Absci Corp (ABSI) 2025 Q1 法說會逐字稿

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Thank you for standing by, and welcome to Absci first quarter 2025 business update and financial and operating results conference call. (Operator Instructions) I would now like to hand the call over to Alex Khan, VP, Finance, Investor Relations. Please go ahead.

    感謝您的支持,歡迎參加 Absci 2025 年第一季業務更新及財務及經營業績電話會議。(操作員指示)現在我想將電話交給財務、投資者關係副總裁 Alex Khan。請繼續。

  • Alexander Khan - Vice President, Finance & Investor Relations

    Alexander Khan - Vice President, Finance & Investor Relations

  • Thank you. Earlier today, Absci released financial and operating results for the quarter ended March 31, 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 email 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.

    謝謝。今天早些時候,Absci 發布了截至 2025 年 3 月 31 日的季度財務和營運業績。如果您尚未收到此新聞稿,或您希望加入公司的分發列表,請發送電子郵件至 investors@absci.com。本次電話會議的存檔網路直播將在會議結束後至少 90 天內在 Absci 投資者關係網站 investors.absci.com 上提供重播。

  • Joining me today are Sean McClain, Absci's Founder and CEO; and Zach Jonasson, Chief Financial Officer and Chief Business Officer. Christian Stegmann, Absci's SCP of Drug Creation, will also join for Q&A following prepared remarks.

    今天與我一起出席的還有 Absci 的創辦人兼執行長 Sean McClain;以及財務長兼首席商務長 Zach Jonasson。Absci 藥物研發 SCP Christian Stegmann 也將在準備好的發言後參加問答環節。

  • 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. 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.

    在我們開始之前,我想提醒您,管理層將在本次電話會議中發表符合聯邦證券法含義的前瞻性聲明。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有重大差異,而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 Securities and Exchange Commission.

    有關這些風險、不確定性和可能導致結果不同的因素的更多信息,請參閱 Absci 今天發布的新聞稿中標題為“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 for other forward-looking statements, either because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of live broadcast May 13, 2025.

    除法律要求外,Absci 不承擔因新資訊、未來事件或其他原因而更新或修改其他前瞻性聲明的任何財務或產品線預測的意圖或義務。本次電話會議包含時間敏感訊息,僅截至 2025 年 5 月 13 日現場直播時準確。

  • With that, I'll turn the call over to Sean.

    說完這些,我會把電話轉給肖恩。

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Good afternoon, everyone. Thank you for joining our Q1 2025 business update call. Today marks a significant milestone for Absci. We have initiated our first in-human clinical trial for ABS-101, officially making Absci a clinical-stage biotech company. It's incredible to see how far we've come in just a short time.

    大家下午好。感謝您參加我們的 2025 年第一季業務更新電話會議。今天對 Absci 來說是一個重要的里程碑。我們已經啟動了 ABS-101 的首次人體臨床試驗,正式使 Absci 成為一家臨床階段的生物技術公司。看到我們在短短的時間內取得如此大的進步真是令人難以置信。

  • About 2.5 years ago, Andreas Busch, an experienced drug hunter, joined Absci as our Chief Innovation Officer. Under Andreas' leadership and with the talented team he assembled, we quickly leveraged our AI platform to create a robust pipeline of potential best-in-class and first-in-class therapeutics.

    大約 2.5 年前,經驗豐富的藥物獵人 Andreas Busch 加入 Absci,擔任首席創新長。在安德烈亞斯的領導下,以及在他組建的優秀團隊的幫助下,我們迅速利用我們的人工智慧平台創建了強大的潛在一流和一流治療方法。

  • Today, I'm proud to announce the start of our Phase 1 clinical trial for ABS-101, our potential best-in-class anti-TL1A antibody. This randomized double-blind placebo-controlled trial of single-summing doses of ABS-101 will evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in approximately 40 healthy adult volunteers.

    今天,我很自豪地宣布我們潛在的最佳抗 TL1A 抗體 ABS-101 的 1 期臨床試驗開始。這項對單劑量 ABS-101 的隨機雙盲安慰劑對照試驗將在約 40 名健康成年志願者中評估其安全性、耐受性、藥物動力學和藥效學。

  • The primary focus is safety and tolerability, with PK, PD, and immunogenicity as secondary endpoints. We expect interim results later this year from this ongoing study in Australia. As a reminder, ABS-101 is a potential best-in-class TL1A antibody, demonstrating high affinity, potency, ability to bind both TL1A monomer and trimer, anticipated low immunogenicity, and high bioavailability shown in non-human primates.

    主要關注點是安全性和耐受性,PK、PD 和免疫原性為次要終點。我們預計今年稍後將會公佈這項在澳洲進行的研究的中期結果。提醒一下,ABS-101 是一種潛在的同類最佳 TL1A 抗體,表現出高親和力、效力、結合 TL1A 單體和三聚體的能力、預期的低免疫原性和在非人類靈長類動物中表現出的高生物利用度。

  • Additionally, it's formulated for convenient sub-Q administration with an anticipated dosing interval of 8 weeks to 12 weeks. Recent data indicates ABS-101 may have a lower chance of developing anti-drug antibodies in clinical settings compared to a competitor molecule with high clinical ADA rate.

    此外,其配方方便皮下給藥,預計給藥間隔 8 週至 12 週。最近的數據表明,與臨床 ADA 率高的競爭分子相比,ABS-101 在臨床環境中產生抗藥性抗體的可能性較低。

  • Our recent NHP studies confirmed prolonged dose-dependent target engagement with a clear ceiling effect, and ABS-101 was well tolerated in a 13-week GLP study in NHP. Interest from potential partners remains high for this program.

    我們最近的 NHP 研究證實了長期劑量依賴性標靶作用具有明顯的上限效應,且 ABS-101 在 NHP 的 13 週 GLP 研究中耐受性良好。潛在合作夥伴對該計劃的興趣仍然很高。

  • Additionally, we are progressing on a bi-specific program with a novel arm in conjunction with our TL1A antibody. We'll share more details on this program at a later date for competitive reasons. ABS-101 exemplifies the power of our generative AI platform, demonstrating our capability to rapidly engineer therapeutics with precision. With a growing pipeline of AI-designed antibodies, we're accelerating our mission of bringing better biologics to patients faster.

    此外,我們正在進行一項雙特異性項目,該項目採用與我們的 TL1A 抗體相結合的新型臂。出於競爭原因,我們將稍後分享有關該計劃的更多詳細資訊。ABS-101 體現了我們生成式 AI 平台的強大功能,證明了我們快速且精確地設計治療方法的能力。隨著人工智慧設計的抗體管道不斷擴大,我們正在加快實現為患者提供更好的生物製劑的使命。

  • Turning to ABS 201, our potential groundbreaking anti-prolactin receptor antibodies for androgenetic alopecia, commonly known as male and female pattern hair loss. This condition affects approximately 80 million adults in the US alone and hasn't seen significant therapeutic innovation in nearly 30 years.

    談到 ABS 201,我們針對雄性禿(俗稱男性和女性型禿)的潛在突破性抗催乳素受體抗體。光是在美國就有大約 8,000 萬成年人患有這種疾病,近 30 年來一直沒有出現重大的治療創新。

  • ABS-201 represents a potential new category of therapy, offering durable, effective hair regrowth. We recently nominated a development candidate with strong pre-clinical evidence that we believe supports high potency, favorable safety, low mutagenicity, extended half-life, and manufacturability.

    ABS-201 代表了一種潛在的新型治療方法,可以提供持久、有效的頭髮生長。我們最近提名了一位具有強有力的臨床前證據的開發候選人,我們相信該證據支持其高效力、良好的安全性、低致突變性、延長的半衰期和可製造性。

  • We believe ABS-201 could offer significant improvements over current standard of care treatments like finasteride and minoxidil, known for their side effects and variable or limited efficacy. We've previously shown in pre-clinical models that ABS-201 outperform minoxidil and hair regrowth. Today, we're pleased to share results from our recent NHP study confirming ABS 201's extended half-life and potential to translate into the dosing interval of every 8 weeks to 12 weeks in humans.

    我們相信,ABS-201 可以顯著改善目前的標準護理療法,如非那雄胺和米諾地爾,這些療法以副作用和療效不穩定或有限而聞名。我們先前在臨床前模型中表明,ABS-201 的效果優於米諾地爾和頭髮生長。今天,我們很高興分享我們最近的 NHP 研究結果,該研究證實了 ABS 201 的半衰期延長以及轉化為人類每 8 週至 12 週的給藥間隔的潛力。

  • The data also indicates excellent subcutaneous bioavailability of greater than 90% in NHPs. The observed PK profile is projected to result in substantial exposure in skin and hair follicles at clinically relevant doses. We believe ABS-201 also supports high concentration formulation potential of greater than 150 mgs per mil, facilitating patient convenience. We're advancing rapidly towards the clinic with guidance from a network of leading hair and dermatology experts.

    數據還表明,非人靈長類動物的皮下生物利用度高達 90% 以上。預計觀察到的 PK 曲線將導致臨床相關劑量在皮膚和毛囊中大量暴露。我們相信 ABS-201 也支持每毫升超過 150 毫克的高濃度配方潛力,從而為患者提供便利。在頂尖頭髮和皮膚病學專家網絡的指導下,我們正在迅速推進臨床治療。

  • ABS-201 continues IND-enabling studies for the Phase 1 trial expected in early 2026 and interim efficacy data anticipated later that year. Given its potentially promising profile, defined development path, and large market, we plan to develop ABS-201 internally through later stage clinical development and proof of concept to retain maximum value.

    ABS-201 將繼續進行 IND 支持研究,預計在 2026 年初進行第 1 階段試驗,並預計在當​​年稍後獲得中期療效數據。鑑於其潛在的前景、明確的發展路徑和巨大的市場,我們計劃透過後期臨床開發和概念驗證在內部開發 ABS-201,以保留最大價值。

  • We're also progressing on two other additional programs. ABS-301, a potential -in-class antibody targeting an undisclosed immune oncology target identified through our reverse immunology platform. Early data indicate potential broad applicability to squamous cells, carcinomas, and other indications.

    我們還在推進另外兩個附加項目。ABS-301 是一種潛在的同類抗體,針對透過我們的反向免疫學平台確定的未公開的免疫腫瘤標靶。早期數據顯示其對鱗狀細胞、癌症和其他適應症具有廣泛的適用性。

  • ABS-501, a potential best-in-class anti-HER2 antibody identified using our Dearshot De Novo AI models. These AI-designed leads display novel epitope interactions, increased or equivalent affinity to Trastuzumab in preclinical settings, efficacy against Trastuzumab-resistant xenograft tumor-expressing wild-type HER2, and good developability.

    ABS-501 是一種潛在的最佳抗 HER2 抗體,使用我們的 Dearshot De Novo AI 模型來識別。這些 AI 設計的先導化合物表現出新的抗原決定位交互作用、在臨床前環境中對曲妥珠單抗具有增加或相當的親和力、對錶達野生型 HER2 的曲妥珠單抗抗藥性異種移植腫瘤有效且具有良好的可開發性。

  • Innovation is at the core of outside success, and we must constantly strive for improvement. Recent initiatives like the National Security Commission on Emerging Biotechnology report support US leadership in biotech, aligning closely with our mission, a topic I spoke passionately about at the 2023 US Senate AI Forum on Innovation.

    創新是外部成功的核心,我們必須不斷努力進步。國家新興生物技術安全委員會的報告等最新舉措支持美國在生物技術領域的領導地位,這與我們的使命緊密結合,我在 2023 年美國參議院人工智慧創新論壇上熱情地談論了這個話題。

  • We were also encouraged by the FDA's recent proposal to reduce or eliminate certain animal tests for monoclonal antibodies, favoring advanced technologies like AI and biosimulation models. This roadmap fits squarely with our approach of using AI models to design and optimize antibodies for safety, specificity, and efficacy.

    FDA 最近提出的減少或取消某些單株抗體動物試驗的提議也令我們感到鼓舞,該提案有利於人工智慧和生物模擬模型等先進技術。該路線圖與我們使用人工智慧模型設計和優化抗體的安全性、特異性和有效性的方法完全吻合。

  • For example, our AI models for naturalness introduced in our 2022 manuscript evaluate how closely an antibody resembles the natural immune repertoire, and mitigate potential downstream developability and immunogenicity issues by prioritizing more natural antibody variants. As a leader in AI drug discovery, we are encouraged by this recent announcement from the FDA and look forward to next steps.

    例如,我們在 2022 年手稿中引入的自然性 AI 模型可以評估抗體與天然免疫組庫的相似程度,並透過優先考慮更天然的抗體變體來減輕潛在的下游可開發性和免疫原性問題。作為人工智慧藥物研發領域的領導者,我們對 FDA 的最新聲明感到鼓舞,並期待下一步的行動。

  • In conclusion, Absci remains committed to leading biotech innovation, harnessing AI to deliver life-changing treatments. Thank you to our talented team, the dedicated and limiters at Absci, whose hard work and dedication drive our mission each and every day.

    總之,Absci 仍致力於引領生物技術創新,利用人工智慧提供改變生活的治療。感謝我們才華橫溢的團隊、Absci 的敬業精神和限制者,他們的辛勤工作和奉獻精神每天都在推動我們的使命。

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

    說完這些,我現在將電話轉給扎克,讓他介紹我們的合作夥伴關係、我們的前景,並提供我們的財務最新情況。扎克?

  • Zach Jonasson - Chief Financial Officer & Chief Business Officer

    Zach Jonasson - Chief Financial Officer & Chief Business Officer

  • Thanks, Sean. As Sean mentioned, we continue to execute across all aspects of our business. This includes progressing our internal and partner programs, as well as advancing discussions with prospective new high-quality partners.

    謝謝,肖恩。正如肖恩所提到的,我們將繼續執行我們業務的各個方面。這包括推進我們的內部和合作夥伴計劃,以及推進與潛在的新的高品質合作夥伴的討論。

  • As our business development discussions remain robust, we continue to anticipate signing one or more drug creation partnerships, including with a large pharma company this year. We also plan to continue providing material updates when possible about ongoing internal and partner programs as they advance through development.

    由於我們的業務發展討論仍然活躍,我們預計今年將簽署一個或多個藥物研發合作夥伴關係,包括與一家大型製藥公司的合作。我們也計劃在內部和合作夥伴計劃持續推進開發的過程中,盡可能提供重要更新。

  • As we think about the growing capabilities of our AI platform, we believe our greatest value proposition is designing novel and differentiated therapeutic assets that address unmet medical needs. Accordingly, in addition to leveraging our platform to reduce drug design timelines and costs, we are increasingly focused on applying the platform to design therapeutics addressing disease targets for which legacy drug discovery approaches have been unsuccessful.

    當我們思考我們的人工智慧平台不斷增長的能力時,我們相信我們最大的價值主張是設計新穎且差異化的治療資產,以滿足未滿足的醫療需求。因此,除了利用我們的平台來減少藥物設計時間和成本之外,我們還越來越注重應用該平台來設計針對傳統藥物發現方法無法成功的疾病目標的治療方法。

  • The HIV Caldera case study, which we have shared previously, as well as recent successes in several of our partnerships, give us confidence in our ability to design therapeutics addressing challenging target classes, both in our own internal programs and in our partnerships. We are pleased to note a growing number of discussions with industry participants who recognize the potential unique value we can bring to drug creation collaborations.

    我們之前分享過的 HIV Caldera 案例研究以及我們最近在多個合作夥伴關係中取得的成功,讓我們對自己設計針對具有挑戰性的目標類別的治療方法的能力充滿信心,無論是在我們自己的內部項目還是在我們的合作夥伴關係中。我們很高興地註意到,與行業參與者的討論越來越多,他們認識到我們可以為藥物創造合作帶來的潛在獨特價值。

  • As Sean discussed earlier, we recently achieved a key milestone in our evolution as we officially became a clinical stage biotech with ABS-101 entering the clinic. We are also excited to see ABS-201, our hair regrowth program, accelerating toward the clinic as we anticipate initiation of a first in human trial in early 2026.

    正如肖恩之前所討論的,我們最近在發展過程中取得了一個關鍵的里程碑,隨著 ABS-101 進入臨床,我們正式成為一家臨床階段的生物技術公司。我們也很高興看到我們的頭髮生長計畫 ABS-201 正在加速進入臨床,我們預計將於 2026 年初啟動首次人體試驗。

  • As a reminder, our business model is focused on out licensing or selling our internal programs and co-develop programs following value inflection proof points. These potential transactions could occur as early as preclinical proof of concept or at much later stages.

    提醒一下,我們的商業模式專注於授權或銷售我們的內部程序以及根據價值拐點證明點共同開發程序。這些潛在交易可能早在臨床前概念驗證階段就發生,也可能在較晚的階段發生。

  • Along those lines, we continue to be engaged with multiple interested parties regarding a potential transaction for our ABS-101 TL1A program. Meanwhile, as Sean mentioned earlier, we see strong rationale to retain and develop our ABS-201 and your genetic alopecia program through much later stages of development.

    沿著這一思路,我們繼續與多個感興趣的方就我們的 ABS-101 TL1A 項目的潛在交易進行接觸。同時,正如肖恩之前提到的,我們認為有充分的理由在開發的後期階段保留和開發我們的 ABS-201 和您的遺傳性脫髮項目。

  • This program offers a straightforward clinical development pathway, which includes objective endpoints and the potential for rapid clinical trial recruitment, as well as the potential to achieve a proof of concept in our phase one trial design.

    該計劃提供了一條簡單的臨床開發途徑,其中包括客觀終點和快速臨床試驗招募的潛力,以及在我們的第一階段試驗設計中實現概念驗證的潛力。

  • Turning now to our financials. Revenue in the first quarter was $1.2 million as we continue to progress our partner programs. Research and development expenses were $16.4 million for the three months ended March 31, 2025, as compared to $12.2 million for the prior year period.

    現在來談談我們的財務狀況。隨著我們繼續推進合作夥伴計劃,第一季的收入為 120 萬美元。截至 2025 年 3 月 31 日的三個月,研發費用為 1,640 萬美元,去年同期為 1,220 萬美元。

  • This increase was primarily driven by advancement of our internal programs, including direct costs associated with external preclinical development and an increase in personnel and stock compensation expense.

    這一成長主要得益於我們內部專案的進展,包括與外部臨床前開發相關的直接成本以及人員和股票薪酬費用的增加。

  • Selling general and administrative expenses were $9.5 million for the three months ended March 31, 2025, as compared to $8.7 million for the prior year period. This increase was due to an increase in stock compensation expense.

    截至 2025 年 3 月 31 日的三個月,銷售一般及行政費用為 950 萬美元,去年同期為 870 萬美元。這一增長是由於股票薪酬費用的增加。

  • Turning to our balance sheet, we ended the quarter with $134 million in cash, cash equivalents and short term investments as compared to $112.4 million as of December 31, 2024. With this strong balance sheet and line of sight to multiple potential catalysts in the near term, we will continue to invest in our internal program portfolio, including supporting the acceleration of development for ABS-201 androgenetic alopecia program and ensure that we maintain a strong, healthy capital position while executing on the strategy.

    回顧我們的資產負債表,截至本季末,我們的現金、現金等價物和短期投資為 1.34 億美元,而截至 2024 年 12 月 31 日為 1.124 億美元。憑藉強勁的資產負債表和對短期內多個潛在催化劑的關注,我們將繼續投資於我們的內部項目組合,包括支持加速 ABS-201 雄激素性脫髮項目的開發,並確保我們在執行戰略的同時保持強勁、健康的資本狀況。

  • Overall, we continue to deepen our focus on high value proprietary internal programs by also seeking high quality co-development and drug creation partnerships with industry leaders who bring synergistic expertise and technology. We believe that this strategy and balanced approach will provide the best return for our shareholders.

    總體而言,我們將繼續深化對高價值專有內部專案的關注,同時尋求與帶來協同專業知識和技術的行業領導者建立高品質的共同開發和藥物創造合作夥伴關係。我們相信,這項策略和平衡方法將為我們的股東帶來最佳回報。

  • Based on our current plan, we believe our existing cash, cash equivalents and short term investments will be sufficient to fund our operations into the first half of 2027. And as a reminder, we see additional upside to this forecast through non-dilutive cash inflows, which could come from potential new platform collaborations with large pharma and or an asset transaction around any of our wholly owned programs, such as our ABS-101 TL1A asset. In sum, we are very pleased with our recent progress and are confident in our ability to execute across our portfolio programs this year and beyond.

    根據我們目前的計劃,我們相信我們現有的現金、現金等價物和短期投資將足以資助我們到 2027 年上半年的營運。需要提醒的是,我們認為非稀釋性現金流入將為此預測帶來額外的上行空間,這些現金流入可能來自與大型製藥公司的潛在新平台合作,或圍繞我們任何全資項目的資產交易,例如我們的 ABS-101 TL1A 資產。總而言之,我們對最近的進展感到非常滿意,並對我們今年及以後執行投資組合計劃的能力充滿信心。

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

    說完這些,我就把話題轉回給肖恩。

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Thanks, Zach. Today is a deeply gratifying day. Not just for me as a founder, but for all of Absci and the dedicated and limiters who bring our mission to life. 14 years ago, when we started this journey, we knew nothing would come easy.

    謝謝,扎克。今天是令人深感欣慰的一天。這不僅對我作為創始人來說如此,對 Absci 的所有員工以及那些將我們的使命變為現實的奉獻者和限制者來說也是如此。 14 年前,當我們開始這段旅程時,我們就知道一切都不會輕易發生。

  • From the beginning, we've relied on drive, tenacity, innovation and perseverance. Not just to survive, but to thrive in the face of uncertainty. As we complete our transition to a clinical stage company, I think back to those early days in the basement lab. Our mission hasn't changed to harness technology and science to improve the lives of patients everywhere. And today I'm proud to see our continued execution bring us closer to that goal.

    從一開始,我們就依靠動力、堅韌、創新和毅力。不僅要生存,更要在面對不確定性時蓬勃發展。當我們完成向臨床階段公司的轉型時,我想起了早期在地下室實驗室的日子。我們的使命始終沒有改變,那就是利用科技來改善世界各地患者的生活。今天,我很自豪地看到,我們持續的執行使我們更接近這一目標。

  • Looking ahead, ABS-101 is now in the clinic and we expect to share interim data in the second half of this year. ABS-201, our hair regrowth program is also gaining momentum as it moves towards the clinic. We plan to begin first in human studies in early 2026 with an interim efficacy readout expected later that year.

    展望未來,ABS-101 現已進入臨床階段,我們預計將在今年下半年分享中期數據。我們的頭髮生長計劃 ABS-201 也正在走向臨床,並獲得了良好的發展勢頭。我們計劃於 2026 年初首次進行人體研究,並預計在當​​年稍後公佈中期療效數據。

  • Beyond our internal programs and as Zach mentioned, we have a clear line of sight to bring one or more new large pharma partners into our growing ecosystem of collaborators this year. None of this would be possible without the incredible work of our limiters. To everyone at Absci, thank you for your continued dedication to our mission.

    除了我們的內部專案之外,正如扎克所提到的,我們今年還明確計劃將一個或多個新的大型製藥合作夥伴納入我們不斷成長的合作夥伴生態系統。如果沒有我們的限制器的出色工作,這一切都不可能實現。感謝 Absci 的每一位員工對我們使命的持續奉獻。

  • With that, I'll turn the call back over to our operator to begin Q&A. Operator.

    說完這些,我將把電話轉回給我們的接線生開始問答。操作員。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Arseniy Shabashvili, Guggenheim Securities.

    古根漢證券公司的 Arseniy Shabashvili。

  • Arseniy Shabashvili - Analyst

    Arseniy Shabashvili - Analyst

  • Hi, this is Arseniy on Fulvamo. Thank you for taking our questions and congrats on all your progress. Regarding ABS-101, what are you hoping to see in the Phase 1 top line in the second half of the year in terms of decay and the misunicity endpoints as well as any other metrics you may be looking at?

    大家好,我是 Fulvamo 的 Arseniy。感謝您回答我們的問題,並祝賀您所取得的所有進步。關於 ABS-101,您希望在下半年第一階段的衰減和誤讀終點以及您可能正在關注的任何其他指標方面看到什麼?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yeah, thanks, Arseniy. First off, we're looking to see a really nice safety profile, looking at immunogenicity. The second is looking at target engagement. We're hoping to see similar target engagement data as what we saw and presented at the JPMorgan Healthcare Conference earlier this year. And Christian, is there anything else that you'd like to add in terms of what we'd like to see for ABS-101?

    是的,謝謝,Arseniy。首先,我們希望看到真正好的安全性,並觀察免疫原性。第二是關注目標參與度。我們希望看到與今年稍早在摩根大通醫療保健會議上看到和展示的類似目標參與度的數據。克里斯蒂安,關於我們希望看到的 ABS-101,您還有什麼要補充的嗎?

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Yeah, absolutely. In addition to what Sean mentioned, we would like to validate the extended half-life to really demonstrate that in humans, we can potentially support dosing of every 2 months to every 12 weeks. And then as Sean mentioned, we will continue to observe and hopefully validate expected low immunogenicity and overall good tolerability and safety profile and then demonstrate target engagement as measured by the elevation of total soluble TL1A. And note that the elevation of total soluble TL1A will also be measured over an extended period of time, really then demonstrating not only an extended half-life in terms of the PK of the antibody, but also the pharmacodynamics, meaning we see an elevation of total soluble TL1A over an extended period of time, really demonstrating target engagement and confirming the overall target product profile.

    是的,絕對是如此。除了 Sean 提到的之外,我們還想驗證延長的半衰期,以真正證明在人類中,我們可以支持每 2 個月到每 12 週進行一次給藥。然後,正如肖恩所提到的,我們將繼續觀察並希望驗證預期的低免疫原性和整體良好的耐受性和安全性,然後透過總可溶性 TL1A 的增加來證明目標參與度。需要注意的是,總可溶性 TL1A 的升高也將在較長時間內進行測量,這實際上不僅證明了抗體 PK 的半衰期延長,而且還證明了藥效學,這意味著我們可以看到總可溶性 TL1A 在較長時間內的升高,這確實證明了目標參與並確認了整體目標產品概況。

  • Arseniy Shabashvili - Analyst

    Arseniy Shabashvili - Analyst

  • Thank you. And one more, if I may, regarding 201. Obviously, it is the early days, but based on what you now know, do you think this product can potentially be self-administered in the future?

    謝謝。如果可以的話,我還想問一下關於 201 的問題。顯然,現在還為時過早,但根據您現在所了解的情況,您認為該產品將來有可能實現自我管理嗎?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yes, we do believe this can be self-administered. Right now, though, we are working -- we want to work with dermatologists on being able to make sure that this is effectively administered. Then so we do think over time it could be self-administered, but we do think working with the providers initially is likely the best route to go.

    是的,我們確實相信這可以自我管理。不過,現在我們正在努力——我們希望與皮膚科醫生合作,確保有效地實施這項措施。那麼我們確實認為隨著時間的推移它可以自我管理,但我們確實認為最初與供應商合作可能是最好的途徑。

  • Arseniy Shabashvili - Analyst

    Arseniy Shabashvili - Analyst

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Brendan Smith, TD Cowen.

    布倫丹·史密斯(Brendan Smith),TD Cowen。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • Great. Thanks for taking the questions, guys. Congrats on all the progress. Maybe just a quick one from us on 201. And as you look at the data today and think about potential clinical trial ahead, I guess, how are you thinking about potential market segmentation here?

    偉大的。謝謝大家回答這些問題。祝賀你取得的所有進展。也許我們只是在 201 上快速回答一個問題。當您查看今天的數據並思考未來潛在的臨床試驗時,我想,您是如何看待這裡潛在的市場區隔的?

  • And I guess maybe just among that 80 million to 90 million patient figure that I think you flagged in the past, I guess who among them do you think would maybe be, loathing fruit to target first and just kind of think about that rollout?

    我想也許就在您過去提到的 8000 萬到 9000 萬患者數字中,您認為其中誰可能是第一個討厭水果的人,並且只是考慮推出該產品?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Zach and Christian, do you want to take that?

    扎克和克里斯蒂安,你們想接受這個嗎?

  • Zach Jonasson - Chief Financial Officer & Chief Business Officer

    Zach Jonasson - Chief Financial Officer & Chief Business Officer

  • Yeah, this is Zach. I'd be happy to. It's a great question. Ben and we spent a lot of time with our KOL network evaluating that. At this point, we think this mechanism could be efficacious in almost all of those segments for endogenetic alopecia.

    是的,這是紮克。我很樂意。這是一個很好的問題。本和我們花了很多時間與我們的 KOL 網路一起評估這一點。目前,我們認為這種機制幾乎對內源性脫髮的所有部位都有效。

  • So we are looking at a Phase 1 trial design where we'll see some breadth in terms of age, both male and female. We'll put out more data around that trial design later this year. But as of today, just looking at the mechanism and the strong translational data, including the human genetics that support safety. We don't see any particular segment of that population that could not be treated. But it's certainly something we're going to have to evaluate in the human clinical trial setting.

    因此,我們正在研究第一階段的試驗設計,我們將看到年齡的廣度,包括男性和女性。我們將在今年稍後發布有關該試驗設計的更多數據。但截至今天,只需研究機制和強大的轉換數據,包括支持安全的人類遺傳學。我們沒有發現該群體中有任何特定群體無法得到治療。但我們肯定要在人體臨床試驗中對此進行評估。

  • Christian, I don't know if you want to add anything.

    克里斯蒂安,我不知道您是否想補充一些內容。

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Yeah, great point, Zach. Not much to add. As you correctly pointed out, we will observe as we go into clinical development how this product is best administered, how it is best served in different populations. And I think this will inform our commercialization strategy.

    是的,扎克,說得非常好。沒什麼好補充的。正如您正確指出的那樣,在進入臨床開發階段時,我們將觀察如何最好地使用該產品,如何使其在不同人群中發揮最佳作用。我認為這將會為我們的商業化策略提供參考。

  • I will flag that beyond endogenic alopecia, there is potential for this mechanism as well. So beyond the market segmentation in endogenetic alopecia, it will also be interesting to look in indications such as endometriosis where this mechanism has a potential and we are actively exploring that as well.

    我要指出的是,除了內源性脫髮之外,這種機制也有可能。因此,除了內源性脫髮的市場細分之外,研究子宮內膜異位症等適應症也將很有趣,因為這種機制具有潛力,我們也在積極探索這一點。

  • Brendan Smith - Analyst

    Brendan Smith - Analyst

  • Okay, great. Thanks, Zach.

    好的,太好了。謝謝,扎克。

  • Operator

    Operator

  • Gil Blum, Needham and Company.

    吉爾布魯姆,尼德漢姆公司。

  • Gil Blum - Analyst

    Gil Blum - Analyst

  • Good afternoon, everyone, and allow me to add my congrats to the progress here. So maybe a couple of questions on 201. Now that we have some pharmacokinetics from the non-human primate model, maybe the kind of initial thoughts on the type of dosing you're going to first look at in humans and kind of as a follow on. So I remember the idea was to inject the compound to the target site. How much systemic exposure did you observe in the NHB model? Thank you.

    大家下午好,請容許我對這裡的進展表示祝賀。所以也許關於 201 有幾個問題。現在我們已經從非人類靈長類動物模型中獲得了一些藥物動力學信息,也許您可以對在人類身上首先研究的劑量類型以及後續研究有一些初步的想法。所以我記得這個想法是將化合物注射到目標部位。您在 NHB 模型中觀察到了多少系統性暴露?謝謝。

  • Operator

    Operator

  • Christian, you want to take that?

    克里斯蒂安,你想拿走那個嗎?

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Yeah, so we will disclose the full pharmacokinetic data set at a later point in time at a scientific venue. I will say that we have -- as we've shown, a very attractive pharmacokinetic profile in non-human primates. We think it is conducive based on the pharmacokinetic thermocondynamic modeling we've done to a dosing of every 8 weeks to 12 weeks, as Sean mentioned earlier.

    是的,所以我們將在稍後的科學場所披露完整的藥物動力學數據集。我想說的是,正如我們所展示的,我們在非人類靈長類動物中具有非常有吸引力的藥物動力學特徵。正如 Sean 之前提到的,根據我們所做的藥物動力學熱力學模型,我們認為每 8 週到 12 週給藥一次是有利的。

  • We think this is overall a very attractive profile in particular for an aesthetic indication as androgenic alopecia. And we anticipate that this product would be dosed every 6 -- over a 6 month treatment period. So you could imagine that we can achieve this treatment regimen in just two doses or three doses. So we think that's attractive. And with regards to the total exposure, stay tuned. We will disclose the full data at a scientific venue at a later point in time.

    我們認為這總體上是一個非常有吸引力的概況,特別是對於雄性禿這樣的美學指徵而言。我們預計產品將在 6 個月的治療期內每 6 次服用一次。因此你可以想像,我們只需兩劑或三劑就能實現這個治療方案。所以我們認為這很有吸引力。關於總曝光量,請繼續關注。我們將在稍後的科學會場上揭露完整數據。

  • Gil Blum - Analyst

    Gil Blum - Analyst

  • Thanks.

    謝謝。

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Is that answered your question?

    這回答了你的問題嗎?

  • Gil Blum - Analyst

    Gil Blum - Analyst

  • Yep.

    是的。

  • Operator

    Operator

  • Vikram Purohit, Morgan Stanley.

    摩根士丹利的維克拉姆·普羅希特(Vikram Purohit)。

  • Unidentified Participant

    Unidentified Participant

  • Hi, everyone. This is Morgan on from Vikram. Thanks for taking our question. And again, wanted to extend our congratulations and all the progress this quarter. I wanted to ask a quick question on ABS-301 and when we can expect that development candidate to be shared. Thank you so much.

    大家好。我是維克拉姆 (Vikram) 的摩根 (Morgan)。感謝您回答我們的問題。再次,我們想對本季度取得的所有進展表示祝賀。我想問一個關於 ABS-301 的簡單問題,以及我們何時可以預期該開發候選版本會被分享。太感謝了。

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Thanks, Morgan. We are continuing to advance it. We recently showed some recent target validation data last quarter, and we are still progressing towards a DC. We have not disclosed at this point in time when that DC will be ready, but we are doing in vivo validation or in vivo studies currently. And after that should be ready to nominate a drug candidate.

    謝謝,摩根。我們正在繼續推進這一進程。我們最近展示了上個季度的一些最新目標驗證數據,並且我們仍在朝著 DC 邁進。目前我們尚未透露 DC 何時準備就緒,但我們目前正在進行體內驗證或體內研究。之後就應該準備提名候選藥物。

  • Unidentified Participant

    Unidentified Participant

  • Okay, appreciate it. And then one last question on ABS-201 for that interim data readout. I know it's still very early days, but do you have a sense of what kind of data will be shared there and what could be expected based on what you're seeing right now?

    好的,謝謝。然後是關於 ABS-201 的最後一個問題,關於中期數據讀數。我知道現在還為時過早,但您是否知道那裡將共享什麼樣的數據,以及根據您現在看到的情況可以期待什麼?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yes, we are looking to have that be a interim proof of concept readout from both potentially -- both from the sad portion as well as the mad portion of of that study, which would be in the second half of this year. Now, as we get closer to that study, we will be disclosing more of the study design of that. But again, we do expect a potential efficacy readout the second half of next year on that trial.

    是的,我們希望將其作為中期概念驗證讀數,該讀數既來自該研究的悲傷部分,也來自瘋狂部分,這將在今年下半年完成。現在,隨著我們越來越接近這項研究,我們將揭露更多有關該研究的設計。但是,我們確實預計明年下半年試驗的潛在療效將會公佈。

  • Unidentified Participant

    Unidentified Participant

  • Excellent. Thank you very much.

    出色的。非常感謝。

  • Operator

    Operator

  • George Farmer, Scotiabank.

    加拿大豐業銀行的喬治法默。

  • George Farmer - Analyst

    George Farmer - Analyst

  • Hi, good afternoon. Thanks for taking my question. Sean, can you elaborate a little bit more on this combo strategy that you have with 101? That sounds pretty intriguing. And regarding the partnership that you have with AstraZeneca, I recall that there was a big milestone that you guys had hit with them, can you give us an indication of like, whether you might be getting any milestones in the near future, maybe just on a qualitative basis, how substantial those could be? And then number three, regarding 501, how do you see this drug fitting into the competitive landscape? It's a pretty, pretty crowded area. And how is this really differentiated? Thanks.

    嗨,下午好。感謝您回答我的問題。肖恩,你能更詳細地介紹一下你在 101 中採用的組合策略嗎?這聽起來很有趣。關於您與阿斯特捷利康的合作關係,我記得你們曾一起取得了一個重要的里程碑,您能否向我們透露一下,在不久的將來,您是否可能取得任何里程碑,也許只是從質量上講,這些里程碑有多大?第三,關於 501,您認為這種藥物如何適應競爭格局?這是一個相當非常擁擠的地區。這究竟有何差別?謝謝。

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yeah, so first off on the combo, what we're seeing, especially as we're engaging with large pharma on this, there is a push into combo based approaches. You're seeing J&J really lead the way on this. And you're starting to see also combo based approaches coming from AbbVie as well. And so we do think that a TL1A combo based strategy is likely to help increase overall efficacy and durability. And that's a direction that potential partners are thinking of with regards to ABS-101.

    是的,首先就組合而言,我們看到,特別是當我們與大型製藥公司就此展開合作時,正在推動基於組合的方法。您會看到強生確實在這方面處於領先地位。而且您也開始看到來自 AbbVie 的組合方法。因此,我們確實認為基於 TL1A 組合的策略可能有助於提高整體功效和耐用性。這是潛在合作夥伴針對 ABS-101 所考慮的方向。

  • And then we also have a bi-specific strategy with a novel arm. So the TL1A with a novel arm. And this is not the typical IL-23 or alpha-4 beta-7 arm. This is a novel target we are pursuing with that bi-specific strategy. And I'll let Zach take the easy question. And then Christian can take 501.

    然後我們還有一個具有新穎手臂的雙特異性策略。因此 TL1A 配備了新穎的手臂。這不是典型的 IL-23 或 alpha-4 beta-7 臂。這是我們透過雙特異性策略追求的一個新目標。我請札克來回答這個簡單的問題。然後克里斯蒂安就可以拿下 501。

  • Zach Jonasson - Chief Financial Officer & Chief Business Officer

    Zach Jonasson - Chief Financial Officer & Chief Business Officer

  • Hi, George. It's Zach. Unfortunately, we can't give any specific commentary around any of those partnerships, as you'll appreciate. They're all under MNDA provisions. I can share more generally, I think we've mentioned publicly about some more recent successes in some of our other partnerships, including applying our platform to develop antibodies that actually effectively block an ion channel. That's been one of these targets that's been very challenging to address. So I can make some general comments like that, but I can't give you anything specific.

    你好,喬治。是札克。不幸的是,我們無法對任何合作關係發表任何具體的評論,正如您所理解的那樣。它們都受到 MNDA 條款的約束。我可以更廣泛地分享,我想我們已經公開提到我們在其他一些合作夥伴關係中取得的一些最新成功,包括應用我們的平台開發實際上有效阻斷離子通道的抗體。這是非常難以實現的目標之一。因此我可以做出一些類似的一般性評論,但無法提供任何具體資訊。

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Thanks, Christian, answering your question on ABS 501. Yes, obviously, you're correct. HER2 Phase is indeed a very competitive space. We have currently ongoing a number of preclinical studies that will help us to position ABS-501 in this space. Among them could also be combination approaches. And we are exploring actively where that potential niche is. These studies are currently ongoing. We may have a drug candidate this year, but potentially also next year, depending on the timing of the studies and the data as they emerge.

    謝謝,克里斯蒂安,回答您關於 ABS 501 的問題。是的,顯然你是對的。HER2 階段確實是一個競爭非常激烈的領域。我們目前正在進行多項臨床前研究,這將有助於我們將 ABS-501 定位於此領域。其中也可以採用組合方法。我們正在積極探索這個潛在的市場。這些研究目前正在進行中。我們今年可能會有候選藥物,但明年也可能會有,這取決於研究的時間和出現的數據。

  • George Farmer - Analyst

    George Farmer - Analyst

  • Okay, thanks. And Sean, again, back to the combo approach. This bi-specific that you're referring to -- is this one of you an in-house bi-specific that you're making or is it somebody else's?

    好的,謝謝。肖恩再次回到組合方法。您所指的這種雙特異性——是您自己製作的還是其他人的?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • This is an in-house bi-specific that we have developed. And so we're in addition to that bi-specific, we're also developing the other arm of this novel target as well as a monobased therapy. But this is all developed in Absci.

    這是我們開發的內部雙特異性抗體。因此,除了雙特異性之外,我們還在開發這一新標靶的另一個分支以及單一療法。但這一切都是在 Absci 中開發的。

  • George Farmer - Analyst

    George Farmer - Analyst

  • Okay, thanks.

    好的,謝謝。

  • Operator

    Operator

  • Kripa Devarakonda, Truist Securities.

    Kripa Devarakonda,Truist 證券公司。

  • Unidentified Participant

    Unidentified Participant

  • Hello, this is Alex on for Kripa. First, congrats on the progress and becoming commercial stage. That's fantastic. And question from our side. As the assets continue in development, ABS-101 and ABS-202, as they progress, is there also an updated sentiment on how you think about future partnerships? Namely, do you think you can command improved economics? Is there any change to that? Or any key differences that you see, how your business might evolve given the success in the clinic?

    大家好,我是 Kripa 的 Alex。首先,祝賀取得進展並進入商業階段。太棒了。還有我們這邊的問題。隨著資產 ABS-101 和 ABS-202 的不斷開發,您對未來合作關係的看法是否也有所更新?也就是說,您認為您可以改善經濟狀況嗎?有沒有任何改變?或者您看到了什麼關鍵的差異?鑑於診所的成功,您的業務將如何發展?

  • And then another one from us on your cost structure. Could you speak to how flexible it is with fixed and variable costs? And namely, as many people are concerned about the state of the markets, biotech markets specifically at the moment, are you able to run any more leanly if you need to? Thanks.

    然後我們再問一下你們的成本結構。能談談固定成本和變動成本的彈性嗎?而且,由於許多人都擔心市場狀況,特別是目前的生物技術市場,如果需要的話,您是否能夠更精簡地運作?謝謝。

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yeah, thanks, Alex. I'll let Zach take both those questions.

    是的,謝謝,亞歷克斯。我請札克來回答這兩個問題。

  • Zach Jonasson - Chief Financial Officer & Chief Business Officer

    Zach Jonasson - Chief Financial Officer & Chief Business Officer

  • Hey, Alex. Great questions. In terms of the platform and the kind of deal terms that we think we'll see in the future and going forward, I would answer your question by saying yes, but due to two reasons. I mean, we do hope to see enhanced deal terms, certainly with some success with ABS-101 and that interim data readout. I think that's an important milestone for the company and helps provide additional validation of the platform.

    嘿,亞歷克斯。很好的問題。就我們認為未來會看到的平台和交易條款而言,我的答案是肯定的,但有兩個原因。我的意思是,我們確實希望看到交易條款的改善,當然 ABS-101 和中期數據讀數也會取得一些成功。我認為這是公司的一個重要里程碑,有助於為平台提供額外的驗證。

  • But the other really exciting developments on the platform is that now that we're in version three of our models, moving into version four. We've shown an ability to address these very challenging target classes. And, as an example, that is the HIV Caldera case study that we've put out publicly at the end of last year, but also more recently, some successes in various partnerships that we have ongoing.

    但該平台上另一個真正令人興奮的發展是,現在我們的模型已經進入第三版,並即將進入第四版。我們已經展現出解決這些極具挑戰性的目標類別的能力。舉個例子,這是我們在去年年底公開發布的 HIV Caldera 案例研究,而且最近,我們正在進行的各種合作中也取得了一些成功。

  • And so we feel like that is a really significant value proposition that differentiates us from many other players really in the field. And so we're seeing a lot of engagement from Pharma around how they can potentially leverage our platform to address some of these targets that they've struggled with.

    因此,我們認為這是一個非常重要的價值主張,它使我們與該領域的許多其他參與者真正區分開來。因此,我們看到許多製藥公司參與其中,探討如何利用我們的平台來解決他們一直難以解決的一些目標。

  • So we're looking forward to advancing these discussions and negotiations over the next year to see what kind of terms we can reach on drug creation partnerships. But we do expect to see them increase materially versus what we've done in prior years.

    因此,我們期待在明年推進這些討論和談判,看看我們能在藥物創製夥伴關係方面達成什麼樣的條款。但我們確實預計,與前幾年相比,這一數字將大幅增加。

  • And then on your question pertaining to cost structure, I would say we continually look for ways to leverage more efficiencies out of the AI platform. And I just mentioned we've made some advances there and we continue to make advances year on year, really on a quarterly basis with the platform.

    關於成本結構的問題,我想說我們一直在尋找方法,以提高人工智慧平台的效率。我剛才提到,我們在那裡取得了一些進展,並且我們繼續逐年、實際上是按季度透過該平台取得進展。

  • So we do see opportunities to reallocate resourcing and also to reduce certain areas of resourcing as we leverage more and more of our AI capability. And that's a -- for Absci, that's an ongoing process that we evaluate each and every quarter.

    因此,隨著我們越來越多地利用人工智慧能力,我們確實看到了重新分配資源以及減少某些資源領域的機會。對於 Absci 來說,這是一個持續的過程,我們每季都會進行評估。

  • Unidentified Participant

    Unidentified Participant

  • Thank you.

    謝謝。

  • Operator

    Operator

  • Dabhanjana Chatterjee, Jones.

    達巴漢賈納·查特吉,瓊斯。

  • Debanjana Chatterjee - Analyst

    Debanjana Chatterjee - Analyst

  • Hi. Thanks for taking my question. So I have two. The first one is that, you know, assuming that you see optimal results, as you expect, in the Phase 1 readout for ABS-101, as you think about the Phase 2, will the study include both open-level and randomized arms similar to the design in one of the competitor trials?

    你好。感謝您回答我的問題。所以我有兩個。第一個問題是,您知道,假設您在 ABS-101 的第 1 階段讀數中看到了預期的最佳結果,當您考慮第 2 階段時,該研究是否會包括與競爭對手試驗之一的設計類似的開放等級和隨機組?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Thanks. That's a great question. At this time, we have not disclosed what the Phase 1B 2A is going to look like. As the interim data comes out, we'll be sharing more information on what those studies are going to be looking like in the future.

    謝謝。這是一個很好的問題。目前,我們尚未透露第 1B 2A 階段的具體內容。隨著中期數據的公佈,我們將分享更多有關這些研究未來進展的資訊。

  • Debanjana Chatterjee - Analyst

    Debanjana Chatterjee - Analyst

  • Okay, great. And one follow-up. So this is broader. As the FDA shifts towards minimizing animal use for safety testing and emphasizes AI-based safety predictions, can you leverage AppSight's data for its AI-driven platform to model toxicity and predict safety? And is AppSight better positioned than its -AI-driven peers to navigate this shift?

    好的,太好了。還有一個後續行動。所以這個範圍更廣。隨著 FDA 轉向盡量減少使用動物進行安全測試並強調基於人工智慧的安全預測,您能否利用 AppSight 的數據為其人工智慧驅動平台建模毒性並預測安全性?AppSight 是否比其 AI 驅動的同行更有能力應對這一轉變?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yes, absolutely. We're really excited to see the FDA wanting to leverage AI models to help reduce toxicity and immunogenicity. And as we mentioned on the call, one of the models that we've developed that we released in 2022 was our naturalness model, being able to ensure that the model, that the data is the antibodies are as human-like as possible.

    是的,絕對是。我們非常高興看到 FDA 希望利用 AI 模型來幫助降低毒性和免疫原性。正如我們在電話中提到的,我們開發的模型之一是我們在 2022 年發布的自然性模型,能夠確保模型、抗體數據盡可能與人類相似。

  • And we see this as a big advantage for us moving forward, in particular, in being able to reduce overall immunogenicity and ensure favorable developability and manufacturability, but also helping to align with the FDA on where they're going. And so we see this definitely as a big advantage for us moving forward. And Christian, please add in anything else.

    我們認為這對我們未來的發展來說是一個巨大的優勢,特別是能夠降低整體免疫原性並確保良好的可開發性和可製造性,同時也有助於與 FDA 保持一致。因此,我們認為這對我們未來的發展無疑是一個巨大的優勢。克里斯蒂安,請補充其他內容。

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Yeah, very well said, Sean. Indeed, I think the developments at the administration are very exciting for us. We will continue to engage and continue to follow the FDA's process and advisory relationships to observe what the next steps are.

    是的,肖恩,說得很好。事實上,我認為政府的進展令我們非常興奮。我們將繼續參與並繼續關注 FDA 的流程和諮詢關係,以觀察下一步的行動。

  • These things will usually also result in revised global, globally harmonized guidelines. And this is indeed a very exciting opportunity as these efforts towards reducing usage of animals are taking these measures are taking place. We will see a much more broad adoption of AI models. And clearly, this is a very interesting opportunity for Absci.

    這些事情通常也會導致全球修訂、全球統一的指導方針。這確實是一個非常令人興奮的機會,因為減少動物使用的努力正在採取這些措施。我們將看到人工智慧模型得到更廣泛的應用。顯然,這對 Absci 來說是一個非常有趣的機會。

  • Debanjana Chatterjee - Analyst

    Debanjana Chatterjee - Analyst

  • Okay, that's very helpful. Thank you.

    好的,這非常有幫助。謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員指示)

  • Li Chen, HC [Rain White].

    李晨,HC[Rain White]。

  • Unidentified Participant

    Unidentified Participant

  • Hello, everyone. Congratulations on the quarter. So to expand on the TL1A questions a little bit. So can you give us some understanding of the strategy behind going after the novel target of the bi-specific instead of your competitive strategy of going forward, clinical approved targets, what's the advantage of this novel target?

    大家好。恭喜本季。因此,稍微擴充一下 TL1A 問題。那麼,您能否向我們介紹一下追求雙特異性新目標背後的策略,而不是您前進的競爭策略,臨床批准的目標,這個新目標的優勢是什麼?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • Yeah, thank you, Li Chen. So this is a known target with known biology. It's been difficult to drug both from an antibody standpoint as well as small molecule. And we have figured out a way to drug it with an antibody. And we do think that it has really strong synergy with our TL1A app and I'll hand it over to Christian to maybe go in a little bit more depth on some of the biology.

    是的,謝謝你,李晨。所以這是一個已知目標,具有已知的生物學特性。無論從抗體或小分子的角度來看,用藥都是很困難的。我們已經找到了用抗體治療它的方法。我們確實認為它與我們的 TL1A 應用程式具有很強的協同作用,我會把它交給克里斯蒂安,讓他更深入地研究一些生物學知識。

  • Christian Stegmann - Senior Vice President, Drug Creation

    Christian Stegmann - Senior Vice President, Drug Creation

  • Yes, 100%. So this target, as Sean mentioned, we have not disclosed this target. So we have to tread a little bit lightly in terms of what I can tell you in terms of the details here. But what I can say that just like TL1A, the mechanism is a pro-inflammatory mechanism that is clinically highly relevant in autoimmune diseases. Hence, we believe there's a very good rationale for combining it with an anti-TL1A antibody.

    是的,100%。正如肖恩所提到的那樣,我們尚未披露這個目標。因此,對於我可以告訴您的細節,我們必須謹慎行事。但我可以說,就像 TL1A 一樣,該機制是一種促發炎機制,與自體免疫疾病在臨床上高度相關。因此,我們認為將其與抗 TL1A 抗體結合具有非常好的理由。

  • As Sean mentioned, we are actively working on a bi-specific on this combination. And we think this particular combination could indeed be very differentiating from other combinations that others are pursuing, for example, what is already out there, TL1A alpha-4 beta-7 or TL1A IL-23.

    正如肖恩所提到的,我們正在積極研究這種組合的雙特異性。我們認為這種特殊的組合確實與其他人正在追求的組合有很大區別,例如已經存在的 TL1A alpha-4 beta-7 或 TL1A IL-23。

  • We thought rather than following these paths that others have already taken, we're exploring a novel combination here with a difficult to drug target, at least historically, and thereby potentially really have a very differentiated and potentially highly efficacious bi-specific antibody in our hands.

    我們認為,我們不會遵循其他人已經走過的路,而是在這裡探索一種至少在歷史上難以實現的藥物靶點的新型組合,從而有可能真正擁有一種非常差異化且可能非常有效的雙特異性抗體。

  • Unidentified Participant

    Unidentified Participant

  • Got it. Thanks for the color. And if I may, a quick follow up. So for example, when should we expect to see some go-no-go decision about prioritizing the monomeric TL1A versus the bi-specific?

    知道了。謝謝你的顏色。如果可以的話,請快速跟進。那麼,例如,我們應該何時看到關於優先考慮單體 TL1A 還是雙特異性 TL1A 的可行或不可行的決定?

  • Sean McClain - Chief Executive Officer, Founder, Director

    Sean McClain - Chief Executive Officer, Founder, Director

  • So at this point in time, we are planning on pursuing both of these assets. And in terms of partners, partners are both interested in the TL1A monotherapy as well as the bi-specific. And so we, again, continue to develop both of these in parallel and see value in both of those. And I think it's important to have both of these from a partnering perspective as well.

    因此,目前我們正計劃追求這兩項資產。就合作夥伴而言,合作夥伴都對 TL1A 單一療法和雙特異性療法感興趣。因此,我們再次繼續並行開發這兩者,並看到它們的價值。我認為從合作的角度來看,這兩者也很重要。

  • Unidentified Participant

    Unidentified Participant

  • Okay, thanks for taking the questions.

    好的,感謝您回答這些問題。

  • Operator

    Operator

  • Thank you. That does end our Q&A session and concludes today's conference call. Thank you for participating. You may now disconnect.

    謝謝。我們的問答環節到此結束,今天的電話會議也圓滿結束。感謝您的參與。您現在可以斷開連線。