BioAge Labs (BIOA) Status update summary

Program and pipeline overview

• Lead program BGE-102 is an oral, brain-penetrant NLRP3 inhibitor targeting inflammation in cardiovascular and retinal diseases, with Phase I data showing strong efficacy and safety.

• BGE-102 demonstrated up to 86% CRP reduction in obese subjects, with 87%-93% achieving normalized CRP below 2 mg/L, a threshold linked to cardiovascular benefit.

• The molecule shows best-in-class CNS penetration and a novel binding site, enabling inhibition of both inactive and active NLRP3 conformations, with high selectivity.

• The pipeline includes an APJ agonist for obesity, with IND submission planned by year-end, and ongoing partnerships with Novartis and Lilly.

• Key catalysts: cardiovascular risk trial to read out by year-end, DME trial starting mid-year, and strong cash position supports further development.

Phase I clinical results and safety

• Phase I included dose escalation in healthy and obese volunteers, showing dose-proportional PK and robust pharmacodynamic effects.

• BGE-102 achieved >90% IL-1β suppression and 86% CRP reduction at both 60 mg and 120 mg doses, with most subjects reaching CRP <2 mg/L.

• Safety profile was favorable: all adverse events were mild to moderate, self-limited, and not dose-dependent; no serious adverse events or discontinuations.

• The drug demonstrated strong CNS and retinal penetration, supporting its use in both cardiovascular and ophthalmology indications.

• Comparable decreases in IL-6 and fibrinogen were observed, indicating broad anti-inflammatory effects.

Cardiovascular and metabolic development strategy

• BGE-102 targets residual inflammatory risk, a major contributor to cardiovascular events, with a large addressable population in the US.

• Phase II-A study will assess dose response (30, 60, 90 mg) over 12 weeks, with endpoints including CRP change, normalization rates, and metabolic markers.

• Oral administration offers advantages over injectables, enabling primary and secondary prevention and easier integration with statin regimens.

• Data readout for the Phase II-A trial is anticipated in the second half of 2026.