BioAge Labs (BIOA) investor relations material

Lead program and clinical progress

• Lead asset BGE-102 is a differentiated NLRP3 inhibitor showing strong biomarker reductions and excellent safety in phase I, with tissue distribution enabling access to protected compartments like CSF and retina.

• Two phase II trials are ongoing: QUELL-CV in obese, inflamed individuals (top-line data expected end of year) and QUELL-DME in diabetic macular edema, now powered for visual acuity improvement with data expected by end of next year.

• Phase I data showed rapid reductions in hsCRP, IL-6, and fibrinogen, with high target inhibition and favorable tolerability.

• The ASCVD phase III trial is on pause pending further data from external studies; focus is shifting to additional indications de-risked by cytokine experience, with at least one new indication to be announced by year-end.

• Ophthalmology strategy leverages BGE-102’s tissue distribution, aiming for proof of concept in DME and broader expansion in eye diseases.

Platform, collaborations, and pipeline

• Platform leverages longitudinal biobank data and omics to identify aging-related disease targets, informing therapeutic hypotheses.

• Collaborations include Novartis (target discovery at the intersection of healthy aging and exercise) and Eli Lilly (molecule discovery against novel targets from the platform).

• APJ agonist program targets longevity and muscle preservation, with both oral and parenteral candidates in development, aiming to improve weight loss and body composition in the GLP-1 market.

• Collaboration with JiKang Therapeutics in China supports APJ agonist nanobody development.

• Broad IP estate covers novel chemistry and binding sites for BGE-102, supporting competitive positioning.

Strategic and industry insights

• Negative results from ZEUS (IL-6 inhibitor in ASCVD) reinforce the rationale for targeting upstream NLRP3 biology; further clarity expected from upcoming ARTEMIS trial data.

• DME trial design aims to address unmet needs for oral therapies, potentially delaying or supplementing intravitreal injections and improving patient compliance.

• AI is integrated across all company functions, with a focus on change management and promoting adoption of new tools.

• Commercialization strategies for ophthalmology indications remain flexible, with both independent and partnership options considered.

• Policy variables such as FDA, Medicare negotiation, and global pricing are monitored, with impact varying over time.