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BioAge Doses First Patient in BGE-102 Phase 2 Trial

The company said QUELL-CV topline data are expected in the second half of 2026, with cash of about $381.3 million funding operations through 2029.

BioAge Labs, Inc. (BIOA) dosed the first participant in QUELL-CV, a Phase 2 dose-ranging proof-of-concept trial of its oral NLRP3 inhibitor BGE-102, after announcing in the prior quarter that the study was planned to start in mid-2026.

The Emeryville, Calif.-based clinical-stage biopharmaceutical company said the randomized, double-blind, placebo-controlled study will evaluate three once-daily oral doses of BGE-102 (30 mg, 60 mg, and 90 mg) against placebo in approximately 160 adults with obesity and elevated baseline inflammation. The primary endpoint is percent change from baseline in hsCRP over 12 weeks of dosing. Topline data are anticipated in the second half of 2026.

QUELL-CV builds on the full Phase 1 dataset, in which BGE-102 achieved up to 98% suppression of IL-1β at trough in an ex vivo whole-blood assay and median hsCRP reductions of 86% from baseline at both 60 mg and 120 mg once daily. The company said the drug was well tolerated across all dose levels evaluated, with no serious adverse events and no treatment-emergent adverse events leading to discontinuation.

Chief executive Kristen Fortney said the Phase 1 data show BGE-102 is a potential best-in-class NLRP3 inhibitor: a well-tolerated once-daily pill that delivered up to 98% suppression of IL-1β and brought hsCRP down to normal levels in most participants. She said the company is actively evaluating additional indications where NLRP3 inhibition can deliver benefit.

Following an indication expansion into ocular diseases, BioAge plans to initiate QUELL-DME, a Phase 1b/2a proof-of-concept trial of BGE-102 in diabetic macular edema, in mid-2026, with results anticipated in mid-2027. The study is designed to demonstrate pharmacodynamic target engagement in the eye. That timing matched the plan already outlined after the January 2026 ophthalmology expansion.

Collaboration revenue was $2.4 million for the quarter ended June 30, 2026, matching the year-earlier quarter. Research and development expenses were $24.4 million, compared with $19.8 million a year earlier. The company said the $4.6 million increase was primarily a $7.9 million rise in BGE-102 direct costs associated with QUELL-CV initiation, QUELL-DME start-up, licensing fees, and drug-product manufacturing, plus $1.5 million more personnel costs, partially offset by a $3.3 million decrease in other-program direct costs and a $1.9 million decrease in azelaprag direct costs after that program’s termination in January 2025.

General and administrative expenses were $7.4 million, compared with $7.3 million a year earlier. Net loss was $26.1 million, or $0.58 a share, compared with a net loss of $21.6 million, or $0.60 a share, in the year-earlier quarter.

As of June 30, 2026, BioAge had approximately $381.3 million in cash, cash equivalents, and marketable securities. Based on its current operating plan, the company said existing cash will be sufficient to fund operations and capital expenses through 2029.

BioAge continues to advance oral and injectable APJ agonist development, including a novel APJ agonist antibody under an option agreement with JiKang Therapeutics. The company intends to file its first IND for an APJ program by year-end 2026. Its multi-year research collaboration with Novartis and its strategic collaboration with Lilly ExploR&D continued to advance.

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