PART I – FINANCIAL INFORMATION Presents the unaudited condensed consolidated financial information for PMGC Holdings Inc., including financial statements, management's discussion, and controls [Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Presents PMGC Holdings Inc.'s unaudited condensed consolidated financial statements for Q1 2025 and 2024, including Balance Sheets, Statements of Operations, and Cash Flows Condensed Consolidated Balance Sheet Highlights (Unaudited) (in US Dollars) | As of | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Assets** | **$8,888,780** | **$8,993,165** | | Total Current Assets | $6,816,148 | $6,051,001 | | Intangibles, net | $2,072,632 | $2,801,993 | | **Total Liabilities** | **$760,268** | **$2,333,601** | | Total Current Liabilities | $760,268 | $1,799,134 | | **Total Equity** | **$8,128,512** | **$6,659,564** | Condensed Consolidated Statements of Operations Highlights (Unaudited) (in US Dollars) | For the three months ended | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Total operating expenses | $1,201,724 | $799,974 | | Net loss from continuing operations | $(1,580,811) | $(544,121) | | Loss from discontinued operations | $(27,644) | $(853,129) | | **Total net loss** | **$(1,608,455)** | **$(1,397,250)** | | Basic and diluted loss per share - continuing | $(2.902) | $(43.937) | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) (in US Dollars) | For the three months ended | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Cash flows used in operating activities | $(1,347,416) | $(2,324,068) | | Cash flows used in investing activities | $(215,319) | $(59,160) | | Cash flows provided by financing activities | $2,943,185 | $0 | | **Increase (decrease) in cash** | **$1,379,981** | **$(2,383,054)** | | **Cash, ending of period** | **$5,364,434** | **$943,797** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of accounting policies and specific financial statement items, including reorganization, going concern, and equity transactions - The company underwent a name change to PMGC Holdings Inc., redomiciled to Nevada, and executed a combined **1-for-1,400 reverse stock split**[21](index=21&type=chunk)[22](index=22&type=chunk) - The company sold its skincare business in January 2025, transitioning to a diversified holding company model with subsidiaries in biopharmaceuticals, R&D, and investments[23](index=23&type=chunk)[24](index=24&type=chunk) - A **net loss of $1.6 million** for Q1 2025 and an **accumulated deficit of $14.9 million** raise substantial doubt about the company's going concern ability, with management planning financing and asset acquisitions[26](index=26&type=chunk)[28](index=28&type=chunk) - The skincare business sale yielded **1,267,040 shares** of buyer stock (valued at **$728,550**), **$56,525** cash, and assumed liabilities, resulting in a **$39,676 loss on sale**[41](index=41&type=chunk)[42](index=42&type=chunk)[44](index=44&type=chunk) - In Q1 2025, the company terminated License 1, recognizing a **gain of $129,613**, and expanded License 2 rights to include the animal health market[52](index=52&type=chunk)[54](index=54&type=chunk)[61](index=61&type=chunk) - In Q1 2025, the company raised **$1.94 million** from a warrant inducement and **$1.48 million** from a registered direct offering[72](index=72&type=chunk)[75](index=75&type=chunk) - Subsequent to quarter-end, the company entered a **$100 million ATM sales agreement** and sold **491,004 shares** for approximately **$1.24 million** gross proceeds[107](index=107&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and results, highlighting the transition to a diversified holding company, increased operating expenses, and going concern uncertainty - The company transitioned from a skincare business to a diversified holding company, focusing on strategic acquisitions, investments, and development through its subsidiaries[113](index=113&type=chunk) Comparison of Operating Expenses from Continuing Operations (Three Months Ended March 31) (in US Dollars) | Expense Category | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Marketing and Promotion | $35,594 | $131,516 | $(95,922) | | Consulting Fees | $547,557 | $378,473 | $169,084 | | Office and Administration | $209,031 | $132,459 | $76,572 | | Professional Fees | $266,468 | $43,290 | $223,178 | | Research and Development | $32,433 | $2,782 | $29,651 | | **Total operating expenses** | **$1,121,624** | **$799,974** | **$321,649** | - Net loss from continuing operations increased to **$1,580,811** in Q1 2025 from **$544,121** in Q1 2024, driven by higher consulting and professional fees and a **$527,000** net loss on investments[114](index=114&type=chunk)[122](index=122&type=chunk) - As of March 31, 2025, the company held **$5.4 million** in cash and **$6.1 million** in working capital, but recurring losses raise going concern doubts despite management's liquidity confidence[124](index=124&type=chunk) Cash Flow Summary from Continuing Operations (Three Months Ended March 31) (in US Dollars) | Cash Flow Activity | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Cash used in operating activities | $(1,155,514) | $(889,600) | $(265,914) | | Cash used in investing activities | $(215,319) | $(50,000) | $(165,319) | | Cash provided by financing activities | $2,943,185 | $0 | $2,943,185 | [Quantitative and Qualitative Disclosure About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company is exempt from providing quantitative and qualitative market risk disclosures as a smaller reporting company - PMGC Holdings Inc. is exempt from quantitative and qualitative market risk disclosures as a **smaller reporting company**[148](index=148&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that disclosure controls and procedures were **effective** as of March 31, 2025, ensuring timely information recording and reporting[149](index=149&type=chunk)[150](index=150&type=chunk) - No material changes occurred in internal control over financial reporting during the quarter[152](index=152&type=chunk) PART II – OTHER INFORMATION Provides additional information including legal proceedings, equity sales, and exhibits, relevant to the company's operations and governance [Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any pending legal proceedings expected to materially affect its business or financial condition - The company is not currently involved in any material pending legal proceedings[154](index=154&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) As a smaller reporting company, PMGC Holdings Inc. is not required to provide risk factor disclosures - Disclosure of risk factors is not required as the company qualifies as a **smaller reporting company**[155](index=155&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds; Issuer Purchases of Equity Securities](index=37&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%3B%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Discloses the issuance of unregistered equity securities, including common stock and Series B Preferred Stock, and the repurchase of 100 common shares in Q1 2025 - The company issued unregistered securities exempt under Section 4(a)(2), including **438** and **12,000** common shares to a consultant, and **3,036,437** and **3,336,437** Series B Preferred shares to entities owned by the CEO/CFO and Chairman, respectively[157](index=157&type=chunk)[158](index=158&type=chunk) Issuer Purchases of Common Stock (Q1 2025) (Shares and US Dollars) | Period | Total Number of Shares Purchased | Average Price Paid Per Share | | :--- | :--- | :--- | | January 2025 | - | - | | February 2025 | - | - | | March 2025 | 100 | $4.98 | | **Total** | **100** | **N/A** | [Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - No defaults upon senior securities were reported[162](index=162&type=chunk) [Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This disclosure item is not applicable[163](index=163&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - No other information is reported for this item[164](index=164&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) Lists all exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, material contracts, and required certifications - Numerous exhibits are included, such as Articles of Incorporation, Bylaws, related party consulting agreements, license agreements, and securities purchase agreements[167](index=167&type=chunk)[169](index=169&type=chunk) - Certifications by the Principal Executive Officer and Principal Financial Officer under Sections 302 and 906 of Sarbanes-Oxley Act are filed as exhibits[169](index=169&type=chunk)

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]