BioAge Labs (BIOA) investor relations material

BGE-102 profile

• Phase I showed 98% trough IL-1β suppression at 120 mg and 86% hsCRP reduction in obese, inflamed participants, with once-daily dosing and placebo-like tolerability.

• Target inhibition lasted 24 hours; CSF exposure reached IC90 coverage at 60 mg and ~3× IC90 at 120 mg, supporting potential activity in protected tissues.

• A distinct NLRP3 binding site may enable inhibition in both active and inactive forms; related IP claims extend through 2045.

QUELL-CV and cardiovascular strategy

• QUELL-CV is testing 30, 60 and 90 mg once daily versus placebo; primary endpoint is hsCRP, with inflammatory and metabolic biomarkers plus liver MRI, and data expected by year-end.

• The dose-ranging study is designed to assess links between exposure, IL-1β suppression and downstream markers, including liver fat and inflammation, to inform cardiometabolic indications.

• ASCVD is paused and no longer a priority; a decisive ARTEMIS result, by statistical significance or effect magnitude, would be needed to reconsider.

Ophthalmology strategy

• QUELL-DME is evaluating BGE-102 monotherapy and BGE-102 plus anti-VEGF in center-involved DME; visual acuity is the primary endpoint, with the trial powered for a four-letter improvement in each comparison.

• Enrollment is underway, including patients with compromised vision; top-line data remain expected by the end of next year.

• DME strategy targets both watch-and-wait patients and patients with incomplete control on VEGF therapy; oral treatment could reduce injection burden and address retinal inflammation.

• Exploratory systemic measures will include glucose control, kidney function and other cardiometabolic comorbidities.

• Geographic atrophy is another priority: oral BGE-102 analogs prevented retinal pigment epithelium deterioration in models and blocked further lipofuscin accumulation in an aged-mouse model.

• DME is positioned as a beachhead for broader ophthalmology development, including geographic atrophy, MEsi and UME, contingent on demonstrating ocular pharmacodynamics and target engagement.