Metsera Inc(US:MTSR)2025-07-28 20:20PART I. FINANCIAL INFORMATION This section presents Metsera, Inc.'s unaudited financial statements and management's analysis of its financial condition and operational results Item 1. Financial Statements (Unaudited) The unaudited condensed consolidated financial statements for Metsera, Inc. as of June 30, 2025, show a significant increase in cash and total assets, primarily due to the net proceeds from its Initial Public Offering (IPO) in February 2025 - In February 2025, the company completed its IPO, selling 17,569,444 shares of common stock at $18.00 per share, receiving net proceeds of $288.4 million36 - Immediately prior to the IPO closing, all outstanding shares of convertible preferred stock were converted into 71,904,475 shares of common stock93 - The company operates as a single reportable segment focused on developing treatments for obesity, overweight, and related conditions45 Condensed Consolidated Balance Sheets As of June 30, 2025, the company's balance sheet reflects a strong liquidity position with $530.9 million in cash and cash equivalents, a substantial increase from $352.4 million at year-end 2024, mainly due to IPO proceeds Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $530,919 | $352,447 | | Total current assets | $538,076 | $359,133 | | Total assets | $639,660 | $450,988 | | Liabilities & Equity | | | | Total liabilities | $190,428 | $163,638 | | Redeemable convertible preferred stock | $0 | $540,857 | | Total stockholders' equity (deficit) | $449,232 | $(253,507) | Condensed Consolidated Statements of Operations and Comprehensive Loss For the three and six months ended June 30, 2025, the company reported no revenue and significantly higher operating expenses compared to the same periods in 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $60,511 | $20,855 | $117,697 | $38,668 | | General and administrative | $11,482 | $5,643 | $20,085 | $9,718 | | Loss from operations | $(71,123) | $(28,005) | $(150,932) | $(49,068) | | Net loss | $(68,715) | $(26,728) | $(145,303) | $(46,608) | | Net loss per share | $(0.66) | $(1.86) | $(1.62) | $(3.31) | Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2025, net cash used in operating activities was $113.3 million, reflecting higher R&D and G&A spending, while financing activities provided $287.0 million from the IPO Six-Month Cash Flow Summary (in thousands) | Cash Flow Activity | H1 2025 | H1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(113,306) | $(35,366) | | Net cash used in investing activities | $(198) | $(42) | | Net cash provided by financing activities | $287,047 | $36,608 | | Net increase in cash and cash equivalents | $178,472 | $1,173 | | Cash and cash equivalents, end of period | $530,919 | $76,368 | Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's position as a clinical-stage biopharmaceutical firm focused on obesity and metabolic diseases, highlighting its broad portfolio of oral and injectable therapies and the financial strengthening from its February 2025 IPO - The company is a clinical-stage biopharmaceutical company focused on developing medicines for obesity and metabolic diseases, utilizing proprietary platforms like MINT, HALO™, and MOMENTUM™113114 - Existing cash and cash equivalents as of the report date are expected to be sufficient to fund operating expenses, working capital, and capital expenditure needs into 2027125163 - The company anticipates continued significant and increasing net operating losses as it advances its product candidates through clinical development, seeks regulatory approval, and prepares for potential commercialization126161 Our Pipeline and Key Developments The company's pipeline is led by MET-097i, a monthly GLP-1 RA in Phase 2b trials, with promising Phase 1 results for MET-233i and ongoing advancements in its oral peptide platform Anticipated Pipeline Milestones | Program | Milestone | Expected Timing | | :--- | :--- | :--- | | MET-097i | Phase 2b (VESPER-1) topline data | September 2025 | | | Phase 3 initiation | Late 2025 | | | Phase 2b monthly (VESPER-3) preliminary data | YE 2025 / Early 2026 | | MET-233i | 12-week monotherapy data | Late 2025 | | MET-233i + MET-097i | 12-week co-administration data | YE 2025 / Early 2026 | | Oral Platform | 4-week lead candidate data | Late 2025 | - MET-233i monotherapy demonstrated a mean placebo-subtracted weight loss of up to 8.4% at Day 36 in a Phase 1 trial, with a 19-day observed half-life, supporting its potential as a first-in-class monthly amylin analog122126 Results of Operations Operating expenses for Q2 2025 increased to $71.1 million from $28.0 million in Q2 2024, driven by a significant rise in R&D and G&A expenses, while interest income grew due to higher cash balances Research and Development Expenses by Program (in thousands) | Strategy | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Fully biased, monthly GLP-1 RA | $22,513 | $5,146 | $45,462 | $8,845 | | Amylin agonism + GLP-1 RA | $12,039 | $3,137 | $20,565 | $6,685 | | Oral peptide platform | $7,211 | $6,025 | $18,102 | $11,349 | | Total R&D Expenses | $60,511 | $20,855 | $117,697 | $38,668 | - The increase in G&A expenses for Q2 2025 was primarily driven by a $2.1 million increase in personnel-related expenses, a $2.2 million increase in stock-based compensation, and a $1.2 million increase in professional fees associated with being a public company149 Liquidity and Capital Resources The company's liquidity has been significantly enhanced by the February 2025 IPO, providing $288.4 million in net proceeds and bringing cash and cash equivalents to $530.9 million as of June 30, 2025, sufficient to support operations into 2027, though substantial future capital will be needed - As of June 30, 2025, the company had cash and cash equivalents of $530.9 million and an accumulated deficit of $402.4 million159 - Net cash used in operating activities for the first six months of 2025 was $113.3 million, reflecting a net loss of $145.3 million adjusted for non-cash charges like a $13.2 million change in fair value of contingent consideration and $6.4 million in stock-based compensation166 - The company will need substantial additional funding for its continuing operations, including advancing clinical trials, seeking regulatory approval, and potential commercialization efforts161162 Item 3. Quantitative and Qualitative Disclosures About Market Risk The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is therefore not required to provide the information requested under this item - As a smaller reporting company, Metsera is not required to provide quantitative and qualitative disclosures about market risk204 Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded that as of June 30, 2025, they were effective at a reasonable assurance level, with no material changes in internal control over financial reporting during the quarter - The CEO and CFO concluded that as of June 30, 2025, the company's disclosure controls and procedures were effective at the reasonable assurance level206 - No changes occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting207 PART II. OTHER INFORMATION This section covers legal proceedings, comprehensive risk factors, equity sales, and other disclosures relevant to the company's operations Item 1. Legal Proceedings As of the filing date, the company reports that it is not subject to any material legal proceedings - The company is not currently subject to any material legal proceedings210 Item 1A. Risk Factors The company outlines a comprehensive set of risks associated with its business, including its limited operating history, significant losses, need for substantial additional capital, and extensive uncertainties in drug development, regulatory approval, commercialization, and intellectual property protection - The company is a clinical-stage biotechnology company with a limited operating history, no commercialized products, and has incurred significant operating losses since its inception in June 2022212 - The company faces significant competition from large pharmaceutical companies with approved therapies for obesity and overweight, such as Novo Nordisk (Wegovy) and Eli Lilly (Zepbound)303 - The company relies on third parties to conduct clinical trials and manufacture its product candidates, which exposes it to risks of delays, non-compliance with regulations (GCP, cGMP), and supply interruptions281284 - The company's success is dependent on its ability to obtain, maintain, and enforce intellectual property protection for its product candidates and technology, which is an uncertain and expensive process385 Risks Related to Our Limited Operating History, Financial Position and Capital Requirements This section details the risks stemming from the company's status as a clinical-stage entity with a limited operating history and no revenue, including a history of significant operating losses, the expectation of continued losses, and the need to raise substantial additional capital - The company has incurred significant operating losses since inception, with an accumulated deficit of $402.4 million as of June 30, 2025, and expects to incur significant losses for the foreseeable future213 - Substantial additional capital will be required to finance operations. A failure to obtain this capital on acceptable terms could force the company to delay, limit, or terminate its development programs215 - Raising additional capital may cause dilution to stockholders, restrict operations, or require the company to relinquish rights to its technologies or product candidates219 Risks Related to the Development and Regulatory Approval of Our Product Candidates This section highlights the inherent uncertainties and high risks of biopharmaceutical development, including potential preclinical program failures, lengthy and expensive clinical trials with uncertain outcomes, and unpredictable regulatory approval processes that may result in restrictive labeling - The company's business is entirely dependent on the success of its product candidates, and drug development is a highly uncertain, lengthy, and expensive process with a substantial degree of risk221225 - Use of product candidates could be associated with adverse side effects or safety risks, which could delay or preclude regulatory approval, cause trials to be suspended, or limit the commercial profile of an approved product243 - The FDA has required other approved GLP-1 RAs to carry a boxed warning regarding the risk of thyroid C-cell tumors, and it is expected that the company's GLP-1 RA product candidates, if approved, may carry similar warnings251 Risks Related to Commercialization of Our Product Candidates This section outlines the significant hurdles to commercial success, even if regulatory approval is achieved, including intense competition, uncertain market acceptance, challenges in securing adequate coverage and reimbursement, and the need to build marketing and sales capabilities - The company faces significant competition from large pharmaceutical companies like Novo Nordisk and Eli Lilly, who have well-established, marketed therapies for obesity and overweight303 - Commercial success depends on market acceptance by physicians, patients, and payors, which is influenced by factors like clinical efficacy, safety, pricing, and reimbursement309310 - The ability to achieve coverage and adequate reimbursement from governmental and private payors is uncertain and essential for commercial viability, with significant pricing pressure existing in the market311313 - The company currently has no marketing, sales, or distribution capabilities and will need to invest significant resources to build these functions or collaborate with third parties331 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period and confirms the completion of its IPO on February 3, 2025, with no material change in the intended use of net proceeds - On February 3, 2025, the company completed its IPO, selling 17,569,444 shares of common stock at $18.00 per share484 - There has been no material change in the expected use of net proceeds from the IPO486 Item 3. Defaults Upon Senior Securities This item is not applicable to the company - Not applicable488 Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable489 Item 5. Other Information The company reports that none of its directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - During the quarter ended June 30, 2025, no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement490 Item 6. Exhibits This section lists the exhibits filed with the quarterly report, including the 2023 Equity Incentive Plan, an offer letter for an executive, and certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act