Results from Phase 2 trial of once-weekly canvuparatide accepted for oral presentation at ENDO in June 2026

Phase 3 trial of once-weekly canvuparatide on track to initiate in Q3 2026

Appointment of Mark Soued as Chief Commercial Officer adds launch and commercialization expertise

Company to host Obesity Day on May 11(th) featuring initial blinded data from ongoing MBX 4291 Phase 1 trial and update on expanding obesity portfolio

$440.0 million in cash and investments expected to support operations into 2029

CARMEL, Ind. and BURLINGTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress.

"We continue to make excellent progress across our pipeline in 2026, including advancement toward initiation of our Phase 3 trial of once-weekly canvuparatide following a successful End-of-Phase 2 meeting with the FDA," said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. "Now we look forward to presenting our full Phase 2 Avail$(TM)$ results, including one-year open-label extension data for canvuparatide, while continuing to advance a growing obesity pipeline enabled by our Precision Endocrine Peptide (PEP(TM)) platform. With a world-class leadership team and a strong balance sheet, we are well positioned to execute on our goal of delivering improved, long-acting and well-tolerated peptide therapies for patients."

First Quarter 2026 and Corporate Highlights

Once-Weekly Canvuparatide for Hypoparathyroidism

   -- Presentation of Phase 2 results and one-year follow-up data in June: 
      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 Saturday, June 13, 2026. In addition, MBX 
      will 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 Friday, June 12, 2026. 
 
   -- Phase 3 trial of once-weekly canvuparatide on track to initiate in Q3 
      2026: Following a successful End-of-Phase 2 meeting with the U.S. Food 
      and Drug Administration (FDA), MBX remains on track to initiate a Phase 3 
      confirmatory trial of once-weekly canvuparatide in chronic 
      hypoparathyroidism in Q3 2026. 

MBX 4291 and Expanding Obesity Pipeline

   -- Obesity Day to highlight MBX 4291 and expanding obesity pipeline: MBX 
      announced plans to host an Obesity Day on May 11, 2026, featuring initial 
      blinded data from the ongoing Phase 1 trial of MBX 4291 and an update on 
      its expanding obesity pipeline. For more details and to register for the 
      event, click here. The Company remains on track to report data from the 
      12-week multiple ascending dose (MAD) portion of the ongoing Phase 1 
      trial of MBX 4291 in Q4 2026. 
 
   -- Growing obesity pipeline designed to address full spectrum of patient 
      needs: MBX plans to nominate additional obesity development candidates 
      enabled by its PEPTM platform, each designed for potential once-monthly 
      dosing with improved tolerability. These candidate nominations include an 
      amycretin prodrug, on track for this quarter, and a GLP-1/GIP/glucagon 
      receptor (GCGR) triple-agonist prodrug, expected in Q3 2026. 

Corporate

   -- Expansion of leadership team adds launch and commercialization expertise: 
      Earlier today, MBX announced the appointment of Mark Soued as Chief 
      Commercial Officer. Mr. Soued is a seasoned commercial biopharma 
      executive with deep experience building and growing global commercial 
      organizations. Most recently he led Alnylam Pharmaceuticals' US 
      amyloidosis business, including the category-defining launch of 
      AMVUTTRA$(R)$ in ATTR cardiomyopathy. 

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(TM) trial of imapextide for the 
      treatment of post-bariatric hypoglycemia $(PBH)$ 

First Quarter 2026 Financial Results

   -- Cash and Cash Equivalents and Marketable Securities: As of March 31, 
      2026, MBX had cash, cash equivalents and marketable securities of $440.0 
      million. Based on its current operating plan, the Company expects the 
      combined cash, cash equivalents and marketable securities balance to fund 
      operations into 2029. 
 
   -- R&D Expenses: 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. 
 
   -- G&A Expenses: 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 resulting from the continued expansion of the 
      Company's infrastructure to support growth in operations and 
      separation-related costs. 
 
   -- Net Loss: 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. 

About MBX Biosciences

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP(TM) 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 canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism preparing for Phase 3 development; an obesity portfolio that includes MBX 4291 in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates; and imapextide (MBX 1416) for the treatment of PBH in Phase 2 development. The Company is based in Carmel, Indiana and Burlington, Massachusetts. 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(TM)) 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(TM) (PEP(TM)) 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 further advancement of its pipeline of programs in endocrine and metabolic disorders, including timing of initiation of a Phase 3 trial for canvuparatide in Q3 2026 and clinical data presentation at ENDO 2026 in Q2 2026; the potential for canvuparatide to be a once-weekly PTH replacement therapy; the expected timing of the Phase 1 readout for MBX 4291 and planned obesity day presentation; the timing of additional obesity candidate nominations in Q2 and Q3 2026; the potential for MBX Biosciences to develop therapies for obesity dosed once monthly; the expected timing for the Phase 2a STEADI(TM) trial results; the ability of MBX 1416 to be a treatment of PBH; the potential contributions of the new Chief Commercial Officer; and expectations regarding MBX Biosciences' uses of capital, expenses and financial results, including the anticipated cash runway timing.

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