BioAge Labs (BIOA) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Platform and pipeline

• Human aging platform uses thousands of longitudinal samples spanning 50 years to link proteins and metabolites with later health, lifespan, physical function, and cognitive outcomes.

• Platform-derived programs target NLRP3 and APJ; lead BGE-102 is a brain-penetrant NLRP3 inhibitor in two Phase II trials, with readouts expected later this year and in H2 next year.

• APJ program is on track for an IND filing by year-end; clinical timing is to be provided with that milestone.

• Lilly collaboration covers novel targets and molecule building, with programs intended for future internal development; Novartis collaboration studies aging and exercise biology, with upfront payments, milestones, and FTE funding.

BGE-102 and NLRP3 data

• Human data linked elevated NLRP3 with shorter lifespan and accelerated cognitive decline; BGE-102 was designed for brain penetration and binds a novel site available in both active and inactive NLRP3 states.

• Phase I data showed up to 98% IL-1β reduction and 86% CRP reduction, described as best-in-class; tolerability was similar to placebo to date.

• Human CSF Kp,uu was 0.7, described as the strongest brain penetration shown to date; retinal penetration is also cited as a potential differentiator.

• ZEUS failed to show a cardiovascular outcome effect for downstream IL-6 inhibition, with a hazard ratio near 1; upstream NLRP3 may suppress IL-1β and multiple inflammatory pathways.

Phase II studies and indication strategy

• QUELL-CV tests 30 mg, 60 mg, and 90 mg once daily for three months in obese participants with high inflammation, using metabolic and inflammatory biomarkers, liver MRI, and DEXA; results are expected soon.

• QUELL-CV dose selection remains open: 90 mg is expected to maximize IL-1β inhibition, while the study will assess whether 60 mg provides similar effects.

• Diabetic macular edema Phase II enrolls 180 patients across BGE-102 monotherapy, VEGF, and combination groups; the trial is powered to detect a four-letter improvement and is expected to read out in H2 next year.

• Positive DME data could support progression to a pivotal study; an oral therapy may serve patients who are not treated with eye injections and could also offer systemic benefits.

• A MACE trial is on pause; positive ARTEMIS data could prompt reconsideration, while the next NLRP3 study is planned for a peripheral indication with an approvable endpoint.