BioAge Labs (BIOA) investor relations material

Program and Pipeline Overview

• 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, and Phase 2 CV risk results expected in H2 2026 and DME Phase 1b/2a results in mid-2027.

• 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, patented 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 2026, and ongoing partnerships with Novartis and Lilly.

• Platform leverages over 150M molecular data points and collaborations with University of Bonn for structural biology insights.

Clinical Trial Data and Development Milestones

• Phase I included dose escalation in healthy and obese volunteers, showing dose-proportional PK, robust pharmacodynamic effects, and ≥90% IL-1β suppression for 24 hours at 60 mg QD.

• BGE-102 achieved 86% CRP reduction and 87-93% normalization 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.

• Planned CV risk POC study will assess % change in hsCRP and normalization rates, with additional metabolic and imaging endpoints; DME Phase 1b/2a trial will evaluate intraocular IL-6 reduction and other ocular biomarkers.

• Data readout for the Phase II-A trial is anticipated in the second half of 2026, with DME POC data in mid-2027.

R&D Strategy and Innovation Priorities

• Focus on targeting inflammation-driven diseases of aging using a validated human data platform.

• BGE-102 is designed as a "pipeline in a pill" with potential efficacy comparable to injectable anti-inflammatories.

• Unique, patented binding site on NLRP3 enables inhibition of both resting and active forms, differentiating from other inhibitors.

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

• FDA has recognized the ellipsoid zone (EZ) as an approvable endpoint for retinal trials, supporting future regulatory strategies.