−Removed: manage and operate a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors:
−Removed: ● Northstrive
−Removed: Biosciences Inc.
−Removed: is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines and
−Removed: therapeutic products.
−Removed: Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s
−Removed: pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
−Removed: PMGC Research Inc.
−Removed: based in Canada, is currently dedicated to medical scientific research and development efforts, utilizing Canadian research grants
−Removed: and partnering with leading Canadian Universities to push the boundaries of innovation.
−Removed: PMGC Capital LLC
−Removed: is a multi-strategy investment firm focused on direct investments, strategic lending, and acquiring undervalued companies and assets
−Removed: across diverse markets.
−Removed: Its mission is to identify and seize high-potential opportunities, delivering sustainable growth and maximizing
−Removed: returns on capital.
−Removed: are dedicated to enhancing our portfolio through the acquisition of operating companies and innovative biotechnology assets that align
−Removed: with our growth mission, while actively pursuing opportunities to foster growth and drive innovation.
−Removed: of January 16, 2025, we completed the divestiture of the assets relating to our prior Elevai Skincare Inc.
−Removed: Elevai Skincare
−Removed: Inc., previously specializing in developing and commercializing physician-dispensed skincare products, is no longer part of our operations.
−Removed: Post closing of the asset sale, we changed the name of Elevai Skincare Inc.
−Removed: changed its name to PMGC Impasse Corp.
−Removed: on January 17, 2025.
−Removed: The Skincare asset divestiture enables us to dedicate more resources and time to advancing our initiatives and assets in larger markets
−Removed: with unmet needs, creating greater growth opportunities for the Company and its shareholders.
−Removed: Our efforts will focus on the clinical
−Removed: development of biotechnology assets through NorthStrive Biosciences Inc.
−Removed: while leveraging our R&D capabilities through PMGC Research
−Removed: Moreover, this strategic shift positions us to actively explore and execute potential business acquisitions and high-value biotechnology
−Removed: assets, further strengthening our portfolio and driving long-term growth.
+Added: As of December 31, 2025, we manage and operate a diverse
+Added: portfolio of four (4) wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors:
+Added: ● Northstrive Biosciences
+Added: (“Northstrive Biosciences”) is a biopharmaceutical company focusing on the development and acquisition of cutting-edge
+Added: aesthetic medicines and therapeutic products.
+Added: Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to
+Added: address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
+Added: ● PMGC Capital LLC (“PMGC
+Added: Capital”) is a multi-strategy investment firm focused on direct investments, strategic lending, and acquiring undervalued companies
+Added: and assets across diverse markets.
+Added: Our mission is to identify and seize high-potential opportunities, delivering sustainable growth and
+Added: maximizing returns on capital.
+Added: Pacific Sun Packaging, Inc.
+Added: (“Pacific Sun Packaging” or “Pacific Sun”) is a specialty packaging provider focused on high-precision, component-level packaging solutions for the electronics and information technology (“IT”) hardware industries.
+Added: The company designs and supplies custom-engineered protective packaging for delicate components such as central processing units (“CPUs”), memory modules (Dual In-line Memory Modules (“DIMMs”) and Small Outline Dual Inline Memory Modules (“SO-DIMMs”), solid state drives (“SSDs”), hard disk drives (“HDDs”), and fiber-optic transceivers, serving customers across the semiconductor, data center, and networking equipment supply chains.
+Added: AGA Precision Systems LLC (“AGA Precision Systems” or “AGA”) is a specialized computer numerical control (“CNC”) machine shop focused on high-tolerance milling, turning, mold manufacturing, and machining of complex metals including titanium and Inconel.
+Added: The company serves customers across the aerospace, defense, and industrial sectors, delivering precision components to demanding technical specifications.
+Added: We are dedicated to enhancing our portfolio through
+Added: the acquisition of operating companies and innovative biotechnology assets that align with our growth mission, while actively pursuing
+Added: the acquisition of operating companies.
+Added: On January 16, 2025, we completed the divestiture of the assets relating
+Added: to our prior Elevai Skincare Inc.
+Added: Elevai Skincare Inc., previously specializing in developing and commercializing physician-dispensed
+Added: skincare products, is no longer part of our operations.
+Added: The Skincare asset divestiture enabled us to dedicate more resources and time
+Added: to advancing our initiatives and assets in larger markets with unmet needs, creating greater growth opportunities for the Company and
+Added: its shareholders.
+Added: Our efforts are now focused on the clinical development of biotechnology assets through NorthStrive Biosciences.
+Added: this strategic shift has positioned us to actively explore and execute potential business acquisitions and high-value biotechnology assets,
+Added: further strengthening our portfolio and driving long-term growth.
+Added: Business Strategy
PMGC Holdings Inc.
−Removed: currently operates as a holding
−Removed: company focusing on developing biotechnology assets, advancing novel science and discoveries through collaborative strategic research
−Removed: and development partnerships.
−Removed: We intend to find and acquire additional operating companies in agnostic sectors.
−Removed: Biosciences Inc.
−Removed: Biosciences Inc., a wholly owned subsidiary of PMGC Holdings Inc., is a biopharmaceutical company focusing on the development and acquisition
−Removed: of cutting-edge aesthetic medicines and therapeutic products.
−Removed: Currently, more than 40% of adults in the United States live with obesity
−Removed: - a figure predicted to rise to approximately 50% by 2030.
−Removed: Obesity is a leading risk factor for the development of serious health conditions,
−Removed: including Type 2 diabetes and heart failure.
−Removed: Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity
−Removed: lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving
−Removed: muscle while on weight loss treatments, including GLP-1 receptor agonists.
−Removed: EL-22 has completed a Phase 1 clinical trial in South Korea,
−Removed: demonstrating it was generally well tolerated and safe in healthy volunteers.
+Added: is a diversified holding company
+Added: focused on acquiring and growing valuable assets and operating businesses across various industries.
+Added: Our strategy is to identify and invest
+Added: in compelling opportunities—regardless of sector—with strong fundamentals, growth potential, and scalable operations.
+Added: seek acquisitions that complement our existing portfolio and align with our long-term value creation objectives.
+Added: Northstrive Biosciences Inc.
+Added: Northstrive Biosciences Inc., a wholly owned subsidiary
+Added: of PMGC Holdings Inc., is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines
+Added: and therapeutic products.
+Added: Currently, more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately
+Added: Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure.
+Added: Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.
+Added: Our lead asset, EL-22, is leveraging a
+Added: first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss
+Added: treatments, including GLP-1 receptor agonists.
+Added: EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it was
+Added: generally well tolerated and safe in healthy volunteers.
No subjects dropped out due to adverse events and no statistically
significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
−Removed: Elevai intends
−Removed: to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal
−Removed: of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
−Removed: We are working towards filing
−Removed: an IND with the FDA to test EL-22 in human subjects.
−Removed: Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin
−Removed: & activin-A and also being positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1
−Removed: receptor agonists.
+Added: intends to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with
+Added: the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
+Added: We are working
+Added: towards either submitting an Investigational New Drug application (“IND”) with the FDA to test EL-22 in human subjects,
+Added: assuming we have sufficient working capital, or collaborating with another company in order to facilitate completing and submitting
+Added: an IND more quickly.
+Added: Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and
+Added: also being positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1 receptor
In a preclinical healthy mouse model, EL-32 demonstrated a statistically significant increase in Activin-A and myostatin
antibodies, confirming the efficacy using the ELISA test.
−Removed: Research Inc .
−Removed: Research Inc., a wholly owned subsidiary of PMGC Holdings Inc., is dedicated to advancing innovative research and development initiatives
−Removed: in Canada by leveraging government grants and funding programs.
−Removed: Through strategic collaborations with leading research institutions and
−Removed: industry partners, PMGC Research Inc.
−Removed: aims to accelerate scientific discovery and transform cutting-edge technologies into commercially
−Removed: viable products.
−Removed: Capital LLC, a wholly owned subsidiary of PMGC Holdings Inc., is a multi-strategy investment vehicle engaged in investing, lending and
−Removed: pursuing diversified investment opportunities.
−Removed: PMGC Capital LLC actively supports the growth and expansion of PMGC Holdings’ portfolio
−Removed: The subsidiary’s dynamic investment approach is designed to capitalize on high yield returns on capital and investing
−Removed: into and acquiring assets and companies that are undervalued.
−Removed: Biosciences Products
−Removed: Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while
−Removed: on weight loss treatments, including GLP-1 receptor agonists.
−Removed: Our lead asset, EL-22, has completed a Phase 1 clinical trial in South
−Removed: Korea, demonstrating it was generally well tolerated and safe in healthy volunteers.
−Removed: No subjects dropped out due to adverse events and
−Removed: no statistically significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
−Removed: results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional
−Removed: (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD) 1 .
−Removed: believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor
−Removed: agonists, by preserving muscle mass while decreasing fat mass.
−Removed: We plan to submit an Investigational New Drug (IND) application in 2025
−Removed: that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the
−Removed: market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
−Removed: bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
−Removed: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
−Removed: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
−Removed: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
+Added: Northstrive Biosciences Products
+Added: Northstrive Biosciences leverages a first-in-class
+Added: engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including
+Added: GLP-1 receptor agonists.
+Added: Our lead asset, EL-22, has completed a Phase 1 clinical trial in South Korea, demonstrating it was generally
+Added: well tolerated and safe in healthy volunteers.
+Added: No subjects dropped out due to adverse events and no statistically significant difference
+Added: was found between the intervention groups in the incidence of treatment emergent adverse events.
+Added: Preclinical results of EL-22 from a 2022 study demonstrated physiological
+Added: (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of
+Added: mdx mice, a mouse model of Duchenne muscular dystrophy (“DMD”) 1 .
+Added: Elevai believes that EL-22 has the potential to treat obesity
+Added: in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat
+Added: We hope to either submit or partner with another biopharmaceutical company in 2026 to submit an IND application in 2025 that utilizes
+Added: the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the
+Added: goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
+Added: Regulatory bodies might require
+Added: us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
+Added: Our second asset, EL-32, is a preclinical engineered
+Added: probiotic expressing dual myostatin & activin-A and also positioned for the muscle preservation space as a combination to weight loss
+Added: treatments, including GLP-1 receptor agonists.
+Added: Several key companies are actively developing GLP-1
+Added: drugs for obesity and complementary treatments to address associated conditions such as muscle wasting.
These companies include:
−Removed: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market.
−Removed: shown significant efficacy in weight loss and improving cardiovascular health.
−Removed: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss.
−Removed: also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
−Removed: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
−Removed: Biohaven’t taldefgrobep is an investigational fusion protein targeting myostatin to impact skeletal muscle growth relevant to individuals
−Removed: living with overweight and obesity.
−Removed: Scholar Rock’s apitegromab is an inhibitor of the activation of latent myostatin, with the aim of improving patients’
−Removed: motor function.
−Removed: Scholar Rock is assessing apitegromab’s ability to preserve lean muscle mass in individuals on GLP-1 receptor agonist
−Removed: therapy for obesity.
−Removed: Veru’s enobosarm is an androgen receptor modulator, also known as a SARM, to address the loss of muscle in patients undergoing
−Removed: weight loss therapy with GLP-1 drugs.
−Removed: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
−Removed: A New Method of Myostatin Inhibition in Mice via Oral Administration
−Removed: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: Novo Nordisk:
+Added: Known for its
+Added: GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market.
+Added: They have shown significant efficacy
+Added: in weight loss and improving cardiovascular health.
+Added: Another major player
+Added: with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss.
+Added: Eli Lilly also acquired Versanis Bio,
+Added: which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
+Added: Developing danuglipron,
+Added: an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
+Added: taldefgrobep is an investigational fusion protein targeting myostatin to impact skeletal muscle growth relevant to individuals living
+Added: with overweight and obesity.
+Added: Scholar Rock:
+Added: Scholar Rock’s
+Added: apitegromab is an inhibitor of the activation of latent myostatin, with the aim of improving patients’ motor function.
+Added: Rock is assessing apitegromab’s ability to preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity.
+Added: Veru’s enobosarm
+Added: is an androgen receptor modulator, also known as a SARM, to address the loss of muscle in patients undergoing weight loss therapy with
+Added: Sung DK, Kim H, Park
+Added: SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus
+Added: casei Expressing Modified Myostatin Protein, BLS-M22, Int.
2022, 23, 9059.
https://doi.org/10.3390/ijms23169059
−Removed: companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective
−Removed: obesity management and the prevention of muscle wasting associated with weight loss.
−Removed: and Competitive Strengths
−Removed: face competition from both commercialized obesity medications, as well as clinical candidates that are still in the development stage.
−Removed: We believe the primary competitive factors in our favor for EL-22 & EL-32 are the following:
−Removed: First-in-Class Approach and Early Results
−Removed: Biosciences is developing EL-22, an engineered probiotic with myostatin antigens, to elicit an immune response that could help people
−Removed: achieve substantial fat loss while preserving muscle mass.
−Removed: Based on the generated preclinical data and the mechanism of the myostatin-activin
−Removed: signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity in combination with GLP-1 receptor
−Removed: agonists by preserving muscle mass while decreasing fat mass.
+Added: These companies are at the forefront of developing
+Added: both GLP-1 drugs and complementary treatments to address the growing need for effective obesity management and the prevention of muscle
+Added: wasting associated with weight loss.
+Added: PMGC Capital LLC
+Added: PMGC Capital LLC, a wholly owned subsidiary of PMGC
+Added: Holdings Inc., is a multi-strategy investment vehicle engaged in investing, lending and pursuing diversified investment opportunities.
+Added: PMGC Capital LLC actively supports the growth and expansion of PMGC Holdings Inc.’s portfolio companies.
+Added: The subsidiary’s
+Added: dynamic investment approach is designed to capitalize on high yield returns on capital and investing into and acquiring assets and companies
+Added: that are undervalued.
+Added: Pacific Sun Packaging, Inc.
+Added: Pacific Sun Packaging is a specialty provider
+Added: of high-precision, component-level packaging solutions serving the electronics and IT hardware industries.
+Added: Headquartered in San Clemente,
+Added: California, Pacific Sun Packaging designs and supplies custom-engineered protective packaging for sensitive IT hardware components, including
+Added: CPUs, memory modules (DIMMs and SO-DIMMs), SSDs, HDDs, and fiber-optic transceivers.
+Added: Pacific Sun Packaging’s packaging solutions
+Added: are engineered to meet demanding standards of durability, electrostatic discharge (ESD) protection, and dimensional precision.
+Added: Sun Packaging serves customers across the semiconductor, data center, and networking equipment supply chains, ensuring the secure transport,
+Added: handling, and storage of delicate, high-value electronic components.
+Added: Pacific Sun Packaging offers a portfolio of custom
+Added: and standard packaging solutions designed for component-level IT hardware applications.
+Added: Its product offerings include:
+Added: ● CPU Packaging – precision
+Added: trays and protective carriers designed to protect processors during handling and shipment.
+Added: ● Memory Module Packaging –
+Added: custom trays for DIMMs and SO-DIMMs used in servers, workstations, and PCs.
+Added: ● Storage Device Packaging –
+Added: protective packaging for solid state drives (SSDs) and hard disk drives (HDDs).
+Added: ● Optical and Networking Packaging
+Added: – solutions for fiber-optic transceivers and related networking hardware components.
+Added: ● Custom Packaging Solutions
+Added: – tailored designs engineered to meet specific customer and component requirements.
+Added: Each solution is engineered to deliver protection against electrostatic
+Added: discharge vibration, and mechanical damage, while enabling ease of handling, automated processing, and efficient integration into customer
+Added: supply chains.
+Added: Pacific Sun Packaging serves a diverse base of over
+Added: 300 commercial customers across North America.
+Added: Its customers include:
+Added: ● Original equipment manufacturers
+Added: ● Contract manufacturers;
+Added: ● Global technology distributors;
+Added: ● Data center operators;
+Added: ● IT asset disposition (“ITAD”)
+Added: and lifecycle management firms.
+Added: These customers rely on Pacific Sun Packaging’s
+Added: specialized solutions to protect valuable IT hardware during manufacturing, distribution, and resale.
+Added: Sales and Marketing
+Added: Pacific Sun Packaging markets its products primarily
+Added: through a direct sales force.
+Added: Pacific Sun Packaging maintains long-standing relationships with customers by focusing on reliability, speed
+Added: of delivery, and the ability to provide tailored solutions.
+Added: Sales efforts emphasize:
+Added: ● Technical collaboration with
+Added: customers during design and production stages;
+Added: ● Responsiveness and speed to
+Added: market for new product requirements;
+Added: ● Consistent product quality
+Added: that reduces returns and integration issues.
+Added: Pacific Sun Packaging also participates in trade shows
+Added: and industry events to strengthen brand visibility.
+Added: The packaging industry is highly competitive and includes
+Added: large multinational packaging companies as well as smaller specialized providers.
+Added: Pacific Sun Packaging differentiates itself through
+Added: ● Focus on component-level IT
+Added: hardware packaging;
+Added: ● Custom engineering capabilities
+Added: tailored to customer needs;
+Added: ● Technical expertise in ESD
+Added: protection and precision molding;
+Added: ● Established reputation for
+Added: reliability among IT hardware supply chain participants.
+Added: Competitive Strengths
+Added: Pacific Sun Packaging’s competitive position
+Added: is supported by the following key strengths:
+Added: Specialization in High-Value
+Added: IT Hardware Packaging – Unlike general packaging providers, Pacific Sun Packaging focuses exclusively on component-level electronics,
+Added: enabling deep technical expertise and customer trust.
+Added: Custom Engineering Capabilities
+Added: – Pacific Sun Packaging’s ability to collaborate directly with OEMs and IT service providers on tailored solutions creates
+Added: high switching costs and long-term customer relationships.
+Added: U.S.-Based Operations –
+Added: Domestic manufacturing and fulfillment provide shorter lead times, reduced logistics risk, and alignment with industry trends favoring
+Added: onshoring of critical supply chains.
+Added: Established Customer Base –
+Added: With over 300 commercial customers, Pacific Sun Packaging benefits from a diversified client network across OEMs, distributors, and ITAD
+Added: Lean and Scalable Operations
+Added: – Pacific Sun Packaging’s disciplined cost structure and quality-focused processes provide a foundation for profitable growth
+Added: and operational scalability.
+Added: Growth Strategy
+Added: Pacific Sun Packaging intends to expand its market
+Added: Broadening its Customer Base
+Added: – targeting new OEMs, distributors, and ITAD firms in growing sectors such as cloud computing and AI infrastructure.
+Added: Expanding Product Offerings
+Added: – developing additional packaging solutions for next-generation IT hardware components.
+Added: Leveraging Industry Trends
+Added: – capitalizing on increased demand for IT lifecycle management, resale, and refurbishment, where packaging plays a critical role
+Added: in maintaining product value.
+Added: Operational Scaling –
+Added: investing in expanded production capacity and efficiency improvements to meet growing demand.
+Added: AGA Precision Systems LLC
+Added: AGA Precision Systems is a specialized computer numerical code CNC
+Added: machine shop focused on high-tolerance milling, turning, mold manufacturing, and machining of complex metals including titanium and Inconel.
+Added: Headquartered in California, AGA Precision Systems serves customers across the aerospace, defense, and industrial sectors, delivering
+Added: precision components to demanding technical specifications.
+Added: AGA Precision Systems has built its business over
+Added: more than a decade, growing primarily via referrals and repeat orders without a formal sales or marketing function.
+Added: Its operations emphasize
+Added: quality, precision, and reliability.
+Added: Precision Machining Industry Overview
+Added: The precision machining industry is a critical part
+Added: of the advanced manufacturing supply chain, supporting sectors such as aerospace, defense, medical devices, energy, and industrial equipment.
+Added: The market is characterized by:
+Added: ● Increasing Demand for High-Precision
+Added: Components – Aerospace and defense programs, particularly those involving next-generation aircraft, spacecraft, and defense systems,
+Added: require components manufactured to extremely tight tolerances.
+Added: ● Specialized Metals Usage –
+Added: Growth in the use of exotic materials such as titanium, Inconel, and other high-performance alloys reflects the need for strength, heat
+Added: resistance, and lightweight performance in mission-critical applications.
+Added: ● Reshoring and Supply Chain
+Added: Security – U.S.
+Added: government initiatives and defense priorities emphasize domestic production of critical parts to reduce reliance
+Added: on foreign suppliers, creating opportunity for U.S.-based CNC machine shops.
+Added: ● Industrial and Commercial Applications
+Added: – Beyond aerospace and defense, precision machining is essential for industries such as energy infrastructure, automotive performance,
+Added: and heavy machinery, all of which rely on exacting quality and reliability.
+Added: Within this context, AGA Precision Systems is positioned
+Added: as a niche provider specializing in high-tolerance machining of complex metals, enabling it to serve programs and customers with stringent
+Added: technical requirements.
+Added: Products & Services
+Added: AGA Precision Systems offers a suite of high-precision
+Added: manufacturing services, including:
+Added: ● High-Tolerance Milling &
+Added: Turning – machining of complex parts to tight tolerances from hard or exotic metals.
+Added: ● Mold Manufacturing –
+Added: design and fabrication of molds used in industrial and aerospace processes.
+Added: ● Specialty Metals Machining
+Added: – handling of difficult materials (e.g., titanium, Inconel) that require specialized tooling, processes, and quality oversight.
+Added: Components produced by AGA Precision Systems are often
+Added: used in mission-critical applications where dimensional accuracy, material properties, and surface finish are essential.
+Added: AGA Precision Systems serves a diversified group of
+Added: clients primarily in:
+Added: ● Aerospace manufacturers and
+Added: ● Defense contractors and programs;
+Added: ● Industrial equipment producers.
+Added: These customers require precision machining of components
+Added: with high standards for performance, durability, and regulatory compliance.
+Added: Long-standing relationships and repeat business are characteristic
+Added: of AGA Precision Systems’ customer base.
+Added: Sales & Marketing
+Added: AGA Precision Systems has historically grown via referrals
+Added: and repeat orders.
+Added: The company has not maintained a formalized sales or marketing department but relies on:
+Added: ● Reputation for precision, quality,
+Added: and reliability;
+Added: ● Word-of-mouth, referrals, and
+Added: customer networks;
+Added: ● Technical credibility and capability
+Added: to meet or exceed customer specifications.
+Added: Going forward, we believe there is opportunity to
+Added: augment growth via more proactive business development, targeted outreach in aerospace/defense programs, and participation in trade or
+Added: industry events.
+Added: Manufacturing & Operations
+Added: AGA Precision Systems operates from its manufacturing
+Added: facility in California.
+Added: Key operational and technical features include:
+Added: ● Capabilities to machine exotic
+Added: and high-performance metals such as titanium and Inconel, which require specialized processes and tooling;
+Added: ● High-precision tolerances,
+Added: strict quality assurance, and inspection processes;
+Added: ● Mold manufacturing capabilities
+Added: that complement standard CNC machining;
+Added: ● Experienced management and
+Added: technical staff with machine shop expertise.
+Added: The precision machining and specialty metals CNC market
+Added: is competitive and includes both small niche shops and larger, vertically integrated manufacturers.
+Added: AGA Precision Systems differentiates
+Added: ● Specialized machining of hard
+Added: and exotic metals to high tolerances;
+Added: ● Reputation and proven reliability
+Added: in aerospace, defense, and industrial segments;
+Added: ● Existing customer relationships
+Added: and repeat business without reliance on large marketing expenditures;
+Added: ● Flexibility in managing small
+Added: to medium-sized, highly technical orders.
+Added: Competitive Strengths
+Added: AGA Precision Systems’ competitive advantages
+Added: Technical Specialization in Exotic Metals & Tight Tolerances
+Added: – its expertise in machining titanium, Inconel, and other challenging metals required for aerospace and defense applications.
+Added: Recognized Industry Certifications & Compliance –
+Added: AGA is International Traffic in Arms Regulations (“ITAR”) registered and maintains AS9100 certification, reinforcing its
+Added: credibility as a qualified manufacturing partner for aerospace and defense customers with strict quality and regulatory requirements.
+Added: Mold Manufacturing Capability
+Added: – its ability to design and fabricate molds provides value beyond standard machining services.
+Added: Long-Standing Customer Relationships
+Added: – its repeat business and referrals from established aerospace, defense, and industrial customers reflect trust and reliability.
+Added: U.S.-Based Operations –
+Added: domestic manufacturing reduces logistics risks, ensures regulatory compliance, and aligns with defense and aerospace reshoring priorities.
+Added: Growth Strategy
+Added: AGA Precision Systems intends to expand its market
+Added: Business Development &
+Added: Marketing Enhancements – formalizing efforts to reach new customers in aerospace, defense, and industrial sectors.
+Added: Expanding Capacity & Efficiency
+Added: – investing in machinery, tooling, process improvements, and quality systems to improve throughput and reduce cost.
+Added: Leveraging Strategic Support
+Added: – using financial and operational resources provided under its parent company to scale operations and compete for larger contracts.
+Added: Diversification of Customer & Program Exposure – pursuing opportunities in government defense programs, industrial supply chains, and emerging sectors beyond its core niches.
+Added: Operational and Competitive Strengths
+Added: We face competition from both commercialized obesity
+Added: medications, as well as clinical candidates that are still in the development stage.
+Added: We believe the primary competitive factors in our
+Added: favor for EL-22 & EL-32 are the following:
+Added: ● Our First-in-Class Approach
+Added: and Early Results
+Added: Northstrive Biosciences is developing EL-22, an engineered
+Added: probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle
+Added: Based on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we
+Added: believe that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing
In the preclinical studies 1 :
−Removed: showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator
−Removed: of muscle growth.
−Removed: showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
−Removed: administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated
−Removed: by a longer duration during rotarod tests.
−Removed: on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we believe that
−Removed: EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass.
−Removed: The Company intends
−Removed: to complete an IND submission in 2025 and to initiate clinical trials in the U.S.
−Removed: to evaluate the myostatin approach in combination with
−Removed: one or more GLP-1 receptor agonists in obesity.
−Removed: Our ability to proceed with human trials is contingent upon the FDA clearing the IND
−Removed: Candidates’ Ease of Use and Convenient Oral Administration
−Removed: believe our product candidates EL-22 and EL-32 would be the only oral myostatin formulations to date, making Northstrive Bioscience an
−Removed: early mover in the emerging GLP-1 combination space for muscle preservation.
−Removed: Existing approaches targeting obesity with combinations
−Removed: to preserve muscle mass while on weight loss therapies are administered through injectable forms;
+Added: ● EL-22 showed a statistically
+Added: significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator of muscle growth.
+Added: ● EL-22 showed a statistically
+Added: significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
+Added: ● EL-22 administered to mdx mice,
+Added: a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated by a longer duration
+Added: during rotarod tests.
+Added: Based on the generated preclinical data and the mechanism of the myostatin-activin
+Added: signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving
+Added: muscle mass while decreasing fat mass.
+Added: The Company aspires to either complete an IND submission in 2026, assuming it has sufficient working
+Added: capital, or to enter into a collaboration with another company to do so.
+Added: Our ability to proceed with human trials in the U.S.
+Added: the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity is contingent upon the FDA clearing the IND
+Added: ● Our Candidates’ Ease
+Added: of Use and Convenient Oral Administration
+Added: We believe our product candidates EL-22 and EL-32
+Added: would be the only oral myostatin formulations to date, making Northstrive Bioscience an early mover in the emerging GLP-1 combination
+Added: space for muscle preservation.
+Added: Existing approaches targeting obesity with combinations to preserve muscle mass while on weight loss therapies
+Added: are administered through injectable forms;
either subcutaneously or intravenously.
−Removed: Although effective, many patients in general prefer orally administered medications over injections due to factors like convenience,
−Removed: ease of administration, and fear of needles.
−Removed: Our product candidates have been designed to be oral capsules to provide benefits without
−Removed: any needling.
−Removed: Biosciences’ strategy focuses primarily on the clinical development and commercialization of novel medicines for the treatment
−Removed: of metabolic diseases, including obesity.
−Removed: We will need substantial capital to support our drug development and any related commercialization
−Removed: efforts for our drug candidates.
−Removed: The key elements of our strategy are:
−Removed: EL-22 & EL-32 for obesity.
−Removed: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
−Removed: A New Method of Myostatin Inhibition in Mice via Oral Administration
−Removed: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: Although effective, many patients in general prefer
+Added: orally administered medications over injections due to factors like convenience, ease of administration, and fear of needles.
+Added: candidates have been designed to be oral capsules to provide benefits without any needling.
+Added: Northstrive Biosciences’ strategy focuses primarily
+Added: on the clinical development and commercialization of novel medicines for the treatment of metabolic diseases, including obesity.
+Added: need substantial capital to support our drug development and any related commercialization efforts for our drug candidates.
+Added: The key elements
+Added: of our strategy are:
+Added: ● Develop EL-22 & EL-32 for
+Added: 1 Sung DK, Kim H, Park SE, Lee J,
+Added: Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei
+Added: Expressing Modified Myostatin Protein, BLS-M22, Int.
2022, 23, 9059.
https://doi.org/10.3390/ijms23169059
−Removed: metabolic drug pipeline is focused on the clinical development of EL-22, a first-in-class engineered probiotic approach to address obesity’s
−Removed: pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
−Removed: Currently, more than 40% of adults
−Removed: in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.
−Removed: 1 Obesity is a leading risk
−Removed: factor for the development of serious health conditions, including Type 2 diabetes and heart failure.
−Removed: Goldman Sachs predicts that this
−Removed: epidemic will create a $100 billion market for anti-obesity players.
−Removed: GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s
−Removed: Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape.
−Removed: However, past studies of these
−Removed: highly effective drugs show that up to 20-50% of the weight loss is due to loss of lean muscle.
−Removed: is necessary for metabolism, strength, and physical function.
−Removed: As a result, we believe that one of the key unmet needs in the current
−Removed: obesity landscape is the avoidance of muscle loss while on weight loss treatments.
−Removed: Northstrive Biosciences is developing EL-22, an engineered
−Removed: probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving
−Removed: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
−Removed: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
−Removed: believe this urgent unmet medical need could be addressed by both EL-22 and EL-32, that may effectively prevent the loss of muscle mass
−Removed: and increase the fat loss experienced by older patients receiving GLP-1 drugs for the treatment of obesity.
−Removed: History and Structure
−Removed: PMGC Holdings Inc.
−Removed: three wholly owned subsidiaries, PMGC Research Inc.
−Removed: (FKA Reactive Medical Inc.), Northstrive Biosciences Inc.
−Removed: and PMGC Capital LLC.
−Removed: Medical Labs Inc.
−Removed: (referred to herein as “Reactive Labs”) was incorporated in Delaware on June 9, 2020.
−Removed: On December 3, 2021,
−Removed: Reactive Labs changed its name to Elevai Labs, Inc.
−Removed: (referred to herein as “Elevai”).
−Removed: Reactive Medical Inc.
−Removed: herein as “Reactive”) was incorporated in British Columbia, Canada on February 5, 2018.
−Removed: On September 7, 2022, Reactive changed
−Removed: its name to Elevai Research Inc.
−Removed: Elevai Research Inc.
−Removed: is a wholly owned subsidiary of the Company.
−Removed: December 20, 2024, the Company re-domesticated to Nevada and changed its name to “PMGC Holdings Inc.”
−Removed: June 2021, we entered into a stock transfer agreement with Reactive, whereby we purchased substantially all of the assets and liabilities
−Removed: Under the stock transfer agreement, we acquired 100% of the issued and outstanding common shares of Reactive.
−Removed: before the stock transfer agreement BWL Investments Ltd., a British Columbia Canada corporation owned 100% of the issued and outstanding
−Removed: common shares of Reactive.
−Removed: In consideration of 100% of the issued and outstanding common shares of Reactive we issued 100 shares of our
−Removed: Common Stock to BWL Investments Ltd.
−Removed: Upon completion of the stock transfer agreement, Reactive became our wholly owned subsidiary.
−Removed: September 2022, Reactive changed its name to Elevai Research Inc.
−Removed: On January 10, 2025, Elevai Research Inc.
−Removed: changed its name to PMGC
−Removed: Research Inc.
−Removed: Industry and Other Research-Based Data
−Removed: Market and Industry
−Removed: have transitioned to a biotechnology holding company focused on acquiring, licensing, and developing biotechnology assets across various
−Removed: pharmaceutical indications.
−Removed: Our business model consists of two primary components:
−Removed: Capital LLC, our multi-strategy investment vehicle, which seeks to generate revenue through capital deployment in undervalued biotechnology
−Removed: assets, structured financings, and public and private market investments.
−Removed: NorthStrive Biosciences Inc., our biotechnology subsidiary focused on advancing clinical-stage assets toward regulatory approval and commercialization.
−Removed: ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL.
+Added: Our metabolic drug pipeline is focused on the clinical
+Added: development of EL-22, a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while
+Added: on weight loss treatments, including GLP-1 receptor agonists.
+Added: Currently, more than 40% of adults in the United States live with obesity
+Added: - a figure predicted to rise to approximately 50% by 2030.
+Added: 1 Obesity is a leading risk factor for the development of serious
+Added: health conditions, including Type 2 diabetes and heart failure.
+Added: Goldman Sachs predicts that this epidemic will create a $100 billion market
+Added: for anti-obesity players.
+Added: Approved GLP-1 drugs used in weight loss, such as
+Added: Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s Zepbound (tirzepatide), and Mounjaro®
+Added: (tirzepatide) have transformed the obesity treatment landscape.
+Added: However, past studies of these highly effective drugs show that up to
+Added: 20-50% of the weight loss is due to loss of lean muscle.
+Added: Muscle is necessary for metabolism, strength, and
+Added: physical function.
+Added: As a result, we believe that one of the key unmet needs in the current obesity landscape is the avoidance of muscle
+Added: loss while on weight loss treatments.
+Added: Northstrive Biosciences is developing EL-22, an engineered probiotic with myostatin antigens, to
+Added: elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass.
+Added: Our second asset, EL-32, is a preclinical engineered
+Added: probiotic expressing dual myostatin & activin-A and also positioned for the muscle preservation space as a combination to weight loss
+Added: treatments, including GLP-1 receptor agonists.
+Added: We believe this urgent unmet medical need could be
+Added: addressed by both EL-22 and EL-32, that may effectively prevent the loss of muscle mass and increase the fat loss experienced by older
+Added: patients receiving GLP-1 drugs for the treatment of obesity.
+Added: Ward ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL.
Projected U.S.
−Removed: State-Level Prevalence of Adult Obesity
−Removed: and Severe Obesity.
+Added: State-Level Prevalence of Adult Obesity and Severe Obesity.
N Engl J Med 2019;381:2440-2450.
https://www.nejm.org/doi/full/10.1056/NEJMsa1909301.
−Removed: the anti-obesity drug market could grow to $100 billion by 2030.
+Added: Why the anti-obesity drug market could grow to $100 billion by 2030.
https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
−Removed: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
−Removed: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose
−Removed: Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
+Added: Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
+Added: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
Endocrinol Metab (Seoul).
1 unchanged sentence
10.3803/EnM.2019.34.3.247.
−Removed: part of this strategic shift, we no longer operate in the physician-dispensed cosmetics or medical aesthetics markets.
−Removed: Instead, our focus
−Removed: is on developing and acquiring biotechnology assets that address critical unmet medical needs.
−Removed: global biotechnology market continues to grow, driven by advancements in gene therapies, regenerative medicine, and biologics.
−Removed: to market research, the global biotechnology industry was valued at approximately $1.37 trillion in 2022 and is expected to grow at a
−Removed: CAGR of 12.8% from 2023 to 2030.
−Removed: 28 This expansion is fueled by rising R&D investments, regulatory approvals, and the increasing
−Removed: adoption of biotechnology-based therapies.
−Removed: biopharmaceutical sector, which includes therapeutic proteins, monoclonal antibodies, and cell & gene therapies, represents a significant
−Removed: share of this growth.
−Removed: The market for gene therapies alone is expected to exceed $25 billion by 2028, with companies rapidly advancing
−Removed: clinical-stage assets in oncology, metabolic diseases, and neurodegenerative disorders.
−Removed: weight-loss drug market has also emerged as a high-growth sector, with GLP-1 receptor agonists such as Novo Nordisk’s Ozempic®
−Removed: and Eli Lilly’s Mounjaro® driving unprecedented demand.
−Removed: Goldman Sachs projects the anti-obesity drug market could reach $100
−Removed: billion by 2030.
−Removed: 30 However, research indicates that up to 40% of weight loss from GLP-1 drugs comes from lean muscle loss,
−Removed: creating an unmet need for therapies that preserve muscle mass during treatment.
−Removed: Lead Asset - EL-22:
−Removed: A Myostatin-Targeting Probiotic for Obesity and Muscle Preservation
−Removed: is currently developing EL-22, an engineered probiotic expressing myostatin antigens, designed to elicit an immune response that helps
−Removed: preserve muscle mass while promoting fat loss.
−Removed: Based on preclinical data and the role of myostatin-activin signaling in muscle metabolism,
−Removed: we believe EL-22 has the potential to:
−Removed: existing GLP-1 receptor agonists (e.g., Ozempic®, Wegovy®, Mounjaro®) by reducing muscle degradation while facilitating fat
−Removed: muscle function and physical endurance, addressing key concerns associated with weight loss treatments.
−Removed: studies demonstrated that EL-22:
−Removed: ● Significantly
−Removed: increased anti-myostatin IgG antibody concentration, blocking myostatin-a known negative regulator of muscle growth.
−Removed: creatine kinase levels, indicating lower muscle destruction.
−Removed: physical activity and motor function in mdx mice, a model for Duchenne muscular dystrophy (DMD).
−Removed: intends to submit an Investigational New Drug (IND) application for EL-22 in 2025 and initiate clinical trials in the U.S.
−Removed: its potential in combination with GLP-1 receptor agonists for obesity treatment.
−Removed: However, human trials are contingent upon FDA clearance
−Removed: of the IND submission.
−Removed: PMGC Capital LLC driving investment revenue and NorthStrive Biosciences Inc.
−Removed: advancing clinical assets like EL-22, our business is well-positioned
−Removed: to capitalize on emerging opportunities in biotechnology.
−Removed: By focusing on strategic acquisitions, clinical development, and high-growth
−Removed: markets, we aim to enhance shareholder value and establish PMGC Holdings as a leader in biotechnology innovation.
−Removed: Biotechnology
−Removed: Market Size Report, 2023-2030.
+Added: Corporate History and Structure
+Added: As of December 31, 2025, PMGC Holdings Inc.
+Added: (4) wholly owned subsidiaries, Northstrive Biosciences Inc., PMGC Capital LLC, Pacific Sun Packaging, Inc., and AGA Precision Systems
+Added: Our predecessor company, Elevai Labs, Inc., was
+Added: incorporated in Delaware in June 2020, and completed its initial public offering of Common Stock on November 24, 2023.
+Added: On December 20,
+Added: 2024, the Company re-domesticated to Nevada and changed its name to “PMGC Holdings Inc.” In January 2025, the Company completed
+Added: its divestiture of the Elevai Skincare business and another operating subsidiary, Elevai Biosciences, Inc., changed its name to Northstrive
+Added: In July 2025, the Company acquired both AGA Precision Systems and
+Added: Pacific Sun Packaging, respectively.
+Added: Market, Industry and Other Research-Based Data
+Added: Our Market and Industry
+Added: We have transitioned to a diversified holding
+Added: company focused on acquiring and growing valuable assets and operating businesses across various industries.
+Added: Our strategy is to identify
+Added: and invest in compelling opportunities—regardless of sector—with strong fundamentals, growth potential, and scalable operations.
+Added: We actively seek acquisitions that complement our existing portfolio and align with our long-term value creation objectives.
+Added: business model consists of four (4) primary components:
+Added: PMGC Capital LLC, our multi-strategy
+Added: investment vehicle, which seeks to generate revenue through capital deployment in undervalued assets, structured financings,
+Added: and public and private market investments.
+Added: NorthStrive Biosciences Inc.,
+Added: our biotechnology subsidiary focused on advancing clinical-stage assets toward regulatory approval and commercialization.
+Added: Pacific Sun Packaging, Inc., our specialty packaging subsidiary focused
+Added: on high-precision, component-level packaging solutions for the electronics and IT hardware industries, including custom-engineered protective
+Added: packaging for central processing units, memory modules, solid-state drives, hard disk drives, and fiber-optic transceivers across semiconductor,
+Added: data center, and networking supply chains.
+Added: AGA Precision Systems LLC, our precision manufacturing
+Added: subsidiary focused on high-tolerance CNC milling and turning, mold manufacturing, and machining of complex metals such as titanium and
+Added: Inconel, serving aerospace, defense, and industrial customers, and operating with ITAR registration and AS9100 certification to meet stringent
+Added: regulatory and quality requirements.
+Added: As part of this strategic shift, we no longer
+Added: operate in the physician-dispensed cosmetics or medical aesthetics markets.
+Added: The Company has transitioned to a diversified holding company
+Added: structure, operating through wholly owned subsidiaries across the biotechnology, advanced manufacturing, specialty packaging, and investment
+Added: We believe this diversified structure provides the Company with the ability to pursue growth opportunities across multiple industries
+Added: and reduces the risks associated with concentration in a single market or product line.
+Added: Industry Data
+Added: The following industry data is derived from third-party
+Added: sources that we believe to be reliable but that we have not independently verified.
+Added: Investors should not place undue reliance on these
+Added: estimates, and there can be no assurance that our business will grow at rates comparable to the industry projections described below.
+Added: See “Risk Factors — Certain market opportunity data and forecasts in this Annual Report were obtained from third-party sources
+Added: and were not independently verified by us.”
+Added: Biotechnology and Anti-Obesity Therapeutics
+Added: The global biotechnology market continues to grow,
+Added: driven by advancements in gene therapies, regenerative medicine, and biologics.
+Added: According to Grand View Research, the global biotechnology
+Added: industry was valued at approximately $1.37 trillion in 2022 and is expected to grow at a compound annual growth rate (“CAGR”)
+Added: of 12.8% from 2023 to 2030.¹ This expansion is fueled by rising research and development investments, regulatory approvals, and the
+Added: increasing adoption of biotechnology-based therapies.
+Added: The weight-loss drug market has emerged as a high-growth
+Added: sector, with GLP-1 receptor agonists such as Novo Nordisk’s Ozempic® and Eli Lilly’s Mounjaro® driving significant demand.
+Added: Sachs projects the anti-obesity drug market could reach $100 billion by 2030.² Currently, more than 40% of adults in the United States
+Added: live with obesity, a figure predicted to rise to approximately 50% by 2030.³ Obesity is a leading risk factor for the development
+Added: of serious health conditions, including Type 2 diabetes and heart failure.
+Added: However, research indicates that up to 40% of weight loss from GLP-1 drugs comes from loss
+Added: of lean muscle mass, creating an unmet need for therapies that preserve muscle mass during treatment.⁴ We believe this represents
+Added: a significant market opportunity for our lead asset, EL-22.
+Added: Precision Manufacturing and Aerospace &
+Added: The precision machining industry is a critical
+Added: component of the advanced manufacturing supply chain, supporting sectors such as aerospace, defense, medical devices, energy, and industrial
+Added: According to Grand View Research, the global precision machining market was valued at approximately $123 billion in 2025 and
+Added: is expected to grow at a CAGR of approximately 8.1% from 2026 to 2033, driven by rising demand for high-precision components across advanced
+Added: industries and accelerated adoption of CNC automation and smart manufacturing.⁵
+Added: The aerospace and defense sector in
+Added: particular requires components manufactured to extremely tight tolerances from specialized materials such as titanium, Inconel, and
+Added: other high-performance alloys.
+Added: government initiatives and defense priorities continue to emphasize domestic production of
+Added: critical parts to reduce reliance on foreign suppliers, creating opportunity for U.S.-based precision manufacturers.⁶ The
+Added: global aerospace parts manufacturing market was valued at approximately $913 billion in 2023 and is expected to grow at a CAGR of
+Added: approximately 4.2% from 2024 to 2030.⁷
+Added: Specialty IT Hardware Packaging
+Added: The global electronic packaging market serves
+Added: the semiconductor, data center, and networking equipment supply chains and is driven by increasing demand for IT infrastructure, cloud
+Added: computing, and artificial intelligence applications.
+Added: According to Grand View Research, the market was valued at approximately $62.5 billion
+Added: in 2024 and is expected to reach $89.7 billion by 2030, growing at a CAGR of about 6.2%, supported by expanding data center construction,
+Added: growth in semiconductor production, and increasing demand for IT asset lifecycle management, resale, and refurbishment, where packaging
+Added: plays a critical role in maintaining product value.⁸
+Added: The trend toward onshoring critical supply chains
+Added: in the United States, combined with increasing data center capital expenditure, creates favorable demand dynamics for domestic specialty
+Added: packaging providers focused on component-level IT hardware protection.
+Added: Northstrive Biosciences Products
+Added: Northstrive Biosciences leverages a first-in-class
+Added: engineered probiotic approach to address the pressing issue of preserving muscle mass while on weight loss treatments, including GLP-1
+Added: receptor agonists.
+Added: Our lead asset, EL-22, is an engineered probiotic
+Added: expressing myostatin antigens, designed to elicit an immune response that helps preserve muscle mass while promoting fat loss.
+Added: completed a Phase 1 clinical trial in South Korea, demonstrating it was generally well tolerated and safe in healthy volunteers.
+Added: dropped out due to adverse events and no statistically significant difference was found between the intervention groups in the incidence
+Added: of treatment-emergent adverse events.
+Added: Preclinical results of EL-22 from a 2022 study
+Added: demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in
+Added: the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy
+Added: Based on the generated preclinical data and the
+Added: mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity
+Added: in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing fat mass.
+Added: In the preclinical studies:
+Added: ● EL-22 showed a statistically significant increase in anti-myostatin IgG antibody concentration, where
+Added: myostatin is a key negative regulator of muscle growth.
+Added: ● EL-22 showed a statistically significant decrease in creatine kinase levels, which indicates a decrease
+Added: of muscle destruction.
+Added: ● EL-22 administered to mdx mice had improved physical activity and gross motor function, as demonstrated
+Added: by a longer duration during rotarod tests.
+Added: The Company intends to complete an IND submission
+Added: in 2025 and to initiate clinical trials in the U.S.
+Added: to evaluate the myostatin approach in combination with one or more GLP-1 receptor
+Added: agonists in obesity.
+Added: Our ability to proceed with human trials is contingent upon the FDA clearing the IND submission.
+Added: Regulatory bodies might require us to conduct
+Added: preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
+Added: Our second asset, EL-32, is a preclinical engineered
+Added: probiotic expressing dual myostatin & activin-A antigens and is also positioned for the muscle preservation space as a combination
+Added: to weight loss treatments, including GLP-1 receptor agonists.
+Added: In a preclinical healthy mouse model, EL-32 demonstrated a statistically
+Added: significant increase in activin-A and myostatin antibodies, confirming the efficacy using the ELISA test.
+Added: Pacific Sun Packaging Products and Services
+Added: Pacific Sun Packaging offers a portfolio of custom
+Added: and standard packaging solutions designed for component-level IT hardware applications, including CPU packaging, memory module packaging
+Added: (DIMMs and SO-DIMMs), storage device packaging (SSDs and HDDs), optical and networking packaging (fiber-optic transceivers and related
+Added: networking hardware), and custom packaging solutions tailored to specific customer and component requirements.
+Added: Each solution is engineered
+Added: to deliver protection against electrostatic discharge (“ESD”), vibration, and mechanical damage, while enabling ease of handling,
+Added: automated processing, and efficient integration into customer supply chains.
+Added: AGA Precision Systems Products and Services
+Added: AGA Precision Systems offers a suite of high-precision
+Added: manufacturing services, including high-tolerance milling and turning of complex parts from hard or exotic metals, mold manufacturing for
+Added: industrial and aerospace applications, and specialty metals machining of difficult materials such as titanium and Inconel that require
+Added: specialized tooling, processes, and quality oversight.
+Added: Components produced by AGA Precision Systems are often used in mission-critical
+Added: applications where dimensional accuracy, material properties, and surface finish are essential.
+Added: We face competition across each of our operating
+Added: Northstrive Biosciences — Biotechnology
+Added: The obesity and muscle preservation therapeutic market is highly
+Added: Several key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address
+Added: associated conditions such as muscle wasting.
+Added: These companies include:
+Added: Novo Nordisk — a leader in the GLP-1 drug market with its products Ozempic® (semaglutide)
+Added: and Wegovy® (semaglutide), which have shown substantial efficacy in weight loss and improving cardiovascular health.
+Added: Eli Lilly — developer of Mounjaro® (tirzepatide) and Zepbound® (tirzepatide) for
+Added: obesity treatment.
+Added: Eli Lilly also acquired Versanis Bio, which is developing bimagrumab, a drug designed to increase lean muscle mass
+Added: while reducing fat.
+Added: Pfizer — developing danuglipron, an oral GLP-1 analog aimed at offering a more convenient
+Added: dosing regimen for obesity treatment.
+Added: Biohaven — developing taldefgrobep, an investigational fusion protein targeting myostatin
+Added: to impact skeletal muscle growth in individuals living with overweight and obesity.
+Added: Scholar Rock — developing apitegromab, an inhibitor of latent myostatin activation, and assessing
+Added: its ability to preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity.
+Added: Veru — developing enobosarm, an androgen receptor modulator to address the loss of muscle
+Added: in patients undergoing weight loss therapy with GLP-1 drugs.
+Added: Altimmune — developing pemvidutide, a GLP-1 drug that has shown potential in weight loss
+Added: and reduction of dyslipidemia.
+Added: AstraZeneca, Bristol Myers Squibb, Novartis, and Amgen — in the early stages of developing
+Added: obesity treatments, including various GLP-1 receptor agonists and other pharmacological approaches.
+Added: These companies have significantly greater financial,
+Added: technical, manufacturing, marketing, and human resources than we do.
+Added: There can be no assurance that we will be able to compete effectively
+Added: against these or other competitors.
+Added: Pacific Sun Packaging — Specialty Packaging
+Added: The packaging industry is highly competitive and
+Added: includes large multinational packaging companies as well as smaller specialized providers.
+Added: Pacific Sun Packaging differentiates itself
+Added: through its focus on component-level IT hardware packaging, custom engineering capabilities tailored to customer specifications, technical
+Added: expertise in ESD protection and precision molding, and established reputation for reliability among IT hardware supply chain participants.
+Added: We compete with both domestic and international packaging providers, some of which have substantially greater resources than we do.
+Added: AGA Precision Systems — Precision Manufacturing
+Added: The precision machining and specialty metals CNC
+Added: market is competitive and includes both small niche machine shops and larger, vertically integrated manufacturers.
+Added: AGA Precision Systems
+Added: differentiates itself through specialized machining of hard and exotic metals to high tolerances, reputation and proven reliability in
+Added: aerospace, defense, and industrial segments, existing customer relationships and repeat business, ITAR registration and AS9100 certification,
+Added: mold manufacturing capabilities, and flexibility in managing small to medium-sized highly technical orders.
+Added: We compete with other domestic
+Added: CNC machine shops and larger manufacturers, some of which have substantially greater resources, broader capabilities, and more established
+Added: customer relationships.
+Added: Operational and Competitive Strengths
+Added: We believe our competitive position is supported
+Added: by the following key strengths across our operating segments:
+Added: ● Diversified Holdings Across Multiple Industries.
+Added: We operate wholly owned subsidiaries across the
+Added: biotechnology, advanced manufacturing, specialty packaging, and investment sectors.
+Added: This diversified structure provides the Company with
+Added: exposure to multiple end markets and reduces the risks associated with concentration in a single industry.
+Added: ● Strategic Capital Deployment.
+Added: Through PMGC Capital LLC, we seek to deploy capital into undervalued
+Added: assets and investment opportunities, with the objective of generating returns on capital while expanding our portfolio of operating businesses
+Added: and investments.
+Added: ● Advancement of High-Potential Biotechnology Assets.
+Added: Our subsidiary, Northstrive Biosciences Inc.,
+Added: is advancing EL-22 and EL-32, product candidates targeting muscle preservation in combination with weight loss treatments, addressing
+Added: what we believe to be a significant unmet medical need in the obesity treatment landscape.
+Added: ● First-in-Class Oral Myostatin Approach.
+Added: We believe our product candidates EL-22 and EL-32 would
+Added: represent the only oral myostatin formulations currently in development, providing a potential competitive advantage over existing injectable
+Added: approaches to muscle preservation.
+Added: Existing approaches targeting muscle preservation in combination with weight loss therapies are administered
+Added: through injectable forms, whereas our product candidates have been designed as oral capsules.
+Added: ● Specialized Precision Manufacturing Capabilities.
+Added: AGA Precision Systems provides high-tolerance
+Added: machining of complex and exotic metals, including titanium and Inconel, for aerospace, defense, and industrial customers.
+Added: AGA’s ITAR registration
+Added: and AS9100 certification position it to serve customers with stringent regulatory and quality requirements, and its U.S.-based operations
+Added: align with industry trends favoring domestic production of critical components.
+Added: ● Niche IT Hardware Packaging Expertise.
+Added: Pacific Sun Packaging focuses exclusively on component-level
+Added: electronics packaging, providing deep technical expertise, custom engineering capabilities, and high switching costs that support long-term
+Added: customer relationships.
+Added: Pacific Sun serves a diversified base of commercial customers across OEMs, distributors, and ITAD firms.
+Added: ● U.S.-Based Operations.
+Added: Both Pacific Sun Packaging and AGA Precision Systems operate from facilities
+Added: in California, providing shorter lead times, reduced logistics risk, and alignment with industry trends favoring onshoring of critical
+Added: supply chains and domestic manufacturing.
+Added: ● Flexible M&A and Licensing Model.
+Added: Our holding company structure allows for strategic acquisitions,
+Added: licensing arrangements, and potential spin-offs of wholly owned subsidiaries or specific assets, providing flexibility to pursue value
+Added: creation opportunities across multiple sectors.
+Added: Biotechnology Market Size Report, 2023-2030.
(Grand View Research).
−Removed: Therapy Market Growth, 2028.
−Removed: (Fortune Business Insights)
−Removed: the Anti-Obesity Drug Market Could Grow to $100 Billion by 2030.
+Added: Why the Anti-Obesity Drug Market Could Grow to $100 Billion by 2030.
(Goldman Sachs).
−Removed: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
−Removed: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists on Lean Body
−Removed: Mass in Humans.
−Removed: Endocrinol Metab (Seoul).
−Removed: 2019 Sep;34(3):247-262.
−Removed: 10.3803/EnM.2019.34.3.247.
−Removed: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
−Removed: A New Method of Myostatin Inhibition in Mice via Oral Administration
−Removed: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22.
−Removed: 2022, 23, 9059.
−Removed: https://doi.org/10.3390/ijms23169059.
−Removed: more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.
−Removed: Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure.
−Removed: Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.
−Removed: GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s
−Removed: Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape.
−Removed: However, past studies of these
−Removed: highly effective drugs show that up to 40% of the weight loss is due to loss of lean muscle.
−Removed: is necessary for metabolism, strength, and physical function.
−Removed: As a result, we believe that one of the key unmet needs in the current
−Removed: obesity landscape is the avoidance of muscle loss while on weight loss treatments.
−Removed: PMGC is developing EL-22, an engineered probiotic
−Removed: with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass.
−Removed: on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, PMGC believes
−Removed: that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing
−Removed: In the preclinical studies, 27
−Removed: showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator
−Removed: of muscle growth.
−Removed: showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
−Removed: administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function,
−Removed: as demonstrated by a longer duration during rotarod tests.
−Removed: on the highlighted preclinical data, PMGC believes that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving
−Removed: muscle mass while decreasing fat mass.
−Removed: The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the
−Removed: to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity.
−Removed: Our ability to proceed with
−Removed: a human trial is contingent upon the FDA clearing the IND submission.
−Removed: ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL.
+Added: Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, Gortmaker SL.
Projected U.S.
−Removed: State-Level Prevalence of Adult Obesity
−Removed: and Severe Obesity.
+Added: Prevalence of Adult Obesity and Severe Obesity.
N Engl J Med 2019;381:2440-2450.
−Removed: https://www.nejm.org/doi/full/10.1056/NEJMsa1909301.
−Removed: the anti-obesity drug market could grow to $100 billion by 2030.
−Removed: https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
−Removed: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
−Removed: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose
−Removed: Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
+Added: Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
+Added: A Review of the Effects of Glucagon-Like
+Added: Peptide-1 Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
Endocrinol Metab (Seoul).
Sep;34(3):247-262.
−Removed: 10.3803/EnM.2019.34.3.247.
−Removed: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
−Removed: A New Method of Myostatin Inhibition in Mice via Oral Administration
−Removed: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
−Removed: 2022, 23, 9059.
−Removed: https://doi.org/10.3390/ijms23169059.
−Removed: Biosciences Products
−Removed: Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while
−Removed: on weight loss treatments, including GLP-1 receptor agonists.
−Removed: Our lead asset, EL-22, has completed a Phase 1 clinical trial in South
−Removed: Korea, demonstrating it was generally well tolerated and safe in healthy volunteers.
−Removed: No subjects dropped out due to adverse events and
−Removed: no statistically significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
−Removed: results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional
−Removed: (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD) 1 .
−Removed: PMGC believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor
−Removed: agonists, by preserving muscle mass while decreasing fat mass.
−Removed: We plan to submit an Investigational New Drug (IND) application in 2025
−Removed: that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the
−Removed: market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
−Removed: bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
−Removed: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
−Removed: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
−Removed: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
−Removed: These companies include:
−Removed: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market.
−Removed: shown significant efficacy in weight loss and improving cardiovascular health.
−Removed: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss.
−Removed: also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
−Removed: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
−Removed: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reduction of dyslipidemia.
−Removed: Bristol Myers Squibb, Novartis, and Amgen:
−Removed: These companies are in the early stages of developing obesity treatments, including various
−Removed: GLP-1 receptor agonists and other innovative pharmacological approaches.
−Removed: Developing S-309309, an oral MGAT2 inhibitor, which targets lipid metabolism for weight loss.
−Removed: Their APHD-012 mimics the metabolic benefits of bypass surgery.
−Removed: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
−Removed: A leader in the GLP-1 drug market with its products Ozempic and Wegovy.
−Removed: These drugs have shown substantial efficacy in weight
−Removed: loss and improving cardiovascular health.
−Removed: Eli Lilly’s GLP-1 drug, Mounjaro (tirzepatide), is known for its significant weight loss results.
−Removed: Additionally, Eli Lilly acquired
−Removed: Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
−Removed: Pfizer is developing an oral GLP-1 analog, danuglipron, aimed at offering a more convenient dosing regimen for obesity treatment.
−Removed: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reducing dyslipidemia, contributing to overall metabolic health.
−Removed: Bristol Myers Squibb, Novartis, and Amgen:
−Removed: These companies are in the early stages of developing obesity treatments, including various
−Removed: GLP-1 receptor agonists and other innovative pharmacological approaches.
−Removed: Shionogi is developing S-309309, an oral MGAT2 inhibitor that targets lipid metabolism for weight loss.
−Removed: Their drug APHD-012 mimics the metabolic benefits of bypass surgery, offering a novel approach to weight loss.
−Removed: companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective
−Removed: obesity management and the prevention of muscle wasting associated with weight loss.
+Added: Precision Machining Market (2026 - 2033) (Grand View Research).
+Added: Department of Defense, Securing Defense-Critical Supply Chains (Feb.
+Added: Aerospace Parts Manufacturing Market Report (Grand View Research)
+Added: Electronic Packaging Market (2025 - 2030) (Grand View Research)
Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
−Removed: A New Method of Myostatin Inhibition in Mice via Oral Administration
−Removed: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: A New Method of Myostatin Inhibition
+Added: in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22.
2022, 23, 9059.
https://doi.org/10.3390/ijms23169059.
−Removed: and Competitive Strengths
−Removed: operate in a highly competitive biotechnology and investment landscape, facing competition from pharmaceutical companies, biotechnology
−Removed: firms, and investment funds.
−Removed: Our key competitive advantages include:
−Removed: Capital Deployment:
−Removed: Through PMGC Capital LLC, we seek to acquire undervalued assets, optimizing capital returns while expanding our portfolio.
−Removed: ● Diversified
−Removed: Biotechnology Holdings:
−Removed: We establish wholly owned subsidiaries to develop clinical-stage and preclinical assets across multiple therapeutic
−Removed: Advancement of High-Potential Biotechnology Assets:
−Removed: Our subsidiary, NorthStrive Biosciences Inc., is progressing EL-22, a lead asset targeting muscle preservation in obesity treatment.
−Removed: M&A and Licensing Model:
−Removed: Our structure allows for strategic acquisitions, licensing deals, and potential spin-offs, creating value
−Removed: for shareholders.
−Removed: As of the date of this Annual Report on Form 10-K,
−Removed: there are no FDA approved medical products utilizing exosomes.
−Removed: Well Recognized and Award-winning Team and Brand
−Removed: Executive Officer and Chief Financial Officer
−Removed: Bensler is a financial professional and executive with over seven years of experience in financial consulting and management for both
−Removed: private businesses and U.S./Canadian publicly traded companies.
−Removed: He co-founded an EdTech curriculum management and scheduling company
−Removed: in 2017, which was implemented in academic institutions across Canada and the United States.
−Removed: From 2017 to 2019, he served as an account
−Removed: manager at a leading Canadian investor relations firm, collaborating with investment banks, brokers, and company executives across various
−Removed: Between 2019 and 2021, Mr.
−Removed: Bensler was a Senior Associate at Evans & Evans, a Canadian boutique investment banking firm,
−Removed: where he led valuations and facilitated public offerings for companies in Canada and the U.S.
−Removed: He holds a Bachelor of Management and Organizational
−Removed: Studies degree with a specialization in Finance from the University of Western Ontario and is a CFA Charterholder.
−Removed: Northstrive Biosciences Inc.
−Removed: Mero is a biotechnology analyst who served as Research Director at PropThink, a leading online platform for healthcare investors.
−Removed: has a talent for business development and identifying pharmaceutical licensing opportunities from top collaborators and university researchers.
−Removed: Mero was instrumental in discovering our lead asset, EL-22, and in the formation of NorthStrive Biosciences.
−Removed: He earned his Bachelor
−Removed: of Commerce degree with a specialization in Finance and Economics from the University of Toronto.
−Removed: Advisory Board
−Removed: Fielding, PhD
−Removed: Fielding serves as Team Lead and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Team at the Jean Mayer
−Removed: USDA Human Nutrition Research Center on Aging at Tufts University.
−Removed: He is also a Professor of Nutrition at Tufts’ Friedman School
−Removed: of Nutrition Science and Policy, a Professor of Medicine at Tufts University School of Medicine, and the Associate Director of the Boston
−Removed: Pepper Older Americans Independence Center.
−Removed: Fielding is an internationally recognized researcher studying the mechanisms
−Removed: contributing to age-associated decline in skeletal muscle mass and function, and the potential role of exercise, nutrition, physical
−Removed: activity, and other therapies in mitigating this process.
−Removed: He has published over 300 peer-reviewed papers and has a strong record of extramural
−Removed: funding from the NIH, USDA, foundations, and industry.
−Removed: Grunvald is a board-certified obesity medicine physician and serves as the Director of the Weight Management Program at the University
−Removed: of California, San Diego.
−Removed: He evaluates and manages patients through their health and weight-loss journeys and has extensive experience
−Removed: using medications for weight management.
−Removed: As a professor in the Department of Medicine, Dr.
−Removed: Grunvald is active in teaching topics such
−Removed: as metabolism, weight regulation, and the treatment of obesity and weight-related medical conditions.
−Removed: He completed his residency training
−Removed: at the UC San Diego School of Medicine and earned his medical degree at the University of Washington School of Medicine.
−Removed: is board certified in internal medicine and obesity medicine and is a fellow of the American College of Physicians (FACP).
−Removed: Shirihai, MD, PhD
−Removed: Shirihai is a Professor of Medicine at the University of California, Los Angeles (UCLA), where he serves as Director of the UCLA Metabolism
−Removed: Research Theme.
−Removed: His laboratory focuses on mitochondrial structure, function, and quality control, making key contributions to mitochondrial
−Removed: biology, including the discovery of the life cycle of mitochondria and the relationship between mitochondrial architecture and nutrient
−Removed: utilization in metabolic diseases.
−Removed: Shirihai received his MD and PhD from the Technion - Israel Institute of Technology in 1997.
−Removed: Roadhouse is an analyst with experience in financial analysis and research.
−Removed: He has worked in various capacities within the financial
−Removed: industry, contributing to investment strategies and portfolio management.
−Removed: Roadhouse holds a degree in Finance and has been involved
−Removed: in multiple projects aimed at optimizing investment performance.
−Removed: Lichti, a co-founder and our Chairman of the Board, has served as our strategic consultant since July 2020 through his firm NorthStrive
−Removed: Companies Inc.
−Removed: (“NorthStrive”).
−Removed: Lichti is the founder and CEO of NorthStrive since its inception in 2020.
−Removed: is a California corporation that focuses on identifying public markets venture capital investment opportunities in high-growth early-stage
−Removed: NorthStrive is a sector agnostic privately held firm that has identified and invested, through its principal owners, in industries,
−Removed: including biotechnology, medical devices, and medical aesthetics.
−Removed: We believe Mr.
−Removed: Lichti will be a continued asset to the Company due
−Removed: to his network within the healthcare and aesthetic business community, and his experience identifying investment opportunities.
−Removed: will be beneficial to the Company as it seeks to identify new business and capital opportunities which led to the conclusion that NorthStrive
−Removed: should continue to be our advisor.
−Removed: Green is an experienced healthcare executive with a broad background in life sciences and biotechnology finance and operations.
−Removed: over ten years of business development experience in the medical aesthetics field including Allergan Plc, a division of AbbVie Inc.,
−Removed: Elsie Biotechnologynologies, and Bioniz, LLC.
−Removed: Kevin has been involved in multiple acquisitions for companies that remain our competitors,
−Removed: such as SkinMedica Inc.
−Removed: With Kevin’s broad operations and finance expertise, he brings relevant generalist experience to assist
−Removed: in our business development functions.
−Removed: He has been an advisor to us and made several key introductions between our founders and prominent
−Removed: executives and practitioners in the physician-dispensed aesthetic space.
−Removed: We expect Kevin to continue to network on our behalf and provide
−Removed: key input on key business dealings and product development moving forward.
−Removed: We aim to position PMGC Holdings Inc.
−Removed: holding company, leveraging strategic acquisitions, capital deployment, and asset optimization to drive long-term growth.
−Removed: strategy is built on three key pillars:
−Removed: Deployment for Stronger Returns Through PMGC Capital LLC, we focus on achieving high returns on capital by investing in undervalued assets,
−Removed: deploying treasury funds into public and private investments, and leveraging structured financings to maximize value.
−Removed: and Scaling Biotechnology and High-Growth Operating Companies We actively seek acquisitions in the biotechnology sector and other high-growth
−Removed: industries, financing their expansion through equity, debt, and available grants.
−Removed: By integrating synergistic businesses under our portfolio,
−Removed: we enhance operational efficiencies, accelerate commercialization, and unlock market opportunities.
−Removed: and Strategic Portfolio Optimization We continuously evaluate spin-off opportunities for wholly owned subsidiaries or specific assets,
−Removed: allowing us to unlock shareholder value and create independent, specialized companies.
−Removed: This approach enables us to capitalize on advanced
−Removed: scientific research and address significant unmet medical needs while maintaining a diversified and scalable business model.
−Removed: Holdings Inc.
+Added: Intellectual Property
+Added: We have developed a comprehensive
+Added: portfolio of intellectual property, consisting of patents, patent applications, domain names, know-how and trade secrets.
+Added: As of the date
+Added: of this Annual Report, we have two registered domain names, six non-provisional patent applications filed, and four provisional patent
+Added: applications filed.
+Added: We believe our intellectual
+Added: property adequately protects our products and technology and may prevent others from commercializing products or methods substantially
+Added: similar to ours.
+Added: PMGC Holdings Inc.
Below is a table, with footnotes, that includes
−Removed: our United States patents, with their referenced property numbers, that are material to our business as of March 21, 2025:
−Removed: Expiration Date
−Removed: Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients
−Removed: Labs, Inc., 04/29/2025
−Removed: Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients
−Removed: Labs, Inc., 04/29/2025
−Removed: Pharmaceutical
−Removed: Composition for Treatment of Muscle Loss Due to Obesity
−Removed: Labs, Inc., 04/29/2025
−Removed: Therapy for Treatment of Muscle Loss Due to Obesity
−Removed: Labs, Inc., 04/29/2025
−Removed: is a table that includes our granted United States patents as of March 26, 2025:
−Removed: patent based on Property.
−Removed: Below is a table that
−Removed: includes our United States patent applications as of January 24, 2025:
+Added: our United States patent applications with the referenced property number(s) that are material to our business, as well as our two anticipated
+Added: patent applications:
Application Type
Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients
+Added: Combination Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients
+Added: Pharmaceutical Composition for Treatment of Muscle Loss Due to Obesity
+Added: Combination Therapy for Treatment of Muscle Loss Due to Obesity
+Added: Below is a table that
+Added: includes our United States patent applications as of December 31, 2025:
+Added: Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients (1)
Non-provisional
5 unchanged sentences
Non-provisional
−Removed: (1) Non-provisional
−Removed: patent application based on Property.
−Removed: (2) Non-provisional
−Removed: patent application based on Property.
+Added: Fusion Protein of Myo-2 for Use in Encouraging Muscle Growth in Animals (5)
Non-provisional
−Removed: patent application based on Property.
+Added: Animal Feed Additive to Encourage Muscle Growth (6)
Non-provisional
−Removed: patent application based on Property.
−Removed: Docket Number
−Removed: Country / Region
−Removed: Application No.
−Removed: Registration No.
−Removed: ELEVAI BIOSCIENCES
−Removed: United States - (US)
−Removed: Pending - (PEND)
−Removed: ELEVAI BIOSCIENCES (& Des.)
−Removed: United States - (US)
−Removed: Pending - (PEND)
−Removed: have the right to use the following domain registration issued in the United States, as noted below:
−Removed: Expiration Date
−Removed: Registration Agency
+Added: Non-provisional patent application based on Property.
+Added: Non-provisional patent application based on Property.
+Added: Non-provisional patent application based on Property.
+Added: Non-provisional patent application based on Property.
+Added: Non-provisional patent application based on Property.
+Added: Non-provisional patent application based on Property.
+Added: We have the right to use the following domain registration issued in
+Added: the United States, as noted below:
July 31, 2024
6 unchanged sentences
PMGC Holdings Inc.
−Removed: Biosciences Inc.
−Removed: Licensed Product/ Nation
−Removed: Registration Number
+Added: NorthStrive Biosciences Inc.
Registration Date
7 unchanged sentences
Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
−Removed: Licensed Product/ Nation
−Removed: Patent Application Serial No
+Added: Patent Applications
+Added: Licensed Product/
Pharmaceutical composition for alleviation, treatment, and prevention of sarcopenia containing microorganism transformed with cell surface display vector operably linked with gene encoding myostatin and activin A proteins as active ingredient
1 unchanged sentence
A pharmaceutical composition for alleviation, treatment and prevention of sarcopenia containing a microorganism transformed with a vector expressing myostatin and activin A on the cell surface as an active ingredient
−Removed: Docket Number
−Removed: Country / Region
−Removed: Application No.
−Removed: Registration No.
−Removed: ELEVAI BIOSCIENCES
−Removed: United States - (US)
−Removed: Pending - (PEND)
−Removed: ELEVAI BIOSCIENCES (& Des.)
−Removed: and Marketing
−Removed: a biotechnology holding company, our sales and marketing efforts focus on maximizing asset value through strategic partnerships, licensing
−Removed: agreements, and investment-driven growth strategies rather than traditional direct sales models.
−Removed: Commercialization
−Removed: and Licensing Strategy
−Removed: seek commercial partnerships, licensing agreements, and strategic acquisitions to monetize our biotechnology assets.
−Removed: of building a direct sales force, we collaborate with biotechnology, pharmaceutical, and healthcare companies to facilitate late-stage
−Removed: clinical development and commercialization.
−Removed: approach includes leveraging key opinion leaders (KOLs), industry networks, and advisory boards to enhance visibility and credibility.
−Removed: and Investor Relations
−Removed: actively market our portfolio companies, investment strategies, and biotechnology assets to institutional investors, venture partners,
−Removed: and strategic acquirers.
−Removed: engage in scientific conferences, industry events, and investor presentations to generate interest and attract potential commercial partners
−Removed: or acquirers.
−Removed: focusing on strategic alliances, funding opportunities, and investment-driven asset growth, we aim to enhance portfolio value and drive
−Removed: commercialization through industry partnerships.
−Removed: principal executive office is located at 120 Newport Center Drive, Newport Beach, CA 92660.
−Removed: The office has 500 square feet, and the lease
−Removed: runs from April 2024 to February 2025.
+Added: Fusion Protein of Myo-2 for Use in Encouraging Muscle Growth in Animals
+Added: Animal Feed Additive to Encourage Muscle Growth
+Added: Fusion Protein of Myo-2 for Use in Reducing Animal Gas Emissions
+Added: Animal Supplement for Use in Reducing Animal Gas Emissions
+Added: Fusion Protein of Myo-2 for Use in Encouraging Muscle Growth in Aquatic Animals
+Added: Aquatic Animal Supplement for Use in Encouraging Muscle Growth
+Added: Fusion Protein of Myo-2 for Use in Reducing Emissions in Aquatic Animals
+Added: Aquatic Animal Supplement for Use in Reducing Emissions
+Added: Fusion Protein of Myo-2 for Use in Encouraging Muscle Growth in Poultry
+Added: Poultry Supplement for Use in Encouraging Muscle Growth
+Added: Operational and Competitive Strengths
+Added: We operate in a highly competitive biotechnology and
+Added: investment landscape, facing competition from pharmaceutical companies, biotechnology firms, and investment funds.
+Added: Our key competitive
+Added: advantages include:
+Added: Strategic Capital Deployment:
+Added: Through PMGC Capital LLC, we seek to acquire undervalued assets, optimizing capital returns while expanding our portfolio.
+Added: Diversified Holdings:
+Added: We establish and acquire wholly
+Added: owned subsidiaries across biotechnology, advanced manufacturing, and specialty industrial sectors, including clinical-stage and
+Added: preclinical therapeutic assets, precision engineering businesses, and high-value component and packaging solutions.
+Added: Advancement of High-Potential Biotechnology Assets:
+Added: Our subsidiary, NorthStrive Biosciences Inc., is progressing EL-22, a lead asset targeting muscle preservation in obesity treatment.
+Added: Flexible M&A and Licensing Model:
+Added: Our structure allows for strategic acquisitions, licensing deals, and potential spin-offs, creating value for shareholders.
+Added: Sales and Marketing
+Added: As a diversified holding company, our sales and
+Added: marketing activities are conducted both at the parent level and through our wholly owned subsidiaries, with strategies tailored to the
+Added: specific industries in which each subsidiary operates.
+Added: Our approach is designed to drive revenue growth, enhance asset value, and support
+Added: strategic partnerships, licensing arrangements, and capital deployment initiatives across our biotechnology, advanced manufacturing, specialty
+Added: packaging, and investment operations.
+Added: At the parent level, we focus on communicating
+Added: our overall platform strategy, capital allocation approach, and subsidiary performance to investors, strategic partners, and other stakeholders.
+Added: We engage with institutional investors, strategic acquirers, and industry participants to enhance awareness of our diversified business model and growth strategy.
+Added: We support our subsidiaries’ business development efforts through targeted marketing, industry engagement, and strategic introductions.
+Added: We participate in industry conferences, trade events, and investor presentations across our operating sectors to facilitate relationship development, generate opportunities, and support long-term value creation.
+Added: This diversified platform allows us to allocate
+Added: capital across multiple sectors, pursue complementary growth opportunities, and enhance long-term shareholder value.
+Added: We aim to position PMGC Holdings Inc.
+Added: diversified investment and holding company, leveraging strategic acquisitions, capital deployment, and asset optimization to
+Added: drive long-term growth.
+Added: Our strategy is built on three key pillars:
+Added: Capital Deployment for Stronger Returns
+Added: Through PMGC Capital, we focus on achieving high returns on capital by investing in undervalued assets, deploying
+Added: treasury funds into public and private investments, and leveraging structured financings to maximize value.
+Added: Acquiring and Scaling Biotechnology and High-Growth Operating
+Added: We actively seek acquisitions in the biotechnology sector and other high-growth industries, financing their expansion
+Added: through equity, debt, and available grants.
+Added: By integrating synergistic businesses under our portfolio, we enhance operational efficiencies,
+Added: accelerate commercialization, and unlock market opportunities.
+Added: Spin-Offs and Strategic Portfolio Optimization
+Added: We continuously evaluate spin-off opportunities for wholly owned subsidiaries or specific assets, allowing us
+Added: to unlock shareholder value and create independent, specialized companies.
+Added: This approach enables us to capitalize on advanced scientific
+Added: research and address significant unmet medical needs while maintaining a diversified and scalable business model.
+Added: Commercialization and Growth Strategy
+Added: Our commercialization and growth strategy varies
+Added: by business segment:
+Added: NorthStrive Biosciences Inc.
+Added: – focused on advancing our preclinical and clinical-stage assets and seek to create value through strategic partnerships, licensing agreements, and collaborative arrangements with biotechnology, pharmaceutical, and healthcare companies to support continued development and progression of our programs.
+Added: PMGC Capital LLC – focused on identifying and executing investment opportunities across public and private markets, including structured financings and investments in undervalued assets, with an emphasis on capital deployment and value creation.
+Added: Pacific Sun Packaging, Inc.
+Added: – generates revenue through direct customer relationships, providing custom packaging solutions to customers in the semiconductor, data center, and information technology hardware industries, with a focus on customer retention and long-term supply relationships .
+Added: AGA Precision Systems
+Added: LLC – generates revenue through contract manufacturing and precision machining services for customers in the aerospace,
+Added: defense, and industrial sectors.
+Added: Competitive positioning in this company is supported by technical capabilities, high-tolerance
+Added: manufacturing expertise, and compliance with industry standards, including ITAR registration and AS9100 certification.
+Added: Our Facilities
+Added: Our principal executive office is located at 120 Newport Center Drive,
+Added: Newport Beach, CA 92660.
+Added: The office has 1,650 square feet, and the lease is on a month-to-month basis.
The monthly rent is $9,273.50.
−Removed: following table sets forth the leases term and monthly rent:
+Added: The following table sets forth the leases term and
+Added: monthly rent:
(square feet)
−Removed: April 2024 to February 2025
+Added: Month to Month
120 Newport Center Drive, Newport Beach, CA 92660
−Removed: members of our management work outside of these premises in office space that we do not rent.
−Removed: As of the date of this Annual Report, we have
−Removed: two (2) full-time employees and one part-time employee.
−Removed: We provide employee benefits for each employee which include medical, unemployment,
−Removed: and work injury compensation.
+Added: Some members of our management work outside of these
+Added: premises in office space that we do not rent.
+Added: As of the date of this Annual Report, we have 32 full-time employees
+Added: and 2 part-time employee.
+Added: We provide employee benefits for each employee which include medical, unemployment, and work injury compensation.
Our employees have not formed any employee union or association.
−Removed: We have developed various methods to train
−Removed: our employees adequately for the functions they perform and are aware of the laws and regulations affecting our industry.
−Removed: depends on our ability to attract, retain and motivate qualified employees.
−Removed: We endeavor to offer employees competitive compensation packages
−Removed: and a positive, dynamic and creative work environment.
−Removed: We believe that we maintain a good working relationship with our employees and
−Removed: have not experienced any difficulty in recruiting staff for our operations.
−Removed: Regulation and Biologic Drug Approval
−Removed: authorities in the United States, at the federal, state and local level, and other countries, extensively regulate, among other things,
−Removed: the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising,
−Removed: distribution, marketing and export and import of products such as those we are selling and developing.
−Removed: Because we are developing product
−Removed: candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely clear and may
−Removed: Regulatory requirements governing our product candidates have changed frequently and will likely continue to change in the future.
−Removed: We believe that the FDA will regulate part of our product candidates as a biologic drug (i.e., a biologic) through the Biologics License
−Removed: Application (“BLA”) process under the jurisdiction of the Office of Therapeutic Products within the Center for Biologics
−Removed: Evaluation and Research (“CBER”).
−Removed: We will work with FDA to confirm that a BLA is the most appropriate pathway and that CBER
−Removed: will be the FDA center responsible for review and licensure (i.e., approval).
−Removed: For future product candidates, we will also confirm the
−Removed: appropriate approval pathway (i.e., BLA or new drug application (“NDA”)) and the appropriate FDA center with regulatory oversight
−Removed: (i.e., CBER or the Center for Drug Evaluation and Research (“CDER”)).
+Added: We have developed various methods to train our employees adequately for
+Added: the functions they perform and are aware of the laws and regulations affecting our industry.
+Added: Our success depends on our ability to attract,
+Added: retain and motivate qualified employees.
+Added: We endeavor to offer employees competitive compensation packages and a positive, dynamic and
+Added: creative work environment.
+Added: We believe that we maintain a good working relationship with our employees and have not experienced any difficulty
+Added: in recruiting staff for our operations.
+Added: Government Regulation and Biologic Drug Approval
+Added: Government authorities in the United States, at the
+Added: federal, state and local level, and other countries, extensively regulate, among other things, the research, development, testing, manufacture,
+Added: quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, marketing and export and
+Added: import of products such as those we are selling and developing.
+Added: Because we are developing product candidates that are unique biological
+Added: entities, the regulatory requirements that we will be subject to are not entirely clear and may change.
+Added: Regulatory requirements governing
+Added: our product candidates have changed frequently and will likely continue to change in the future.
+Added: We believe that the FDA will regulate
+Added: part of our product candidates as a biologic drug (i.e., a biologic) through the Biologics License Application (“BLA”) process
+Added: under the jurisdiction of the Office of Therapeutic Products within the Center for Biologics Evaluation and Research (“CBER”).
+Added: We will work with FDA to confirm that a BLA is the most appropriate pathway and that CBER will be the FDA center responsible for review
+Added: and licensure (i.e., approval).
+Added: For future product candidates, we will also confirm the appropriate approval pathway (i.e., BLA or new
+Added: drug application (“NDA”)) and the appropriate FDA center with regulatory oversight (i.e., CBER or the Center for Drug Evaluation
+Added: and Research (“CDER”)).
Biologic Drug Development Process
−Removed: the United States, biologic drugs (“biologics”) are regulated under two statutes:
−Removed: The Public Health Service Act (“PHS
−Removed: Act”) and the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and their implementing regulations.
−Removed: However, submission
−Removed: and approval of only one application-typically either a BLA or an NDA-is required prior to marketing.
−Removed: The FDA has also issued numerous
−Removed: “Guidance Documents” and other materials that address specific aspects of biologic development for particular types of product
−Removed: candidates (e.g., cells, tissues, etc.).
−Removed: Substantial time and financial resources are required to obtain regulatory approvals and subsequently
−Removed: comply with appropriate federal, state, and local statutes and regulations.
−Removed: Failure to comply with the applicable U.S.
−Removed: requirements at
−Removed: any time during the biologic development, approval, or post-approval processes may subject an applicant to administrative or judicial
−Removed: These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition
−Removed: of a clinical hold on ongoing clinical trials, issuance of warning or untitled letters, product recalls, product seizures, total or partial
−Removed: suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or
−Removed: criminal penalties.
−Removed: Any agency or judicial enforcement action could have a material adverse effect on us.
−Removed: process required by the FDA before a biologic may be marketed in the United States generally involves the following steps:
−Removed: of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s current good laboratory practice
−Removed: requirements and other applicable regulations;
−Removed: to the FDA of an IND, which must become effective before human clinical trials may begin;
−Removed: by an independent institutional review board (“IRB”) at each clinical site (or by one “commercial IRB”) before
−Removed: each trial may be initiated;
−Removed: ● performance
−Removed: of adequate and well-controlled human clinical trials in accordance with cGCP requirements to establish the safety, purity, and potency
+Added: In the United States, biologic drugs (“biologics”) are
+Added: regulated under two statutes:
+Added: The Public Health Service Act PHS Act and the Federal Food, Drug, and Cosmetic Act and their implementing
+Added: However, submission and approval of only one application—typically either a BLA or an NDA—is required prior to
+Added: The FDA has also issued numerous “Guidance Documents” and other materials that address specific aspects of biologic
+Added: development for particular types of product candidates (e.g., cells, tissues, etc.).
+Added: Substantial time and financial resources are required
+Added: to obtain regulatory approvals and subsequently comply with appropriate federal, state, and local statutes and regulations.
+Added: comply with the applicable U.S.
+Added: requirements at any time during the biologic development, approval, or post-approval processes may subject
+Added: an applicant to administrative or judicial sanctions.
+Added: These sanctions could include the FDA’s refusal to approve pending applications,
+Added: withdrawal of an approval, imposition of a clinical hold on ongoing clinical trials, issuance of warning or untitled letters, product
+Added: recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts,
+Added: restitution, disgorgement or civil or criminal penalties.
+Added: Any agency or judicial enforcement action could have a material adverse effect
+Added: The process required by the FDA before a biologic
+Added: may be marketed in the United States generally involves the following steps:
+Added: ● completion of preclinical laboratory
+Added: tests, animal studies and formulation studies in accordance with FDA’s current good laboratory practice requirements and other
+Added: applicable regulations;
+Added: ● submission to the FDA of an
+Added: IND, which must become effective before human clinical trials may begin;
+Added: ● approval by an independent
+Added: institutional review board (“IRB”) at each clinical site (or by one “commercial IRB”) before each trial may be
+Added: ● performance of adequate and well-controlled human clinical trials in
+Added: accordance with current Good Clinical Practices (“cGCPs”) requirements to establish the safety, purity, and potency ( i.e.
efficacy) of the proposed biologic for its intended use;
−Removed: to the FDA of a BLA after completion of all clinical trials;
−Removed: ● satisfactory
−Removed: outcome of an FDA advisory committee review, if applicable;
−Removed: ● satisfactory
−Removed: completion of an FDA inspection of the manufacturing facility or facilities at which the biologic is produced to assess compliance with
−Removed: cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength,
−Removed: quality and purity, and FDA inspection of selected clinical investigation sites to assess compliance with cGCPs;
−Removed: review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.
−Removed: specific preclinical studies and clinical testing that is required for a BLA varies widely depending upon the specific type of product
−Removed: candidate under development.
−Removed: Prior to beginning a human clinical trial with either a biologic or drug product candidate in the United
−Removed: States, we must submit an IND to the FDA and that IND must become effective.
−Removed: The focus of an IND submission is the general investigational
−Removed: plan and protocol for the proposed clinical study.
−Removed: The IND also includes results of animal and in vitro studies assessing the toxicology,
−Removed: pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product;
−Removed: Chemistry Manufacturing and Controls (“CMC”)
−Removed: and any available human data or literature to support the use of the investigational product.
−Removed: An IND must become effective
−Removed: before human clinical trials may begin.
−Removed: The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within
−Removed: the 30-day time period, raises safety concerns or questions about the proposed clinical trial.
−Removed: In such a case, the IND may be placed
−Removed: on clinical hold, and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical hold is lifted
−Removed: and the clinical trial can begin.
−Removed: Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
−Removed: trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
−Removed: accordance with cGCPs, which include the requirement that all research subjects provide their informed consent for their participation
−Removed: in any clinical trial.
−Removed: Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the
−Removed: parameters for monitoring safety and the effectiveness criteria to be evaluated.
−Removed: A separate submission to the existing IND must be made
−Removed: for each successive clinical trial conducted during product development.
−Removed: Other submissions to an IND include protocol amendments, information
−Removed: amendments, IND safety reports and annual reports.
−Removed: Furthermore, an independent IRB for each clinical trial site (or a “commercial
−Removed: IRB” that acts as the IRB at one or more of the clinical trial sites) must review and approve the protocol and informed consent
−Removed: form before the clinical trial may begin.
+Added: ● submission to the FDA of a
+Added: BLA after completion of all clinical trials;
+Added: ● satisfactory outcome of an
+Added: FDA advisory committee review, if applicable;
+Added: ● satisfactory completion of
+Added: an FDA inspection of the manufacturing facility or facilities at which the biologic is produced to assess compliance with cGMP requirements
+Added: to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity,
+Added: and FDA inspection of selected clinical investigation sites to assess compliance with cGCPs;
+Added: ● FDA review and approval of
+Added: the BLA to permit commercial marketing of the product for particular indications for use in the United States.
+Added: The specific preclinical studies and clinical testing
+Added: that is required for a BLA varies widely depending upon the specific type of product candidate under development.
+Added: Prior to beginning a
+Added: human clinical trial with either a biologic or drug product candidate in the United States, we must submit an IND to the FDA and that
+Added: IND must become effective.
+Added: The focus of an IND submission is the general investigational plan and protocol for the proposed clinical study.
+Added: The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic
+Added: characteristics of the product;
+Added: Chemistry Manufacturing and Controls (“CMC”) information;
+Added: and any available human data or
+Added: literature to support the use of the investigational product.
+Added: An IND must become effective before human clinical trials may begin.
+Added: IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns
+Added: or questions about the proposed clinical trial.
+Added: In such a case, the IND may be placed on clinical hold, and the IND sponsor and the FDA
+Added: must resolve any outstanding concerns or questions before the clinical hold is lifted and the clinical trial can begin.
+Added: Submission of
+Added: an IND therefore may or may not result in FDA authorization to begin a clinical trial.
+Added: Clinical trials involve the administration of the investigational product
+Added: to human subjects under the supervision of qualified investigators in accordance with cGCPs, which include the requirement that all research
+Added: subjects provide their informed consent for their participation in any clinical trial.
+Added: Clinical trials are conducted under protocols detailing,
+Added: among other things, the objectives of the study, the parameters for monitoring safety and the effectiveness criteria to be evaluated.
+Added: A separate submission to the existing IND must be made for each successive clinical trial conducted during product development.
+Added: submissions to an IND include protocol amendments, information amendments, IND safety reports and annual reports.
+Added: Furthermore, an independent
+Added: IRB for each clinical trial site (or a commercial IRB that acts as the IRB at one or more of the clinical trial sites) must review and
+Added: approve the protocol and informed consent form before the clinical trial may begin.
The IRB also monitors the clinical trial until completed.
−Removed: authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects
−Removed: are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.
−Removed: Some clinical trials also
−Removed: include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring
−Removed: board (“DSMB”).
−Removed: A DSMB authorizes whether or not a study may move forward at designated check points based on access to certain
−Removed: data from the trial.
−Removed: The DSMB may halt the clinical trial if it determines there is an unacceptable safety risk for subjects or on other
−Removed: grounds, such as no demonstration of efficacy.
−Removed: Related reporting requirements for the sponsor, clinical investigator, and/or IRB also
−Removed: include IND safety reports and updating clinical trial results in public registries (e.g., ClinicalTrials.gov).
−Removed: clinical trials are typically conducted in three sequential phases that may overlap or be combined:
−Removed: The product candidate is initially introduced into healthy human subjects.
−Removed: These clinical trials are designed to test the safety,
−Removed: dosage tolerance, absorption, metabolism, distribution, excretion, side effects, and, if possible, early evidence of effectiveness.
−Removed: the case of some products for severe or life-threatening diseases when the product may be too inherently toxic to ethically administer
−Removed: it to healthy volunteers, the initial human testing is often conducted in individuals who have the targeted disease or condition instead
−Removed: of healthy subjects;
−Removed: The product candidate is administered to a limited population of individuals who have the specified disease or condition to continue
−Removed: to evaluate safety, as well as preliminary efficacy, optimal dosages and dosing schedule, possible adverse side effects and safety risks.
−Removed: Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 (i.e., pivotal)
−Removed: clinical trials;
−Removed: Generally, the largest in size, Phase 3 clinical trials are generally conducted at multiple geographically dispersed clinical
−Removed: The product candidate is administered to an expanded population of individuals who have the specified disease or condition
−Removed: to further evaluate dosage, provide statistically significant evidence of clinical efficacy and gain additional safety data.
−Removed: These clinical
−Removed: trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product
−Removed: with clinical trials, sponsors usually complete additional animal studies.
−Removed: Sponsors must also develop information about the chemical
−Removed: and physical characteristics of the biologic and finalize a process for manufacturing the product in commercial quantities in accordance
−Removed: with cGMP requirements.
−Removed: The manufacturing process must be capable of consistently producing quality batches of the product candidate,
−Removed: and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final biologic.
−Removed: In addition, the sponsor must develop and test appropriate packaging, and must conduct stability studies to demonstrate that the product
−Removed: candidate does not undergo unacceptable deterioration over its shelf life.
−Removed: Before approval of a BLA, FDA evaluates the establishment
−Removed: by an on-site inspection to ensure the facilities and controls used for the manufacture, processing, packaging, and testing of the drug
−Removed: are adequate to ensure and preserve its identity, strength, quality, and purity.
−Removed: the development of a new biologic, sponsors are given opportunities to meet with the FDA.
−Removed: These meetings typically occur before the submission
−Removed: of an IND (i.e., pre-IND meeting), at the end of Phase 2 (i.e., EOP2 meeting), and before a BLA is submitted (i.e., pre-BLA meeting).
+Added: Regulatory authorities, the IRB or the sponsor may
+Added: suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health
+Added: risk or that the trial is unlikely to meet its stated objectives.
+Added: Some clinical trials also include oversight by an independent group
+Added: of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board (“DSMB”).
+Added: A DSMB authorizes
+Added: whether or not a study may move forward at designated check points based on access to certain data from the trial.
+Added: The DSMB may halt the
+Added: clinical trial if it determines there is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy.
+Added: Related reporting requirements for the sponsor, clinical investigator, and/or IRB also include IND safety reports and updating clinical
+Added: trial results in public registries (e.g., ClinicalTrials.gov).
+Added: Human clinical trials are typically conducted in three
+Added: sequential phases that may overlap or be combined:
+Added: candidate is initially introduced into healthy human subjects.
+Added: These clinical trials are designed to test the safety, dosage tolerance,
+Added: absorption, metabolism, distribution, excretion, side effects, and, if possible, early evidence of effectiveness.
+Added: In the case of some
+Added: products for severe or life-threatening diseases when the product may be too inherently toxic to ethically administer it to healthy volunteers,
+Added: the initial human testing is often conducted in individuals who have the targeted disease or condition instead of healthy subjects;
+Added: candidate is administered to a limited population of individuals who have the specified disease or condition to continue to evaluate
+Added: safety, as well as preliminary efficacy, optimal dosages and dosing schedule, possible adverse side effects and safety risks.
+Added: Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 (i.e., pivotal) clinical
+Added: the largest in size, Phase 3 clinical trials are generally conducted at multiple geographically dispersed clinical trial sites.
+Added: candidate is administered to an expanded population of individuals who have the specified disease or condition to further evaluate dosage,
+Added: provide statistically significant evidence of clinical efficacy and gain additional safety data.
+Added: These clinical trials are intended to
+Added: establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
+Added: Concurrent with clinical trials, sponsors usually
+Added: complete additional animal studies.
+Added: Sponsors must also develop information about the chemical and physical characteristics of the biologic
+Added: and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
+Added: The manufacturing
+Added: process must be capable of consistently producing quality batches of the product candidate, and, among other things, the manufacturer
+Added: must develop methods for testing the identity, strength, quality, and purity of the final biologic.
+Added: In addition, the sponsor must develop
+Added: and test appropriate packaging, and must conduct stability studies to demonstrate that the product candidate does not undergo unacceptable
+Added: deterioration over its shelf life.
+Added: Before approval of a BLA, FDA evaluates the establishment by an on-site inspection to ensure the facilities
+Added: and controls used for the manufacture, processing, packaging, and testing of the drug are adequate to ensure and preserve its identity,
+Added: strength, quality, and purity.
+Added: During the development of a new biologic, sponsors
+Added: are given opportunities to meet with the FDA.
+Added: These meetings typically occur before the submission of an IND (i.e., pre-IND meeting),
+Added: at the end of Phase 2 (i.e., EOP2 meeting), and before a BLA is submitted (i.e., pre-BLA meeting).
Meetings at other times may be requested.
−Removed: These meetings provide an opportunity for the sponsor to share information about the data gathered
−Removed: to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development.
−Removed: typically use EOP2 meetings to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe
−Removed: will support approval of the new biologic.
−Removed: Review and Approval Process for Biologic Drugs
−Removed: successful completion of all required testing in accordance with the applicable statutory and regulatory requirements, the sponsor submits
−Removed: a BLA to the FDA.
−Removed: A BLA contains the results of product development, preclinical and other non-clinical studies and clinical trials,
−Removed: descriptions of the manufacturing process, analytical testing, proposed labeling and other relevant information.
−Removed: The submission of a
−Removed: BLA is subject to the payment of a substantial application fee under the Prescription Drug User Fee Amendments (“PDUFA”).
+Added: These meetings provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice,
+Added: and for the sponsor and the FDA to reach agreement on the next phase of development.
+Added: Sponsors typically use EOP2 meetings to discuss Phase
+Added: 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new biologic.
+Added: Review and Approval Process for Biologic
+Added: Assuming successful completion of all required testing
+Added: in accordance with the applicable statutory and regulatory requirements, the sponsor submits a BLA to the FDA.
+Added: A BLA contains the results
+Added: of product development, preclinical and other non-clinical studies and clinical trials, descriptions of the manufacturing process, analytical
+Added: testing, proposed labeling and other relevant information.
+Added: The submission of a BLA is subject to the payment of a substantial application
+Added: fee under the Prescription Drug User Fee Amendments (“PDUFA”).
PDUFA fees apply to both drugs and biologics.
−Removed: Sponsors may seek a waiver of these fees in certain limited circumstances, including a
−Removed: waiver of the application fee for the first BLA or NDA submitted by a small business.
−Removed: Product candidates with an Orphan Drug Designation
−Removed: (“ODD”) are not subject to the BLA application fee unless the product application also includes a non-orphan indication.
−Removed: FDA reviews a BLA to determine, among other things, whether a biologic is safe, pure, and potent (i.e., effective) for its intended use
−Removed: and whether its manufacturing is GMP-compliant to assure the product’s identity, strength, quality and purity.
−Removed: Under PDUFA, the
−Removed: FDA has a goal date of ten months from the date of “filing” to review and act on the submission.
−Removed: However, the time between
−Removed: submission and filing can add an additional two months as FDA conducts a preliminary review to ensure that the BLA is sufficiently complete
−Removed: to permit substantive review.
−Removed: Formal FDA review of the BLA does not begin until FDA has accepted it for filing.
−Removed: The FDA may refer an
−Removed: application in some cases to an advisory committee for its independent review.
−Removed: An advisory committee is a panel of independent experts,
−Removed: including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation to FDA as to whether the application
−Removed: should be approved and under what conditions.
−Removed: The FDA is not bound by the recommendations of an advisory committee, but it considers
−Removed: such recommendations carefully when making decisions.
−Removed: approving a BLA, the FDA will typically inspect the locations where the product is manufactured.
−Removed: The FDA will not approve an application
−Removed: unless it determines that the manufacturing processes and facilities are in compliance with cGMPs, and are adequate to assure consistent
−Removed: production of the product within required specifications.
−Removed: An important part of a BLA is a lot release protocol that the sponsor will
−Removed: use to test each lot of product made after BLA approval, as well as the FDA’s own test plan that will be used for confirmatory
−Removed: testing of each post-approval product lot that is made before it is released to the public.
−Removed: If the FDA determines that the data and information
−Removed: in the application, including about the manufacturing process or manufacturing facilities, are not acceptable, then the FDA will outline
−Removed: the deficiencies and often will request additional testing or information.
−Removed: Notwithstanding the submission of any requested additional
−Removed: information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
−Removed: the FDA evaluates a BLA, it will either issue an approval letter or a Complete Response Letter (“CRL”).
−Removed: The approval letter
−Removed: authorizes commercial marketing of the biologic with approved prescribing information for specific approved indications.
−Removed: hand, a CRL indicates that the review cycle of the application is complete but the BLA cannot be approved in its present form.
−Removed: usually describes the specific deficiencies identified by the FDA and describes the actions the sponsor must take to correct those deficiencies.
−Removed: A sponsor that receives a CRL must resubmit the BLA after addressing the deficiencies or withdraw the application.
−Removed: Even if such additional
−Removed: data and information are submitted to address the deficiencies, the FDA may decide that the data and information in the resubmitted BLA
−Removed: do not satisfy the approval criteria.
−Removed: marketing approval, a sponsor may need to fulfill certain post-marketing requirements (“PMRs”) or post-marketing commitments
−Removed: For example, post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing
−Removed: These trials are used to gain additional experience from the treatment of patients for the intended therapeutic indication.
−Removed: The trials may be agreed upon prior to approval, or the FDA may require them if new safety issues emerge.
−Removed: Following approval, a sponsor
−Removed: may also need to conduct a pediatric study that was temporarily deferred during the initial product development process.
−Removed: Under the Pediatric
−Removed: Research Equity Act (“PREA”), a sponsor must conduct pediatric clinical trials for most new drugs or biologics, for a new
−Removed: active ingredient, new indication, new dosage form, new dosing regimen or new route of administration.
−Removed: The required assessment must evaluate
−Removed: the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and
−Removed: administration for each pediatric subpopulation for which the product is safe and effective.
−Removed: PREA studies must be included in the application
−Removed: unless the sponsor has received a deferral or waiver.
−Removed: risk evaluation and mitigation strategy (“REMS”) may also be an important component of a BLA approval that requires sponsor
−Removed: post-marketing regulatory efforts.
−Removed: A REMS is a safety strategy to manage a known or potential serious risk associated with a drug or
−Removed: biologic and to enable patients to have continued access to such medicines by managing their safe use.
−Removed: A REMS may include medication
−Removed: guides, physician communication plans, or elements to assure safe use (ETASU) such as restricted distribution methods, patient registries,
−Removed: and other risk minimization tools.
−Removed: approved, the FDA may withdraw the product approval if compliance with PMRs, PMCs, or a REMS program is not maintained or if problems
−Removed: occur after the product reaches the marketplace.
−Removed: The FDA may also request that a product be recalled for an identified safety issue.
−Removed: In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies
−Removed: may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.
−Removed: following table sets forth certain information with respect to our directors, executive officers and significant employees as of March
−Removed: Executive Officers:
−Removed: Graydon Bensler
−Removed: Chief Executive Officer, Chief Financial Officer and
−Removed: Braeden Lichti
−Removed: Chairman of the Board
−Removed: Non-Executive Directors:
−Removed: Jeffrey Parry (1)(2)(3)
−Removed: Independent Director and Chair of Nominating Committee
−Removed: George Kovalyov (1)(2)(3)
−Removed: Independent Director and Chair of Compensation Committee
−Removed: Juliana Daley (1)(2)(3)
−Removed: Independent Director and Chair of the Audit Committee
−Removed: of the Audit Committee.
−Removed: of the Compensation Committee.
−Removed: of the Nominating Committee.
−Removed: of our directors serves for a term of one year ending on the date of the subsequent annual meeting of stockholders following the annual
−Removed: meeting at which such director was elected.
−Removed: Notwithstanding the foregoing, each director is to serve until his or her successor is elected
−Removed: and qualified or until his death, resignation or removal.
−Removed: Our Board appoints our officers, and each officer is to serve until his or
−Removed: her successor is appointed and qualified or until his or her death, resignation or removal.
−Removed: Bensler, CFA , Chief Executive Officer, Chief Financial Officer and Director
−Removed: Bensler has served as our Chief Executive Officer since June 2024 and Chief Financial Officer since inception and a director since June
−Removed: Bensler is a financial professional and analyst with over seven years of experience in financial consulting and management
−Removed: for both private businesses and US/Canadian publicly traded companies and is a CFA Charterholder (CFA) In 2017, Mr.
−Removed: Bensler Co-founded
−Removed: an Ed Tech curriculum management and scheduling company that was implanted in academic schools in Canada and the United States.
−Removed: 2017 to 2019, Mr.
−Removed: Bensler was an account manager at a leading Canadian investor relations firm where he represented publicly traded companies
−Removed: across a wide range of sectors where he worked directly with investment banks, investment brokers and company executives and directors.
−Removed: During his tenure, Mr.
−Removed: Bensler created and conveyed messaging about his clients’ strategic position in the market and successfully
−Removed: guided several companies through multiple financings.
−Removed: From 2019 to 2021, Mr.
−Removed: Bensler was a Senior Associate at Evans & Evans, a Canadian
−Removed: boutique investment banking firm where he led valuations and going public transactions for Canadian and United States companies.
−Removed: capacity, Mr.
−Removed: Bensler gained strong knowledge of the capital markets, public company compliance requirements, and regularly interfaced
−Removed: with regulators, auditors, board and executive management.
−Removed: Bensler was also a director of publicly traded Health Logic Interactive
−Removed: (TSXv:CHIP) from 2020 to 2024.
−Removed: We believe that Mr.
−Removed: Bensler’s past experience as our Chief Financial Officer, his familiarity
−Removed: with both the banking and the financial consulting sectors and his having served as an account manager for similarly situated companies
−Removed: makes him a qualified director for our Company.
−Removed: Bensler received his Bachelor of Management and Organizational Studies degree from the University of Western Ontario, with specialization
−Removed: in Finance, and is a CFA Charterholder.
−Removed: Lichti , Chairman of the Board
−Removed: Lichti is the founder and Chief Executive Officer of BWL Investments Ltd., a privately held holding corporation he established in 2016,
−Removed: and NorthStrive Companies, Inc., a U.S.
−Removed: based investment and advisory services company he founded in 2021.
−Removed: Lichti also serves as
−Removed: Chairman of Hydromer, Inc., a global leader in surface modification and coating solutions, focusing on hydrophilic, thromboresistant
−Removed: and antimicrobial coatings for medical devices and various industrial applications.
−Removed: Established in 1980 and headquartered in Concord,
−Removed: North Carolina, Hydromer offers a wide range of services, including polymer research and development, contract coating and specialized
−Removed: analytical testing.
−Removed: Lichti co-founded PMGC Holdings Inc.
−Removed: in 2020 and has served as its advisor and has been a principal stockholder
−Removed: since its formation.
−Removed: He has remained the largest stockholder through companies he controls and recently assumed the role of Chairman
−Removed: We believe that Mr.
−Removed: Lichti’s past experience as our director and advisor, his extensive executive experience and his having
−Removed: served as Chairman for similarly situated companies makes him a qualified director for our Company.
−Removed: Parry , Independent Director, Chair of the Nominating Committee and member of the of Audit Committee and Compensation Committee
−Removed: Parry was appointed as an independent director in June 2023 and
−Removed: is a partner of Mystic Marine Advisors LLC, a Connecticut based advisory firm he founded in 1998 focused on emerging and turnaround situations
−Removed: for strategic and financial stakeholders.
−Removed: Jeffrey served as Executive Chairman of TBS Shipping Limited from 2012 to 2018 where he led
−Removed: a successful restructuring and co-founded Valhalla Shipping, Inc with an $167 million equity investment by institutional investors.
−Removed: July 2008 to October 2009, Mr.
−Removed: Parry was the Chief Executive Officer of Nasdaq-listed Aries Maritime Transport Limited and led a successful
−Removed: turn-around and sale to strategic investors.
−Removed: Parry was a Managing Director of Poten & Partners, an international energy advisor,
−Removed: from 2001 to 2007 where in 2006 he co-founded Poten Capital Services LLC, a New York based broker-dealer.
−Removed: Earlier in his career, Mr.
−Removed: founded Cool FM and 7X Television in Athens, Greece and served as President of One Fifth Avenue Apartment Corporation.
−Removed: Since 2010, Jeffrey
−Removed: has served as an independent director of Nasdaq listed Globus Maritime Ltd.
−Removed: where he sits on the audit committee.
−Removed: Parry holds a BA
−Removed: from Brown University and MBA from Columbia University.
−Removed: His educational and professional experience in business, his background and familiarity
−Removed: in investment banking, and his having served as a director of a company listed on Nasdaq makes him a qualified director candidate for
−Removed: Kovalyov , Independent Director, Chair of the Compensation Committee and member of the of Audit Committee and Nominating Committee
−Removed: Kovalyov has acted as Chief Financial Officer and Treasurer of Marizyme, Inc.
−Removed: since December 2021.
−Removed: Since November 2022, Mr.
−Removed: has also been a director of DGTL Holdings Inc.
−Removed: Previously he served as the chief operating officer and director of Health Logic Interactive
−Removed: (“HLII”) from September 2020 to November 2021, and as HLII’s chief financial officer from December 2021 to September
−Removed: In addition, Mr.
−Removed: Kovalyov served as a director and audit committee member of Margaret Lake Diamonds Inc.
−Removed: from January 2021 to August
−Removed: From September 2018 to September 2020, Mr.
−Removed: Kovalyov was VP of Finance and director of Phivida Holdings Inc., a brand of cannabidiol-infused
−Removed: foods, beverages and clinical products.
−Removed: From October 2016 to September 2020, Mr.
−Removed: Kovalyov was the principal owner of Schindler and Company,
−Removed: an accounting consulting firm.
−Removed: Kovalyov is a chartered accountant and is a member of Chartered Professional Accountants of Canada.
−Removed: Kovalyov is qualified to serve on the Board due to his extensive accounting and finance experience.
−Removed: Daley , CPA Independent Director, Chair of the Audit Committee and member of the of Compensation Committee and Nominating Committee
−Removed: Daley was appointed as an independent director in June 2023 and holds over eleven years of accounting, controller, and financial reporting
−Removed: experience in the public sector.
−Removed: Daley has worked a variety of industries in both the United States and Canada.
−Removed: Since July 2021,
−Removed: Daley has served as Manager of Accounting at Anavex Life Sciences Corp.
−Removed: AVXL), a clinical-stage biopharmaceutical company
−Removed: based in New York, NY that is focused on developing treatments for debilitating neurodegenerative and neurodevelopmental diseases.
−Removed: addition, from August 2021 to July 2022, she served as an independent director and audit committee chair to Vegano Foods (CSE:
−Removed: during Vegano Food’s initial public offering in February 2022.
−Removed: From October 2015 to July 2021, Ms.
−Removed: Daley was a Manager of Financial
−Removed: Reporting and Advisory Services to various public companies in the United States and Canada, through her position with the accounting
−Removed: firm, Treewalk (previously ACM Management, Inc.).
−Removed: At Treewalk Ms.
−Removed: Daley assisted clients in meeting their quarterly and annual reporting
−Removed: requirements including the preparation of complete financial reporting packages and managing assurance engagements from start to finish.
−Removed: At Treewalk, she also served as chief financial officer to Makena Resources Inc.
−Removed: MKNA) (April 2018 - April 2019) and Naked Brand
−Removed: NAKD) (March 2018 - June 2018) until the completion of their prospective mergers in April 2019 and June 2018, respectively.
−Removed: From September 2011 to April 2015, Ms.
−Removed: Daley was employed with Naked Brand Group Inc., where she worked in the accounting department,
−Removed: serving as controller from August 2013 until her departure in April 2015, and where she was also responsible for assisting in various
−Removed: operational functions including EDI implementation, ERP implementation, inventory management, information technology and office administration.
−Removed: From July 2021 to present, Ms.
−Removed: Daley has acted as manager of accounting at Anavex Life Sciences where she assists to in the finalization
−Removed: of all internal reporting, budgeting, and operational matters such as annual SOX audits, quarterly reviews, IT audits, and annual audits.
−Removed: Daley’s expertise in financial accounting for public companies and her having served as a chief financial officer and controller
−Removed: on companies listed on United States public exchanges makes her a qualified director candidate for our company.
+Added: seek a waiver of these fees in certain limited circumstances, including a waiver of the application fee for the first BLA or NDA submitted
+Added: by a small business.
+Added: Product candidates with an Orphan Drug Designation (“ODD”) are not subject to the BLA application fee
+Added: unless the product application also includes a non-orphan indication.
+Added: The FDA reviews a BLA to determine, among other things,
+Added: whether a biologic is safe, pure, and potent (i.e., effective) for its intended use and whether its manufacturing is GMP-compliant to
+Added: assure the product’s identity, strength, quality and purity.
+Added: Under PDUFA, the FDA has a goal date of ten months from the date of
+Added: “filing” to review and act on the submission.
+Added: However, the time between submission and filing can add an additional two months
+Added: as FDA conducts a preliminary review to ensure that the BLA is sufficiently complete to permit substantive review.
+Added: Formal FDA review of
+Added: the BLA does not begin until FDA has accepted it for filing.
+Added: The FDA may refer an application in some cases to an advisory committee for
+Added: its independent review.
+Added: An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that
+Added: reviews, evaluates and provides a recommendation to FDA as to whether the application should be approved and under what conditions.
+Added: FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
+Added: Before approving a BLA, the FDA will typically inspect
+Added: the locations where the product is manufactured.
+Added: The FDA will not approve an application unless it determines that the manufacturing processes
+Added: and facilities are in compliance with cGMPs, and are adequate to assure consistent production of the product within required specifications.
+Added: An important part of a BLA is a lot release protocol that the sponsor will use to test each lot of product made after BLA approval, as
+Added: well as the FDA’s own test plan that will be used for confirmatory testing of each post-approval product lot that is made before
+Added: it is released to the public.
+Added: If the FDA determines that the data and information in the application, including about the manufacturing
+Added: process or manufacturing facilities, are not acceptable, then the FDA will outline the deficiencies and often will request additional
+Added: testing or information.
+Added: Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the
+Added: application does not satisfy the regulatory criteria for approval.
+Added: After the FDA evaluates a BLA, it will either issue
+Added: an approval letter or a Complete Response Letter (“CRL”).
+Added: The approval letter authorizes commercial marketing of the biologic
+Added: with approved prescribing information for specific approved indications.
+Added: On the other hand, a CRL indicates that the review cycle of the
+Added: application is complete but the BLA cannot be approved in its present form.
+Added: A CRL usually describes the specific deficiencies identified
+Added: by the FDA and describes the actions the sponsor must take to correct those deficiencies.
+Added: A sponsor that receives a CRL must resubmit
+Added: the BLA after addressing the deficiencies or withdraw the application.
+Added: Even if such additional data and information are submitted to address
+Added: the deficiencies, the FDA may decide that the data and information in the resubmitted BLA do not satisfy the approval criteria.
+Added: Following marketing approval, a sponsor may need to
+Added: fulfill certain post-marketing requirements (“PMRs”) or post-marketing commitments (“PMCs”).
+Added: For example, post-approval
+Added: trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval.
+Added: These trials are used to gain additional
+Added: experience from the treatment of patients for the intended therapeutic indication.
+Added: The trials may be agreed upon prior to approval, or
+Added: the FDA may require them if new safety issues emerge.
+Added: Following approval, a sponsor may also need to conduct a pediatric study that was
+Added: temporarily deferred during the initial product development process.
+Added: Under the Pediatric Research Equity Act (“PREA”), a sponsor
+Added: must conduct pediatric clinical trials for most new drugs or biologics, for a new active ingredient, new indication, new dosage form,
+Added: new dosing regimen or new route of administration.
+Added: The required assessment must evaluate the safety and effectiveness of the product for
+Added: the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation
+Added: for which the product is safe and effective.
+Added: PREA studies must be included in the application unless the sponsor has received a deferral
+Added: A risk evaluation and mitigation strategy (“REMS”)
+Added: may also be an important component of a BLA approval that requires sponsor post-marketing regulatory efforts.
+Added: A REMS is a safety strategy
+Added: to manage a known or potential serious risk associated with a drug or biologic and to enable patients to have continued access to such
+Added: medicines by managing their safe use.
+Added: A REMS may include medication guides, physician communication plans, or elements to assure safe
+Added: use (ETASU) such as restricted distribution methods, patient registries, and other risk minimization tools.
+Added: Once approved, the FDA may withdraw the product approval
+Added: if compliance with PMRs, PMCs, or a REMS program is not maintained or if problems occur after the product reaches the marketplace.
+Added: FDA may also request that a product be recalled for an identified safety issue.
+Added: In addition, new government requirements, including those
+Added: resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory
+Added: approval or otherwise impact ongoing development programs.
+Added: Regulations Applicable to Our Precision Manufacturing
+Added: Our precision manufacturing operations serve customers
+Added: in the aerospace, defense, and industrial sectors and are subject to a range of federal and state regulatory requirements.
+Added: International Traffic in Arms Regulations (ITAR)
+Added: Certain of our precision manufacturing operations are registered with
+Added: Department of State’s Directorate of Defense Trade Controls under the ITAR, 22 C.F.R.
+Added: Parts 120–130.
+Added: ITAR controls the
+Added: export, temporary import, and brokering of defense articles, defense services, and related technical data listed on the United States
+Added: Munitions List (“USML”).
+Added: As an ITAR-registered entity, our applicable subsidiaries are authorized to manufacture defense articles
+Added: and provide defense services, and are required to comply with all applicable ITAR requirements, including restrictions on the transfer
+Added: of controlled technical data and defense articles to foreign persons, whether inside or outside the United States.
+Added: ITAR registration must
+Added: be renewed annually, and we are required to maintain records, implement security protocols, and ensure that all employees with access
+Added: to ITAR-controlled information are U.S.
+Added: persons as defined under the regulations.
+Added: Failure to comply with ITAR requirements could result
+Added: in civil penalties, criminal penalties, debarment from government contracting, loss of export privileges, and reputational harm.
+Added: Export Administration Regulations
+Added: In addition to ITAR, certain of the products and technical data produced
+Added: by our precision manufacturing operations may be subject to the Export Administration Regulations (“EAR”), administered by
+Added: the Bureau of Industry and Security within the U.S.
+Added: Department of Commerce.
+Added: The EAR controls the export, reexport, and transfer of dual-use
+Added: items — goods, software, and technology that have both commercial and military or proliferation applications — that are listed
+Added: on the Commerce Control List or that are subject to EAR jurisdiction.
+Added: We are required to determine the applicable export classification
+Added: of our products and technical data and to comply with all applicable licensing requirements, end-use restrictions, and screening obligations
+Added: under the EAR.
+Added: Violations of the EAR may result in civil and criminal penalties, denial of export privileges, and other sanctions.
+Added: AS9100 Quality Management System Certification
+Added: Certain of our precision manufacturing operations maintain certification
+Added: under AS9100, the internationally recognized quality management system standard for the aerospace, defense, and space industries, published
+Added: by the Society of Automotive Engineers International.
+Added: AS9100 incorporates the requirements of ISO 9001 and adds additional requirements
+Added: specific to the aerospace and defense industries, including requirements related to configuration management, risk management, product
+Added: safety, counterfeit parts prevention, and first article inspection.
+Added: AS9100 certification is required or strongly preferred by many aerospace
+Added: and defense prime contractors and government agencies as a condition to qualifying as an approved supplier.
+Added: Our certified facilities are
+Added: subject to periodic surveillance audits and recertification audits conducted by accredited third-party certification bodies, and must
+Added: maintain ongoing compliance with the standard’s requirements to retain certification.
+Added: Loss of AS9100 certification could result in the
+Added: loss of existing customer qualifications, disqualification from bidding on new contracts, and reputational harm.
+Added: Occupational Safety and Health Regulations
+Added: Our precision manufacturing operations are subject to federal and state
+Added: occupational safety and health laws and regulations, including those administered by the Occupational Safety and Health Administration
+Added: (“OSHA”) under the Occupational Safety and Health Act of 1970.
+Added: These regulations establish requirements for workplace safety,
+Added: including standards related to machine guarding, hazard communication, personal protective equipment, lockout/tagout procedures, noise
+Added: exposure, and other hazards associated with CNC machining and metalworking operations.
+Added: Our operations in California are also subject to
+Added: California Occupational Safety and Health Administration regulations, which in certain respects impose requirements that are more stringent
+Added: than federal OSHA standards.
+Added: Failure to comply with applicable occupational safety and health requirements could result in citations,
+Added: fines, work stoppages, employee injury claims, and increased workers’ compensation costs.
+Added: Environmental Regulations
+Added: Our precision manufacturing operations involve the use, storage, handling,
+Added: and disposal of materials that may be subject to federal, state, and local environmental laws and regulations, including the Resource
+Added: Conservation and Recovery Act (“RCRA”), the Clean Air Act, the Clean Water Act, the Toxic Substances Control Act, and their
+Added: state-law equivalents.
+Added: The machining of metals, including specialty and exotic alloys, involves the use of cutting fluids, coolants, lubricants,
+Added: and other substances that may constitute hazardous materials or generate hazardous waste.
+Added: We are required to comply with applicable requirements
+Added: for the storage, handling, labeling, transportation, and disposal of such materials.
+Added: Failure to comply with applicable environmental laws
+Added: and regulations could result in fines, penalties, remediation costs, and restrictions on operations.
+Added: Government Contracting Regulations
+Added: To the extent our precision manufacturing operations provide products
+Added: or services directly or indirectly to the U.S.
+Added: government, such operations may be subject to federal government contracting regulations,
+Added: including the Federal Acquisition Regulation and the Defense Federal Acquisition Regulation Supplement.
+Added: These regulations impose requirements
+Added: relating to cost accounting, pricing, procurement integrity, subcontracting, and compliance with socioeconomic policies.
+Added: Non-compliance
+Added: with government contracting regulations could result in contract termination, suspension or debarment from future government contracts,
+Added: civil and criminal penalties, and reputational harm.
+Added: Regulations Applicable to Our Specialty Packaging
+Added: Our specialty packaging operations provide custom-engineered
+Added: protective packaging solutions for electronic and IT hardware components and are subject to a range of federal, state, and local regulatory
+Added: requirements.
+Added: Electrostatic Discharge (ESD) Protection Standards
+Added: Our packaging solutions are engineered to comply with industry standards
+Added: for electrostatic discharge protection, including standards published by the ESD Association, such as ANSI/ESD S20.20 and ANSI/ESD S541.
+Added: These standards establish requirements for the handling, packaging, and transportation of ESD-sensitive electronic components.
+Added: While compliance
+Added: with ESD standards is generally voluntary, many of our customers in the semiconductor, data center, and networking equipment supply chains
+Added: require their suppliers to demonstrate compliance with applicable ESD standards as a condition of doing business.
+Added: Failure to meet customer-required
+Added: ESD standards could result in product returns, customer claims, loss of business, and reputational harm.
+Added: Occupational Safety and Health Regulations
+Added: Our specialty packaging operations are subject
+Added: to federal and state occupational safety and health laws and regulations, including those administered by OSHA and, for operations located
+Added: in California, Cal/OSHA.
+Added: These regulations establish requirements for workplace safety applicable to our manufacturing and warehouse operations,
+Added: including standards related to material handling, hazard communication, personal protective equipment, and ergonomic safety.
+Added: comply with applicable occupational safety and health requirements could result in citations, fines, work stoppages, and employee injury
+Added: Environmental Regulations
+Added: Our specialty packaging manufacturing operations
+Added: may involve the use of materials and processes that are subject to federal, state, and local environmental laws and regulations, including
+Added: requirements related to air emissions, waste disposal, and the handling and storage of chemicals used in the packaging manufacturing process.
+Added: We are required to comply with applicable environmental regulations, including those administered under the Clean Air Act, the Clean Water
+Added: Act, RCRA, and their state-law equivalents.
+Added: Failure to comply with applicable environmental laws and regulations could result in fines,
+Added: penalties, and remediation costs.
+Added: California Proposition 65
+Added: Our operations and products may be subject to
+Added: the requirements of California’s Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65.
+Added: 65 requires businesses operating in California to provide warnings to consumers when their products contain chemicals known to the State
+Added: of California to cause cancer, birth defects, or other reproductive harm.
+Added: The list of chemicals subject to Proposition 65 is maintained
+Added: and periodically updated by the California Office of Environmental Health Hazard Assessment (“OEHHA”).
+Added: Non-compliance with Proposition
+Added: 65 can result in significant civil penalties and private enforcement actions.
+Added: Packaging and Labeling Regulations
+Added: Our packaging products may be subject to federal and state packaging
+Added: and labeling requirements, including requirements imposed by the Federal Trade Commission and state consumer protection agencies.
+Added: extent we make environmental claims about our packaging products (e.g., recyclability, sustainability), such claims are subject to the
+Added: Federal Trade Commission (“FTC”)’s Guides for the Use of Environmental Marketing Claims and analogous state regulations.
+Added: We are also required to comply with any applicable product marking, labeling, or material disclosure requirements imposed by our customers
+Added: or required by industry standards.
+Added: Trade and Customs Regulations
+Added: To the extent our specialty packaging operations source materials or
+Added: components from international suppliers or ship products internationally, such operations may be subject to U.S.
+Added: customs laws and regulations
+Added: administered by U.S.
+Added: Customs and Border Protection, including requirements related to import classification, valuation, country of origin
+Added: marking, and applicable tariffs and duties.
+Added: Changes in U.S.
+Added: trade policy, including the imposition or escalation of tariffs on imported
+Added: materials, could increase our cost of goods and adversely affect our margins and competitive position.
+Added: General Regulatory Matters Applicable to All
+Added: In addition to the industry-specific regulations
+Added: described above, all of the Company’s subsidiaries are subject to a broad range of federal, state, and local laws and regulations of general
+Added: applicability, including laws and regulations relating to employment and labor (including wage and hour, anti-discrimination, and workplace
+Added: accommodation requirements), employee benefits, data privacy and security, tax, anti-corruption, anti-money laundering, and securities
+Added: Our operations in California subject us to California-specific regulatory requirements that may, in certain respects, be more stringent
+Added: than federal requirements, including those related to employment, environmental protection, and consumer protection.
+Added: As we grow and expand
+Added: our operations, including through acquisitions, we may become subject to additional regulatory requirements in new jurisdictions.
+Added: with existing and evolving regulatory requirements may increase our costs, require changes to our business practices, and divert management
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.