Absci Q3 2026 Earnings Call Transcript

Absci (NASDAQ:ABSI) reported third-quarter financial results on Thursday. The transcript from the company’s third-quarter earnings call has been provided below.

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Access the full call at https://edge.media-server.com/mmc/p/c639wcfw/

Summary

Absci reported increased R&D expenses to $23.6 million for Q3 2026, up from $19.2 million, driven by ABS201 development. SG&A expenses rose to $9 million, primarily due to stock-based compensation.

The company anticipates releasing interim 13-week proof-of-concept data for ABS201 in pattern hair loss next month, with full 26-week data expected early next year.

Absci plans to start a Phase 2 trial for ABS201 in endometriosis by mid-2027, targeting significant unmet medical needs in women’s health.

Cash reserves stand at $173.7 million, sufficient to fund operations into the second half of 2028.

Strategically, Absci is focused on expanding its prolactin receptor antibody franchise, exploring additional indications, and developing direct-to-consumer programs.

Full Transcript

OPERATOR

Good day and thank you for standing by. Welcome to the Absci Q3 2026 Business Update and Financial and Operating Results conference 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 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, Alex Khan, Investor Relations. Please go ahead.

Alex Khan (Investor Relations)

Thank you. Earlier today, Absci released financial and operating results for the quarter ended September 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 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’d like to remind you that management will make statements during this call that are forward looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated and you should not place undue reliance on forward-looking statements.

These statements involve forward-looking statements regarding ABS201 and our other pipeline programs, including the conduct and timing of our Phase IIa HEADLINE trial in pattern hair loss with interim proof-of-concept data expected in December 2026 and full proof-of-concept data in early 2027; potential advance into Phase 3, including an expedited path directly from Phase I/IIa; the planned Phase 2 endometriosis trial starting in mid-2027; ABS201’s anticipated product profile and target product profile; planned FDA engagement on development strategy; ABS201’s market opportunity and commercial prospects; and the capabilities and benefits of our platform technologies. Market projections rely on assumptions including regulatory approval, the final label, and the competitive landscape, any of which could cause the actual addressable market to differ materially. Certain research findings discussed today reflect participant responses to a hypothetical product profile and are not clinical results for ABS201.

Additional information regarding the risks and uncertainties that could affect our forward-looking statements is set forth in the press release Absci issued today, including in 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 and is accurate only as of the live broadcast November 12, 2026. With that, I’ll turn the call over to Sean.

Sean McClain (Chief Executive Officer)

Thanks, Alex. Good morning, everyone. Thanks for joining us. Absci continues to make strides across our whole business. Today we’ll walk you through the exciting developments we’re looking forward to, including our upcoming 13-week interim POC data in pattern hair loss next month, the full POC data in pattern hair loss early next year, our planned endometriosis Phase 2 clinical trial, and the expansive potential we see with our prolactin franchise.

I’m pleased to share that the HEADLINE trial has been progressing according to plan. We’re continuing to enroll and execute the trial towards near-term proof-of-concept data. Ransi will discuss this later in the call. Next month we anticipate sharing interim 13-week data. The data set could demonstrate early signs of a regenerative prolactin mechanism stimulating and promoting hair growth. We are incredibly excited to be gathering and sharing these data with you all very soon.

As we mentioned in September, we’re also excited to be moving toward initiation of our planned Phase 2 clinical trial in endometriosis. This disease has been severely overlooked and underinvested in for far too long. Our STORYLINE trial is being designed to measure pain-related outcomes. We also believe that the prolactin mechanism has the potential to be disease-modifying based on prolactin’s described role in endometrial tissue proliferation and lesion growth.

In that sense, the prolactin mechanism for endometriosis could represent a novel treatment for women suffering from this painful and burdensome disease. While we remain laser focused on executing our HEADLINE and upcoming STORYLINE clinical trials for ABS201, we’ve also been exploring other potential indications for the prolactin receptor antibodies. These additional indications give us a path forward to further expand our prolactin franchise. Our team and our end-to-end platform have together generated novel insights into prolactin biology. We are proud to be pioneers and leaders in this space. Our aim is to harness this biology for the betterment of human health across various disease and lifestyle areas.

Our early-stage pipeline, also including non-prolactin targets, is being developed for indications within metabolism, immunity, healthy aging, preventative care, and lifestyle optimization, and most or all of these would be developed with a direct-to-consumer focus. I’m also thrilled to be welcoming Gary Muhl to Absci as our first Chief Commercial Officer. We’re continuing to advance ABS201 through the clinic and build out our franchise of potential direct-to-consumer programs. Gary’s wealth of experience in pharma, aesthetics, and consumer products makes him uniquely suited for this role. I’m excited to be working with him as we build out our infrastructure to support the potential commercial future of Absci.

ABS201 is the blueprint: a novel mechanism for a large patient population with high medical need. Our platform and business strategy are made for this, and assets which stem from the platform are the results as well. We’ll have a first look at the results very soon. Our interim 13-week PHL data is anticipated next month, then early next year we anticipate our full 26-week data. With that, I’ll turn it over to Ransi to walk through the ABS201 clinical program.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Thanks, Sean. Good morning, everyone. I am pleased to say that the ongoing Headline trial continues to enroll and progress according to plan. 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 suggested study drug was well tolerated and exhibited a favorable safety and tolerability profile. Additionally, the estimated half-life based on available interim pharmacokinetic data across all four supports the potential to achieve ABS201’s targeted dosing regimen of two or three injections over a six-month period.

As Sean mentioned, we are very excited to be sharing our interim 13-week PHL data with you all next month. We also continue to anticipate our full 26-week proof-of-concept data early next year. As a reminder, our ongoing Headline trial is a randomized, double-blind, placebo-controlled study. The primary endpoints for the study are safety and tolerability. Secondary endpoints include PK, PD, immunogenicity, target area hair count, target area hair width, and target area darkening (pigmentation).

We will also be collecting patient-reported outcomes data from this study at the early time point. The 13-week interim POC data we anticipate sharing next month, we plan to report male pattern hair loss data including target area hair count, or TAHC, which counts the non-vellus hairs which are 30 microns or greater, target area hair width, as well as total hairs, a measure that also includes vellus hairs in addition to non-vellus. As the prolactin receptor mechanism represents novel biology for hair regrowth, we believe examining only the conventional metrics of hair growth studies like non-vellus hairs wouldn’t tell us the full story. We believe ABS201’s mechanism of action would support growth in active and potentially in dormant follicles, though we are also interested in looking at the total hair count which includes vellus hairs that we believe may have the potential to convert to non-vellus hairs at a later time point.

Taken together, we believe the 13-week interim POC data we plan to share next month could show a strong directional signal of biological activity which could lead to even more robust hair growth at the 26-week time point and beyond. We’ve also begun enrollment of two cohorts of female participants with PHL at doses of 1200 mg and 300 mg. We will share additional details about these female cohorts and timing for data at a later date. As Sean mentioned earlier, we are excited by the advances we have made for our ABS201 program in endometriosis. In September, we announced additional details for our planned global multicenter Phase 2 Storyline clinical trial.

This Phase 2 double-blind, randomized, placebo-controlled trial would assess efficacy and safety in participants with surgically diagnosed endometriosis and moderate to severe endometriosis-associated pain after a two-cycle run-in period. Efficacy endpoints for the trial would include reductions in dysmenorrhea and non-menstrual pelvic pain as reported via patient-reported measures. We anticipate recruiting approximately 150 patients from approximately 10 or more countries, subject to protocol finalization and regulatory clearance.

Leveraging the safety, tolerability, and PK data being generated for ABS201 in our ongoing Headline trial, we anticipate initiation of this Phase 2 clinical trial for endometriosis in mid-2027. We are designing Storyline as a dose-ranging trial and anticipate testing two or three dose levels that will be confirmed following review of Headline data. Endometriosis is a disease with significant unmet medical need, and we are motivated to make strides for the millions of women suffering from this condition.

Overall, we remain focused on executing our ABS201 program for both pattern hair loss and endometriosis and look forward to sharing our 13-week interim PHL data with you all next month. With that, I’ll pass it over to Zach to discuss our business strategy and to provide an update on our financials.

Zachariah Jonasson (Chief Financial Officer / Chief Business Officer)

Thanks, Ransi. We continue to execute on our asset-centric strategy. We prioritize capital allocation to pipeline programs that are geared towards large patient populations experiencing significant unmet need. Every program is evaluated through a commercial lens, including its potential for direct-to-consumer telemedicine and distribution channels. ABS201 fits squarely within these parameters. We continue to build on our leadership position in prolactin biology by executing on our current ABS201 clinical trials while simultaneously developing new prolactin receptor antibodies such as ABS202 for new indications. Today our primary objective is to execute our ABS201 clinical trials in male and female pattern hair loss and in endometriosis. Our clinical development plans are relatively capital efficient, particularly in the context of the significant market opportunities available in each of these indications.

Hence, we believe these programs offer outsized return on investment. As Ransi mentioned, the Headline clinical trial for ABS201 continues to advance according to plan with our first interim data release coming next month. Standard-of-care options in the pattern hair loss market remain inadequate. Minoxidil in both topical and oral forms, finasteride, nutraceuticals, and other interventions offer mixed efficacy, inconvenient administration, and other undesired trade-offs of varying severity. Patients are looking for something new and innovative.

Our conversations with KOLs and our quantitative consumer research study reinforce both the lack of satisfaction with standard of care and the desire for new treatment options. We look forward to sharing our 13-week interim proof-of-concept data in PHL next month, followed by our full 26-week data early next year. ABS201’s target product profile defines a new category of therapy by combining convenient administration with strong and durable efficacy. Our consumer research and KOL surveys support 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. Based on our consumer and KOL research, this hair growth effect size combined with the convenience and durability of the ABS201 TPP supports an estimated $25 billion in total addressable market in the U.S. alone.

Our research suggests that a target area hair count result above that level could unlock an even greater market. We believe ABS201 is positioned to create a massive consumer market opportunity as a new premium category of PHL therapy. Our strategic priority is the continued execution of ABS201 clinical development to demonstrate convenient, durable, regenerative hair growth in PHL patients. We look forward to sharing our 13-week interim data next month, where a directional signal of biological activity would further reinforce our conviction that ABS201 can provide meaningful hair growth at 26 weeks and beyond.

In addition to pattern hair loss, we see a significant commercial opportunity for ABS201 in endometriosis. Endometriosis affects up to 10% of women worldwide, including an estimated 9 million women in the U.S. alone. These patients remain underserved; existing treatment options are limited, and the broader pharmaceutical industry has underinvested in developing new therapeutics. Despite the large unmet medical need, we aim to offer patients a safer, more effective therapeutic option.

If our clinical development of ABS201 is successful, we estimate this program could generate more than $4 billion in peak sales. Turning now to our financials, research and development expenses were $23.6 million for the three months ended September 30, 2026, as compared to $19.2 million for the prior-year period. This increase was primarily driven by advancement of Absci’s internal programs, including direct costs associated with external nonclinical and clinical development of ABS201, offset by a decrease in personnel-related costs. Selling, general, and administrative expenses were $9 million for the three months ending September 30, 2026, as compared to $8.4 million for the prior-year period.

This increase was primarily due to stock-based compensation. Cash, cash equivalents, and marketable securities as of September 30, 2026, were $173.7 million as compared to $201.1 million as of June 30, 2026. Based on our current projections, we believe our cash, cash equivalents, and marketable securities will be sufficient to fund our operating plans into the second half of 2028. Our strong balance sheet and refined strategy allow us to focus on executing our business objectives. This includes creating, developing, and potentially commercializing fully owned programs that we believe offer outsized commercial opportunities with the potential to be distributed direct to consumer. As Sean mentioned, we are beginning to build out our DTC commercial infrastructure with the addition of Gary Muhl as Absci’s Chief Commercial Officer.

We have seen high interest across the broader industry with consumers wanting to take control of their health and wellness. We have also seen intense and renewed interest in both hair loss and women’s health. These are two key areas where we believe ABS201 has the opportunity to be positioned as a leading product. We are excited to be advancing ABS201 towards proof-of-concept data followed by later-stage development as the flagship asset of our innovative franchise.

With that, I’ll now turn it back to Sean.

Sean McClain (Chief Executive Officer)

Thanks, Zach. As always, I want to thank the amazing team at Absci for their unwavering dedication to our mission. I’d also like to thank all of our investors, both new and existing, for their support. The coming months are shaping up to be historic for Absci. We anticipate our 13-week interim POC data for PHL next month, our 26-week full POC data for PHL early next year, and initiation of our Phase 2 Storyline endometriosis trial next year. These will be key opportunities to demonstrate the therapeutic potential of our antiprolactin receptor antibodies and the power of the platform and the team that developed them.

Operator, let’s open the call for questions.

OPERATOR

Thank you. At this time we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star-1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star-1-1 again. Please limit yourselves to one question and a follow-up. Our first question comes from the line of Vamil Divan of Guggenheim Securities. Your line is now open.

Vamil Divan (Analyst at Guggenheim Securities)

Great, thanks. Thanks for taking the questions and congrats on the progress. So maybe just one question I have on the upcoming data release here next month for pattern hair loss. It sounds like—maybe I’m misinterpreting a little bit—but more recently focusing a little more on the total hair count that you’ll be disclosing, not just a sort of non-vellus hair count. I know you talked about this a little bit on the call already, but maybe you can give a little more color on if that’s a shift or maybe I’m just misinterpreting that, and just kind of the focus more on the total side as opposed to just non-vellus would be helpful.

And then just a second question, sort of building off of that: I’m just curious—obviously the more important, bigger sort of 26-week data release early next year—is there anything in this data release that we’ll get next month that could change kind of how the trial’s being done or what we should expect at 26 weeks, or is this really just an interim and then things we should expect to just continue as is until early next year’s readout? Thank you.

Sean McClain (Chief Executive Officer)

Yeah, thanks for the question, Vamil. So first off, on the total hair count, looking at both vellus and non-vellus, that is definitely not a change. As a reminder, what we’re looking at for this 13-week readout is really showing the mechanism is working. This is a brand new novel mechanism. And looking at not only non-vellus but vellus hairs as well is critically important because some of these other mechanisms really don’t drive both of these. And this, I think, has a real opportunity as you look further out in time to convert the vellus hairs to non-vellus hairs at later points in time, like the 26 weeks.

So we really want to have a holistic picture of this. And I’ll hand it over to Ransi to dive a bit deeper into that. Ransi.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Thanks, Sean. So the mechanism should promote or support hair growth across the board, right? We think that it’s supporting the stem cell niche, we think it’s supporting the energetics, the proliferation of keratinocytes. And that’s not really reserved for one width of hair follicle. And also it’s important to remember that this definition of vellus versus non-vellus is kind of a numerical cutoff. It’s not really a biological cutoff. So you could have hairs that are 20 to 30 microns that are on the cusp of being a non-vellus hair.

So we’re really interested in the entire picture. The other thing is, if we are restoring hair growth in empty follicles, we need to be open to the fact that these follicles may grow a hair that is less than 30 microns in width. So that’s why we’re really interested at this stage of the program at looking broadly and holistically. Your second question, do we expect it to change the conduct of the trial? Absolutely not. In fact, I think we’ve stated in the protocol that this interim is in no way or fashion designed to change the conduct of the trial.

We’re also happy to report that we finished enrolling the highest dose cohort. So right now, from here on out, it’s going to be continuing to bring patients back or volunteers back and do their photography and assessments.

Vamil Divan (Analyst at Guggenheim Securities)

Okay, thank you.

OPERATOR

Thank you. Our next question comes from the line of Brian Cheng of JP Morgan. Your line is now open.

Brian Cheng (Analyst at JP Morgan)

Hey guys, thanks for taking our questions this morning and congrats on the progress. I remember that we talked about total hair count and non-vellus hair count before the summer. But just looking a bit deeper here, how should we think about the placebo response at week 13 for total hair count and also non-vellus hair count, these metrics? Because I don’t think that there are a lot of data for week 13 historically. And then we have a quick follow-up.

Thank you.

Sean McClain (Chief Executive Officer)

Yeah, it’s a great question, Brian, in terms of what you should see from a placebo standpoint. So when we’ve talked with KOLs about this, when we’ve looked at other studies, you usually do see a -5 target area hair count in overall change. So non-vellus change. And so we do expect there to be potentially negative hair growth. Because if you do look at change over time with AGA patients, you are losing those hairs and they are converting to vellus.

Ransi, I don’t know if you have anything else you want to add to that.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Yeah, it’s a really interesting question. The placebo data are at week 26. There’s, as Sean said, negative and positive. But it’s important to remember that AGA is a progressive condition. And naturally, one doesn’t expect things like vellus hair counts to show a consistent gain over time. I mean, vellus hairs cycle much faster than non-vellus, non-miniaturized hairs. So you wouldn’t expect to see these things go up, and we think that looking at total area hair count, not just target area hair count, is going to give us a better picture of the drug’s overall MOA.

Brian Cheng (Analyst at JP Morgan)

Got it. And then I think I heard that for the female cohort, you guys have started enrolling for those patients and you have picked 300 and 1200 milligrams as the dosage, which I think in the male cohorts, you have tested 300, 600 and 1200. Just curious if you can elaborate a little bit more on the selection of those doses for the female cohort. Is that based on the efficacy that you have seen so far in the male cohort? Thank you.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Sean, I can take that one. It’s not based on what we’ve seen in the male cohorts. This is something you do in an exploratory stage. And these two female cohorts are open-label. There’s no placebo arm, and it’s very much exploratory. And the reason we pick the low and the high end is it’s sort of a dose-bracketed approach where we can get sense of efficacy at either end of the dosing range and then we can infer what happens in the middle.

Brian Cheng (Analyst at JP Morgan)

Thank you.

OPERATOR

Thank you. Our next question comes from the line of Gil Blum of Needham. Your line is now open.

Gil Blum (Analyst at Needham)

Good morning and thank you for taking our question. So maybe a first one as it relates to one of your competitors showed some really strong one-year data very recently. Do you think that changes how we should look at 26-week data, at 13-week data, or does everything else kind of remain the same? And I do have a follow-up. Thank you.

Sean McClain (Chief Executive Officer)

Yeah, thanks, Gil. So first off, with that particular study that was done, there was no placebo arm. Looking at the 12 months, that is from baseline. So we don’t know how placebo did change there. And if you look at it from baseline, I would say that you saw really no change in overall hair growth. And what we’re, I think, quite excited about with this particular mechanism is the continued hair growth. If you look at the stump-tailed macaques at 26 weeks, or six months, they are still increasing in their overall hair count for non-vellus.

And we believe that you have the potential to continue hair growth past six months. So as minoxidil plateaus at six months, I think there really is that potential to continue to gain hair growth past six months in addition to the overall durability. So again, one of the things we’re really excited about with this is both convenience—so two to three doses over six months—and then you get hair regrowth for the next potentially couple of years. The year follow-up period will show that. But you saw that with the stump-tailed macaques. And so we believe that there is a lot of room for differentiation with this mechanism and how the drug was designed. Ransi, Zach, I don’t know if you guys have anything else to add there.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

I think you covered it, Sean. Again, we look back to the stump-tailed macaque data and again the mechanism of action that we’ve uncovered in the ex vivo data. This is a process that, if we are truly replenishing the stem cell support for individual hair follicles, that effect will take hold over time. So I think you’re going to see differentiation from six months and beyond. I don’t think that the other company released at one year—again, not placebo-adjusted—is going to change the way we look at ABS201’s results at 6 months or even at 1 year and potentially beyond 1 year.

Gil Blum (Analyst at Needham)

Thanks for the clarification, very helpful. And you also mentioned pigmentation. Just maybe you can remind us how that is even assessed, especially compared to a control or baseline. Thank you.

Sean McClain (Chief Executive Officer)

Ransi, you want to take that?

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Yeah, yeah. Pigmentation is assessed by hair darkness. This is part of the standard photography analysis that we do. This is not something that’s subjective. A software analyzes the number of pixels in a given hair and assigns a darkness score. So again, if the human data recapitulate the non-human primate data, we would expect to see a change in pigmentation or a darkening of the hairs over time. It’s not something we’re going to be reporting at 13 weeks, but certainly we’ll be looking at this at 26 weeks and beyond.

OPERATOR

Thank you. Our next question comes from the line of Kambiz Yazdi of US Bancorp BTIG. Your line is now open.

Ivana

Hi there, this is Ivana on for Kambiz. Thanks for taking your question and congrats on the continued progress. So two questions for me. If relatively modest human doses of ABS201 can achieve the level of receptor occupancy that requires substantially higher nominal dosing in the historical non-human primate studies that are mentioned, can you describe some of the molecular or pharmacologic properties of ABS201 that are driving that difference? And I’ll ask my follow-up after that.

Sean McClain (Chief Executive Officer)

I’ll hand that over to you.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Yeah, I’m trying to understand exactly what the question is. Could you rephrase it?

Ivana

Sure. So just trying to understand some of the molecular or pharmacologic properties that are different between ABS201 and HMI-115, if you’re able to disclose some of that.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Oh, I see. Yeah. I don’t think we comment on the actual sequences between our drug and any other molecule. We’re really looking at this from a dosing perspective. Let’s assume that they both bind to the prolactin receptor. What we have strived to do, and we based our dosing on what we think the receptor occupancy was in the non-human primate study, which was actually quite high. So our dosing range, particularly once you get in over 300 mg, 300 mg and over, is designed to keep at least 90% of the receptors occupied.

The prolactin receptor has a high degree of reserve capacity, meaning that you have to really block it down in order to prevent the signaling cascade from continuing unimpeded. So I would say that the best way to think about contrasting ABS201 to any other molecule is that we are studying doses that are in excess of that 90% receptor occupancy range. Other molecules have shorter half-lives and, based on the modeling that we’ve done, based on publicly available data, we think that they are much, much lower than that 90% receptor occupancy level.

And that could be why you see certain efficacy results in hair or other disease trials.

Sean McClain (Chief Executive Officer)

Yeah, and another piece I’ll point out is the half-life of HMI-115 is two weeks. We have a 65-day half-life, which allows us to dose every 8 to 12 weeks. We believe that is highly differentiated. And additionally we do believe that exposure at greater than 90%, and a nice steady exposure above that 90%, is really important to make sure that the follicle stays in anagen by blocking the prolactin receptor. Because one of the things that we see when modeling out HMI-115 is that you get this oscillation and you’re essentially going in and out of anagen and catagen.

And again, as Ramzi had stated, that exposure greater than 90%, which is what the stump-tailed macaques were at, is really important for that overall hair biology to take hold and to be able to give time for the hairs to go into anagen and to be able to reverse the miniaturization that you’ve seen.

Ivana

Thanks, that’s very helpful. And I guess following on to that, how can we think about the lag between this receptor blockade and the visible hair count improvement? So particularly, can we expect the fractional improvement at week 13 to continue on, or a substantially larger effect to be seen at week 26?

Sean McClain (Chief Executive Officer)

Yeah, so we’ve talked about this before, but at least in the stump-tailed macaque data what you saw were two different slopes. It takes a little bit more time at the beginning to start to kick the follicle into the anagen state. So you’re getting a little bit slower growth on the target area hair count. And then from 13 to 26 weeks we do expect there to be a ramp up, and that’s what this study is looking at. And again, we see the 13-week as a directional readout here, and we do expect to see that increase from 13 to 26 weeks and then potentially even past 26 weeks.

Ivana

Great, thank you so much.

OPERATOR

Our next question comes from the line of Andrew Tsai of Jefferies. Your line is now open.

Andy (Analyst at Jefferies)

Hi, this is Andy on for Andrew. Thanks so much for taking our question. For your top-line release, should investors expect only a week 13 data point, or will you share the overall kinetics including earlier time points to elucidate the trajectory?

Sean McClain (Chief Executive Officer)

Thanks, Andy. So we are—we’ve got it to the 13-week, and that is our plan is to share the 13-week data at this time. So given where the trial started, yes, you have patients that have advanced past 13 weeks, but as I just stated, we’re planning on sharing the 13-week data.

OPERATOR

Thank you. Our next question comes from the line of Brendan Smith of TD Cowen. Your line is now open.

Brendan Smith (Analyst at TD Cowen)

Great. Thanks for taking the questions, guys, and congratulations here on the 13 versus 26 weeks expectations. But maybe looking a little farther out since I think we’ve kind of walked around that quite a bit. What are you kind of looking for across both readouts to give you a sense of the go-forward dose? Is that something you’ll need to see longer-term follow-up and washout after the 26-weeks readout to really see durability and make that decision?

And I guess related to that, can you just give us a sense from maybe preclinical studies how comparable dose in PHL will be to endometriosis, just what kind of gives you confidence those dose ranges and efficacy will translate into those patients? Thanks.

Sean McClain (Chief Executive Officer)

Thanks, Frank. Ronzi, you want to take that?

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Yeah. So the approval endpoint for PHL has traditionally been 26 weeks. So we’re really interested to see what happens at 26 weeks. As we said before, the 13 weeks is directional in nature for us, but we will plan our phase three doses based on what we get out of the cohorts at 26 weeks. Anything after that would be a sign of continued durability. But we’re really mostly interested in the 26 weeks. For endometriosis, as we said before, we are dosing healthy female volunteers without pattern hair loss. This is outside of the two exploratory PHL cohorts in women that I just mentioned. We are dosing healthy volunteers in every dosing cohort of the headline trial, and their safety, tolerability, PK data are going to inform what we do with the endometriosis dosing. Again, we are looking for at least 90% receptor occupancy, and that’s why we’re waiting for the PK data from all three dosing cohorts before choosing the endometriosis dose.

OPERATOR

Thank you. Our next question comes from the line of Remy Katkuda of LifeSci Capital. Your line is now open.

Remy Katkuda (Analyst at LifeSci Capital)

Hey, guys, thanks for taking my questions as well, I guess. Are there any specific patient characteristics that you believe could influence responsiveness to a prolactin receptor inhibitor? I know there’s baseline severity and age, for example, in the broader PHL population, but more so specific to the mechanism itself.

Sean McClain (Chief Executive Officer)

What we’ve seen… Yeah, go forward.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Yeah, that’s one of the things that you get out of a clinical trial. So we’re not pre-specifying any specific response characteristic or baseline characteristic that predicts response to the drug.

Sean McClain (Chief Executive Officer)

And I will note in our ex vivo study that we did, the six individuals—three female, three male—you do see that when you block the prolactin receptor, you see STAT5 go down for all six. And for all six you see an increase in percent anagen within the hair follicles that were studied. And so the fact that all six rose—obviously that’s an n of six—but we, you know, as Ronse said, the clinical study will show this, but we don’t have any reason to believe that there may be differences.

But again, we’ll see in this study.

Remy Katkuda (Analyst at LifeSci Capital)

Got it. And then going off a previous question, is there additional PK/PD data that you need to support every two or every three month dosing, or is it just going to come down to data at the end of the day? Thank you.

Sean McClain (Chief Executive Officer)

We’re very confident in what we’ve seen so far with the dosing, the PK data that we’ve gotten to date, that it’s going to be every two to every three months. I think accumulating data will only refine that dosing interval. But right now we’re very comfortable saying that it’s going to be every two or every three—sorry, two to three doses every six months. And again, this is not something you repeat. We’re designing the program so that you take the two or three doses and then you stop.

Remy Katkuda (Analyst at LifeSci Capital)

Got it. Thank you.

OPERATOR

Thank you. Our next question comes from the line of Kripa Devarakonda of Truist Securities. Your line is now open.

Kripa Devarakonda (Analyst at Truist Securities)

Hey guys, thank you so much for taking my question and congratulations on all the progress this year. So in terms of dose levels that we will see next month, will we see 13-week data from all the dose levels that patients have been treated with? I know you said that patients have already been treated with the highest dose. And then I have a follow-up question.

Sean McClain (Chief Executive Officer)

Yeah. So what you’re going to be seeing at the 13-week is all of the 300, I would say a majority of the 600, and potentially a kind of sneak peek into the 1200.

Kripa Devarakonda (Analyst at Truist Securities)

Great. And the PR highlights that hair width and pigmentation are secondary endpoints. When we think about what could be an indicator for how the 26-week data might be reflected in the data that you’re showing at 13 weeks, which do you think is the most important endpoint, or should we look at the totality of the data for the 13-week?

Sean McClain (Chief Executive Officer)

I think you have to look at everything together. You have to look at how the hair width is changing; you have to look at how non-vellus, vellus—all of that is critically important in just seeing how the follicle is transitioning into the anagen state, how you’re potentially reactivating these catagen follicles, being able to regrow hairs in these dormant follicles where current standard of care does not touch these follicles. And so we have to look at it in totality.

And as Ronnie mentioned previously, the endpoints at the end of the day at the 26 are still the same. It’s still the non-vellus counts as well as the patient-reported outcomes. Those are the two co-primary endpoints. But again, from a mechanistic standpoint for this mechanism, we have to be looking at all these at the 13-week.

Mudalinayake Ransi Somaratne (Chief Medical Officer)

Please add anything else there if I missed anything—I think you captured everything. We look holistically. Obviously, target area hair count, which is hairs over 30 microns, is what’s been used for regulatory approval. But at this stage of the program, we’re interested in everything and we think that the drug is going to support every follicle with the ability to generate or continue growing the hair.

Kripa Devarakonda (Analyst at Truist Securities)

Thank you so much.

OPERATOR

As a reminder, to ask a question or rejoin the queue, you will need to press star 11 on your telephone. Our next question comes from the line of Devanjana Chatterjee of Jones. Your line is now open.

Devanjana Chatterjee (Analyst at Jones)

Hi, thanks for taking my question and congrats on the progress. So as we think of benchmarking ABS201 efficacy at week 26 on the total hair count endpoint, what’s your latest thinking on the placebo-adjusted improvement that would be clinically meaningful?

Sean McClain (Chief Executive Officer)

Yeah. Zach, do you want to take that and how that looks from a commercial standpoint?

Zachariah Jonasson (Chief Financial Officer / Chief Business Officer)

Yeah, happy to. So I think as we look out to the 26-week readout, we are very confident based on our consumer research that if we show an effect size similar with high-dose oral minoxidil—so think of something in the 30 to 35 hairs per square centimeter range in target area hair count—we think that’ll translate to very rapid and widespread adoption in the market. What we’ve seen when we talk to patients is they really want something that gives them durable efficacy and something that has a convenient administration profile.

I think if we’re delivering on target area hair count both in vellus—particularly non-vellus—but also vellus, I think consumers will be very happy with that. At the end of the day, they’re looking for regrowth of hair and coverage so that they look more youthful, they look the way they used to look. And I think that with this mechanism, we should be able to deliver that at 26 weeks for sure. And then beyond that, we would expect to see that durability of that hair regrowth and potentially additional hair growth as we follow these patients out.

Devanjana Chatterjee (Analyst at Jones)

Great. So the 30 hairs per centimeter square is the benchmark for both non-vellus and the total hair count. I have a quick follow-up.

Zachariah Jonasson (Chief Financial Officer / Chief Business Officer)

Based on your conversation—just to clarify—for the 26-week readout, that’s what we’ve tested in our consumer research surveys. There’s a target area hair count in that range which would be consistent with high-dose oral minoxidil. So that’s for non-vellus. My point is we may see that plus additional vellus hair growth, all of which will go to kind of the aesthetic endpoint that the patients are looking for.

Devanjana Chatterjee (Analyst at Jones)

Thanks for the clarification. And a quick follow-up: based on your conversations with KOLs, on the safety front, how long of a follow-up do you think KOLs would like to see to understand the effects of sustained prolactin receptor blockage?

Mudalinayake Ransi Somaratne (Chief Medical Officer)

I can take that one. Yeah. You know, when you think about the safety of a drug, you generally want to make sure that you understand safety within the terminal half-life of a drug. And so that’s generally five half-lives. And that’s the way the regulators look at it, if that makes sense to you. So the half-life is currently about 60 days.

Devanjana Chatterjee (Analyst at Jones)

That’s very helpful. Thank you.

OPERATOR

Thank you. Our next question comes from the line of Charles Wallace of H.C. Wainwright. Your line is now open.

Charles Wallace (Analyst at H.C. Wainwright)

Hi, this is Charles on for ARCA. Thanks for taking my question. So maybe first from me: you mentioned that for the 13-week data we’re going to see all the 300 milligram cohort, the majority of the 600, and a sneak peek of the 1200. At 13-week follow-up, will we see the full safety data set for all three cohorts at that point, now that all of them are fully enrolled?

Sean McClain (Chief Executive Officer)

Yeah, we will present aggregated safety data. By that I mean that we as the company are not unblinding ourselves to safety in the drug arm versus the placebo arm. And that’s really important, because this is an ongoing trial and we don’t want to introduce any sort of bias, specifically in terms of safety reporting. So the safety data that you’ll see will be presented at a dose-group level, not by ABS201 versus placebo.

Charles Wallace (Analyst at H.C. Wainwright)

Great, that’s helpful. And maybe one more: for the endometriosis—so, you know, in late September you shifted the study initiation for Storyline to mid-2027. So just curious where this puts the proof-of-concept topline data from the study. Thanks.

Sean McClain (Chief Executive Officer)

Yeah, we’ll be coming out with more clarity on the POC data and potential interim—if we decide to have one—earlier in the year next year. So be on the lookout for that.

Charles Wallace (Analyst at H.C. Wainwright)

Great. Thanks for taking my questions.

OPERATOR

I am showing no further questions at this time. Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect.

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