Absci (NASDAQ:ABSI) provided a fourth-quarter and full-year 2025 business update on Monday, highlighting early progress for lead candidate ABS-201, expansion into a second indication, and continued investment in its AI-enabled drug creation platform.
ABS-201 advances in the clinic with early safety and PK observations
Founder and CEO Sean McClain said Absci “had a strong fourth quarter,” led by the clinical advancement of ABS-201. The company’s ongoing Phase I/IIa HEADLINE trial has now dosed the first three cohorts in the single-ascending dose (SAD) portion, with what management described as “favorable emerging safety data.”
Somaratne said primary endpoints are safety and tolerability, while secondary endpoints include pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and several hair-related measures such as target area hair count and hair width. The trial is enrolling up to 227 healthy volunteers with or without AGA, with four intravenous SAD dose groups followed by three subcutaneous MAD dose groups in participants with AGA.
On the call, Somaratne said ABS-201 has been “well-tolerated” so far, adding that “there’s no evidence of any on-target or off-target safety signal” based on data reviewed to date. He also said emerging PK data support the current dosing regimen being used in the study. Management indicated the company is on track to dose SAD Cohort 4 and begin the first MAD cohort, with Somaratne later noting the company hoped to dose the first MAD participants “towards the end of the week.”
Upcoming ABS-201 catalysts: H1 safety/PK, H2 interim POC, and 2027 readouts
Absci reiterated several anticipated clinical updates for ABS-201. McClain said the company expects to share preliminary safety, tolerability, and PK data from HEADLINE in the first half of 2026, followed by interim 13-week POC data in the second half of 2026. Full 26-week POC data are expected in early 2027.
Somaratne said the MAD portion has been powered to demonstrate proof of concept in AGA. He added that with the 13-week data, the company hopes to show “directionally positive hair growth compared to baseline,” which it believes would translate into more robust effects by the 26-week readout and beyond.
In Q&A, management discussed how it is thinking about potential efficacy benchmarks. CFO and Chief Business Officer Zach Jonasson said that if ABS-201 can deliver an effect size in terminal area hair count consistent with high-dose oral minoxidil—described as “35–40 hairs per square centimeter”—the company would view that as a “home run product,” particularly when combined with durability and convenient dosing.
Somaratne also addressed expectations for registrational trial design, saying the company has not yet engaged the FDA on Phase III design and that the 13-week interim readout is expected to better inform what Phase III could look like. He noted that other companies in the space are developing six-month pivotal endpoints with additional long-term safety follow-up.
Endometriosis added as a second indication; Phase II start targeted for Q4
Absci highlighted endometriosis as a new target indication for ABS-201. McClain said the company plans to use safety, tolerability, and PK data from the HEADLINE trial to support initiation of a Phase II endometriosis study in the fourth quarter of 2026, “subject to data and regulatory review.” Somaratne said the company anticipates an interim POC readout from the endometriosis trial in the second half of 2027.
Management positioned ABS-201 as targeting a non-sex hormone pathway distinct from existing hormonal therapies. McClain said the company’s preclinical work, along with Phase II results from a competitor anti-prolactin receptor antibody, supports the potential for ABS-201 to modify disease progression, address pain and lesion growth, and offer a differentiated safety profile.
Somaratne also discussed clinical trial considerations in endometriosis, emphasizing that these studies are “really pain studies” and require careful protocol design, site selection, and management of placebo effects, given the reliance on numerical rating scores.
Consumer and physician interest research cited for AGA opportunity
Jonasson shared results from a consumer survey commissioned by the company involving 610 participants experiencing AGA, based on a hypothetical target product profile (TPP). The TPP assumed hair regrowth comparable to what has been reported for high-dose oral minoxidil, with potential durability of 2–3 years, and a six-month regimen of approximately three subcutaneous administrations rather than daily or twice-daily use of topical or oral therapies.
According to Jonasson, key findings included:
- 87% of men and 69% of women surveyed said they would be “extremely likely” or “very likely” to ask a healthcare professional about ABS-201 if it were available.
- Among respondents using oral standard-of-care therapies such as oral minoxidil, the figures increased to 92% for men and 89% for women.
- More than two-thirds of men and women currently using another hair loss product said they would be “extremely” or “very” likely to try ABS-201 as first-line therapy if it were available.
Based on market research discussed on the call, Jonasson estimated a potential total addressable AGA population in the U.S. of approximately 15–18 million consumers. Assuming 2–3-year durability, he estimated annual treatable patient volume could range from 5–9 million consumers per year. Jonasson added that the company believes the total addressable market in the U.S. “could be substantial,” with some estimates exceeding $25 billion annually, while cautioning that actual market size and uptake would depend on clinical outcomes, regulatory approval, pricing, and competition.
Financial update: R&D spending increased; cash runway into 1H 2028
For the fourth quarter, Absci reported revenue of $700,000. Research and development expenses were $25.3 million for the quarter ended December 31, 2025, compared with $18.4 million in the prior-year quarter, driven primarily by advancing internal programs and external preclinical and clinical development costs for ABS-101 and ABS-201.
Selling, general, and administrative expenses were $8.6 million, compared with $8.8 million in the prior-year quarter. The company also recorded a $5.1 million gain related to the settlement of contingent consideration during the fourth quarter, which Jonasson said resulted in net proceeds of $8.7 million of unrestricted cash.
Cash, cash equivalents, and marketable securities totaled $144.3 million as of December 31, 2025, compared with $152.5 million as of September 30, 2025. Jonasson said the company believes its cash resources will be sufficient to fund operations into the first half of 2028, while it continues to pursue non-dilutive funding opportunities, including early-stage asset transactions and potential platform collaborations with large pharmaceutical companies.
Looking ahead, McClain said 2026 is expected to include multiple catalysts, including ABS-201 safety and PK data in the first half of the year, interim 13-week AGA proof-of-concept data in the second half, and initiation of the Phase II endometriosis trial in the fourth quarter.
About Absci (NASDAQ:ABSI)
Absci Corporation (NASDAQ: ABSI) is a biotechnology company that applies machine learning, synthetic biology and automation to accelerate the discovery and development of protein-based therapeutics. The company’s Integrated Drug Creation® (IDC®) platform is designed to identify and produce novel antibody and enzyme candidates at speeds and scales that traditional biopharma discovery methods cannot match. Absci works with pharmaceutical and biotechnology partners to generate, screen and optimize protein molecules for a wide range of therapeutic applications.
The core of Absci’s offering is its end-to-end discovery engine, which combines proprietary algorithms, high-throughput laboratory automation and a deep learning framework.
