BioAge Labs (BIOA) Piper Sandler 36th Annual Healthcare Conference summary

Differentiation and strategy in obesity therapeutics

• Lead asset azelaprag is an oral small molecule that increases energy expenditure, not appetite suppression, and is positioned as a complementary therapy to oral incretins for obesity and metabolic syndrome.

• STRIDES trial aims to show that combining azelaprag with tirzepatide can increase weight loss by 5% over tirzepatide alone, meeting FDA guidance for approval and bridging the gap between oral and injectable therapies.

• Azelaprag is expected to have a favorable tolerability profile, potentially matching higher doses of tirzepatide in weight loss without worsening GI side effects.

• Exploratory endpoints include lean mass preservation and rebound weight gain, with DEXA and wearables used for body composition and activity measures.

• Future strategy includes pursuing an incretin-agnostic label and potential fixed-dose combinations with other oral or injectable agents.

Clinical development and regulatory plans

• STRIDES trial is a six-month study in collaboration with Lilly, using a 5mg dose of tirzepatide to mimic oral kinetics, with top-line data expected in Q3.

• A larger semaglutide combination study will run through 2026, enrolling 300 patients for up to 64 weeks, capturing a full year of weight loss data and including a broader age range.

• Both STRIDES and semaglutide studies focus on pure obesity populations, not including diabetics, to ensure clean efficacy signals.

• Plans for a type 2 diabetes monotherapy study with azelaprag are set for 1H25, targeting specific subpopulations where the drug may have unique benefits.

• Phase III trials may begin before semaglutide study readout, with a safety database target of 3,000 patients as per FDA requirements.

Partnerships, execution, and financials

• Collaboration with Lilly provides drug supply, trial design, and access to high-quality clinical sites, with Lilly holding a right of first negotiation post-STRIDES readout.

• Top-line data from STRIDES will be released publicly, with Lilly granted a period for deeper data access for negotiation.

• Execution is supported by a strong CRO and experienced team, with clinical supply being manufactured at risk to ensure readiness for further studies.

• Cash position of $360 million provides runway through multiple phase II and I studies and into 2029, with plans for a significant raise post-STRIDES to fund phase III.