Abcellera Biologics Inc (ABCL) 2025 Q1 法說會逐字稿

Good afternoon and welcome to the Abcellera's first quarter 2025 business update and conference call.

下午好，歡迎參加 Abcellera 2025 年第一季業務更新和電話會議。

My name is Jasmine and I will facilitate the audio portion of today's interactive broadcast.

我叫 Jasmine，我將負責今天互動廣播的音訊部分。

(Operator Instructions)

（操作員指示）

At this time I would like to turn the call over to Tryn Stimart as Chief Legal and Compliance Officer. You may proceed.

現在，我想將電話轉給首席法律和合規官 Tryn Stimart。您可以繼續。

Thank you. Hello everyone.

謝謝。大家好。

Thank you for joining us for Abcellera's first quarter 2025 earnings call. I'm Tryn Stimart of Abcellera's chief legal and compliance officer. Dr. Carl Hansen of Abcellera's President and Chief Executive Officer, and Andrew Booth, of Abcellera's Chief Financial Officer, are joining me on today's call.

感謝您參加 Abcellera 2025 年第一季財報電話會議。我是 Abcellera 的首席法律和合規官 Tryn Stimart。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 according to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995.

在本次電話會議中，我們預計將根據我們目前的預期以及 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。

Our actual results could differ materially due to several factors outlined in our latest Form 10K and subsequent Forms 10k and 8k filed with the Securities and Exchange Commission.

由於我們向美國證券交易委員會提交的最新 10K 表格以及後續 10k 和 8k 表格中概述的幾個因素，我們的實際結果可能存在重大差異。

Abcellera's is not obligated to update any forward-looking statements whether due to new information, future events, or otherwise.

Abcellera 沒有義務更新任何前瞻性聲明，無論由於新資訊、未來事件或其他原因。

Our presentation today, including our earnings press release and SEC filings published earlier today, are available on our investor relations website.

我們今天的簡報，包括今天稍早發布的收益新聞稿和美國證券交易委員會 (SEC) 文件，均可在我們的投資者關係網站上查閱。

The information we provide about our pipeline is for the benefit of the investment community and is not intended to be promotional.

我們提供的有關我們管道的資訊是為了投資界的利益，並非旨在用於促銷。

As we transition to our prepared remarks, please note that all dollars referred to during the call are US dollars.

當我們轉到準備好的發言時，請注意，通話中提到的所有美元均為美元。

After our prepared remarks, we will open the lines for questions and answers.

在我們準備好的發言之後，我們將開放問答環節。

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

現在，我將把電話轉給卡爾。

Thanks Tryn and thank you everyone for joining us today.

感謝 Tryn，也感謝大家今天的參與。

This first quarter we continue to execute against our key priorities for 2025, which include initiating phase one clinical trials for ABCL635 and ABCL575.

第一季度，我們繼續執行 2025 年的關鍵優先事項，其中包括啟動 ABCL635 和 ABCL575 的第一階段臨床試驗。

Nominating one or more additional development candidates and moving these into CTA-enabling studies.

提名一個或多個額外的開發候選人並將其納入 CTA 支援研究。

Completing platform investments and starting to use our clinical manufacturing capabilities.

完成平台投資並開始使用我們的臨床製造能力。

Today my prepared remarks are focused on providing additional details about ABCL635, including revealing its target and indication for the first time.

今天我準備的演講主要集中在提供有關 ABCL635 的更多細節，包括首次披露其目標和適應症。

ABCL635 is a potential first in class therapeutic antibody being developed for non-hormonal treatment of moderate to severe vasomotor symptoms, more commonly known as hot flashes that are associated with menopause.

ABCL635 是一種潛在的首創治療性抗體，正在開髮用於非荷爾蒙治療中度至重度血管舒縮症狀，通常稱為與更年期相關的潮熱。

ABCL635 targets Neurokinin 3 receptor or NK3R, which is a GPCR involved in endocrine homeostasis and thermal regulation.

ABCL635 靶向神經激肽 3 受體或 NK3R，這是一種參與內分泌穩態和熱調節的 GPCR。

Notably, ABCL635 is the first program from our GPCR and ion channels platform to advance into our pipeline.

值得注意的是，ABCL635 是我們 GPCR 和離子通道平台中第一個進入我們研發管線的計畫。

On our last earnings call, we discussed how we assess program investment decisions, and this slide summarizes our view of ABL635 in each of the four dimensions of our investment framework.

在我們上次的收益電話會議上，我們討論瞭如何評估專案投資決策，這張投影片總結了我們對 ABL635 在投資框架的四個維度上的看法。

First, starting with the science.

首先，從科學開始。

The NK3R pathway is well understood and has been clinically validated with small molecules, giving us high confidence in the biology.

NK3R 路徑已被充分理解，並已通過小分子進行臨床驗證，這讓我們對其生物學特性充滿信心。

Accordingly, we believe the main scientific risk for ABCL635 is whether or not we can achieve sufficient target engagement.

因此，我們認為 ABCL635 的主要科學風險在於我們是否能夠實現足夠的目標參與。

From a commercial perspective, VMS associated with menopause presents a large unmet medical need and a significant market opportunity.

從商業角度來看，與更年期相關的 VMS 代表著巨大的未滿足的醫療需求和巨大的市場機會。

Approximately 30% of women experience moderate to severe VMS at some point in their lives, with more than half seeking treatment.

約有 30% 的女性在一生中的某個階段會經歷中度至重度 VMS，其中超過一半的女性正在尋求治療。

ABCL635 has the potential to be the first antibody therapy in the NK3R class, a market estimated to reach over $2 billion in annual sales.

ABCL635 有可能成為 NK3R 類中的首個抗體療法，該市場的年銷售額預計超過 20 億美元。

With respect to differentiation, ABCL635 has the potential to be a first in class antibody treatment for VMS with dosing every four weeks and an improved safety profile as compared to small molecules.

就分化而言，ABCL635 有可能成為治療 VMS 的一流抗體藥物，每四周給藥一次，與小分子相比具有更好的安全性。

And finally, this program has a well established development path with potential for important early readouts on biomarkers and efficacy.

最後，該計畫擁有完善的發展路徑，有可能在生物標記和功效方面獲得重要的早期讀數。

VMS represents an underserved, underappreciated, and serious unmet medical need.

VMS 代表著一種服務不足、重視不足且嚴重未被滿足的醫療需求。

They impact the well-being, the productivity, the career advancement, and the income of millions of women in North America alone.

它們影響著北美數百萬女性的福祉、生產力、職業發展和收入。

In the United States, there are approximately 40 million women of menopausal age.

在美國，約有4000萬更年期女性。

VMS are the most common symptoms of menopause, and as I noted earlier, about 30% of women will experience moderate to severe VMS in their lifetimes.

VMS 是更年期最常見的症狀，正如我之前提到的，大約 30% 的女性在一生中會經歷中度至重度 VMS。

The median duration of VMS is 7.5 years.

VMS 的平均持續時間為 7.5 年。

Approximately 12% of women will experience symptoms for more than 10 years, and in some cases, VMS can last for decades.

約有 12% 的女性會出現持續 10 年以上的症狀，在某些情況下，VMS 可能會持續數十年。

This is why new treatments for VMS are an important addition to available therapies for women who suffer from this serious and long overlooked condition.

這就是為什麼針對 VMS 的新療法對於患有這種嚴重且長期被忽視的疾病的女性來說，是現有療法的重要補充。

Menopause hormone therapy or MHT is recognized as an effective treatment for VMS and is the current standard of care.

更年期荷爾蒙療法或 MHT 被公認為治療 VMS 的有效方法，也是目前的標準治療方法。

While effective, MHT is not for everyone.

儘管 MHT 有效，但它並不適合所有人。

Approximately 12% of women are contraindicated for MHT, and 8% of women who begin MHT discontinue within 12 months.

約有 12% 的女性不適合接受 MHT，8% 開始接受 MHT 治療的女性會在 12 個月內停止接受治療。

Additionally, in a recent global study, it was found that 57% of women who were eligible for MHT were against using it.

此外，最近的一項全球研究發現，57% 符合 MHT 條件的女性反對使用它。

Non-hormonal treatments for VMS are therefore an important option for women who either cannot or who choose not to use MHT.

因此，對於不能或選擇不使用 MHT 的女性來說，非荷爾蒙治療 VMS 是一個重要的選擇。

NK3R antagonists have recently been proven as effective non-hormonal options for the treatment of VMS.

NK3R 拮抗劑最近已被證明是治療 VMS 的有效非荷爾蒙選擇。

NK3R is a GPCR protein expressed by KNDy neurons that are located in the infundibular nucleus, also known as the arcuate nucleus, which is a region of the hypothalamus.

NK3R 是一種 GPCR 蛋白，由位於漏斗核（也稱為弓狀核）的 KNDy 神經元表達，該核是下丘腦的一個區域。

KNDy neurons play a central role in regulating endocrine reproductive function and also impact thermal regulatory control via an interdependent neuronal pathway.

KNDy 神經元在調節內分泌生殖功能中起著核心作用，並且還透過相互依賴的神經路徑影響熱調節控制。

Prior to menopause, KNDy neuronal activity is balanced by stimulatory NKB NK3R tingling and the inhibitory effect of estrogen.

在更年期之前，KNDy 神經元活動受到刺激性 NKB NK3R 刺痛和雌激素的抑製作用的平衡。

In menopause, when estrogen levels decrease due to the natural process of reproductive aging, this neuronal activity becomes unbalanced.

在更年期，當雌激素水平因生殖老化的自然過程而下降時，這種神經活動就會變得不平衡。

As a result, NKB increasingly binds NK3R, causing KNDy neurons to overactivate and stimulate the thermoregulatory neurons in another region of the brain called the pre-optic nucleus, which leads to hot flashes.

結果，NKB 越來越多地與 NK3R 結合，導致 KNDy 神經元過度激活並刺激大腦另一個區域（稱為視前核）中的體溫調節神經元，從而導致潮熱。

ABCL635 was designed to bind to NK3R and to prevent the activation of KNDy neurons by NKB.

ABCL635 旨在與 NK3R 結合併阻止 NKB 活化 KNDy 神經元。

Blocking NKB/NK3R signalling with small molecules have been clinically shown to reduce both the frequency and severity of VMS associated with menopause.

臨床證明，利用小分子阻斷 NKB/NK3R 訊號傳導可以降低與更年期相關的 VMS 的頻率和嚴重程度。

Importantly, the infundibular nucleus responds to soluble factors in the blood and is therefore one of the few specialized areas of the brain that is not isolated behind the blood-brain barrier.

重要的是，漏斗核對血液中的可溶性因子作出反應，因此是大腦中少數幾個未被血腦屏障隔離的特殊區域之一。

Because of this, we believe that ABCL635 should be able to engage NK3R on KNDy neurons, and our preclinical studies support this hypothesis.

因此，我們相信 ABCL635 應該能夠與 KNDy 神經元上的 NK3R 結合，我們的臨床前研究支持這一假設。

Translating this result into humans and confirming that target engagement is sufficient to reduce VMS is the key scientific risk in this program.

將這一結果轉化為人類並確認目標參與足以減少 VMS 是該計劃的關鍵科學風險。

There are two small molecule NK3R antagonists that have recently been demonstrated clinically to be both safe and effective.

有兩種小分子 NK3R 拮抗劑最近已被臨床證明是安全有效的。

Therefore, ABCL635 has the potential to enter the market at a time when the class has already been established and small molecules are approaching peak sales.

因此，ABCL635 有可能在該類別藥物已經建立且小分子藥物即將達到銷售高峰時進入市場。

Fezolinetant, a once daily oral treatment, was approved in May 2023 and is the first available NK3R antagonist for the treatment of VMS.

Fezolinetant 是一種每日一次的口服藥物，於 2023 年 5 月獲得批准，是第一個可用於治療 VMS 的 NK3R 拮抗劑。

Elinzanetant, also a once daily oral treatment, successfully completed base three trials and is expected to be approved within the year.

Elinzanetant 也是一種每日一次的口服藥物，已成功完成三項基礎試驗，預計今年內獲得批准。

Unlike fezolinetant, elinzanetantis a non-selective antagonist that blocks both NK3R and a related receptor, NK1R.

與 fezolinetant 不同，elinzanetant 是一種非選擇性拮抗劑，可阻斷 NK3R 和相關受體 NK1R。

Because ABCL635 is an NK3R specific antibody, we expect that it will avoid some side effects that have been observed with small molecules in the clinic.

由於 ABCL635 是一種 NK3R 特異性抗體，我們預計它將避免臨床中觀察到的小分子的一些副作用。

First, unlike small molecules that are metabolized in the liver, antibodies are generally not associated with liver toxicity.

首先，與在肝臟中代謝的小分子不同，抗體通常不具有肝毒性。

And second, because ABCL635 is specific to NK3R, we do not expect fatigue or somnolence that is believed to be related to the antagonism of NK1R.

其次，由於 ABCL635 針對 NK3R 具有特異性，我們預期不會出現與 NK1R 拮抗作用有關的疲勞或嗜睡症狀。

In addition to having potential for an improved safety profile, we also believe ABCL635 can achieve convenient dosing that would be preferred by a large fraction of women with VMS.

除了具有提高安全性的潛力之外，我們還相信 ABCL635 可以實現方便的給藥方式，這將是大部分 VMS 女性患者的首選。

To confirm this, we conducted a market research survey of 75 women who have VMS and found that assuming equal efficacy and safety profiles, more than 50% said they would prefer the convenience of a once monthly injectable over a daily oral treatment.

為了證實這一點，我們對 75 名患有 VMS 的女性進行了市場調查，發現假設療效和安全性相同，超過 50% 的人表示，與每日口服治療相比，她們更喜歡每月注射一次的便利性。

In addition, for the subset of women with experience using auto injectors, a large majority, approximately 70%, said they would select a once monthly injectable over a daily pill.

此外，對於有使用自動注射器經驗的女性來說，絕大多數（約 70%）表示，她們會選擇每月注射一次，而不是每天服用藥丸。

In summary, the recent and upcoming approvals of novel non-hormonal treatments for VMS are an important and long overdue solution for millions of women.

總而言之，最近和即將批准的治療 VMS 的新型非荷爾蒙療法對於數百萬女性來說是一個重要且早就應該得到的解決方案。

ABCL635 is being developed as a next generation NK3R antagonist with both an improved safety profile and a more convenient dosing regimen.

ABCL635 正在開發為下一代 NK3R 拮抗劑，具有更高的安全性和更方便的給藥方案。

If ultimately successful, we believe it can be a highly differentiated product that is launched into a large and established market.

如果最終取得成功，我們相信它可以成為高度差異化的產品，並進入龐大而成熟的市場。

In terms of timing, our plans include Completing the CTA process this quarter.

在時間方面，我們的計劃包括本季完成 CTA 流程。

Starting our phase one study in Q3 of 2025 and reporting key readouts of safety and early efficacy in mid 2026.

我們將於 2025 年第三季開始第一階段研究，並於 2026 年中期報告安全性和早期療效的關鍵讀數。

As ADCL635 goes into clinical trials, we have high conviction in the biology, the differentiation thesis, and the unmet medical need.

隨著 ADCL635 進入臨床試驗，我們對其生物學、分化理論和未滿足的醫療需求充滿信心。

We expect the most important risk regarding target engagement will be addressed in phase one, making this an important near-term clinical readout.

我們預計，與目標參與有關的最重要風險將在第一階段解決，這使其成為重要的近期臨床讀數。

Turning to our second program, we have been advancing ABCL575 concurrently with ABCL635. It is also on track with the CTA filing in Q2, and we anticipate starting phase one clinical trials in the third quarter.

談到我們的第二個項目，我們一直在同時推進 ABCL575 和 ABCL635。該公司還將在第二季按計劃提交 CTA 文件，我們預計將在第三季開始第一階段臨床試驗。

Later this week, our team will be in San Diego presenting preclinical data on ABCL575 at the annual meeting of the Society for Investigative Dermatology.

本週晚些時候，我們的團隊將在聖地牙哥舉行的研究皮膚病學會年會上展示 ABCL575 的臨床前數據。

You can download the poster presentation on our website when it becomes available tomorrow, May 9.

海報簡報將於明天（5 月 9 日）發布，您可以在我們的網站上下載。

With our first two programs nearing the clinic, our transition from a platform company to a clinical stage biotech is nearly complete.

隨著我們的前兩個項目即將進入臨床階段，我們從平台公司向臨床階段生物技術公司的轉型已接近完成。

Behind ABCL635 and ABCL575, we are working on a portfolio of more than 20 internal and co-development programs from which we will continue to build our pipeline.

在 ABCL635 和 ABCL575 背後，我們正在進行 20 多個內部和聯合開發項目，並將繼續建立我們的產品線。

As mentioned earlier, ABCL635 will be the first clinical program derived from our GPCR and ion channels platform.

如前所述，ABCL635將是我們GPCR和離子通道平台衍生的第一個臨床項目。

We view this as an important proof point that our technology can unlock these challenging and high value target classes which represent approximately 50% of our preclinical programs.

我們認為這是一個重要的證明點，證明我們的技術可以解鎖這些具有挑戰性和高價值的目標類別，這些目標類別約占我們臨床前項目的 50%。

We expect to elect an additional development candidate from this platform in the near future and look forward to sharing updates with you as they become available.

我們期望在不久的將來從該平台選出另一位開發候選人，並期待在更新後與您分享。

Similarly, we see our T-cell-engager platform as a source of internal programs and also as a basis for future partnering activities.

同樣，我們將 T 細胞接合器平台視為內部專案的來源，也是未來合作活動的基礎。

Last month we provided an update on our TCE platform, including in vivo data that was presented at Abcellera's annual meeting.

上個月，我們提供了有關 TCE 平台的更新，包括在 Abcellera 年度會議上展示的體內數據。

And finally, investments in building our clinical manufacturing are on track and are nearing completion. We expect to start using these capabilities later this year.

最後，我們對臨床製造的投資正在按計劃進行並即將完成。我們預計將於今年稍後開始使用這些功能。

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

說完這些，我會把時間交給安德魯來討論我們的財務狀況，安德魯。

Thanks Carl.

謝謝卡爾。

As Carl pointed out, Abcellera continues to be in a strong liquidity position with approximately $630 million in cash and equivalents and with roughly $180 million in available committed government funding to continue to execute on our strategy.

正如卡爾所指出的，Abcellera 繼續保持強勁的流動性，擁有約 6.3 億美元的現金和等價物，以及約 1.8 億美元的可用承諾政府資金，以繼續執行我們的策略。

We are continuing our plans with a focus on internal programs and completing our CMC and GMP investments.

我們將繼續我們的計劃，重點關注內部項目並完成我們的 CMC 和 GMP 投資。

Looking at our key business metrics in the fourth quarter, we started to work on one partner initiated program which takes us to a cumulative total of 97 programs with downstream participation.

從第四季度的關鍵業務指標來看，我們開始著手開展一項由合作夥伴發起的計劃，這使我們累計擁有 97 個下游參與的計劃。

We saw no new molecules advancing into the clinic in the quarter, maintaining our cumulative total of 16 molecules to have reached the clinic, and we understand the development of the four Trianni licensed molecules that Novarock advanced into phase one are currently paused.

本季我們沒有看到任何新的分子進入臨床，我們累積共有 16 個分子進入臨床，我們了解到 Novarock 進入第一階段的四種 Trianni 許可分子的開發目前已暫停。

As we have stated previously, we view the overall progress of molecules in the clinic as a potential source of near and midterm revenue from downstream milestone fees and royalty payments in the longer term.

正如我們之前所說，我們認為臨床中分子的整體進展是來自下游里程碑費用和長期特許權使用費的潛在近期和中期收入來源。

Turning to revenue and expenses, revenue for the quarter was about $4 million mostly driven by research fees relating to the work on partnered programs. This compares to revenue of $10 million in the same quarter of 2024.

談到收入和支出，本季收入約為 400 萬美元，主要來自與合作項目工作相關的研究費用。相較之下，2024 年同期的營收為 1,000 萬美元。

As we have mentioned in the past, we expect research fee revenue to continue to trend lower as we increasingly focus on internal and co-development programs.

正如我們過去提到的，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繼續呈下降趨勢。

Our research and development expenses for the quarter were approximately $43 million and $3 million dollars more than last year.

本季我們的研發費用約為 4,300 萬美元，比去年同期增加了 300 萬美元。

This expense is driven by increasing investment in our internal and co-development programs.

這筆開支源自於我們內部和共同開發項目的投資增加。

In sales and marketing, expenses for Q1 were about $3 million a modest reduction relative to the same quarter last year, and in general in administration, expenses were approximately $16 million compared to roughly $17 million in Q1 of 2024.

在銷售和行銷方面，第一季的支出約為 300 萬美元，與去年同期相比略有減少；整體管理費用約為 1,600 萬美元，而 2024 年第一季約為 1,700 萬美元。

Looking at earnings We are reporting a net loss of roughly $46 million for the quarter compared to a loss of around $41 million in the same quarter last year. In terms of earnings per share, this result works out to a loss of $0.15 per share on a basic and diluted basis.

從收益來看，我們報告本季淨虧損約為 4,600 萬美元，而去年同期的虧損約為 4,100 萬美元。就每股收益而言，這一結果相當於基本和稀釋後每股虧損 0.15 美元。

Looking at cash flows, operating activities for Q1 of 2025 used approximately $12 million in cash and equivalents, excluding investments in marketable securities.

從現金流來看，2025 年第一季的經營活動使用了約 1,200 萬美元的現金和等價物，不包括對有價證券的投資。

Investment activities amounted to a net $17 million mostly in property plant and equipment driven by our ongoing work to establish CMC and GMP manufacturing capabilities.

投資活動淨額達 1,700 萬美元，主要用於房地產、廠房和設備，這得益於我們持續致力於建立 CMC 和 GMP 製造能力。

The investments in [PP&E] were partially offset by government contributions.

對[PP&E]的投資部分被政府撥款所抵銷。

And as a part of our treasury strategy, we have nearly $450 million invested in short-term marketable securities. Our investment activities for the quarter included approximately $25 million net decrease in these holdings.

作為我們財務策略的一部分，我們已在短期有價證券上投資了近 4.5 億美元。本季我們的投資活動包括這些持股淨減少約 2,500 萬美元。

Altogether we finished the quarter with over $630 million of total cash equivalents, and marketable securities.

本季我們總共擁有超過 6.3 億美元的現金等價物和有價證券。

As a reminder, we have received commitments for funding for 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.

提醒一下，我們已從加拿大政府戰略創新基金和不列顛哥倫比亞省政府獲得為我們的 GMP 設施和內部管道推進提供資金的承諾。

This available capital does not show up on our balance sheet. With over $630 million in cash and equivalents and the unused portion of our secured government funding, we have approximately $810 million in total available liquidity to continue executing on our strategy.

這筆可用資本並未出現在我們的資產負債表上。我們擁有超過 6.3 億美元的現金和等價物以及我們擔保的政府資金中未使用的部分，總共擁有約 8.1 億美元的可用流動資金來繼續執行我們的策略。

The cash usage for the remainder of 2025 will continue to prioritize advancing our two lead programs to the clinic, building the pre-clinical pipeline, and completing our investment in the integrated CMC and GMP capabilities.

2025 年剩餘時間的現金使用將繼續優先用於推進我們的兩個主要臨床項目、建立臨床前管道以及完成對綜合 CMC 和 GMP 能力的投資。

As previously communicated, the new manufacturing facility is scheduled to come online at the end of 2025.

如前所述，新製造工廠計劃於 2025 年底投入使用。

With respect to our overall operating expenses, our capital needs are very manageable. We continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments, and with that, we'll be happy to take questions.

就我們的整體營運費用而言，我們的資本需求非常可控。我們仍然相信，我們有足夠的流動資金來為未來三年增加的管道投資提供資金，因此，我們很樂意回答問題。

Thank you.

謝謝。

We will now begin the Q&A portion of the call.

我們現在開始電話會議的問答部分。

(Operator Instructions)

（操作員指示）

Our first question comes from Brendan Smith with TD Securities. You may now proceed.

我們的第一個問題來自道明證券的布倫丹史密斯。您現在可以繼續。

Hi, this is Jackie on for Brendan. Congrats on the quarter and thank you for taking my question.

大家好，我是 Jackie，為 Brendan 服務。恭喜本季取得佳績，感謝您回答我的問題。

Maybe just a quick one on 635. What do you expect this asset needs to see in terms of phase one data and any follow up data to really capture that competitive edge given the head start that peers have, going beyond just, that it's more of a nicer dose and the preferred kind of type of medicine.

也許只是 635 上的一個快速操作。考慮到同行所擁有的領先優勢，您認為該資產需要在第一階段數據和任何後續數據方面看到什麼才能真正抓住競爭優勢，而不僅僅是更好的劑量和首選的藥物類型。

Sure, I'm happy to take that question, Carl, here.

當然，卡爾，我很樂意回答這個問題。

So, obviously, there's some recent activity in the approval of NK3R antagonists with Fezolinetant and Elinzanetant.

因此，顯然，最近在 NK3R 拮抗劑 Fezolinetant 和 Elinzanetant 的批准方面有一些進展。

That's a terrific outcome for patients that are looking for non-hormonal treatments.

對於尋求非荷爾蒙治療的患者來說，這是一個非常好的結果。

We view, the validation and the success of those molecules as very positive for this program. There's going to be some time required to communicate to medical practitioners and patients and to start to build the class, and we are positioned with a molecule that would take advantage of that growing awareness and would be positioned if it is successful, to launch into what has become a large and established class.

我們認為這些分子的驗證和成功對該計劃來說非常積極。需要一些時間與醫務人員和患者溝通並開始建立該類別，並且我們定位於一種分子，可以利用這種日益增長的意識，如果成功的話，它將進入一個龐大而成熟的類別。

In terms of, what we need to see in the phase one studies, we haven't disclosed the design of those studies, but we will be looking, of course, at safety, but also at some very important data on biomarkers which are an early sign of target engagement and on the latter part of the study evaluating efficacy in in a population of participants.

至於我們需要在第一階段研究中看到什麼，我們還沒有披露這些研究的設計，但我們當然會關注安全性，但也會關註一些非常重要的生物標誌物數據，這些數據是目標參與的早期跡象，並在研究的後期評估參與者群體的療效。

So, one of the really attractive things about this program is that by midpoint next year we should have data that tells us a lot about the success of the program and the science, and with that we'd be in a position to double down and to invest further from a differentiation perspective, which was, related to or part of your question, really it's two things.

因此，該計劃真正吸引人的地方之一是，到明年年中，我們應該能獲得大量數據，這些數據可以告訴我們很多有關該計劃和科學的成功的信息，有了這些數據，我們就可以加倍投入，從差異化的角度進一步投資，這與您的問題相關或部分相關，實際上是兩件事。

The first is we do believe that an antibody that is specific to NK3R can have a cleaner safety profile.

首先，我們確實相信針對 NK3R 的抗體具有更高的安全性。

Which is something that we believe is highly valued and differentiated and perhaps even more in differentiation is the dosing.

我們認為，這是非常受重視和差異化的地方，也許更大的差異化在於劑量。

As mentioned in my prepared remarks, we have conducted a study that shows that a majority of women would prefer to have a once monthly subcutaneous self-administered injection over a daily pill.

正如我在準備好的演講中提到的，我們進行的一項研究表明，大多數女性更願意每月進行一次皮下注射，而不是每天服用藥丸。

And for women that have experience with auto injectors, that number goes up to about 70%.

對於有使用自動注射器經驗的女性來說，這個數字上升到約 70%。

With the growing use of auto injectors, particularly in the [GOP] one class, we see that as a trend that's going to continue to grow over time. It's a matter of convenience.

隨著自動注射器的使用日益增多，特別是在共和黨這一階層，我們認為這種趨勢將會隨著時間的推移而持續增長。這是為了方便。

It's a matter of compliance, and you know people that have busy lives would prefer to have something that is, something you do once a month and then you don't have to worry about it after that.

這是一個遵從的問題，你知道，生活忙碌的人們更喜歡做一些事情，每月做一次，之後就不必再擔心了。

If we are successful, and of course we're just at the very beginning of this, so you know our eyes are laser focused on getting this early data, but if successful again it launches into a large class, and we think that there's a significant population, in fact, the majority, that would prefer that format.

如果我們成功了，當然我們才剛開始，所以你知道我們的目光將集中在獲取早期數據上，但如果再次成功，它將進入一個大群體，我們認為有相當一部分人，事實上，大多數人，更喜歡這種形式。

No, that's very helpful.

不，這非常有幫助。

Thank you.

謝謝。

Then maybe one just a quick one, what should we expect to see from the upcoming 575 free clinical data tomorrow, presented at the medical meeting?

那麼也許我只是想快速地問一下，我們應該期待從明天醫學會議上公佈的 575 份免費臨床數據中看到什麼？

Sure, yeah.

當然，是的。

So, we are presenting at [SI], as I mentioned, the pre-clinical data will include, some early early animal work that supported the filing, and probably the most important data is the first glimpse at [PK] analysis and predictions of what that would lead to in human studies.

因此，正如我所提到的，我們在 [SI] 上展示的臨床前數據將包括一些支持申請的早期動物研究，可能最重要的數據是首次看到 [PK] 分析和對其在人體研究中將產生的影響的預測。

The main pillar of differentiation for ABCL575 is that we believe it will be differentiated in having a superior dosing regimen, and we're aiming for having, at least three months, if not six months dosing and are optimistic that you'll be pleased with the data when you see it.

ABCL575 的主要差異化支柱是我們相信它將在擁有更優越的給藥方案方面有所差異，我們的目標是至少三個月，甚至六個月的給藥時間，並且樂觀地認為當您看到數據時您會感到滿意。

Great, thank you so much.

太好了，非常感謝。

Thank you.

謝謝。

My next question comes from Andrea Newkirk with Goldman Sachs, who may now proceed.

我的下一個問題來自高盛的 Andrea Newkirk，她現在可以繼續提問了。

Hi all, this is Tawane on for Andrea.

大家好，我是 Tawane，為 Andrea 獻聲。

Thanks for taking the questions and congrats on the progress.

感謝您回答問題並祝賀取得的進展。

Just one another quick one on 635. Given the risk you had mentioned facing the program around translatability of the NK3R engagement from the pre-clinical studies into humans, is there a precedent you could point to that gives you confidence that those observations will still hold in the clinical setting?

635 上還有另一個快速的。鑑於您提到的該計劃面臨的風險，即 NK3R 參與從臨床前研究到人類的可轉化性，您是否可以指出一個先例，讓您有信心這些觀察結果在臨床環境中仍然成立？

That's a great question.

這是一個很好的問題。

So, you know we have preclinical data including data on NHP that give us, a lot of reason to be optimistic that this will translate into humans.

所以，您知道我們擁有臨床前數據，包括有關 NHP 的數據，這些數據為我們提供了充分的理由，讓我們樂觀地相信這將轉化為人類。

And so I think I am being circumspect largely because drug development is a humbling industry and you're often surprised and of course non-human primates are not humans, so it needs to be shown there.

所以我認為我之所以如此謹慎，主要是因為藥物開發是一個令人謙卑的行業，你經常會感到驚訝，當然非人類靈長類動物不是人類，所以需要在那裡展示。

In terms of precedent, there are There are some antibodies, I believe, CGRP receptor that are in a similar part of the brain, so there is some precedent, but you know this is a different pathway and the details of where the neurons are in that part of the brain.

就先例而言，我相信有一些抗體，CGRP 受體位於大腦的類似部位，所以有一些先例，但你知道這是一條不同的途徑，以及神經元在大腦該部位的位置細節。

And of course, behind that, whether or not we have complete understanding of the pathway, which we believe we do, but sometimes you can be surprised, all of those things need to be de-rest and the important thing for ABCL635 is that.

當然，在這背後，無論我們是否完全了解該途徑，我們相信我們已經完全了解了，但有時你可能會感到驚訝，所有這些都需要解除休息，而對於 ABCL635 來說，重要的是這一點。

The development path allows us to test both of those main risks early in clinical development through the through a biomarker readout and early efficacy.

此開發路徑使我們能夠透過生物標記讀數和早期功效在臨床開發早期測試這兩個主要風險。

So, it's not, it's not that I would bet against it, but I think in all drug development we should be cautious and not assume that things are going to translate directly from nonhuman primates to humans.

所以，我並不是反對它，但我認為在所有藥物開發中我們都應該謹慎，不要假設事情會直接從非人類靈長類動物轉移到人類。

Okay, understood, thank you.

好的，明白了，謝謝。

And then just one more if I may, with both 575 and 635 now advancing into the clinic, how are you thinking about the next development candidates?

如果可以的話，我再問一個問題，575 和 635 現在都已進入臨床階段，您如何考慮下一個開發候選人？

And is there any line of sight at the time as to what targets or indications might be selected or of interest?

當時是否有任何關於可能選擇或感興趣的目標或跡象的線索？

Sure, I'll take that one again.

當然，我會再選一個。

Yeah, so we are, building our our portfolio and making investment decisions according to the framework that I outlined in some detail in the last earnings call and that I alluded to at the start at the start today.

是的，我們正在根據我在上次財報電話會議上詳細概述的框架以及我今天開始時提到的框架來建立我們的投資組合併做出投資決策。

Basically we're looking for high conviction biology with a large unmet medical need, a compelling case for differentiation, and importantly, a development path that allows us to get as much information as quickly as possible and it doesn't pose, undue risk or or require a huge amount of time and money to get those early answers.

基本上，我們正​​在尋找具有巨大未滿足醫療需求、令人信服的差異化案例的、具有高度說服力的生物學，而且重要的是，我們正在尋找一種發展路徑，使我們能夠盡快獲得盡可能多的信息，並且不會帶來過度風險或需要大量的時間和金錢來獲得這些早期答案。

Beyond that we are target agnostics, so we have been looking broadly across indications, broadly across biology to look for opportunities that we're excited about.

除此之外，我們對目標一無所知，因此我們一直在廣泛地研究各種適應症和生物學，以尋找令我們興奮的機會。

A substantial portion of that that effort has brought us to the difficult target classes, so ion channels and GPCRs, and as I said in my prepared remarks, it's likely that the next development candidate that will come up will be another one that is either a GPCR or ion channel that builds on what has been years of technology and capability building to unlock that class, and we're quite excited about that.

我們所做的很大一部分努力已經將我們引向了困難的目標類別，即離子通道和 GPCR，正如我在準備好的發言中所說，下一個要開發的候選藥物很可能是 GPCR 或離子通道，它建立在多年來為解鎖該類別而進行的技術和能力建設的基礎之上，我們對此感到非常興奮。

Typically we will not be discussing targets or indications until a program has moved at least to development candidate and once it is a development candidate we will disclose the indication the target if we believe that that is strategically wise and we will avoid doing that if we think that there's a downside in terms of competition.

通常情況下，在一個專案至少進入開發候選階段之前，我們不會討論目標或跡象，一旦它成為開發候選，如果我們認為這在策略上是明智的，我們就會披露目標跡象，如果我們認為在競爭方面存在不利因素，我們就會避免這樣做。

And so depending on what the target is, we'll either disclose very early as we did with 575, or we will hold it closer to our chest and disclose it closer to CPA filing as we have done with NK3R.

因此，根據目標，我們要么像 575 那樣儘早披露，要么將其保密，等到接近 CPA 備案時再披露，就像 NK3R 那樣。

Makes sense thank you.

有道理，謝謝。

Our next question comes from Puneet Souda with Lerink Partners. You may now proceed.

我們的下一個問題來自 Lerink Partners 的 Puneet Souda。您現在可以繼續。

My first one has to do with the 575 asset.

我的第一個問題與 575 資產有關。

So, during the quarter we saw some updates from lacotinlamab as well as amletelamab and asthma. I was wondering if you had any comments on how those readouts inform your updated view of the opportunities for the particular asset.

因此，在本季度，我們看到了有關 lacotinlamab 以及 amletelamab 和哮喘的一些更新。我想知道您是否對這些讀數如何為您提供有關特定資產機會的最新看法有何評論。

Yes, Carl, here I'm happy to take that one. Thanks for the question, Puneet.

是的，卡爾，我很樂意接受這個。謝謝你的提問，Puneet。

So, first of all, our investment thesis in 575 is is reinforced by the hypothesis that the Ox40 ligand class is going to be a huge class, important not just in atopic dermatitis, which is obviously a huge market, but also we'll find applications across other indications.

因此，首先，我們對 575 的投資論點得到了以下假設的支持：Ox40 配體類將成為一個巨大的類，不僅對異位性皮膚炎（這顯然是一個巨大的市場）很重要，而且我們還會在其他適應症中找到應用。

Over the last quarter, I think there's been, several points that confirm and reinforce that hypothesis. So, there is the Sanofi trial in asthma, and while they did not read out on the top line, there was a subset of patients for which they got 70% responses, which is excellent.

在過去的一個季度，我認為有幾點可以證實並強化這個假設。因此，賽諾菲在氣喘方面進行了試驗，雖然他們沒有在第一行讀出結果，但有一部分患者獲得了 70% 的反應，這非常好。

That subset of patients are the patients with high eosinophil counts, which is the same patient group for which [Dupiant] is being used and so we view that as a very strong positive signal that Ox40 ligand is going to have applications and be an important therapeutic option in asthma. And of course, Sanofi has put their money where their mouth is they're advancing that into phase three, so we see that as a very positive outcome.

這部分患者是嗜酸性粒細胞計數高的患者，與使用 [Dupiant] 的患者群體相同，因此我們認為這是一個非常強烈的積極信號，表明 Ox40 配體將得到應用並成為哮喘的重要治療選擇。當然，賽諾菲已經說到做到，他們正在推進研究的第三階段，因此我們認為這是一個非常積極的結果。

In addition to that, there was a readout for another Ox40 ligand molecule from imaging with some early efficacy in alopecia, which again highlights that Ox40 ligand will have applications broadly in INI, and while it has not been widely covered.

除此之外，還有另一種 Ox40 配體分子的成像讀數，該分子在脫髮方面具有一些早期療效，這再次強調了 Ox40 配體將在 INI 中廣泛應用，儘管它尚未得到廣泛報導。

Sanofi has decided to advance an Ox40 ligand TNF-alpha by specific for HS.

賽諾菲已決定推出專門針對 HS 的 Ox40 配體 TNF-alpha。

So, that is another example of Ox40 ligand being important in HS and also reinforces a second pillar of our investment thesis, which is that Ox40 ligand is a particularly good pathway or Ox40 ligand is a particularly good pathway for combination therapy.

因此，這是 Ox40 配體在 HS 中發揮重要作用的另一個例子，同時也強化了我們投資論點的第二個支柱，即 Ox40 配體是一種特別好的途徑，或者 Ox40 配體是一種特別好的聯合治療途徑。

You asked also about rocatinlamab they've released additional data. I mean, I would say that the data is disappointing compared to what has been seen with amlatilumab.

您還詢問了有關 rocatinlamab 的問題，他們已經發布了更多數據。我的意思是，我想說，與 amlatilumab 的情況相比，這些數據令人失望。

It's not clear if that is a reflection of the difference between targeting Ox40 ligand and Ox40, or if it's a difference with the mechanism of action, because rocatinlamab is of course a depleting antibody, whereas we have an FC effector null variant which will not deplete cells.

目前尚不清楚這是否反映了針對 Ox40 配體和 Ox40 之間的差異，或者是否反映了作用機制的差異，因為 rocatinlamab 當然是一種消耗性抗體，而我們有一種不會消耗細胞的 FC 效應物無效變體。

So, all of that we view as being very positive and a tailwind for the program, in our shop we're currently focused on getting the early phase one data.

因此，我們認為所有這些都是非常積極的，對該計劃來說是一個順風，在我們的商店中，我們目前專注於獲取早期第一階段的數據。

The most important part of that is going to be demonstrating the long extended PK, and then a lot of the big catalysts are going to come from outside of Abcellera and examples of the Ox40 ligand class working at other indications.

其中最重要的部分是展示長期延長的 PK，然後許多大的催化劑將來自 Abcellera 之外，以及 Ox40 配體類在其他適應症下發揮作用的例子。

Or working in combination are things that we believe, add value to that program and make it more attractive, going forward. So we're keeping an eye on that just like you are.

或者我們相信，結合起來可以為該計劃增加價值，並使其在未來更具吸引力。因此，我們會像您一樣密切關注此事。

Okay, and then I want maybe a bit of a deep cut, but, given pharma tariffs, there's been a lot of talk about where IP gets domiciled as a Canada-based company.

好的，然後我可能想要大幅削減，但是，考慮到製藥關稅，關於 IP 作為加拿大公司應該在何處註冊的討論很多。

I was wondering if that becomes an element of discussion when you're thinking about, spinning off assets to potential partners.

我想知道，當您考慮將資產剝離給潛在合作夥伴時，這是否會成為討論的要素。

Hey thanks. It's Andrew here.

嘿，謝謝。我是安德魯。

I think at the moment we haven't had a discussion in terms of spinning off assets. We have our intellectual property up here in Canada and for now it remains a good jurisdiction for us to hold intellectual property, so we haven't had many discussions further than that.

我認為目前我們還沒有討論過剝離資產的問題。我們的智慧財產權在加拿大，目前它仍然是我們持有智慧財產權的良好司法管轄區，因此我們還沒有進行過太多進一步的討論。

Got it, thank you.

知道了，謝謝。

Thank you.

謝謝。

Our next question comes from Malcolm Hoffman with BMO. You may now proceed.

下一個問題來自 BMO 的 Malcolm Hoffman。您現在可以繼續。

Hi, I'm Malcolm Hoffman for Evan Sugarman from BMO.

大家好，我是 BMO 的 Evan Sugarman 的 Malcolm Hoffman。

You called up for Nova Rock molecules in the clinic that have been paused. Can you provide some more context to this pause and what it means for future development, and then kind of extending off the conversation around IP in Paris.

您呼叫了診所中已暫停的 Nova Rock 分子。您能否提供一些關於這次停頓的更多背景資訊以及它對未來發展的意義，然後延伸一下有關巴黎智慧財產權的討論。

I know a decent amount of the manufacturing capabilities for Abcellera, based in Canada. Is there any consideration for potentially producing US-based manufacturing redundancies to kind of address that? Potential risk in the future.

我對總部位於加拿大的 Abcellera 的製造能力有相當的了解。是否有考慮透過在美國製造工廠裁員來解決這個問題？未來的潛在風險。

Thank you.

謝謝。

Yeah, sure, I'm happy to take that one. With regard to the Nova Rock molecules, I think we just thought it prudent to disclose what we had seen on their own website.

是的，當然，我很樂意接受這個。關於 Nova Rock 分子，我認為我們只是認為披露我們在其網站上看到的資訊是謹慎的。

We believe it's related to fundraising, which is not uncommon in the current in the present environment for them to complete fundraising in order to continue those trials.

我們認為這與籌款有關，在當前環境下，他們為了繼續這些試驗而完成籌款的情況並不少見。

But we'll keep an eye on that and give any updates as we see it with regards to the manufacturing facility, and we do have this manufacturing facility in Canada.

但我們會密切關注這一點，並在看到有關製造工廠的任何更新時提供信息，我們在加拿大確實有這個製造工廠。

Right now we are, we have built this manufacturing facility in order to support us in our phase one, phase two clinical trials, so still during research phase of the manufacturing the product, and as as we have mentioned, our first two molecules, we are advancing them through to CTA in Canada, but even as it's still, even if wear trials in the United States.

目前，我們已經建造了這個製造工廠，以支持我們進行第一階段、第二階段的臨床試驗，因此仍處於產品製造的研究階段，正如我們所提到的，我們的前兩種分子，我們正在將它們推進到加拿大的 CTA，但即使它仍然在美國進行試驗。

I don't believe it will be an issue in moving those products over the border in order to conduct those clinical trials.

我認為將這些產品運送到邊境進行臨床試驗不會有問題。

We haven't given any thought. It's still quite early to think about when we get to commercial, when we think about commercial manufacturing for any of these molecules, where that might be done, and that's still a topic for much in the distant future.

我們還沒有考慮過。現在考慮何時商業化、何時實現這些分子的商業化生產、在哪裡進行商業化生產還為時過早，而且這在遙遠的未來仍是一個話題。

Appreciate it, Thank you guys.

非常感謝，謝謝大家。

Thank you.

謝謝。

Our next question comes from Srikripa Devarakonda, which is, you may now proceed.

我們的下一個問題來自 Srikripa Devarakonda，您現在可以繼續了。

Hey guys, congrats on all the progress and thank you so much for taking my question.

嘿，夥計們，祝賀你們取得的所有進展，非常感謝你們回答我的問題。

I know you've not yet talked about trial design, but as you go through your planning, I was wondering if there are any specific learnings from all the other trials relevant to 635 that have already been done.

我知道您還沒有談論試驗設計，但是在您進行規劃時，我想知道您是否從已經完成的所有其他與 635 相關的試驗中獲得了任何具體的經驗。

That can help you optimize your trials and also if I'm not mistaken, as a target has had NK3R has had a long history in terms of drug development with earlier trials focused on neuropsychiatry, wondering if there's good enough understanding and if that could be, I know it's really early stages, but there is a potential to expand beyond VMS.

這可以幫助您優化試驗，而且如果我沒有記錯的話，作為目標，NK3R 在藥物開發方面有著悠久的歷史，早期的試驗重點是神經精神病學，想知道是否有足夠的了解，如果可以的話，我知道這確實還處於早期階段，但有可能擴展到 VMS 之外。

Thank you.

謝謝。

Carl, here I'll take that. I'm actually not aware of the development of NK3R in neurological indications. I think there is some precedent for NK1R, which is the second target that is hit by Elinzanetant. Beyond that, I don't think I'd be able to comment.

卡爾，這個我來拿。我其實並不知道 NK3R 在神經系統適應症的發展。我認為 NK1R 有一些先例，它是 Elinzanetant 攻擊的第二個目標。除此之外，我想我無法發表評論。

Coming back to the development path, it is a big advantage that there is a clear development path that has now been successfully navigated by two products.

回到開發路徑，一個很大的優勢是，有一個清晰的開發路徑，現在已經有兩款產品成功導航。

So, it's obvious what the final endpoints should be the patient population, how to set that up.

因此，很明顯最終終點應該是患者群體，以及如何設定。

So, we have an advantage from that perspective in that we don't have a lot of ambiguity as to what will be the bar for getting approval of ABCL635.

因此，從這個角度來看，我們有一個優勢，那就是對於獲得 ABCL635 批准的門檻，我們並不存在太多的模糊性。

We haven't yet disclosed details of the clinical development plan. But as for my previous comments, our emphasis right now is to design the first trial and not to pull punches so that we can take as much risk off the off the table as soon as possible.

我們尚未披露臨床開發計劃的細節。但正如我之前的評論，我們現在的重點是設計第一次試驗，而不是採取強硬措施，以便我們能夠盡快消除盡可能多的風險。

So, we are looking in this first trial, not just to get a look at safety, which we believe will be good, but you always have to prove that, but also to get early evidence from biomarkers on target engagement and an early read on efficacy.

因此，我們在第一次試驗中不僅要觀察安全性，我們相信安全性會很好，但你必須證明這一點，而且還要從生物標記中獲得有關目標參與的早期證據和對療效的早期解讀。

So, once we have that in hand, then if it looks the way that we we hope, we would be working to accelerate the path forward to development, and there's already some thinking and planning around that, but of course it depends upon regulatory engagement and on the data that we get from the phase one trial.

因此，一旦我們掌握了這些，如果它看起來像我們所希望的那樣，我們就會努力加快發展的步伐，並且已經圍繞這一點進行了一些思考和規劃，但當然這取決於監管部門的參與以及我們從第一階段試驗中獲得的數據。

Okay great thank you so much.

好的，太好了，非常感謝。

Thank you.

謝謝。

Our next question comes from Stephen Willey for Stifel. You may now proceed.

我們的下一個問題來自 Stifel 的 Stephen Willey。您現在可以繼續。

Hey thanks for taking our question. This is Josh on for Steve.

嘿，感謝您回答我們的問題。喬希代替史蒂夫發言。

Quick one on 635 in terms of the development plan, do you think you and I know you said that you haven't really disclosed the full plan just yet, but do you think you'd have to go into healthy volunteers first to kind of establish the preliminary PKPD and safety analysis ?

關於 635 的開發計劃，您認為您和我知道您說過您還沒有真正披露完整的計劃，但您是否認為您必須首先進入健康志願者的體內，以建立初步的 PKPD 和安全分析？

and then just to follow up on some of the questions related to biomarkers and target engagement.

然後只是跟進一些與生物標記和目標參與相關的問題。

Could you maybe just provide us with some color on what types of biomarkers you'll be looking at preliminarily to get a sense as to the target engagement here?

您能否向我們提供一些信息，說明您將初步研究哪些類型的生物標誌物，以了解這裡的目標參與度？

And then I just have a follow up.

然後我只需要跟進一下。

Sure, yeah, so the short answer is in the early part of the trial we will be enrolling healthy volunteers and connecting that with your second question, we expect to enrol both male and female healthy volunteers and the most reliable biomarker of NK3R engagement would be testosterone levels.

當然，是的，所以簡短的回答是在試驗的早期階段，我們將招募健康的志願者，並將其與您的第二個問題聯繫起來，我們預計招募男性和女性健康志願者，而 NK3R 參與的最可靠生物標誌物是睾酮水平。

So that's probably one of the early readouts that we get, which gives you some strong evidence of target engagement, but of course that's not conclusive until you can show that that also translates into efficacy.

所以這可能是我們獲得的早期讀數之一，它為您提供了目標參與的有力證據，但當然，除非您能證明這也能轉化為功效，否則這還不是定論。

Great, thank you.

太好了，謝謝。

And then just my follow up was on the PSMA by CD3 T-cell engager presentation you guys made it [ACR] could you just maybe tell us about, and I know it's early, but is there anything you could tell us about which format you currently believe can have the best target profile in terms of threading the needle on both efficacy and safety as it pertains to CRS risk.

然後我的後續問題是你們在 [ACR] 上所做的關於 PSMA 的 CD3 T 細胞接合劑演示，您能否向我們介紹一下，我知道現在還為時過早，但是您能否告訴我們，您目前認為哪種格式在兼顧功效和安全性方面可以具有最佳目標概況，因為它與 CRS 風險有關。

And then, is this you know what's the timeline for maybe nominating a development candidate and is there kind of an appetite for out licensing with BD?, or is this something that you maybe want to develop internally?

然後，您是否知道提名開發候選人的時間表是什麼，以及您是否有興趣獲得 BD 的授權？或者這是您可能想要在內部開發的東西？

Yeah, I'll start with the question about about format and honestly that is the multi-billion dollar question that everyone across the industry is trying to answer, at ACR as as in previous years, at a high level there is increasing, I'd say accelerating enthusiasm for TCE as a class.

是的，我首先要問的是格式問題，說實話，這是一個價值數十億美元的問題，整個產業都在試圖回答這個問題。在 ACR，就像前幾年一樣，我認為高層對 TCE 課程的熱情正在不斷提高，甚至正在加速成長。

A lot of that has been driven by very exciting data in solid tumours.

其中很大一部分是由實體腫瘤領域令人興奮的數據所推動的。

When you talk to all the different groups, it's also apparent that it doesn't look as though there's going to be one technology and one solution that is the magic bullet for every solid tumours or for every target.

當你與所有不同的團體交談時，你會發現，似乎沒有一種技術和解決方案能夠成為治療所有實體腫瘤或所有目標的靈丹妙藥。

And many pharma companies and the big players who have committed to the space, and I would say that list is growing quickly, are placing multiple bets because you need to do these experiments in the clinic to find out what is working.

許多製藥公司和大型企業都已投身於該領域，而且我想說這個名單正在快速增長，他們正在進行多重押注，因為你需要在臨床上進行這些實驗才能找出有效的方法。

Our approach to this has been to not cut corners but to do the hard work to put in place, the tools, the workflows, the assays, to start to systematically investigate.

我們對此採取的做法是不偷工減料，而是努力工作，落實工具、工作流程和分析，開始有系統地進行調查。

Which targets, which formats, which modalities, perhaps even combinations with co-stimulation are going to be needed to get efficacy and tolerable safety in the clinic.

為了在臨床上獲得療效和可耐受的安全性，需要哪些目標、哪些格式、哪些方式，甚至與共刺激的組合。

And that foundation is allowing us to make in our shop what I believe is some pretty rapid progress, but we are of course only one company in an ecosystem that's working on this problem and we're also working with partners to solve this as well.

這個基礎使我們能夠在自己的商店中取得我認為相當快速的進展，但我們當然只是生態系統中一家致力於解決這個問題的公司，我們也在與合作夥伴合作解決這個問題。

So, when we start to get, a hook on the science or when the breakthroughs come, we're going to be very well positioned to capitalize on that, and we're already seeing, some really promising results with some of the internal programs.

因此，當我們開始對科學產生興趣或取得突破時，我們將處於非常有利的位置來利用這一點，而且我們已經看到一些內部專案取得了一些非常有希望的成果。

You asked if we'd be open to licensing, or if we bring them into the portfolio, and I think both those options are on the table. I think I said in my prepared remarks we see this as both a platform for for building our pipeline as well as for partnering.

您詢問我們是否願意接受許可，或者是否將它們納入投資組合，我認為這兩個選項都在考慮範圍內。我想我在準備好的演講中說過，我們將其視為建立管道和合作的平台。

And we make those decisions based on, the opportunity and the framework that I described in response to the previous question.

我們根據我在回答上一個問題時所描述的機會和框架做出這些決定。

So, TBD there. But we are increasingly excited about the TC space, and it should be no surprise to anyone that if the class is to have the promise that everyone believes it does, which is to provide, perhaps not curative but very meaningful treatments to patients who have no options in cancer.

所以，還有待確定。但我們對 TC 領域越來越感到興奮，如果該領域真的像大家相信的那樣有希望，那麼任何人都不會感到驚訝，即為那些沒​​有選擇的癌症患者提供可能不是治癒性的但卻非常有意義的治療。

That isn't something that's going to come easily and it's going to take the combined efforts of many groups in the clinic as well as in the lab.

這不是一件容易的事情，需要診所和實驗室中許多團隊的共同努力。

And so that's that's something we're committed to and we think it's going to be a long game.

這就是我們所致力於的事情，我們認為這將是一場持久戰。

Okay great.

好的，太好了。

Thank you for taking the questions.

感謝您回答這些問題。

Thank you.

謝謝。

There are no questions waiting at this time, so I'll pass the conference back over to the management team for any further remarks.

目前沒有問題，因此我將把會議交還給管理團隊，以便他們可以發表進一步的評論。

No further remarks. Just thank you everyone for joining us today. We're excited about the progress and looking forward to the next call.

沒有其他註釋。非常感謝大家今天的參與。我們對進展感到非常興奮，並期待下一次通話。

Take care.

小心。

That concludes today's conference call.

今天的電話會議到此結束。

Thank you for your participation. You may now disconnect your line.

感謝您的參與。現在您可以斷開線路了。