Absci Corp (ABSI) 2025 Q3 法說會逐字稿

Thank you for standing by. My name is Rochelle, and I will be your operator today. At this time, I would like to welcome everyone to the Absci Q3 2025 business update. (Operator Instructions)

感謝您的耐心等待。我叫羅謝爾，今天由我來為您接聽電話。在此，我謹代表 Absci 向大家介紹 2025 年第三季業務更新。（操作說明）

Thank you. I will now turn the conference call over to Alex Khan, VP of Finance and Investor Relations. Please go ahead.

謝謝。現在我將把電話會議交給財務和投資者關係副總裁 Alex Khan。請繼續。

Thank you. Earlier today, Absci released financial and operating results for the quarter ended September 30, 2025. If you haven't received this news release or if you would like to be added to the company's distribution list, please send an e-mail to investors@absci.com. An archived webcast of this call will be available for replay on Absci's Investor Relations website at investors.absci.com for at least 90 days after this call. Joining me today are Sean McClain, Absci's Founder and CEO; and Zach Jonasson, Chief Financial Officer and Chief Business Officer.

謝謝。今天早些時候，Absci 發布了截至 2025 年 9 月 30 日的季度財務和營運業績。如果您尚未收到此新聞稿，或希望加入公司郵件列表，請發送電子郵件至 investors@absci.com。本次電話會議的網路直播錄影將在 Absci 的投資者關係網站 investors.absci.com 上保留至少 90 天，供您重播。今天和我一起的有 Absci 的創始人兼首席執行官 Sean McClain，以及首席財務官兼首席商務官 Zach Jonasson。

Andreas Busch, Absci's Chief Innovation Officer, will also join for Q&A following prepared remarks. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws.

Absci 首席創新長 Andreas Busch 也將發表準備好的講話，並參與問答環節。在開始之前，我想提醒各位，管理層將在本次電話會議中發表一些符合聯邦證券法規定的前瞻性聲明。

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated, and you should not place undue reliance on forward-looking statements.

這些聲明涉及重大風險和不確定性，可能導致實際結果或事件與預期結果或事件有重大差異，因此您不應過度依賴前瞻性聲明。

Additional information regarding these risks, uncertainties and factors that could cause results to differ appears in the section titled Forward-Looking Statements in the press release Absci issued today and the documents and reports filed by Absci from time to time with the Securities and Exchange Commission.

有關這些風險、不確定性和可能導致結果出現差異的因素的更多信息，請參閱 Absci 今天發布的新聞稿中題為“前瞻性聲明”的部分，以及 Absci 不時向美國證券交易委員會提交的文件和報告。

Except as required by law, Absci disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward-looking statements either because of new information, future events or otherwise.

除法律要求外，Absci 不承擔任何因新資訊、未來事件或其他原因而更新或修改任何財務或產品線預測或其他前瞻性聲明的意圖或義務。

This conference call contains time-sensitive information and is accurate only as of the live broadcast, November 12, 2025. With that, I'll turn the call over to Sean.

本次電話會議包含有時效性的訊息，僅在 2025 年 11 月 12 日直播時有效。接下來，我將把電話交給肖恩。

Thanks, Alex. Good afternoon, everyone. Thank you for joining us for our Q3 business update call. Today, we'll be sharing updates about our pipeline, including interim Phase 1 results for ABS-101, acceleration of ABS-201 development in angiogenetic alopecia or AGA, and expansion of ABS-201 development in a second indication, endometriosis. Interim results from first cohorts of our ongoing ABS-101 Phase 1 trial in healthy volunteers demonstrated extended half-life as compared to first-generation anti-TL1A competitor programs, but not versus next-generation programs.

謝謝你，亞歷克斯。大家下午好。感謝您參加我們的第三季業務更新電話會議。今天，我們將分享有關我們研發管線的最新進展，包括 ABS-101 的 1 期中期結果、加速 ABS-201 在血管生成性脫髮或雄激素性脫髮 (AGA) 方面的開發，以及擴大 ABS-201 在第二個適應症——子宮內膜異位症方面的開發。我們正在進行的 ABS-101 1 期試驗在健康志願者中進行了，第一批受試者的中期結果表明，與第一代抗 TL1A 競爭藥物相比，該藥物的半衰期延長，但與下一代藥物相比則沒有延長。

There was also no apparent impact of ADA on PK and overall safety profile was favorable with no serious adverse events reported to date. The Phase 1 trial is on track to complete in Q1 of 2026. Our progress developing ABS-201 for androgenetic alopecia is ahead of plan as we expect to initiate a Phase 1/2a trial in December of this year with an interim proof-of-concept readout anticipated in the second half of 2026.

ADA 對 PK 沒有明顯影響，整體安全性良好，迄今沒有報告嚴重不良事件。第一階段試驗預計將於 2026 年第一季完成。我們用於治療雄性禿的 ABS-201 的研發進展超前於計劃，預計將於今年 12 月啟動 1/2a 期試驗，並預計在 2026 年下半年獲得中期概念驗證結果。

Additionally, we are excited to announce that we are developing ABS-201 in endometriosis and expect to initiate a Phase 2 proof-of-concept clinical trial in the fourth quarter of 2026. Preclinical and clinical data support the prolactin receptor mechanism in endometriosis, where we believe ABS-201 has the potential to be a safe, effective therapy for the estimated 10% of women globally who suffer from this debilitating disease.

此外，我們很高興地宣布，我們正在開發用於治療子宮內膜異位症的 ABS-201，預計將於 2026 年第四季啟動 2 期概念驗證臨床試驗。臨床前和臨床數據支持催乳素受體機制在子宮內膜異位症中的作用，我們相信 ABS-201 有潛力成為一種安全有效的療法，用於治療全球約 10% 患有這種衰弱性疾病的女性。

Our development plans for endometriosis are synergistic with our already planned ABS-201 Phase 1/2a clinical trial in AGA, which is on track to initiate next month. Given the significantly greater opportunity for value creation, we have made the strategic decision to prioritize ABS-201 development in endometriosis. This is in addition to ABS-201's ongoing clinical development for angiogenetic alopecia.

我們針對子宮內膜異位症的研發計劃與我們已經計劃的 ABS-201 1/2a 期 AGA 臨床試驗具有協同效應，該試驗預計將於下個月啟動。鑑於創造價值的機會更大，我們已做出策略決策，優先開發 ABS-201 用於治療子宮內膜異位症。此外，ABS-201 也正在進行針對血管性脫髮的臨床開發。

Therefore, we will seek a partner for ABS-101 and no longer pursue additional internal clinical development for this asset following the completion of the Phase 1 clinical trial. The decision to reallocate our pipeline priorities reflects rigorous discipline we employ in allocating our capital and resources.

因此，在完成 1 期臨床試驗後，我們將為 ABS-101 尋找合作夥伴，不再對該資產進行額外的內部臨床開發。重新調整管道建設優先事項的決定反映了我們在分配資金和資源時所秉持的嚴格原則。

We believe our strategy to advance ABS-201 through human proof-of-concept in both AGA and endometriosis will maximize the value created using our current balance sheet. Both indications are characterized by significant unmet medical need and poor standard of care.

我們相信，透過在 AGA 和子宮內膜異位症中進行人體概念驗證來推進 ABS-201 的策略，將最大限度地利用我們目前的資產負債表創造價值。這兩種適應症的特徵是存在嚴重的未滿足醫療需求和低下的醫療水準。

There is biological and clinical rationale for the prolactin receptor mechanism in both indications. Our strategy leverages shared Phase 1 development, which enables faster, more efficient clinical trial development and both indications offer multibillion-dollar market opportunities.

催乳素受體機制在這兩種適應症中都有生物學和臨床上的合理性。我們的策略利用共享的 1 期開發，從而實現更快、更有效率的臨床試驗開發，而這兩種適應症都蘊藏著數十億美元的市場機會。

Looking ahead, we're excited to execute on the dual development of ABS-201, leveraging its best-in-class profile, targeting two proof-of-concept readouts in the next 24 months, a Phase 1/2a proof-of-concept interim data readout in AGA in the second half of 2026, and a Phase 2 proof-of-concept interim data readout for endometriosis in the second half of 2027.

展望未來，我們很高興能夠利用 ABS-201 的一流特性，推進其雙重開發，目標是在未來 24 個月內完成兩項概念驗證性結果的公佈，在 2026 年下半年公佈一項針對 AGA 的 1/2a 期概念驗證性中期數據，並在 2027 年下半年公佈一項針對 AGA 的 1/2a 期概念驗證性中期數據，並在 2027 年下半年公佈一項針對內膜異位症的 2 期異位症。

Taken together, this strategy represents our strongest value creation opportunity for patients and shareholders alike. Zach will speak in more detail on our strategy for endometriosis later in the call. Turning now to our clinical development plans for ABS-201 in angiogenetic alopecia.

綜合來看，這項策略代表了我們為病患和股東創造價值的最強機會。Zach 將在稍後的通話中更詳細地談論我們治療子宮內膜異位症的策略。現在讓我們來談談 ABS-201 在血管生成性脫髮方面的臨床開發計劃。

We have accelerated our clinical development timeline and expect to dose our first participant next month in our Phase 1/2a study. On December 11th, we'll host a KOL seminar to discuss anticipated clinical development path, market opportunity and differentiated profile of the ABS-201 program.

我們加快了臨床開發進度，預計下個月將在 1/2a 期研究中為首位受試者給藥。12月11日，我們將舉辦一場KOL研討會，討論ABS-201計畫的預期臨床開發路徑、市場機會和差異化優勢。

We also plan to disclose additional human ex vivo data that further supports the mechanism of action underlying this program. We designed ABS-201 to unlock a potential new category of therapy for AGA, which we believe could offer efficacious, durable, convenient hair regrowth.

我們也計劃公佈更多人體離體數據，以進一步支持該計畫的作用機制。我們設計 ABS-201 的目的是為了開啟治療 AGA 的潛在新療法，我們相信它可以提供有效、持久、方便的毛髮再生。

This condition, better known as male and female pattern hair loss, affects approximately 80 million adults in the US alone and has seen little therapeutic innovation in nearly 30 years. In preclinical studies, ABS-201 has shown high potency, low immunogenicity, extended half-life and improved manufacturability.

這種疾病，更廣為人知的名稱是男性和女性型脫髮，僅在美國就影響了大約 8000 萬成年人，而且近 30 年來幾乎沒有治療方面的創新。在臨床前研究中，ABS-201 顯示出高效性、低免疫原性、延長的半衰期和改進的生產性能。

We believe it offers an alternative to current treatments such as minoxidil and finasteride, which have variable or limited efficacy, low compliance and in some cases, serious side effects. Based on the body of evidence from in vitro and in vivo animal studies, we believe that a simple infrequent course of just two to three injections of ABS-201 could deliver durable multiyear hair regrowth.

我們認為它為目前的治療方法（如米諾地爾和非那雄胺）提供了一種替代方案，這些治療方法療效不一或有限，依從性低，並且在某些情況下還會產生嚴重的副作用。根據體外和體內動物研究的證據，我們認為，只需簡單、不頻繁地註射兩到三次 ABS-201，即可實現持久多年的頭髮再生。

Today's standard of care treatments have limited efficacy and require frequent once or twice daily administration, leading to poor compliance. Our KOL network of leading dermatologists have indicated compliance for topical as well as oral minoxidil can be poor in practice, either because of side effects or inconvenience of lifelong daily administration. A recent study showed that over 86% of AGA patients who try topical minoxidil discontinued treatment.

目前的標準治療方案療效有限，需要每天服用一到兩次，導致患者依從性差。我們由頂尖皮膚科醫師組成的KOL網路表示，局部用藥和口服米諾地爾的依從性在實務上可能較差，原因可能是副作用或終身每日用藥的不便。最近的一項研究表明，超過 86% 的 AGA 患者在使用局部米諾地爾後停止了治療。

Our own market research underscores that consumers valuable durable efficacy and prefer a treatment that works with infrequent administration. For these reasons, we believe ABS-201 has the potential to be a dominant new category of therapy, offering convenient durable hair regrowth.

我們自己的市場調查也強調，消費者重視持久的療效，並且更喜歡無需頻繁用藥即可見效的治療方法。基於這些原因，我們相信 ABS-201 有潛力成為一種新的指導療法類別，提供方便且持久的頭髮再生。

Given this differentiated profile, the straightforward clinical development path and the massive multibillion-dollar market opportunity, we plan to develop ABS-201 through later-stage clinical development and potentially commercialization. As we advance development of ABS-201 for AGA, we're thrilled to welcome doctors, Rod Sinclair and David Goldberg, to our KOL Advisory Board. Dr.

鑑於其獨特的特性、直接的臨床開發路徑以及數十億美元的龐大市場機遇，我們計劃透過後期臨床開發和潛在的商業化來開發 ABS-201。隨著我們推進 ABS-201 用於治療 AGA 的研發，我們非常高興地歡迎 Rod Sinclair 醫生和 David Goldberg 醫生加入我們的 KOL 顧問委員會。博士

Sinclair is a Professor of Dermatology at the University of Melbourne and the Director of Sinclair Dermatology. He is a world-renowned expert in hair loss with over three decades dedicated to research, clinical practice and patient advocacy. He has more than 1,000 publications, including contributions to major dermatology textbooks.

辛克萊是墨爾本大學皮膚病學教授，也是辛克萊皮膚病診所的主任。他是世界知名的脫髮專家，三十多年來一直致力於研究、臨床實踐和患者權益倡導。他發表過 1000 多篇論文，其中包括對主要皮膚病學教科書的貢獻。

Dr. Goldberg brings nearly 40 years of clinical dermatology experience. He is a clinical professor of Dermatology at the Icahn School of Medicine at Mount Sinai and has led pivotal research studies in dermatology and hair loss, including the original minoxidil trials.

戈德堡博士擁有近40年的臨床皮膚病學經驗。他是西奈山伊坎醫學院的皮膚病學臨床教授，曾領導皮膚病學和脫髮領域的關鍵研究，包括最初的米諾地爾試驗。

Dr. Goldberg has published more than 200 academic papers, contributed to over 15 textbooks on hair restoration and dermatology and served on the boards of the American Academy of Dermatology and American Society of Dermatologic Surgery.

戈德堡博士發表了 200 多篇學術論文，參與撰寫了 15 多本關於毛髮修復和皮膚病學的教科書，並在美國皮膚病學會和美國皮膚外科協會的理事會任職。

We invite you to join our virtual seminar on December 11, where Dr. Sinclair, Dr. Goldberg and other top KOLs will discuss the ABS-201 program. We are also progressing several additional programs that we aim to partner prior to clinical development. ABS-301, this is a potential first-in-class antibody targeting an undisclosed immuno-oncology target identified through our reverse immunology platform.

我們誠摯邀請您參加 12 月 11 日的線上研討會，屆時辛克萊博士、戈德堡博士和其他頂級 KOL 將討論 ABS-201 計畫。我們也正在推進幾個其他項目，目標是在臨床開發之前找到合作夥伴。ABS-301 是一種潛在的首創抗體，針對透過我們的反向免疫學平台發現的未公開的免疫腫瘤學標靶。

Early data suggests potential in squamous cell carcinoma and other indications. ABS-501, this is a potential best-in-class anti-HER2 antibody identified using our zero-shot de novo AI models. These AI design leads displayed novel epitope interactions, increased or equivalent potency to trastuzumab in preclinical disease models, efficacy against a trastuzumab-resistant xenograft tumor in a in vivo model and good developability. Beyond these, we have innovative early-stage programs in our pipeline that we plan to reveal at a later date.

早期數據顯示，該藥物在治療鱗狀細胞癌和其他適應症方面具有潛在療效。ABS-501 是一種潛在的同類最佳抗 HER2 抗體，它是利用我們的零樣本從頭 AI 模型發現的。這些 AI 設計先導化合物展現出新的抗原決定位交互作用，在臨床前疾病模型中表現出比曲妥珠單抗更強或相當的效力，在體內模型中對曲妥珠單抗抗藥性的異種移植腫瘤有效，並且具有良好的開發潛力。除此之外，我們還有一些處於早期階段的創新項目正在籌備中，我們計劃在稍後公佈。

With that, I'll now turn the call over to Zach to walk through our strategy, partnerships and outlook and to provide an update on our financials.

接下來，我將把電話交給 Zach，讓他介紹我們的策略、合作夥伴關係和前景，並報告我們的財務狀況。

Thanks, Sean. As Sean mentioned, we continue to sharpen our strategic focus and in so doing have made decisions recently about which internal programs to advance versus partner. Our decisions continue to be based on careful assessment of the potential risks and return for each program given our available resources.

謝謝你，肖恩。正如肖恩所提到的，我們不斷加強策略重點，並因此最近決定要推進哪些內部項目，以及與合作夥伴進行哪些合作。我們始終堅持根據現有資源，對每個專案的潛在風險和回報進行仔細評估，並以此作為決策依據。

Broadly, I am happy to report that we continue to execute on our strategic objectives, including advancing ABS-101 through an interim phase I readout, expediting the initiation of our ABS-201 Phase 1/2a trial for androgenetic alopecia by approximately one quarter, expanding ABS-201 development into endometriosis, and progressing our portfolio of discovery partnership programs.

總的來說，我很高興地報告，我們繼續執行我們的策略目標，包括推進 ABS-101 完成 I 期中期讀數，加快啟動治療雄激素性脫髮的 ABS-201 1/2a 期試驗（大約提前四分之一），將 ABS-201 的開發擴展到子宮內膜異位症領域，並推進我們的發現合作項目組合。

We also continue to expand our AI platform capabilities, which, in addition to enabling our own preclinical R&D programs focused on challenging targets, has helped generate partnership interest in our platform. Accordingly, we continue to anticipate signing one or more drug creation partnerships, including with a large pharma company, by year-end.

我們也不斷擴展我們的人工智慧平台功能，這不僅支持我們自身針對具有挑戰性目標的臨床前研發項目，還有助於吸引合作夥伴對我們的平台產生興趣。因此，我們仍預計在年底前簽署一項或多項藥物研發合作協議，其中包括與一家大型製藥公司的合作。

As Sean discussed earlier, we will be focused on partnering ABS-101 and do not currently plan to develop the program ourselves into phase two. We remain engaged with multiple potential large and mid-cap pharmaceutical companies regarding a potential partnership transaction, some of which are focused on first-in-class indications outside of IBD.

正如肖恩之前討論的那樣，我們將專注於與 ABS-101 合作，目前沒有計劃自行開發該專案進入第二階段。我們仍在與多家潛在的大型和中型製藥公司就潛在的合作交易進行接觸，其中一些公司專注於 IBD 以外的首創適應症。

As discussed, we have decided to prioritize the clinical development of ABS-201 for two potential multi-billion dollar indications: androgenetic alopecia and endometriosis, each characterized by high unmet need and poor standard of care.

如同先前討論過的，我們決定優先開發 ABS-201 的臨床應用，用於治療兩種潛在的數十億美元適應症：雄激素性脫髮和子宮內膜異位症，這兩種疾病都存在未被滿足的巨大需求和較差的治療標準。

We see strong scientific and business rationale for developing ABS-201 in both of these indications. Moreover, our planned Phase 1/2a clinical trial in AGA will provide safety, tolerability, and PK assessments that will support Phase 2 clinical development in endometriosis.

我們認為，在這兩種適應症中開發 ABS-201 具有很強的科學和商業合理性。此外，我們計劃在 AGA 中進行 1/2a 期臨床試驗，以提供安全性、耐受性和藥物動力學評估，從而支持子宮內膜異位症的 2 期臨床開發。

The Phase 1/2a proof of concept trial in AGA will be a randomized, double-blind, placebo-controlled study. The primary endpoints will be safety and tolerability. Secondary endpoints will include PK, PD, immunogenicity, target area hair count, target area width, target area darkening and pigmentation of hair, as well as patient-reported outcome measures.

AGA 的 1/2a 期概念驗證試驗將是一項隨機、雙盲、安慰劑對照研究。主要終點指標為安全性和耐受性。次要終點包括藥物動力學、藥效學、免疫原性、標靶區毛髮數量、標靶區寬度、標靶區毛髮顏色加深和色素沉著，以及患者報告的結果指標。

The trial will enroll up to 227 healthy volunteers with or without AGA. The single ascending dose or SAD portion of the trial will test approximately four to six IV dose groups for safety, tolerability, PK, and PD. The SAD portion of the trial will be followed by approximately three to four subcutaneous multiple ascending dose groups in healthy volunteers with androgenetic alopecia.

該試驗將招募至多 227 名患有或未患有雄性禿的健康志願者。此試驗的單次遞增劑量或 SAD 部分將測試約四到六個 IV 劑量組的安全性、耐受性、PK 和 PD。在試驗的 SAD 部分之後，將對患有雄性禿的健康志願者進行大約三到四個皮下多劑量遞增組試驗。

The MAD portion of this clinical trial is powered to demonstrate human proof of concept for the use of ABS-201 to treat androgenetic alopecia by stimulating significant hair regrowth. We believe that this trial, if successful, will position the program for accelerated registrational trials.

此臨床試驗的 MAD 部分旨在證明 ABS-201 透過刺激顯著的毛髮再生來治療雄性禿的人體概念驗證。我們相信，如果這項試驗成功，將為該計畫加速註冊試驗奠定基礎。

Ahead of initiating the Phase 1/2a trial, we are excited to share that we have generated additional ex vivo human data supporting the durable, condition-modifying hair regrowth mechanism of ABS-201. Preliminary data from experiments using human scalp biopsies shows the ability of ABS-201 to transition hair follicles into the anagen growth phase and to counteract suppressive catechin effects of prolactin.

在啟動 1/2a 期試驗之前，我們很高興地宣布，我們已經產生了額外的體外人體數據，支持 ABS-201 的持久、改善毛髮生長狀況的機制。使用人類頭皮活檢進行的實驗的初步數據顯示，ABS-201 能夠使毛囊進入生長期，並抵消催乳素的兒茶素抑製作用。

This study also shows ABS-201's ability to promote the proliferation of hair follicle stem cells, as indicated by upregulation of corresponding markers, as well as reduce hair follicle stem cell apoptosis. We look forward to sharing more about this study and its results at our upcoming KOL seminar on December 11.

研究還表明，ABS-201 能夠促進毛囊幹細胞的增殖，如相應標記物的上調所示，並能減少毛囊幹細胞的凋亡。我們期待在12月11日即將舉行的KOL研討會上分享更多關於這項研究及其結果的資訊。

As Sean mentioned earlier, in addition to treating androgenetic alopecia, we believe ABS-201 will be effective in treating endometriosis, a second multi-billion dollar market opportunity characterized by high unmet patient need and poor standard of care.

正如肖恩之前提到的，除了治療雄性禿外，我們相信 ABS-201 也將有效治療子宮內膜異位症，這是另一個價值數十億美元的市場機會，其特點是患者需求未得到滿足，且護理標準較差。

Endometriosis is an inflammatory disease defined by endometrial-like lesions found outside the uterine lining. Symptoms include pelvic pain, heavy bleeding, infertility, and ovarian cysts. It is a chronic, painful condition that significantly impacts the quality of life of these patients.

子宮內膜異位症是一種發炎性疾病，其特徵是子宮內膜樣病變出現在子宮內膜以外。症狀包括骨盆腔疼痛、大量出血、不孕症和卵巢囊腫。這是一種慢性、痛苦的疾病，嚴重影響患者的生活品質。

Moreover, there is currently no therapeutic or surgical cure for this disease, which is prevalent in an estimated 10% of women worldwide, including an estimated 9 million women in the US alone. During our R&D day last year, we discussed how members of our R&D team initially discovered the prolactin receptor inhibition mechanism for hair regrowth during animal studies investigating prolactin inhibition as a treatment for endometriosis.

此外，目前尚無針對此疾病的治療方法或手術治癒手段，據估計，全球約有 10% 的女性患有此病，光在美國就有約 900 萬名女性患有此病。在去年的研發日上，我們討論了研發團隊成員最初是如何在動物研究中發現催乳素受體抑制機制，從而促進毛髮再生的。當時，他們正在研究催乳素抑製作為治療子宮內膜異位症的方法。

Based on additional preclinical research, including our own in vivo animal studies, as well as recent human clinical proof of concept data reported for the HMI-115 program, we believe ABS-201 has significant potential to become a best-in-class, efficacious, and safe therapeutic treatment for endometriosis.

基於額外的臨床前研究，包括我們自己的體內動物研究，以及最近報告的 HMI-115 項目人體臨床概念驗證數據，我們相信 ABS-201 具有成為一流、有效且安全的子宮內膜異位症治療方法的巨大潛力。

ABS-201 was designed using our AI platform to antagonize the prolactin receptor and thereby block prolactin signaling. Scientific data support the dual role of prolactin signaling in endometrial lesion formation, as well as associated pain.

ABS-201 是利用我們的人工智慧平台設計的，旨在拮抗催乳素受體，從而阻斷催乳素訊號傳導。科學數據支持催乳素訊號在子宮內膜病灶形成以及相關疼痛中的雙重作用。

Prolactin and prolactin receptors are overexpressed in the endometrium of patients with endometriosis. Furthermore, while prolactin supports endometrium formation and desiderialization, dysregulated expression of prolactin and its receptor have been found in ectopic endometrial lesions.

子宮內膜異位症患者的子宮內膜中催乳素和催乳素受體過度表現。此外，雖然催乳素支持子宮內膜的形成和去內皮化，但在異位子宮內膜病變中發現了催乳素及其受體的表達失調。

Prolactin receptors are also present in sensory neurons and can sensitize these neurons, potentially leading to increased pain perception. The prolactin pathway is distinct from sex hormone signaling, further differentiating it from current therapeutic mechanisms of action for treating endometriosis.

催乳素受體也存在於感覺神經元中，並能使這些神經元敏感化，可能導致疼痛感知增強。催乳素路徑與性荷爾蒙訊號傳導不同，這進一步使其與目前治療子宮內膜異位症的治療機制有所區別。

Preclinical data have shown that prolactin receptor antagonism suppresses postoperative pain in female mice and inhibits endometriosis interna formation. A recent preclinical study in a homologous mouse model of endometriosis shows that ABS-201 treatment improves pain-related outcomes, similarly to GnRH modulation.

臨床前數據表明，催乳素受體拮抗劑可抑制雌性小鼠術後疼痛並抑制子宮內膜異位症的形成。最近一項在子宮內膜異位症同源小鼠模型中進行的臨床前研究表明，ABS-201 治療可以改善疼痛相關結果，類似於 GnRH 調節。

Mice treated with ABS-201 demonstrated greater locomotor activity and distance traveled as compared to placebo-treated mice, indicating reduced pain-like behavior. ABS-201 also significantly lowered inflammatory cytokines in the peritoneal fluid, which have been shown to be elevated in endometriosis patients. These results support our development of ABS-201 as a potential therapy for endometriosis-associated pain.

與接受安慰劑治療的小鼠相比，接受 ABS-201 治療的小鼠表現出更高的運動活性和更長的運動距離，顯示疼痛樣行為減少。ABS-201 也顯著降低了腹膜液中的發炎細胞因子，而子宮內膜異位症患者的腹膜液中發炎細胞因子水平升高。這些結果支持我們開發 ABS-201 作為治療子宮內膜異位症相關疼痛的潛在療法。

Additionally, recent positive top-line results from a phase two trial of HMI-115, a competitor anti-prolactin receptor antibody in endometriosis, provided human proof of concept and derisking of the mechanism of action.

此外，HMI-115（一種治療子宮內膜異位症的競爭性抗催乳素受體抗體）的二期試驗近期取得了積極的初步結果，為人體概念驗證和作用機制的風險降低提供了依據。

We believe that ABS-201's profile exhibits best-in-class potential when compared to the HMI-115 antibody. For example, ABS-201 exhibits superior PK and bioavailability in NHP studies, which we expect to translate to better efficacy in humans via sustained target engagement in relevant endometrial tissue.

我們認為，與 HMI-115 抗體相比，ABS-201 的特性展現出同類最佳的潛力。例如，ABS-201 在 NHP 研究中表現出優異的藥物動力學和生物利用度，我們期望透過持續靶向相關子宮內膜組織，將其轉化為更好的人體療效。

ABS-201 also has 3 to 4 times longer half-life in NHPs, as well as a higher concentration formulation, both of which should enable more convenient dosing for patients. We plan to initiate Phase 2 clinical development of ABS-201 in endometriosis in Q4 of 2026, using the safety and tolerability data generated from the SAD portion of our Phase 1/2a androgenetic alopecia study.

ABS-201 在 NHP 中的半衰期也延長了 3 到 4 倍，並且具有更高的濃度配方，這兩點都應該能夠為患者提供更方便的給藥方式。我們計劃於 2026 年第四季度啟動 ABS-201 在子宮內膜異位症領域的 2 期臨床開發，利用我們 1/2a 期雄激素性脫髮研究的 SAD 部分產生的安全性和耐受性數據。

Based on this timeline, we expect to share an interim readout from the Phase 2 trial in endometriosis in the second half of 2027. With respect to ABS-301 and ABS-501, our immunooncology and oncology programs, respectively, we continue to believe that these programs are better suited for development by a large pharmaceutical or biotech company.

根據這項時間表，我們預計將於 2027 年下半年公佈子宮內膜異位症 2 期試驗的中期結果。對於我們的免疫腫瘤學計畫 ABS-301 和腫瘤學計畫 ABS-501，我們仍然認為這些計畫更適合由大型製藥公司或生物技術公司進行開發。

Accordingly, we intend to seek partners for these programs prior to clinical development. We continue to utilize our growing AI platform capabilities to create an early-stage pipeline focused on indications characterized by high unmet medical need.

因此，我們打算在臨床開發之前為這些項目尋找合作夥伴。我們將繼續利用我們不斷增強的人工智慧平台能力，打造專注於具有高度未滿足醫療需求的適應症的早期研發管線。

Our unique ability to address difficult-to-drug target classes has enabled us to pursue new opportunities for creating novel and differentiated therapeutic programs in our internal pipeline, as well as in our drug creation partnerships.

我們獨特的針對難以成藥標靶類別的能力，使我們能夠在內部研發管線以及藥物研發合作關係中，尋求創造新穎和差異化治療項目的新機會。

Turning now to our financials. Revenue in the third quarter was $400,000 as we continue to progress our partnered programs. Research and development expenses were $19.2 million for the three months ended September 30, 2025, as compared to $18 million for the prior year period.

現在來看財務數據。第三季營收為 40 萬美元，我們持續推進合作專案。截至 2025 年 9 月 30 日止三個月，研發費用為 1,920 萬美元，去年同期為 1,800 萬美元。

This increase was primarily driven by advancement of outside internal programs, including direct costs associated with external preclinical and clinical development. Selling, general, and administrative expenses were $8.4 million for the three months ended September 30, 2025, as compared to $9.3 million for the prior year period.

這一成長主要由外部內部專案的推進所驅動，包括與外部臨床前和臨床開發相關的直接成本。截至 2025 年 9 月 30 日止三個月的銷售、一般及行政費用為 840 萬美元，而去年同期為 930 萬美元。

This decrease was primarily due to a decrease in personnel-related expenses. Cash, cash equivalents, and marketable securities as of September 30, 2025, were $152.5 million as compared to $117.5 million as of June 30, 2025.

這一下降主要是由於人員相關費用的減少。截至 2025 年 9 月 30 日，現金、現金等價物及有價證券為 1.525 億美元，截至 2025 年 6 月 30 日為 1.175 億美元。

We believe our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the first half of 2028. We see additional upside to this forecast based on potential non-dilutive cash inflows that could come from new platform collaborations with large pharma and/or an asset transaction associated with any of our wholly-owned programs such as ABS-101.

我們相信，我們現有的現金、現金等價物和短期投資足以支持我們的營運到 2028 年上半年。我們認為，基於與大型製藥公司開展新的平台合作和/或與我們任何全資擁有的項目（如 ABS-101）相關的資產交易可能帶來的非稀釋性現金流入，這一預測還有進一步上漲的空間。

As a reminder, we still anticipate signing one or more drug creation partnerships, including with a large pharma company, before the end of this year. With our current balance sheet, we believe we are well-positioned to execute on our strategy, including delivering potential proof of concept readouts for ABS-201 in both AGA and endometriosis.

再次提醒大家，我們仍預計在今年年底前簽署一項或多項藥物研發合作協議，其中包括與一家大型製藥公司的合作。憑藉我們目前的資產負債表，我們相信我們有能力執行我們的策略，包括為 ABS-201 在 AGA 和子宮內膜異位症方面提供潛在的概念驗證讀數。

We are also resourced to progress our early-stage pipeline and to advance new partnership discussions related to our AI drug creation platform, wholly-owned asset programs, or both.

我們也有足夠的資源來推進我們的早期研發管線，並推動與我們的人工智慧藥物研發平台、全資資產項目或兩者相關的新的合作洽談。

With that, I'll now turn it back to Sean.

接下來，我將把麥克風交還給肖恩。

Thanks, Zach. I want to thank our Absci team for their relentless drive, tenacity and belief in our mission to achieve the impossible. This is a pivotal moment for Absci. As you heard today, ABS-201 is moving into the clinic with real momentum. And we're expanding its potential beyond hair regrowth into endometriosis, a major disease area where innovation is long overdue.

謝謝你，扎克。我要感謝我們的 Absci 團隊，感謝他們不懈的努力、堅韌不拔的精神以及對我們使命的堅定信念，使我們實現了不可能的目標。這對Absci來說是一個關鍵時刻。正如你今天聽到的，ABS-201 正在以強勁的勢頭進入臨床試驗階段。我們正在將其潛力從頭髮再生擴展到子宮內膜異位症，這是一個亟需創新的重大疾病領域。

Together, these efforts underscore the potential of the prolactin receptor mechanism and demonstrate our commitment to translating generative AI protein design into clinical realities. We've made deliberate choices to focus our resources where we see the greatest opportunity for transformational impact and value creation.

這些努力共同凸顯了催乳素受體機制的潛力，並表明了我們致力於將人工智慧蛋白質設計轉化為臨床現實的決心。我們經過深思熟慮，選擇將資源集中在最有可能產生變革性影響和創造價值的地方。

By refining our focus on ABS-201, we're leaning into the data, the science and the market opportunity where Absci can lead. Looking ahead, the momentum is unmistakable. The ABS-201 Phase 1/2a trial in AGA begins in just a few weeks, putting us on track for interim efficacy and proof-of-concept data in the second half of next year.

透過更專注於 ABS-201，我們正深入研究數據、科學和市場機遇，Absci 將在這些領域發揮領導作用。展望未來，發展動能十分強勁。ABS-201 治療 AGA 的 1/2a 期試驗將在幾週後開始，這將使我們預計在明年下半年獲得中期療效和概念驗證數據。

We are expanding ABS-201 into endometriosis with a Phase II trial anticipated to initiate Q4 2026. We anticipate to close at least one new large pharma partnership this year. And I invite you to join our ABS-201 KOL event on December 11. Details are on our IR website. Absci is executing with precision and agility, translating AI designed biologics into real clinical impact.

我們正在將 ABS-201 應用於子宮內膜異位症領域，預計 2026 年第四季啟動 II 期試驗。我們預計今年至少會達成一項新的大型製藥公司合作協議。我誠摯邀請您參加我們於 12 月 11 日舉辦的 ABS-201 KOL 活動。詳情請見我們的投資者關係網站。Absci 以精準和敏捷的方式執行，將人工智慧設計的生物製劑轉化為真正的臨床影響。

What truly excites me is the potential ahead. We are energized by what's next and confident in our path to deliver meaningful value for patients, partners and shareholders alike. Thank you for your continued support.

真正讓我興奮的是未來的潛力。我們對未來充滿熱情，並有信心為患者、合作夥伴和股東創造有意義的價值。感謝您一直以來的支持。

Operator, let's open the call for questions.

接線員，現在開始接受提問。

(Operator Instructions)

（操作說明）

Vamil Divan, Guggenheim Securities.

瓦米爾·迪萬，古根漢證券公司。

Hi, great. Thanks for taking my question. So I just have two, if I could. One, I understand what you're saying around the TL1A program and looking to partner that. I'm wondering if you just -- if there's any more details you can share just in terms of what you saw in terms of the half-life or anything else in the trial?

嗨，太好了。謝謝您回答我的問題。所以如果可以的話，我只想要兩個。第一，我理解您所說的關於 TL1A 專案以及尋求合作的意思。我想知道您是否可以分享更多關於試驗中觀察到的半衰期或其他方面的細節？

And then second on just the endometriosis side, it's interesting news there. So looking forward to hearing and learning more about that. But I'm just curious right now if you can maybe just give some sense of the competitive landscape as you're thinking about sort of designing a Phase 2 trial in that indication or how that would look and how -- just generally how you design it and what's the right comparison to think about?

其次，就子宮內膜異位症而言，這方面也有一些有趣的消息。非常期待能聽到和了解更多相關資訊。但我現在只是好奇，您能否就您考慮如何設計該適應症的 2 期試驗，以及試驗的總體設計思路和合適的比較對象，談談當前的競爭格局？

Yeah, absolutely. Thanks, Vamil. Yes. So we took a really hard look at ABS-101. We were, in general, really happy with the safety profile that we saw.

是的，絕對的。謝謝你，瓦米爾。是的。所以我們認真研究了 ABS-101。總的來說，我們對所看到的安全性表現非常滿意。

We were able to have a half-life that was extended past what we saw with first-gen competitors. But we fell short of second gen. And we were exploring some, I think, really exciting first-in-class indications we could have gone into.

我們實現了比第一代競爭對手更長的半衰期。但我們距離第二代產品還很遠。我們當時正在探索一些我認為非常令人興奮的、同類首創的指標，我們本來可以深入研究這些指標的。

And we compared that to taking ABS-201 into endometriosis. And just given the competitive landscape we were seeing in IBD, we saw it made a ton of sense to take the capital we'd be investing into ABS-101 Phase 2a study and reinvest that into ABS-201 in endometriosis.

我們將此與服用 ABS-201 治療子宮內膜異位症進行了比較。鑑於我們在 IBD 領域看到的競爭格局，我們認為將原本要投資 ABS-101 2a 期研究的資金再投資於子宮內膜異位症的 ABS-201 是非常有意義的。

And we did this for a few reasons. One, there's a big unmet medical need here. The standard of care is really poor. There's not a lot of competition in this space. And additionally, the mechanism, the prolactin receptor is -- has been ultimately derisked with the HMI-115 data that came out showing proof-of-concept for this particular mechanism.

我們這樣做有幾個原因。第一，這裡存在著龐大的未滿足醫療需求。醫療水平非常差。這個領域的競爭並不激烈。此外，催乳素受體這一機制最終因 HMI-115 數據的公佈而降低了風險，該數據證明了這一特定機制的概念。

So we see this as a derisked mechanism. And again, standard of care is pretty poor here. And we really believe that we have the opportunity to potentially deliver a disease-modifying treatment there. And with that, I'll hand it over to Zach to talk a little bit more about the Phase 2 trial design for endometriosis.

所以我們認為這是一種降低風險的機制。再次強調，這裡的醫療水準相當差。我們堅信，我們有機會在那裡提供一種能夠改變疾病進程的治療方法。接下來，我會把麥克風交給 Zach，讓他再詳細談談子宮內膜異位症的 2 期試驗設計。

Yes. Thanks, Sean. And just to echo a couple of points Sean made. We don't -- we see the endometriosis indication much less competitive than you see in Crohn's. And that certainly was a factor in our decision here.

是的。謝謝你，肖恩。我只想重申一下肖恩提出的幾點觀點。我們認為子宮內膜異位症的適應症競爭遠不如克隆氏症激烈。這無疑是我們做出這項決定的因素。

Moreover, the cost of these trials is a fraction of what a full Phase 2 proof-of-concept study in the IBD space would be. So we think there's a significant ROI on resourcing this strategy for development in endometriosis. We will talk more about the specific trial design. But I think what we're really excited about here with the ABS-201 mechanism is that there's a potential not just to address pain, but also to be disease-modifying. And so we're currently engaged with our KOLs and have a draft study design that we'll share more about in the new year.

此外，這些試驗的成本僅為 IBD 領域完整的 2 期概念驗證研究成本的一小部分。因此，我們認為投入資源發展這種策略在子宮內膜異位症方面具有顯著的投資報酬率。我們將進一步討論具體的試驗設計。但我認為，ABS-201 機制真正讓我們感到興奮的地方在於，它不僅有可能解決疼痛問題，還可能改變疾病進程。因此，我們目前正在與關鍵意見領袖 (KOL) 進行溝通，並制定了一份研究設計草案，我們將在新的一年分享更多相關資訊。

Brendan Smith, TD Cowen.

布倫丹史密斯，TD Cowen。

Hi, guys. Thanks for taking the question. Appreciate it. So maybe just a quick one first on actually just the profile for 101. And apologies if I missed it here. But can you confirm if any of the potential partners you had been in touch with prior to now have already seen the data or if that's kind of the plan over the next few weeks? I'm just wondering on initial feedback there. And then maybe quickly on 201.

嗨，大家好。感謝您回答這個問題。謝謝。所以，或許可以先簡單介紹101的個人資料。如果我遺漏了什麼，請見諒。但您能否確認一下，您之前聯繫過的潛在合作夥伴中，是否有人已經看過這些數據，或者這是否是未來幾週的計劃？我只是想了解初步回饋。然後可能很快就能上 201 號公路了。

I know you've talked a bit about kind of endometriosis versus alopecia. But just wondering if there's ever -- if there's any -- maybe even at a high level, thoughts on market segmentation, just given 201's mechanism and any considerations on how you're thinking about enrollment for that? Thanks.

我知道你之前談過子宮內膜異位症和掉髮的差別。但我只是想知道，對於市場細分，您是否有過任何想法——如果有的話——即使只是從宏觀層面來說，考慮到 201 的機制，以及您在考慮如何進行招生方面有哪些考慮？謝謝。

Yeah. Great. Thanks. So, to address the first question, since this data has just recently come in, we have not had the opportunity to share this data with our partners yet. We plan to share that with them in the coming weeks.

是的。偉大的。謝謝。所以，為了回答第一個問題，由於這些數據是最近才獲得的，我們還沒有機會與我們的合作夥伴分享這些數據。我們計劃在未來幾週內與他們分享這些資訊。

And then additionally, as I mentioned previously, we have been exploring other first-in-class indications that we believe there's strong biological rationale for this and it actually expands the buyer universe for ABS-101. And we have been exploring that prior to this call and those discussions have been going quite well. And I'll hand it over to Zach to answer the second question.

此外，正如我之前提到的，我們一直在探索其他同類首創的跡象，我們認為這有很強的生物學依據，而且實際上擴大了 ABS-101 的客戶群。在這通電話之前，我們已經探討過這個問題，而且討論進展得相當順利。接下來，我將把問題交給札克來回答。

Yes. Thanks, Brendan. We're -- As I mentioned, we'll release more details about the trial design for endometriosis. But I will comment that we will be looking to enroll patients that are confirmed to have endometriosis and that we'll be looking to enroll patients that have a significant amount of pain. And I think that was one of the challenges in the study with HMI-115.

是的。謝謝你，布倫丹。正如我之前提到的，我們將公佈更多關於子宮內膜異位症試驗設計的細節。但我要說明的是，我們將招募確診患有子宮內膜異位症的患者，並且我們將招募有明顯疼痛症狀的患者。我認為這是 HMI-115 研究中面臨的挑戰之一。

I think they had some enrollment issues around exclusion criteria, that we will be careful to address in our trial. And I think we've got some leading KOLs advising us here. So we feel very confident and excited about moving that program forward.

我認為他們在入組方面存在一些排除標準方面的問題，我們將在試驗中謹慎解決這些問題。我認為我們這裡有一些業內頂尖的意見領袖在給我們建議。因此，我們對推進該專案感到非常有信心和興奮。

There's a very large unmet medical need there and I think a very large opportunity based on what we saw from the HMI trial, that was a nice proof-of-concept on the mechanism. As you know, the trial there in the high dose saw a statistically significant reduction in pain in dysmenorrhea.

那裡存在著巨大的未滿足的醫療需求，而且我認為，根據我們從 HMI 試驗中看到的情況來看，這是一個非常大的機會，該試驗很好地驗證了這一機制的概念。如您所知，那裡的高劑量試驗顯示，經痛在統計學上顯著減輕。

And so, I think that's a nice readout for us derisking the mechanism and the mechanism also looks safe in that trial setting. So, we feel very confident about bringing ABS-201 into development for that indication.

因此，我認為這是一個很好的結果，表明我們可以降低該機制的風險，而且該機制在試驗環境中看起來也很安全。因此，我們對將 ABS-201 應用於該適應症的開發非常有信心。

Yes. And I'd also like to just loop in Andreas Busch, our Chief Innovation Officer, into this question. He had experience at Bayer actually developing an antibody, which is now HMI-115 for endometriosis. And so Andreas, do you have anything else to add here?

是的。我也想請我們的首席創新官安德烈亞斯·布施也參與這個問題。他在拜耳公司有過開發抗體的經驗，該抗體現在是用於治療子宮內膜異位症的 HMI-115。那麼，安德烈亞斯，你還有什麼要補充的嗎？

Yes, sure. Thanks, Sean. I think it may be irrelevant to point out here that the drug innovation around prolactin receptor antibodies started around endometriosis and not hair loss. And the hair loss observation was actually that it is finding at the time.

當然可以。謝謝你，肖恩。我認為在這裡指出催乳素受體抗體藥物創新始於子宮內膜異位症而不是脫髮可能無關緊要。而脫髮的觀察結果實際上是當時發現的。

Again, it's very clear, very well validated that prolactin has dual mechanism in endometriosis, both in promoting and generating the lesions as well as in sensory neurons where it clearly affects the pain and the pain sensation.

再次強調，催乳素在子宮內膜異位症中具有雙重機制，這一點已得到充分證實，它既能促進和產生病灶，又能影響感覺神經元，從而明顯影響疼痛和疼痛感。

And in preclinical experiments, it was nicely shown that prolactin antibodies in our experiments now at Absci as well as previously in Bayer's hands that it can indeed affect both pain as well as reducing the lesions, as Zach has indicated before.

在臨床前實驗中，我們已經很好地證明，催乳素抗體（無論是在我們目前在 Absci 進行的實驗中，還是之前在拜耳進行的實驗中）確實可以影響疼痛并減少病變，正如 Zach 之前指出的那樣。

I also want to point out that there is a significant unmet medical need based on the fact that there are not any non-hormonal treatments around in endometriosis. There is, of course, the approved GnRH antagonist treatment, which has the typical side effects of estrogen reduction. And there is a significant need of nonhormonal safe approaches in endometriosis.

我還想指出，由於目前還沒有針對子宮內膜異位症的非荷爾蒙治療方法，因此存在著巨大的未滿足醫療需求。當然，還有已核准的 GnRH 拮抗劑治療，其典型副作用是雌激素水平降低。子宮內膜異位症領域迫切需要安全有效的非荷爾蒙治療方法。

And this is what all data of prolactin receptor antibodies so far have shown by safety, both in preclinical experiments as well as in human genetics, where women with complete knockout of prolactin receptors have been shown to be perfectly healthy and even being very easily able to bear children.

到目前為止，所有關於催乳素受體抗體的數據都表明，無論是在臨床前實驗還是在人類遺傳學中，催乳素受體完全被敲除的女性都非常健康，甚至很容易就生育孩子。

Sean Laaman, Morgan Stanley.

肖恩拉曼，摩根士丹利。

Sean, just to gauge your confidence on the data that you do have of being able to partner 101 out. And what are you looking for in a partner?

肖恩，我只是想評估你對你現有數據是否有信心完成 101 項合作。你希望在伴侶身上看到什麼？

Yeah, absolutely, it's a great question. So what we're looking for in a partner is, one, the domain expertise in the particular indication that we're looking to go into and have the ability to actually develop it in that particular indication and ultimately be able to take it through approval. And so, again, I think we have a much bigger buyer universe with the different indications that we are looking at here. And we are excited to begin to engage with -- in those discussions.

是的，沒錯，這是一個很好的問題。因此，我們尋找的合作夥伴，第一，要具備我們想要進入的特定領域的專業知識，並且有能力在該特定領域進行實際開發，並最終能夠獲得批准。所以，我認為，根據我們目前所關注的不同指標，我們的買家群體要大得多。我們很高興能夠參與這些討論。

I don't know, Zach, if you have anything else to add on the partnering front?

扎克，我不知道你對合作方面還有什麼補充嗎？

I would just add that, as Sean mentioned, we have done some work on a first-in-class indication for ABS-101. And we've had some engagement already on that indication. We'll be continuing those discussions as we move towards the end of the year and into early next year. But we feel pretty excited about the potential to partner this asset with a pharma that will be exploring first-in-class type indications.

我只想補充一點，正如肖恩所提到的，我們已經針對 ABS-101 的首個同類指標進行了一些研究。我們已經就此跡象進行了一些回應。我們將繼續就這些議題展開討論，直至年底和明年初。但我們對與一家將探索首創適應症的製藥公司合作開發這項資產的潛力感到非常興奮。

Sure. And just on 201, just to sort of gauge your feeling on how easy the trial is going to be to recruit? I imagine it'd be a fairly facile process, but I could be wrong. And then just maybe sort of the cost to getting it to sort of proof-of-concept status? And how long do you anticipate a patient would need to be on drug to potentially reach the outcome that you're looking for?

當然。還有，關於 201 號問題，我想了解您對招募試驗參與者是否容易的看法？我想這應該是一個相當簡單的過程，但我可能錯了。那麼，將其發展到概念驗證階段的成本大概是多少呢？您預計患者需要服用藥物多久才能達到您所期望的治療效果？

Great. Zach, do you want to take the first two questions and then Andreas, I'll hand it over to you for the third?

偉大的。札克，​​你想先回答前兩個問題嗎？安德烈亞斯，第三個問題我交給你回答。

Yes, absolutely. And just to clarify, when you asked the question, are you referring to endometriosis or AGA?

是的，絕對的。另外，為了澄清一下，您問這個問題時，指的是子宮內膜異位症還是雄性禿？

Sorry, alopecia, sorry.

對不起，脫髮，對不起。

Yeah. Okay. Perfect. So, we feel very confident in the ability to recruit for that trial. We have multiple sites in Australia, including a major KOL, who'll be speaking at our KOL event on December 11th, who are heavily engaged in recruiting and are confident that we will recruit that trial on time.

是的。好的。完美的。因此，我們對招募試驗參與者的能力非常有信心。我們在澳洲有多個試驗點，包括一位重要的KOL，他將於12月11日在我們的KOL活動上發表演講。這些試驗點都在積極招募受試者，我們有信心能準時完成試驗招募。

And for -- in terms of when we would expect to see efficacy, we're looking to have an interim readout that will be in the early part of the second half of next year. And that's going to look at a 12-week -- a 12 -- -- sorry, a 13-week time point where we'll -- not only we're going to be obviously measuring safety and tolerability to the SAD and we'll see that data well before the second half.

至於何時能看到療效，我們預計明年下半年初會有一個中期結果公佈。我們將觀察 12 週——抱歉，是 13 週的時間點，屆時我們不僅會衡量 SAD 的安全性和耐受性，而且我們會在下半年之前看到這些數據。

But in the second half for efficacy, we look at that 13-week readout. We expect to see significant hair growth in the terminal area hair count relative to baseline. We'll be doing additional measures of efficacy at the 20-week and the 24-week as well.

但就療效而言，下半年我們將專注於 13 週的讀數。我們預計終末區域的毛髮數量將比基線水平有顯著增長。我們還將在第 20 週和第 24 週進行額外的療效評估。

Got you, thank you.

明白了，謝謝。

Gil Blum.

吉爾布魯姆。

Good afternoon and thanks for the update. So maybe a quick one on TL1A. Just to understand the features here. So, the half-life wasn't as much as a second gen asset, but you mentioned that the ADAs didn't affect the PK. Where do you think that fits the asset as it relates to an indication? I mean, is this one of the reasons you're looking at alternative indications? And I have a follow-up.

下午好，謝謝你的最新消息。那麼，或許可以簡單介紹一下TL1A。只是為了了解這裡的功能。所以，它的半衰期不如第二代資產長，但你提到ADA不會影響PK。您認為這在與指標相關的資產方面處於什麼位置？我的意思是，這是你考慮其他適應症的原因之一嗎？我還有一個後續問題。

Sean, you may be on mute. This is Zach. I can take that question. Look, we looked at the profile and a full disclosure. We're still waiting for data to come in on the highest dose patients before we have a final read on what the half-life looks like.

肖恩，你可能處於靜音狀態。這是札克。我可以回答這個問題。我們查看了個人資料和完整披露資訊。我們仍在等待最高劑量患者的數據，才能最終了解半衰期的情況。

But in our assessment, the molecule looks safe, well tolerated. We did not see an effect of ADA on PK as well. But we do think it has an additional advantage, which we'll be getting better measurements around, which is tissue distribution, which potentially could lead to better efficacy in a number of indications. And this is one of the areas that's gotten us focused on a couple of newer indications where the molecule could be first-in-class.

但根據我們的評估，該分子看起來安全，耐受性良好。我們沒有觀察到 ADA 對 PK 的影響。但我們認為它還有一個額外的優勢，我們將對此進行更精確的測量，那就是組織分佈，這可能會在多種適應症中帶來更好的療效。而這正是讓我們專注於幾個新適應症的領域之一，在這些新適應症中，該分子可能成為同類首創。

Okay. That's helpful. And as it relates to endometriosis, just to clarify, are we looking initially at a subcu dosing or also IV first?

好的。那很有幫助。至於子宮內膜異位症，為了澄清一下，我們最初是考慮皮下給藥還是先考慮靜脈注射？

Yes. Great question, Gil. I think our view -- go ahead, Sean.

是的。吉爾，問得好。我認為我們的觀點是──肖恩，你繼續。

Sorry, I got kicked off there for a minute. Yes, so the plan would be subcu in the Phase 2, very similar to how we're planning on running the AGA trial. As we mentioned previously, we're at 200 mg per ml. And we'll do the SAD portion in IV and then go to the subcu in the MAD and then same with the endometriosis trial as well.

抱歉，我剛才被踢出伺服器一會兒了。是的，所以第二階段的計劃是皮下注射，與我們計劃進行 AGA 試驗的方式非常相似。正如我們之前提到的，我們目前的濃度是每毫升 200 毫克。我們將先進行靜脈注射的SAD部分，然後再進行MAD的皮下注射，子宮內膜異位症試驗也是如此。

So you'll use subcu initially in endometriosis? I just want to make sure I understand.

所以你會先用皮下注射治療子宮內膜異位症嗎？我只是想確認我理解了。

Yes. In that Phase 2 trial, that is the plan to use subcu.

是的。在第二階段試驗中，計畫採用皮下注射的方式。

Okay. And maybe the last point, just to make sure -- so focus remains both on AGA and endo, not endo taking the lead here. Is that correct?

好的。最後一點，為了確保萬無一失——重點仍然是 AGA 和子宮內膜異位症，而不是子宮內膜異位症在這裡佔據主導地位。是這樣嗎？

100%. I would say that they are co-leads. Our main focus this next year is to get the Phase 2 readout in AGA. And then the year following, it would be endometriosis. So the plan is still full steam ahead on AGA.

100%。我認為他們是共同主演。我們明年的主要目標是獲得 AGA 的 2 期臨床試驗結果。第二年，就罹患了子宮內膜異位症。所以AGA計劃仍在全力進行中。

Nothing has changed on that front at all.

在這方面，沒有任何改變。

Okay, thank you for taking our questions and.

好的，謝謝您回答我們的問題。

And maybe it's important also to even add that, of course, the Phase 2 trial in endometriosis takes full advantage of Phase 1 trial in AGA.

或許還有必要補充一點，子宮內膜異位症的 2 期試驗當然充分利用了 AGA 的 1 期試驗。

Yeah. This is Zach. To put a finer point on that. It's a very capital-efficient development plan since the Phase 2 trial in endometriosis will leverage all the safety data we generated in the Phase 1/2a trial in AGA.

是的。這是札克。更確切地說。這是一個非常節約資金的發展計劃，因為子宮內膜異位症的 2 期試驗將利用我們在 AGA 的 1/2a 期試驗中產生的所有安全性數據。

Ryan Cheng, JPMorgan.

Ryan Cheng，摩根大通。

Hey, guys. Thanks for taking our questions this evening. As we think about the timing of the interim alopecia data and also the start of the Phase 2 endometriosis trial next year, will you want to wait for the interim data from alopecia before you start the endometriosis trial? Just curious if there's any read-through between the two items.

嘿，夥計們。感謝您今晚回答我們的問題。考慮到脫髮中期數據的公佈時間以及明年開始的 2 期子宮內膜異位症試驗，您是否希望在開始子宮內膜異位症試驗之前，先等待脫髮中期數據的公佈？只是好奇這兩件事之間是否有某種關聯。

So obviously, we're going to have to get the SAD safety portion before going into the Phase 2 study. But assuming the Phase 1 SAD data looks good from the AGA trial, we plan to march full steam ahead in terms of going into endometriosis. And we -- yes, we do not plan to wait to see the AGA readout before starting that Phase 2.

顯然，在進入第二階段研究之前，我們必須先完成 SAD 安全性部分。但假設 AGA 試驗的第一階段 SAD 數據看起來不錯，我們計劃全力以赴地進軍子宮內膜異位症領域。是的，我們並不打算等到看到 AGA 的讀數後再開始第二階段試驗。

Got it. And maybe just one quick one about what we have seen so far from HOPE Medicine's 115, specifically in endometriosis. How much read-through do you see from 115 to your 201 program so far? And how are you using the data that they have seen to your own advantage?

知道了。最後，我想簡單談談我們目前從 HOPE Medicine 的 115 項研究中看到的成果，特別是關於子宮內膜異位症的成果。到目前為止，您認為從 115 級課程到 201 級課程的閱讀轉換率是多少？你是如何利用他們所看到的數據為自己謀利的？

Absolutely. Zach, do you want to take that question? And Andreas?

絕對地。札克，​​你想回答這個問題嗎？安德烈亞斯呢？

Yeah, absolutely. Yes, absolutely. We look at the trial design, was not the best. So there's definitely some learnings there. And you can be assured we will have a well-structured design trial that's adequately powered.

是的，絕對的。是的，絕對的。我們審視了一下試驗設計，發現它並不理想。所以這裡面一定有一些值得我們學習的地方。您可以放心，我們將進行結構完善、樣本量充足的設計測試。

But the key point that we take away from that trial that I think is very encouraging for proof-of-concept in endometriosis is the following. One, the first point being they saw -- in their effect size they saw a dose response during treatment -- during the 12 weeks of treatment and a statistically significant response in pain for the high dose and this is in dysmenorrhea. So this would be the primary endpoint or one of the primary endpoints we would look at in our trial as well. So we find that to be very encouraging.

但從那次試驗中我們得出的關鍵一點，我認為對於子宮內膜異位症的概念驗證來說非常令人鼓舞，那就是以下幾點。第一點是，他們觀察到——在治療期間，他們的效果大小顯示出劑量反應——在 12 週的治療期間，高劑量組的疼痛有統計學意義上的顯著反應，這是針對經痛的。所以，這將是我們試驗中要考察的主要終點之一。所以我們覺得這非常令人鼓舞。

I think there's some learnings from, as I mentioned, the way they structured and designed the trial where we will be sure to power correctly and make sure we design for entrance requirement with a little more rigor. But we think it's, like I said, a very encouraging proof-of-concept that derisks the mechanism.

我認為我們可以從他們構建和設計試驗的方式中吸取一些經驗教訓，正如我之前提到的，我們將確保正確地分配功率，並確保我們在設計准入要求時更加嚴格。但正如我所說，我們認為這是一個非常令人鼓舞的概念驗證，降低了該機制的風險。

[Devin Beckert ], KeyBanc.

[Devin Beckert]，KeyBanc。

Just wondering if the ex vivo results you mentioned with 201 are better than expected or generally in line with what you thought? And then could 201 be expanded to additional indications?

我想知道您提到的 201 的體外實驗結果是否比預期的要好，或者是否與您的預期基本一致？那麼，第 201 條能否擴展到其他適應症呢？

Yes. Regarding the ex vivo data, obviously, when you're dealing with human biopsies, a lot of things can go wrong. And from what we saw just from the biomarkers, that were upregulated. The stem cell growth that we saw that was driving the hair shaft production as well as the melanin production for re-pigmentation. All of that was really, really exciting to see and it validated the mechanism in a really fantastic way.

是的。關於體外數據，顯然，在處理人體切片樣本時，很多事情都可能出錯。從我們看到的生物標記來看，這些標誌物都上調了。我們觀察到的幹細胞生長促進了毛幹的生成以及黑色素的生成，從而實現了色素再生。這一切都真的非常令人興奮，並以一種非常棒的方式驗證了這一機制。

And it lines up really nicely with what you're seeing in the stem cell [Maca] data as well as the mouse shaving study that we did. And so we think it just ties together everything really nicely. And this was in -- of three different patients. And you saw the same response across all three patients. And so, we were -- yes, just really pleased with what we saw.

這與你在幹細胞[瑪卡]數據以及我們進行的小鼠剃毛研究中看到的結果非常吻合。所以我們認為它把所有事情都很好地聯繫起來了。而這種情況發生在──三位不同的患者身上。而且這三位患者的反應都一樣。所以，是的，我們對所看到的景象非常滿意。

And I think that gives us really strong confidence going into the Phase 2 study.

我認為這讓我們對進入二期臨床試驗充滿信心。

And I'll add to that, to your second question. We do see potential additional indications for 201. We're not ready to speak about those today. I think we're laser-focused on driving that program through the Phase 1/2a for endometria, for AGA as well as the Phase 2 for endometriosis.

我還要補充一點，關於你的第二個問題。我們確實看到了 201 的潛在其他適應症。我們今天還不方便談論這些事情。我認為我們正全力推動該計畫完成針對子宮內膜異位症和雄性禿的 1/2a 期臨床試驗，以及針對子宮內膜異位症的 2 期臨床試驗。

Got it.

知道了。

Kripa Devarakonda, Truist.

Kripa Devarakonda，Truist。

Hey guys, thank you so much for taking my question. For the in vivo program with 201, can you remind me if you expect to be able to target all endometriosis patients or if there is any restriction or subgroups that you would expect to target? And I know it's really early. But when you think about drugs that are standard of care that have been commercialized in endometriosis, what do you see as the hurdles in the space as you take 201 forward?

各位好，非常感謝你們回答我的問題。對於 201 號體內試驗項目，您能否提醒我一下，您是否預期能夠針對所有子宮內膜異位症患者，或者是否存在任何限製或您預期會針對的亞組？我知道現在時間還很早。但是，當您考慮那些已商業化的、用於治療子宮內膜異位症的標準藥物時，您認為在推進 201 的過程中，該領域存在哪些障礙？

Yes, that's a great question. Zach, I'll hand it over to you and then to Andreas.

是的，這是一個很好的問題。札克，​​我先把它交給你，然後再交給安德烈亞斯。

Yes. Terrific question. I think a couple of points here. One is we're looking to address patients that are on -- potentially displace GnRH therapy. Those haven't -- that therapy has a sort of unwanted side effects for reduction in bone mineral density.

是的。非常好的問題。我認為有兩點需要說明。一方面，我們正在尋求解決正在接受 GnRH 療法的患者——可能會取代 GnRH 療法。那些療法並沒有──這種療法會產生一些不良副作用，例如降低骨礦物質密度。

It does show some efficacy. But we think trying to place a new option in the arsenal that's more effective, does not have a side effect profile like that could be game-changing for these patients. So that's our mission. In terms of how we recruit and segment the trial, that's something we'll comment on later next year as we get closer to the start of the trial. And Andreas, if you'd like to add something, please feel free.

它確實顯示出一定的療效。但我們認為，嘗試在治療方案中加入更有效、副作用更小的新選擇，可能會為這些患者帶來翻天覆地的變化。這就是我們的使命。至於我們如何招募和劃分試驗對象，我們將在明年晚些時候，也就是試驗開始前夕，對此發表評論。安德烈亞斯，如果你有什麼要補充的，請隨意。

Yes. I mean -- so these are two different aspects. So one is what do we believe where it will work versus what's the design of the trial. So from the scientific rationale, there is only reason to believe that the prolactin receptor antibody should work in every endometriosis patient, because we do know that in endometriosis patients, you do have an increased prolactin receptor as well as prolactin expression in the endometriosis lesions as well as in sensory neurons. Therefore, having an effect on both the reduction of lesions as well as on the pain aspect.

是的。我的意思是——這是兩個不同的面向。所以，一方面是我們認為它在哪些情況下會奏效，另一方面是試驗的設計是什麼。因此，從科學原理來看，我們有理由相信催乳素受體抗體對每位子宮內膜異位症患者都有效，因為我們知道，在子宮內膜異位症患者中，子宮內膜異位症病灶以及感覺神經元中催乳素受體和催乳素的表達均有所增加。因此，對減少病灶和緩解疼痛都有效果。

And this, of course, is going to be sex hormone independent effect, which is critical. So we can with all rational applied say that there shouldn't be any female patient with endometriosis, which should not be potentially treated with a prolactin receptor antibody.

當然，這將是一種與性荷爾蒙無關的影響，這一點至關重要。因此，我們可以運用所有理性來得出結論：任何患有子宮內膜異位症的女性患者都不應該接受催乳素受體抗體的治療。

Okay. Thank you so much.

好的。太感謝了。

That ends our Q&A session. I will now turn the call back over to Sean McClain, Founder and CEO, for closing remarks. Please go ahead.

我們的問答環節到此結束。現在我將把電話轉回給創辦人兼執行長肖恩·麥克萊恩，請他作總結發言。請繼續。

Yeah. I just want to first thank our team at Absci for all the hard work they put into not only getting 201 into AGA, but now expanding into endometriosis. And I want to thank all of our investors and analysts for all the support. We're really excited about what's ahead. And we have some exciting catalysts over the next 24 months. So look for another exciting year.

是的。首先我要感謝 Absci 團隊的辛勤付出，他們不僅將 201 應用於 AGA，現在將其擴展到子宮內膜異位症領域。我還要感謝所有投資人和分析師的支持。我們對未來充滿期待。未來24個月，我們有一些令人振奮的催化劑。敬請期待又一個精彩的年份。

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.

女士們、先生們，今天的電話會議到此結束。感謝各位的參與。您現在可以斷開連線了。