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Absci Corporation
3/24/2026
Good day and thank you for standing by. Welcome to the AppSci fourth quarter and full year 2025 business update conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, we'll open up for questions. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1-1 again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Alex Kahn, Corporate Vice President in Investor Relations. Please go ahead.
Thank you. Earlier today, AppSci released financial and operating results for the quarter and full year ended December 31st, 2025. If you haven't received this news release or if you'd like to be added to the company's distribution list, please send an email to investors at AppSci.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, Zach Jonathan, chief financial officer and chief business officer, and Rathi Somaratne, Abcide's new chief medical officer. Before we begin, I'd like to remind you the management will make statements during this call that are forward-looking within the meaning of the federal securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. These should not replace undue reliance on forward-looking statements. These include statements regarding the development and clinical progress of ABS-201, anticipated clinical trial design, enrollment and timelines, expected clinical data readouts and their timing, anticipated characteristics and product profile of ABS-201 as a drug product, our target product profile and its attributes, the potential for an expedited development pathway, including the possibility of advancing directly from Phase I-IIa into Phase III, our planning engagement with the FDA regarding development strategy and potential market opportunity, and commercial prospects for ABS-201. Certain statements may also include projections regarding potential market opportunity. These estimates are based on various assumptions, including potential regulatory approval, the final approved label, and the evolving competitive landscape, any of which could cause our actual or decimal market to differ materially from these projections. In addition, certain research findings discussed today reflect participant responses to a hypothetical product profile and do not represent clinical results for ABS-201. Additional information regarding these risks, uncertainties, and factors that could cause results to differ appears in the section titled Forward-Looking Statements in the Press Release to AFSCI Issue Today and in the documents and reports filed by AFSCI from now to time with the Securities and Exchange Commission. Except as required by law, AFSCI disclaims any intention or obligation to update or revise any financial or product pipeline projections or other forward-looking statements either because of new information, future events, or otherwise. This conference call contains time-sensitive information and is accurate only as of the live broadcast, March 24th, 2026. 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. EDS-201 is in the clinic, and we have dosed our first three SAD cohorts in our phase one 2A headline trial with favorable emerging safety data. We expanded into endometriosis as a second multi-billion dollar indication. As we published what we believe is the first demonstration of de novo full-length antibody designed to zero prior epitopes. I'll walk you through each of these today. Also on the call today is Dr. Ransi Samaratne, our new chief medical officer. Ransi spent nearly two decades in clinical development across multiple therapeutic areas at Amgen, Biomarin, and most recently Vertex. where he served as SVP of Clinical Development and Translational Medicine. At Birkhex, he was instrumental in the development of Gernavix, the first NAV 1.8 inhibitor approved for acute pain. Taking it from late stage development through FDA approval, that registrational experience is exactly what we need as ABS 201 advances towards proof of concept, and if successful, into registrational trials. He'll walk you through the clinical development program in detail shortly. I also want to acknowledge Andreas Bosch, who retires this month. Andreas built our drug creation organization from the ground up. He integrated our AI design capabilities with our wet lab platform and recruited the leadership team that will carry that work forward. He'll continue as co-chair of our scientific advisory board. Andreas has been more than a colleague to me. He's been a trusted partner and a friend. Our development operations are in excellent hands because of the foundation he built. Our KLO advisory networks for both AJA and endometriosis continue to expand. You heard from Professors Paus, Sinclair, and Dr. Goldberg at our December seminar, and we have now assembled a dedicated endometriosis advisory board of esteemed experts that is actively shaping our phase two trial design and endpoint selection. In December, we hosted a seminar on ABS-201 for AGA, featuring the Abcite team and several of our KOL advisors. 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-201 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-201 stimulates hair growth by generating the stem cell niche. In addition of prolactin receptor signaling correlates with prolongation of antigen and restoration of growth signaling. preservation and expansion of stem cell niche, and potential for follicular reconversion from dayless to terminal hair follicles. Importantly, ABS-201 showed growth-promoting effects without exogenous prolactin, meaning it effectively neutralizes locally produced intrafollicular prolactin signaling. The clinical implication is significant. We believe ABS-201 201's mechanism is not limited to patients with elevated systemic galactin, but that it can engage the target at anyone who has active local galactin receptor signaling. ABS-201 was engineered with an extended half-life design to support infrequent dosing. In preclinical studies, it demonstrated a three to four-fold longer half-life than the competitor antibody. We believe this profile may enable a convenient dosing regime of just two to three administrations for durable multi-year hair regrowth. Looking at our clinical timeline, we anticipate training preliminary safety, tolerability, and PK data for our ongoing headline trial in the first half of this year. That will be followed by an interim 13-week proof of concept data including exploratory efficacy in the second half. Full 26-week proof of concept data will come in early 27. Ronzi will discuss the trial progress in more detail shortly. As a reminder, we intend to use safety, tolerability, and PK from the ongoing ABS-201 study to support initiation of the Phase II clinical trial in endometriosis in Q4 this year. The engagement we have had with endometriosis patients, advocacy groups, and KOLs has reinforced our conviction. This condition has been underserved for decades and patients need better options. Endometriosis is estimated to affect approximately 10% of women of reproductive age worldwide. There is currently no FDA approved disease modifying therapy. Current medical and surgical management strategies have significant limitations. ABS-201 targets a non-sex hormone pathway distinct from existing hormonal therapies. Our preclinical data combined with positive phase 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. Beyond ABS 201, our other programs, ABS 101, 301, and 501, continue to progress. Each of these we see as better suited for our partner, and we remain engaged in discussions with multiple strategic parties. This allows us to focus our resources on ABS 201 and invest in additional early stage programs. Our strategy is to go after underexplored targets in large markets where unmet need is significant and competition is low. That's where the platform creates the most differentiation and where we see the highest return on our R&D investment. Put a number on it, we have advanced our first two programs from AI design to IND in approximately two years at a roughly $15 million investment per program. compared to an industry standard of four to six years and $50 million or more. Earlier this year, we published details on OriginOne, our generative AI platform for de novo antibody design, integrated with our Lab in the Loop validation. OriginOne designs full-length antibodies against zero prior episodes, targets with no reported complex structure. It generates lead candidates by screening fewer than 100 designs per target with atomically accurate predicted structures and confirmed functional activity. 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-201 clinical program. Ronzi.
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