−Removed: are a physician-dispensed skincare company with a focus on modernizing aesthetic skincare.
−Removed: We conduct research and development to advance
−Removed: innovative and science-driven topical skincare that complements the medical aesthetics industry.
−Removed: Upon our founding in 2020, we initiated
−Removed: our research and development phase for our current product formulations.
−Removed: Since 2022, we have principally employed a business-to-business
−Removed: model in which we produce and commercialize a new generation of topical skincare products that contain our proprietary stem cell-derived
−Removed: Elevai Exosomes TM designed to enhance the appearance of skin.
−Removed: We have designed our innovative and meticulously produced Elevai
−Removed: Exosomes TM infused cosmetics for the physician-dispensed industry that we believe has lacked significant and recent new biotechnological
−Removed: innovations or advancements.
−Removed: We expect exosomes, nano-sized, natural delivery mechanism that affect important biological factors, to
−Removed: become a focal point that will change the nature of how medical aesthetics cosmetic skincare and related aesthetic products are used
−Removed: and adopted for years to come.
−Removed: team bridges years of cutting-edge molecular biotechnology research with our company’s flexibility to fully scale pipeline products
−Removed: through our refined competencies in biochemical engineering and bioprocessing prowess.
−Removed: We believe this potent combination of know-how
−Removed: is not found elsewhere in the cosmetics brands utilized by the physician-dispensed skincare industry and these proficiencies validate
−Removed: our early-mover advantage.
−Removed: Although the relationship between biochemical engineering, and stem cell research in cosmetics is not widely
−Removed: understood, we have built a team with mastery in both disciplines.
−Removed: Because we strive to refine the advancement of those intersectant
−Removed: technologies, we are well situated in our ambition to develop and market next-generation products that can improve skin aesthetics while
−Removed: maintaining the ability to fully scale our operations at a level that we believe other companies of a similar size cannot.
−Removed: manufacturing process from source to skin is known as ‘Precision Regenerative Exosome Technology™’ or ‘PREx™’.
−Removed: PREx™ utilizes advanced patent-pending stem cell processing technology as part of our cohesive production process involving
−Removed: carefully controlled stem cell culture to produce stem cell derived factors that are featured in our topical exosome products.
−Removed: Our proprietary
−Removed: PREx™ process yields exosome lots from any hUMSC supplier that provide the source for our specialty physician-dispensed
−Removed: skincare product lines.
−Removed: Our products are comprised of topical cosmetic solutions.
−Removed: These products are not drug products or considered
−Removed: regenerative medicine, nor have any of our products received FDA approval.
−Removed: Our cosmetic products are not intended to prevent, treat or
−Removed: cure diseases or medical conditions.
−Removed: Moreover, our cosmetic products are not intended to be injected or delivered intravenously.
−Removed: our exosome-infused skincare products are topically applied to the skin to aid in the reduction of the appearance of a range of the most
−Removed: common cosmetic skin conditions, including the appearance of skin firmness, oxidative stress, photodamage, hyperpigmentation, and texture
−Removed: of soft tissue deficits, such as reducing the appearance of fine lines and wrinkles.
−Removed: More specifically, our E-Series™ line is marketed
−Removed: as a post-procedure care cosmetic that is applied to the skin after a medical aesthetics procedure such as skin laser therapy, micro
−Removed: needling, rejuvenation peels and Botox injections.
−Removed: addition to antiquated technology, we believe the current skincare market is dominated by confusing marketing claims, leaving skincare
−Removed: consumers with little more than subjective analyses or non-quantitative measures to assess a product before purchasing.
−Removed: We founded Elevai
−Removed: with the intention of offering cosmetics products built on over fifteen years of innovative stem-cell biotechnology and scientific development
−Removed: by our Co-founders and Chief Executive Officer.
−Removed: With this goal in mind, we developed a proprietary commercialization process for producing
−Removed: and distributing non-invasive topical cosmetics products featuring our Elevai Exosomes™.
−Removed: Our aptitude in biochemical research and
−Removed: bioprocessing development coupled with a mission to provide scientifically backed skincare technology enables our high potential to become
−Removed: one of the early movers in the medical aesthetics cosmetics industry with international reach.
−Removed: We believe the potency and innovation
−Removed: of our product lines will be supported by our early-study data which will facilitate a shift in the physician-dispensed market towards
−Removed: the use of biotechnology to complement services provided within the medical aesthetics industry.
−Removed: seek to revolutionize the physician-dispensed cosmetics skincare market by providing unmet consumer needs to aid those individuals receiving
−Removed: services within the medical aesthetics industry through our innovative, but approachable skin-centric technology:
−Removed: our Elevai Exosomes TM .
−Removed: We believe we will be able to show that our exosomes provide aesthetic benefits and in turn can improve the appearance of skin that is
−Removed: prone to temporary inflammation and damage normally experienced by individuals immediately after receiving cosmetic or medical aesthetic
−Removed: procedures in either a physicians’ office, medical spa or by a licensed aesthetician.
−Removed: Through our ongoing rigorous testing and
−Removed: data analysis, we believe our products have the potential to demonstrate that they complement and enhance commonly performed cosmetic
−Removed: procedures such as skin laser therapy, micro needling, rejuvenation peel, and Botox injections.
−Removed: We believe our products have properties
−Removed: that can reduce the appearance of post-inflammatory hyperpigmentation that typically follows cosmetic or medical aesthetics services,
−Removed: such as laser therapy, micro needling and other minor ablative procedures.
−Removed: We further believe that our products have the potential to
−Removed: be used in a number of applications and other procedures beyond their current use.
−Removed: For example, we are in the early stages of evaluating
−Removed: the adjunctive use of our exosomes in the promotion of healthy hair growth cycles and noticeable improvement to hair appearance, fullness,
−Removed: and thickness.
−Removed: current cosmetic product formulations do not contain living cells, are patent pending and utilize our Elevai Exosomes TM .
−Removed: Exosomes TM are nano-sized extracellular vesicles packed with growth factors that we believe support skin health, including
−Removed: cytokines, peptides and other small molecules involved in the body’s natural healing.
−Removed: Elevai Exosomes™ are the powerhouse
−Removed: ingredient in all current Elevai products that we believe mimics the elegant repair process of the body alongside carefully selected
−Removed: high-quality active ingredients, such as hyaluronic acid and ceramides, to help maintain skin health for any skin type.
−Removed: While our products
−Removed: contain no living cells, they leverage the novel use of ethically sourced and thoroughly tested, human umbilical mesenchymal stem cells
−Removed: (“hUMSC”) that we culture under proprietary in vitro lab conditions and secrete Elevai Exosomes™ from.
−Removed: Exosomes TM are produced from hUMSCs that are derived under current Good Manufacturing Practices (“cGMP”) conditions.
−Removed: Our hUMSCs are rigorously tested from consenting, and carefully selected donors.
−Removed: These hUMSCs then undergo cell expansion in vitro under
−Removed: proprietary conditions in our state-of-the-art laboratory operated under cGMP compliance.
−Removed: We specifically isolate hUMSCs from the Wharton’s
−Removed: Jelly portion of umbilical cords because these stem cells’ conditioned media (“CM”) or stem cells’ secretome
−Removed: is capable of resulting in exosomes with a protein profile that uniquely mimics the profile of proteins that these very young cells produce
−Removed: naturally when supporting the body’s healing and repair process.
−Removed: CM is a collective term for the paracrine soluble factors (a form
−Removed: of cellular communication in which a cell produces to signal to induce changes in nearby cells) produced by stem cells and utilized for
−Removed: intercellular communication.
−Removed: The CM of the hUMSCs we source is made up of growth factors, exosomes, lipids, microvesicles, and nutrients.
−Removed: Our hUMSCs are purified through our proprietary method, resulting in Elevai Exosomes TM .
−Removed: Every product we develop originates
−Removed: with a deep understanding of the skin, what healthy skin needs to look healthy, and how our next-generation, stem-cell exosome technology
−Removed: can help maintain the appearance of healthy skin.
−Removed: We specifically designed our Elevai Exosomes™ to be bottled in stable solutions
−Removed: so they can be topically applied.
−Removed: when cultured under the right conditions, produce nano-vesicles (~30-150nm) called exosomes, or extracellular vesicles.
−Removed: Biologically,
−Removed: exosomes are roughly spherical and made up of a lipid bilayer produced by the cell they originate from.
−Removed: This lipid bilayer forms a protective
−Removed: “shell” or outer casing, and within the “shell” exists the exosome payload containing molecules deposited there
−Removed: by the cell that generated the exosome.
−Removed: While exosomes are generated using some of the origin cell’s own cellular material, the
−Removed: exosomes do not contain cells, nor are they explicitly cellular material.
−Removed: Instead, exosomes represent a powerful, nano-sized, natural
−Removed: delivery mechanism for protecting important biological factors and this enables them to be directed to where they are needed most.
−Removed: use of exosomes has been found to penetrate the skin better, absorb more easily, and protect the active ingredients fused into our products,
−Removed: including stem cell derived proteins, peptides, and growth factors.
−Removed: the stratum corneum barrier:
−Removed: a nano approach.
−Removed: Drug Deliv Transl Res.
−Removed: 2013 Jun;3(3):205-8.
−Removed: 10.1007/s13346-013-0149-8.
−Removed: Exosomes™ are produced in-house through our proprietary manufacturing process, called Precision Regenerative Exosome Technology™
−Removed: or PREx™ Our PREx™ technology is based on over 15 years of stem-cell research, bioprocessing, pharmaceutical- and biotech-product
−Removed: development by CEO and chief scientist Dr.
−Removed: Through PREx™, we have produced exosomes that have been developed
−Removed: into topical serums and creams which we believe aesthetically enhance the skin with a more youthful appearance.
−Removed: maintain quality control over our Elevai Exosomes™ commercialization and manufacturing process, we only purchase hUMSCs that are
−Removed: derived and banked by a cGMP-compliant third-party manufacturer.
−Removed: We similarly produce our final products in an FDA-inspected, cGMP compliant
−Removed: The hUMSCs are shipped to our laboratory where we similarly operate our lab under strict good laboratory practice (“GLP”)
−Removed: protocols to produce the highest quality of exosomes for our products.
−Removed: Not only are all our ingredients and products subject to multiple
−Removed: quality control tests before bottling, but each lot is also tested, and batch numbered to enhance safety and traceability.
−Removed: stem cell line is carefully derived and closely monitored throughout the process by highly trained personnel, only the highest quality
−Removed: stem cells are used to generate Elevai Exosomes™.
−Removed: If cells show any deviation in morphology or vitality, or any signs of contamination,
−Removed: the cell lines and exosomes from those cells are discarded.
−Removed: Currently, we are reliant on suppliers and manufacturers for both our raw
−Removed: materials and formulations and packaging of our final products, however we may build up additional manufacturing capabilities to become
−Removed: more vertically integrated.
−Removed: To this end, we are currently exploring the possibility of acquiring products, technologies, or companies
−Removed: to assist in our integrative goals.
−Removed: believe that we are at the fore of the biotech aesthetic revolution by innovating new cosmetic products at a level of biotech and aesthetics
−Removed: cosmetics research rarely observed in over-the-counter or physician-dispensed cosmetics skincare market.
−Removed: Our patent pending flagship
−Removed: Elevai E-Series™ products include Empower™ and Enfinity™ which are sold exclusively through our business-to-business
−Removed: model channel and via our distribution agreements channel.
−Removed: These products complement those individuals receiving services within the
−Removed: medical aesthetics industry who are in need of cosmetics to improve the appearance of skin in addition to receiving aesthetics treatments.
−Removed: Empower™ was developed to provide immediate post-treatment skin support and Enfinity™ for ongoing daily aftercare.
−Removed: Both products
−Removed: contain our patent-pending Elevai Exosomes™.
−Removed: regenerative medicines, including those that may contain exosomes usually refers to the use of a cell or a gene therapy to actually repair
−Removed: or replace damaged cells, tissues, or organs as opposed to enhancing the appearance of skin through cosmetics.
−Removed: When these regenerative
−Removed: medicines are advertised to repair, or replace damaged cells, or tissues while treating diseases and conditions in humans, they may be
−Removed: regulated as drugs and biological products under the Federal Food Drug and Cosmetic Act (“FD&C Act”).
−Removed: The FDA regulates
−Removed: the interstate manufacture and distribution of certain biological products, and drugs derived from human cells, tissues and cellular
−Removed: and tissue-based products or “HCT/Ps” under the Public Health Service Act (the “PHSA”).
−Removed: Moreover, to lawfully
−Removed: market a drug that is also a biological product, a biologics license must be in effect under the PHSA.
−Removed: As of the date of this report,
−Removed: we are not aware of any FDA approved exosome biological products or drugs for any use.
−Removed: Our products are not considered a regenerative
−Removed: medicine intended to be used to treat any disease or condition.
−Removed: As a result, we do not believe our products qualify as HCT/Ps as it relates
−Removed: to their intended use as defined by the FDA, we expect they will remain cosmetic products.
−Removed: of our topical products are currently sold nationally under a business-to-business (“B2B”) model while others are currently
−Removed: sold through our licensing and manufacturing agreements with third-party distributors to sell our products internationally in Kuwait,
−Removed: Serbia, Albania, North Macedonia, Kosovo and Bosnia-Herzegovina (the “Balkans”), the Philippines and Vietnam.
−Removed: As of the date
−Removed: of this report, except for product sales made by our Vietnamese, and Canadian distributors, our distributors have not made any sales
−Removed: under any of our active exclusive distribution agreements, and we have made no direct international sales.
−Removed: However, On March 6, 2024,
−Removed: we received notice from Health Canada that it reviewed the make-up of our cosmetic products and determined our products do not meet the
−Removed: conditions for sale as cosmetics in Canada.
−Removed: On March 18, 2024, we responded to Health Canada to dispute the determination and clarify
−Removed: the materials Health Canada relied upon in order to make its determination.
−Removed: As of March 18, 2024, and the date of this report, we are
−Removed: continuing to communicate with Health Canada and have voluntarily stopped the sale of our products in Canada until a time that a resolution
−Removed: can be reached with Health Canada with regard to how the products can be marketed in Canada.
−Removed: Depending on the outcome of Elevai’s
−Removed: engagement with Health Canada, Elevai products may become subject to additional regulatory requirements in order to be marketed in Canada.
−Removed: This determination will impede sales in Canada until resolved and raises concerns about our future collaboration with our distributor,
−Removed: Evolve Medical Inc.
−Removed: products are primarily sold to medical practices or spas often overseen by licensed medical professionals through licensing agreements
−Removed: in which those select outlets are required to provide proof of licensure and sign a reseller’s agreement.
−Removed: These arrangements protect
−Removed: our brand and are designed to ensure that our products remain positioned as professional luxury cosmetics products that are only sold
−Removed: via partners with sufficient training and know-how to properly highlight the unique benefits that our topical products offer.
−Removed: these licensed professionals or medical spa staff know when the topical application of our products is most beneficial to any affected
−Removed: region of the skin following an in-office medical aesthetic treatment to aid and hasten the recovery process and to ameliorate the appearance
−Removed: of inflammation.
−Removed: In turn, licensed skincare professionals value their relationship with us, as it also protects them from unscrupulous
−Removed: non-professional skincare resellers and online outlets that would simply undercut on price and endanger their repeat business.
−Removed: that physicians and their trained staff are the best source of trustworthy skincare information.
−Removed: Their deep understanding of the science,
−Removed: chemistry and structure of skin gives them clinical insight to select the most effective cosmetics products for their clients such as
−Removed: our cosmetics products.
−Removed: addition to providing client-based physician practices, medical spas and licensed aestheticians with product, we offer complimentary
−Removed: educational programs and webinars, and make appearances at medical aesthetic conferences to showcase our cosmetics products and latest
−Removed: From time to time, our free informational sessions educate physicians on the variety of benefits carrying our cosmetics products
−Removed: will have on their practices and patients, and under what circumstances it may be advantageous for physicians to implement use of our
−Removed: cosmetics products.
−Removed: We also host patient-driven events to help our physicians connect with those patients seeking to utilize our cosmetics
−Removed: products which helps to grow their practices.
−Removed: Often, we will also provide useful information and in-office literature on our cosmetics
−Removed: products for those patients who may be interested in our products during a regular visit.
−Removed: Moreover, to further expand our product reach
−Removed: we have entered into a white-label supply contract and other regional and international supply contracts with select sales distribution
−Removed: channel partners that distribute our Elevai branded products internationally or incorporate our proprietary Elevai Exosomes TM
−Removed: into their own new product lines to reach customers globally.
−Removed: our product lines become more pervasive, we anticipate working with additional distribution channel partners that will fuse our Elevai
−Removed: Exosomes TM into diverse product offerings and increase our overall share of the cosmetics market.
−Removed: Overview and History
−Removed: has one wholly owned subsidiary, Elevai Research Inc.
−Removed: (FKA Reactive Medical Inc.).
+Added: manage and operate a diverse portfolio of three wholly owned subsidiaries across the medical aesthetics and biopharmaceutical sectors:
+Added: ● Northstrive
+Added: Biosciences Inc.
+Added: is a biopharmaceutical company focusing on the development and acquisition of cutting-edge aesthetic medicines and
+Added: therapeutic products.
+Added: Our lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s
+Added: pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
+Added: PMGC Research Inc.
+Added: based in Canada, is currently dedicated to medical scientific research and development efforts, utilizing Canadian research grants
+Added: and partnering with leading Canadian Universities to push the boundaries of innovation.
+Added: PMGC Capital LLC
+Added: is a multi-strategy investment firm focused on direct investments, strategic lending, and acquiring undervalued companies and assets
+Added: across diverse markets.
+Added: Its mission is to identify and seize high-potential opportunities, delivering sustainable growth and maximizing
+Added: returns on capital.
+Added: are dedicated to enhancing our portfolio through the acquisition of operating companies and innovative biotechnology assets that align
+Added: with our growth mission, while actively pursuing opportunities to foster growth and drive innovation.
+Added: of January 16, 2025, we completed the divestiture of the assets relating to our prior Elevai Skincare Inc.
+Added: Elevai Skincare
+Added: Inc., previously specializing in developing and commercializing physician-dispensed skincare products, is no longer part of our operations.
+Added: Post closing of the asset sale, we changed the name of Elevai Skincare Inc.
+Added: changed its name to PMGC Impasse Corp.
+Added: on January 17, 2025.
+Added: The Skincare asset divestiture enables us to dedicate more resources and time to advancing our initiatives and assets in larger markets
+Added: with unmet needs, creating greater growth opportunities for the Company and its shareholders.
+Added: Our efforts will focus on the clinical
+Added: development of biotechnology assets through NorthStrive Biosciences Inc.
+Added: while leveraging our R&D capabilities through PMGC Research
+Added: Moreover, this strategic shift positions us to actively explore and execute potential business acquisitions and high-value biotechnology
+Added: assets, further strengthening our portfolio and driving long-term growth.
+Added: PMGC Holdings Inc.
+Added: currently operates as a holding
+Added: company focusing on developing biotechnology assets, advancing novel science and discoveries through collaborative strategic research
+Added: and development partnerships.
+Added: We intend to find and acquire additional operating companies in agnostic sectors.
+Added: Biosciences Inc.
+Added: Biosciences Inc., a wholly owned subsidiary of PMGC Holdings Inc., is a biopharmaceutical company focusing on the development and acquisition
+Added: of cutting-edge aesthetic medicines and therapeutic products.
+Added: Currently, more than 40% of adults in the United States live with obesity
+Added: - a figure predicted to rise to approximately 50% by 2030.
+Added: Obesity is a leading risk factor for the development of serious health conditions,
+Added: including Type 2 diabetes and heart failure.
+Added: Goldman Sachs predicts that this epidemic will create a $100 billion market for anti-obesity
+Added: lead asset, EL-22, is leveraging a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving
+Added: muscle while on weight loss treatments, including GLP-1 receptor agonists.
+Added: EL-22 has completed a Phase 1 clinical trial in South Korea,
+Added: demonstrating it was generally well tolerated and safe in healthy volunteers.
+Added: No subjects dropped out due to adverse events and no statistically
+Added: significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
+Added: Elevai intends
+Added: to evaluate EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the market, with the goal
+Added: of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
+Added: We are working towards filing
+Added: an IND with the FDA to test EL-22 in human subjects.
+Added: Our second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin
+Added: & activin-A and also being positioned for the muscle preservation space as a combination to weight loss treatments, including GLP-1
+Added: receptor agonists.
+Added: In a preclinical healthy mouse model, EL-32 demonstrated a statistically significant increase in Activin-A and myostatin
+Added: antibodies, confirming the efficacy using the ELISA test.
+Added: Research Inc .
+Added: Research Inc., a wholly owned subsidiary of PMGC Holdings Inc., is dedicated to advancing innovative research and development initiatives
+Added: in Canada by leveraging government grants and funding programs.
+Added: Through strategic collaborations with leading research institutions and
+Added: industry partners, PMGC Research Inc.
+Added: aims to accelerate scientific discovery and transform cutting-edge technologies into commercially
+Added: viable products.
+Added: Capital LLC, a wholly owned subsidiary of PMGC Holdings Inc., is a multi-strategy investment vehicle engaged in investing, lending and
+Added: pursuing diversified investment opportunities.
+Added: PMGC Capital LLC actively supports the growth and expansion of PMGC Holdings’ portfolio
+Added: The subsidiary’s dynamic investment approach is designed to capitalize on high yield returns on capital and investing
+Added: into and acquiring assets and companies that are undervalued.
+Added: Biosciences Products
+Added: Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while
+Added: on weight loss treatments, including GLP-1 receptor agonists.
+Added: Our lead asset, EL-22, has completed a Phase 1 clinical trial in South
+Added: Korea, demonstrating it was generally well tolerated and safe in healthy volunteers.
+Added: No subjects dropped out due to adverse events and
+Added: no statistically significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
+Added: results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional
+Added: (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD) 1 .
+Added: believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor
+Added: agonists, by preserving muscle mass while decreasing fat mass.
+Added: We plan to submit an Investigational New Drug (IND) application in 2025
+Added: that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the
+Added: market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
+Added: bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
+Added: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
+Added: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
+Added: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
+Added: These companies include:
+Added: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market.
+Added: shown significant efficacy in weight loss and improving cardiovascular health.
+Added: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss.
+Added: also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
+Added: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
+Added: Biohaven’t taldefgrobep is an investigational fusion protein targeting myostatin to impact skeletal muscle growth relevant to individuals
+Added: living with overweight and obesity.
+Added: Scholar Rock’s apitegromab is an inhibitor of the activation of latent myostatin, with the aim of improving patients’
+Added: motor function.
+Added: Scholar Rock is assessing apitegromab’s ability to preserve lean muscle mass in individuals on GLP-1 receptor agonist
+Added: therapy for obesity.
+Added: Veru’s enobosarm is an androgen receptor modulator, also known as a SARM, to address the loss of muscle in patients undergoing
+Added: weight loss therapy with GLP-1 drugs.
+Added: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration
+Added: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: 2022, 23, 9059.
+Added: https://doi.org/10.3390/ijms23169059
+Added: companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective
+Added: obesity management and the prevention of muscle wasting associated with weight loss.
+Added: and Competitive Strengths
+Added: face competition from both commercialized obesity medications, as well as clinical candidates that are still in the development stage.
+Added: We believe the primary competitive factors in our favor for EL-22 & EL-32 are the following:
+Added: First-in-Class Approach and Early Results
+Added: Biosciences is developing EL-22, an engineered probiotic with myostatin antigens, to elicit an immune response that could help people
+Added: achieve substantial fat loss while preserving muscle mass.
+Added: Based on the generated preclinical data and the mechanism of the myostatin-activin
+Added: signaling pathway effect on muscle wasting, we believe that EL-22 has the potential to treat obesity in combination with GLP-1 receptor
+Added: agonists by preserving muscle mass while decreasing fat mass.
+Added: In the preclinical studies 1 :
+Added: showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator
+Added: of muscle growth.
+Added: showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
+Added: administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function, as demonstrated
+Added: by a longer duration during rotarod tests.
+Added: on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, we believe that
+Added: EL-22 has the potential to treat obesity in combination with GLP-1 by preserving muscle mass while decreasing fat mass.
+Added: The Company intends
+Added: to complete an IND submission in 2025 and to initiate clinical trials in the U.S.
+Added: to evaluate the myostatin approach in combination with
+Added: one or more GLP-1 receptor agonists in obesity.
+Added: Our ability to proceed with human trials is contingent upon the FDA clearing the IND
+Added: Candidates’ Ease of Use and Convenient Oral Administration
+Added: believe our product candidates EL-22 and EL-32 would be the only oral myostatin formulations to date, making Northstrive Bioscience an
+Added: early mover in the emerging GLP-1 combination space for muscle preservation.
+Added: Existing approaches targeting obesity with combinations
+Added: to preserve muscle mass while on weight loss therapies are administered through injectable forms;
+Added: either subcutaneously or intravenously.
+Added: Although effective, many patients in general prefer orally administered medications over injections due to factors like convenience,
+Added: ease of administration, and fear of needles.
+Added: Our product candidates have been designed to be oral capsules to provide benefits without
+Added: any needling.
+Added: Biosciences’ strategy focuses primarily on the clinical development and commercialization of novel medicines for the treatment
+Added: of metabolic diseases, including obesity.
+Added: We will need substantial capital to support our drug development and any related commercialization
+Added: efforts for our drug candidates.
+Added: The key elements of our strategy are:
+Added: EL-22 & EL-32 for obesity.
+Added: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration
+Added: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: 2022, 23, 9059.
+Added: https://doi.org/10.3390/ijms23169059
+Added: metabolic drug pipeline is focused on the clinical development of EL-22, a first-in-class engineered probiotic approach to address obesity’s
+Added: pressing issue of preserving muscle while on weight loss treatments, including GLP-1 receptor agonists.
+Added: Currently, more than 40% of adults
+Added: in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.
+Added: 1 Obesity is a leading risk
+Added: factor for the development of serious health conditions, including Type 2 diabetes and heart failure.
+Added: Goldman Sachs predicts that this
+Added: epidemic will create a $100 billion market for anti-obesity players.
+Added: GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s
+Added: Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape.
+Added: However, past studies of these
+Added: highly effective drugs show that up to 20-50% of the weight loss is due to loss of lean muscle.
+Added: is necessary for metabolism, strength, and physical function.
+Added: As a result, we believe that one of the key unmet needs in the current
+Added: obesity landscape is the avoidance of muscle loss while on weight loss treatments.
+Added: Northstrive Biosciences is developing EL-22, an engineered
+Added: probiotic with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving
+Added: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
+Added: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
+Added: 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
+Added: and increase the fat loss experienced by older patients receiving GLP-1 drugs for the treatment of obesity.
+Added: History and Structure
+Added: PMGC Holdings Inc.
+Added: three wholly owned subsidiaries, PMGC Research Inc.
+Added: (FKA Reactive Medical Inc.), Northstrive Biosciences Inc.
+Added: and PMGC Capital LLC.
Medical Labs Inc.
8 unchanged sentences
Elevai Research Inc.
−Removed: is a wholly owned subsidiary of Elevai.
+Added: is a wholly owned subsidiary of the Company.
+Added: December 20, 2024, the Company re-domesticated to Nevada and changed its name to “PMGC Holdings Inc.”
June 2021, we entered into a stock transfer agreement with Reactive, whereby we purchased substantially all of the assets and liabilities
6 unchanged sentences
September 2022, Reactive changed its name to Elevai Research Inc.
+Added: On January 10, 2025, Elevai Research Inc.
+Added: changed its name to PMGC
+Added: Research Inc.
+Added: Industry and Other Research-Based Data
Market and Industry
−Removed: currently distribute our cosmetics products through three distinct channels, including business-to-business and direct-to-consumer sales
−Removed: channels where we sell our products directly within the United States and through our distribution sales channel where we sell our products
−Removed: directly to distributors with international or regional reach under exclusive and non-exclusive territorial agreements.
−Removed: We have employed
−Removed: a combination of multiple distribution channels via distribution agreements, online direct-to-consumer and directed business-to-business
−Removed: channels to optimize our sales reach and strategy.
−Removed: specifically place our products with physicians’ offices and medically directed businesses through our business-to-business model
−Removed: channel via our online sales portal, and our trained direct sales force comprised of employed, and independently contracted aesthetic
−Removed: account managers.
−Removed: Consumers are increasingly looking to their physicians for advice on cosmetic product selection because they are overwhelmed
−Removed: by the marketing hype that often creates unrealistic expectations and some degree of consumer confusion.
−Removed: Gradually, we believe consumers
−Removed: are also looking for individualized skin care regimens and want to know from their physicians, what works and what does not.
−Removed: to the business-to-business sales channels, our products are available for purchase direct-to-consumer via our digital retail website.
−Removed: Our products are also distributed within the physician-dispensed cosmetics skincare market through both exclusive and non-exclusive distribution
−Removed: term ‘physician-dispensed’ refers to a sales channel where cosmetics products are exclusively sold in physician clinics or
−Removed: medically directed businesses by licensed medical professionals or that have a medical professional on staff.
−Removed: We include medical spas
−Removed: under this category such as standalone, or hospitality-affiliated clinics focused on cosmetic treatments such as injections, micro needling,
−Removed: and some plastic surgery services.
−Removed: Cosmetic products like ours are only available through a medically-directed business and are geared
−Removed: towards nourishing, protecting and supporting healthy looking skin.
−Removed: cosmetic products are highly sought after by consumers making them one of the fastest growing segments of the personal care market.
−Removed: We believe consumers often turn to cosmetics to enhance the appearance of dull or aging skin and to brighten the skin by lessening
−Removed: the appearance of a myriad of aesthetics concerns such as unwanted pigmentation, acne, melasma and rosacea because these consumers view
−Removed: these products as alternatives to medications and often try cosmetics products before seeking medicinal solutions.
−Removed: Physicians also value
−Removed: well designed, topical skincare products formulated and manufactured with our biotechnology for their complementary aesthetic effects
−Removed: in conjunction with medications to improve skin appearance and to enhance the benefits of in-office procedures.
−Removed: Most of our product sales
−Removed: are within the physician-dispensed market through business-to-business channels, chiefly to dermatologists, plastic surgeons, and other
−Removed: physicians who are focused on medical aesthetics and therapeutic skincare, including some physicians practicing in medical esthetician
−Removed: Our products complement those medical aesthetics services provided in these professional settings.
−Removed: business-to-business sales channel within the physician-dispensed cosmetics skincare market utilizes both online sales, and our trained
−Removed: direct sales force comprised of employed, and independently contracted aesthetic account managers.
−Removed: This business-to-business sales channel
−Removed: is distinct from our leverage of non-exclusive distribution agreements third-party distributors or resellers, who in turn sell our products
−Removed: to end customers.
−Removed: Under distribution agreements our relationship between the seller and the buyer is more indirect, because our distributors
−Removed: serve as an intermediaries, however we believe scaling our product lines through larger distribution sales channels will lead to faster
−Removed: brand expansion, recognition and market reach.
−Removed: Our direct-to-consumer channel allows our cosmetic products to remain conveniently available
−Removed: to those consumers without the need to visit a medically directed business to make a purchase, or prefer the ease of purchasing our products
−Removed: objective of the medical aesthetics industry is to offer medical education and care in a setting that includes spa facilities as well
−Removed: as conventional, complementary, and/or alternative aesthetics-focused therapies and cosmetic treatments.
−Removed: These medical aesthetics services
−Removed: include cosmetic procedures such as micro needling, Botox injections, anti-wrinkle and fine line reduction therapies, acne surgery, fillers
−Removed: and facial and massage services performed with highly specialized lasers and instruments.
−Removed: Beauty & Personal
−Removed: Care 2023-2026 | Statista.
−Removed: Products and Products in Development
−Removed: products rely on Elevai Exosomes TM that are derived from, ethically sourced and thoroughly tested, human umbilical mesenchymal
−Removed: stem cells (“hUMSCs”) originating from umbilical cord tissue.
−Removed: Our products include Empower™ and Enfinity™, two
−Removed: post-skincare procedure care serums that target the face and neck, and upper chest regions which are sold exclusively through our business-to-business
−Removed: model channel and via our distribution agreements channel.
−Removed: currently purchase our hUMSCs for our products from third parties that source umbilical tissue from consenting donors and are manufactured
−Removed: under cGMP conditions.
−Removed: We infuse our product lines with exosomes derived from these hUMSCs which are replete with growth factors.
−Removed: January 16, 2023, we entered into a License Agreement (the “EMx License Agreement”) with INmune Bio, Inc., a Nevada corporation
−Removed: Under the License Agreement, INmune granted the Company certain worldwide exclusive and non-exclusive license
−Removed: rights to develop, manufacture, and commercialize INmunes’s EMx technology, (“EMx”) a proprietary equipment, processes
−Removed: and consumables useful for isolation and cGMP manufacture of hUMSCs for a period of ten years from the effective date of the EMx License
−Removed: Agreement (collectively, the “Field”).
−Removed: cosmetic topical products do not contain any living cells but do include our Elevai Exosomes TM .
−Removed: That is because Exosomes are
−Removed: not actually cells.
−Removed: Rather, they are cellular byproducts that are tiny, subcellular, membrane-bound vesicles approximately 30-150 nanometers
−Removed: These vesicles are released by and can be derived from almost all cell types, including hUMSCs, whereas growth factors are
−Removed: signaling proteins that assist in hydrating and nourishing skin and do not by their nature have any form of protective envelope or encapsulation
−Removed: In comparison, exosomes are the delivery mechanism or envelope in which proteins (including growth factors), lipids, and other
−Removed: factors are contained within and can be applied topically to skin.
−Removed: Most notably, hUMSCs’ secretome produced by stem cells, also
−Removed: known as their conditioned media (“CM”) contain exosomes, proteins, growth factors, cytokines and other substances.
−Removed: competing products have attempted to synthetically use growth factors to recreate the messaging process from hUMSCs’ CMs, including
−Removed: recombinant bacteria, peptides, and/or small molecules.
−Removed: However, we believe many of these synthetic modalities are ineffective due to
−Removed: their lack of protection or encasement, which our Elevai Exosomes TM provide.
−Removed: Without protection, many synthetic modalities
−Removed: may end up undelivered due to their size, charge, shape, which we believe would not result in positive impact on existing skin concerns
−Removed: or bring skin a more youthful and healthy appearance.
−Removed: Instead, we believe a well-constructed exosome can overcome the deficiencies of
−Removed: synthetic versions.
−Removed: Our platform technology intentionally utilizes hUMSCs derived from umbilical cords of healthy full term newborns.
−Removed: These cells are then triggered under laboratory-controlled in vitro culture conditions to produce a reliable and consistent exosome ingredient
−Removed: harnessed by our Elevai Exosomes TM which support skin health.
−Removed: Our statements herein regarding our topical cosmetic and exosome-containing
−Removed: serums have not been reviewed or approved by the FDA.
−Removed: At this early stage, the continued success of the early positive results of our
−Removed: products is highly subjective to consumers and we have yet to complete clinical validation studies to demonstrate support for any performance
−Removed: claims of our products, such as their ability to aesthetically improve the skin.
−Removed: than try to synthetically design a specific ingredient or synthetic protein or peptide one at a time, we instead rely on hUMSCs’
−Removed: innate ability to assist in nourishing, protecting and supporting healthy looking skin in the form of their derived exosomes.
−Removed: PREx™ process, we believe our ethically sourced hUMSCs utilize multiple triggering modalities and protocols, enabling us to create
−Removed: multiple types of exosome messages or message profiles, each suited for a different purpose to enhance the texture and appearance of
−Removed: For example, just as an individual would expect their stem cells to produce exosomes to help them smooth skin texture and replace
−Removed: lost moisture, we expect to trigger similar exosomes, isolate and purify them, and then provide them topically in our product lines in
−Removed: order to nourish, protect and support healthy looking skin.
−Removed: We believe our in vitro culture process to create Elevai Exosomes TM
−Removed: leverages this natural support to the moisture recovery and feeling of rejuvenation to skin, as opposed to pulling together a manmade
−Removed: CM which is essentially an educated guess at what that message construction should look like.
−Removed: Many of these synthetic CMs are utilized
−Removed: by our competitors alongside the addition of peptides or growth factors tied to improving skin appearance, which we believe does not
−Removed: make up for their inferior product design.
−Removed: hUMSCs are triggered under proprietary laboratory conditions via our PREx™ process so as to result in the secretion of exosomes
−Removed: that carry a variety of proteins, including growth factors and calming cytokines which we then purify and capture to include in our topical
−Removed: Elevai Exosomes TM that we secrete are about 1/100 th the diameter of a cell and their lipid bilayer protects
−Removed: their contents while also helps them to be absorbed by the skin and support the skin’s moisture barrier.
−Removed: We believe that our products
−Removed: promote and support healthy support skin rejuvenation of the skin’s moisture barrier that will help skin look and feel healthy
−Removed: by topically providing growth factors tied to maintaining the skin’s moisture barrier and promoting the appearance of a more radiant
−Removed: and even toned complexion that often decreases with age.
−Removed: the skin ages there is often an increase in the appearance of age-related pigments and fine lines and wrinkles.
−Removed: This appearance may be
−Removed: attributable to diet, genetics, or environmental/lifestyle factors such as the sun or smoking but it generally occurs naturally with
−Removed: age and causes the skin’s repair systems to break down which may result in visual signs of aging or disease.
−Removed: Working together in
−Removed: harmony we believe hUMSC derived growth factors encapsulated in exosomes have the potential to reduce the appearance of aging by supporting
−Removed: the skin’s natural moisture barrier.
−Removed: Our in-house laboratory experience has shown that when we expose the hUMSC-derived growth
−Removed: factors to artificially aged skin, or when we specifically trigger those growth factors using our proprietary PREx™ processes,
−Removed: we are then able to topically deliver growth factors back to skin, so that it appeared to be firmer and youth as if the skin had naturally
−Removed: and abundantly created those growth factors on its own.
−Removed: our experience, the process of hUMSC derived growth factors being repeatedly introduced and absorbed by skin over time often results
−Removed: in skin appearing more youthful as if the skin was expressing proteins typical of younger skin.
−Removed: have integrated the use of stem cell exosomes into our initial product line:
−Removed: our Elevai Post Treatment E-Series™.
−Removed: The E-Series™
−Removed: is comprised of two post-skincare procedure care products that target the face and neck, and upper chest regions.
−Removed: Our products include
−Removed: Empower™-, and Enfinity™-serums, which are sold exclusively through our business-to-business model channel and via our distribution
−Removed: agreements channel.
−Removed: We aim to disrupt the post-procedure market with these products by providing a best-in-class system of topicals that
−Removed: work to complement the aesthetic results of in-office procedures, such as laser skin resurfacing or peels, microdermabrasion, or microneedling,
−Removed: among other procedures.
−Removed: Both E-Series™ products contain our Elevai Exosomes TM , those ultra-small, nanoparticle compartments
−Removed: packed with growth factors known to support skin health alongside hyaluronic acid, vitamin C, ceramides, niacinamide, glutathione and
−Removed: a proprietary blend of peptides to promote our formulations support both skin complexion and appearance.
−Removed: Our Empower™ serum retails
−Removed: at $149 per tube and wholesales for $596 for an eight-product pack.
−Removed: Our Enfinity™ serum retails at $299 a bottle and wholesales
−Removed: for $149 a bottle.
−Removed: Our products are sold as complementary to in-office procedures and are provided at the option of our physician client
−Removed: or at the request of that physician’s customer.
−Removed: In most cases the customer is being examined by the physician beforehand to determine
−Removed: the procedure.
−Removed: Often the customer is purchasing our Enfinity™ serum to precondition the skin prior to the procedure.
−Removed: of the procedure a medical professional applies the Empower™ serum post-procedure.
−Removed: Then the customer is recommended to continue
−Removed: using Enfinity™ at home within 24 to 48 hours of the procedure.
−Removed: products are being dispensed in two different models that are complementary to the service provided.
−Removed: In the first model the physician
−Removed: client includes our products in the price of the entire procedure.
−Removed: In the other models the physician client recommends both products
−Removed: and the patients decide whether they would like to add one or both products.
−Removed: In both models the physician client buys the product at
−Removed: the foregoing price points.
−Removed: The physician client retains the difference in between the wholesale price and the suggested retail price.
−Removed: statements herein regarding our Empower™, and Enfinity™ topical cosmetic and exosome-containing serums have not been reviewed
−Removed: or approved by the FDA.
−Removed: For a discussion of certain risks and governmental regulation related to these products, see “Part 1.
−Removed: Risk Factors—Risks Related to Our Products Legal and Regulatory Risks” below.
−Removed: is our after-treatment topical product that supports skin health and promotes an even toned complexion.
−Removed: Empower™ serum is a concentrated
−Removed: serum, designed specifically for a one-time application post ablative procedures and treatments such as such as post mid-depth chemical
−Removed: peels, post micro needling, and post injectables.
−Removed: The ingredient-rich formulation is designed to support the skin’s moisture recovery
−Removed: and improve the appearance of the health of the skin while promoting the appearance of healthy skin texture.
−Removed: is our after-treatment topical product that supports the appearance of healthy skin and is designed to promote an even toned complexion.
−Removed: Empower™ serum is a concentrated serum, designed specifically for application post ablative procedures and treatments such as such
−Removed: as energy device treatments, mid-depth chemical peels, micro needling, or injectables.
−Removed: Enfinity™ is our continuing care product
−Removed: that we recommend for daily use.
−Removed: Our Enfinity™ daily serum is a stable serum for at-home daily use that contains a blend of Elevai
−Removed: Exosomes TM combined with complementary stem cell growth factors.
−Removed: This daily product contains complimentary skincare ingredients
−Removed: designed to support the appearance of healthy skin including Elevai Exosomes TM , vitamin C, hyaluronic acid, and copper peptides.
−Removed: Our exosome-based products, Enfinity™ are designed to remain shelf stable, are subject to minimal degradation over time when used
−Removed: and stored as directed, and do not require freezing or reconstitution prior to each use.
−Removed: We believe that our Enfinity™ serum with
−Removed: repeated use catalyzes healthier looking, and more balanced skin tone and texture, offering results that visibly reduces the appearance
−Removed: of age-related pigment and fine lines.
−Removed: further believe that our products have the potential to be used in a number of applications and other procedures beyond their current
−Removed: For example, we are in the early stages of evaluating the adjunctive use of our exosomes in the promotion of healthy hair growth
−Removed: cycles and noticeable improvement to hair appearance, fullness and thickness.
−Removed: Similarly, on November 28, 2023, we entered into a collaboration
−Removed: and license agreement (the “Collaboration Agreement”) with Yuva BioSciences, Inc., a Delaware corporation (“Yuva”).
−Removed: Under the Collaboration Agreement, we have agreed to collaborate with Yuva on the research, development, manufacture and commercialization
−Removed: of a potentially new cosmetic product for Company’s aesthetics skincare offerings.
−Removed: See “Our Product Development and Manufacturing
−Removed: Process” for more information.
−Removed: December 2021, we achieved positive results from two multi-week clinical dermal safety evaluations of our Empower™ serum and Enfinity™
−Removed: For the dermal safety evaluations, Essex Testing Clinic, Inc.
−Removed: (“Essex”) conducted two separate single-center,
−Removed: semi-occlusive patch test trials to evaluate the irritation and sensitization potential of our Empower™ serum and Enfinity™
−Removed: daily serum in 56 healthy adult male and female volunteers.
−Removed: The studies utilized cumulative as well as repeat insult patch designs, which
−Removed: aim to provide a standard assessment of cutaneous tolerability and safety.
−Removed: The studies’ results demonstrated our Empower™
−Removed: serum and Enfinity™ daily serum were topically well tolerated.
−Removed: There was no irritation or sensitization caused by our Empower™
−Removed: serum and Enfinity™ daily serum at any time during the course of the evaluations, and no adverse events and no severe or serious
−Removed: adverse events were reported.
−Removed: January 2022, we entered into a white label non-exclusive authorized global distribution agreement and trademark license agreement with
−Removed: the premier aesthetic device company DermapenWorld Inc..
−Removed: DermaPenWorld are makers of the DermaPen micro needling device and have an established
−Removed: customer base across many geographies.
−Removed: When pressed onto skin, DermaPenWorld’s high quality micro needling device encourages collagen
−Removed: production but causes minor levels of skin trauma and redness.
−Removed: Our Elevai Exosomes™ infused products offer synergistic value to
−Removed: DermapenWorld’s device because our products may be applied afterward to support recovery and enable consumers to conclude their
−Removed: treatment session with what we believe to be less visible redness and faster comfort levels.
−Removed: Under the agreement, DermapenWorld agreed
−Removed: to purchase minimum quantities of Elevai Exosomes™ to be included as a key ingredient within DermapenWorld’s “Dp Dermaceuticals TM
−Removed: Meso-Glide EXO-SKIN TM ” products that will be distributed globally, spanning across Europe, Asia, Africa, the Americas
−Removed: and Australia.
−Removed: DermapenWorld’s Dp Dermaceuticals TM product line was specifically developed to be used when performing
−Removed: microneedling, which are now enhanced by ELEVAI Exosomes™, along with our Enfinity™ daily serum, which will be packaged in
−Removed: DermapenWorld’s Dp Dermaceuticals TM packaging.
−Removed: The DermapenWorld distribution agreement requires a royalty to be paid
−Removed: for sales within the United States or Canada.
−Removed: In FY 2021 the DermapenWorld distribution agreement formed none of our overall revenue
−Removed: and in FY 2022 no sales under the DermapenWorld distribution agreement were recorded within the United States or Canada.
−Removed: In FY 2022 and
−Removed: FY 2023 sales recorded outside of the United States and Canda under the DermapenWorld distribution agreement formed part of our overall
−Removed: Because of the foregoing, we did not receive any revenue attributable from royalty payments.
−Removed: On June 26, 2023, pursuant to the
−Removed: terms of our white label non-exclusive authorized global distribution agreement and trademark license agreement with DermaPenWorld, we
−Removed: sent a termination letter to DermaPenWorld providing notice that we will not renew the distribution agreement and trademark license agreement
−Removed: upon their expiration.
−Removed: The termination notice was effective as of the end of business on January 16, 2024.
−Removed: August 2022, we entered into a non-exclusive authorized distribution agreement with one of the preeminent manufacturers and distributors
−Removed: of innovative aesthetic medical device technologies and clinical grade skincare, Refine USA, LLC (“Refine”).
−Removed: Under the agreement,
−Removed: Refine may purchase unlimited quantities of Elevai Exosomes™ and distribute them throughout the United States to their network
−Removed: of consumers and physicians.
−Removed: times, because of our limited internal research and development capacity, we outsource portions of our product research and development
−Removed: and have joined force with Raydus Research Inc.
−Removed: (“Raydus Research”), a contract research organization (“CRO”)
−Removed: under a formal statement of work to analyze the cell population our cultured hUMSCs produce under varied in-vitro culture conditions
−Removed: and the concentration of exosomes contained therein.
−Removed: Any data resulting from our CRO under this agreed upon statement of work is our
−Removed: with Raydus Research, we are utilizing a number of advanced analytical techniques to help us improve our current processes
−Removed: and keep our brand at the forefront of exosome products.
−Removed: To analyze our exosomes, we utilize NanoSight, a nanoparticle tracking analysis
−Removed: instrument so we may evaluate the proteomic characteristics (or characterization of the protein makeup) of our exosomes.
−Removed: thorough process we access the make-up of our finalized exosomes while balancing the efficiency of different adjustments to our cell-culturing
−Removed: production process.
−Removed: Taking the time to note the variability in our production based on establishing notable and favorable characteristics
−Removed: of the exosomes produced from those variations help keep our final products optimized.
−Removed: Our analysis is dependent on analyzing characteristics
−Removed: such as those exosomes’ nanoscopic scale (or nanoscale) which is often dependent on the unique culture techniques we may subject
−Removed: our hUMSCs to.
−Removed: Through these measurements, we can better understand those processes that lead to optimal production of exosomes from
−Removed: our hUMSCs that exhibit characteristics that are most effectively absorbed and utilized topically.
−Removed: We will further conduct this analysis
−Removed: from time to time to perform quality control on our processes to confirm the size and distribution of our exosomes and so that we are
−Removed: generating the best possible exosome products under the most efficient production conditions.
−Removed: NanoSight is one of a few technologies
−Removed: to detect the size of exosomes and count them and group them or graph out their distribution.
−Removed: This also helps us to identify whether
−Removed: our process results in fully intact exosomes or if under our culturing process, we may have damaged our hUMSCs.
−Removed: Any such damage tends
−Removed: to release apoptotic bodies (or damaged cells), and allows us to modify our purification process, which can remove most apoptotic bodies.
−Removed: Since we are able to identify those processes that produce the best possible quality exosomes, we are able to remain confident that our
−Removed: products continue to work the way we expect them to.
−Removed: Raydus Research
−Removed: is integral to our research and development to assist in media formulation.
−Removed: With their assistance, we better understand how to trigger
−Removed: the stem cells into producing the right exosomes and in the right quantities.
−Removed: The media we use to grow the stem cells is constantly being
−Removed: fine-tuned with different growth factors to determine what the right ratios should be and which growth factors that are needed to best
−Removed: optimize our production process.
−Removed: Raydus Research’s analysis allows us to understand how reproducible our production process
−Removed: from batch to batch is, but also gives us quantitative analysis for how we can best culture our hUMSCs and perfect our PREx™ process.
−Removed: addition to the above, we are actively seeking potential strategic partnerships in the medical aesthetics skincare market that may add
−Removed: value to our product lines and broaden our distribution.
−Removed: Between February and December of 2023, we entered into five high-volume distribution
−Removed: agreements in Canada, Vietnam, the Philippines, the Balkans and Kuwait.
−Removed: As of March 18, 2024, and the date of this report, we no longer
−Removed: distribute or advertise our products in Canada through our distribution agreement until a time that a resolution can be reached with
−Removed: Health Canada with regard to how the products can be marketed in Canada.
−Removed: Depending on the outcome of Elevai’s engagement with Health
−Removed: Canada, Elevai products may become subject to additional regulatory requirements in order to be marketed in Canada.
−Removed: However aside from
−Removed: expanding sales of our current products, we also plan to continue to invest in our research and development capabilities which will assist
−Removed: in the expansion of manufacturing and marketing new flagship products in addition to our E-Series™ product line through our Collaboration
−Removed: Agreement and through independent research and testing.
−Removed: As of the date of this report, we have several pipeline products in the early
−Removed: development stages that we intend to complement our current product offerings.
−Removed: Product Development and Manufacturing Process
−Removed: currently lease a lab and office space within a larger facility that contains over 5,000 square feet of clean lab space where we manufacture
−Removed: exosomes and run daily business operations that are staffed by trained biochemical engineers from some of the top US medical colleges.
−Removed: All lab staff participate in a stringent training program and detailed standard operating procedures are followed throughout the entire
−Removed: commercialization process with multiple checks in place throughout to promote the quality of our product lines.
−Removed: have exclusively developed our manufacturing process through our management team’s experience in developing and curating the production
−Removed: needed for our robust skin care products, which we believe provides us with a competitive edge.
−Removed: Success in manufacturing our Elevai Exosomes TM
−Removed: requires refined processes that are reliable, scalable, and economical.
−Removed: In our lab, we grow our ethically sourced stem cells and
−Removed: trigger them such that they produce exosomes under our proprietary method.
−Removed: We take the exosome ingredient from our lab to our formulator
−Removed: on a non-exclusive basis who follows our specified parameters to support our exosomes’ ability to maintain our high quality and
−Removed: integrity standards.
−Removed: We maintain manufacturing scalability and flexibility through our in-house exosome process that we closely monitor
−Removed: to promote quality control in the commercialization of all of our proprietary product concepts.
−Removed: In January 2023, we
−Removed: entered into the EMx License Agreement under which we were granted worldwide exclusive and non-exclusive license rights to develop, manufacture,
−Removed: and commercialize EMx technology which will allow us to isolate and independently engage in the cGMP manufacture of hUMSCs for a period
−Removed: of ten years from the effective date of the License Agreement.
−Removed: of the date of this report, we own or have an agreement in principle for the right to purchase the related manufacturing processes, and
−Removed: methods with our third-party vendors.
−Removed: We also maintain an agreement with our formulator which provides us with the right to purchase
−Removed: the product formulas.
−Removed: Moreover, we also oversee our leased laboratory space in California which operate under Good Laboratory Practices
−Removed: (“GLP”) and adhere to cGMP for the production of our Elevai Exosomes TM .
−Removed: Similarly, our products are formulated
−Removed: by a third-party in an FDA inspected facility that adheres to GMP guidelines because GMP guidelines promotes the manufacture of our products
−Removed: at the highest recommended safety and quality standards for cosmetic products.
−Removed: July 2023, we expanded a portion of our laboratory space by an additional 721 square feet in order to store additional materials which
−Removed: in turn enables us to stage larger batches of our Elevai Exosomes TM and increase the amount of Elevai Exosomes TM
−Removed: we can produce per production-run via our Precision Regenerative Exosome Technology TM , or PREx™ Technology.
−Removed: expanded space, we estimate our batch size has increased about 50%, therefore we can manufacture about 50% more of our Elevai Exosomes TM
−Removed: per production-run.
−Removed: We believe this expansion will increase our efficiency by enhancing our ability to meet a particular target
−Removed: production level during the timeframe in which we set such a target and with less production-runs via PREx™.
−Removed: Expanding the batch
−Removed: size enables more time in between batches for us to plan, scale, and focus on research and development activities.
−Removed: rental facility contains multiple cell and tissue culture suites containing biosafety cabinets and cell culture incubators.
−Removed: does our facility provide a significant amount of cold storage and processing space that permit large-scale culture of hUMSCs and the
−Removed: ability to mass produce of stem cell-derived exosomes but allows us to perform cryo-preservation, cryo-storage, various forms of microscopy
−Removed: and cell analysis.
−Removed: Some additional key features of our rental facility include 24/7 security, advanced climate control, increased cold
−Removed: storage, additional cell culture and R&D suites to perform supplemental in-house research.
−Removed: have also collaborated with third parties such as through our Collaboration Agreement with Yuva under which we will conduct joint trials
−Removed: in order to evaluate Yuva’s licensed compound’s effect on improving the appearance of skin.
−Removed: Under the Collaboration Agreement,
−Removed: we obtained the non-exclusive, nontransferable, non-assignable, royalty-bearing rights and a license, with the right to sublicense certain
−Removed: of Yuva’s intellectual property to develop, manufacture and commercialize cosmetic products that contains Yuva’s proprietary
−Removed: compound and any of the Company’s exosome-based ingredients, or products under which exosomes serve as a carrier for Yuva’s
−Removed: proprietary compound in the United States, Canada and other mutually agreed to territories .
−Removed: of our rental facility operate under strict aseptic conditions following GLP standards which are used for cell culture and production
−Removed: of the company’s proprietary stem cell exosomes for topical applications while other portions of the lab provide access to a cGMP
−Removed: suite for ultra-pure, medical-grade research and development.
−Removed: Because we maintain the unique capacity to isolate and hUMSCs for use in
−Removed: preclinical and clinical trials and have access to cGMP labs alongside stem cell research and development labs with class II biosafety
−Removed: cabinets and the latest cellular research and production technologies, we are able to not only focus on cosmetic topical products for
−Removed: the physician-dispensed cosmetics skincare market but also address and explore clinical applications of these products in the future.
−Removed: manufacturing process begins once we receive ethically sourced and thoroughly tested hUMSCs, from consenting donors who are themselves
−Removed: rigorously questioned and tested for communicable diseases.
−Removed: Elevai purchases hUMSCs from third-party cGMP sources in the US and in the
−Removed: UK where the Wharton’s Jelly portion of the hUMSCs are captured and extracted within twenty-four hours of a full-term healthy birth.
−Removed: Wharton’s Jelly is a mucous connective tissue primarily made up of hyaluronic acid and chondroitin sulfate and the main purpose
−Removed: of Wharton’s jelly is to provide insulation and protection to the umbilical cord.
−Removed: These properties make our use of these cord derived
−Removed: cells ideal for our commercialization process.
−Removed: This is because these stem cells’ conditioned media (“CM”) or stem cells’
−Removed: secretome is capable of resulting in exosomes with a protein profile that uniquely mimics the profile of proteins that these very young
−Removed: cells naturally produce when supporting healing and repair process that we believe complement the aesthetic results of our serums in
−Removed: improving the appearance of the skin.
−Removed: work with multiple suppliers to source our high quality hUMSCs for research and development, which are provided after isolating those
−Removed: hUMSCs from multiple umbilical cords under specific proprietary conditions where cell expansion and cryopreservation is utilized, followed
−Removed: by creation of a master and working cell bank under cGMP.
−Removed: A master cell bank (“MCB”) is a uniform, well-characterized, and
−Removed: carefully preserved set of cells.
−Removed: These cells are derived from a single, well-defined source.
−Removed: The advantage of establishing a MCB is
−Removed: to ensure that set of cells serves as the primary stock of cells from which all subsequent cell banks (e.g., working cell banks) and
−Removed: final products are derived.
−Removed: We believe that establishing a MCB is essential for ensuring the consistency, and quality because there are
−Removed: less variations for characterization and increased quality control of the MCB.
−Removed: The formation of an MCB involves rigorous testing for
−Removed: identity, purity, potency, and stability, as well as screening for the presence of any contaminants, such as bacteria, fungi, viruses,
−Removed: or mycoplasma.
−Removed: Similarly, using multiple cords to source our hUMSCs from a blend of Wharton’s Jelly MSCs from ten or more donor
−Removed: cords ensures that any gene expression issues or donor to donor variability is diluted out, protecting from causing variability in our
−Removed: final product.
−Removed: Using a mixture of donors helps to normalize any issue with any single donor and we believe it to improve our batch consistency
−Removed: and limit the impact of any deficiencies from a single donor.
−Removed: of the date of this report, we rely on one supplier to source hUMSCs for our cosmetic products under a non-exclusive supply agreement
−Removed: in principle for the proprietary production of hUMSCs with INmune Bio International Ltd (England) (“INmune UK”).
−Removed: agreement exists in principle at the time of this report, and we operate through purchase orders.
−Removed: INmune UK has developed a proprietary
−Removed: know how manufacturing process that reliably produces clinical grade cGMP quality hUMSCs.
−Removed: INmune UK’s hUMSCs are rigorously tested
−Removed: for common sources of contamination (bacterial and fungal contamination) as well as for a wide variety of viruses, including HIV, Hepatitis,
−Removed: Herpes, and current known viruses that are standard to test for when blood or tissue is donated for transplant.
−Removed: These hUMSCs are express
−Removed: shipped to our lab in California on dry ice, where we keep them cryopreserved until processing using PREx™.
−Removed: hUMSCs are thereafter subjects in our proprietary production process called Precision Regenerative Exosome Technology TM , or
−Removed: PREx™ Technology, which is used to produce Elevai Exosomes™.
−Removed: Cell therapy and biotech companies also currently utilize this
−Removed: same technique of combining multiple, well tested lots of donor cells to promote reliable, consistent production of their cell-based
−Removed: products and this represents the current standard for safety, aesthetic results, and reproducibility for cell-based therapies.
−Removed: from this well tested cell bank of Wharton’s Jelly hUMSCs, we utilize proprietary cell culture techniques to trigger the production
−Removed: of our Elevai Exosomes TM through proprietary controlled in vitro culture conditions.
−Removed: The conditions in which Elevai Exosomes™
−Removed: are secreted are designed to simulate what young healthy stem cells experience when damage to the skin occurs.
−Removed: Thereafter, we filter
−Removed: out cells and cell debris, and work to isolate exosomes and nanoscale growth factors that are then further purified and stabilized to
−Removed: formulate our products which are rich in Elevai Exosomes TM .
−Removed: our lab, we transfer our Elevai Exosomes TM to an FDA inspected cGMP-compliant formulator who specializes in the formulation
−Removed: and manufacture of prescription, over-the-counter pharmaceutical, and cosmetic products.
−Removed: This formulator produces our products pursuant
−Removed: to our specifications under our non-exclusive agreement.
−Removed: The manufacturer is required by law and by our manufacturing standards to comply
−Removed: with current Good Manufacturing Practices.
−Removed: Elevai pre-qualifies its manufacturers and formulators and works only with manufacturer’s
−Removed: that are FDA inspected.
−Removed: This requires our formulators to test both their ingredients and final products for quality, traceability and
−Removed: safety per FDA recommended GMP guidelines for cosmetic products.
−Removed: Additionally, these guidelines include testing each ingredient prior
−Removed: to use in a formulation as well as testing the final product produced for microbial contamination.
−Removed: Once with our formulator, the Elevai
−Removed: Exosomes TM are processed into final formulations and stabilized in a temperature-controlled environment where they are combined
−Removed: with ingredients at a low shear forces and controlled potential of Hydrogen (“pH”) to promote stability.
−Removed: Additionally, the
−Removed: final formulations are preserved using minimal preservatives, kept in viscose solution to prevent effects of shear forces in the downstream
−Removed: processes, such as during transport or rapid temperature fluctuations that may result in the breaking down of exosomes.
−Removed: These final formulations
−Removed: are placed into opaque containers which help protect from oxidation through a sealed and double walled airless pump and final products
−Removed: are stored in a temperature-controlled warehouse prior to being brought to market.
−Removed: We have and will continue to devote significant resources
−Removed: to process development and manufacturing scale-up to optimize process robustness and success rates in developing our Elevai Exosomes
−Removed: TM and other potential product candidates, as well as to reduce per-unit manufacturing costs and enable us to further enhance
−Removed: our scale for regional and global sales.
−Removed: infused with our Elevai Exosomes TM , our products require no additional specialty manufacturing capabilities or unique, sole-source
−Removed: This reduces our dependence on any single manufacturer.
−Removed: and Marketing
−Removed: the United States, we are primarily a B2B distributor and sell and market our skincare products to top-end dermatologists, plastic surgeons,
−Removed: medical spa owners and other physicians who are focused on aesthetic and therapeutic skincare.
−Removed: As of the date of this report, we primarily
−Removed: sell and market through our team of eight independent contractors or aesthetic account managers (“AAMs”) and direct sales
−Removed: force of six full time AAMs.
−Removed: This team is led by our director of aesthetic clinical education.
−Removed: Currently we maintain domestic sales coverage
−Removed: in the Pacific Southwest including Texas, Atlantic Northeast including New England, the Atlantic Southeast, and Midwestern regions of
−Removed: the United States.
−Removed: Our AAMs receive ongoing education in both our product lineup and sales strategies, which we believe prepares them
−Removed: for progression to regional sales managers within their designated regions.
−Removed: Following this advancement, our sales strategy involves subdividing
−Removed: the aforementioned territories, with our aim to staff a minimum of one AAM per state in the United States.
−Removed: We believe this subdivision
−Removed: will continue in alignment with our growth trajectory, in order to provide each of our territories with dedicated support from our AAMs,
−Removed: who are trained to provide premium, personalized service.
−Removed: Furthermore, we are committed to implementing a structured engagement plan,
−Removed: including 30-60-90 day calling schedules and setting tailored sales goals for each AAM.
−Removed: These objectives will be adjusted based on both
−Removed: the geographical scope and the market potential of each AAM’s territories.
−Removed: medical professionals we sell to dispense our products in-office directly to their patients, a distribution method commonly referred
−Removed: to as the “physician-dispensed” channel.
−Removed: Additionally, we have broadened our sales channel to include our cosmetic product
−Removed: offerings at medical spa locations to their customers who receive micro-needling, and laser treatments.
−Removed: our professional clients receive a markup on each of our products that they sell to customers of their practices.
−Removed: We believe our professional
−Removed: clients financially and strategically benefit by collecting a margin and competitively adding a new income stream and distinguishing
−Removed: product-line to their practices’ milieu.
−Removed: Additionally, we offer these professional clients the ability to sell our products directly
−Removed: to their customers through our online store where capture a percentage of the sale.
−Removed: We also sell our products nationally on a business-to-business
−Removed: basis through our sales representatives.
−Removed: We believe that our market position in the physician-dispensed channel presents us with the
−Removed: opportunity to increase the market share of our existing products and to launch a range of new products.
−Removed: Moreover, we believe the physician-dispensed
−Removed: distribution model ultimately results in higher patient satisfaction because it is better suited to the provision of system-based skin
−Removed: care than traditional distribution channels.
−Removed: We have built long-term relationships with skin health professionals based on the success
−Removed: of our products during the first few formative years since launching our Elevai Post Treatment E-Series™.
−Removed: We will continue our
−Removed: sales and marketing efforts aimed at helping physicians understand how our products can meet growing patient demand for effective skin
−Removed: care treatments, thereby generating additional sources of revenue for physician practices.
−Removed: Furthermore, we believe that our product offerings,
−Removed: and our experienced sales force, uniquely position us to benefit from growth in the number of physicians who dispense skin care products
−Removed: directly to their patients.
−Removed: 2023, we established three core strategic imperatives to drive our collective marketing and branding campaigns with an overarching goal
−Removed: of opening new physician accounts specifically in the fields of dermatology and plastic surgery.
−Removed: In doing so, we intended to grow our
−Removed: product footprint to grow our month-over-month sales by adding new accounts each month and growing monthly sales in those accounts.
−Removed: three core strategies included (i) accelerating our branding through product awareness, (ii) focusing on product differentiation and
−Removed: our unique value proposition, and (iii) building well-regarded clinical evidence alongside key opinion leader (“KOL”) advocacy
−Removed: for our current and future products.
−Removed: 2024 our strategic imperatives are built on the framework and the momentum gained in 2023 with our core business-to-business strategy.
−Removed: Our growth strategy for 2024 has now expanded to include a new direct-to-consumer sales channel which together with a potential product
−Removed: expansion may drive an effective marketing-led growth strategy designed to produce additional revenue on both the core business-to-business
−Removed: and direct-to-consumer sales channels.
−Removed: We plan to continue to leverage our core strategic imperatives of accelerating brand and product
−Removed: awareness, focusing on differentiation and unique value propositions, and building clinical evidence alongside key opinion leader advocacy
−Removed: among dermatologists and plastic surgeons.
−Removed: addition to the foregoing relationships with our core physician practices, we plan to continue accelerating our company, brand, and product
−Removed: awareness through multiple marketing channels.
−Removed: These include driving traffic to our branded website through advertising and paid media.
−Removed: These media partners include but not limited to print and digital advertisements, social media advertising, and email marketing and social
−Removed: media campaigns.
−Removed: Our ongoing email campaigns include keeping our current accounts and leads updated regarding our brand and products,
−Removed: and we plan to expand social media presence on TikTok to reach new audiences.
−Removed: Other valuable marketing includes accelerating our industry-specific
−Removed: advertising and sponsorships at key conferences, ten of which we have identified opportunities for in 2023 alone.
−Removed: Additionally, we attempt
−Removed: to create and build relationships with our physician’s clients through these physicians displaying and marketing our products to
−Removed: their patients.
−Removed: We believe that physicians and their trained staff are the best source of trustworthy skincare information.
−Removed: understanding of the science, chemistry and structure of skin gives them clinical insight to select the most effective products for patients
−Removed: such as ours.
−Removed: To support this effort, we offer educational programs and webinars on our products and patient events to help these physicians
−Removed: grow their practices.
−Removed: We also offer in-office materials on our products for their patients, as an organic form of direct-to-consumer
−Removed: advertising in addition to public relations programs for patient referrals.
−Removed: Together these paid advertisements, conference sponsorships,
−Removed: public webinars and in-office education represents an important part of our overall marketing and advertising strategy.
−Removed: Overall, we believe
−Removed: educating current and potential consumers will drive consumer inclination to request our products from their physician to drive organic
−Removed: demand and market penetration.
−Removed: brand our current and future products, we believe focusing on our differentiation and unique value proposition will set us apart for
−Removed: maximized growth and new and evolving partnerships.
−Removed: We plan to expand unbranded and branded product education for our aesthetic account
−Removed: managers and KOLs in order to position our brand as a leader in the physician-dispensed cosmetics space with both exosome biotechnology
−Removed: and engineering expertise.
−Removed: This cohesion amongst our key representatives will differentiate our brands from competitors at every stage
−Removed: with our source to skin manufacturing and technology.
−Removed: From there, we will propel our brand forward to promote a clear value proposition
−Removed: and business value for Elevai with our team and KOLs in lockstep.
−Removed: Ultimately, we believe this strategy will demonstrate to our current
−Removed: and prospective physician accounts how our brand can bring value to their practice as a business.
−Removed: we intend to build clinical validation study evidence and brand our products through a groundswell of KOL advocacy to establish and expand
−Removed: on core clinic data for our E-Series™ product line and eventual product entrants.
−Removed: As we authenticate and build up quantitative
−Removed: data for new publication opportunities, we plan to validate our product offerings through additional medical aesthetic device pairings.
−Removed: Our ability to form device company collaborations provides additional authenticity and validation amongst larger companies in adjacent
−Removed: cosmetics or aesthetics industries.
−Removed: Our endorsements through branded partnerships will further support KOL development and advocacy through
−Removed: ongoing education and peer-to-peer opportunities including wider endorsements of the Elevai brand to drive physician adoption.
−Removed: A well-developed
−Removed: combination of our core KOLs and co-branding opportunities will present the Elevai brand with the ability to retain a broader reach in
−Removed: the physician-dispensed industry and more of the market share.
−Removed: Internationally,
−Removed: we have the ability to sell our products through authorized wholesale distributors.
−Removed: As of the date of this report, we have not made any
−Removed: direct international sales.
−Removed: Instead, our Vietnamese, Philippines and Canadian distributors have sold our products and are three out of
−Removed: a number of distributors with whom we have entered into exclusive and non-exclusive distribution agreements.
−Removed: Under this distribution
−Removed: agreement channel, we sell our products to a distributor, who resells our products to the physician practice customers after placing
−Removed: their order in a designated territory that is either exclusive or non-exclusive to that distributor.
−Removed: In 2022 alone, we signed a white
−Removed: label non-exclusive authorized global distribution agreement with premier aesthetic device company DermapenWorld Inc.
−Removed: and a non-exclusive
−Removed: distribution agreement with medical device technologies manufacturer and clinical grade skincare distributor, Refine USA, LLC.
−Removed: February and December of 2023, we entered into five high-volume distribution agreements in Canada, Vietnam, the Philippines, the Balkans
−Removed: and Kuwait whereby those distributors are permitted to promote, market, sell and distribute our products within their designated countries.
−Removed: Under these exclusive distribution agreements, we granted each a nonexclusive, nontransferable, royalty free license to use our branded
−Removed: products and marketing literature.
−Removed: As of March 18, 2024, and the date of this report, we no longer distribute or advertise our products
−Removed: in Canada through our distribution agreement until a time that a resolution can be reached with Health Canada with regard to how the
−Removed: products can be marketed in Canada.
−Removed: Depending on the outcome of Elevai’s engagement with Health Canada, Elevai products may become
−Removed: subject to additional regulatory requirements in order to be marketed in Canada.
−Removed: Except for product sales made by our Vietnamese, and
−Removed: Canadian distributors, as of the date of this report, our distributors have not made any sales under any of our exclusive distribution
−Removed: Growth Strategy
−Removed: believe we have the potential to be one of the most disruptive brands in the physician-dispensed cosmetics skincare market.
−Removed: the early stages of new product development and have significant room to grow by attracting more consumers to the brand, making our current
−Removed: products more widely available and offering more innovative products to our consumers.
−Removed: We expect the United States to be the largest
−Removed: source of our growth over the next few years and see ample opportunity to expand in select international markets.
−Removed: We also believe we
−Removed: have an opportunity to improve our margins through greater operating leverage and efficiency once we begin distributing our product more
−Removed: Technology and Research :
−Removed: believe we are one of the first to adapt stem cell technology from cGMP grade hUMSCs to produce purified extracellular vesicles, also
−Removed: referred to as exosomes into topical skincare products to capture market share in the high growth physician-dispensed cosmetics skincare
−Removed: This strategy is not only based on our understanding of consumers’ interest in the appearance of a quicker post-procedure
−Removed: recovery, but our research into what the physician-dispensed cosmetics skincare market is currently lacking and our belief in our products’
−Removed: ability—based on early imaging data leveraging quantitative analysis and visual assessments of photographic progress photos.
−Removed: imaging study data is gathered utilizing an advanced imaging and analysis device made by Canfield Scientific, called “VISIA”.
−Removed: This complexion analysis system captures high-quality, standardized images that are monitored following a medical aesthetic procedure
−Removed: at regular intervals to assess redness, discomfort, tone, texture, wrinkles, and other measures of skin appearance.
−Removed: 2020, we have invested in the creation of a commercial process that began in 2022 which leverages the use of hUMSCs to produce extracellular
−Removed: vesicles, or exosomes in our products because not only do these factors have the ability to enhance the appearance of the skin, but they
−Removed: can do so without the tumorigenic or ethical concerns associated with the use of embryonic stem cells or induced pluripotent stem cells.
−Removed: Because we recognized the potential of utilizing hUMSCs for the skin, it was natural for us to utilize them as the basis for formulating
−Removed: our products.
−Removed: In addition, we entered into the EMx License Agreement in January 2023 under which
−Removed: we were granted worldwide exclusive and non-exclusive license rights to develop, manufacture, and commercialize EMx technology which
−Removed: will allow us to isolate and independently engage in the cGMP manufacture of hUMSCs for a period of ten years from the effective date
−Removed: of the EMx License Agreement .
−Removed: The investment in the use of hUMSCs and extraction of exosomes found therein is founded on our belief
−Removed: that our products can improve the appearance of skin prone to appearing temporarily red and puffy that is normally experienced by consumers
−Removed: while attending to their aesthetics needs in physicians’ offices or medical spa.
−Removed: Visionary and Experienced Management Team:
−Removed: have made significant investments in our business over the past four years by building our own exosome manufacturing lab, hiring top
−Removed: talent to help us build functional and streamlined capabilities in our commercialization process.
−Removed: Our management team comes from leading
−Removed: international skincare companies, with world-class research, marketing, and e-commerce experience to implement growth strategies and
−Removed: drive operational improvements.
−Removed: and Product Expansion :
−Removed: plan to continue to grow our young brand’s reputation.
−Removed: We plan to continue to expand our brand by attending events, presenting
−Removed: at scientific and medical aesthetic and cosmetic skincare conferences, engaging in our Collaborative Agreement with Yuva, and conducting
−Removed: clinical validation studies to further validate the aesthetic results of our products.
−Removed: We believe what differentiates us from many traditional
−Removed: cosmetics companies is our lean, but aggressive ability to make fast market-driven decisions and execute with quality control standards.
−Removed: We believe we have a major speed-to-market advantage over many other companies because of our size and aptitude in bioprocessing.
−Removed: Similarly, we are highly responsive to market-trends alongside physician and aesthetics consumer needs alike.
−Removed: We will continue to leverage
−Removed: our executional excellence as we combine our aptitude in stem cell research and bioprocessing while seeking to become the preferred partner
−Removed: of our key customers.
−Removed: Additionally, we have a robust product pipeline that we believe is likely to address the many evolving needs of
−Removed: customers, physicians, and clinicians in the aesthetic and cosmetics market ultimately increasing our branding and the number of customers
−Removed: Should any of our pipeline products over perform, especially those product lines that may focus on aesthetic needs other than
−Removed: skin appearance it may be advantageous for our branding to spin off those product lines and further focus on our core market:
−Removed: skin improvement
−Removed: and appearance.
−Removed: Expansion, Production Capacity, and International Growth :
−Removed: strategic focus remains on the physician-dispensed cosmetic skincare market while embracing a broader sales channel approach.
−Removed: successfully expanded our sales channels to include direct-to-consumer e-commerce on our own website.
−Removed: This expansion allows us to reach
−Removed: customers directly, offering them comprehensive product information, a seamless purchase experience, and exclusive online offerings.
−Removed: We have also made our products available for purchase through our medical-spa, physician and physician group partners’ websites.
−Removed: We believe being featured on a variety of partner websites will strengthen our brand and provide a unique direct-to-consumer e-commerce
−Removed: model via our business-to-business relationships where our e-commerce partners receive a share of product purchase revenue.
−Removed: our business-to-business model will strengthen our relationships with our physician partners, while an eventual e-commerce model broadens
−Removed: our market exposure and drive traffic and conversion to our other social media profiles.
−Removed: Additionally, we expect our current and prospective
−Removed: exclusive and non-exclusive distribution agreements to penetrate global markets and pique consumer interest not typically within our
−Removed: current reach.
−Removed: We believe both our products and white-label products can drive new market demand for our brand in those international
−Removed: markets that our distribution partners sell our products in.
−Removed: Qiu G, Zheng G, Ge M,
−Removed: Wang J, Huang R, Shu Q, et al .
−Removed: Functional proteins of mesenchymal stem cell-derived extracellular vesicles.
−Removed: Stem Cell Res Ther.
+Added: have transitioned to a biotechnology holding company focused on acquiring, licensing, and developing biotechnology assets across various
+Added: pharmaceutical indications.
+Added: Our business model consists of two primary components:
+Added: Capital LLC, our multi-strategy investment vehicle, which seeks to generate revenue through capital deployment in undervalued biotechnology
+Added: assets, structured financings, and public and private market investments.
+Added: NorthStrive Biosciences Inc., our biotechnology subsidiary focused on advancing clinical-stage assets toward regulatory approval and commercialization.
+Added: ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL.
+Added: Projected U.S.
+Added: State-Level Prevalence of Adult Obesity
+Added: and Severe Obesity.
+Added: N Engl J Med 2019;381:2440-2450.
+Added: https://www.nejm.org/doi/full/10.1056/NEJMsa1909301.
+Added: the anti-obesity drug market could grow to $100 billion by 2030.
+Added: https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
+Added: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
+Added: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose
+Added: Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
+Added: Endocrinol Metab (Seoul).
+Added: 2019 Sep;34(3):247-262.
+Added: 10.3803/EnM.2019.34.3.247.
+Added: part of this strategic shift, we no longer operate in the physician-dispensed cosmetics or medical aesthetics markets.
+Added: Instead, our focus
+Added: is on developing and acquiring biotechnology assets that address critical unmet medical needs.
+Added: global biotechnology market continues to grow, driven by advancements in gene therapies, regenerative medicine, and biologics.
+Added: to market research, the global biotechnology industry was valued at approximately $1.37 trillion in 2022 and is expected to grow at a
+Added: CAGR of 12.8% from 2023 to 2030.
+Added: 28 This expansion is fueled by rising R&D investments, regulatory approvals, and the increasing
+Added: adoption of biotechnology-based therapies.
+Added: biopharmaceutical sector, which includes therapeutic proteins, monoclonal antibodies, and cell & gene therapies, represents a significant
+Added: share of this growth.
+Added: The market for gene therapies alone is expected to exceed $25 billion by 2028, with companies rapidly advancing
+Added: clinical-stage assets in oncology, metabolic diseases, and neurodegenerative disorders.
+Added: weight-loss drug market has also emerged as a high-growth sector, with GLP-1 receptor agonists such as Novo Nordisk’s Ozempic®
+Added: and Eli Lilly’s Mounjaro® driving unprecedented demand.
+Added: Goldman Sachs projects the anti-obesity drug market could reach $100
+Added: billion by 2030.
+Added: 30 However, research indicates that up to 40% of weight loss from GLP-1 drugs comes from lean muscle loss,
+Added: creating an unmet need for therapies that preserve muscle mass during treatment.
+Added: Lead Asset - EL-22:
+Added: A Myostatin-Targeting Probiotic for Obesity and Muscle Preservation
+Added: is currently developing EL-22, an engineered probiotic expressing myostatin antigens, designed to elicit an immune response that helps
+Added: preserve muscle mass while promoting fat loss.
+Added: Based on preclinical data and the role of myostatin-activin signaling in muscle metabolism,
+Added: we believe EL-22 has the potential to:
+Added: existing GLP-1 receptor agonists (e.g., Ozempic®, Wegovy®, Mounjaro®) by reducing muscle degradation while facilitating fat
+Added: muscle function and physical endurance, addressing key concerns associated with weight loss treatments.
+Added: studies demonstrated that EL-22:
+Added: ● Significantly
+Added: increased anti-myostatin IgG antibody concentration, blocking myostatin-a known negative regulator of muscle growth.
+Added: creatine kinase levels, indicating lower muscle destruction.
+Added: physical activity and motor function in mdx mice, a model for Duchenne muscular dystrophy (DMD).
+Added: intends to submit an Investigational New Drug (IND) application for EL-22 in 2025 and initiate clinical trials in the U.S.
+Added: its potential in combination with GLP-1 receptor agonists for obesity treatment.
+Added: However, human trials are contingent upon FDA clearance
+Added: of the IND submission.
+Added: PMGC Capital LLC driving investment revenue and NorthStrive Biosciences Inc.
+Added: advancing clinical assets like EL-22, our business is well-positioned
+Added: to capitalize on emerging opportunities in biotechnology.
+Added: By focusing on strategic acquisitions, clinical development, and high-growth
+Added: markets, we aim to enhance shareholder value and establish PMGC Holdings as a leader in biotechnology innovation.
+Added: Biotechnology
+Added: Market Size Report, 2023-2030.
+Added: (Grand View Research)
+Added: Therapy Market Growth, 2028.
+Added: (Fortune Business Insights)
+Added: the Anti-Obesity Drug Market Could Grow to $100 Billion by 2030.
+Added: (Goldman Sachs)
+Added: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
+Added: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists on Lean Body
+Added: Mass in Humans.
+Added: Endocrinol Metab (Seoul).
+Added: 2019 Sep;34(3):247-262.
+Added: 10.3803/EnM.2019.34.3.247.
+Added: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration
+Added: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22.
2022, 23, 9059.
−Removed: intend to expand the production capacity of our products and to develop new pipeline products in response to a number of potential growth
−Removed: factors, including:
−Removed: our organic growth, the development of research and development of pipeline products, and the expected increase in
−Removed: our product popularity, expansions of our distributor networks and channels through exclusive and non-exclusive international distributional
−Removed: agreements, and other potential strategic partnerships with industry leaders.
−Removed: Moreover, in addition to and as a result of the foregoing
−Removed: growth factors we expect an increase in orders for our products and a continuous rise in sales volume in the future based on our market
−Removed: research and estimates.
−Removed: To keep pace with this rise in sales volume, we anticipate the need to expand our production capacity in 2025.
−Removed: This expansion will enable us to meet our projected demand and we anticipate doubling our production capacity would cost between $1,500,000
−Removed: and $2,000,000.
−Removed: This additional capital would cover our expenses relating to expanded capacity, including increased rent, additional
−Removed: lab equipment, and an increase to our overall headcount.
−Removed: We expect increasing our production capacity will lower manufacturing costs
−Removed: through economies of scale and improve overall cost-efficiency and profit margins.
−Removed: Ultimately, we can provide our products at a competitive
−Removed: price, especially to cost-sensitive physicians or medical spa owners, and consumers in the skincare aesthetics market, who may be relatively
−Removed: new to the concept of medical aesthetics cosmetic skincare.
−Removed: expect to expand our product offerings in response to this estimated growth, which are subject to additional costs.
−Removed: To expand a single
−Removed: pipeline product, we currently estimate capital requirements of approximately $250,000 for equipment to support the initial development
−Removed: of that product.
−Removed: We further estimate an additional $100,000 worth of funds to arrange for the testing protocol, clinical validations
−Removed: and to fully launch any product at scale.
−Removed: We estimate the operational framework to prepare for the launch of a pipeline product such
−Removed: as a topical haircare product, would take six to twelve months of development work with an additional four to six months to fully scale
−Removed: such product before an official product launch.
−Removed: We estimate that this pipeline development and scaling effort would not likely begin
−Removed: until the end of quarter one of 2024 and conclude until quarter two of 2025.
−Removed: This estimate depends on whether we may need to expand our
−Removed: operations and development work of any new pipeline product, which is dependent on the results of the development work, continued research
−Removed: and initial rounds of validation testing.
−Removed: we directly distribute our products in the United States through both our business-to-business and direct-to-consumer sales channels
−Removed: and licensing and manufacturing agreements with third-party distributors that include our products in their suite of domestic and international
−Removed: sales through our sales distribution channel.
−Removed: Under this sales distribution channel, we sell our products to a distributor, who resells
−Removed: our products to the physician practice customers after placing their order in a designated territory that is either exclusive or non-exclusive
−Removed: to that distributor.
−Removed: We have broadened our sales channel to include our cosmetic product offerings at medical spa locations throughout
−Removed: the United States, many of which are housed inside boutique and upscale hotels.
−Removed: In March 2023, we entered negotiations to provide our
−Removed: cosmetic products to the spa operator.
−Removed: In May 2023, we began supplying a number of that company’s medical spa locations that provide
−Removed: ablative services such as micro-needling, and laser treatments.
−Removed: bolster our regional sales, we entered into a non-exclusive authorized distribution agreement in August 2022 with Refine USA, LLC (“Refine”),
−Removed: one of the preeminent manufacturers and distributors of innovative aesthetic medical device technologies and clinical grade skincare.
−Removed: Under the agreement, Refine may purchase unlimited quantities of our topical cosmetics subject to minimum order size limits and distribute
−Removed: them throughout the United States to their network of consumers and physicians.
−Removed: As we continue to enhance our own United States sales
−Removed: channels, we are focused on bringing on third-party distributors in key large international markets, such as Canada, Europe, Brazil,
−Removed: Southeast Asia and the Middle East.
−Removed: We also plan to drive the distribution of our products through strategic relationships in specific
−Removed: countries, such as Japan.
−Removed: To continue growing in the physician-dispensed market, we intend to onboard more direct sales representatives
−Removed: that can reach geographic markets we currently do not have a presence in and partner with cosmetic device companies to co-market and
−Removed: sell our products.
−Removed: To this end, in January 2022, we signed a white label non-exclusive authorized global distribution agreement with
−Removed: premier aesthetic device company DermapenWorld, which expanded the reach of our branding and serum integration.
−Removed: Under a ‘white
−Removed: label’ agreement our products or ingredients may be combined with another company’s ingredients or products and sold under
−Removed: that company’s brand name.
−Removed: Essentially, under these arrangements we provide products or ingredients that can be customized with
−Removed: branding and packaging to match the branding of the company that will be selling the product directly.
−Removed: Pursuant to that white label agreement,
−Removed: we provide a shared distributor wholesale quantities of our serums that are formulated together with DermapenWorld’s and products
−Removed: which are marketed globally subject to previously agreed upon key performance indicators.
−Removed: In addition, February and December of 2023,
−Removed: we entered into five high-volume distribution agreements in Canada, Vietnam, the Philippines, the Balkans and Kuwait whereby those distributors
−Removed: are permitted to promote, market, sell and distribute our products within their designated countries.
−Removed: Under these exclusive distribution
−Removed: agreements, we granted each a nonexclusive, nontransferable, royalty free license to use our branded products and marketing literature.
−Removed: Because we are entering new markets under each contract, we also arranged for each distributor to assist us in obtaining any required
−Removed: registrations, licenses and other applicable governmental approvals necessary to import, sell and distribute our products at our expense.
−Removed: As of March 18, 2024, and the date of this report we have voluntarily stopped the sale of our products in Canada through our distribution
−Removed: agreement following a communication from Health Canada determining that our products do not meet the conditions for sale as cosmetics
−Removed: As of March 18, 2024, and the date of this report, we are continuing to communicate with Health Canada and have voluntarily
−Removed: stopped the sale of our products in Canada until a time that a resolution can be reached with Health Canada with regard to how the products
−Removed: can be marketed in Canada.
−Removed: Depending on the outcome of Elevai’s engagement with Health Canada, Elevai products may become subject
−Removed: to additional regulatory requirements in order to be marketed in Canada.
−Removed: This will impede sales in Canada until resolved and raises concerns
−Removed: about our future collaboration with our distributor, Evolve Medical Inc.
−Removed: Moreover, on June 26, 2023, pursuant to the terms of our white
−Removed: label non-exclusive authorized global distribution agreement with DermaPenWorld, we sent a termination letter to DermaPenWorld providing
−Removed: notice that we will not renew the distribution agreement upon its expiration.
−Removed: The termination notice was effective as of the end of business
−Removed: on January 16, 2024.
−Removed: commercially viable, as our manufacturing process becomes more vertically integrated partially through the EMx License Agreement, we
−Removed: may expand our business model to provide mesenchymal stem cells (MSCs) to companies needing MSCs, large-scale stem cell culturing, or
−Removed: those companies developing MSC-derived products.
−Removed: This expanded role would position the company as a contract manufacturer and distributor
−Removed: of MSCs because we may become a dependable and well-regarded source of exosomes enriched cosmetic products which have been designed for
−Removed: topical application to assist in the recovery after the delivery of medical aesthetic services.
−Removed: Nonetheless, we aim to remain focused
−Removed: on developing and marketing topical products that are enhanced by unique stem cell derived additives and possibly expand from there into
−Removed: other high-science aesthetic skincare applications, given our biochemical engineering and bioprocessing prowess and ability to manufacture
−Removed: laboratory-based skincare additives ourselves.
−Removed: Thus, any expansion into our role as a manufacturer and distributor of MSCs would only
−Removed: come to fruition if funding and bandwidth were such that we felt we met all our aesthetic market goals and had remaining capacity, or
−Removed: we identified an overwhelming interest and opportunity to benefit from such a paradigm shift.
−Removed: In expanding under this strategic channel,
−Removed: we would likely partner, license, or outsource any non-aesthetics-based business so as not to complicate or defocus our Elevai product
−Removed: are committed to developing and protecting our intellectual property and, where appropriate, filing patent applications to protect our
−Removed: Since our establishment, we have focused on building an established brand for our products to achieve brand recognition and
−Removed: to increase our market share.
−Removed: We believe that increased brand awareness will increase sales and sales margins and improve customer loyalty.
−Removed: We have consistently marketed our products under the Elevai brand.
−Removed: rely on a combination of patent, copyright, trademark and trade secret laws and other agreements with employees and third parties to
−Removed: establish and protect our proprietary intellectual property rights.
−Removed: We require our officers, employees and consultants to enter into
−Removed: standard agreements containing provisions requiring confidentiality of proprietary information and assignment to us of all inventions
−Removed: made during the course of their employment or consulting relationship.
−Removed: We also enter into nondisclosure agreements with our commercial
−Removed: counterparties and limit access to, and distribution of, our proprietary information.
−Removed: As of the date of this report, we have 15 registered
−Removed: trademarks inclusive of 12 global trademarks and 3 United States trademarks, and 15 trademark applications pending, 2 registered domain
−Removed: names, 1 patent, 2 pending US patent applications, and 3 pending International Patent Corporation Treaty (“PCT”) patents.
−Removed: Precision Regenerative Exosome Technology™, or PREx™, process is used to produce Elevai Exosomes™ and the exact process
−Removed: remains a trade secret.
−Removed: We have strategically decided to not pursue a patent around the process.
−Removed: of the date hereof, we have 18 full-time employees.
−Removed: The following table sets forth the number of our employees by function:
−Removed: of Employees (1)
−Removed: Research and Development
−Removed: Financial Department
−Removed: Branding/Marketing
−Removed: This figure does not include
−Removed: our approximately 8 independently contracted aesthetic account managers, as of the date of this report.
−Removed: provide employee benefits for each employee which include medical, unemployment, and work injury compensation.
−Removed: employees have not formed any employee union or association.
−Removed: We have developed various methods to train our employees adequately for
−Removed: the functions they perform and are aware of the laws and regulations affecting our industry.
−Removed: Our success depends on our ability to attract,
−Removed: retain, and motivate qualified employees.
−Removed: We endeavor to offer employees competitive compensation packages and a positive, dynamic, and
−Removed: creative work environment.
−Removed: We believe that we maintain a good working relationship with our employees and have not experienced any difficulty
−Removed: in recruiting staff for our operations.
+Added: https://doi.org/10.3390/ijms23169059.
+Added: more than 40% of adults in the United States live with obesity - a figure predicted to rise to approximately 50% by 2030.
+Added: Obesity is a leading risk factor for the development of serious health conditions, including Type 2 diabetes and heart failure.
+Added: Sachs predicts that this epidemic will create a $100 billion market for anti-obesity players.
+Added: GLP-1 drugs used in weight loss, such as Novo Nordisk’s Ozempic® (semaglutide) & Wegovy®(semaglutide) and Eli Lilly’s
+Added: Zepbound (tirzepatide), and Mounjaro® (tirzepatide) have transformed the obesity treatment landscape.
+Added: However, past studies of these
+Added: highly effective drugs show that up to 40% of the weight loss is due to loss of lean muscle.
+Added: is necessary for metabolism, strength, and physical function.
+Added: As a result, we believe that one of the key unmet needs in the current
+Added: obesity landscape is the avoidance of muscle loss while on weight loss treatments.
+Added: PMGC is developing EL-22, an engineered probiotic
+Added: with myostatin antigens, to elicit an immune response that could help people achieve substantial fat loss while preserving muscle mass.
+Added: on the generated preclinical data and the mechanism of the myostatin-activin signaling pathway effect on muscle wasting, PMGC believes
+Added: that EL-22 has the potential to treat obesity in combination with GLP-1 receptor agonists by preserving muscle mass while decreasing
+Added: In the preclinical studies, 27
+Added: showed a statistically significant increase in anti-myostatin IgG antibody concentration, where myostatin is a key negative regulator
+Added: of muscle growth.
+Added: showed a statistically significant decrease in creatine kinase levels, which indicates a decrease of muscle destruction.
+Added: administered to mdx mice, a mouse model of Duchenne muscular dystrophy, had improved physical activity and gross motor function,
+Added: as demonstrated by a longer duration during rotarod tests.
+Added: on the highlighted preclinical data, PMGC believes that EL-22 has the potential to treat obesity in combination with GLP-1 by preserving
+Added: muscle mass while decreasing fat mass.
+Added: The Company intends to complete an IND submission in 2025 and to initiate clinical trials in the
+Added: to evaluate the myostatin approach in combination with one or more GLP-1 receptor agonists in obesity.
+Added: Our ability to proceed with
+Added: a human trial is contingent upon the FDA clearing the IND submission.
+Added: ZJ, BleichSN, Cradock AL, Barrett JL, Giles CM, Flax CN, Long MW, GortmakerSL.
+Added: Projected U.S.
+Added: State-Level Prevalence of Adult Obesity
+Added: and Severe Obesity.
+Added: N Engl J Med 2019;381:2440-2450.
+Added: https://www.nejm.org/doi/full/10.1056/NEJMsa1909301.
+Added: the anti-obesity drug market could grow to $100 billion by 2030.
+Added: https://www.goldmansachs.com/insights/articles/anti-obesity-drug-market.html.
+Added: JA, Henson J, King JA, Yates T, Khunti K, Davies MJ.
+Added: A Review of the Effects of Glucagon-Like Peptide-1 Receptor Agonists and Sodium-Glucose
+Added: Cotransporter 2 Inhibitors on Lean Body Mass in Humans.
+Added: Endocrinol Metab (Seoul).
+Added: 2019 Sep;34(3):247-262.
+Added: 10.3803/EnM.2019.34.3.247.
+Added: DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration
+Added: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: 2022, 23, 9059.
+Added: https://doi.org/10.3390/ijms23169059.
+Added: Biosciences Products
+Added: Biosciences leverages a first-in-class engineered probiotic approach to address obesity’s pressing issue of preserving muscle while
+Added: on weight loss treatments, including GLP-1 receptor agonists.
+Added: Our lead asset, EL-22, has completed a Phase 1 clinical trial in South
+Added: Korea, demonstrating it was generally well tolerated and safe in healthy volunteers.
+Added: No subjects dropped out due to adverse events and
+Added: no statistically significant difference was found between the intervention groups in the incidence of treatment emergent adverse events.
+Added: results of EL-22 from a 2022 study demonstrated physiological (serum creatine kinase level), physical (body weight change), and functional
+Added: (rotarod test) improvements in the dystrophic features of mdx mice, a mouse model of Duchenne muscular dystrophy (DMD) 1 .
+Added: PMGC believes that EL-22 has the potential to treat obesity in combination with popular weight loss therapeutics, including GLP-1 receptor
+Added: agonists, by preserving muscle mass while decreasing fat mass.
+Added: We plan to submit an Investigational New Drug (IND) application in 2025
+Added: that utilizes the licensed asset EL-22 for efficacy and safety in combination with popular weight-loss therapeutics currently on the
+Added: market, with the goal of decreasing fat mass while preventing the muscle wasting that commonly occurs with weight-loss drugs.
+Added: bodies might require us to conduct preclinical bridge studies in order to pivot EL-22 from DMD to obesity indications.
+Added: second asset, EL-32, is a preclinical engineered probiotic expressing dual myostatin & activin-A and also positioned for the muscle
+Added: preservation space as a combination to weight loss treatments, including GLP-1 receptor agonists.
+Added: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
+Added: These companies include:
+Added: Known for its GLP-1 drugs, Ozempic and Wegovy, Novo Nordisk remains a dominant player in the obesity drug market.
+Added: shown significant efficacy in weight loss and improving cardiovascular health.
+Added: Another major player with its GLP-1 drug, Mounjaro (tirzepatide), which has shown promising results in weight loss.
+Added: also acquired Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
+Added: Developing danuglipron, an oral GLP-1 analog, aimed at carving out a niche in the obesity market with a more convenient dosing regimen.
+Added: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reduction of dyslipidemia.
+Added: Bristol Myers Squibb, Novartis, and Amgen:
+Added: These companies are in the early stages of developing obesity treatments, including various
+Added: GLP-1 receptor agonists and other innovative pharmacological approaches.
+Added: Developing S-309309, an oral MGAT2 inhibitor, which targets lipid metabolism for weight loss.
+Added: Their APHD-012 mimics the metabolic benefits of bypass surgery.
+Added: key companies are actively developing GLP-1 drugs for obesity and complementary treatments to address associated conditions such as muscle
+Added: A leader in the GLP-1 drug market with its products Ozempic and Wegovy.
+Added: These drugs have shown substantial efficacy in weight
+Added: loss and improving cardiovascular health.
+Added: Eli Lilly’s GLP-1 drug, Mounjaro (tirzepatide), is known for its significant weight loss results.
+Added: Additionally, Eli Lilly acquired
+Added: Versanis Bio, which is developing bimagrumab, a drug that helps increase lean muscle mass while reducing fat.
+Added: Pfizer is developing an oral GLP-1 analog, danuglipron, aimed at offering a more convenient dosing regimen for obesity treatment.
+Added: Their GLP-1 drug, pemvidutide, has shown potential in weight loss and reducing dyslipidemia, contributing to overall metabolic health.
+Added: Bristol Myers Squibb, Novartis, and Amgen:
+Added: These companies are in the early stages of developing obesity treatments, including various
+Added: GLP-1 receptor agonists and other innovative pharmacological approaches.
+Added: Shionogi is developing S-309309, an oral MGAT2 inhibitor that targets lipid metabolism for weight loss.
+Added: Their drug APHD-012 mimics the metabolic benefits of bypass surgery, offering a novel approach to weight loss.
+Added: companies are at the forefront of developing both GLP-1 drugs and complementary treatments to address the growing need for effective
+Added: obesity management and the prevention of muscle wasting associated with weight loss.
+Added: Sung DK, Kim H, Park SE, Lee J, Kim JA, Park YC, Jeon HB, Chang JW, Lee J.
+Added: A New Method of Myostatin Inhibition in Mice via Oral Administration
+Added: of Lactobacillus casei Expressing Modified Myostatin Protein, BLS-M22, Int.
+Added: 2022, 23, 9059.
+Added: https://doi.org/10.3390/ijms23169059.
+Added: and Competitive Strengths
+Added: operate in a highly competitive biotechnology and investment landscape, facing competition from pharmaceutical companies, biotechnology
+Added: firms, and investment funds.
+Added: Our key competitive advantages include:
+Added: Capital Deployment:
+Added: Through PMGC Capital LLC, we seek to acquire undervalued assets, optimizing capital returns while expanding our portfolio.
+Added: ● Diversified
+Added: Biotechnology Holdings:
+Added: We establish wholly owned subsidiaries to develop clinical-stage and preclinical assets across multiple therapeutic
+Added: Advancement of High-Potential Biotechnology Assets:
+Added: Our subsidiary, NorthStrive Biosciences Inc., is progressing EL-22, a lead asset targeting muscle preservation in obesity treatment.
+Added: M&A and Licensing Model:
+Added: Our structure allows for strategic acquisitions, licensing deals, and potential spin-offs, creating value
+Added: for shareholders.
+Added: As of the date of this Annual Report on Form 10-K,
+Added: there are no FDA approved medical products utilizing exosomes.
+Added: Well Recognized and Award-winning Team and Brand
+Added: Executive Officer and Chief Financial Officer
+Added: Bensler is a financial professional and executive with over seven years of experience in financial consulting and management for both
+Added: private businesses and U.S./Canadian publicly traded companies.
+Added: He co-founded an EdTech curriculum management and scheduling company
+Added: in 2017, which was implemented in academic institutions across Canada and the United States.
+Added: From 2017 to 2019, he served as an account
+Added: manager at a leading Canadian investor relations firm, collaborating with investment banks, brokers, and company executives across various
+Added: Between 2019 and 2021, Mr.
+Added: Bensler was a Senior Associate at Evans & Evans, a Canadian boutique investment banking firm,
+Added: where he led valuations and facilitated public offerings for companies in Canada and the U.S.
+Added: He holds a Bachelor of Management and Organizational
+Added: Studies degree with a specialization in Finance from the University of Western Ontario and is a CFA Charterholder.
+Added: Northstrive Biosciences Inc.
+Added: Mero is a biotechnology analyst who served as Research Director at PropThink, a leading online platform for healthcare investors.
+Added: has a talent for business development and identifying pharmaceutical licensing opportunities from top collaborators and university researchers.
+Added: Mero was instrumental in discovering our lead asset, EL-22, and in the formation of NorthStrive Biosciences.
+Added: He earned his Bachelor
+Added: of Commerce degree with a specialization in Finance and Economics from the University of Toronto.
+Added: Advisory Board
+Added: Fielding, PhD
+Added: Fielding serves as Team Lead and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia (NEPS) Team at the Jean Mayer
+Added: USDA Human Nutrition Research Center on Aging at Tufts University.
+Added: He is also a Professor of Nutrition at Tufts’ Friedman School
+Added: of Nutrition Science and Policy, a Professor of Medicine at Tufts University School of Medicine, and the Associate Director of the Boston
+Added: Pepper Older Americans Independence Center.
+Added: Fielding is an internationally recognized researcher studying the mechanisms
+Added: contributing to age-associated decline in skeletal muscle mass and function, and the potential role of exercise, nutrition, physical
+Added: activity, and other therapies in mitigating this process.
+Added: He has published over 300 peer-reviewed papers and has a strong record of extramural
+Added: funding from the NIH, USDA, foundations, and industry.
+Added: Grunvald is a board-certified obesity medicine physician and serves as the Director of the Weight Management Program at the University
+Added: of California, San Diego.
+Added: He evaluates and manages patients through their health and weight-loss journeys and has extensive experience
+Added: using medications for weight management.
+Added: As a professor in the Department of Medicine, Dr.
+Added: Grunvald is active in teaching topics such
+Added: as metabolism, weight regulation, and the treatment of obesity and weight-related medical conditions.
+Added: He completed his residency training
+Added: at the UC San Diego School of Medicine and earned his medical degree at the University of Washington School of Medicine.
+Added: is board certified in internal medicine and obesity medicine and is a fellow of the American College of Physicians (FACP).
+Added: Shirihai, MD, PhD
+Added: Shirihai is a Professor of Medicine at the University of California, Los Angeles (UCLA), where he serves as Director of the UCLA Metabolism
+Added: Research Theme.
+Added: His laboratory focuses on mitochondrial structure, function, and quality control, making key contributions to mitochondrial
+Added: biology, including the discovery of the life cycle of mitochondria and the relationship between mitochondrial architecture and nutrient
+Added: utilization in metabolic diseases.
+Added: Shirihai received his MD and PhD from the Technion - Israel Institute of Technology in 1997.
+Added: Roadhouse is an analyst with experience in financial analysis and research.
+Added: He has worked in various capacities within the financial
+Added: industry, contributing to investment strategies and portfolio management.
+Added: Roadhouse holds a degree in Finance and has been involved
+Added: in multiple projects aimed at optimizing investment performance.
+Added: Lichti, a co-founder and our Chairman of the Board, has served as our strategic consultant since July 2020 through his firm NorthStrive
+Added: Companies Inc.
+Added: (“NorthStrive”).
+Added: Lichti is the founder and CEO of NorthStrive since its inception in 2020.
+Added: is a California corporation that focuses on identifying public markets venture capital investment opportunities in high-growth early-stage
+Added: NorthStrive is a sector agnostic privately held firm that has identified and invested, through its principal owners, in industries,
+Added: including biotechnology, medical devices, and medical aesthetics.
+Added: We believe Mr.
+Added: Lichti will be a continued asset to the Company due
+Added: to his network within the healthcare and aesthetic business community, and his experience identifying investment opportunities.
+Added: will be beneficial to the Company as it seeks to identify new business and capital opportunities which led to the conclusion that NorthStrive
+Added: should continue to be our advisor.
+Added: Green is an experienced healthcare executive with a broad background in life sciences and biotechnology finance and operations.
+Added: over ten years of business development experience in the medical aesthetics field including Allergan Plc, a division of AbbVie Inc.,
+Added: Elsie Biotechnologynologies, and Bioniz, LLC.
+Added: Kevin has been involved in multiple acquisitions for companies that remain our competitors,
+Added: such as SkinMedica Inc.
+Added: With Kevin’s broad operations and finance expertise, he brings relevant generalist experience to assist
+Added: in our business development functions.
+Added: He has been an advisor to us and made several key introductions between our founders and prominent
+Added: executives and practitioners in the physician-dispensed aesthetic space.
+Added: We expect Kevin to continue to network on our behalf and provide
+Added: key input on key business dealings and product development moving forward.
+Added: We aim to position PMGC Holdings Inc.
+Added: holding company, leveraging strategic acquisitions, capital deployment, and asset optimization to drive long-term growth.
+Added: strategy is built on three key pillars:
+Added: Deployment for Stronger Returns Through PMGC Capital LLC, we focus on achieving high returns on capital by investing in undervalued assets,
+Added: deploying treasury funds into public and private investments, and leveraging structured financings to maximize value.
+Added: and Scaling Biotechnology and High-Growth Operating Companies We actively seek acquisitions in the biotechnology sector and other high-growth
+Added: industries, financing their expansion through equity, debt, and available grants.
+Added: By integrating synergistic businesses under our portfolio,
+Added: we enhance operational efficiencies, accelerate commercialization, and unlock market opportunities.
+Added: and Strategic Portfolio Optimization We continuously evaluate spin-off opportunities for wholly owned subsidiaries or specific assets,
+Added: allowing us to unlock shareholder value and create independent, specialized companies.
+Added: This approach enables us to capitalize on advanced
+Added: scientific research and address significant unmet medical needs while maintaining a diversified and scalable business model.
+Added: Holdings Inc.
+Added: Below is a table, with footnotes, that includes
+Added: our United States patents, with their referenced property numbers, that are material to our business as of March 21, 2025:
+Added: Expiration Date
+Added: Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients
+Added: Labs, Inc., 04/29/2025
+Added: Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients
+Added: Labs, Inc., 04/29/2025
+Added: Pharmaceutical
+Added: Composition for Treatment of Muscle Loss Due to Obesity
+Added: Labs, Inc., 04/29/2025
+Added: Therapy for Treatment of Muscle Loss Due to Obesity
+Added: Labs, Inc., 04/29/2025
+Added: is a table that includes our granted United States patents as of March 26, 2025:
+Added: patent based on Property.
+Added: Below is a table that
+Added: includes our United States patent applications as of January 24, 2025:
+Added: Application Type
+Added: Fusion Protein of Myo-2 for Use in Treating Muscle Loss in Obese Patients (1)
+Added: Non-provisional
+Added: Combination Therapy of a Fusion Protein of Myo-2 with a GLP-1 Receptor Agonist for Use in Treating Muscle Loss in Obese Patients (2)
+Added: Non-Provisional
+Added: Pharmaceutical Composition for Treatment of Muscle Loss Due to Obesity (3)
+Added: Non-provisional
+Added: Combination Therapy for Treatment of Muscle Loss Due to Obesity (4)
+Added: Non-provisional
+Added: (1) Non-provisional
+Added: patent application based on Property.
+Added: (2) Non-provisional
+Added: patent application based on Property.
+Added: (3) Non-provisional
+Added: patent application based on Property.
+Added: (4) Non-provisional
+Added: patent application based on Property.
+Added: Docket Number
+Added: Country / Region
+Added: Application No.
+Added: Registration No.
+Added: ELEVAI BIOSCIENCES
+Added: United States - (US)
+Added: Pending - (PEND)
+Added: ELEVAI BIOSCIENCES (& Des.)
+Added: United States - (US)
+Added: Pending - (PEND)
+Added: have the right to use the following domain registration issued in the United States, as noted below:
+Added: Expiration Date
+Added: Registration Agency
+Added: July 31, 2024
+Added: July 31, 2027
+Added: www.pmgcholdings.com
+Added: PMGC Holdings Inc.
+Added: April 10, 2024
+Added: April 10, 2025
+Added: www.northstrivebio.com
+Added: PMGC Holdings Inc.
+Added: Biosciences Inc.
+Added: Licensed Product/ Nation
+Added: Registration Number
+Added: Registration Date
+Added: 10-0857861-0000
+Added: Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
+Added: 10-0872042-0000
+Added: Cell Surface Expression Vector of Myostatin and Microorganisms Transformed Thereby
+Added: Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
+Added: Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
+Added: ZL200780101116.2
+Added: Surface Expression Vector for Fusion Protein of Myo-2 Peptide Multimer and Myostatin, and Microorganism Transformed by Therof
+Added: Licensed Product/ Nation
+Added: Patent Application Serial No
+Added: 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
+Added: 10-2022-0136606
+Added: 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
+Added: Docket Number
+Added: Country / Region
+Added: Application No.
+Added: Registration No.
+Added: ELEVAI BIOSCIENCES
+Added: United States - (US)
+Added: Pending - (PEND)
+Added: ELEVAI BIOSCIENCES (& Des.)
+Added: and Marketing
+Added: a biotechnology holding company, our sales and marketing efforts focus on maximizing asset value through strategic partnerships, licensing
+Added: agreements, and investment-driven growth strategies rather than traditional direct sales models.
+Added: Commercialization
+Added: and Licensing Strategy
+Added: seek commercial partnerships, licensing agreements, and strategic acquisitions to monetize our biotechnology assets.
+Added: of building a direct sales force, we collaborate with biotechnology, pharmaceutical, and healthcare companies to facilitate late-stage
+Added: clinical development and commercialization.
+Added: approach includes leveraging key opinion leaders (KOLs), industry networks, and advisory boards to enhance visibility and credibility.
+Added: and Investor Relations
+Added: actively market our portfolio companies, investment strategies, and biotechnology assets to institutional investors, venture partners,
+Added: and strategic acquirers.
+Added: engage in scientific conferences, industry events, and investor presentations to generate interest and attract potential commercial partners
+Added: or acquirers.
+Added: focusing on strategic alliances, funding opportunities, and investment-driven asset growth, we aim to enhance portfolio value and drive
+Added: commercialization through industry partnerships.
+Added: principal executive office is located at 120 Newport Center Drive, Newport Beach, CA 92660.
+Added: The office has 500 square feet, and the lease
+Added: runs from April 2024 to February 2025.
+Added: The monthly rent is $1,561.
+Added: following table sets forth the leases term and monthly rent:
+Added: (square feet)
+Added: April 2024 to February 2025
+Added: 120 Newport Center Drive, Newport Beach, CA 92660
+Added: members of our management work outside of these premises in office space that we do not rent.
+Added: As of the date of this Annual Report, we have
+Added: two (2) full-time employees and one part-time employee.
+Added: We provide employee benefits for each employee which include medical, unemployment,
+Added: and work injury compensation.
+Added: Our employees have not formed any employee union or association.
+Added: We have developed various methods to train
+Added: our employees adequately for the functions they perform and are aware of the laws and regulations affecting our industry.
+Added: depends on our ability to attract, retain and motivate qualified employees.
+Added: We endeavor to offer employees competitive compensation packages
+Added: and a positive, dynamic and creative work environment.
+Added: We believe that we maintain a good working relationship with our employees and
+Added: have not experienced any difficulty in recruiting staff for our operations.
+Added: Regulation and Biologic Drug Approval
+Added: authorities in the United States, at the federal, state and local level, and other countries, extensively regulate, among other things,
+Added: the research, development, testing, manufacture, quality control, approval, labeling, packaging, storage, recordkeeping, promotion, advertising,
+Added: distribution, marketing and export and import of products such as those we are selling and developing.
+Added: Because we are developing product
+Added: candidates that are unique biological entities, the regulatory requirements that we will be subject to are not entirely clear and may
+Added: Regulatory requirements governing our product candidates have changed frequently and will likely continue to change in the future.
+Added: We believe that the FDA will regulate part of our product candidates as a biologic drug (i.e., a biologic) through the Biologics License
+Added: Application (“BLA”) process under the jurisdiction of the Office of Therapeutic Products within the Center for Biologics
+Added: Evaluation and Research (“CBER”).
+Added: We will work with FDA to confirm that a BLA is the most appropriate pathway and that CBER
+Added: will be the FDA center responsible for review and licensure (i.e., approval).
+Added: For future product candidates, we will also confirm the
+Added: appropriate approval pathway (i.e., BLA or new drug application (“NDA”)) and the appropriate FDA center with regulatory oversight
+Added: (i.e., CBER or the Center for Drug Evaluation and Research (“CDER”)).
+Added: Biologic Drug Development Process
+Added: the United States, biologic drugs (“biologics”) are regulated under two statutes:
+Added: The Public Health Service Act (“PHS
+Added: Act”) and the Federal Food, Drug, and Cosmetic Act (“FFDCA”) and their implementing regulations.
+Added: However, submission
+Added: and approval of only one application-typically either a BLA or an NDA-is required prior to marketing.
+Added: The FDA has also issued numerous
+Added: “Guidance Documents” and other materials that address specific aspects of biologic development for particular types of product
+Added: candidates (e.g., cells, tissues, etc.).
+Added: Substantial time and financial resources are required to obtain regulatory approvals and subsequently
+Added: comply with appropriate federal, state, and local statutes and regulations.
+Added: Failure to comply with the applicable U.S.
+Added: requirements at
+Added: any time during the biologic development, approval, or post-approval processes may subject an applicant to administrative or judicial
+Added: These sanctions could include the FDA’s refusal to approve pending applications, withdrawal of an approval, imposition
+Added: of a clinical hold on ongoing clinical trials, issuance of warning or untitled letters, product recalls, product seizures, total or partial
+Added: suspension of production or distribution, injunctions, fines, refusals of government contracts, restitution, disgorgement or civil or
+Added: criminal penalties.
+Added: Any agency or judicial enforcement action could have a material adverse effect on us.
+Added: process required by the FDA before a biologic may be marketed in the United States generally involves the following steps:
+Added: of preclinical laboratory tests, animal studies and formulation studies in accordance with FDA’s current good laboratory practice
+Added: requirements and other applicable regulations;
+Added: to the FDA of an IND, which must become effective before human clinical trials may begin;
+Added: by an independent institutional review board (“IRB”) at each clinical site (or by one “commercial IRB”) before
+Added: each trial may be initiated;
+Added: ● performance
+Added: of adequate and well-controlled human clinical trials in accordance with cGCP requirements to establish the safety, purity, and potency
+Added: , efficacy) of the proposed biologic for its intended use;
+Added: to the FDA of a BLA after completion of all clinical trials;
+Added: ● satisfactory
+Added: outcome of an FDA advisory committee review, if applicable;
+Added: ● satisfactory
+Added: completion of an FDA inspection of the manufacturing facility or facilities at which the biologic is produced to assess compliance with
+Added: cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the biologic’s identity, strength,
+Added: quality and purity, and FDA inspection of selected clinical investigation sites to assess compliance with cGCPs;
+Added: review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the United States.
+Added: specific preclinical studies and clinical testing that is required for a BLA varies widely depending upon the specific type of product
+Added: candidate under development.
+Added: Prior to beginning a human clinical trial with either a biologic or drug product candidate in the United
+Added: States, we must submit an IND to the FDA and that IND must become effective.
+Added: The focus of an IND submission is the general investigational
+Added: plan and protocol for the proposed clinical study.
+Added: The IND also includes results of animal and in vitro studies assessing the toxicology,
+Added: pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product;
+Added: Chemistry Manufacturing and Controls (“CMC”)
+Added: and any available human data or literature to support the use of the investigational product.
+Added: An IND must become effective
+Added: before human clinical trials may begin.
+Added: The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within
+Added: the 30-day time period, raises safety concerns or questions about the proposed clinical trial.
+Added: In such a case, the IND may be placed
+Added: on clinical hold, and the IND sponsor and the FDA must resolve any outstanding concerns or questions before the clinical hold is lifted
+Added: and the clinical trial can begin.
+Added: Submission of an IND therefore may or may not result in FDA authorization to begin a clinical trial.
+Added: trials involve the administration of the investigational product to human subjects under the supervision of qualified investigators in
+Added: accordance with cGCPs, which include the requirement that all research subjects provide their informed consent for their participation
+Added: in any clinical trial.
+Added: Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the
+Added: parameters for monitoring safety and the effectiveness criteria to be evaluated.
+Added: A separate submission to the existing IND must be made
+Added: for each successive clinical trial conducted during product development.
+Added: Other submissions to an IND include protocol amendments, information
+Added: amendments, IND safety reports and annual reports.
+Added: Furthermore, an independent IRB for each clinical trial site (or a “commercial
+Added: IRB” that acts as the IRB at one or more of the clinical trial sites) must review and approve the protocol and informed consent
+Added: form before the clinical trial may begin.
+Added: The IRB also monitors the clinical trial until completed.
+Added: authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects
+Added: are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives.
+Added: Some clinical trials also
+Added: include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring
+Added: board (“DSMB”).
+Added: A DSMB authorizes whether or not a study may move forward at designated check points based on access to certain
+Added: data from the trial.
+Added: The DSMB may halt the clinical trial if it determines there is an unacceptable safety risk for subjects or on other
+Added: grounds, such as no demonstration of efficacy.
+Added: Related reporting requirements for the sponsor, clinical investigator, and/or IRB also
+Added: include IND safety reports and updating clinical trial results in public registries (e.g., ClinicalTrials.gov).
+Added: clinical trials are typically conducted in three sequential phases that may overlap or be combined:
+Added: The product candidate is initially introduced into healthy human subjects.
+Added: These clinical trials are designed to test the safety,
+Added: dosage tolerance, absorption, metabolism, distribution, excretion, side effects, and, if possible, early evidence of effectiveness.
+Added: the case of some products for severe or life-threatening diseases when the product may be too inherently toxic to ethically administer
+Added: it to healthy volunteers, the initial human testing is often conducted in individuals who have the targeted disease or condition instead
+Added: of healthy subjects;
+Added: The product candidate is administered to a limited population of individuals who have the specified disease or condition to continue
+Added: to evaluate safety, as well as preliminary efficacy, optimal dosages and dosing schedule, possible adverse side effects and safety risks.
+Added: Multiple Phase 2 clinical trials may be conducted to obtain information prior to beginning larger and more expensive Phase 3 (i.e., pivotal)
+Added: clinical trials;
+Added: Generally, the largest in size, Phase 3 clinical trials are generally conducted at multiple geographically dispersed clinical
+Added: The product candidate is administered to an expanded population of individuals who have the specified disease or condition
+Added: to further evaluate dosage, provide statistically significant evidence of clinical efficacy and gain additional safety data.
+Added: These clinical
+Added: trials are intended to establish the overall risk/benefit ratio of the investigational product and to provide an adequate basis for product
+Added: with clinical trials, sponsors usually complete additional animal studies.
+Added: Sponsors must also develop information about the chemical
+Added: and physical characteristics of the biologic and finalize a process for manufacturing the product in commercial quantities in accordance
+Added: with cGMP requirements.
+Added: The manufacturing process must be capable of consistently producing quality batches of the product candidate,
+Added: and, among other things, the manufacturer must develop methods for testing the identity, strength, quality, and purity of the final biologic.
+Added: In addition, the sponsor must develop and test appropriate packaging, and must conduct stability studies to demonstrate that the product
+Added: candidate does not undergo unacceptable deterioration over its shelf life.
+Added: Before approval of a BLA, FDA evaluates the establishment
+Added: by an on-site inspection to ensure the facilities and controls used for the manufacture, processing, packaging, and testing of the drug
+Added: are adequate to ensure and preserve its identity, strength, quality, and purity.
+Added: the development of a new biologic, sponsors are given opportunities to meet with the FDA.
+Added: These meetings typically occur before the submission
+Added: of an IND (i.e., pre-IND meeting), at the end of Phase 2 (i.e., EOP2 meeting), and before a BLA is submitted (i.e., pre-BLA meeting).
+Added: Meetings at other times may be requested.
+Added: These meetings provide an opportunity for the sponsor to share information about the data gathered
+Added: to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development.
+Added: typically use EOP2 meetings to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe
+Added: will support approval of the new biologic.
+Added: Review and Approval Process for Biologic Drugs
+Added: successful completion of all required testing in accordance with the applicable statutory and regulatory requirements, the sponsor submits
+Added: a BLA to the FDA.
+Added: A BLA contains the results of product development, preclinical and other non-clinical studies and clinical trials,
+Added: descriptions of the manufacturing process, analytical testing, proposed labeling and other relevant information.
+Added: The submission of a
+Added: BLA is subject to the payment of a substantial application fee under the Prescription Drug User Fee Amendments (“PDUFA”).
+Added: PDUFA fees apply to both drugs and biologics.
+Added: Sponsors may seek a waiver of these fees in certain limited circumstances, including a
+Added: waiver of the application fee for the first BLA or NDA submitted by a small business.
+Added: Product candidates with an Orphan Drug Designation
+Added: (“ODD”) are not subject to the BLA application fee unless the product application also includes a non-orphan indication.
+Added: FDA reviews a BLA to determine, among other things, whether a biologic is safe, pure, and potent (i.e., effective) for its intended use
+Added: and whether its manufacturing is GMP-compliant to assure the product’s identity, strength, quality and purity.
+Added: Under PDUFA, the
+Added: FDA has a goal date of ten months from the date of “filing” to review and act on the submission.
+Added: However, the time between
+Added: submission and filing can add an additional two months as FDA conducts a preliminary review to ensure that the BLA is sufficiently complete
+Added: to permit substantive review.
+Added: Formal FDA review of the BLA does not begin until FDA has accepted it for filing.
+Added: The FDA may refer an
+Added: application in some cases to an advisory committee for its independent review.
+Added: An advisory committee is a panel of independent experts,
+Added: including clinicians and other scientific experts, that reviews, evaluates and provides a recommendation to FDA as to whether the application
+Added: should be approved and under what conditions.
+Added: The FDA is not bound by the recommendations of an advisory committee, but it considers
+Added: such recommendations carefully when making decisions.
+Added: approving a BLA, the FDA will typically inspect the locations where the product is manufactured.
+Added: The FDA will not approve an application
+Added: unless it determines that the manufacturing processes and facilities are in compliance with cGMPs, and are adequate to assure consistent
+Added: production of the product within required specifications.
+Added: An important part of a BLA is a lot release protocol that the sponsor will
+Added: 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
+Added: testing of each post-approval product lot that is made before it is released to the public.
+Added: If the FDA determines that the data and information
+Added: in the application, including about the manufacturing process or manufacturing facilities, are not acceptable, then the FDA will outline
+Added: the deficiencies and often will request additional testing or information.
+Added: Notwithstanding the submission of any requested additional
+Added: information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
+Added: the FDA evaluates a BLA, it will either issue an approval letter or a Complete Response Letter (“CRL”).
+Added: The approval letter
+Added: authorizes commercial marketing of the biologic with approved prescribing information for specific approved indications.
+Added: hand, a CRL indicates that the review cycle of the application is complete but the BLA cannot be approved in its present form.
+Added: usually describes the specific deficiencies identified by the FDA and describes the actions the sponsor must take to correct those deficiencies.
+Added: A sponsor that receives a CRL must resubmit the BLA after addressing the deficiencies or withdraw the application.
+Added: Even if such additional
+Added: data and information are submitted to address the deficiencies, the FDA may decide that the data and information in the resubmitted BLA
+Added: do not satisfy the approval criteria.
+Added: marketing approval, a sponsor may need to fulfill certain post-marketing requirements (“PMRs”) or post-marketing commitments
+Added: For example, post-approval trials, sometimes referred to as Phase 4 studies, may be conducted after initial marketing
+Added: These trials are used to gain additional experience from the treatment of patients for the intended therapeutic indication.
+Added: The trials may be agreed upon prior to approval, or the FDA may require them if new safety issues emerge.
+Added: Following approval, a sponsor
+Added: may also need to conduct a pediatric study that was temporarily deferred during the initial product development process.
+Added: Under the Pediatric
+Added: Research Equity Act (“PREA”), a sponsor must conduct pediatric clinical trials for most new drugs or biologics, for a new
+Added: active ingredient, new indication, new dosage form, new dosing regimen or new route of administration.
+Added: The required assessment must evaluate
+Added: the safety and effectiveness of the product for the claimed indications in all relevant pediatric subpopulations and support dosing and
+Added: administration for each pediatric subpopulation for which the product is safe and effective.
+Added: PREA studies must be included in the application
+Added: unless the sponsor has received a deferral or waiver.
+Added: risk evaluation and mitigation strategy (“REMS”) may also be an important component of a BLA approval that requires sponsor
+Added: post-marketing regulatory efforts.
+Added: A REMS is a safety strategy to manage a known or potential serious risk associated with a drug or
+Added: biologic and to enable patients to have continued access to such medicines by managing their safe use.
+Added: A REMS may include medication
+Added: guides, physician communication plans, or elements to assure safe use (ETASU) such as restricted distribution methods, patient registries,
+Added: and other risk minimization tools.
+Added: approved, the FDA may withdraw the product approval if compliance with PMRs, PMCs, or a REMS program is not maintained or if problems
+Added: occur after the product reaches the marketplace.
+Added: The FDA may also request that a product be recalled for an identified safety issue.
+Added: In addition, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies
+Added: may change, which could impact the timeline for regulatory approval or otherwise impact ongoing development programs.
+Added: following table sets forth certain information with respect to our directors, executive officers and significant employees as of March
+Added: Executive Officers:
+Added: Graydon Bensler
+Added: Chief Executive Officer, Chief Financial Officer and
+Added: Braeden Lichti
+Added: Chairman of the Board
+Added: Non-Executive Directors:
+Added: Jeffrey Parry (1)(2)(3)
+Added: Independent Director and Chair of Nominating Committee
+Added: George Kovalyov (1)(2)(3)
+Added: Independent Director and Chair of Compensation Committee
+Added: Juliana Daley (1)(2)(3)
+Added: Independent Director and Chair of the Audit Committee
+Added: of the Audit Committee.
+Added: of the Compensation Committee.
+Added: of the Nominating Committee.
+Added: of our directors serves for a term of one year ending on the date of the subsequent annual meeting of stockholders following the annual
+Added: meeting at which such director was elected.
+Added: Notwithstanding the foregoing, each director is to serve until his or her successor is elected
+Added: and qualified or until his death, resignation or removal.
+Added: Our Board appoints our officers, and each officer is to serve until his or
+Added: her successor is appointed and qualified or until his or her death, resignation or removal.
+Added: Bensler, CFA , Chief Executive Officer, Chief Financial Officer and Director
+Added: Bensler has served as our Chief Executive Officer since June 2024 and Chief Financial Officer since inception and a director since June
+Added: Bensler is a financial professional and analyst with over seven years of experience in financial consulting and management
+Added: for both private businesses and US/Canadian publicly traded companies and is a CFA Charterholder (CFA) In 2017, Mr.
+Added: Bensler Co-founded
+Added: an Ed Tech curriculum management and scheduling company that was implanted in academic schools in Canada and the United States.
+Added: 2017 to 2019, Mr.
+Added: Bensler was an account manager at a leading Canadian investor relations firm where he represented publicly traded companies
+Added: across a wide range of sectors where he worked directly with investment banks, investment brokers and company executives and directors.
+Added: During his tenure, Mr.
+Added: Bensler created and conveyed messaging about his clients’ strategic position in the market and successfully
+Added: guided several companies through multiple financings.
+Added: From 2019 to 2021, Mr.
+Added: Bensler was a Senior Associate at Evans & Evans, a Canadian
+Added: boutique investment banking firm where he led valuations and going public transactions for Canadian and United States companies.
+Added: capacity, Mr.
+Added: Bensler gained strong knowledge of the capital markets, public company compliance requirements, and regularly interfaced
+Added: with regulators, auditors, board and executive management.
+Added: Bensler was also a director of publicly traded Health Logic Interactive
+Added: (TSXv:CHIP) from 2020 to 2024.
+Added: We believe that Mr.
+Added: Bensler’s past experience as our Chief Financial Officer, his familiarity
+Added: with both the banking and the financial consulting sectors and his having served as an account manager for similarly situated companies
+Added: makes him a qualified director for our Company.
+Added: Bensler received his Bachelor of Management and Organizational Studies degree from the University of Western Ontario, with specialization
+Added: in Finance, and is a CFA Charterholder.
+Added: Lichti , Chairman of the Board
+Added: Lichti is the founder and Chief Executive Officer of BWL Investments Ltd., a privately held holding corporation he established in 2016,
+Added: and NorthStrive Companies, Inc., a U.S.
+Added: based investment and advisory services company he founded in 2021.
+Added: Lichti also serves as
+Added: Chairman of Hydromer, Inc., a global leader in surface modification and coating solutions, focusing on hydrophilic, thromboresistant
+Added: and antimicrobial coatings for medical devices and various industrial applications.
+Added: Established in 1980 and headquartered in Concord,
+Added: North Carolina, Hydromer offers a wide range of services, including polymer research and development, contract coating and specialized
+Added: analytical testing.
+Added: Lichti co-founded PMGC Holdings Inc.
+Added: in 2020 and has served as its advisor and has been a principal stockholder
+Added: since its formation.
+Added: He has remained the largest stockholder through companies he controls and recently assumed the role of Chairman
+Added: We believe that Mr.
+Added: Lichti’s past experience as our director and advisor, his extensive executive experience and his having
+Added: served as Chairman for similarly situated companies makes him a qualified director for our Company.
+Added: Parry , Independent Director, Chair of the Nominating Committee and member of the of Audit Committee and Compensation Committee
+Added: Parry was appointed as an independent director in June 2023 and
+Added: is a partner of Mystic Marine Advisors LLC, a Connecticut based advisory firm he founded in 1998 focused on emerging and turnaround situations
+Added: for strategic and financial stakeholders.
+Added: Jeffrey served as Executive Chairman of TBS Shipping Limited from 2012 to 2018 where he led
+Added: a successful restructuring and co-founded Valhalla Shipping, Inc with an $167 million equity investment by institutional investors.
+Added: July 2008 to October 2009, Mr.
+Added: Parry was the Chief Executive Officer of Nasdaq-listed Aries Maritime Transport Limited and led a successful
+Added: turn-around and sale to strategic investors.
+Added: Parry was a Managing Director of Poten & Partners, an international energy advisor,
+Added: from 2001 to 2007 where in 2006 he co-founded Poten Capital Services LLC, a New York based broker-dealer.
+Added: Earlier in his career, Mr.
+Added: founded Cool FM and 7X Television in Athens, Greece and served as President of One Fifth Avenue Apartment Corporation.
+Added: Since 2010, Jeffrey
+Added: has served as an independent director of Nasdaq listed Globus Maritime Ltd.
+Added: where he sits on the audit committee.
+Added: Parry holds a BA
+Added: from Brown University and MBA from Columbia University.
+Added: His educational and professional experience in business, his background and familiarity
+Added: in investment banking, and his having served as a director of a company listed on Nasdaq makes him a qualified director candidate for
+Added: Kovalyov , Independent Director, Chair of the Compensation Committee and member of the of Audit Committee and Nominating Committee
+Added: Kovalyov has acted as Chief Financial Officer and Treasurer of Marizyme, Inc.
+Added: since December 2021.
+Added: Since November 2022, Mr.
+Added: has also been a director of DGTL Holdings Inc.
+Added: Previously he served as the chief operating officer and director of Health Logic Interactive
+Added: (“HLII”) from September 2020 to November 2021, and as HLII’s chief financial officer from December 2021 to September
+Added: In addition, Mr.
+Added: Kovalyov served as a director and audit committee member of Margaret Lake Diamonds Inc.
+Added: from January 2021 to August
+Added: From September 2018 to September 2020, Mr.
+Added: Kovalyov was VP of Finance and director of Phivida Holdings Inc., a brand of cannabidiol-infused
+Added: foods, beverages and clinical products.
+Added: From October 2016 to September 2020, Mr.
+Added: Kovalyov was the principal owner of Schindler and Company,
+Added: an accounting consulting firm.
+Added: Kovalyov is a chartered accountant and is a member of Chartered Professional Accountants of Canada.
+Added: Kovalyov is qualified to serve on the Board due to his extensive accounting and finance experience.
+Added: Daley , CPA Independent Director, Chair of the Audit Committee and member of the of Compensation Committee and Nominating Committee
+Added: Daley was appointed as an independent director in June 2023 and holds over eleven years of accounting, controller, and financial reporting
+Added: experience in the public sector.
+Added: Daley has worked a variety of industries in both the United States and Canada.
+Added: Since July 2021,
+Added: Daley has served as Manager of Accounting at Anavex Life Sciences Corp.
+Added: AVXL), a clinical-stage biopharmaceutical company
+Added: based in New York, NY that is focused on developing treatments for debilitating neurodegenerative and neurodevelopmental diseases.
+Added: addition, from August 2021 to July 2022, she served as an independent director and audit committee chair to Vegano Foods (CSE:
+Added: during Vegano Food’s initial public offering in February 2022.
+Added: From October 2015 to July 2021, Ms.
+Added: Daley was a Manager of Financial
+Added: Reporting and Advisory Services to various public companies in the United States and Canada, through her position with the accounting
+Added: firm, Treewalk (previously ACM Management, Inc.).
+Added: At Treewalk Ms.
+Added: Daley assisted clients in meeting their quarterly and annual reporting
+Added: requirements including the preparation of complete financial reporting packages and managing assurance engagements from start to finish.
+Added: At Treewalk, she also served as chief financial officer to Makena Resources Inc.
+Added: MKNA) (April 2018 - April 2019) and Naked Brand
+Added: NAKD) (March 2018 - June 2018) until the completion of their prospective mergers in April 2019 and June 2018, respectively.
+Added: From September 2011 to April 2015, Ms.
+Added: Daley was employed with Naked Brand Group Inc., where she worked in the accounting department,
+Added: serving as controller from August 2013 until her departure in April 2015, and where she was also responsible for assisting in various
+Added: operational functions including EDI implementation, ERP implementation, inventory management, information technology and office administration.
+Added: From July 2021 to present, Ms.
+Added: Daley has acted as manager of accounting at Anavex Life Sciences where she assists to in the finalization
+Added: of all internal reporting, budgeting, and operational matters such as annual SOX audits, quarterly reviews, IT audits, and annual audits.
+Added: Daley’s expertise in financial accounting for public companies and her having served as a chief financial officer and controller
+Added: on companies listed on United States public exchanges makes her a qualified director candidate for our company.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.