MBX Biosciences Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Corporate Highlights

Phase 3 trial of once-weekly canvuparatide remains on track to initiate in Q3 2026 following recently completed, successful End-of-Phase 2 meeting with FDA

12-week MAD Phase 1 data from MBX 4291 for obesity anticipated in Q4 2026

Planned nomination of amycretin and GLP-1/GIP/glucagon receptor triple-agonist development candidates for obesity expected in Q2 and Q3 2026

$459.1 million in pro forma cash and investments as of December 31, 2025, including $85.4 million in net proceeds from top-tier institutional investors through ATM program; expected to support operations into 2029

CARMEL, Ind., March 12, 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 fourth quarter and full year ended December 31, 2025, and highlighted recent corporate progress.

“2025 was a year of continued growth and execution for MBX, highlighted by the clinical validation of our Precision Endocrine Peptide (PEP™) platform,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Following a successful End-of-Phase 2 meeting with the FDA, we now have a clear path to initiate our Phase 3 trial of once-weekly canvuparatide. We are also advancing a growing obesity pipeline, built on our clinically validated PEPTM platform and designed for once-monthly dosing and improved tolerability. We look forward to a data-rich year ahead and to continuing our pursuit of bringing differentiated and best-in-class medicines to patients.”

Fourth Quarter 2025 and Recent Corporate Highlights

Once-Weekly Canvuparatide for Hypoparathyroidism (HP)

• End-of-Phase 2 FDA meeting for once-weekly canvuparatide completed: FDA feedback supported advancement into a Phase 3 trial and trial design elements have now been selected, including the number of patients, primary endpoint and key secondary endpoints, as well as dose selection, titration schedule and duration of the study. Initiation of the Phase 3 program remains on track for Q3 2026.
• EU Orphan Drug Designation granted for canvuparatide: The European Medicines Agency granted orphan drug designation to canvuparatide for the treatment of chronic hypoparathyroidism, supporting its continued clinical development in Europe.
• MBX expects to present the complete 12-week dataset and one-year follow-up data from the Phase 2 AvailTM trial for once-weekly canvuparatide at a medical conference in Q2 2026.

MBX4291 and Early Pipeline Programs for Obesity

• MBX 4291 advancing through Phase 1: MBX 4291, a GLP-1/GIP co-agonist prodrug designed for potential once-monthly dosing, continues to advance through Phase 1, with 12-week multiple ascending dose data on track to be reported in Q4 2026.
• Obesity portfolio expansion planned in 2026: MBX expects to nominate two additional obesity development candidates enabled by its PEPTM platform, each designed for potential once-monthly dosing with improved tolerability, including an amycretin prodrug targeted for nomination in Q2 2026 and a GLP-1/GIP/glucagon receptor (GCGR) triple-agonist prodrug candidate targeted for nomination in Q3 2026.

Long-Acting Imapextide (MBX 1416) for Post-Bariatric Hypoglycemia (PBH)

• Phase 2a trial of imapextide (MBX 1416) ongoing: Results from the ongoing Phase 2a STEADITM trial of potential once-weekly imapextide for post-bariatric hypoglycemia are expected in Q2 2026.

Corporate

• Board Appointment: In January 2026, the Company announced the appointment of Laurie Stelzer to its Board of Directors as an independent director and Audit Committee Chair, adding strategic, commercial, and financial leadership to support the Company’s advancement toward late-stage development and long-term growth objectives.
• Leadership Addition: In March 2026, MBX announced the appointment of Karen Basbaum, MBA, as Chief Business Officer. Ms. Basbaum brings more than two decades of leadership in corporate strategy, business development, and strategic transactions across the biotechnology and pharmaceutical industries.
• Strengthened Balance Sheet: In February 2026, the Company raised $85.4 million in net proceeds through its At-the-Market (ATM) facility, with participation from new and existing institutional investors.

Anticipated Milestones

• Canvuparatide Q2 2026: Presentation of full Phase 2 AvailTM results at a medical conference, including data from the open-label extensionQ3 2026: Initiation of Phase 3 trial in chronic hypoparathyroidism
• MBX 4291 and Early Obesity Pipeline Q2 2026: Nomination of amycretin prodrug candidateQ3 2026: Nomination of GLP-1/GIP/GCGR triple-agonist prodrug candidateQ4 2026: Results from 12-week multiple ascending dose portion of Phase 1 trial of MBX 4291
• Imapextide Q2 2026: Phase 2a STEADI™ trial results of imapextide for the treatment of post-bariatric hypoglycemia

Fourth Quarter and Full Year 2025 Financial Results

• Cash and Cash Equivalents and Marketable Securities: As of December 31, 2025, MBX Biosciences had cash, cash equivalents and marketable securities of $373.7 million. Subsequently, on February 4, 2026, the Company raised an additional $85.4 million in net proceeds through its ATM program, resulting in pro forma cash and investments of $459.1 million as of December 31, 2025. 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 and full year ended December 31, 2025, were $19.8 million and $79.2 million, respectively, compared to $15.2 million and $57.4 million for the same periods in 2024. The increases of $4.6 million and $21.8 million respectively were driven by costs associated with the ongoing MBX 4291 Phase 1 clinical trial, the canvuparatide Phase 2 AvailTM clinical trial and preparation activities for a Phase 3 clinical trial in canvuparatide.
• G&A Expenses: General and administrative expenses for the three months and full year ended December 31, 2025, were $6.0 million and $18.9 million, respectively, compared to $3.4 million and $10.8 million for the same periods in 2024. The increases of $2.6 million and $8.1 million, respectively, were driven by increased personnel-related costs as the Company expanded its infrastructure to support its growth in operations and higher professional fees to support operations as a public company.
• Net Loss: Net loss for the three months ended December 31, 2025, was $22.1 million compared to a net loss of $15.6 million for the same period in 2024. Net loss for the full year ended December 31, 2025 was $87.0 million compared to a net loss of $61.9 million for the same period in 2024.

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™ 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 (HP) 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 post-bariatric hypoglycemia (PBH) in Phase 2 development. 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.

Media Contact

George Shea We. Communications [email protected]

Investor Contact

Jim DeNike MBX Biosciences [email protected]

MBX BIOSCIENCES, INC.

SELECTED FINANCIAL INFORMATION

(Unaudited)

Statements of Operations Data:

Three months ended December 31,

Year ended December 31,

(in thousands, except per share and per share data)

2025

2024

2025

2024

Operating expenses:

Research and development

$

19,759

$

15,223

$

79,159

$

57,415

General and administrative

6,036

3,387

18,896

10,779

Total operating expenses

25,795

18,610

98,055

68,194

Loss from operations

(25,795

)

(18,610

)

(98,055

)

(68,194

)

Interest and other income, net

3,733

3,024

11,084

6,272

Net loss

$

(22,062

)

$

(15,586

)

$

(86,971

)

$

(61,922

)

Net loss per common share, basic and diluted

$

(0.49

)

$

(0.47

)

$

(2.38

)

$

(5.82

)

Weighted average number of common shares outstanding used in computation of net loss per common share, basic and diluted

44,866,468

33,392,615

36,506,092

10,642,954

(Unaudited)

Balance Sheets Selected Financial Data:

December 31,

December 31,

(in thousands)

2025

2024

Cash, cash equivalents and marketable securities

$

373,705

$

262,149

Working capital(1)

366,044

256,235

Total assets

385,144

268,535

Total liabilities

15,921

11,093

Accumulated deficit

(224,476

)

(137,505

)

Total stockholders’ equity

369,223

257,442

(1) Working capital is defined as total current assets less total current liabilities. See our financial statements and the related notes thereto included in our Annual Report on Form 10-K for the Years Ending December 31, 2025 and December 31, 2024 for further details regarding our current assets and current liabilities.