MBX Biosciences Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Highlights
Enrollment complete in Phase 2 Avail™ trial of canvuparatide in hypoparathyroidism; topline results on track for Q3 2025
MBX 1416 Phase 2 trial in patients with post-bariatric hypoglycemia expected to begin in 2H 2025
Investigational New Drug submission anticipated in Q2 2025 for MBX 4291 in obesity
$262.1 million in cash, cash equivalents and marketable securities as of December 31, 2024; expected to support operations into mid-2027
CARMEL, Ind., March 17, 2025 (GLOBE NEWSWIRE) - MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today reported financial results for the fourth quarter and full year ended December 31, 2024, and highlighted recent corporate progress.
"MBX is entering 2025 with strong momentum following significant and transformational progress in 2024," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. "We are poised to deliver Phase 2 clinical data on our lead program in hypoparathyroidism, canvuparatide, with topline results from our Avail™ trial anticipated in the third quarter of 2025. Additionally, we are well-positioned to enter the clinic with our first obesity candidate later this year, pending clearance of our investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA). Finally, we look forward to initiating a Phase 2 trial evaluating MBX 1416 in post-bariatric hypoglycemia (PBH) patients in the second half of 2025."
Fourth Quarter 2024 and Recent Corporate Highlights
Hypoparathyroidism (HP): Canvuparatide (MBX 2109)
Post-bariatric Hypoglycemia (PBH): MBX 1416
Obesity: MBX 4291
Corporate
Fourth Quarter and Full Year 2024 Financial Results
About MBX Biosciences
MBX Biosciences is a biopharmaceutical company focused on the discovery and development of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company's pipeline includes its lead product candidate canvuparatide (MBX 2109), in Phase 2 development for the treatment of chronic hypoparathyroidism (HP); MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH); and an obesity portfolio that includes MBX 4291, with an IND filing anticipated in Q2 2025, as well as multiple discovery and pre-clinical candidates in development for the treatment of obesity. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.
About MBX's Proprietary Precision Endocrine Peptide (PEP™) Platform
MBX was founded by global leaders with a transformative approach to peptide drug design and development. Leveraging this expertise, the Company designed its proprietary Precision Endocrine Peptide™ (PEP™) platform to overcome the key limitations of unmodified and modified peptide therapies and to improve clinical outcomes and simplify disease management for patients. PEPs are selectively engineered to have optimized pharmaceutical properties, including extended time-action profiles and consistent drug concentrations with low peak-to-trough concentration ratios, consistent exposure to target tissues, and less frequent dosing.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences' expectations regarding the Phase 2 Avail™ trial of canvuparatide , including enrollment and the timing of topline results; statements related to the potential for canvuparatide to be a once-weekly PTH replacement therapy; the expected timing for the Phase 2 trial for MBX 1416 and statements related to an end-of-phase 1 meeting with the FDA; statements related to the ability of MBX 1416 to be a treatment of PBH; the expected timing of the IND filing for MBX 4291 and initiation of a Phase 1 trial thereafter; statements related to the contribution of leadership; and expectations regarding MBX Biosciences' uses of capital, expenses and financial results, including the anticipated cash runway timing.
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MBX Biosciences Inc. published this content on March 17, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on March 17, 2025 at 12:09:48.580.
