Absci Corp(ABSI)Q2 2026 法說會逐字稿

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 star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 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, Alexander Khan, Corporate Vice President and Investor Relations. Please go ahead.

Thank you. Earlier today, Absci released financial and operating results for the quarter ended 06/30/2026. If you have not 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; Zachariah Jonasson, Chief Financial Officer and Chief Business Officer; and Ransi Somaratne, Chief Medical Officer, Head of R&D. Before we begin, I would 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. You should not place undue reliance on forward-looking statements. These include statements regarding the development and clinical progress of our pipeline programs including ABS-201, the design, enrollment, conduct, and timelines of our ongoing Phase IIa HEADLINE trial of ABS-201, the anticipated timing of an interim proof-of-concept data readout for ABS-201 in the second half of 2026 and full proof-of-concept data in early 2027, the potential advancement of ABS-201 into Phase III development, the anticipated initiation of a Phase II clinical trial of ABS-201 for endometriosis in the fourth quarter of 2026 and potential proof-of-concept readout in the second half of 2027, anticipated characteristics and product profile of ABS-201 as the drug product, our target product profile attributes, the potential for an expedited development pathway, including the possibility of advancing directly from Phase IIa to Phase III, a plan to engage 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 and anticipated benefits of our platform technology such as Atlas, and potential market opportunity and commercial prospects for ABS-201. 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 of ABS-201. Additional information regarding the risks and uncertainties that could affect our forward-looking statements is set forth in the press release Absci issued today, our most recent annual report on Form 10-K, and subsequent documents and reports filed by Absci from time to time 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 that is accurate only as of the live broadcast August 11, 2026. With that, I will turn the call over to Sean.

Thanks, Alex. Good afternoon, everyone. Thanks for joining us today. Absci continues to execute. I will walk you through recent highlights, including key progress on the ongoing HEADLINE trial, our new partnership with Eli Lilly, and our $100 million financing completed at the end of June. Starting with HEADLINE: In June, we released positive interim Phase I data. The data suggests the study drug was well tolerated with favorable safety and tolerability. And based on interim PK data, ABS-201's half life supports the potential for just 2 to 3 injections over 6 months. This is exactly why we built our AI platform: to design molecules that meet our target product profile that we set out from day one. You have heard us say the prolactin mechanism is underappreciated. Everything we have learned has only strengthened that conviction, and we believe targeting the prolactin receptor has potential across numerous diseases. We are also excited to have a partner who shares that vision. As you saw in June, we announced that Eli Lilly made a $40 million strategic investment in Absci. Our partnership with Eli Lilly is tailored around the clinical development strategy for ABS-201, and as part of this collaboration we are happy to be welcoming a representative from Lilly onto our endometriosis advisory board. Zachariah will provide more details of this partnership later in the call. In addition to Lilly, we have seen elevated interest from the investment community in prolactin biology. In June, we completed a $100 million financing including the $40 million investment from Lilly, from a group of blue-chip investors. We are grateful for their support, which enables the continued development of our existing programs as well as future expansion of our pipeline. ABS-201'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 have 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 hypotheses. These flow directly into Origin for epitope-specific de novo design and then into our in-house wet lab 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 are 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 will continue deploying this AI-native platform to create therapeutics like ABS-201 with the potential to change the treatment paradigm for patients. With that, I will turn it over to Ransi to walk through the ABS-201 clinical program.

Thanks, Sean, and good afternoon, everyone. In June, we released positive interim Phase I data from the ongoing HEADLINE trial of ABS-201. 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 the study 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 ABS-201 is estimated to be at least 65 days. These results support the potential for dosing 2 or 3 times over a 6-month period pending confirmation through continued follow-up across all cohorts. Additionally, new modeling continues to suggest that 2 to 3 doses of ABS-201 over 6 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 is unblinded. 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 13-week data later this year. Then, we anticipate our full proof-of-concept data in the form of 26-week data in early 2027. 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 ABS-201 is regenerative for the hair follicle: protecting and promoting hair follicle stem cells, restoring CD34 progenitor cells, and stimulating key growth factors IGF-1 and FGF-7 while decreasing the catechin driving TGF-beta 2. This regenerative mechanism is unique to the anti-prolactin receptor pathway and supports significant durable effects with the potential to grow new hair and dormant follicles. Our clinical study is designed to showcase this unique mechanism with our 13-week assessment, which is interim in nature, intended to provide a directionally positive signal (i.e., has the mechanism begun to take hold?) and is it building all the machinery and building blocks we see responsible for regenerating the hairs? A directionally positive signal of hair growth at 13 weeks would give us even further confidence in seeing more robust hair growth at 26 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 ABS-201 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. With the safety, tolerability, and PK data generated in the SAD portion of the HEADLINE trial, we anticipate initiating a Phase II study in endometriosis in the fourth quarter of this year. With that, I will pass it over to Zachariah to discuss our business strategy and to provide an update on our financials.

Thanks, Ransi. We continue to focus our strategy on creating and advancing high-value pipeline programs like ABS-201. Our primary objective today is the successful execution of our clinical trial for ABS-201 in male and female pattern hair loss and in endometriosis. 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-201 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 billion in the U.S. alone. In addition to pattern hair loss, we also see a significant multibillion-dollar market for endometriosis, with potential peak sales of over $4 billion. 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. We are leveraging our leadership in prolactin biology by advancing ABS-201 towards proof of concept in both pattern hair loss and endometriosis, and by progressing our preclinical anti-prolactin receptor program ABS-202 in an undisclosed immunological and inflammatory indication. 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. As a reminder, our consumer research survey as well as input from leading KOLs inform our view that a 26-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. Our consumer and KOL research support an estimated $25 billion TAM associated with such a hair growth effect size, given ABS-201'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 multibillion-dollar market opportunity. ABS-201, 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. Our platform continues to evolve and deliver new capabilities and efficiency gains. As you will recall, our first programs were advanced to IND-enabling studies in under 2.5 years, and under $15 million 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. For example, our latest Origin models allow for a 1,000x reduction in library size for identification of high-quality leads. We are 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. 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. Our partnership with Eli Lilly is tailored around the clinical development strategy for ABS-201 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. Turning now to our financials: research and development expenses were $22.6 million for the three months ending 06/30/2026, as compared to $20.5 million 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-201, offset by a decrease in personnel-related costs. Selling, general and administrative expenses were $9.2 million for the three months ending 06/30/2026, as compared to $8.5 million for the prior year period. This increase was primarily due to stock-based compensation and other administrative costs. Cash, cash equivalents, and marketable securities as of 06/30/2026 were $201.1 million as compared to $125.7 million as of 03/31/2026. In June, we completed an underwritten offering of common stock. The net proceeds from the offering were approximately $93.6 million. 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. 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 2028. With that, I will now turn it back to Sean.

Thanks, Zachariah. As always, I want to thank the Absci team for making all this possible. I would also like to thank Eli Lilly for their partnership and all of our investors, both new and existing, for their support. We are fast approaching pivotal moments for Absci. Our first look at interim POC data for pattern hair loss is anticipated later this year. Our full 26-week POC data should follow early next year where we anticipate showing robust hair regrowth from our regenerative prolactin mechanism. I am incredibly excited for both of these readouts. We are energized for what we are building in our early-stage pipeline. We see a huge opportunity to capitalize on the interest in total vitality combined with a 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 cannot wait for everyone to see the results of our hard work in the coming months. Operator, let's open the call for questions.

Thank you. To withdraw your question, please press 11 again. In the interest of time, we do ask that you please limit your questions to one and one follow-up. Please standby while we compile the Q&A roster. And our first question comes from Brian Chang 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. In prior communications, you have been indicating that the lead indication has been androgenetic alopecia. So is there any read-through in terms of how you're defining the target indication today? Is there any change in terms of the lead indication for ABS-201? And then we have a quick follow-up. Thank you.

Yeah, thanks, Brian. It is a great question. We decided to change the name for two reasons. First, if you think of androgenetic alopecia, it implies the androgen receptor, and we know that targeting the androgen receptor, such as finasteride or other androgen receptor antagonists, do not fully regrow hair. We do have evidence that supports that prolactin appears to sit upstream of the androgen receptor and actually drive androgen receptor expression. Based on the underlying biology and the importance of prolactin within pattern hair loss, we decided to switch the name from androgenetic alopecia to pattern hair loss. Additionally, we had gotten feedback from other KOLs that they thought that this was a more appropriate name. And on the consumer front, pattern hair loss is much better understood among consumers than androgenetic alopecia. For all of these reasons, we have changed the name, but not the indication itself. Ransi and Zachariah, please chime in if there is anything else I missed there.

Thanks, Sean. So, yeah, the term pattern hair loss also encompasses the entire population. We are still studying the same population; the indications encompass the same population. In the U.S., there are about 80 million people and 30 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.

I was just going to add too that the change in name does not have any impact on how we have assessed the market opportunity. It is still fundamentally the same market opportunity, number of patients, and our consumer surveys were focused on identifying that. So this does not have any effect on those estimates.

Thank you. That is very helpful. And as a follow-up, in prior discussions, we all have a pretty good sense of what we want to see in terms of non-vellus hair count at week 13 and week 26 from your MAD portion. Looking at other metrics, you mentioned that the terminal-to-vellus (T-to-V) ratio metric is also important in terms of giving a directional insight of whether ABS-201 is giving benefits towards the goalpost. Can you help us think about the magnitude that you want to see in terms of the T-to-V ratio? And do you have a sense of what current standard of care can offer in terms of ratio changes around week 13? Thanks for your help.

Yeah, do you want to take that one? An interesting question. At least for the interim, we are interested in a broad set of data. I am not particularly focused on a specific V-to-T ratio for the interim readout. Honestly, Brian, I am not sure I have seen specific V-to-T ratios from other programs, so I cannot really answer that one for you.

Yeah, I think how we are thinking about 13 weeks is looking at not only the terminal hairs, but also V-to-T, the potential to regrow hair in dormant follicles, whether that comes up as a terminal hair, a vellus hair, or you have more of a V-to-T transition. The key point with this readout is being able to show potentially new mechanisms that other drugs do not show. Regrowing a dormant follicle where you have been bald for many years—if we start to see changes there, whether it is on the vellus hair or the terminal hair—we think that is really exciting and could be a big game changer for this particular mechanism, in addition to the regenerative aspect.

And Brian, that is why we have 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 clarify quickly on ABS-201. Is it fair to assume you will get the interim data in hand and put it out before initiating the endometriosis study, and then full POC hair loss data in Q1 thereafter? Is that a fair assumption on the order of events? And to follow up on the platform itself: it sounds like plans outside of prolactin receptors are still largely developed targets out-licensed prior to entering the clinic on your own. If that is the case, how should we think about the cadence of new assets coming out of the platform? Do you have a target partner-deal cadence in mind? Any color on output we should keep in mind over the next 12 to 18 months would be helpful. Thanks, guys.

Thanks, Brendan. To your first point, I think that is a fair assumption. On the second point, we are planning on taking ABS-201 to market ourselves and everything that we have coming behind ABS-201 we are looking at from the lens of what could we commercialize ourselves, what could potentially be an OTC that you could sell alongside ABS-201, and then make the determination: do we have the capital, is the cost of capital right to continue to develop this ourselves, or do we want to find a partner given the indication or the cash situation. Everything we are developing would be with that commercialization in mind, and then we have the optionality to partner. That is the current view we have. Zachariah, chime in as well.

I think Sean said it well. The only other point I would make is Sean described some of the advances in our platform. We are 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 are very rigorous about providing a strategic and ROI-based perspective on which programs we will advance with our own balance sheet versus the ones we will partner.

Thank you. And our next question comes from Vimal Divan of Guggenheim. Your line is open.

Great. Thanks for taking my question. One quick follow-up on partnerships: last year you talked about likely signing a partnership by the end of the year. Has that happened? Would all your partnerships be disclosed, or have you signed any since late last year that were not disclosed publicly? Any update would be helpful. The other question is around the 13-week data, which everyone is eagerly waiting for. Can you level-set expectations on what you plan to disclose in the topline release so we know what to expect? Tied to that, one potential selling point of ABS-201 would be the durability of the hair that is regrown. I know we are not going to know that at 13 weeks. How long of follow-up would you need before you start getting comfort that the dosing regimen and target profile are right for a durable response? Thanks.

Thanks, Vimal. On partnerships: the partnership we inked with Eli Lilly—both the investment and the clinical collaboration on ABS-201—we view as achieving that large pharma partnership.

Hey, Vimal. Thanks for the question. We plan to show the data that we think will give us that interim look—just a status on what the drug is doing. We have talked about total area hair count, so that will be target area hair count, which is the terminal hairs. We will get a look at target area hair width to see how wide the hair caliber is, and we will be looking at darkness as well. Those are the big things. In addition, we will have a look at the updated safety and tolerability data. Great question on durability: we are actively working on trying to figure out how we can get that from this study. It is not going to be answered at 13 or 26 weeks. We do have a safety follow-up period after this trial, and that is probably the first indication of durability of effect. We will get the same duration of safety follow-up on the cohorts. It is based on PK, and we are looking at what to do thereafter in terms of describing the durability of effect. So more to come on that. Thank you.

Thank you. And our next question comes from Arseniy Shabashvili of BTIG. Your line is open.

Hi, team. Thank you so much for taking my question. It appears from your modeling that ABS-201 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 in endometriosis? Thanks so much.

It is a great question. We set out some modeling on the website today that illustrates this clearly. If you look at HMI-115, the once-every-two-week dosing at 240 milligrams showed oscillation with receptor occupancy between roughly 60% and 70%. We believe the prolactin receptor needs to be well above 90% to achieve the signaling blockade necessary. Even a little bit of receptor left can cause quite a bit of signaling through the prolactin receptor. Our belief is that other molecules that did not achieve sustained receptor occupancy were not able to achieve efficacy because they could not get that prolonged anagen phase. With our profile, two to three doses are well above 90% receptor occupancy, ensuring the follicle can stay in the prolonged anagen state to rebuild the stem cell niche. Growth does not happen overnight; you need that sustained period of blockade to get regrowth. If you look at the stump-tailed macaques, when you got greater than 90% receptor occupancy you saw robust efficacy. We are targeting 30 hairs, but I believe if you hit the receptor appropriately and keep the follicle in anagen, there's potential for further upside beyond what we've been discussing. That makes this an exciting opportunity given the PK profile we've achieved.

I will add that the same philosophy applies to endometriosis. You look at the other prolactin receptor antibody data that was published, and there was an effect on dysmenorrhea at the highest dose. We think the same principle is in play: you have to really achieve that high level of receptor occupancy to get efficacy in endometriosis, even though the disease state is quite different from pattern hair loss.

Thank you. Star 1. And our next question comes from Gil Blum of Needham. Your line is open.

Good afternoon. Thanks for squeezing me in. We saw some interesting data for oral minoxidil extended release from Veradermics in women. Do you think the data they put up changes where the bar is as it relates to hair regrowth, or does it not really matter as it relates to your programs? Thank you.

The data they put out shows that the standard of care is still poor even with their approach. There is much room to improve from a standard-of-care perspective, and that is something we are very excited about. We recently showed the female ex vivo data, and it looked very similar to what we saw in males. We are very excited to get the female cohort enrolled in the study. I think there is a real opportunity due to the poor standard of care currently available.

This concludes the question-and-answer session and also today's conference call. Thank you for participating and you may now disconnect.