MBX Biosciences, Inc.(MBX) - 2025 Q1 - Quarterly Results

Report Highlights MBX Biosciences reported significant progress in its clinical programs during the first quarter of 2025, with key milestones anticipated later in the year, including topline data for canvuparatide and an imminent IND submission for MBX 4291, while maintaining a strong financial position with a cash runway into mid-2027 - Topline results for the Phase 2 Avail™ trial of canvuparatide in patients with hypoparathyroidism are expected in the third quarter of 2025[1][2][3] - An Investigational New Drug (IND) application for MBX 4291, a novel treatment for obesity, is on track for submission in the second quarter of 2025[1][2][4] - The company holds $240.8 million in cash, cash equivalents, and marketable securities as of March 31, 2025, which is expected to fund operations into mid-2027[1][9] Clinical Program and Corporate Highlights The company provided specific updates on its three main clinical programs, including completed enrollment for canvuparatide, imminent IND submission for MBX 4291, and planned Phase 2 trial for MBX 1416, alongside a new board appointment Hypoparathyroidism (HP): Canvuparatide (MBX 2109) - Enrollment for the Phase 2 Avail trial of canvuparatide was completed with 64 participants, exceeding the original target, with topline results expected in Q3 2025[3] Obesity: MBX 4291 - The company is on track to submit an IND application for MBX 4291, a once-monthly GLP-1/GIP co-agonist prodrug for obesity, in Q2 2025[4] Post-bariatric Hypoglycemia (PBH): MBX 1416 - Following an End of Phase 1 meeting with the FDA, a Phase 2 trial for MBX 1416 is expected to be initiated in the second half of 2025[5] Corporate - In April, Steve Hoerter, a veteran executive with extensive pharmaceutical leadership, was appointed as an independent director to the company's board[6] First Quarter 2025 Financial Results For the first quarter of 2025, MBX Biosciences reported a net loss of $23.9 million, an increase from the $12.3 million loss in the same period of 2024, primarily due to a significant rise in R&D expenses related to the advancement of its clinical trials, while maintaining a strong financial position with $240.8 million in cash and marketable securities Financial Metric | Financial Metric | Q1 2025 | Q1 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | R&D Expenses | $22.4 million | $11.0 million | +$11.4 million | | G&A Expenses | $4.1 million | $2.3 million | +$1.8 million | | Net Loss | $23.9 million | $12.3 million | +$11.6 million | Financial Position | Financial Position | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $240.8 million | $262.1 million | | Total Assets | $245.9 million | $268.5 million | | Total Stockholders' Equity | $235.4 million | $257.4 million | Statements of Operations Data Statements of Operations Data (in thousands, except per share data) | (in thousands, except per share data) | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $22,405 | $11,049 | | General and administrative | $4,124 | $2,265 | | Total operating expenses | $26,529 | $13,314 | | Loss from operations | $(26,529) | $(13,314) | | Interest and other income, net | $2,649 | $977 | | Net loss | $(23,880) | $(12,337) | | Net loss per common share, basic and diluted | $(0.71) | $(10.26) | Balance Sheet Data Balance Sheet Data (in thousands) | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $240,786 | $262,149 | | Working capital | $233,795 | $256,235 | | Total assets | $245,926 | $268,535 | | Total liabilities | $10,504 | $11,093 | | Total stockholders' equity | $235,422 | $257,442 | Company and Technology Overview MBX Biosciences is a clinical-stage biopharmaceutical company developing novel peptide therapies for endocrine and metabolic disorders, leveraging its proprietary Precision Endocrine Peptide (PEP™) platform to engineer drugs with optimized properties for conditions like hypoparathyroidism, post-bariatric hypoglycemia, and obesity - The company's pipeline includes canvuparatide (Phase 2 for HP), MBX 1416 (Phase 1 for PBH), and an obesity portfolio led by MBX 4291[8] - The proprietary PEP™ platform is designed to create therapies with improved pharmaceutical properties, including extended time-action profiles and consistent drug concentrations, allowing for less frequent dosing[10] Forward-Looking Statements This section provides a standard safe harbor statement, cautioning that the press release contains forward-looking statements regarding clinical trial timelines, regulatory submissions, and financial projections, which are subject to various risks and uncertainties detailed in the company's SEC filings - The report contains forward-looking statements regarding the timing of clinical trial results, IND submissions, product development, and financial runway[11] - Investors are advised that actual results could differ materially from expectations due to risks and uncertainties detailed in the company's SEC filings, such as the Form 10-Q and Form 10-K[12]