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

PART I. FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) The unaudited condensed financial statements for the quarter ended March 31, 2025, show a significant increase in net loss to $23.9 million compared to $12.3 million in the prior year's quarter, driven by higher research and development expenses. The company's financial position remains strong with $240.8 million in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations for at least the next 12 months Condensed Balance Sheets Total assets decreased to $245.9 million as of March 31, 2025, from $268.5 million at year-end 2024, mainly due to a reduction in cash and cash equivalents. Total liabilities saw a minor decrease, while total stockholders' equity fell from $257.4 million to $235.4 million, reflecting the net loss for the period Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $29,903 | $49,351 | | Marketable securities | $210,883 | $212,798 | | Total current assets | $244,276 | $267,286 | | Total assets | $245,926 | $268,535 | | Liabilities & Equity | | | | Total current liabilities | $10,481 | $11,051 | | Total liabilities | $10,504 | $11,093 | | Total stockholders' equity | $235,422 | $257,442 | | Total liabilities and stockholders' equity | $245,926 | $268,535 | Condensed Statements of Operations and Comprehensive Loss For the three months ended March 31, 2025, the company reported a net loss of $23.9 million, nearly double the $12.3 million loss from the same period in 2024. The increased loss was primarily driven by a significant rise in operating expenses, with R&D costs increasing to $22.4 million and G&A costs to $4.1 million. Net loss per share was $(0.71) Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 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) | Condensed Statements of Stockholders' Equity (Deficit) and Convertible Preferred Stock Total stockholders' equity decreased by $22.0 million during the first quarter of 2025, from $257.4 million to $235.4 million. The reduction was primarily due to the net loss of $23.9 million, partially offset by $1.8 million in stock-based compensation expense - The primary driver for the decrease in stockholders' equity was the net loss of $23.9 million for the quarter[21] - All outstanding convertible preferred stock was converted into common stock in September 2024, prior to the company's IPO. As of March 31, 2025, there were no shares of convertible preferred stock outstanding[52] Condensed Statements of Cash Flows Net cash used in operating activities was $22.7 million for Q1 2025, a significant increase from $10.7 million in Q1 2024, reflecting higher operating losses. Net cash provided by investing activities was $3.2 million. The company's cash and cash equivalents decreased by $19.4 million during the quarter, ending at $29.9 million Cash Flow Summary (in thousands) | Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(22,678) | $(10,710) | | Net cash provided by investing activities | $3,226 | $15,429 | | Net cash provided by financing activities | $4 | $183 | | Net (decrease) increase in cash | $(19,448) | $4,902 | Notes to Unaudited Condensed Financial Statements The notes detail the company's business as a clinical-stage biopharmaceutical firm and confirm its liquidity position, stating that existing cash of $240.8 million is sufficient to fund operations for at least 12 months. Key disclosures include details on marketable securities, lease commitments, an amended license agreement with IURTC potentially requiring $9.3 million in future milestone payments, and stock-based compensation plans - The company is a clinical-stage biopharmaceutical company focused on novel precision peptide therapies for endocrine and metabolic disorders[27] - As of March 31, 2025, the company had $240.8 million in cash, cash equivalents, and marketable securities and believes this is sufficient to fund obligations for at least 12 months[29] - An amendment to the license agreement with IURTC in January 2024 could result in up to $9.3 million in future clinical and regulatory milestone payments[48][87] - Total unrecognized stock-based compensation cost was $23.2 million as of March 31, 2025, expected to be recognized over a weighted-average period of 3.1 years[64] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses significant progress in its clinical pipeline, including the completion of enrollment for the Phase 2 trial of canvuparatide with data expected in Q3 2025, and plans to initiate a Phase 2 trial for MBX 1416 in H2 2025. The analysis of financial results highlights a $11.4 million year-over-year increase in R&D expenses, driven by advancing these programs. The company confirms its cash runway, with existing funds of $240.8 million expected to support operations into mid-2027 - The company is advancing its pipeline, with key updates on its lead candidates: - canvuparatide (HP): Phase 2 enrollment of 64 patients is complete; topline data anticipated in Q3 2025[75] - MBX 1416 (PBH): Phase 1 trial completed; a Phase 2 trial is expected to start in the second half of 2025[76] - MBX 4291 (Obesity): An Investigational New Drug (IND) submission is anticipated in Q2 2025[77] Operating Expense Changes (Q1 2025 vs Q1 2024, in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change ($) | | :--- | :--- | :--- | :--- | | Research and development | $22,405 | $11,049 | $11,356 | | General and administrative | $4,124 | $2,265 | $1,859 | | Total operating expenses | $26,529 | $13,314 | $13,215 | - The $11.4 million increase in R&D expenses was primarily due to the ongoing Phase 2 trial for canvuparatide and IND-enabling studies for MBX 4291[98] - The company believes its existing cash, cash equivalents, and marketable securities of $240.8 million will be sufficient to fund operating expenses and capital expenditure requirements into mid-2027[83][103] Item 3. Quantitative and Qualitative Disclosures About Market Risk The company is a smaller reporting company and, as such, is not required to provide the information requested by this item - As a smaller reporting company, MBX Biosciences is exempt from the requirement to provide quantitative and qualitative disclosures about market risk[124] Item 4. Controls and Procedures Based on an evaluation as of March 31, 2025, the company's management, including the CEO and CFO, concluded that its disclosure controls and procedures were effective. There were no material changes in the company's internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable level as of March 31, 2025[126] - No changes occurred in the company's internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[127] PART II. OTHER INFORMATION Item 1. Legal Proceedings The company reports that it is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - The company is not currently involved in any material legal proceedings[129] Item 1A. Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - The company refers stakeholders to the risk factors disclosed in its 2024 Annual Report on Form 10-K, stating no material changes have occurred[130] Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities During the quarter, the company did not have any unregistered sales of equity securities. It repurchased 173 shares of its common stock from a former consultant at an average price of $0.48 per share in February 2025 - There were no unregistered sales of equity securities during the three months ended March 31, 2025[131] Issuer Repurchases of Securities (Q1 2025) | Period | Total Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | February 2025 | 173 | $0.48 | Item 3. Defaults Upon Senior Securities The company reports that there were no defaults upon senior securities during the period - None[136] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[137] Item 5. Other Information On May 9, 2025, the company amended its principal executive office lease in Carmel, expanding the office space to 8,260 square feet and extending the lease term to December 31, 2028. Additionally, no directors or officers adopted or terminated a Rule 10b5-1 trading plan during the quarter - On May 9, 2025, the company amended its Carmel office lease, expanding the premises and extending the term through December 31, 2028, with future minimum rent payments under the amendment totaling $0.7 million[138][139] - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or arrangement during the fiscal quarter[141] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including required certifications by the CEO and CFO, and the first amendment to the company's office lease - Key exhibits filed include the First Amendment to the Office Lease and certifications from the Principal Executive Officer and Principal Financial Officer[142] Signatures