Abcellera Biologics Inc (ABCL) 2025 Q3 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 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 third-quarter 2025 business update conference call. My name is Cameron, and I'll facilitate the audio portion of today's interactive broadcast. (Operator Instructions)

    下午好,歡迎參加 AbCellera 2025 年第三季業務更新電話會議。我叫卡梅倫,我將負責今天互動直播的音訊部分。(操作說明)

  • At this time, I would like to turn the call over to Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. You may proceed. Thank you.

    此時,我想把電話交給 AbCellera 的首席法律和合規官 Tryn Stimart。您可以繼續。謝謝。

  • 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

  • Hello, everyone. Thank you for joining us for AbCellera's third-quarter 2025 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 also on today's call.

    大家好。感謝您參加 AbCellera 2025 年第三季財報電話會議。我是 Tryn Stimart,AbCellera 的首席法律和合規官。AbCellera 總裁兼執行長 Carl Hansen 博士和 AbCellera 財務長 Andrew Booth 也參加了今天的電話會議。

  • During this call, we anticipate making projections and forward-looking statements based on our current expectations and in accordance with the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Our actual results could differ materially due to several factors outlined in our latest Form 10-K and subsequent Forms 10-Q and 8-Q filed with the Securities and Exchange Commission.

    在本次電話會議中,我們預計將根據我們目前的預期,並按照 1995 年《私人證券訴訟改革法案》的安全港條款,做出預測和前瞻性聲明。由於我們在最新的 10-K 表格以及隨後向美國證券交易委員會提交的 10-Q 表格和 8-Q 表格中概述的幾個因素,我們的實際結果可能會與預期有重大差異。

  • AbCellera is not obligated to update any forward-looking statements, whether due to new information, future events or otherwise. 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沒有義務更新任何前瞻性聲明,無論是由於新資訊、未來事件或其他原因。我們今天的簡報、獲利新聞稿以及提交給美國證券交易委員會的文件都可以在我們的投資者關係網站上找到。我們提供的產品線資訊僅供投資界參考,不具推廣性質。

  • As we transition to our prepared remarks, please note that all dollars referred to during the call are US dollars. After our prepared remarks, we will open the lines for questions and answers.

    在我們開始發言之前,請注意,通話中提到的所有美元均為美元。在我們發言結束後,我們將開放問答環節。

  • Now, I'll turn the call over to Carl.

    現在,我把電話交給卡爾。

  • 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, Tryn, and thank you, everyone, for joining us today. Last quarter, we completed our transition from a platform company to a clinical stage biotech with the initiation of our Phase 1 clinical trials for ABCL635 and ABCL575. Both trials are progressing to plan and remain on track for readouts next year.

    謝謝特林,也謝謝各位今天能來參加。上個季度,我們完成了從平台公司到臨床階段生物技術的轉型,啟動了 ABCL635 和 ABCL575 的 1 期臨床試驗。兩項試驗均按計畫進行,預計明年將公佈結果。

  • I'm pleased to report that this quarter, we have also started activities at our new clinical manufacturing facility, and we have substantially completed our platform investments. We ended the quarter with approximately $680 million in available liquidity to execute in our strategy, and as we close out the year, we are confident in achieving all our corporate priorities, including advancing at least one more development candidate into IND-enabling studies.

    我很高興地報告,本季度我們新的臨床生產設施也已開始投入運營,並且我們的平台投資已基本完成。本季末,我們擁有約 6.8 億美元的可用流動資金,可用於執行我們的策略。隨著年底的臨近,我們有信心實現所有公司優先事項,包括至少推進一個候選藥物進入 IND 申報研究階段。

  • A highlight of this quarter was the appointment of Dr. Sarah Noonberg as Chief Medical Officer. Sarah is a physician-scientist with over 20 years of clinical drug development experience. She has worked across a broad range of modalities and indications and has led programs through all stages of development from discovery through to approval. You can expect Sarah to join future earnings calls to provide updates on our clinical pipeline.

    本季的一大亮點是任命 Sarah Noonberg 博士為首席醫療官。Sarah是一位擁有20多年臨床藥物開發經驗的醫生科學家。她曾參與多種治療方式和適應症的研發,並領導過從發現到獲準的各個階段的計畫。預計 Sarah 將在未來參加財報電話會議,為大家帶來我們臨床研發管線的最新進展。

  • With Sarah taking the helm, Dr. Jeff Nickel will be stepping down as our SVP of Development. I'd like to thank Jeff for his leadership in building development as we transitioned from a platform company to a clinical stage biotech.

    隨著 Sarah 接任領導職務,Jeff Nickel 博士將卸任資深副總裁(發展)一職。我要感謝 Jeff 在公司發展建設方面的領導作用,幫助我們從平台公司轉型為臨床階段的生技公司。

  • And with that, I will hand it over to Andrew to discuss our financials. Andrew?

    接下來,我將把發言權交給安德魯,讓他來討論我們的財務狀況。安德魯?

  • 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 approximately $520 million in cash and cash equivalents, and with roughly $160 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 CMC and GMP investments.

    謝謝你,卡爾。正如卡爾指出的那樣,AbCellera 的流動性狀況仍然強勁,擁有約 5.2 億美元的現金及現金等價物,以及約 1.6 億美元的可用政府承諾資金,用於執行我們的策略。我們將繼續執行我們的計劃,重點是內部項目,並充分利用我們在CMC和GMP方面的投資。

  • Looking at our business metrics, in the third quarter, we started work on one additional partner-initiated program, which takes us to a cumulative total of 103 programs with downstream participation. With Phase 1 trials for ABCL635 and ABCL575 underway, we maintained a cumulative total of molecules to have reached the clinic at 18, including both our own pipeline and those led by partners. As we have stated previously, we view the overall progress of molecules in the clinic as potential source of near- and mid-term revenue from downstream milestone fees and royalty payments in the longer term.

    從我們的業務指標來看,在第三季度,我們啟動了一個額外的合作夥伴發起的項目,這使我們有下游參與的項目累計達到 103 個。ABCL635 和 ABCL575 的 1 期試驗正在進行中,我們累計進入臨床階段的分子總數保持在 18 個,其中包括我們自己的研發管線和合作夥伴主導的研發管線。正如我們之前所述,我們認為分子在臨床上的整體進展是近期和中期收入的潛在來源,下游里程碑付款和長期特許權使用費也將帶來收入。

  • Turning to revenue and expenses, revenue for the quarter was $9 million, predominantly from research fees relating to work-on-partner programs. This compares to revenue of approximately $7 million in the same quarter of last year. With respect to research fee revenue, as we have mentioned in the past, we expect these to continue to trend lower as we increasingly focus on our internal pipeline.

    再來看收入和支出,本季收入為 900 萬美元,主要來自與合作夥伴計畫相關的研究費用。相比之下,去年同期營收約 700 萬美元。關於研發費用收入,正如我們之前提到的,隨著我們越來越專注於內部研發項目,我們預計這些收入將繼續呈下降趨勢。

  • Our research and development expenses for the quarter were $55 million, approximately $14 million more than last year. This expense reflects the focus on investment in our internal and co-development programs. The increase over the recent run rate expense levels in Q3 is largely due to specific investments of $15 million on two internal programs.

    本季我們的研發費用為 5,500 萬美元,比去年同期增加了約 1,400 萬美元。這項支出反映了我們對內部和合作開發專案投資的重視。第三季支出水準較近期正常水準增加,主要是因為兩個內部專案進行了 1,500 萬美元的專項投資。

  • In sales and marketing, expenses for Q3 were just under $3 million, a small reduction relative to the same quarter of last year. And in general and administration, expenses were approximately $22 million compared to roughly $19 million in Q3 of 2024. Included in these expenses are the ongoing expenses related to the defense of our intellectual property.

    第三季的銷售和行銷費用略低於 300 萬美元,與去年同期相比略有下降。一般而言,行政開支約為 2,200 萬美元,而 2024 年第三季約為 1,900 萬美元。這些費用包括與保護我們的智慧財產權相關的持續性費用。

  • Looking at earnings, we're reporting a net loss of roughly $57 million for the quarter compared to a loss of about $51 million in the same quarter of last year. In terms of earnings per share, this result works out to a loss of $0.19 per share on a basic and diluted basis.

    從獲利情況來看,本季淨虧損約 5,700 萬美元,而去年同期虧損約 5,100 萬美元。以每股收益計算,無論以基本面或稀釋面計算,每股虧損 0.19 美元。

  • Looking at cash flows, operating activities for the first nine months of 2025 used approximately $97 million in cash and equivalents. Excluding investments in marketable securities, investment activities amounted to $49 million year to date. This is predominantly in property, plant, and equipment, driven by investments in establishing clinical manufacturing, which are now substantially complete as we had expected. The investments in PP&E were partially offset by government contributions.

    從現金流來看,2025 年前九個月的經營活動大約使用了 9,700 萬美元的現金及等價物。不包括對有價證券的投資,今年迄今的投資活動總額為 4,900 萬美元。這主要體現在房地產、廠房和設備方面,主要得益於對建立臨床生產設施的投資,而這些設施現在已基本完成,正如我們所預期的。固定資產的投資部分被政府撥款抵銷。

  • And as a part of our treasury strategy, we have $413 million invested in short-term marketable securities. Our investment activities for the quarter included a $62 million net divestment of these holdings.

    作為我們財務策略的一部分,我們已投資 4.13 億美元於短期有價證券。本季我們的投資活動包括淨減持這些資產 6,200 萬美元。

  • Altogether, we finished the quarter with $523 million of total cash, cash equivalents, and marketable securities. And as a reminder, we have received commitments for funding for 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, and with over $520 million in cash and equivalents, and the unused portion of our secure government funding, we have approximately $680 million in available liquidity to execute on our strategy.

    本季末,我們總共持有現金、現金等價物和有價證券共 5.23 億美元。此外,我們也要提醒大家,加拿大政府戰略創新基金和不列顛哥倫比亞省政府已承諾為推動我們的內部研發項目提供資金。這筆可用資金並未顯示在我們的資產負債表上,加上超過 5.2 億美元的現金及等價物,以及未使用的政府擔保資金,我們大約有 6.8 億美元的可用流動資金來執行我們的策略。

  • In addition, we have available liquidity in our ownership of both Vancouver-based lab and office buildings as well as our GMP manufacturing facility, both of which have been financed off of our balance sheet. The operating cash usage for the remainder of 2025 will continue to prioritize advancing our two lead programs through their Phase 1 clinical studies and building a strong preclinical pipeline. With respect to our overall company expenditures, our capital needs are very manageable, and we continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments.

    此外,我們擁有位於溫哥華的實驗室和辦公大樓以及符合 GMP 標準的生產設施,這兩處設施都已透過資產負債表融資,因此我們擁有可用的流動資金。2025 年剩餘時間的營運現金使用將繼續優先用於推進我們兩個主要項目的 1 期臨床研究,並建立強大的臨床前產品線。就公司整體支出而言,我們的資金需求完全可控,我們仍然相信我們擁有足夠的流動資金,足以支持未來三年及以後不斷增長的管道投資。

  • And with that, we'll be happy to take your questions. Operator?

    那麼,我們很樂意回答您的問題。操作員?

  • Operator

    Operator

  • (Operator Instructions)

    (操作說明)

  • Malcolm Hoffman, BMO.

    馬爾科姆·霍夫曼,BMO。

  • Malcolm Hoffman - Equity Analyst

    Malcolm Hoffman - Equity Analyst

  • I want to ask how to think about partner-initiated programs in the clinic. These look somewhat stagnant since 2024, and to be clear, we appreciate the conversion to more AbCellera-led development. I just wanted to understand why these partner-initiated programs may not be progressing clinically. Is it just a timing issue?

    我想請教一下,如何看待診所中由合作夥伴發起的計畫。自 2024 年以來,這些面向似乎有些停滯不前,但需要明確的是,我們讚賞這種向 AbCellera 主導的開發模式的轉變。我只是想了解為什麼這些由合作夥伴發起的計畫在臨床上可能沒有進展。只是時間問題嗎?

  • And then a second one about Dr. Noonberg and her new role as CMO. Can you comment on why you felt like now was the appropriate time to bring Dr. Noonberg in? And what do you think she uniquely brings to AbCellera that the company may have lacked before?

    然後還有一篇關於 Noonberg 博士及其擔任首席行銷長新角色的文章。您能否解釋為什麼您認為現在是請努恩伯格醫師介入的好時機?你認為她為 AbCellera 帶來了哪些該公司之前可能缺乏的獨特之處?

  • 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. So I'm happy to take that one. Carl Hansen here. So first on the partner-initiated programs. So as you know, in the early stages of the company and through until 2023, our business was primarily focused on a partnership mode where we were doing discovery on behalf of partners and keeping a position in the resulting molecules, both in royalties and in milestones.

    當然。所以我很高興接受這個任務。我是卡爾漢森。首先來看合作夥伴發起的專案。如您所知,在公司成立初期以及直到 2023 年,我們的業務主要集中在合作模式上,我們代表合作夥伴進行藥物發現,並在由此產生的分子中保持一定的地位,包括特許權使用費和里程碑付款。

  • We have handed off a large number of those, and as Andrew mentioned, I believe we have initiated about 103 programs to date. We do expect that some fraction of those are going to move forward into clinical development, and we continue to report on that. I would say that our experience has been that it takes longer than we had initially anticipated. So we have examples where programs that were handed off ultimately go into clinical development as much as six years later.

    我們已經移交了大量此類項目,正如安德魯所提到的,我相信到目前為止我們已經啟動了大約 103 個項目。我們預計其中一部分將進入臨床開發階段,我們將繼續通報相關進展。我想說,根據我們的經驗,實際花費的時間比我們最初預想的要長。因此,我們有一些例子,一些移交的計畫最終在長達六年的時間內進入臨床開發階段。

  • So it's difficult to make an assessment as to what will be the number of those that ultimately make it into clinical development, but we do think that there is value there that's going to accrue over time, as mentioned by Andrew on his prepared remarks.

    因此,很難評估最終會有多少藥物進入臨床開發階段,但正如安德魯在準備好的演講稿中所提到的,我們認為隨著時間的推移,這些藥物的價值將會不斷累積。

  • Moving to the question of bringing Sarah on, Obviously, in 2023, we made the definitive decision to back away from that partnership business and to move into doing drug development on our own behalf. Over the past few months, we've succeeded in bringing the first two programs into clinical development. We have a robust pipeline coming behind that. And as the portfolio matures, we definitely thought it was time to bring in a senior executive with experience in clinical development. And also that the company was at a position where we would be able to attract someone that was absolutely top notch.

    至於讓 Sarah 加入的問題,顯然,在 2023 年,我們做出了最終決定,退出合夥業務,轉而獨立進行藥物研發。在過去的幾個月裡,我們成功地將前兩個項目推進了臨床開發階段。我們後續還有強大的產品線正在開發中。隨著產品組合的成熟,我們認為現在是時候引進一位在臨床開發方面有經驗的高階主管了。而且公司當時也處於能夠吸引頂尖人才的位置。

  • So we're thrilled to have Sarah on board and we look forward to working with her and with you over the coming years as the pipeline matures.

    因此,我們非常高興 Sarah 加入我們,並期待在未來幾年隨著專案線的成熟,與她以及你們一起合作。

  • Operator

    Operator

  • Andrea Newkirk, Goldman Sachs.

    安德里亞·紐柯克,高盛集團。

  • Andrea Newkirk - Analyst

    Andrea Newkirk - Analyst

  • Carl, I was just wondering if you might be willing to speak a little bit on the data disclosure strategy that you plan on taking for the Phase 1 635 study, particularly given you do have the various cohorts, SAD, MAD, dosing, as well as the proof of concept section where you're evaluating efficacy. Just curious if this will all come within one disclosure.

    卡爾,我想問你是否願意談談你計劃在 1 期 635 研究中採取的數據披露策略,特別是考慮到你有各種隊列、SAD、MAD、劑量,以及你正在評估療效的概念驗證部分。我只是好奇這些資訊是否會在一次披露中全部包含進去。

  • And then if you could help frame expectations for the profile you would deem supportive to continue advancing this further into a Phase 2 study. And then I have one following that.

    然後,如果您能幫助我們明確您認為有助於推進這項研究進入二期臨床試驗的預期目標,那就太好了。然後我還有一篇。

  • 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, Andrea. So to your first question, you know, our expectation is to make a single disclosure after we have completed the proof-of-concept part where we have a double-blind, placebo-controlled, evaluation of ABCL635 in the patient population that it's intended for. We do expect that'll come sometime in the new year. I think we had said before around mid-new year, but give that a couple months on either side for error bars.

    謝謝你,安德里亞。所以對於你的第一個問題,你知道,我們的預期是在完成概念驗證部分之後進行一次披露,屆時我們將對 ABCL635 在目標患者群體中進行雙盲、安慰劑對照評估。我們預計這將在新年的某個時候發生。我想我們之前說過大概在新年年中左右,但考慮到誤差範圍,前後留出幾個月的時間。

  • What we're looking for is that we have a safety signal and we have efficacy that shows that we're in the game to have a competitive product against the other products that are now in the market. And the study is powered to do that. So somewhere around midpoint next year, we should know a lot about this program.

    我們正在尋找的是,我們擁有安全訊號和有效性,這表明我們有能力推出一款與目前市場上其他產品競爭的產品。這項研究也具備這樣的能力。所以到明年年中左右,我們應該會對這個計畫有更深入的了解。

  • So far, we're encouraged by what we're seeing. Everything is on track. And if that continues on track, then we're getting ready to be in position to aggressively move it into later-stage trials.

    目前來看,我們感到鼓舞。一切進展順利。如果一切按計劃進行,那麼我們將做好準備,積極推進其進入後期試驗階段。

  • Andrew Booth - Chief Financial Officer

    Andrew Booth - Chief Financial Officer

  • Got it. Okay. And if you do achieve your desired target product profile when you see the data emerge next year, how validating would that be for your platform and technology? And do you think there is read-through to the rest of your pipeline?

    知道了。好的。如果明年數據出來後,你實現了預期的目標產品概況,這對你的平台和技術來說將是多麼具有驗證意義?你認為這能對你流程中的其他部分產生影響嗎?

  • 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's a great question. So you know, we have highlighted before that one of the areas where we've been investing for a long time and where I believe we have world-class capabilities is in making antibodies against ion channel and GPCR targets. Obviously, NK3R is a GPCR target, so it's the first from that platform to move forward. I think that's strong evidence that the platform is working and that we can make highly differentiated molecules. Of course, you know, evidence of a platform doesn't happen with a single asset, and our intent is to follow that up again and again with other molecules from that pipeline that we're equally excited about.

    這是一個很好的問題。你知道,我們之前已經強調過,我們長期以來一直投資的領域之一,也是我相信我們擁有世界一流能力的領域,就是製造針對離子通道和 GPCR 靶點的抗體。顯然,NK3R 是一個 GPCR 靶點,因此它是該平台上第一個取得進展的靶點。我認為這有力地證明了該平台是有效的,我們可以製造出高度差異化的分子。當然,你也知道,一個平台的成功並非僅靠單一資產就能證明,我們的目標是用該研發管線中其他同樣令人振奮的分子一次又一次地進行驗證。

  • Operator

    Operator

  • Stephen Willey, Stifel.

    Stephen Willey,Stifel。

  • Unidentified Participant 1

    Unidentified Participant 1

  • This is Josh on for Steve. Thanks for taking our question. Is there anything you can tell us about how enrollment's going in the Phase 1 trial for 575? And maybe potentially some color on some of the doses you've reached in this cohort?

    這裡是喬什,替史蒂夫報道。感謝您回答我們的問題。能否透露一下 575 號藥物 1 期試驗的招募情況?或許還可以詳細介紹一下本組患者所達到的劑量水平?

  • 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, so in terms of enrollment, as I mentioned, the program is going as expected, so everything is on track and at the pace that we anticipated. We are not disclosing preliminary results in terms of how far we got in dosing. But as I said, we're encouraged by what we're seeing, and so far everything is as expected.

    當然,就招生情況而言,正如我所提到的,該計畫進展順利,一切都在按計劃進行,速度也符合我們的預期。我們不會透露我們在給藥方面取得的初步結果。但正如我所說,我們對目前的情況感到鼓舞,到目前為止一切都在預期中。

  • Unidentified Participant 1

    Unidentified Participant 1

  • Okay, great. And then just another quick one. I know you said on the 2Q call you were in line to declare a potential fourth AbCellera-led candidate by the end of this year. Are you guys still on track to do so?

    好的,太好了。然後又快速地來了一個。我知道你在第二季財報電話會議上說過,你打算在今年底前宣布由AbCellera領導的第四位候選人。你們目前還在照計畫進行嗎?

  • 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, that's correct. I think I said that in my prepared remarks that we are on track before the end of the year to bring an additional development candidate forward, and that would be the fourth in the pipeline.

    是的,沒錯。我想我在事先準備好的演講稿中說過,我們預計在年底前推出另一個研發候選藥物,這將是第四個在研藥物。

  • Operator

    Operator

  • Faisal Khurshid, Leerink Partners.

    Faisal Khurshid,Leerink Partners。

  • Faisal Khurshid - Analyst

    Faisal Khurshid - Analyst

  • On 635, could you speak to us about whether there's a specific benchmark or bar that you would want to see on testosterone reduction in healthy male volunteers?

    關於第 635 點,您能否談談您希望在健康男性志願者中看到的睪固酮降低的具體基準或標準?

  • 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 wouldn't punch out a specific level, but there is good literature out there disclosing testosterone levels from small molecules that were in development, particularly fezolinetant, and so we would, within the power of the study, look for something that shows that we're getting engagement that is at least as good as that to move forward.

    當然。我不會給出具體的數值,但是有很多文獻披露了正在研發的小分子藥物(特別是 fezolinetant)的睾酮水平,因此,在研究能力範圍內,我們會尋找能夠證明我們獲得的參與度至少與這些藥物一樣好的東西,以便繼續推進。

  • Faisal Khurshid - Analyst

    Faisal Khurshid - Analyst

  • Got it. Okay. And then could you also discuss the risk of engaging this target with a map given it's a CNS target?

    知道了。好的。那麼,鑑於該目標是中樞神經系統目標,您能否也討論一下使用地圖攻擊該目標的風險?

  • 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. That's a great question. I think it's one that I touched on an earlier call. So we believe that the pathway -- the NK3R pathway, is very well validated. And so that if we can engage NK3R in the relevant neurons, that it's highly likely to be an efficacious drug. The NK3R is expressed in [candy] neurons in the arcuate nucleus, and those neurons connect both to the endocrine system and also go through the blood-brain barrier into the thermoregulatory center of the brain.

    當然。這是一個很好的問題。我想我之前在電話裡提到過這個問題。因此,我們認為 NK3R 路徑得到了充分的驗證。因此,如果我們能夠激活相關神經元中的 NK3R,那麼它很可能是一種有效的藥物。NK3R 在弓狀核的 [candy] 神經元中表達,這些神經元既與內分泌系統相連,也穿過血腦屏障進入大腦的體溫調節中心。

  • So we expect that we should be able to engage NK3R in the arcuate nucleus, and given our understanding of the biology, we believe that that should be sufficient that might be efficacious in treating VMS. But, of course, we have not yet proven that, and so we need to wait for the proof-of-concept study and that readout to have conviction to move the program forward.

    因此,我們預計應該能夠激活弓狀核中的 NK3R,並且根據我們對生物學的理解,我們認為這應該足以有效治療 VMS。當然,我們還沒有證明這一點,所以我們需要等待概念驗證研究和結果報告,才能有信心推進該計劃。

  • Operator

    Operator

  • Steve Dechert, Key Corp.

    史蒂夫·德切特,Key Corp.

  • Steven Dechert - Equity Analyst

    Steven Dechert - Equity Analyst

  • Steve on for Scott. I was hoping you could talk about what the benefits are of 635 versus existing hormonal treatments for hot flashes. And then as a follow-up, are there any molecules currently being developed that would compete directly with 635?

    史蒂夫代替斯科特上場。我希望您能談談 635 與現有的治療潮熱的荷爾蒙療法相比有哪些優勢。那麼,作為後續問題,目前是否有任何正在開發的分子能夠與 635 直接競爭?

  • 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. So 635 is not being developed as a substitute for hormonal therapies. It's being developed as an alternative to menopausal hormone therapy. I think, as I mentioned on a previous call, there are roughly 12% of women that have a strong contraindication against using menopausal hormone therapy. In addition to that, about 8% that end up discontinuing because of adverse events or tolerability. So there's a significant portion of women that have fewer options or cannot avail themselves of MHT, which is the first-line therapy for treating VMS.

    當然。因此,635 的研發目的並非為了取代荷爾蒙療法。它正在被開發為更年期荷爾蒙療法的替代方案。我認為,正如我在先前的電話會議中提到的,大約有 12% 的女性存在使用更年期荷爾蒙療法的強烈禁忌症。此外,約有 8% 的人因不良事件或耐受性問題而最終停止使用。因此,相當一部分女性的選擇較少,或無法獲得 MHT,而 MHT 是治療 VMS 的第一線療法。

  • In terms of alternative therapies, of course, there are now two molecules that have approval. One is Veozah by Astellas, and one is LYNKUET by Bayer. Those are both now on the market. We believe that we have -- we're in a great position to have these two products out there, providing good options for people that need these treatments, and build the market for us so that we can come in with a molecule that we believe can be differentiated in dosing, in safety, and potentially also in efficacy, depending on how we do a target engagement.

    至於替代療法,目前當然有兩種分子獲得了批准。其中一款是安斯泰來製藥的Veozah,另一款是拜耳製藥的LYNKUET。這兩款產品目前都在市場上銷售。我們相信我們已經——我們處於非常有利的位置,可以推出這兩款產品,為需要這些治療的人們提供良好的選擇,並為我們建立市場,以便我們能夠推出一種我們認為在劑量、安全性和療效方面都具有差異化的分子,這取決於我們如何進行標靶結合。

  • Operator

    Operator

  • Brendan Smith, TD Securities.

    布倫丹·史密斯,TD證券。

  • Unidentified Participant 2

    Unidentified Participant 2

  • This is Jackie on for Brendan. Just a quick one, and maybe just to remind us, but with earlier in competitors like Dupixent and Sanofi's assets, what do you expect we need to see from the Phase 1 data for 575 to really solidify the drug's positioning within the pretty competitive landscape?

    這裡是傑基替布倫丹解說。簡單提一下,也算是提醒一下,考慮到像 Dupixent 和賽諾菲的資產等競爭對手的早期進展,您認為我們需要從 575 的 1 期臨床試驗數據中看到什麼,才能真正鞏固該藥物在競爭激烈的市場中的地位?

  • 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. So 575 is obviously coming behind amlitelimab and also rocatinlimab from Amgen. And our differentiation thesis when we began this program was really about less frequent dosing. What has happened recently, particularly with the readout in the COAST trial with amlitelimab, is that they have shown that the class is efficacious, although not as efficacious as was expected, as Dupixent had been on previous trials. So it looks like it's going to be approved as a second-line therapy. But they also showed that the one-month dosing and the three-month dosing were relatively equivalent.

    當然。所以,575 顯然落後於 amlitelimab 和安進公司的 rocatinlimab。我們啟動這個計畫時提出的差異化論點其實是減少給藥頻率。最近發生的事情,特別是關於 amlitelimab 的 COAST 試驗的結果,表明這類藥物是有效的,儘管不如預期有效,因為 Dupixent 在先前的試驗中效果很好。看來它將被批准作為二線療法。但他們也表明,一個月給藥方案和三個月給藥方案的效果相對相當。

  • So at this point, we have a drug that the data would suggest would allow for even less frequent dosing, perhaps six months. It's unclear how important that's going to be in a clinical setting. So our position in 575 right now is that we have a terrific molecule. The early readouts are going to show safety, obviously, but also PK and half-life that would support that dosing hypothesis.

    所以目前,根據數據來看,這種藥物可以減少給藥頻率,也許可以每六個月給藥一次。目前尚不清楚這在臨床環境中有多重要。所以,我們目前對 575 的看法是,我們擁有一個非常棒的分子。早期讀數顯然會顯示安全性,但也會顯示藥物動力學和半衰期,支持此給藥假設。

  • And probably the most important catalysts are going to come from outside of AbCellera, and they will be readouts on amlitelimab or the OX40-OX40 ligand class and other indications that are being evaluated by Sanofi and by others.

    而最重要的催化劑可能來自 AbCellera 之外,它們將是 amlitelimab 或 OX40-OX40 配體類藥物以及賽諾菲和其他公司正在評估的其他適應症的檢測結果。

  • Operator

    Operator

  • There are currently no questions registered. (Operator Instructions)

    目前暫無任何問題登記。(操作說明)

  • There are no additional questions waiting at this time. I would now like to pass the conference back for any closing remarks.

    目前沒有其他問題待問。現在我把會議交還給各位,請你們作總結發言。

  • 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 us today. This is an exciting time for AbCellera, and we're moving into 2026 with some exciting progress in the pipeline, both in programs that are coming and what's in the clinic. And we look forward to updating you on future calls. Thanks so much.

    謝謝各位今天蒞臨。對於 AbCellera 來說,這是一個令人興奮的時刻,我們即將邁入 2026 年,並且在即將推出的計畫和正在進行的臨床試驗方面都取得了一些令人興奮的進展。我們期待在未來的通話中與您取得聯繫。非常感謝。

  • Operator

    Operator

  • That concludes today's call. Thank you for your participation, and enjoy the rest of your day.

    今天的電話會議到此結束。感謝您的參與,祝您今天餘下的時間愉快。