BioAge Labs (BIOA) investor relations material

NLRP3 program and clinical progress

• Lead program BGE-102 showed best-in-class brain penetration and full IL-1 beta suppression in phase I, with two phase II trials now running: one in obese inflamed patients and one in diabetic macular edema (DME).

• Recent setbacks in the IL-6 cardiovascular outcomes trial (ZEUS) have shifted focus, but NLRP3 remains promising due to its distinct mechanism and full IL-1 beta inhibition.

• QUELL-CV phase II study is fully enrolled, with top-line data expected by year-end, focusing on a broad obese, inflamed population and multiple biomarkers for dose selection and future indications.

• NLRP3's safety profile may offer advantages over IL-1 beta inhibitors, as it selectively targets inflammation while preserving infection response.

• The company is prepared to pivot quickly in ASCVD if upcoming ARTEMIS trial data are positive, but is prioritizing indications manageable for a smaller biotech.

Ophthalmology and new indications

• Initiated phase II QUELL-DME trial for DME, leveraging BGE-102's strong eye penetration and oral administration, with both monotherapy and VEGF combination arms.

• The trial targets typical DME patients, including both naïve and VEGF-experienced, with BCVA as the primary endpoint; top-line data expected in the second half of next year.

• Oral therapy could address large patient segments currently untreated due to aversion to injections, especially in early-stage or VEGF-refractory populations.

• Preclinical and early clinical data suggest potential expansion into geographic atrophy (GA) and other ocular diseases, supported by natural aging models and external inflammasome inhibitor data.

• The phase II design enables direct progression to phase III, accelerating the development timeline.

Pipeline, partnerships, and financials

• IND filing for next-generation APJ agonists for obesity is on track for year-end, with both oral and injectable candidates aiming for enhanced weight loss and muscle retention.

• The proprietary longitudinal Healthspan database underpins target discovery, supporting both internal pipeline growth and collaborations with Novartis and Lilly.

• AI and large language models are integral to data analysis and regulatory documentation, enhancing efficiency.

• Cash position of $381 million at Q2-end provides runway through 2029, funding current programs and up to two additional NLRP3 indications.

• Plans to announce at least one new NLRP3 indication by year-end, with a focus on diseases where oral anti-inflammatory therapy is attractive.