BioAge Labs, Inc. 8-K

What Happened

• On January 20, 2026, BioAge Labs, Inc. (BIOA) announced via an 8-K (Regulation FD disclosure) that it is expanding the indications for its oral NLRP3 inhibitor BGE-102 to include diabetic macular edema (DME). The company plans to initiate a Phase 1b/2a proof‑of‑concept (POC) clinical trial in DME patients in mid‑2026. The announcement was made by press release (Exhibit 99.1).

Key Details

• Date of filing/announcement: January 20, 2026 (8-K Items 7.01 and 8.01).
• Planned trial start: Phase 1b/2a POC in DME — targeted initiation mid‑2026.
• Preclinical results cited: oral BGE-102 showed dose‑dependent preservation of retinal vascular integrity in a DME model, with near‑complete protection from vascular leakage and up to 90% preservation of microvascular integrity.
• Clinical status and milestones:
  • Ongoing Phase 1 trial with favorable tolerability and reductions in inflammatory biomarkers (hsCRP, IL‑6, IL‑1β).
  • 1H 2026: completion of Phase 1 trial and initiation of a Phase 2a POC in patients with obesity and cardiovascular risk factors.
  • 2H 2026: anticipated CV risk Phase 2a POC data readout.
  • Mid‑2027: anticipated DME Phase 1b/2a POC data readout.

Why It Matters

• The filing signals BIOA is broadening BGE-102’s development from cardiovascular/inflammatory indications into retinal disease (DME), an inflammation‑driven eye condition. A successful POC in DME would support further development across retinal diseases where the inflammasome is implicated.
• Upcoming clinical milestones (Phase 1 completion, Phase 2a starts and data readouts through 2027) create a near‑term timeline of potential catalysts for investors. All timelines and expectations are forward‑looking and subject to clinical, regulatory, and operational risks disclosed by the company.