BioAge Completes QUELL-CV Enrollment, Doses First DME Patient
The company posted a $33.5 million net loss, or $0.73 a share, as BGE-102 trial costs lifted research spending to $30.2 million.
BioAge Labs, Inc. (BIOA), a clinical-stage biopharmaceutical company developing oral NLRP3 inhibitors for cardiometabolic disease, completed enrollment of approximately 160 participants in QUELL-CV, its Phase 2 dose-ranging trial of BGE-102 in adults with obesity and elevated inflammation, and dosed the first participant in QUELL-DME, a Phase 2 study of the same compound in diabetic macular edema.
QUELL-CV, a randomized, double-blind, placebo-controlled trial of three once-daily oral doses (30 mg, 60 mg, and 90 mg) against placebo, now has topline data anticipated in the fourth quarter of 2026. The primary endpoint is percent change from baseline in hsCRP over 12 weeks of dosing. The company said the study is designed to characterize the dose-response relationship and support dose selection for further development.
QUELL-DME, an approximately 180-participant randomized, controlled study, evaluates once-daily oral BGE-102 as monotherapy and in combination with standard-of-care anti-VEGF therapy, with participants randomized 1:1:1 across three arms. The primary endpoint is change from baseline in best-corrected visual acuity at week 12. Topline results are anticipated in the second half of 2027. Chief executive Kristen Fortney said the endpoint is the same one used for approval of existing therapies, and that a positive result could support a streamlined path into a pivotal trial. Results from QUELL-DME are also expected to inform development in other NLRP3-driven retinal diseases, including geographic atrophy.
In the three months ended September 30, 2026, research and development expenses were $30.2 million, compared with $18.5 million a year earlier. The company said the $11.7 million increase was primarily a $13.2 million rise in direct BGE-102 costs for QUELL-CV and QUELL-DME and drug product manufacturing, plus a $1.7 million increase in personnel-related expenses, partially offset by a $3.3 million decrease in direct costs for other programs, primarily the timing of research under its Novartis collaboration.
Collaboration revenue was $0.3 million, compared with $2.1 million in the year-ago quarter. The company said the $1.8 million decrease was primarily due to a $1.7 million cumulative catch-up adjustment tied to a September 2026 amendment to the Novartis agreement that added $0.9 million of research funding and expanded the research activities required to satisfy the performance obligation.
General and administrative expenses were $7.5 million. Net loss was $33.5 million, or $0.73 a share, compared with a net loss of $20.2 million, or $0.56 a share, a year earlier.
As of September 30, 2026, BioAge had approximately $352.3 million in cash, cash equivalents, and marketable securities. Based on its current operating plan, the company said existing cash is expected to fund operations and capital expenses through 2029.
The APJ agonist program, an exercise-mimetic approach to obesity, remained on track for an IND submission by year-end 2026. In October 2026, BioAge’s AI-driven drug discovery collaboration with Deep Origin reached its first milestone: computationally identified hits against a novel BioAge target were validated in BioAge’s laboratory, and the company said it is advancing the target into hit-to-lead optimization. Multi-year research collaborations with Novartis and Lilly ExploR&D continued.