Metsera Inc(MTSR) - 2024 Q4 - Annual Results

Metsera Q4 and Full Year 2024 Financial Results and Portfolio Update Metsera advanced its clinical pipeline for obesity and metabolic diseases, including MET-097i into Phase 2b, and secured $316.2 million from an IPO, extending its financial runway into 2027 Overview Metsera reported significant progress in its clinical pipeline for obesity and metabolic diseases in 2024, highlighted by the advancement of its GLP-1 RA injectable, MET-097i, into Phase 2b trials. The company also initiated clinical trials for its amylin analog (MET-233i) and a prototype oral peptide. A successful IPO in early 2025 raised approximately $316.2 million, extending the company's financial runway into 2027 - Successfully completed an Initial Public Offering (IPO) with gross proceeds of approximately $316.2 million, extending the company's operational runway into 2027[1][3][8] - Advanced MET-097i, a monthly GLP-1 RA injectable, through a Phase 2a trial and fully enrolled a Phase 2b trial in 2024[2] - Key clinical data readouts are expected in mid-to-late 2025 for MET-097i, MET-233i, and MET-224o[1] Pipeline Highlights and Upcoming Milestones The company's pipeline highlights include rapid advancement of MET-097i towards Phase 3, progress in amylin analog and oral peptide programs, and initiation of a MET-097i prodrug MET-097i (GLP-1 RA) MET-097i, a monthly injectable GLP-1 receptor agonist, is rapidly advancing toward Phase 3. Positive Phase 2a data showed significant weight loss (up to 11.3% placebo-subtracted) and supported a monthly dosing schedule. Multiple Phase 2b trials (VESPER-1, -2, -3) are underway to further evaluate its efficacy and tolerability, with preliminary data from VESPER-1 expected in mid-2025. A Phase 3 program is planned for late 2025 - Topline Phase 2a data demonstrated up to 11.3% mean placebo-subtracted weight loss after 12 weekly doses, with no plateau observed[3] - The VESPER-1 Phase 2b trial, evaluating titration-free weekly doses, completed enrollment in December 2024, with preliminary data expected in mid-2025[6] - The VESPER-3 Phase 2b trial is planned to evaluate monthly dosing, with preliminary results expected by year-end 2025 or early 2026[6] - Pending positive Phase 2b results, the company plans to initiate a Phase 3 program for MET-097i in late 2025[6] MET-233i (Amylin Analog) MET-233i, a monthly injectable amylin analog, is progressing through Phase 1 studies. Pharmacokinetic data support its potential for monthly combination therapy with MET-097i. Preliminary efficacy and tolerability data from the multiple ascending dose (MAD) study are expected in mid-2025, with data from a combination study with MET-097i anticipated in late 2025 - MET-233i is designed as a monthly, ultra-long acting amylin analog combinable with MET-097i[6] - Preliminary 4-week efficacy and tolerability data from the multiple ascending dose (MAD) study are expected in mid-2025[4][6] - A combination Phase 1 study for MET-233i and MET-097i is planned, with preliminary data expected in late 2025[6] Oral Peptide Platform (MET-224o & MET-097o) The company is developing oral GLP-1 receptor agonists, MET-224o and MET-097o. An ongoing Phase 1 formulation optimization study is on track to support the initiation of clinical trials for these candidates. Preliminary 4-week efficacy and tolerability data for MET-224o are expected in late 2025 - MET-224o and MET-097o are oral, fully biased, ultra-long acting GLP-1 RAs in development[6] - Preliminary 4-week efficacy and tolerability data for MET-224o are expected in late 2025[5][6] MET-815i (Prodrug of MET-097i) Metsera has initiated IND-enabling studies for MET-815i, a prodrug of MET-097i. This candidate is designed to smooth drug exposure and prolong its clinical effect, potentially allowing for less frequent dosing and improved tolerability - MET-815i is a prodrug of MET-097i designed to offer less frequent dosing and improved tolerability[7] Business and Financial Highlights Metsera completed a successful IPO in February 2025, raising $316.2 million, and reported increased R&D expenses and a net loss of $209.1 million for full year 2024 Recent Business Highlights In February 2025, Metsera successfully completed its initial public offering (IPO), raising significant capital to fund its ongoing and future operations - Completed an IPO in February, raising approximately $316.2 million in gross proceeds before expenses[8] Full Year 2024 Financial Results For the full year 2024, Metsera's financial results reflect its transition into a clinical-stage company with increased R&D and G&A spending. The company ended the year with a strong cash position of $352.4 million, which, combined with IPO proceeds, is expected to fund operations into 2027. The net loss for the year was $209.1 million, a significant increase from $47.2 million in 2023, driven by higher clinical development costs and a non-cash charge related to the fair value of contingent consideration Cash, Cash Equivalents and Marketable Securities | Financial Metric | 2024 (in millions) | 2023 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $352.4 | $75.2 | - Current cash position, together with net proceeds from the IPO, is estimated to be sufficient to fund operations into 2027[9] R&D and G&A Expenses | Expense Category (Full Year) | 2024 (in millions) | 2023 (in millions) | | :--- | :--- | :--- | | R&D Expenses | $107.5 | $15.6 | | G&A Expenses | $26.8 | $15.0 | R&D and G&A Expenses (Q4) | Expense Category (Q4) | Q4 2024 (in millions) | Q4 2023 (in millions) | | :--- | :--- | :--- | | R&D Expenses | $38.9 | $7.6 | | G&A Expenses | $9.7 | $3.6 | - The change in fair value of contingent consideration increased to $90.4 million for FY 2024 from $2.9 million in FY 2023, primarily due to the inclusion of a new product and an increased probability of success related to the 2023 Zihipp acquisition[12] Profitability | Profitability (Full Year) | 2024 | 2023 | | :--- | :--- | :--- | | Net Loss (in millions) | ($209.1) | ($47.2) | | Net Loss Per Share | ($14.49) | ($3.48) | Financial Statements Metsera's 2024 financial statements show increased assets and liabilities, with a net loss of $209.1 million, reflecting significant R&D and contingent consideration expenses Consolidated Balance Sheets As of December 31, 2024, Metsera's total assets increased to $451.0 million from $168.8 million in 2023, primarily driven by a significant rise in cash and cash equivalents. Total liabilities grew to $163.6 million from $70.3 million, largely due to increased accounts payable, accrued expenses, and long-term contingent consideration. The company reported a total stockholders' deficit of $253.5 million Balance Sheet Summary | Financial Metric | Dec 31, 2024 (in thousands) | Dec 31, 2023 (in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $352,447 | $75,195 | | Total current assets | $359,133 | $76,804 | | Total assets | $450,988 | $168,841 | | Liabilities & Stockholders' Deficit | | | | Total current liabilities | $67,307 | $20,169 | | Contingent consideration, long-term | $87,850 | $32,500 | | Total liabilities | $163,638 | $70,340 | | Total stockholders' deficit | ($253,507) | ($45,182) | | Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $450,988 | $168,841 | Consolidated Statement of Operations and Comprehensive Loss For the year ended December 31, 2024, Metsera reported a net loss of $209.1 million, compared to a net loss of $47.2 million in 2023. The increased loss was primarily due to a substantial rise in R&D expenses to $107.5 million and a $90.4 million charge for the change in fair value of contingent consideration. For the fourth quarter of 2024, the net loss was $52.9 million, up from $13.0 million in the same period of 2023 Statement of Operations (Full Year) | Expense Category | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development (in thousands) | $107,517 | $15,564 | | General and administrative (in thousands) | $26,797 | $15,042 | | Change in fair value of contingent consideration (in thousands) | $90,429 | $2,884 | | Total operating expenses (in thousands) | $224,833 | $43,669 | | Loss from operations (in thousands) | ($224,833) | ($43,669) | | Interest income (in thousands) | $6,185 | $1,918 | | Net loss (in thousands) | ($209,127) | ($47,206) | | Net loss per share, basic and diluted | ($14.49) | ($3.48) | Statement of Operations (Q4) | Expense Category | Q4 2024 | Q4 2023 | | :--- | :--- | :--- | | Total operating expenses (in thousands) | $64,500 | $13,873 | | Net loss (in thousands) | ($52,871) | ($13,029) | | Net loss per share, basic and diluted | ($3.52) | ($0.94) | Company Information and Disclosures Metsera, a clinical-stage biopharmaceutical company, provides information on its focus on obesity and metabolic diseases, alongside disclosures on forward-looking statements and associated risks About Metsera Metsera is a clinical-stage biopharmaceutical company founded in 2022 and based in New York City. The company focuses on accelerating the development of next-generation oral and injectable medicines for obesity and metabolic diseases, advancing a broad portfolio of therapies targeting multiple pathways - Metsera is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases[14] Forward-Looking Statements This press release contains forward-looking statements regarding clinical trial timelines, pipeline milestones, market strategy, and financial projections. These statements are based on current expectations and are subject to inherent uncertainties and risks. Actual results could differ materially, and the company disclaims any obligation to update these statements - The report includes forward-looking statements concerning clinical trial timelines, product pipeline events, and future financial results, which are subject to risks and uncertainties[16] - The company cautions that actual results could differ materially from those implied by forward-looking statements and directs readers to its SEC filings for a discussion of risk factors[17]