Absci outlines dual ABS-201 proof-of-concept readouts by 2027 while prioritizing endometriosis expansion

Earnings Call Insights: Absci Corporation (ABSI) Q3 2025

MANAGEMENT VIEW

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Sean McClain, Founder, CEO, President & Director, announced "interim Phase I results for ABS-101, acceleration of ABS-201 development in androgenetic alopecia (AGA), and expansion of ABS-201 development in a second indication, endometriosis." He stated the Phase I trial for ABS-101 is on track to complete in Q1 2026, with extended half-life versus first-generation anti-TL1A competitors but not next-generation programs, and a favorable safety profile.

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McClain revealed that ABS-201's development for AGA is ahead of plan, with a Phase 1/2a trial set to begin in December and an "interim proof-of-concept readout anticipated in the second half of 2026." He also disclosed the initiation of ABS-201 in endometriosis with a Phase 2 proof-of-concept clinical trial planned for Q4 2026, emphasizing, "we have made the strategic decision to prioritize ABS-201 development in endometriosis."

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The company will seek a partner for ABS-101 and will not pursue further internal clinical development for this asset after Phase I, reflecting a capital reallocation to maximize value creation.

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McClain stated, "Looking ahead, we're excited to execute on the dual development of ABS-201, leveraging its best-in-class profile, targeting 2 proof-of-concept readouts in the next 24 months."

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Zachariah Jonasson, Chief Business Officer & CFO, remarked, "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/IIa trial for androgenetic alopecia by approximately 1 quarter, expanding ABS-201 development into endometriosis and progressing our portfolio of discovery partnership programs."

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Jonasson confirmed ongoing discussions with potential partners for ABS-101 and anticipated signing one or more drug creation partnerships, "including with a large pharma company by year-end."

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ABS-301 and ABS-501 are being positioned for partnerships prior to clinical development.

OUTLOOK

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Jonasson outlined that the Phase I/IIa trial for AGA will be a randomized, double-blind, placebo-controlled study with up to 227 healthy volunteers, focusing on safety, tolerability, and multiple efficacy endpoints. He stated, "the trial will enroll up to 227 healthy volunteers with or without AGA."

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The interim proof-of-concept data readout for ABS-201 in AGA is targeted for the second half of 2026, and for endometriosis in the second half of 2027.

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McClain said, "the ABS-201 Phase I/IIa 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."

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Plans include initiating a Phase II trial in endometriosis in Q4 2026, leveraging safety and tolerability data from the AGA study.

FINANCIAL RESULTS

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Jonasson reported, "Revenue in the third quarter was $400,000 as we continue to progress our partnered programs."

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Research and development expenses were $19.2 million for Q3 2025, compared to $18 million for the prior year period. Selling, general and administrative expenses were $8.4 million, down from $9.3 million.

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Cash, cash equivalents and marketable securities as of September 30, 2025, were $152.5 million. Jonasson stated, "We believe our existing cash, cash equivalents and short-term investments will be sufficient to fund our operations into the first half of 2028."

Q&A

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Vamil Divan, Guggenheim Securities: Asked about details on the ABS-101 trial's half-life and more on the endometriosis competitive landscape. McClain explained the decision to prioritize ABS-201 in endometriosis, citing "a big unmet medical need," poor standard of care, and a derisked mechanism based on competitor data. Jonasson added, "the cost of these trials is a fraction of what a full Phase II proof-of-concept study in the IBD space would be."

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Brendan Smith, TD Cowen: Inquired about partner feedback on ABS-101 data and market segmentation for ABS-201. McClain said data has not yet been shared with partners but discussions are ongoing. Jonasson stated, "we will be looking to enroll patients that are confirmed to have endometriosis and that we'll be looking to enroll patients that have a significant amount of pain."

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Sean Laaman, Morgan Stanley: Asked about partnering ABS-101 and recruitment ease for the ABS-201 AGA trial. McClain indicated a wider buyer universe for ABS-101 due to first-in-class indications. Jonasson voiced confidence in recruiting for the AGA trial and expects "significant hair growth in the terminal area hair count relative to baseline" at the 13-week readout.

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Gil Blum, Needham & Company: Inquired about dosing plans for endometriosis. McClain clarified, "the plan would be subcu in the Phase II, very similar to how we're planning on running the AGA trial."

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Lut Ming Cheng, JPMorgan: Asked about sequencing of AGA and endometriosis trials. McClain stated, "we do not plan to wait to see the AGA readout before starting that Phase II" in endometriosis.

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Srikripa Devarakonda, Truist: Asked about patient targeting for endometriosis. Jonasson indicated the plan to potentially displace GnRH therapy and to "place a new option in the arsenal that's more effective" and without the side effect profile.

SENTIMENT ANALYSIS

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Analysts focused on pipeline reprioritization, competitive landscape in endometriosis, and partnering strategy. Their tone was neutral to slightly positive, with questions seeking clarity on clinical and strategic details rather than expressing skepticism.

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Management maintained a confident and optimistic tone in both prepared remarks and the Q&A, evidenced by statements like "we are energized by what's next and confident in our path to deliver meaningful value for patients, partners and shareholders alike" (McClain).

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Compared to the previous quarter, management's tone was more focused on decisive pipeline reallocation and the dual-pronged ABS-201 strategy, while analysts maintained a consistent, fact-seeking approach.

QUARTER-OVER-QUARTER COMPARISON

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The current quarter introduced the explicit prioritization of ABS-201 in endometriosis and a strategic shift to partner ABS-101 post-Phase I, which was not present in the previous quarter.

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Guidance shifted to faster clinical development timelines for ABS-201 in AGA, now set to initiate the Phase I/IIa trial a quarter earlier than previously indicated.

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Key metrics show a decrease in revenue and R&D expenses compared to the prior quarter, alongside a material increase in cash and equivalents following capital raises.

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Management's confidence has become more pronounced, highlighting focused capital allocation and anticipation of two proof-of-concept readouts for ABS-201 by 2027.

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Analyst questions continued to focus on trial design, competitive differentiation, and partnering, but the shift toward endometriosis as a near-term value driver was more prominent.

RISKS AND CONCERNS

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Management acknowledged safety and half-life limitations for ABS-101 compared to next-generation competitors, leading to the decision to seek partners for further development.

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There was recognition of the competitive and scientific landscape in endometriosis, but management highlighted derisking due to recent competitor data and the lack of non-hormonal options for patients.

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Analysts raised questions regarding trial recruitment, design, and the ability to differentiate ABS-201 in competitive markets, as well as potential hurdles in commercialization.

FINAL TAKEAWAY

Absci is advancing a dual development strategy for ABS-201, targeting proof-of-concept readouts in both androgenetic alopecia and endometriosis within the next two years, while reallocating resources and seeking partners for ABS-101. Management emphasized disciplined capital deployment, confidence in the scientific rationale and commercial potential of ABS-201, and continued pursuit of new partnerships, with a strengthened balance sheet supporting execution of these priorities.

Read the full Earnings Call Transcript [https://seekingalpha.com/symbol/absi/earnings/transcripts]

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