ABSI - NASDAQ

Ladies and gentlemen, thank you for standing by. Welcome to Absci's 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, Finance and Investor Relations. Please go ahead.

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 e-mail to [email protected]. 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

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 I 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 remain 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 antip-prolactin receptor antibody for androgenetic alopecia, commonly known as male and female pattern hair loss. This condition affects approximately 8 million adults in the U.S. 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 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. We anticipate initiation of a Phase I/IIa 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. 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 our reverse immunology platform. Early data indicate potential broad applicability to squamous cell carcinoma and other indications. ABS-501, this is a potential best-in-class anti-HER2 antibody identified using our zero-shot de novo AI models. These AI design leads displayed novel epitope interactions, increased or equivalent potency to trastuzumab in preclinical 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. 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 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. As

Thanks, Sean. 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. 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. 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. Under the terms of the 2 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-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. 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. 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 a 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. Moreover, based on our Phase I/IIa 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 4 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. Turning now to our financials. Revenue in the second quarter was $600,000 as we continue to progress our partnered programs. Research and development expenses were $20.5 million for the 3 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 3 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. 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 size 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. We see additional upside to this forecast based on potential nondilutive cash inflows that could come from new platform collaborations with large pharma and/or an asset transaction associated with our wholly 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. With that, I'll turn it back to Sean.

Thanks,

[Operator Instructions]. The first question comes from Brendan Smith with TD Cowen.

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.

Yes, absolutely. Thanks, Brandon. We'll -- I'll pass that over to Christian to answer that.

Thanks, Sean. This is Christian Stegmann. Yes, we have planned to dose approximately 40 healthy volunteers for the ABS-101 Phase I study, and we expect to see pharmacokinetic and pharmacokinetic data at the interim readout, plus we expect to have a first read on immunogenic study. Does that answer your question?

Yes. Yes, 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 subcu and just any important potential pivot points in development path ahead kind of driving some of those decisions.

Yes, absolutely...

Go ahead, Sean.

Go for it, Christian.

All right. Thanks, Sean. We absolutely intend to deliver a subcutaneous formulation for this product as well. We expect to see a 6- month treatment cycle for this product. And assuming that we reach the expected TPP, that will be 2 or 3 doses over a period of 6 months delivered subcutaneously. Now depending on the progress in developing the subcutaneous formulation, we will see the usage of this formulation during the Phase I study. It may not be ready for the single ascending dose, but we assume it to be ready for the multiple ascending dose.

Yes. And to double-click on that, we are planning to have IV for the SAD and then the subcu for the MAD portion for the efficacy readout in the second half of next year.

And that subcu is being developed internally?

That is correct in partnership with our CDMO provider. But we do believe that we will ultimately get between 180 to 200 mg per ml. So we see this being able to formulate for subcu.

And the next question will come from Kripa Devarakonda with Truist.

All right. This is Alex on for Kripa. 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 given the parallel developments at other companies?

Yes, 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 are 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 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 partner, ship 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.

And looking forward to the interim results later this year.

And the next question is going to come from Sean Laman with Morgan Stanley.

This is Morgan on for Sean. On the Phase I 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 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 semiannually dosing and what your response would be to that data?

Yes, 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 semiannually.

Yes. 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 6 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.

Yes. 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 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 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.

And the next question will come from Arseniy Shabashvili with Guggenheim.

It's Arseniy. On your early oncology programs, ADS-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 rationale for these programs?

Yes, absolutely. And maybe I'll hand this over to

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. 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.

Yes. And in terms of where we're headed as a company, a lot of the earlier-stage pipeline continues to be in I&I, 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 I&I. And this is where we want to continue to kind of build out our own internal portfolio and in oncology on those 2 particular assets, as

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?

Yes, absolutely. We think endometriosis is a really exciting indication to go after. And we are going to be positioning the Phase I/IIa trial for 201 to include female patients to be able to, if we so choose to, in parallel to a Phase II/III in androgenic alopecia, we could also run a Phase II 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 II. But we are excited about that indication, and we'll be providing more information here at a later date.

And our next question will come from Gil Blum with Needham & Company.

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 your 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 -- these discussions are going in parallel?

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 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 that would be lumpy thereafter. So yes, 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 drug targets. This would include the ion 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. 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.

And the next question will come from Debanjana Chatterjee with Jones.

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?

Yes, absolutely. Christian, do you want to take that?

Yes, 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 headcount is obviously the #1 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.

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?

It will definitely be a controlled study.

And the next question will come from Steven Dechert with KeyBanc.

Just given the expanded partnership with Almirall, we're wondering how much capacity do you feel like you have for additional programs and partnerships.

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. 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. So just 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.

And then you kind of mentioned it in a previous question, but just hoping to get an update on the Caldera region of HIV. Just anything new with that program that you can talk about?

Yes. 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.

[Operator Instructions]. The next question will come from Swayampakula Ramakanth with H.C.W.

This is RK from H.C.W. Wainwright. So 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 III study? And what sort of time line are we talking about for this drug to get to commercialization?

Yes, that's a great question, RK. And the way we're looking at this is after the Phase I/IIa trial, we would then plan to do a worldwide Phase II, Phase III trial and would anticipate a potential approval in 2030, 2031, if all goes to plan. Obviously, all of this is still very early 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?

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 I, Phase IIa study that will allow us to go directly into a combined Phase II, Phase III 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 time frame.

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. So the 4 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 under a specific therapeutic category? Or is it all dependent on what comes down your way?

Yes. So we're going to continue to work with partners in 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 I&I 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.