. The trials that have been done have all shown a pronounced placebo response. And so our expectation coming into the study is that we will also have a placebo response and that it will be in the range that's comparable to what has been seen. That's our working hypothesis.
可以。既往已完成的試驗都顯示出明顯的安慰劑反應。因此我們在進入本研究時的預期是,我們也會看到安慰劑反應,而且其幅度會落在與既往觀察到的相當的範圍內。這是我們目前的工作假設。
We're going to know that very soon when we read out the data. In terms of trying to reduce that response, apart from good clinical operations, having a period where you're enrolling patients, not telling people exactly what the numbers need to be before they're enrolled, all of that has been put in place. We feel very confident about the execution.
我們很快就會在宣讀數據時知道答案。就降低該反應而言,除了良好的臨床營運之外,我們也設置了一段病患收案期,在收案前不向外界明確透露需要達到的數字等;這些措施都已到位。我們對執行非常有信心。
But I do think one of the big questions is exactly where that placebo response is going to come out. And we'll know shortly. Thanks for the question.
但我確實認為,其中一個重大問題是安慰劑反應最終會落在什麼水準。我們很快就會知道。謝謝你的提問。
Operator
Operator
Brendan Smith, TD Cowen.
Brendan Smith,TD Cowen。
Brendan Smith - Analyst
Brendan Smith - Analyst
Maybe another one on 635 from us. I guess, first, just quickly, can you confirm that the Phase II efficacy data will be out to four weeks in all patients? Or will you have any data out to 12 weeks in some patients? Just to kind of check that box there. And then maybe secondly, when you look at the commercial opportunity, I guess, in BMS, how are you kind of thinking about a potential Phase III in terms of target patients?
我們這邊可能再問一個關於 635 的問題。我想先快速確認一下:第二期的療效數據會涵蓋所有受試者到第 4 週嗎?還是你們會在部分受試者身上提供到第 12 週的數據?只是想把這點確認清楚。另外,談到商業機會,我想在 BMS(血管舒縮症狀)方面,你們如何思考第三期試驗在目標病患上的定位?
I guess, are you thinking of this exclusively as a non-hormonal alternative? Or would you kind of consider a comparison in a pivotal study maybe with some patients on or refractory to HRT? Just kind of trying to think about how we should segment that market.
你們是把它完全定位為非荷爾蒙替代方案嗎?還是會考慮在關鍵性試驗中做比較,例如納入一些正在使用 HRT 或對 HRT 反應不佳(難治)的病患?我只是想了解我們應該如何切分那個市場。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Yes. So first, the data that we're expecting very soon is going to be data that is four weeks in all patients, and we will not report data on other -- a subset of patients out to 12 weeks. So that's the top line data. And historically, if you look at efficacy data, there's been a very good follow-through between 4-week data and 12-week data. So we're feeling confident that we're in a great spot.
是的。首先,我們很快將取得的數據會是所有受試者到第 4 週的數據,我們不會公布其他——也就是某個子集到第 12 週的數據。所以那會是我們的重點(top line)數據。而從歷史經驗來看,如果你看療效數據,第 4 週與第 12 週之間通常有非常好的延續性。因此我們有信心目前處於很好的位置。
Also, I should mention that the Phase II was done with a single dose of ABCL635. And so part of the study is that we are not dosing again. And as the dose comes down, we're getting an effective dose response curve. So we would expect that by 12 weeks, the effect should be certainly diminished, although we'll see that when it comes out.
另外我也要提到,第二期試驗採用的是 ABCL635 的單次給藥。因此研究設計的一部分是我們不會再次給藥。隨著劑量逐漸下降,我們會得到一條有效劑量反應曲線。所以我們預期到第 12 週時,效果應該會明顯減弱,當然最終還是要等數據出來再看。
In terms of the Phase III, I think it's a little bit early to talk about the design. I think it is a good question as to how you exactly design this and really speaks to the medical need. We think at the very base case, there are a large number of women that are contraindicated and that would benefit from a non-hormonal option.
至於第三期,我認為現在談設計還稍早。但這確實是個好問題:究竟要如何設計,這也真正反映了醫療需求。我們認為在最基本的情境下,有大量女性因禁忌症而無法使用荷爾蒙治療,並且會受益於非荷爾蒙選項。
As I've said on previous calls, we think that, that's roughly -- it's probably over 1 million women in the U.S. alone. In addition to that, there's a very substantial number of people that would benefit from a treatment for hot flashes associated with cancer therapy where hormones are not an option. That would include both prostate cancer and breast cancer.
如同我在先前的電話會議中提過,我們認為這大約——在美國單一市場就可能超過 100 萬名女性。此外,還有相當可觀的人群會受益於針對癌症治療相關熱潮紅的療法,因為荷爾蒙並非選項。這包括前列腺癌與乳癌。
And then there will be some subset that are not tolerant to HRT or that decide not to. And that's a bit of a moving bar these days, but we think there's a big opportunity there as well. So we will take all that into consideration once we have the data, and we're making plans for the larger trial.
另外也會有一部分人對 HRT 不耐受,或選擇不使用。這些年這個門檻有些變動,但我們認為那裡同樣存在很大的機會。因此,一旦我們拿到數據並規劃更大型的試驗時,會把上述因素都納入考量。
Operator
Operator
Debanjana Chatterjee, Jones.
Debanjana Chatterjee,Jones。
Debanjana Chatterjee - Analyst
Debanjana Chatterjee - Analyst
On the progress with the trial. Curious if you could add any additional color on the blinded safety data that's emerging from the trial? Are the -- like the overall adverse event rates that you're seeing on a blinded basis and any potential discontinuation rates tracking within expectations? And I have a quick follow-up.
關於試驗進展。想請問你們能否就試驗中逐步浮現的盲態安全性數據提供更多說明?例如在盲態下你們看到的整體不良事件發生率,以及任何可能的停藥率,是否都符合預期?我還有一個簡短的追問。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Yes. We haven't disclosed any safety data past what we did on the last call. What I will say is that there's nothing that we've seen that has given us any pause or damage our thesis. But of course, we're going to wait until the unblinding and have a close look at that. But so far, things are on track.
是的。除了我們在上一次電話會議中披露的內容之外,我們尚未公布更多安全性數據。我能說的是,目前我們沒有看到任何讓我們需要停下來或動搖我們核心假設的訊號。但當然,我們會等到解盲後再仔細檢視。截至目前,一切都按計畫進行。
Debanjana Chatterjee - Analyst
Debanjana Chatterjee - Analyst
Appreciate it. And a quick follow-up. What's your latest take on the debate around whether targeting the median freeoptic nucleus, I mean, inhibiting the NK3R receptors there is crucial to seeing potential benefit versus just suppressing the candy neurons in the ARCUS nucleus?
了解,謝謝。我有個簡短追問。你們目前對於這個爭論的最新看法是什麼:是否必須鎖定正中視前核(median preoptic nucleus),也就是抑制那裡的 NK3R 受體,才能看到潛在效益;相較之下,僅僅抑制 ARCUS 核中的 KNDy 神經元是否就足夠?
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
That is a great question, and it's one, I think, that we've highlighted on past calls. So that is the key remaining scientific risk in the program. What I will say is that the Phase I data that we presented on the last call shows that we can get profound suppression of testosterone and that we can do that in a way that is deeper than what has been seen by the small molecules and that lasts for the entire dosing interval.
這是個很好的問題,也是我認為我們在過去幾次電話會議中強調過的。因此,這是該計畫剩餘的關鍵科學風險。我想說的是,我們在上次電話會議中展示的第一期數據顯示,我們可以顯著抑制睪固酮,而且抑制深度比小分子藥物所見更深,並且可維持整個給藥間隔。
So the candy neurons -- so that reads right through to the candy neurons in the infantibular nucleus. Those are believed to be the most important neurons. I think everyone would agree with that. And so from that perspective, if those are the only neurons that matter, then we would expect an efficacious drug and probably a drug that has even better efficacy than what has been seen with the small molecules because the testosterone suppression has been greater.
因此,KNDy 神經元——這會直接反映到漏斗核(infundibular nucleus)中的 KNDy 神經元。一般認為這些是最重要的神經元。我想大家都會同意這點。所以從這個角度來看,如果只有這些神經元才是關鍵,那我們預期會有療效,而且可能比小分子藥物看到的療效更好,因為睪固酮抑制更強。
The open question remains as to whether also blocking NK3R in the preoptic nucleus has an effect. We have not done a conclusive experiment preclinically to prove that. The experiment to prove that is the Phase II data that we'll read out shortly. And so that's the remaining question. I'm not going to speculate further, but we're feeling very good that we have great target engagement in the neurons that are the main drivers of this, whether or not taking another kick at the can in the preoptic nucleus matters is something that we're going to find out very shortly.
尚未解答的問題是:同時阻斷視前核(preoptic nucleus)中的 NK3R 是否也會產生影響。我們在臨床前尚未做出能夠定論的實驗來證明這點。用來證明這點的實驗,就是我們即將公布的第二期數據。因此這就是剩下的問題。我不會再進一步推測,但我們對於在主要驅動此機制的神經元上達到良好靶點結合(target engagement)感到非常樂觀;至於在視前核再「多踢一腳」是否重要,我們很快就會知道。
Operator
Operator
There are no further questions at this time. We have reached the end of the Q&A session. I will now turn the call back to Carl for closing remarks.
目前沒有其他問題。問答環節到此結束。我現在把電話交回給 Carl 做結語。
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Carl Hansen - Chairman of the Board, President, Chief Executive Officer, Co-Founder
Thank you, everyone, for joining the call today. AbCellera is moving into a very exciting time, and we look forward to updating you shortly on our pipeline and our portfolio. Thank you.
感謝各位今天參與電話會議。AbCellera 正進入一個非常令人振奮的階段,我們期待很快向各位更新我們的研發管線與產品組合。謝謝。
Operator
Operator
This concludes today's call. Thank you for attending. You may now disconnect.
今天的電話會議到此結束。感謝各位出席。您現在可以掛線。