Q2 2025 Absci Corp Earnings Call
Speaker #1: Quarter 2025 business update call. At this time, all participants are on the listen-only mode. After the speaker's presentation, there will be a question and answer session.
Operator: Second quarter 2025 business update call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Alec Khan, Vice President, Finance and Investor Relations. Please go ahead.
Speaker #1: To ask a question during the session, you will need to press star one on your telephone. You will then hear an automated message advising your hand is raised.
Speaker #1: To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to Alex Khan, Vice President, Finance and Investor Relations.
Speaker #1: Please go ahead.
Speaker #2: Thank you. Earlier today, Absci released financial and operating results for the quarter ended June 30th, 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.
Alex Khan: Thank you. Earlier today, Absci released financial and operating results for the quarter ended June 30th, 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. Joining me today are Sean McClain, Absci's founder and CEO, and Zach Johnson Johnasson, Chief Financial Officer and Chief Business Officer. Christian Stegemann, Absci's SVP of Drug Creation, will also be joined for Q&A following prepared remarks. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws.
Speaker #2: 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.
Speaker #2: Joining me today are Sean McClain, Absci's founder and CEO, and Zach Jonasson, Chief Financial Officer and Chief Business Officer. Christian Stegman, Absci's SVP of Drug Creation, will also be joined for Q&A following the prepared remarks.
Speaker #2: Before we begin, I'd like to remind you that the manager will make statements during this call that are forward-looking within the meaning of the Federal Securities Laws.
Speaker #2: 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.
Alex Khan: 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. Additional information regarding these risks, uncertainties, and factors that could cause results to differ appears in the section entitled "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 12th, 2025. With that, I'll turn the call over to Sean.
Speaker #2: Additional information regarding these risks, uncertainties, and factors that could cause results to differ appears in the section entitled '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.
Speaker #2: This conference call contains time-sensitive information and is accurate only as of the live broadcast on August 12, 2025. With that, I'll turn the call over to Sean.
Speaker #3: 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.
Sean McClain: 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 one clinical trials for ABS-101, a potential best-in-class anti-TL1A antibody. 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 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 bispecific antibody that leverages ABS-101 in conjunction with a novel arm. We are pleased to share that interest from potential partners regarding our TL1A antibody, as well as our potential bispecific program, remains very strong.
Speaker #3: In May, we initiated phase one clinical trials for ABS 101. Our potential best-in-class anti-TL1A antibody; this ongoing study is designed to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of this program.
Speaker #3: We continue to see tremendous value in the potentially differentiated profile of this molecule and expect to report interim results later this year from this ongoing study in Australia.
Speaker #3: We also continue to make progress in a potentially first-in-class bispecific antibody that leverages ABS 101 in conjunction with a novel arm. We are pleased to share that interest from potential partners regarding our TL1A antibody as well as our potential bispecific program remain very strong.
Speaker #3: 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 antiprolactin receptor antibody for androgenetic alopecia, commonly known as male and female pattern hair loss.
Sean McClain: 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 antiprolactin receptor antibody for androgenetic alopecia, commonly known as male and female pattern hair loss. 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. 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 of well-known variable or limited efficacy, and in some cases, serious side effects.
Speaker #3: This condition affects approximately 80 million adults in the U.S. alone, and there has not been significant therapeutic innovation in this area for nearly 30 years.
Speaker #3: With our program, ABS201 represents a potential new category of therapy for androgenetic alopecia, which we believe could offer durable, effective hair regrowth. In preclinical studies, ABS201 demonstrates evidence of high potency, favorable safety, low immunogenicity, extended half-life, and great manufacturability.
Speaker #3: ABS 201 is designed to offer significant improvements as compared to current treatments such as minoxidil and finasteride. Those treatments are well known to variable or limited efficacy and in some cases serious side effects.
Speaker #3: We continue to rapidly advance this program towards the clinic, guided by a network of distinguished hair and dermatology experts across the globe. We anticipate initiation of a phase one QA trial in early 2026 with potential interim efficacy and proof of concept data anticipated later that year.
Sean McClain: We continue to rapidly advance this program towards the clinic, guided by a network of distinguished hair and dermatology experts across the globe. We anticipate initiation of a phase one QA trial in early 2026, 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. 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 in squamous cell carcinoma and other indications. ABS-501, this is a potential best-in-class anti-HER2 antibody identified using our zero-shot de novo AI models.
Speaker #3: 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, as a reminder, we also continue to progress on several additional programs.
Speaker #3: 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.
Speaker #3: 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, increase or equivalent potency to trastuzumab in preclinical settings, efficacy against a trastuzumab-resistant xenograft tumor, and good developability.
Sean McClain: 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. As a demonstration of the power of our platform's differentiated 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. 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.
Speaker #3: Beyond all these programs, we have a number of exciting early-stage programs in our pipeline that we have not yet revealed. As a demonstration of the power of our platform's differentiated capabilities, many of these programs are designed to target traditionally difficult-to-drug targets such as GPCRs and ion channels.
Speaker #3: We look forward to sharing additional information on these at a later date. 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 a differentiated value proposition for potential drug creation partners.
Speaker #3: 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.
Sean McClain: 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. 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 compute solutions support key workloads across our antibody design platform. We will continue to share key updates to this strategic collaboration in the future as they occur. 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.
Speaker #3: 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.
Speaker #3: Our collaboration continues to advance, and AMD compute 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.
Speaker #3: As Zachariah Jonasson 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.
Speaker #3: We are grateful for all of the investors' new and existing that have continued to support our mission. 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.
Sean McClain: We're grateful for all of the investors, new and existing, that have continued to support our mission. 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? 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. 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 partner programs as they advance through development. Case in point, we are pleased to have recently shared an exciting update from our ongoing collaboration with Almiral.
Speaker #3: Zach, thanks, Sean.
Speaker #4: As Sean mentioned, we continue to execute across all aspects of our business. Our portfolio of internal and partnered 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.
Speaker #4: 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.
Speaker #4: Case in point, we are pleased to have recently shared an exciting update from our ongoing collaboration with Amaryl. Based on our successful AI de novo design of functional antibodies against the collaboration's first target, a difficult-to-drug ion channel, Amaryl has elected a second pair of targets for a bispecific antibody.
Sean McClain: Based on our successful AI de novo design of functional antibodies against the collaboration's first target, a difficult-to-drug ion channel, Almiral 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. 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 out-licensing or selling our internal programs and co-develop 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. Accordingly, potential transactions may occur as early as preclinical proof of concept or at much later stages of development.
Speaker #4: The first program, having achieved a key technical milestone, will continue to advance in parallel with the new bispecific program. 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.
Speaker #4: As a reminder, our business strategy is focused on out-licensing 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.
Speaker #4: Accordingly, potential transactions may occur as early as preclinical proof of concept or at much later stages of development. With respect to ABS101, we continue to be engaged with multiple interested parties regarding a potential transaction following positive clinical data readouts.
Sean McClain: 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. 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.
Speaker #4: 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.
Speaker #4: With respect to ABS 301 and ABS 501, our immuno-oncology and oncology programs, respectively, we continue to believe that these programs are better suited for development with a large pharma or biotech company.
Speaker #4: Accordingly, we intend to seek partners for these programs at earlier stages of development, including potentially at preclinical validation. Conversely, we see a strong rationale for developing our ABS 201 androgenetic alopecia program through much later stages of development and potentially through commercialization.
Speaker #4: This program offers a straightforward clinical development pathway, which includes objective endpoints and the potential for rapid clinical trial recruitment. Moreover, based on our phase one/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.
Sean McClain: This program offers a straightforward clinical development pathway, which includes objective endpoints and the potential for rapid clinical trial recruitment. Moreover, based on our phase one slash two A 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 partner programs, we have a number of exciting earlier-stage programs in our R&D pipeline, which we plan to discuss at a later date. Turning now to our financials, revenue in the second quarter was $600,000 as we continue to progress our partner programs.
Speaker #4: 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.
Speaker #4: Which we plan to discuss at a later date. Turning now to our financials, revenue in the second quarter was $600,000, as we continue to progress our partnered programs.
Speaker #4: Research and development expenses were $20.5 million for the three months ended June 30th, 2025, as compared to $15.3 million for the prior year period.
Sean McClain: Research and development expenses were $20.5 million for the three months ended 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. 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.
Speaker #4: 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.
Speaker #4: Selling, general, and administrative expenses were $8.5 million for the three months ended June 30, 2025, compared to $9.3 million for the prior-year period.
Speaker #4: 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.
Speaker #4: Which will in part offset elevated spending in other areas of R&D, such as clinical trial expenses. Cash, cash equivalents, and short-term investments as of June 30th, 2025, were $117.5 million as compared to $134 million as of March 31st, 2025.
Sean McClain: 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 close, 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. 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.
Speaker #4: 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.
Speaker #4: 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.
Speaker #4: 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.
Speaker #4: 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 wholly-owned program, such as ABS 101.
Sean McClain: 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 wholly owned program, 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. With that, I'll turn it back to Sean. 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.
Speaker #4: With this strength and 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.
Speaker #4: 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.
Speaker #4: With that, I'll turn it back to Sean.
Speaker #3: 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, both new and existing, we thank you for your continued support.
Sean McClain: 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. Looking ahead, we have strengthened our financial position and now have cash runway into the first half of 2028. We anticipate interim phase one 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. To reflect, last year we had a fully preclinical pipeline. This year, we have become a clinical stage biotech company with ABS-101 entering the clinic.
Speaker #3: 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.
Speaker #3: Looking ahead, we have strengthened our financial position and now have cash runway, into the first half of 2028. We anticipate interim phase one readout for ABS 101 later this year.
Speaker #3: 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.
Speaker #3: To reflect, last year we had a fully preclinical pipeline. This year, we have become a clinical stage biotech company with ABS 101 entering the clinic.
Speaker #3: 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.
Sean McClain: 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. With that, I'll turn the call back over to the operator to begin Q&A. Operator?
Speaker #3: For Absci, the future has never been brighter. With that, I'll turn the call back over to the operator to begin Q&A. Operator,
Speaker #1: Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced.
Operator: Thank you. As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. The first question comes from Brendan Smith with TVCO, and your line is open.
Speaker #1: To withdraw your question, please press star one one again. The first question comes from Brendan Smith with TV Co. In your line is open.
Speaker #5: Great. Thanks for taking the questions, guys. Congrats to 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 we can expect from this first TL1A data readout later this year?
Brendan Smith: Great. Thanks for taking the questions, guys. Congrats on all the progress. It's 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.
Speaker #5: and and then I'll, I have a follow-up.
Speaker #3: Yeah, absolutely. Thanks. Brendan, we'll, I'll pass that, over to Christian to answer that.
Sean McClain: Yeah, absolutely. Thanks, Brendan. I'll pass that over to Christian to answer that.
Speaker #6: Thanks, Sean. This is Christian Stegman. Yes, we, have, planned to dose approximately 40 healthy volunteers for, the ABS 101 phase one study. and we expect to see, pharmacokinetic and pharmacokinetic data at the interim, readout.
Christian Stegemann: Thanks, Sean. This is Christian Stegemann. Yes, we have planned to dose approximately 40 healthy volunteers for the ABS-101 phase one study. And we expect to see pharmacokinetic and pharmacogenetic data at the interim readout. Plus, we expect to have a first read on immunogenicity. Does that answer your question?
Speaker #6: Plus, we expect to have a first read on immunogenicity. Does that answer your question?
Speaker #5: Yes. Yep, that's great. and and then just quickly on on TL1, can you just remind us what what the current plan is, kind of from a formulation and dosing perspective?
Brendan Smith: Yes. Yep, that's great. And then just quickly on 201, can you just remind us what the current plan is, kind of 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 sub-Q and just any important potential pivot points and development path ahead that's kind of driving some of those decisions?
Speaker #5: 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 sub-Q? And just any important potential pivot points in the development path ahead that's kind of driving some of those decisions?
Speaker #3: Yeah. Yeah, absolutely.
Sean McClain: Yeah, absolutely.
Speaker #6: So, go ahead, Sean.
Christian Stegemann: So go ahead, Sean.
Speaker #3: Go, go for it, Christian.
Sean McClain: Go for it, Christian.
Speaker #6: All All right. Thanks, Sean. 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.
Christian Stegemann: All right. Thanks, Sean. 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 would 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 one study. It may not be ready for the single-assending dose, but we assume it to be ready for the multiple-assending dose.
Speaker #6: And assuming that we reach the expected TPP, that would 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, the, we will see the the usage of this formulation during the phase one study.
Speaker #6: it may not be ready for the single-sending dose, but we assume, it to be ready for the multiple-sending dose.
Speaker #3: Yeah. And to double-click on on that, we we are planning to, have IV for the the SAD and then the the sub-Q for the MAD.
Brendan Smith: Yeah, and to double-click on that, we are planning to have IV for the FAD and then the sub-Q for the MAD portion for the efficacy readout in the second half of next year.
Speaker #3: portion, for the the efficacy readout, in the second half of next year.
Speaker #5: Okay, got it. And that sub-Q is being developed internally?
Sean McClain: Okay, got it. And that sub-Q is being developed internally?
Speaker #3: that is correct. in in partnership with, our, CDMO provider. but we do believe that we, will ultimately, get between, 180 to 200 mgs per ml.
Brendan Smith: That is correct, in partnership with our CDMO provider. But we do believe that we will ultimately get between 180 to 200 mgs/ml. So we see this being able to formulate for sub-Q.
Speaker #3: so we we see this being, able to formulate, for for sub-Q.
Speaker #5: Awesome. Great. Thanks, guys.
Sean McClain: Awesome. Great. Thanks guys.
Speaker #1: And the next question will come from Kripal Devakhanda with TrueWest. Your line is open. Kripal, your line is now open. Please check your mute button.
Operator: And the next question will come from Kripal Devakanda with TrueWith. Your line is open. Kripal, your line is now open. Please check your mute button.
Speaker #4: hello. Can you hear me now?
Alex Long: Hello. Can you hear me now?
Speaker #1: Yes.
Operator: Yes.
Speaker #4: Yep. All right. This is Alex one for Kripa. Maybe a big picture question from us. We've heard through investor discussions 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.
Alex Long: Yep. All right. This is Alex Long for Kripal. Maybe a big picture question from us. We've heard through investor discussion that 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 proposition to remain competitive, you know, given the parallel developments at other companies? Thanks.
Speaker #4: what is your longer-term vision or your your longer-term value proposition to remain competitive, you know, given the parallel developments at other companies? Thanks.
Speaker #3: Yeah, that's a great question. I think really where we're wanting to focus is on the de novo side, so creating these antibodies from scratch.
Sean McClain: Yeah, that'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 Almiral, you know, we were working on an ion channel, a very difficult-to-drug target. And we were successful in being able to drug that target. And that's actually led to the second election for that Almiral partnership, another difficult-to-drug target. It's going to be a bispecific. But, you know, 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.
Speaker #3: But not only just creating them from scratch, but also being able to go after hard-to-drug targets like ion channels and GPCRs. And, you know, the recent partnership with Amaryl— we were working on an ion channel, a very difficult-to-drug target.
Speaker #3: And we were successful in being able to drug that target, and that's actually led to the the second election, for that Amaryl partnership, another, difficult, to-drug target.
Speaker #3: It's going to be a bispecific. but, you know, in in, you know, all of our partnership discussions and, you know, the, partnership discussions we have for large pharma partnership, we're we're looking to announce this year, not all, tracks on those hard-to-drug, targets.
Speaker #3: And so we really see that being a fundamental, value prop for us, both for our, partnered programs, but also for our own, internal development.
Sean McClain: 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.
Speaker #4: That's great. Thanks, and I look forward to the interim results later this year. Thank you.
Alex Long: That's great. Thanks. And looking forward to the interim results later this year.
Sean McClain: Thank you.
Speaker #1: And the next question is going to come from Sean Lahman with Morgan Stanley. Your line is open.
Operator: And the next question is going to come from Sean Lahman with Morgan Stanley. Your line is open.
Speaker #7: Hi, everyone. This is Morgan on for Sean. On the phase one interim readout for ABS 101, I just wanted to double-check one of the primary goals would be seeing the potential for quarterly dosing.
Morgan: Hi, everyone. This is Morgan on for Sean. On the phase one NTR 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 wanted to get your view on the Aspire 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.
Speaker #7: and also 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.
Speaker #7: Thank you.
Speaker #3: Yeah, absolutely. So, the data readout will, be able to confirm, the the half-life, which we are anticipating to be, once quarterly. So that will be important, readout, at at the end of this year for ABS 101.
Sean McClain: 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 Aspire data and what we're hearing from KOLs in terms of quarterly versus semi-annually.
Speaker #3: and I'll hand it over to to Christian to respond to the, the the SPIRE data and and what we're hearing from from KOLs in terms of, quarterly versus, semi, annually.
Speaker #6: 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.
Christian Stegemann: Yeah, thanks, Sean. Absolutely. So yes, we think Aspire 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. 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 state of our program, it would not be prudent to make such claims.
Speaker #6: In particular, when it comes to, the likelihood of success for, combination formulations, at the needed dose, at the needed doses that they, they intend to deliver.
Speaker #6: In principle, we think that just like their molecule, our molecule will have an extended half-life. 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.
Speaker #6: plus commercial considerations. so we will, expect to be in a similar, similar range here. But at this point, given the stage of our program, it would not be prudent to make such claims.
Speaker #3: Yeah. And additionally, I'll just mention that we, at least talking with with KOLs, we actually think once quarterly lines up really nicely with, in-doctor, visits, for patients and, you know, that that convenience, is important and we don't really see a major difference between, once quarterly and and twice a year.
Sean McClain: Yeah, and additionally, I'll just mention that we, at least talking with KOLs, we actually think once quarterly lines up really nicely with in-doctor visits for patients. And you know that convenience is important, and we don't really see a major difference between once quarterly and twice a year. We do continue to believe that differentiation with different bispecific approaches is going to be important to show potential better efficacy. And you know 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 the mono based therapy.
Speaker #3: we we do, continue to believe that, differentiation, with, you know, different bispecific approaches, is going to be, important to show, you know, potential, better efficacy.
Speaker #3: And, you know, that's where, I think we're getting a lot of interest on this bispecific that that we're developing that does have a a novel arm, and, we'll we're we're excited to see, what, that efficacy, looks like, compared to, other-based other combo-based, approaches as well as head-to-head to, you know, TL1A as as the mono-based, therapy.
Speaker #7: Okay. Thank you.
Morgan: Okay. Thank you.
Speaker #1: And the next question will come from Arsali Shabashbili with Guggenheim. Your line is open.
Operator: And the next question will come from Arsenlie Shabashvili with Guggenheim. Your line is open.
Speaker #8: Hi, it's Arsali on for Vamo. thank you for taking our questions. on your earlier oncology programs, ABS 301 and 501, what are the next preclinical milestones?
Christian Stegemann: It's Arsenlie on for Vamel. 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 ING enabling studies? And can you also provide more detail on the competitive landscape and commercial rationale for these programs?
Speaker #8: And what would trigger advancements into IND-enabling studies? And can you also provide more detail on the competitive landscape and commercialization now for these programs?
Speaker #3: Yeah, absolutely. And maybe I'll hand this over to Zach. I think, you know, he can answer it in the context of what some of our potential partners are looking for for these assets and, you know, kind of our strategic thought on how to best pursue these assets.
Sean McClain: Yeah, absolutely. And maybe I'll hand this over to Zach, and I think you know he can answer it in the context of what some of our potential partners are looking for for these assets and you know kind of our strategic thought on how to best pursue these assets. So, Zach, I'll hand it over to you.
Speaker #3: So, Zach, I'll I'll hand it over to you.
Speaker #4: Thanks, Sean. And, thanks for the question, Arsali. The the major thrust there right now for both of those programs is doing additional in vivo work.
Zachariah Jonasson: Thanks, Sean, and thanks for the question, Arsenlie. 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. 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.
Speaker #4: And I think when we complete that work, we will have a DC package. From a business standpoint, as Sean mentioned, we will look to partner those programs early.
Speaker #4: 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.
Speaker #4: So we would expect to transition those programs into, partnering, strategy once we complete the the drug, the DC package. either later this year or early next year.
Speaker #3: Yeah. And, you know, 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.
Sean McClain: Yeah, and you know in terms of where we're headed as a company, you know a lot of the earlier stage pipeline continues to be in INI, and we really want to stay focused on that. And you know 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 that 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.
Speaker #3: And, you know, at our, upcoming R&D day, we 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 in oncology on those two particular assets that Zach mentioned, being able to, out-license those once we have that DC package and that in vivo validation and, and I think those discussions that we've had with large pharma around those assets, I think, have been going really well.
Speaker #6: Understood. And, maybe one more related question on 301. 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?
Christian Stegemann: 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?
Speaker #3: Yeah, absolutely. We think, endometriosis is a really exciting indication to go after. And we are going to be, positioning the, phase one/2A trial for 201, to include, female, patients, to be able to, if we so choose to, in parallel to a phase two, three, and and, androgenic alopecia, we could also run a phase two efficacy in, endometriosis and, we will, at a later point in time, be talking more about, this particular, indication.
Sean McClain: Yeah, absolutely. We think endometriosis is a really exciting indication to go after. And we are going to be positioning the phase one slash two A trial for 201 to include female patients to be able to, if we so choose, in parallel to a phase two, three, and in the androgenetic alopecia, we could also run a phase two 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 two. But we are excited about that indication and will be providing more information here at a later date.
Speaker #3: and that's currently, you know, all, upside and kind of optionality, but we we are making sure that we have that that optionality, if if the capital is is is there to prosecute on that that phase two.
Speaker #3: But we are excited about that indication and, we'll be providing, more information, here at a later date.
Speaker #6: Thank you.
Christian Stegemann: Thank you.
Speaker #1: And our next question will come from Gill Blum with Needham & Company. Your line is open.
Operator: And our next question will come from Gil Blum with Needham & Company. Your line is open.
Speaker #5: Good Good afternoon, everyone. And thanks for taking our question. So, maybe a a general one here. should we expect to start seeing revenue recognition from partners, I'm I'm assuming, there's there's some you know transfer of of money from partners to considering all the work that you're currently doing.
Gil Blum: Good afternoon, everyone, and thanks for taking our question. So maybe a general one here. Should we expect to start seeing a bit of a new 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 this, you know, these discussions are going in parallel? Thank you.
Speaker #5: And as a follow-on, is the ongoing debate with additional pharma predicated on any specific data you're going to put out, or is it just that these discussions are going in parallel?
Speaker #5: Thank you.
Speaker #3: Zach, I'll let you take that.
Sean McClain: Zach, I'll let you take that.
Speaker #4: Sure. Gill, and 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 is is going to be relatively lumpy.
Zachariah Jonasson: Sure. Gil, on 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 is is going to be relatively lumpy. And the same would would apply to an asset-based transaction. We would expect a large upfront and then milestone payments. It would be lumpy thereafter. So yeah, so the answer is the short answer is yes, but the more detailed answer is you would see that kind of lumpy over the course of the development of those programs. 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-to-drug targets.
Speaker #4: In the same way, this would apply to an asset-based transaction. We would expect a large upfront payment, followed by milestone payments that would be lumpy thereafter.
Speaker #4: So I, you know, the short answer is yes, but the more detailed answer is you would see that kind of lumpy over the course of the development of those programs.
Speaker #4: 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.
Speaker #4: This would include the ion channel that we've worked on with Amaryl, but also what we've done with Caltech against, HIV epitope, and some other work we've done with some partners.
Zachariah Jonasson: This would include the IN channel that we've worked on with Almiral, but also what we've done with Caltech against the HIV epitope and some other work we've done with some partners. 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 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.
Speaker #4: 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 meet our guidance of signing at least one large pharma partnership around the platform this year.
Speaker #4: And I think we're well-positioned to do more of those partnerships as we move into '26.
Speaker #1: And the next question will come from Devanana Chatterjee with Jones. Your line is open. Devanana, your line is open. Please check your mute button.
Operator: And the next question will come from Devanjana Chatterjee with Jones. Your line is open. Devanjana, your line is open. Please check your mute button.
Speaker #7: 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?
Devanjana Chatterjee: 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?
Speaker #7: How we should benchmark the data set?
Speaker #3: Yeah, absolutely. Christian, do you want to take that?
Sean McClain: Yeah, absolutely. Christian, do you want to take that?
Speaker #6: 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.
Christian Stegemann: 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.
Speaker #6: And we are, actively, designing our study to deliver efficacy readout against this, this endpoint. And we'll share more details in terms of, the exact, bar, at R&D day later this year.
Speaker #7: 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?
Devanjana Chatterjee: 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?
Speaker #6: It will definitely be a controlled study.
Christian Stegemann: It will definitely be a controlled study.
Speaker #7: Okay. Thank you so much.
Devanjana Chatterjee: Okay. Thank you so much.
Speaker #1: And the next question will come from Steven Deckert with KeyBank. Your line is open.
Operator: And the next question will come from Stephen Deckert with KeyBank. Your line is open.
Speaker #5: Hey, guys. Just given the expanded...
Stephen Deckert: Hey, guys. Just given the expanded partnership with Almiral, we're wondering how much capacity do you feel like you have for additional programs and partnerships? Thanks.
Speaker #4: partnership with Amaryl, we're wondering how much capacity do you feel like you have for additional programs and partnerships? Thanks.
Speaker #3: Zach, do you want to take that?
Sean McClain: Zach, you want to take that?
Speaker #4: 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 a new large pharma partnership later this year.
Zachariah Jonasson: 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, you know, in conjunction with what we're doing to build our own internal portfolio. 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.
Speaker #4: And that's also, you know, in conjunction with what we're doing to build our own internal portfolio. 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.
Speaker #4: Which allows us to leverage our manpower better and essentially take on, more programs per unit cost. So, just to put a finer point on it, we make that evaluation on a quarterly basis.
Zachariah Jonasson: So just to put a finer point in 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.
Speaker #4: 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.
Speaker #3: Great. Thanks. And then you you kind of mentioned in a, previous question, but just hoping to get an update on the caldera region of of HIV.
Stephen Deckert: Great. Thanks. And then you kind of mentioned in a previous question, but just hoping to get an update on the Caldera region of HIV. Just anything new with that program you can talk about? Thanks.
Speaker #3: Just anything new with that program that you can talk about? Thanks.
Speaker #4: Yeah. We have nothing new to update on in with that, particular program. it is, you know, currently in in the hands of of Caltech for their, portion of the the collaboration, but it is, you know, progressing well.
Sean McClain: 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.
Speaker #4: And we plan to update, everyone once we have, more, information to share on that program. But it is, you know, progressing, and we're very excited about, the the potential of that program.
Speaker #3: All right. Thank you.
Stephen Deckert: All right. Thank you.
Speaker #1: As a reminder to ask a question, please press star one one on your telephone and wait for your name to be announced. The next question will come from Swayam Pakula Ramakanth with HCW.
Operator: As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. The next question will come from Swayam Pakula Ramakanth with HCW. Your line is open.
Speaker #1: Your line is open.
Speaker #5: Thank you. this is all clear from HCW and, good afternoon, Sean. I'm Zach. so, it's it's it's quite clear that you want to take the 201 program all the way to commercialization.
Christian Stegemann: Thank you. This is RK from H2NO. Good afternoon, Sean and Zach. So it's quite clear that we want to take the 201 program all the way to commercialization. In general, you know, what's the development plan for this? So beyond the study that you're planning to do, you know, does it require just one phase three study? And you know, what sort of timeline are we talking about for this drug to get to commercialization?
Speaker #5: in in general, you know, what what's the, development plan for this? So beyond the the the study that you're planning to do, you know, the the does it require just one phase three study and, you know, what what sort of timeline are we are we talking about?
Speaker #5: For this, drug to get to commercialization?
Speaker #3: Yeah, that's a great question. RK and and the way we're, looking at this is after the, phase one, two A, trial, we would then plan to do a worldwide, phase two, phase three, trial.
Sean McClain: Yeah, that's a great question, RK. And the way we're looking at this is after the phase one, two A trial, we would then plan to do a worldwide phase two, phase three trial and would anticipate, you know, a potential approval in 2030, 2031 if all goes to plan. Obviously, you know, all of this is still very early and in the works. That's kind of our initial plan at the moment. But you know, 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.
Speaker #3: And, would, anticipate, you know, a potential approval in, you know, 2030, 2031, if if all goes to to plan. Obviously, you know, all of this is is still, very early and in in the works.
Speaker #3: That's kind of our our initial, plan at at the moment. but, you know, as we progress in, you know, this initial trial, we'll we'll plan to provide more updates, on on that.
Speaker #3: And I don't know, Christian, if you have anything else to add on that.
Speaker #6: No, absolutely, Sean. we will set up this, clinical development program in a very, time, sensitive manner. As Sean mentioned, our, study, would be a phase one, phase two A study.
Christian Stegemann: 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 one, phase two A study that will allow us to go directly into a combined phase two, phase three 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 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. Thanks. And 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.
Speaker #6: that will allow us to go directly into a combined phase two, phase three study, and obviously, this indication requires, a very, benign safety profile, for, for this indication.
Speaker #6: Hence, we pay a lot of attention to designing 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.
Speaker #5: Thanks. And the second question from me is, Sean, during the prepared remarks you were saying something about, unveiling additional programs during an R&D day.
Speaker #5: this year, so the the four programs that we are talking of today, obviously, they're on, you know, in different therapeutic categories, so as you go forward, you know, is there a plan to be focusing more in under a specific therapeutic category, or is it all dependent on, you know, what what comes down down, down your way?
Christian Stegemann: So the four programs that we are talking of today, obviously, they're on, you know, in different therapeutic categories. So as you go forward, you know, is there a plan to be focusing more on a specific therapeutic category, or is it all dependent on, you know, what comes down, down, down your way?
Speaker #3: Yeah. So we're going to, you know, continue to work with partners and, you know, 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 on INI as well as, metabolism and cardiometabolic, diseases.
Sean McClain: Yeah, so we're going to, you know, continue to work with partners and, you know, 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 you know, 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.
Speaker #3: And, you know, 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 is going to be at the current moment.
Speaker #3: But we will have further updates on our internal pipeline at that point in time.
Speaker #5: Thank you. Thanks for taking my question.
Christian Stegemann: Thank you. Thanks for taking my question.
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.