Absci (NASDAQ:ABSI) Q2 2026 Earnings Call

0:00 Good day, and thank you for standing by. Welcome to the Absci Second Quarter Business Update. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Alex Kahn, Corporate Vice President and Investor Relations. Please go ahead.

0:44 Thank you. Earlier today, Absci released financial and operating results for the quarter ended 06/30/2026. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an email to investorsabsci dot 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 ninety days after this call. Joining me today are Sean McLean, Absci's Founder and CEO Zach Jonizen, Chief Financial Officer and Chief Business Officer and Ronti Somrodhni, Chief Medical Officer, Head of R and D. Before we begin, I'd like to remind you that management will make statements during this call that are forward looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated.

1:32 You should not place undue reliance on forward looking statements. These include statements regarding the development and clinical progress of our pipeline programs, including ABS201, the design, enrollment conduct and timelines of our ongoing Phase onetwo A headline trial of ABS201, anticipated timing of an interim proof of concept data readout for ABS-two zero one in the second half of twenty twenty six and full proof of concept data in early twenty twenty seven. The potential events of ABS-two zero one into Phase three development. The anticipated initiation of a Phase two clinical trial of ABS-two zero one for endometriosis in the fourth quarter twenty twenty six and potential proof of concept readout in the second half of twenty twenty seven anticipated characteristics and product profile of ABSI-one as

2:09 a drug product our target product profile attributes the potential for an expedited development pathway, including the possibility of advancing directly from Phase onetwo and to Phase three our plan engagement with the FDA regarding development strategy, our partnership with Eli Lilly including anticipated benefits thereof and Eli Lilly's participation on our endometriosis advisory board, the capabilities anticipated benefits are of our platform technology such as Atlas and potential market opportunity and commercial prospects for ABS two zero one. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, final approved label and the evolving competitive landscape, any of which could cause our actual addressable market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product profile and do not represent clinical results for ABUS-two zero one.

2:57 Additional information regarding the risks and uncertainties that could affect our forward looking statements is set forth in the press release that Absci issued today, our most recent annual report on Form 10 ks and subsequent documents and reports filed by Absci were diagnosed with the SEC. 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 is accurate only as of the live broadcast 08/11/2026. With that, I'll turn the call over to Sean. Thanks Alex. Good afternoon, everyone. Thanks for joining us today. Absci continues to execute and I'll walk you through recent highlights, including key progress on ongoing headline trial, our new partnership with Eli Lilly and our $100,000,000 financing completed at the end of June.

3:52 Starting with headlines. In June, we released positive interim phase one data. The data suggests the study drug was well tolerated with favorable safety and tolerability. And based on interim PK data, ABS201 half life supports the potential for just two to three injections over six months. This is exactly why we built our AI platform to design molecules that meet our target product profile we set out from day one. You've heard us say the prolactin mechanism is underappreciated. Everything we've learned has only strengthened that conviction, and we believe targeting the prolactin receptor has the potential across numerous diseases.

4:39 And we are also excited to have a partner who shares in that vision. As you saw in June, we announced that Eli Lilly made a $40,000,000 strategic investment in Absci. Our partnership with Eli Lilly is tailored around the clinical development strategy for AVS-two zero one. And as a part of this collaboration, we are happy to be welcoming a representative from Lilly onto our endometriosis advisory board. Zach will provide more details of this partnership later in the call. In addition to Lilly, we've seen elevated interest from the investment community in prolactin biology. In June, we completed $100,000,000 financing, including the $40,000,000 investment from Lilly from a group of blue chip investors.

5:27 We're grateful for this support, which enables the continued development of our existing programs, as well as future expansion of our pipeline. ABS201's progress is a testament to the platform and the team that created it. Building on that leadership in de novo antibody design with origin, we've now extended the platform upstream with Atlas, Absci's target to lead autonomous scientists. Atlas is an agentic discovery engine built to remove the bottleneck ahead of design, rapidly identifying and validating the right targets. Atlas integrates literature, genetics and single cell sequencing data to surface and triage novel target hypothesis.

6:19 These flow directly into origin for epitope specific de novo design, and then into our in house wet lab for characterization and pathway validation. This process closes a hypothesis to molecule loop and turns discovery into a high throughput fail fast engine by having more shots on goal and better ones. We're already seeing this at work. Atlas has surfaced potential new indications for our prolactin receptor franchise and independently recovered genetic evidence linking this pathway to pattern hair loss and endometriosis. This is a powerful new tool that every drug hunter at Absci can now leverage. We'll continue deploying this AI native platform to create therapeutics like ABS201 with the potential to change the treatment paradigm for patients.

7:15 With that, I'll turn it over to Ranzi to walk through the ABS201 clinical program. Ranzi?

7:23 Thanks, Sean, and good afternoon, everyone. In June, we released positive interim phase one data from the ongoing headline trial of ABS-two zero one. We continue to be encouraged by the emerging safety pharmacokinetic and immunogenicity profile observed to date. As we said in June, blinded aggregate interim data suggests that a drug was well tolerated and exhibited a favorable safety and tolerability profile. Additionally, based on available interim pharmacokinetic data across all four single ascending dose cohorts, half life for ABS201 is estimated to be at least sixty five days. These results support the potential for dosing two or three times over a six month period pending confirmation through continued follow-up across all cohorts.

8:20 Additionally, new modeling continues to suggest that two to three doses of ABS201 over six months would be able to achieve greater than 90% receptor occupancy, which we believe is a key driver of meaningful clinical efficacy for hair growth. These new data are available in the updated corporate deck published on our website today. We are very eager to share our clinical data with you once it's available. Today, we are pleased to share that the multiple ascending dose portion of the study continues to enroll according to plan. We continue to anticipate an interim proof of concept readout in the form of thirteen week data later this year.

9:07 Then we anticipate our full proof of concept data in the form of twenty six week data in early twenty twenty seven. As a reminder, the HEADLINE trial is a randomized double blind placebo controlled study. The primary endpoints are safety and tolerability, while secondary endpoints include PK, PD, immunogenicity, target area hair count, target area hair width, and target area darkening pigmentation. We will also collect patient reported outcomes data in this study. The prolactin receptor mechanism for hair growth is unique. Unlike minoxidil, finasteride or nutraceuticals, the mechanism underlying ABS201 is regenerative for the hair follicle, protecting and promoting hair follicle stem cells, restoring CD34 progenitor cells, and stimulating key growth factors IGF-one and FGF-seven while decreasing the catagen driving TGF beta-two.

10:15 This regenerative mechanism is unique to the anti prolactin receptor pathway and supports the significant durable effects with potential to grow new hair and dormant follicles. Our clinical study is designed to showcase this unique mechanism with our thirteen week assessment, which is interim in nature, intended to provide a directionally positive signal. Has the mechanism begun to take hold? And is it building all the machinery and building blocks we see responsible for regenerating the hairs?

10:49 A directionally positive signal of hair growth at thirteen weeks would give us even further confidence in seeing more robust hair growth at twenty six weeks and beyond, as is supported by preclinical data in the stump tailed macaque. Altogether, the preclinical stump tailed macaque data, as well as our human ex vivo data from skin biopsies of both male and female donors provide robust support for this mechanism and its ability to provide durable hair growth. We are also excited to be progressing our ABS201 program for endometriosis. As Sean mentioned earlier, we are pleased to be welcoming Axel Haupt, MD, Senior Vice President Clinical Investigation at Eli Lilly and Company onto our Endometriosis Advisory Board.

11:40 And with the safety, tolerability and PK data generated in the SAD portion of the HEADLINE trial, we anticipate initiating a Phase two study for endometriosis in the fourth quarter of this year. With that, I'll pass it over to Zach to discuss our business strategy and to provide an update on our financials. Zach?

12:02 Thanks, Renzi. We continue to focus our strategy on creating and advancing high value pipeline programs like ABS201. Our primary objective today is the successful execution of our clinical trial for ABS201 in male and female pattern hair loss and in endometriosis.

12:22 We are also advancing a preclinical pipeline focused on immunological and inflammatory indications that fit into our broader strategy, including programs that can ultimately be commercialized direct to consumer. The clinical trial for ABS-two zero one continues to progress according to plan. We believe this program offers an outsized ROI based on its relatively capital efficient clinical development plan and significant market opportunity. Based on our market research, we estimate a potential total available market greater than $25,000,000,000 in The US alone.

13:01 In addition to pattern hair loss, we also see a significant multi billion dollar market for endometriosis with potential peak sales of over $4,000,000,000 These programs are emblematic of how we prioritize and allocate our resources to programs that offer high ROIs based on addressing large underserved patient populations.

13:25 We are leveraging our leadership in prolactin biology by advancing ABS201 towards proof of concept in both pattern hair loss and endometriosis, and by progressing our preclinical anti prolactin receptor program, ABS-two zero two, in an undisclosed I and I indication.

13:44 We are also actively exploring other potential underserved indications for which prolactin receptor inhibition could offer a differentiated therapeutic mechanism. We look forward to sharing our interim proof of concept data in pattern hair loss later this year, and our full proof of concept data early next year.

14:06 As a reminder, our consumer research survey, as well as input from leading KOLs inform our view that a twenty six week increase in target area hair count of 30 to 35 hairs per centimeter squared, roughly on par with high dose oral minoxidil, would enable a home run product.

14:25 Our consumer and KOL research support an estimated $25,000,000,000 TAM associated with such a hair growth effect size, given ABS201's expected unique durability and administration convenience. We believe a target area hair count result above that level would expand the market further, and that a less robust result would still unlock a multi billion dollar market opportunity.

14:53 ABS201, with its novel prolactin receptor mechanism, is positioned to become a new premium category of pattern hair loss therapy, offering consumers convenient, durable, regenerative hair growth. Continuing to execute the development of this program remains our top strategic priority.

15:14 Our platform continues to evolve and deliver new capabilities and efficiency gains. As you will recall, our first programs were advanced through IND enabling studies in under two and a half years and under $15,000,000 in total cost. Based on our current origin model improvements in combination with our agentic Atlas platform, we believe we can significantly improve on these metrics.

15:41 For example, our latest origin models allow for a 1,000 x reduction in library size for identification of high quality leads. We're also finding ways to reduce IND enabling study timelines, based on the quality of our AI designed drug candidates, which for example, are well suited to high concentration formulation development. We anticipate additional efficiency and capability improvements as we further advance our platform.

16:12 We are grateful for our partners, new and existing, for their support. As discussed, we are excited to be collaborating with Eli Lilly, and to welcome a member of their leadership team onto our Endometriosis Advisory Board.

16:25 Our partnership with Eli Lilly is tailored around the clinical development strategy for AVS-two zero one, and does not confer rights to the program, which we plan to develop ourselves. We appreciate Eli Lilly's support, as well as their interest in prolactin biology within pattern hair loss, women's health, and beyond.

16:45 Turning now to our financials. Research and development expenses were $22,600,000 for the three months ending 06/30/2026, as compared to $20,500,000 for the prior year period. This increase was primarily driven by advancement of Absci's internal programs, including direct costs associated with external preclinical and clinical development of ABS-two zero one, offset by a decrease in personnel related costs.

17:16 Selling, general and administrative expenses were $9,200,000 for the three months ending 06/30/2026, as compared to $8,500,000 for the prior year period. This increase was primarily due to stock based compensation and other administrative costs.

17:35 Cash, cash equivalents and marketable securities as of 06/30/2026 were $201,100,000 as compared to $125,700,000 as of 03/31/2026. In June, we completed an underwritten offering of common stock. The net proceeds from the offering were approximately $93,600,000 Our current balance sheet, including this additional capital supports our execution of key upcoming catalysts and continued progress of our early stage pipeline, as well as an expansion of our planned endometriosis clinical trial. As we finalize our clinical trial design, we anticipate sharing additional details of the endometriosis clinical development plan later in the third quarter.

18:28 Based on our current projections, we now believe our cash, cash equivalents and marketable securities will be sufficient to fund our operating plan into the second half of twenty twenty eight. With that, I'll now turn it back to Sean.

18:44 Thanks Zach. As always, I want to thank the Absci team for making all this possible. I'd also like to thank Eli Lilly for their partnership and all of our investors, both new and existing for their support. We're fast approaching pivotal moments for Absci. Our first look at interim POC data for pattern hair loss is anticipated later this year. Our full twenty six week POC data should follow early next year, where we anticipate showing robust hair regrowth from our regenerative prolactin mechanism.

19:21 I'm incredibly excited for both of these readouts. We're energized for what we're building in our early stage pipeline. We see a huge opportunity to capitalize on an interest in total vitality combined with consumer shift towards more direct to consumer and cash pay products. Our current and future pipeline focuses squarely on these emerging trends. We continue to fire on all cylinders, and I can't wait for everyone to see the results of our hard work in the coming months. Operator, let's open the call for questions. Thank please press 11 again. In the interest of time, we do ask that you please limit your questions to one question and one follow-up.

20:16 Please stand by while we compile the Q and A roster. And our first question comes from Brian Cheng of JPMorgan. Your line is open. Hey guys, thanks for taking our question this afternoon. Maybe just to start off, we noticed that your indication on your press release is now defined as pattern hair loss. And I think in the prior communication, you have been indicating that the lead indication has androgenetic alopecia. So is there any read or in terms of how you're defining the target indication today? Is there any change in terms of the lead indication for two zero one? And then we have a quick follow-up. Thank you. Yes.

21:03 Thanks, Brian. It's great question. So we decided to change the name for two reasons. First, if you think of androgenic alopecia, you know, it implies the antigen receptor, and we know that targeting the androgen receptor, such as, you know, fenestrate or other androgen receptor antagonists, do not fully regrow hair. And we do have evidence that does support that prolactin looks to sit upstream of the androgen receptor, and actually drives androgen receptor expression. And so based on the underlying biology and the importance of prolactin within pattern hair loss, we decided to, you know, switch the name from androgenetic alopecia to patterned hair loss.

22:04 Additionally, we had gotten feedback from other KOLs that they thought that this was a more appropriate name. And the last piece is on the consumer front. We think that pattern hair loss is much better understood amongst consumers than androgenetic alopecia. And so, you know, for all of these reasons, you know, we have changed the name, but not the indication itself. And Ramzi and Zach, please chime in if there's anything else I missed there. Thanks, John. So, yeah, I mean, sorry, go ahead, Zach. No, no, go ahead, Ramzi. I think the term pattern hair loss also encompasses the entire population. Like we're still studying the same population or indications encompass the same population.

23:00 But really when you think about the disease state The U. S, there's eighty million people, and thirty million of those are women. So we think the term pattern hair loss is more appropriate to describe who it is that we are targeting. Thank you, Renzi. I was just going to add to the change in name does not have any impact on how we've assessed the market opportunity. It's still fundamentally the same market opportunity number of patients in our consumer surveys were focused on identifying that. So this does not have any effect on those estimates. Thank you. That's very helpful. And as a follow-up, think, you know, in our prior discussions, we all have a pretty good sense of what we want to see in terms of non villous hair count at week thirteen and week twenty six from your math portion.

23:54 And just looking at other metrics, I think you have mentioned that the terminal to villous ratio metric is also super important in terms of giving you a directional insight of whether ABS two zero one is giving you some benefits towards the goalpost. Can you help us think about what is the magnitude that you want to see in terms of Q2B ratio? And then also curious if you have a sense of what some of the current standard of care can offer in terms of the ratio changes at around week thirteen. Thanks for your help. Ramzi, do you want to take that one? Yeah, so it's an interesting question. I think we're, at least for the interim, we're interested in a broad set of data.

24:48 I'm particularly not focused on a specific V to T ratio. And I honestly, Brian, I'm not sure I've seen specific V to T ratios from other programs. So can't really answer that one for you. Yeah, I think how we're thinking about the thirteen week is really looking at not only the terminal, also V to T, but also the potential to regrow hair in dormant follicles, whether that comes up as a terminal hair, a valous hair, or you have more V to T transition. I think the key point with this readout is being able to show potentially new mechanisms that other drugs do not show. And I think regrowing that, you know, dormant follicle where you've been bald for many years, we start to see changes there, again, whether it's on the valus hair or the terminal hair. We think that that's really exciting and could be a big game changer for this particular mechanism in addition to the regenerative aspect.

25:59 And Brian, that's why we talked about total hair count in the past, and that encompasses what Sean was just talking about. Thanks guys. Thank you. And our next question comes from Brendan Smith of TD Cowen. Your line is open. Great. Thanks for taking the questions guys. Wanted to just first clarify quickly on 02/2001. Is it maybe fair for us to assume you'll get the interim data in hand and put it out before initiating endometriosis study and then full POC hair loss data in Q1 thereafter? Is that kind of just a fair assumption on the order of events coming up there? And then as a follow-up on the platform itself, sounds like plan outside of prolactin receptors still largely developed targets out licensed prior to entering the clinic on your own. So if that is the case, I guess, wondering at a strategy level how we should think about potential cadence of new assets coming out of the platform, if you kind of have a target partner deal cadence in mind, just any color there on output that we should keep in mind over the next, I don't know, twelve to eighteen months? Thanks, guys.

27:04 Yes. Thanks, Brendan. So to your first point, I think that that's a fair assumption. On second point, we are planning on taking ABS two zero one to market ourselves, and everything that we have coming behind ABS two zero one, we are looking at it from the lens of what could we commercialize ourselves, what could potentially be a DTC that you could sell alongside ABS two zero one, and then make the determination, do we have the capital, is the cost capital right to continue to develop this ourselves, or do we want to find a partner given the indication or the cash situation. But everything we are developing would be with that commercialization in mind, and then we have the optionality to partner.

27:59 That is the current strategy we have, and Zach, Lisa chime in as well. Yeah, think you said it well, Sean. Think the only other point I would make is Sean described some of the advances in our platform, so we're becoming more and more efficient at generating new molecules and new programs, and so I think we will be creating a lot of optionality for ourselves. But to Sean's point, we're very rigorous about providing like a strategic and ROI based perspective on which programs we will advance with our own balance sheet versus the ones we'll partner. Thank you. And our next question comes from Vamil Divan of Guggenheim.

28:47 Your line is open. Great. Thanks for taking my question. Maybe one just quick follow-up on the conversation around the partnerships. Like, I think last year you guys had talked about, you know, likely signing a partnership by the end of the year. I don't know if that's happened or not. I'm curious, like, would all your partnerships be disclosed? Is there anything or have you signed any sort of since later last year that maybe just were not disclosed publicly? Maybe any sort of update on that side would be helpful. And then the other question I have is just around this thirteen week data, which obviously everyone's equally waiting for. And then just to maybe sort of level set expectation, if you can sort of share what you plan to disclose in the top line release so we all kind of know what to expect there. And sort of tied to that, I know one of the big potential selling points of 02/2001 would be the durability of the hair that's recrown.

29:41 Not we're not going know that at thirteen weeks, obviously. I'm just trying to get a sense of how you think about sort of how long the duration of follow-up would need to be before you start getting comfort that this dosing regimen that your target profile is the right dosing regimen for the durable response? Thanks. Yeah, thanks, Vamil. So in terms of partnership, yeah, the partnership that we had inked with Eli Lilly, both the investment and the collaboration on ABS201 on clinical development, We do see that as achieving that large pharma partnership. And with regards to the top line readout for the thirteen and twenty six week, I'll hand that over to Ron C.

30:34 Hey, Vamil, thanks for the question. Yeah, so we're going to show the data that we think will give us that interim look, just sort of a status check on what the drug is doing. So we've talked about total area hair count. So that'll be their target area hair count, which is the terminal hairs. We'll get a look at target area hair width to see how wide the hair caliber is. And we'll be looking at darkness as well. So I think those are the big things. And in addition we'll have a look at the updated safety and tolerability data as well. Great question on the durability. We are actively working on trying to figure out how we can get that from this study.

31:25 It's not going to be answered in the thirteen or the twenty six weeks. We do have a safety follow-up period after this trial. And that's probably the first indication of durability of effect. And we'll get the same duration of safety follow-up on the cohorts. It's based on PK. And we're looking at what to do thereafter in terms of describing the durability of effects. So more to come on that. Thank you. Okay, thank you. And our next question comes from Kamriz Yazdi of BTIG. Your line is open. Hi, team. Thank you so much for the question.

32:13 So it appears from your modeling that you confirmed ABS201 can maintain greater than 90% prolactin receptor occupancy without cycling. How should the greater, more sustained receptor occupancy impact efficacy compared to other prolactin receptor antibodies in pattern hair loss and then secondarily as in endometriosis? Thanks so much. Yeah, it's a great question, and we actually just put out some modeling on the website today with the updated corporate back end. I think it's a very clear illustration. If you look at HMI one hundred fifteen, the once every two week dosing at two forty milligrams, You saw this oscillation that occurred between 6070% receptor occupancy.

33:17 And we know that the receptor occupancy for the prolactin receptor needs to be, you know, well above, you know, 90% to achieve, you know, the signal blocking that's necessary. Even a little bit of receptor left can cause, you know, quite a bit of signaling through the prolactin receptor. And essentially, the HMI115 molecule, without oscillation and not achieving the receptor occupancy, our belief is that they essentially weren't able to achieve the efficacy because they weren't able to get that prolonged antigen phase.

34:04 And so that's what we believe that we are going to be able to achieve now. If you look at, again, the receptor occupancy, those, you know, two to three doses, or well above ninety percent, and we can ensure that the follicle can stay in the prolonged antigen state in order to rebuild that stem cell niche. Hair growth doesn't happen overnight, you need that sustained period of blockade in order to get the regrowth. And I think the really exciting part is like, look, if you look at the stump tail macaques, when you've got the greater than 90% receptor occupancy, I mean, you saw a really, really robust efficacy there, and, you know, we're obviously targeting 30, but I do believe that if you get the mechanism, if you hit the receptor, you know, appropriate here, appropriately to stay in the antigen state, I think you have the potential for even further upside than what we've been discussing. And so I think it's a really exciting opportunity with the PK profile that we've been able to achieve.

35:17 And then a quick follow-up, how do you expect that to impact endometriosis? Bronzi, do you want to take that one? Yeah, happy to. I think it's the same philosophy, Candice. If you look at the other prolactin receptor antibody, you know, they published their data in The Lancet, and you saw that there was an effect on dysmenorrhea at the highest dose. And we think the same principle applies and that you have to really achieve that high level of receptor occupancy to see efficacy there. So, though it's a disease state that's quite different from pattern hair loss, we think the same principle is in play. Thank you so much. Thank you. And our next question comes from Joel Bloom of Needham. Your line is open.

36:15 Good afternoon. Thanks for squeezing me in. So, saw some interesting data for the oral minoxidil extended release from Verodermix in women. Do you think the data that they put up changes maybe where the bar is as it relates to hair regrowth or it doesn't really matter as it relates to your own programs? Thank you. I mean, the data that they put out, I mean, shows that standard of care is really poor, even with what they have. There's so much more room to improve from a standard of care perspective, and that is something we're very excited about. We recently showed the female ex vivo data, it looked very similar to what we saw in the males.

37:10 And we're very excited to get this cohort kicked off in this study in female patients. And I think that there is a real exciting opportunity just due to the really, really poor standard of care out there. Thank you. This concludes the question and answer session and also today's conference call. Thank you for participating and you may now disconnect.