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]
MBX Biosciences Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights