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Date

Wednesday, November 12, 2025 at 4:30 p.m. ET

Call participants

  • Founder and Chief Executive Officer — Sean McClain
  • Chief Financial Officer and Chief Business Officer — Zachariah Jonasson
  • Chief Innovation Officer — Andreas Busch
  • Vice President, Investor Relations — Alexander Khan

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Takeaways

  • Revenue -- $400,000 reported for the quarter, reflecting continued progress on partnered programs.
  • R&D Expenses -- $19.2 million, up from $18 million for the same quarter last year, primarily from advancement of internal programs and increased preclinical and clinical activity.
  • Selling, general, and administrative expenses -- $8.4 million, a decrease from $9.3 million for the previous year’s quarter, mainly due to lower personnel spending.
  • Cash position -- $152.5 million in cash, cash equivalents, and marketable securities as of September 30, 2025, versus $117.5 million on June 30, 2025.
  • Funding outlook -- Management stated, "We believe our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into 2028."
  • ABS-201 (Androgenetic Alopecia) -- Phase 1/2a trial set to begin dosing next month with proof-of-concept interim data expected in 2026. The planned trial will enroll up to 227 participants in a randomized, double-blind, placebo-controlled design, with primary endpoints of safety and tolerability and secondary endpoints covering pharmacokinetics, pharmacodynamics, immunogenicity, hair count, and patient-reported outcomes.
  • ABS-201 (Endometriosis) -- Phase 2 proof-of-concept trial planned for 2026, with interim data expected in 2027. Management is prioritizing ABS-201 development in endometriosis due to perceived value creation opportunity and synergy with ongoing AGA studies.
  • ABS-101 (Anti-TL1A) -- Interim Phase 1 results show extended half-life versus first-generation anti-TL1A competitors, but not versus next-generation compounds. No serious adverse events or ADA impact on PK observed. The company will seek a partner and discontinue additional internal clinical development after completing the ongoing Phase 1 study.
  • AI partnership outlook -- Management "anticipate signing one or more drug creation partnerships, including with a large pharma company by year-end."
  • ABS-301 and ABS-501 programs -- Both preclinical programs will be offered to prospective partners before beginning clinical development, reflecting a focus on capital efficiency and core pipeline prioritization.
  • ABS-201 ex vivo data -- New ex vivo human scalp data demonstrated ABS-201's ability to induce the hair growth anagen phase and counteract prolactin-mediated suppression, with repeatable results across all three patient samples studied.
  • KOL seminar -- Company will host an educational event on December 11 to present the clinical development plan and additional human data for ABS-201 in AGA.
  • Clinical development efficiency -- Safety data from the AGA Phase 1/2a study will be leveraged for the endometriosis proof-of-concept trial, allowing parallel advancement and capital efficiency according to management.

Summary

Absci Corporation (ABSI 22.65%) is reallocating clinical development resources to prioritize ABS-201 in both androgenetic alopecia and endometriosis, discontinuing further internal development of ABS-101 after Phase 1 and seeking a partner for that asset. Management projects that existing cash and investments will fund operations into 2028, citing a strengthened liquidity position. The company expects to initiate the ABS-201 AGA trial by next month, with interim efficacy data targeted for the second half of 2026, and plans to launch a phase 2 endometriosis study in 2026 leveraging safety data from the AGA study. An AI-driven partnering strategy remains a key focus, with management stating an expectation of closing one or more drug creation partnerships, potentially with large pharmaceutical companies, before year-end.

  • Chief Executive Officer McClain said, "we have made the strategic decision to prioritize ABS-201 development in endometriosis."
  • Chief Business Officer Jonasson confirmed, "do not currently plan to develop the program ourselves into phase two," citing the competitive landscape and resource discipline.
  • ABS-201 was designed to enable convenience for patients, with preclinical results indicating potential for "a simple, infrequent course of just two to three injections of ABS-201 could deliver durable, multiyear hair regrowth."
  • The company noted positive human proof-of-concept in endometriosis for a competing anti-prolactin receptor antibody (HMI-115), which management believes "derisks the mechanism" for ABS-201 and supports its best-in-class potential based on non-human primate data.
  • Both ABS-301 (first-in-class immuno-oncology antibody) and ABS-501 (anti-HER2 antibody) will be offered for external partnership rather than advanced internally, reflecting strategic prioritization.
  • New ex vivo scalp biopsy data for ABS-201 showed "the ability of ABS-201 to transition hair follicles into the anagen growth phase and to counteract suppressive catagen effects of prolactin."

Industry glossary

  • ADA: Anti-drug antibodies; immune system proteins that may bind a therapeutic and impact its effectiveness or pharmacokinetics.
  • PK: Pharmacokinetics; the study of how a drug moves through the body.
  • PD: Pharmacodynamics; the study of a drug’s biological effects on the body.
  • SAD: Single ascending dose; a clinical trial design where participants receive increasing single doses to evaluate safety and pharmacokinetics.
  • MAD: Multiple ascending dose; a study design where participants receive multiple doses at increasing amounts to assess safety and effects over time.
  • KOL: Key opinion leader; a recognized expert in a particular medical or scientific field.

Full Conference Call Transcript

Sean McClain, Absci's Founder and CEO, and Zachariah Jonasson, Chief Financial Officer and Chief Business Officer. Andreas Busch, Absci's Chief Innovation Officer, will also join for Q&A following prepared remarks. Before we begin, I would like to remind you that management will make statements during this call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated, and you should not place undue reliance on forward-looking statements.

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 Absci issued today, and 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 on 11/12/2025. With that, I will turn the call over to Sean.

Sean McClain: Thanks, Alex. Good afternoon, everyone. Thank you for joining us for our Q3 business update call. Today, we will be sharing updates about our pipeline, including interim phase one results for ABS-101, acceleration of ABS-201 development in androgenetic alopecia or AGA, and expansion of ABS-201 development in a second indication, endometriosis. Interim results from the first cohorts of our ongoing ABS-101 phase one trial in healthy volunteers demonstrated extended half-life as compared to first-generation anti-TL1A competitor programs but not versus next-generation programs. There was also no apparent impact of ADA on PK, and the overall safety profile was favorable with no serious adverse events reported to date. The phase one trial is on track to complete in 2026.

Our progress developing ABS-201 for androgenetic alopecia is ahead of plan as we expect to initiate a phase 1/2a trial in December with an interim proof of concept readout anticipated in 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 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 ten percent 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 androgenetic alopecia. Therefore, we will seek a partner for ABS-101 and no longer pursue additional internal clinical development for this asset beyond the completion of the phase one clinical trial. The decision to reallocate our pipeline priorities reflects the 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 need and poor standard of care. There is biological and clinical rationale for the prolactin 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 are 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 twenty-four months. A phase 1/2a proof of concept interim data readout in AGA in 2026 and a phase two proof of concept interim data readout for endometriosis in 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 ABS-201 in androgenetic alopecia. We have accelerated our clinical development timeline and expect to dose our first participant next month in our phase 1/2a study.

On December 11, we will host a KOL seminar to discuss the anticipated clinical development path, market opportunity, and differentiated profile of the ABS-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 AGA, which we believe could offer efficacious, durable, convenient hair regrowth. This condition, better known as male and female pattern hair loss, affects approximately eighty million adults in the US alone and has seen little therapeutic innovation in nearly thirty 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 studies, we believe that a simple, infrequent course of just two to three injections of ABS-201 could deliver durable, multiyear hair regrowth. Today's standard of care treatments have limited efficacy and require frequent once or twice daily administration, leading to poor compliance. Our KOL network of leading dermatologists has indicated compliance for topical as well as oral minoxidil can be poor in practice, either because of side effects or the inconvenience of lifelong daily administration.

A recent study showed that over eighty-six percent of AGA patients who tried topical minoxidil discontinued 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, straightforward clinical development path, and the massive multibillion-dollar market opportunity, we plan to develop ABS-201 through later-stage clinical development and potentially commercialization. As we advance the development of ABS-201 for AGA, we are thrilled to welcome Doctors Rod Sinclair and David Goldberg to our KOL advisory board.

Doctor 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. Doctor Goldberg brings nearly forty years of clinical dermatology experience. He is a clinical professor of dermatology at the Icahn School of Medicine at Mount Sinai and has led pivotal research studies in dermatology and hair loss, including the original minoxidil trials.

Doctor 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 the American Society of Dermatologic Surgery. We invite you to join our virtual seminar on December 11, where Doctor Sinclair, Doctor 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 an undisclosed immuno-oncology target identified through our reverse immunology platform. Early data suggest potential in squamous cell carcinoma and other indications.

ABS-501, 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 trastuzumab in preclinical disease models, efficacy against a trastuzumab-resistant xenograft tumor in an 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 will now turn the call over to Zach to walk through our strategy, partnerships, and outlook and to provide an update on our financials.

Zachariah Jonasson: Thanks, Sean. As Sean mentioned, we continue to sharpen our strategic focus, and in so doing, we made decisions recently about which internal programs to advance versus partner. Our decisions continue to be based on careful assessment of the potential risks and 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 one readout, expediting the initiation of our ABS-201 phase 1/2a 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 two. 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: androgenetic 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 1/2a clinical trial in AGA will provide safety, tolerability, and PK assessments that will support phase two clinical development in endometriosis. The phase 1/2a 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 androgenetic alopecia. The MAD portion of this clinical trial is powered to demonstrate human proof of concept for the use of ABS-201 to treat androgenetic alopecia by stimulating significant hair regrowth.

We believe that if this trial is successful, it will 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 anagen 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 11. As Sean mentioned earlier, in addition to treating androgenetic 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 ten percent of women worldwide, including an estimated nine million women in the US 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 support 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 individualization, regulated 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.

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 two trial of HMI-115, a competitor anti-prolactin receptor antibody in endometriosis, provided human proof of concept and derisking 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 a three to four times 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 two clinical development of ABS-201 in endometriosis in 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 two trial in endometriosis in 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 continue to progress our partnered programs. Research and development expenses were $19.2 million for the three months ended 09/30/2025, as compared to $18 million for the prior year period. This increase was primarily driven by the advancement of Absci's internal programs, including direct costs associated with external preclinical and clinical development.

Alexander Khan: Selling, general, and administrative expenses were $8.4 million for the three months ended 09/30/2025, 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 09/30/2025 were $152.5 million, as compared to $117.5 million as of 06/30/2025. We believe our existing cash, cash equivalents, and short-term investments will be sufficient to fund our operations into 2028. We see additional upside to this forecast based on potential nondilutive 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, wholly-owned asset programs, or both. With that, I will now turn it back to Sean.

Sean McClain: Thanks, Zach. 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 Corporation. As you heard today, ABS-201 is moving into the clinic with real momentum, and we are 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 have 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 are leaning into the data, the science, and the market opportunity where Absci Corporation can lead. Looking ahead, the momentum is unmistakable. The ABS-201 phase 1/2a trial in AGA 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 in Q4 2026. We anticipate closing at least one new large pharma partnership this year, and I invite you to join our ABS-201 KOL event on December 11. Details are on our IR website.

Absci Corporation 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 is 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.

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

Vamil Divan: Hi. Great. Thanks for taking my questions. So I just have two, if I could. One, I understand what you are saying about the TL1A program and looking to partner it out. I am wondering if you have 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, on just the endometriosis side, it is interesting news there. So looking forward to seeing, hearing, and learning more about that. But I am just curious right now if you can maybe just get some sense of the competitive landscape as you are thinking about sort of designing a Phase II trial in that indication?

Or how that would look and how you know, just generally how you design it and the right comparison to think about. Thank you.

Sean McClain: Yeah. Absolutely. Thanks, Vamil. Yeah. So, you know, we took a really hard look at ABS-101. You know, we were, you know, in general, really happy with the, you know, 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 would 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 is a big unmet medical need here. The standard of care is really poor. There is not a lot of competition in the space. Additionally, the mechanism has been ultimately derisked with the HMI-115 data that came out, showing proof of concept for this particular mechanism. So we see this as a derisked mechanism.

And, again, the 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 will hand it over to Zach to talk a little bit more about the phase two trial design for endometriosis.

Zachariah Jonasson: Yeah. Thanks, Sean. And just to echo a couple of points Sean made, we do not see the endometriosis indication as much less competitive than you see in Crohn's. That certainly was a factor in our decision here. Moreover, the cost of these trials is a fraction of what a full phase two proof of concept study in the IBD space would be. So we think there is 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 are really excited about here with the ABS-201 mechanism is that there is a potential not just to address pain, but also to be disease-modifying.

And so we are currently engaged with our KOLs and have a draft study design that we will share more about in the New Year.

Vamil Divan: Okay. Thank you. Thanks.

Operator: Your next question comes from the line of Brendan Smith with David Cohen. Please go ahead.

Brendan Smith: Hi, guys. Thanks for taking the questions. I appreciate it. So maybe if just a quick one first. On actually, just the profile for 101, 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 is kind of now the plan over the next few weeks? I am just wondering on initial feedback there. And then maybe quickly on 201.

I know you have talked a bit about endometriosis versus alopecia, but just wondering if there is ever or there are any maybe even at a high level thoughts on market segmentation just given 201's mechanism and any considerations on how you are thinking about enrollment for that? Thanks.

Sean McClain: 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 this data with our partners yet. We plan to share that with them in the coming weeks. Then additionally, as I mentioned previously, we have been exploring other first-in-class indications that we believe there is 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 will hand it over to Zach to answer the second question.

Zachariah Jonasson: Yeah. Thanks, Brendan. As I mentioned, we will release more details about the trial design for endometriosis. But I will comment that, you know, 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 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 have got some leading KOLs advising us here, so we feel very confident and excited about moving that program forward. There is a very large unmet medical need there.

And I think a very large opportunity based on what we saw from the HMI trial, you know, with a nice proof of concept on the mechanism. As you know, the trial there in the high dose saw a statistically significant reduction in pain and dysmenorrhea. And so I think that is a nice readout for us, derisking 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.

Sean McClain: Yeah. And I would also like to just loop in Andreas Busch, our Chief Innovation Officer, into this question. He had experience at Bayer actually developing an antibody, which is now HMI-115, for endometriosis. And so Andreas, do you have anything else to add here?

Andreas Busch: Yeah. Sure. Thanks, Sean. I think it may be relevant to point out here that the drug innovation around molecular receptor antibodies started around endometriosis and not hair loss, and the hair loss observation was actually the serendipitous finding at the time. Again, it is 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 preclinical experiments, it was nicely shown that prolactin antibodies in our experiments now at Absci as well as previously in Bayer's hands that it can indeed affect both pain, as Zach has indicated before, as well as reducing the lesions. 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 is, of course, the approved GnRH antagonist treatment, which has the typical side effects of estrogen reduction.

And there is a significant need for non-hormonal safe approaches in endometriosis, and this is what all data of prolactin receptor antibodies so far have shown by safety both in preclinical 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.

Brendan Smith: Thank you, Sean.

Operator: Your next question comes from the line of Shen LeMun with Morgan Stanley. Please go ahead.

Shen LeMun: 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?

Sean McClain: Yeah. Absolutely. It is a great question. So what we are looking for in a partner is one, the domain expertise in the particular indication that we are 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, you know, we are excited to engage in those discussions. Zach, if you have anything else to add on the partnering front?

Zachariah Jonasson: I would just add that as Sean mentioned, we have done some work on a first-in-class indication for ABS-101, and we have had some engagement already on that indication. We will 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.

Shen LeMun: 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. That should be a fairly facile process, but I could be wrong. And then just, you know, maybe sort of the cost to 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 are looking for?

Sean McClain: Great. Zach, do you want to take the first two questions and then Andreas hand it over to you for the third?

Zachariah Jonasson: Yeah. Absolutely. And just to clarify, when you asked the question, are you referring to endometriosis or AGA?

Shen LeMun: Oh, sorry. Alopecia. Sorry.

Zachariah Jonasson: Yeah. Okay. Perfect. We feel very confident in the ability to recruit for that trial. We have multiple sites in Australia, including a major KOL who will be speaking at our KOL event on December 11, 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 are looking to have an interim readout that will be in the early part of the second half of next year. And that is going to look at a thirteen-week time point. We are obviously measuring safety and tolerability through the SAD, and we will see that data well before the second half.

But in the second half for efficacy, we would look at that thirteen-week readout. We expect to see significant hair growth in the terminal area hair count relative to baseline. We will be doing additional measures of efficacy at the twenty-week and the twenty-four-week as well.

Shen LeMun: Got you. Thank you.

Operator: Your next question comes from the line of Gil Blum. Please go ahead and provide the company you are with.

Gil Blum: Good afternoon, and thanks for the update. So maybe a quick one on TL1A. Just to understand the features here. So the half-life was not as much as a second-gen asset, but you mentioned that the ADAs did not affect the PK. Where do you think that fits the asset as it was an indication? I mean, is this one of the reasons you are looking at alternative indications? And I have a follow-up.

Zachariah Jonasson: Hi, Sean. You may be on mute. Gil, I can take that question. We looked at the profile, and in full disclosure, we are 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 will 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 has gotten us focused on a couple of newer indications where the molecule could be first-in-class.

Gil Blum: Okay. That is helpful. And as it relates to endometriosis, just to clarify, are we looking initially at a subcu dose or also IV first?

Sean McClain: Yeah. So the plan would be subcu in the phase two, very similar to how we are planning on running the AGA trial. As we mentioned previously, we are at 200 mgs per mil, and we will do the SAD portion in IV and then go to the subcu in the MAD and then, same with the endometriosis trial as well.

Gil Blum: So you will use subcu initially in endometriosis? I just want to make sure I understand.

Sean McClain: Yes. In that phase two trial, we plan to use subcu.

Gil Blum: Okay. And maybe the last point that I just want to make sure, so focus remains both on AGA and Endo, not Endo taking the lead here. Is that correct?

Sean McClain: 100%. I would say that they are co-leads. Our main focus this next year is to get the phase two 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.

Gil Blum: Okay. Thank you for taking our questions.

Andreas Busch: Maybe it is important also to add that, of course, the phase two trial in endometriosis takes full advantage of the phase one trial in AGA.

Zachariah Jonasson: Yeah, this is Zach. To put a finer point on that, it is a very capital-efficient development plan since the phase two trial in endometriosis will leverage all the safety data we generate in the phase 1/2a trial in AGA.

Operator: Your next question comes from the line of Ryan Chang with JPMorgan. Please go ahead.

Ryan Chang: Hey, guys. Thanks for taking our questions this evening. As we think about the timing of the interim data and also the start of the phase two 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.

Sean McClain: So, obviously, we are going to have to get the SAD safety portion before going into the phase two study. But assuming the phase one 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.

Ryan Chang: 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 the 201 program so far? And how are you using the data that they have seen to your own advantage?

Zachariah Jonasson: Absolutely. You know, we look at the trial design was not the best, so there are definitely some learnings there. And you can be assured we will have a well-structured design trial that is adequately powered. But the key point that we take away from that trial that I think is very encouraging for proof of concept in endometriosis is the following. One, the first point being they saw in their effect size, they saw a dose response during treatment, during the twelve weeks of treatment. And a statistically significant response in pain at 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 are 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 is a, like I said, a very encouraging proof of concept that derisks the mechanism.

Ryan Chang: Great. Thank you.

Operator: Next question comes from the line of Devin Deckert with KeyBanc. Please go ahead.

Devin Deckert: 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.

Sean McClain: Yeah. Regarding the ex vivo data, obviously, when you are dealing with human biopsies, a lot of things can go wrong. And 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 that was really, really exciting to see and get validated the mechanism in a really fantastic way, and it lines up really nicely with what you are seeing in the stump 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 an n of three different patients, and you saw the same response across all three patients. And so we were just really pleased with what we saw, and I think that gives us really strong confidence going into the phase two study.

Zachariah Jonasson: And I will add to that up to your second question. We do see potential additional indications for 201. We are not ready to speak about those today. I think we are laser-focused on driving that program through the phase 1/2a for AGA as well as the phase two for endometriosis.

Devin Deckert: Got it. Thank you.

Operator: Again, if you would like to ask a question, press 1 on your telephone keypad. Your final question comes from the line of Kripa Devarakonda with Truist. Please go ahead.

Kripa Devarakonda: 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 are any restrictions or subgroups that you would expect to target? And I know it is 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.

Sean McClain: Yeah. That is a great question. Zach, I will hand it over to you and then to Andreas.

Zachariah Jonasson: Yeah. Terrific question. I think a couple of points here. One is we are looking to address patients that are on GnRH and potentially displace GnRH therapy. That therapy has 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 is more effective and does not have a side effect profile like that could be game-changing for these patients. So that is our mission. In terms of how we recruit and segment the trial, that is something we will comment on later next year as we get closer to the start of the trial.

And, Andreas, if you would like to add something, please feel free.

Andreas Busch: Yeah. I mean, so these are two different aspects. One is, you know, what do we believe where it will work versus what is 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 should not be any female patient with endometriosis who should not be potentially treated with a prolactin antibody.

Kripa Devarakonda: Okay. Thank you so much.

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

Sean McClain: Yeah. I just want to first thank our team at Absci for all of the hard work they have 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 are really excited about what is ahead, and we have some exciting catalysts over the next twenty-four months. So look forward to another exciting year.

Operator: Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.