Absci (NASDAQ:ABSI) Q4 2025 Earnings Call

0:00 Good day, and thank you for standing by. Welcome to the Absci Fourth Quarter and Full Year twenty twenty five Business Update Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, we'll open up for questions. To ask a question during the session, you will need to press 11 on your telephone. You 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 call is being recorded. I would now like to hand it over to our first speaker, Alex Khan, Corporate Vice President, Investor Relations. Please go ahead. Thank you. Earlier today, ABSI released financial and operating results for the quarter and full year ended 12/31/2025. 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 investorsabsci dot 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 ninety days after this call.

1:02 Joining me today are Sean McLean, Absci's Founder and CEO Zach Jonasson, Chief Financial Officer and Chief Business Officer and Rothy Somarotni, Absci's new Chief Medical Officer. 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 replace undue reliance on forward looking statements. These include statements regarding the development and clinical progress of ABS-two zero one, anticipated clinical trial design, enrollment and timelines, expected clinical data readouts and their timing, anticipated characteristics and product profile of ABS-two zero as a drug product, our target product profile and attributes the potential for an expedited development pathway, including the possibility of advancing directly from Phase one, 2A into Phase three our planned engagement with the FDA regarding development strategy and potential market opportunity and commercial prospects for ABS-two zero one. Certain statements may also include projections regarding potential market opportunity.

1:58 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 addressable market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product profile and do not represent clinical results for ABSI-two zero one. Additional information regarding these risks, uncertainties and factors that could cause results to differ appears in the section entitled Forward Looking Statements in the press release that Absci issued today and in the documents and reports filed by Absci from time to time with the Securities and Exchange Commission. 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, 03/24/2026.

2:47 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-two zero one is in the clinic, and we have dosed our first three SAD cohorts in our Phase one two a 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 doctor Ramzi Somerotnick, our new chief medical officer. Ronci 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.

3:48 At Vertex, he was instrumental in the development of Ternavix, the first mAbs one point eight inhibitor approved for acute pain. Taking it from late stage development through FDA approval, That registrational experience is exactly what we need as ABS two zero one 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 wanna acknowledge Andreas Boesch who retires this month. Andreas built our drug creation organization from the ground up, 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.

4:34 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 Doctor. Goldberg at our December seminar, And we have now assembled a dedicated endometriosis advisory board of esteem experts that is actively shaping our phase two trial design and endpoint selection. In December, we hosted a seminar on ABS two zero one for AGA featuring the Absci team and several of our KOL advisers.

5:19 A full replay is available on our website. Durable hair regrowth remains a significant unmet need in AGA with current approved therapies showing meaningful limitations in long term efficacy for patients. ABS two zero one was designed with the aim to change that. During the seminar, we presented human ex vivo data demonstrating the prolactin receptor mechanism in androgenic alopecia. Working with Professor Paus using translational human ex vivo scalp models, we showed that ABS two zero one stimulates hair growth by generating the stem cell niche. Inhibition of prolactin receptor signaling correlates with prolongation of antigen and restoration of gross signaling, preservation and expansion of stem cell niche, and potential for follicular reconversion from valence to terminal hair follicles.

6:20 Importantly, ABS two zero one showed growth promoting effects without exogenous prolactin, meaning it effectively neutralizes locally produced intrafollicular prolactin signaling. The clinical implication is significant. We believe ABS two zero one'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 two zero one was engineered with an extended half life designed to support infrequent dosing. In preclinical studies, it demonstrated a three to fourfold longer half life than the competitor antibody.

7:06 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 thirteen week proof of concept data, including exploratory efficacy endpoints in the second half. Full twenty six week proof of concept data will come in early twenty seven. Ronzi will discuss the trial progress in more detail shortly. As a reminder, we intend to use safety, tolerability and PK from the ongoing ABS201 study to support initiation of the phase two clinical trial in endometriosis in Q4 this year.

8:02 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 ten percent 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 two zero one targets a non sex hormone pathway distinct from existing hormonal therapies. Our preclinical data combined with positive phase two results from a competitor anti prolactin 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.

9:01 Beyond ABS two zero one, our other programs, ABS one zero one, three zero one, and five zero one, continue to progress. Each of these we see as better suited for a partner, and we remain engaged in discussions with multiple strategic parties. This allows us to focus our resources on ABS two zero one 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 and d investment. To put a number on it, we have advanced our first two programs from AI design to IND in approximately two years at a roughly $15,000,000 investment per program compared to an industry standard of four to six years and $50,000,000 or more.

10:01 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 epitopes, targets with no reported complex structure. It generates lead candidates by screening fewer than a 100 designs per target with atomically accurate predictive structures and confirmed functional activity. But 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 two zero one clinical program. Ronzi?

10:50 Thanks, Sean. Good afternoon, everyone. It's great to be here. My name is Ronci Somerotne and I am thrilled to be joining the Absci 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 GERNAVEX at Vertex, the first NAV one point eight 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.

11:43 In the near term, I'm excited to be advancing our ABS201 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 I'm impressed by the Absci team's rigorous approach to the ABS two zero one clinical trial designs. I believe Absci 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 two zero one at this stage of the company's growth.

12:33 We are advancing the clinical development of ABS201 for two indications with significant unmet medical need, androgenetic alopecia and endometriosis. Our ongoing phase one2a headline trial is a randomized double blind placebo controlled study, efficiently serving both as a first in human study of ABS201, while also providing preliminary proof of concept data in 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 PKPD immunogenicity, target area hair count, target area hair width, and target area darkening and pigmentation.

13:27 We will also collect patient reported outcomes data. The trial is enrolling up to two twenty seven 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 in 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 thirteen week interim proof of concept data in the second half of this year, followed by twenty six week data in early twenty twenty seven.

14:23 With the thirteen week data, we hope to demonstrate directionally positive hair growth compared to baseline, which would translate to even more robust growth at the twenty six week readout and beyond. These results would be consistent with our understanding of the mechanism of action and supported by a naturally occurring nonhuman 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 one, two, a into phase three registrational trials. Today, we are pleased to share that we have successfully dosed the first three cohorts in the SAD portion of our ongoing Phase one2a headline trial.

15:13 To date, ABS201 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 SAD Cohort four, as well as the first MAD Cohort. For endometriosis, we plan to use data from the phase one, two, a headline trial to provide safety, tolerability and PK assessments that will support phase two clinical development beginning in Q4. We anticipate an interim proof of concept readout from this trial in the second half of twenty twenty seven. With that, I'll pass it over to Zack to discuss our strategy, partnerships and outlook, and to provide an update on our financials.

16:05 Zach? Thanks, Rancy. Our strategic priority is executing the clinical development of ABS201 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 Rancy discussed, we are currently executing an efficient phase one, 2A trial design to position us for registrational studies that could enable a potential FDA approval in the 2030 timeframe.

16:55 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 ABS201 KOL seminar in December, supports the commercial potential of ABS201 as a new premium category of AGA therapy. Results from the survey we commissioned, which included six ten participants experiencing AGA, support our belief that there is a meaningful demand for a product with the ABS two zero one's anticipated minimum target product profile. The TTP 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.

17:50 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 eighty seven percent of men and sixty nine percent of women surveyed indicated they would be extremely likely or very likely to ask a healthcare professional about ABS two zero one if it were available on the market today. Moreover, these figures increased to ninety two percent and eighty nine percent 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 two zero one as first line if it were available.

18:53 These results together with data from our survey of key opinion leaders are supportive of potentially significant adoption of ABS201 among AGA consumers if the product is successfully developed and approved. Based on our market research, we estimate a potential total addressable AGA population for ABS201 in The US of approximately 15 to 18,000,000 consumers. Assuming a two to three year treatment durability, the total potential annual treatable patient volume could range between five and nine million consumers per year. Our survey data suggests this segment of the AGA population would be interested in purchasing a product with ABS201's anticipated profile at a premium price relative to the current standard of care treatment.

19:46 Accordingly, based on all of our market research, we believe the total addressable market for ABS201 in The United States could be substantial, with some estimates exceeding $25,000,000,000 on an annual basis. While we believe our estimates are reasonable and based on available data, actual market size and ABS201'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 two zero one can achieve other aesthetic outcomes such as restoration of hair pigmentation.

20:33 If such outcomes are demonstrated in clinical studies and supported by regulatory approval, they could open up additional significant markets beyond AGA. If ABS two zero one 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 two zero one target product profile. Approximately eighty percent of consumers seek care 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.

21:31 As AVS-two zero one 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 continue to progress our partner programs. Research and development expenses were $25,300,000 for the three months ending 12/31/2025, as compared to $18,400,000 for the prior year period. This increase was primarily driven by advancement of Absci's internal programs, including direct costs associated with external preclinical and clinical development of ABS 101 and ABS two zero one.

22:31 Selling, general and administrative expenses were $8,600,000 for the three months ending 12/31/2025, as compared to 8,800,000 for the prior year period. Additionally, we recorded a $5,100,000 gain on the settlement of the company's contingent consideration during the fourth quarter of twenty twenty five. This resulted in net proceeds of $8,700,000 of unrestricted cash. Cash, cash equivalents, and marketable securities as of 12/31/2025 were $144,300,000 as compared to $152,500,000 as of 09/30/2025.

23:17 We believe our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operations into the first half of twenty twenty eight. We remain focused on opportunities to generate additional non dilutive cash inflows that could come from early stage asset transactions associated with our wholly 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.

24:03 With that, I'll now turn it back to Sean. Thanks, Zach. 2025 was the defining year for Absci. We dosed our first patient with AVS-two zero one, 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 ABS two zero one in the first half, interim thirteen week proof of concept hair regrowth data in the second half, and initiation of our phase two endometriosis trial in Q4, subject to data and regulatory review. Full twenty six week proof of concept data for ABS201 and AGA will follow in early twenty seven.

24:53 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 support. Operator, let's open the call for questions. Thank you. First question will come from the line of Vamil Divan from Guggenheim Partners. Your line is open. Great. Thanks so much for taking the question. So I guess, obviously, a lot of focus on two zero one. 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 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 what you're hoping to see from an efficacy perspective.

26:00 We obviously have minoxidil options that are out there. We have competitors in development. Just where hope do 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 efficacy perspective? Thank you so much. Yeah, thank you, Vamil. 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 durable treatment, as well as being able to achieve at or above minoxidil efficacy, we'll definitely have a very attractive PPP.

26:49 And Zach, please feel free to kind of walk through more of the details on that given the consumer quant study we had just completed. Yeah, thanks Sean. Yeah, and Dom, I would just note that PPP that ABS201 embodies or we think will embody is really a new category therapy that we hope will deliver not only efficacy, but durable efficacy and convenient administration. To Sean's point, if the effect size in terms of terminal area hair count, the growth in 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.

27:38 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 additive with the other features of the profile, which would include durability and that convenient dosing of just a few injections. Okay, thanks. And one other one, sorry, go ahead. I was just gonna 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, room to to run on on this. I think as as Zach said, this is, you know, a home run product, but from what we're seeing from the the stump tail macaque and even ex vivo data, you know, could be well above that as well for an upside scenario.

28:31 Okay. Thank you. And then one other one, just a follow-up is on the safety side. 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. Ramzi, 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 our review of the safety data accumulated today, but it's encouraging so far. Okay, thanks for taking my question.

29:17 Thank you. One moment for our next question. Our next question will come from the line of Brendan Smith from TD Cowen. Your line is open. Great. Thanks for taking the questions, guys. Maybe just another one quick on two zero one. I guess kind of given other pivotal studies in the 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 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, is what are they still coming to Absci for and how should we really think about them leveraging the platform within the components of those deals?

30:07 Thanks. Yeah, thanks. Ronzi, you want to answer that first one and then, Zach, you can take the second one. Yeah. So, we have not yet engaged FDA on the design of our Phase three program. We're going to one of the reasons we're excited about the thirteen week interim readout is that it's going to give us a much better idea of what the Phase three 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 thirteen week interim to and give you more details on that once we see the data. Thanks, and this is Zach. I comment on the partnership discussion.

31:00 We continue to have productive discussions with pharma 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 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. Thanks, guys. One moment for our next question. Our next question comes from line of Brian Chang from JPMorgan.

31:49 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, three zero one and five zero one continued progress. Each of these you see better suited for partner. Just to clarify, are often now on the table for partnerships? Or do you think that you want to develop three zero one or five zero one a bit more internally? Thanks. Yeah, thanks. That's a great question, Brian. Just given our focus in particular in INI, given ABS two zero one, we believe us developing oncology doesn't make sense. And so with 03/2001 and five zero one being in oncology, we think that this is much better suited for a partner. We do have a earlier stage pipeline that is developing where we should be nominating DCs this year that have not been announced that are in I and I.

32:54 And these, we could potentially take these forward ourselves, assuming the cash balance sheet is there. Then we also have the optionality to partner those well. So we've definitely been hard at work kind of building up that I and I 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 particular impact of interest? I'm just curious if you can give us a little bit more color on how we should think about the TAE profile.

33:43 Yeah, absolutely. As Ramzi said, I think we're really pleased with the profile that we're seeing to date. And Ramzi, 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 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 you know I have to caveat that it's early in the study without a ton of people exposed.

34:35 I'll also say, know, given the encouraging profile, it definitely lines up really nicely with what you see from other studies, know, HMI one hundred fifteen, 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 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, tracks very nicely to what we're seeing in our own study.

35:31 As Ranzi said, it's early early days, but very encouraging. Great. Thank you so much for tonight for the color. Thank you. Thank you. One moment for our next question. Next question will come from the line of Devarukonda from Touro Securities. Your line is open. Hi. This is Alex on for Kripa. Congrats on all the progress. We had a question on 02/2001 as well. Some of the investors that we talked to express caution about the ability for a molecule to get into the hair follicles 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?

36:24 Thanks. Yeah, so you're definitely not gonna have penetration you'd have or the biodistribution, should say, in other organs, but there's definitely ample blood flow going into follicle. And again, you saw the data with the stumped tummy tucks, you saw the data as well with the mice. And so, 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 fire distribution coefficient for the scalp and hair follicle, which is much lower than other tissues.

37:26 Ranze, I don't know if you have anything else you want to add on that point. No, 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 two zero one and Absci's own work. Great. Thanks, everyone. Thank you. One moment for our next question. Next question will come from the line of Debajanja Chatterjee from Jones Trading. Your line is open. Hi. Thanks for taking my question. So, I wanted to ask that, we have seen some, recent updates, for these candidates including flavacosteron and also oral extended release minoxidil is gaining traction.

38:21 So how, like you know, 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 headcount improvement? Yeah, it's a great question. First off, I think the success that Veradermics and others are having is really great. I think at first it shows that there's a huge unmet medical need for androgenic alopecia, and it affects over eighty million Americans and there is treatment that's needed.

39:13 And we see what we're doing as very synergistic. Think even with oral minoxidil, some patients aren't seeing the full hair regrowth that they would like to see. Additionally, with a lot of these medications, you have to take it once or twice daily. 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.

40:07 This is a brand new novel mechanism. Oraminoxylphenasteride, they've been around for a long time. And the biology that we've seen here, it does appear that prolactin is furthest upstream, driving the hair loss. You can see that in the ex vivo studies we've done. And so overall, we think that this is a potential paradigm shifting asset here within AGA. But again, we're really excited that other companies such as Veradermyx are having the success that they're having because it does shed a light on how important this space is.

41:02 I'd just add 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 ABSI-two zero one across the board for men and women. But when we segment out participants who have AGA who are currently using minoxidil, oral minoxidil, the interest level goes up even higher. So we saw ninety two percent of men, eighty nine percent of women who are currently using oral minoxidil said they would be highly inclined to go seek out the product. So extremely or very likely to go to a healthcare professional to obtain ABS201 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, and 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.

42:10 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 both products. Okay, thank you. Thank you. One moment for our next question. Our next question will come from the line of Caleb Blum of Needham. Your line is open.

42:58 Good afternoon, and thanks for taking our questions. Maybe a bit of a mask question. You said three cohorts were dosed. Should we assume this is about twenty four patients at this point? Ron, do you want to take that? Yeah, I have to look at the actual map, but I don't think that's too far off. Okay. It's a it's a rough rough ballpark there, Gil. Yeah. Okay. That's fair. I I do have a question specifically for doctor Ramsey. Yeah. Can you discuss some of the expected challenges in developing a drug for endometriosis, especially when assessing involvement of pain measures?

43:47 It seems like you have the right experience here. Yeah, it's interesting because these really pain studies. 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 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 two zero one 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.

44:50 All right, 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. 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 one, two, a trial that's on running that's ongoing today for AGA.

45:43 We'll use the SAD portion of that as safety to support initiating a phase two trial in 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. But 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.

46:36 All right, excellent. Thanks for taking our questions. Thank you. One moment for our next question. Our next question comes from the line of Sean Lammen from Morgan Stanley. Your line is open. Good morning, Sean and team. Hope everyone's well, congrats on all the progress. I have a question back on the platform. We do get a lot of inbound on potential AI crowding, if you like to call it that. But in the March deck, you emphasized Origin One and the zero pro epitope design as key differentiators. Based on some of your twenty twenty five 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?

47:36 Yeah, I would say first off, pharma has very much embraced AI and 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. I think the validations that we've been able to show in the preprint and 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 within this industry or the LLMs.

48:34 And 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 AgenSci AI, really being able to start to have this fully autonomous workflow where you can have an agent help you look at targets, help you identify the epitope, then that feeds directly into the de novo model, then helps you design the killer experiment and rapidly develop assets that quickly rapidly test hypotheses.

49:20 So I would say that we're very excited about the future and where things are at. Yeah, it's been an exciting start of the year. Thank you, Sean. And then just sorry, go ahead. Yeah. Mean, 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 an 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 One models, which we've been working on for, you know, the past year to develop pipeline assets that we can either take forward or we can partner.

50:06 And we have a number of those that 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 from the line of Charles Wallace from H. C. Wainwright. Your line is open. Hi, thanks for taking my question. This is Charles on for RK. So a question on two zero one 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 $4,500,000,000 in endometriosis for the nine million patients.

51:01 And then for the AGA, I think you're targeting five to nine 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? Thanks. I think both of these indications are very large indications. One in ten 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, eighty million Americans in The US.

51:57 And so again, we see these as both very large opportunities. Think, at the end of the day, I think AGA is likely a larger opportunity. But at the end of the day, these are both very exciting opportunities from just a market size perspective. Okay, great. And maybe just a follow-up. So given that endometriosis would be more of a therapeutic payer market, while AGA would be a cosmetic kind of self pay market. How do you kind of anticipate pricing would be once if both came to market? Would it be similar or different? Zach, you want to take that?

52:44 Yeah. So we can't disclose what we think the actual price point will be. We wouldn't announce those till date of launch. But I can tell you in our own internal analysis, 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 in a good position to leverage efficiencies of pursuing both indications with ABS201. Great, thanks for taking my questions. Yeah, and maybe before we close out call today, just wanted to share one exciting piece. Actually, I'll have Randy share that to close out the earnings call today. Randy, over to you.

53:36 Yeah, thanks, Sean. As we said, the SADMED study is going well. We're on track and in fact, we hope to dose our first towards the end of the week. So first we were very pleased with the progress. Thank you. As for that, I'd like to thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great