MBX Biosciences, Inc.(MBX) - 2025 Q2 - Quarterly Results

MBX Biosciences Second Quarter 2025 Report Overview MBX Biosciences reports Q2 2025 financial results, detailing clinical pipeline progress and corporate updates Recent Corporate Highlights The company provided updates on its clinical pipeline, including Phase 2 data for canvuparatide, Phase 2a screening for imapextide, and Phase 1 initiation for MBX 4291, alongside a key leadership appointment Hypoparathyroidism (HP): Canvuparatide (MBX 2109) Updates on the clinical development of canvuparatide for hypoparathyroidism, including expected Phase 2 topline data - Phase 2 topline data from Avail trial for canvuparatide, a potential long-acting, once-weekly PTH peptide prodrug, expected in Q3 2025[3] Post-bariatric Hypoglycemia (PBH): Imapextide (MBX 1416) Progress on imapextide for post-bariatric hypoglycemia, with patient screening underway for its Phase 2a clinical trial - Patient screening is underway for the Phase 2a clinical trial evaluating imapextide, a long-acting GLP-1 receptor antagonist for PBH[4] - Phase 2a trial expected to begin in Q3 2025 after completing an end-of-Phase 1 meeting[4][5] Obesity: MBX 4291 Updates on MBX 4291 for obesity, including IND clearance and anticipated Phase 1 trial initiation - MBX 4291, a GLP-1/GIP co-agonist prodrug for once-monthly obesity treatment, received Investigational New Drug (IND) clearance in July[6] - Phase 1 trial initiation for MBX 4291 anticipated in Q3 2025[6] Corporate Developments Key corporate developments, including a strategic appointment to the leadership team - Andreas Moraitis, M.D., appointed as Senior Vice President of Clinical Development in June, overseeing canvuparatide advancement[7] Company Overview and PEP™ Platform MBX Biosciences is a clinical-stage biopharmaceutical company leveraging its proprietary PEP™ platform for novel precision peptide therapies in endocrine and metabolic disorders - MBX Biosciences focuses on discovery and development of novel precision peptide therapies using its proprietary PEP™ platform for endocrine and metabolic disorders[9][11] - The company's pipeline includes canvuparatide (HP, Phase 2), imapextide (PBH, Phase 2), and MBX 4291 (Obesity, Phase 1), along with discovery and pre-clinical obesity candidates[9] - The proprietary PEP™ platform aims to overcome limitations of traditional peptide therapies by optimizing properties like extended time-action profiles and consistent drug concentrations for less frequent dosing[11] Second Quarter 2025 Financial Performance MBX Biosciences' Q2 2025 financial performance reflects increased net loss driven by higher R&D and G&A expenses, while maintaining a strong cash position Financial Summary MBX Biosciences reported an increased net loss in Q2 2025 due to higher R&D and G&A expenses, while maintaining a strong cash position expected to fund operations into mid-2027 Cash Position and Runway | Metric | Value | | :--- | :--- | | Cash, cash equivalents and marketable securities (as of June 30, 2025) | $224.9 million | | Expected operational runway | Into mid-2027 | Key Operating Expense Changes (Q2 2025 vs Q2 2024) | Expense Category | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $17.7 million | $14.4 million | +$3.3 million | | G&A Expenses | $4.1 million | $2.3 million | +$1.8 million | - Increase in R&D expenses driven by ongoing IND-enabling studies for MBX 4291 and the canvuparatide Phase 2 clinical trial[10] - Increase in G&A expenses due to increased personnel-related costs supporting growth as a public company[10] Net Loss (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Net Loss | $(19.4) million | $(15.9) million | Statements of Operations Data MBX Biosciences reported a net loss of $19.4 million for Q2 2025, an increase from the prior year, driven by higher R&D and G&A expenses Condensed Statements of Operations Data (Q2 2025 vs Q2 2024) | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $17,724 | $14,396 | $40,130 | $25,445 | | General and administrative | $4,081 | $2,262 | $8,204 | $4,527 | | Total operating expenses | $21,805 | $16,658 | $48,334 | $29,972 | | Loss from operations | $(21,805) | $(16,658) | $(48,334) | $(29,972) | | Interest and other income, net | $2,394 | $801 | $5,043 | $1,778 | | Net loss | $(19,411) | $(15,857) | $(43,291) | $(28,194) | | Net loss per common share, basic and diluted | $(0.58) | $(12.62) | $(1.30) | $(22.93) | | Weighted average common shares outstanding | 33,446,385 | 1,256,549 | 33,429,479 | 1,229,473 | Balance Sheet Data As of June 30, 2025, MBX Biosciences reported $224.9 million in cash and equivalents, with total assets at $231.5 million and an increased accumulated deficit Condensed Balance Sheet Data (as of June 30, 2025 vs December 31, 2024) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $224,906 | $262,149 | | Working capital | $217,434 | $256,235 | | Total assets | $231,522 | $268,535 | | Total liabilities | $12,283 | $11,093 | | Accumulated deficit | $(180,796) | $(137,505) | | Total stockholders' equity | $219,239 | $257,442 | Forward-Looking Statements This section outlines forward-looking statements regarding clinical development, potential therapies, and financial expectations, subject to inherent risks and uncertainties - This section contains forward-looking statements regarding clinical trial timings (canvuparatide Phase 2, imapextide Phase 2a, MBX 4291 Phase 1), potential therapies, and financial expectations including cash runway[12] - Statements are subject to risks and uncertainties, including those related to R&D, regulatory approvals, third-party dependence, financial condition, and intellectual property[13] - MBX Biosciences disclaims any obligation to publicly update or revise forward-looking statements, except as required by law[13] Investor and Media Information Information for investors and media, including disclosure practices and contact details for inquiries - MBX Biosciences uses its Investor Relations website as a means of disclosing material nonpublic information and complying with Regulation FD[14][15] - Investors should monitor the Company's Investor Relations website, press releases, SEC filings, public conference calls, presentations, and webcasts[15] - Contact information for media and investor inquiries is provided[16]