MBX Biosciences (MBX) investor relations material

Key program updates

• Positive phase II results for once-weekly Canvuparatide in hypoparathyroidism showed a 79% responder rate at six months, surpassing the 69% rate of the once-daily injectable comparator.

• All patients completed the Canvuparatide trial, with 94% enrolling in a two-year extension, and no treatment-related serious adverse events or discontinuations were observed.

• Phase III registration study for Canvuparatide is planned, with dose selection focused on balancing efficacy and minimizing hypercalcemia during titration.

• MBX 1416, a GLP-1 antagonist for post-bariatric hypoglycemia, demonstrated a long half-life and promising pharmacodynamic signals in phase I, with phase II-A data expected next year.

• MBX 4291, an ultra-long-acting GLP-1/GIP co-agonist, is in phase I for obesity, aiming for once-monthly dosing and improved tolerability, with preclinical data showing strong weight loss and safety.

Platform and pipeline strategy

• Precision Endocrine Peptide (PEP) platform enables best-in-class, long-acting peptide therapeutics with blockbuster potential.

• Obesity portfolio includes MBX 4291 and additional candidates in lead optimization, leveraging continuous infusion-like drug exposure for improved tolerability.

• The company is considering strategic partnerships for large-scale obesity programs due to the need for extensive registration studies and sales forces.

• The pipeline is constructed to address validated and emerging targets in obesity, with a focus on best-in-class profiles and precision medicine.

• Strong cash position of $412 million as of June 30, 2025, expected to fund operations into 2029 and support key milestones across the pipeline.

Clinical differentiation and future outlook

• Canvuparatide aims to differentiate through reduced urinary calcium excretion, a potential label advantage if confirmed in phase III.

• MBX 4291’s once-monthly dosing and flat pharmacokinetic profile are designed to improve adherence, tolerability, and weight loss durability.

• MBX 1416 targets an unmet need in post-bariatric hypoglycemia, with a mechanism and dosing profile tailored for full day and night coverage.

• No weight gain or significant glucose increases observed with MBX 1416 in preclinical or phase I studies.

• End of phase II meeting for Canvuparatide is planned for Q4, with updates on global phase III study design and timelines to follow.