Absci Corporation

Thank you for standing by. My name is Roselle and I will be your operator today. At this time, I would like to welcome everyone to the ABE PSY Q3 2025 Business Update. All lines have been placed on mute to prevent any background noise. After the speaker remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, press star one again. Thank you. I will now turn the conference call over to Alex Kan, VP, Finance and Investor Relations. Please go ahead.

Thank you.

Earlier today, ABSA released the financial and operating results for the quarter ended September 30th, 2025. If you haven't received this news release or if you would like to be added to the company's distribution list, please send an email to investors.absa.com. An archived webcast of this call will be available for replay on Abcide's investor relations website at investors.abcide.com for at least 90 days after this call. Joining me today are Sean McClain, Abcide's founder and CEO, and Zach Jonason, Chief Financial Officer and Chief Business Officer. Andreas Busch, Abcide's Chief Innovation Officer, will also join for Q&A following prepared remarks. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated, and you should not place undue reliance in forward-looking statements. 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 ABSEI Issued Today and the documents and reports filed by ABSEI from time to time with the Securities and Exchange Commission. Except as required by law, ABSEI disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward-looking statements are because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as is live broadcast November 12, 2025. With that, I'll turn the call over to Sean.

Thanks, Alex. Good afternoon, everyone. Thank you for joining us for our Q3 Business Update Call. Today we'll be sharing updates about our pipeline, including interim Phase I results for ABS-101, acceleration of ABS-201 development in angiogenetic alopecia, or AGA, and expansion of ABS-201 development in a second indication, endometriosis. Interim results from first cohorts of our ongoing ABS-101 Phase I trial in Healthy Volunteers demonstrated extended half-life as compared to first-generation anti-TR1A competitor programs, but not versus next-generation programs. There was also no apparent impact of PDA on PK, and overall safety profile was favorable with no serious adverse events reported to date. The Phase 1 trial is on track to complete in Q1 of 2026. Our progress developing JBS201 for antigenetic alopecia is ahead of plan, as we expect to initiate a Phase 1 2A trial in December of this year with an interim proof of concept readout anticipated in the second half of 2026. Additionally, we are excited to announce that we are developing ABS-201 in endometriosis and expect to initiate a phase two proof of concept clinical trial in the fourth quarter of 2026. Preclinical and clinical data support the prolactin receptor mechanism in endometriosis where we believe ABS-201 has the potential to be a safe effective therapy for the estimated 10% of women globally who suffer from this debilitating disease. Our development plans for endometriosis are synergistic with our already planned ABS-201 Phase 1-2A clinical trial in AGA, which is on track to initiate next month. Given the significantly greater opportunity for value creation, we have made the strategic decision to prioritize ABS-201 development in endometriosis. This is in addition to ABS 201's ongoing clinical development for angiogenetic alopecia. Therefore, we will seek a partner for ABS 101 and no longer pursue additional internal clinical development for this asset following the completion of the phase one clinical trial. The decision to reallocate our pipeline priorities reflects rigorous discipline we employ in allocating our capital and resources. We believe our strategy to advance ABS-201 through human proof of concept in both AGA and endometriosis will maximize the value created using our current balance sheet. Both indications are characterized by significant unmet medical needs and poor standard of care. There is biological and clinical rationale for the prolactin receptor mechanism in both indications. Our strategy leverages shared phase one development which enables faster, more efficient clinical trial development. And both indications offer multibillion-dollar market opportunities. Looking ahead, we're excited to execute on the dual development of ABS-201, leveraging its best-in-class profile, targeting two proof-of-concept readouts in the next 24 months, a Phase I-II-A proof-of-concept interim data readout in AGA in the second half of 2026, and a phase two proof of concept interim data readout for endometriosis in the second half of 2027. Taken together, this strategy represents our strongest value creation opportunity for patients and shareholders alike. Zach will speak in more detail on our strategy for endometriosis later in the call. Turning now to our clinical development plans for AVS201 in antigenetic alopecia. We have accelerated our clinical development timeline and expect to dose our first participant next month in our phase one two-way study. On December 11th, we'll host a KOL seminar to discuss anticipated clinical development path, market opportunity, and differentiated profile of the ADS 201 program. We also plan to disclose additional human ex vivo data that further supports the mechanism of action underlying this program. We designed ABS-201 to unlock a potential new category of therapy for ADAs, which we believe could offer efficacious, durable, convenient hair regrowth. This condition, better known as male and female pattern hair loss, affects approximately 80 million adults in the U.S. alone and has seen little therapeutic innovation in nearly 30 years. In preclinical studies, ABS-201 has shown high potency, low immunogenicity, extended half-life, and improved manufacturability. We believe it offers an alternative to current treatments, such as minoxidil and finasteride, which have variable or limited efficacy, low compliance, and in some cases, serious side effects. Based on the body of evidence from in vitro and in vivo animal studies, we believe that a simple, infrequent course of just two to three injections of ABS-201 could deliver durable multi-year hair regrows. Today's standard of care treatments have limited efficacy and require frequent once or twice daily administration, leading to poor compliance. Our KLO network of leading dermatologists have indicated compliance for topical as well as oral minoxidil can be poor in practice, either because of side effects or inconvenience of lifelong daily administration. A recent study showed that over 86% of AGA patients who try topical minoxidil discontinue treatment. Our own market research underscores that consumers value durable efficacy and prefer a treatment that works with infrequent administration. For these reasons, we believe ABS-201 has the potential to be a dominant new category of therapy offering convenient, durable hair regrowth. Given this differentiated profile, the straightforward clinical development path, and the massive multi-billion dollar market opportunity, we plan to develop ABS-201 through later stage clinical development and potentially commercialization. As we advance development of ABS-201 for ABA, we're thrilled to welcome Doctors Rod Sinclair and David Goldberg to our KOL Advisory Board. Dr. Sinclair is a professor of dermatology at the University of Melbourne and the director of Sinclair Dermatology. He is a world-renowned expert in hair loss with over three decades dedicated to research, clinical practice, and patient advocacy. He has more than a thousand publications, including contributions to major dermatology textbooks. Dr. Goldberg brings nearly 40 years of clinical dermatology experience. He is a clinical professor of dermatology at the Eichen School of Medicine at Mount Sinai. and has led pivotal research studies in dermatology and hair loss, including the original menospital trials. Dr. Goldberg has published more than 200 academic papers, contributed to over 15 textbooks on hair restoration and dermatology, and served on the boards of the American Academy of Dermatology and American Society of Dermatologic Surgery. We invite you to join our virtual seminar on December 11th, where Dr. Sinclair, Dr. Goldberg, and other top KOLs will discuss the ABS-201 program. We are also progressing several additional programs that we aim to partner prior to clinical development. ABS-301, this is a potential first-in-class antibody targeting undisclosed immune oncology target identified through our reverse immunology platform. Early data suggests potential in squamous cell carcinoma and other indications. AVS501. This is a potential best-in-class anti-HER2 antibody identified using our zero-shot de novo AI models. These AI-designed leads displayed novel epitope interactions, increased or equivalent potency to trisuzumab in preclinical disease models, efficacy against a trisuzumab-resistant xenograft tumor in a in vivo model, and good developability. Beyond these, we have innovative early-stage programs in our pipeline that we plan to reveal at a later date. With that, I'll now turn the call over to Zach to walk through our strategy, partnerships, and outlook, and to provide an update on our financials.

Thanks, Sean. As Sean mentioned, we continue to sharpen our strategic focus, and in so doing, have made decisions recently about which internal programs to advance versus partner. Our decisions continue to be based on careful assessment of the potential risks in return for each program, given our available resources. Broadly, I am happy to report that we continue to execute on our strategic objectives, including advancing ABS-101 through an interim Phase I readout, expediting the initiation of our ABS-201 Phase I 2A trial for androgenetic alopecia by approximately one quarter, expanding ABS 201 development into endometriosis, and progressing our portfolio of discovery partnership programs. We also continue to expand our AI platform capabilities, which, in addition to enabling our own preclinical R&D programs focused on challenging targets, has helped generate partnership interest in our platform. Accordingly, we continue to anticipate signing one or more drug creation partnerships, including with a large pharma company by year end. As Sean discussed earlier, we will be focused on partnering ABS 101 and do not currently plan to develop the program ourselves into Phase 2. We remain engaged with multiple potential large and mid-cap pharmaceutical companies regarding a potential partnership transaction, some of which are focused on first-in-class indications outside of IBD. As discussed, we have decided to prioritize the clinical development of ABS 201 for two potential multibillion-dollar indications, endogenetic alopecia and endometriosis, each characterized by high unmet need and poor standard of care. We see strong scientific and business rationale for developing ABS-201 in both of these indications. Moreover, our planned Phase I-II-A clinical trial in AGA will provide safety, tolerability, and PK assessments that will support Phase II clinical development in endometriosis. The Phase 128 proof-of-concept trial in AGA will be a randomized, double-blind, placebo-controlled study. The primary endpoints will be safety and tolerability. Secondary endpoints will include PK, PD, immunogenicity, target area hair count, target area width, target area darkening and pigmentation of hair, as well as patient-reported outcome measures. The trial will enroll up to 227 healthy volunteers with or without AGA. The single ascending dose or SAD portion of the trial will test approximately four to six IV dose groups for safety, tolerability, PK, and PD. The SAD portion of the trial will be followed by approximately three to four subcutaneous multiple ascending dose groups in healthy volunteers with antigenetic alopecia. The MAD portion of this clinical trial is powered to demonstrate human proof of concept for the use of ABS-201 to treat endogenetic alopecia by stimulating significant hair regrowth. We believe that this trial is successful. We'll position the program for accelerated registrational trials. Ahead of initiating the Phase 1-2A trial, we are excited to share that we have generated additional ex vivo human data supporting the durable, condition-modifying hair regrowth mechanism of ABS-201. Preliminary data from experiments using human scalp biopsies shows the ability of ABS-201 to transition hair follicles into the antigen growth phase and to counteract suppressive catagen effects of prolactin. This study also shows ABS-201's ability to promote the proliferation of hair follicle stem cells, as indicated by upregulation of corresponding markers, as well as reduce hair follicle stem cell apoptosis. We look forward to sharing more about this study and its results at our upcoming KOL seminar on December 11th. As Sean mentioned earlier, in addition to treating endogenetic alopecia, we believe ABS-201 will be effective in treating endometriosis, a second multibillion-dollar market opportunity characterized by high unmet patient need and poor standard of care. Endometriosis is an inflammatory disease defined by endometrial-like lesions found outside the uterine lining. Symptoms include pelvic pain, heavy bleeding, infertility, and ovarian cysts. It is a chronic, painful condition that significantly impacts the quality of life of these patients. Moreover, there is currently no therapeutic or surgical cure for this disease, which is prevalent in an estimated 10% of women worldwide, including an estimated 9 million women in the U.S. alone. During our R&D day last year, we discussed how members of our R&D team initially discovered the prolactin receptor inhibition mechanism for hair regrowth during animal studies investigating prolactin inhibition as a treatment for endometriosis. Based on additional preclinical research, including our own in vivo animal studies, as well as recent human clinical proof of concept data reported for the HMI 115 program, We believe ABS-201 has significant potential to become a best-in-class, efficacious, and safe therapeutic treatment for endometriosis. ABS-201 was designed using our AI platform to antagonize the prolactin receptor and thereby block prolactin signaling. Scientific data supports the dual role of prolactin signaling in endometrial lesion formation as well as associated pain. Prolactin and prolactin receptors are overexpressed in the endometrium of patients with endometriosis. Furthermore, while prolactin supports endometrium formation and desidualization, dysregulated expression of prolactin and its receptor have been found in ectopic endometrial lesions. Prolactin receptors are also present in sensory neurons and can sensitize these neurons, potentially leading to increased pain perception. The prolactin pathway is distinct from sex hormone signaling, further differentiating it from current therapeutic mechanisms of action for treating endometriosis. And preclinical data have shown that prolactin receptor antagonism suppresses postoperative pain in female mice and inhibits endometriosis interna formation. A recent preclinical study in a homologous mouse model of endometriosis shows that ABS-201 treatment improves pain-related outcomes, similarly to GnRH modulation. Mice treated with ABS-201 demonstrated greater locomotor activity and distance traveled as compared to placebo-treated mice, indicating reduced pain-like behavior. ABS-201 also significantly lowered inflammatory cytokines in the peritoneal fluid, which have been shown to be elevated in endometriosis patients. These results support our development of ABS-201 as a potential therapy for endometriosis-associated pain. Additionally, recent positive top-line results from a Phase II trial of HMI-115, a competitor antiprolactin receptor antibody, in endometriosis provided human proof of concept and de-risking of the mechanism of action. We believe that ABS-201's profile exhibits best-in-class potential when compared to the HMI-115 antibody. For example, ABS-201 exhibits superior PK and bioavailability in NHP studies, which we expect to translate to better efficacy in humans via sustained target engagement in relevant endometrial tissue. ABS-201 also has 3 to 4X longer half-life in NHPs, as well as a higher concentration formulation, both of which should enable more convenient dosing for patients. We plan to initiate Phase 2 clinical development of ABS-201 in endometriosis in Q4 of 2026, using the safety and tolerability data generated from the SAD portion of our Phase 1-2A androgenetic alopecia study. Based on this timeline, we expect to share an interim readout from the Phase 2 trial in endometriosis in the second half of 2027. With respect to ABS 301 and ABS 501, our immuno-oncology and oncology programs respectively, we continue to believe that these programs are better suited for development by a large pharmaceutical or biotech company. Accordingly, we intend to seek partners for these programs prior to clinical development. We continue to utilize our growing AI platform capabilities to create an early stage pipeline focused on indications characterized by high unmet medical need. Our unique ability to address difficult to drug target classes has enabled us to pursue new opportunities for creating novel and differentiated therapeutic programs in our internal pipeline, as well as in our drug creation partnerships.

Turning now to our financials.

Revenue in the third quarter was $400,000 as we continued to progress our partner programs. Research and development expenses were $19.2 million for the three months ended September 30, 2025, as compared to $18 million for the prior year period. This increase was primarily driven by advancement of AFSCI's internal programs, including direct costs associated with external, preclinical, and clinical development. Selling, general, and administrative expenses were $8.4 million for the three months ended September 30, 2025, as compared to $9.3 million for the prior year period. This decrease was primarily due to a decrease in personnel-related expenses. Cash, cash equivalents, and marketable securities as of September 30, 2025, for $152.5 million as compared to $117.5 million as of June 30, 2025. We believe our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into the first half of 2028 We see additional upside to this forecast based on potential non-dilutive cash inflows that could come from new platform collaborations with large pharma and or an asset transaction associated with any of our wholly owned programs, such as ABS 101. As a reminder, we still anticipate signing one or more drug creation partnerships, including with a large pharma company, before the end of this year. With our current balance sheet, we believe we are well-positioned to execute on our strategy, including delivering potential proof-of-concept readouts for ABS-201 in both AGA and endometriosis. We are also resourced to progress our early-stage pipeline and to advance new partnership discussions related to our AI drug creation platform, fully-owned asset programs, or BOLT.

With that, I'll now turn it back to Sean. Thanks, Max.

I want to thank our AbSci team for their relentless drive, tenacity, and belief in our mission to achieve the impossible. This is a pivotal moment for AbSci. As you heard today, ABS 201 is moving into the clinic with real momentum, and we're expanding its potential beyond hair regrowth into endometriosis, a major disease area where innovation is long overdue. Together, These efforts underscore the potential of the prolactin receptor mechanism and demonstrate our commitment to translating generative AI protein design into clinical realities. We've made deliberate choices to focus our resources where we see the greatest opportunity for transformational impact and value creation. By refining our focus on ABS-201, we're leaning into the data, the science, and the market opportunity where AbPsy can lead. Looking ahead, the momentum is unmistakable. The ABS-201 phase one two-way trial in HAA begins in just a few weeks, putting us on track for interim efficacy and proof of concept data in the second half of next year. We are expanding ABS-201 into endometriosis with a phase two trial anticipated to initiate due for 2026. We anticipate to close at least one new large pharma partnership this year, and I invite you to join our ADS 201 KOL event on December 11th. Details are on our IR website. AbbSci is executing with precision and agility, translating AI-designed biologics into real clinical impact. What truly excites me is the potential ahead. We are energized by what's next and confident in our path to deliver meaningful value for patients, partners, and shareholders alike.

Thank you for your continued support. Operator, let's open the call for questions.

At this time, I would like to remind everyone in order to ask a question, press star, then the number one in your telephone keypad. We will pause for just a moment to completely compile the Q&A roster. Your first question comes from the line of Amil Devan with Guggenheim Securities. Please go ahead.

Hi, great. Thanks for taking my questions. So I just have two if I could. One, I understand what you're saying around the TL1A program and looking to partner that out. I'm wondering if there's any more details you can share just in terms of what you saw in terms of the half-life or anything else in the trial. And then second, I'm just seeing the mutual assistance. Interesting news there. So I'm looking forward to hearing and learning more about that. But I'm just curious right now if you can maybe just give some sense of the competitive landscape as you're thinking about designing a page to trial in that indications or how that would look and just generally how you design it and what's the right comparison to think about. Thank you.

Yeah, absolutely. Thanks, Vamal. Yeah, so we took a really hard look at ABS 101. We were, in general, really happy with the safety profile that we saw. We were able to have a half-life that was extended past what we saw with first-gen competitors, but we fell short of second-gen. And we were exploring some really exciting first-in-class indications we could have gone into. And we compared that to taking ABS-201 into endometriosis. And just given the competitive landscape we were seeing in IBD, We saw it made a ton of sense to take the capital we'd be investing into ABS 101 Phase 2a study and reinvest that into ABS 201 in endometriosis. And we did this for a few reasons. One, there's a big unmet medical need here. The standard of care is really poor. There's not a lot of competition in this space. And additionally, the mechanism, the prolactin receptor has been ultimately de-risked with the HMI 115 data that came out showing proof of concept for this particular mechanism. So we see this as a de-risked mechanism. And again, standard of care is pretty poor here, and we really believe that we have the opportunity to potentially deliver a disease-modifying treatment there. And with that, I'll hand it over to Zach to talk a little bit more about the phase two trial design for endometriosis.

Yeah, thanks, Sean. Just to echo a couple points Sean made, we see the endometriosis indications much less competitive than you see in Crohn's, and that certainly was a factor in our decision here. Moreover, the cost of these trials is a fraction of what a full Phase II proof-of-concept study in the IBT space would be. So we think there's a significant ROI on resourcing this strategy for development in endometriosis. We will talk more about the specific trial design, but I think what we're really excited about here with the ABS-201 mechanism is that there's a potential not just to address pain, but also to be disease-modifying. And so we're currently engaged with our KOLs and have a draft study design that we'll share more about in the new year.

Okay, thank you. Thanks.

Your next question comes from the line of Brandon Smith with David Coleman. Please go ahead.

Hi, guys. Thanks for taking the questions. Appreciate it. So maybe just a quick one first on actually just a profile for one-on-one. And apologies if I missed it here. But can you confirm if any of the potential partners you had been in touch with prior to now have already seen the data or if that's kind of not the plan over the next few weeks? I'm just wondering on initial feedback there. And then maybe quickly on 201, I know you've talked a bit about endometriosis versus alopecia, but just wondering if there's ever, or if there's any, maybe even at a high level, thoughts on market segmentation, just given 201's mechanism, and any considerations on how you're thinking about enrollment for that. Thanks.

Yeah, great. Thanks. So to address the first question, since this data has just recently come in, we have not had the opportunity to share information this data with our partners yet. We plan to share that with them in the coming weeks. And then additionally, as I mentioned previously, we have been exploring other first-in-class indications that we believe there's strong biological rationale for this, and it actually expands the buyer universe for ABS-101. And we have been exploring that prior to this call, and those discussions have been going quite well. And I'll hand it over to Zach to answer the second question.

Yeah, thanks, Brendan. As I mentioned, we'll release more details about the trial design for endometriosis. But I will comment that we will be looking to enroll patients that are confirmed to have endometriosis and that we will be looking to enroll patients that have a significant amount of pain. And I think that was one of the challenges in the study with HMI 115. I think they had some enrollment issues around exclusion criteria that we will be careful to address in our trial. And I think we've got some leading KOLs advising us here. So we feel... We feel very confident and excited about moving that program forward. There's a very large unmet medical need there. And I think a very large opportunity based on what we saw from the HMI trial, that was a nice proof of concept on the mechanism. As you know, the trial there in the eye dose saw statistically significant reduction in pain and dysmenorrhea. And so I think that's a nice readout for us de-risking the mechanism. And the mechanism also looks safe in that trial setting. So we feel very confident about bringing ABS-201 into development for that indication.

Yeah, and I'd also like to just loop in Andreas, our chief innovation officer, into this question. He had experience out there actually developing an antibody which is now HMI 115 for endometriosis. And so, Andreas, do you have anything else to add here?

Yeah, sure. Thanks, Shaw. I think it may be relevant to point out here that the drug innovation around prolactin receptor antibodies started around endometriosis and not hair loss. And the hair loss observation was actually the third individuals finding at the time. Again, it's very clear, very well validated that prolactin has a dual mechanism in endometriosis, both in promoting and generating the lesions as well as in sensory neurons where it clearly affects the pain and the pain sensation. And in preclinic experiments, it was nicely shown that prolactin antibodies in our experiments, now at EPSA, as well as previously in Bayer's hands, that it can indeed affect both pain as well as reducing the lesions, as Zach has indicated before. I also want to point out that there is a significant unmet medical need based on the fact that there are not any non-hormonal treatments around in endometriosis. There's, of course, the approved TNRH antagonist treatment, which has the typical side effects of estrogen reduction. And there is a significant need of non-hormonal safe approaches in endometriosis, and this is what all data of prolactin receptor antibodies so far have shown. By safety, both in preclinic experiments as well as in human genetics, where women with complete knockout of prolactin receptors have been shown to be perfectly healthy and even being very easily able to bear children.

Your next question comes from the line of Sean Lemon with Morgan Stanley. Please go ahead.

Hi, Sean, and hi, team. Hope everyone's well. Sean, just to gauge your confidence on the data that you do have of being able to partner 101 out, and what are you looking for in a partner?

Yeah, absolutely. It's a great question. So what we're looking for in a partner is one, the domain expertise in the particular indication that we're looking to go into and have the ability to actually develop it in that particular indication and ultimately be able to take it through approval. And so again, I think we have a much bigger buyer universe with the different indications that we are looking at here, and we are excited to begin to engage in those discussions. Zach, do you have anything else to add on the partnering front?

I would just add that, as Sean mentioned, we have done some work on a first-in-class indication for ABS 101, and we've had some engagement already on that indication. We'll be continuing those discussions as we move towards the end of the year and into early next year, but we feel pretty excited about the potential to partner this asset with a pharma that will be exploring first-in-class type indications.

Sure. Thank you. And just on 201, just to sort of gauge your feeling on how easy the trial is going to be to recruit, I imagine it'd be a fairly facile process, but I could be wrong. and then just, you know, maybe sort of the cost of getting it to sort of proof-of-concept status, and how long do you anticipate a patient would need to be on drug to potentially reach the outcome that you're looking for?

Great, Zach. Do you want to take the first two questions, and then Andrea's on it already for the third?

Yeah, absolutely. And just to clarify, when you ask the question, are you referring to endometriosis or AGA?

Oh, sorry, alopecia, sorry.

Yeah, perfect. We feel very confident in the ability to recruit for that trial. We have multiple sites in Australia, including a major KOL. We'll be speaking at our KOL event on December 11th, who are heavily engaged in recruiting and are confident that we will recruit that trial on time. And in terms of when we would expect to see efficacy, we're looking to have an interim readout that'll be in the early part of the second half of next year. And that's gonna look at a 12 week, sorry, a 13 week time point where we'll not only, we're gonna be obviously measuring safety and tolerability to the SAD and we'll see that data well before the second half. But in the second half for efficacy, We'd look at that 13-week readout. We expect to see significant hair growth in the terminal area hair count relative to baseline. We'll be doing additional measures of efficacy at the 20-week and the 24-week as well.

Got you. Thank you.

Your next question comes from the line of Gil Bloom. Please go ahead and provide the company you're with.

Good afternoon, and thanks for the update. So maybe a quick one on TL1A. Just to understand the features here, so the Half-Life wasn't as much as a second-gen asset, but you mentioned that the ADAs didn't affect the PK. Where do you think that fits the asset as it relates to an indication? I mean, is this one of the reasons you're looking at alternative indications?

Have a follow-up. Hi, Sean. You may be on mute. This is Zach.

I can take that question. Look, we looked at the profile, and in full disclosure, you know, we're still waiting for data to come in on the highest-dose patients before we have a final read on what the half-life looks like. But in our assessment, the molecule looks safe, well-tolerated. We did not see an effect of ADA on PK as well. but we do think it has an additional advantage, which we'll be getting better measurements around, which is tissue distribution, which potentially could lead to better efficacy in a number of indications. And this is one of the areas that's gotten us focused on a couple of newer indications where the molecule could be first in class.

Okay, that's helpful. And as it relates to endometriosis, just to clarify, Are we looking initially at a sub-Q dosing or also IV first?

Great question, Gil. I think our view – go ahead, Sean.

Sorry, I got kicked off there for a minute. Yeah, so the plan would be sub-Q in the phase two, very similar to how we're planning on running the AGA trial. As Edwin mentioned previously, we're at 200 mg per ml, and we'll do the SAD portion in IV and then go to the sub-Q in the MAD, and then same with the endometriosis trial as well.

So you'll use sub-Q initially in endometriosis?

I just want to make sure I understand.

Yes, in that phase two trial, that is the plan to use SubQ.

Okay. And maybe the last point, just to make sure. So focus remains both on AGA and ENDO, not ENDO taking the lead here. Is that correct?

100%. I would say that they are co-leads, our main focus. This next year is to get the Phase II readout in AGA, and then the year following, it would be endometriosis. So the plan is still full steam ahead on AGA. Nothing has changed on that front at all.

Okay. Thank you for taking our questions. And maybe it's important also to even add that, of course, the Phase II trial in endometriosis is takes full advantage of the Phase 1 trial in AGA.

Yeah, this is Zach.

To put a finer point on that, it's a very capital-efficient development plan since the Phase 2 trial in endometriosis will leverage all the safety data we generate in the Phase 1, 2A trial in AGA.

Your next question comes from the line of Ryan Chang with JP Morgan. Please go ahead.

Hey, guys. Thanks for taking our questions this evening. As we think about the timing of the interim alopecia data and also the start of the Phase II endometriosis trial next year, will you want to wait for the interim data for alopecia before you start the endometriosis trial? Just curious if there is any read-through between the two items.

So obviously we're going to have to get the SAD safety portion before going into the Phase 2 study. But assuming the Phase 1 SAD data looks good from the AGA trial, we plan to march full steam ahead in terms of going into endometriosis. And we do not plan to wait to see the AGA readout before starting that phase two.

Got it. And maybe just one quick one about what we have seen so far from Hope Medicine's 115, specifically in endometriosis. How much read-through do you see from 115 to your 201 program so far? And And how are you using the data that they have seen to your own advantage?

Absolutely. Zach, do you want to take that question? And Andres? Yeah, absolutely.

Yeah, absolutely. You know, we look at the trial design was not the best, so there's definitely some learnings there. And you can be assured we will have a well-structured design trial that's adequately powered. But the key point that we take away from that trial that I think is very encouraging for proof of concept in the endometriosis is the following. One, the first point being they saw in their effect size, they saw a dose response during treatment, during the 12 weeks of treatment, and a statistically significant response in pain for the high dose. And this is in dysmenorrhea. So this would be the primary endpoint or one of the primary endpoints we would look at in our trial as well. So we find that to be very encouraging. I think there's some learnings from, as I mentioned, the way they structured and designed the trial where we will be sure to power correctly and make sure we design for entrance requirement with a little more rigor. But we think it's, like I said, a very encouraging proof of concept that de-risks the mechanism.

Great. Thank you.

Your next question comes from the line of Steven Deckard with KBank. Please go ahead.

Hey, thanks, guys. Just wondering if the ex vivo results you mentioned with 201 are better than expected or generally in line with what you thought?

And then, could 201 be expanded to additional indications? Thank you.

Yeah, regarding the ex vivo data, obviously when you're, you know, dealing with, you know, human biopsies, a lot of things can go wrong. From what we saw, just from the biomarkers that were upregulated, the stem cell growth that we saw that was driving the hair shaft production, as well as the melanin production for repigmentation, All of that was really, really exciting to see. I think it validated the mechanism in a really fantastic way, and it lines up really nicely with what you're seeing in the stem-tail macaque data as well as the mouse-shaving study that we did. And so we think it just ties together everything really nicely. And this was, you know, in of three, three different patients. You know, you saw the same response across all three patients, and so we were, yeah, just really pleased with what we saw, and I think that gives us, you know, really strong confidence going into the Phase 2 study.

And I'll add to that up to your second question.

We do see potential additional indications for 201. We're not ready to speak about those today. I think we're laser focused on driving that program through the phase 1, 2A for AGA, as well as the phase 2 for endometriosis.

Got it. Thank you.

Again, if you would like to ask a question, press star 1 in your telephone keypad. Your final question comes from the line of Tess Ramon-Consen with 10CRW.com. Please go ahead. Again, your next question comes from the line of Pastor Mankantan with 10CRW.com. Please go ahead. Your final question comes from the line of Kripa Devarakonda with Truist. Please go ahead.

Hey, guys. Thank you so much for taking my question. For the endo program, the 201, can you remind me if you expect to be able to target all endometriosis patients or if there is any restriction or subgroups that you would expect to target? And I know it's really early, but when you think about drugs that are standard of care that have been commercialized in endometriosis. What do you see as the hurdles in this space as you take 201 forward? Thank you.

Yeah, that's a great question. Zach, I'll hand it over to you and then to Andreas.

Yeah, terrific question. I think a couple points here. One is we're looking to address patients that are on potentially displaced GnRH therapy. That therapy has a sort of unwanted side effects for reduction in bone mineral density. It does show some efficacy, but we think trying to place a new option in the arsenal that's more effective does not have a side effect profile like that could be game-changing for these patients. So that's our mission. In terms of how we recruit and segment the trial, that's something we'll comment on later next year as we get closer to the start of the trial.

And Andre, if you'd like to add something, please feel free.

Yeah, I mean, so these are two different aspects. The one is, you know, what do we believe where it will work versus what's the design of the trial? So from the scientific rationale, there is only reason to believe that the prolactin receptor antibody should work in every endometriosis patient. because we do know that in endometriosis patients you do have an increased prolactin receptor as well as prolactin expression in the endometriosis lesions as well as in sensory neurons. Therefore, having an effect on both the reduction of lesions as well as on the pain aspect. And this, of course, is going to be a sex hormone independent effect, which is critical. So we can, with all rational applied say, there shouldn't be any female patient with endometriosis, which should not be potentially treated with a prolactin receptor antibody.

Thank you so much.

That ends our Q&A session. I will now turn the call back over to Sean McClain, Founder and CEO for Closing Works. Please go ahead.

Yeah, I just want to first thank our team at Abzai for all the hard work they've put into not only getting 201 into AGA, but now expanding into endometriosis. And I want to thank all of our investors and analysts for All the support, we're really excited about what's ahead, and we have some exciting catalysts over the next 24 months.

So look forward for another exciting year. Ladies and gentlemen, that concludes today's call. Thank you all for joining Human Outdoors Connect.