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 one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Alex Khan, Investor Relations. Please go ahead.
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, Zach 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 ABS-201 and our other pipeline programs, including the conduct and timing of our phase I/II-A HEADLINE trial in pattern hair loss, with an interim proof of concept data expected in December 2026 and full proof of concept data in early 2027, potential advance into phase III, including an expedited path directly from phase I/II-A, a planned phase II endometriosis trial starting in mid-2027, ABS-201's anticipated product profile and target product profile, planned FDA engagement on development strategy, ABS-201'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 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 and our most recent annual report on Form 10-K and subsequent documents or 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.
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 II 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 dataset could demonstrate early signs of 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 II 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 ABS-201, 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 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, I&I, healthy aging, preventative care, and lifestyle optimization. Most or all of these would be developed with a direct-to-consumer focus. I'm also thrilled to be welcoming Gerry Muhle to Absci as our first Chief Commercial Officer. We're continuing to advance ABS-201 through the clinic and build out our franchise of potential direct-to-consumer programs. Gerry'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.
ABS-201 is the blueprint, a novel mechanism for a large patient population with high unmet medical need. Our platform and business strategy are made for this, and the 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 ABS-201 clinical program. Ransi?
Thanks, Sean, and 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 SAD cohorts, supports the potential to achieve ABS-201'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 ABS-201's mechanism of action would support growth in active and potentially in dormant follicles.
Though we're 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 1,200 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 ABS-201 program in endometriosis. In September, we announced additional details for our planned global, multicenter phase II STORYLINE clinical trial.
This phase II 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 ABS-201 in our ongoing HEADLINE trial, we anticipate initiation of this phase II 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 ABS-201 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. Zach?
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. ABS-201 fits squarely within these parameters. We continue to build on our leadership position in prolactin biology by executing on our current ABS-201 clinical trials while simultaneously developing new prolactin receptor antibodies, such as ABS-202, for new indications. Today, our primary objective is to execute our ABS-201 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 ABS-201 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. ABS-201'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- 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 ABS-201 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 ABS-201 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 ABS-201 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 ABS-201 can provide meaningful hair growth at 26 weeks and beyond. In addition to pattern hair loss, we see a significant commercial opportunity for ABS-201 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 ABS-201 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, non-clinical, and clinical development of ABS-201, 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 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 allows 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 Gerry Muhle 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 ABS-201 has the opportunity to be positioned as a leading premium product. We are excited to be advancing ABS-201 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.
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 II STORYLINE endometriosis trial next year. These will be key opportunities to demonstrate the therapeutic potential of our anti-prolactin receptor antibodies and the power of the platform and the team that developed them. Operator, let's open the call for questions.
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 one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one 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.
Great. Thanks for taking the questions, and congrats on the progress. 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 been focusing a little bit more on the total hair count that you'll be disclosing, not just the 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 sort of if that's a shift, or is there 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. Then just a second question, sort of building off of that.
I'm just curious, obviously, you have 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 sort of continue as is until early next year's readout? Thank you.
Yeah, thanks for the question, Vamil. 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. 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?
Thanks, Sean. The mechanism should promote or support hair growth across the board, right? We think that it's in 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. 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- 30 microns in width 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.
Okay, thank you.
Thank you. Our next question comes from the line of Brian Cheng of JPMorgan. Your line is now open.
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. 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 not a lot of data for week 13 historically. Then we have a quick follow-up. Thank you.
Yeah, it's a great question, Brian, in terms of what you should see from a placebo standpoint. When we've talked with KOLs about this, when we've looked at other studies, usually do see a plus or minus five target area hair count in overall change, so non-vellus change. 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.
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 that's why 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.
Got it. Then, I think I heard that for the female cohort, you guys have started enrolling for those patients, and you have picked 300 mg and 1,200 mg as the dosage, which I think in the male cohorts, you have tested 300 mg, 600 mg, and 1,200 mg. Just curious if you can elaborate a little bit more on the selection of those two doses for the female cohort. Is that based on the efficacy that you have seen so far in the male cohort? Thank you.
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. The reason we picked the low and the high end is it's sort of a dose-bracketed approach where we can get a sense of efficacy at either end of the dosing range, and then we can infer what happens in the middle.
Great. Thank you.
Thank you. Our next question comes from the line of Gil Blum of Needham. Your line is now open.
Good morning, and thank you for taking our question. 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 is everything else kind of remains the same? I do have a follow-up. Thank you.
Yeah. Thanks, Gil. First off, with that particular study that was done, there was no placebo arm looking at the 12 months. That is from baseline. We don't know how placebo did change there. If you look at it from baseline, I would say that you saw really no change in overall hair growth. What we're, I think, quite excited about with this particular mechanism is the continued hair growth. If you look at the stump-tail macaques at 26 weeks or six months, they are still increasing in their overall hair counts for non-vellus. We believe that you have the potential to continue hair growth past six months. 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.
Again, one of the things we're really excited about 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-tail macaques. 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.
I think you covered it, Sean. Again, we look back to the stump-tail macaque data, and again, the mechanism of action that we have 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. I think you are going to see differentiation from six months and beyond. I do not think that what the other company released at one year, again, not placebo-adjusted, is going to change the way we look at ABS-201's results at six months or even at one year and potentially beyond one year.
All right. Thanks for the clarification. Very helpful. You also mentioned pigmentation. Maybe you can remind us how is that even assessed, especially compared to a control or baseline? Thank you.
Ransi, you want to take that?
Yeah. Pigmentation is assessed by hair darkness. This is part of the standard photography analysis that we do. This is not something that is subjective. A software analyzes the number of pixels in a given hair and assigns a darkness score. 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 is not something we are going to be reporting at 13 weeks, but certainly, we will be looking at this at 26 weeks and beyond.
Thank you. Our next question comes from the line of Kambiz Yazdi of BTIG. Your line is now open.
Hi there. This is Ivana on for Kambiz. Thanks for taking our question, and congrats on the continued progress. Two questions for me. If relatively modest human doses of ABS-201 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 ABS-201 that are driving that difference? Then I'll ask my follow-up after that.
Ransi, I'll hand that over to you.
Yeah. I'm trying to understand exactly what the question is. Could you rephrase it?
Sure. Just trying to understand some of the molecular or pharmacologic properties that are different between ABS-201 and HMI-115, if you are able to disclose some of that.
Oh, I see. Yeah, I don't think we comment on the actual sequences between our drug and any other molecule. We are 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 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.
I would say that the best way to think about contrasting ABS-201 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 have 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.
Yeah, and another piece I will 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 eight to 12 weeks. We believe that is highly differentiated. 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 are essentially going in and out of anagen and catagen.
Again, as Ransi had stated, that exposure at greater than 90%, which is what the stump-tail 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.
Thanks. That's very helpful. I guess following on to that is just how can we think about the lag between this receptor blockade and the visible hair count improvement? Particularly, can we expect the fractional improvement at week 13 to continue on, or a substantially larger effect to be seen at week 26?
Yeah. We've talked about this before, but at least in the stump-tail 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. Then from 13- 26 week, we do expect there to be a ramp up. That's what this study is looking at. Again, we see the 13 week as a directional readout here, and we do expect to see that increase from 13- 26 weeks, and then potentially even past 26 weeks.
Great. Thank you so much.
Our next question comes from the line of Andrew Tsai of Jefferies. Your line is now open.
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 restate the trajectory?
Thanks, Andy. We've got it to the 13 week, and that is our plan, is to share the 13-week data at this time.
Got it. It is time for just one more follow-up. Is there going to be any 26-week data possibly in this top-line release, and some patients could be done already?
Given where the trial started, yes, you have patients that have advanced past 13 weeks, but as I just stated, we are planning on sharing the 13-week data.
Got it. Thanks.
Thank you. Our next question comes from the line of Brendan Smith of TD Cowen. Your line is now open.
Great. Thanks for taking the questions, guys. And congrats here on the 13 versus 26 weeks expectations. Maybe looking a little farther out, since I think we have 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 will need to see longer-term follow-up and washout after the 26 weeks readout to really see durability and make that decision? 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.
Thanks, Brendan. Ransi, you want to take that?
Yeah. The approval endpoint for PHL has traditionally been 26 weeks, so we're really interested in seeing what happens at 26 weeks. As we said before, the 13 weeks is directional in nature for us. But we will plan our phase III 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've 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 female 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.
Thank you. Our next question comes from the line of Rami Katkhuda of LifeSci Capital. Your line is now-
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.
You want me to take that, Sean?
I think what we've seen. Yeah, go for it.
Yeah. That's one of the things that you get out of a clinical trial. We're not pre-specifying any specific response characteristic or baseline characteristic that predicts response to the drug.
Yeah. 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. The fact that all six rose, obviously, that's an N of six. But as Ransi 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.
Got it. 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?
Ransi, I'll let you take that.
Yeah, thank you. 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. Again, this is not something you repeat. We're designing the program that you take the two or three doses, and then you stop.
Got it. Thank you.
Thank you. Our next question comes from the line of Kripa Devarakonda of Truist Securities. Your line is now open.
Hey, guys. Thank you so much for taking my question, and congratulations on all the progress this year. So, in terms of doses, 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. Then I have a follow-up question.
Yeah, so what you're going to be seeing at the 13 week is all of the 300 mg, I would say a majority of the 600 mg, and potentially a kind of sneak peek into the 1200 mg.
Great. The PR highlights that your hair width and pigmentation are secondary endpoints, right? We know that. 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 week, which do you think is the most important endpoint, or should we look at all the totality of the data?
For the 13 week, 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 kenogen follicles, being able to regrow hairs in these dormant follicles where current standard of care does not touch these follicles. We have to look at it on kind of the totality. As Ransi 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.
Ransi, please add anything else there if I missed anything.
No, 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 a hair.
Thank you so much.
As a reminder, to ask a question or rejoin the queue, you will need to press star one one on your telephone. Our next question comes from the line of Debanjana Chatterjee of JonesTrading. Your line is now open.
Hi, thanks for taking my question, and congrats on the progress. As we think of benchmarking ABS-201 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?
Yeah, Zach, do you want to take that and how that looks from a commercial standpoint?
Yeah, happy to. 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- 35 hairs per square centimeter range in target area hair count, we think that will 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, or particularly non-vellus, but also vellus, I think consumers are going to 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. I think that with this mechanism, we should be able to deliver that at 26 weeks for sure. 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.
Great. So the 30 hairs per centimeter square is the benchmark for both non-vellus and the total hair counts. I have a quick follow-up. Based on your conversation-
No, just to clarify. Just to clarify.
Yeah.
For the 26-week readout, that is what we have tested in our consumer research surveys, is a target area hair count in that range, which would be consistent with high-dose oral minoxidil. So that is for non-vellus. My point was 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.
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 blockade?
I can take that one. 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 is generally five half-lives. And that is the way the regulators look at it, if that makes sense to you. So the half-life is currently about 60 days.
That is very helpful. Thank you.
Thank you. Our next question comes from the line of Charles Wallace of H.C. Wainwright. Your line is now open.
Hi, this is Charles on for RK. Thanks for taking my question. Maybe first from me, you mentioned that for the 13-week data that we're going to see all of the 300 mg cohorts, the majority of the 600 mg, and a sneak peek of the 1200 mg at 13-week follow-up. Will we see the full safety data set for all the three cohorts at that point, now that all of them are fully enrolled?
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. 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 ABS-201 versus placebo.
Great. That's helpful. Maybe one more. For the endometriosis, in late September, you shifted the study initiation for STORYLINE to mid-2027. Just curious where this puts the proof of concept top-line data from the study. Thanks.
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. Be on the lookout for that.
Great. Thanks for taking my questions.
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.