Absci Delays Endometriosis Phase 2 Start to Mid-2027
Cash, cash equivalents and marketable securities stood at $173.7 million as the company named a new chief commercial officer.
Absci Corporation (ABSI), a clinical-stage biopharmaceutical company advancing therapeutics designed with generative AI, said it now anticipates initiating a planned global Phase 2 trial of ABS-201 for endometriosis in mid-2027, later than the fourth-quarter 2026 start it had outlined after the second quarter.
The company also said it expects 13-week interim proof-of-concept data from the HEADLINE trial of ABS-201 in pattern hair loss in December 2026 and full 26-week proof-of-concept data in early 2027. Founder and CEO Sean McClain said the company is approaching its first look at proof-of-concept data for ABS-201 next month, followed by full data early next year.
STORYLINE is planned as a global, multi-center, double-blind, randomized, placebo-controlled Phase 2 study in participants with surgically diagnosed endometriosis and moderate to severe endometriosis-associated pain. Absci said it anticipates recruiting approximately 150 patients from about 10 or more countries, subject to protocol finalization and regulatory clearance, and is designing the study as a dose-ranging trial with two or three dose levels to be confirmed after review of HEADLINE data. The company said it anticipates initiation of the Phase 2 clinical trial in mid-2027.
In June, Absci announced positive interim Phase 1 data from HEADLINE, saying the study medication appears well tolerated with favorable safety data across all blinded single ascending dose cohorts. The company said the estimated half-life of at least 65 days supports a potential dosing interval of two or three injections over a six-month period. It continued to dose participants with pattern hair loss in the multiple ascending dose portion of the trial.
As ABS-201 progresses through the clinic, Absci said it has begun building commercial infrastructure to support the program and potential future programs. It appointed former Galderma executive Gerry Muhle as Chief Commercial Officer. Muhle brings more than 25 years of experience across pharma, aesthetics, and consumer brands, the company said.
Revenue was $0.3 million for the three months ended September 30, 2026, compared with $0.4 million a year earlier. Research and development expenses were $23.6 million, compared with $19.2 million a year earlier. The company said the increase was primarily driven by advancement of internal programs, including direct costs associated with external nonclinical and clinical development of ABS-201, offset by a decrease in personnel-related costs. Selling, general, and administrative expenses were $9.0 million, compared with $8.4 million a year earlier, primarily due to stock-based compensation.
Net loss was $33.3 million for the three months ended September 30, 2026, compared with $28.7 million a year earlier. Cash, cash equivalents, and marketable securities as of September 30, 2026 were $173.7 million, compared with $201.1 million as of June 30, 2026. Based on current projections, Absci said its cash, cash equivalents, and marketable securities will be sufficient to fund operating plans into the second half of 2028.
ABS-202, an anti-PRLR antibody in preclinical development for an undisclosed immunology and inflammation indication, remained in the pipeline.