MBX Biosciences Announces Q3 2024 Financial Results and Business Update

MBX Biosciences, Inc., headquartered in Carmel, Indiana, is a clinical-stage biopharmaceutical company dedicated to the development of precision peptide therapies aimed at treating endocrine and metabolic disorders. Recently, MBX presented its financial results for the third quarter ending September 30, 2024, and provided significant updates on its clinical and corporate progress.

During the third quarter of 2024, MBX transitioned to a publicly traded entity, marking a pivotal period for the company. Kent Hawryluk, President and CEO of MBX Biosciences, expressed the company's steadfast commitment to achieving upcoming clinical milestones. Notably, the final subject visit for MBX 1416's Phase 1 trial is anticipated by the end of November 2024, with top line results expected in early January 2025. Additionally, the enrollment for the Phase 2 Avail™ trial of MBX 2109 in patients with hypoparathyroidism remains on schedule to be completed in Q1 2025, with topline results anticipated in Q3 2025.

In August 2024, MBX dosed its first patient in the Phase 2 Avail trial of MBX 2109, a potential long-acting parathyroid hormone peptide prodrug. The trial design and rationale were showcased at the 2024 American Society for Bone and Mineral Research Annual Meeting in Toronto.

MBX 1416, a long-acting GLP-1 receptor antagonist for the treatment of post-bariatric hypoglycemia, is progressing with the final subject visit in its Phase 1 trial anticipated by late November 2024. The company plans to report topline results in January 2025.

MBX is also advancing MBX 4291, a GLP-1/GIP co-agonist prodrug for obesity treatment. The investigational new drug (IND) enabling studies are underway, with an IND submission to the U.S. Food and Drug Administration expected in Q2 2025. Beyond this, MBX is developing additional programs focused on obesity and associated comorbidities.

On the corporate front, MBX successfully completed its upsized initial public offering in September 2024, following a Series C financing round in August. The combined gross proceeds from these financings amounted to approximately $251.2 million. These funds will facilitate the advancement of MBX’s clinical milestones and early-stage pipeline programs, including those targeting obesity.

Financially, MBX reported significant growth in its cash reserves, with $277.1 million in cash, cash equivalents, and marketable securities as of September 30, 2024, compared to $80.7 million at the end of 2023. This strong cash position is expected to sustain the company’s operations into mid-2027.

Research and development expenses for Q3 2024 totaled $16.7 million, a notable increase from $9.1 million in the same period of the previous year. This rise was largely attributed to costs associated with ongoing IND-enabling studies for MBX 4291 and the ongoing Phase 2 clinical trial for MBX 2109. Similarly, general and administrative expenses rose to $2.9 million from $1.9 million in Q3 2023, driven by increased personnel-related costs as the company expanded its infrastructure to support growth.

The net loss for the three months ended September 30, 2024, was $18.1 million, compared to $10.2 million in the same period of 2023, reflecting the increased investment in the company’s development programs.

MBX Biosciences remains focused on leveraging its proprietary Precision Endocrine Peptide (PEP™) platform to overcome the limitations of current peptide therapies, aiming to improve clinical outcomes and simplify disease management for patients. The company's pipeline includes MBX 2109 for chronic hypoparathyroidism, MBX 1416 for post-bariatric hypoglycemia, and an obesity portfolio featuring MBX 4291 and other candidates in discovery and pre-clinical stages.