CARMEL, Ind. and BURLINGTON, Mass. — May 7, 2026 — Leads & Copy —
MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company, announced first quarter 2026 financial results and corporate progress today. The company is focused on discovering, developing, and commercializing precision peptide therapies for endocrine and metabolic disorders.
The company anticipates its cash and investments of $440.0 million will support operations into 2029.
MBX Biosciences plans to host an Obesity Day on May 11, 2026, to highlight initial blinded data from the MBX 4291 Phase 1 trial and provide an update on its expanding obesity portfolio.
According to Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences, the company continues to advance its pipeline, including progress toward initiating a Phase 3 trial of once-weekly canvuparatide, following a successful End-of-Phase 2 meeting with the FDA.
Hawryluk added that the company looks forward to presenting Phase 2 Avail™ results, including one-year open-label extension data for canvuparatide, while continuing to advance its obesity pipeline enabled by its Precision Endocrine Peptide (PEP™) platform.
Mark Soued has been appointed Chief Commercial Officer, bringing launch and commercialization expertise to the company.
The Phase 3 trial of once-weekly canvuparatide remains on track to start in Q3 2026, following a successful meeting with the FDA.
MBX plans to nominate additional obesity development candidates, including an amycretin prodrug this quarter and a GLP-1/GIP/glucagon receptor (GCGR) triple-agonist prodrug in Q3 2026. These candidates are designed for potential once-monthly dosing with improved tolerability.
Results from the 12-week AvailTM trial of once-weekly canvuparatide have been accepted for oral presentation at the Endocrine Society’s ENDO 2026 annual meeting in Chicago on June 13, 2026. MBX will also present one-year open-label extension (OLE) data for once-weekly canvuparatide at the 3rd Parathyroid Summit during the ENDO 2026 annual meeting in Chicago on June 12, 2026.
MBX expects to report data from the 12-week multiple ascending dose (MAD) portion of the ongoing Phase 1 trial of MBX 4291 in Q4 2026.
First Quarter 2026 Financial Results:
As of March 31, 2026, MBX had cash, cash equivalents and marketable securities of $440.0 million. The company expects this balance to fund operations into 2029.
Research and development expenses for the three months ended March 31, 2026, were $18.5 million, compared to $22.4 million for the same period in 2025. The decrease of $3.9 million was driven by higher costs for the canvuparatide Phase 2 clinical trial and timing of preclinical studies and manufacturing activities for MBX 4291 in the first quarter of 2025.
General and administrative expenses for the three months ended March 31, 2026, were $8.8 million, compared to $4.1 million for the same period in 2025. The increase of $4.7 million was driven by increased personnel-related costs and separation-related costs.
Net loss for the three months ended March 31, 2026, was $23.5 million compared to a net loss of $23.9 million for the same period in 2025.
MBX’s pipeline includes canvuparatide (MBX 2109) for chronic hypoparathyroidism, MBX 4291 in Phase 1 development for obesity, multiple discovery and pre-clinical obesity candidates, and imapextide (MBX 1416) for post-bariatric hypoglycemia (PBH) in Phase 2 development.
The company is based in Carmel, Indiana and Burlington, Massachusetts.
MBX Biosciences’ proprietary Precision Endocrine Peptide™ (PEP™) platform is designed to overcome the limitations of unmodified and modified peptide therapies.
Anticipated Milestones:
Canvuparatide
Q2 2026: Oral presentation of Phase 2 AvailTM results and one-year OLE data during ENDO 2026
Q3 2026: Initiation of Phase 3 trial in chronic hypoparathyroidism
MBX 4291 and Expanding Obesity Pipeline
Q2 2026: Nomination of amycretin prodrug candidate
Q3 2026: Nomination of GLP-1/GIP/GCGR triple-agonist prodrug candidate
Q4 2026: Results from 12-week MAD portion of ongoing Phase 1 trial of MBX 4291
Imapextide
Q2 2026: Results from Phase 2a STEADI™ trial of imapextide for the treatment of post-bariatric hypoglycemia (PBH)
Source: MBX Biosciences
