BioAge Labs (BIOA) investor relations material

Portfolio strategy and pipeline updates

• Lead asset BGE-102, an oral NLRP3 inhibitor, showed 86% CRP reduction in phase I obese cohorts, matching injectable anti-inflammatories for ASCVD.

• Cardiovascular phase II proof-of-concept study for BGE-102 will read out by year-end, with phase III targeted for next year; ophthalmology DME study to start mid-year with results expected mid-next year.

• APJ agonist programs (oral and subcutaneous) are advancing, aiming to improve both weight loss and body composition in obesity, with potential for combination with incretins.

• Collaborations with Novartis (target discovery at the intersection of aging and exercise) and Lilly (molecule discovery) leverage a large human aging dataset for novel target identification.

• Backup NLRP3 compound in development to enable commercial flexibility between ASCVD and ophthalmology indications.

Clinical data and differentiation

• BGE-102 demonstrated normalization of CRP below 2 mg/L in 87–93% of phase I participants, a key threshold for cardiovascular benefit.

• Safety and tolerability profile in phase I was strong, with a low-dose, once-daily oral regimen supporting commercial and patient convenience.

• Novel binding site for BGE-102 allows inhibition of NLRP3 in all conformations, potentially enhancing onset and magnitude of anti-inflammatory effect.

• Phase II will explore multiple doses, with 90 mg QD expected to achieve 98% target suppression at steady state.

• Aggressive timeline maintained for phase III initiation, with ongoing CMC and dose-ranging activities.

Market positioning and strategic outlook

• Residual inflammatory risk remains in 60% of ASCVD patients despite lipid-lowering therapies; hsCRP is a strong, independent predictor of MACE.

• Oral NLRP3 inhibitor could address unmet needs in both cardiovascular and ophthalmology markets, offering convenience and potential for fixed-dose combinations.

• In ophthalmology, BGE-102 targets DME and geographic atrophy, leveraging strong CNS and retinal penetration; oral therapy could benefit both early and refractory DME patients.

• For geographic atrophy, oral BGE-102 may offer disease control and convenience in a population underserved by current injectables.

• APJ agonists aim to complement both oral and injectable obesity therapies, focusing on efficacy and body composition with favorable tolerability.