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MBX Biosciences (MBX) investor relations material

MBX Biosciences Stifel Virtual Cardiometabolic Forum summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Stifel Virtual Cardiometabolic Forum summary30 Sep, 2025

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.

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Frequently asked questions

MBX Biosciences Inc. is a U.S.-based biotechnology company focused on developing precision medicines for endocrine disorders. The company’s research and development efforts target rare hormonal conditions, with a focus on creating peptide therapies that improve patient outcomes. Leveraging proprietary technology, MBX Biosciences aims to design therapies that address specific needs in endocrinology, including disorders related to hormone deficiencies or imbalances. The company advances its drug candidates through preclinical and clinical stages, seeking to bring effective treatments to patients with unmet medical needs. The company is headquartered in Carmel, Indiana, and its shares are listed on the NASDAQ.

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