Absci Corporation (ABSI) Q3 2026 Earnings Call Transcript

Operator: Good day, and thank you for standing by. Welcome to the AbSci Q3 26 business update and financial and operating results conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question and answer session. To ask a question during the session, you will need to press 11 on your telephone. Will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Alexander Khan, Investor Relations. Please go ahead.

Alexander Khan: Thank you. Earlier today, Absci released financial and operating results for the quarter ended 09/30/2026. 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, and Head of R&D. Before we begin, I would like to remind you that management will make statements during the 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 2 zero 1 and our other pipeline programs, including conduct and timing of our Phase 1, 2a headline trial in pattern hair loss, an 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 1, 2a, the planned phase 2 endometriosis trial starting in mid-2027, ABS-201's zero 1's anticipated product profile and target product profile, planned FDA engagement on development strategy, AVS-201's zero 1'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 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 issued today and our most recent annual report on Form 10-K and subsequent documents 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 will turn the call over to Sean.

Sean McClain: Thanks, Alex. Morning, everyone, and thank you for joining us. Absci continues to make strides across our whole business. Today, we will walk you through the exciting developments we are 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 am pleased to share that the headline trial has been progressing according to plan. We are continuing to enroll and execute the trial towards near term proof of concept data, Ransi will discuss this later on 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 are 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, perforation, 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 AVS-2 zero 1, We have 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, INI, healthy aging, preventative care, lifestyle optimization. And most or all of these would be developed with a direct to consumer focus. I am also thrilled to be welcoming Gary Mule, to Absci as our first chief commercial officer. We continue to advance ABS 2 zero 1 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 am excited to be working with him as we build out our infrastructure to support the potential commercial future of Absci. A b s 2 zero 1 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 assets which stem from the platform are the results as well. We will 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 will turn it over to Ransi to walk through ABS-201 clinical program. Ransi?

Ransi Somaratne FACC: Thanks, Sean, and good morning, everyone. I am pleased to say that the ongoing HEDLINE 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 4 SAD cohorts, supports the potential to achieve ABS-201's targeted dosing regimen of 2 or 3 injections over a 6-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 HEDLINE 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 targeted hair count or TAHC, which counts the non-vellus hairs, which are 30 µm 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, would not tell us the full story. We believe ABS-201's mechanism of action would support growth in active and potentially in dormant follicles. So 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 have also begun enrollment of 2 cohorts of female participants with PHL at doses of 12 hundred milligrams and 3 hundred milligrams. 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 STORILINE 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 2 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 AVS-201 in our ongoing headline trial, we anticipate initiation of this Phase II clinical trial for endometriosis in mid-2027. We are designing STORILINE as a dose ranging trial and anticipate testing 2 or 3 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 will pass it over to Zack to discuss our business strategy and to provide an update on our financials. Zachariah?

Zachariah Jonasson: 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 distribution channels. AVS-201 fits squarely within these parameters. We continue to build on our leadership position in prolactin biology, by executing on our current ABS-2 zero 1 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 Rancy 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 reinforced 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. AVS-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 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 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 can 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 AVS-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 US 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 3 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 AVS-201, offset by a decrease in personnel related costs. Selling, general and administrative expenses were $9 million for the 3 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, 2020. 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 allows us to focus on executing our business objectives This includes creating, developing, and potentially commercializing wholly 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 Mule, 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 2 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 will now turn it back to Sean.

Sean McClain: Thanks, Zachariah. As always, I want to thank the amazing team at Absci for their unwavering dedication to our mission. I would 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 demonstrate the therapeutic potential of our anti prolactin receptor antibodies, the power of the platform, and the team that developed them. Operator, let's open the call for questions.

Operator: At this time, we will conduct the question and answer session. A reminder, to ask a question, you will need to press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Please limit yourselves to 1 question and 1 follow-up. Our first question comes from the line of Vimal Divan of Guggenheim Securities. Your line is now open.

Vamil Divan: Great. Thanks for taking the questions, and congrats on the progress. Maybe just 1 question I have on the upcoming data release here next month for a pattern hair loss. It sounds like I. Maybe I am misinterpreting a little bit, but more recently been focusing a little bit more on the total hair count that you will 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 is a shift or is there. Maybe I am just misinterpreting that. Just kind of the focus more on the total side. As opposed to just non. non-vellus would be helpful. And then just a second question, sort of building off of that, I am just curious, how do you view the more important, bigger sort of 26 week data release early next year Is there anything in this data release that we will 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 we should expect to just sort of continue as is until early next year's readout? Thank you.

Sean McClain: 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 are 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 as well, is critically important because some of these other mechanisms really do not 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 wanna have a holistic picture of this, and I will hand it over to Ransi to dive a bit deeper into that. Ransi?

Ransi Somaratne FACC: Thanks, Sean. So the mechanism should promote or support hair growth across the board. Right, we think that it is in supporting the stem cell niche. We think it is supporting the energetics. The proliferation of keratinocytes. And that is not really reserved for 1 width of hair follicle. And also, it is important to remember that this definition of vellus versus non-vellus is kind of a numerical cutoff. it is not really a biological cutoff. So you could have hairs that are 20 to 30 µm in width, that are on the cusp of being a vellus hair or a non-vellus hair. So we are really interested in the entire picture. The other thing is if we are restoring hair growth and follicles, we need to be open to the fact that these follicles may grow a hair that is less than 30 µm. In width. So that is why we are 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 have stated in the protocol that this interim is in no way or fashion designed to change the conduct of the trial. We are also happy to report that we finished enrolling the highest dose cohort. So, right now, from here on out, it is gonna be continuing to bring patients back or volunteers back and do their photography and assessment. Okay. Thank you.

Operator: Thank you. Our next question comes from the line of Brian Cheng of JPMorgan. Your line is now open.

Brian Cheng: Hey, guys. Thanks for taking our questions this morning, and congrats on the progress I remember that we talked about total hair count and nonvillous 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 do not think that these. There are not a lot of data for week 13 in historically, and then we have a quick follow-up. Thank you.

Sean McClain: Yeah. it is a great question, Brian. In terms of, you know, what you should see from, you know, a placebo standpoint. So when we have talked with KOLs about this, when we have looked at other studies, you usually do see a plus or minus 5 target area hair count in overall change of some non-vellus change. And so we do expect there to be, potentially negative hair growth because if you do look at, you know, change over time with AGA patients, you are losing those hairs, and they are, you know, converting to vellus. Ransi, do not know if you have anything else you wanna add to that.

Ransi Somaratne FACC: Yeah, it is a really interesting question. The placebo data at week 26. there is, as Sean said, negative and positive. But it is important to remember that AGA is a progressive condition, and naturally, 1 does not expect things like hair counts to show a consistent gain over time. I mean, vellus hairs cycle much faster than non-vellus, non-miniaturized hairs. So you would not expect to see these things go up, and that is why we think that looking at total area hair count, not just target area hair count, is gonna give us a better picture of the drug's overall MOA.

Brian Cheng: 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 1.2 thousand mg as a dosage, which I think in the male cohorts you have tested 300, 600, and 1.2 thousand. Just curious, if you can elaborate a little bit more on the selection of those 2 doses for the female cohort. Is that based on the efficacy that you have seen so far in the male cohort? Thank you.

Ransi Somaratne FACC: Sean, I can take that 1. it is not based on what we have seen in the male cohorts. You know, this is something you do in an exploratory stage. And these 2 female cohorts are open label, there is no placebo arm. And it is very much exploratory. And the reason we picked the low and the high end is it is 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.

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

Gil Blum: Good morning, and thank you for taking our question. So maybe a first 1, as it relates to 1 of your competitors showed some really strong 1-year data very recently. Do you think that changes how we should look at 26 week data, 13-week data, or is everything else kind of remains the same? And I do have a follow-up. Thank you.

Sean McClain: Yeah. Thanks, Gil. So first off, with that particular study that was done, there was no placebo arm looking at the 12 months. So that is from baseline. So we do not know how placebo did change. And if you look at it, you know, from baseline, I would say that you saw really no change in overall hair growth. What we are, I think, quite excited about with this particular mechanism is the continued growth. If you look at the stump tail macaques at 26 weeks or 6 months, they are still increasing in their overall hair count for non-vellus. And, you know, we believe that you have the potential to continue hair growth past 6 months. So as minoxidil,, you know, plateaus at that 6 months, I think there really is that potential to continue to gain hair growth past 6 months in addition to the overall durability. So again, 1 of the things we are really excited about this is both convenience, so 2 to 3 doses over 6 months, and then you get hair regrowth for the next, potentially a couple of years, you know, the follow-up, 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, Zachariah, I do not know if you have any. If you guys have anything else to add there.

Ransi Somaratne FACC: I think you covered it, Sean. I. Again, we look back to the stump-tailed 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. So I think you are gonna see differentiation, from 6 months and beyond. I do not think that what the other company released at 1 year, again, not placebo adjusted, is going to change the way we look at ABS-201's results at 6 months or even at 1 year and potentially beyond 1 year.

Gil Blum: Okay. Thanks for the clarification. Very helpful. And you also mentioned pigmentation. Just maybe you can remind us how is that even assessed? Especially if compared to a control or baseline. Thank you.

Ransi Somaratne FACC: Ransi, do 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 a number of pixels in a given hair and assigns a darkness score So, we--you know, again, if the human data recapitulate the nonhuman 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 gonna be reporting at 13-weeks, but certainly we will be looking at this at 26 weeks and beyond.

Operator: Thank you. Our next question comes from the line of Kombiz Yazdi of U.S. Bancorp, BTIG. Line is now open.

Ivana: Hi there. This is Ivana on for Kombiz. Thanks taking our question, and congrats on the continued progress. So 2 questions for me. If relatively modest human doses of AVS-201 can achieve the level of receptor occupancy that requires substantially higher nominal dosing in kind of the historical nonhuman primate studies that were mentioned. Can you describe some of the molecular or pharmacologic properties of ABS-201 that are driving that difference? I will ask my follow-up. After that.

Ransi Somaratne FACC: Ransi, I will hand that over to you. Yeah, I am 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 ABS-201 and HMI-115 if you are able to disclose some of that.

Ransi Somaratne FACC: Oh, I see. Yeah. I do not think we have commented on the actual sequences. between the 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 nonhuman primate study, which was actually quite high. So our dosing range, particularly once you get in over 3 hundred milligrams 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 ABS 1 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.

Sean McClain: Yeah. And another piece I will point out is the, you know, half life of HMI-115 is 2 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 nice steady exposure above that 90% is really important to make sure that the follicle stays in antigen by blocking the receptor. Because 1 of the things that we see when modeling out, you know, HMI-115 is that you get this oscillation and you are essentially going in and out of antigen and catagen. And again, as Ransi had stated that exposure greater than 90%, which is, you know, 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 in the antigen and to be able to reverse the miniaturization that you have seen.

Ivana: Thanks. that is very helpful. And 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 like, the fractional improvement at Week 13 to continue on or a substantially larger effect to be seen at week 26.

Sean McClain: Yeah. So we have talked about this before, but at least in the stump-tailed macaque data, what you saw were 2 different-- it takes a little bit more time at the beginning to start to kick the follicle into the antigen. State. So you are getting a little bit slower growth on the target area hair count. And then, you know, from 13 to 26 weeks, we do expect, you know, there to be a ramp up And, you know, that is 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. Great.

Operator: Thank you so much. Our next question comes from the line of Andreas Tsai of Jefferies. Your line is now open.

Andy: Hi. This is Andy on for Andreas. 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?

Sean McClain: Thanks, Andy. So we have got it to the 13-week, and that is our plan. Is to share the 13-week data at this time.

Andy: Got it. And it is time for just 1 more follow-up. And then I guess is there going to be any 26 week data possibly in this top line release, and some patients could be done already.

Sean McClain: So given when 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.

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

Brendan Smith: Great. Thanks for taking the questions, guys, and congrats on the 13 versus 26 weeks expectations. But 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-week 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 a dose in PHL will be to endometriosis? Just what kind of gives you confidence, dose ranges and efficacy will translate into those patients. Thanks.

Ransi Somaratne FACC: Thanks, Brendan. Ransi, you want to take that? So the approval endpoint for PHL has traditionally been 26 weeks. So we are really interested to see what happens at 26 weeks. The, as we said before, the 13-weeks is directional in nature for us. But we will plan our Phase 3 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 are really mostly interested in the 26 weeks. For endometriosis, as we have said before, we are dosing healthy female volunteers without pattern hair loss. This is outside of the 2 exploratory PHL cohorts in women that I just mentioned. We are dosing healthy volunteers. Healthy female volunteers in every dosing cohort of the headline trial. And their safety, tolerability, and PK data are going to inform what we do with the endometriosis dosing. Again, we are looking for at least 90% occupancy, and that is why we are waiting for the PK data all 3 dosing cohorts before choosing the--before choosing the endometriosis dose.

Operator: Thank you. Our next question comes from the line of Reni Kattakutta of LifeSci Capital. Line is now open.

Analyst: Hey, 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 is baseline severity in age, for example, in the broader PHL population, but more so specific to the mechanism itself.

Ransi Somaratne FACC: Want me to take that, Sean? What we have seen-- yeah, go for it. Yeah. that is 1 of the things that you get out of a clinical trial. So we are not pre specifying any specific response characteristic or baseline characteristic that predicts response to the drug. Got it.

Sean McClain: And I will note in our ex vivo study that we did with the 6 individuals, you know, 3 female, 3 male, you do see that when you block the prolactin receptor, you see STAT5 go down. For all 6, and for all 6 you see an increase in percent antigen within the hair follicles that were studied. And so the fact that all 6 rows obviously, that is the N of 6. But we--you know, as Ransi said, the clinical study will show this, but we do not have any reason to believe that they are that there may be differences. But, again, we will see in this study.

Analyst: Got it. And then going off of previous question, is there additional PKPD data that you need to support every 2 or every 3 month dosing? Or is it just going to come down to the data at the end of the day?

Ransi Somaratne FACC: From a PK perspective, it is going to come-- yeah. Thank you. there is. We are very confident in what we have seen so far. With the dosing, the PK data that we have gotten to date, that it is going to be every 2 to every 3 months. I think accumulating data will only refine that dosing interval. But right now, we are very comfortable saying that it is going to be every 2 or every 3--I am sorry--2 to 3 doses every 6 months. And, again, this is not something you repeat. We are designing the program so that you take the 2 or 3 doses and then you stop. 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: Congratulations on all the progress this year. So in terms of dose levels that we will see next month, will we see data 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: Yeah. So what you are gonna be seeing at the 13-week is all of the 3 hundred, I would say, the majority of the 6 hundred, and potentially a kind of sneak peek into the 1.2 thousand. Right?

Kripa Devarakonda: And you know, the PR highlights, you know, hair width and pigmentation are secondary endpoints. Right? We have known that. When we think about what could be an indicator for how the 26 week data might be reflected in the data that you are showing at 13 weeks. Which do you think is the most important endpoint, or should we look at all the totality of the data?

Sean McClain: 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 antigen state. How you are potentially reactivating these telogen 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 on kind of the totality. And as, you know, Ransi mentioned previously, the endpoints at the end of the day, at the 26 are still the same. it is still the, the non-vellus, counts as well as the patient reported outcomes. Those are the 2 co primary endpoints, but again, from a mechanistic standpoint for this mechanism, we have to be looking at all of these at the 13-week. Ransi, you have anything else there if I missed anything.

Ransi Somaratne FACC: No. I think you captured everything. We look holistically. Obviously, target area hair count, which is hairs over 30 µm, is what is been used for regulatory approval, but at this stage of the program, we are 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.

Operator: Thank you so much. As a reminder, to ask a question or rejoin the queue, you will need to press 11 on your telephone. Our next question comes from the line of Debanjana Chatterjee of JonesTrading. Your line is now open.

Debanjana Chatterjee: Hi, thanks for taking my question and congrats on the progress. So as we think of benchmarking ABS-201 efficacy at week 26 on the total hair count endpoint, what is your latest thinking on the adjusted improvement that would be clinically meaningful?

Zachariah Jonasson: Yeah. Zachariah, do you want to take that? And how that, you know, 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 to high dose oral so think of something in the 30 to 35 hairs per square centimeter range and target area hair count. We think that will translate to very rapid and widespread adoption in the market. What we have seen when we talk to patients is they really want something that gives them durable efficacy. And something that has a convenient administration profile. So I think if we are delivering on targeted 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 are 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. Great.

Debanjana Chatterjee: So the 30 hairs per cm² is the benchmark for both nonvellous and the total hair count. I have a quick follow-up.

Zachariah Jonasson: No. I am sorry. Just to clarify. Just to clarify. for the 26-week data, that is what we have tested in our consumer surveys as a target area hair count in that range, which we. Which would be consistent with high dose oral minoxidil. So that is 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 patient is looking for. Thanks for the clarification.

Debanjana Chatterjee: 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?

Ransi Somaratne FACC: I can take that 1. 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 is generally 5 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.

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

Charles: Hi. This is Charles on for Ramakanth. Thanks for taking my question. So maybe first for me. So you mentioned that for the 13-week data that we are gonna see all of the 300 milligram cohort, the majority of the 6 hundred, and the sneak peak of the 12 hundred at a 13-week follow-up. Will we see the full, safety dataset for all the 3 cohorts at that point. Now that all of them are fully enrolled?

Ransi Somaratne FACC: 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 is really important because this is an ongoing trial, and we do not want to introduce any sort of bias specifically in terms of safety reporting. So the safety data that you will see will be presented at a dose group level, not by ABS 2 zero 1 versus placebo.

Charles: Great. that is helpful. And maybe 1 more. So on the. For the endometriosis, so, you know, in late September, you shifted the study initiation of STORILINE to mid 27. So just curious where this puts the proof of concept top line data from the study. Thanks.

Sean McClain: Yeah. We will be coming out with more clarity on the POC data and, you know, potential interim if we decide to have 1 earlier in the year, next year. So, be on the lookout for that. 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.