MBX Biosciences (MBX) investor relations material

Key program updates and clinical milestones

• Strong Phase II AVAIL top-line data for once-weekly canvuparatide in hypoparathyroidism, with 79% treatment response at six months and 63% at 12 weeks, surpassing competitor benchmarks.

• End-of-phase I meetings with FDA and EMA are scheduled for Q1, with global Phase III registration study planned to start in Q3, using a new single-use, patient-friendly injector device.

• Phase III study will use a starting dose between 400–600 micrograms weekly, with a 1 mL injection volume, and will last at least 24 weeks with a primary endpoint similar to Phase II.

• 94% of AVAIL completers opted into a two-year open-label extension; one-year data expected as a key catalyst in Q2 2026, focusing on efficacy, safety, urine calcium, bone biomarkers, and BMD.

• Regulatory paths for FDA and EMA are aligned, with no expected differences in endpoints or requirements.

Market research and product differentiation

• Market research with 27 physicians indicates strong preference for once-weekly dosing due to convenience and comparable efficacy, with high likelihood of switching from once-daily therapies.

• Patient feedback at advocacy meetings shows high enthusiasm for weekly dosing and strong interest in trial participation.

Pipeline and future catalysts

• MBX-4291, a GLP-1/GIP agonist for obesity, leverages PEP technology for once-monthly dosing, aiming for improved GI tolerability and sustained weight loss; 12-week MAD data in 30 patients expected in Q4 2026.

• Phase I study in obese subjects includes SAD, MAD, and 12-week cohorts, focusing on PK, tolerability, and weight loss, with a goal of demonstrating monthly dosing and steady-state tolerability.

• MBX-1416 for post-bariatric hypoglycemia has Phase IIa data expected in Q2 2026; study will assess glucose nadir, insulin, and C-peptide changes to establish proof of concept.