Core Insights - MBX Biosciences reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide for hypoparathyroidism, indicating potential best-in-class status in a multibillion-dollar market [2][3] - The company completed an upsized public offering, raising approximately $200 million in gross proceeds, which is expected to support operations into 2029 [1][5] - Updated corporate milestones for 2026 include clinical data for three Precision Endocrine Peptide™ (PEP) programs and the initiation of a Phase 3 trial in hypoparathyroidism [1][2] Clinical Developments - Canvuparatide achieved the primary composite endpoint in the Phase 2 Avail™ trial, with 63% of treated patients achieving responder status at 12 weeks and 79% at six months in the ongoing open-label extension study [3][4] - The company plans to conduct an End of Phase 2 meeting with the U.S. FDA and seek Scientific Advice from the European Medicines Agency in Q1 2026 [3] - The first participant has been dosed in the Phase 1 trial of MBX 4291 for obesity, which is designed to evaluate safety, tolerability, and pharmacokinetics [3][4] Financial Performance - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $391.7 million, an increase from $262.1 million at the end of 2024 [9][16] - Research and development expenses for Q3 2025 were $19.3 million, up from $16.7 million in Q3 2024, driven by ongoing clinical trials [9][16] - The net loss for Q3 2025 was $21.6 million, compared to a net loss of $18.1 million for the same period in 2024 [9][16] Corporate Governance - Steve Hoerter was appointed as executive chairperson to support the executive team with commercialization experience as the company prepares for the Phase 3 trial [2] - Jim Cornelius retired from the board after over five years of service [2]

Core Insights - MBX Biosciences has appointed Dr. Andreas Moraitis as Senior Vice President of Clinical Development, bringing extensive experience in endocrinology to lead the clinical development of its lead product candidate, canvuparatide [1][2] Company Overview - MBX Biosciences is a clinical-stage biopharmaceutical company focused on developing novel precision peptide therapies for endocrine and metabolic disorders, utilizing its proprietary PEP™ platform [3] - The company is advancing a pipeline that includes canvuparatide (MBX 2109) in Phase 2 for chronic hypoparathyroidism, imapextide (MBX 1416) in Phase 1 for post-bariatric hypoglycemia, and an obesity portfolio with multiple candidates in development [3] Leadership and Expertise - Dr. Moraitis has over a decade of experience in leading clinical development programs at Corcept Therapeutics, where he oversaw programs for rare endocrine diseases and supported NDA filings [2] - His background includes serving as Clinical Assistant Professor in the Endocrine Oncology Program at the University of Michigan and completing a fellowship in Adult and Reproductive Endocrinology at the National Institutes of Health [2] Product Potential - Canvuparatide is positioned as a meaningful new treatment option for patients with hypoparathyroidism, addressing significant unmet medical needs in this area [2] - The company aims to deliver differentiated endocrine and metabolic compounds to underserved patients, leveraging Dr. Moraitis's expertise to advance its pipeline [2][3]