EDGAR 10-K Filing

Company CIK: 1840563
Filing Year: 2025
Filename: 1840563_10-K_2025_0001013762-25-003553.json

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ITEM 1. BUSINESS
Item 1. Business
Overview
We manage and operate a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors:
● Northstrive Biosciences Inc. is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines and therapeutic products. Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
● PMGC Research Inc., based in Canada, is currently dedicated to medical scientific research and development efforts, utilizing Canadian research grants and partnering with leading Canadian Universities to push the boundaries of innovation.
● PMGC Capital LLC is a multi-strategy investment firm focused on direct investments, strategic lending, and acquiring undervalued companies and assets across diverse markets. Its mission is to identify and seize high-potential opportunities, delivering sustainable growth and maximizing returns on capital.
We are dedicated to enhancing our portfolio through the acquisition of operating companies and innovative biotechnology assets that align with our growth mission, while actively pursuing opportunities to foster growth and drive innovation.
As of January 16, 2025, we completed the divestiture of the assets relating to our prior Elevai Skincare Inc. business. Elevai Skincare Inc., previously specializing in developing and commercializing physician-dispensed skincare products, is no longer part of our operations. Post closing of the asset sale, we changed the name of Elevai Skincare Inc. changed its name to PMGC Impasse Corp. on January 17, 2025. The Skincare asset divestiture enables us to dedicate more resources and time to advancing our initiatives and assets in larger markets with unmet needs, creating greater growth opportunities for the Company and its shareholders. Our efforts will focus on the clinical development of biotechnology assets through NorthStrive Biosciences Inc. while leveraging our R&D capabilities through PMGC Research Inc. Moreover, this strategic shift positions us to actively explore and execute potential business acquisitions and high-value biotechnology assets, further strengthening our portfolio and driving long-term growth.
Business Strategy
PMGC Holdings Inc. currently operates as a holding company focusing on developing biotechnology assets, advancing novel science and discoveries through collaborative strategic research and development partnerships. We intend to find and acquire additional operating companies in agnostic sectors.
Northstrive Biosciences Inc.
Northstrive Biosciences Inc., a wholly owned subsidiary of PMGC Holdings Inc., is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines and therapeutic products. Currently, more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030. Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure. Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.
Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. EL-22 has completed a Phase 1 clinical trial in South Korea, demonstrating it was 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. Elevai intends to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs. We are working towards filing an IND with the FDA to test EL-22 in human subjects. Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also being positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists. 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.
PMGC Research Inc.
PMGC Research Inc., a wholly owned subsidiary of PMGC Holdings Inc., is dedicated to advancing innovative research and development initiatives in Canada by leveraging government grants and funding programs. Through strategic collaborations with leading research institutions and industry partners, PMGC Research Inc. aims to accelerate scientific discovery and transform cutting-edge technologies into commercially viable products.
PMGC Capital LLC
PMGC Capital LLC, a wholly owned subsidiary of PMGC Holdings Inc., is a multi-strategy investment vehicle engaged in investing, lending and pursuing diversified investment opportunities. PMGC Capital LLC actively supports the growth and expansion of PMGC Holdings’ portfolio companies. The subsidiary’s dynamic investment approach is designed to capitalize on high yield returns on capital and investing into and acquiring assets and companies that are undervalued.
Northstrive Biosciences Products
Northstrive Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. Our lead asset, EL-22, has completed a Phase 1 clinical trial in South Korea, demonstrating it was 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.
Preclinical results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD)1. Elevai believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass. We plan to submit an Investigational New Drug (IND) application in 2025 that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs. Regulatory bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
Several key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle wasting. These companies include:
1. Novo Nordisk: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market. They have shown significant efficacy in weight loss and improving cardiovascular health.
2. Eli Lilly: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss. Eli Lilly also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
3. Pfizer: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
4. Biohaven: Biohaven’t taldefgrobep is an investigational fusion protein targeting myostatin to impact skeletal muscle growth relevant to individuals living with overweight and obesity.
5. Scholar Rock: Scholar Rock’s apitegromab is an inhibitor of the activation of latent myostatin, with the aim of improving patients’ motor function. Scholar Rock is assessing apitegromab’s ability to preserve lean muscle mass in individuals on GLP-1 receptor agonist therapy for obesity.
6. Veru: Veru’s enobosarm is an androgen receptor modulator, also known as a SARM, to address the loss of muscle in patients undergoing weight loss therapy with GLP-1 drugs.
1. Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059
These companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective obesity management and the prevention of muscle wasting associated with weight loss.
Operational and Competitive Strengths
We face competition from both commercialized obesity medications, as well as clinical candidates that are still in the development stage. We believe the primary competitive factors in our favor for EL-22 & EL-32 are the following:
● Our First-in-Class Approach and Early Results
Northstrive Biosciences is developing EL-22, an engineered probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass. Based on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing fat mass. In the preclinical studies1:
● EL-22 showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator of muscle growth.
● EL-22 showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
● EL-22 administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated by a longer duration during rotarod tests.
Based on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity. Our ability to proceed with human trials is contingent upon the FDA clearing the IND submission.
● Our Candidates’ Ease of Use and Convenient Oral Administration
We believe our product candidates EL-22 and EL-32 would be the only oral myostatin formulations to date, making Northstrive Bioscience an early mover in the emerging GLP-1 combination space for muscle preservation. Existing approaches targeting obesity with combinations to preserve muscle mass while on weight loss therapies are administered through injectable forms; either subcutaneously or intravenously. Although effective, many patients in general prefer orally administered medications over injections due to factors like convenience, ease of administration, and fear of needles. Our product candidates have been designed to be oral capsules to provide benefits without any needling.
Strategy
Northstrive Biosciences’ strategy focuses primarily on the clinical development and commercialization of novel medicines for the treatment of metabolic diseases, including obesity. We will need substantial capital to support our drug development and any related commercialization efforts for our drug candidates. The key elements of our strategy are:
● Develop EL-22 & EL-32 for obesity.
Reference:
1 Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059
Our metabolic drug pipeline is focused on the clinical development of EL-22, a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. Currently, more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.1 Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure. Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.2
Approved GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape. However, past studies of these highly effective drugs show that up to 20-50% of the weight loss is due to loss of lean muscle.3
Muscle is necessary for metabolism, strength, and physical function. As a result, we believe that one of the key unmet needs in the current obesity landscape is the avoidance of muscle loss while on weight loss treatments. Northstrive Biosciences is developing EL-22, an engineered probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass.
Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
We 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 and increase the fat loss experienced by older patients receiving GLP-1 drugs for the treatment of obesity.
Corporate History and Structure
PMGC Holdings Inc. has three wholly owned subsidiaries, PMGC Research Inc. (FKA Reactive Medical Inc.), Northstrive Biosciences Inc. and PMGC Capital LLC.
Reactive Medical Labs Inc. (referred to herein as “Reactive Labs”) was incorporated in Delaware on June 9, 2020. On December 3, 2021, Reactive Labs changed its name to Elevai Labs, Inc. (referred to herein as “Elevai”). Reactive Medical Inc. (referred to herein as “Reactive”) was incorporated in British Columbia, Canada on February 5, 2018. On September 7, 2022, Reactive changed its name to Elevai Research Inc. Elevai Research Inc. is a wholly owned subsidiary of the Company.
On December 20, 2024, the Company re-domesticated to Nevada and changed its name to “PMGC Holdings Inc.”
In June 2021, we entered into a stock transfer agreement with Reactive, whereby we purchased substantially all of the assets and liabilities of Reactive. Under the stock transfer agreement, we acquired 100% of the issued and outstanding common shares of Reactive. Immediately before the stock transfer agreement BWL Investments Ltd., a British Columbia Canada corporation owned 100% of the issued and outstanding common shares of Reactive. In consideration of 100% of the issued and outstanding common shares of Reactive we issued 100 shares of our Common Stock to BWL Investments Ltd. Upon completion of the stock transfer agreement, Reactive became our wholly owned subsidiary. In September 2022, Reactive changed its name to Elevai Research Inc. On January 10, 2025, Elevai Research Inc. changed its name to PMGC Research Inc.
Market, Industry and Other Research-Based Data
Our Market and Industry
We have transitioned to a biotechnology holding company focused on acquiring, licensing, and developing biotechnology assets across various pharmaceutical indications. Our business model consists of two primary components:
1. PMGC Capital LLC, our multi-strategy investment vehicle, which seeks to generate revenue through capital deployment in undervalued biotechnology assets, structured financings, and public and private market investments.
2. NorthStrive Biosciences Inc., our biotechnology subsidiary focused on advancing clinical-stage assets toward regulatory approval and commercialization.
References:
1 Ward ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL. Projected U.S. 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.
2 Why the anti-obesity drug market could grow to $100 billion by 2030. https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
3 Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. 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). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. PMID: 31565876; PMCID: PMC6769337.
As part of this strategic shift, we no longer operate in the physician-dispensed cosmetics or medical aesthetics markets. Instead, our focus is on developing and acquiring biotechnology assets that address critical unmet medical needs.
Industry Data
The global biotechnology market continues to grow, driven by advancements in gene therapies, regenerative medicine, and biologics. According to market research, the global biotechnology industry was valued at approximately $1.37 trillion in 2022 and is expected to grow at a CAGR of 12.8% from 2023 to 2030.28 This expansion is fueled by rising R&D investments, regulatory approvals, and the increasing adoption of biotechnology-based therapies.
The biopharmaceutical sector, which includes therapeutic proteins, monoclonal antibodies, and cell & gene therapies, represents a significant share of this growth. The market for gene therapies alone is expected to exceed $25 billion by 2028, with companies rapidly advancing clinical-stage assets in oncology, metabolic diseases, and neurodegenerative disorders.29
The weight-loss drug market has also emerged as a high-growth sector, with GLP-1 receptor agonists such as Novo Nordisk’s Ozempic® and Eli Lilly’s Mounjaro® driving unprecedented demand. Goldman Sachs projects the anti-obesity drug market could reach $100 billion by 2030.30 However, research indicates that up to 40% of weight loss from GLP-1 drugs comes from lean muscle loss, creating an unmet need for therapies that preserve muscle mass during treatment.31
Our Lead Asset - EL-22: A Myostatin-Targeting Probiotic for Obesity and Muscle Preservation
PMGC is currently developing EL-22, an engineered probiotic expressing myostatin antigens, designed to elicit an immune response that helps preserve muscle mass while promoting fat loss. Based on preclinical data and the role of myostatin-activin signaling in muscle metabolism, we believe EL-22 has the potential to:
● Complement existing GLP-1 receptor agonists (e.g., Ozempic®, Wegovy®, Mounjaro®) by reducing muscle degradation while facilitating fat loss.
● Improve muscle function and physical endurance, addressing key concerns associated with weight loss treatments.
Preclinical studies demonstrated that EL-22:
● Significantly increased anti-myostatin IgG antibody concentration, blocking myostatin-a known negative regulator of muscle growth.
● Reduced creatine kinase levels, indicating lower muscle destruction.
● Improved physical activity and motor function in mdx mice, a model for Duchenne muscular dystrophy (DMD).32
PMGC intends to submit an Investigational New Drug (IND) application for EL-22 in 2025 and initiate clinical trials in the U.S. to evaluate its potential in combination with GLP-1 receptor agonists for obesity treatment. However, human trials are contingent upon FDA clearance of the IND submission.
With PMGC Capital LLC driving investment revenue and NorthStrive Biosciences Inc. advancing clinical assets like EL-22, our business is well-positioned to capitalize on emerging opportunities in biotechnology. By focusing on strategic acquisitions, clinical development, and high-growth markets, we aim to enhance shareholder value and establish PMGC Holdings as a leader in biotechnology innovation.
References
28. Biotechnology Market Size Report, 2023-2030. (Grand View Research)
29. Gene Therapy Market Growth, 2028. (Fortune Business Insights)
30. Why the Anti-Obesity Drug Market Could Grow to $100 Billion by 2030. (Goldman Sachs)
31. Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists on Lean Body Mass in Humans. Endocrinol Metab (Seoul). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. PMID: 31565876; PMCID: PMC6769337.
32. Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22. Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
Currently, more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.24 Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure. Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.25
Approved GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape. However, past studies of these highly effective drugs show that up to 40% of the weight loss is due to loss of lean muscle.26
Muscle is necessary for metabolism, strength, and physical function. As a result, we believe that one of the key unmet needs in the current obesity landscape is the avoidance of muscle loss while on weight loss treatments. PMGC is developing EL-22, an engineered probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass.
Based on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, PMGC believes that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing fat mass. In the preclinical studies,27
● EL-22 showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator of muscle growth.
● EL-22 showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
● EL-22 administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated by a longer duration during rotarod tests.
Based on the highlighted preclinical data, PMGC believes that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass. The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the U.S. to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity. Our ability to proceed with a human trial is contingent upon the FDA clearing the IND submission.
References:
24 Ward ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL. Projected U.S. 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.
25 Why the anti-obesity drug market could grow to $100 billion by 2030. https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
26 Sargeant JA, Henson J, King JA, Yates T, Khunti K, Davies MJ. 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). 2019 Sep;34(3):247-262. doi: 10.3803/EnM.2019.34.3.247. PMID: 31565876; PMCID: PMC6769337.
27 Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
Northstrive Biosciences Products
Northstrive Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. Our lead asset, EL-22, has completed a Phase 1 clinical trial in South Korea, demonstrating it was 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.
Preclinical results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD)1. PMGC believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor agonists, by preserving muscle mass while decreasing fat mass. We plan to submit an Investigational New Drug (IND) application in 2025 that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs. Regulatory bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
Competition
Several key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle wasting. These companies include:
1. Novo Nordisk: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market. They have shown significant efficacy in weight loss and improving cardiovascular health.
2. Eli Lilly: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss. Eli Lilly also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
3. Pfizer: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
4. Altimmune: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reduction of dyslipidemia.
5. AstraZeneca, Bristol Myers Squibb, Novartis, and Amgen: These companies are in the early stages of developing obesity treatments, including various GLP-1 receptor agonists and other innovative pharmacological approaches.
6. Shionogi: Developing S-309309, an oral MGAT2 inhibitor, which targets lipid metabolism for weight loss.
7. Aphaia Pharma: Their APHD-012 mimics the metabolic benefits of bypass surgery.
Several key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle wasting:
1. Novo Nordisk: A leader in the GLP-1 drug market with its products Ozempic and Wegovy. These drugs have shown substantial efficacy in weight loss and improving cardiovascular health.
2. Eli Lilly: Eli Lilly’s GLP-1 drug, Mounjaro (tirzepatide), is known for its significant weight loss results. Additionally, Eli Lilly acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
3. Pfizer: Pfizer is developing an oral GLP-1 analog, danuglipron, aimed at offering a more convenient dosing regimen for obesity treatment.
4. Altimmune: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reducing dyslipidemia, contributing to overall metabolic health.
5. AstraZeneca, Bristol Myers Squibb, Novartis, and Amgen: These companies are in the early stages of developing obesity treatments, including various GLP-1 receptor agonists and other innovative pharmacological approaches.
6. Shionogi: Shionogi is developing S-309309, an oral MGAT2 inhibitor that targets lipid metabolism for weight loss.
7. Aphaia Pharma: Their drug APHD-012 mimics the metabolic benefits of bypass surgery, offering a novel approach to weight loss.
These companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective obesity management and the prevention of muscle wasting associated with weight loss.
1 Reference: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J. A New Method of Myostatin Inhibition in Mice via Oral Administration of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int. J. Mol. Sci. 2022, 23, 9059. https://doi.org/10.3390/ijms23169059.
Operational and Competitive Strengths
We operate in a highly competitive biotechnology and investment landscape, facing competition from pharmaceutical companies, biotechnology firms, and investment funds. Our key competitive advantages include:
● Strategic Capital Deployment: Through PMGC Capital LLC, we seek to acquire undervalued assets, optimizing capital returns while expanding our portfolio.
● Diversified Biotechnology Holdings: We establish wholly owned subsidiaries to develop clinical-stage and preclinical assets across multiple therapeutic areas.
● Advancement of High-Potential Biotechnology Assets: Our subsidiary, NorthStrive Biosciences Inc., is progressing EL-22, a lead asset targeting muscle preservation in obesity treatment.
● Flexible M&A and Licensing Model: Our structure allows for strategic acquisitions, licensing deals, and potential spin-offs, creating value for shareholders.
As of the date of this Annual Report on Form 10-K, there are no FDA approved medical products utilizing exosomes.
Our Well Recognized and Award-winning Team and Brand
Executive Team
Graydon Bensler
Chief Executive Officer and Chief Financial Officer
Mr. Bensler is a financial professional and executive with over seven years of experience in financial consulting and management for both private businesses and U.S./Canadian publicly traded companies. He co-founded an EdTech curriculum management and scheduling company in 2017, which was implemented in academic institutions across Canada and the United States. From 2017 to 2019, he served as an account manager at a leading Canadian investor relations firm, collaborating with investment banks, brokers, and company executives across various sectors. Between 2019 and 2021, Mr. Bensler was a Senior Associate at Evans & Evans, a Canadian boutique investment banking firm, where he led valuations and facilitated public offerings for companies in Canada and the U.S. He holds a Bachelor of Management and Organizational Studies degree with a specialization in Finance from the University of Western Ontario and is a CFA Charterholder.
Daniel Mero
Co-Founder, Northstrive Biosciences Inc.
Mr. Mero is a biotechnology analyst who served as Research Director at PropThink, a leading online platform for healthcare investors. He has a talent for business development and identifying pharmaceutical licensing opportunities from top collaborators and university researchers. Mr. Mero was instrumental in discovering our lead asset, EL-22, and in the formation of NorthStrive Biosciences. He earned his Bachelor of Commerce degree with a specialization in Finance and Economics from the University of Toronto.
Scientific Advisory Board
Roger A. Fielding, PhD
Dr. Fielding serves as Team Lead and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Team at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. He is also a Professor of Nutrition at Tufts’ Friedman School of Nutrition Science and Policy, a Professor of Medicine at Tufts University School of Medicine, and the Associate Director of the Boston Claude D. Pepper Older Americans Independence Center. Dr. Fielding is an internationally recognized researcher studying the mechanisms contributing to age-associated decline in skeletal muscle mass and function, and the potential role of exercise, nutrition, physical activity, and other therapies in mitigating this process. He has published over 300 peer-reviewed papers and has a strong record of extramural funding from the NIH, USDA, foundations, and industry.
Eduardo Grunvald, MD
Dr. Grunvald is a board-certified obesity medicine physician and serves as the Director of the Weight Management Program at the University of California, San Diego. He evaluates and manages patients through their health and weight-loss journeys and has extensive experience using medications for weight management. As a professor in the Department of Medicine, Dr. Grunvald is active in teaching topics such as metabolism, weight regulation, and the treatment of obesity and weight-related medical conditions. He completed his residency training at the UC San Diego School of Medicine and earned his medical degree at the University of Washington School of Medicine. Dr. Grunvald is board certified in internal medicine and obesity medicine and is a fellow of the American College of Physicians (FACP).
Orian Shirihai, MD, PhD
Dr. Shirihai is a Professor of Medicine at the University of California, Los Angeles (UCLA), where he serves as Director of the UCLA Metabolism Research Theme. His laboratory focuses on mitochondrial structure, function, and quality control, making key contributions to mitochondrial biology, including the discovery of the life cycle of mitochondria and the relationship between mitochondrial architecture and nutrient utilization in metabolic diseases. Dr. Shirihai received his MD and PhD from the Technion - Israel Institute of Technology in 1997.
Justin Roadhouse
Analyst
Mr. Roadhouse is an analyst with experience in financial analysis and research. He has worked in various capacities within the financial industry, contributing to investment strategies and portfolio management. Mr. Roadhouse holds a degree in Finance and has been involved in multiple projects aimed at optimizing investment performance.
Braeden Lichti, a co-founder and our Chairman of the Board, has served as our strategic consultant since July 2020 through his firm NorthStrive Companies Inc. (“NorthStrive”). Mr. Lichti is the founder and CEO of NorthStrive since its inception in 2020. NorthStrive is a California corporation that focuses on identifying public markets venture capital investment opportunities in high-growth early-stage companies. NorthStrive is a sector agnostic privately held firm that has identified and invested, through its principal owners, in industries, including biotechnology, medical devices, and medical aesthetics. We believe Mr. Lichti will be a continued asset to the Company due to his network within the healthcare and aesthetic business community, and his experience identifying investment opportunities. Mr. Lichti will be beneficial to the Company as it seeks to identify new business and capital opportunities which led to the conclusion that NorthStrive should continue to be our advisor.
Kevin Green is an experienced healthcare executive with a broad background in life sciences and biotechnology finance and operations. He has over ten years of business development experience in the medical aesthetics field including Allergan Plc, a division of AbbVie Inc., Elsie Biotechnologynologies, and Bioniz, LLC. Kevin has been involved in multiple acquisitions for companies that remain our competitors, such as SkinMedica Inc. With Kevin’s broad operations and finance expertise, he brings relevant generalist experience to assist in our business development functions. He has been an advisor to us and made several key introductions between our founders and prominent executives and practitioners in the physician-dispensed aesthetic space. We expect Kevin to continue to network on our behalf and provide key input on key business dealings and product development moving forward.
Strategy
We aim to position PMGC Holdings Inc. as a leading holding company, leveraging strategic acquisitions, capital deployment, and asset optimization to drive long-term growth.
Our strategy is built on three key pillars:
1. Capital Deployment for Stronger Returns Through PMGC Capital LLC, we focus on achieving high returns on capital by investing in undervalued assets, deploying treasury funds into public and private investments, and leveraging structured financings to maximize value.
2. Acquiring and Scaling Biotechnology and High-Growth Operating Companies We actively seek acquisitions in the biotechnology sector and other high-growth industries, financing their expansion through equity, debt, and available grants. By integrating synergistic businesses under our portfolio, we enhance operational efficiencies, accelerate commercialization, and unlock market opportunities.
3. Spin-Offs and Strategic Portfolio Optimization We continuously evaluate spin-off opportunities for wholly owned subsidiaries or specific assets, allowing us to unlock shareholder value and create independent, specialized companies. This approach enables us to capitalize on advanced scientific research and address significant unmet medical needs while maintaining a diversified and scalable business model.
Intellectual Property
PMGC Holdings Inc.
Patents
Below is a table, with footnotes, that includes our United States patents, with their referenced property numbers, that are material to our business as of March 21, 2025:
Property No.
Patent Title
Application
Number and
Filing Date
Application Type
Jurisdiction
Ownership
Status and
Expiration Date
1.
Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients
63/639,722, 04/29/2024
Provisional
USA
Elevai Labs, Inc., 04/29/2025
2.
Combination Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients
63/639,723, 04/29/2024
Provisional
USA
Elevai Labs, Inc., 04/29/2025
3.
Pharmaceutical Composition for Treatment of Muscle Loss Due to Obesity
63/639,727, 04/29/2024
Provisional
USA
Elevai Labs, Inc., 04/29/2025
4.
Combination Therapy for Treatment of Muscle Loss Due to Obesity
63/639,728, 04/29/2024
Provisional
USA
Elevai Labs, Inc., 04/29/2025
Below is a table that includes our granted United States patents as of March 26, 2025:
(1) Granted patent based on Property.
Below is a table that includes our United States patent applications as of January 24, 2025:
Patent Title Filing Date Application Type Jurisdiction
Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients (1) 9/30/2024 Non-provisional USA
Combination Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients (2) 9/30/2024 Non-Provisional USA
Pharmaceutical Composition for Treatment of Muscle Loss Due to Obesity (3) 10/15/2024 Non-provisional USA
Combination Therapy for Treatment of Muscle Loss Due to Obesity (4) 04/28/2025 Non-provisional USA
(1) Non-provisional patent application based on Property.
(2) Non-provisional patent application based on Property.
(3) Non-provisional patent application based on Property.
(4) Non-provisional patent application based on Property.
Trademarks
Docket Number Trademark Country / Region Classes Application No. Registration No. Status Substatus
15981-0119 ELEVAI BIOSCIENCES United States - (US) 5, 42
Filed - (F) Pending - (PEND)
15981-0119.1 ELEVAI BIOSCIENCES (& Des.) United States - (US) 5, 42
Filed - (F) Pending - (PEND)
Domain Names
We have the right to use the following domain registration issued in the United States, as noted below:
Number Issue Date Expiration Date Registration Agency Domain Name Owner
July 31, 2024 July 31, 2027 GoDaddy www.pmgcholdings.com PMGC Holdings Inc.
April 10, 2024 April 10, 2025 GoDaddy www.northstrivebio.com PMGC Holdings Inc.
NorthStrive Biosciences Inc.
Patents
Property No. Licensed Product/ Nation Registration Number Registration Date Title
1. EL-22 Korea 10-0857861-0000 2008.09.03 Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
2. EL-22 Korea 10-0872042-0000 2008.11.28 Cell Surface Expression Vector of Myostatin and Microorganisms Transformed Thereby
3. EL-22 USA 2013.06.25 Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
4. EL-22 Japan 2014.10.24 Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
5. EL-22 China ZL200780101116.2 2013.06.19 Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
Patent Applications
Property No. Licensed Product/ Nation Patent Application Serial No Filing Date Title
1. EL-32 USA 18/627,462 2024.04.05 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
2. EL-32 Korea 10-2022-0136606 2022.10.21 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
Trademarks
Docket Number Trademark Country / Region Classes Application No. Registration No. Status Substatus
15981-0119 ELEVAI BIOSCIENCES United States - (US) 5, 42
Filed - (F) Pending - (PEND)
15981-0119.1 ELEVAI BIOSCIENCES (& Des.)
Sales and Marketing
As a biotechnology holding company, our sales and marketing efforts focus on maximizing asset value through strategic partnerships, licensing agreements, and investment-driven growth strategies rather than traditional direct sales models.
Commercialization and Licensing Strategy
● We seek commercial partnerships, licensing agreements, and strategic acquisitions to monetize our biotechnology assets.
● Instead of building a direct sales force, we collaborate with biotechnology, pharmaceutical, and healthcare companies to facilitate late-stage clinical development and commercialization.
● Our approach includes leveraging key opinion leaders (KOLs), industry networks, and advisory boards to enhance visibility and credibility.
Marketing and Investor Relations
● We actively market our portfolio companies, investment strategies, and biotechnology assets to institutional investors, venture partners, and strategic acquirers.
● We engage in scientific conferences, industry events, and investor presentations to generate interest and attract potential commercial partners or acquirers.
By focusing on strategic alliances, funding opportunities, and investment-driven asset growth, we aim to enhance portfolio value and drive commercialization through industry partnerships.
Our Facilities
Our principal executive office is located at 120 Newport Center Drive, Newport Beach, CA 92660. The office has 500 square feet, and the lease runs from April 2024 to February 2025. The monthly rent is $1,561.
The following table sets forth the leases term and monthly rent:
Lease Term Address Space
(square feet) Average
Monthly Rent
April 2024 to February 2025 120 Newport Center Drive, Newport Beach, CA 92660 $ 1,561
Some members of our management work outside of these premises in office space that we do not rent.
Employees
As of the date of this Annual Report, we have two (2) full-time employees and one part-time employee. 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. We have developed various methods to train our employees adequately for the functions they perform and are aware of the laws and regulations affecting our industry. Our success depends on our ability to attract, retain and motivate qualified employees. We endeavor to offer employees competitive compensation packages and a positive, dynamic and creative work environment. We believe that we maintain a good working relationship with our employees and have not experienced any difficulty in recruiting staff for our operations.
Regulations
Government Regulation and Biologic Drug Approval
Government authorities in the United States, at the federal, state and local level, and other countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising, distribution, marketing and export and import of products such as those we are selling and developing. Because we are developing product candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely clear and may change. Regulatory requirements governing our product candidates have changed frequently and will likely continue to change in the future. We believe that the FDA will regulate part of our product candidates as a biologic drug (i.e., a biologic) through the Biologics License Application (“BLA”) process under the jurisdiction of the Office of Therapeutic Products within the Center for Biologics Evaluation and Research (“CBER”). 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 and licensure (i.e., approval). For future product candidates, we will also confirm the appropriate approval pathway (i.e., BLA or new drug application (“NDA”)) and the appropriate FDA center with regulatory oversight (i.e., CBER or the Center for Drug Evaluation and Research (“CDER”)).
U.S. Biologic Drug Development Process
In the United States, biologic drugs (“biologics”) are regulated under two statutes: The Public Health Service Act (“PHS Act”) and the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and their implementing regulations. However, submission and approval of only one application-typically either a BLA or an NDA-is required prior to marketing. The FDA has also issued numerous “Guidance Documents” and other materials that address specific aspects of biologic development for particular types of product candidates (e.g., cells, tissues, etc.). Substantial time and financial resources are required to obtain regulatory approvals and subsequently comply with appropriate federal, state, and local statutes and regulations. Failure to comply with the applicable U.S. requirements at any time during the biologic development, approval, or post-approval processes may subject an applicant to administrative or judicial sanctions. These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition of a clinical hold on ongoing clinical trials, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have a material adverse effect on us.
The process required by the FDA before a biologic may be marketed in the United States generally involves the following steps:
● completion of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s current good laboratory practice requirements and other applicable regulations;
● submission to the FDA of an IND, which must become effective before human clinical trials may begin;
● approval by an independent institutional review board (“IRB”) at each clinical site (or by one “commercial IRB”) before each trial may be initiated;
● performance of adequate and well-controlled human clinical trials in accordance with cGCP requirements to establish the safety, purity, and potency (i.e., efficacy) of the proposed biologic for its intended use;
● submission to the FDA of a BLA after completion of all clinical trials;
● satisfactory outcome of an FDA advisory committee review, if applicable;
● satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the biologic is produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength, quality and purity, and FDA inspection of selected clinical investigation sites to assess compliance with cGCPs; and
● FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.
The specific preclinical studies and clinical testing that is required for a BLA varies widely depending upon the specific type of product candidate under development. Prior to beginning a 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 IND must become effective. The focus of an IND submission is the general investigational plan and protocol for the proposed clinical study. The IND also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; Chemistry Manufacturing and Controls (“CMC”) information; and any available human data or literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises safety concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold, and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical hold is lifted and the clinical trial can begin. Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in accordance with cGCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters for monitoring safety and the effectiveness criteria to be evaluated. A separate submission to the existing IND must be made for each successive clinical trial conducted during product development. Other submissions to an IND include protocol amendments, information amendments, IND safety reports and annual reports. Furthermore, an independent 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 approve the protocol and informed consent form before the clinical trial may begin. The IRB also monitors the clinical trial until completed.
Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some clinical trials also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board (“DSMB”). A DSMB authorizes whether or not a study may move forward at designated check points based on access to certain data from the trial. The DSMB may halt the clinical trial if it determines there is an unacceptable safety risk for subjects or on other grounds, such as no demonstration of efficacy. Related reporting requirements for the sponsor, clinical investigator, and/or IRB also include IND safety reports and updating clinical trial results in public registries (e.g., ClinicalTrials.gov).
Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:
● Phase 1: The product candidate is initially introduced into healthy human subjects. These clinical trials are designed to test the safety, dosage tolerance, absorption, metabolism, distribution, excretion, side effects, and, if possible, early evidence of effectiveness. In the case of some products for severe or life-threatening diseases when the product may be too inherently toxic to ethically administer it to healthy volunteers, the initial human testing is often conducted in individuals who have the targeted disease or condition instead of healthy subjects;
● Phase 2: The product candidate is administered to a limited population of individuals who have the specified disease or condition to continue to evaluate safety, as well as preliminary efficacy, optimal dosages and dosing schedule, possible adverse side effects and safety risks. Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 (i.e., pivotal) clinical trials; and
● Phase 3: Generally, the largest in size, Phase 3 clinical trials are generally conducted at multiple geographically dispersed clinical trial sites. The product candidate is administered to an expanded population of individuals who have the specified disease or condition to further evaluate dosage, provide statistically significant evidence of clinical efficacy and gain additional safety data. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product approval.
Concurrent with clinical trials, sponsors usually complete additional animal studies. Sponsors must also develop information about the chemical and physical characteristics of the biologic and finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently producing quality batches of the product candidate, and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final biologic. In addition, the sponsor must develop and test appropriate packaging, and must conduct stability studies to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life. Before approval of a BLA, FDA evaluates the establishment by an on-site inspection to ensure the facilities and controls used for the manufacture, processing, packaging, and testing of the drug are adequate to ensure and preserve its identity, strength, quality, and purity.
During the development of a new biologic, sponsors are given opportunities to meet with the FDA. These meetings typically occur before the submission 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). Meetings at other times may be requested. These meetings provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development. Sponsors typically use EOP2 meetings to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new biologic.
U.S. Review and Approval Process for Biologic Drugs
Assuming successful completion of all required testing in accordance with the applicable statutory and regulatory requirements, the sponsor submits a BLA to the FDA. A BLA contains the results of product development, preclinical and other non-clinical studies and clinical trials, descriptions of the manufacturing process, analytical testing, proposed labeling and other relevant information. The submission of a BLA is subject to the payment of a substantial application fee under the Prescription Drug User Fee Amendments (“PDUFA”). PDUFA fees apply to both drugs and biologics. Sponsors may seek a waiver of these fees in certain limited circumstances, including a waiver of the application fee for the first BLA or NDA submitted by a small business. Product candidates with an Orphan Drug Designation (“ODD”) are not subject to the BLA application fee unless the product application also includes a non-orphan indication.
The FDA reviews a BLA to determine, among other things, whether a biologic is safe, pure, and potent (i.e., effective) for its intended use and whether its manufacturing is GMP-compliant to assure the product’s identity, strength, quality and purity. Under PDUFA, the FDA has a goal date of ten months from the date of “filing” to review and act on the submission. However, the time between submission and filing can add an additional two months as FDA conducts a preliminary review to ensure that the BLA is sufficiently complete to permit substantive review. Formal FDA review of the BLA does not begin until FDA has accepted it for filing. The FDA may refer an application in some cases to an advisory committee for its independent review. An advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation to FDA as to whether the application should be approved and under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.
Before approving a BLA, the FDA will typically inspect the locations where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMPs, and are adequate to assure consistent production of the product within required specifications. 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 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 it is released to the public. If the FDA determines that the data and information in the application, including about the manufacturing process or manufacturing facilities, are not acceptable, then the FDA will outline the deficiencies and often will request additional testing or information. Notwithstanding the submission of any requested additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
After the FDA evaluates a BLA, it will either issue an approval letter or a Complete Response Letter (“CRL”). The approval letter authorizes commercial marketing of the biologic with approved prescribing information for specific approved indications. On the other hand, a CRL indicates that the review cycle of the application is complete but the BLA cannot be approved in its present form. A CRL usually describes the specific deficiencies identified by the FDA and describes the actions the sponsor must take to correct those deficiencies. A sponsor that receives a CRL must resubmit the BLA after addressing the deficiencies or withdraw the application. Even if such additional data and information are submitted to address the deficiencies, the FDA may decide that the data and information in the resubmitted BLA do not satisfy the approval criteria.
Following marketing approval, a sponsor may need to fulfill certain post-marketing requirements (“PMRs”) or post-marketing commitments (“PMCs”). For example, post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing approval. These trials are used to gain additional experience from the treatment of patients for the intended therapeutic indication. The trials may be agreed upon prior to approval, or the FDA may require them if new safety issues emerge. Following approval, a sponsor may also need to conduct a pediatric study that was temporarily deferred during the initial product development process. Under the Pediatric Research Equity Act (“PREA”), a sponsor must conduct pediatric clinical trials for most new drugs or biologics, for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration. The required assessment must evaluate the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and administration for each pediatric subpopulation for which the product is safe and effective. PREA studies must be included in the application unless the sponsor has received a deferral or waiver.
A risk evaluation and mitigation strategy (“REMS”) may also be an important component of a BLA approval that requires sponsor post-marketing regulatory efforts. A REMS is a safety strategy to manage a known or potential serious risk associated with a drug or biologic and to enable patients to have continued access to such medicines by managing their safe use. A REMS may include medication guides, physician communication plans, or elements to assure safe use (ETASU) such as restricted distribution methods, patient registries, and other risk minimization tools.
Once approved, the FDA may withdraw the product approval if compliance with PMRs, PMCs, or a REMS program is not maintained or if problems occur after the product reaches the marketplace. The FDA may also request that a product be recalled for an identified safety issue. In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.
MANAGEMENT
The following table sets forth certain information with respect to our directors, executive officers and significant employees as of March 26, 2025:
Name
Age
Position
Executive Officers:
Graydon Bensler
Chief Executive Officer, Chief Financial Officer and Director
Braeden Lichti
Chairman of the Board
Non-Executive Directors:
Jeffrey Parry(1)(2)(3)
Independent Director and Chair of Nominating Committee
George Kovalyov(1)(2)(3)
Independent Director and Chair of Compensation Committee
Juliana Daley(1)(2)(3)
Independent Director and Chair of the Audit Committee
(1) Member of the Audit Committee.
(2) Member of the Compensation Committee.
(3) Member of the Nominating Committee.
Each of our directors serves for a term of one year ending on the date of the subsequent annual meeting of stockholders following the annual meeting at which such director was elected. Notwithstanding the foregoing, each director is to serve until his or her successor is elected and qualified or until his death, resignation or removal. Our Board appoints our officers, and each officer is to serve until his or her successor is appointed and qualified or until his or her death, resignation or removal.
Graydon Bensler, CFA, Chief Executive Officer, Chief Financial Officer and Director
Mr. Bensler has served as our Chief Executive Officer since June 2024 and Chief Financial Officer since inception and a director since June 9, 2020. Mr. Bensler is a financial professional and analyst with over seven years of experience in financial consulting and management for both private businesses and US/Canadian publicly traded companies and is a CFA Charterholder (CFA) In 2017, Mr. Bensler Co-founded an Ed Tech curriculum management and scheduling company that was implanted in academic schools in Canada and the United States. From 2017 to 2019, Mr. Bensler was an account manager at a leading Canadian investor relations firm where he represented publicly traded companies across a wide range of sectors where he worked directly with investment banks, investment brokers and company executives and directors. During his tenure, Mr. Bensler created and conveyed messaging about his clients’ strategic position in the market and successfully guided several companies through multiple financings. From 2019 to 2021, Mr. Bensler was a Senior Associate at Evans & Evans, a Canadian boutique investment banking firm where he led valuations and going public transactions for Canadian and United States companies. In this capacity, Mr. Bensler gained strong knowledge of the capital markets, public company compliance requirements, and regularly interfaced with regulators, auditors, board and executive management. Mr. Bensler was also a director of publicly traded Health Logic Interactive Inc. (TSXv:CHIP) from 2020 to 2024. We believe that Mr. Bensler’s past experience as our Chief Financial Officer, his familiarity with both the banking and the financial consulting sectors and his having served as an account manager for similarly situated companies makes him a qualified director for our Company.
Mr. Bensler received his Bachelor of Management and Organizational Studies degree from the University of Western Ontario, with specialization in Finance, and is a CFA Charterholder.
Braeden Lichti, Chairman of the Board
Braeden Lichti is the founder and Chief Executive Officer of BWL Investments Ltd., a privately held holding corporation he established in 2016, and NorthStrive Companies, Inc., a U.S. based investment and advisory services company he founded in 2021. Mr. Lichti also serves as Chairman of Hydromer, Inc., a global leader in surface modification and coating solutions, focusing on hydrophilic, thromboresistant and antimicrobial coatings for medical devices and various industrial applications. Established in 1980 and headquartered in Concord, North Carolina, Hydromer offers a wide range of services, including polymer research and development, contract coating and specialized analytical testing. Mr. Lichti co-founded PMGC Holdings Inc. in 2020 and has served as its advisor and has been a principal stockholder since its formation. He has remained the largest stockholder through companies he controls and recently assumed the role of Chairman in 2024. We believe that Mr. Lichti’s past experience as our director and advisor, his extensive executive experience and his having served as Chairman for similarly situated companies makes him a qualified director for our Company.
Jeffrey Parry, Independent Director, Chair of the Nominating Committee and member of the of Audit Committee and Compensation Committee
Mr. Parry was appointed as an independent director in June 2023 and is a partner of Mystic Marine Advisors LLC, a Connecticut based advisory firm he founded in 1998 focused on emerging and turnaround situations for strategic and financial stakeholders. Jeffrey served as Executive Chairman of TBS Shipping Limited from 2012 to 2018 where he led a successful restructuring and co-founded Valhalla Shipping, Inc with an $167 million equity investment by institutional investors. From July 2008 to October 2009, Mr. Parry was the Chief Executive Officer of Nasdaq-listed Aries Maritime Transport Limited and led a successful turn-around and sale to strategic investors. Mr. Parry was a Managing Director of Poten & Partners, an international energy advisor, from 2001 to 2007 where in 2006 he co-founded Poten Capital Services LLC, a New York based broker-dealer. Earlier in his career, Mr. Parry founded Cool FM and 7X Television in Athens, Greece and served as President of One Fifth Avenue Apartment Corporation. Since 2010, Jeffrey has served as an independent director of Nasdaq listed Globus Maritime Ltd. where he sits on the audit committee. Mr. Parry holds a BA from Brown University and MBA from Columbia University. His educational and professional experience in business, his background and familiarity in investment banking, and his having served as a director of a company listed on Nasdaq makes him a qualified director candidate for our Company.
George Kovalyov, Independent Director, Chair of the Compensation Committee and member of the of Audit Committee and Nominating Committee
Mr. Kovalyov has acted as Chief Financial Officer and Treasurer of Marizyme, Inc. since December 2021. Since November 2022, Mr. Kovalyov has also been a director of DGTL Holdings Inc. Previously he served as the chief operating officer and director of Health Logic Interactive Inc. (“HLII”) from September 2020 to November 2021, and as HLII’s chief financial officer from December 2021 to September 2022. In addition, Mr. Kovalyov served as a director and audit committee member of Margaret Lake Diamonds Inc. from January 2021 to August 2022. From September 2018 to September 2020, Mr. Kovalyov was VP of Finance and director of Phivida Holdings Inc., a brand of cannabidiol-infused foods, beverages and clinical products. From October 2016 to September 2020, Mr. Kovalyov was the principal owner of Schindler and Company, an accounting consulting firm. Mr. Kovalyov is a chartered accountant and is a member of Chartered Professional Accountants of Canada. Mr. Kovalyov is qualified to serve on the Board due to his extensive accounting and finance experience.
Juliana Daley, CPA Independent Director, Chair of the Audit Committee and member of the of Compensation Committee and Nominating Committee
Ms. Daley was appointed as an independent director in June 2023 and holds over eleven years of accounting, controller, and financial reporting experience in the public sector. Ms. Daley has worked a variety of industries in both the United States and Canada. Since July 2021, Ms. Daley has served as Manager of Accounting at Anavex Life Sciences Corp. (NASDAQ: AVXL), a clinical-stage biopharmaceutical company based in New York, NY that is focused on developing treatments for debilitating neurodegenerative and neurodevelopmental diseases. In addition, from August 2021 to July 2022, she served as an independent director and audit committee chair to Vegano Foods (CSE: VAGN) during Vegano Food’s initial public offering in February 2022. From October 2015 to July 2021, Ms. Daley was a Manager of Financial Reporting and Advisory Services to various public companies in the United States and Canada, through her position with the accounting firm, Treewalk (previously ACM Management, Inc.). At Treewalk Ms. Daley assisted clients in meeting their quarterly and annual reporting requirements including the preparation of complete financial reporting packages and managing assurance engagements from start to finish. At Treewalk, she also served as chief financial officer to Makena Resources Inc. (CSE: MKNA) (April 2018 - April 2019) and Naked Brand Group Inc. (NASDAQ: NAKD) (March 2018 - June 2018) until the completion of their prospective mergers in April 2019 and June 2018, respectively. From September 2011 to April 2015, Ms. Daley was employed with Naked Brand Group Inc., where she worked in the accounting department, serving as controller from August 2013 until her departure in April 2015, and where she was also responsible for assisting in various operational functions including EDI implementation, ERP implementation, inventory management, information technology and office administration. From July 2021 to present, Ms. Daley has acted as manager of accounting at Anavex Life Sciences where she assists to in the finalization of all internal reporting, budgeting, and operational matters such as annual SOX audits, quarterly reviews, IT audits, and annual audits. Ms. Daley’s expertise in financial accounting for public companies and her having served as a chief financial officer and controller on companies listed on United States public exchanges makes her a qualified director candidate for our company.

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ITEM 1A. RISK FACTORS
Item 1A. Risk Factors.
Risks Related to Our Financial Condition
Our financial statements have been prepared on a going-concern basis and our continued operations are in doubt.
The uncertainty about our ability to continue in operation is based on our continuing losses from operation, limited revenue and limited working capital, among other things which existed as of year-end December 31, 2023 and December 31, 2022. As of December 31, 2024 and December 31, 2023, the Company had net working capital of $4,251,867 and $3,622,091, respectively, and has an accumulated deficit of $13,269,627 and $7,023,890, respectively. Included in the accumulated deficit are losses of $6,245,737 for the year ended December 31, 2024 and $4,301,517 for the year ended December 31, 2023. Given all these facts, we are dependent on obtaining funding from operations and the sale of debt or equity to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that might be necessary should we be unable to continue as a going concern.
Our ability to continue as a going concern depends on the success of any future offering and receipt of additional funds through debt or equity financing and our operations. In the event we are unable to obtain such funding, we may have to delay, reduce or eliminate certain of our planned operations, including some of our research and development and/or clinical validation studies to demonstrate aesthetic improvement, reduce overall overhead expense, or divest assets. This in turn may have an adverse effect on our ability to realize the value of our assets. If we are unable to continue as a going concern, you may lose all or part of your investment.
We have a history of net losses, and we may not be able to achieve or maintain profitability in the future.
We have incurred net losses each year since our inception, and we may not be able to achieve or maintain profitability in the future. We incurred net losses of $6,245,737 and $4,301,517, for the years ended December 31, 2024 and 2023, respectively. Our expenses will likely increase in the future and may be more costly than we expect and may not result in increased revenue or growth in our business. These offerings may require significant capital investments and recurring costs, maintenance, depreciation, asset life and asset replacement costs, and if we are not able to maintain sufficient levels of utilization of such assets or such offerings are otherwise not successful, our investments may not generate sufficient returns and our financial condition may be adversely affected. Any failure to increase our revenue sufficiently to keep pace with our investments and other expenses could prevent us from achieving or maintaining profitability or positive cash flow on a consistent basis. If we are unable to successfully address these risks and challenges as we encounter them, our business, financial condition, results of operations and prospects could be adversely affected. If we are unable to generate adequate revenue growth and manage our expenses, we may continue to incur significant losses in the future and may not be able to achieve or maintain profitability.
Our current growth may not be indicative of our future growth and, if we begin to grow rapidly, we may not be able to effectively manage our growth or evaluate our future prospects. If we fail to effectively manage our future growth or evaluate our future prospects, our business could be adversely affected.
We have experienced minimal growth since our launch in 2020. For example, our revenue increased from nil in 2020 to $827 in 2021, to $766,277 in 2022, to $1,712,595 in 2023, and increased to $2,467,298 for the year ended December 31, 2024. Moreover, the number of our full-time employees increased as of December 31, 2024. As of the date of this Annual Report, we have two (2) full time employees and one part-time employee. This growth has placed significant demands on our management, financial, operational, technological and other resources. The anticipated growth and expansion of our business depends on a number of factors, including our ability to:
● Identify and acquire biotechnology assets and companies with strong commercial potential;
● Efficiently integrate acquired businesses and optimize their operations;
● Secure financing and capital to support acquisitions and subsequent growth;
● Develop and commercialize biotechnology innovations through our portfolio companies;
● Protect and expand our intellectual property portfolio, including patents, trademarks, and proprietary technologies;
● Navigate the complex regulatory landscape for drug development, medical devices, and other biotechnology-related products; and
● Establish strategic partnerships to enhance market penetration and revenue generation.
Such growth and expansion of our business will place significant demands on our management and operations teams and require significant additional resources, financial and otherwise, to meet our needs, which may not be available in a cost-effective manner, or at all. We expect to continue to expend substantial resources on:
● Mergers and acquisitions of companies and assets to expand our portfolio;
● Research and development initiatives within our acquired companies;
● Patents and patent enforcement and other intellectual property protections to maintain competitive advantages;
● Regulatory compliance, including FDA and other global regulatory approvals;
● Sales and marketing efforts to support commercialization strategies; and
● General administration, including increased finance, legal, and accounting expenses associated with operating as a public company.
These investments may not result in the growth of our business. Even if these investments do result in the growth of our business, if we do not effectively manage our growth, we may not be able to execute on our business plan, respond to competitive pressures, take advantage of market opportunities, satisfy our client requirements or maintain high-quality product offerings, any of which could adversely affect our business, financial condition, results of operations and prospects. You should not rely on our historical rate of revenue growth as an indication of our future performance or the rate of growth we may experience in any new category or internationally.
In addition, to support continued growth, we must effectively integrate, develop and motivate a large number of new employees while maintaining our corporate culture. We face significant competition for personnel. To attract top talent, we have had to offer, and expect to continue to offer, competitive compensation and benefits packages before we can validate the productivity of new employees. We may also need to increase our employee compensation levels to remain competitive in attracting and retaining talented employees. The risks associated with a rapidly growing workforce will be particularly acute as we choose to expand into new product categories and global markets. Additionally, we may not be able to hire new employees quickly enough to meet our needs. If we fail to effectively manage our hiring needs or successfully integrate new hires, our efficiency, ability to meet forecasts and employee morale, productivity and retention could suffer, which could have an adverse effect on our business, financial condition, results of operations and prospects.
We are also required to manage numerous relationships with various vendors and other third parties. Further growth of our operations, client base, or internal controls and procedures may not be adequate to support our operations. If we are unable to manage the growth of our organization effectively, our business, financial condition, results of operations and prospects may be adversely affected.
We will need additional capital to conduct our operations and develop our products and our ability to obtain the necessary funding is uncertain.
During the years ended December 31, 2024, and December 31, 2023 we used a significant amount of cash to finance our continued operations, and we need to obtain significant additional capital resources in order to develop products going forward. We may not be successful in maintaining our normal operating cash flow and the timing of our capital expenditures may not result in cash flows sufficient to sustain our operations through the next twelve months. If financing is not sufficient and additional financing is not available or available only on terms that are detrimental to our long-term survival, it could have a major adverse effect on our ability to pursue our clinical research and product development programs and could ultimately affect our ability to continue to function. The timing and degree of any future capital requirements and our ability to meet such capital requirements in a timely manner, on favorable terms or at all will depend on many factors, including:
● the accuracy of the assumptions underlying our estimates for capital needs in 2025 and beyond;
● scientific progress in our research and development programs;
● the magnitude and scope of our research and development programs and our ability to establish, enforce and maintain strategic arrangements for research, development, product testing, manufacturing, third-party agreements and marketing;
● the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims;
● the number and type of pipeline product that we pursue; and
● the development of major widespread events, including the possibility of a recession in the U.S. and globally, market volatility the potential for future pandemics or outbreaks such as any future COVID-19 outbreak, geopolitical conflict and other events which could impact us and third parties on which we depend.
● The progress, timing, and cost of clinical trials, regulatory submissions, and potential commercialization efforts for our biotech assets;
● The identification, evaluation, and execution of potential acquisitions in industries beyond biotechnology;
● The level of cash flows generated by current subsidiaries and any future acquired businesses;
● Our ability to access capital markets or secure alternative financing sources under favorable conditions;
● The structure and terms of any future financing transactions, including potential equity or debt offerings;
● The performance and capital requirements of any new business lines or investments we may pursue;
● Fluctuations in interest rates, inflationary pressures, and broader macroeconomic conditions;
● Changes in investor sentiment and public market conditions, particularly for holding companies and emerging growth businesses;
● The costs associated with maintaining our public company status, including legal, accounting, and compliance-related expenses; and
● Unforeseen events such as litigation, regulatory changes, or operational disruptions that could impact our liquidity or access to capital.
Additional financing through strategic collaborations, public or private equity or debt financings or other financing sources may not be available on acceptable terms, or at all. Additional equity financing could result in significant dilution to our stockholders, and any debt financings will likely involve covenants restricting our business activities. Additional financing may not be available on acceptable terms, or at all. Further, if we obtain additional funds through arrangements with collaborative partners, these arrangements may require us to relinquish rights to some of our technologies, pipeline product or products that we might otherwise seek to develop and commercialize on our own. If sufficient capital is not available, we may be required to delay, reduce the scope of or eliminate one or more of our research or product development initiatives, any of which could have a material adverse effect on our financial condition or business prospects.
Risks Related to Our Business, Our Portfolio Companies, and the Biotechnology Industry
Our acquired technologies and products under development could be rendered obsolete by technological, regulatory, or medical advances.
The biotechnology industry is highly competitive and rapidly evolving. The technologies and product candidates developed by our portfolio companies may become obsolete or uneconomical due to advancements in scientific research, new treatment modalities, disruptive innovations, or competitive products that better or more cost-effectively address the conditions our assets aim to target.
Competitors, including well-funded pharmaceutical and biotechnology companies, academic institutions, and research organizations, may develop more effective, safer, or commercially viable solutions, rendering the technologies we acquire or invest in less attractive or non-competitive. Additionally, shifts in regulatory frameworks or treatment paradigms could impact the viability of certain products in our portfolio.
To mitigate these risks, we focus on acquiring intellectual property rights, including patents and proprietary technologies, to safeguard competitive advantages. However, there is no guarantee that our patents will be sufficient to prevent competitors from developing similar or superior solutions. Furthermore, if our portfolio companies fail to innovate or adapt to industry advancements, the commercial potential of their technologies may diminish, negatively affecting our business, financial condition, and long-term growth strategy.
To sustain our continued growth, we will need to increase the size of our organization, and we may encounter difficulties managing our growth, which could adversely affect our results of operations.
We may experience growth in the number of our employees and the scope of our operations. To that extent, the resulting growth and expansion of our sales force will place a significant demand on our financial, managerial and operational resources. We may not be able to accurately forecast the number of employees required, the timing of their hire or the associated costs with our expansion and/or our entrance into new markets. The extent of any expansion we may experience will be driven largely by the success of our new products. As a result, management’s ability to project the size of any such expansion and its cost to the company is limited by the following uncertainties: (i) we will not have previously sold any of the new products and the ultimate success of these new products and applications is unknown; (ii) we will be entering new markets; and (iii) the costs will be partially driven by factors that may not be fully in our control (e.g., timing of hiring, market salary rates, ability to hire new managerial and senior staff). Our success will also depend on the ability of our executive officers and senior management to continue to implement and improve our operational, information management and financial control systems to comply with the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, and to expand, train and manage our employee base. Our inability to manage growth effectively could cause our operating costs to grow even faster than we are currently anticipating and adversely affect our results of operations.
If we are unable to secure strategic commercial partnerships, licensing agreements, funding, or other key business relationships following successful clinical results, our revenue potential may be limited.
Unlike traditional biotechnology companies that build internal sales forces, we focus on strategic pathways to commercialization, including partnerships, licensing agreements, acquisitions, and collaborations with larger pharmaceutical and biotechnology companies. Our ability to generate revenue and successfully bring products to market depends on multiple factors, including:
● Achieving positive clinical trial results that demonstrate the viability, efficacy, and safety of our portfolio companies’ technologies;
● Securing strategic commercial partnerships or licensing agreements with larger pharmaceutical or biotechnology companies to support late-stage clinical trials, regulatory approvals, manufacturing, and distribution;
● Attracting additional funding to continue development efforts, including non-dilutive funding sources such as government grants, private partnerships, and strategic investments;
● Navigating regulatory requirements, including obtaining FDA, European Medicines Agency (“EMA”), or other global regulatory approvals necessary for commercialization;
● Protecting and enforcing intellectual property, including patents and proprietary technologies, to maintain competitive advantages and prevent market erosion from competitors;
● Managing operational and financial risks associated with product development timelines, regulatory setbacks, and clinical trial failures; and
● Avoiding disruptions from changing government regulations, healthcare reimbursement policies, or shifts in market demand that could impact product viability.
In addition to the risks associated with clinical and regulatory success, our business strategy is dependent on external partners who may not have aligned priorities, sufficient resources, or the willingness to enter into agreements on terms favorable to us. If we are unable to secure the necessary partnerships, licensing deals, funding, or commercialization pathways, we may struggle to generate revenue or achieve sustainable growth.
Furthermore, external factors such as macroeconomic conditions, evolving healthcare policies, investor sentiment toward the biotechnology sector, and industry competition could significantly impact our ability to successfully bring products to market. Any failure to effectively manage these risks could materially and adversely affect our financial condition, business strategy, and long-term growth prospects.
Potential business combinations and licensing agreements could require significant management attention and prove difficult to integrate, which could divert attention away from management, disrupt our normal course of business, dilute stockholder value, and adversely affect our operating results.
As a biotechnology-focused holding company, our business strategy relies heavily on acquiring, licensing, and investing in biotechnology assets, early-stage life sciences companies, and commercial-stage enterprises. Business combinations and licensing agreements involve several inherent risks, including:
● Challenges in integrating newly acquired companies or licensed technologies into our existing structure, including management information systems, personnel, regulatory compliance, intellectual property protection, and financial reporting systems;
● Dependence on third-party licensors for key intellectual property, which may limit our control over development timelines, commercial strategies, or pricing decisions;
● The risk of acquiring or licensing assets that fail to generate expected revenue or return on investment due to scientific, regulatory, or market challenges;
● Potential failure to secure exclusive rights in licensing agreements, exposing us to competitive pressures and reduced market opportunity;
● Unanticipated costs and liabilities, including intellectual property disputes, regulatory compliance issues, or unforeseen operational inefficiencies;
● Potential delays or failures in the commercialization of acquired or licensed product candidates due to clinical trial setbacks, changes in regulatory requirements, or loss of key industry partnerships;
● Disruption of ongoing business operations within acquired or partnered companies, leading to employee turnover, loss of strategic partners, or reputational risks; and
● Challenges in integrating financial, accounting, and intellectual property portfolios, which could result in difficulties in reporting and forecasting earnings.
Additionally, we may not realize the expected benefits of any business combination or licensing agreement if we fail to successfully integrate these businesses, optimize their research and development efforts, or effectively monetize their intellectual property. Any setbacks in evaluating, structuring, integrating, or commercializing acquired or licensed assets could have an adverse effect on our revenue, operating results, and overall strategic growth.
If we fail to cost-effectively acquire, license, or develop biotechnology assets, our business could be adversely affected.
Our success depends in part on our ability to acquire and license promising biotechnology assets, advance them through preclinical and clinical stages, and secure commercial partnerships for further development and distribution. If we fail to do so cost-effectively, our business, financial condition, and growth prospects may be adversely affected Risks related to the acquisition, licensing and development of biotechnology assets include:
● Dependence on licensing: We rely on in-licensing agreements for a significant portion of our biotechnology assets. If we are unable to secure favorable licensing terms or if licensors terminate agreements, our ability to develop and commercialize key technologies may be compromised.
● Intellectual property risks: Our business depends on the strength and enforceability of our licensed and acquired intellectual property. If we are unable to obtain or maintain robust patent protections, we may lose competitive advantages. Additionally, disputes over intellectual property ownership, validity, or infringement could result in costly litigation and potential loss of key assets.
● Regulatory uncertainty: Acquiring or licensing assets requires navigating complex regulatory frameworks. Any failure to obtain necessary regulatory approvals or unexpected changes in regulatory requirements could result in delays, increased costs, or inability to commercialize certain products.
● Competitive market pressures: The biotechnology industry is highly competitive, and other companies with greater resources may outbid us for attractive assets or develop competing products that render our acquisitions or licenses obsolete.
● Capital constraints: Advancing biotechnology assets requires significant capital for preclinical and clinical development. If we are unable to secure sufficient funding, we may be forced to delay, scale down, or abandon promising programs.
Furthermore, external factors such as macroeconomic conditions, evolving healthcare policies, investor sentiment toward the biotechnology sector, and industry competition could significantly impact our ability to successfully bring products to market. Any failure to effectively manage these risks could materially and adversely affect our financial condition, business strategy, and long-term growth prospects.
If we fail to secure strategic partnerships or commercialization agreements, our revenue potential may be limited.
Rather than building an internal sales force, we rely on strategic partnerships, licensing agreements, and collaborations with pharmaceutical and biotechnology companies to bring our portfolio assets to market. Our ability to generate revenue and successfully commercialize these assets depends on:
● Securing commercial partnerships with pharmaceutical companies willing to invest in late-stage clinical development and regulatory approval;
● Licensing our assets to established players who have the infrastructure to manufacture, distribute, and market biotechnology products;
● Attracting non-dilutive funding sources such as government grants, private partnerships, and strategic investments to support product development;
● Successfully negotiating revenue-sharing agreements, royalty structures, and milestone payments that provide sufficient financial return;
● Managing potential conflicts of interest with licensors, co-development partners, or other stakeholders that may have competing priorities; and
● Avoiding disruptions from changing government regulations, reimbursement policies, or shifts in market demand that could impact commercialization pathways.
If we are unable to secure strategic partnerships or licensing agreements, we may face challenges in bringing our portfolio assets to market, which could significantly impact our revenue potential and long-term viability.
Our brand and reputation may be diminished due to intellectual property disputes, perceived scientific failures, or negative publicity, which could have an adverse effect on our business.
In the biotechnology industry, intellectual property is a critical competitive asset. Any loss of confidence in our ability to protect our intellectual property, secure regulatory approvals, or successfully develop our portfolio assets could harm our reputation and business prospects. Risks include:
● Patent litigation and intellectual property challenges: If our patents, or those of our licensors, are challenged, invalidated, or circumvented, we could lose key competitive advantages and revenue opportunities. Competitors or third parties may also claim that our licensed or acquired technologies infringe on their intellectual property, resulting in costly litigation.
● Public perception of scientific validity: If any of our portfolio companies experience clinical trial failures, safety concerns, or unexpected regulatory hurdles, our brand and ability to attract investors or partners may be negatively impacted.
● Negative publicity in the biotechnology industry: Misinformation, activist campaigns, or unfavorable media coverage related to biotechnology, drug pricing, or perceived ethical concerns could reduce investor confidence and impact our ability to secure partnerships.
● Dependence on third-party data and clinical results: We rely on external research partners, licensors, and academic collaborations for much of the underlying data supporting our biotechnology assets. If any of these third parties publish misleading or inaccurate findings, or if data discrepancies emerge, our reputation could suffer.
● Evolving social media and digital risks: With the rapid spread of information on social media, any negative sentiment regarding our portfolio companies, partners, or industry practices could quickly impact investor and stakeholder confidence.
If our brand reputation is damaged, it may become more difficult to attract investment, secure licensing agreements, or acquire high-value biotechnology assets, all of which could have a material adverse impact on our business.
Economic downturns, shifts in healthcare investment trends, regulatory changes, and evolving market demand for biotechnology products could negatively affect our business.
We have positioned our business as a biotechnology-focused holding company, acquiring and licensing promising life sciences technologies with the intent to develop, commercialize, or out-license them to strategic partners. The biotechnology sector is highly sensitive to economic conditions, regulatory environments, investment cycles, and shifts in healthcare and pharmaceutical spending. Changes in these areas could significantly impact our ability to execute our business strategy. Economic downturns, fluctuations in capital markets, and changing investment trends in the biotechnology sector may adversely affect our ability to secure financing, complete acquisitions, and license or commercialize our portfolio companies’ assets. Factors that could impact our business include:
● Capital market conditions and investor sentiment: The biotechnology industry is dependent on access to capital for research, clinical development, and regulatory approvals. Economic recessions, rising interest rates, inflation, or market downturns could reduce the availability of funding from venture capital, institutional investors, and public markets. A decline in investor confidence in biotechnology stocks could negatively affect our ability to raise capital, acquire new assets, or finance ongoing operations.
● Regulatory and policy changes: Government regulations, reimbursement policies, and drug approval processes can shift rapidly, affecting the commercialization prospects of our biotechnology assets. If regulators impose stricter safety requirements, pricing controls, or reimbursement restrictions, it may impact the potential market for certain therapies and reduce the value of our acquired or licensed assets.
● Shifts in pharmaceutical and biotechnology research and development spending: Large pharmaceutical companies and institutional investors dictate much of the demand for biotechnology innovations. If there is a shift away from investing in the types of assets we acquire or license-such as a focus on gene therapy over small molecules, or increased preference for in-house research and development versus external licensing-it may negatively affect our business strategy.
● Intellectual property and patent risks: Biotechnology companies rely heavily on intellectual property protections, including patents, exclusivity periods, and licensing rights. If we are unable to secure strong IP protections, or if patents related to our portfolio assets expire, are challenged, or become unenforceable, we could lose competitive advantages and revenue potential. Additionally, litigation risks related to patent disputes could lead to costly legal battles, settlements, or lost licensing deals.
● Market demand for biotechnology products: The success of our portfolio companies’ assets depends on healthcare providers, insurers, and patients perceiving their benefits over existing treatments. If scientific advancements, competitive innovations, or pricing pressures reduce the demand for our acquired or licensed technologies, our ability to monetize these assets could be impaired.
● Public perception and media influence: The biotechnology sector is highly scrutinized by regulatory agencies, advocacy groups, and media outlets. Negative coverage of clinical trial failures, ethical concerns related to biotechnology innovations (e.g., gene editing, stem cell therapy), or pricing controversies could impact investor confidence, regulatory approvals, and commercial adoption of our assets.
● Dependence on strategic partnerships: Since we do not build an internal sales force, we rely on external partnerships for commercialization. If potential partners-such as pharmaceutical companies or larger biotechnology firms-are unwilling to license, acquire, or invest in our assets due to economic pressures, shifting priorities, or competitive concerns, our revenue potential may be significantly limited.
A general decline in healthcare and biotechnology investments, unexpected changes in regulatory requirements, or shifts in the demand for certain therapies could adversely affect our ability to execute our growth strategy. If we fail to anticipate industry trends, secure financing, maintain strong intellectual property protections, or establish successful commercialization partnerships, our business, financial condition, and results of operations could be materially and adversely affected.
If we cannot maintain our company culture or focus on our strategic mission as we grow, our success and competitive position may be harmed.
We believe our entrepreneurial approach, scientific focus, and commitment to acquiring and developing high-value biotechnology assets have been key contributors to our success to date. As a biotechnology-focused holding company, our ability to identify promising assets, secure strategic partnerships, and drive innovation relies heavily on maintaining a strong leadership vision, a disciplined investment strategy, and a culture of transparency and scientific integrity.
As we scale our operations, pursue acquisitions, and develop the infrastructure of a public company, we may face challenges in maintaining these core principles. Factors that could negatively impact our corporate culture and strategic mission include:
● Operational expansion and complexity: As we acquire and license additional biotechnology assets, we may need to expand our management team, increase regulatory and compliance functions, and establish new operational structures. This could create challenges in maintaining our entrepreneurial decision-making process and alignment with our long-term strategy.
● Attracting and retaining talent: The biotechnology industry is highly competitive, and our ability to execute our business model depends on recruiting and retaining experienced scientists, regulatory experts, and business development professionals. If we fail to maintain a corporate culture that attracts top-tier talent, it could impact our ability to manage and grow our portfolio effectively.
● Alignment of acquired companies and partners: As we acquire or partner with biotechnology companies, differences in corporate culture, management philosophies, or strategic priorities could create integration challenges, slowing execution and reducing operational efficiency.
● Increased public company responsibilities: As a publicly traded entity, we must comply with additional regulatory, reporting, and governance requirements. If these obligations divert management’s attention away from our core mission of identifying and developing valuable biotechnology assets, it could negatively impact our growth trajectory.
● Balancing short-term and long-term goals: Investor expectations, market conditions, and financial pressures may require us to make short-term decisions that could conflict with our long-term strategic vision. If we prioritize immediate financial performance over scientific innovation and strategic acquisitions, it could weaken our competitive advantage in the biotechnology sector.
If we fail to preserve our entrepreneurial mindset, maintain our disciplined approach to asset selection, or sustain a culture that fosters innovation and collaboration, our ability to compete, execute acquisitions successfully, and generate long-term shareholder value could be significantly impaired. A loss of focus on our strategic mission could adversely affect our business, financial condition, and long-term growth prospects.
If we lose key personnel or are unable to attract and retain other qualified personnel, we may be unable to execute our business plan, and our business could be materially adversely affected.
As of March 26, 2025, we have only two (2) full-time employees and one part-time employee. Our executive leadership and key personnel provide services to us primarily through consulting agreements. Braeden Lichti, our Founder and Chairman, serves as a non-employee consultant and plays a critical role in shaping the strategic direction of the company. Through his company, NorthStrive Companies, Inc., Braeden provides consulting services and, from time to time, funding and advisory services to support our acquisitions, corporate restructuring efforts, and overall growth strategy.
Graydon Bensler, our Chief Executive Officer and Chief Financial Officer, also serves in a non-employee capacity through his consulting agreement with us. Our business strategy relies heavily on these key individuals for capital markets expertise, merger and acquisition execution, regulatory oversight, and financial structuring.
Our success depends on our continued ability to attract, retain, and motivate highly qualified management, business development, finance, regulatory, and scientific personnel. The biotechnology and life sciences industries are highly competitive, and securing experienced professionals with the necessary expertise is challenging. In particular, our ability to successfully execute our acquisition and licensing strategy depends on retaining key executives and advisors with deep experience in biotechnology asset evaluation, intellectual property protection, clinical development, and financial structuring.
We are expanding our executive leadership team by hiring key personnel, including a new Chief Financial Officer, and we are looking to hire additional employees in positions that will support the operations of our Company and its subsidiaries. However, as part of our corporate restructuring, we also terminated our Chief Marketing Officer and Chief Commercial Officer, which may have an adverse impact on certain operational functions.
Although we maintain “key employee” insurance policies on our executive officers that would compensate us for the loss of their services, replacing critical personnel could be difficult and time-consuming. The loss of Braeden Lichti, Graydon Bensler, or other senior personnel could significantly disrupt our ability to execute our strategic business plan, impair investor confidence, and hinder capital-raising and M&A activities.
Moreover, given our reliance on non-employee consultants for executive management, we are exposed to additional risks, including:
● The potential for misalignment between our long-term strategic goals and consultants’ personal or business interests;
● Limited day-to-day oversight and direct control over key operational decisions;
● The risk that consulting agreements may not be renewed or could be terminated, leading to leadership instability;
● Increased difficulty in retaining executive talent who may be recruited by competing firms offering full-time roles with equity-based incentives; and
● Dependence on external funding sources, including capital contributions from NorthStrive Companies, Inc., which may fluctuate based on market conditions and investment opportunities.
If we fail to recruit and retain qualified personnel-particularly in finance, acquisitions, clinical development, and regulatory affairs-our ability to execute acquisitions, commercialize biotechnology assets, and achieve long-term profitability could be materially impaired. A leadership transition or prolonged vacancies in key roles could negatively affect our financial condition, business operations, and future growth.
We may be unable to accurately forecast revenue and appropriately plan our expenses in the future.
Revenue forecasting presents significant challenges as we continue to expand our biotechnology portfolio, acquire new assets, secure licensing agreements, and pursue commercial partnerships. Unlike traditional operating companies with consistent revenue streams, our revenue generation depends on various factors, including:
● The successful completion of acquisitions and licensing deals;
● The ability of our portfolio companies to advance product candidates through clinical and regulatory milestones;
● The timing and terms of strategic partnerships, royalty agreements, and potential asset monetization events; and
● Market conditions, investment cycles, and availability of funding for early-stage biotechnology assets.
We base our expense levels and investment plans on revenue projections and anticipated gross margins. However, due to the unpredictable nature of the biotechnology industry, revenue realization may not align with our projections. If our assumptions prove incorrect, we may overspend on acquisitions, clinical development, or business expansion without generating the expected financial returns, adversely impacting our business, financial condition, and results of operations.
Additionally, PMGC Capital LLC, our newly established multi-strategy investment vehicle, introduces additional financial and operational risks. As we deploy capital across different asset classes, including biotechnology equities, private investments, and structured financial instruments, our ability to generate consistent returns will be influenced by market volatility, economic downturns, and sector-specific risks. If PMGC Capital LLC underperforms or fails to achieve targeted returns, it could affect our ability to allocate capital efficiently, potentially impacting the overall financial health of our holding company.
We have a limited operating history at our current scale, which may make it difficult to evaluate our business and future prospects.
We began commercial operations in 2020 and have undergone significant strategic transitions, evolving from a single-product skincare company into a biotechnology-focused holding company with multiple subsidiaries and investment vehicles. Given our relatively short operating history at this scale, we have limited financial data available to evaluate the long-term viability and success of our business model.
Our evolving strategy presents increased risks, uncertainties, and challenges, including:
● The ability to successfully integrate and manage multiple biotechnology assets with different risk profiles, regulatory pathways, and commercialization strategies;
● Navigating the uncertainties of clinical development, licensing negotiations, and regulatory approvals across our portfolio companies;
● The reliance on PMGC Capital LLC as a multi-strategy investment vehicle, which introduces exposure to market volatility and investment risks beyond traditional biotechnology operations; and
● The necessity of securing consistent external funding to finance acquisitions, clinical trials, and operational growth.
Any evaluation of our business must consider these risks, as well as the unpredictability of biotechnology asset monetization, regulatory timelines, and capital market conditions. Our limited operating history at our current scale may make it difficult for investors and stakeholders to accurately assess our future financial performance and long-term viability.
A disruption in our operations could have an adverse effect on our business.
As a biotechnology-focused holding company, we rely on a combination of licensing agreements, acquisitions, research partnerships, and strategic investments. Our operations, including those of our portfolio companies, licensors, and third-party manufacturers, are subject to various risks, including:
● Disruptions in research and development at partner institutions, contract research organizations (“CROs”), or third-party laboratories;
● Regulatory and compliance issues that could delay clinical trials, impact licensing agreements, or restrict the commercialization of biotechnology assets;
● Cybersecurity threats and data integrity risks, particularly concerning confidential clinical research data, intellectual property, and regulatory filings;
● Market volatility and investment risks associated with PMGC Capital LLC, our multi-strategy investment vehicle, which could impact capital allocation decisions;
● Supply chain disruptions affecting critical raw materials, specialized equipment, or active pharmaceutical ingredients (APIs) necessary for drug development; and
● Global economic conditions, pandemics, geopolitical conflicts, and border disputes that may affect cross-border licensing agreements, manufacturing, or capital markets.
Since we do not manufacture or distribute physical products directly, we are dependent on third-party contract manufacturers, biotechnology partners, and pharmaceutical collaborators for the development, scaling, and commercialization of our portfolio assets. If any of these third parties face operational failures, financial distress, or regulatory setbacks, our business, financial condition, and results of operations could be negatively impacted.
Our business is at an early stage of asset development, and we may not successfully develop, License, or commercialize biotechnology assets.
As of the date of this Annual Report, we have not yet commercialized any biotechnology assets at scale, and our business model relies on acquiring, licensing, and monetizing promising biotechnology technologies rather than direct product development. Our ability to generate revenue and grow our business depends on:
● Successfully identifying and acquiring high-potential biotechnology assets in early or mid-stage development;
● Securing regulatory approvals for portfolio companies’ product candidates in different jurisdictions;
● Establishing commercial partnerships or licensing agreements with pharmaceutical companies, research institutions, and biotechnology firms;
● Managing intellectual property risks, including patent expiration, challenges, and disputes; and
● Navigating market competition, scientific advancements, and evolving healthcare policies that may impact the value and relevance of our assets.
Given the complexities of drug development and regulatory approvals, there is a significant risk that assets within our portfolio:
● May fail to demonstrate safety or efficacy in clinical trials, leading to project abandonment or financial losses;
● May face unforeseen regulatory challenges that delay commercialization or limit market access;
● May be rendered obsolete by competitors’ innovations, market trends, or changing treatment standards; or
● May struggle to attract commercial partners, impacting our ability to generate licensing revenue.
Furthermore, the success of PMGC Capital LLC, our multi-strategy investment vehicle, introduces additional financial and operational risks. If biotechnology market volatility, unsuccessful investments, or capital misallocation affect our ability to sustain operations and finance acquisitions, it could impair our long-term growth prospects.
Uncertainty in market demand, regulatory approval, and investment cycles could impact our future growth.
Unlike companies that generate revenue from direct product sales, our ability to generate consistent financial returns depends on strategic licensing, asset monetization, and investment performance. Our long-term success relies on:
● Accurately anticipating industry trends and investing in biotechnology assets with high commercial potential;
● Securing FDA, EMA, and other regulatory approvals for key assets within our portfolio;
● Effectively negotiating licensing agreements and revenue-sharing deals with pharmaceutical and biotechnology partners; and
● Managing investment risks associated with PMGC Capital LLC, which may be affected by market downturns, liquidity constraints, and shifting investor sentiment in the biotechnology sector.
If we fail to secure regulatory approvals, commercial partnerships, or licensing deals for our portfolio assets, our ability to generate meaningful revenue, sustain operations, and expand our investment portfolio may be significantly impacted. Additionally, unforeseen macroeconomic factors, public health crises, regulatory changes, or geopolitical tensions could further compound risks and limit our growth potential.
We may incur product liability or intellectual property claims that could harm our business.
As a biotechnology-focused holding company, we do not manufacture or sell physical products directly. Instead, we acquire, license, and develop biotechnology assets through our portfolio companies, many of which may engage in drug development, medical device innovation, or therapeutic biotechnology applications. These industries inherently involve significant legal, regulatory, and liability risks, including:
● Clinical trial risks: Our portfolio companies may conduct preclinical and clinical trials that expose participants to investigational treatments. Any adverse events, unforeseen side effects, or trial-related injuries could lead to legal claims, regulatory scrutiny, and financial liabilities.
● Product liability risks for licensed or commercialized assets: If any of our acquired or licensed technologies progress to commercialization, we or our partners could face product liability claims related to safety concerns, manufacturing defects, mislabeling, or improper usage instructions. Regulatory agencies, including the FDA, EMA, and other global health authorities, may require market withdrawals, labeling changes, or additional safety warnings, which could negatively impact the commercial viability of a product.
● Third-party intellectual property claims: The biotechnology industry is highly patent-driven, and competitors, research institutions, or other companies may challenge the validity of our patents or claim that our portfolio assets infringe on their intellectual property. If we or our licensing partners are sued for patent infringement, trade secret misappropriation, or IP violations, we could face costly legal battles, licensing fees, or restrictions on commercialization.
● Regulatory compliance and liability risks: Biotechnology and pharmaceutical companies must comply with stringent regulatory requirements, including Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and post-market surveillance obligations. If a portfolio company fails to meet these standards, we could be subject to regulatory fines, warnings, or litigation.
There is a risk that our insurance policies and our portfolio companies’ insurance policies are inadequate to cover liabilities.
Although we maintain general liability and directors’ & officers’ (D&O) insurance, these policies may not fully cover potential liabilities arising from product safety issues, regulatory penalties, or IP disputes. Additionally, some of our portfolio companies, licensees, or strategic partners may not maintain adequate insurance coverage, which could expose us to indirect liabilities. If such insurance policies are not adequate, our financial results may be adversely impacted.
We face additional business risks through our multi-strategy investment vehicle, PMGC Capital LLC, which risks may adversely impact our financial performance.
Through PMGC Capital LLC, our multi-strategy investment vehicle, we engage in public and private investments, structured financing, and biotechnology-related asset trading. These financial activities introduce additional risks, including:
● Investment losses and market volatility: If we invest in biotechnology equities, structured finance deals, or private placements, we may experience significant losses due to market fluctuations, sector downturns, or investment miscalculations.
● Exposure to third-party legal and compliance risks: Some investments may involve joint ventures, co-development agreements, or financing arrangements with third parties. If these partners fail to meet regulatory requirements or face lawsuits, we could be indirectly exposed to financial, reputational, or legal consequences.
● Liquidity and capital constraints: If PMGC Capital LLC underperforms, we may have limited access to capital for acquisitions or operational needs, which could disrupt our biotechnology strategy and portfolio growth.
Our employees, independent contractors, consultants, strategic partners, and third parties may engage in unethical misconduct, regulatory noncompliance, or other improper activities that could harm our business.
As a biotechnology-focused holding company, we rely on a network of independent consultants, advisors, licensing partners, contract research organizations (CROs), pharmaceutical collaborators, and strategic investment partners to execute our business strategy. We are exposed to the risk that these third parties, as well as our employees, independent contractors, and vendors, may engage in unethical, fraudulent, or illegal activities that could have significant regulatory, financial, and reputational consequences.
We also face the risk of abusive sales and marketing practices through our portfolio companies and licensing partners, which risks may adversely impact our financial performance. While we do not directly commercialize products, our portfolio companies and licensing partners may be involved in sales and distribution agreements that expose us to commercial compliance risks, including anti-kickback and unfair trade practices laws. Such risks may include:
● Improper financial incentives: Licensing or sales arrangements that incentivize monetary gain over patient outcomes could be subject to regulatory scrutiny under anti-kickback laws and fair competition statutes.
● Misleading marketing claims: Portfolio companies, partners, or distributors could misrepresent the efficacy, safety, or regulatory status of biotechnology assets, leading to potential litigation or consumer backlash.
● Unethical distribution practices: Partners or licensees may engage in self-dealing, unauthorized discounting, or stockpiling inventory to manipulate financial results, which could negatively impact product valuation and revenue expectations.
Additionally, we operate in highly regulated industries, including biotechnology, pharmaceuticals, and public markets, and misconduct by third parties could include:
● Regulatory noncompliance: Failure to adhere to FDA, EMA, and other foreign regulatory standards, including improper handling of clinical trial data, inaccurate regulatory filings, and noncompliance with good manufacturing practices (GMP) or good clinical practices (GCP).
● Intellectual property violations: Unauthorized disclosure of trade secrets, proprietary technologies, or confidential licensing agreements, which could result in patent disputes or loss of competitive advantages.
● Financial misrepresentation or securities law violations: Improper reporting of financial transactions, investment performance, or acquisition valuations, which could lead to regulatory investigations by the SEC, FINRA, or other governing bodies.
● Investment or trading violations: Since we operate PMGC Capital LLC, a multi-strategy investment vehicle, we are also exposed to risks related to insider trading, conflicts of interest, and improper market practices by third-party investment managers or financial partners.
● Fraudulent licensing or partnership agreements: Misrepresentation of clinical trial data, exaggeration of asset valuation, or deceptive licensing negotiations by third parties could result in unfavorable deals, financial losses, or reputational harm.
Because we rely on third-party contractors and partners rather than a fully integrated internal workforce, our ability to monitor compliance is inherently limited. We may not always be able to detect, deter, or prevent misconduct before it results in regulatory investigations, fines, legal proceedings against us or our portfolio companies, reputational damage, diminished investor confidence, legal costs, loss of strategic relationships with licensing partners, biotechnology startups or financial institutions, to name only some. Further, even if we are not directly responsible for unethical conduct, any association with misconduct by partners or portfolio companies could damage our reputation and negatively impact our ability to raise capital, attract strategic investors, or execute future M&A transactions.
If we are unable to detect, mitigate, or respond to unethical behavior in a timely manner, our business, financial condition, and long-term growth strategy could be significantly impacted.
Our portfolio companies’ products and technologies may fail to achieve the broad adoption necessary for commercial success, which may negatively impact our financial performance.
The commercial success of the biotechnology assets being developed by our portfolio companies and strategic partners depends on:
● Physician and healthcare provider adoption: Even if our portfolio companies successfully develop innovative therapies, medical devices, or biologics, their products must gain broad acceptance among physicians, hospitals, and healthcare institutions to achieve significant market penetration.
● Competitive landscape: The biotechnology and pharmaceutical industries are highly competitive, with many well-funded companies developing alternative treatments, gene therapies, small-molecule drugs, and novel biologics. If superior or more cost-effective solutions enter the market, demand for our licensed or acquired assets may be diminished.
● Regulatory approval and reimbursement challenges: Many biotechnology innovations require FDA, EMA, or other global regulatory approvals. Additionally, payers, including insurance providers and government healthcare programs, must determine reimbursement eligibility. If our portfolio companies fail to obtain regulatory approvals or favorable reimbursement terms, market adoption may be limited.
● Investment and market sentiment: PMGC Capital LLC, our multi-strategy investment vehicle, actively invests in biotechnology companies and public markets. The valuation and adoption of our portfolio assets may be affected by broader investment trends, market downturns, and changes in investor sentiment toward biotechnology stocks.
● Manufacturing and supply chain risks: Even if portfolio companies receive regulatory approval, scaling manufacturing, ensuring consistent supply, and maintaining cost-efficient production remain significant challenges.
● Physician skepticism or resistance: New therapies and treatment modalities often face skepticism from medical professionals, particularly if they challenge existing treatment paradigms or require new training, infrastructure, or procedural adjustments.
● Scientific and clinical validation: Our success depends on portfolio companies generating robust clinical data that proves safety, efficacy, and superiority over existing treatments. If clinical trials fail to demonstrate clear advantages, regulatory agencies or healthcare providers may hesitate to adopt new technologies.
We cannot assure that these biotechnology assets will achieve commercial success or achieve commercial success at a level needed for our business to profit. In such cases, our financial performance may be negatively impacted. Furthermore, our ability to generate returns on acquired and licensed assets depends on their ability to differentiate from competing technologies, secure market share, and establish strong intellectual property protections. If our portfolio companies fail to achieve market acceptance, struggle with regulatory hurdles, or cannot differentiate from competing technologies, our ability to monetize our assets, secure licensing deals, and generate shareholder value may be negatively impacted.
The outcome of clinical and product testing for our portfolio companies is uncertain.
Our portfolio companies rely on clinical trials and validation studies to demonstrate the safety, efficacy, and commercial viability of their biotechnology assets. If clinical testing fails to produce positive, timely, or cost-effective results, it may hinder regulatory approvals, limit physician adoption, and reduce the likelihood of securing commercial partnerships.
Failure to achieve strong clinical outcomes could delay, prevent, or limit revenue generation, negatively impacting our ability to monetize assets, secure licensing deals, and sustain business operations. Any setbacks in clinical development could adversely affect our financial condition and long-term growth strategy.
Even if our portfolio companies’ technologies are successful, rapid advancements in biotechnology could make them obsolete.
The biotechnology and pharmaceutical industries evolve rapidly, and new discoveries could render our portfolio companies’ technologies obsolete. Even if their products demonstrate positive clinical results, adoption may be limited due to competing treatments, evolving scientific advancements, or superior alternative solutions.
Maintaining competitiveness requires continuous innovation, additional investment, and strategic adaptation. If our portfolio companies fail to keep pace with technological progress or market demands, the commercial viability of their assets-and our ability to generate revenue-could be negatively impacted, which may adversely impact our financial performance.
The high costs of manufacturing biotechnology products may negatively impact profitability.
Biotechnology products often require complex, costly manufacturing processes. If our portfolio companies fail to optimize production, scale efficiently, or negotiate favorable supply chain agreements, their profit margins may be significantly lower than competing therapies.
Even if these portfolio companies’ products achieve regulatory approval, the products must be priced competitively while covering production costs. If the portfolio companies cannot achieve cost efficiencies or command premium pricing, profitability may be limited, negatively impacting our financial performance.
Evolving regulations governing biotechnology, pharmaceuticals, and investments could negatively impact our business.
Our portfolio companies and investment strategies are subject to extensive government regulation, which varies across federal, state, and international markets. Changes in laws governing biotechnology, drug approvals, licensing, and investment disclosures could impact our ability to develop, acquire, or commercialize biotechnology assets. Regulatory challenges may include:
● Delays or restrictions on product approvals due to changes in FDA or EMA guidelines.
● Increased compliance costs related to clinical trials, manufacturing, and post-market surveillance.
● Limitations on licensing agreements or commercial partnerships due to regulatory uncertainties.
● Restrictions on investment strategies within PMGC Capital LLC, including compliance with SEC, FINRA, or global financial regulations.
● Patent law changes affecting intellectual property protections for portfolio assets.
Regulatory trends show increasing scrutiny over biotechnology ingredients, drug pricing, and marketing practices, requiring us to adapt our business model, investment strategies, and licensing terms to comply with evolving laws. If regulatory changes negatively impact biotechnology valuations, investment returns, or portfolio company operations, our financial condition, business performance, and future growth prospects could be negatively affected.
Government regulations and private party actions relating to the marketing and advertising of biotechnology and pharmaceutical products may restrict, inhibit, or delay commercialization efforts.
Our portfolio companies and licensing partners are subject to strict advertising and promotional regulations governing biotechnology, pharmaceuticals, and medical devices. If a portfolio company markets or advertises a product outside of its approved indications, regulatory agencies such as the FDA, Federal Trade Commission (“FTC”), or international health authorities could issue warning letters, impose fines, or initiate enforcement actions that may result in mandatory corrective measures or product sales restrictions.
Additionally, government agencies regulate claims related to product efficacy, safety, and comparative benefits. Regulators may require robust clinical evidence to substantiate marketing claims, and failure to meet these requirements could lead to demand for claim modifications, product labeling revisions, or advertising restrictions.
● Unauthorized health claims, exaggerated efficacy statements, or misleading promotions could trigger regulatory scrutiny, fines, or forced marketing adjustments.
● Variations in international advertising laws create compliance challenges, requiring us and our portfolio companies to adapt promotional strategies across different jurisdictions.
● Failure to comply with the FTC’s Guides on Endorsements and Testimonials could lead to enforcement actions requiring transparent disclosures, limitations on marketing partnerships, or penalties for misleading advertising.
If regulatory authorities impose restrictions on advertising or promotional claims, it could delay product adoption, limit revenue generation, and negatively impact commercialization efforts for our portfolio companies. Such actions could also damage investor confidence, impact licensing opportunities, and hinder our ability to monetize biotechnology assets effectively and negatively impact our financial performance.
The development and acquisition of therapeutic product candidates could expose us to significant legal and regulatory risks.
Our acquisition and development of innovative therapeutic product candidates, specifically with our lead asset, EL-22, could expose us to significant legal and regulatory risks. The development and commercialization of therapeutic product candidates, including EL-22, are subject to extensive regulation by the FDA and other regulatory authorities. The regulations govern all aspects of product development, including pre-clinical studies, clinical trials, manufacturing and marketing. Any failure to comply with the regulations might result in significant delays in product development, approval and commercialization or suspension or termination of clinical trials. Any non-compliance could lead to enforcement actions, including warning letters, fines, injunctions and withdrawal of marketing approvals.
The ability to proceed with human clinical trials for our product candidates is contingent upon receiving FDA clearance of our IND submission. If the FDA requires us to provide extensive additional data to demonstrate safety and efficacy, including without limitation, generating additional preclinical data, conducting further toxicology or pharmacology studies or addressing unforeseen issues, we may face significant delays or be unable to proceed as planned. In addition, as one of the first companies pursuing an oral myostatin formulation combined with GLP-1 receptor agonists, we may encounter heightened regulatory scrutiny. Regulators may impose unexpected conditions, mandate more extensive trials or request additional safety and efficacy data, all of which could increase our costs and delay timelines.
Any unexpected requirements or delays in the approval process could adversely impact our ability to bring EL-22, or any of our other therapeutic product candidates, to market and achieve commercial success.
We license from a third party the rights to product candidates related to the potential prevention and treatment of muscular and obesity-related conditions, and are therefore subject to the risk that we lose the license after investing substantial resources into the research and development of these product candidates.
Under a License Agreement entered into on April 30, 2024 between MOA Life Plus Co., Ltd., a South Korean corporation (“MOA”) and the Company (“License Agreement”), MOA granted the Company an exclusive license to commercialize under certain of MOA’s patent rights concerning two licensed products,: (i) a clinical stage engineered probiotic expressing myostatin and, (ii) preclinical engineered probiotic expressing dual myostatin & activin-A antigens (collectively, “Licensed Products”). If MOA terminates the License Agreement, or if we breach our obligations under the License Agreement, which include, amongst other things, using commercially reasonable efforts to develop the Licensed Products in accordance with the License Agreement, or the license expires before we can successfully commercialize a product candidate, or investment in research, development, and commercialization efforts for such product candidate(s) would be lost. Additionally, if we or MOA fail to adequately protect or informed the related intellectual property rights relating to the Licensed Products, we may not realize the perceived or potential benefits of the License Agreement.
Since we expect to continue to rely on third parties to conduct, supervise and monitor pre-clinical and clinical trials with respect to the Licensed Products, if these third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific and safety requirements, it may materially harm our business.
We will rely on CROs and other third parties to ensure the proper and timely conduct of our pre-clinical and clinical trials for the Licensed Products. While we establish agreements governing the activities of such CROs and other third parties, we and our partners will have limited influence over their actual performance. Nevertheless, we and our partners will be responsible for ensuring that each of our clinical trials is conducted in accordance with its protocol, and that all legal, regulatory and scientific standards are met. Our reliance on the CROs and other third parties does not relieve us of our regulatory responsibilities.
We, our partners and our CROs must comply with current Good Clinical Practices, or cGCPs, as defined by the FDA and the International Conference on Harmonization, for conducting, recording and reporting the results of preclinical studies and clinical trials, to ensure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are protected. The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal investigators, and clinical trial sites. If we or our CROs fail to comply with cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or other regulators may require us to perform additional clinical trials before approving any marketing applications. Our clinical trials will require a sufficiently large number of test subjects to evaluate the safety and effectiveness of a product candidate. If our CROs fail to comply with these regulations or fail to recruit a sufficient number of patients, fail to recruit properly qualified patients or fail to properly record or maintain patient data, we may be required to repeat such clinical trials, which would delay the regulatory approval process.
Our contracted CROs will not be our employees, and we cannot control whether they devote sufficient time and resources to our clinical and nonclinical programs. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities that could harm our competitive position. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to failing to adhere to our clinical protocols or regulatory requirements, or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not obtain regulatory approval for, or successfully commercialize our product candidates. Our financial results and the commercial prospects for such products and any product candidates we develop would be harmed, our costs could increase, and our ability to generate revenues could be delayed.
We also expect to rely on other third parties to manufacture, store and distribute drug products for any clinical trials we may conduct. Any performance failure or defect resulting from our manufacturers or distributors could delay or hinder clinical development or marketing approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of potential product revenue.
Because our future commercial success with respect to the Licensed Products depends on gaining regulatory approval for our products, we cannot generate revenue without obtaining approvals.
Our long-term success and generation of revenue with respect to the Licensed Products will depend upon the successful development of these product candidates from our research and development activities. Product development is very expensive and involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. For example, the FDA indicates that approximately 70% of drugs proceed past Phase 1 studies, 33% proceed past Phase 2, and just 25%-30% proceed past Phase 3 to Phase 4 which is the final phase in the FDA review and approval process for marketing therapeutic product candidates. The process for obtaining regulatory approval to market product candidates is expensive, usually takes many years, and can vary substantially based on the type, complexity, and novelty of the product candidates involved. Our ability to generate revenue from the Licensed Products would be adversely affected if we are delayed or unable to successfully develop our products.
We cannot guarantee that any marketing application for our product candidates will be approved. If we do not obtain regulatory approval of our products or we are significantly delayed or limited in doing so, we cannot generate revenue, and we may need to significantly curtail operations.
If we are unable to successfully complete preclinical testing and clinical trials of the Licensed Products or experience significant delays in doing so, our business will be materially harmed.
We expect to invest material efforts and financial resources in the development of the Licensed Products. Our ability to generate product revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of the Licensed Products.
The commercial success of the Licensed Products will depend on several factors, including:
● successful completion of preclinical studies and clinical trials;
● receipt of marketing and pricing approvals from regulatory authorities;
● obtaining and maintaining patent and trade secret protection for the Licensed Products;
● establishing and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability; and
● commercializing our products, if and when approved, whether alone or in collaboration with others.
If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully complete development of, or to successfully commercialize, the Licensed Products, which would materially harm our business. Most pharmaceutical products that do overcome the long odds of drug development and achieve commercialization still do not recoup their cost of capital. If we are unable to design and develop each drug to meet a commercial need far in the future, the approved drug may become a commercial failure and our investment in those development and commercialization efforts will have been commercially unsuccessful.
The Licensed Products may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the scope of any approved label or market acceptance.
Adverse events (“AEs”) or serious adverse events (“SAEs”), that may be observed during clinical trials of the Licensed Products could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt such trials and could cause denial of regulatory approval. If AEs or SAEs are observed in any clinical trials of the Licensed Products, our ability to obtain regulatory approval for the Licensed Products may be negatively impacted.
Serious or unexpected side effects caused by an approved product could result in significant negative consequences, including the following:
● regulatory authorities may withdraw prior approval of the product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy (“REMS”) which may restrict the manner in which the product can be distributed or administered;
● we may be required to add labeling statements, such as warnings or contraindications;
● we may be required to change the way the product is administered or conduct additional clinical trials;
● we may decide or be forced to temporarily or permanently remove the affected product from the marketplace;
● we could be sued and held liable for harm caused to patients; and
● our reputation may suffer.
These events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing the Licensed Products and impair our ability to generate revenues from the commercialization of these products.
Because third parties may be developing competitive products without our knowledge, we may later learn that competitive products are superior to the Licensed Products which may force us to terminate our research efforts of one or more product candidates.
We face potential competition from companies that may be developing competitive products that are superior to one or more of the Licensed Products. If in the future, we learn of the existence of one or more competitive products, we may be required to:
● cease our development efforts for a product candidate;
● cause a partner to terminate its support of a product candidate;
● cause a potential partner to terminate discussions about a potential license.
Any of these events may occur after we have spent substantial sums in connection with the clinical research of one or more product candidates.
The divestiture of our Elevai Skincare business could negatively impact our operations and strategic positioning.
In January 2025, we completed the divestiture of our Elevai Skincare business as part of our strategic shift toward a biotechnology-focused holding company. While this divestiture enables us to focus on our core business of acquiring and developing biotechnology assets, it may result in operational, legal, and strategic challenges, including:
● Disruptions in operations and market perception: The transition away from the skincare segment may cause short-term operational inefficiencies, impact our brand recognition, and result in adverse market perception, potentially affecting investor confidence and market valuation.
● Legal claims from former employees: Employees who were terminated as part of the divestiture may bring claims against us for wrongful termination, severance disputes, or other employment-related matters. Even if meritless, these claims could lead to legal expenses, reputational risks, and potential financial settlements.
● Loss of strategic relationships: The sale of the skincare business may result in the loss of long-standing customer relationships, distribution partners, and supplier agreements, impacting our ability to leverage past business networks.
● Limited diversification and growth constraints: While the divestiture aligns with our biotechnology investment strategy, it reduces business diversification, potentially limiting future growth opportunities.
If we fail to manage this transition effectively, we may incur unforeseen costs, legal liabilities, and operational inefficiencies, which could adversely impact our financial condition, results of operations, and long-term growth prospects.
International trade disputes, including U.S. trade tariffs and retaliatory tariffs, could adversely impact our business.
International trade disputes, including threatened or implemented tariffs by the United States and threatened or implemented tariffs by foreign countries in retaliation, could adversely impact our business. Many of our tenants sell imported goods and tariffs or other trade restrictions could increase costs for these tenants. To the extent our tenants are unable to pass these costs on to their customers, our tenants could be adversely impacted. In addition, international trade disputes, including those related to tariffs, could result in inflationary pressures that directly impact our costs, such as costs for steel, lumber and other materials applicable to our redevelopment projects. Trade disputes could also adversely impact global supply chains which could further increase costs for us and our tenants or delay delivery of key inventories and supplies.
Significant political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial condition or results of operations.
Significant political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on our business operations. For example, during the prior Trump administration, increased tariffs were implemented on goods imported into the U.S., particularly from China, Canada, and Mexico. On February 1, 2025, the U.S. imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China. Historically, tariffs have led to increased trade and political tensions, between not only the U.S. and China, but also between the U.S. and other countries in the international community. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. Any changes in political, trade, regulatory, and economic conditions, including, but not limited to, U.S. and China trade policies, could have a material adverse effect on our financial condition or results of operations.
Regulatory changes or actions may alter the nature of an investment in us or restrict the use of cryptocurrencies in a manner that adversely affects our business, prospects, or operations.
As cryptocurrencies have grown in both popularity and market size, governments around the world have reacted differently to cryptocurrencies; certain governments have deemed them illegal, and others have allowed their use and trade without restriction, while some jurisdictions, such as the United States, subject the mining, ownership and exchange of cryptocurrencies to extensive, and in some cases overlapping, unclear and evolving regulatory requirements.
In January 2025, U.S. President Donald Trump issued an executive order forming a presidential working group to establish a clear regulatory framework for digital assets, and leaders in both houses of the U.S. Congress have announced a bicameral working group with the objective of passing legislation to provide regulatory clarity for the industry. Committees in both houses of the U.S. Congress have held hearings to ensure fair access to financial services, including for companies operating in the digital asset space. Additionally, President Trump and members of the U.S. Congress announced that they are studying the possibility of creating a national strategic digital asset reserve to include Bitcoin, and at least twelve states have introduced legislation to create strategic Bitcoin reserves.
While these ongoing regulatory developments appear to be positive, and we anticipate greater regulatory certainty in the future, given the difficulty of predicting the outcomes of ongoing and future regulatory actions and legislative developments, it is possible that future developments could have a material adverse effect on our business, prospects, or operations.
Our business, operations, financial position and clinical development plans and timelines, could be materially adversely affected by the continuing military action in Ukraine and the war between Israel and Hamas.
As a result of the military action commenced in February 2022 by the Russian Federation and Belarus in Ukraine and the war between Israel and Hamas commenced in October 2023, and related economic sanctions imposed or that may in the future be imposed by certain governments, our financial position and operations may be materially and adversely affected. As our ability to continue to operate will be dependent on raising debt and equity finance, any adverse impact to those markets as a result of these conflicts, including due to increased market volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all), could negatively impact our business, results of operations, cash flows, financial condition, and/or prospects. The extent of any potential impact is not yet determinable, however.
Risks Related to Our Dependence on Third Parties
We depend on our collaborators to help us develop and test our proposed products, and our ability to develop and commercialize products may be impaired or delayed if collaborations are unsuccessful.
Our strategy for the development, product testing and commercialization of our proposed products may require entering into collaborations with corporate partners, licensors, licensees and others. We may then be dependent upon the subsequent success of these other parties in performing their respective responsibilities and the continued cooperation of our partners. Our potential collaborators may not cooperate with us or perform their obligations under our agreements with them. We cannot control the amount and timing of our collaborators’ resources that will be devoted to our research and development activities related to our collaborative agreements with them. Our collaborators may choose to pursue existing or alternative technologies in preference to those being developed in collaboration with us.
Under agreements with collaborators, we may rely significantly on such collaborators to, among other things:
● design and conduct product testing and studies to demonstrate aesthetic improvement;
● fund research and development activities with us;
● pay us fees upon the achievement of milestones; and
● market with us any commercial products that result from our collaborations.
Should we collaborate with others in the development and commercialization of potential products, those expected product pipeline timelines may be delayed if collaborators fail to conduct these activities in a timely manner, or at all. In addition, our potential collaborators could terminate their agreements with us, and we may not receive any development or milestone payments. If we do not achieve milestones set forth in the agreements, or if our collaborators breach or terminate their collaborative agreements with us, our business may be materially harmed.
Our reliance on the activities of our non-employee consultants, third-party vendors, and operational contractors, whose activities are not wholly within our control, may lead to delays in development of our proposed products.
As an early-stage company, we rely extensively upon and have relationships with in-house consultants and with expertise in strategy or other business matters. These consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. We have limited control over the activities of these consultants and, except as otherwise required by our collaboration and consulting agreements to the extent they exist, can expect only limited amounts of their time to be dedicated to our activities. These consultants may have commitments to other commercial and non-commercial entities. We have limited control over the operations of our consultants and can expect only limited amounts of time to be dedicated to our research, development and business goals.
Certain market opportunity data and forecasts in this Annual Report were obtained from third-party sources and were not independently verified by us. We believe the estimates of market opportunity data and forecasts of market growth included in this Annual Report are reliable, but may prove to be inaccurate, and even if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.
This Annual Report contains certain data and information that we obtained from various government and private entity publications and reports. There is no guarantee that any particular number or percentage of market participants covered by our market opportunity estimates will purchase our products at all or generate any particular level of revenue for us. While we have not independently verified the data and information contained therein and such data and information may have been collected using third-party methodologies, we believe that the data and information, including projections based on a number of assumptions, from these third-party publications and reports used in this Annual Report is reliable. Any expansion in the medical aesthetics industry on a number of factors, including the cost and perceived value associated with our product offerings and those of our competitors. Even if the markets in which we compete meet the size estimates and growth forecast in this Annual Report, our business could fail to grow at the rate we anticipate, if at all, which could adversely affect our business, financial condition, results of operations and prospects. Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many risks and uncertainties. Accordingly, the forecasts of market growth included in this Annual Report should not be taken as indicative of our future growth. For more information regarding the estimates of market opportunity and forecasts of market growth included in this Annual Report, see the section titled “Business- Market, Industry and Other Research-Based Data.”
We or our third-party vendors may experience in the future network or system failures, or service interruptions, including cybersecurity attacks, or other technology risks. Our inability to protect our systems and data against such risks could harm our business and reputation.
Our ability to operate uninterrupted and provide high levels of service depends upon the performance of our internal network, systems and related infrastructure, and those of our third-party vendors. Any significant interruptions in, or degradation of, the quality of the services, including infrastructure storage and support, that these third parties provide to us could severely harm our business and reputation and lead to the loss of customers and revenue. Our internal network, systems, and related infrastructure, in addition to the networks, systems, and related infrastructure of our third-party vendors, may be vulnerable to computer viruses and other malware that infiltrate such systems and networks, as well as physical or electronic security breaches, natural disasters, and similar disruptions. They have been and may continue to be the target of attempts to identify and exploit network and system vulnerabilities, penetrate or bypass security measures in order to interrupt or degrade the quality of the services we receive or provide, or otherwise gain unauthorized access to our networks and systems or those of our third-party vendors. These vulnerabilities or other attempts at access may result from, or be caused by, human error or technology failures, however, they may also be the product of malicious actions by third parties intending to harm our business. The methods that may be used by these third parties to cause interruptions or failures or to obtain unauthorized access to information change frequently, are difficult to detect, evolve rapidly, and are increasingly sophisticated and hard to defend against.
Although we have not experienced any security breaches or attempted security breaches and continue to invest in security measures, we cannot be certain that our defensive measures, and those employed by our third-party vendors, will be sufficient to defend against all such current and future methods.
Any actual or perceived security breach, whether experienced by us or a third-party vendor; the reporting or announcement of such an event, or reports of perceived security vulnerabilities of our systems or the systems of our third-party service providers whether accurate or not; or our failure or perceived failure to respond or remediate an event or make adequate or timely disclosures to the public, regulatory or law enforcement agencies following any such event may be material and lead to harm to our financial condition, business reputation, and prospects of future business due to, among other factors: loss of customer confidence arising from interruptions or outages, delays, failure to meet contractual obligations, and loss of data or public release of confidential data; increase regulatory scrutiny on us; compromise our trade secret and intellectual property; expose us to costly uninsured liabilities such as material fines, penalties, liquidated damages, and overall margin compression due to renegotiation of contracts on less favorable terms or loss of business; liability for claims relating to misuse of personal information in violation of contractual obligations or data privacy laws; and potential theft of our intellectual property.
A security breach could occur and persist for an extended period of time without detection. We expect that any investigation of a security breach could take a substantial amount of time, and during such time we may not necessarily know the extent of the harm or how best to remediate it, and certain errors or actions could be repeated or compounded before they are discovered and remediated, all of which could further increase the costs and consequences of such a breach. Further, detecting and remediating such incidents may require specialized expertise and there can be no assurance that we will be able to retain or hire individuals who possess, or otherwise internally develop, such expertise. Our remediation efforts therefore may not be successful. The inability to implement, maintain, and upgrade adequate safeguards could have a material and adverse impact on our business, financial condition and results of operations. Moreover, there could be public announcements regarding any data security-related incidents and any steps we take to respond to or remediate such incidents.
The occurrence of any such failure may also subject us to costly lawsuits, claims for contractual indemnities, as well as divert valuable management, research and development, information technology, and marketing resources toward addressing these issues and delay our ability to achieve our strategic initiatives. In addition, we gather, as permitted by law, non-public, personally-identifiable financial information from customers, such as names, addresses, telephone numbers, bank and credit card account numbers and financial transaction information, and the compromise of such data, which may subject us to fines and other related costs of remediation.
Our business could be negatively impacted by cybersecurity threats and other security threats and disruptions.
Because our business relies on proprietary technology and computer systems, we face certain security threats, including threats to our information technology infrastructure, attempts to gain access to our proprietary or confidential information, threats to physical security, and domestic terrorism events. Our information technology networks and related systems are critical to the operation of our business and our research and development efforts. We are also involved with information technology systems for certain third parties, which generally face similar security threats. Cybersecurity threats in particular, are persistent, evolve quickly and include, but are not limited to, computer viruses, attempts to access information, denial of service and other electronic security breaches believe that we have implemented appropriate measures and controls and invested in skilled information technology resources to appropriately identify threats and mitigate potential risks, but there can be no assurance that such actions will be sufficient to prevent disruptions to critical systems, the unauthorized release of confidential information or corruption of data. A security breach or other significant disruption involving these types of information and information technology networks and related systems could:
● disrupt the proper functioning of these networks and systems and therefore its operations and/or those of third parties on which we rely;
● result in the unauthorized access to, and destruction, loss, theft, misappropriation or release of, our proprietary, confidential, sensitive or otherwise valuable information, or that of third parties with which we collaborate or otherwise depend, which others could use to compete against us or for disruptive, destructive or otherwise harmful purposes and outcomes;
● delay or compromise preclinical or clinical studies or the analysis and use of data collected in our efforts to develop product candidates;
● require significant attention and resources of management and key personnel to remedy any damages or other adverse consequences that result;
● subject us to claims for breach of contract, damages, credits, penalties or termination with respect to our relationships with third parties, or regulatory actions by governmental agencies; and
● damage our reputation with industry participants, existing or prospective strategic alliances, and the public generally.
Any or all of the foregoing could have a material negative impact on its business, financial condition and prospects.
If our third-party suppliers, logistics, and manufacturers do not comply with ethical business practices or with applicable laws and regulations, our reputation, business, financial condition, results of operations and prospects could be harmed.
Our reputation and our clients’ willingness to purchase our products depend in part on our suppliers’, packagers’, manufacturers’, and formulators’ compliance with ethical employment practices, such as with respect to child labor, wages and benefits, forced labor, discrimination, safe and healthy working conditions, and with all legal and regulatory requirements relating to the conduct of their businesses. We do not exercise control over our suppliers, packagers, shippers, manufacturers, and formulators and cannot guarantee their compliance with ethical and lawful business practices. If our suppliers, packagers, shippers, manufacturers, or formulators fail to comply with applicable laws, regulations, safety codes, employment practices, human rights standards, quality standards, environmental standards, production practices, or other obligations, norms, or ethical standards, our reputation and brand image could be harmed, and we could be exposed to litigation, investigations, enforcement actions, monetary liability, and additional costs that would harm our reputation, business, financial condition, results of operations and prospects.
If we, or our third-party manufacturers fail to comply with environmental laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.
Our research and development activities and our third-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts, business operations and environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance.
Risks Related to Our Intellectual Property
If we fail to protect or enforce our intellectual property or confidential proprietary information relating to our current and any future medical aesthetics products or medical aesthetics pipeline product, others could compete against us more directly and we may not be able to compete effectively in our market.
Our success depends in part on our ability to protect our intellectual property rights. We rely on a combination of trademarks, trade secrets, confidential proprietary information, domains, patent rights and other intellectual property rights to protect our intellectual property. We also rely on and patent applications licensed by us for the Licensed Products which we are contractually obligated to file, prosecute and maintain under our License Agreement with MOA. Patent protection is limited in time, and we may be unsuccessful in developing and commercializing a product before a patent expires and the underlying technology becomes available for commercialization by competitors, in which case our investment of substantial time and resources towards the applicable product or product candidate could be lost without the realization of the benefits we anticipated or sought.
Certain of our technology may not be subject to protection through patents, which leaves us vulnerable to theft of our technology.
Certain parts of our know-how and technology are not patentable or are trade secrets. To protect our proprietary position in such know-how and technology, we have entered and intend to require all employees, consultants, advisors and collaborators to enter into confidentiality and invention ownership agreements with us. These agreements may not provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure. Further, in the absence of patent protection, competitors who independently develop substantially equivalent technology may harm our business. There can be no assurances that we will be able to enforce these agreements or alternatively, these agreements may be deemed to be unenforceable. If we cannot adequately protect or enforce our intellectual property rights, we may not be able to adequately compete, and our business and prospects could be adversely affected.
We may not be able to protect our proprietary technology, which could harm our ability to operate profitably.
The molecular biology and bioprocessing industries place considerable importance on obtaining patent and trade secret protection for new technologies, medical aesthetics products and processes. Our success will depend, to a substantial degree, on our ability to obtain and enforce patent protection for our products, preserve any trade secrets and operate without infringing the proprietary rights of others. We cannot assure you that:
● we will succeed in obtaining any patents, obtain them in a timely manner, or that the breadth or degree of protection that any such patents will protect our interests;
● the use of our technology will not infringe on the proprietary rights of others;
● patent applications relating to our products candidates will result in the issuance of any patents or that, if issued, such patents will afford adequate protection to us or will not be challenged, invalidated or infringed;
● we will be successful or effective in monitoring, enforcing or otherwise protecting our patents or other intellectual property rights from third party infringement; or
● patents will not be issued to other parties, which may be infringed by our potential medical aesthetics products or technologies.
Considerable research in the areas of stem cells, molecular biology and bioprocessing is being performed in countries outside of the United States, and a number of our competitors are located in those countries. The laws protecting intellectual property in some of those countries may not provide adequate protection to prevent our competitors from misappropriating our intellectual property.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our target markets and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks. We may not be able to protect our rights in these trademarks and trade names, which we need in order to build name recognition with potential partners or customers in our target markets. If we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected.
If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed.
Our research, development and commercialization activities may infringe or otherwise violate or be alleged to infringe or otherwise violate patents owned or controlled by other parties. Additionally, a number of biotechnology companies, universities, and research institutions have filed patent applications or hold issued patents related to technologies potentially relevant to our portfolio assets. The scope and validity of these patents can be unpredictable, and we cannot determine in advance whether any claims in pending applications will be granted or how they may impact our ability to commercialize or license certain technologies. If third-party patents are found to cover technologies used in our portfolio assets, we may be unable to license these patents at a reasonable cost, if at all, or develop suitable alternatives. This could limit our ability to advance certain biotechnology assets through research, development, and commercialization.
Competitors in the field of aesthetics have developed large portfolios of patents and patent applications in fields relating to our business. Additionally, there may also be patent applications that have been filed but not published that, when issued as patents, could be asserted against us. These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages and/or we could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit. Further, if a patent infringement suit were brought against us, during the pendency of the litigation, we could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit. If we are unable to effectively navigate intellectual property risks, our ability to license, develop, and commercialize our biotechnology assets could also be negatively impacted.
We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
We may employ individuals who were previously employed at universities or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject to such claims. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
We may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.
A third party may hold intellectual property, including patent rights that are important or necessary to the development of our future products. It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our prospective products, in which case we would be required to obtain a license from these third parties. There can be no assurance that such third parties will grant us the necessary licenses on commercially reasonable terms or at all. Failure to obtain such licenses on commercially reasonable terms could limit or eliminate our ability to develop or commercialize our future product candidates, which would have a negative impact on our business and results of operations.
Risks Related to Our Capital Requirements and Finances
If we fail to generate sufficient cash flow from our operations, we will be unable to continue to develop and commercialize our products.
We expect capital outlays and operating expenditures to increase over the next several years as we expand our operations, and our commercialization, product validation studies, research and development and manufacturing activities. However, our present and future funding requirements will depend on many factors, including, among other things:
● the level of research and development investment required to maintain and improve our competitive position;
● the success of our product sales and related collections;
● our need or decision to acquire or license complementary businesses, products or technologies or acquire complementary businesses;
● costs relating to the expansion of the sales force, management and operational support;
● competing technological and market developments; and
● costs relating to changes in regulatory policies or laws that affect our operations.
As a result of these factors, we may need to raise additional funds, and we cannot be certain that such funds will be available to us on acceptable terms when needed, if at all. In addition, if we raise additional funds through collaboration, licensing or other similar arrangements, it may be necessary to relinquish potentially valuable rights to our future products or proprietary technologies, or grant licenses on terms that are not favorable to us. If we cannot raise funds on acceptable terms, we may not be able to expand our operations, develop new products, take advantage of future opportunities or respond to competitive pressures or unanticipated customer requirements.
Risks Related to the Ownership of Our Securities
The price of our Common Stock may be adversely affected by the future issuance and sale of shares of our Common Stock or other equity securities.
We cannot predict the size of future issuances or sales of our Common Stock or other equity securities, future acquisitions or capital raising activities, or the effect, if any, that such issuances or sales may have on the market price of our Common Stock. The issuance and sale of substantial amounts of Common Stock or other equity securities or announcement that such issuances and sales may occur, could adversely affect the market price of our Common Stock.
Future sales by stockholders, or the perception that such sales may occur, may depress the price of our Common Stock.
The sale or availability for sale of substantial amounts of our shares in the public market or exercise of Common Stock warrants or other derivative securities or the perception that such sales could occur, could adversely affect the market price of our Common Stock and also could impair our ability to raise capital through future offerings of our shares. As of March 26, 2025, we had 577,961 outstanding shares of Common Stock. Any decline in the price of our Common Stock may encourage short sales, which could place further downward pressure on the price of our Common Stock and may impair our ability to raise additional capital through the sale of equity securities.
The issuance of shares upon exercise of derivative securities may cause immediate and substantial dilution to our existing stockholders.
The issuance of shares upon exercise of options and settlement of outstanding derivative securities may result in substantial dilution to the interests of other shareholders since these selling shareholders may ultimately convert or exercise and sell all or a portion of the full amount issuable upon exercise. If all derivative securities outstanding as of March 26, 2025, including the Warrants, were converted or exercised into shares of Common Stock, there would be approximately an additional 531,353 shares of Common Stock outstanding as a result. The issuance of these shares will have the effect of further diluting the proportionate equity interest and voting power of holders of our Common Stock.
Our Common Stock may be affected by limited trading volume and price fluctuations, which could adversely impact the value of our Common Stock.
Our Common Stock has experienced and is likely to experience in the future, significant price and volume fluctuations, which could adversely affect the market prices of our Common Stock without regard to our operating performance. In addition, we believe that factors such as quarterly fluctuations in our financial results and changes in the overall economy or the condition of the financial markets could cause the market prices of our Common Stock to fluctuate substantially. These fluctuations may also cause short sellers to periodically enter the market in the belief that we will have poor results in the future. We cannot predict the actions of market participants and, therefore, can offer no assurances that the market for our Common Stock will be stable or appreciate over time.
We may not be able to continue to satisfy listing requirements of Nasdaq to maintain a listing of our Common Stock.
Our Common Stock is currently listed on Nasdaq and we must meet certain financial and liquidity criteria to maintain such listing. If we violate the maintenance requirements for continued listing of our Common Stock, our Common Stock may be delisted.
There can be no assurance that we will maintain compliance with any of the other Nasdaq continued listing requirements. If the Common Stock is delisted, it could be more difficult to buy or sell the Common Stock or to obtain accurate quotations, and the price of the shares of Common Stock could suffer a material decline. Delisting could also impair our ability to raise capital.
In addition, our Board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of such listing. A delisting of our Common Stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our Common Stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our Common Stock. In addition, the delisting of our Common Stock could significantly impair our ability to raise capital.
We currently do not intend to declare dividends on our Common Stock in the foreseeable future and, as a result, your returns on your investment may depend solely on the appreciation of our Common Stock.
We currently do not expect to declare any dividends on our Common Stock in the foreseeable future. Instead, we anticipate that all of our earnings in the foreseeable future will be used to provide working capital, to support our operations and to finance the growth and development of our business. Any determination to declare or pay dividends in the future will be at the discretion of our Board, subject to applicable laws and dependent upon a number of factors, including our earnings, capital requirements and overall financial conditions. In addition, terms of any future debt or preferred securities may further restrict our ability to pay dividends on our Common Stock. Accordingly, your only opportunity to achieve a return on your investment in our Common Stock may be if the market price of our Common Stock appreciates and you sell your shares at a profit. The market price for our Common Stock may never exceed, and may fall below, the price that you pay for such Common Stock. See “Dividend Policy.”
An investment in our securities is speculative and there can be no assurance of any return on any such investment.
An investment in our securities is speculative and there can be no assurance that investors will obtain any return on their investment. Investors may be subject to substantial risks involved in an investment in the Company, including the risk of losing their entire investment.
We may need, but be unable, to obtain additional funding on satisfactory terms, which could dilute our stockholders or impose burdensome financial restrictions on our business.
We have relied upon cash from financing activities and in the future, we hope to rely on revenues generated from operations to fund the cash requirements of our activities. However, there can be no assurance that we will be able to generate any significant cash from our operating activities in the future. Future financing may not be available on a timely basis, in sufficient amounts or on terms acceptable to us, if at all. Any debt financing or other financing of securities senior to the Common Stock will likely include financial and other covenants that will restrict our flexibility. Any failure to comply with these covenants would have a material adverse effect on our business, prospects, financial condition and results of operations because we could lose our existing sources of funding and impair our ability to secure new sources of funding.
The requirements of being a public company may strain our resources, divert management’s attention and affect our results of operations.
As a public company in the United States, we face increased legal, accounting, administrative and other costs and expenses. We are subject to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act of 2002. The Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. For example, Section 404 requires that our management report on the effectiveness of our internal controls structure and procedures for financial reporting. Section 404 compliance may divert internal resources and will take a significant amount of time and effort to complete. If we fail to maintain compliance under Section 404, or if in the future management determines that our internal control over financial reporting are not effective as defined under Section 404, we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Furthermore, investor perceptions of our Company may suffer, and this could cause a decline in the market price of our Common Stock. Any failure of our internal control over financial reporting could have a material adverse effect on our stated results of operations and harm our reputation. If we are unable to implement these changes effectively or efficiently, it could harm our operations, financial reporting or financial results and could result in an adverse opinion on internal controls from our independent auditors. We may need to hire a number of additional employees with public accounting and disclosure experience in order to meet our ongoing obligations as a public company, particularly if we become fully subject to Section 404 and its auditor attestation requirements, which will increase costs. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time consuming and costly, although we are currently unable to estimate these costs with any degree of certainty. A number of those requirements will require us to carry out activities we have not done previously. Our management team and other personnel will need to devote a substantial amount of time to new compliance initiatives and to meeting the obligations that are associated with being a public company, which may divert attention from other business concerns, which could have a material adverse effect on our business, financial condition and results of operations.
Additionally, the expenses incurred by public companies generally for reporting and corporate governance purposes have been increasing. These increased costs will require us to divert a significant amount of money that we could otherwise use to develop our business. If we are unable to satisfy our obligations as a public company, we could be subject to delisting of our Common Stock, fines, sanctions and other regulatory action and potentially civil litigation.
New laws, regulations and standards relating to corporate governance and public disclosure may create uncertainty for public companies, increasing legal and financial compliance costs and making some activities more time consuming.
These laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, may evolve over time as new guidance is provided by the courts and other bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. If our efforts to comply with new laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatory authorities may initiate legal proceedings against us and our business may be adversely affected.
As a public company subject to these rules and regulations, we may find it more expensive for us to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult in the future for us to attract and retain qualified members of our Board, particularly to serve on its audit committee and compensation committee, and qualified executive officers.
If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
The trading market for our Common Stock will depend in part on the research and reports that securities or industry analysts publish about us or our business. Several analysts may cover our stock. If one or more of those analysts downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts cease coverage of our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.
If there is no active public market for our Common Stock, you may be unable to sell your shares at or above your purchase price.
Although our Common Stock is listed on Nasdaq, an active trading market for our shares may not be sustained following the purchase of your Common Stock. You may be unable to sell your shares quickly or at the market price if trading in shares of our Common Stock is not active. Further, an inactive market may also impair our ability to raise capital by selling shares of our Common Stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using our shares of Common Stock as consideration.
We may be subject to securities litigation, which is expensive and could divert our management’s attention.
The market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their securities have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns.
IN ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT. IN REVIEWING THIS FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT OUR BUSINESS OPERATIONS AND THE VALUE OF OUR SECURITIES.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
Item 1B. Unresolved Staff Comments.
Smaller reporting companies are not required to provide the information required by this item.

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ITEM 2. PROPERTIES
Item 2. Properties.
Our principal executive office is located at 120 Newport Center Drive, Newport Beach, CA 92660. The office has 500 square feet, and the lease runs from March 2024 to February 2025. The monthly rent is $1,725.
Our medical grade production laboratory spaces are located at 1743 Creekside Dr. Folsom, CA 95630 (the “1743 Lab”), and 1739 Creekside Dr. # 110 Folsom, CA 95630 (the “1739 Lab”). Our 1743 Lab has 1,388 square feet while our 1739 Lab has 1,600 square feet and the lease for both the 1743 Lab and 1739 Lab runs from June 2022 to May 2025. The monthly rent for both the 1743 Lab and 1739 Lab is $13,476.75.
The following table sets forth the leases term and monthly rent:
Lease Term Address Space
(square feet) Average
Monthly Rent
March 2024 to February 2025 Newport Center Drive, Newport Beach, CA 92660 $ 1,725
June 2022 to May 2025 1739 Creekside Dr., Ste. 110 Folsom, CA 95630 1,388 $ 13,476.75 (1)
June 2022 to May 2025 1743 Creekside Dr. Folsom, CA 95630 1,600
(1) Our average monthly rental payment of $13,476.75 includes one payment for our laboratory locations at both 1739 and 1743 Creekside Dr. Folsom, CA 95630.
We use these facilities for administrative purposes, research and development, manufacturing of our products and analysis by our laboratory. We believe that these facilities will satisfy our current manufacturing and research and development needs over the next 24 months. However, if we decide to expand our manufacturing capabilities in order to begin the developing the means produce a new topical haircare product within the next 12 months, we estimate we would require a capital intensive purchase of laboratory new equipment and funds to arrange testing protocols in amounts between $250,000 and $300,000 to establish that type of capability over the course of an estimated seven to eighteen months.
Some members of our management work outside of these premises in office space that we do not rent.

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ITEM 3. LEGAL PROCEEDINGS
Item 3. Legal Proceedings.
As of the date of this Annual Report, there are no active legal proceedings pending or threatened against the Company. However, from time to time, we may be subject to various legal claims and proceedings that arise from the normal course of business activities, including, third party intellectual property infringement claims against us in the form of letters and other forms of communication. Litigation or any other legal or administrative proceeding, regardless of the outcome, could result in substantial cost, diversion of our resources, including management’s time and attention, and, depending on the nature of the claims, reputational harm. In addition, if any litigation results in an unfavorable outcome, there exists the possibility of a material adverse impact on our results of operations, prospects, cash flows, financial position and brand.

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ITEM 4. MINE SAFETY DISCLOSURE
Item 4. Mine Safety Disclosures.
Not Applicable.
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.
Our Common Stock is currently quoted on The Nasdaq Capital Market under the symbol “ELAB.” We had 438,987 shares of Common Stock issued and outstanding as of December 31, 2024.
Holders of Capital Stock
As of December 31, 2024, we had 47 holders of our Common Stock.
Stock Option Grants
As of the date of this Annual Report, options to purchase an aggregate of 699 Common Stock have been granted and 74 Common Stock have been issued under the 2020 Plan.
Transfer Agent
The transfer agent for our Common Stock is VStock Transfer, LLC. The transfer agent’s telephone number and address is (212) 828-8436 and 18 Lafayette Place Woodmere, New York 11598.
Dividends
To date, we have not declared or paid any dividends on our Common Stock. We currently do not anticipate paying any cash dividends in the foreseeable future on our Common Stock. Although we intend to retain our earnings, if any, to finance the exploration and growth of our business, the board of directors of the Company (the “Board) has the discretion to declare and pay dividends in the future.
Payment of dividends in the future will depend upon our earnings, capital requirements, and any other factors that our Board deems relevant.
Nasdaq Compliance
On March 6, 2024, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) notifying the Company that, based on the closing bid price of our Common Stock, for the last 30 consecutive trading days preceding each letter, we were no longer compliant with the minimum bid price requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5450(a)(1) requires listed securities to maintain the Minimum Bid Price Requirement, and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues for a period of 30 consecutive trading days.
Recent Sales of Unregistered Securities
Except as set forth below or in a Current Report on Form 8-K, there were no equity securities of the registrant sold by the registrant during the period covered by this Annual Report that were not registered under the Securities Act.

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ITEM 6. SELECTED FINANCIAL DATA
Item 6. [Reserved]
Smaller reporting companies are not required to provide the information required by this item.

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation.
The information set forth in this section contains certain “forward-looking statements”, including, among others (i) expected changes in our revenue and profitability, (ii) prospective business opportunities and (iii) our strategy for financing our business. Forward-looking statements are statements other than historical information or statements of current condition. Some forward-looking statements may be identified by use of terms such as “believes”, “anticipates”, “intends” or “expects”. These forward-looking statements relate to our plans, liquidity, ability to complete financing and purchase capital expenditures, growth of our business including entering into future agreements with companies, and plans to successfully develop and obtain approval to market our product. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs.
Although we believe that our expectations with respect to the forward-looking statements are based upon reasonable assumptions within the bounds of our knowledge of our business and operations, in light of the risks and uncertainties inherent in all future projections, the inclusion of forward-looking statements in this Annual Report should not be regarded as a representation by us or any other person that our objectives or plans will be achieved.
We assume no obligation to update these forward-looking statements to reflect actual results or changes in factors or assumptions affecting forward-looking statements.
Our revenues and results of operations could differ materially from those projected in the forward-looking statements as a result of numerous factors, including, but not limited to, the following: the risk of significant natural disaster, the inability of our company to insure against certain risks, inflationary and deflationary conditions and cycles, currency exchange rates, and changing government regulations domestically and internationally affecting our products and businesses.
You should read the following discussion and analysis in conjunction with the Financial Statements and Notes attached hereto, and the other financial data appearing elsewhere in this Annual Report.
US Dollars are denoted herein by “USD”, “$” and “dollars”.
Organization and Overview of Operations
On December 31, 2024, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with an unrelated third party, pursuant to which it was agreed to sell the skincare business. The sale of the skincare business closed on January 16, 2025.
Prior to entering into the Asset Purchase Agreement, the Company’s principal business was operating a skincare development company engaged in the design, manufacture, and marketing of skincare products in the skincare industry. With the sale of the skincare business, the Company changed its principal business. PMGC Holdings Inc. is a diversified holding company that manages and grows its portfolio through strategic acquisitions, investments, and development across various industries. The Company currently manages and operates a diverse portfolio of three wholly owned subsidiaries:
● NorthStrive BioSciences Inc. - is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines and therapeutic products. Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists. For more information, please visit www.northstrivebio.com.
● PMGC Research Inc. - based in Canada, is currently dedicated to medical scientific research and development efforts, utilizing Canadian research grants and partnering with leading Canadian Universities to push the boundaries of innovation.
● PMGC Capital LLC - is a multi-strategy investment firm focused on direct investments, strategic lending, and acquiring undervalued companies and assets across diverse markets. Our mission is to identify and seize high-potential opportunities, delivering sustainable growth and maximizing returns on capital.
Outlook
Management’s Plans
Over the next twelve months, we intend to focus on:
● Growing revenue by achieving successful returns on capital through PMGC Capital LLC, our multi-strategy investment vehicle, by acquiring and managing undervalued assets, public and private investments, and structured financing opportunities.
● Establishing new wholly owned subsidiaries to develop and commercialize newly acquired or licensed biotechnology assets across various unrelated pharmaceutical indications.
● Utilizing clinical validation studies to strengthen the commercial potential and scientific credibility of our portfolio companies’ technologies.
● Advancing clinical development to progress NorthStrive Biosciences, Inc.’s clinical assets toward Investigational New Drug (IND) applications.
● Pursuing additional acquisitions of operating companies and biotechnology assets to expand and diversify our portfolio.
● Evaluating potential spin-offs of wholly owned subsidiaries, creating new publicly traded companies to unlock shareholder value.
Results of Operations
Comparison of the Years Ended December 31, 2024 and 2023.
The following table provides certain selected financial information for continuing operations for the periods presented:
Year Ended December 31, 2024 Year Ended December 31, 2023 Change
Marketing and Promotion $ 292,522 256,450 36,072
Consulting Fees $ 1,367,273 279,767 1,087,506
Office and Administration $ 1,092,576 347,653 744,923
Professional Fees $ 563,242 132,600 430,642
Investor Relations $ 208,326 91,009 117,317
Research and Development $ 104,654 7,410 97,244
Total operating expenses $ 3,663,566 1,140,958 2,522,608
Other income (expense)1 $ (353,148 ) (515,781 ) 162,633
Net loss from continuing operations $ (4,016,714 ) (1,656,739 ) (2,359,975 )
Basic and dilutive loss per common share - continuing operations $ (50.473 ) (215.834 ) 165.361
Weighted average number of shares outstanding - basic and diluted 79,582 7,676
1 Other expenses relate to interest income, interest expense, listing expense and fair value gain/loss on derivative liability.
Research and Development Expenses
Research and development expenses for the year ended December 31, 2024, were $104,654 compared to $7,410 for the year ended December 31, 2023, an increase of $97,244. Research and Development related to the development of the Company’s intangible assets. The increase in R&D is due to the intangible assets acquired during fiscal 2024 and includes amortization of intangible assets of $82,556 during the year ended December 31, 2024 compared to Nil during the year ended December 31, 2023.
Marketing and Promotion
Marketing and promotion expenses for the year ended December 31, 2024, were $292,522 compared to $256,450 for the year ended December 31, 2023, an increase of $36,072. The Company’s marketing and promotional efforts were consistent year of year.
Office and Administrative Expenses
Office and administrative expenses for the year ended December 31, 2024, were $1,092,576, compared to $347,653 for year ended December 31, 2023, an increase of $744,923. Approximately $400,000 of the increase is the result of directors’ and officers’ insurance for the full 12 months of 2024 compared to only one month post IPO in 2023. In addition, during 2024 the Company paid directors fees of $165,000 ($55,000 each to its three independent directors) compared to Nil in 2023.
Consulting Fees
Consulting fees for the year ended December 31, 2024, were $1,367,273, compared to $279,767 for the year ended December 31, 2023, an increase of $1,087,506. The Company’s CEO, CFO and Chairman provide services in a consulting capacity. During 2024, consulting fees to key management (excluding 2024 year-end bonuses) increased by $177,233 to bring compensation in line with market rates for similar public companies. In addition, the Company accrued $350,000 in bonuses payable to key management following the successful recapitalization and restructuring of the business during Q3-Q4 2024. The remaining increase in consulting fees relates to business advisory and strategy services acquired during 2024 that were not present in 2023.
Professional Fees
Professional fees for the year ended December 31, 2024, was $563,242, compared to $132,600 for the year ended December 31, 2023, an increase of $430,642. Professional fees comprise of legal, audit and accounting services. The increase during 2024, is primarily due to an increase in audit, legal and accounting services as the company is now listed on the NASDAQ exchange.
Investor Relations
Investor relations for the year ended December 31, 2024, was $208,326, compared to $91,009 for the year ended December 31, 2023. The increase in investor relations spending is consistent with the Company’s growth strategy, which includes promotion to current and potential investors as the company is now listed on the NASDAQ exchange.
Liquidity and Capital Resources
The accompanying consolidated financial statements have been prepared on a going concern basis, which implies the Company will continue to realize its assets and discharge its liabilities in the normal course of business. The continuation of the Company as a going concern is dependent upon the continued financial support from its shareholders, the ability of the Company to obtain necessary equity financing to continue operations, and ultimately the attainment of profitable operations.
As of December 31, 2024 and 2023, the Company had a net working capital of $4,251,867 and $3,622,091, respectively, and has an accumulated deficit of $13,269,627 and $7,023,890, respectively. Furthermore, for the years ended December 31, 2024 and 2023, the Company incurred a net loss of $6,245,737 and $4,301,517, respectively and used $5,486,980 and $4,556,811, respectively of cash flows for operating activities. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. These Company’s consolidated financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Our principal liquidity requirements are for working capital, capital expenditure and research and development. We fund our liquidity requirements primarily through cash on hand, cash flows from operations, the issuance of common, warrants and preferred stock, and the issuance of Notes. As of December 31, 2024, we had cash of $3,984,453, with $3,326,851 as of December 31, 2023.
The Company expects an improvement in liquidity and capital resources, including cash used in operations following the sale of the loss-making skincare business on January 16, 2025. Cash flows used in discontinued operating and investing activities and assets and liabilities held for sale have been excluded from our analysis.
The following table provides selected financial data as of December 31, 2024, and December 31, 2023, respectively (excluding assets and liabilities held for sale).
December 31, 2024 December 31, 2023 Change
Current assets $ 4,858,193 $ 4,231,976 $ 626,217
Current liabilities $ 1,250,218 $ 580,299 $ 669,919
Working capital $ 3,607,975 $ 3,651,677 $ (43,702 )
The following table summarizes our cash flows from operating, investing and financing activities from continuing operations:
Year Ended December 31, 2024 Year Ended December 31, 2023 Change
Cash used in operating activities $ (2,800,601 ) $ (2,114,871 ) $ (685,730 )
Cash used in investing activities $ (601,404 ) $ - $ (601,404 )
Cash provided by financing activities $ 6,757,500 $ 6,738,890 $ 18,610
Cash Flow from Operating Activities
For the year ended December 31, 2024, net cash flows used in operating activities for continuing operations was $2,800,601 compared to $2,114,871 used during the year ended December 31, 2024, respectively, primarily due to net loss and timing of settlement of assets and liabilities.
Cash Flows from Investing Activities
During the year ended December 31, 2024, and 2023, we used $601,404 and $nil, respectively, in investing activities primarily related to the acquisition of intangible assets of $462,320. In addition, the Company participated in a private placement of a company in the U.S. uranium energy market with an investment of 139,084.
Cash Flows from Financing Activities
During the year ended December 31, 2024, we had net cash flow provided by financing activities of $6,757,500 compared to cash flow provided by financing activities of $6,738,890 in 2023. During 2024, and 2023, the Company raised $6,993,058 and $1,463,586, respectively, through the issuance of common stock and common stock purchase warrants; $914,442 and $Nil, respectively, through the issuance of Notes; and $Nil and $37,500, respectively, upon the exercise of stock options in exchange for common stock. The cash provided by financing activities during the year ended December 31, 2024, was partially offset by the repayment of Notes of $1,150,000. In addition, during 2023 the Company completed its IPO financing and raised net proceeds of $5,237,805.
Critical Accounting Policies and Significant Judgments and Estimates
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company regularly evaluates estimates and assumptions related to revenue recognition, the collectability of receivables, valuation of inventory, fair value of derivative liabilities and stock options, useful lives and recoverability of long-lived assets, and deferred income tax asset valuation allowances. The Company bases its estimates and assumptions on current facts, historical experience and various other factors that it believes to be reasonable under the circumstances, the results of which form the basis for making judgements about the carrying value of assets and liabilities and the accrual of costs and expenses that are not readily apparent from other sources. The actual results experienced by the Company may differ materially and adversely from those estimates. Estimates and assumptions are reviewed periodically, and the effects of revisions are reflected in the consolidated financial statements in the period they are determined.
The Company’s policy for intangible assets require judgement in determining whether the present value of future expected economic benefits exceeds capitalized costs. The policy requires management to make certain estimates and assumptions about future economic benefits related to its operations. Estimates and assumptions may change if new information becomes available. If information becomes available suggesting that the recovery of capitalized cost is unlikely, the capitalized cost is written off/impaired to the consolidated statement of operations.
The assessment of whether the going concern assumption is appropriate requires management to take into account all available information about the future, which is at least, but not limited to, 12 months from the date the financial statements are issued. The Company is aware that material uncertainties related to events or conditions may cast substantial doubt upon the Company’s ability to continue as a going concern.
Foreign Currency Translation
The Company’s functional and reporting currency is the U.S. dollar. The functional currency of the Company’s Canadian subsidiary, PMGC Research Inc. (“PMGC Research”) is the Canadian dollar. Monetary assets and liabilities denominated in foreign currencies are translated using the exchange rate prevailing at the balance sheet date. Non-monetary assets, liabilities, and items recorded in income arising from transactions denominated in foreign currencies are translated at rates of exchange in effect at the date of the transaction. Gains and losses arising on translation or settlement of foreign currency denominated transactions or balances are included in the determination of income.
The accounts of PMGC Research are translated to U.S. dollars using the current rate method. Accordingly, assets and liabilities are translated into U.S. dollars at the period-end exchange rate while revenues and expenses are translated at the average exchange rates during the period. Related exchange gains and losses are included in a separate component of stockholders’ equity as accumulated other comprehensive income (loss).
Share-Based Compensation
Employees - The Company accounts for share-based compensation under the fair value method which requires all such compensation to employees, including the grant of employee stock options, to be calculated based on its fair value at the measurement date (generally the grant date), and recognized in the consolidated statement of operations over the requisite service period.
Nonemployees - During June 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”) to simplify the accounting for share-based payments to nonemployees by aligning it with the accounting for share-based payments to employees. Under the requirements of ASU 2018-07, the Company accounts for share-based compensation to non-employees under the fair value method which requires all such compensation to be calculated based on the fair value at the measurement date (generally the grant date) and recognized in the statement of operations over the requisite service period.
During the years ended December 31, 2024 and 2023, the Company recorded $97,167 and $487,738, respectively, in share-based compensation expense, of which $93,449 and $3,718, and $250,067 and $237,671, respectively is included in office and administration and discontinued operations, respectively. Within discontinued operations for the years ended December 31, 2024 and 2023, ($599) and $4,317, and $226,838 and $10,833, respectively is included in office and administration and research and development, respectively.
Determining the appropriate fair value model and the related assumptions requires judgment. During the years ended December 31, 2024 and 2023, the fair value of each option grant was estimated using a Black-Scholes option-pricing model.
The expected volatility represents the historical volatility of comparable publicly traded companies in similar industries, adjusted for variables such as stock price, market capitalization and life cycle. Due to limited historical data, the expected term for options granted is equal to the contractual life. The risk-free interest rate is based on a treasury instrument whose term is consistent with the expected life of stock options. The Company has not paid and does not anticipate paying cash dividends on its shares of common stock; therefore, the expected dividend yield is assumed to be zero.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditure or capital resources that is material to investors.
JOBS Act
On April 5, 2012, the Jumpstart Our Business Startups Act (the “JOBS Act”) was signed into law. The JOBS Act contains provisions that, among other things, eases certain reporting requirements for qualifying public companies. We will qualify as an “emerging growth company” and under the JOBS Act will be allowed to comply with new or revised accounting pronouncements based on the effective date for private (not publicly traded) companies. We are electing to delay the adoption of new or revised accounting standards, and as a result, we may not comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. As a result, our financial statements may not be comparable to companies that comply with new or revised accounting pronouncements as of public company effective dates.
Future Related Party Transactions
The Corporate Governance Committee of our Board of Directors is required to approve all related party transactions. All related party transactions are made or entered into on terms that are no less favorable to use than can be obtained from unaffiliated third parties.
Impact of Inflation
We do not believe the impact of inflation on our Company is material.
Inflation Risk
We are also exposed to inflation risk. Inflationary factors, such as increases in labor costs, could impair our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain current levels of gross margin and operating expenses.
Market Risk
Market risk is the risk of loss arising from adverse changes in market rates and prices. Our market risk exposure is generally limited to those risks that arise in the normal course of business, as we do not engage in speculative, non-operating transactions, nor do we utilize financial instruments or derivative instruments for trading purposes.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 7A. Quantitative and Qualitative Disclosures about Market Risk.
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 8. Financial Statements and Supplementary Data
PAGE
Report of Independent Registered Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations and Comprehensive Loss
Consolidated Statements of Stockholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
We have not had any disagreements with our accountants or auditors that would need to be disclosed pursuant to Item 304 of Regulation S-K promulgated under the Securities Act of 1933.

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ITEM 9A. CONTROLS AND PROCEDURES
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934 (“Exchange Act”), the Company carried out an evaluation, with the participation of the Company’s management, including the Company’s Chief Executive Officer (the Company’s principal executive officer and interim principal accounting officer), of the effectiveness of the Company’s disclosure controls and procedures (as defined under Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, the Company’s Chief Executive Officer concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Exchange Act Rule 13a-15(f) and 15d-15(f) under the Exchange Act. Internal control over financial reporting is a process used to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external purposes in accordance with U.S. GAAP. Internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our assets; provide reasonable assurance that transactions are recorded as necessary to permit preparation of our financial statements in accordance with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with the authorization of our Board and management; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on our financial statements.
Any system of internal control, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the objectives of the system are met. Because of the inherent limitations in all internal control systems, no system of internal control over financial reporting can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected.
Our management conducted an evaluation of the effectiveness of our internal control over financial reporting. Based on this evaluation, management concluded that Elevai has limited accounting personnel and other resources with which to address its internal control over financial reporting in accordance with requirements applicable to public companies. Historically, Elevai had not retained a sufficient number of professionals with an appropriate level of accounting knowledge, training and experience to appropriately analyze, record and disclose accounting matters under U.S. GAAP.
Material Weakness
Our management’s conclusion that our disclosure controls and procedures were ineffective was due to the identification of a material weakness in our internal control over financial reporting in connection with the preparation of our year-end Financial Statements. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements would not be prevented or detected on a timely basis. Our management identified the following material weakness in our internal control over financial reporting:
● We have insufficiently designed and operating controls surrounding the accounting policies and controls, including standardized reconciliation schedules to ensure the company’s books and records are maintained in accordance with GAAP.
Notwithstanding the identified material weakness, management believes that the consolidated financial statements included in this Form 10-K present fairly, in all material respects, our consolidated financial position, consolidated results of operations, and consolidated cash flows as of and for the periods presented in accordance with U.S. GAAP.
Changes in Internal Controls over financial reporting
No change in our internal control over financial reporting occurred during the fiscal year ended December 31, 2024, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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ITEM 9B. OTHER INFORMATION
Item 9B. Other Information.
During the year ended December 31, 2024, no director or officer adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
The Company has adopted an insider trading policy governing the purchase, sale, and/or other dispositions of the Company’s securities by directors, officers and employees, or the registrant itself, that have been designed to promote compliance with insider trading laws, rules and regulations, and Nasdaq’s listing standards.

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 10. Directors, Executive Officers and Corporate Governance.
The following table sets forth certain information with respect to our directors, executive officers and significant employees as of March 31, 2025:
Name
Age
Position
Executive Officers:
Graydon Bensler
Chief Executive Officer, Chief Financial Officer and Director
Braeden Lichti
Chairman of the Board
Non-Executive Directors:
Jeffrey Parry(1)(2)(3)
Independent Director and Chair of Nominating Committee
George Kovalyov(1)(2)(3)
Independent Director and Chair of Compensation Committee
Juliana Daley(1)(2)(3)
Independent Director and Chair of the Audit Committee
(1) Member of the Audit Committee.
(2) Member of the Compensation Committee.
(3) Member of the Nominating Committee.
Each of our directors serves for a term of one year ending on the date of the subsequent annual meeting of stockholders following the annual meeting at which such director was elected. Notwithstanding the foregoing, each director is to serve until his or her successor is elected and qualified or until his death, resignation or removal. Our Board appoints our officers, and each officer is to serve until his or her successor is appointed and qualified or until his or her death, resignation or removal.
Graydon Bensler, CFA, Chief Executive Officer, Chief Financial Officer and Director
Mr. Bensler has served as our Chief Executive Officer since June 2024 and Chief Financial Officer since inception and a director since June 9, 2020. Mr. Bensler is a financial professional and analyst with over seven years of experience in financial consulting and management for both private businesses and US/Canadian publicly traded companies and is a CFA Charterholder (CFA) In 2017, Mr. Bensler Co-founded an Ed Tech curriculum management and scheduling company that was implanted in academic schools in Canada and the United States. From 2017 to 2019, Mr. Bensler was an account manager at a leading Canadian investor relations firm where he represented publicly traded companies across a wide range of sectors where he worked directly with investment banks, investment brokers and company executives and directors. During his tenure, Mr. Bensler created and conveyed messaging about his clients’ strategic position in the market and successfully guided several companies through multiple financings. From 2019 to 2021, Mr. Bensler was a Senior Associate at Evans & Evans, a Canadian boutique investment banking firm where he led valuations and going public transactions for Canadian and United States companies. In this capacity, Mr. Bensler gained strong knowledge of the capital markets, public company compliance requirements, and regularly interfaced with regulators, auditors, board and executive management. Mr. Bensler was also a director of publicly traded Health Logic Interactive Inc. (TSXv:CHIP) from 2020 to 2024. We believe that Mr. Bensler’s past experience as our Chief Financial Officer, his familiarity with both the banking and the financial consulting sectors and his having served as an account manager for similarly situated companies makes him a qualified director for our Company.
Mr. Bensler received his Bachelor of Management and Organizational Studies degree from the University of Western Ontario, with specialization in Finance, and is a CFA Charterholder.
Braeden Lichti, Chairman of the Board
Braeden Lichti is the founder and Chief Executive Officer of BWL Investments Ltd., a privately held holding corporation he established in 2016, and NorthStrive Companies, Inc., a U.S. based investment and advisory services company he founded in 2021. Mr. Lichti also serves as Chairman of Hydromer, Inc., a global leader in surface modification and coating solutions, focusing on hydrophilic, thromboresistant and antimicrobial coatings for medical devices and various industrial applications. Established in 1980 and headquartered in Concord, North Carolina, Hydromer offers a wide range of services, including polymer research and development, contract coating and specialized analytical testing. Mr. Lichti co-founded PMGC Holdings Inc. in 2020 and has served as its advisor and has been a principal stockholder since its formation. He has remained the largest stockholder through companies he controls and recently assumed the role of Chairman in 2024. We believe that Mr. Lichti’s past experience as our director and advisor, his extensive executive experience and his having served as Chairman for similarly situated companies makes him a qualified director for our Company.
Jeffrey Parry, Independent Director, Chair of the Nominating Committee and member of the of Audit Committee and Compensation Committee
Mr. Parry was appointed as an independent director in June 2023 and is a partner of Mystic Marine Advisors LLC, a Connecticut based advisory firm he founded in 1998 focused on emerging and turnaround situations for strategic and financial stakeholders. Jeffrey served as Executive Chairman of TBS Shipping Limited from 2012 to 2018 where he led a successful restructuring and co-founded Valhalla Shipping, Inc with an $167 million equity investment by institutional investors. From July 2008 to October 2009, Mr. Parry was the Chief Executive Officer of Nasdaq-listed Aries Maritime Transport Limited and led a successful turn-around and sale to strategic investors. Mr. Parry was a Managing Director of Poten & Partners, an international energy advisor, from 2001 to 2007 where in 2006 he co-founded Poten Capital Services LLC, a New York based broker-dealer. Earlier in his career, Mr. Parry founded Cool FM and 7X Television in Athens, Greece and served as President of One Fifth Avenue Apartment Corporation. Since 2010, Jeffrey has served as an independent director of Nasdaq listed Globus Maritime Ltd. where he sits on the audit committee. Mr. Parry holds a BA from Brown University and MBA from Columbia University. His educational and professional experience in business, his background and familiarity in investment banking, his having served as a director of a company listed on Nasdaq makes him a qualified director candidate for our Company.
George Kovalyov, Independent Director, Chair of the Compensation Committee and member of the of Audit Committee and Nominating Committee
Mr. Kovalyov has acted as Chief Financial Officer and Treasurer of Marizyme, Inc. since December 2021. Since November 2022, Mr. Kovalyov has also been a director of DGTL Holdings Inc. Previously he served as the chief operating officer and director of Health Logic Interactive Inc. (“HLII”) from September 2020 to November 2021, and as HLII’s chief financial officer from December 2021 to September 2022. In addition, Mr. Kovalyov served as a director and audit committee member of Margaret Lake Diamonds Inc. from January 2021 to August 2022. From September 2018 to September 2020, Mr. Kovalyov was VP of Finance and director of Phivida Holdings Inc., a brand of cannabidiol-infused foods, beverages and clinical products. From October 2016 to September 2020, Mr. Kovalyov was the principal owner of Schindler and Company, an accounting consulting firm. Mr. Kovalyov is a chartered accountant and is a member of Chartered Professional Accountants of Canada. Mr. Kovalyov is qualified to serve on the Board due to his extensive accounting and finance experience.
Juliana Daley, CPA Independent Director, Chair of the Audit Committee and member of the of Compensation Committee and Nominating Committee
Ms. Daley was appointed as an independent director in June 2023 and holds over eleven years of accounting, controller, and financial reporting experience in the public sector. Ms. Daley has worked a variety of industries in both the United States and Canada. Since July 2021, Ms. Daley has served as Manager of Accounting at Anavex Life Sciences Corp. (NASDAQ: AVXL), a clinical-stage biopharmaceutical company based in New York, NY that is focused on developing treatments for debilitating neurodegenerative and neurodevelopmental diseases. In addition, from August 2021 to July 2022, she served as an independent director and audit committee chair to Vegano Foods (CSE: VAGN) during Vegano Food’s initial public offering in February 2022. From October 2015 to July 2021, Ms. Daley was a Manager of Financial Reporting and Advisory Services to various public companies in the United States and Canada, through her position with the accounting firm, Treewalk (previously ACM Management, Inc.). At Treewalk Ms. Daley assisted clients in meeting their quarterly and annual reporting requirements including the preparation of complete financial reporting packages and managing assurance engagements from start to finish. At Treewalk, she also served as chief financial officer to Makena Resources Inc. (CSE: MKNA) (April 2018 - April 2019) and Naked Brand Group Inc. (NASDAQ: NAKD) (March 2018 - June 2018) until the completion of their prospective mergers in April 2019 and June 2018, respectively. From September 2011 to April 2015, Ms. Daley was employed with Naked Brand Group Inc., where she worked in the accounting department, serving as controller from August 2013 until her departure in April 2015, and where she was also responsible for assisting in various operational functions including EDI implementation, ERP implementation, inventory management, information technology and office administration. From July 2021 to present, Ms. Daley has acted as manager of accounting at Anavex Life Sciences where she assists to in the finalization of all internal reporting, budgeting, and operational matters such as annual SOX audits, quarterly reviews, IT audits, and annual audits. Ms. Daley’s expertise in financial accounting for public companies and her having served as a chief financial officer and controller on companies listed on United States public exchanges makes her a qualified director candidate for our company.
Term of Office
Our directors are appointed for a one-year term to hold office until the next annual general meeting of our shareholders or until removed from office in accordance with our bylaws. Our officers are appointed by our board of directors and hold office until removed by the board.
Board Leadership Structure and Risk Oversight
Our Board has responsibility for the oversight of our risk management processes and, either as a whole or through its committees, regularly discusses with management our major risk exposures, their potential impact on our business and the steps we take to manage them. The risk oversight process includes receiving regular reports from Board committees and members of senior management to enable our Board to understand our risk identification, risk management and risk mitigation strategies with respect to areas of potential material risk, including operations, finance, legal, regulatory, cybersecurity, strategic and reputational risk.
Director Independence
Our Board is composed of a majority of “independent directors” as defined under the rules of Nasdaq. We use the definition of “independence” applied by Nasdaq to make this determination. Nasdaq Listing Rule 5605(a)(2) provides that an “independent director” is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion of the Company’s Board, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. The Nasdaq listing rules provide that a director cannot be considered independent if:
● the director is, or at any time during the past three (3) years was, an employee of the company;
● the director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of twelve (12) consecutive months within the three (3) years preceding the independence determination (subject to certain exemptions, including, among other things, compensation for board or board committee service);
● the director or a family member of the director is a partner in, controlling shareholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exemptions);
● the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three (3) years, any of the executive officers of the company served on the compensation committee of such other entity; or
● the director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three (3) years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.
Under such definitions, our Board has undertaken a review of the independence of each director. Based on information provided by each director concerning his background, employment and affiliations, our Board has determined that Jeffrey Parry, George Kovalyov and Juliana Daley are independent directors of the Company.
Board Committees
We have established three committees under the board of directors: an audit committee, a compensation committee and a nominating committee. We have adopted a charter for each of the three committees. Copies of our committee charters are posted on our corporate investor relations website.
Each committee’s members and functions are described below.
Audit Committee. Our Audit Committee consists of Jeffrey Parry, George Kovalyov and Juliana Daley. Ms. Daley is the chairman of our audit committee. We have determined that these directors satisfy the “independence” requirements of Nasdaq Rule 5605 and Rule 10A-3 under the Securities Exchange Act of 1934. Our board of directors has determined that Ms. Daley qualifies as an audit committee financial expert and has the accounting or financial management expertise as required under Item 407(d)(5)(ii) and (iii) of Regulation S-K. The audit committee will oversee our accounting and financial reporting processes and the audits of the financial statements of our company. The audit committee is responsible for, among other things:
● appointing the independent auditors and pre-approving all auditing and non-auditing services permitted to be performed by the independent auditors;
● reviewing with the independent auditors any audit problems or difficulties and management’s response;
● discussing the annual audited financial statements with management and the independent auditors;
● reviewing the adequacy and effectiveness of our accounting and internal control policies and procedures and any steps taken to monitor and control major financial risk exposures;
● reviewing and approving all proposed related party transactions;
● monitoring management’s communication and implementation of the Company’s anti-fraud policy;
● reviewing the Company’s cybersecurity mitigation measures and practices periodically;
● meeting separately and periodically with management and the independent auditors; and
● monitoring compliance with our code of business conduct and ethics, including reviewing the adequacy and effectiveness of our procedures to ensure proper compliance.
Compensation Committee. Our Compensation Committee consists of Jeffrey Parry, George Kovalyov and Juliana Daley. Mr. Kovalyov is the chairman of our compensation committee. The compensation committee assists the board in reviewing and approving the compensation structure, including all forms of compensation, relating to our directors and executive officers. Our chief executive officer may not be present at any committee meeting during which his compensation is deliberated. The compensation committee is responsible for, among other things:
● reviewing and approving, or recommending to the board for its approval, the compensation for our chief executive officer and other executive officers;
● reviewing and recommending to the shareholders for determination with respect to the compensation of our directors;
● reviewing periodically and approving any incentive compensation or equity plans, programs or similar arrangements; and
● selecting compensation consultant, legal counsel or other adviser only after taking into consideration all factors relevant to that person’s independence from management.
Nomination Committee. Our Nomination Committee consists of Jeffrey Parry, George Kovalyov and Juliana Daley. Mr. Parry is the chairman of our nomination committee. The nomination committee assists the board of directors in selecting individuals qualified to become our directors and in determining the composition of the board and its committees. The nomination committee is responsible for, among other things:
● selecting and recommending to the board nominees for election by the shareholders or appointment by the board;
● reviewing annually with the board the current composition of the board with regards to characteristics such as independence, knowledge, skills, experience and diversity;
● making recommendations on the frequency and structure of board meetings and monitoring the functioning of the committees of the board; and
● advising the board periodically with regards to significant developments in the law and practice of corporate governance as well as our compliance with applicable laws and regulations, and making recommendations to the board on all matters of corporate governance and on any remedial action to be taken.
Family Relationships
There are no family relationships between any of our directors or executive officers.
Certain Legal Proceedings
To our knowledge, no director, independent director, or executive officer of the Company has been a party in any legal proceeding material to an evaluation of his ability or integrity during the past ten years.
Code of Ethics
The Company adopted a Code of Ethics applicable to its directors, officers, and employees. This includes our principal executive officer, principal financial officer, and principal accounting officer or controller, or persons performing similar functions. The full text of our Code of Ethics is posted on our website.
Insider Trading Policy
The Company has adopted an insider trading policy that governs the purchase, sale, and/or other transactions of our securities by our directors, officers and employees. A copy of our insider trading policy is filed as Exhibit 19.1 to this Annual Report for the fiscal year ended December 31, 2024. In addition, with regard to the Company’s trading in its own securities, it is the Company’s policy to comply with the federal securities laws and the applicable exchange listing requirements.
Compensation Recovery Policy
Under the Sarbanes-Oxley Act, in the event of misconduct that results in a financial restatement that would have reduced a previously paid incentive amount, we can recoup those improper payments from our executive officers. The SEC also recently adopted rules which direct national stock exchanges to require listed companies to implement policies intended to recoup bonuses paid to executives if the company is found to have misstated its financial results.
In 2023, we adopted an executive compensation recovery policy or “Clawback Policy” in compliance with Nasdaq rules. Under our Clawback Policy, if we are required to prepare an accounting restatement due to material noncompliance with the financial reporting requirements under any United States securities laws, we will be entitled to recover (and will seek to recover), from our executive officers, any excess incentive-based compensation received by our executive officers during the three-year period prior to the date on which we are required to prepare the restatement. This policy applies to both equity-based and cash compensation awards. The “excess compensation” is the difference between the actual amount that was paid and the amount that would have been paid if the financial statements were prepared properly in the first instance.
Involvement in Certain Legal Proceedings
To our knowledge, none of our current directors or executive officers has, during the past 10 years:
● been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);
● had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two (2) years prior to that time;
● been subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending or otherwise limiting, his or her involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;
● been found by a court of competent jurisdiction in a civil action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
● been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or
● been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity or organization that has disciplinary authority over its members or persons associated with a member.

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ITEM 11. EXECUTIVE COMPENSATION
Item 11. Executive Compensation.
Introduction
We are an emerging growth company, as defined in the JOBS Act. As an emerging growth company, we will be exempt from certain requirements related to executive compensation, including, but not limited to, the requirements to hold a nonbinding advisory vote on executive compensation and to provide information relating to the ratio of total compensation of our Chief Executive Officer to the median of the annual total compensation of all of our employees, each as required by the Investor Protection and Securities Reform Act of 2010, which is part of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
This section provides an overview of our executive compensation programs, including a narrative description of the material factors necessary to understand the information disclosed in the summary compensation table below.
Our named executive officers (“Named Executive Officers” or “NEOs”) are or were, as applicable:
● Graydon Bensler, Chief Executive Officer and Chief Financial Officer;
● Jordan R. Plews, former Chief Executive Officer and President;
● Brenda Buechler, former Chief Marketing Officer; and
● Christoph Kraneiss, former Chief Commercial Officer.
The objective of our compensation program is to provide a total compensation package to each NEO that will enable us to attract, motivate and retain outstanding individuals, align the interests of our executive team with those of our equity holders, encourage individual and collective contributions to the successful execution of our short- and long-term business strategies and reward NEOs for performance.
Compensation of Directors and Named Executive Officers
The following table presents information regarding the total compensation (excluding equity-based compensation reported) awarded to, earned by, and paid to our NEOs for services rendered to us in all capacities for the years indicated.
Name and Principal Position Year Salary ($) Bonus ($) Option
Awards ($) Total ($)
Graydon Bensler $ 196,333 $ 195,000 - $ 391,333
Chief Executive Officer, Chief Financial Officer and Director $ 85,000 $ 25,000 $ - $ 110,000
Jordan R. Plews (1) $
$
Director and Former CEO and President $ 200,000 - - $ 200,000
Brenda Buechler(2) $ - - - $ -
Former Chief Marketing Officer $ 190,000 - - $ 190,000
Christoph Kraneiss(3) $ - - - $ -
Former Commercial Officer $ 180,000 - - $ 180,000
(1) On December 23, 2024, Jordan Plews resigned as Director of the Company.
(2) On June 20, 2024, we notified Brenda Buechler that she was involuntarily terminated without “cause” or laid off from employment as part of a wider job elimination/restructuring or reduction in force of the Company in order to streamline the Company’s operations and organizational structure.
(3) On June 20, 2024, we notified Christoph Kraneiss that he was involuntarily terminated without “cause” or laid off from employment as part of a wider job elimination/restructuring or reduction in force of the Company in order to streamline the Company’s operations and organizational structure.
Employment Arrangements with Named Executive Officers
Graydon Bensler
Mr. Bensler serves as Chief Executive Officer and Chief Financial Officer of the Company, which positions he accepted the Board’s appointment for as of the close of business on June 21, 2024. On October 25, 2024, the Company entered into the Second Amended and Restated Consulting Agreement for Non-Employee Chief Executive Officer (the Second Amended Bensler Consulting Agreement”) with GB Capital Ltd, a British Colombia, Canada corporation (“GB Capital”), an entity controlled by Mr. Bensler. The Second Amended Bensler Consulting Agreement amended and restated the terms of that certain Amended and Restated Consulting Agreement between the Company and GB Capital for Non-Employee Chief Executive Officer dated June 1, 2020 (the “Original Bensler Consulting Agreement”). The Original Bensler Consulting Agreement was amended and restated again on June 21, 2024 pursuant to that certain Amended and Restated Consulting Agreement for Non-Employee Chief Executive Officer between the Company and GB Capital. Under the Second Amended Bensler Consulting Agreement, GB Capital agreed to designate Mr. Graydon Bensler, Director of GB Capital, to perform the Services (as defined in the Second Amended Bensler Consulting Agreement).
Pursuant to the terms of the Second Amended Bensler Consulting Agreement, as consideration for Mr. Bensler’s services as non-employee Chief Executive Officer of the Company, the Company would pay GB Capital a consultant fee of $250,000 per annum and certain bonuses. Upon execution of the Second Amended Bensler Consulting Agreement, the Company would make the following payments to GB Capital (such payments, the Bensler Sign-on Bonuses”): (a) a one-time bonus of $175,000, with (1) $100,000 of such bonus to be paid to GB Capital in cash and (2) $75,000 of such bonus to be remitted to GB Capital in Series B Preferred Stock, with the cash equivalent of such shares of Series B Preferred Stock to be determined by mutual agreement of the Company and GB Capital, and provided such issuance of Series B Preferred Stock was approved by the Company’s shareholders. In the Board’s sole discretion, it may also award GB Capital a bonus at the end of the applicable fiscal year in the amounts it determines in its sole discretion (each of such bonuses, the “Bensler Annual Bonus”), provided that GB Capital meets the Board’s performance objectives for GB Capital and GB Capital is engaged by the Company for such fiscal year in full. The target of the Annual Bonus is 125% or greater of the Bensler Annual Consultant Fee. For the avoidance of doubt, the first fiscal year for which the Company will consider whether GB Capital qualifies for the Bensler Annual Bonus is the fiscal year in which the Effective Date falls. Pursuant to the Second Amended Bensler Consulting Agreement, the Company shall also pay GB Capital in the first fiscal quarter of 2026 a bonus in the amount of $60,000 if the Company has a positive adjusted Earnings Before Interest, Taxes, Depreciation, and Amortization (“EBITDA”) in 2025. Subject to the terms of the Second Amended Bensler Consulting Agreement, GB Capital is also entitled to each of the following bonus payments (collectively, the “Bensler Milestone Bonuses”). Such Bensler Milestone Bonuses are payable upon the occurrence of the following events, at which time the Company shall remit the applicable Milestone Bonuses to GB Capital as follows:
(A) The Company shall pay GB Capital $50,000 for each Company acquisition consummated, provided the target company of such acquisition has $2,000,000 in annual revenue or more upon consummation of such acquisition.
(B) The Company shall pay GB Capital $50,000 upon any closing of an equity or equity-linked financing of the Company which results in net proceeds being raised in such financing of $3,000,000 in a fiscal quarter (the closing which qualifies GB Capital for such payment, the “GB Triggering Equity Financing,” and such payment, the “GB Equity Financing Bonus”). For the avoidance of doubt, GB Capital is entitled only to a one-time payment of the GB Equity Financing Bonus $50,000 per fiscal quarter and the Company will not make further payments as an Equity Financing Bonus in spite of the occurrence of any of the following events: (A) the closing of any equity or equity-linked financings subsequent to the GB Triggering Equity Financing in such fiscal quarter which result in proceeds of $3,000,000 to the Company; (B) any closings for the same equity financing round subsequent to the GB Triggering Equity Financing in such fiscal quarter which result in additional proceeds of $3,000,000 or more to the Company.
(C) If and when the Company achieves each of the targeted EBITDA amounts in one fiscal quarter, as set forth in this Section 1(e)(iii) (each of such amounts, “EBITDA Milestone”), the Company shall pay GB Capital a fee equal to 25% of the applicable EBITDA Milestone (such fee, the “EBITDA Milestone Bonus”: (A) $50,000; (B) $150,000; (C) $250,000; (D) $350,000. For the avoidance of doubt, GB Capital may only receive a one-time payment of the EBITDA Milestone Bonus in each fiscal quarter, upon the Company’s achievement of the applicable EBITDA Milestone, and the Company will not make further payments to GB Capital as the EBITDA Milestone Bonus even upon achievement of an EBITDA Milestone in the same fiscal quarter which value exceeds the value of the first EBITDA Milestone GB Capital has achieved in such fiscal quarter.
(D) The Company shall pay GB Capital $300,000 each time the Company achieves a Market Valuation (as defined in the Second Amended Bensler Consulting Agreement) of $50,000,000 and $100,000,000, provided that each of such Market Valuations continues for each at least 5 consecutive Trading Days (as defined in the Second Amended Bensler Consulting Agreement).
Additionally, GB Capital may elect to accrue the Bensler Milestone Bonuses and convert the cash amount of the Bensler Milestone Bonus into shares of the Company’s Common Stock or preferred stock. In such event, the conversion ratio of the Bensler Milestone Bonus shall be determined by mutual agreement between the Company and GB Capital. The Second Amended Bensler Consulting Agreement is filed herein as Exhibit 10.19.
On October 25, 2024, the Company entered into the Amendment to the Second Amended Bensler Consulting Agreement which stipulated that the Company’s issuances of Series B Preferred Stock to GB Capital as the Bensler Sign-on Bonuses, were subject to shareholder approval. The Amendment to the Second Amended Bensler Consulting Agreement is filed herein as Exhibit 10.21.
Jordan R. Plews
In September 2021, we entered into an employment contract with Dr. Jordan R. Plews pursuant to which he served as the Company’s Chief Executive Officer, effective as of October 1, 2021 until his resignation on June 21, 2024.
The agreement is at will and subject to termination prior to completion of the services at any time by us, or with 14 days’ prior written notice by Dr. Plews and for any reason not prohibited by law.
Pursuant to the terms and provisions of the agreement: (a) Dr. Plews was appointed as our Chief Executive Officer and undertook and performed the duties and responsibilities normally and reasonably associated with such office; and (b) we agreed to pay Dr. Plews an annual salary of $200,000 in addition to equity compensation in the form of stock options in accordance with our 2020 Equity Incentive Plan, as amended.
Brenda Buechler
In June 2022, we entered into an employment contract with Brenda Buechler as the Company’s Chief Marketing Officer, effective as of August 1, 2022. On June 20, 2024, we terminated this employment agreement.
Pursuant to the terms and provisions of the agreement: (a) Ms. Buechler was appointed as our Chief Marketing Officer and undertook and performed the duties and responsibilities normally and reasonably associated with such office; and (b) we agreed to pay Ms. Buechler an annual salary of $190,000 in addition to equity compensation in the form of stock options in accordance with our 2020 Equity Incentive Plan, as amended. except that 25% of those stock-options shall not vest and become exercisable until the first anniversary of the grant date and, thereafter, the options shall vest at a rate of 25% per annum and become exercisable with respect to 100% of the shares subject to the option on the fourth anniversary of the grant date.
Christoph Kraneiss
In August 2022, we entered into an employment contract with Christoph Kraneiss as the Company’s Chief Commercial Officer, effective as of August 8, 2022. Pursuant to the terms and provisions of the agreement: (a) Mr. Kraneiss was appointed as our Chief Commercial Officer and undertook and performed the duties and responsibilities normally and reasonably associated with such office; and (b) we agreed to pay Mr. Kraneiss an annual salary of $180,000 in addition to equity compensation in the form of stock options in accordance with our 2020 Equity Incentive Plan, as amended. except that 25% of those stock-options shall not vest and become exercisable until the first anniversary of the grant date and, thereafter, the options shall vest at a rate of 25% per annum and become exercisable with respect to 100% of the shares subject to the option on the fourth anniversary of the grant date.
On June 20, 2024, we terminated this employment agreement.
Director Compensation
We intend to and have agreed to compensate our independent directors for their service as directors through a mix of cash and stock options. In addition to in-person attendance bonuses, we intend to reimburse our non-employee directors for reasonable travel and out-of-pocket expenses incurred in connection with attending board of director and committee meetings.
On June 1, 2023, we rescinded previously granted but unissued nonstatutory stock options to each of our independent director nominees and instead granted nonstatutory stock options to purchase 240,000 shares of the Company’s Common Stock to our then independent director nominees and related parties Jeffery Parry, Crystal Muilenburg and Julianna Daley under our 2021 Equity Incentive Plan. The equity compensation grants were directly in relation to the appointment of Mr. Parry, Ms. Daley and Ms. Muilenburg as our independent directors. The options maintain a contractual life of 10 years and an exercise price of $5.00 per share of Common Stock. All options vest at a rate of 25% on the first anniversary of the date of grant and the remaining 75% vest evenly over 36 months thereafter.
Equity Incentive Awards
The Company has historically granted stock options to its employees, including its executive officers, under the 2020 Equity Incentive Plan where our Board or any of its committees can grant issuances of incentives stock options, nonstatutory stock options, and restricted stock to our employees, advisors and directors. The exercise price of incentive stock options and nonqualified stock options will be no less than 100% of the fair value per share of the Company’s Common Stock on the date of grant. If an individual owns Common Stock representing more than 10% of the voting shares and the grant is an incentive stock option, the price of each share will be at least 110% of the fair value on the date of grant.
The aggregate number of shares of Common Stock allocated and made available for issuance pursuant to stock options granted under the Plan may not exceed 8,671 shares of Common Stock. As of the date of this Annual Report, options to purchase 4,925 shares of Common Stock under the Plan were outstanding, and 3,225 shares were available for future grant. Each option granted under the Plan will carry a term of no more than 10 years from the date of grant and the Plan will remain in effect until it is terminated by the Board. The term and vesting periods for options granted under the Plan are determined by the Board. The summary does not contain a complete description of all provisions of the 2020 Plan and is qualified in its entirety by reference to the 2020 Plan, a copy of which is filed as Exhibit 10.2 to our offering statement of which this Annual Report forms a part.
Policies and Practices for Granting Certain Equity Awards
Our policies and practices regarding the granting of equity awards are carefully designed to ensure compliance with applicable securities laws and to maintain the integrity of our executive compensation program. The Compensation Committee is responsible for the timing and terms of equity awards to executives and other eligible employees.
The timing of equity award grants is determined with consideration to a variety of factors, including but not limited to, the achievement of pre-established performance targets, market conditions and internal milestones. The Company does not follow a predetermined schedule for the granting of equity awards; instead, each grant is considered on a case-by-case basis to align with the Company’s strategic objectives and to ensure the competitiveness of our compensation packages.
In determining the timing and terms of an equity award, the Board or the Compensation Committee may consider material nonpublic information to ensure that such grants are made in compliance with applicable laws and regulations. The Board’s or the Compensation Committee’s procedures to prevent the improper use of material nonpublic information in connection with the granting of equity awards include oversight by legal counsel and, where appropriate, delaying the grant of equity awards until the public disclosure of such material nonpublic information.
The Company is committed to maintaining transparency in its executive compensation practices and to making equity awards in a manner that is not influenced by the timing of the disclosure of material nonpublic information for the purpose of affecting the value of executive compensation. The Company regularly reviews its policies and practices related to equity awards to ensure they meet the evolving standards of corporate governance and continue to serve the best interests of the Company and its shareholders.
Equity Compensation Plan Information
The table below sets forth information concerning securities granted under equity compensation plans approved and not approved by security holders of the Company and the weighted average exercise price for such securities as of December 31, 2024.
Plan Category Number of
securities
to be
issued upon
exercise of
outstanding
options,
warrants
and rights Weighted-
average
exercise
price of
outstanding
options,
warrants
and rights Number of
securities
remaining
available for
future issuance
under equity
compensation
plans
(excluding
securities
reflected in
column (a))
(a) (b) (c)
Equity compensation plans approved by security holders $ 5,228 $ 335.32 $ 2,922 (1)
Equity compensation plans not approved by security holders - $ - -
Total $ 5,228 $ 335.32 2,922
(1) 2,922 securities remaining available for future issuance under the Company’s 2020 Equity Incentive Plan (the “Plan”). The aggregate number of shares allocated and made available for issuance pursuant to stock options granted under the Plan shall not exceed 8,671 shares.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The following table provides information with respect to the beneficial ownership of our Common Stock as of March 26, 2025 by:
● each of our executive officers and directors;
● all of our current directors and executive officers as a group; and
● each person or entity, or group of persons or entities, known by us to own beneficially more than 5% of our Common Stock.
We have determined beneficial ownership in accordance with the rules and regulations of the SEC, and the information is not necessarily indicative of beneficial ownership for any other purpose. In general, under these rules a beneficial owner of a security includes any person who, directly or indirectly, through any contract, arrangement, understanding, relationship or otherwise has or shares voting power or investment power with respect to such security. A person is also deemed to be a beneficial owner of a security if that person has the right to acquire beneficial ownership of such security within 60 days of March 26, 2025. Except as indicated by the footnotes below, we believe, based on information furnished to us, that the persons and entities named in the table below have sole voting and sole investment power with respect to all shares that they beneficially own, subject to applicable community property laws.
Percentage ownership is based on 577,961 shares of Common Stock outstanding as of March 26, 2025.
Name and Address of Beneficial Owner(1)
Amount and
Nature of
Beneficial
Ownership
Percentage of
Beneficial
5% or Greater Shareholders:
Directors, Named Executive Officers and Other Executive Officers:
Graydon Bensler, Chief Executive Officer, Chief Financial Officer and Director
(2)
* %
Braeden Lichti, Chairman of the Board
2,732 (3)
* %
Jeffrey Parry, Director
(4)
* %
George Kovalyov, Director
-
- %
Juliana Daley, Director
(5)
* %
All executive officers and directors as a group (5 persons)
4,489 (6)
* %
* Denotes less than one (1%) percent.
(1) Unless otherwise indicated, the business address of each of the individuals is our address of c/o PMGC Inc., 120 Newport Center Drive, Ste. 250, Newport Beach, CA 92660.
(2) Consists of (i) 601 shares of Common Stock held by GB Capital Ltd., of which Mr. Bensler has sole voting and dipositive power over the shares and (ii) 143 shares of Common Stock that Mr. Bensler has the right to acquire from us within 60 days of March 26, 2025 pursuant to the exercise of stock options granted under the 2020 Equity Incentive Plan.
(3) Consists of (i) 143shares of Common Stock that Mr. Lichti has the right to acquire from us within 60 days of March 26, 2025 pursuant to the exercise of stock options granted under the 2020 Equity Incentive Plan, (ii) 1362 shares of Common Stock held by BWL Investments Ltd. of which Mr. Lichti has sole voting and dipositive power over the shares, (iii) 591 shares of Common Stock held by BWL Holdings Ltd. of which Mr. Lichti has sole voting and dipositive power over the shares, (iv) 591 shares of Common Stock held by Northstrive Fund II LP of which Mr. Lichti has sole voting and dipositive power over the shares and (v) 44 shares of Common Stock underlying warrants held by BWL Investments Ltd.
(4) Consists of (i) 30 shares of Common Stock and (ii) 29 shares of Common Stock that Mr. Parry has the right to acquire from us within 60 days of March 26, 2025, pursuant to the exercise of stock options granted under the 2020 Equity Incentive Plan.
(5) Consists of (i) one share of Common Stock and (ii) 24 shares of Common Stock that Ms. Daley has the right to acquire from us within 60 days of March 26, 2025, pursuant to the exercise of stock options granted under the 2020 Equity Incentive Plan.
(6) Consists of (i) 4,489 shares of Common Stock beneficially owned by our directors and executive officers and (ii) 338 shares of Common Stock underlying outstanding options, exercisable within 60 days of March 26, 2025 and (iii) 44 shares of Common Stock underlying warrants.

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 13. Certain Relationships and Related Transactions, and Director Independence.
Our audit committee, pursuant to its written charter, is responsible for reviewing and approving related party transactions to the extent we enter into such transactions. The audit committee will consider all relevant factors when determining whether to approve a related party transaction, including whether the related party transaction is on terms no less favorable than terms generally available to an unaffiliated third-party under the same or similar circumstances and the extent of the related party’s interest in the transaction. These procedures are intended to determine whether any such related party transaction impairs the independence of a director or presents a conflict of interest on the part of a director, employee or officer.
The following is a summary of transactions entered since January 1, 2022 to which we have been a party in which the amount involved exceeded or will exceed $70,915, which represents 1% of the average of our total assets amounts as of December 31, 2024 and 2023), and in which any of our directors, executive officers or, to our knowledge, beneficial owners of more than 5% of our capital stock or any member of the immediate family of any of the foregoing persons had or will have a direct or indirect material interest, other than equity and other compensation, termination, change in control and other arrangements, which are described under “Executive and Director Compensation.” We also describe below certain other transactions with our directors, executive officers and stockholders.
The Company paid consulting fees of $391,333, $110,000, and $95,078 to GB Capital Ltd., a company controlled by Graydon Bensler, Chief Financial Officer and Director in 2024, 2023, and 2022, respectively.
BWL Investments Ltd., a British Columbia Canadian Corporation (“BWL”) owned and managed by Braeden Lichti and Hatem Abou-Sayed “Tim” Sayed, our former Chief Medical Officer, subscribed to $48,980 and $10,000 in promissory notes, respectively. On July 15, 2022, these promissory notes and accrued interest were converted into Series A preferred shares and warrants as follows:
Series A
preferred
shares Warrants Promissory
notes and
accrued
interest
BWL Investments Ltd. 61,551 61,551 $ 49,538
Tim Sayed, former director and Chief Medical Officer 12,563 12,563 10,112
74,114 74,114 $ 59,650
Pursuant to an advisory board agreement between us and Jeffery Parry, (an independent director to the Company as of June 1, 2023) dated August 12, 2021, on August 16, 2021, the Company granted Mr. Parry equity compensation in the form of non-statutory stock options to purchase 208 shares of the Company’s Common Stock (41,667 pre 200:1 share consolidation). Under an amended advisory board agreement between us and Jeffery Parry dated September 30, 2022 additional nonstatutory stock options to purchase 80 shares of the Company’s Common Stock (16,000 pre 200:1 share consolidation) were granted to Mr. Parry. The stock options held a contractual life of ten years and exercise price of $120 ($0.60 pre 200:1 share consolidation) per Common Stock. These stock options were valued at $10,630 using the Black-Scholes Option Pricing Model. The options vest 25% on the first anniversary of the grant date and the remaining 75% vest evenly over 36 months thereafter. Through unanimous written consent, the Board of the Company amended the vesting schedule for those stock options to accelerate the vesting of such stock options so that those stock options fully vested as of December 3, 2022. On December 16, 2022, Mr. Parry exercised all 41,667 (pre 200:1 stock consolidation) stock options for a total exercise price of $25,000.20. On June 1, 2023, we terminated the advisory board agreement between us and Jeffery Parry.
As amended and agreed to on May 1, 2023, and as effective on January 4, 2022, we entered into a consulting agreement (the “Lichti Consulting Agreement”) with NorthStrive Companies Inc., a California Corporation (“NorthStrive”) owned and managed by Braeden Lichti. Pursuant to the Lichti Consulting Agreement, NorthStrive is to assist us in a variety of business matters, including assistance in our overall investor outreach and communications strategy, and advising us on becoming a “public” company. As of May 31, 2023, the Company had $192,705 (2022 - $120,000, 2021 - $23,520) due to NorthStrive, of which $22,705 (2021 - $23,520) is unsecured, non-interest bearing and are due on demand. $120,000 was due as of December 31, 2022, and the remaining $50,000 was due as of May 31, 2022. The aforementioned fees are due in contemplation for NorthStrive’s advisement under the CA, whereby starting on January 4, 2022, we agreed to compensate NorthStrive $10,000 per month (the “Compensation”). We retained the option, but not the obligation to issue the amount of Compensation due NorthStrive in shares of our Common Stock equal to our series A preferred stock price at $1.34138 per share (pre 200:1 stock consolidation) equal to the value of the Compensation due to NorthStrive for services provided through and up to March 31, 2023 and $3.00 per share (pre 200:1 stock consolidation) equal to the value of the Compensation due to NorthStrive for services provided after March 31, 2023 or via cash payment equal to the amount of Compensation outstanding however, that Compensation due NorthStrive shall accrue interest-free and payment of that Compensation has been deferred until the earlier of either (a) our raising an aggregate of at least US$2,000,000 of equity and/or debt investment from and after October 1, 2022, (b) our becoming listed on any established stock exchange or a national market system, or (c) a determination by our Board that Company has sufficient cash flows to support payment of the Compensation due to NorthStrive at the time of that determination. For the fiscal year ended December 31, 2022, we did not make payments to Northstrive under the Lichti Consulting Agreement. For the fiscal year ended December 31, 2023, we paid Northstrive $230,000 under the Lichti Consulting Agreement. On June 21, 2024, we entered into the Amended and Restated Consulting Agreement with Northstrive (the “First Amended Lichti Consulting Agreement”), pursuant to which Mr. Lichti would serve as non-executive Chairman of the Company. As consideration for his services as non-executive Chairman, the Company agreed to pay Northstrive $16,000 per month. The First Amended Lichti Consulting Agreement is filed herein as Exhibit 10.13.
On October 25, 2024, the Company entered into the Second Amended and Restated Consulting Agreement for Non-Executive Chairman (the “Second Amended Lichti Consulting Agreement”) with Northstrive. The Second Amended Lichti Consulting Agreement provided that, as consideration for Mr. Lichti’s provision of his services as non-executive Chairman, as set forth more fully in such agreement, the Company would compensate Northstrive as such: (i) an annual consultant fee of $300,000 per annum (the “Lichti Annual Consultant Fee”), 1/12 of which Lichti Annual Consultant Fee will be paid to Northstrive once per calendar month (“Northstrive Payment Cycle”), provided that Northstrive performs the Services required to be performed in each Northstrive Payment Cycle. The Company agreed that upon execution of the Second Amended Lichti Consulting Agreement, the Company would make the following payments to Northstrive (such payments, the “Northstrive Sign-on Bonuses”): (a) a one-time bonus of $175,000, with (1) $100,000 of such bonus to be paid to Northstrive in cash and (2) $75,000 of such bonus to be remitted to Northstrive in Series B Preferred Stock, with the cash equivalent of such shares of Series B Preferred Stock to be determined by mutual agreement of the Company and Northstrive; and (b) 300,000 shares of Series B Preferred Stock. In the Board’s sole discretion, it may also award Northstrive a bonus at the end of the applicable fiscal year in the amounts it determines in its sole discretion (each of such bonuses, the “Lichti Annual Bonus”), provided that Northstrive meets the Board’s performance objectives for Northstrive and Northstrive is engaged by the Company for such fiscal year in full. The target of the Lichti Annual Bonus is 125% or greater of the Lichti Annual Consultant Fee.
Subject to the terms of the Second Amended Lichti Consulting Agreement, Northstrive is also entitled to each of the following bonus payments (collectively, the “Northstrive Milestone Bonuses”). Such Northstrive Milestone Bonuses are payable upon the occurrence of the following events, at which time the Company shall remit the applicable Northstrive Milestone Bonuses to Northstrive as follows:
(A) The Company shall pay Northstrive $150,000 for each Company acquisition consummated, provided that the target company of such acquisition has $2,000,000 in annual revenue or more upon consummation of the acquisition.
(B) The Company shall pay Northstrive $50,000 upon any closing of an equity or equity- linked financing of the Company which results in net proceeds being raised in such financing of $3,000,000 in a fiscal quarter (the closing which qualifies Northstrive for such payment, the “Northstrive Triggering Equity Financing,” and such payment, the “Northstrive Equity Financing Bonus”). For the avoidance of doubt, Northstrive is entitled only to a one-time payment of the Northstrive Equity Financing Bonus $50,000 per fiscal quarter and the Company will not make further payments as a Northstrive Equity Financing Bonus in spite of the occurrence of any of the following events: (A) the closing of any equity or equity-linked financings subsequent to the Northstrive Triggering Equity Financing in such fiscal quarter which result in proceeds of $3,000,000 to the Company; (B) any closings for the same equity financing round subsequent to the Northstrive Triggering Equity Financing in such fiscal quarter which result in additional proceeds of $3,000,000 or more to the Company.
(C) The Company shall pay Northstrive $75,000 each time the Company achieves a Market Valuation (as defined in the Second Amended Lichti Consulting Agreement) of $10,000,000, $20,000,000, $30,000,000, and $40,000,000 (each of such payments, “Northstrive Valuation Payment”), provided that each of such market valuations continue for each at least five (5) consecutive Trading Days, and provided further that the Company may only recover any erroneously awarded amounts in Northstrive Valuation Payments for one (1) year following the date of such erroneous award.
(D) The Company shall pay Northstrive $300,000 each time the Company achieves a Market Valuation of $50,000,000 and $100,000,000, provided that each of such Market Valuations continues for each at least two (2) consecutive Trading Days.
Notwithstanding anything to the contrary stated in the Second Amended Lichti Consulting Agreement, Northstrive may elect to accrue the Northstrive Milestone Bonuses and convert the cash amount of the Northstrive Milestone Bonus into shares of the Company’s common stock or preferred stock. In such event, the conversion ratio of the Northstrive Milestone Bonus shall be determined by mutual agreement between the Company and Northstrive. The Second Amended Lichti Consulting Agreement is filed herein as Exhibit 10.20.
On October 25, 2024, the Company entered into the Amendment to the Second Amended Lichti Consulting Agreement, which stipulated that the Company’s issuances of Series B Preferred Stock to Northstrive as the Northstrive Sign-on Bonuses, were subject to shareholder approval. The Amendment to the Second Amended Lichti Consulting Agreement is filed herein as Exhibit 10.22. For the fiscal year ended December 31, 2024, we paid Northstrive $188,500 under the Second Amended Lichti Consulting Agreement.
On May 1, 2023, as effective on February 1, 2023, we entered into an advisory agreement (the “Advisory Agreement”) with Braeden Litchi which terminates after twenty-two months to strategically assist us in our maintenance of board governance, director recruitment, and direction for our board of directors strategy sessions. The Advisory Agreement was entered into under contemplation of Mr. Litchi’s resignation from our Board effective February 1, 2023, and our desire to maintain Mr. Litchi’s compensation as a valuable advisor to us. Pursuant to the Advisory Agreement, we agreed with Mr. Litchi that in exchange for services under the Advisory Agreement, his options granted on February 9, 2021 to purchase 1,000 shares of our Common Stock (200,000 pre 200:1 share consolidation) under our 2020 Equity Incentive Plan shall continue to vest pursuant to the aforementioned terms of the Advisory Agreement. On June 21, 2024, we terminated the Advisory Agreement, which was a condition to Mr. Lichti’s appointment to the Board and as non-executive Chairman of the Board on the same date.
Prior to our reorganization, BWL Investments Ltd., a British Columbia Canadian Corporation (“BWL”) also owned and managed by Braeden Lichti, owned approximately 29.4% of our issued and outstanding shares of Common Stock and 100% of the equity interests in Reactive Labs. On June 4, 2021, we issued 100 shares of Common Stock (pre 200:1 stock consolidation) to BWL in in exchange for substantially all of the assets and liabilities of Reactive Labs.
Braeden Lichti is one of our co-founders and our current Chairman and director. He is the current chief executive officer of NorthStrive and BWL, as described herein and may be deemed a “promoter” as defined by Rule 405 of the Securities Act though we elect to refer to him as a “founder” or “organizer” as permitted under Rule 405. There are no other promoters of the Company.
In May, and December of 2022, we granted nonstatutory stock options to purchase1,250 ( 250,000 pre 200:1 share consolidation) shares of the Company’s Common Stock to Brenda Buechler, our former Chief Marketing Officer, and Christoph Kraneiss, our former Chief Commercial Officer. The options maintain a contractual life of ten years and weighted average exercise price of $244 ($1.22 pre 200:1 share consolidation) per share of Common Stock. These stock options were valued at $264,906 using the Black-Scholes Option Pricing Model. The options vest 25% on the first anniversary of the grant date and the remaining 75% vest evenly over 36 months thereafter. Details of the fair value granted to each individual and the related expense recorded for the year ended December 31, 2022, are as follows:
December 31,
Fair value
of stock
options
granted
Brenda Buechler, former Chief Marketing Officer $ 43,488 $ 143,679
Christoph Kraneiss, former Chief Commercial Officer 28,344 121,227
$ 71,832 $ 264,906
On June 1, 2023, we rescinded previously granted but unissued nonstatutory stock options to each of our independent director nominees and instead granted nonstatutory stock options to purchase 1,200 (240,000 pre 200:1 share consolidation) shares of the Company’s Common Stock to our then independent director nominees and related parties Jeffery Parry, Crystal Muilenburg and Julianna Daley under our 2021 Equity Incentive Plan. The equity compensation grants were directly in relation to the appointment of Mr. Parry, Ms. Daley and Ms. Muilenburg as our independent directors. The options maintain a contractual life of ten years and an exercise price of $1,000 ($5.00 pre 200:1 share consolidation) per share of Common Stock. All options vest at a rate of 25% on the first anniversary of the date of grant and the remaining 75% vest evenly over 36 months thereafter.
Other Agreements with Our Stockholders
In connection with our Series A convertible preferred stock financing, we entered into an investors’ rights, and voting agreements containing registration rights, information rights, voting rights among other things, with certain holders of our preferred stock. Similarly, in connection with our Common Stock financing, we entered into a subordinate investors’ rights agreement containing registration rights and information rights with certain holders of our Common Stock. Each of those stockholder agreements terminated upon the closing of our initial public offering in 2023 whereby such stockholders are no longer entitled to the rights to them afforded therein.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14. Principal Accounting Fees and Services.
The following table sets forth fees billed to us by our independent auditor for the years ended December 31, 2024, and 2023, for (i) services rendered for the audit of our annual consolidated financial statements and the review of our quarterly consolidated financial statements, (ii) services rendered that are reasonably related to the performance of the audit or review of our consolidated financial statements that are not reported as audit fees, and (iii) services rendered in connection with tax preparation, compliance, advice and assistance.
SERVICES
Audit fees
$ 60,000
$ 29,000
Audit-related fees
27,000
-
Tax fees
-
-
All other fees
-
-
Total fees
$ 87,000
$ 29,000
Audit fees and audit related fees represent amounts billed for professional services rendered for the audit of our annual consolidated financial statements and the review of our interim consolidated financial statements. Before our independent accountants were engaged to render these services, their engagement was approved by our Directors.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Item 15. Exhibits and Financial Statement Schedules.
(a) The following documents are filed as part of this report:
(1) Financial Statements:
The audited balance sheet of the Company as of December 31, 2024, the related statements of operations and comprehensive loss, changes in stockholders’ equity and cash flows for the year then ended, the footnotes thereto, and the report of TPS Thyer, independent auditors, are filed herewith.
(2) Financial Schedules:
None
Financial statement schedules have been omitted because they are either not applicable or the required information is included in the financial statements or notes hereto.
(3) Exhibits:
The exhibits listed in the accompanying index to exhibits are filed or incorporated by reference as part of this Report.
(b) The following are exhibits to this Report and, if incorporated by reference, we have indicated the document previously filed with the SEC in which the exhibit was included.
Certain of the agreements filed as exhibits to this Report contain representations and warranties by the parties to the agreements that have been made solely for the benefit of the parties to the agreement. These representations and warranties:
● may have been qualified by disclosures that were made to the other parties in connection with the negotiation of the agreements, which disclosures are not necessarily reflected in the agreements;
● may apply standards of materiality that differ from those of a reasonable investor; and
● were made only as of specified dates contained in the agreements and are subject to subsequent developments and changed circumstances.
Accordingly, these representations and warranties may not describe the actual state of affairs as of the date that these representations and warranties were made or at any other time. Investors should not rely on them as statements of fact.
Exhibit Number
Description
3.1
Articles of Incorporation of the Registrant (incorporated by reference to Exhibit 3.1 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
3.2
Bylaws of Registrant(incorporated by reference to Exhibit 3.2 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
3.3
Certificate of Designations, Rights, and Preferences of Series B Preferred Stock. (incorporated by reference to Exhibit 3.3 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
10.1+
2020 Equity Incentive Plan, as amended, and forms of award agreements thereunder. (incorporated by reference to Exhibit 10.1 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
10.2
Form of Amended and Restated Consulting Agreement between the Registrant and Northstrive Companies Inc. (incorporated by reference to Exhibit 10.2 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
10.3
Form of Advisory Agreement between the Registrant and Braeden Lichti (incorporated by reference to Exhibit 10.3 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
10.4†
Authorized Distributor Agreement, dated August 30, 2022, between the Registrant and Refine USA, LLC (incorporated by reference to Exhibit 10.4 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025)
10.5†
Authorized Distributor and Trademark License Agreement, dated January 17, 2022, between the Registrant and Dermapenworld Pty Ltd. (incorporated by reference to Exhibit 10.5 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.6†
Collaboration Agreement, dated November 28, 2023, by and between the Registrant and Yuva BioSciences, Inc. (incorporated by reference to Exhibit 10.6 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.7†
License Agreement, dated January 16, 2024, by and between the Company and INmune Bio, Inc. (incorporated by reference to Exhibit 10.7 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.8+†
Employment Agreement of Jordan R. Plews, dated September 26, 2021 (incorporated by reference to Exhibit 10.8 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.9†
Employment Agreement of Brenda Buechler, dated June 24, 2022 (incorporated by reference to Exhibit 10.9 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.10†
Employment Agreement of Chris Kraneiss, dated August 6, 2022 (incorporated by reference to Exhibit 10.10 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.11†
License Agreement, dated April 30, 2024, by and between the Company and MOA Life Plus Co., Ltd. (incorporated by reference to Exhibit 10.11 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.12
Consulting Agreement with Santorio Biomedical, LLC. (incorporated by reference to Exhibit 10.12 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.13+
Amended and Restated Consulting Agreement by and between the Company and GB Capital Ltd. (incorporated by reference to Exhibit 10.13 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.14+
Amended and Restated Consulting Agreement by and between the Company and NorthStrive Companies Inc. (incorporated by reference to Exhibit 10.14 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.15+
Chairman Appointment Letter to Mr. Braeden Lichti (incorporated by reference to Exhibit 10.15 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
Exhibit Number
Description
10.16
Termination Agreement by and between the Company and Mr. Lichti (incorporated by reference to Exhibit 10.16 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.17†
First Amendment to License Agreement dated as of July 9, 2024, by and between the Company and INmune Bio, Inc. (incorporated by reference to Exhibit 10.17 to the Company’s registration statement on Form S-1, filed with the SEC on February 12, 2025).
10.18
Form of Securities Purchase Agreement dated September 22, 2024 (incorporated by reference to Exhibit 10.18 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.19
Second Amended and Restated Consulting Agreement for Non-Employee Chief Executive Officer by and between the Company and GB Capital Ltd. (incorporated by reference to Exhibit 10.19 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.20
Second Amended and Restated Consulting Agreement for Non-Executive Chairman by and between the Company and Northstrive Companies Inc. (incorporated by reference to Exhibit 10.20 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.21
Amendment to the Second Amended and Restated Consulting Agreement for Non-Employee Chief Executive Officer by and between the Company and GB Capital Ltd. (incorporated by reference to Exhibit 10.21 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.22
Amendment to the Second Amended and Restated Consulting Agreement for Non-Executive Chairman by and between the Company and GB Capital Ltd Northstrive Companies Inc. (incorporated by reference to Exhibit 10.22 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.23
Form of Warrant Inducement Agreement (incorporated by reference to Exhibit 10.23 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.24
Form of Warrant (incorporated by reference to Exhibit 10.24 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
10.25
Mutual Termination of License Agreement dated as of February 27, 2025, by and between the Company and INmune Bio, Inc. (incorporated by reference to Exhibit 10.1 to the Company’s Fork 8-K, filed with the SEC on March 3, 2025)
14.1
Code of Ethics (incorporated by reference Exhibit 14.1 to the Company’s registration statement on Form S-1, filed with the SEC on September 28, 2023).
19.1
Registrant’s Insider Trading Policy
21.1
List of Subsidiaries. (incorporated by reference Exhibit 21.1 to the Company’s registration statement on Form S-1, filed with the SEC on February 11, 2025).
23.1
Consent of TPS Thayer.
23.2
Consent of HTL International, LLC.
24.1
Powers of Attorney (the signature page to this registration statement)
31.1
Certification of Principal Executive Officer required by Rule 13a-14(a).
31.2
Certification of Principal Financial Officer required by Rule 13a-14(a).
32.1
Certification required by Section 1350 of Chapter 63 of Title 18 of the United States Code.
32.2
Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
97.1
Registrant’s Policy Related to Recovery of Erroneously Awarded Compensation
101. INS
Inline XBRL Instance Document.
101. SCH
Inline XBRL Taxonomy Extension Schema Document.
101. CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101. DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document.
101. LAB
Inline XBRL Taxonomy Extension Label Linkbase Document.
101. PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document.
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
† Information in this exhibit identified by brackets is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is both (i) not material and (ii) the type the Company treats as private or confidential.
+ Management contract or compensatory plan