Core Insights - Northstrive Biosciences Inc. has signed a binding term sheet with Modulant Biosciences LLC for a future licensing agreement related to EL-22 in animal health, granting Modulant exclusive global rights to develop and commercialize this intellectual property [1][9] - The licensing agreement will focus on the use of EL-22 as a feed additive, targeting the myostatin pathway to improve body composition in livestock and companion animals [3][9] - Modulant will pay Northstrive a share of revenues generated from sublicensing and commercial activities, with a decreasing royalty rate after reaching a certain revenue threshold [4] Company Overview - Northstrive Biosciences Inc. is a biopharmaceutical company under PMGC Holdings Inc., focusing on developing innovative aesthetic medicines, with EL-22 as its lead asset [6] - PMGC Holdings Inc. is a diversified holding company managing a portfolio through strategic acquisitions and investments across various industries [7] - Modulant Biosciences LLC specializes in veterinary medicine innovation, led by CEO Tom Campi, who has extensive experience in animal drug development [10]

Core Viewpoint - Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., has filed four novel patent applications for its candidates EL-22 and EL-32, targeting both the animal market and muscle loss treatment in obese patients, either as standalone therapies or in combination with GLP-1 receptor agonists [1][2][3]. Patent Applications - The four patent applications filed include: - EL-32 in the USA and Korea for treating sarcopenia with transformed microorganisms [4]. - EL-22 in the USA for treating muscle loss in obese patients and in combination with GLP-1 receptor agonists [4][5]. - EL-22 for encouraging muscle growth in animals [5]. - EL-32 as a pharmaceutical composition for treating muscle loss due to obesity and as a combination therapy utilizing GLP-1 receptor agonists [5][6]. Intellectual Property Portfolio - Northstrive's patent portfolio now consists of 8 patent applications and 5 issued patents, providing protection in key markets including the USA, Japan, China, and Korea [3][7]. Company Overview - Northstrive Biosciences Inc. focuses on developing innovative solutions for obesity treatment, particularly through preserving muscle mass during weight loss [7]. - PMGC Holdings Inc. manages a diversified portfolio through strategic acquisitions and investments across various industries, including biopharmaceuticals [8].

Core Viewpoint - Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., has filed four novel patent applications for its candidates EL-22 and EL-32, targeting both the animal market and muscle loss treatment in obese patients, either as standalone therapies or in combination with GLP-1 receptor agonists [1][2][3]. Patent Applications - The four patent applications filed include compositions for treating sarcopenia and muscle loss in both humans and animals, emphasizing the engineered probiotic platform aimed at obesity care [2][5]. - The patents cover various formulations, including a fusion protein of Myo-2 for treating muscle loss in obese patients and animal feed additives to encourage muscle growth [4][5]. Intellectual Property Portfolio - Northstrive's patent portfolio now consists of 8 patent applications and 5 issued patents, providing protection in key markets such as the USA, Japan, China, and Korea [3][4]. - The newly filed patents are expected to strengthen the company's intellectual property position as it seeks to transform obesity care standards and enter the animal health market [3][4]. Company Overview - Northstrive Biosciences Inc. focuses on developing innovative solutions for obesity, particularly through preserving muscle mass during weight loss treatments [7]. - PMGC Holdings Inc. manages a diversified portfolio through strategic acquisitions and investments across various industries, including biopharmaceuticals [8].

Core Insights - Northstrive Biosciences Inc., a subsidiary of PMGC Holdings Inc., announced that Co-Founder Deniel Mero was featured in an interview discussing the company's recent FDA interactions regarding its clinical development plans for EL-22, a treatment aimed at obesity [1][2][4] Company Overview - Northstrive Biosciences Inc. focuses on developing innovative aesthetic medicines, with its lead asset EL-22 utilizing a myostatin-engineered probiotic approach to help preserve muscle during weight loss treatments, particularly in conjunction with GLP-1 receptor agonists [5] - PMGC Holdings Inc. is a diversified holding company managing a portfolio that includes Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC, with a commitment to exploring growth opportunities across various sectors [6] Industry Context - The interview highlighted the importance of addressing obesity's unmet needs, particularly the challenge of maintaining muscle mass during weight loss, which is a significant concern in the healthcare industry [2][4]

Core Viewpoint - Northstrive Biosciences Inc. has received preliminary feedback from the FDA regarding its pre-IND meeting, indicating support for the IND submission to initiate a Phase 2 clinical study for EL-22 in combination with GLP-1 receptor agonists [1][2][6] Group 1: FDA Feedback and Clinical Development - The FDA agreed that Northstrive's pharmacology studies support the activity of EL-22 [2] - The FDA indicated that Northstrive's nonclinical studies are adequate to support the safety and activity of EL-22 in overweight and obese populations [2] - Data from Northstrive's Phase 1 study and completed nonclinical studies are sufficient to allow the initiation of the proposed Phase 2 clinical trial [2] Group 2: EL-22 Overview - EL-22 is a novel, patent-pending engineered probiotic designed to express myostatin on its surface, targeting the myostatin pathway to support muscle health [3] - Preclinical studies have shown significant physiological and functional improvements in mdx mice, a model for Duchenne muscular dystrophy [3][4] - EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it to be generally well-tolerated and safe in healthy volunteers [3] Group 3: Company Strategy and Future Plans - Northstrive aims to file the Investigational New Drug application in 2025 and subsequently initiate a Phase 2 clinical trial for obesity treatment [2] - The company is in discussions with cGMP manufacturing partners to prepare for the production of EL-22 [2] - The development of EL-22 addresses the need for preserving muscle in patients undergoing GLP-1 therapies for weight loss [4]

NEWPORT BEACH, Calif., April 16, 2025 (GLOBE NEWSWIRE) -- PMGC Holdings Inc. (NASDAQ:PMGC) (the "Company," "PMGC," "we," or "us"), a diversified public holding company, is pleased to announce the signing of a non-binding Letter of Intent ("LOI") to acquire a U.S.-based, cash-flow positive information technology ("IT") custom packaging company. About the Target Company Founded in 2011 and headquartered in Southern California, the Target is a well-established provider of custom packaging solutions for IT prod ...

Core Viewpoint - Northstrive Biosciences has entered into a Development and License Agreement with Yuva Biosciences to develop novel pharmaceutical treatments for obesity, type 2 diabetes, and other cardiometabolic conditions using YuvaBio's AI-powered mitochondrial science platform MitoNova [1][2][7] Group 1: Agreement Details - The Agreement involves collaboration on an AI Development Program where YuvaBio will develop technology related to mitochondrial science and identify drug candidates to improve mitochondrial health and cardiometabolic function [2][3] - YuvaBio will grant Northstrive an exclusive, worldwide license to the developed technology for therapeutic products targeting cardiac diseases and obesity [2][5] Group 2: AI Development Program - The AI Development Program will utilize YuvaBio's proprietary AI platform combined with laboratory validation to identify and advance novel drug candidates that target mitochondrial function [3][4] - The collaboration will include phases such as in silico modeling, virtual compound screening, and experimental testing to shortlist promising candidates for clinical development [3][4] Group 3: Financial Terms - In exchange for the rights and license, YuvaBio will receive an upfront fee, milestone payments based on program phases, and royalties on net sales of certain therapeutic products developed by Northstrive [5]

Core Viewpoint - PMGC Holdings Inc. has filed its Annual Report for the fiscal year ended December 31, 2024, with the SEC, highlighting its commitment to innovative solutions and long-term shareholder value [1][2]. Company Overview - PMGC is a diversified holding company that manages a portfolio through strategic acquisitions, investments, and development across various industries [3]. - The current portfolio includes three wholly owned subsidiaries: Northstrive Biosciences Inc., PMGC Research Inc., and PMGC Capital LLC [3]. Strategic Initiatives - The company is actively seeking acquisition opportunities that can drive meaningful revenue growth and enhance shareholder value as part of its strategic growth initiatives [2].

Company Strategy and Focus - The company completed the divestiture of Elevai Skincare Inc. on January 16, 2025, allowing it to focus on biotechnology assets and larger market opportunities[19] - PMGC aims to enhance shareholder value by focusing on strategic acquisitions and clinical development in high-growth biotechnology markets[53] - The company actively seeks acquisitions in the biotechnology sector and other high-growth industries to enhance operational efficiencies and unlock market opportunities[89] - The company has established a flexible M&A and licensing model to create value for shareholders through strategic acquisitions and potential spin-offs[89] - The company plans to identify and acquire biotechnology assets and companies with strong commercial potential as part of its growth strategy[141] - The company aims to secure financing and capital to support acquisitions and subsequent growth initiatives[141] Market Opportunities - Northstrive Biosciences Inc. targets the obesity market, with over 40% of U.S. adults affected, projected to rise to 50% by 2030, creating a potential $100 billion market for anti-obesity solutions[21][35] - The anti-obesity drug market could reach $100 billion by 2030, driven by GLP-1 receptor agonists like Novo Nordisk's Ozempic® and Eli Lilly's Mounjaro®[51] - More than 40% of adults in the U.S. currently live with obesity, a figure expected to rise to approximately 50% by 2030, creating a substantial market opportunity[57] Product Development and Clinical Trials - The lead asset, EL-22, has completed a Phase 1 clinical trial in South Korea, showing it was well tolerated and safe, with no significant adverse events reported[23][26] - The company plans to submit an Investigational New Drug (IND) application for EL-22 in 2025 to evaluate its efficacy and safety in combination with GLP-1 receptor agonists[27][32] - PMGC is developing EL-22, an engineered probiotic targeting myostatin, with plans to submit an IND application in 2025 and initiate clinical trials in the U.S.[52] - The company is also developing a second asset, EL-32, which targets muscle preservation in conjunction with weight loss treatments[67] - Preclinical studies of EL-22 demonstrated a significant increase in anti-myostatin IgG antibody concentration and a decrease in creatine kinase levels, indicating reduced muscle destruction[64] Financial Performance - For the year ended December 31, 2024, the company reported net losses of $6,245,737, compared to $4,301,517 for the year ended December 31, 2023[138] - The company's revenue increased from $1,712,595 in 2023 to $2,467,298 in 2024, reflecting a growth of approximately 44%[139] - As of December 31, 2024, the company had net working capital of $4,251,867, up from $3,622,091 in 2023[136] - The accumulated deficit as of December 31, 2024, was $13,269,627, compared to $7,023,890 in 2023[136] - The company has experienced minimal growth since its launch in 2020, with revenue increasing from nil in 2020 to $827 in 2021[139] Regulatory Environment - The FDA regulates biologic drugs through the Biologics License Application (BLA) process, which is subject to changing regulatory requirements[107] - A BLA submission requires substantial time and financial resources, with potential sanctions for non-compliance, including refusal of approval and product recalls[108] - The FDA aims to review and act on a BLA within ten months of filing, but preliminary reviews can add an additional two months[117] - The BLA must include results from preclinical and clinical studies, manufacturing process descriptions, and proposed labeling[116] - Post-marketing requirements may include Phase 4 studies to gather additional safety and efficacy data after initial approval[120] - A risk evaluation and mitigation strategy (REMS) may be required to manage serious risks associated with a biologic[121] - The FDA may withdraw product approval if compliance with post-marketing commitments is not maintained[122] - The IND must become effective within 30 days of submission unless the FDA raises safety concerns[110] - Clinical trials are conducted in three phases, with Phase 3 trials typically being the largest and aimed at establishing the overall risk/benefit ratio[113] - The FDA conducts inspections of manufacturing facilities before approving a BLA to ensure compliance with Good Manufacturing Practices (GMP)[118] Competitive Landscape - The competitive landscape includes major players like Novo Nordisk and Eli Lilly, who are developing GLP-1 drugs for obesity, highlighting the urgency of addressing muscle loss during weight loss treatments[28][36] - PMGC's competitive advantages include a well-recognized team and a focus on innovative biotechnology solutions addressing critical unmet medical needs[73] Risks and Challenges - The company faces significant competition for personnel and may need to increase employee compensation levels to attract and retain talent[142] - The biotechnology industry is highly competitive, and advancements in scientific research could render the company's technologies obsolete[147] - The company relies on strategic partnerships and licensing agreements for revenue generation, and failure to secure these could limit revenue potential[151] - The company must navigate complex regulatory requirements for commercialization, which could impact product viability and market entry[155] - Economic downturns and shifts in healthcare investment trends could adversely affect the company's ability to execute its growth strategy[167] - The company is dependent on the strength of its intellectual property; any challenges could result in loss of competitive advantages[166] - The success of new products and market expansion will significantly impact the company's operational costs and growth[150] - The company may struggle to manage growth effectively, which could lead to increased operating costs and negatively affect results[150] - The ability to attract non-dilutive funding sources is crucial for supporting product development and commercialization efforts[161] - Negative publicity or scientific failures could harm the company's brand and reputation, impacting its ability to secure partnerships and investments[163] - The biotechnology industry is highly dependent on capital access for research and development, with economic downturns potentially reducing funding availability from investors[27] - Regulatory changes can rapidly affect commercialization prospects, with stricter safety requirements or pricing controls potentially reducing asset value[27] - Market demand for biotechnology products is crucial, as healthcare providers and patients must perceive benefits over existing treatments for success[27] - The company relies on strategic partnerships for commercialization, and any reluctance from potential partners could significantly limit revenue potential[27] Human Resources and Operations - As of March 26, 2025, the company has only two full-time employees, relying heavily on non-employee consultants for strategic direction[173] - The company is expanding its executive leadership team and hiring key personnel to support operations, but recent terminations may adversely impact certain functions[176] - The company has a principal executive office of 500 square feet with a monthly rent of $1,561, under a lease running from April 2024 to February 2025[102] Financial Risks - The newly established PMGC Capital LLC introduces additional financial risks, influenced by market volatility and sector-specific risks[181] - The company has a limited operating history at its current scale, making it difficult to evaluate long-term viability and success[182] - The biotechnology business model relies on acquiring and licensing assets, with significant risks associated with regulatory approvals and market demand[190] - The company faces significant investment losses and market volatility risks in biotechnology equities and structured finance deals[196] - There is exposure to third-party legal and compliance risks that could lead to financial, reputational, or legal consequences[197] - The company relies on third-party contractors, which limits its ability to monitor compliance and could result in regulatory investigations or reputational damage[199] - The commercial success of biotechnology assets depends on achieving broad adoption, which is uncertain and could negatively impact financial performance[202] - High manufacturing costs for biotechnology products may significantly lower profit margins compared to competing therapies[207] - Regulatory approval and reimbursement challenges could limit market adoption of portfolio companies' products[208] - Evolving regulations may negatively impact the company's ability to develop, acquire, or commercialize biotechnology assets[212] - The company is exposed to significant legal and regulatory risks related to the development and commercialization of therapeutic product candidates[216]

Company Overview - PMGC Holdings Inc. announced a significant amendment to its License Agreement with MOA Life Plus Co., Ltd. for its subsidiary NorthStrive Biosciences, expanding the license rights to all uses in animal health, including feed additives [1][2] - NorthStrive Biosciences aims to capture new revenue streams from high-growth markets and lower barriers to entry in the animal health pharmaceutical sector [2][3] - The company focuses on developing advanced solutions to meet unmet needs in the U.S. animal health market [2][3] Industry Insights - The U.S. animal health market was valued at USD 12.65 billion in 2024 and is projected to grow at a CAGR of 7.97% from 2025 to 2030 [7] - Growth factors include innovations in companion animal pharmaceuticals, increasing pet adoption rates among millennials, and rising livestock populations in developing countries [7] - The amendment allows NorthStrive Biosciences to develop a comprehensive range of animal health products, which are essential for improving animal health and food security [7]