BioAge Labs (BIOA) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Pipeline overview and key priorities

• Lead program BGE-102, a potential best-in-class NLRP3 inhibitor, is in two phase II trials: one for cardiovascular outcomes and another for diabetic macular edema (DME), with efficacy data expected in the second half of next year.

• Apelin agonist program is on track for its first IND filing by year-end, with both oral and injectable candidates in development.

• Plans to select and announce another indication for BGE-102 in the coming months, expanding beyond current trials.

• Internal pipeline includes additional NLRP3 molecules and other targets, with further candidates expected to advance toward the clinic over time.

• Strong patent position for BGE-102, covering a novel NLRP3 binding site.

Clinical trial updates and differentiation

• BGE-102 demonstrated best-in-class brain penetration, IL-1β suppression, and CRP reduction in phase I, with up to 98% IL-1β reduction at higher doses.

• QUELL-CV phase II trial is testing three doses in an obese, inflamed population, with results expected by year-end; data will inform dose selection for future indications.

• DME phase II trial was recently redesigned to focus on BCVA efficacy, aiming for a four-letter improvement, and includes monotherapy, VEGF, and combination arms.

• BGE-102 offers once-daily dosing and superior CRP and IL-1β reductions compared to competitors like Ventyx and NodThera.

• Safety profile remains clean up to three months, with theoretical advantages over IL-6 and IL-1 antibodies due to selective inflammasome targeting.

Strategic and scientific context

• ZEUS trial results paused plans for a phase III ASCVD trial, but ongoing ARTEMIS trial in post-MI patients may provide further insights into NLRP3's role.

• NLRP3 is considered a more promising upstream target than IL-6 for cardiovascular and inflammatory diseases, with potential to impact multiple cytokines.

• Retinal indications are prioritized due to strong preclinical and early clinical evidence, with BGE-102 showing robust ocular penetration and efficacy in animal models.

• Strategic partnerships with Novartis and Lilly leverage proprietary longitudinal human data to identify novel aging and cardiometabolic targets.

• Cash position of $380 million as of Q2, funding operations and trials well into 2029.