智通财经APP获悉，据报道，辉瑞(PFE.US)即将以73亿美元收购减肥药初创公司Metsera(MTSR.US)，此 举旨在其备受关注的减肥药项目近期受挫后强化产品线布局。据知情人士透露，该交易最早可能于周一 正式宣布。辉瑞将以每股47.50美元现金收购Metsera，若达成特定业绩里程碑，还将额外支付每股22.50 美元，这一报价较Metsera上周五33.32美元的收盘价显著溢价。截至非工作时间，双方暂未对此置评。 作为新一代减肥药物领域的潜力企业之一，Metsera正参与争夺规模达数十亿美元的减肥药市场。收购 完成后，辉瑞将获得Metsera的减肥针剂MET-233i——在早期小型试验中，该药物帮助患者在36天内减 重最多达8.4%。 值得关注的是，与诺和诺德(NVO.US)、礼来(LLY.US)等市场龙头的现有产品相比，MET-233i可能实现 更低频次给药，使患者从每周注射一次减少至每月一次，可能与现有疗法形成差异。 据悉，辉瑞计划今年完成两至三笔总规模达150亿美元的交易以补充产品线，其自有减肥药业务此前被 视为进军该市场的核心突破口，但其减肥药丸项目的失败加大了首席执行官阿尔伯特·布尔拉的压力 ...

(Reuters) -Pfizer (PFE) said on Monday it would acquire weight-loss drug developer Metsera (MTSR) in a deal valued at up to $7.3 billion, including future payments, to secure its position in the lucrative obesity treatment market. The global obesity drug market, projected to reach $150 billion by early 2030s, has been booming over the last few years, driven by the success of highly effective GLP-1-targeting therapies from companies such as Novo Nordisk (NVO, NOVO-B.CO) and Eli Lilly (LLY) — both fiercely ...

Core Insights - Metsera, Inc. (NASDAQ:MTSR) is recognized as a leading player in the biotech sector, focusing on innovative treatments for obesity and metabolic diseases [1][2] - The company's lead candidate, MET-233i, demonstrated significant efficacy in Phase 1 trials, with patients achieving up to 8% body weight reduction over five weeks [2][3] - MET-233i's extended half-life allows for once-monthly dosing, enhancing patient convenience and adherence compared to existing therapies [2] - Another promising asset, MET-097i, is undergoing multiple Phase 2b trials, with results anticipated later in 2025 and Phase 3 trials set to commence by year-end [3] Company Developments - Metsera, Inc. is developing next-generation injectable and oral hormone analog peptides aimed at improving treatment outcomes for obesity [1] - The company is preparing to present data from its ongoing trials at medical and investor conferences, indicating a growing interest in its scientific advancements [3]

Core Insights - Metsera, Inc. is set to present clinical and preclinical data on its next-generation therapies for obesity and metabolic diseases at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) from September 15-19, 2025 in Vienna, Austria [1][2] Company Overview - Metsera is a clinical-stage biopharmaceutical company focused on developing innovative medicines for obesity and metabolic diseases, founded in 2022 and based in New York City [4] - The company is advancing a diverse portfolio of oral and injectable therapies, including incretin and non-incretin options, aimed at addressing multiple therapeutic targets in the evolving weight loss treatment landscape [4] Clinical and Preclinical Presentations - The company will present a late-breaking oral presentation on the pharmacokinetics, weight loss, and tolerability of its ultra-long acting amylin analog MET-233i on September 17, 2025 [3] - Two preclinical presentations will focus on the combination of MET-233i with MET-097i, an ultra-long acting GLP-1 receptor agonist, showcasing significant weight loss in preclinical studies [2][3]

Group 1 - Metsera, Inc. (NASDAQ:MTSR) is identified as one of the best stocks to buy for the next three months according to hedge funds, with Bank of America Securities raising the price target from $45 to $50 while maintaining a Buy rating [1][2] - The company reported significant progress in its obesity and metabolic disease drug pipeline, particularly with its lead drug MET-097i, which is a once-monthly GLP-1 receptor agonist showing strong potential for weight loss and good tolerability in Phase 2b trials [2][3] - Another drug, MET-233i, a once-monthly amylin analog, demonstrated impressive Phase 1 results with an 8.4% weight loss over five weeks and a 19-day half-life, with full 12-week monotherapy data expected by late 2025 [3] Group 2 - Metsera, Inc. is advancing oral peptide programs, with data from MET-097o and MET-224o anticipated in late 2025, indicating a robust pipeline of innovative injectable and oral hormone analog peptides [3]

Financial Data and Key Metrics Changes - The company is focused on the next generation of obesity therapy, particularly therapeutic peptides targeting nutrient-stimulated hormone pathways, with a strong emphasis on scalability and combinability [2][3] - The clinical stage assets include MET-097i, an ultra-long-acting GLP-1 receptor agonist, which is rapidly approaching phase three trials [3][4] Business Line Data and Key Metrics Changes - MET-097i has shown to be tenfold more potent than tirzepatide, which improves manufacturability and lowers active pharmaceutical ingredient (API) requirements [4][5] - The amylin analog MET-233i is designed to be co-formulated with MET-097i, allowing for monthly dosing due to matched half-lives of 18 and 19 days respectively [5][6] Market Data and Key Metrics Changes - The company is addressing the challenges of oral peptide delivery, aiming to achieve injectable-like efficacy with low-dose oral formulations [7][8] - The competitive landscape includes dual agonists like tirzepatide, with MET-097i expected to perform similarly in terms of efficacy and tolerability [15][28] Company Strategy and Development Direction - The company aims to position MET-097i as a best-in-class candidate for obesity treatment, focusing on monthly dosing and competitive tolerability [37][56] - There is a strong emphasis on maintenance therapies, with plans to explore prodrugs that could allow for quarterly dosing [71][72] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data readouts, particularly for MET-097i and the amylin analog, which are expected to demonstrate strong efficacy and tolerability [19][39] - The company is optimistic about the potential for combination therapies to enhance weight loss outcomes while maintaining tolerability [56][57] Other Important Information - The company has a broad pipeline with multiple catalysts expected in the next 9 to 12 months, including phase two readouts for MET-097i [9][19] - The oral peptide strategy is seen as a significant advancement, with the potential to overcome the limitations of current oral peptide formulations [63][67] Q&A Session Summary Question: Can you elaborate on the long half-life and its impact on tolerability? - Management explained that the long half-life allows for a smoother rise in drug concentration, reducing gastrointestinal adverse events associated with rapid concentration changes [11][12] Question: What is the rationale behind the study design for VESPER-1? - The design was focused on dose selection without titration to expedite the process of moving towards phase three trials [21][22] Question: How does the company view the competitive landscape for MET-097i? - The company believes MET-097i can achieve dual agonist-like efficacy while being more tolerable, positioning it favorably against competitors [28][37] Question: What are the expectations for the upcoming data releases? - Management anticipates that the data will support the efficacy and tolerability claims for both MET-097i and the amylin analog, with significant implications for market positioning [61][72]

Financial Data and Key Metrics Changes - The company is focused on next-generation obesity therapies, particularly therapeutic peptides targeting hormone pathways, with a strong emphasis on scalability and combinability [2][3] - The clinical stage assets include MET-097i, an ultra-long-acting GLP-1 receptor agonist, which is expected to enter phase three trials later this year [3][4] - The company reported a 10% to 11% placebo-adjusted weight loss at 12 weeks for MET-097i, which is competitive within the landscape [15][30] Business Line Data and Key Metrics Changes - MET-097i has shown a unique profile with a half-life of 18 days, allowing for better tolerability and efficacy compared to existing treatments [11][12] - The amylin analog MET-233i demonstrated up to 8.5% placebo-adjusted weight loss with well-tolerated starting doses [5][45] - The oral peptide strategy aims to deliver injectable-like efficacy at lower doses, with clinical data expected later this year [6][65] Market Data and Key Metrics Changes - The company is positioning itself as a best-in-class candidate in the obesity treatment market, targeting a significant portion of the population that benefits from dual agonists [40][56] - The competitive landscape includes drugs like tirzepatide, with MET-097i aiming to match or exceed its efficacy and tolerability [30][40] Company Strategy and Development Direction - The company is focused on developing scalable oral peptides that can provide the same benefits as injectables, addressing the limitations of small molecules [66][67] - The strategy includes exploring combination therapies with MET-097i and MET-233i, leveraging their compatible pharmacokinetics for enhanced efficacy [46][57] - The long-term vision includes maintenance therapies that could potentially reduce the frequency of dosing, aiming for quarterly dosing strategies [75][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming clinical data and the potential for MET-097i to set a new standard in obesity treatment [9][19] - The company anticipates significant advancements in the obesity treatment landscape, with a focus on maintaining weight loss over extended periods [74][76] - Management highlighted the importance of tolerability and efficacy in their drug development, aiming to provide alternatives for patients who struggle with existing therapies [56][58] Other Important Information - The company is preparing for multiple data readouts in the coming months, including interim data from ongoing studies [19][42] - The development of prodrugs and combination therapies is seen as a key area for future growth and innovation [75][76] Q&A Session Summary Question: Can you elaborate on the long half-life of MET-097i and its impact on tolerability? - The long half-life allows for a smoother concentration rise, reducing gastrointestinal adverse events associated with rapid concentration changes [11][12] Question: What are the expectations for the upcoming VESPER-1 and VESPER-3 studies? - The target profile for MET-097i is to achieve dual agonist-like efficacy, with expectations of over 10% placebo-adjusted weight loss at 28 weeks [30][32] Question: How does the company differentiate itself from competitors in the obesity treatment market? - The company aims to provide a more consumer-friendly profile with fewer titration steps and a focus on monthly dosing, setting it apart from other treatments [40][56]

Core Insights - Metsera, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases [2] - The company is advancing a diverse portfolio of therapies, including oral and injectable incretin, non-incretin, and combination therapies, aimed at addressing multiple therapeutic targets in the evolving weight loss treatment landscape [2] Company Overview - Metsera was founded in 2022 and is headquartered in New York City [2] - The company emphasizes its commitment to accelerating innovative treatments for obesity and metabolic diseases [2] Upcoming Events - CEO Whit Bernard will present at the Cantor Global Healthcare Conference on September 3, 2025, from 3:20 to 3:50 P.M. EDT [5] - Bernard will also present at the Wells Fargo 2025 Healthcare Conference on September 4, 2025, from 4:30 to 5:05 P.M. EDT [5] Investor Relations - Metsera utilizes its website as a distribution channel for material information, with financial and important updates accessible through the Investors & News section [3] - Investors can sign up for email alerts to receive updates about the company [3]

PART 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)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(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 million**[36](index=36&type=chunk) - Immediately prior to the IPO closing, all outstanding shares of convertible preferred stock were converted into **71,904,475** shares of common stock[93](index=93&type=chunk) - The company operates as a single reportable segment focused on developing treatments for obesity, overweight, and related conditions[45](index=45&type=chunk) [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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™[113](index=113&type=chunk)[114](index=114&type=chunk) - 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 2027[125](index=125&type=chunk)[163](index=163&type=chunk) - 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 commercialization[126](index=126&type=chunk)[161](index=161&type=chunk) [Our Pipeline and Key Developments](index=23&type=section&id=Our%20Pipeline%20and%20Key%20Developments) 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 analog[122](index=122&type=chunk)[126](index=126&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) 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 company[149](index=149&type=chunk) [Liquidity and Capital Resources](index=30&type=section&id=Liquidity%20and%20Capital%20Resources) 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 million**[159](index=159&type=chunk) - 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 compensation[166](index=166&type=chunk) - The company will need substantial additional funding for its continuing operations, including advancing clinical trials, seeking regulatory approval, and potential commercialization efforts[161](index=161&type=chunk)[162](index=162&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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 risk[204](index=204&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) 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 level[206](index=206&type=chunk) - 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 reporting[207](index=207&type=chunk) 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](index=38&type=section&id=Item%201.%20Legal%20Proceedings) 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 proceedings[210](index=210&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) 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 2022[212](index=212&type=chunk) - 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](index=303&type=chunk) - 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 interruptions[281](index=281&type=chunk)[284](index=284&type=chunk) - 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 process[385](index=385&type=chunk) [Risks Related to Our Limited Operating History, Financial Position and Capital Requirements](index=39&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Position%20and%20Capital%20Requirements) 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 future[213](index=213&type=chunk) - 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 programs[215](index=215&type=chunk) - Raising additional capital may cause dilution to stockholders, restrict operations, or require the company to relinquish rights to its technologies or product candidates[219](index=219&type=chunk) [Risks Related to the Development and Regulatory Approval of Our Product Candidates](index=41&type=section&id=Risks%20Related%20to%20the%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) 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 risk[221](index=221&type=chunk)[225](index=225&type=chunk) - 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 product[243](index=243&type=chunk) - 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 warnings[251](index=251&type=chunk) [Risks Related to Commercialization of Our Product Candidates](index=55&type=section&id=Risks%20Related%20to%20Commercialization%20of%20Our%20Product%20Candidates) 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 overweight[303](index=303&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and payors, which is influenced by factors like clinical efficacy, safety, pricing, and reimbursement[309](index=309&type=chunk)[310](index=310&type=chunk) - 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 market[311](index=311&type=chunk)[313](index=313&type=chunk) - 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 parties[331](index=331&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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 share[484](index=484&type=chunk) - There has been no material change in the expected use of net proceeds from the IPO[486](index=486&type=chunk) [Item 3. Defaults Upon Senior Securities](index=88&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[488](index=488&type=chunk) [Item 4. Mine Safety Disclosures](index=88&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[489](index=489&type=chunk) [Item 5. Other Information](index=88&type=section&id=Item%205.%20Other%20Information) 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 arrangement[490](index=490&type=chunk) [Item 6. Exhibits](index=88&type=section&id=Item%206.%20Exhibits) 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

[Key Highlights](index=1&type=section&id=Key%20Highlights) Metsera reported significant progress in its clinical pipeline for obesity and metabolic diseases, with key data releases for its leading candidates MET-097i and MET-233i expected in late 2025. The company is well-capitalized with $530.9 million in cash, providing a financial runway into 2027 - The company has a strong cash position of **$530.9 million**, which is expected to fund operations into **2027**[1](index=1&type=chunk) Upcoming Clinical Milestones | Candidate/Program | Milestone | Expected Timing | | :--- | :--- | :--- | | **MET-097i** | VESPER-1 & interim VESPER-3 data release | September 2025 | | **MET-097i** | Phase 3 initiation | Late 2025 | | **MET-233i** | 12-week monotherapy data | Late 2025 | | **MET-233i + MET-097i** | 12-week co-administration data | Year-end 2025 or early 2026 | | **Oral Peptide Program** | 4-week data for selected lead | Late 2025 | [Pipeline Highlights and Upcoming Milestones](index=1&type=section&id=Pipeline%20Highlights%20and%20Upcoming%20Milestones) Metsera is advancing a robust pipeline of injectable and oral therapies for obesity. Key programs like MET-097i (GLP-1 RA) and MET-233i (amylin analog) are progressing rapidly, with multiple clinical data readouts and a Phase 3 trial initiation scheduled for the second half of 2025. The company is also developing combination therapies and oral peptides to address the evolving treatment landscape - CEO Whit Bernard highlighted rapid progress across the pipeline, including positive Phase 1 data for MET-233i and accelerated enrollment for MET-097i studies[3](index=3&type=chunk) [MET-097i (Monthly GLP-1 RA)](index=1&type=section&id=MET-097i%20(Monthly%20GLP-1%20RA)) MET-097i, a once-monthly injectable GLP-1 receptor agonist, is on track for a major data release in September 2025 from its Phase 2b VESPER-1 and VESPER-3 trials. These results will inform the dosing for the global Phase 3 program, which is set to begin in late 2025 - MET-097i is a fully biased, monthly, ultra-long acting, subcutaneously injectable GLP-1 receptor agonist (RA)[4](index=4&type=chunk) - Topline data from the VESPER-1 trial and interim data from the VESPER-3 trial are expected in September 2025[4](index=4&type=chunk) - The company is on track to initiate the Phase 3 program for MET-097i in late 2025[8](index=8&type=chunk) [MET-233i (Monthly Amylin Analog)](index=2&type=section&id=MET-233i%20(Monthly%20Amylin%20Analog)) MET-233i, a once-monthly amylin analog, demonstrated class-leading Phase 1 results with significant weight loss and favorable tolerability. Its 19-day half-life enables a potential monthly combination therapy with MET-097i. Further 12-week monotherapy data is anticipated in late 2025 - Phase 1 results showed mean placebo-subtracted weight loss of up to **8.4%** at Day 36 with placebo-like tolerability[5](index=5&type=chunk)[8](index=8&type=chunk) - The drug demonstrated a **19-day** observed half-life, matching the pharmacokinetics of MET-097i for a potential monthly combination therapy[8](index=8&type=chunk) - Topline 12-week data from the MET-233i monotherapy trial is expected in late 2025[8](index=8&type=chunk) [MET-233i + MET-097i Combination](index=2&type=section&id=MET-233i%20%2B%20MET-097i%20Combination) The company is evaluating the co-administration of its monthly amylin analog (MET-233i) and GLP-1 RA (MET-097i). Topline 12-week data from this combination trial is expected by the end of 2025 or in early 2026 - Topline 12-week data from the co-administration trial of MET-233i and MET-097i is expected by year-end 2025 or in early 2026[6](index=6&type=chunk) [Oral Peptide Platform](index=2&type=section&id=Oral%20Peptide%20Platform) Metsera is developing oral GLP-1 receptor agonists, MET-097o and MET-224o. The company plans to release preliminary four-week weight loss, tolerability, and pharmacokinetic data for the selected lead candidate in late 2025 - The oral platform includes MET-097o and MET-224o, which are oral, fully biased, ultra-long acting GLP-1 receptor agonists[8](index=8&type=chunk) - Four-week topline data for the selected lead candidate is expected in late 2025[7](index=7&type=chunk) [Additional Key Pipeline Programs](index=2&type=section&id=Additional%20Key%20Pipeline%20Programs) The company is also advancing other candidates, including MET-034 (GIP RA) for combination therapy and MET-815, a prodrug of MET-097i with potential for quarterly dosing. Clinical milestones for these programs are expected in late 2025 and early 2026 - Preliminary data from the co-administration of MET-034 (GIP RA) with MET-097i are expected in late 2025[8](index=8&type=chunk) - IND-enabling studies are progressing for MET-815, a prodrug of MET-097i, with clinical trial initiation planned for year-end 2025 or early 2026[8](index=8&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) For the second quarter of 2025, Metsera reported a strong cash position of $530.9 million, ensuring a financial runway into 2027. Operating expenses increased significantly, with R&D expenses rising to $60.5 million and G&A expenses to $11.5 million, driven by pipeline advancement and public company costs. This resulted in a net loss of $68.7 million for the quarter Financial Summary (Q2 2025 vs Q2 2024) | Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | R&D Expenses | $60.5M | $20.9M | | G&A Expenses | $11.5M | $5.6M | | Net Loss | $68.7M | $26.7M | - Cash and cash equivalents were **$530.9 million** as of June 30, 2025, which is estimated to be sufficient to fund operations into **2027**[7](index=7&type=chunk) [R&D Expenses](index=3&type=section&id=R%26D%20Expenses) Research and development expenses increased substantially to $60.5 million for the second quarter and $117.7 million for the first six months of 2025. The rise was primarily due to costs related to product candidate development, manufacturing, and increased personnel expenses R&D Expense Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $60.5 | $20.9 | | Six months ended June 30 | $117.7 | $38.7 | - Increases were driven by product development costs for preclinical and clinical candidates, contract manufacturing, and higher personnel-related expenses, including stock-based compensation[9](index=9&type=chunk) [G&A Expenses](index=3&type=section&id=G%26A%20Expenses) General and administrative expenses for the second quarter and first six months of 2025 were $11.5 million and $20.1 million, respectively. The increase was mainly attributed to higher personnel-related costs and professional fees associated with operating as a public company G&A Expense Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $11.5 | $5.6 | | Six months ended June 30 | $20.1 | $9.7 | - The increase was primarily due to personnel-related expenses (including stock-based compensation) and professional fees associated with being a public company[10](index=10&type=chunk) [Net Loss](index=3&type=section&id=Net%20Loss) The company's net loss widened to $68.7 million for the second quarter and $145.3 million for the first six months of 2025. The higher loss reflects the significant ramp-up in R&D and G&A spending to advance its clinical pipeline Net Loss Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three months ended June 30 | $(68.7) | $(26.7) | | Six months ended June 30 | $(145.3) | $(46.6) | - Net cash used in operating activities for the six months ended June 30, 2025 was **$113.3 million**[11](index=11&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated financial statements as of June 30, 2025, and for the three and six-month periods then ended. It includes the Balance Sheets and the Statement of Operations, providing a detailed view of the company's financial position and performance [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, Metsera's balance sheet showed total assets of $639.7 million, a significant increase from $451.0 million at the end of 2024. This was driven by a rise in cash and cash equivalents to $530.9 million. Total liabilities stood at $190.4 million, and total stockholders' equity was $449.2 million Condensed Consolidated Balance Sheets (in thousands) | | 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 and Stockholders' Equity** | | | | Total current liabilities | $102,308 | $67,307 | | **Total liabilities** | **$190,428** | **$163,638** | | **Total stockholders' equity (deficit)** | **$449,232** | **$(253,507)** | | **Total liabilities and stockholders' equity** | **$639,660** | **$450,988** | [Condensed Consolidated Statement of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statement%20of%20Operations) For the three months ended June 30, 2025, Metsera reported a net loss of $68.7 million, or ($0.66) per share, compared to a net loss of $26.7 million, or ($1.86) per share, for the same period in 2024. The increased loss was driven by a near tripling of R&D expenses and a doubling of G&A expenses Condensed Consolidated Statement of Operations (in thousands, except per share data) | | Three Months Ended June 30 | Six Months Ended June 30 | | :--- | :--- | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | Research and development | $60,511 | $20,855 | $117,697 | $38,668 | | General and administrative | $11,482 | $5,643 | $20,085 | $9,718 | | Total operating expenses | $71,123 | $28,005 | $150,932 | $49,068 | | Loss from operations | $(71,123) | $(28,005) | $(150,932) | $(49,068) | | **Net loss** | **$(68,715)** | **$(26,728)** | **$(145,303)** | **$(46,608)** | | **Net loss per share, basic and diluted** | **$(0.66)** | **$(1.86)** | **$(1.62)** | **$(3.31)** |