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Operator
Operator
Ladies and gentlemen, thank you for standing by. Welcome to Absci second-quarter 2025 business update call. (Operator Instructions) Please be advised that today's conference is being recorded. I would now like to turn the conference over to Alex Khan, Vice President of Finance and Investment Relations. Please go ahead.
女士們、先生們,感謝你們的支持。歡迎參加 Absci 2025 年第二季業務更新電話會議。(操作員指示)請注意,今天的會議正在錄音。現在,我想將會議交給財務和投資關係副總裁 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 June 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 email to investors@absci.com. An archived webcast of this call will be available for replay on Absci 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 6 月 30 日的季度財務和營運業績。如果您尚未收到此新聞稿,或希望加入公司通訊錄,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 Finance and Chief Business Officer. Christian Stegmann, Absci's SVP 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 和財務長兼首席商務長 Zach Jonasson。Absci 藥物研發資深副總裁 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 the Securities and Exchange Commission. 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. This conference call contains time-sensitive information and is accurate only as of the live broadcast, August 12, 2025.
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。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任何財務或產品線預測或其他前瞻性聲明的意圖或義務。本次電話會議包含時間敏感訊息,僅截至 2025 年 8 月 12 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
Thanks, Alex. Good afternoon, everyone. Thank you for joining our Q2 2025 business update call. The last few months have been very productive for Absci as we continue to execute across all aspects of our business. In May, we initiated Phase 1 clinical trials for ABS-101, a potential best-in-class anti-TL1A antibody.
謝謝,亞歷克斯。大家下午好。感謝您參加我們的 2025 年第二季業務更新電話會議。過去幾個月對 Absci 來說是非常有成效的,因為我們繼續執行業務的各個方面。5 月,我們啟動了 ABS-101(一種潛在的最佳抗 TL1A 抗體)的 1 期臨床試驗。
This ongoing study is designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of this program. We continue to see tremendous value in the potentially differentiated profile of this molecule, and I expect to report interim results later this year from this ongoing study in Australia. We also continue to make progress in a potentially first-in-class by-specific antibody that leverages ABS-101 in conjunction with a novel arm.
這項正在進行的研究旨在評估該計劃的安全性、耐受性、藥物動力學和藥效學。我們繼續看到這種分子的潛在差異化特徵的巨大價值,我預計將在今年稍後報告這項在澳洲正在進行的研究的中期結果。我們也持續在利用 ABS-101 與新型臂結合的潛在同類首創特異性抗體方面取得進展。
We are pleased to share that interest from potential partners regarding our TL1A antibody, as well as our potential bispecific program remained very strong. While ABS-101 advances through the clinic, we are excited to have our second program, ABS-201, accelerating towards the clinic too. As a reminder, ABS-201 is our innovative anti-prolactin receptor antibody for androgenetic alopecia, commonly known as male and female pattern hair loss.
我們很高興地告訴大家,潛在合作夥伴對我們的 TL1A 抗體以及我們的潛在雙特異性計畫的興趣仍然非常強烈。在 ABS-101 臨床研究取得進展的同時,我們很高興我們的第二個計畫 ABS-201 也在加速進入臨床研究。提醒一下,ABS-201 是我們針對雄性禿(俗稱男性和女性型禿頭)的創新抗催乳素受體抗體。
This condition affects approximately 80 million adults in the US alone, and there has not been significant therapeutic innovation in this area for nearly 30 years. With our program, ABS-201 represents a potential new category of therapy for androgenetic alopecia, which we believe could offer durable, effective hair regrowth.
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,該領域的治療一直沒有重大創新。透過我們的項目,ABS-201 代表了治療雄性禿的一種潛在新類別,我們相信它可以提供持久、有效的頭髮生長。
In preclinical studies, ABS-201 demonstrates evidence of high potency, favorable safety, low immunogenicity, extended half-life, and great manufacturability. ABS-201 is designed to offer significant improvements as compared to current treatments, such as minoxidil and finasteride. Those treatments are well-known variable or limited efficacy, and in some cases, serious side effects. We continue to rapidly advance this program towards the clinic, guided by a network of distinguished hair and dermatology experts across the globe.
在臨床前研究中,ABS-201 表現出高效力、安全性好、免疫原性低、半衰期延長和可製造性好等特徵。ABS-201 旨在與米諾地爾和非那雄胺等現有治療方法相比提供顯著的改進。眾所周知,這些治療方法療效不穩定或有限,並且在某些情況下會產生嚴重的副作用。在全球傑出的頭髮和皮膚病學專家網絡的指導下,我們將繼續快速推進該計劃向臨床應用。
We anticipate initiation of a Phase I QA trial in early '26 with potential interim efficacy and proof-of-concept data anticipated later that year. We plan to develop ABS-201 internally through later stage clinical development and proof-of-concept to realize maximum value, given its potentially promising profile, defined development path, and large market.
我們預計將於 26 年初啟動 I 期 QA 試驗,並預計在當年稍後獲得潛在的中期療效和概念驗證數據。鑑於 ABS-201 的潛在前景、明確的發展路徑和龐大的市場,我們計劃透過後期臨床開發和概念驗證在內部進行開發,以實現其最大價值。
As a reminder, we also continue to progress on several additional programs. ABS-301, this is a potential first-in-class antibody targeting, an undisclosed immuno-oncology target identified through a reverse immunology platform. Early data indicate potential broad applicability, squamous cell, carcinoma, and other indications.
提醒一下,我們還在繼續推進幾個其他項目。ABS-301,這是一種潛在的同類首創抗體標靶藥物,是透過反向免疫學平台確定的未公開的免疫腫瘤學標靶。早期數據顯示其具有廣泛的適用性,包括鱗狀細胞、癌症和其他適應症。
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 settings, efficacy against a trastuzumab-resistant xenograft tumor, and good developability. Beyond all these programs, we have a number of exciting early-stage programs in our pipeline we have not yet revealed.
ABS-501。這是使用我們的零樣本從頭 AI 模型識別出的潛在最佳抗 HER2 抗體。這些 AI 設計線索顯示出新的抗原決定位交互作用、在臨床前環境中與曲妥珠單抗相比增強或相當的效力、對曲妥珠單抗抗藥性異種移植腫瘤的療效以及良好的可開發性。除了這些項目之外,我們還有許多令人興奮的早期項目正在籌備中,但尚未公佈。
As a demonstration of the power of our platform's differentiate capabilities, many of these programs are designed to go after traditionally difficult-to-drug targets such as GPCRs and ion channels. We look forward to sharing additional information on these at a later date.
為了證明我們平台的差異化能力,許多此類程序都旨在追蹤傳統上難以用藥的靶點,例如 GPCR 和離子通道。我們期待稍後分享有關這些的更多資訊。
While we make progress across our portfolio, we continue to advance our AI-integrated drug creation platform, which enables our pipeline of assets and programs and offers differentiated value proposition for potential drug creation partners. Our integrated wet lab and AI approach allows us to generate scalable high-quality data to train our models. We have built a team of world-class AI researchers who harness this data along with industry-leading compute to rapidly validate, iterate on, and optimize our models.
在我們的產品組合取得進展的同時,我們繼續推動我們的人工智慧整合藥物創造平台,這使我們的資產和專案管道更加豐富,並為潛在的藥物創造合作夥伴提供差異化的價值主張。我們整合的濕實驗室和人工智慧方法使我們能夠產生可擴展的高品質資料來訓練我們的模型。我們已經建立了一支世界一流的人工智慧研究團隊,他們利用這些數據以及業界領先的運算能力來快速驗證、迭代和優化我們的模型。
As a reminder, earlier this year, AMD made a $20 million strategic investment in Absci, reflecting their conviction in the potential of our AI-driven drug creation platform. Our collaboration continues to advance, and AMD computes solutions supporting key workloads across our antibody design platform. We will continue to share key updates to this strategic collaboration in the future as they occur.
提醒一下,今年早些時候,AMD 對 Absci 進行了 2000 萬美元的策略性投資,這反映了他們對我們的人工智慧驅動的藥物創造平台潛力的信心。我們的合作不斷推進,AMD 運算解決方案支援我們抗體設計平台上的關鍵工作負載。我們將在未來繼續分享這項戰略合作的重要更新。
As Zach will discuss further in detail, last month we took action to further strengthen our balance sheet. In July, we raised approximately $64 million in gross proceeds through a $50 million underwritten public offering and $14 million from one premier investment firm utilizing our at-the-market facility. We're grateful for all of the investors, new and existing, that have continued to support our mission.
正如扎克將進一步詳細討論的那樣,上個月我們採取了行動來進一步加強我們的資產負債表。7 月份,我們透過 5,000 萬美元的承銷公開發行籌集了約 6,400 萬美元的總收益,並利用我們的市場融資工具從頂級投資公司籌集了 1,400 萬美元。我們感謝所有新舊投資者對我們使命的持續支持。
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?
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Thanks, Sean. As Sean mentioned, we continue to execute across all aspects of our business. Our portfolio of internal and partner programs continues to progress. And we continue to advance discussions with multiple prospective high-quality new partners interested in our platform and or specific internal programs.
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。我們的內部和合作夥伴專案組合不斷取得進展。我們將繼續與對我們的平台和/或特定內部計劃感興趣的多個潛在高品質新合作夥伴推進討論。
This year, we continue to anticipate signing one or more drug creation partnerships, including with a large pharma company. As we have said previously, we plan to provide material updates, when possible, about ongoing internal and partnered programs as they advance through development.
今年,我們將繼續期待與包括一家大型製藥公司在內的多家公司簽署一項或多項藥物研發合作協議。正如我們之前所說,我們計劃在可能的情況下提供有關正在進行的內部和合作計劃在開發過程中取得進展的重要更新。
Case in point, we are pleased to have recently shared an exciting update from our ongoing collaboration with Almirall. Based on our successful AI de novo design of functional antibodies against the collaboration's first target, a difficult to drug ion channel, Almirall has elected a second pair of targets for a bispecific antibody. The first program, having achieved a key technical milestone, will continue to advance in parallel with the new bispecific program.
例如,我們很高興最近分享了與 Almirall 持續合作的令人興奮的最新消息。基於我們針對合作的第一個目標——難以用藥的離子通道——成功進行 AI 從頭設計的功能性抗體,Almirall 選擇了雙特異性抗體的第二對目標。第一個專案已經實現了關鍵的技術里程碑,將繼續與新的雙特異性專案同步推進。
Under the terms of the two-program collaboration, in addition to royalties on future product sales, Absci is eligible to receive up to approximately $650 million in upfront R&D and post-approval milestone payments across both programs. As a reminder, our business strategy is focused on outlicensing or selling our internal programs and co-developed programs, following value inflection proof points. We make decisions about transacting individual programs based on multiple factors with the aim of maximizing overall shareholder value.
根據兩個專案合作的條款,除了未來產品銷售的特許權使用費外,Absci 還可獲得兩個專案高達約 6.5 億美元的前期研發費用和上市後里程碑付款。提醒一下,我們的業務策略重點是遵循價值拐點證明點,對外授權或銷售我們的內部程序和共同開發的程序。我們根據多種因素來決定是否執行單一項目,目的是實現整體股東價值的最大化。
Accordingly, potential transactions may occur as early as preclinical proof-of-concept or at much later stages of development. With respect to ABS-101, we continue to be engaged with multiple interested parties regarding a potential transaction following positive clinical data readouts. We have also identified interest in our TL1A bispecific program, which is currently in early preclinical development. Based on these discussions, we believe there are multiple parties who have strategic interest in acquiring a TL1A asset and also remain confident in our ability to execute a value-accretive ABS-101 transaction.
因此,潛在交易可能早在臨床前概念驗證階段或開發的後期階段就發生。關於 ABS-101,在獲得積極的臨床數據後,我們將繼續與多個感興趣的方就潛在交易進行接觸。我們還發現了人們對 TL1A 雙特異性計畫的興趣,該計畫目前處於早期臨床前開發階段。根據這些討論,我們相信有多方對收購 TL1A 資產有策略興趣,並且對我們執行增值 ABS-101 交易的能力充滿信心。
With respect to ABS-301 and ABS-501, our immuno-oncology and oncology program, respectively, we continue to believe that these programs are better suited for development with a large pharma or biotech company. Accordingly, we intend to seek partners for these programs at earlier stages of development, including potentially at preclinical validation. Conversely, we see strong rationale for developing our ABS-201 androgenetic alopecia program through much later stages of development and potentially through commercialization. This program offers a straightforward clinical development pathway, which includes objective endpoints and the potential for rapid clinical trial recruitment.
對於我們的免疫腫瘤學和腫瘤學計畫 ABS-301 和 ABS-501,我們仍然相信這些計畫更適合與大型製藥或生物技術公司合作開發。因此,我們打算在開發的早期階段為這些項目尋找合作夥伴,包括可能的臨床前驗證階段。相反,我們認為透過更後期的開發階段以及潛在的商業化來開發我們的 ABS-201 雄性禿計畫具有強有力的理由。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。
Moreover, based on our Phase 1/2A clinical trial design, we expect to generate a potential interim proof-of-concept readout for the treatment of androgenetic alopecia in the second half of 2026. We believe we are well-positioned to execute on this clinical development plan, which offers the potential for substantial near-term value creation. As Sean mentioned earlier, beyond these four programs and our partnered programs, we have a number of exciting earlier stage programs in our R&D pipeline, which we plan to discuss at a later date.
此外,根據我們的 1/2A 期臨床試驗設計,我們預計將在 2026 年下半年產生治療雄性禿的潛在中期概念驗證讀數。我們相信,我們已準備好執行這項臨床開發計劃,該計劃有可能在短期內創造巨大的價值。正如肖恩之前提到的,除了這四個項目和我們的合作項目之外,我們的研發管道中還有許多令人興奮的早期項目,我們計劃稍後討論。
Turning now to our financials. Revenue in the second quarter was $600,000 as we continued to progress our partnered programs. Research and development expenses were $20.5 million for the three months and the June 30, 2025, as compared to $15.3 million for the prior year period. This increase was primarily driven by advancement of our internal programs, including direct costs associated with external preclinical and clinical development and an increase in personnel costs and stock compensation expense.
現在來談談我們的財務狀況。隨著我們繼續推進合作項目,第二季的收入達到 60 萬美元。截至 2025 年 6 月 30 日的三個月研發費用為 2,050 萬美元,去年同期為 1,530 萬美元。這一成長主要得益於我們內部專案的進展,包括與外部臨床前和臨床開發相關的直接成本以及人員成本和股票薪酬費用的增加。
Selling, general, and administrative expenses were $8.5 million for the three months ended June 30, 2025, as compared to $9.3 million for the prior year period. This decrease was primarily due to a decrease in stock compensation expense. As an organization, we have continued to identify and realize operational efficiencies in R&D and SG&A, which will in part offset elevated spending in other areas of R&D, such as clinical trial expenses.
截至 2025 年 6 月 30 日的三個月,銷售、一般及行政費用為 850 萬美元,去年同期為 930 萬美元。這一下降主要是由於股票薪酬費用的減少。作為一個組織,我們不斷識別和實現研發和銷售、一般及行政費用方面的營運效率,這將在一定程度上抵消研發其他領域(如臨床試驗費用)的支出增加。
Cash, cash equivalents, and short-term investments as of June 30, 2025 were $117.5 million as compared to $134 million as of March 31, 2025. After the quarter closed, we raised an additional approximately $64 million in gross proceeds, $50 million of which was raised through an underwritten public offering, and $14 million of which was raised through our ATM facility. The utilization of the ATM facility was entirely related to a single large inbound order placed by a premier long-only mutual fund investor. Our decision to execute these capital raises was strategic, targeted, and sized to proactively improve our balance sheet, supporting the achievement of key clinical readouts and other potential catalysts.
截至 2025 年 6 月 30 日的現金、現金等價物和短期投資為 1.175 億美元,而截至 2025 年 3 月 31 日為 1.34 億美元。本季結束後,我們又籌集了約 6,400 萬美元的總收益,其中 5,000 萬美元是透過承銷公開發行籌集的,1,400 萬美元是透過我們的 ATM 設施籌集的。ATM 設施的使用完全與主要多頭共同基金投資者下達的一筆大額入場訂單有關。我們決定進行這些融資是具有戰略意義的、有針對性的,而且規模適中,可以積極改善我們的資產負債表,支持實現關鍵的臨床讀數和其他潛在催化劑。
With this additional capital, we believe our existing cash, cash equivalents, and short-term investments will now 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 our fully-owned programs such as ABS-101. With this strengthened balance sheet, we believe we are well-positioned to advance our internal programs including accelerating the development of ABS-201 toward a potential proof-of-concept readout in the second half of next year and to advance ongoing and new partnership discussions associated with our internal programs and platform. In sum, we are encouraged by our recent progress and excited to execute on the next phases of our strategy.
有了這些額外的資本,我們相信我們現有的現金、現金等價物和短期投資將足以支持我們到 2028 年上半年的營運。我們認為,基於與大型製藥公司的新平台合作和/或與我們全資擁有的項目(如 ABS-101)相關的資產交易可能帶來的潛在非稀釋性現金流入,這一預測還有額外的上行空間。憑藉這一增強的資產負債表,我們相信我們已做好準備,推進我們的內部項目,包括加速 ABS-201 的開發,以便在明年下半年獲得潛在的概念驗證讀數,並推進與我們的內部項目和平台相關的正在進行的和新的合作夥伴關係討論。總之,我們對最近的進展感到鼓舞,並對執行我們策略的下一階段感到興奮。
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. I'd like to close by thanking our team at Absci for their dedication and drive as we seek to achieve the impossible. And to all of our shareholders, new and existing, we thank you for your continued support. We see a number of potential major catalysts for our company over the next 18 months and beyond, and we're excited to share these updates with you all along the way.
謝謝,扎克。最後,我要感謝 Absci 團隊在我們努力實現不可能的過程中所展現的奉獻精神和動力。我們感謝所有新舊股東一直以來的支持。我們看到,未來 18 個月及以後,我們公司將面臨許多潛在的重大推動因素,我們很高興與大家分享這些最新動態。
Looking ahead, we have strengthened our financial position and now have cash runway into the first half of 2028. We anticipate interim Phase 1 readout for ABS-101 later this year. We expect to close at least one new large pharma deal this year. And our ABS-201 program for androgenetic alopecia is on track to potentially see an interim efficacy readout next year.
展望未來,我們已經加強了財務狀況,現在有足夠的現金儲備維持到 2028 年上半年。我們預計今年稍後將發布 ABS-101 第一階段的中期讀數。我們預計今年將完成至少一項新的大型製藥交易。我們的針對雄性禿的 ABS-201 計畫預計在明年獲得中期療效數據。
To reflect, last year, we had a fully preclinical pipeline. This year, we've become a clinical stage biotech company with ABS-101 entering the clinic. And next year, we anticipate another milestone and potentially major value inflection point for ABS-201, with an interim efficacy and proof of concept readout. For Absci, the future has never been brighter.
回想一下,去年,我們有一個完整的臨床前管道。今年,我們已成為一家臨床階段的生物技術公司,ABS-101 已進入臨床階段。明年,我們預計 ABS-201 將迎來另一個里程碑和潛在的重大價值轉折點,並公佈中期療效和概念驗證讀數。對 Absci 來說,未來從未如此光明。
With that, I'll turn the call back over to the operator to begin Q&A. Operator?
說完這些,我將把電話轉回給接線生開始問答。操作員?
Operator
Operator
(Operator Instructions) Brendan Smith, TD Cowen.
(操作員指示) Brendan Smith,TD Cowen。
Brendan Smith - Analyst
Brendan Smith - Analyst
Great. Thanks for taking the questions, guys. Congrats on all the progress. Great to see. First, quickly, can you just remind us what kind of data, maybe how many patients, and length of follow-up we can expect from this first TL1A data readout later this year, and then I'll have a follow-up.
偉大的。謝謝大家回答這些問題。祝賀你取得的所有進展。很高興看到。首先,您能否快速提醒我們,今年稍後我們可以從第一個 TL1A 數據讀數中獲得什麼樣的數據、可能有多少患者以及隨訪時長,然後我會進行跟進。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, absolutely. Thanks, Brandon. I'll pass that over to Christian to answer that.
是的,絕對是如此。謝謝,布蘭登。我將把這個問題交給克里斯蒂安來回答。
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
Thanks, John. This is Christian Stegman. Yes, we have planned to dose approximately 40 healthy volunteers for the ABS-101 Phase 1 study. And we expect to see pharmacokinetic and pharmacokinetic data at the interim readout, plus we expect to have a first read on immunogenicity. Does that answer your question?
謝謝,約翰。我是克里斯蒂安‧史特格曼。是的,我們計劃為 ABS-101 第一階段研究招募約 40 名健康志願者。我們希望在中期讀數中看到藥物動力學和藥物動力學數據,此外,我們還希望對免疫原性進行首次讀數。這回答了你的問題嗎?
Brendan Smith - Analyst
Brendan Smith - Analyst
Yes, that's great. And then just quickly on 201, can you just remind us what the current plan is from a formulation and dosing perspective? I understand it's not going to be in the clinic until early next year. But do you have a sense of maybe how often you think you'd need to dose and whether you'll do IV or subq, and just any important potential pivot points and development path ahead that's kind of driving some of those decisions?
是的,太棒了。然後就 201 問題,您能否從配方和劑量的角度提醒我們目前的計劃是什麼?據我所知,它要到明年年初才能在臨床上投入使用。但是,您是否知道可能需要多久服用一次藥物,是否需要靜脈注射或皮下注射,以及任何重要的潛在轉折點和未來發展路徑,這些都會影響到這些決定?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, absolutely.
是的,絕對是如此。
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
Go ahead, John.
繼續吧,約翰。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Go for it, Christian.
加油,克里斯蒂安。
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
All right. Thanks, John. We absolutely intend to deliver a subcutaneous formulation for this product as well. We expect to see a six-month treatment cycle for this product and assuming that we reach the expected [TPP]. That will be two or three doses over a period of six months delivered subcutaneously. Now depending on the progress in developing the subcutaneous formulation, we will see the usage of this formulation during the Phase 1 study. It may not be ready for the single ascending dose, but we assume it to be ready for the multiple ascending dose.
好的。謝謝,約翰。我們絕對打算為該產品提供皮下配方。我們預計該產品的治療週期為六個月,並假設我們達到預期[跨太平洋夥伴關係協定]。這將是在六個月內透過皮下注射兩到三劑。現在,根據皮下製劑的開發進展,我們將在第一階段研究中看到該製劑的使用情況。它可能還沒有為單次遞增劑量做好準備,但我們假設它已經為多次遞增劑量做好準備。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, and to double-click on that, we are planning to have IV for the SAD and then the subq for the MAD portion for the efficacy readout in the second half of next year.
是的,為了進一步了解這一點,我們計劃在明年下半年對 SAD 進行靜脈注射,然後對 MAD 部分進行皮下注射,以獲得療效讀數。
Brendan Smith - Analyst
Brendan Smith - Analyst
Okay, got it. And that subq is being developed internally?
好的,明白了。那個 subq 是內部開發的嗎?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
That is correct, in partnership with our CDMO provider. But we do believe that we will ultimately get between 180 to 200 mgs per ml. So we see this being able to formulate for subq.
沒錯,與我們的 CDMO 供應商合作。但我們確實相信,最終我們將獲得每毫升 180 至 200 毫克的濃度。因此,我們看到這可以為 subq 制定公式。
Brendan Smith - Analyst
Brendan Smith - Analyst
Great. Thanks, guys
偉大的。謝謝大家
Operator
Operator
Srikripa Devarakonda, Truist.
Srikripa Devarakonda,Truist。
Your line is now open. Please check your mute button.
您的線路現已開通。請檢查您的靜音按鈕。
Unidentified Participant
Unidentified Participant
Hello, can you hear me now?
你好,現在能聽到我說話嗎?
Operator
Operator
Yeah.
是的。
Unidentified Participant
Unidentified Participant
All right, this is Alex on for Kripa. But maybe a big picture question from us, we've heard through investor discussion that you know many big pharma players have advanced AI-based systems that they might not talk about with regularity but are still there and that includes drug discovery. What is your longer-term vision or your longer term value propositions to remain competitive, given the parallel developments at other companies?
好的,我是 Alex,代表 Kripa 發言。但也許我們要問的一個大問題是,我們透過投資者討論聽說,許多大型製藥公司都擁有先進的基於人工智慧的系統,他們可能不會定期談論這些系統,但這些系統仍然存在,其中包括藥物發現。考慮到其他公司的類似發展,您的長期願景或長期價值主張是什麼,以保持競爭力?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, it's a great question. I think really where we're wanting to focus in our AI is on the de novo side, so creating these antibodies from scratch. But not only just creating them from scratch, being able to go after hard-to-drug targets like ion channels and GPCRs. And the recent partnership with Almirall, we were working on an ion channel, a very difficult-to-drug target.
是的,這是一個很好的問題。我認為我們真正想要關注的人工智慧是從頭開始的,也就是從頭開始創造這些抗體。但不只是從頭開始創造它們,還能夠追蹤離子通道和 GPCR 等難以用藥的目標。最近,我們與 Almirall 合作,研究離子通道,這是一種很難用藥的目標。
And we were successful in being able to drug that target. And that's actually led to the second election for that Almirall partnership, another difficult to drug target. It's going to be a bispecific. But in all of our partnership discussions and the partnership discussions we have for a large pharma partnership we're looking to announce this year, that all tracks on those hard to drug targets. And so we really see that being a fundamental value prop for us, both for our partner programs, but also for our own internal development.
我們成功地對該目標進行了藥物治療。這實際上導致了 Almirall 合作夥伴關係的第二次選舉,這是另一個難以藥物化的目標。這將是雙特異性的。但是,在我們所有的合作夥伴關係討論中,以及我們希望今年宣布的大型製藥合作夥伴關係討論中,所有這些都圍繞著那些難以實現的藥物目標。因此,我們確實認為這對我們來說是一個基本的價值主張,不僅對我們的合作夥伴計劃,而且對我們自己的內部發展也是如此。
Unidentified Participant
Unidentified Participant
That's great. Thanks. And looking forward to the interim results later this year. Thank you.
那太棒了。謝謝。並期待今年稍後公佈的中期業績。謝謝。
Operator
Operator
Sean Laaman, Morgan Stanley.
摩根士丹利的肖恩拉曼。
Unidentified Participant
Unidentified Participant
Hi, everyone. This is Morgan on for Sean. On the Phase 1 -interim readout for ABS-101, I just wanted to double check one of the primary goals would be seeing the potential for quarterly dosing. And also, I wanted to get your view on the [SPIRE] data that was recently released and how the half-life data showed the potential for quarterly to potentially semi-annually dosing? And what your response would be to that data? Thank you.
大家好。這是摩根 (Morgan) 代替肖恩 (Sean)。在 ABS-101 的第 1 期中期讀數中,我只是想再次確認主要目標之一是否是看到每季給藥的可能性。另外,我想聽聽您對最近發布的 [SPIRE] 數據的看法,以及半衰期數據如何顯示每季度或每半年給藥的可能性?您對這些數據的反應是什麼?謝謝。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, absolutely. So the data readout will be able to confirm the half-life, which we are anticipating to be once quarterly. So that will be an important readout at the end of this year for ABS-101. And I'll hand it over to Christian to respond to the SPIRE data and what we're hearing from KOLs in terms of quarterly versus semi-annually.
是的,絕對是如此。因此數據讀數將能夠確認半衰期,我們預計每季一次。因此,這將是今年年底 ABS-101 的一個重要讀數。我將把時間交給克里斯蒂安 (Christian),讓他對 SPIRE 數據以及我們從 KOL 那裡聽到的有關季度和半年的數據做出回應。
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
Yeah, thanks, Sean. Absolutely. So yes, we think SPIRE definitely has shown very solid data. We cannot comment on specific properties of their molecule. We will note, though, that their CMC package does potentially have a few open questions, in particular when it comes to the likelihood of success for combination formulations at the needed doses that they intend to deliver.
是的,謝謝,肖恩。絕對地。所以是的,我們認為 SPIRE 確實顯示了非常可靠的數據。我們無法評論其分子的具體性質。不過,我們會注意到,他們的 CMC 方案確實可能存在一些懸而未決的問題,特別是在涉及他們打算提供的所需劑量的組合配方成功的可能性時。
In principle, we think that just like their molecule, our molecule will have an extended half-life. And whether we talk about once quarterly or every six months is ultimately going to be driven by the chosen dose and by the overall observed terminal half-life of the molecules, plus commercial considerations. So we will expect to be in a similar range here. But at this point, given the stage of our program, it would not be prudent to make such claims.
原則上,我們認為就像他們的分子一樣,我們的分子也會有延長的半衰期。我們談論的是每季一次還是每六個月一次,最終將取決於所選劑量和分子的整體觀察到的終末半衰期以及商業考慮。因此我們期望這裡也處於類似的範圍內。但目前,考慮到我們計劃所處的階段,做出這樣的聲明並不明智。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah. And additionally, I'll just mention that at least talking with KOLs, we actually think once quarterly lines up really nicely with in-doctor visits for patients. And that convenience is important, and we don't really see a major difference between once quarterly and twice a year.
是的。此外,我還要提一下,至少在與 KOL 交談時,我們實際上認為每季一次的就診與患者的就診非常吻合。這種便利性非常重要,我們並沒有發現每季一次和每年兩次之間有什麼重大差異。
We do continue to believe that differentiation with different bispecific approaches is going to be important to show potential better efficacy. And that's where I think we're getting a lot of interest on this bispecific that we're developing that does have a novel arm. And we're excited to see what that efficacy looks like compared to other combo-based approaches as well as head-to-head to TL1A as a mono-based therapy.
我們確實繼續相信,採用不同的雙特異性方法進行區分對於顯示潛在的更好的功效非常重要。這就是我認為我們對正在開發的這種具有新穎功能的雙特異性抗體產生濃厚興趣的原因。我們很高興看到這種療法與其他組合療法以及與 TL1A 單一療法的正面對比效果。
Unidentified Participant
Unidentified Participant
Okay. Thank you.
好的。謝謝。
Operator
Operator
Arseniy Shabashvili, Guggenheim.
阿爾謝尼·沙巴什維利,古根漢。
Arseniy Shabashvili - Analyst
Arseniy Shabashvili - Analyst
Thank you for taking our questions. On your early oncology programs, ABS-301 and 501, what are the next preclinical milestones? And what would trigger advancement into IND-enabling studies? And can you also provide more detail on the competitive landscape and commercial ratio now for these programs?
感謝您回答我們的問題。在您早期的腫瘤學計畫 ABS-301 和 501 中,下一個臨床前里程碑是什麼?那麼什麼會推動 IND 支持研究的進展呢?您能否提供這些項目目前的競爭格局和商業比例的更多細節?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, absolutely. And maybe I'll hand this over to Zach, and I think he can answer it in the context of what some of our potential partners are looking for these assets and our strategic thought on how to best pursue these assets. So Zach, I'll hand it over to you.
是的,絕對是如此。也許我會把這個問題交給扎克,我認為他可以根據我們的一些潛在合作夥伴正在尋找這些資產以及我們如何最好地追求這些資產的戰略思想來回答這個問題。那麼扎克,我將把它交給你。
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Thanks, Sean, and thanks for the question, Arseniy. The major thrust there right now for both of those programs is doing additional in vivo work. And I think when we complete that work, we would have a DC package.
謝謝,肖恩,也謝謝你的提問,阿謝尼。目前這兩個項目的主要重點是進行額外的體內研究。我認為當我們完成這項工作時,我們將擁有一個 DC 包。
And from a business standpoint, as Sean mentioned, we would look to partner those programs early. We believe those are both better suited to a large pharma. And we've certainly had quite a lot of engagement from large pharma and interest around the 301 program. So we would expect to transition those programs into a partnering strategy once we complete the drug, the DC package, either later this year or early next year.
從商業角度來看,正如肖恩所提到的,我們希望儘早與這些項目建立合作關係。我們相信這兩種方式都更適合大型製藥公司。確實,我們已經得到了很多大型製藥公司的參與,他們對 301 計畫也很感興趣。因此,我們希望在今年稍後或明年年初完成藥物 DC 方案後,將這些項目轉變為合作策略。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, and in terms of where we're headed as a company, a lot of the earlier stage pipeline continues to be in [INI], and we really want to stay focused on that. And at our upcoming R&D day, we will be talking about another DC that is within INI, and this is where we want to continue to kind of build out our own internal portfolio. And in oncology, on those two particular assets, as Zach mentioned, being able to out-license those once we have that DC package and that in vivo validation. And I think those discussions that we've had with large pharma around those assets, I think, have been going really well.
是的,就我們公司的發展方向而言,許多早期階段的管道仍然處於 [INI] 狀態,我們確實希望繼續專注於此。在我們即將到來的研發日上,我們將討論 INI 內的另一個 DC,我們希望在這裡繼續建立我們自己的內部產品組合。在腫瘤學方面,正如 Zach 所提到的那樣,對於這兩個特定資產,一旦我們擁有了 DC 包和體內驗證,就能夠將其授權出去。我認為我們與大型製藥公司就這些資產進行的討論進展非常順利。
Arseniy Shabashvili - Analyst
Arseniy Shabashvili - Analyst
Understood. And maybe one more related question on 201. You previously talked about the potential development of ABS-201 for endometriosis. Could you talk about your latest thinking on prioritizing the endometriosis indication versus alopecia?
明白了。也許還有一個關於 201 的相關問題。您之前談到 ABS-201 治療子宮內膜異位症的潛在發展。您能談談您對優先考慮子宮內膜異位症還是脫髮症的最新想法嗎?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, absolutely. We think endometriosis is a really exciting indication to go after. And we are going to be positioning the Phase 1/2A trial for 201 to include female patients to be able to, if we choose to in parallel to a Phase 2/3. And androgenic alopecia, we could also run a Phase 2 efficacy in endometriosis. And we will at a later point in time be talking more about this particular indication. And that's currently all upside and kind of optionality, but we are making sure that we have that optionality if the capital is there to prosecute on that Phase 2. But we are excited about that indication, and we'll be providing more information here at a later date.
是的,絕對是如此。我們認為子宮內膜異位症是一個非常令人興奮的指標。如果我們選擇與 2/3 期試驗同時進行,我們將在 201 年定位 1/2A 期試驗,以便能夠將女性患者納入其中。對於雄性禿,我們也可以對子宮內膜異位症進行第 2 期療效研究。我們稍後會進一步討論這一特定指徵。目前這些都是好處和可選性,但如果有足夠的資金來執行第二階段,我們會確保我們有這種可選性。但我們對此跡象感到興奮,稍後我們將提供更多資訊。
Arseniy Shabashvili - Analyst
Arseniy Shabashvili - Analyst
Thank you.
謝謝。
Operator
Operator
Gil Blum, Needham and Company.
吉爾布魯姆,尼德漢姆公司。
Gil Blum - Equity Analyst
Gil Blum - Equity Analyst
Good afternoon, everyone, and thanks for taking our question. So maybe a general one here. Should we expect to start seeing revenue recognition from partners? I'm assuming there's some transfer of money from partners, considering all the work that you're currently doing. And as a follow-on, is ongoing debate with additional pharma, is that predicated on any specific data you're going to put out? Or is these discussions are going in parallel? Thank you.
大家下午好,感謝您回答我們的問題。所以這裡可能有一個普遍的情況。我們是否應該期待看到來自合作夥伴的收入確認?考慮到您目前所做的所有工作,我假設合作夥伴會轉移一些資金。作為後續問題,您正在與其他製藥公司進行辯論,這是否基於您要發布的任何具體數據?還是這些討論是同時進行的?謝謝。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Zach, I'll let you take that.
札克,我讓你拿著它。
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Sure. Gil, the revenue recognition question, the answer is yes. But as you know, these partnership agreements, particularly around the platform, are milestone-oriented. So the revenue is going to be relatively lumpy. And the same would apply to an asset-based transaction. We would expect a large upfront and then milestone payments. It would be lumpy better after. So yeah. So the short answer is yes, but the more detailed answers is you would see that kind of lumpy over the course of the development of those programs.
當然。吉爾,關於收入確認問題,答案是肯定的。但如你所知,這些合作協議,特別是圍繞平台的合作協議,都是以里程碑為導向的。因此收入將會相對不穩定。這同樣適用於基於資產的交易。我們期望獲得大筆預付款,然後是里程碑付款。之後就會好起來。是的。所以簡短的回答是肯定的,但更詳細的答案是,你會在這些程式的開發過程中看到這種不平衡。
And then with respect to our ongoing discussions with pharma, I think what Sean alluded to earlier is there's been a lot of interest in how we've expanded our capabilities to address these difficult drug targets. This would include the INI channel that we've worked on with Almirall, but also what we've done with Caltech against HIV epitope and some other work we've done with some partners.
關於我們與製藥公司正在進行的討論,我認為肖恩之前提到的是,人們對我們如何擴展能力以解決這些困難的藥物目標很感興趣。這包括我們與 Almirall 合作開發的 INI 通道,也包括我們與加州理工學院合作開發的針對 HIV 抗原表位的通道,以及我們與一些合作夥伴共同開發的其他一些工作。
Those are really catalyzing. Those discussions pharma moves at its own pace. But I can tell you we've had very substantive discussions, a lot of diligence work. And we feel confident that we're going to going to meet our guidance of signing at least one large pharma partnership around the platform this year. And I think we're well positioned to do more of those partnerships as we move into '26.
這些確實具有催化作用。這些討論都是製藥公司按照自己的步調進行的。但我可以告訴你,我們進行了非常實質的討論,做了大量的盡職調查工作。我們有信心,今年我們將實現我們的目標,圍繞該平台簽署至少一個大型製藥合作協議。我認為,隨著我們進入26年,我們已準備好建立更多的合作關係。
Operator
Operator
Debanjana Chatterjee, Jones
德班加納·查特吉,瓊斯
Debanjana, your line is open. Please check your mute button.
Debanjana,您的線路已開通。請檢查您的靜音按鈕。
Debanjana Chatterjee - Analyst
Debanjana Chatterjee - Analyst
Hi. Sorry, I was on mute. Thanks for taking my question. So in terms of the ABS-201 data expected in the second half of 2026, could you tell us what is the bar for good data in terms of hair density and terminal hair count improvement? How we should benchmark the data set?
你好。抱歉,我靜音了。感謝您回答我的問題。那麼,就預計在 2026 年下半年獲得的 ABS-201 數據而言,您能否告訴我們,在毛髮密度和終毛數量改善方面,良好數據的標準是什麼?我們應該如何對資料集進行基準測試?
Alexander Khan - Vice President, Finance & Investor Relations
Alexander Khan - Vice President, Finance & Investor Relations
Yeah, absolutely. Christian, do you want to take that?
是的,絕對是如此。克里斯蒂安,你想接受這個嗎?
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
Yeah, a great question. We have not yet disclosed our clinical development and target product profile plan in detail, but you're totally correct. The target area hair count is obviously the number one efficacy endpoint to look for in an androgenic alopecia trial. And we are actively designing our study to deliver efficacy readout against this endpoint. And we'll share more details in terms of the exact bar at R&D day later this year.
是的,這是一個很好的問題。我們尚未詳細披露我們的臨床開發和目標產品概況計劃,但您完全正確。目標區域的毛髮數量顯然是雄性禿試驗中要尋找的首要療效終點。我們正在積極設計我們的研究,以針對此終點提供療效讀數。我們將在今年稍後的研發日上分享更多有關具體標準的細節。
Debanjana Chatterjee - Analyst
Debanjana Chatterjee - Analyst
Sure. And maybe a quick follow-up. Are you able to share if this will be an open-label trial or this will be like a controlled one?
當然。或許還會有快速的跟進。您能否透露這是否是一個開放標籤試驗或是對照試驗?
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
It will definitely be a controlled study.
這肯定是一項對照研究。
Debanjana Chatterjee - Analyst
Debanjana Chatterjee - Analyst
Okay. Thank you so much.
好的。太感謝了。
Operator
Operator
[Steven Deckert], KeyBanc.
[Steven Deckert],KeyBanc。
Steven Deckert - Analyst
Steven Deckert - Analyst
Hey, guys, just given the expanded partnership with Almirall, we're wondering how much capacity you feel like you have for additional programs and partnerships. Thanks.
嘿,夥計們,鑑於與 Almirall 的合作關係剛剛擴大,我們想知道您認為自己有多少能力開展更多項目和合作。謝謝。
Alexander Khan - Vice President, Finance & Investor Relations
Alexander Khan - Vice President, Finance & Investor Relations
Zach, you want to take that?
札克,你想拿走那個嗎?
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Zachariah Jonasson - Chief Financial Officer, Chief Business Officer
Sure. It's a great question. We look at our capacity on a quarterly basis. And I think we're in good shape for what we want to accomplish with existing partners, as well as what we're projecting for a new large pharma partnership later this year. And that's also in conjunction with what we're doing to build our own internal portfolio.
當然。這是一個很好的問題。我們按季度審視我們的產能。我認為,我們與現有合作夥伴的合作進展順利,我們計劃在今年稍後與新的大型製藥公司建立合作關係。這也與我們建立自己的內部投資組合的做法一致。
One of the really exciting things about the AI platform we're building is it not only is increasing its capabilities to address these difficult-to-target drugs, but it also creates a number of efficiencies, which allows us to leverage our manpower better and essentially take on more programs per unit cost. To put a finer point on it, we make that evaluation on a quarterly basis and make sure that we have sufficient capacity to do everything we need to do with partners as well as what we're working on for our internal portfolio.
我們正在建立的人工智慧平台真正令人興奮的一點是,它不僅提高了解決這些難以靶向的藥物的能力,而且還提高了許多效率,這使我們能夠更好地利用我們的人力,並從本質上以單位成本承擔更多的項目。更確切地說,我們每季進行一次評估,並確保我們有足夠的能力與合作夥伴一起完成我們需要做的一切,以及我們正在為內部投資組合進行的工作。
Steven Deckert - Analyst
Steven Deckert - Analyst
Great. Thanks. You kind of mentioned it in a previous question, but I'm just hoping to get an update on the caldera region of HIV. Just anything new with that program you can talk about. Thanks.
偉大的。謝謝。您在之前的問題中提到過這一點,但我只是希望了解 HIV 火山口區域的最新情況。您可以談論有關該程式的任何新內容。謝謝。
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, we have nothing new to update on -- with that particular program. It is currently in the hands of Caltech for their portion of the collaboration. But it is progressing well, and we plan to update everyone once we have more information to share on that program. But it is progressing, and we're very excited about the potential of that program.
是的,對於該特定程序,我們沒有什麼新內容可以更新。目前,該部分合作由加州理工學院負責。但進展順利,一旦我們有更多關於該計劃的資訊可以分享,我們計劃向大家通報。但它正在取得進展,我們對該計劃的潛力感到非常興奮。
Steven Deckert - Analyst
Steven Deckert - Analyst
All right, thank you.
好的,謝謝。
Operator
Operator
(Operator Instructions) Swayampakula Ramakanth, HCW.
(操作員說明)Swayampakula Ramakanth,HCW。
Unidentified Participant
Unidentified Participant
Thank you. This is (inaudible) Good afternoon, Sean and Zach. It's quite clear that you want to take the 201 program all the way to commercialization. In general, what's the development plan for this? So beyond the study that you're planning to do, does it require just one Phase 3 study? And what sort of timeline are we talking about for this drug to get to commercialization?
謝謝。這是(聽不清楚)下午好,肖恩和札克。很明顯,您想將 201 計劃推向商業化。整體來說,這個的發展計畫是怎樣的?那麼除了您計劃進行的研究之外,是否只需要進行第 3 階段研究?我們談論的這種藥物實現商業化的時間表是什麼樣的?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, that's a great question, RK. And the way we're looking at this is after the Phase 1/2A trial, we would then plan to do a worldwide Phase 2, Phase 3 trial and would anticipate a potential approval in 2030, 2031, if all goes to plan. Obviously, all of this is still very early and in the works. That's kind of our initial plan at the moment. But as we progress in this initial trial, we'll plan to provide more updates on that. And I don't know, Christian, if you have anything else to add on that.
是的,RK,這是一個很好的問題。我們對此的看法是,在完成 1/2A 期試驗後,我們計劃進行全球 2 期、3 期試驗,如果一切按計劃進行,預計可能在 2030 年、2031 年獲得批准。顯然,所有這一切仍處於早期階段並正在進行中。這就是我們目前的初步計劃。但隨著初步試驗的進展,我們計劃提供更多相關更新。克里斯蒂安,我不知道你對此還有什麼要補充的。
Christian Stegmann - Senior Vice President, Drug Creation
Christian Stegmann - Senior Vice President, Drug Creation
No, absolutely, Sean. We will set up this clinical development program in a very time-sensitive manner. As Sean mentioned, our study will be a Phase 1, Phase 2a study that will allow us to go directly into a combined Phase 2, Phase 3 study. And obviously, this indication requires a very benign safety profile for this indication. Hence, we pay a lot of attention to design our study in a prudent manner. At the same time, we are confident that we can execute this program in a way that allows us to get to a BLA submission, as Sean mentioned, in the 2030, 2031 timeframe.
不,絕對不,肖恩。我們將以非常及時的方式建立這個臨床開發計劃。正如肖恩所提到的,我們的研究將是第 1 階段、第 2a 階段的研究,這將使我們能夠直接進入第 2 階段、第 3 階段的共同研究。顯然,該適應症需要非常良好的安全性。因此,我們非常重視以審慎的方式設計我們的研究。同時,我們有信心以一種允許我們在 2030 年、2031 年期間提交 BLA 的方式執行該計劃。
Unidentified Participant
Unidentified Participant
Thanks. The second question from me is, Sean, during the prepared remarks, you were saying something about unveiling additional programs during an R&D day this year. So the four programs that we are talking of today, obviously, they're in different therapeutic categories. So as you go forward, is there a plan to be focusing more on the specific therapeutic category? Or is it all dependent on what comes down your way?
謝謝。我的第二個問題是,肖恩,在準備好的演講中,您談到了在今年的研發日期間公佈更多項目的事情。因此,我們今天討論的四個項目顯然屬於不同的治療類別。那麼,在未來的發展中,是否有計劃更加關注特定的治療類別?還是一切都取決於你接下來會發生什麼事?
Sean McClain - Chief Executive Officer, Founder, Director
Sean McClain - Chief Executive Officer, Founder, Director
Yeah, so we're going to continue to work with partners and a lot of different indications. But as we look to build out our own internal pipeline, I think we do have more of a focus on INI as well as metabolism and cardiometabolic diseases. And we'll be sharing more at R&D day. I don't think we've sent out an exact time on when that R&D day is going to be at the current moment. But we will have further updates on our internal pipeline at that point in time.
是的,所以我們將繼續與合作夥伴合作並嘗試許多不同的方法。但當我們尋求建立自己的內部管道時,我認為我們確實更加關注 INI 以及代謝和心臟代謝疾病。我們將在研發日分享更多資訊。我認為我們目前還沒有公佈研發日的具體時間。但我們將在那時對我們的內部管道進行進一步的更新。
Unidentified Participant
Unidentified Participant
Thank you. Thanks for taking my question.
謝謝。感謝您回答我的問題。
Operator
Operator
This will end today's question-and-answer session and concludes today's conference call. Thank you for participating, and you may now disconnect.
今天的問答環節和電話會議到此結束。感謝您的參與,您現在可以斷開連接了。