Good day and thank you for standing by. Welcome to the AppSci fourth quarter and full year 2025 business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, we'll open up for questions. 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 call is being recorded. I would now like to hand it over to our first speaker, Alex Kahn, Corporate Vice President in Investor Relations. Please go ahead.

Earlier today, Absai released financial and operating results for the quarter and full year ended December 31, 2025. 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 at absai.com. An archived webcast of this call will be available for replay on Absai's investor relations website at investors.absai.com for at least 90 days after this call. Joining me today are Sean McLean, Absai's founder and CEO, Zach Johnison, chief financial officer and chief business officer, and Rathi Somaratmi, Absai's new chief medical officer. Before we begin, I'd like to remind you the 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 that materially differ from those anticipated, and you should now replace undue reliance on forward-looking statements. These include statements regarding the development and clinical progress of ABS-201, anticipated clinical trial design, enrollment and timelines, expected clinical data readouts and their timing, anticipated characteristics and product profile of ABS-201 as a drug product, our target product profile and its attributes, the potential for an expedited development pathway, including the possibility of advancing directly from Phase 1, 2A into Phase 3, our planning engagement with the FDA regarding development strategy and potential market opportunity and commercial prospects for ABS-201. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual redressible market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product profile and do not represent clinical results for ABS-201. Additional information regarding these risks, uncertainties, and factors that could cause results to differ appears in the section titled forward-looking statements in the press release to AFSCI issued today and in the documents and reports filed by AFSCI from time to time with the Securities and Exchange Commission. Except as required by law, AFSCI 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 March 24, 2026. Thanks, Alex. With that, I'll turn the call over to Sean.

Thanks, Alex. Good afternoon, everyone. Thank you for joining us for our fourth quarter business update call. We had a strong fourth quarter. ABS-201 is in the clinic, and we have dosed our first three SAD cohorts in our Phase I 2A headline trial with favorable emerging safety data. We expanded into endometriosis as a second multibillion-dollar indication. as we published what we believe is the first demonstration of de novo full-length antibody designed to zero prior epitopes. I'll walk you through each of these today. Also on the call today is Dr. Ransi Samaratne, our new chief medical officer. Ransi spent nearly two decades in clinical development across multiple therapeutic areas at Amgen, Biomarin, and most recently, Vertex, where he served as SVP of clinical development and translational medicine. At Vertex, he was instrumental in the development of Gernavix, the first MAV 1.8 inhibitor approved for acute pain. Taking it from late stage development through FDA approval, that registrational experience is exactly what we need as ABS-201 advances towards proof of concept and if successful, into registrational trials. He'll walk you through the clinical development program in detail shortly. I also want to acknowledge Andreas Bush, who retires this month. Andreas built our drug creation organization from the ground up. He integrated our AI design capabilities with our wet lab platform and recruited the leadership team that will carry that work forward. He'll continue as co-chair of our scientific advisory board. Andreas has been more than a colleague to me. He's been a trusted partner and a friend. Our development operations are in excellent hands because of the foundation he built. Our KOL advisory networks for both AJA and endometriosis continue to expand. You heard from Professors Paus Sinclair and Dr. Goldberg at our December seminar, and we have now assembled a dedicated endometriosis advisory board of of esteemed experts that is actively shaping our phase two trial design and in-point selection. In December, we hosted a seminar on ABS 201 for AGA, featuring the ADSITE team and several of our KOL advisors. A full replay is available on our website. Durable hair regrets remains a significant unmet need in AGA with current approved therapies showing meaningful limitations in long-term efficacy for patients. ABS-201 was designed with the aim to change that. During the seminar, we presented human ex-FIVO data demonstrating the prolactin receptor mechanism in antigenic alopecia. Working with Professor Paus using translational human ex-FIVO scalp models, we showed that ABS-201 stimulates hair growth by generating the stem cell niche. Inhibition of prolactin receptor signaling correlates with prolongation of antigen and restoration of growth signaling, preservation and expansion of stem cell niche, and potential for follicular reconversion from delus to terminal hair follicles. Importantly, ABS-201 showed growth-promoting effects without exogenous prolactin, meaning it effectively neutralizes locally produced interfollicular prolactin signaling. The clinical implication is significant. We believe ABS-201's mechanism is not limited to patients with elevated systemic prolactin, but that it can engage the target at anyone who has active local prolactin receptor signaling. ABS-201 was engineered with an extended half-life designed to support infrequent dosing. In preclinical studies, it demonstrated a three to four-fold longer half-wives than the competitor antibody. We believe this profile may enable a convenient dosing regime of just two to three administrations for durable multi-year hair regrowth. Looking at our clinical timeline, we anticipate training preliminary safety tolerability and PK data for our ongoing headline trial in the first half of this year. That will be followed by an interim 13-week proof-of-concept data, including exploratory efficacy inputs in the second half. Full 26-week proof-of-concept data will come in early 27. Ronzi will discuss the trial progress in more detail shortly. As a reminder, we intend to use safety, tolerability, and PK from the ongoing ABS-201 study to support initiation of the Phase II clinical trial in endometriosis in Q4 this year. The engagement we have had with endometriosis patients, advocacy groups, and KOLs has reinforced our conviction. This condition has been underserved for decades, and patients need better options. Endometriosis is estimated to affect approximately 10% of women of reproductive age worldwide. There is currently no FDA-approved disease-modifying therapy. Current medical and surgical management strategies have significant limitations. ABS-201 targets a non-sex hormone pathway distinct from existing hormonal therapies. Our preclinical data combined with positive Phase II results from a competitor antiprolactin receptor antibody, validating the mechanism in humans, support the potential to modify disease progression, address both pain and lesion growth, and offer differentiated safety profile. Beyond ABS-201, our other programs, ABS-101, 301, and 501, continue to progress. Each of these we see as better suited for our partner, and we remain engaged in discussions with multiple strategic parties. This allows us to focus our resources on ABS-201 and invest in additional early stage programs. Our strategy is to go after underexplored targets in large markets where unmet need is significant and competition is low. That's where the platform creates the most differentiation and where we see the highest return on our R&D investment. Put a number on it, we have advanced our first two programs from AI design to IND in approximately two years at a roughly $15 million investment per program, compared to an industry standard of four to six years and $50 million or more. Earlier this year, we published details on Origin One, our generative AI platform for de novo antibody design, integrated with our lab-in-the-loop validation. Origin One designs full-length antibodies against zero prior episodes, targets with no reported complex structure it generates lead candidates by screening fewer than 100 designs per target with atomically accurate predicted structures and confirmed functional activity so the value of the platform is measured by the assets we create we are expanding our pipeline and expect to advance additional programs we'll provide updates as those programs mature. With that, I'll turn it over to Ronzi to walk you through the ABS-201 clinical program. Ronzi.

Thanks, Sean. Good afternoon, everyone. It's great to be here. My name is Ronzi Somaratne, and I am thrilled to be joining the ABS-I team as its chief medical officer. I'm a cardiologist and internist by training, and I've had the opportunity to work at great organizations such as BioMarin and Amgen, and most recently, Vertex Pharmaceuticals, where I served as Senior Vice President of Clinical Development and Translational Medicine. I've been fortunate enough to lead clinical development of groundbreaking programs during my career, including Gernavix at Vertex, the first NAV 1.8 inhibitor approved for moderate to severe acute pain. I'm excited to join Absci at such an important time as we continue on our journey to use our integrated AI and wet lab platform to create new and differentiated medicines to improve the lives of patients in need in the near term i'm excited to be advancing our abs 201 program for both aga and endometriosis through the clinic both of these programs could represent significant advances compared to available therapies i've been involved with multiple complex clinical trials spanning pain cardiovascular disease nephrology, and other diverse disease areas, and am impressed by the ABS-CY team's rigorous approach to the ABS-201 clinical trial designs. I believe ABS-CY has built a differentiated platform, and as a drug developer, I am so enthusiastic about the opportunity to contribute to the advancement of its pipeline, including ABS-201, at this stage of the company's growth. We are advancing the clinical development of ABS-201 for two indications with significant unmet medical need, androgenetic alopecia and endometriosis. Our ongoing phase 1-2-A headline trial is a randomized, double-blind, placebo-controlled study, efficiently serving both as a first-in-human study of ABS 201 while also providing preliminary proof of concept data and AGA. The AGA POC component is incorporated into the multiple ascending dose part of the trial. The primary endpoints are safety and tolerability, while secondary endpoints include PK, PD, immunogenicity, target area hair count, target area hair width, and target area darkening and pigmentation. We will also collect patient-reported outcomes data. The trial is enrolling up to 227 healthy volunteers with or without AGA. The single ascending dose or SAD portion of the trial is testing four intravenous dose groups for safety tolerability pk and pd the sad portion of the trial will be followed by three subcutaneous multiple ascending dose groups and healthy volunteers with androgenetic alopecia while the mad portion of the study also looks at safety tolerability and pkpd we have powered the mad portion to demonstrate proof of concept in AGA. We plan to share 13-week interim proof of concept data in the second half of this year, followed by 26-week data in early 2027. With the 13-week data, we hope to demonstrate directionally positive hair growth compared to baseline, which would translate to even more robust growth at the 26-week readout and beyond. These results would be consistent with our understanding of the mechanism of action and supported by a naturally occurring non-human primate model for AGA. Furthermore, we have ongoing engagement with the FDA regarding an efficient clinical development strategy that could support expedited clinical development with the potential of advancing directly from phase 1 to A into phase 3 registrational trials. Today, we are pleased to share that we have successfully dosed the first three cohorts in the SADD portion of our ongoing Phase 1-2-A headline trial. To date, ABS-201 has been well tolerated with favorable emerging safety data. Additionally, emerging PK data support the current dosing regimen in the headline trial as we have modeled. We are on track to dose SADD Cohort 4, as well as the first MADD cohort. For endometriosis, we plan to use data from the Phase 1-2A headline trial to provide safety, tolerability, and PK assessments that will support Phase 2 clinical development beginning in Q4. We anticipate an interim proof-of-concept readout from this trial in the second half of 2027. With that, I'll pass it over to Zach to discuss our strategy, partnership, and outlook, and to provide an update on our financials. Zach?

Thanks, Rancy. Our strategic priority is executing the clinical development of ABS-201 in both AGA and endometriosis, given the significant potential return on investment these programs offer. In particular, our LEAD program in AGA represents a unique opportunity. We believe this program has the potential for streamlined clinical development and a potentially significant commercial opportunity in the cash pay market if the program is successfully advanced through development. As Ramsey discussed, we are currently executing an efficient Phase I-2A trial design to position us for registrational studies that could enable a potential FDA approval in the 2030 timeframe. We expect the registrational trials to enroll rapidly and to cost significantly less than typical registrational trials for other large indications. Our market research, some of which was shared during the ABS-201 KOL seminar in December, supports the commercial potential of ABS-201 as a new premium category of AGA therapy. Results from the survey we commissioned, which included 610 participants experiencing AGA, support our belief that there is a meaningful demand for a product with the ABS-201's anticipated minimum target product profile. The TPP evaluated in the survey assumed a level of hair regrowth comparable to that reported in the literature for high-dose oral minoxidil, but with a potential durability of two to three years. The hypothetical profile also contemplated a six-month dosing regimen consisting of approximately three subcutaneous administrations as compared to currently available oral or topical treatments that require daily or twice-daily administration. Key highlights from the consumer survey include 87% of men and 69% of women surveyed indicated they would be extremely likely or very likely to ask a healthcare professional about ABS-201 if it were available on the market today. Moreover, these figures increased to 92% and 89% respectively for men and women who are currently using oral standard of care, for example, oral minoxidil. And over two-thirds of men and women who are currently using another hair loss product that they would be extremely or very likely to try ABS-201 as first line if it were available. These results, together with data from our survey of key opinion leaders, are supportive of potentially significant adoption of ABS-201 among AGA consumers if the product was successfully developed and approved. Based on our market research, we estimate a potential total addressable AGA population for ABS-201 in the U.S. of approximately 15 to 18 million consumers. Assuming a two- to three-year treatment durability, the total potential annual treatable patient volume could range between 5 and 9 million consumers per year. Our survey data suggests this segment of the AGA population would be interested in purchasing a product with ABS-201's anticipated profile at a premium price relative to the current standard of care treatment. Accordingly, based on all of our market research, we believe the total addressable market for ABS-201 in the United States could be substantial, with some estimates exceeding $25 billion on an annual basis. While we believe our estimates are reasonable and based on available data, actual market size and ABS-201's ability to capture any portion of said market will depend on numerous factors, including clinical trial outcomes, regulatory approval, pricing, and competition. This program may offer additional commercial upside, as the headline clinical trial is also designed to explore whether ABS-201 can achieve other aesthetic outcomes, such as restoration of hair pigmentation. If such outcomes are demonstrated in clinical studies and supported by regulatory approval, they could open up additional significant markets beyond AGA. If ABS-201 is approved, we believe we will be well positioned for commercialization in the United States. Existing go-to-market channels and provider networks appear to be suited for a premium product with the anticipated ABS-201 target product profile. Approximately 80% of consumers seek hair treatments from dermatologists, med spas, and plastic surgeons, which together offer over 30,000 potential retail locations across the United States. We have begun establishing relationships with these practitioner market channels. And looking ahead, we aim to continue to create awareness among this practitioner community, and, when appropriate, to establish direct patient engagement. As ABS-201 moves forward towards major potential value inflection points, we plan to continue progressing our internal preclinical programs as well as our partner programs. In all, we remain highly focused and committed to diligently allocating our capital and resources to programs that offer the greatest potential return on investment. Turning now to our financials. Revenue in the fourth quarter was $700,000 as we continued to progress our partner programs. Research and development expenses were $25.3 million for the three months ending December 31st, 2025, as compared to $18.4 million for the prior year period. This increase was primarily driven by advancement of absides internal programs, including direct costs associated with external preclinical and clinical development of ABS-101 and ABS-201. Spelling, general, and administrative expenses were $8.6 million for the three months ending December 31st, 2025, as compared to $8.8 million for the prior year period. Additionally, we recorded a $5.1 million gain on the settlement of the company's contingent consideration during the fourth quarter of 2025. This resulted in net proceeds of $8.7 million of unrestricted cash. Cash, cash equivalents, and marketable securities as of December 31st, 2025, were $144.3 million as compared to $152.5 million as of September 30th, 2025. We believe our existing cash equivalents and marketable securities will be sufficient to fund our operations into the first half of 2028. We remain focused on opportunities to generate additional non-dilutive cash inflows that could come from early-stage asset transactions associated with our fully-owned internal programs and or new platform collaborations with large pharma. Our current balance sheet supports our execution of key upcoming catalysts, including potential proof-of-concept readouts for both AGA and endometriosis. We are also well-positioned to continue progressing our early-stage pipeline and to advance new partnership discussions in line with our business strategy. With that, I'll now turn it back to Sean.

Thanks, Zach. 2025 was a defining year for APPSI. We dosed our first patient with AVS-201, expanded into a second multibillion-dollar indication, and published what we believe is the first demonstration of de novo antibody design to zero prior epitopes. In 2026, we expect to deliver on our catalysts. preliminary safety and PK data for AVS-201 in the first half, interim 13-week proof-of-concept hair regrowth data in the second half, and initiation of our phase 2 endometriosis trial in Q4, subject to data and regulatory review. Full 26-week proof-of-concept data for ABS-201 and AGA will follow in early 27. We have clinical momentum, the balance sheet to reach proof-of-concept in both indications, and the team to execute. Thank you for your continued need support. Operator, let's open the call for questions. Thank you. 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 stand by while we comply with the Q&A roster. One moment for our first question. First question comes from the line of Emil Devin from Guggenheim Partners. Your line is open.

Great. Thanks so much for taking the question. So I guess obviously a lot of focus on 201 and a common question we've been getting from investors is just what we should be looking for, what you're looking for in terms of a target product profile, especially from an efficacy perspective. Obviously there's not a lot of great options out there, but others that are in development. So I realize it's still a little bit early, but just if you can give a better sense of sort of What you're hoping to see from an efficacy perspective, we have the minoxidil options that are out there, we have competitors in development, just where do you hope to see this land, given that it'll be an injectable, sounds like it may be more of a premium priced product, what are you hoping to see from an efficacy perspective? Thank you so much.

Yeah, thank you, Vommel. It's a great question, and what we're looking to achieve, and I'll have Zach go into more details on this from our consumer quant study but talking to physicians as well as patients we believe that if we achieve a durable treatment as well as being able to to achieve at or above minoxidil efficacy we'll definitely have a very attractive ppp and zach please feel free to kind have walked through more of the details on that, given the consumer quant study we had just completed. Yeah, thanks, Sean.

And I would just note that the PPP that ABS-201 embodies, or we think it will embody, is really a new category of therapy that we hope will deliver not only efficacy, but durable efficacy and convenient administration. So, to Sean's point, if the effect size in terms of terminal area hair count and the growth of terminal area hair count is consistent with high-dose oral minoxidil, so 35 to 40 hairs per square centimeter, we think that's a home-run product. And that's supported by the research we've done with consumers and KOLs. We think there's a significant product even below that threshold. But I think at that threshold, it's a very significant product we would characterize as a home run product and keep in mind that's that's um additive with the other features of the profile which would include durability and that convenient dosing of just a few injections

okay one other one oh sorry go ahead i was just going to also mention that you know if you look at the stump tail macaque data it was well above that so i we do even have uh room to to run on this. I think, as Zach said, this is a home run product, but from what we're seeing from the stump tail macaque and even ex-fever data, you know, could be well about that as well for an

upside scenario. Okay. Thank you. And one other one, just to follow up, is on the safety side. So, I think the words you use are favorable emerging safety profiles. So, I don't know what you can elaborate at this point. So, what you've seen from the cohorts that have gone through the

SAD portion. Thank you. Yeah, absolutely. Ronzi, do you want to take that? Yeah, thanks. So it's

early in the trial, but at this point, there's no evidence of any on-target or off-target safety signal based on a review of the safety data accumulated today, but it's encouraging so far.

Okay, thanks for taking my question. Thank you. One moment for our next question. Our next question from Comfortline, Brendan Smith from TD Callen. Your line is open.

Thanks for taking some questions, guys. Maybe just another one quick on 201. I guess kind of given other pivotal studies in this space and maybe even in your conversations with FDA to date, maybe first, is it fair to expect that six-month primary endpoint you're using in the MAD is the same duration of follow-up you'd expect for a registrational study? And then separately, just on the drug creation partnership, I think you flagged at least one new one with Big Pharma this year. Can you maybe just tell us, even qualitatively, how those conversations are going? We get asked all the time, like, kind of given all the money pharma spending internally on AI, I guess, what are they still coming to AppSize for, and how should we really think about them leveraging the platform within the confines of those deals? Thanks.

Yeah, thanks. Ronzi, you want to answer that first one, and then, Doc, you can take the second one.

Yeah. So, we have not yet engaged FDA on the Designer for Phase 3 program. We're going to, one of the reasons we're excited about the 13-week interim readout is that it's going to give us a much better idea of what the Phase III program will look like. But certainly other companies are developing a six-month pivotal endpoint with another six months of long-term safety data follow-up. So there are some predicates in the field, but we're going to look forward to our 13-week interim and give you more details on that once we see the data.

thanks and this is zach i can i can comment on the partnership discussion um we continue to have productive discussions with pharma uh regarding platform partnerships i do think it's important to note that we're focused on doing the right deal not doing a deal and so we're currently actively negotiating and looking at deal structures that could work for us and i would comment as well we have a healthy pipeline of internal programs that are being developed today we We haven't announced several of them. We have not yet announced several of those, but we will be looking to initiate partnering discussions around those programs later in this year.

Got it.

One moment for our next question. Our next question on the line of Brian Chang from JPMorgan. Your line is open.

Hey, guys. Thanks for taking our question this afternoon. Sean, I think you said in your prepared remarks, you said 101, 301, and 501 continue progress. Each of these you see better suited for a partner. Just to clarify, are all of them now on the table for partnerships, or do you think that you will want to develop 301 or 501 a bit more internally?

Yeah, thank you. That's a great question, Brian. And just given our focus, in particular in INI, given ABS-201, we believe us developing oncology doesn't make sense. And so with 301 and 501 being in oncology, we think that this is much better suited for a partner. We do have an earlier stage pipeline that is developing where we should be nominating DCs this year that have not been announced that are in INI, and we could potentially take these forward ourselves, assuming that the cash balance sheet is there. And then we also have the optionality to partner those as well, so we've definitely been harder work kind of building up that INI platform or pipeline, I should say.

Got it. And maybe just one quick one on safety. I know you touched on this a little bit already. Just is the profile that you're seeing in terms of safety consistent with what you have seen in non-human primates? And are you seeing any, you know, particularly impact of interest? I'm just curious if you can give us a little bit more color on, you know, how we should think about the TEAE profile.

Yeah, absolutely. You know, as Ronzi said, I think we're really pleased with the profile that we're seeing to date. And Ronzi, I don't know if there's anything or any further details

you can comment on from a safety perspective. Yeah, we've looked at the TEAEs. There's there's really nothing that you would, that would point to any sort of mechanism-related safety signal or off-target mechanism-related safety signal. We're looking very closely at labs and, you know, other than onesie-twosie things, there's no pattern of anything at this point. But, again, I have to caveat that it's early in the study without a ton of people exposed.

I'll also say, you know, given the encouraging profile, it definitely lines up really nicely with what you see from other studies, you know, HMI-115, you know, hitting a similar target, as well as a few other assets that have been developed in oncology. You can see safety signals there for this particular pathway. And then you also have loss of function mutations that in the prolactin receptor, and these individuals were perfectly healthy, just did not have the ability to lactate. So I would say from what we've seen in other studies, as well as these loss-of-function mutations, it tracks very nicely to what we're seeing in our own study. And as Runzi said, it's early days, but very encouraging.

Great. Thank you so much for tonight, for the color.

Thank you. One moment for our next question. Next question, we're coming from the line of Kripa Devarokonda from Truer Securities. Your line is open.

Hi, this is Alex on for Kripa. Congrats on all the progress.

We had a question on 201 as well. Some of the investors that we talked to expressed caution about the ability for a molecule to get into the hair follicle to inhibit the prolactin receptor. Can you talk about the data that supports the ability for the molecule to engage the target or if there's any reason to believe otherwise based on your perspective? Yeah, so you're definitely not going to have the penetration you'd have or the biodistribution, I should say, in other organs, but there's definitely ample blood flow going into the follicle. And again, you saw the data with the stumped macaques. You saw the data as well with the mice. And so, you know, based on that, we have no reason to believe you wouldn't be able to get an antibody into the follicle. And the way we modeled the receptor occupancy was using a known biodistribution coefficient for the scalp and hair follicle, which is much lower than other tissues. Ronzi, I don't know if you have anything else you want to add on that point.

No, I think the—thanks, Sean. I think the animal data are very encouraging, suggesting that there's adequate tissue penetration with other antibodies and even in 201 and abscite zone work.

Great. Thanks, everyone.

Thank you. One moment for our next question. Our next question will come flying with Deba Janja Chatterjee from Jones Trading. Your line is open.

Thanks for taking my question. So I wanted to ask that we have seen some recent updates for these candidates, including flascosterone and also oral extended-release minoxidil is gaining traction. So could you remind us how you envision an anti-PRLR antibody to be used relative to such agents, assuming that they are approved? And also, do these new developments or agents shift the bar for success that you have in mind, particularly in terms of expected target area health count improvement?

Yeah, it's a great question. First off, I think, you know, the success that, you know, Veridermix and others are having is really great. I think at first it shows that there's a huge unmet medical need for endogenic alopecia, and, you know, it affects over 80 million Americans, and there is treatment that's needed. And we see what we're doing as very synergistic, I think, even with oral minoxidil, you know, patients still aren't, you know, some patients aren't seeing the full hair regrowth that they would like to see. Additionally, you know, with a lot of these medications, you have to take it, you know, once or twice daily. And if you have the potential to take two to three doses over six months and then have durable hair regrowth after that, we see that being very attractive, assuming that you can reach the efficacy of oral minoxidil. And so that's really where we see this as being a premium product, really being able to rejuvenate that hair follicle and get that durable hair regrowth. this is a brand new novel mechanism. You know, oral monaxilofinesteride, they've been around for a long time. And the biology that we've seen here, it does appear that prolactin is, you know, kind of furthest upstream, really driving the hair loss. And you can see that in the ex-civo studies we've done. And so, overall, we think that this is a potential paradigm-shifting asset here within EGA. But again, we're really excited that other companies such as Varidermics are having the success that they're having because it does shed a light on how

important uh that this uh space is um thank you to what sean said too we saw that in our survey right we saw a very high level of interest in the target product profile for abs 201 across the board for men and women but when we segment out um participants who have aga who are currently using minoxidil oral minoxidil the interest level goes up even higher so we saw 92 percent of men and 89% of women were currently using oral minoxidil, so they would be highly inclined to go seek out the product. So extremely or very likely to go to a healthcare professional to obtain ABS-201 if it were on the market today. And I think what you're seeing there are a couple things. One is the attractiveness of the TPP and the convenience in patients wanting something that's durable and convenient. And then also some dissatisfaction with standard of care, in particular oral minoxidil, because you really have to take that once a day or in some cases twice a day to see the efficacy. And then as Sean pointed out, the efficacy can be very variable across patients. Some patients don't see much. Some patients will see pretty decent efficacy. And then finally, there's some side effects with oral minoxidil as well, which some patients experience, including unwanted hair growth and a shedding cycle that may happen when you first go on the drug. So I think, you know, if you roll it all together, I think the TPP here really resonates with the AGA community because it sort of checks off the boxes of being durable, very convenient to administer. You kind of imagine a set it and forget it sort of solution. And we do believe long-term in the market, there'll be a significant number of patients who probably use bulk products.

Okay, thank you.

Thank you. One moment for our next question. Our next question will come from the line of Neatom. The line is open.

in, and thanks for taking our questions. Maybe a bit of a math question. You said three cohorts were a dose. Should we assume this is about 24 patients at this point?

Ron, do you want to take that?

Yeah, I have to look at the actual math, but I don't think that's too far off. It's a rough ballpark there, Gil.

Okay, that's fair. I do have a question specifically for Dr. Ramsey. Yeah. Can you discuss some of the expected challenges in developing a drug for endometriosis, especially when assessing involvement of pain measures? It seems like you have the right experience here.

Yeah. Yeah, it's interesting because these are really pain studies. And pain studies require a lot of thought in how you select your sites, how the patients are selected. and how the placebo effects are mitigated. And so, you know, I've learned a lot over the last three years working in pain. And I don't know if this has been previously appreciated in endometriosis studies, but these are the things that I think about because in addition to treating the underlying biology, which we hope that ADS-2011 will certainly do, we have to think about the end in mind And at the end, these are numerical rating scores, so we have to be extremely thoughtful in how we write the protocol, select our sites, and then oversee the conduct of the trial.

And maybe a last one for Zach. How should we think about resource allocation between AGA and endometriosis?

Yeah, thanks for the question, Gil. I think both opportunities are very significant. And I think we talked about the unmet medical needs in endometriosis and really not much competition there. We also think the similar view applies to AGA where this would be a completely new category of therapy. And so, when we think about resource allocation, these are both programs where we think the potential ROI is very significant. And then the other thing that these programs allow us to do is take advantage of a streamlined development path. So, as Nancy noted, we'll be using this Phase 1, 2A trial that's on running, that's ongoing today for AGA. We'll use the SAD portion of that as safety to support initiating a Phase 2 trial endometriosis later this year. So, we're leveraging the current trial to support moving into proof-of-concept studies in endo very rapidly. And I think one other comment I'll just make on the AGA trials is we're really excited there because those trials recruit very rapidly. So, when we think ahead to registrational studies, we think about trials that can recruit very rapidly and that will be significantly less in terms of investment, invested capital to execute those than you would see for other traditional indications that would be for large market opportunities. So, I think you look at these two together and, you know, when we look at these programs internally, we obviously have other things we can pursue, but these really stand out as unique opportunities. So we're really excited to pursue them.

All right. Excellent. Thanks for taking our question.

Thank you. One moment for our next question. Our next question comes from Sean Lauman from Oregon Stanley. Your line is open.

Good morning, Sean and team. Hope everyone's well and congrats on all the progress.

I have a question back on the platform, and we do get a lot of inbound on potential AI crowding, if you like to call it that. But in the March deck, you emphasize Origin One and the zero-prior epitope design as key differentiators. Based on some of your 2025 interactions with potential partners, where do you see the strongest external validation of your platform relative to other AI-enabled discovery companies? And where is skepticism still the most common?

Yeah, so I would say first off, pharma has very much embraced AI. I think it's progressing faster than we have anticipated in some regards and then not as quickly in others. But overall, I would say pharma's appetite on this and whether it's partnering or building out internally is very strong. And I think the validations that we've been able to show in the preprint and kind of just the extensive validations towards the zero prior epitopes I think has been some of the most rigorous work that has been published to date. And I will note that a lot of these models are not being disclosed, whether it's, you know, within this industry or the LLMs. And, you know, we disclosed the methods and how we went about doing it. And we're now applying this to our internal pipeline to really be able to create differentiated assets. And I think with the emergence of agendic AI, really being able to start to have this a fully autonomous workflow where you can have an agent help you look at targets, help you identify the epitope, and then that feeds directly into the de novo model and then helps you design the killer experiment and rapidly develop assets to quickly and rapidly test hypotheses. season. So I would say that we're very excited about the, you know, the future and where things are at. And yeah, it's been an exciting start of the year. Thank you, Sean. And then just

sorry, go ahead. Yeah, I mean, just to add to Sean's comments, when you look at the value of doing a platform deal versus doing an asset deal, the value on the asset deal is significantly higher, and you can risk adjust that, and it's still a multiple. And so, I think what we're really excited about is leveraging the Origin 1 models, which we've been working on for, you know, the past year to develop pipeline assets that we could either take forward or we could partner. And we have a number of those, which Sean mentioned, that we're bringing towards DC this year that could become excellent candidates for partnering activity. Right. Thank you both.

thank you and one moment for our next question our next question will come flying up Charles Wallace from H.C. Wainwright line is open all right thanks

for taking my question this is a Charles on for RK so a question on a 201 and kind of distinguishing between how internally you're thinking about the market opportunity for the two different indications I know you mentioned earlier that both indications probably be favorable but maybe to dig a little more you mentioned you provided a peak sales of more than $4.5 billion in endometriosis for the 9 million patients. And then for the AGA, I think you're targeting 5 to 9 million patients per year. So I'm just curious, should we assume that the endometriosis opportunity is going to be the larger opportunity because it's a therapeutic? Or is that maybe not the right assumption?

I think both of these indications are very large indications. I mean, one in 10 women are estimated to have endometriosis worldwide. That's a very large population, most likely underdiagnosed due to poor standard of care and poor diagnostics in the space. And then, obviously, AGA is a massive opportunity, a huge patient population as well, 80 million Americans in the U.S. And so, again, we see these as both very large opportunities. I think at the end of the day, I think AGA is likely a larger opportunity. But at the end of the day, both very exciting opportunities from just a market-sized perspective.

okay great and maybe just a follow-up so given uh you know endometriosis would be more of a therapeutic pair market well AGA would be a cosmetic kind of self-pay market um how do you kind of anticipate pricing would be once if both came to market would it be similar

or different yeah zach you want to take that yeah so we can't disclose what we think the actual price point will be we wouldn't announce those till day of launch but i can tell you in our own internal analysis um we think the pricing for both of them and given you know that endometriosis will also have predicted to have insurance coverage we don't think there'll be an arbitrage opportunity there and so we think we're we're in a good position to leverage the development efficiencies of uh pursuing both indications with abs 201 great thanks for making my questions

Yeah, and maybe before we close out the call today, I just wanted to share one exciting piece. Actually, I'll have Ramsey share that to close out the earnings call today. Ramsey, over to you.

Yeah, thanks. Thanks, Sean. As we said, the SADMED study is going well. we're on track and in fact we hope to dose our first and that portion participants towards the end of the week so we were very pleased with the

progress thank you thanks for that thank you for participation in today's conference this doesn't include the program you may now disconnect everyone have a great