HALO™

Search documents
Metsera Reports Positive Phase 2b Results for First- and Best-in-Class Ultra-long Acting GLP-1 RA Candidate MET-097i, Enabling Rapid Transition into Phase 3
Globenewswire· 2025-09-29 20:01
Core Insights - Metsera, Inc. announced positive topline data from two Phase 2b trials, VESPER-1 and VESPER-3, for its drug MET-097i, showing a placebo-subtracted mean weight loss of up to 14.1% after 28 weeks with no plateau observed [1][3][7] - The drug demonstrated potentially best-in-class tolerability, with minimal diarrhea signals and low rates of nausea (13%) and vomiting (11%) [1][5][6] - High retention rates were noted in both trials, with only 2.9% discontinuation in VESPER-1, supporting the drug's advancement to Phase 3 trials expected to start in late 2025 [2][7] Trial Details - VESPER-1 involved 239 participants with doses ranging from 0.4 mg to 1.2 mg administered weekly over 28 weeks, while VESPER-3 included 268 subjects evaluating multiple monthly doses [2][3] - In VESPER-1, the highest dose of 1.2 mg resulted in a mean weight loss of 14.1%, with individual responses reaching up to 26.5% [3][4] - The ongoing VESPER-3 trial is designed to assess the efficacy and tolerability of MET-097i with a pre-specified interim analysis after 12 weeks [2][8] Efficacy and Tolerability - The drug's efficacy was dose-dependent, with significant weight loss observed at higher doses [3][4] - Tolerability results indicated a placebo-like frequency of gastrointestinal adverse events, with nausea and vomiting risk differences from placebo being 13% and 11%, respectively [5][6] - The tolerability profile of MET-097i at higher doses without titration was comparable to existing agents that require prolonged titration [5][6] Future Development - Metsera plans to initiate a global Phase 3 program in late 2025 based on the positive topline data [7] - Additional Phase 2b trials are ongoing to explore the long-term maintenance profile of MET-097i and its effects in populations with type 2 diabetes [7][8] - MET-097i is positioned as the foundational incretin backbone for multiple clinical programs, indicating a robust pipeline for Metsera [7][9] Technology and Platform - MET-097i is a fully biased, ultra-long acting GLP-1 receptor agonist designed for monthly dosing, showcasing class-leading potency and durability [9][10] - The HALO™ peptide stabilization and lipidation platform enhances the drug's half-life, potentially improving tolerability and scalability [10] Company Overview - Metsera, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases [11] - The company aims to address multiple therapeutic targets with a broad portfolio of therapies, including oral and injectable options [11]
Worthington Enterprises Reports First Quarter Fiscal 2026 Results
Globenewswire· 2025-09-23 20:15
Core Insights - Worthington Enterprises Inc. reported strong financial results for the first quarter of fiscal 2026, with significant growth in net sales and earnings compared to the previous year [4][5][6]. Financial Performance - Net sales reached $303.7 million, an increase of 18% from $257.3 million in the first quarter of fiscal 2025 [4][5]. - Net earnings rose by 45% to $34.8 million, up from $24.0 million in the prior year [5][6]. - Adjusted EBITDA grew by 34% to $65.1 million, compared to $48.4 million in the same quarter last year [5][6]. - Diluted earnings per share improved from $0.48 to $0.70, while adjusted diluted EPS increased from $0.50 to $0.74 [5][6]. Segment Performance - The Building Products segment generated net sales of $184.8 million, a 32.2% increase driven by higher volumes and contributions from the recent acquisition of Elgen, which added $20.9 million in sales [12][13]. - Consumer Products segment sales were $118.9 million, slightly up from $117.6 million, although adjusted EBITDA decreased due to lower volumes and increased expenses [12][13]. Cash Flow and Capital Expenditures - Operating cash flow remained flat at $41.1 million compared to the prior year, while free cash flow decreased by 12% to $27.9 million due to increased capital expenditures [5][10]. - The company invested approximately $13.2 million in capital expenditures, including $8.6 million for ongoing facility modernization projects [10][11]. Balance Sheet and Debt - The company ended the quarter with cash of $167.1 million, down from $250.1 million at the end of the previous quarter, primarily due to the acquisition of Elgen [10][11]. - Total debt increased to $306.0 million, all of which is long-term debt, reflecting a $3.1 million rise from the previous quarter [11]. Strategic Developments - The acquisition of Elgen Manufacturing for $91.2 million enhances Worthington's position in the commercial HVAC market and broadens its product offerings [5][14]. - The company declared a quarterly dividend of $0.19 per share, payable on December 29, 2025, to shareholders of record on December 15, 2025 [5].
Worthington Enterprises Releases 2025 Corporate Citizenship and Sustainability Report
Globenewswire· 2025-09-16 12:35
Core Viewpoint - Worthington Enterprises Inc. has published its annual Corporate Citizenship and Sustainability Report, highlighting its commitments and achievements in sustainability across the categories of People, Planet, Products, and Governance [1][2]. Group 1: Sustainability Achievements - The company aims to balance people, planet, and prosperity, achieving significant accomplishments in fiscal 2025 [2]. - Worthington Enterprises has reduced its environmental footprint by recycling or recovering 88% of total waste in FY25 [6]. - The company has avoided $6.05 million in costs through climate risk mitigation actions over the last three fiscal years [6]. - Worthington Enterprises contributed $3.1 million to 73 non-profit organizations, including the West Africa Clean Cooking Fund [6]. Group 2: Corporate Governance and Standards - The Corporate Citizenship and Sustainability Report was developed in accordance with Global Reporting Initiative (GRI) Standards and incorporates elements from the Task Force on Climate-related Financial Disclosures (TCFD) and Sustainability Accounting Standards Board (SASB) [3]. - Company activities align with the United Nations Sustainable Development Goals (SDGs) [3]. Group 3: Employee Engagement and Safety - The company prioritizes safety, outperforming the industry's average safety total case incident rate by 40% [6]. - An annual employee engagement survey saw participation from 85% of the workforce [6]. - The company has reinvigorated its internal safety program to foster a culture of health and well-being [6]. Group 4: Business Segments and Operations - Worthington Enterprises operates primarily in two business segments: Building Products and Consumer Products [4]. - The Building Products segment includes HVAC components, construction solutions, and water solutions, while the Consumer Products segment covers tools and outdoor living [4]. - The company employs approximately 6,000 people across North America and Europe [5].
Worthington Enterprises Participating in Fireside Chat at Canaccord Genuity Growth Conference
Globenewswire· 2025-08-05 12:30
Company Overview - Worthington Enterprises (NYSE: WOR) is a designer and manufacturer of market-leading brands that enhance everyday life by improving spaces and experiences [3] - The company operates in two primary business segments: Building Products and Consumer Products [3] - The Building Products segment includes solutions for heating and cooling, cooking, construction, and water systems, while the Consumer Products segment focuses on tools, outdoor living, and celebrations [3] - Worthington Enterprises employs approximately 6,000 people across North America and Europe [4] Leadership and Strategy - President and CEO Joe Hayek and CFO Colin Souza will participate in a fireside chat at the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025 [1][2] - The discussion will focus on the company's strategies for accelerating long-term growth and shareholder value through the Worthington Business System, which emphasizes innovation, transformation, and mergers and acquisitions (M&A) [2] Corporate Philosophy and Community Engagement - Founded in 1955, Worthington Enterprises follows a people-first philosophy, prioritizing shareholder earnings as its primary corporate goal [5] - The company empowers employees to innovate and grow within attractive markets, while also engaging with local communities through volunteer efforts and workforce development programs [5]
Worthington Enterprises Reports Fourth Quarter Fiscal 2025 Results
Globenewswire· 2025-06-24 20:10
Core Insights - Worthington Enterprises Inc. reported strong fourth quarter results for fiscal 2025, showing year-over-year and sequential growth in adjusted EBITDA, adjusted EPS, and free cash flow, driven by effective cost management and execution in its Consumer and Building Products segments [3][4][6]. Financial Performance - Net sales for Q4 2025 were $317.9 million, a slight decrease of 0.3% compared to Q4 2024, primarily due to the deconsolidation of the Sustainable Energy Solutions segment [5][6][8]. - The operating loss improved to $30.4 million from $56.1 million in the prior year, with adjusted operating income rising to $21.8 million, an increase of $16.0 million [5][9]. - Net earnings from continuing operations increased by 111% to $3.6 million, with adjusted EBITDA growing 35% to $85.1 million [6][9]. - Earnings per share from continuing operations improved from a loss of $(0.64) to a profit of $0.08, while adjusted EPS rose from $0.74 to $1.06 [6][28]. Cash Flow and Capital Management - Operating cash flow increased by 38% to $62.4 million, and free cash flow rose by 46% to $49.3 million [6][12]. - The company repurchased 200,000 shares for $9.8 million and declared a quarterly dividend of $0.19 per share, a 12% increase from the previous quarter [6][12]. Segment Performance - Consumer Products segment generated net sales of $125.6 million, remaining flat year-over-year, while adjusted EBITDA increased by $3.7 million to $20.8 million [14]. - Building Products segment saw net sales rise by 25.2% to $192.3 million, with adjusted EBITDA increasing by $19.6 million to $71.3 million, driven by higher volumes and contributions from the Ragasco acquisition [15][18]. Strategic Developments - The acquisition of Elgen Manufacturing for approximately $93 million was completed on June 19, 2025, aligning with the company's growth strategy in niche markets [6][16]. - The company expressed confidence in its ability to drive sustainable growth and long-term value heading into fiscal 2026 [16].
Worthington Enterprises Acquires Elgen Manufacturing; Expands Building Systems and Components Portfolio
Globenewswire· 2025-06-19 17:00
Core Viewpoint - Worthington Enterprises has acquired Elgen Manufacturing for approximately $93 million, enhancing its position in the HVAC market and aligning with its strategy to build leadership in niche markets [1][4]. Company Overview - Worthington Enterprises is a designer and manufacturer of brands that improve everyday life, operating primarily in two segments: Building Products and Consumer Products [5][6]. - The Building Products segment includes solutions for heating, cooling, construction, and water applications, while the Consumer Products segment covers tools and outdoor living [5]. Acquisition Details - Elgen Manufacturing, based in Closter, New Jersey, specializes in HVAC parts and components, generating net sales of $114.9 million and EBITDA of $13.3 million for the trailing 12 months ended April 30, 2025 [4]. - The acquisition is expected to create synergies and growth opportunities by leveraging Worthington's manufacturing expertise and distribution model [2][3]. Strategic Fit - The acquisition aligns with Worthington's strategy to acquire businesses with strong market positions, as Elgen's manufacturing processes and sales strategies complement those of Worthington [2][3]. - Elgen's products are used in commercial buildings, and its sales strategy focuses on direct sales to contractors and partnerships with distributors, enhancing customer service and lead times [2]. Leadership and Integration - Elgen's leadership team, including CEO David Young, will remain with the company, ensuring continuity and commitment to customer service and innovation [3].
Metsera Announces Positive Phase 1 Data of First-in-Class Once-Monthly Amylin Candidate MET-233i
Globenewswire· 2025-06-09 11:00
Core Insights - Metsera, Inc. announced positive topline data from the Phase 1 clinical trial of MET-233i, showing up to 8.4% mean placebo-subtracted weight loss at Day 36, supporting its potential as a once-monthly monotherapy and in combination with MET-097i [1][2][4] - The trial demonstrated favorable tolerability with no safety signals, indicating a promising profile for MET-233i as a potential best-in-class amylin analog [2][4] Group 1: Clinical Trial Results - The Phase 1 trial was randomized, placebo-controlled, and double-blind, involving 80 participants with overweight or obesity without type 2 diabetes, evaluating doses from 0.15 mg to 2.4 mg [2][3] - Body weight loss was dose-dependent, with a mean of 8.4% at Day 36 after five weekly doses of 1.2 mg, and individual responses reached as high as 10.2% [4] - The pharmacokinetics showed a 19-day half-life, supporting once-monthly dosing and indicating the most durable profile among known amylin analogs [4] Group 2: Safety and Tolerability - Gastrointestinal adverse events were mild and primarily occurred in the first week, suggesting rapid tolerance development [4] - Anticipated starting doses of 0.15 mg and 0.3 mg showed tolerability results comparable to placebo [4] - No severe or serious adverse events were reported during the trial [4] Group 3: Future Developments - Metsera plans to advance MET-233i as a monotherapy and in combination with MET-097i, with topline data from an ultra-long acting GIP receptor agonist, MET-034i, expected in late 2025 [5][12] - The company is pursuing regulatory approval for the combination of MET-233i and MET-097i via the FDA biologic pathway [7] Group 4: Technology and Platform - MET-233i is developed using Metsera's HALO™ platform, which enhances peptide stability and allows for a longer half-life, potentially enabling monthly dosing [8] - The HALO™ platform is designed to improve tolerability and scalability of peptide therapies [8]