Abcellera Biologics Inc (ABCL) 2024 Q3 法說會逐字稿

Good afternoon and welcome to AbCellera's Q3 2024 business update conference call. My name is Tamia and I will facilitate the audio portion of today's interactive broadcast. (Operator Instructions).

下午好，歡迎參加 AbCellera 2024 年第三季業務更新電話會議。我叫塔米亞，我將負責今天互動廣播的音訊部分。（操作員說明）。

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

現在，我想將電話轉給 AbCellera 首席法律與合規官 Tryn Stimart。您可以繼續。

Thank you. Good morning, good afternoon, and good evening to everyone listening around the world. Thank you for joining us for AbCellera's 2024 third quarter earnings call. I'm Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. Joining me on today's call are Dr. Carl Hansen, AbCellera's President and CEO, and Andrew Booth, AbCellera's Chief Financial Officer.

謝謝。世界各地的聽眾早安、下午好、晚上好。感謝您參加 AbCellera 2024 年第三季財報電話會議。我是 AbCellera 的首席法律與合規官 Tryn Stimart。參加今天電話會議的有 AbCellera 總裁兼執行長 Carl Hansen 博士和 AbCellera 財務長 Andrew Booth。

During this call, we anticipate making projections and forward-looking statements based on our current expectations and pursuant to the safe harbor provisions of the private securities litigation Reform Act of 1995. Our actual results could differ materially due to several factors as set forth in our latest form 10-K and subsequent forms, 10-Q and 8-K filed with the Securities and Exchange commission. AbCellera does not undertake any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise.

在本次電話會議中，我們預計將根據我們目前的預期並根據 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陳述。由於我們向美國證券交易委員會提交的最新表格 10-K 以及後續表格 10-Q 和 8-K 中規定的幾個因素，我們的實際結果可能會存在重大差異。AbCellera 不承擔任何更新任何前瞻性聲明的義務，無論是由於新資訊、未來事件或其他原因。

Our presentation today including our earnings press release issued earlier today and our SEC filings are available on our investor relations website. The information we provide about our pipeline is for the benefit of the investment community and is not intended to be promotional. As we transition to our prepared remarks, please note that all dollars referred to during the call are in US dollars. After our prepared remarks, we will open the lines for questions and answers.

我們今天的演示包括今天早些時候發布的收益新聞稿以及我們向 SEC 提交的文件，可在我們的投資者關係網站上查看。我們提供的有關管道的資訊是為了投資界的利益，而不是為了促銷。當我們轉向準備好的演講時，請注意，電話會議中提到的所有美元均為美元。在我們準備好發言後，我們將開放問答熱線。

Now I'll turn the call over to Carl Hansen.

現在我將把電話轉給卡爾漢森。

Thanks, Tryn, and thank you, everyone for joining us today. Given that there are a few new disclosures this quarter, I'll use today's prepared remarks to give a brief update on AbCellera's position and our progress. It was a year ago that we committed to building an internal pipeline and transitioning from a platform company to a clinical stage biotech. Over the past 12 months, we've reorganized our teams and reallocated our investments, focusing on advancing our internal programs and completing the build of our platform capabilities.

謝謝 Tryn，也謝謝大家今天加入我們。鑑於本季度有一些新的披露，我將利用今天準備好的發言來簡要介紹 AbCellera 的立場和進展。一年前，我們致力於建立內部管道，並從平台公司轉型為臨床階段生物技術公司。在過去的12個月裡，我們重組了我們的團隊並重新分配了我們的投資，重點是推進我們的內部計劃並完成我們平台能力的建立。

The first two programs in our pipeline, ABCL635 and ABCL575 are on track for CTA filings in Q2 of next year. Behind them, we are prosecuting a broad portfolio of discovery stage programs. This includes wholly owned programs against multipass transmembrane protein targets, T-cell engager, and a smaller number of 50-50 co-development programs on novel targets and to greater antibody conjugates.

我們管道中的前兩個項目 ABCL635 和 ABCL575 預計將在明年第二季提交 CTA 備案。在他們的背後，我們正在實施一系列廣泛的發現階段計畫。這包括針對多通道跨膜蛋白靶點、T 細胞接合器的全資項目，以及針對新標靶和更大抗體偶聯物的少量 50-50 共同開發項目。

We are pleased with the breadth and the quality of this portfolio, and we are confident that it will mature into a pipeline of differentiated clinical assets. At the same time, we are now in the final stages of building our capabilities and facilities. Notably, this quarter, we completed the move in to our new headquarters in Vancouver, finalizing a project that began back in 2020. We also continued to make steady progress on our GMP manufacturing facility which remains on track and will come online in 2025.

我們對該投資組合的廣度和品質感到滿意，並相信它將成熟為差異化臨床資產的管道。同時，我們現在正處於建設能力和設施的最後階段。值得注意的是，本季度，我們完成了遷入溫哥華新總部的工作，完成了 2020 年開始的專案。我們的 GMP 生產設施也繼續取得穩步進展，該設施仍在正常運行，並將於 2025 年上線。

Additionally, over the past year, we have built our translational and development teams and are well prepared for our first two clinical trials starting next year. We anticipate further investments in this team as our pipeline continues to advance and to grow.

此外，在過去的一年裡，我們建立了轉化和開發團隊，並為明年開始的前兩項臨床試驗做好了充分準備。隨著我們的管道不斷推進和成長，我們預計會對該團隊進行進一步投資。

Turning to partnering, as mentioned on the last call this quarter, we expanded our partnership with Eli Lilly. Consistent with our focus on pipeline development, our partnering priority moving forward is to build on co-development collaborations where we have co-ownership of resulting assets.

談到合作關係，正如本季最後一次電話會議中所提到的，我們擴大了與禮來公司的合作關係。與我們對管道開發的關註一致，我們前進的合作重點是建立共同開發合作，我們對所得資產擁有共同所有權。

In addition, we will continue to look to engage with existing and new partners on our TCE platform. And in relation to this, we will be presenting updated data on our TCE platform later this week Stifeli. I'd like to end by thanking our leadership and teams for their work in successfully navigating what has been a year full of change and challenge. We are clearly on track in our transition to a clinical stage company. Over the coming years with focus and execution, I am confident that this path will deliver maximum value to patients and to shareholders.

此外，我們將繼續尋求與 TCE 平台上的現有和新合作夥伴進行合作。與此相關，我們將於本週稍後在我們的 TCE 平台 Stifeli 上提供更新數據。最後，我要感謝我們的領導階層和團隊在成功度過充滿變化和挑戰的一年中所做的工作。顯然，我們正在向臨床階段公司轉型。在未來的幾年裡，透過專注和執行，我相信這條道路將為患者和股東帶來最大的價值。

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

接下來，我將把它交給安德魯來討論我們的財務狀況。安德魯？

Thanks, Carl. AbCellera continues to be in a strong liquidity position with approximately $670 million in cash and equivalents and with roughly $210 million in available government funding to execute on our strategy. In the third quarter of 2024, we continued to execute on our plans to advance both partner-initiated and internal programs and to complete our CMC and GMP investments.

謝謝，卡爾。AbCellera 繼續保持強勁的流動性狀況，擁有約 6.7 億美元的現金和等價物，以及約 2.1 億美元的可用政府資金來執行我們的策略。2024 年第三季度，我們繼續執行計劃，推進合作夥伴發起的項目和內部項目，並完成 CMC 和 GMP 投資。

Looking at our key business metrics, in the third quarter, we started work on two partner-initiated programs which takes us to a cumulative total of 95 programs with downstream participation. During the quarter, Abdera announced that ABD-147 received orphan drug designation from the FDA. As we have stated previously, we view our growing list of progressing molecules in the clinic as specific examples of our near and midterm potential revenue from downstream milestone fees and royalty payments in the longer term.

從我們的關鍵業務指標來看，第三季度，我們開始實施兩個合作夥伴發起的計劃，這使我們累計有 95 個下游參與的計劃。本季度，Abdera 宣布 ABD-147 獲得 FDA 的孤兒藥資格認定。正如我們之前所說，我們將臨床中不斷增長的進展分子清單視為我們近期和中期從下游里程碑費用和長期特許權使用費中獲得潛在收入的具體例子。

Turning to revenue and expenses. Revenue in the quarter was almost $7 million mostly driven by research fees relating to work on partnered programs. This compares to revenue of also approximately $7 million in Q3 of last year. We expect research fee revenue to trend lower as we increasingly focus on internal and co-development programs. Our R&D -- research and development expenses for the quarter were approximately $41 million, $3 million more than last year.

轉向收入和支出。該季度的收入接近 700 萬美元，主要來自與合作項目工作相關的研究費用。相比之下，去年第三季的營收也約為 700 萬美元。隨著我們越來越關注內部和共同開發項目，我們預計研究費用收入將呈下降趨勢。我們的研發—本季的研發費用約為 4,100 萬美元，比去年增加了 300 萬美元。

This expense is driven by ongoing program execution, continuing platform development, and our increasing investment in our internal program pipeline. In sales and marketing, expenses for Q3 were about $3 million, a small reduction relative to last year. And in general and administration, expenses were approximately $19 million compared to roughly $14 million in Q3 of 2023. The increase is driven primarily by expenses related to the defense of our intellectual property.

這項費用是由持續的專案執行、持續的平台開發以及我們對內部專案管道不斷增加的投資所驅動的。在銷售和行銷方面，第三季的費用約為 300 萬美元，較去年略有減少。在一般和管理方面，費用約為 1,900 萬美元，而 2023 年第三季約為 1,400 萬美元。這一增長主要是由與保護我們的智慧財產權相關的費用所推動的。

Looking at earnings, we are reporting a net loss of roughly $51 million for the quarter compared to a loss of nearly $29 million in the same quarter of last year. This loss includes a non-cash impairment charge for in process R&D of approximately $32 million. This impairment resulted from our prioritization of internal programs and the decision to discontinue the development of next generation transgenic mice. In terms of earnings per share, this quarter's result works out to a loss of $0.17 per share on a basic and diluted basis.

從收益來看，我們報告本季淨虧損約 5,100 萬美元，而去年同期淨虧損近 2,900 萬美元。該損失包括正在進行的研發的非現金減損費用約 3,200 萬美元。這種損害是由於我們對內部計劃的優先考慮以及停止開發下一代基因轉殖小鼠的決定所造成的。就每股收益而言，本季的業績計算得出，基本和攤薄後每股虧損 0.17 美元。

Looking at cash flows. In the first nine months of 2024, we have used approximately $118 million in cash and equivalents. This includes funding all operations as well as the investments, completing our infrastructure build of our headquarters and CMC GMP manufacturing capabilities. Operating activities for the first nine months of 2024 used roughly $100 million.

看看現金流。2024 年前 9 個月，我們使用了約 1.18 億美元的現金及等價物。這包括為所有營運和投資提供資金，完成我們總部的基礎設施建設和 CMC GMP 製造能力。2024 年前 9 個月的營運活動使用了大約 1 億美元。

As a part of our treasury strategy, we have nearly $520 million invested in short-term marketable securities. Our investment activities for the nine months included an approximately $124 million net decrease in these holdings. All other investment activities amounted to a net $38 million including approximately $63 million invested in property plant and equipment driven by our ongoing work to establish CMC and GMP manufacturing capabilities. The investments [PP&E] were partially offset by government contributions and the cash proceeds from the sale of our stake in tax in this quarter.

作為我們財務策略的一部分，我們投資了近 5.2 億美元於短期有價證券。我們這 9 個月的投資活動包括這些持股淨減少約 1.24 億美元。所有其他投資活動淨額達 3,800 萬美元，其中約 6,300 萬美元投資於房地產工廠和設備，這些投資是由我們持續致力於建立 CMC 和 GMP 製造能力而推動的。投資 [PP&E] 被政府捐款和本季出售我們的稅務股份所獲得的現金收益部分抵銷。

We expect our investments in PP&E to continue at approximately this rate through the fourth quarter of 2024 and be substantially complete in early 2025. Altogether, we finished the quarter with $670 million of total cash, cash equivalents, and marketable securities.

我們預計我們對 PP&E 的投資將繼續以大約這一速度持續到 2024 年第四季度，並在 2025 年初基本完成。本季結束時，我們的現金、現金等價物和有價證券總額為 6.7 億美元。

As a reminder, we have received commitments for funding of our GMP facility and 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. With approximately $670 million in cash and equivalents and the unused portion of our secured government funding, we have approximately $880 million in total available liquidity to execute on our strategy.

謹此提醒，我們已收到加拿大戰略創新基金政府和不列顛哥倫比亞省政府為我們的 GMP 設施提供資金以及推進我們的內部管道的承諾。該可用資本不會顯示在我們的資產負債表上。憑藉約 6.7 億美元的現金和等價物以及我們獲得的政府資金中未使用的部分，我們總共擁有約 8.8 億美元的可用流動資金來執行我們的策略。

With respect to our overall operating expenditures, our capital needs are very manageable. We continue to believe that we have sufficient liquidity to fund well beyond the next three years of pipeline and platform investments.

就我們的整體營運支出而言，我們的資本需求非常可控。我們仍然相信，我們有足夠的流動性來為未來三年的管道和平台投資提供資金。

And with that, we'll be happy to take your questions. I'll turn it back to the operator.

因此，我們很樂意回答您的問題。我會將其返還給接線員。

(Operator Instructions)

（操作員說明）

Allison Bratzel, Piper Sandler.

艾莉森‧布拉澤爾，派珀‧桑德勒。

Can you hear me? Hey, sorry about that. I had a question -- okay, great, sorry. Maybe just a question for me on OX40 the competitive landscape there. I just considering some recent competitive updates like from rocatinlimab, which I think kind of underwhelmed investors. I'm just curious, could you update us or share your thinking on advantages of an OX40 ligand targeted therapy such as 575? Does that data change your view of the landscape? And just your overall view of the space in a top of term versus other inflamm indications? I just be curious to get your thoughts on that as it relates to 575. Thanks.

你聽得到我嗎？嘿，對此感到抱歉。我有一個問題——好吧，很好，抱歉。也許只是我想問一下 OX40 那裡的競爭格局。我只是考慮最近的一些競爭性更新，例如來自 rocatinlimab 的更新，我認為這讓投資者有點不知所措。我只是很好奇，您能否向我們介紹最新情況或分享您對 OX40 配體標靶治療（如 575）優勢的看法？這些數據會改變您對景觀的看法嗎？您對術語頂部空間與其他發炎跡象的整體看法？我只是想知道你對 575 的看法。謝謝。

Sure, Allison. Carl here. So first, yes, we did see the update on rocatinlimab. And I think that does put some additional data on the table to address this question that we've gotten a lot about the difference between OX40 lig and OX40. You know, before going there, I would emphasize that roc is also an antibody with a different mechanism of action than what we have in 575. So Roc is engineered to be a depleting antibody, which means that it ablates or kills the cells that express OX40.

當然，艾莉森。卡爾在這裡。首先，是的，我們確實看到了 rocatinlimab 的更新。我認為這確實提供了一些額外的數據來解決這個問題，我們已經了解了很多有關 OX40 lig 和 OX40 之間差異的資訊。你知道，在討論之前，我想強調一下，roc也是一種抗體，其作用機制與我們575中的抗體不同。因此，Roc 被設計為一種消耗性抗體，這意味著它可以消除或殺死表達 OX40 的細胞。

Whereas what we have is an affector null antibody that is non-depleting of the target cells, which are antigen presenting cells typically. So I've had this question a lot. My scientific response has been for some time that this pathway is critical to the expansion and survival of both B-cells and T-cells, and that you should be able to get the effect if you block either OX40 or OX40L.

而我們擁有的是無影響因子的抗體，它不會消耗目標細胞，這些細胞通常是抗原呈現細胞。所以我有很多這個問題。一段時間以來，我的科學回應是，這條路徑對於 B 細胞和 T 細胞的擴增和存活至關重要，如果您阻斷 OX40 或 OX40L，您應該能夠獲得效果。

So prior to that data, I would have said it's unclear that one has a definitive advantage over the other. What we did see with the Amgen data was significantly less response or efficacy as compared to what was seen with rocatinlimab.

因此，在獲得這些數據之前，我會說尚不清楚一個人是否比另一個人有明確的優勢。與 rocatinlimab 相比，我們從安進數據中看到的反應或療效明顯較低。

So from our perspective that reinforces the view that non depleting OX40 ligand antibodies are currently the lead horse in this race. And of course, [amatilamab] is the first one that's out there. 575, as I've said before, is engineered to have a best-in-class profile, namely, potency and developability and half life that we believe will make it if not best-in-class, very comparable to the best-in-class. It remains to be seen what the early assets will look like.

因此，從我們的角度來看，這強化了這樣的觀點：非消耗性 OX40 配體抗體目前是這場競賽中的領頭羊。當然，[amatilamab] 是第一個上市的。正如我之前所說，575 被設計為具有一流的特性，即效力、可開發性和半衰期，我們相信即使不是一流的，也足以與一流的產品相媲美。早期資產會是什麼樣子還有待觀察。

And we are more bullish than ever on that pathway and its potential. So obviously, atopic dermatitis is one of the big indications and the first one that we have stated that we're going to develop into. But beyond that, it has potential in probably a dozen different indications, many of which are significant. And so we remain bullish on that program, and we expect to update -- we plan to present preclinical data at a conference sometime next year, close to the CTA filing on 575.

我們比以往任何時候都更加看好這條道路及其潛力。顯然，異位性皮膚炎是重要的適應症之一，也是我們表示將發展為的第一個適應症。但除此之外，它還具有十幾種不同適應症的潛力，其中許多都很重要。因此，我們仍然看好該計劃，我們預計會更新——我們計劃在明年某個時間的會議上展示臨床前數據，接近 575 的 CTA 備案。

Got it, thank you.

明白了，謝謝。

Andrea Tan, Goldman Sachs.

安德里亞·譚，高盛。

Good afternoon. Thanks so much for taking our questions. Carl, could you just speak a little bit more about the extent of data we can expect at SITC for the T-cell engagers? Thanks so much.

午安.非常感謝您回答我們的問題。Carl，您能多談談我們在 SITC 上可以期待的 T 細胞參與者的數據範圍嗎？非常感謝。

Got it. Yeah, Andrea. So SITC, we're going to be presenting updated data from the platform technology including highlighting a few programs where we have demonstrated we can use the combination of TIA antibodies and our unique CD3 panel to get desired profiles in both killing and cytokine response. In addition to that, we will be presenting some of the work that we've done that sets up developing TCEs that are trispecifics. And that include binders that are designed to provide coactivation or co-stimulation to get a better sustained t-cell killing that is work that's still in progress, but an area that we think is going to be important certainly in some cancers for getting the FC that's needed.

知道了。是的，安德里亞。因此，SITC，我們將展示平台技術的最新數據，包括重點介紹一些項目，在這些項目中，我們已經證明我們可以使用TIA 抗體和我們獨特的CD3 組合的組合來獲得所需的殺傷和細胞因子反應特徵。除此之外，我們也將介紹我們在開發三特異性傳統文化表現形式所做的一些工作。其中包括旨在提供共激活或共刺激以獲得更好持續的T 細胞殺傷的粘合劑，這項工作仍在進行中，但我們認為在某些癌症中對於獲得FC 來說這肯定是重要的領域這是需要的。

Okay, thank you.

好的，謝謝。

Stephen Willey, Stifel.

史蒂芬威利，斯蒂菲爾。

Yeah, good afternoon. Thanks for taking the questions. I guess just with respect to the TCE platform, I know you've talked about how you've been engaged with various partners on this front. But just kind of curious, as you think about what you want the wholly owned pipeline to look like and as you think about the longer-term investment that is necessary to support an expanding pipeline, how many of these programs do you think you could push forward independently on your own in the absence of a broader platform-based partnership?

是的，下午好。感謝您提出問題。我想就 TCE 平台而言，我知道您已經談到了您如何在這方面與各個合作夥伴接觸。但只是有點好奇，當你考慮你想要的全資管道是什麼樣子，當你考慮支持不斷擴大的管道所需的長期投資時，你認為你可以推動多少這樣的項目在沒有更廣泛的基於平台的合作關係的情況下，您自己獨立前進嗎？

Thanks, Steve. Carl here. I'll take that one. So first, pulling back, over the past 12 years, we have been working heavily to build the core capabilities to develop new best-in-class and first-in-class antibody therapies. As mentioned in my prepared remarks, we are getting very close to the end of that investment. And so, the foundation in being able to develop lead assets is in place. And we also have just under $900 million in available liquidity to fund the use of that platform to populate a clinical pipeline of what we hope will be and what we intend to be exciting assets for development.

謝謝，史蒂夫。卡爾在這裡。我會接受那個。首先，在過去的 12 年裡，我們一直在大力建立核心能力，以開發新的一流和一流的抗體療法。正如我在準備好的演講中提到的，我們已經非常接近這項投資的結束。因此，開發主導資產的基礎已經具備。我們還有近 9 億美元的可用流動資金來資助該平台的使用，以填充我們希望的臨床管道以及我們打算成為令人興奮的開發資產。

We have already, for some time, been working on preclinical programs. We have a broad portfolio and are just in the process of doing a portfolio review to prioritize the programs on which we are going to really lean in to populate that clinical pipeline. We're excited about what's there. I think there's a lot there that have potential to be the big winner that we need and to back it up with other ones.

一段時間以來，我們一直致力於臨床前計畫。我們擁有廣泛的投資組合，並且正在進行投資組合審查，以確定我們將真正依靠的項目的優先順序，以填充臨床管道。我們對那裡的一切感到興奮。我認為有很多東西有潛力成為我們需要的大贏家，並與其他人一起支持它。

Right now, we have an anticipated pace of perhaps as many as two or three new development candidates per year starting next year, and we have liquidity to move those forward past three years, as Andrew mentioned. So once we get there, if we get this positive data on a clinical asset, so compelling data that shows that we have a much better-than-average chance of moving forward a molecule that can address a large unmet medical need, that opens a lot of possibilities for the business. And we would expect that if we take those into late-stage trials, we will need to raise equity financing or out-license another asset in order to fund that.

目前，我們預計從明年開始每年可能有多達兩到三個新的開發候選者，正如安德魯所提到的那樣，我們有流動性將這些推進到過去三年。因此，一旦我們到達那裡，如果我們獲得有關臨床資產的積極數據，如此令人信服的數據表明我們有比平均水平更好的機會來推進一種可以解決大量未滿足的醫療需求的分子，這將打開一個新的領域。我們預計，如果我們將這些納入後期試驗，我們將需要籌集股權融資或許可另一項資產來為其提供資金。

And is there any time frame for the completion of this portfolio review?

完成此投資組合審查是否有時間表？

We'll have that wrapped up near the end of the year. December is the official date.

我們將在年底前完成這項工作。十二月是正式日期。

Okay. And then just another question on the CTA filings that are going to be taking place next year. I know you have funding in place from the Canadian government. But just curious as to whether or not clinical development because of that funding, if there's a requisite amount of that development work that needs to occur through Canadian trial sites, is there some minimal number of sites that need to be used? And if so, how do you think that impacts, if at all, your ability to move through Phase 1?

好的。然後是關於明年將進行的 CTA 備案的另一個問題。我知道加拿大政府已經為您提供了資金。但只是好奇是否因為這筆資金而進行臨床開發，如果需要透過加拿大試驗站點進行必要數量的開發工作，是否需要使用最少數量的站點？如果是這樣，您認為這會如何影響（如果有的話）您度過第一階段的能力？

Steve, it's Andrew here. Yes, good question. The funding is oriented towards taking close to 15 or up to 17 molecules into Phase 1. And as you note, we have this funding both from the government of Canada and the government of British Columbia to do that very cost effectively. But with those Phase 1s being done in Canada.

史蒂夫，我是安德魯。是的，好問題。這筆資金旨在近 15 個或最多 17 個分子帶入第一階段。正如您所指出的，我們從加拿大政府和不列顛哥倫比亞省政府獲得了這筆資金，可以非常經濟有效地做到這一點。但第一階段是在加拿大完成的。

So far with the molecules that we're looking at, certainly 575 and 635, we don't anticipate having any issue or any headwind in completing those Phase 1 by running those Phase 1s in Canada, and it is our intent to do that in Canada. If that turns out to be a requirement or an issue, let's say, for future trials, we can also expand trial sites into the United States, if necessary or around the world. But in order to qualify for that funding, those Phase 1 would need to be conducted in Canada.

到目前為止，對於我們正在研究的分子，當然是 575 和 635，我們預計透過在加拿大運行這些第一階段來完成這些第一階段不會有任何問題或任何阻力，我們打算在加拿大。如果這最終成為未來試驗的要求或問題，我們也可以將試驗地點擴展到美國（如有必要）或世界各地。但為了有資格獲得這筆資金，第一階段需要在加拿大進行。

Okay. Thanks for taking my questions.

好的。感謝您回答我的問題。

Srikripa Devarakonda, Truist.

Srikripa Devarakonda，真理主義者。

Hey guys, thank you so much for taking my question. I have a question about ABCL635. You mentioned that it's being developed for metabolic and endocrine conditions and also target the GPCR or ion channel, which if experience serves well has been pretty challenging in the field. Can you provide any more color about this target? What sort of market it targets? I think you've said [$2 billion] in the past, but just wanted to confirm that. And also, how competitive you think this space is?

嘿夥計們，非常感謝你們回答我的問題。我有關於 ABCL635 的問題。您提到它是針對代謝和內分泌條件而開發的，並且還針對 GPCR 或離子通道，如果經驗豐富的話，這在該領域是相當具有挑戰性的。您能提供更多有關該目標的資訊嗎？它針對什麼樣的市場？我想你過去曾說過[20億美元]，但只是想確認這一點。另外，您認為這個領域的競爭力如何？

Kripa, yes, so we have disclosed previously, I think you've covered most of it, that this is a first-in-class antibody against a target for a condition in endocrine or metabolic disorders. And it is against a target that is a multipass transmembrane protein target, which has been one of the key areas of emphasis. We do believe that quite conservatively, there is an addressable market in excess of $2 billion. Beyond that, we're not disclosing any details about that program. We do expect that when the CTA is approved that we will then disclose both the target and the indication. But until then, we're keeping our cards close to our chest for strategic reasons.

Kripa，是的，所以我們之前已經披露過，我想您已經涵蓋了大部分內容，這是針對內分泌或代謝紊亂疾病靶標的一流抗體。它針對的是多次跨膜蛋白靶標，這一直是重點關注的領域之一。我們確實相信，相當保守地說，潛在市場超過 20 億美元。除此之外，我們不會透露有關該計劃的任何細節。我們確實希望，當 CTA 獲得批准後，我們將披露目標和適應症。但在那之前，出於戰略原因，我們將保守秘密。

Got it. Thank you.

知道了。謝謝。

Evan Seigerman, BMO.

埃文·西格曼，BMO。

Hi there. This is Connor on for Evan. Thanks for taking our question. With a few assets entering clinic in the near term, can you maybe just remind us how you're thinking about ramping spend into the new year and sort of allocation of resources for internal programs versus partnered programs given the recent shift?

你好呀。這是埃文的康納。感謝您提出我們的問題。隨著一些資產在短期內進入臨床，您能否提醒我們考慮到最近的轉變，您如何考慮在新的一年中增加支出以及內部專案與合作專案的資源分配？

Yes. Conor, Andrew here. I think into the new year, the Phase 1 clinical trials for 635 and 575, we're not expecting that to be too significant an increase certainly for 2025 and maybe even into 2026. The costs are still very manageable. I think our R&D expense, the run rate into 2025 will be very similar to as it is in this quarter and in Q4, which we expect to be pretty similar.

是的。康納，安德魯在這裡。我認為進入新的一年，635 和 575 的一期臨床試驗，我們預計 2025 年甚至 2026 年肯定不會有太大的增長。成本還是很可控制的。我認為我們的研發費用、到 2025 年的運行率將與本季和第四季非常相似，我們預計會非常相似。

You may remember at the beginning of the year, we had projected overall expenses to be relatively flat from Q4 of last year, and it has maintained that. The difference is going to be in the first part of 2025, we expect our PP&E, so our CapEx expenses to drop off significantly. They have still been quite significant through 2025, as we've been completing these big facility -- or 2024, as we've been completing the big facilities build, but that will be much different into 2025. But in terms of operating expenses, actually, I would expect 2025 to be very similar to 2024.

您可能還記得，在今年年初，我們預計整體支出與去年第四季相比相對持平，並且總是保持這一趨勢。差異將出現在 2025 年上半年，我們預計我們的 PP&E，因此我們的資本支出將大幅下降。到 2025 年，它們仍然相當重要，因為我們已經完成了這些大型設施；或者到 2024 年，因為我們已經完成了大型設施的建設，但到 2025 年，情況將會有很大不同。但就營運支出而言，實際上，我預計 2025 年將與 2024 年非常相似。

Thank you.

謝謝。

David Martin, Bloom Burton.

大衛馬丁，布魯姆伯頓。

Thank you for taking my question. Back to 575, you positioned it relative to the other OX40s and OX40 ligands. I'm wondering what about vis-a-vis the IL receptor antibodies? Would you expect that you compete for first line with them or for second line? And is there evidence that patients might respond to anti-OX40 ligand if they failed IL-4 receptor antibodies?

感謝您回答我的問題。回到 575，您將其相對於其他 OX40 和 OX40 配體進行定位。我想知道 IL 受體抗體怎麼樣？你希望和他們爭奪一線還是二線？是否有證據表明，如果患者的 IL-4 受體抗體失敗，他們可能會對抗 OX40 配體產生反應？

Great question. So first, I'll say that in atopic dermatitis, I think it's important to specify the indication. There's really, to my mind,three mechanisms that are working and driving a lot of the interest is JAKs. Obviously, there's the IL-13 antibodies, of which Dupixent is the big one. And then now OX40/OX40 ligand coming up.

很好的問題。首先，我想說，對於異位性皮膚炎，我認為明確適應症很重要。在我看來，JAK 確實有三種正在發揮作用並引起人們興趣的機制。顯然，有 IL-13 抗體，其中 Dupixent 是最重要的一種。現在 OX40/OX40 配體即將出現。

Our view is that Dupixent is a great drug, but it is not working for everyone, and there's a substantial fraction of patients that are non-responders or that discontinue. I think that's roughly 40%. I'd have to check that. But it doesn't work for everyone, and there's a large unmet medical need and obviously, not a huge penetration yet in biologics for atopic dermatitis.

我們的觀點是，Dupixent 是一種很好的藥物，但它並不適合所有人，並且有相當一部分患者沒有反應或停藥。我認為大約是 40%。我必須檢查一下。但它並不適合所有人，而且還有大量未滿足的醫療需求，顯然，治療異位性皮膚炎的生物製劑尚未得到巨大普及。

So based on that, we would think that an OX40 -- the OX40/OX40 ligand mechanism would probably enter second line behind Dupixent. And that over time, we think it could have real potential to take first line, as people start to recognize the advantage, particularly in the durability. So Dupixent being a 2-week administration and Sanofi testing right now both one month andthree months, and we have a molecule that we believe would get at leastthree months, perhaps even more. So we think it could be a competitive product in that space.

因此，基於此，我們認為 OX40——OX40/OX40 配體機制可能會進入 Dupixent 之後的第二線。隨著時間的推移，我們認為它可能具有佔據第一線的真正潛力，因為人們開始認識到其優勢，特別是在耐用性方面。因此，Dupixent 的給藥時間為兩週，賽諾菲現在的測試時間為一個月和三個月，我們相信這種分子至少會持續三個月，甚至可能更長。所以我們認為它可能是該領域的一個有競爭力的產品。

And the other part of your question was, do you think that patients would respond differently to IL-13 versus OX40/OX40 ligand. Based on the biology, we think that, that's a pretty good bet, but that remains to be shown in the clinic. I have heard anecdotally that response rates for patients on roc was similar post Dupixent, and so that would lend some credence to the idea that this is an orthogonal therapy that would catch patients that fail on dupi. But I don't think that is really -- or that proposition has really been tested yet in the clinic.

你問題的另一部分是，你認為病人對 IL-13 和 OX40/OX40 配體的反應是否不同？根據生物學，我們認為這是一個相當不錯的選擇，但這仍有待臨床證明。據我所知，在 Dupixent 治療後，roc 患者的反應率相似，因此這為以下觀點提供了一定的可信度：這是一種正交療法，可以捕獲 dupi 治療失敗的患者。但我認為這並不是真的——或者說這個提議還沒有在臨床上得到真正的測試。

(Operator Instructions)

（操作員說明）

Brendan Smith, TD Securities.

布倫丹‧史密斯，道明證券。

All right. Great. Maybe just one more on the TCE platform and maybe zooming out just a little bit. I mean, can you just remind us, what an ideal partnership there would actually look like? I mean, I understand the timing is still CBD, but kind of just looking at how the T cell -- excuse me, T cell space a little bit more broadly has evolved with oncology and autoimmunity example. Just trying to understand a bit more concretely how you're thinking about the direction for that vertical based on maybe what you're seeing in your data and kind of how that could evolve over the next year or so? Thanks.

好的。偉大的。也許只是 TCE 平台上的一個，也許只是縮小一點。我的意思是，您能否提醒我們，理想的合作關係實際上是什麼樣子？我的意思是，我知道時機仍然是 CBD，但只是看看 T 細胞——對不起，更廣泛的 T 細胞空間如何隨著腫瘤學和自體免疫的例子而進化。只是想根據您在數據中看到的內容以及在未來一年左右的時間裡如何發展來更具體地了解您如何思考該垂直方向的方向？謝謝。

Sure. That's an interesting question. First, I'd say that it's typical that modalities sort of rise and fall and sort of ebb and wane in their attention and enthusiasm. We certainly see right now that there's a groundswell of excitement about TCEs. You're seeing that in conversations. You're seeing that some of the clinical data and also in some of the deals that have been announced recently. So our view is that we have put in place what we still believe are some of, if not the best tools to create TCEs.

當然。這是一個有趣的問題。首先，我想說的是，人們的注意力和熱情有起有落，有起有落，這是很典型的。我們現在當然看到人們對傳統文化表現感到興奮不已。你在談話中看到了這一點。您會看到一些臨床數據以及最近宣布的一些交易。因此，我們的觀點是，我們已經採用了一些我們仍然認為是創造傳統文化表現的工具（即使不是最好的工具）。

What we really need to do right now is address the science and figure out how to put those together to make drugs that are effective and safe for patients. That's going to be played out in part by the work we're doing internally, but also through collaborations with companies that have experience in that space and have interest and commitment to start to do some of the clinical testing that's really going to be needed to make these therapies or to get these therapies the potential that I think a lot of people believe that they have.

我們現在真正需要做的是解決科學問題，並找出如何將它們組合在一起來製造對患者有效且安全的藥物。這將部分透過我們內部所做的工作來實現，同時也透過與在該領域擁有經驗、有興趣並致力於開始進行一些真正需要的臨床測試的公司的合作來實現。具有我認為很多人相信它們所具有的潛力。

So in terms of a first partnership, of course, we'd love to get something that brings in some cash upfront, it shows some validation for the deal. But honestly, the most important thing from my perspective is that we work with teams that are deep in the science and working with us to help to understand how best to use these tools to make new drugs that actually work for cancer patients.

因此，就首次合作而言，我們當然希望獲得一些能夠預先帶來一些現金的東西，這表明了這筆交易的一些驗證。但老實說，從我的角度來看，最重要的是我們與深入科學的團隊合作，幫助我們了解如何最好地使用這些工具來製造真正對癌症患者有效的新藥。

And this is a story that is not going to play out over a quarter or a year. This is story is going to play out over several years. But we are enthusiastic, and I think excited about what we're seeing both internally and externally and believe that we're well positioned to participate in what's going to be an important part of cancer therapy.

這個故事不會在一個季度或一年內結束。這個故事將在幾年內上演。但我們很熱情，我認為我們對內部和外部所看到的情況感到興奮，並相信我們有能力參與癌症治療的重要組成部分。

Got it. Thanks very much.

知道了。非常感謝。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Yeah. Hi, Carl. Andrew. Thanks for taking my question. So maybe first one on -- can you provide us an update on the GMP facility? And I wanted to see how the pipeline stacks today and into that? And then just a broader question on BIOSECURE. Curious if you're seeing any inbounds, as a result of the US BIOSECURE. I'm just wondering if people are looking for capacity and whatnot. Maybe that's first question and I have a follow-up.

是的。嗨，卡爾。安德魯.感謝您提出我的問題。那麼，也許第一個——您能為我們提供 GMP 設施的最新情況嗎？我想看看今天的管道是如何堆疊的？然後是關於 BIOSECURE 的更廣泛的問題。很好奇您是否看到任何由於 US BIOSECURE 造成的入境行為。我只是想知道人們是否在尋找容量之類的東西。也許這是第一個問題，我有一個後續問題。

Puneet, I'll take the first part of that and then hand it off to Carl. So you'll remember about 4 years ago, we started in -- on this project, and with the plan to bring our first molecules through that facility in like late 2024, early 2025. So we are now believing it's going to be in late 2025 that we'll be bringing our first molecules through.

普尼特，我將把第一部分交給卡爾。所以你會記得大約 4 年前，我們開始了這個項目，並計劃在 2024 年底、2025 年初通過該設施引入我們的第一個分子。因此，我們現在相信，我們將在 2025 年底推出第一個分子。

I'd say the project has been doing extremely well. A big -- it's been a big lift over the last number of years to build the team and get the facility. As you'll remember, it's a greenfield site that we used here, not far from our headquarters. And we're pretty excited to be bringing the first molecules and engineering runs through there in 2025.

我想說這個項目做得非常好。在過去的幾年裡，建立團隊和獲得設施是一個巨大的進步。您可能還記得，這是我們在這裡使用的綠地，距離我們的總部不遠。我們非常高興能夠在 2025 年將第一個分子和工程運行通過那裡。

And then our next molecules, not 575 and 635 would be manufactured in that facility. And maybe I'll hand off to Carl just to talk a little bit more about that.

然後我們的下一個分子，而不是 575 和 635 將在該設施中生產。也許我會交給卡爾多談談這個問題。

Sure. So we have, as I mentioned in my prepared remarks, a broad preclinical pipeline that we are moving forward. There's a substantial number of those or several of those that are now getting pretty close to development candidate. And so, over the next couple of months or a few months, we'll have clarity on which of those molecules, either from wholly owned AbCellera internal programs or through co-development are likely to be the first ones to go through the facility.

當然。因此，正如我在準備好的發言中所提到的，我們正在推動廣泛的臨床前研發工作。其中有相當多的或其中幾個現在已經非常接近開發候選者。因此，在接下來的幾個月或幾個月裡，我們將清楚哪些分子（無論是來自 AbCellera 全資內部專案還是透過共同開發）可能是第一個通過該設施的分子。

And based on where the portfolio is and how the science is advancing, and of course, there's always risk until things are done. We don't expect there'll be any problem in having valuable programs to work on through the first year. The first year of this facility is going to be about demonstrating the capabilities and making sure that we've got everything working exactly, as it should.

根據投資組合的位置以及科學的進展情況，當然，在事情完成之前總是存在風險。我們預計第一年進行有價值的專案不會出現任何問題。該設施的第一年將是展示功能並確保我們讓一切正常運轉，正如它應該的那樣。

After that, I expect we're going to be well positioned to control that capability, particularly given what is currently looking like headwinds geopolitically with the BIOSECURE Act. So we believe that over time, as this capability builds, controlling your own manufacturing will be a major advantage that will provide speed and honestly, over time, also reduce cost in moving molecules from concept through the clinic.

在那之後，我預計我們將能夠很好地控制這種能力，特別是考慮到目前《BIOSECURE 法案》在地緣政治上面臨的阻力。因此，我們相信，隨著時間的推移，隨著這種能力的建立，控制自己的製造將成為一個主要優勢，它將提供速度，並且隨著時間的推移，老實說，還可以降低分子從概念到臨床的成本。

Got it. My second question is on sort of the priority levels and activity levels within AbCellera. You have a number of internal programs. You talked about pipeline moving forward, 575, the 635, 675 programs, the TCE program, you have efforts ongoing on the manufacturing facility sites. Can you maybe -- Carl, can you prioritize for us what are sort of the near-term priorities and more sort of medium term, as you go into 2025?

知道了。我的第二個問題是關於 AbCellera 內的優先順序和活動等級。您有許多內部程序。您談到了管道的進展，575、635、675 計劃、TCE 計劃，您在製造設施現場正在進行的工作。卡爾，您能否為我們優先考慮 2025 年的近期優先事項和中期優先事項？

Sure. So as I mentioned in response to Steve's question, the situation is that we have, in a quite a unique way for a company at our stage, a fully built platform that can generate high-quality antibody assets. And we have the capital that we're going to turn over the next few years into a clinical pipeline. So the priorities in the company are really simple. It's -- make sure that we're making good capital allocation decisions in that portfolio, so that we find our first big winner.

當然。正如我在回答史蒂夫的問題時所提到的，情況是，對於我們這個階段的公司來說，我們以一種非常獨特的方式擁有一個完全建構的平台，可以產生高品質的抗體資產。我們擁有資本，將在未來幾年內將其轉變為臨床管道。所以公司的優先事項非常簡單。確保我們在該投資組合中做出良好的資本配置決策，以便我們找到第一個大贏家。

And then the second priority is to make sure we back that up with a differentiated portfolio of exciting assets. And the third is to make sure that we continue to work on efficiency and keep our operations focused on that priority, so that we stay in control of our future. And as Andrew mentioned, we have a terrific liquidity position. We have lots of runway, and we intend to do what it takes to make sure that stays the case.

第二要務是確保我們用令人興奮的差異化資產組合來支持這一點。第三是確保我們繼續致力於提高效率，並將我們的營運重點放在這項優先事項上，以便我們能夠掌控我們的未來。正如安德魯所提到的，我們的流動性狀況非常好。我們有很多跑道，我們打算盡一切努力確保這種情況保持下去。

Okay. Thanks guys.

好的。謝謝你們。

Thank you. I'm showing no further questions at this time. I will now turn it back over to Carl Hansen for closing remarks.

謝謝。我目前沒有提出任何進一步的問題。現在我將把它轉回給卡爾漢森做總結發言。

Thank you everyone for joining the call today. We appreciate your time and we look forward to providing more updates in the future. Enjoy your evening and we'll talk soon.

感謝大家今天加入電話會議。感謝您的寶貴時間，我們期待將來提供更多更新。祝您度過愉快的夜晚，我們很快就會再談。

This concludes today's conference call. Thank you for your participation. You may now disconnect your line.

今天的電話會議到此結束。感謝您的參與。現在您可以斷開線路。