Risk Factors.
−Removed: Related to Our Business, Our Brand, Our Products and Our Industry
−Removed: revenues and financial results depend significantly on sales of our Elevai Post Treatment E-Series™.
−Removed: If we are unable to manufacture
−Removed: or sell our Elevai Post Treatment E-Series™ in sufficient quantities and in a timely manner or maintain client acceptance of our
−Removed: Elevai Post Treatment E-Series™, our business will be materially and adversely impacted.
−Removed: date, a substantial majority of our revenues have resulted from sales of our principal product line, our Elevai Post Treatment E-Series™.
−Removed: Our Elevai Post Treatment E-Series™ and related products accounted for a substantial majority of our net sales for the years ended
−Removed: December 31, 2023, and 2022.
−Removed: Although we intend to introduce additional products, we expect sales of our Elevai Post Treatment E-Series™
−Removed: to continue to account for a significant majority of our sales for the foreseeable future.
−Removed: Because our business is highly dependent on
−Removed: our Elevai Post Treatment E-Series™, factors adversely affecting the pricing of, or demand for, these products could have a material
−Removed: and adverse effect on our business.
−Removed: Additionally, our commercial success depends in large part on our ability to sustain market acceptance
−Removed: of our Elevai Post Treatment E-Series™ through physician practices and under both our exclusive and non-exclusive distribution
−Removed: If existing users of our products determine that our products do not satisfy their requirements, or if our competitors develop
−Removed: a product that is perceived by medical aesthetics consumers, physicians or distributors to better satisfy their respective aesthetics
−Removed: requirements, sales of our Elevai Post Treatment E-Series™, and our total net sales may correspondingly decline which could adversely
−Removed: affect our business, financial condition, results of operations and prospects.
−Removed: results of operations could be harmed if we are unable to accurately forecast demand for our products.
−Removed: maintain an adequate inventory supply, we must forecast inventory needs and place orders with our third-party suppliers, formulators
−Removed: and packagers before firm orders are placed by our clients or distribution partners.
−Removed: If we fail to accurately forecast client demand,
−Removed: we may experience excess inventory levels or a shortage of product to deliver to our clients.
−Removed: Factors that could affect our ability to
−Removed: accurately forecast demand for our products include:
−Removed: an unanticipated increase or decrease in demand for our products;
−Removed: our failure to
−Removed: accurately forecast acceptance for our new products;
−Removed: product introductions by competitors;
−Removed: unanticipated changes in general market conditions
−Removed: or other factors, which may result in cancellations of advance orders or a reduction or increase in the rate of reorders or at-once orders
−Removed: placed by clients or distribution partners;
−Removed: the impact on demand due to unseasonable weather conditions;
−Removed: weakening of economic conditions
−Removed: or consumer or client confidence in future economic conditions, which could reduce demand for discretionary items, such as aesthetics
−Removed: services and our complementary cosmetics products;
−Removed: and terrorism or acts of war, or the threat thereof, or political or labor instability
−Removed: or unrest, which could adversely affect consumer or client confidence and spending or interrupt production and distribution of product
−Removed: and raw materials.
−Removed: levels in excess of client or distribution partner demand may result in inventory write-downs or write-offs and the sale of excess inventory
−Removed: at discounted prices or in less preferred distribution channels, which could impair our brand image and harm our business.
−Removed: if we underestimate the demand for our products, our third-party suppliers, formulators, and packagers may not be able to facilitate
−Removed: bringing our cosmetics products to market or in time to meet our client or distribution partner requirements, and this could result in
−Removed: delays in the shipment of our products and our ability to recognize revenue, lost sales, as well as damage to our reputation and client
−Removed: and distributor relationships.
−Removed: difficulty in forecasting demand also makes it difficult to estimate our future results of operations and financial condition from period
−Removed: A failure to accurately predict the level of demand for our products could adversely affect our business, financial condition,
−Removed: results of operations, and prospects.
−Removed: face intense competition, in some cases from companies that have significantly greater resources than we do, which could limit our ability
−Removed: to generate sales.
−Removed: market for aesthetic and cosmetic skin health products is highly competitive and we expect the intensity of competition to increase in
−Removed: the future as market acceptance grows and related technology advances.
−Removed: We also expect to encounter increased competition as we enter
−Removed: new markets and as we attempt to penetrate existing markets with new products.
−Removed: We may not be able to compete effectively in these markets,
−Removed: we may face significant pricing pressure from our competitors, and we may lose market share to our competitors.
−Removed: Our principal competitors
−Removed: are large, well-established companies in the fields of pharmaceuticals, medical devices, cosmetics and health care.
−Removed: Our direct competitors
−Removed: include SkinCeuticals, a division of L’Oréal S.A., SkinMedica, Inc., a division of Allergan, Inc., ZO Skin Health, PCA Skin,
−Removed: EltaMD, each a division of Colgate-Palmolive, Dermalogica, Murad and Eminence.
−Removed: also face competition from medical device companies offering products used to enhance the skin’s appearance to physicians, such
−Removed: cosmetic device companies that provide complementary microneedling serum treatment, and those companies may offer similar complementary
−Removed: products to physicians, aestheticians, spas, and wellness centers that provide facial treatment services.
−Removed: may not be able to successfully expand the use of our current product lines or develop new products.
−Removed: are constantly working to improve, extend the stability of and reformulate our existing products.
−Removed: Continued market acceptance of our
−Removed: products will depend on our ability to successfully develop additional applications of our Elevai Exosomes™.
−Removed: The development of
−Removed: additional applications will require significant commitments of personnel and financial resources and we cannot assure you that they
−Removed: will be successful.
−Removed: If the attempted extensions of our product lines and new applications for our Elevai Exosomes ™ are
−Removed: not commercially successful, our business will be adversely affected.
−Removed: are researching and working alongside contract research organizations to developing new product lines by applying our Elevai Exosomes ™
−Removed: technology to new agents.
−Removed: We also have applied for intellectual property rights to cover our use of certain patents in relation
−Removed: to additional methods and formulations of our Elevai Exosomes ™ .
−Removed: New products, in various stages of development, include
−Removed: skin discoloration, and hair loss products and systems.
−Removed: These development activities, as well as new clinical validation studies to demonstrate
−Removed: aesthetic improvements, which may assist us in the marketing and sale of our cosmetic products.
−Removed: Completion of any clinical validation
−Removed: studies requires significant commitments of our personnel, time, and financial resources.
−Removed: We cannot assure you that we will be able to
−Removed: develop new products or formulations in a timely manner, or at all.
−Removed: Delays in the development or testing processes will cause a corresponding
−Removed: delay in revenue generation from those products.
−Removed: Regardless of whether such new products or formulations are ever released to the market,
−Removed: the expense of such processes, which may be considerable, will have already been incurred and we may not be able to recover such expenses.
−Removed: reevaluate our formulation and product development efforts regularly to assess whether our efforts to develop a particular new product
−Removed: or formulation are progressing at a rate that justifies our continued expenditures.
−Removed: On the basis of these reevaluations, we have abandoned
−Removed: development efforts in the past, and may abandon those development efforts in the future.
−Removed: New products that we develop may not be successfully
−Removed: commercialized.
−Removed: If we fail to take a product or technology from the development stage to market on a timely basis, we may incur significant
−Removed: expenses without a near-term financial return or any financial return.
−Removed: failure to successfully research and develop additional technologies would impair our ability to grow.
−Removed: intend to develop and acquire and market new products and technologies though our own internal research capabilities and through the
−Removed: assistance of CROs.
−Removed: Our business model depends in part on our ability to patents new products and/or technologies.
−Removed: The success of this
−Removed: strategy also depends upon our ability and the ability of our third-party formulators to formulate products under such patents, as well
−Removed: as our ability to manufacture, market and sell such patented products.
−Removed: may not be able to internally develop new products or technologies successfully.
−Removed: Moreover, vetting, negotiating and implementing design
−Removed: protocols for new product and formulation development with CROs can be a lengthy and complex process.
−Removed: Other companies, including those
−Removed: with substantially greater financial, research and technology, marketing and sales resources, may compete with us for contracts with
−Removed: CROs and development of these technologies.
−Removed: We may not be able to negotiate with or find acceptable CROs to develop such products on
−Removed: terms that we find acceptable, or at all.
−Removed: As a result, our ability to grow our business or increase our profits could be adversely impacted.
−Removed: marketed products and our products under development could be rendered obsolete by technological or other medical advances.
−Removed: marketed products and our products under development may be rendered obsolete or uneconomical by our competitors’ products or technological
−Removed: advances or those other advances within other markets that may better or more inexpensively address the conditions that our products
−Removed: are designed to address.
−Removed: of our products address the condition-, and the enhancement of the appearance-of skin by utilizing our Elevai Exosomes ™ .
−Removed: This market is the subject of active research and development by many potential competitors, including major pharmaceutical companies,
−Removed: specialized biotechnology firms, universities, hospitals, clinics and other research institutions.
−Removed: Competitive advances may also include
−Removed: the potential development of new therapies aimed at treating hyperpigmentation and photo-damaged skin that utilize other lab techniques
−Removed: involving stem-cell secretion, lasers or other advanced technologies.
−Removed: While we intend to expand our technological capabilities to remain
−Removed: competitive, research and development by others may render our technology or products obsolete or noncompetitive or result in treatments
−Removed: superior to any therapies we develop, as our competitors may develop and patent products which are better than ours, which could harm
−Removed: our competitive position.
−Removed: sustain our continued growth, we will need to increase the size of our organization, and we may encounter difficulties managing our growth,
−Removed: which could adversely affect our results of operations.
−Removed: we are able to successfully develop additional products and expand the application of our current products, we may experience growth
−Removed: in the number of our employees and the scope of our operations.
−Removed: To the extent that we acquire and launch additional cosmetics products,
−Removed: the resulting growth and expansion of our sales force will place a significant demand on our financial, managerial and operational resources.
−Removed: Since many of the new cosmetics products or pipeline products we are working on may involve using our technologies under new applications
−Removed: or circumstances, it may require our entering into new markets.
−Removed: We may not be able to accurately forecast the number of employees required,
−Removed: the timing of their hire or the associated cost with our expansion and/or our entrance into new markets.
−Removed: The extent of any expansion
−Removed: we may experience will be driven largely by the success of our new cosmetics products.
−Removed: As a result, management’s ability to project
−Removed: the size of any such expansion and its cost to the company is limited by the following uncertainties:
−Removed: (i) we will not have previously
−Removed: sold any of the new products and applications and the ultimate success of these new products and applications is unknown;
−Removed: be entering new markets;
−Removed: and (iii) the costs associated with any expansion will be partially driven by factors that may not be fully
−Removed: in our control (e.g., timing of hiring, market salary rates, ability to hire new managerial and senior staff).
−Removed: Subject to these uncertainties,
−Removed: we estimate that our current business plan may require us to hire new rounds of employees, specifically for our salesforce within the
−Removed: next 12 months.
−Removed: Due to the uncertainty surrounding the new cosmetics products, this estimate may prove to be incorrect, and our costs
−Removed: could be significantly higher.
−Removed: Our success will also depend on the ability of our executive officers and senior management to continue
−Removed: to implement and improve our operational, information management and financial control systems, particularly in light of our status as
−Removed: a newly public company subject to the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, and to expand,
−Removed: train and manage our employee base.
−Removed: Our inability to manage growth effectively could cause our operating costs to grow even faster than
−Removed: we are currently anticipating and adversely affect our results of operations.
−Removed: we are unable to retain our existing sales force and recruit additional people to join our sales force, our revenue may not increase
−Removed: and may even decline.
−Removed: products are primarily marketed by our sales force to form new accounts with medical practices, and we depend on those medical practices
−Removed: to generate a substantial majority of our revenue.
−Removed: Our current sales force is independently contracted and may terminate their services
−Removed: at any time, and we may experience high turnover among our sales force from year to year.
−Removed: To increase our revenue, we must increase the
−Removed: number of and/or the productivity of our sales force.
−Removed: We must also expand our outreach and outbound efforts to attract, connect and nurture
−Removed: new customers for a wider medical practice base who purchase product and whom we can foster relationships with to promote retention and
−Removed: higher value over the life of the medical practice.
−Removed: we take many steps to help train, motivate and retain our sales force, we cannot accurately predict how the number and productivity of
−Removed: our sales force may fluctuate.
−Removed: Our operating results could be harmed if we do not generate sufficient interest in our business and its
−Removed: products to retain and motivate our existing sales force and attract new people to join our sales force.
−Removed: number and productivity of our sales force is negatively impacted by several additional factors, including:
−Removed: adverse publicity or negative public perception regarding us, our products or ingredients,
−Removed: our sales distribution channel, or our industry or competitors;
−Removed: of interest in, dissatisfaction with, or the technical failure of, existing or new products;
−Removed: of compelling products or income opportunities;
−Removed: sales force reaction to changes in our sales compensation plans or to our failure to make
−Removed: changes that would be necessary to keep our compensation competitive with the market;
−Removed: ● interactions
−Removed: with our company, including our actions to enforce our policies and procedures and the quality
−Removed: of our customer service;
−Removed: regulatory actions or charges against us or others in our industry, as well as regulatory
−Removed: changes that impact product formulations and sales viability;
−Removed: economic, business and public health conditions, including employment levels, employment
−Removed: trends such as the gig and sharing economies, and pandemics or other conditions that curtail
−Removed: person-to-person interactions;
−Removed: in the policies of social media platforms used to prospect or recruit potential consumers
−Removed: and sales force participants;
−Removed: efforts of our competitors and changes in consumer-loyalty trends;
−Removed: saturation or maturity levels in a given market, which could negatively impact our ability
−Removed: to attract and retain our sales force in such market.
−Removed: growth may suffer if an economic downturn in any of our major markets inhibits consumers from spending their disposable income on aesthetic
−Removed: and skin health products.
−Removed: growth depends significantly on continued economic growth in the markets where we sell our products.
−Removed: Because many treatments in which
−Removed: our products are used are considered cosmetic in nature, they are typically paid directly by consumers out of their disposable income
−Removed: and are not subject to reimbursement by third-party payers such as health insurance organizations.
−Removed: As a result, an economic downturn
−Removed: in any of our major markets could have an adverse effect on the sales and profitability of our products.
−Removed: products may cause undesirable side effects that could limit their use, require their removal from the market or prevent further development.
−Removed: there are no known side-effects of our products during any initial or prolonged use, any occurrence of side-effects or appearance that
−Removed: any of the ingredients we use may cause undesirable side-effects could limit consumer purchase and use of our products, particularly
−Removed: if physicians or their medical aesthetics consumers perceive that the risks or discomfort outweigh the benefits or if they perceive that
−Removed: the side effects of competitive products are less significant.
−Removed: side effects that may, in some cases be caused by our products could interrupt, delay or halt our research and development programs,
−Removed: including any clinical validation studies, and could result in adverse regulatory action by the FDA or other regulatory authorities.
−Removed: More severe side effects associated with our products may be observed in the future.
−Removed: Even if we are able to complete the development
−Removed: of a new product and obtain any required regulatory approval, undesirable side effects could prevent us from achieving or maintaining
−Removed: market acceptance of our current or prospective products or could substantially increase the costs and expenses of commercializing any
−Removed: future products.
−Removed: Negative publicity concerning our products, whether accurate or inaccurate, could also reduce market or regulatory acceptance
−Removed: of our products, which could result in decreased product demand, removal from the market or an increased number of product liability
−Removed: claims, whether or not such claims have merit.
−Removed: liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our products.
−Removed: business exposes us to the risk of product liability claims that are inherent to the development, clinical validation studies and testing
−Removed: to demonstrate aesthetic improvement and marketing of aesthetic and cosmetic skin products.
−Removed: These lawsuits may divert our management
−Removed: from pursuing our business strategy and may be costly to defend.
−Removed: In addition, if we are held liable in any of these lawsuits, we may
−Removed: incur substantial liabilities and may be forced to limit or forgo further commercialization of those products.
−Removed: Although we maintain general
−Removed: liability insurance in an amount that we believe is reasonably adequate to insulate us from potential claims, this insurance may not
−Removed: fully cover potential liabilities.
−Removed: In addition, our inability to obtain or maintain sufficient insurance coverage at an acceptable cost
−Removed: or to otherwise protect against potential product liability claims could prevent or inhibit the commercial production and sale of our
−Removed: products, which could adversely affect our business.
−Removed: are subject to risks associated with doing business internationally.
−Removed: international sales will depend upon the success under both our exclusive and non-exclusive distribution partners and associated marketing
−Removed: efforts of and sales of our third-party distributors via our distribution and license agreements with these partners.
−Removed: Although none of
−Removed: our international distribution or license partners accounted for any of our net sales in 2021 and 2022, our business is subject to certain
−Removed: risks inherent in international business as we continue to expand, many of which are beyond our control.
−Removed: These risks include:
−Removed: changes in tariff and trade protection measures;
−Removed: changes in foreign regulatory requirements;
−Removed: potential of negative consequences from changes in tax laws;
−Removed: potential of business failure of one or more of our distribution partners;
−Removed: economic conditions in countries where our products are sold;
−Removed: unexpected fluctuations in
−Removed: exchange rates;
−Removed: political unrest and hostilities;
−Removed: degrees of protection for intellectual property;
−Removed: ● difficulties
−Removed: in coordinating foreign distribution.
−Removed: of the foregoing factors could adversely affect our business, financial condition and results of operations.
−Removed: We cannot assure you that
−Removed: we can successfully manage these risks or avoid their effects when doing business internationally.
−Removed: business combinations could require significant management attention and prove difficult to integrate with our business, which could
−Removed: divert the attention of our management, disrupt our normal course of business, dilute stockholder value and adversely affect our operating
−Removed: we become aware of potential business combination candidates that are complementary to our business, we may decide to combine with such
−Removed: businesses or acquire their assets in the future.
−Removed: Business combinations generally involve a number of additional difficulties and risks
−Removed: to our business, including:
−Removed: to integrate management information systems, personnel, research and development and marketing,
−Removed: operations, sales and support;
−Removed: of our ongoing business and diversion of management’s attention from other business
−Removed: loss of the acquired company’s customers;
−Removed: to further develop or integrate the acquired company’s products or technology successfully;
−Removed: ● unanticipated
−Removed: costs and liabilities;
−Removed: accounting system consequences.
−Removed: addition, we may not realize benefits from any business combination we may undertake in the future.
−Removed: If we fail to successfully integrate
−Removed: such businesses, or the products and technologies associated with such business combinations into our company, the revenue and operating
−Removed: results of the combined company could be adversely affected.
−Removed: Any integration process would require significant time and resources, and
−Removed: we may not be able to manage the process successfully.
−Removed: If our customers are uncertain about our ability to operate on a combined basis,
−Removed: they may delay or cancel orders for our products.
−Removed: We may not successfully evaluate, integrate or utilize the acquired technology and
−Removed: product lines or accurately forecast the financial impact of a combination, including accounting system charges or volatility in the
−Removed: stock price of the combined entity, should it be a publicly traded target.
−Removed: If we fail to successfully integrate other companies with
−Removed: which we may combine in the future, our business could be adversely affected.
−Removed: we fail to cost-effectively acquire new client accounts or retain our existing clients, our business could be adversely affected.
−Removed: sales and profit are dependent upon our ability to expand sales to our existing client relationships and acquire new client accounts.
−Removed: success, and our ability to increase revenue and achieve profitability, depend in part on our ability to cost-effectively acquire new
−Removed: client accounts, retain existing clients and keep existing aesthetics-consumers engaged so that they continue to request and purchase
−Removed: our products.
−Removed: While we intend to continue to invest significantly in sales and marketing to educate medical clients about our brand,
−Removed: our values and our products, there is no assurance that these efforts will generate further demand for our products or expand our client
−Removed: Our ability to attract new client accounts and retain our existing accounts will depend on, among other items, the perceived value
−Removed: and quality of our products, consumer demand for thoughtfully designed and innovative cosmetic products at a premium, competitive offerings,
−Removed: our ability to offer new and relevant products and the effectiveness of our marketing efforts.
−Removed: We may also lose loyal clients to our
−Removed: competitors if we are unable to meet client demand for product in a timely manner.
−Removed: If we are unable to cost-effectively acquire new client
−Removed: accounts, retain existing clients and keep existing clients engaged, our business, financial condition, results of operations and prospects
−Removed: could be adversely affected.
−Removed: strategies we employ to pursue this growth are subject to numerous factors outside of our control.
−Removed: Our medical clients continue to be
−Removed: aggressively marketed to for other private label or competitive cosmetic products in the medical aesthetics space, which could reduce
−Removed: demand for our products.
−Removed: The expansion of our business also depends on our ability to increase sales through our distribution agreements
−Removed: and white-label product channels.
−Removed: Any growth within our existing distribution agreement channels may also affect our existing client
−Removed: relationships and present additional challenges, including those related to pricing strategies.
−Removed: Our direct connections to our clients
−Removed: may become more limited as we expand our distribution channels.
−Removed: Additionally, we may need to increase or reallocate spending
−Removed: on marketing and promotional activities, such as temporary price reductions, off-invoice discounts, advertisements, product
−Removed: coupons and other trade activities, and these expenditures are subject to risks, including risks related to our clients’ acceptance
−Removed: of our marketing efforts.
−Removed: Our strategy to grow international sales may also increase our marketing spend.
−Removed: Our failure to obtain new clients,
−Removed: or expand our business with existing clients, could have an adverse effect on our business, financial condition, results of operations
−Removed: and prospects.
−Removed: also use paid and non-paid advertising.
−Removed: Our paid advertising may include search engine marketing, display, paid social media
−Removed: and product placement and traditional advertising, such as direct mail, television, radio and magazine advertising.
−Removed: Our non-paid advertising
−Removed: efforts include search engine optimization, non-paid social media and e-mail marketing.
−Removed: We drive a significant amount
−Removed: of traffic to our website via search engines.
−Removed: However, search engines frequently update and change the logic that determines the placement
−Removed: and display of results of a user’s search, such that the purchased or algorithmic placement of links to our website can be negatively
−Removed: Moreover, a search engine could, for competitive or other purposes, alter its search algorithms or results, causing our website
−Removed: to place lower in search query results.
−Removed: also drive a significant amount of traffic to our website via social networking or other ecommerce channels used by our current and prospective
−Removed: clients and medical aesthetics cosmetics consumers.
−Removed: As social networking and ecommerce channels continue to rapidly evolve, we may be
−Removed: unable to develop or maintain a presence within these channels.
−Removed: If we are unable to cost-effectively drive traffic to our website, or
−Removed: if the popularity of our social media presence declines, our ability to acquire new clients or interest via consumers could be adversely
−Removed: Additionally, if we fail to increase our revenue per client, generate repeat purchases or maintain high levels of client engagement,
−Removed: our business, financial condition, results of operations and prospects could be adversely affected.
−Removed: must expend resources to maintain awareness of our brand, build brand loyalty and generate interest in our products.
−Removed: Our marketing strategies
−Removed: and channels will evolve, and our efforts may or may not be successful.
−Removed: order to remain competitive and expand and keep market share for our cosmetics products across our various distribution and business
−Removed: channels, we may need to increase our marketing and advertising spending to maintain and increase brand and client awareness, protect
−Removed: and grow our existing market share or promote new products, which could impact our operating results.
−Removed: Substantial advertising and promotional
−Removed: expenditures may be required to maintain or improve our brand’s market position or to introduce new products to the market, presenting
−Removed: at medical aesthetic conferences, traveling to tradeshows as well as increasingly engaging with non-traditional media.
−Removed: Non-traditional
−Removed: media meets many clients and their cosmetic aesthetics consumers where they are most active which includes outreach through social media
−Removed: and web-based channels, however these channels may not prove successful in building brand awareness.
−Removed: Thus, an increase in our
−Removed: marketing and advertising efforts may not maintain our current reputation or lead to increased market share.
−Removed: Further, social media platforms
−Removed: frequently change the algorithms that determine the ranking and display of results of a user’s search and may make other changes
−Removed: to the way results are displayed, or may increase the costs of such advertising, which can negatively affect the placement of our links
−Removed: and, therefore, reduce the number of visits to our website and social media channels or make such marketing cost-prohibitive.
−Removed: social media platforms typically require compliance with their policies and procedures, which may be subject to change or new interpretation
−Removed: with limited ability to negotiate, which could negatively impact our marketing capabilities.
−Removed: If we are unable to maintain and promote
−Removed: a favorable perception of our brand and products on a cost-effective basis, our business, financial condition, results of operations
−Removed: and prospects could be adversely affected.
−Removed: to leverage our brand value propositions through our novel exosome technology to compete against well-known cosmetics products, especially
−Removed: during an economic downturn, may adversely affect our ability to achieve or maintain profitability.
−Removed: the medical aesthetic cosmetics product category, we compete not only with other widely advertised branded products, but also with well-known
−Removed: branded cosmetics products that have larger market share within the medical aesthetics cosmetics space and may have the capacity to be
−Removed: sold at lower prices.
−Removed: Medical businesses are more likely to purchase our products if they believe that our products provide greater value
−Removed: than less expensive alternatives and if their medical aesthetics consumers demand our products.
−Removed: If the difference in perceived value
−Removed: between our brand and well-known cosmetics products narrows, or if there is a perception of such a narrowing, clients may choose not
−Removed: to buy our products at prices that are profitable for us.
−Removed: We believe that in periods of economic uncertainty, such as the current economic
−Removed: uncertainty surrounding COVID-19, clients may purchase less inventory from us or more from lower-priced brands despite our
−Removed: value proposition.
−Removed: To the extent this occurs, we could experience a reduction in the sales volume of our products or an unfavorable shift
−Removed: in the types of products medical aesthetics consumers demand, which could have an adverse effect on our business, financial condition,
−Removed: results of operations and prospects.
−Removed: brand and reputation may be diminished due to real or perceived quality, safety, aesthetic results or environmental impact issues with
−Removed: our products, which could have an adverse effect on our business, financial condition, results of operations and prospects.
−Removed: believe our clients and their medical aesthetics consumers rely on us to provide them with high quality, innovative, well-designed, and
−Removed: effective products.
−Removed: Any loss of confidence on the part of medical aesthetics consumers in our products or the ingredients used in our
−Removed: products, whether related to product contamination or product safety or quality failures, actual or perceived, environmental impacts,
−Removed: or inclusion of prohibited ingredients, or ingredients that are perceived to be “toxic”, could tarnish the image of our brand
−Removed: and could cause consumers to choose other products.
−Removed: Allegations of contamination or other adverse effects on product safety or aesthetic
−Removed: results or suitability for use by a particular consumer or on the environment, even if untrue, may require us to expend significant time
−Removed: and resources responding to such allegations and could, from time to time, result in a recall of a product from any or all of the markets
−Removed: in which the recalled product was distributed.
−Removed: Any such issues or recalls could negatively affect our ability to achieve or maintain
−Removed: profitability and brand image.
−Removed: also have no control over our products once purchased by medical aesthetics consumers of our clients.
−Removed: For example, medical aesthetics
−Removed: consumers may store or use our products under conditions and for periods of time inconsistent with approved directions for use or the
−Removed: listed shelf life or required warnings or other governmental guidelines on our labels, which may adversely affect the quality and safety
−Removed: of our products or the perceived quality and safety.
−Removed: our products are found to be, or perceived to be, defective or unsafe, or if they otherwise fail to meet our clients and their medical
−Removed: aesthetics consumers’ expectations, our relationships with our client base could suffer, the appeal of our brand could be diminished,
−Removed: we may need to recall some of our products and/or become subject to regulatory action, and we could lose sales or market share or become
−Removed: subject to boycotts or liability claims.
−Removed: In addition, safety or other defects in our competitors’ products or products using our
−Removed: branded name via white-label agreements in other distributed products could reduce overall demand for products with our brand if consumers
−Removed: generally view them to be similar to our products.
−Removed: Any such adverse effect could be exacerbated by our market positioning as a purveyor
−Removed: of high quality, innovative, well-designed, and effective products and may significantly reduce our brand value.
−Removed: Issues regarding the
−Removed: safety, aesthetic results, quality or environmental impact of any of our products, regardless of the cause, may have an adverse effect
−Removed: on our brand, reputation and operating results.
−Removed: Further, the growing use of social and digital media by us, our clients and third parties
−Removed: increases the speed and extent that information or misinformation and opinions can be shared.
−Removed: Negative publicity about us, our brand
−Removed: or our products on social or digital media could seriously damage our brand and reputation.
−Removed: Any loss of confidence on the part of clients
−Removed: and their medical aesthetics consumers in the quality, safety, aesthetic results or environmental suitability of our products would be
−Removed: difficult and costly to overcome, even if such concerns were based on inaccurate or misleading information.
−Removed: If we do not maintain a favorable
−Removed: perception of our brand, and project our positions regarding our product safety effectively, our business, financial condition, results
−Removed: of operations and prospects could be adversely affected.
−Removed: downturns or a change in medical aesthetic consumer preferences, perception and spending habits in the medical aesthetic cosmetic products
−Removed: categories, in particular, could limit aesthetic consumer demand for our cosmetic products and negatively affect our business.
−Removed: have positioned our brand to capitalize on growing consumer interest in complementary cosmetics for the medical aesthetics services industry.
−Removed: The medical aesthetics cosmetics product industry is sensitive to national and regional economic conditions and the demand for the products
−Removed: that we distribute may be adversely affected from time to time by economic downturns that impact consumer spending on cosmetics products,
−Removed: including discretionary spending.
−Removed: Future economic conditions such as employment levels, business conditions, housing starts, interest
−Removed: rates, inflation rates, energy and fuel costs, and tax rates could reduce consumer spending or change consumer purchasing habits.
−Removed: these changes could be a reduction in the number of medical aesthetics cosmetics products that medical aesthetics consumers purchase
−Removed: when they receive medical aesthetics services, given that many products in this category often have higher retail prices than do their
−Removed: conventional counterparts found in retail stores.
−Removed: the high-end cosmetics markets in which we operate are subject to changes in consumer preference, trends, new technology, perception
−Removed: and discretionary spending habits.
−Removed: Our performance depends significantly on factors that may affect the level and pattern of medical
−Removed: aesthetics consumer spending in the markets in which we operate.
−Removed: Such factors include medical aesthetics consumer preference, medical
−Removed: aesthetics consumer confidence, medical aesthetics consumer income, medical aesthetics consumer perception of the safety and quality
−Removed: of our products and shifts in the perceived value for our cosmetics products relative to conventional alternatives.
−Removed: The medical aesthetics
−Removed: cosmetics market is also subject to changes in the rate of procedures, which have been increasing in developed countries like the United
−Removed: In addition, media coverage regarding the safety or quality of, our products or the biological raw materials, ingredients
−Removed: or bioengineering processes involved in their manufacturing may damage consumer confidence in our cosmetics products.
−Removed: general decline in the consumption of our cosmetics products could occur at any time as a result of change in medical aesthetics consumer
−Removed: preference, perception, confidence and spending habits, including an unwillingness to pay a premium or an inability to purchase our products
−Removed: due to financial hardship or increased price sensitivity, which may be exacerbated by the effects of the COVID-19 pandemic
−Removed: or economic downturn.
−Removed: If medical aesthetics consumer preferences shift away from complementary cosmetic products, our business,
−Removed: financial condition and results of operations could be adversely affected.
−Removed: success of our products depends on a number of factors Including our ability to accurately anticipate changes in the medical aesthetics
−Removed: cosmetics market demand and medical aesthetics consumer preferences, our ability to differentiate the quality and innovativeness of our
−Removed: cosmetics products from those of our competitors, and the effectiveness of our marketing and advertising campaigns for our cosmetics
−Removed: We may not be successful in identifying trends in medical aesthetics preferences and developing cosmetics products that respond
−Removed: to or lead the way in such trends in a timely manner.
−Removed: We also may not be able to effectively promote our cosmetics products and related
−Removed: technologies by our marketing and advertising campaigns and gain market acceptance.
−Removed: If our cosmetics products fail to gain market acceptance,
−Removed: are restricted by regulatory requirements or have quality problems, we may not be able to fully recover costs and expenses incurred in
−Removed: our operation, and our business, financial condition, results of operations and prospects could be adversely affected.
−Removed: we cannot maintain our company culture or focus on our purpose as we grow, our success and our business and competitive position may
−Removed: believe our culture and our mission have been key contributors to our success to date and that the critical nature of the products that
−Removed: we promote a sense of transparency and scientific innovation to our clients.
−Removed: Any failure to preserve our culture or focus on our mission
−Removed: could negatively affect our ability to retain and recruit clients, and personnel, which is critical to our growth and to effectively
−Removed: focus on and pursue our corporate objectives.
−Removed: As we grow and develop the infrastructure of a public company, we may find it difficult
−Removed: to maintain these important values.
−Removed: If we fail to maintain our company culture or focus on our mission our competitive position and business,
−Removed: financial condition, results of operations and prospects could be adversely affected.
−Removed: we lose key personnel or are unable to attract and retain other qualified personnel, we may be unable to execute our business plan and
−Removed: our business would be materially adversely affected.
−Removed: of September 28, 2023, we had 16 employees.
−Removed: Our success depends on our continued ability to attract, retain and motivate highly qualified
−Removed: management, business development, sales and marketing, product development and other personnel.
−Removed: In the future we may not be able to recruit
−Removed: and retain qualified personnel, particularly for senior sales and marketing, research and product development positions due to intense
−Removed: competition for personnel among businesses like ours, and the failure to do so could have a significant negative impact on our future
−Removed: product sales and business results.
−Removed: Our success depends in large part on the efforts and abilities of Jordan R.
−Removed: Plews, our President
−Removed: and Chief Executive Officer;
−Removed: Graydon Bensler, our Chief Financial Officer;
−Removed: Tim Sayed, our Chief Medical Officer;
−Removed: Brenda Buechler, our
−Removed: Chief Marketing Officer;
−Removed: and Christoph Kraneiss, our Chief Commercial Officer—as well as other members of our senior management
−Removed: and our scientific and technical personnel.
−Removed: ability to maintain our competitive position is largely dependent on the services of our senior management and other key personnel, including
−Removed: our co-founder, President and Chief Executive Officer, Jordan R.
−Removed: The loss of the services of Dr.
−Removed: Plews could have an adverse effect
−Removed: on our business, financial condition, results of operations and prospects.
−Removed: Plews is a well-recognized bioengineer, doctor and entrepreneur.
−Removed: We believe that the success of our brand depends in part on our ongoing affiliation with Dr.
−Removed: We have an agreement with Dr.
−Removed: or the Inventions and Proprietary Information Agreement, which, among other things, includes an assignment to us for any of Dr.
−Removed: inventions, know-how or intellectual property, among other items that are legally protectable that result or relatedly-arise from any
−Removed: work performed in his capacity as our employee and imposes various obligations on us.
−Removed: Should that Inventions and Proprietary Information
−Removed: Agreement terminate and upon twelve months after the termination of the Inventions and Proprietary Information Agreement, we could, among
−Removed: other things, lose our ability to control recruiting by Dr.
−Removed: Plews of any of our employees or consultants.
−Removed: Moreover, upon such termination
−Removed: of the Inventions and Proprietary Information Agreement, we may not be able to limit Dr.
−Removed: Plews use of any of our know-how, processes
−Removed: or reverse engineering of our products and sustain reputational damage.
−Removed: We depend on Dr.
−Removed: Plews appearances at industry functions, conferences
−Removed: and his reach and influence to connect with clients and provide insight on current medical aesthetic cosmetics trends.
−Removed: Thus, the loss
−Removed: of the services of Dr.
−Removed: Plews, or the loss of our ability to use Dr.
−Removed: Plews’s likeness, could have an adverse effect on our business,
−Removed: financial condition, results of operations and prospects.
−Removed: we maintain “key employee” insurance policies on our executive officers that would compensate us for the loss of their services,
−Removed: even if we lose the services of one or more of these individuals, finding a replacement could be difficult, may take an extended period
−Removed: of time and could significantly impede the achievement of our business objectives.
−Removed: Moreover, the “key employee” insurance
−Removed: policy limit may not fully cover interim expenses for the services and expertise we may require in order to maintain relatively uninterrupted
−Removed: operations of our business.
−Removed: This gap in coverage and the time it may take to replace a key employee may have a material adverse effect
−Removed: on our results of operations and financial condition.
−Removed: may be unable to accurately forecast revenue and appropriately plan our expenses in the future.
−Removed: and results of operations are difficult to forecast because they generally depend on the volume, timing and type of orders we receive
−Removed: across our various distribution channels, all of which are uncertain.
−Removed: Forecasts may be particularly challenging as we intend to expand
−Removed: into new markets and geographies and develop and market new cosmetics products.
−Removed: We base our expense levels and investment plans on our
−Removed: estimates of revenue and gross margin.
−Removed: However, we cannot be sure the same growth rates and trends are meaningful predictors of future
−Removed: If our assumptions prove to be wrong, we may spend more than we anticipate acquiring and retaining our client or may generate
−Removed: lower revenue per client account than anticipated, either of which could have an adverse effect on our business, financial condition,
−Removed: results of operations and prospects.
−Removed: have a limited operating history at our current scale, which may make it difficult to evaluate our business and future prospects.
−Removed: began commercial operations in 2020 and have a limited history of generating revenue at our current scale.
−Removed: As a result of our relatively
−Removed: short operating history at our current scale, we have limited financial data that can be used to evaluate our business and future prospects.
−Removed: Any evaluation of our business and prospects must be considered in light of our limited operating history, which may not be indicative
−Removed: of future performance.
−Removed: Because of our limited operating history, we face increased risks, uncertainties, expenses, and difficulties,
−Removed: including the risks and uncertainties discussed in this section.
−Removed: disruption in our operations could have an adverse effect on our business.
−Removed: a company engages in sales domestically and internationally, our operations, including those of our third-party formulators, suppliers,
−Removed: and distribution partners, and other service providers, are subject to the risks inherent in such activities, including industrial accidents,
−Removed: environmental events, strikes and other labor disputes, disruptions in information systems, product quality control, safety, licensing
−Removed: requirements and other regulatory issues, as well as natural disasters, pandemics or other public health emergencies, border disputes,
−Removed: acts of terrorism and other external factors over which we and our third-party manufacturers, suppliers and delivery service providers
−Removed: have no control.
−Removed: The loss of, or damage to, the facilities of our third-party formulators, suppliers and delivery service providers could
−Removed: have an adverse effect on our business, financial condition, results of operations and prospects.
−Removed: depend heavily on postal and parcel carriers for the delivery of products sold directly to clients.
−Removed: Interruptions to or failures in these
−Removed: delivery services could prevent the timely or successful delivery of our products.
−Removed: These interruptions or failures may be due to unforeseen
−Removed: events that are beyond our control or the control of our third-party delivery service providers, such as labor unrest or natural disasters
−Removed: Any failure to provide high-quality delivery services to our clients may negatively affect the ordering and likelihood of repeat-purchasing
−Removed: of our clients, damage our reputation and cause us to lose client accounts.
−Removed: The COVID-19 or
−Removed: another pandemic could have an adverse effect on our business, financial condition, results of operations and prospects.
−Removed: connection with the COVID-19 pandemic, governments have implemented significant measures, including closures, quarantines,
−Removed: travel restrictions and other social distancing directives, intended to control the spread of the virus.
−Removed: Companies have also taken precautions,
−Removed: such as requiring employees to work remotely, imposing travel restrictions and temporarily closing businesses from time to time.
−Removed: extent that these restrictions remain in place, additional prevention and mitigation measures are implemented in the future, or there
−Removed: is uncertainty about the effectiveness of these or any other measures to contain or treat COVID-19 or a variant thereof, there
−Removed: has been and continues to be an adverse impact on global economic conditions and consumer confidence and spending, which could adversely
−Removed: affect our supply chain as well as the demand for our cosmetics products.
−Removed: Although at this time we have not experienced disruptions to
−Removed: our supply chain, and we have not experienced decreases in demand or attributed COVID-19 to any material financial impacts, the fluid
−Removed: nature of the COVID-19 pandemic and uncertainties regarding the related economic impact are likely to result in sustained market
−Removed: uncertainty and turmoil, which could also have an adverse effect on our business, financial condition, results of operations and prospects.
−Removed: impact of the COVID-19 pandemic, or any other eventual pandemic on any of our suppliers, formulators, packagers, shippers,
−Removed: distribution partners, medical business clients or transportation or logistics providers may negatively affect the price and availability
−Removed: of our materials and impact our supply chain.
−Removed: If the disruptions caused by the COVID-19 pandemic continue for an extended period
−Removed: of time, our ability to meet the demands of our clients may be materially impacted.
−Removed: In addition, the conditions caused by the COVID-19 pandemic,
−Removed: or another pandemic may negatively impact collections of accounts receivable and cause some of our clients’ businesses to slow,
−Removed: all of which could adversely affect our business, financial condition, results of operations and prospects.
−Removed: the COVID-19 pandemic may impact medical aesthetic cosmetics consumer demand.
−Removed: Medical aesthetics practices may be impacted
−Removed: if governments continue to implement regional business closures, quarantines, travel restrictions and other social distancing directives
−Removed: to slow the spread of the virus.
−Removed: Further, to the extent our clients’ operations are negatively impacted, their medical aesthetic
−Removed: cosmetics consumers may reduce demand for or spending on our cosmetics products.
−Removed: There may also be significant reductions or volatility
−Removed: in medical aesthetic cosmetics demand for our products due to travel restrictions or social distancing directives, as well as the temporary
−Removed: inability of consumers to purchase our products due to illness, quarantine or financial hardship, shifts in demand away from one or more
−Removed: of our products, decreased consumer confidence and spending or beautification activities, any of which may negatively impact our results,
−Removed: including as a result of an increased difficulty in planning for operations.
−Removed: Additionally, we may be unable to effectively modify our
−Removed: advertising activities to reflect changing medical aesthetic cosmetics interests in beauty, or their general outward appearance, and
−Removed: shopping habits due to event cancellations, reduced in-store visits and travel restrictions, among other things.
−Removed: is not currently possible to ascertain the overall impact of the COVID-19 pandemic on our business.
−Removed: However, if the pandemic
−Removed: continues to persist as a severe worldwide health crisis, the disease could have an adverse effect on our business, financial condition,
−Removed: results of operations and prospects, and may also have the effect of heightening many of the other risks described in this “Part
−Removed: Risk Factors” section.
−Removed: business is at an early stage of product development, and we may not develop additional cosmetics products that can be commercialized
−Removed: or profitably developed and our failure to introduce new products may adversely affect our ability to continue to grow.
−Removed: business is at an early stage of product development.
−Removed: As of the date of this report, we have commercialized two cosmetics products for
−Removed: the medical aesthetics market.
−Removed: We are still in the early stages of identifying and conducting research on potential new cosmetic products.
−Removed: key element of our growth strategy depends on our ability to develop and market new products that meet our standards for quality and
−Removed: appeal to our clients and distribution partners.
−Removed: Our pipeline products will require significant research and development, and clinical
−Removed: validation testing to demonstrate aesthetic improvement of any product.
−Removed: We may not be able to successful commercialize or synthetize
−Removed: any of product candidates or commercialize any products at scale that is profitable.
−Removed: Our product candidates may prove to have undesirable
−Removed: and unintended side effects or other characteristics adversely affecting their safety, aesthetic results or cost effectiveness that could
−Removed: prevent or limit their use.
−Removed: Any product using any of our technology may fail to provide the intended aesthetic improvements or achieve
−Removed: aesthetic results or benefits equal to or better than the standard of treatment at the time of testing or after a product may be formulated.
−Removed: success of our innovation and product development efforts is affected by our ability to anticipate changes in consumer and market preferences
−Removed: within the medical aesthetics cosmetics industry, the technical capability of our laboratory staff, including biochemists and bioengineers, developing
−Removed: and testing product formulas and prototypes, our ability to comply with applicable governmental regulations, and the success of our management
−Removed: and sales and marketing teams in introducing and marketing new products.
−Removed: Our cosmetics product offerings may change over time, which
−Removed: makes it difficult to forecast our future results of operations.
−Removed: There can be no assurance that we will successfully develop and market
−Removed: new products that appeal to clients.
−Removed: For example, product formulas we develop may not contain the product attributes desired by the medical
−Removed: aesthetics consumers that our clients serve.
−Removed: Any such failure may lead to a decrease in our growth, sales and ability to achieve profitability,
−Removed: which could adversely affect our business, financial condition, results of operations and prospects.
−Removed: Additionally,
−Removed: the development and introduction of new products requires substantial marketing expenditures, which we may be unable to recoup if new
−Removed: products do not gain widespread market acceptance.
−Removed: If we are unsuccessful in meeting our objectives with respect to new or improved products,
−Removed: our business, financial condition, results of operations and prospects could be adversely affected.
−Removed: may incur product liability claims that could harm our business.
−Removed: sell a variety of topical cosmetics products for topical human use.
−Removed: Our cosmetics are not generally subject to pre-market approval or
−Removed: registration processes so we cannot rely upon a government safety panel to qualify or approve our products for use, and some ingredients
−Removed: may not have long histories of human consumption or use.
−Removed: We rely upon published and unpublished safety information including clinical
−Removed: validation studies on ingredients used in our products and conduct our own clinical validation and safety studies on some key ingredients
−Removed: and products.
−Removed: A product may be safe for the general population when consumed or used as directed but could cause an adverse reaction
−Removed: for some individuals, such as a person who has a health condition or allergies or who is taking a prescription medication.
−Removed: While we include
−Removed: what we believe are adequate instructions and warnings and we have historically had low or no numbers of reported reactions, previously
−Removed: unknown adverse reactions could occur.
−Removed: While we maintain a policy to insure our product liability risks we will continue to periodically
−Removed: evaluate whether any of our products are found to cause any injury or damage and whether we become subject to product liability claims.
−Removed: a result of the type of products that we sell, we may be subject to various product liability claims, including that the products fail
−Removed: to meet quality or manufacturing specifications, contain contaminants, include inadequate instructions as to their proper use, include
−Removed: inadequate warnings concerning side effects and interactions with other substances or for persons with health conditions or allergies,
−Removed: or cause adverse reactions or side effects.
−Removed: Consumer protection laws and regulations governing our business continue to expand, and in
−Removed: some states such as California, class-action lawsuits based on increasingly novel theories of liability are expanding.
−Removed: Product liability
−Removed: claims could increase our costs, cause negative publicity, and adversely affect our business and financial results.
−Removed: As we continue to
−Removed: offer an increasing number of new products through large product offerings our product liability risk may increase.
−Removed: our sales force or employees provide improper or inappropriate advice regarding our products, their use or safety, we may be subject
−Removed: to additional product liability.
−Removed: If we discover that our products are causing adverse reactions, or if we determine that any of our employees
−Removed: have not properly handled reports of adverse reactions, we could suffer further adverse publicity or government sanctions.
−Removed: employees, independent contractors, consultants, medical professional clients, distributors and vendors may engage in unethical misconduct
−Removed: or other improper sales activities, including noncompliance with regulatory standards and requirements.
−Removed: are exposed to the risk that our employees, independent contractors, consultants, medical professional clients, distributors and vendors
−Removed: and other individuals or entities with whom we have arrangements may engage in unethical, fraudulent or illegal activity.
−Removed: by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates:
−Removed: (i) the laws of the FDA, other similar foreign regulatory authorities and foreign governments, including those laws requiring the reporting
−Removed: of true, complete and accurate information to such regulators;
−Removed: (ii) manufacturing standards;
−Removed: or (iii) laws that require the true, complete
−Removed: and accurate reporting of financial information or data.
−Removed: These laws may impact, among other things, future sales, marketing and promotional
−Removed: is not always possible to identify and deter unethical misconduct by our employees, medical professional clients and other third parties,
−Removed: and the precautions we take to detect and prevent these activities may not be effective in controlling unknown or unmanaged risks or
−Removed: losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance
−Removed: such laws or regulations.
−Removed: If such actions are instituted against us and we are not successful in defending ourselves or asserting our
−Removed: rights, those actions could result in government investigations, legal proceedings, the imposition of significant fines or other sanctions,
−Removed: including the imposition of monetary penalties, damages, monetary fines, contractual damages, reputational harm, diminished profits and
−Removed: future earnings and curtailment of operations, any of which could adversely affect our ability to operate our business and our results
−Removed: of operations.
−Removed: Whether or not we are successful in defending against such actions or investigations, we could incur substantial costs,
−Removed: including legal fees, and divert the attention of management in defending ourselves against any of these claims or investigations, which
−Removed: could have a material adverse effect on our business, financial condition and results of operations.
−Removed: our cosmetics products may be subject to sales and marketing practices subject to business arrangements that may include kickbacks, self-dealing
−Removed: and other abusive practices.
−Removed: Because our medical professional clients receive a markup on each sale of our cosmetics products our medical
−Removed: professional clients may structure their own internal sales and commission programs or promote certain customer incentive programs and
−Removed: other business arrangements that include our cosmetic products and more generally that incentivize monetary gain over effecting positive
−Removed: results for their customers.
−Removed: Such programs may promote perverse incentives relating to the sale, stocking, or purchasing of our cosmetic
−Removed: Such programs could negatively impact our marketing capabilities and favorable perception of our brand and products.
−Removed: are unable to maintain and promote a favorable perception of our brand and products, our business, financial condition, results of operations
−Removed: and prospects could be adversely affected.
−Removed: have limited clinical validation and testing data, and clinical validation testing are subject to extensive regulatory requirements,
−Removed: very expensive, time-consuming and difficult to design and implement.
−Removed: Our products may fail to achieve necessary safety and aesthetic
−Removed: results during clinical validation testing, which may limit our ability to generate revenues from our cosmetics products.
−Removed: have not yet invested significantly in wide-ranging clinical validation testing to demonstrate aesthetic improvement and the few studies
−Removed: we have arranged are in early stages as of the date of this report.
−Removed: We cannot assure you that we will be able to continue to invest or
−Removed: develop resources for conducting these tests in the near future.
−Removed: In particular, clinical validation testing can be very expensive and
−Removed: difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
−Removed: The clinical validation trial
−Removed: process is time consuming.
−Removed: Furthermore, failure can occur at any stage of the testing, and we could encounter problems that cause us
−Removed: to abandon or repeat clinical validation testing.
−Removed: The commencement and completion of clinical validation studies may be affected by several
−Removed: factors, including:
−Removed: safety issues;
−Removed: ● determination
−Removed: of product applicative issues;
−Removed: to demonstrate positive aesthetic results during clinical validation studies;
−Removed: than expected rates of participant recruitment;
−Removed: to monitor or document participants adequately during or after product application;
−Removed: ● developments
−Removed: related to the coronavirus outbreak and impact of it and COVID-19 on the costs and timing
−Removed: associated with the conduct of our clinical validation studies and other related activities.
−Removed: success depends largely upon consumer satisfaction with the aesthetic results of our products.
−Removed: order to generate repeat and referral business from clients, our clients’ medical aesthetics consumers must be satisfied with the
−Removed: aesthetic results of our cosmetics products.
−Removed: Our products are cosmetic in nature and the success of the results are highly subjective.
−Removed: Accordingly, medical aesthetics consumers’ perception of their aesthetic results may greatly vary even if our products and systems
−Removed: associated therewith are shown to be objectively successful.
−Removed: If medical aesthetics consumers are not satisfied with the aesthetic benefits
−Removed: of our products or feel that they are too expensive for the aesthetic results obtained, our reputation and future sales to our clients
−Removed: could suffer.
−Removed: products may fail to achieve the broad degree of physician adoption and use or medical aesthetic consumer demand necessary for commercial
−Removed: cosmetics products, which as of the date of this report are used solely in a clinical or medical spa setting, may fail to gain sufficient
−Removed: market acceptance by physicians and others in the medical aesthetics community.
−Removed: The commercial success of these products and any future
−Removed: products will depend significantly on the broad adoption and use of the resulting product by physicians for the treatment of aesthetic
−Removed: indications that we may seek to pursue.
−Removed: We are aware that other companies are seeking to develop alternative products and treatments,
−Removed: any of which could impact the demand for our cosmetics products.
−Removed: degree and rate of physician adoption of our exosome serums and any future products depend on a number of factors, including the cost,
−Removed: profitability to our clients, medical aesthetic consumer demand, characteristics and aesthetic results of our products.
−Removed: Our success will
−Removed: also depend on our ability to create compelling marketing programs and ability to overcome any biases physicians or consumers may have
−Removed: toward the use, safety and aesthetic results of existing products over ours.
−Removed: Moreover, our competitors may offer more compelling marketing
−Removed: or discounting programs than we are able to offer, including by bundling multiple aesthetic products to provide a more comprehensive
−Removed: offering than we can.
−Removed: We can provide no assurance that health professionals will continue to recommend our products at their current
−Removed: levels, or at all.
−Removed: Additionally, we may be unable to continue to grow our network of health professional clients and therefore may not
−Removed: continue to achieve revenue growth through this channel.
−Removed: respect to medical aesthetic consumer demand, use of our cosmetic products is purely elective with a cost that must be borne by the consumer,
−Removed: and costs related to the use of cosmetics is not reimbursable through any third-party payor, such as Medicaid, Medicare or commercial
−Removed: The decision by a medical aesthetic consumer to purchase our products for aesthetic indications may be influenced by a number
−Removed: of factors, including the cost, aesthetic results, safety, perception, marketing programs for, and physician recommendations of our cosmetics
−Removed: products versus competitive cosmetics products or other procedures provided by the physician.
−Removed: our cosmetics products or any future pipeline product fail to achieve the broad degree of physician adoption necessary for commercial
−Removed: success or the requisite medical aesthetic consumer demand, our operating results and financial condition will be adversely affected,
−Removed: which may delay, prevent or limit our ability to generate revenue and continue our business.
−Removed: outcome of our clinical and product testing of our products is uncertain, and if we are unable to satisfactorily complete such testing,
−Removed: or if such testing yields unsatisfactory results, we may not achieve the broad degree of physician adoption and use or medical aesthetic
−Removed: consumer demand necessary for commercial success.
−Removed: have yet to complete clinical testing to demonstrate our products aesthetic results.
−Removed: The clinical testing of our current products may
−Removed: not demonstrate aesthetic results to the degree we may anticipate or at all.
−Removed: Similarly, this testing may not be completed in a timely
−Removed: manner, if at all, or only after significant increases in costs, program delays or both, all of which could harm our ability to generate
−Removed: In addition, our products may not prove to be more effective for improving appearance than current cosmetic products on the
−Removed: Accordingly, we may have to delay or abandon efforts to research, develop or further market our products.
−Removed: failure to adequately demonstrate the aesthetic results could harm our ability to generate revenues and limit a broader degree of physician
−Removed: adoption necessary for commercial success or the requisite medical aesthetic consumer demand.
−Removed: Accordingly, our operating results and
−Removed: financial condition will be adversely affected, which may delay, prevent or limit our ability to generate revenue and continue our business.
−Removed: if we are successful in product testing of our cosmetic exosome-based products, it is unclear whether cosmetic exosome products can serve
−Removed: as the foundation for a commercially viable and profitable business because of other evolving technologies.
−Removed: cell technology is rapidly developing and could undergo significant change in the future.
−Removed: Such rapid technological development could
−Removed: result in our technologies becoming obsolete.
−Removed: While our cosmetic products appear promising, and even if they achieve positive test results,
−Removed: they may fail to be successfully adopted by physicians for numerous reasons, including, but not limited to, competing cosmetics technologies
−Removed: for the same treatments.
−Removed: There can be no assurance that we will be able to develop a successful market for our cosmetic exosome products
−Removed: based on stem cell technologies.
−Removed: advances in other cosmetic products are rapid and could significantly reduce or entirely eliminate the need for our products.
−Removed: Additionally,
−Removed: keeping up with new technological developments may materially alter the commercial viability of our technology or products and require
−Removed: us to incur significant costs to replace or modify product lines in which we have a substantial investment.
−Removed: We are focused on exosome
−Removed: based cosmetic products, and if this field is substantially unsuccessful, this could jeopardize our success or future results.
−Removed: The occurrence
−Removed: of any of these factors may have a material adverse effect on our business, operating results and financial condition.
−Removed: we are unable to keep up with rapid technological changes in our field or compete effectively, we will be unable to operate profitably.
−Removed: are engaged in activities in the bioengineering and cosmetics field, which is characterized by extensive research efforts and rapid technological
−Removed: If we fail to anticipate or respond adequately to technological developments, our ability to operate profitably could suffer.
−Removed: Research and discoveries by other bioengineering, cosmetics, pharmaceutical or other companies may render our technologies or potential
−Removed: products or services uneconomical or result in products superior to those we develop.
−Removed: Similarly, any technologies, products or services
−Removed: we develop may not be preferred to any existing or newly developed technologies, products or services.
−Removed: on the use of human stem cells, and the ethical, legal and social implications of that research, could prevent us from developing or
−Removed: gaining acceptance for commercially viable products in these areas.
−Removed: stem cells are derived under current Good Manufacturing Practices from Wharton’s Jelly portion of the human umbilical mesenchymal
−Removed: stem cells and captured within twenty-four hours of a full-term healthy birth by consenting donors.
−Removed: Because the use of human umbilical
−Removed: mesenchymal stem cells gives rise to ethical, legal and social issues regarding the appropriate use of these cells, our research related
−Removed: to human umbilical mesenchymal stem cells could become the subject of adverse commentary or publicity and some political and religious
−Removed: groups may still raise opposition to our cosmetics products and practices.
−Removed: In addition, many research institutions, including some of
−Removed: our potential scientific collaborators, have adopted policies regarding the ethical use of human umbilical mesenchymal stem cells, which,
−Removed: if applied to our procedures, may have the effect of limiting the scope of research conducted using our stem cells, thereby impairing
−Removed: our ability to conduct research in this field.
−Removed: products may be expensive to manufacture, and they may not be profitable if we are unable to control the costs to manufacture them.
−Removed: products may be significantly more expensive to manufacture than other traditional cosmetics products currently on the market today.
−Removed: We hope to substantially reduce manufacturing costs through process improvements, development of new methods, increases in manufacturing
−Removed: scale and outsourcing to experienced formulators or manufacturers.
−Removed: If we are not able to make these, or other improvements, and depending
−Removed: on the pricing of our products, our profit margins may be significantly less than that of other cosmetics products on the market today.
−Removed: In addition, we may not be able to charge a high enough price for any cosmetic product we develop, even if they are safe and effective,
−Removed: to make a profit.
−Removed: If we are unable to realize significant profits from our pipeline products, our business would be materially harmed.
−Removed: business is based on novel technologies that are inherently expensive, risky and may not be understood by or accepted in the cosmetics
−Removed: marketplace, which could adversely affect our future value.
−Removed: development, commercialization and marketing of cell and tissue-derived cosmetics are at an early-stage, substantially research-oriented,
−Removed: and financially speculative.
−Removed: To date, very few companies have been successful in their efforts to develop and commercialize a stem cell-derived
−Removed: cosmetic products.
−Removed: In general, stem cell products may be susceptible to various risks, including undesirable and unintended side effects,
−Removed: or other characteristics that may prevent or limit their approval or commercial use.
−Removed: Furthermore, the number of people who currently
−Removed: or may use cell or tissue-derived cosmetics is difficult to forecast with accuracy.
−Removed: Our future success is dependent on the establishment
−Removed: of a significant market for cell- and tissue-derived cosmetics and our ability to capture a share of this market with our product lines.
−Removed: development efforts with our cosmetics products are susceptible to the same risks of failure inherent in the development and commercialization
−Removed: of other topical cosmetics products based on new technologies.
−Removed: The novel nature of exosome-based cosmetics creates significant challenges
−Removed: in the areas of product development and optimization, manufacturing, government regulation, and market acceptance.
−Removed: For example, the United
−Removed: States FDA has relatively limited experience regulating cosmetics derived from stem cells, and there are no FDA approved medical products
−Removed: utilizing exosomes.
−Removed: may not have sufficient product liability insurance, which may leave us vulnerable to future claims we will be unable to satisfy.
−Removed: testing, manufacturing, marketing and sale of stem cell derived products entail an inherent risk of product liability claims.
−Removed: have a limited amount of product liability insurance, which may not be adequate to meet potential product liability claims.
−Removed: we are forced to expend significant funds on defending product liability actions, and in the event those funds come from operating capital,
−Removed: we will be required to reduce our business activities, which could lead to significant losses.
−Removed: Adequate insurance coverage may not be
−Removed: available in the future on acceptable terms, if at all.
−Removed: If available, we may not be able to maintain any such insurance at sufficient
−Removed: levels of coverage and any such insurance may not provide adequate protection against potential liabilities.
−Removed: Whether or not a product
−Removed: liability insurance policy is obtained or maintained in the future, any product liability claim could harm our business or financial
Related to Our Financial Condition
−Removed: described in the report of our auditors for the twelve months ended December 31, 2023, and 2022 and the notes to our consolidated financial
−Removed: statements, there is substantial doubt about our ability to continue as a going concern, and if we are unable to continue, you may lose
−Removed: your entire investment.
−Removed: uncertainty about our ability to continue in operation is based on our continuing losses from operation, limited revenue and limited
−Removed: working capital, among other things which existed as of year-end December 31, 2023 and December 31, 2022.
−Removed: As of December 31, 2023 and
−Removed: December 31, 2022, the Company had a net working capital of $ 3,622,091 and $963,050, respectively, and has an accumulated deficit of
−Removed: $7,023,890 and $2,722,373, respectively.
−Removed: Included in the accumulated deficit are losses of $4,301,517 for the year ended December 31,
−Removed: 2023, and $1,800,268 for the year ended December 31, 2022.
−Removed: Given all these facts, we are dependent on obtaining funding from operations
−Removed: and the sale of debt or equity to continue as a going concern.
−Removed: The financial statements do not include any adjustments relating to the
−Removed: recoverability of assets and classification of liabilities that might be necessary should we be unable to continue as a going concern.
−Removed: ability to continue as a going concern depends on the success of this offering and receipt of additional funds through debt or equity
−Removed: financing and our operations.
−Removed: In the event we are unable to obtain such funding, we may have to delay, reduce or eliminate certain of
−Removed: our planned operations, including some of our research and development and/or clinical validation studies to demonstrate aesthetic improvement,
−Removed: reduce overall overhead expense, or divest assets.
−Removed: This in turn may have an adverse effect on our ability to realize the value of our
+Added: financial statements have been prepared on a going-concern basis and our continued operations are in doubt.
+Added: The uncertainty about our ability to continue
+Added: in operation is based on our continuing losses from operation, limited revenue and limited working capital, among other things which existed
+Added: as of year-end December 31, 2023 and December 31, 2022.
+Added: As of December 31, 2024 and December 31, 2023, the Company had net working capital
+Added: of $4,251,867 and $3,622,091, respectively, and has an accumulated deficit of $13,269,627 and $7,023,890, respectively.
+Added: Included in the
+Added: accumulated deficit are losses of $6,245,737 for the year ended December 31, 2024 and $4,301,517 for the year ended December 31, 2023.
+Added: Given all these facts, we are dependent on obtaining funding from operations and the sale of debt or equity to continue as a going concern.
+Added: The financial statements do not include any adjustments relating to the recoverability of assets and classification of liabilities that
+Added: might be necessary should we be unable to continue as a going concern.
+Added: ability to continue as a going concern depends on the success of any future offering and receipt of additional funds through debt or
+Added: equity financing and our operations.
+Added: In the event we are unable to obtain such funding, we may have to delay, reduce or eliminate certain
+Added: of our planned operations, including some of our research and development and/or clinical validation studies to demonstrate aesthetic
+Added: improvement, reduce overall overhead expense, or divest assets.
+Added: This in turn may have an adverse effect on our ability to realize the
+Added: value of our assets.
If we are unable to continue as a going concern, you may lose all or part of your investment.
have a history of net losses, and we may not be able to achieve or maintain profitability in the future.
−Removed: have incurred net losses each year since our inception, and we may not be able to achieve or maintain profitability in the future.
−Removed: incurred net losses of $4,301,517 and $1,800,268 in the years ended December 31, 2023 and 2022, respectively.
−Removed: Our expenses will
−Removed: likely increase in the future as we develop and launch new cosmetics product offerings, expand in existing and new markets, increase
−Removed: our sales and marketing efforts, and continue to invest in our laboratory facility.
−Removed: These efforts may be more costly than we expect and
−Removed: may not result in increased revenue or growth in our business.
−Removed: These offerings may require significant capital investments and recurring
−Removed: costs, maintenance, depreciation, asset life and asset replacement costs, and if we are not able to maintain sufficient levels of utilization
−Removed: of such assets or such offerings are otherwise not successful, our investments may not generate sufficient returns and our financial
−Removed: condition may be adversely affected.
−Removed: Any failure to increase our revenue sufficiently to keep pace with our investments and other expenses
−Removed: could prevent us from achieving or maintaining profitability or positive cash flow on a consistent basis.
−Removed: If we are unable to successfully
−Removed: address these risks and challenges as we encounter them, our business, financial condition, results of operations and prospects could
−Removed: be adversely affected.
−Removed: If we are unable to generate adequate revenue growth and manage our expenses, we may continue to incur significant
−Removed: losses in the future and may not be able to achieve or maintain profitability.
+Added: We have incurred net losses each year since our
+Added: inception, and we may not be able to achieve or maintain profitability in the future.
+Added: We incurred net losses of $6,245,737 and $4,301,517,
+Added: for the years ended December 31, 2024 and 2023, respectively.
+Added: Our expenses will likely increase in the future and may be more costly
+Added: than we expect and may not result in increased revenue or growth in our business.
+Added: These offerings may require significant capital investments
+Added: and recurring costs, maintenance, depreciation, asset life and asset replacement costs, and if we are not able to maintain sufficient
+Added: levels of utilization of such assets or such offerings are otherwise not successful, our investments may not generate sufficient returns
+Added: and our financial condition may be adversely affected.
+Added: Any failure to increase our revenue sufficiently to keep pace with our investments
+Added: and other expenses could prevent us from achieving or maintaining profitability or positive cash flow on a consistent basis.
+Added: unable to successfully address these risks and challenges as we encounter them, our business, financial condition, results of operations
+Added: and prospects could be adversely affected.
+Added: If we are unable to generate adequate revenue growth and manage our expenses, we may continue
+Added: to incur significant losses in the future and may not be able to achieve or maintain profitability.
current growth may not be indicative of our future growth and, if we begin to grow rapidly, we may not be able to effectively manage
2 unchanged sentences
business could be adversely affected.
−Removed: have experienced minimal growth since our launch in 2020.
−Removed: For example, our revenue increased to $766,277 in 2022, and to $1,712,595 in
−Removed: Moreover, the number of our full-time employees increased.
−Removed: This growth has placed significant demands on our management, financial,
−Removed: operational, technological and other resources.
−Removed: The anticipated growth and expansion of our business depends on a number of factors,
−Removed: including our ability to:
−Removed: awareness of our brand and successfully compete with other companies;
−Removed: our products effectively so that we are able to attract new consumers and expand sales to
−Removed: our existing clients;
−Removed: distribution with new and existing clients;
−Removed: to innovate and introduce new products;
−Removed: our supplier and fulfillment capacities;
−Removed: quality control over our product offerings;
−Removed: internationally.
+Added: We have experienced minimal growth since our launch
+Added: For example, our revenue increased from nil in 2020 to $827 in 2021, to $766,277 in 2022, to $1,712,595 in 2023, and increased
+Added: to $2,467,298 for the year ended December 31, 2024.
+Added: Moreover, the number of our full-time employees increased as of December 31, 2024.
+Added: As of the date of this Annual Report, we have two (2) full time employees and one part-time employee.
+Added: This growth has placed significant
+Added: demands on our management, financial, operational, technological and other resources.
+Added: The anticipated growth and expansion of our business
+Added: depends on a number of factors, including our ability to:
+Added: and acquire biotechnology assets and companies with strong commercial potential;
+Added: ● Efficiently
+Added: integrate acquired businesses and optimize their operations;
+Added: financing and capital to support acquisitions and subsequent growth;
+Added: and commercialize biotechnology innovations through our portfolio companies;
+Added: and expand our intellectual property portfolio, including patents, trademarks, and proprietary technologies;
+Added: the complex regulatory landscape for drug development, medical devices, and other biotechnology-related products;
+Added: strategic partnerships to enhance market penetration and revenue generation.
growth and expansion of our business will place significant demands on our management and operations teams and require significant additional
1 unchanged sentence
continue to expend substantial resources on:
−Removed: sales and marketing efforts to increase brand awareness, further engaging our existing and
−Removed: prospective clients, and driving sales of our products;
−Removed: innovation and development;
−Removed: administration, including increased finance, legal and accounting expenses associated with
−Removed: being a public company;
−Removed: internationally.
+Added: and acquisitions of companies and assets to expand our portfolio;
+Added: and development initiatives within our acquired companies;
+Added: and patent enforcement and other intellectual property protections to maintain competitive advantages;
+Added: compliance, including FDA and other global regulatory approvals;
+Added: and marketing efforts to support commercialization strategies;
+Added: administration, including increased finance, legal, and accounting expenses associated with operating as a public company.
investments may not result in the growth of our business.
25 unchanged sentences
will need additional capital to conduct our operations and develop our products and our ability to obtain the necessary funding is uncertain.
−Removed: the years ended December 31, 2023 and 2022 we used a significant amount of cash to finance our continued operations, and we need
−Removed: to obtain significant additional capital resources in order to develop products going forward.
−Removed: We may not be successful in maintaining
−Removed: our normal operating cash flow and the timing of our capital expenditures may not result in cash flows sufficient to sustain our operations
−Removed: through the next twelve months.
−Removed: If financing is not sufficient and additional financing is not available or available only on terms that
−Removed: are detrimental to our long-term survival, it could have a major adverse effect on our ability to pursue our clinical research and
−Removed: product development programs and could ultimately affect our ability to continue to function.
−Removed: The timing and degree of any future
−Removed: capital requirements will depend on many factors, including:
−Removed: the accuracy of the assumptions
−Removed: underlying our estimates for capital needs in 2023 and beyond;
−Removed: scientific progress in
−Removed: our research and development programs;
−Removed: the magnitude and scope
−Removed: of our research and development programs and our ability to establish, enforce and maintain strategic arrangements for research,
−Removed: development, product testing, manufacturing, third-party agreements and marketing;
−Removed: the costs involved in preparing,
−Removed: filing, prosecuting, maintaining, defending and enforcing patent claims;
−Removed: the number and type of
−Removed: pipeline product that we pursue;
−Removed: the development of major
−Removed: public health concerns, including the novel coronavirus outbreak or other pandemics arising globally, and the current and future
−Removed: impact of it and COVID-19 on our business operations and funding requirements.
+Added: During the years ended December 31, 2024, and
+Added: December 31, 2023 we used a significant amount of cash to finance our continued operations, and we need to obtain significant additional
+Added: capital resources in order to develop products going forward.
+Added: We may not be successful in maintaining our normal operating cash flow
+Added: and the timing of our capital expenditures may not result in cash flows sufficient to sustain our operations through the next twelve
+Added: If financing is not sufficient and additional financing is not available or available only on terms that are detrimental to our
+Added: long-term survival, it could have a major adverse effect on our ability to pursue our clinical research and product development programs
+Added: and could ultimately affect our ability to continue to function.
+Added: The timing and degree of any future capital requirements and our ability
+Added: to meet such capital requirements in a timely manner, on favorable terms or at all will depend on many factors, including:
+Added: accuracy of the assumptions underlying our estimates for capital needs in 2025 and beyond;
+Added: progress in our research and development programs;
+Added: magnitude and scope of our research and development programs and our ability to establish, enforce and maintain strategic arrangements
+Added: for research, development, product testing, manufacturing, third-party agreements and marketing;
+Added: costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims;
+Added: number and type of pipeline product that we pursue;
+Added: development of major widespread events, including the possibility of a recession in the U.S.
+Added: and globally, market volatility the potential
+Added: for future pandemics or outbreaks such as any future COVID-19 outbreak, geopolitical conflict and other events which could impact us
+Added: and third parties on which we depend.
+Added: The progress, timing, and cost of clinical trials, regulatory submissions, and potential commercialization efforts for our biotech assets;
+Added: The identification, evaluation, and execution of potential acquisitions in industries beyond biotechnology;
+Added: The level of cash flows generated by current subsidiaries and any future acquired businesses;
+Added: Our ability to access capital markets or secure alternative financing sources under favorable conditions;
+Added: The structure and terms of any future financing transactions, including potential equity or debt offerings;
+Added: The performance and capital requirements of any new business lines or investments we may pursue;
+Added: Fluctuations in interest rates, inflationary pressures, and broader macroeconomic conditions;
+Added: Changes in investor sentiment and public market conditions, particularly for holding companies and emerging growth businesses;
+Added: The costs associated with maintaining our public company status, including legal, accounting, and compliance-related expenses;
+Added: Unforeseen events such as litigation, regulatory changes, or operational disruptions that could impact our liquidity or access to capital.
financing through strategic collaborations, public or private equity or debt financings or other financing sources may not be available
7 unchanged sentences
research or product development initiatives, any of which could have a material adverse effect on our financial condition or business
−Removed: need for additional capital and ability to raise capital in the future may be limited and our failure to raise capital when needed could
−Removed: prevent us from growing.
−Removed: may also encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may increase capital needs
−Removed: or drive spending and depletion of cash resources faster than expected.
−Removed: Accordingly, the Company will need to obtain substantial additional
−Removed: funding in order to continue and maintain its operations.
−Removed: The uncertainties around the Company’s ability to fund operations raise
−Removed: substantial doubt about its ability to continue as a growing concern.
−Removed: Thus, In the future, we may need to raise capital through public
−Removed: or private financing or other arrangements.
−Removed: Such financing may not be available on acceptable terms, or at all, and our failure to raise
−Removed: capital when needed could harm our business.
−Removed: We may sell Common Stock, convertible securities and other equity securities in one or more
−Removed: transactions at prices and in a manner as we may determine from time to time.
−Removed: If we sell any such securities in subsequent transactions,
−Removed: investors in our Common Stock may be materially diluted.
−Removed: New investors in such subsequent transactions could gain rights, preferences
−Removed: and privileges senior to those of holders of our Common Stock.
−Removed: Debt financing, if available, may involve restrictive covenants and could
−Removed: reduce our operational flexibility or ability to achieve or maintain profitability.
−Removed: If we cannot raise funds on acceptable terms, we
−Removed: may be forced to raise funds on undesirable terms, or our business may contract or we may be unable to grow our business or respond to
−Removed: competitive pressures, any of which could have an adverse effect on our business, financial condition, results of operations and prospects.
+Added: Related to Our Business, Our Portfolio Companies, and the Biotechnology Industry
+Added: acquired technologies and products under development could be rendered obsolete by technological, regulatory, or medical advances.
+Added: biotechnology industry is highly competitive and rapidly evolving.
+Added: The technologies and product candidates developed by our portfolio
+Added: companies may become obsolete or uneconomical due to advancements in scientific research, new treatment modalities, disruptive innovations,
+Added: or competitive products that better or more cost-effectively address the conditions our assets aim to target.
+Added: including well-funded pharmaceutical and biotechnology companies, academic institutions, and research organizations, may develop more
+Added: effective, safer, or commercially viable solutions, rendering the technologies we acquire or invest in less attractive or non-competitive.
+Added: Additionally, shifts in regulatory frameworks or treatment paradigms could impact the viability of certain products in our portfolio.
+Added: mitigate these risks, we focus on acquiring intellectual property rights, including patents and proprietary technologies, to safeguard
+Added: competitive advantages.
+Added: However, there is no guarantee that our patents will be sufficient to prevent competitors from developing similar
+Added: or superior solutions.
+Added: Furthermore, if our portfolio companies fail to innovate or adapt to industry advancements, the commercial potential
+Added: of their technologies may diminish, negatively affecting our business, financial condition, and long-term growth strategy.
+Added: sustain our continued growth, we will need to increase the size of our organization, and we may encounter difficulties managing our growth,
+Added: which could adversely affect our results of operations.
+Added: may experience growth in the number of our employees and the scope of our operations.
+Added: To that extent, the resulting growth and expansion
+Added: of our sales force will place a significant demand on our financial, managerial and operational resources.
+Added: We may not be able to accurately
+Added: forecast the number of employees required, the timing of their hire or the associated costs with our expansion and/or our entrance into
+Added: The extent of any expansion we may experience will be driven largely by the success of our new products.
+Added: As a result, management’s
+Added: ability to project the size of any such expansion and its cost to the company is limited by the following uncertainties:
+Added: not have previously sold any of the new products and the ultimate success of these new products and applications is unknown;
+Added: will be entering new markets;
+Added: and (iii) the costs will be partially driven by factors that may not be fully in our control (e.g., timing
+Added: of hiring, market salary rates, ability to hire new managerial and senior staff).
+Added: Our success will also depend on the ability of our
+Added: executive officers and senior management to continue to implement and improve our operational, information management and financial control
+Added: systems to comply with the reporting requirements of the Securities Exchange Act of 1934, or the Exchange Act, and to expand, train and
+Added: manage our employee base.
+Added: Our inability to manage growth effectively could cause our operating costs to grow even faster than we are
+Added: currently anticipating and adversely affect our results of operations.
+Added: we are unable to secure strategic commercial partnerships, licensing agreements, funding, or other key business relationships following
+Added: successful clinical results, our revenue potential may be limited.
+Added: traditional biotechnology companies that build internal sales forces, we focus on strategic pathways to commercialization, including
+Added: partnerships, licensing agreements, acquisitions, and collaborations with larger pharmaceutical and biotechnology companies.
+Added: to generate revenue and successfully bring products to market depends on multiple factors, including:
+Added: positive clinical trial results that demonstrate the viability, efficacy, and safety of our portfolio companies’ technologies;
+Added: strategic commercial partnerships or licensing agreements with larger pharmaceutical or biotechnology companies to support late-stage
+Added: clinical trials, regulatory approvals, manufacturing, and distribution;
+Added: additional funding to continue development efforts, including non-dilutive funding sources such as government grants, private partnerships,
+Added: and strategic investments;
+Added: regulatory requirements, including obtaining FDA, European Medicines Agency (“EMA”), or other global regulatory approvals
+Added: necessary for commercialization;
+Added: and enforcing intellectual property, including patents and proprietary technologies, to maintain competitive advantages and prevent market
+Added: erosion from competitors;
+Added: operational and financial risks associated with product development timelines, regulatory setbacks, and clinical trial failures;
+Added: disruptions from changing government regulations, healthcare reimbursement policies, or shifts in market demand that could impact product
+Added: addition to the risks associated with clinical and regulatory success, our business strategy is dependent on external partners who may
+Added: not have aligned priorities, sufficient resources, or the willingness to enter into agreements on terms favorable to us.
+Added: If we are unable
+Added: to secure the necessary partnerships, licensing deals, funding, or commercialization pathways, we may struggle to generate revenue or
+Added: achieve sustainable growth.
+Added: external factors such as macroeconomic conditions, evolving healthcare policies, investor sentiment toward the biotechnology sector,
+Added: and industry competition could significantly impact our ability to successfully bring products to market.
+Added: Any failure to effectively
+Added: manage these risks could materially and adversely affect our financial condition, business strategy, and long-term growth prospects.
+Added: business combinations and licensing agreements could require significant management attention and prove difficult to integrate, which
+Added: could divert attention away from management, disrupt our normal course of business, dilute stockholder value, and adversely affect our
+Added: operating results.
+Added: a biotechnology-focused holding company, our business strategy relies heavily on acquiring, licensing, and investing in biotechnology
+Added: assets, early-stage life sciences companies, and commercial-stage enterprises.
+Added: Business combinations and licensing agreements involve
+Added: several inherent risks, including:
+Added: in integrating newly acquired companies or licensed technologies into our existing structure, including management information systems,
+Added: personnel, regulatory compliance, intellectual property protection, and financial reporting systems;
+Added: on third-party licensors for key intellectual property, which may limit our control over development timelines, commercial strategies,
+Added: or pricing decisions;
+Added: risk of acquiring or licensing assets that fail to generate expected revenue or return on investment due to scientific, regulatory, or
+Added: market challenges;
+Added: failure to secure exclusive rights in licensing agreements, exposing us to competitive pressures and reduced market opportunity;
+Added: ● Unanticipated
+Added: costs and liabilities, including intellectual property disputes, regulatory compliance issues, or unforeseen operational inefficiencies;
+Added: delays or failures in the commercialization of acquired or licensed product candidates due to clinical trial setbacks, changes in regulatory
+Added: requirements, or loss of key industry partnerships;
+Added: of ongoing business operations within acquired or partnered companies, leading to employee turnover, loss of strategic partners, or reputational
+Added: in integrating financial, accounting, and intellectual property portfolios, which could result in difficulties in reporting and forecasting
+Added: Additionally,
+Added: we may not realize the expected benefits of any business combination or licensing agreement if we fail to successfully integrate these
+Added: businesses, optimize their research and development efforts, or effectively monetize their intellectual property.
+Added: Any setbacks in evaluating,
+Added: structuring, integrating, or commercializing acquired or licensed assets could have an adverse effect on our revenue, operating results,
+Added: and overall strategic growth.
+Added: we fail to cost-effectively acquire, license, or develop biotechnology assets, our business could be adversely affected.
+Added: success depends in part on our ability to acquire and license promising biotechnology assets, advance them through preclinical and clinical
+Added: stages, and secure commercial partnerships for further development and distribution.
+Added: If we fail to do so cost-effectively, our business,
+Added: financial condition, and growth prospects may be adversely affected Risks related to the acquisition, licensing and development of biotechnology
+Added: assets include:
+Added: on licensing:
+Added: We rely on in-licensing agreements for a significant portion of our biotechnology assets.
+Added: If we are unable to secure favorable
+Added: licensing terms or if licensors terminate agreements, our ability to develop and commercialize key technologies may be compromised.
+Added: ● Intellectual
+Added: property risks:
+Added: Our business depends on the strength and enforceability of our licensed and acquired intellectual property.
+Added: unable to obtain or maintain robust patent protections, we may lose competitive advantages.
+Added: Additionally, disputes over intellectual
+Added: property ownership, validity, or infringement could result in costly litigation and potential loss of key assets.
+Added: Acquiring or licensing assets requires navigating complex regulatory frameworks.
+Added: Any failure to obtain necessary regulatory
+Added: approvals or unexpected changes in regulatory requirements could result in delays, increased costs, or inability to commercialize certain
+Added: ● Competitive
+Added: market pressures:
+Added: The biotechnology industry is highly competitive, and other companies with greater resources may outbid us for attractive
+Added: assets or develop competing products that render our acquisitions or licenses obsolete.
+Added: Advancing biotechnology assets requires significant capital for preclinical and clinical development.
+Added: If we are unable to
+Added: secure sufficient funding, we may be forced to delay, scale down, or abandon promising programs.
+Added: external factors such as macroeconomic conditions, evolving healthcare policies, investor sentiment toward the biotechnology sector,
+Added: and industry competition could significantly impact our ability to successfully bring products to market.
+Added: Any failure to effectively
+Added: manage these risks could materially and adversely affect our financial condition, business strategy, and long-term growth prospects.
+Added: we fail to secure strategic partnerships or commercialization agreements, our revenue potential may be limited.
+Added: than building an internal sales force, we rely on strategic partnerships, licensing agreements, and collaborations with pharmaceutical
+Added: and biotechnology companies to bring our portfolio assets to market.
+Added: Our ability to generate revenue and successfully commercialize these
+Added: assets depends on:
+Added: commercial partnerships with pharmaceutical companies willing to invest in late-stage clinical development and regulatory approval;
+Added: our assets to established players who have the infrastructure to manufacture, distribute, and market biotechnology products;
+Added: non-dilutive funding sources such as government grants, private partnerships, and strategic investments to support product development;
+Added: ● Successfully
+Added: negotiating revenue-sharing agreements, royalty structures, and milestone payments that provide sufficient financial return;
+Added: potential conflicts of interest with licensors, co-development partners, or other stakeholders that may have competing priorities;
+Added: disruptions from changing government regulations, reimbursement policies, or shifts in market demand that could impact commercialization
+Added: we are unable to secure strategic partnerships or licensing agreements, we may face challenges in bringing our portfolio assets to market,
+Added: which could significantly impact our revenue potential and long-term viability.
+Added: brand and reputation may be diminished due to intellectual property disputes, perceived scientific failures, or negative publicity, which
+Added: could have an adverse effect on our business.
+Added: the biotechnology industry, intellectual property is a critical competitive asset.
+Added: Any loss of confidence in our ability to protect our
+Added: intellectual property, secure regulatory approvals, or successfully develop our portfolio assets could harm our reputation and business
+Added: Risks include:
+Added: litigation and intellectual property challenges:
+Added: If our patents, or those of our licensors, are challenged, invalidated, or circumvented,
+Added: we could lose key competitive advantages and revenue opportunities.
+Added: Competitors or third parties may also claim that our licensed or
+Added: acquired technologies infringe on their intellectual property, resulting in costly litigation.
+Added: perception of scientific validity:
+Added: If any of our portfolio companies experience clinical trial failures, safety concerns, or unexpected
+Added: regulatory hurdles, our brand and ability to attract investors or partners may be negatively impacted.
+Added: publicity in the biotechnology industry:
+Added: Misinformation, activist campaigns, or unfavorable media coverage related to biotechnology,
+Added: drug pricing, or perceived ethical concerns could reduce investor confidence and impact our ability to secure partnerships.
+Added: on third-party data and clinical results:
+Added: We rely on external research partners, licensors, and academic collaborations for much of the
+Added: underlying data supporting our biotechnology assets.
+Added: If any of these third parties publish misleading or inaccurate findings, or if data
+Added: discrepancies emerge, our reputation could suffer.
+Added: social media and digital risks:
+Added: With the rapid spread of information on social media, any negative sentiment regarding our portfolio
+Added: companies, partners, or industry practices could quickly impact investor and stakeholder confidence.
+Added: our brand reputation is damaged, it may become more difficult to attract investment, secure licensing agreements, or acquire high-value
+Added: biotechnology assets, all of which could have a material adverse impact on our business.
+Added: downturns, shifts in healthcare investment trends, regulatory changes, and evolving market demand for biotechnology products could negatively
+Added: affect our business.
+Added: have positioned our business as a biotechnology-focused holding company, acquiring and licensing promising life sciences technologies
+Added: with the intent to develop, commercialize, or out-license them to strategic partners.
+Added: The biotechnology sector is highly sensitive to
+Added: economic conditions, regulatory environments, investment cycles, and shifts in healthcare and pharmaceutical spending.
+Added: Changes in these
+Added: areas could significantly impact our ability to execute our business strategy.
+Added: Economic downturns, fluctuations in capital markets, and
+Added: changing investment trends in the biotechnology sector may adversely affect our ability to secure financing, complete acquisitions, and
+Added: license or commercialize our portfolio companies’ assets.
+Added: Factors that could impact our business include:
+Added: market conditions and investor sentiment:
+Added: The biotechnology industry is dependent on access to capital for research, clinical development,
+Added: and regulatory approvals.
+Added: Economic recessions, rising interest rates, inflation, or market downturns could reduce the availability of
+Added: funding from venture capital, institutional investors, and public markets.
+Added: A decline in investor confidence in biotechnology stocks could
+Added: negatively affect our ability to raise capital, acquire new assets, or finance ongoing operations.
+Added: and policy changes:
+Added: Government regulations, reimbursement policies, and drug approval processes can shift rapidly, affecting the commercialization
+Added: prospects of our biotechnology assets.
+Added: If regulators impose stricter safety requirements, pricing controls, or reimbursement restrictions,
+Added: it may impact the potential market for certain therapies and reduce the value of our acquired or licensed assets.
+Added: in pharmaceutical and biotechnology research and development spending:
+Added: Large pharmaceutical companies and institutional investors dictate
+Added: much of the demand for biotechnology innovations.
+Added: If there is a shift away from investing in the types of assets we acquire or license-such
+Added: as a focus on gene therapy over small molecules, or increased preference for in-house research and development versus external licensing-it
+Added: may negatively affect our business strategy.
+Added: ● Intellectual
+Added: property and patent risks:
+Added: Biotechnology companies rely heavily on intellectual property protections, including patents, exclusivity
+Added: periods, and licensing rights.
+Added: If we are unable to secure strong IP protections, or if patents related to our portfolio assets expire,
+Added: are challenged, or become unenforceable, we could lose competitive advantages and revenue potential.
+Added: Additionally, litigation risks related
+Added: to patent disputes could lead to costly legal battles, settlements, or lost licensing deals.
+Added: demand for biotechnology products:
+Added: The success of our portfolio companies’ assets depends on healthcare providers, insurers, and
+Added: patients perceiving their benefits over existing treatments.
+Added: If scientific advancements, competitive innovations, or pricing pressures
+Added: reduce the demand for our acquired or licensed technologies, our ability to monetize these assets could be impaired.
+Added: perception and media influence:
+Added: The biotechnology sector is highly scrutinized by regulatory agencies, advocacy groups, and media outlets.
+Added: Negative coverage of clinical trial failures, ethical concerns related to biotechnology innovations (e.g., gene editing, stem cell therapy),
+Added: or pricing controversies could impact investor confidence, regulatory approvals, and commercial adoption of our assets.
+Added: on strategic partnerships:
+Added: Since we do not build an internal sales force, we rely on external partnerships for commercialization.
+Added: potential partners-such as pharmaceutical companies or larger biotechnology firms-are unwilling to license, acquire, or invest in our
+Added: assets due to economic pressures, shifting priorities, or competitive concerns, our revenue potential may be significantly limited.
+Added: general decline in healthcare and biotechnology investments, unexpected changes in regulatory requirements, or shifts in the demand for
+Added: certain therapies could adversely affect our ability to execute our growth strategy.
+Added: If we fail to anticipate industry trends, secure
+Added: financing, maintain strong intellectual property protections, or establish successful commercialization partnerships, our business, financial
+Added: condition, and results of operations could be materially and adversely affected.
+Added: we cannot maintain our company culture or focus on our strategic mission as we grow, our success and competitive position may be harmed.
+Added: believe our entrepreneurial approach, scientific focus, and commitment to acquiring and developing high-value biotechnology assets have
+Added: been key contributors to our success to date.
+Added: As a biotechnology-focused holding company, our ability to identify promising assets, secure
+Added: strategic partnerships, and drive innovation relies heavily on maintaining a strong leadership vision, a disciplined investment strategy,
+Added: and a culture of transparency and scientific integrity.
+Added: we scale our operations, pursue acquisitions, and develop the infrastructure of a public company, we may face challenges in maintaining
+Added: these core principles.
+Added: Factors that could negatively impact our corporate culture and strategic mission include:
+Added: ● Operational
+Added: expansion and complexity:
+Added: As we acquire and license additional biotechnology assets, we may need to expand our management team, increase
+Added: regulatory and compliance functions, and establish new operational structures.
+Added: This could create challenges in maintaining our entrepreneurial
+Added: decision-making process and alignment with our long-term strategy.
+Added: and retaining talent:
+Added: The biotechnology industry is highly competitive, and our ability to execute our business model depends on recruiting
+Added: and retaining experienced scientists, regulatory experts, and business development professionals.
+Added: If we fail to maintain a corporate
+Added: culture that attracts top-tier talent, it could impact our ability to manage and grow our portfolio effectively.
+Added: of acquired companies and partners:
+Added: As we acquire or partner with biotechnology companies, differences in corporate culture, management
+Added: philosophies, or strategic priorities could create integration challenges, slowing execution and reducing operational efficiency.
+Added: public company responsibilities:
+Added: As a publicly traded entity, we must comply with additional regulatory, reporting, and governance requirements.
+Added: If these obligations divert management’s attention away from our core mission of identifying and developing valuable biotechnology assets,
+Added: it could negatively impact our growth trajectory.
+Added: short-term and long-term goals:
+Added: Investor expectations, market conditions, and financial pressures may require us to make short-term decisions
+Added: that could conflict with our long-term strategic vision.
+Added: If we prioritize immediate financial performance over scientific innovation
+Added: and strategic acquisitions, it could weaken our competitive advantage in the biotechnology sector.
+Added: we fail to preserve our entrepreneurial mindset, maintain our disciplined approach to asset selection, or sustain a culture that fosters
+Added: innovation and collaboration, our ability to compete, execute acquisitions successfully, and generate long-term shareholder value could
+Added: be significantly impaired.
+Added: A loss of focus on our strategic mission could adversely affect our business, financial condition, and long-term
+Added: growth prospects.
+Added: we lose key personnel or are unable to attract and retain other qualified personnel, we may be unable to execute our business plan, and
+Added: our business could be materially adversely affected.
+Added: As of March 26, 2025, we have only two (2) full-time
+Added: employees and one part-time employee.
+Added: Our executive leadership and key personnel provide services to us primarily through consulting agreements.
+Added: Braeden Lichti, our Founder and Chairman, serves as a non-employee consultant and plays a critical role in shaping the strategic direction
+Added: of the company.
+Added: Through his company, NorthStrive Companies, Inc., Braeden provides consulting services and, from time to time, funding
+Added: and advisory services to support our acquisitions, corporate restructuring efforts, and overall growth strategy.
+Added: Bensler, our Chief Executive Officer and Chief Financial Officer, also serves in a non-employee capacity through his consulting agreement
+Added: Our business strategy relies heavily on these key individuals for capital markets expertise, merger and acquisition execution,
+Added: regulatory oversight, and financial structuring.
+Added: success depends on our continued ability to attract, retain, and motivate highly qualified management, business development, finance,
+Added: regulatory, and scientific personnel.
+Added: The biotechnology and life sciences industries are highly competitive, and securing experienced
+Added: professionals with the necessary expertise is challenging.
+Added: In particular, our ability to successfully execute our acquisition and licensing
+Added: strategy depends on retaining key executives and advisors with deep experience in biotechnology asset evaluation, intellectual property
+Added: protection, clinical development, and financial structuring.
+Added: We are expanding our executive leadership team
+Added: by hiring key personnel, including a new Chief Financial Officer, and we are looking to hire additional employees in positions that will
+Added: support the operations of our Company and its subsidiaries.
+Added: However, as part of our corporate restructuring, we also terminated our Chief
+Added: Marketing Officer and Chief Commercial Officer, which may have an adverse impact on certain operational functions.
+Added: we maintain “key employee” insurance policies on our executive officers that would compensate us for the loss of their services,
+Added: replacing critical personnel could be difficult and time-consuming.
+Added: The loss of Braeden Lichti, Graydon Bensler, or other senior personnel
+Added: could significantly disrupt our ability to execute our strategic business plan, impair investor confidence, and hinder capital-raising
+Added: and M&A activities.
+Added: given our reliance on non-employee consultants for executive management, we are exposed to additional risks, including:
+Added: potential for misalignment between our long-term strategic goals and consultants’ personal or business interests;
+Added: day-to-day oversight and direct control over key operational decisions;
+Added: risk that consulting agreements may not be renewed or could be terminated, leading to leadership instability;
+Added: difficulty in retaining executive talent who may be recruited by competing firms offering full-time roles with equity-based incentives;
+Added: on external funding sources, including capital contributions from NorthStrive Companies, Inc., which may fluctuate based on market conditions
+Added: and investment opportunities.
+Added: we fail to recruit and retain qualified personnel-particularly in finance, acquisitions, clinical development, and regulatory affairs-our
+Added: ability to execute acquisitions, commercialize biotechnology assets, and achieve long-term profitability could be materially impaired.
+Added: A leadership transition or prolonged vacancies in key roles could negatively affect our financial condition, business operations, and
+Added: future growth.
+Added: may be unable to accurately forecast revenue and appropriately plan our expenses in the future.
+Added: forecasting presents significant challenges as we continue to expand our biotechnology portfolio, acquire new assets, secure licensing
+Added: agreements, and pursue commercial partnerships.
+Added: Unlike traditional operating companies with consistent revenue streams, our revenue generation
+Added: depends on various factors, including:
+Added: successful completion of acquisitions and licensing deals;
+Added: ability of our portfolio companies to advance product candidates through clinical and regulatory milestones;
+Added: timing and terms of strategic partnerships, royalty agreements, and potential asset monetization events;
+Added: conditions, investment cycles, and availability of funding for early-stage biotechnology assets.
+Added: base our expense levels and investment plans on revenue projections and anticipated gross margins.
+Added: However, due to the unpredictable
+Added: nature of the biotechnology industry, revenue realization may not align with our projections.
+Added: If our assumptions prove incorrect, we
+Added: may overspend on acquisitions, clinical development, or business expansion without generating the expected financial returns, adversely
+Added: impacting our business, financial condition, and results of operations.
+Added: Additionally,
+Added: PMGC Capital LLC, our newly established multi-strategy investment vehicle, introduces additional financial and operational risks.
+Added: we deploy capital across different asset classes, including biotechnology equities, private investments, and structured financial instruments,
+Added: our ability to generate consistent returns will be influenced by market volatility, economic downturns, and sector-specific risks.
+Added: PMGC Capital LLC underperforms or fails to achieve targeted returns, it could affect our ability to allocate capital efficiently, potentially
+Added: impacting the overall financial health of our holding company.
+Added: have a limited operating history at our current scale, which may make it difficult to evaluate our business and future prospects.
+Added: began commercial operations in 2020 and have undergone significant strategic transitions, evolving from a single-product skincare company
+Added: into a biotechnology-focused holding company with multiple subsidiaries and investment vehicles.
+Added: Given our relatively short operating
+Added: history at this scale, we have limited financial data available to evaluate the long-term viability and success of our business model.
+Added: evolving strategy presents increased risks, uncertainties, and challenges, including:
+Added: ability to successfully integrate and manage multiple biotechnology assets with different risk profiles, regulatory pathways, and commercialization
+Added: the uncertainties of clinical development, licensing negotiations, and regulatory approvals across our portfolio companies;
+Added: reliance on PMGC Capital LLC as a multi-strategy investment vehicle, which introduces exposure to market volatility and investment risks
+Added: beyond traditional biotechnology operations;
+Added: necessity of securing consistent external funding to finance acquisitions, clinical trials, and operational growth.
+Added: evaluation of our business must consider these risks, as well as the unpredictability of biotechnology asset monetization, regulatory
+Added: timelines, and capital market conditions.
+Added: Our limited operating history at our current scale may make it difficult for investors and
+Added: stakeholders to accurately assess our future financial performance and long-term viability.
+Added: disruption in our operations could have an adverse effect on our business.
+Added: a biotechnology-focused holding company, we rely on a combination of licensing agreements, acquisitions, research partnerships, and strategic
+Added: Our operations, including those of our portfolio companies, licensors, and third-party manufacturers, are subject to various
+Added: risks, including:
+Added: ● Disruptions
+Added: in research and development at partner institutions, contract research organizations (“CROs”), or third-party laboratories;
+Added: and compliance issues that could delay clinical trials, impact licensing agreements, or restrict the commercialization of biotechnology
+Added: ● Cybersecurity
+Added: threats and data integrity risks, particularly concerning confidential clinical research data, intellectual property, and regulatory
+Added: volatility and investment risks associated with PMGC Capital LLC, our multi-strategy investment vehicle, which could impact capital allocation
+Added: chain disruptions affecting critical raw materials, specialized equipment, or active pharmaceutical ingredients (APIs) necessary for
+Added: drug development;
+Added: economic conditions, pandemics, geopolitical conflicts, and border disputes that may affect cross-border licensing agreements, manufacturing,
+Added: or capital markets.
+Added: we do not manufacture or distribute physical products directly, we are dependent on third-party contract manufacturers, biotechnology
+Added: partners, and pharmaceutical collaborators for the development, scaling, and commercialization of our portfolio assets.
+Added: If any of these
+Added: third parties face operational failures, financial distress, or regulatory setbacks, our business, financial condition, and results of
+Added: operations could be negatively impacted.
+Added: business is at an early stage of asset development, and we may not successfully develop, License, or commercialize biotechnology assets.
+Added: As of the date of this Annual Report, we have
+Added: not yet commercialized any biotechnology assets at scale, and our business model relies on acquiring, licensing, and monetizing promising
+Added: biotechnology technologies rather than direct product development.
+Added: Our ability to generate revenue and grow our business depends on:
+Added: ● Successfully
+Added: identifying and acquiring high-potential biotechnology assets in early or mid-stage development;
+Added: regulatory approvals for portfolio companies’ product candidates in different jurisdictions;
+Added: ● Establishing
+Added: commercial partnerships or licensing agreements with pharmaceutical companies, research institutions, and biotechnology firms;
+Added: intellectual property risks, including patent expiration, challenges, and disputes;
+Added: market competition, scientific advancements, and evolving healthcare policies that may impact the value and relevance of our assets.
+Added: the complexities of drug development and regulatory approvals, there is a significant risk that assets within our portfolio:
+Added: fail to demonstrate safety or efficacy in clinical trials, leading to project abandonment or financial losses;
+Added: face unforeseen regulatory challenges that delay commercialization or limit market access;
+Added: be rendered obsolete by competitors’ innovations, market trends, or changing treatment standards;
+Added: struggle to attract commercial partners, impacting our ability to generate licensing revenue.
+Added: the success of PMGC Capital LLC, our multi-strategy investment vehicle, introduces additional financial and operational risks.
+Added: If biotechnology
+Added: market volatility, unsuccessful investments, or capital misallocation affect our ability to sustain operations and finance acquisitions,
+Added: it could impair our long-term growth prospects.
+Added: in market demand, regulatory approval, and investment cycles could impact our future growth.
+Added: companies that generate revenue from direct product sales, our ability to generate consistent financial returns depends on strategic
+Added: licensing, asset monetization, and investment performance.
+Added: Our long-term success relies on:
+Added: anticipating industry trends and investing in biotechnology assets with high commercial potential;
+Added: FDA, EMA, and other regulatory approvals for key assets within our portfolio;
+Added: ● Effectively
+Added: negotiating licensing agreements and revenue-sharing deals with pharmaceutical and biotechnology partners;
+Added: investment risks associated with PMGC Capital LLC, which may be affected by market downturns, liquidity constraints, and shifting investor
+Added: sentiment in the biotechnology sector.
+Added: we fail to secure regulatory approvals, commercial partnerships, or licensing deals for our portfolio assets, our ability to generate
+Added: meaningful revenue, sustain operations, and expand our investment portfolio may be significantly impacted.
+Added: Additionally, unforeseen macroeconomic
+Added: factors, public health crises, regulatory changes, or geopolitical tensions could further compound risks and limit our growth potential.
+Added: may incur product liability or intellectual property claims that could harm our business.
+Added: a biotechnology-focused holding company, we do not manufacture or sell physical products directly.
+Added: Instead, we acquire, license, and
+Added: develop biotechnology assets through our portfolio companies, many of which may engage in drug development, medical device innovation,
+Added: or therapeutic biotechnology applications.
+Added: These industries inherently involve significant legal, regulatory, and liability risks, including:
+Added: Our portfolio companies may conduct preclinical and clinical trials that expose participants to investigational treatments.
+Added: Any adverse events, unforeseen side effects, or trial-related injuries could lead to legal claims, regulatory scrutiny, and financial
+Added: liability risks for licensed or commercialized assets:
+Added: If any of our acquired or licensed technologies progress to commercialization,
+Added: we or our partners could face product liability claims related to safety concerns, manufacturing defects, mislabeling, or improper usage
+Added: instructions.
+Added: Regulatory agencies, including the FDA, EMA, and other global health authorities, may require market withdrawals, labeling
+Added: changes, or additional safety warnings, which could negatively impact the commercial viability of a product.
+Added: ● Third-party
+Added: intellectual property claims:
+Added: The biotechnology industry is highly patent-driven, and competitors, research institutions, or other companies
+Added: may challenge the validity of our patents or claim that our portfolio assets infringe on their intellectual property.
+Added: If we or our licensing
+Added: partners are sued for patent infringement, trade secret misappropriation, or IP violations, we could face costly legal battles, licensing
+Added: fees, or restrictions on commercialization.
+Added: compliance and liability risks:
+Added: Biotechnology and pharmaceutical companies must comply with stringent regulatory requirements, including
+Added: Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and post-market surveillance obligations.
+Added: If a portfolio company fails
+Added: to meet these standards, we could be subject to regulatory fines, warnings, or litigation.
+Added: is a risk that our insurance policies and our portfolio companies’ insurance policies are inadequate to cover liabilities.
+Added: we maintain general liability and directors’ & officers’ (D&O) insurance, these policies may not fully cover potential
+Added: liabilities arising from product safety issues, regulatory penalties, or IP disputes.
+Added: Additionally, some of our portfolio companies,
+Added: licensees, or strategic partners may not maintain adequate insurance coverage, which could expose us to indirect liabilities.
+Added: insurance policies are not adequate, our financial results may be adversely impacted.
+Added: face additional business risks through our multi-strategy investment vehicle, PMGC Capital LLC, which risks may adversely impact our
+Added: financial performance.
+Added: PMGC Capital LLC, our multi-strategy investment vehicle, we engage in public and private investments, structured financing, and biotechnology-related
+Added: asset trading.
+Added: These financial activities introduce additional risks, including:
+Added: losses and market volatility:
+Added: If we invest in biotechnology equities, structured finance deals, or private placements, we may experience
+Added: significant losses due to market fluctuations, sector downturns, or investment miscalculations.
+Added: to third-party legal and compliance risks:
+Added: Some investments may involve joint ventures, co-development agreements, or financing arrangements
+Added: with third parties.
+Added: If these partners fail to meet regulatory requirements or face lawsuits, we could be indirectly exposed to financial,
+Added: reputational, or legal consequences.
+Added: and capital constraints:
+Added: If PMGC Capital LLC underperforms, we may have limited access to capital for acquisitions or operational needs,
+Added: which could disrupt our biotechnology strategy and portfolio growth.
+Added: employees, independent contractors, consultants, strategic partners, and third parties may engage in unethical misconduct, regulatory
+Added: noncompliance, or other improper activities that could harm our business .
+Added: a biotechnology-focused holding company, we rely on a network of independent consultants, advisors, licensing partners, contract research
+Added: organizations (CROs), pharmaceutical collaborators, and strategic investment partners to execute our business strategy.
+Added: We are exposed
+Added: to the risk that these third parties, as well as our employees, independent contractors, and vendors, may engage in unethical, fraudulent,
+Added: or illegal activities that could have significant regulatory, financial, and reputational consequences.
+Added: also face the risk of abusive sales and marketing practices through our portfolio companies and licensing partners, which risks may adversely
+Added: impact our financial performance.
+Added: While we do not directly commercialize products, our portfolio companies and licensing partners may
+Added: be involved in sales and distribution agreements that expose us to commercial compliance risks, including anti-kickback and unfair trade
+Added: practices laws.
+Added: Such risks may include:
+Added: financial incentives:
+Added: Licensing or sales arrangements that incentivize monetary gain over patient outcomes could be subject to regulatory
+Added: scrutiny under anti-kickback laws and fair competition statutes.
+Added: marketing claims:
+Added: Portfolio companies, partners, or distributors could misrepresent the efficacy, safety, or regulatory status of biotechnology
+Added: assets, leading to potential litigation or consumer backlash.
+Added: distribution practices:
+Added: Partners or licensees may engage in self-dealing, unauthorized discounting, or stockpiling inventory to manipulate
+Added: financial results, which could negatively impact product valuation and revenue expectations.
+Added: Additionally,
+Added: we operate in highly regulated industries, including biotechnology, pharmaceuticals, and public markets, and misconduct by third parties
+Added: could include:
+Added: noncompliance:
+Added: Failure to adhere to FDA, EMA, and other foreign regulatory standards, including improper handling of clinical trial data,
+Added: inaccurate regulatory filings, and noncompliance with good manufacturing practices (GMP) or good clinical practices (GCP).
+Added: ● Intellectual
+Added: property violations:
+Added: Unauthorized disclosure of trade secrets, proprietary technologies, or confidential licensing agreements, which
+Added: could result in patent disputes or loss of competitive advantages.
+Added: misrepresentation or securities law violations:
+Added: Improper reporting of financial transactions, investment performance, or acquisition
+Added: valuations, which could lead to regulatory investigations by the SEC, FINRA, or other governing bodies.
+Added: or trading violations:
+Added: Since we operate PMGC Capital LLC, a multi-strategy investment vehicle, we are also exposed to risks related to
+Added: insider trading, conflicts of interest, and improper market practices by third-party investment managers or financial partners.
+Added: licensing or partnership agreements:
+Added: Misrepresentation of clinical trial data, exaggeration of asset valuation, or deceptive licensing
+Added: negotiations by third parties could result in unfavorable deals, financial losses, or reputational harm.
+Added: we rely on third-party contractors and partners rather than a fully integrated internal workforce, our ability to monitor compliance
+Added: is inherently limited.
+Added: We may not always be able to detect, deter, or prevent misconduct before it results in regulatory investigations,
+Added: fines, legal proceedings against us or our portfolio companies, reputational damage, diminished investor confidence, legal costs, loss
+Added: of strategic relationships with licensing partners, biotechnology startups or financial institutions, to name only some.
+Added: Further, even
+Added: if we are not directly responsible for unethical conduct, any association with misconduct by partners or portfolio companies could damage
+Added: our reputation and negatively impact our ability to raise capital, attract strategic investors, or execute future M&A transactions.
+Added: we are unable to detect, mitigate, or respond to unethical behavior in a timely manner, our business, financial condition, and long-term
+Added: growth strategy could be significantly impacted.
+Added: portfolio companies’ products and technologies may fail to achieve the broad adoption necessary for commercial success, which may
+Added: negatively impact our financial performance.
+Added: commercial success of the biotechnology assets being developed by our portfolio companies and strategic partners depends on:
+Added: and healthcare provider adoption:
+Added: Even if our portfolio companies successfully develop innovative therapies, medical devices, or biologics,
+Added: their products must gain broad acceptance among physicians, hospitals, and healthcare institutions to achieve significant market penetration.
+Added: ● Competitive
+Added: The biotechnology and pharmaceutical industries are highly competitive, with many well-funded companies developing alternative
+Added: treatments, gene therapies, small-molecule drugs, and novel biologics.
+Added: If superior or more cost-effective solutions enter the market,
+Added: demand for our licensed or acquired assets may be diminished.
+Added: approval and reimbursement challenges:
+Added: Many biotechnology innovations require FDA, EMA, or other global regulatory approvals.
+Added: Additionally,
+Added: payers, including insurance providers and government healthcare programs, must determine reimbursement eligibility.
+Added: If our portfolio
+Added: companies fail to obtain regulatory approvals or favorable reimbursement terms, market adoption may be limited.
+Added: and market sentiment:
+Added: PMGC Capital LLC, our multi-strategy investment vehicle, actively invests in biotechnology companies and public
+Added: The valuation and adoption of our portfolio assets may be affected by broader investment trends, market downturns, and changes
+Added: in investor sentiment toward biotechnology stocks.
+Added: ● Manufacturing
+Added: and supply chain risks:
+Added: Even if portfolio companies receive regulatory approval, scaling manufacturing, ensuring consistent supply, and
+Added: maintaining cost-efficient production remain significant challenges.
+Added: skepticism or resistance:
+Added: New therapies and treatment modalities often face skepticism from medical professionals, particularly if they
+Added: challenge existing treatment paradigms or require new training, infrastructure, or procedural adjustments.
+Added: and clinical validation:
+Added: Our success depends on portfolio companies generating robust clinical data that proves safety, efficacy, and
+Added: superiority over existing treatments.
+Added: If clinical trials fail to demonstrate clear advantages, regulatory agencies or healthcare providers
+Added: may hesitate to adopt new technologies.
+Added: cannot assure that these biotechnology assets will achieve commercial success or achieve commercial success at a level needed for our
+Added: business to profit.
+Added: In such cases, our financial performance may be negatively impacted.
+Added: Furthermore, our ability to generate returns
+Added: on acquired and licensed assets depends on their ability to differentiate from competing technologies, secure market share, and establish
+Added: strong intellectual property protections.
+Added: If our portfolio companies fail to achieve market acceptance, struggle with regulatory hurdles,
+Added: or cannot differentiate from competing technologies, our ability to monetize our assets, secure licensing deals, and generate shareholder
+Added: value may be negatively impacted.
+Added: outcome of clinical and product testing for our portfolio companies is uncertain.
+Added: portfolio companies rely on clinical trials and validation studies to demonstrate the safety, efficacy, and commercial viability of their
+Added: biotechnology assets.
+Added: If clinical testing fails to produce positive, timely, or cost-effective results, it may hinder regulatory approvals,
+Added: limit physician adoption, and reduce the likelihood of securing commercial partnerships.
+Added: to achieve strong clinical outcomes could delay, prevent, or limit revenue generation, negatively impacting our ability to monetize assets,
+Added: secure licensing deals, and sustain business operations.
+Added: Any setbacks in clinical development could adversely affect our financial condition
+Added: and long-term growth strategy.
+Added: if our portfolio companies’ technologies are successful, rapid advancements in biotechnology could make them obsolete.
+Added: biotechnology and pharmaceutical industries evolve rapidly, and new discoveries could render our portfolio companies’ technologies
+Added: Even if their products demonstrate positive clinical results, adoption may be limited due to competing treatments, evolving
+Added: scientific advancements, or superior alternative solutions.
+Added: competitiveness requires continuous innovation, additional investment, and strategic adaptation.
+Added: If our portfolio companies fail to keep
+Added: pace with technological progress or market demands, the commercial viability of their assets-and our ability to generate revenue-could
+Added: be negatively impacted, which may adversely impact our financial performance.
+Added: high costs of manufacturing biotechnology products may negatively impact profitability.
+Added: Biotechnology
+Added: products often require complex, costly manufacturing processes.
+Added: If our portfolio companies fail to optimize production, scale efficiently,
+Added: or negotiate favorable supply chain agreements, their profit margins may be significantly lower than competing therapies.
+Added: if these portfolio companies’ products achieve regulatory approval, the products must be priced competitively while covering production
+Added: If the portfolio companies cannot achieve cost efficiencies or command premium pricing, profitability may be limited, negatively
+Added: impacting our financial performance .
+Added: regulations governing biotechnology, pharmaceuticals, and investments could negatively impact our business.
+Added: portfolio companies and investment strategies are subject to extensive government regulation, which varies across federal, state, and
+Added: international markets.
+Added: Changes in laws governing biotechnology, drug approvals, licensing, and investment disclosures could impact our
+Added: ability to develop, acquire, or commercialize biotechnology assets.
+Added: Regulatory challenges may include:
+Added: or restrictions on product approvals due to changes in FDA or EMA guidelines.
+Added: compliance costs related to clinical trials, manufacturing, and post-market surveillance.
+Added: ● Limitations
+Added: on licensing agreements or commercial partnerships due to regulatory uncertainties.
+Added: ● Restrictions
+Added: on investment strategies within PMGC Capital LLC, including compliance with SEC, FINRA, or global financial regulations.
+Added: law changes affecting intellectual property protections for portfolio assets.
+Added: trends show increasing scrutiny over biotechnology ingredients, drug pricing, and marketing practices, requiring us to adapt our business
+Added: model, investment strategies, and licensing terms to comply with evolving laws.
+Added: If regulatory changes negatively impact biotechnology
+Added: valuations, investment returns, or portfolio company operations, our financial condition, business performance, and future growth prospects
+Added: could be negatively affected.
+Added: regulations and private party actions relating to the marketing and advertising of biotechnology and pharmaceutical products may restrict,
+Added: inhibit, or delay commercialization efforts.
+Added: portfolio companies and licensing partners are subject to strict advertising and promotional regulations governing biotechnology, pharmaceuticals,
+Added: and medical devices.
+Added: If a portfolio company markets or advertises a product outside of its approved indications, regulatory agencies
+Added: such as the FDA, Federal Trade Commission (“FTC”), or international health authorities could issue warning letters, impose
+Added: fines, or initiate enforcement actions that may result in mandatory corrective measures or product sales restrictions.
+Added: Additionally,
+Added: government agencies regulate claims related to product efficacy, safety, and comparative benefits.
+Added: Regulators may require robust clinical
+Added: evidence to substantiate marketing claims, and failure to meet these requirements could lead to demand for claim modifications, product
+Added: labeling revisions, or advertising restrictions.
+Added: ● Unauthorized
+Added: health claims, exaggerated efficacy statements, or misleading promotions could trigger regulatory scrutiny, fines, or forced marketing
+Added: in international advertising laws create compliance challenges, requiring us and our portfolio companies to adapt promotional strategies
+Added: across different jurisdictions.
+Added: to comply with the FTC’s Guides on Endorsements and Testimonials could lead to enforcement actions requiring transparent disclosures,
+Added: limitations on marketing partnerships, or penalties for misleading advertising.
+Added: regulatory authorities impose restrictions on advertising or promotional claims, it could delay product adoption, limit revenue generation,
+Added: and negatively impact commercialization efforts for our portfolio companies.
+Added: Such actions could also damage investor confidence, impact
+Added: licensing opportunities, and hinder our ability to monetize biotechnology assets effectively and negatively impact our financial performance.
+Added: development and acquisition of therapeutic product candidates could expose us to significant legal and regulatory risks.
+Added: acquisition and development of innovative therapeutic product candidates, specifically with our lead asset, EL-22, could expose us to
+Added: significant legal and regulatory risks.
+Added: The development and commercialization of therapeutic product candidates, including EL-22, are
+Added: subject to extensive regulation by the FDA and other regulatory authorities.
+Added: The regulations govern all aspects of product development,
+Added: including pre-clinical studies, clinical trials, manufacturing and marketing.
+Added: Any failure to comply with the regulations might result
+Added: in significant delays in product development, approval and commercialization or suspension or termination of clinical trials.
+Added: Any non-compliance
+Added: could lead to enforcement actions, including warning letters, fines, injunctions and withdrawal of marketing approvals.
+Added: ability to proceed with human clinical trials for our product candidates is contingent upon receiving FDA clearance of our IND submission.
+Added: If the FDA requires us to provide extensive additional data to demonstrate safety and efficacy, including without limitation, generating
+Added: additional preclinical data, conducting further toxicology or pharmacology studies or addressing unforeseen issues, we may face significant
+Added: delays or be unable to proceed as planned.
+Added: In addition, as one of the first companies pursuing an oral myostatin formulation combined
+Added: with GLP-1 receptor agonists, we may encounter heightened regulatory scrutiny.
+Added: Regulators may impose unexpected conditions, mandate more
+Added: extensive trials or request additional safety and efficacy data, all of which could increase our costs and delay timelines.
+Added: unexpected requirements or delays in the approval process could adversely impact our ability to bring EL-22, or any of our other therapeutic
+Added: product candidates, to market and achieve commercial success.
+Added: license from a third party the rights to product candidates related to the potential prevention and treatment of muscular and obesity-related
+Added: conditions, and are therefore subject to the risk that we lose the license after investing substantial resources into the research and
+Added: development of these product candidates.
+Added: a License Agreement entered into on April 30, 2024 between MOA Life Plus Co., Ltd., a South Korean corporation (“MOA”) and
+Added: the Company (“License Agreement”), MOA granted the Company an exclusive license to commercialize under certain of MOA’s
+Added: patent rights concerning two licensed products,:
+Added: (i) a clinical stage engineered probiotic expressing myostatin and, (ii) preclinical
+Added: engineered probiotic expressing dual myostatin & activin-A antigens (collectively, “Licensed Products”).
+Added: If MOA terminates
+Added: the License Agreement, or if we breach our obligations under the License Agreement, which include, amongst other things, using commercially
+Added: reasonable efforts to develop the Licensed Products in accordance with the License Agreement, or the license expires before we can successfully
+Added: commercialize a product candidate, or investment in research, development, and commercialization efforts for such product candidate(s)
+Added: would be lost.
+Added: Additionally, if we or MOA fail to adequately protect or informed the related intellectual property rights relating to
+Added: the Licensed Products, we may not realize the perceived or potential benefits of the License Agreement.
+Added: we expect to continue to rely on third parties to conduct, supervise and monitor pre-clinical and clinical trials with respect to the
+Added: Licensed Products, if these third parties fail to perform in a satisfactory manner and one that meets applicable regulatory, scientific
+Added: and safety requirements, it may materially harm our business.
+Added: will rely on CROs and other third parties to ensure the proper and timely conduct of our pre-clinical and clinical trials for the Licensed
+Added: While we establish agreements governing the activities of such CROs and other third parties, we and our partners will have
+Added: limited influence over their actual performance.
+Added: Nevertheless, we and our partners will be responsible for ensuring that each of our
+Added: clinical trials is conducted in accordance with its protocol, and that all legal, regulatory and scientific standards are met.
+Added: on the CROs and other third parties does not relieve us of our regulatory responsibilities.
+Added: our partners and our CROs must comply with current Good Clinical Practices, or cGCPs, as defined by the FDA and the International Conference
+Added: on Harmonization, for conducting, recording and reporting the results of preclinical studies and clinical trials, to ensure that data
+Added: and reported results are credible and accurate and that the rights, integrity and confidentiality of clinical trial participants are
+Added: The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal investigators, and clinical trial sites.
+Added: If we or our CROs fail to comply with cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA
+Added: or other regulators may require us to perform additional clinical trials before approving any marketing applications.
+Added: Our clinical trials
+Added: will require a sufficiently large number of test subjects to evaluate the safety and effectiveness of a product candidate.
+Added: fail to comply with these regulations or fail to recruit a sufficient number of patients, fail to recruit properly qualified patients
+Added: or fail to properly record or maintain patient data, we may be required to repeat such clinical trials, which would delay the regulatory
+Added: approval process.
+Added: contracted CROs will not be our employees, and we cannot control whether they devote sufficient time and resources to our clinical and
+Added: nonclinical programs.
+Added: These CROs may also have relationships with other commercial entities, including our competitors, for whom they
+Added: may also be conducting clinical trials, or other drug development activities that could harm our competitive position.
+Added: If our CROs do
+Added: not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of
+Added: the clinical data they obtain is compromised due to failing to adhere to our clinical protocols or regulatory requirements, or for any
+Added: other reasons, our clinical trials may be extended, delayed or terminated, and we may not obtain regulatory approval for, or successfully
+Added: commercialize our product candidates.
+Added: Our financial results and the commercial prospects for such products and any product candidates
+Added: we develop would be harmed, our costs could increase, and our ability to generate revenues could be delayed.
+Added: also expect to rely on other third parties to manufacture, store and distribute drug products for any clinical trials we may conduct.
+Added: Any performance failure or defect resulting from our manufacturers or distributors could delay or hinder clinical development or marketing
+Added: approval of our product candidates or commercialization of our products, if approved, producing additional losses and depriving us of
+Added: potential product revenue.
+Added: our future commercial success with respect to the Licensed Products depends on gaining regulatory approval for our products, we cannot
+Added: generate revenue without obtaining approvals.
+Added: long-term success and generation of revenue with respect to the Licensed Products will depend upon the successful development of these
+Added: product candidates from our research and development activities.
+Added: Product development is very expensive and involves a high degree of
+Added: Only a small number of research and development programs result in the commercialization of a product.
+Added: For example, the FDA indicates
+Added: that approximately 70% of drugs proceed past Phase 1 studies, 33% proceed past Phase 2, and just 25%-30% proceed past Phase 3 to Phase
+Added: 4 which is the final phase in the FDA review and approval process for marketing therapeutic product candidates.
+Added: The process for obtaining
+Added: regulatory approval to market product candidates is expensive, usually takes many years, and can vary substantially based on the type,
+Added: complexity, and novelty of the product candidates involved.
+Added: Our ability to generate revenue from the Licensed Products would be adversely
+Added: affected if we are delayed or unable to successfully develop our products.
+Added: cannot guarantee that any marketing application for our product candidates will be approved.
+Added: If we do not obtain regulatory approval
+Added: of our products or we are significantly delayed or limited in doing so, we cannot generate revenue, and we may need to significantly
+Added: curtail operations.
+Added: we are unable to successfully complete preclinical testing and clinical trials of the Licensed Products or experience significant delays
+Added: in doing so, our business will be materially harmed.
+Added: expect to invest material efforts and financial resources in the development of the Licensed Products.
+Added: Our ability to generate product
+Added: revenues, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization
+Added: of the Licensed Products.
+Added: commercial success of the Licensed Products will depend on several factors, including:
+Added: completion of preclinical studies and clinical trials;
+Added: of marketing and pricing approvals from regulatory authorities;
+Added: and maintaining patent and trade secret protection for the Licensed Products;
+Added: ● establishing
+Added: and maintaining manufacturing relationships with third parties or establishing our own manufacturing capability;
+Added: ● commercializing
+Added: our products, if and when approved, whether alone or in collaboration with others.
+Added: we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to
+Added: successfully complete development of, or to successfully commercialize, the Licensed Products, which would materially harm our business.
+Added: Most pharmaceutical products that do overcome the long odds of drug development and achieve commercialization still do not recoup their
+Added: cost of capital.
+Added: If we are unable to design and develop each drug to meet a commercial need far in the future, the approved drug may
+Added: become a commercial failure and our investment in those development and commercialization efforts will have been commercially unsuccessful.
+Added: Licensed Products may cause adverse effects or have other properties that could delay or prevent their regulatory approval or limit the
+Added: scope of any approved label or market acceptance.
+Added: events (“AEs”) or serious adverse events (“SAEs”), that may be observed during clinical trials of the Licensed
+Added: Products could cause us, other reviewing entities, clinical trial sites or regulatory authorities to interrupt, delay or halt such trials
+Added: and could cause denial of regulatory approval.
+Added: If AEs or SAEs are observed in any clinical trials of the Licensed Products, our ability
+Added: to obtain regulatory approval for the Licensed Products may be negatively impacted.
+Added: or unexpected side effects caused by an approved product could result in significant negative consequences, including the following:
+Added: regulatory authorities
+Added: may withdraw prior approval of the product or impose restrictions on its distribution in the form of a modified risk evaluation and
+Added: mitigation strategy (“REMS”) which may restrict the manner in which the product can be distributed or administered;
+Added: we may be required to add
+Added: labeling statements, such as warnings or contraindications;
+Added: we may be required to change
+Added: the way the product is administered or conduct additional clinical trials;
+Added: we may decide or be forced
+Added: to temporarily or permanently remove the affected product from the marketplace;
+Added: we could be sued and held
+Added: liable for harm caused to patients;
+Added: our reputation may suffer.
+Added: events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially
+Added: increase the costs of commercializing the Licensed Products and impair our ability to generate revenues from the commercialization of
+Added: these products.
+Added: third parties may be developing competitive products without our knowledge, we may later learn that competitive products are superior
+Added: to the Licensed Products which may force us to terminate our research efforts of one or more product candidates.
+Added: face potential competition from companies that may be developing competitive products that are superior to one or more of the Licensed
+Added: If in the future, we learn of the existence of one or more competitive products, we may be required to:
+Added: cease our development efforts
+Added: for a product candidate;
+Added: cause a partner to terminate
+Added: its support of a product candidate;
+Added: cause a potential partner
+Added: to terminate discussions about a potential license.
+Added: of these events may occur after we have spent substantial sums in connection with the clinical research of one or more product candidates.
+Added: divestiture of our Elevai Skincare business could negatively impact our operations and strategic positioning.
+Added: January 2025, we completed the divestiture of our Elevai Skincare business as part of our strategic shift toward a biotechnology-focused
+Added: holding company.
+Added: While this divestiture enables us to focus on our core business of acquiring and developing biotechnology assets, it
+Added: may result in operational, legal, and strategic challenges, including:
+Added: Disruptions in operations
+Added: and market perception:
+Added: The transition away from the skincare segment may cause short-term operational inefficiencies, impact our
+Added: brand recognition, and result in adverse market perception, potentially affecting investor confidence and market valuation.
+Added: Legal claims from former
+Added: Employees who were terminated as part of the divestiture may bring claims against us for wrongful termination, severance
+Added: disputes, or other employment-related matters.
+Added: Even if meritless, these claims could lead to legal expenses, reputational risks,
+Added: and potential financial settlements.
+Added: Loss of strategic relationships:
+Added: The sale of the skincare business may result in the loss of long-standing customer relationships, distribution partners, and supplier
+Added: agreements, impacting our ability to leverage past business networks.
+Added: Limited diversification
+Added: and growth constraints:
+Added: While the divestiture aligns with our biotechnology investment strategy, it reduces business diversification,
+Added: potentially limiting future growth opportunities.
+Added: we fail to manage this transition effectively, we may incur unforeseen costs, legal liabilities, and operational inefficiencies, which
+Added: could adversely impact our financial condition, results of operations, and long-term growth prospects.
+Added: International
+Added: trade disputes, including U.S.
+Added: trade tariffs and retaliatory tariffs, could adversely impact our business.
+Added: International
+Added: trade disputes, including threatened or implemented tariffs by the United States and threatened or implemented tariffs by foreign countries
+Added: in retaliation, could adversely impact our business.
+Added: Many of our tenants sell imported goods and tariffs or other trade restrictions
+Added: could increase costs for these tenants.
+Added: To the extent our tenants are unable to pass these costs on to their customers, our tenants could
+Added: be adversely impacted.
+Added: In addition, international trade disputes, including those related to tariffs, could result in inflationary
+Added: pressures that directly impact our costs, such as costs for steel, lumber and other materials applicable to our redevelopment projects.
+Added: Trade disputes could also adversely impact global supply chains which could further increase costs for us and our tenants or delay delivery
+Added: of key inventories and supplies.
+Added: political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial
+Added: condition or results of operations.
+Added: political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change
+Added: federal administration, are difficult to predict and may have a material adverse effect on us.
+Added: Similarly, changes in U.S.
+Added: policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on
+Added: our business operations.
+Added: For example, during the prior Trump administration, increased tariffs were implemented on goods imported
+Added: into the U.S., particularly from China, Canada, and Mexico.
+Added: On February 1, 2025, the U.S.
+Added: imposed a 25% tariff on imports from Canada
+Added: and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.
+Added: Historically,
+Added: tariffs have led to increased trade and political tensions, between not only the U.S.
+Added: and China, but also between the U.S.
+Added: countries in the international community.
+Added: In response to tariffs, other countries have implemented retaliatory tariffs on U.S.
+Added: Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities
+Added: between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global
+Added: financial markets.
+Added: Any changes in political, trade, regulatory, and economic conditions, including, but not limited to, U.S.
+Added: trade policies, could have a material adverse effect on our financial condition or results of operations.
+Added: changes or actions may alter the nature of an investment in us or restrict the use of cryptocurrencies in a manner that adversely affects
+Added: our business, prospects, or operations.
+Added: cryptocurrencies have grown in both popularity and market size, governments around the world have reacted differently to cryptocurrencies;
+Added: certain governments have deemed them illegal, and others have allowed their use and trade without restriction, while some jurisdictions,
+Added: such as the United States, subject the mining, ownership and exchange of cryptocurrencies to extensive, and in some cases overlapping,
+Added: unclear and evolving regulatory requirements.
+Added: January 2025, U.S.
+Added: President Donald Trump issued an executive order forming a presidential working group to establish a clear regulatory
+Added: framework for digital assets, and leaders in both houses of the U.S.
+Added: Congress have announced a bicameral working group with the objective
+Added: of passing legislation to provide regulatory clarity for the industry.
+Added: Committees in both houses of the U.S.
+Added: Congress have held hearings
+Added: to ensure fair access to financial services, including for companies operating in the digital asset space.
+Added: Additionally, President Trump and
+Added: members of the U.S.
+Added: Congress announced that they are studying the possibility of creating a national strategic digital asset reserve
+Added: to include Bitcoin, and at least twelve states have introduced legislation to create strategic Bitcoin reserves.
+Added: these ongoing regulatory developments appear to be positive, and we anticipate greater regulatory certainty in the future, given the
+Added: difficulty of predicting the outcomes of ongoing and future regulatory actions and legislative developments, it is possible that future
+Added: developments could have a material adverse effect on our business, prospects, or operations.
+Added: business, operations, financial position and clinical development plans and timelines, could be materially adversely affected by the
+Added: continuing military action in Ukraine and the war between Israel and Hamas.
+Added: a result of the military action commenced in February 2022 by the Russian Federation and Belarus in Ukraine and the war between Israel
+Added: and Hamas commenced in October 2023, and related economic sanctions imposed or that may in the future be imposed by certain governments,
+Added: our financial position and operations may be materially and adversely affected.
+Added: As our ability to continue to operate will be dependent
+Added: on raising debt and equity finance, any adverse impact to those markets as a result of these conflicts, including due to increased market
+Added: volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all),
+Added: could negatively impact our business, results of operations, cash flows, financial condition, and/or prospects.
+Added: The extent of any potential
+Added: impact is not yet determinable, however.
Related to Our Dependence on Third Parties
11 unchanged sentences
may choose to pursue existing or alternative technologies in preference to those being developed in collaboration with us.
−Removed: Under agreements
−Removed: with collaborators, we may rely significantly on such collaborators to, among other things:
−Removed: design and conduct product
−Removed: testing and studies to demonstrate aesthetic improvement;
−Removed: fund research and development
−Removed: activities with us;
−Removed: pay us fees upon the achievement
−Removed: of milestones;
−Removed: market with us any commercial
−Removed: products that result from our collaborations.
+Added: agreements with collaborators, we may rely significantly on such collaborators to, among other things:
+Added: and conduct product testing and studies to demonstrate aesthetic improvement;
+Added: research and development activities with us;
+Added: us fees upon the achievement of milestones;
+Added: with us any commercial products that result from our collaborations.
we collaborate with others in the development and commercialization of potential products, those expected product pipeline timelines
5 unchanged sentences
materially harmed.
−Removed: and future contractual arrangements with licensors or collaborators require or could require that they pay royalties and their failure
−Removed: to do so would adversely affect the level of our future revenues and profits.
−Removed: of our contractual arrangements between us and a licensor, collaborator or other third party in connection with the distribution of our
−Removed: products currently require or may require in the future that those third-parties make royalty or other payments to us.
−Removed: Should those third
−Removed: parties fail to pay those royalties, we would not receive all of the revenue derived from commercial sales of such product.
reliance on the activities of our non-employee consultants, third-party vendors, and operational contractors, whose activities are not
wholly within our control, may lead to delays in development of our proposed products.
−Removed: an early-stage company, we rely extensively upon and have relationships with in-house consultants and with expertise in cosmetics developments
−Removed: strategy or other business matters.
−Removed: These consultants are not our employees and may have commitments to, or consulting or advisory contracts
−Removed: with, other entities that may limit their availability to us.
−Removed: We have limited control over the activities of these consultants and, except
−Removed: as otherwise required by our collaboration and consulting agreements to the extent they exist, can expect only limited amounts of their
−Removed: time to be dedicated to our activities.
+Added: an early-stage company, we rely extensively upon and have relationships with in-house consultants and with expertise in strategy or other
+Added: business matters.
+Added: These consultants are not our employees and may have commitments to, or consulting or advisory contracts with, other
+Added: entities that may limit their availability to us.
+Added: We have limited control over the activities of these consultants and, except as otherwise
+Added: required by our collaboration and consulting agreements to the extent they exist, can expect only limited amounts of their time to be
+Added: dedicated to our activities.
These consultants may have commitments to other commercial and non-commercial entities.
−Removed: limited control over the operations of our consultants and can expect only limited amounts of time to be dedicated to our research, development
+Added: We have limited
+Added: control over the operations of our consultants and can expect only limited amounts of time to be dedicated to our research, development
and business goals.
−Removed: currently contract with third-party contractors, and in some cases, a single contractor, for all aspects of the supply, logistics, and
−Removed: formulation of our cosmetics products, and expect to continue to do so to support commercial scale production of our cosmetics products.
−Removed: There are significant risks associated with contracting with third-party suppliers, including their ability to meet the increased need
−Removed: that may result from our increasing any commercialization efforts.
−Removed: This increases the risk that we will not have sufficient quantities
−Removed: of hUMSCs or be able to obtain such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization
−Removed: currently rely on third-party contract suppliers, packagers, shippers and formulators for all of our required raw materials, bottling
−Removed: and packaging, active ingredients and finished products for our cosmetics products.
−Removed: Because there are a limited number of suppliers for
−Removed: the raw materials that we use to formulate our cosmetics products, we may need to engage alternate suppliers to prevent a possible disruption
−Removed: of the formulations of the materials necessary to produce our cosmetic products.
−Removed: We do not have any control over the availability of
−Removed: hUMSCs that form the basis for our products, raw materials that are formulated along with our exosomes or packaging and bottling supplies
−Removed: that form the basis for our product packaging and bottling.
−Removed: If we or our formulators are unable to purchase these raw materials on acceptable
−Removed: terms, at sufficient quality levels or in adequate quantities, if at all, the development and commercialization of our products or any
−Removed: future products would be delayed, or there would be a shortage in supply, which would impair our ability to meet our development objectives
−Removed: for our pipeline products or generate revenues from the sale of our current line of cosmetics products.
−Removed: We also currently rely on a single
−Removed: supplier and formulator for our hUMSCs, to formulate the final products by adding ingredients to bring finished products to market, and
−Removed: for bottling and packaging our final products.
−Removed: While we believe that alternative sources of commercially viable supply exist for both
−Removed: our hUMSCs and raw materials that we use to formulate our products, there can be no assurance that we will be able to quickly establish
−Removed: additional or replacement sources if needed, and a reduction or interruption in supply could adversely affect our ability to supply our
−Removed: products in a timely or cost-effective manner.
−Removed: expect to continue to rely on these formulators, packagers and bottlers or other subcontractors and suppliers to support our commercial
−Removed: requirements in the near future.
−Removed: We plan to continue to rely on third parties for the raw materials, hUMSCs and formulating of our products
−Removed: necessary to produce our products and bring them to market.
−Removed: continuing reliance on third-party contract formulators, and suppliers entails a number of risks, including reliance on the third party
−Removed: for regulatory compliance and quality assurance, the possible breach of the manufacturing or supply agreement by the third party, and
−Removed: the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us.
−Removed: third-party contract formulators and suppliers may not be able to comply with cGMP requirements, or similar regulatory requirements.
−Removed: If any of these risks transpire, we may be unable to timely retain alternate subcontractors or suppliers on acceptable terms and with
−Removed: sufficient quality standards and production capacity, which may disrupt and delay the commercial sale of our products.
−Removed: failure or the failure of our third-party formulators, packagers, shippers, bottlers and suppliers to comply with applicable regulations
−Removed: could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals,
−Removed: license revocation, seizures or recalls of products, operating restrictions and criminal prosecutions, any of which could significantly
−Removed: and adversely affect supplies of our products or pipeline products.
−Removed: Any failure or refusal to supply or any interruption in supply of
−Removed: the components for our products could delay, prevent or impair our ability to bring our products to market.
−Removed: manufacture and formulation of cosmetics products is complex, and formulators may encounter difficulties in production.
−Removed: of our third-party formulators encounter any difficulties, our ability to provide our products or any pipeline product candidates commercial
−Removed: sales could be delayed or stopped.
−Removed: manufacture and formulation of cosmetics products is complex, and requires significant expertise and capital investment, including the
−Removed: development of advanced manufacturing techniques and process controls.
−Removed: We and our contract manufacturers also comply with cGMP requirements.
−Removed: Formulators of cosmetics products often encounter difficulties in production, particularly in scaling up and validating initial production
−Removed: and contamination controls.
−Removed: These problems include difficulties with production costs and yields, quality control, including stability
−Removed: of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced
−Removed: federal, state and foreign regulations.
−Removed: Furthermore, if microbial, viral or other contaminations are discovered in our product candidates
−Removed: or in the manufacturing and formulating facilities in which our products are made, such facilities may need to be closed for an extended
−Removed: period of time to investigate and remedy the contamination.
−Removed: cannot assure you that any stability or other issues relating to the manufacture of our products or any future pipeline product will
−Removed: not occur in the future.
−Removed: As our formulation and manufacturing processes are scaled up, they may reveal manufacturing challenges or previously
−Removed: unknown impurities that could require resolution in order to proceed with commercial sales of our cosmetics products.
−Removed: reliance on third-party manufacturers and formulators entails risks, including the following:
−Removed: the inability to meet our
−Removed: product specifications, including product formulation, and quality requirements consistently;
−Removed: a delay or inability to
−Removed: procure or expand sufficient manufacturing and formulation capacity;
−Removed: manufacturing and product
−Removed: quality issues, including those related to scale-up of manufacturing;
−Removed: costs and validation of
−Removed: new equipment and facilities required for scale-up;
−Removed: a failure to comply with
−Removed: cGMP and similar quality standards;
−Removed: the inability to negotiate
−Removed: or renegotiate formulation and manufacturing agreements with third parties under commercially reasonable terms;
−Removed: termination or nonrenewal
−Removed: of formulation or manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;
−Removed: reliance on a limited number of sources, and in some cases, single sources for some of our
−Removed: key materials, such that if we are unable to secure a sufficient supply of these key materials,
−Removed: we will be unable to manufacture and sell our products in a timely fashion, in sufficient
−Removed: quantities or under acceptable terms;
−Removed: lack of qualified backup suppliers for those materials that are currently or in the future
−Removed: purchased from a sole or single source supplier;
−Removed: of our third-party manufacturers, formulators or suppliers could be disrupted by conditions
−Removed: unrelated to our business or operations, including the bankruptcy of the manufacturer, formulator
−Removed: constraints, including as a result of labor disputes or unstable political environments;
−Removed: disruptions or increased costs that are beyond our control;
−Removed: failure to deliver our products under specified storage conditions and in a timely manner.
−Removed: we or our third-party formulators or manufacturers were to encounter any of these difficulties, and in particular where we rely on a
−Removed: single formulator and manufacturer, our ability to commercialize our products, would be jeopardized.
−Removed: Any adverse developments affecting
−Removed: commercial formulation or manufacturing of our products or any future pipeline product may result in shipment delays, inventory shortages,
−Removed: lot failures, product withdrawals or recalls, or other interruptions in the supply of our products.
−Removed: We may also have to take inventory
−Removed: write-offs and incur other charges and expenses for products that fail to meet specifications, undertake costly remediation efforts or
−Removed: seek more costly formulation or manufacturing alternatives.
−Removed: Accordingly, failures or difficulties faced at any level of our supply chain
−Removed: could materially adversely affect our business and delay or impede the development and commercialization our products or any future pipeline
−Removed: product and could have a material adverse effect on our business, prospects, financial condition and results of operations.
−Removed: we have limited research and development capabilities, we may become more dependent on third parties to perform research and development
−Removed: have limited internal research and development capabilities and currently outsource portions of our product research and development
−Removed: to third-party research companies.
−Removed: In particular, we have relied heavily on services provided by Radyus Research, Inc.
−Removed: partially in the
−Removed: development of new products, and to analyze the proteomic characteristics of our Elevai Exosomes TM .
−Removed: We have received sufficient
−Removed: support from our third-party research partners to help us drive our new product development, and we expect to continue to rely on third
−Removed: parties to assist in our research and develop new products.
−Removed: are a limited number of third-party research and development companies that specialize or have the expertise required to assist us in
−Removed: our product development objectives.
−Removed: As a result, it may be difficult for us to engage research and development partners and personnel
−Removed: for our anticipated future needs.
−Removed: If we are unable to arrange for third-party research and development of our products, or to do so on
−Removed: commercially reasonable terms, we may not be able to develop new products or expand the application of our existing products as quickly
−Removed: as we could if we were to only perform research and development of new products internally.
−Removed: on third-party research and development partners entails risks to which we would not be subject if we performed the research and development
−Removed: ourselves, including reliance on the third party for maintaining the confidentiality of the proprietary information relating to the product
−Removed: being developed and for maintaining quality assurance, the possibility of breach of the research and development agreement by the third
−Removed: party, and the possibility of termination or non-renewal of the agreement by the third party.
−Removed: upon third parties for the research and development of our future products may limit our ability to commercialize and deliver products
−Removed: on a timely and competitive basis.
−Removed: we currently sublease our laboratory to commercialize our products, we will continue to be dependent on third parties for our own manufacturing
−Removed: capabilities for us for some time.
−Removed: currently sublease our laboratory space from Stem Express LLC in order to meet our commercial manufacturing needs and do not have a long-term
−Removed: The termination of that lease or any loss of services under that agreement would be difficult for us to replace within a short
−Removed: period of time.
−Removed: We expect to continue to rely on third parties to for laboratory space to continue our commercial production of our exosome
−Removed: are a limited number of third-party laboratories that operate under the FDA’s current Good Manufacturing Practices, or cGMP, regulations
−Removed: and that have the necessary expertise and capacity for us to manufacture our products.
−Removed: As a result, should our current relationship with
−Removed: our landlord change or manufacturing needs change it may be difficult for us to locate laboratories for lease that meet our current or
−Removed: anticipated future needs.
−Removed: If we are unable to arrange for third-party laboratory for us to manufacture of our products in, or to find
−Removed: a lease on commercially reasonable terms, we may not be able to complete development of, market and sell our current or new products.
−Removed: on our use of leased laboratories entails risks to which we would not be subject to if we maintained our own laboratory, including reliance
−Removed: on a third-party landlord for regulatory compliance and maintenance of some of the commercial equipment and facilities used in our manufacturing
−Removed: process, and the possibility of early termination or non-renewal of the agreement by the landlord.
−Removed: we continue to grow the size of our company, we may need to further invest in the expansion of our leased manufacturing facilities for
−Removed: the potential need to increase our manufacturing capability, product volume and the necessary personnel.
−Removed: However, in order to make that
−Removed: election, we will need to invest substantial additional funds and recruit qualified personnel in order to operate any new or expanded
−Removed: manufacturing laboratory and there can be no assurance that we will successfully recruit enough qualified personnel to staff and manufacture
−Removed: our products.
−Removed: In order to expand we will also rely on an increase in our need for additional raw materials and other laboratory supplies
−Removed: and there can be no assurance that we will be able to make or obtain adequate supplies of our products.
−Removed: If we are not able to recruit
−Removed: or staff sufficient numbers of qualified personnel or acquire enough supplies necessary for our manufacturing process it will be more
−Removed: difficult for us to launch new products and compete effectively.
−Removed: upon third parties to lease the facilities to manufacture of our products may reduce our profit margins, or the sale of our products
−Removed: and may limit our ability to develop and deliver products on a timely and competitive basis.
−Removed: cannot assure you that we will be able to continue to lease our manufacturing facilities in order to bring commercial quantities of our
−Removed: products to market at acceptable costs.
−Removed: Our inability to do so would adversely affect our operating results and cause our business to
+Added: Certain market opportunity data and forecasts
+Added: in this Annual Report were obtained from third-party sources and were not independently verified by us.
+Added: We believe the estimates of market
+Added: opportunity data and forecasts of market growth included in this Annual Report are reliable, but may prove to be inaccurate, and even
+Added: if the markets in which we compete achieve the forecasted growth, our business could fail to grow at similar rates, if at all.
+Added: This Annual Report contains certain data and information
+Added: that we obtained from various government and private entity publications and reports.
+Added: There is no guarantee that any particular number
+Added: or percentage of market participants covered by our market opportunity estimates will purchase our products at all or generate any particular
+Added: level of revenue for us.
+Added: While we have not independently verified the data and information contained therein and such data and information
+Added: may have been collected using third-party methodologies, we believe that the data and information, including projections based on a number
+Added: of assumptions, from these third-party publications and reports used in this Annual Report is reliable.
+Added: Any expansion in the medical aesthetics
+Added: industry on a number of factors, including the cost and perceived value associated with our product offerings and those of our competitors.
+Added: Even if the markets in which we compete meet the size estimates and growth forecast in this Annual Report, our business could fail to
+Added: grow at the rate we anticipate, if at all, which could adversely affect our business, financial condition, results of operations and prospects.
+Added: Our growth is subject to many factors, including our success in implementing our business strategy, which is subject to many risks and
+Added: uncertainties.
+Added: Accordingly, the forecasts of market growth included in this Annual Report should not be taken as indicative of our future
+Added: For more information regarding the estimates of market opportunity and forecasts of market growth included in this Annual Report,
+Added: see the section titled “ Business- Market, Industry and Other Research-Based Data.
or our third-party vendors may experience in the future network or system failures, or service interruptions, including cybersecurity
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and the compromise of such data, which may subject us to fines and other related costs of remediation.
+Added: business could be negatively impacted by cybersecurity threats and other security threats and disruptions.
+Added: our business relies on proprietary technology and computer systems, we face certain security threats, including threats to our information
+Added: technology infrastructure, attempts to gain access to our proprietary or confidential information, threats to physical security, and
+Added: domestic terrorism events.
+Added: Our information technology networks and related systems are critical to the operation of our business and
+Added: our research and development efforts.
+Added: We are also involved with information technology systems for certain third parties, which generally
+Added: face similar security threats.
+Added: Cybersecurity threats in particular, are persistent, evolve quickly and include, but are not limited to,
+Added: computer viruses, attempts to access information, denial of service and other electronic security breaches believe that we have implemented
+Added: appropriate measures and controls and invested in skilled information technology resources to appropriately identify threats and mitigate
+Added: potential risks, but there can be no assurance that such actions will be sufficient to prevent disruptions to critical systems, the unauthorized
+Added: release of confidential information or corruption of data.
+Added: A security breach or other significant disruption involving these types of
+Added: information and information technology networks and related systems could:
+Added: the proper functioning of these networks and systems and therefore its operations and/or those of third parties on which we rely;
+Added: in the unauthorized access to, and destruction, loss, theft, misappropriation or release of, our proprietary, confidential, sensitive
+Added: or otherwise valuable information, or that of third parties with which we collaborate or otherwise depend, which others could use to
+Added: compete against us or for disruptive, destructive or otherwise harmful purposes and outcomes;
+Added: or compromise preclinical or clinical studies or the analysis and use of data collected in our efforts to develop product candidates;
+Added: significant attention and resources of management and key personnel to remedy any damages or other adverse consequences that result;
+Added: us to claims for breach of contract, damages, credits, penalties or termination with respect to our relationships with third parties,
+Added: or regulatory actions by governmental agencies;
+Added: our reputation with industry participants, existing or prospective strategic alliances, and the public generally.
+Added: or all of the foregoing could have a material negative impact on its business, financial condition and prospects.
our third-party suppliers, logistics, and manufacturers do not comply with ethical business practices or with applicable laws and regulations,
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reputation, business, financial condition, results of operations and prospects.
−Removed: we, or our third-party manufacturers or formulators fail to comply with environmental, health and safety laws and regulations, we could
−Removed: become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.
−Removed: research and development activities and our third-party manufacturers’, formulators’ and suppliers’ activities involve
−Removed: the controlled storage, use and disposal of hazardous materials and other hazardous compounds.
−Removed: We and our manufacturers, formulators
−Removed: and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials.
−Removed: In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities
−Removed: pending their use and disposal.
−Removed: We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization
−Removed: efforts, research and development efforts, business operations and environmental damage resulting in costly clean-up and liabilities
−Removed: under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products.
−Removed: Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials
−Removed: generally comply with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate
−Removed: the risk of accidental contamination or injury from these materials.
−Removed: In such an event, we may be held liable for any resulting damages
−Removed: and such liability could exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials
−Removed: and/or interrupt our business operations.
−Removed: Furthermore, environmental laws and regulations are complex, change frequently and have tended
−Removed: to become more stringent.
+Added: we, or our third-party manufacturers fail to comply with environmental laws and regulations, we could become subject to fines or penalties
+Added: or incur costs that could have a material adverse effect on the success of our business.
+Added: research and development activities and our third-party manufacturers’ and suppliers’ activities involve the controlled storage,
+Added: use and disposal of hazardous materials and other hazardous compounds.
+Added: We and our manufacturers and suppliers are subject to laws and
+Added: regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials.
+Added: In some cases, these hazardous
+Added: materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and
+Added: We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research
+Added: and development efforts, business operations and environmental damage resulting in costly clean-up and liabilities under applicable laws
+Added: and regulations governing the use, storage, handling and disposal of these materials and specified waste products.
+Added: Although we believe
+Added: that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply with
+Added: the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental
+Added: contamination or injury from these materials.
+Added: In such an event, we may be held liable for any resulting damages and such liability could
+Added: exceed our resources and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our
+Added: business operations.
+Added: Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent.
We cannot predict the impact of such changes and cannot be certain of our future compliance.
−Removed: Related to Our Products Legal and Regulatory Risks
−Removed: recall or suspension of sale of our products, or the discovery of serious safety issues with our products or the incorrect application
−Removed: of such products by medical professionals to which we sell such products, could have a significant negative impact on us.
−Removed: FDA and comparable agencies of other countries regulate our cosmetic products.
−Removed: In the United States, FDA regulations govern, among other
−Removed: things, the activities that we perform, including product development, product testing, product labeling, product storage, manufacturing,
−Removed: advertising, promotion, product sales, reporting of certain product adverse events and failures, and distribution.
−Removed: FDA and equivalent foreign regulatory authorities have the authority to require the recall or suspension, either temporarily or permanently,
−Removed: of commercialized products in the event that a product has a reasonable probability of causing a serious adverse health risk due to adulteration
−Removed: or misbranding.
−Removed: Regulatory authorities have broad discretion to require the recall or suspension of a product or to require that manufacturers
−Removed: alert customers of safety risks.
−Removed: Recalls, suspensions or other notices relating to any products that we distribute would divert managerial
−Removed: and financial resources, and have an adverse effect on our reputation, financial condition and operating results.
−Removed: addition, regulatory authorities may require us to, or we may voluntarily, suspend sales of a product if we become aware that the medical
−Removed: professionals to which we sell our products have not followed our instructions for application.
−Removed: For example, when our product is marketed
−Removed: and sold by us to medical professionals throughout the United States and internationally, we include instructions specifying that such
−Removed: product must be applied topically by these medical professionals.
−Removed: Administration outside of those specific directions could result in
−Removed: us running afoul of government rules and regulations.
−Removed: and FTC may enforce against our cosmetic products if they do not accept our advertising and marketing or if those products are used beyond
−Removed: the intended uses that we authorize.
−Removed: our products are marketed outside of their intended use, for example if they are advertised for the treatment, diagnosis, cure, prevention,
−Removed: or mitigation of a disease, then regulatory agencies may issue a warning letter or further investigate our marketing practices to ensure
−Removed: we are complying with advertising and promotional rules that apply to the product category.
−Removed: and foreign government regulations and private party actions relating to the marketing and advertising of our cosmetics products have
−Removed: and may continue to restrict, inhibit or delay our ability to sell our cosmetics products as regulatory agencies consider the use of
−Removed: hUMSCs in cosmetics.
−Removed: Such regulations governing our products, including the formulation, registration, marketing and sale of our products,
−Removed: could harm our business.
−Removed: products are subject to extensive government regulation by numerous federal, state and local government agencies and authorities.
−Removed: of these laws and regulations involve a high level of subjectivity, are subject to interpretation, and vary significantly from market
−Removed: These laws and regulations can, and have already had impacts on our business, including but not limited to:
−Removed: or altogether prohibitions, in introducing or selling a product or ingredient in one or more
−Removed: ● limitations
−Removed: on our ability to import products into a market;
−Removed: ● limitations
−Removed: on the claims we can make regarding our products;
−Removed: and expenses associated with compliance, such as record keeping, documentation of the properties
−Removed: of certain products, labeling, and scientific substantiation;
−Removed: reformulations, or the recall or discontinuation of certain products that cannot be reformulated
−Removed: to comply with new regulations.
−Removed: have observed a general increase in regulatory activity and activism in the United States and across many markets globally where we operate,
−Removed: and the regulatory landscape is becoming more complex with increasingly strict requirements.
−Removed: In particular, the requirements are impacting
−Removed: the ingredients we can include in our products, the accepted quantities of those ingredients and the quality and characterization of
−Removed: the ingredients.
−Removed: Global regulators have in recent years become overall more restrictive on the accepted levels of certain ingredients
−Removed: or sources that we can use in our product, in some cases banning them outright.
−Removed: Further, many of the restrictions regarding ingredient
−Removed: quality are not directly applicable to our products, leaving the possibility that our interpretation of compliance may not match that
−Removed: of the enforcing authorities.
−Removed: Often there is a lack of an equivalent ingredients or source present in the marketplace.
−Removed: In other cases,
−Removed: the removal or reduction of a technical ingredient to stabilize our products, leads to a significant change to the character of the product
−Removed: that may make it no longer desirable or safe to the consumer.
−Removed: If this trend in new regulations continues, we may find it necessary to
−Removed: alter some of the ways we have traditionally marketed our products in order to stay in compliance with a changing regulatory landscape
−Removed: and this could add to the costs of our operations and/or have an adverse impact on our business.
−Removed: example, Health Canada is primarily responsible for administering the Food and Drugs Act (Canada) and the Canadian Regulations.
−Removed: our initial registration of cosmetic products with Health Canada in 2022, the Canadian health ministry confirmed that
−Removed: the ingredients contained in the cosmetic products were permitted for use in cosmetics in Canada, and our cosmetic products as sold were
−Removed: compliant with any applicable requirements of the Food and Drugs Act (Canada) and Cosmetic Regulations pursuant to the Food and Drugs
−Removed: Act (Canada) with respect to all ingredients and composition, including that none of the ingredients contained therein were named on
−Removed: the Cosmetic Ingredient Hotlist (as published by Health Canada).
−Removed: Canada is responsible for regulation of the sale of cosmetics under the Food and Drugs Act and Cosmetic Regulations, including the interpretation
−Removed: of what may be represented on labels and in promotional materials regarding the claimed properties of cosmetic products.
−Removed: Elevai markets
−Removed: its products in Canada as cosmetics under the Food and Drugs Act, having submitted cosmetic notifications to Health Canada for both products
−Removed: as required by the Cosmetic Regulations.
−Removed: There is no pre-market approval required from Health Canada to market a cosmetic in Canada.
−Removed: In March 2024, Elevai received correspondence from Health Canada, advising that Health Canada had reviewed certain undisclosed information
−Removed: about Elevai’s products.
−Removed: Health Canada advised Elevai that based on this review, the products did not meet Health Canada’s
−Removed: interpretation of the conditions required to market a cosmetic in Canada.
−Removed: In response to Health Canada’s communication, Elevai
−Removed: voluntarily stopped sale of the products in Canada.
−Removed: Elevai has engaged Health Canada to obtain clarity about the review and how the products
−Removed: can be marked in Canada.
−Removed: on the outcome of the Elevai’s engagement with Health Canada, Elevai products could be subject to additional regulatory requirements
−Removed: in order to be advertised or sold in Canada.
−Removed: Prior to receiving the March 2024 notice, our distribution agreement partner’s sales
−Removed: in Canada contributed approximately $158,603 to our total revenue of approximately $1.7M in 2023, representing about 9.26% of that figure.
−Removed: laws and regulations govern aspects of regulatory oversight of our products although the FDA currently does not have a pre-market approval
−Removed: system for cosmetics.
−Removed: However, cosmetic products may become subject to more extensive regulation in the future and have recently.
−Removed: events could interrupt the marketing and sale of our products, severely damage our brand reputation and image in the marketplace, increase
−Removed: the cost of our products, cause us to fail to meet customer expectations or cause us to be unable to deliver merchandise in sufficient
−Removed: quantities or of sufficient quality to our stores, any of which could result in lost sales.
−Removed: operations could be harmed if new laws or regulations are enacted that restrict our ability to market or distribute our products or impose
−Removed: additional burdens or requirements on us in order to continue selling our cosmetics products.
−Removed: In addition, the adoption of new regulations
−Removed: or changes in the interpretations and enforcement of existing regulations may result in significant compliance costs or discontinuation
−Removed: of cosmetics products sales and may impair the marketability of our cosmetics products, resulting in significant loss of net sales.
−Removed: cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can we determine what effect additional
−Removed: governmental regulations or administrative orders, when and if promulgated, would have on our business.
−Removed: If new or existing laws and regulations
−Removed: restrict, inhibit or delay our ability to introduce or market our products or limit the claims we are able to make regarding our cosmetics
−Removed: products, this could have a material adverse effect on our business, financial condition, and operating results.
−Removed: If we fail to comply
−Removed: with the laws and regulations governing our products, we could face enforcement action, and we could be fined or forced to alter or stop
−Removed: selling our cosmetics products.
−Removed: authorities regulate advertising and product claims regarding the benefits of our cosmetics products.
−Removed: These regulatory authorities may
−Removed: require us to provide an adequate and reasonable basis to substantiate and support any marketing or product benefits claims.
−Removed: What constitutes
−Removed: such reasonable basis to substantiate such claims can vary widely from market to market and there is no assurance that the research and
−Removed: development efforts that we undertake to support our claims will be deemed adequate for any particular product or product marketing claim.
−Removed: we are unable to show adequate and reliable substantiation for our product claims, or if our marketing materials or the marketing materials
−Removed: of our sales force make claims that exceed the scope of allowed claims for cosmetics that we offer, the United States Food and Drug Administration
−Removed: (the “FDA”), the Federal Trade Commission (the “FTC”) or other regulatory authorities could take enforcement
−Removed: action requiring us to revise our marketing materials, amend our claims or stop selling certain products, which could harm our business.
−Removed: example, in recent years, the FDA has issued warning letters to many cosmetic companies alleging improper structure/function claims regarding
−Removed: their cosmetic products, including, for example, product claims regarding gene activity, cellular rejuvenation, repair, anti-aging and
−Removed: rebuilding collagen.
−Removed: There is a degree of subjectivity in determining whether a claim is an improper structure/function claim.
−Removed: this subjectivity and our research and development focus on the appearance of skin and the influence of certain stem-cell derived ingredients
−Removed: on skin, there is a risk that we could receive a warning letter, be required to modify our product claims or take other actions to satisfy
−Removed: the FDA if the FDA determines any of our marketing materials include improper structure/function claims for our cosmetic products.
−Removed: addition, lawyers have filed class action lawsuits against some cosmetics brands after those brands received these FDA warning letters.
−Removed: There can be no assurance that we will not be subject to government actions or class action lawsuits, which could harm our business.
−Removed: the United States, the FTC’s Guides Concerning the Use of Endorsements and Testimonials in Advertising (“Guides”) require
−Removed: disclosure of material connections between an endorser and the company they are endorsing, and they generally do not allow marketing
−Removed: using atypical results.
−Removed: Our sales force has historically used testimonials and “before and after” photos to market and sell
−Removed: some of our popular products such as our E-Series™ serums.
−Removed: We intend to continue to use testimonials for our popular products.
−Removed: In highly regulated and scrutinized product categories, such as those that promote healthy hair growth cycles, if we or our sales force
−Removed: fails to comply with the Guides or makes improper product claims, the FTC could bring an enforcement action against us, and we could
−Removed: be fined and/or forced to alter our marketing materials.
−Removed: operations could be harmed if we fail to comply with Good Manufacturing Practices.
−Removed: our markets, there are regulations on a diverse range of Good Manufacturing Practices (“GCMPs”) that may eventually apply
−Removed: to us under the recently enacted Modernization of Cosmetic Regulation Act of 2022 (“MoCRA”) which requires the FDA to issue
−Removed: proposed rules relating to GCMPs for cosmetics manufacturers.
−Removed: If we are considered a cosmetic manufacture under MoCRA than we and our
−Removed: vendors may be subject to stringent safety requirements on a variety of topics, including vendor qualifications, ingredient identification,
−Removed: manufacturing controls and record keeping.
−Removed: Ingredient identification requirements, which would require us to confirm the levels, identity
−Removed: and potency of ingredients listed on our product labels within a narrow range, which may be particularly burdensome and difficult for
−Removed: us because our products contain many different ingredients.
−Removed: Additionally, under MoCRA we may be obligated to track and periodically report
−Removed: adverse events to government agencies.
−Removed: Compliance with these increasing regulations may further increase the cost of manufacturing certain
−Removed: of our products as we work with our vendors to assure they are qualified and in compliance.
−Removed: In addition, our operations could be harmed
−Removed: if regulatory authorities determine that we or our vendors are not in compliance with these regulations or if public reporting of adverse
−Removed: events harms our reputation for quality and safety.
−Removed: A finding of noncompliance may result in administrative warnings, penalties or actions
−Removed: impacting our ability to continue selling certain products, including public withdrawals, seizures and recalls.
−Removed: For example, in prior
−Removed: years, our competitors have had product recalls in the United States based on labeling issues.
−Removed: Problems associated with product recalls
−Removed: could be exacerbated due to the global nature of our business because a recall in one jurisdiction could lead to recalls in other jurisdictions.
−Removed: and extensive government regulation could slow or hinder our production of cosmetics containing a stem-cell byproduct and we may be unsuccessful
−Removed: in our efforts to comply with applicable federal, state and international laws and regulations, which could result in government enforcement
−Removed: we seek to conduct our business in compliance with applicable governmental laws and regulations, these laws and regulations are exceedingly
−Removed: complex and often subject to varying interpretations.
−Removed: The cosmetics and stem-cell industry are topics of significant government interest,
−Removed: and thus the laws and regulations applicable to our business are subject to frequent change and/or reinterpretation.
−Removed: As such, there can
−Removed: be no assurance that we will be able, or will have the resources, to maintain compliance with all such laws and regulations.
−Removed: to comply with such laws and regulations, as well as the costs associated with such compliance or with enforcement of such healthcare
−Removed: laws and regulations, may have a material adverse effect on our operations or may require restructuring of our operations or impair our
−Removed: ability to operate profitably.
−Removed: research and development of stem cell byproducts is subject to and restricted by extensive regulation by governmental authorities in
−Removed: the United States and other countries.
−Removed: If in the future we become subject to additional FDA and other necessary regulatory approvals,
−Removed: that process may be lengthy, expensive and uncertain which may have a material adverse effect on our operations or may require restructuring
−Removed: of our operations or impair our ability to operate profitably.
−Removed: regulations could prohibit physicians from dispensing our cosmetics products directly.
−Removed: our primary market, the United States, we market our cosmetics products and systems directly to our physician clients to dispense in
−Removed: their offices.
−Removed: Thereafter, our cosmetics products and systems we sell are dispensed by physicians directly to their medical aesthetics
−Removed: consumers in their offices.
−Removed: In the event state regulations change to limit or prohibit the ability of physicians to dispense our cosmetics
−Removed: products directly to medical aesthetics consumers in their offices, medical aesthetics consumers may be required to purchase our cosmetics
−Removed: products in retail settings or via e-commerce, as opposed to directly from their physicians.
−Removed: If medical aesthetics consumers are unable
−Removed: to purchase our cosmetics products directly from physicians, it could result in medical aesthetics consumers purchasing less of our product
−Removed: than they otherwise would or affect the perception of our cosmetics products are which would harm our business, our operations or impair
−Removed: our ability to operate profitably.
−Removed: to obtain regulatory approvals in foreign jurisdictions would prevent us from marketing our cosmetics products internationally.
−Removed: market our cosmetics products outside of the United States.
−Removed: In order to market our cosmetics products in many non-U.S.
−Removed: jurisdictions
−Removed: we must obtain separate regulatory approvals and comply with numerous and varying regulatory requirements.
−Removed: In others, we do not have
−Removed: to obtain prior regulatory approval but do have to comply with other regulatory restrictions on the manufacturing, marketing and sale
−Removed: of our cosmetics products.
−Removed: We may be unable to file for regulatory approvals and may not receive necessary approvals to commercialize
−Removed: our cosmetics products in any market.
−Removed: The approval procedure varies among countries and can involve additional testing and data review.
−Removed: We may not obtain foreign regulatory approvals on a timely basis, if at all.
−Removed: Moreover, approval by one foreign regulatory authority does
−Removed: not ensure approval by regulatory agencies in other foreign countries or by the FDA.
−Removed: The failure to obtain these approvals could harm
−Removed: our business, our operations or impair our ability to operate profitably.
Related to Our Intellectual Property
we fail to protect or enforce our intellectual property or confidential proprietary information relating to our current and any future
−Removed: cosmetics products or cosmetics pipeline product, others could compete against us more directly and we may not be able to compete effectively
−Removed: in our market.
+Added: medical aesthetics products or medical aesthetics pipeline product, others could compete against us more directly and we may not be able
+Added: to compete effectively in our market.
success depends in part on our ability to protect our intellectual property rights.
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confidential proprietary information, domains, patent rights and other intellectual property rights to protect our intellectual property.
−Removed: In addition, to protect our trade secrets, confidential information and other intellectual property rights, we have entered into confidentiality
−Removed: agreements with third parties, and confidential information and invention assignment agreements with employees, consultants and advisors.
−Removed: There can be no assurances that we will be able to enforce these agreements or alternatively, these agreements may be deemed to be unenforceable.
−Removed: If we cannot adequately protect or enforce our intellectual property rights, we may not be able to adequately compete, and our business
−Removed: and prospects could be adversely affected.
+Added: We also rely on and patent applications licensed by us for the Licensed Products which we are contractually obligated to file, prosecute
+Added: and maintain under our License Agreement with MOA.
+Added: Patent protection is limited in time, and we may be unsuccessful in developing and
+Added: commercializing a product before a patent expires and the underlying technology becomes available for commercialization by competitors,
+Added: in which case our investment of substantial time and resources towards the applicable product or product candidate could be lost without
+Added: the realization of the benefits we anticipated or sought.
of our technology may not be subject to protection through patents, which leaves us vulnerable to theft of our technology.
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who independently develop substantially equivalent technology may harm our business.
−Removed: we fail to generate sufficient cash flow from our operations, we will be unable to continue to develop and commercialize new cosmetics
−Removed: expect capital outlays and operating expenditures to increase over the next several years as we expand our operations, and our commercialization,
−Removed: product validation studies, research and development and manufacturing activities.
−Removed: We believe that our net cash provided by operating
−Removed: activities and existing cash and cash equivalents will be sufficient to fund our operations for at least the next two years.
−Removed: our present and future funding requirements will depend on many factors, including, among other things:
−Removed: level of research and development investment required to maintain and improve our competitive
−Removed: success of our product sales and related collections;
−Removed: need or decision to acquire or license complementary businesses, cosmetics products or technologies
−Removed: or acquire complementary businesses;
−Removed: relating to the expansion of the sales force, management and operational support;
−Removed: competing technological
−Removed: and market developments;
−Removed: costs relating to changes
−Removed: in regulatory policies or laws that affect our operations.
−Removed: a result of these factors, we may need to raise additional funds, and we cannot be certain that such funds will be available to us on
−Removed: acceptable terms when needed, if at all.
−Removed: In addition, if we raise additional funds through collaboration, licensing or other similar
−Removed: arrangements, it may be necessary to relinquish potentially valuable rights to our future cosmetics products or proprietary technologies,
−Removed: or grant licenses on terms that are not favorable to us.
−Removed: If we cannot raise funds on acceptable terms, we may not be able to expand our
−Removed: operations, develop new cosmetics products, take advantage of future opportunities or respond to competitive pressures or unanticipated
−Removed: customer requirements.
+Added: There can be no assurances that we will be able
+Added: to enforce these agreements or alternatively, these agreements may be deemed to be unenforceable.
+Added: If we cannot adequately protect or
+Added: enforce our intellectual property rights, we may not be able to adequately compete, and our business and prospects could be adversely
may not be able to protect our proprietary technology, which could harm our ability to operate profitably.
−Removed: molecular biology, stem cells, cosmetics, and bioprocessing industries place considerable importance on obtaining patent and trade secret
−Removed: protection for new technologies, cosmetics products and processes.
−Removed: Our success will depend, to a substantial degree, on our ability to
−Removed: obtain and enforce patent protection for our cosmetics products, preserve any trade secrets and operate without infringing the proprietary
−Removed: rights of others.
+Added: molecular biology and bioprocessing industries place considerable importance on obtaining patent and trade secret protection for new
+Added: technologies, medical aesthetics products and processes.
+Added: Our success will depend, to a substantial degree, on our ability to obtain and
+Added: enforce patent protection for our products, preserve any trade secrets and operate without infringing the proprietary rights of others.
We cannot assure you that:
−Removed: will succeed in obtaining any patents, obtain them in a timely manner, or that the breadth
−Removed: or degree of protection that any such patents will protect our interests;
+Added: will succeed in obtaining any patents, obtain them in a timely manner, or that the breadth or degree of protection that any such patents
+Added: will protect our interests;
use of our technology will not infringe on the proprietary rights of others;
−Removed: applications relating to our potential cosmetics products or technologies will result in
−Removed: the issuance of any patents or that, if issued, such patents will afford adequate protection
−Removed: to us or will not be challenged, invalidated or infringed;
−Removed: will not be issued to other parties, which may be infringed by our potential cosmetics products
−Removed: or technologies.
−Removed: are aware of certain patents that have been granted to others and certain patent applications that have been filed by others with respect
−Removed: to other stem cell technologies and the use of exosomes for cosmetic aesthetics purposes.
−Removed: The fields in which we operate have been characterized
−Removed: by significant efforts by competitors to establish dominant or blocking patent rights to gain a competitive advantage, and by considerable
−Removed: differences of opinion as to the value and legal legitimacy of competitors’ purported patent rights and the technologies they actually
−Removed: utilize in their businesses.
−Removed: research in the areas of stem cells, molecular biology, cosmetics, and bioprocessing is being performed in countries outside of the United
−Removed: States, and a number of our competitors are located in those countries.
+Added: applications relating to our products candidates will result in the issuance of any patents or that, if issued, such patents will afford
+Added: adequate protection to us or will not be challenged, invalidated or infringed;
+Added: will be successful or effective in monitoring, enforcing or otherwise protecting our patents or other intellectual property rights from
+Added: third party infringement;
+Added: will not be issued to other parties, which may be infringed by our potential medical aesthetics products or technologies.
+Added: research in the areas of stem cells, molecular biology and bioprocessing is being performed in countries outside of the United States,
+Added: and a number of our competitors are located in those countries.
The laws protecting intellectual property in some of those countries
may not provide adequate protection to prevent our competitors from misappropriating our intellectual property.
−Removed: held by other persons may result in infringement claims against us that are costly to defend and which may limit our ability to use the
−Removed: disputed technologies and prevent us from pursuing research and development or commercialization of potential cosmetics products.
−Removed: number of biotechnology and other companies, universities and research institutions have filed patent applications or have been issued
−Removed: patents relating to exosomes, stem cells, and other technologies potentially relevant to or required by our expected cosmetics products.
−Removed: We cannot predict which, if any, of such applications will issue as patents or the claims that might be allowed.
−Removed: We are aware that a
−Removed: number of companies have filed applications relating to stem cells.
−Removed: We are also aware of a number of patent applications and patents
−Removed: claiming use of exosomes and other modified cells to improve aesthetics.
−Removed: third party patents or patent applications contain claims infringed by either our licensed technology or other technology required to
−Removed: make and use our potential cosmetics products and such claims are ultimately determined to be valid, we might not be able to obtain licenses
−Removed: to these patents at a reasonable cost, if at all, or be able to develop or obtain alternative technology.
−Removed: If we are unable to obtain
−Removed: such licenses at a reasonable cost, we may not be able to develop some cosmetics products commercially.
−Removed: We may be required to defend
−Removed: ourselves in court against allegations of infringement of third-party patents.
−Removed: Patent litigation is very expensive and could consume
−Removed: substantial resources and create significant uncertainties.
−Removed: An adverse outcome in such a suit could subject us to significant liabilities
−Removed: to third parties, require disputed rights to be licensed from third parties, or require us to cease using such technology.
our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our target markets
9 unchanged sentences
patents owned or controlled by other parties.
−Removed: Competitors in the field of aesthetics and cosmetics have developed large portfolios of
−Removed: patents and patent applications in fields relating to our business.
−Removed: Additionally, there may also be patent applications that have been
−Removed: filed but not published that, when issued as patents, could be asserted against us.
−Removed: These third parties could bring claims against us
−Removed: that would cause us to incur substantial expenses and, if successful against us, could cause us to pay substantial damages and/or we
−Removed: could be forced to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject
−Removed: Further, if a patent infringement suit were brought against us, during the pendency of the litigation, we could be forced
−Removed: to stop or delay research, development, manufacturing or sales of the product or product candidate that is the subject of the suit.
+Added: Additionally, a number of biotechnology companies, universities, and research institutions
+Added: have filed patent applications or hold issued patents related to technologies potentially relevant to our portfolio assets.
+Added: and validity of these patents can be unpredictable, and we cannot determine in advance whether any claims in pending applications will
+Added: be granted or how they may impact our ability to commercialize or license certain technologies.
+Added: If third-party patents are found to cover
+Added: technologies used in our portfolio assets, we may be unable to license these patents at a reasonable cost, if at all, or develop suitable
+Added: alternatives.
+Added: This could limit our ability to advance certain biotechnology assets through research, development, and commercialization.
+Added: in the field of aesthetics have developed large portfolios of patents and patent applications in fields relating to our business.
+Added: Additionally,
+Added: there may also be patent applications that have been filed but not published that, when issued as patents, could be asserted against
+Added: These third parties could bring claims against us that would cause us to incur substantial expenses and, if successful against us,
+Added: could cause us to pay substantial damages and/or we could be forced to stop or delay research, development, manufacturing or sales of
+Added: the product or product candidate that is the subject of the suit.
+Added: Further, if a patent infringement suit were brought against us, during
+Added: the pendency of the litigation, we could be forced to stop or delay research, development, manufacturing or sales of the product or product
+Added: candidate that is the subject of the suit.
+Added: If we are unable to effectively navigate intellectual property risks, our ability to license,
+Added: develop, and commercialize our biotechnology assets could also be negatively impacted.
may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our
competitors or are in breach of non-competition or non-solicitation agreements with our competitors.
−Removed: may employ individuals who were previously employed at universities or pharmaceutical or cosmetics companies, including our competitors
−Removed: or potential competitors.
−Removed: Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary
−Removed: information or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants
−Removed: or independent contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject
−Removed: to such claims.
+Added: may employ individuals who were previously employed at universities or pharmaceutical companies, including our competitors or potential
+Added: Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information
+Added: or know-how of others in their work for us, and we are not currently subject to any claims that our employees, consultants or independent
+Added: contractors have wrongfully used or disclosed confidential information of third parties, we may in the future be subject to such claims.
Litigation may be necessary to defend against these claims.
−Removed: If we fail in defending any such claims, in addition to paying
−Removed: monetary damages, we may lose valuable intellectual property rights or personnel.
−Removed: Even if we are successful in defending against such
−Removed: claims, litigation could result in substantial costs and be a distraction to management and other employees.
+Added: If we fail in defending any such claims, in addition to paying monetary damages,
+Added: we may lose valuable intellectual property rights or personnel.
+Added: Even if we are successful in defending against such claims, litigation
+Added: could result in substantial costs and be a distraction to management and other employees.
may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially
1 unchanged sentence
third party may hold intellectual property, including patent rights that are important or necessary to the development of our future
−Removed: cosmetics product.
It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our prospective
−Removed: cosmetic products, in which case we would be required to obtain a license from these third parties.
−Removed: There can be no assurance that such
−Removed: third parties will grant us the necessary licenses on commercially reasonable terms or at all.
+Added: products, in which case we would be required to obtain a license from these third parties.
+Added: There can be no assurance that such third
+Added: parties will grant us the necessary licenses on commercially reasonable terms or at all.
Failure to obtain such licenses on commercially
1 unchanged sentence
impact on our business and results of operations.
−Removed: Related to Customer Privacy, Cybersecurity and Data
−Removed: in laws or regulations relating to privacy, data protection or the protection or transfer of personal data, or any actual or perceived
−Removed: failure by us to comply with such laws and regulations or any other obligations relating to privacy, data protection or the protection
−Removed: or transfer of personal data, could adversely affect our business.
−Removed: receive, transmit and stores personally identifiable information and other data relating to the employees, product order processing,
−Removed: and sales transactions.
−Removed: Numerous local, municipal, state, federal and international laws and regulations address privacy, data protection
−Removed: and the collection, storing, sharing, use, disclosure, and protection of certain types of data.
−Removed: These laws, rules and regulations evolve
−Removed: frequently, and their scope may continually change, through new legislation, amendments to existing legislation and changes in enforcement,
−Removed: and may be inconsistent from one jurisdiction to another.
−Removed: Changes in laws or regulations relating to privacy, data protection and information
−Removed: security, particularly any new or modified laws or regulations that require enhanced protection of certain types of data or new obligations
−Removed: with regard to data retention, transfer or disclosure, could greatly increase the cost of providing our offerings, require significant
−Removed: changes to our operations or even prevent us from providing certain offerings in jurisdictions in which we currently operate and in which
−Removed: we may operate in the future.
−Removed: as we continue to expand our geographic reach, our product offerings and user base, we may become subject to additional privacy-related
−Removed: laws and regulations.
−Removed: Additionally, we have incurred, and may continue to incur, significant expenses in an effort to comply with privacy,
−Removed: data protection and information security standards and protocols imposed by law, regulation, industry standards or contractual obligations.
−Removed: In particular, with laws and regulations imposing new and relatively burdensome obligations, and with substantial uncertainty over the
−Removed: interpretation and application of these and other laws and regulations, we may face challenges in addressing their requirements and making
−Removed: necessary changes to our policies and practices and may incur significant costs and expenses in an effort to do so.
−Removed: our efforts to comply with applicable laws, regulations and other obligations relating to privacy, data protection and information security,
−Removed: it is possible that our practices, product sales platform could be inconsistent with, or fail or be alleged to fail to meet all requirements
−Removed: of, such laws, regulations or obligations.
−Removed: The failure, or the failure by third-party providers or partners, to comply with applicable
−Removed: laws or regulations or any other obligations relating to privacy, data protection or information security, or any compromise of security
−Removed: that results in unauthorized access to, or use or release of personally identifiable information or other rider data, or the perception
−Removed: that any of the foregoing types of failure or compromise has occurred, could damage our reputation, discourage new and existing riders
−Removed: from using our product sales platform or result in fines or proceedings by governmental agencies and private claims and litigation, any
−Removed: of which could adversely affect our business, financial condition and results of operations.
−Removed: Even if not subject to legal challenge,
−Removed: the perception of privacy concerns, whether or not valid, may harm our reputation and brand and adversely affect our business, financial
−Removed: condition and results of operations.
−Removed: may be subject to theft, loss, or misuse of personal data about our employees, customers, or other third parties, which could increase
−Removed: our expenses, damage our reputation, or result in legal or regulatory proceedings.
−Removed: business relies on the use of customer accounts linked to bank accounts or credit cards as well as tracking certain movements of our
−Removed: The theft, loss, or misuse of personal data collected, used, stored, or transferred by us to run our business could result
−Removed: in significantly increased business and security costs or costs related to defending legal claims.
−Removed: Global privacy legislation, enforcement,
−Removed: and policy activity in this area are rapidly evolving and expanding, creating a complex regulatory compliance environment.
−Removed: Costs to comply
−Removed: with and implement these privacy-related and data protection measures could be significant.
−Removed: In addition, even our inadvertent failure
−Removed: to comply with federal, state, or international privacy-related or data protection laws and regulations could result in proceedings against
−Removed: us by governmental entities or others.
−Removed: our information technology systems or sensitive information, or those of our collaborators or other contractors or consultants, are or
−Removed: were compromised, we could experience adverse consequences resulting from such compromise, including but not limited to, a significant
−Removed: disruption of our product development programs and our ability to operate our business effectively, regulatory investigations or actions,
−Removed: litigation, fines and penalties, reputational harm, loss of revenue or profits, and other adverse consequences.
−Removed: are increasingly dependent upon information technology systems, infrastructure and data to operate our business.
−Removed: In the ordinary course
−Removed: of business, we and the third parties upon which we rely process sensitive information, and, as a result, we and the third parties upon
−Removed: which we rely face a variety of evolving threats that could cause security incidents.
−Removed: We also have outsourced elements of our operations
−Removed: to third parties, and as a result we manage a number of third-party vendors and other contractors and consultants who have access to
−Removed: our sensitive information.
−Removed: Our ability to monitor these third parties’ information security practices is limited, and these third
−Removed: parties may not have adequate information security measures in place.
−Removed: If our third-party service providers experience a security incident
−Removed: or other interruption, we could experience adverse consequences.
−Removed: While we may be entitled to damages if our third-party service providers
−Removed: fail to satisfy their privacy or security-related obligations to us, any award may be insufficient to cover our damages, or we may be
−Removed: unable to recover such award.
−Removed: internal computer systems, cloud-based computing services and those of our current and any future collaborators and other contractors
−Removed: or consultants are vulnerable to damage or interruption from a variety of sources, including cyberattacks, malicious internet-based activity,
−Removed: and online and offline fraud.
−Removed: These threats include, but are not limited to, social-engineering attacks (including through deep
−Removed: fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms),
−Removed: malware (including as a result of advanced persistent threat intrusions), data corruption, intentional or accidental actions or inactions
−Removed: by our employees or others with access to our network, supply chain attacks, ransomware attacks, denial-of-service attacks (such as credential
−Removed: stuffing), credential harvesting, software bugs, server malfunctions, software or hardware failures, loss of data or other information
−Removed: technology assets, adware, attacks enhanced or facilitated by AI, natural disasters, terrorism, war and telecommunication and electrical
−Removed: failures, and other similar threats that affect service reliability and threaten the confidentiality, integrity, and availability of
−Removed: Attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and
−Removed: intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise,
−Removed: including traditional computer “hackers,” threat actors, personnel (such as through theft or misuse), sophisticated nation
−Removed: states, and nation-state-supported actors.
−Removed: Some actors now engage and are expected to continue to engage in cyber-attacks, including
−Removed: without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.
−Removed: times of war and other major conflicts, we and the third parties upon which we rely may be vulnerable to a heightened risk of these attacks,
−Removed: including cyber-attacks, that could materially disrupt our systems and operations, supply chain, and ability to produce, sell and distribute
−Removed: our goods and services.
−Removed: attacks, including by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent
−Removed: and severe and can lead to significant interruptions in our operations, loss of data and income, reputational harm, and diversion of
−Removed: Extortion payments may alleviate the negative impact of a ransomware attack, but we may be unwilling or unable to make such payments
−Removed: due to, for example, applicable laws or regulations prohibiting such payments.
−Removed: Similarly, supply-chain attacks have increased in frequency
−Removed: and severity, and we cannot guarantee that third parties and infrastructure in our supply chain or our third-party partners’ supply
−Removed: chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption
−Removed: to our information technology systems or the third-party information technology systems that support us.
−Removed: We may also face increased cybersecurity
−Removed: risks due to the number of our employees who are working remotely, which may create additional opportunities for cybercriminals to exploit
−Removed: vulnerabilities and data, as more of our employees utilize network connections, computers, and devices outside our premises or network,
−Removed: including working at home, while in transit and in public locations.
−Removed: Future or past business transactions (such as acquisitions or integrations)
−Removed: could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities
−Removed: present in acquired or integrated entities’ systems and technologies.
−Removed: Furthermore, we may discover security issues that were not
−Removed: found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into our information
−Removed: technology environment and security program.
−Removed: the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched
−Removed: against a target, we may be unable to anticipate these techniques or implement adequate preventative measures.
−Removed: We may also experience
−Removed: security incidents that may remain undetected for an extended period.
−Removed: If any of the previously identified or similar threats were to
−Removed: occur and cause interruptions in our operations, it could result in a disruption of our development programs and our business operations,
−Removed: whether due to a loss of our sensitive information or other similar disruptions.
−Removed: For example, the loss of clinical trial data from completed
−Removed: or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or
−Removed: reproduce the data.
−Removed: Furthermore, our software systems include cloud-based applications that are hosted by third-party service providers
−Removed: with security and information technology systems subject to similar risks.
−Removed: we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we could
−Removed: incur liability, our competitive position could be harmed and the further development and commercialization of our product candidates
−Removed: could be delayed.
−Removed: Security incidents could lead to adverse consequences, including but not limited to:
−Removed: government enforcement actions
−Removed: (for example, investigations, fines, penalties, audits, and inspections);
−Removed: additional reporting requirements and/or oversight;
−Removed: on processing sensitive information (including personal data);
−Removed: litigation (including class claims);
−Removed: indemnification obligations;
−Removed: reputational harm;
−Removed: monetary fund diversions;
−Removed: diversion of management attention;
−Removed: interruptions in our operations (including
−Removed: availability of data);
−Removed: financial loss;
−Removed: and other similar harms.
−Removed: Additionally, applicable data privacy and security obligations may require
−Removed: us to notify relevant stakeholders of security incidents.
−Removed: Such disclosures are costly, and the disclosure or the failure to comply with
−Removed: such requirements could lead to adverse consequences.
−Removed: may expend significant resources or modify our business activities (including our research and development activities) to try to protect
−Removed: against security incidents.
−Removed: Certain data privacy and security obligations may require us to implement and maintain specific security
−Removed: measures, industry-standard or reasonable security measures to protect our information technology systems and sensitive information.
−Removed: we have implemented security measures designed to protect against security incidents, there can be no assurance that these measures will
−Removed: be effective.
−Removed: We may be unable in the future to detect vulnerabilities in our information technology systems because such threats and
−Removed: techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred.
−Removed: Despite our efforts to identify and address vulnerabilities, if any, in our information technology systems, our efforts may not be successful.
−Removed: Further, we may experience delays in deploying remedial measures designed to address any such identified vulnerabilities.
−Removed: contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in
−Removed: our contracts are sufficient to protect us from liabilities, damages, or claims related to our data privacy and security obligations.
−Removed: We cannot be sure that our insurance coverage will be adequate or sufficient to protect us from or to mitigate liabilities arising out
−Removed: of our privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or
−Removed: that such coverage will pay future claims.
−Removed: Additionally, sensitive information of the Company could be leaked, disclosed, or revealed
−Removed: as a result of or in connection with our employees’, personnel’s, or vendors’ use of generative AI technologies.
−Removed: Related to Our Common Stock
−Removed: Common Stock price may be volatile, and the value of our Common Stock may decline.
−Removed: market price of our Common Stock may be highly volatile and may fluctuate or decline substantially as a result of a variety of factors,
−Removed: some of which are beyond our control, including:
−Removed: future financial performance, including expectations regarding our revenue, expenses and
−Removed: other operating results;
−Removed: in customer acceptance rates or the pricing of our products;
−Removed: in the production of our pipeline products;
−Removed: ability to establish new partnerships and successfully retain existing partnerships;
−Removed: ability to anticipate market needs and develop and introduce new and enhanced products to
−Removed: adapt to changes in our industry;
−Removed: success of our competitors;
−Removed: operating results failing to meet the expectations of securities analysts or investors in
−Removed: a particular period;
−Removed: in financial estimates and recommendations by securities analysts concerning us or the industry
−Removed: in which we operate in general;
−Removed: stock price performance of other companies that investors deem comparable to us;
−Removed: ● announcements
−Removed: by us or our competitors of significant business developments, acquisitions, strategic partnerships,
−Removed: joint ventures, collaborations or capital commitments;
−Removed: investments in our business, our anticipated capital expenditures and our estimates regarding
−Removed: our capital requirements;
−Removed: or other developments related to our intellectual property or other proprietary rights, including
−Removed: in our capital structure, including future issuances of securities or the incurrence of debt;
−Removed: in senior management or key personnel;
−Removed: in laws and regulations affecting our business;
−Removed: ● commencement
−Removed: of, or involvement in, investigations, inquiries or litigation;
−Removed: inherent risks related to the electric commercial vehicle industry;
−Removed: trading volume of our Common Stock;
−Removed: economic and market conditions.
−Removed: market and industry fluctuations, as well as general economic, political, regulatory, and market conditions, may also negatively impact
−Removed: the market price of our Common Stock.
−Removed: In addition, stocks of early stage companies have historically experienced high levels of volatility.
−Removed: In 2023, the closing price of our Common Stock on the Nasdaq Capital Market fluctuated between a high of $4.04 to a low of $1.58.In the
−Removed: past, companies that have experienced volatility in the market price of their securities have been subject to securities class action
−Removed: We may be the target of this type of litigation in the future, which could result in substantial expenses and divert our
−Removed: management’s attention.
−Removed: have received letters from Nasdaq stating that we are not in compliance with their continued listing requirements, and we might not be
−Removed: able to regain compliance.
−Removed: If as a result of the non-compliance Nasdaq delists our Common Stock, the liquidity and market price of our
−Removed: Common Stock could decline or cease to exist.
−Removed: Common Stock is currently listed on the Nasdaq Capital Market.
−Removed: In order to maintain that listing, we must satisfy certain continued listing
−Removed: requirements.
−Removed: If we are deficient in maintaining the necessary listing requirements, our common stock may be delisted.
−Removed: March 6, 2024, we received a letter from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) indicating
−Removed: we were not in compliance with its minimum bid price requirement for continued listing on the Nasdaq Capital Market.
−Removed: Nasdaq Listing Rule
−Removed: 5450(a)(1) requires listed securities to maintain a minimum bid price of $1.00 per share (the “Minimum Bid Price Requirement”),
−Removed: and Nasdaq Listing Rule 5810(c)(3)(A) provides that a failure to meet the Minimum Bid Price Requirement exists if the deficiency continues
−Removed: for a period of 30 consecutive trading days.
−Removed: letter had no immediate effect on the listing of our Common Stock on Nasdaq.
−Removed: However, if Nasdaq after the applicable compliance periods
−Removed: proceeds to delisting and we are not able to remedy the non-compliance, Nasdaq could delist our common stock from trading on its exchange.
−Removed: If we are not able to list our securities on another national securities exchange, we expect our securities could be quoted on the OTCQB
−Removed: or the “pink sheets.” If this occurs, we could face material adverse consequences, including:
−Removed: limited availability of market quotations for our securities;
−Removed: liquidity for our securities;
−Removed: determination that our common stock is a “penny stock” which will require brokers
−Removed: trading in our common stock to adhere to more stringent rules and possibly result in a reduced
−Removed: level of trading activity in the secondary trading market for our securities;
−Removed: limited amount of news and analyst coverage;
−Removed: decreased ability to issue additional securities or obtain additional financing in the future.
−Removed: have broad discretion in the use of our existing cash, cash equivalents and may not use them effectively.
−Removed: management will have broad discretion in the application of our existing cash, cash equivalents.
−Removed: Because of the number and variability
−Removed: of factors that will determine our use of our existing cash, cash equivalents and the net proceeds, their ultimate use may vary substantially
−Removed: from their currently intended use.
−Removed: Our management might not apply our cash resources in ways that ultimately increase the value of your
−Removed: The failure by our management to apply these funds effectively could harm our business.
−Removed: Pending their use, we may invest
−Removed: our cash resources in short-term, investment-grade, interest-bearing securities.
−Removed: These investments may not yield a favorable return to
−Removed: our stockholders.
−Removed: have never paid dividends on our common stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable
−Removed: have never declared or paid cash dividends on our Common Stock.
−Removed: We do not anticipate paying any cash dividends on our Common Stock in
−Removed: the foreseeable future.
−Removed: We currently intend to retain all available funds and any future earnings to fund the development and growth
+Added: Related to Our Capital Requirements and Finances
+Added: we fail to generate sufficient cash flow from our operations, we will be unable to continue to develop and commercialize our products.
+Added: expect capital outlays and operating expenditures to increase over the next several years as we expand our operations, and our commercialization,
+Added: product validation studies, research and development and manufacturing activities.
+Added: However, our present and future funding requirements
+Added: will depend on many factors, including, among other things:
+Added: level of research and development investment required to maintain and improve our competitive position;
+Added: success of our product sales and related collections;
+Added: need or decision to acquire or license complementary businesses, products or technologies or acquire complementary businesses;
+Added: relating to the expansion of the sales force, management and operational support;
+Added: technological and market developments;
+Added: relating to changes in regulatory policies or laws that affect our operations.
+Added: a result of these factors, we may need to raise additional funds, and we cannot be certain that such funds will be available to us on
+Added: acceptable terms when needed, if at all.
+Added: In addition, if we raise additional funds through collaboration, licensing or other similar
+Added: arrangements, it may be necessary to relinquish potentially valuable rights to our future products or proprietary technologies, or grant
+Added: licenses on terms that are not favorable to us.
+Added: If we cannot raise funds on acceptable terms, we may not be able to expand our operations,
+Added: develop new products, take advantage of future opportunities or respond to competitive pressures or unanticipated customer requirements.
+Added: Related to the Ownership of Our Securities
+Added: price of our Common Stock may be adversely affected by the future issuance and sale of shares of our Common Stock or other equity securities.
+Added: cannot predict the size of future issuances or sales of our Common Stock or other equity securities, future acquisitions or capital raising
+Added: activities, or the effect, if any, that such issuances or sales may have on the market price of our Common Stock.
+Added: The issuance and sale
+Added: of substantial amounts of Common Stock or other equity securities or announcement that such issuances and sales may occur, could adversely
+Added: affect the market price of our Common Stock.
+Added: sales by stockholders, or the perception that such sales may occur, may depress the price of our Common Stock.
+Added: The sale or availability for sale of substantial
+Added: amounts of our shares in the public market or exercise of Common Stock warrants or other derivative securities or the perception that
+Added: such sales could occur, could adversely affect the market price of our Common Stock and also could impair our ability to raise capital
+Added: through future offerings of our shares.
+Added: As of March 26, 2025, we had 577,961 outstanding shares of Common Stock.
+Added: Any decline in the price
+Added: of our Common Stock may encourage short sales, which could place further downward pressure on the price of our Common Stock and may impair
+Added: our ability to raise additional capital through the sale of equity securities.
+Added: issuance of shares upon exercise of derivative securities may cause immediate and substantial dilution to our existing stockholders .
+Added: issuance of shares upon exercise of options and settlement of outstanding derivative securities may result in substantial dilution to
+Added: the interests of other shareholders since these selling shareholders may ultimately convert or exercise and sell all or a portion of the
+Added: full amount issuable upon exercise.
+Added: If all derivative securities outstanding as of March 26, 2025, including the Warrants, were converted
+Added: or exercised into shares of Common Stock, there would be approximately an additional 531,353 shares
+Added: of Common Stock outstanding as a result.
+Added: The issuance of these shares will have the effect of further diluting the proportionate equity
+Added: interest and voting power of holders of our Common Stock.
+Added: Common Stock may be affected by limited trading volume and price fluctuations, which could adversely impact the value of our Common Stock.
+Added: Common Stock has experienced and is likely to experience in the future, significant price and volume fluctuations, which could adversely
+Added: affect the market prices of our Common Stock without regard to our operating performance.
+Added: In addition, we believe that factors such as
+Added: quarterly fluctuations in our financial results and changes in the overall economy or the condition of the financial markets could cause
+Added: the market prices of our Common Stock to fluctuate substantially.
+Added: These fluctuations may also cause short sellers to periodically enter
+Added: the market in the belief that we will have poor results in the future.
+Added: We cannot predict the actions of market participants and, therefore,
+Added: can offer no assurances that the market for our Common Stock will be stable or appreciate over time.
+Added: may not be able to continue to satisfy listing requirements of Nasdaq to maintain a listing of our Common Stock.
+Added: Common Stock is currently listed on Nasdaq and we must meet certain financial and liquidity criteria to maintain such listing.
+Added: violate the maintenance requirements for continued listing of our Common Stock, our Common Stock may be delisted.
+Added: can be no assurance that we will maintain compliance with any of the other Nasdaq continued listing requirements.
+Added: If the Common Stock
+Added: is delisted, it could be more difficult to buy or sell the Common Stock or to obtain accurate quotations, and the price of the shares
+Added: of Common Stock could suffer a material decline.
+Added: Delisting could also impair our ability to raise capital.
+Added: addition, our Board may determine that the cost of maintaining our listing on a national securities exchange outweighs the benefits of
+Added: such listing.
+Added: A delisting of our Common Stock from Nasdaq may materially impair our stockholders’ ability to buy and sell our Common
+Added: Stock and could have an adverse effect on the market price of, and the efficiency of the trading market for, our Common Stock.
+Added: the delisting of our Common Stock could significantly impair our ability to raise capital.
+Added: currently do not intend to declare dividends on our Common Stock in the foreseeable future and, as a result, your returns on your investment
+Added: may depend solely on the appreciation of our Common Stock.
+Added: currently do not expect to declare any dividends on our Common Stock in the foreseeable future.
+Added: Instead, we anticipate that all of our
+Added: earnings in the foreseeable future will be used to provide working capital, to support our operations and to finance the growth and development
of our business.
−Removed: As a result, capital appreciation, if any, of Common Stock will be our stockholders’ sole source of gain for the
−Removed: foreseeable future.
−Removed: of a substantial number of shares of our common stock in the public market by our existing stockholders could cause our stock price to
−Removed: of a substantial number of shares of our Common Stock in the public market or the perception that these sales might occur, could depress
−Removed: the market price of our Common Stock and could impair our ability to raise capital through the sale of additional equity securities.
−Removed: We are unable to predict the effect that sales may have on the prevailing market price of our Common Stock.
−Removed: largest stockholder’s interests may differ from those of our public stockholders.
−Removed: Approximately
−Removed: 20.56% of the voting power of our Common Stock is controlled, directly or indirectly, by one of our founders, Braeden Lichti.
−Removed: knowledge, no other stockholder owns more than 20% of our voting power.
−Removed: Lichti could exert significant influence over corporate management
−Removed: and affairs, as well as matters requiring stockholder approval, and he is able to, subject to applicable law, participate in the election
−Removed: of the members of the and actions to be taken by us, including amendments to the Amended and Restated Certificate of Incorporation and
−Removed: approval of significant corporate transactions, including mergers and sales of substantially all of our assets.
−Removed: It is possible that the
−Removed: interests of this stockholder may in some circumstances conflict with the Company’s interests and the interests of our other stockholders.
−Removed: could influence his decisions, including with regard to whether and when to dispose of assets and whether and when to incur new or refinance
−Removed: existing indebtedness.
−Removed: In addition, the determination of future tax reporting positions, the structuring of future transactions and the
−Removed: handling of any future challenges by any taxing authorities to the Company’s tax reporting positions may take into consideration
−Removed: this stockholder’s tax or other considerations, which may differ from the Company’s considerations or those of our other
−Removed: stockholders.
−Removed: Concentration
−Removed: of ownership among our executive officers, directors and their affiliates, as well as the Relationship Agreement entered into in connection
−Removed: with the Combination, may prevent new investors from influencing significant corporate decisions.
−Removed: of March 15, 2024, our executive officers, directors and their affiliates beneficially own, in the aggregate, approximately 50.04% of
−Removed: our outstanding Common Stock.
−Removed: In particular, as of March 15, 2023, Dr.
−Removed: Plews, our Chief Executive Officer, beneficially owned
−Removed: approximately 16.45% of our outstanding Common Stock.
−Removed: Plews is able to exercise a significant level of influence over all matters requiring shareholder approval, including the election of
−Removed: directors, amendments of our Constitution and approval of significant corporate transactions.
−Removed: This influence could have the effect of
−Removed: delaying or preventing a change of control of our company or changes in management and may make the approval of certain transactions
−Removed: difficult awithout the support of Mr.
−Removed: are an “emerging growth company,” and we cannot be certain if the reduced reporting and disclosure requirements applicable
−Removed: to emerging growth companies will make our Common Stock less attractive to investors.
−Removed: are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”),
−Removed: and we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that
−Removed: are not “emerging growth companies,” including the auditor attestation requirements of Section 404 of the Sarbanes-Oxley
−Removed: Act, or Section 404 and disclosure obligations regarding executive compensation.
−Removed: Pursuant to Section 107 of the JOBS Act, as an emerging
−Removed: growth company, we have elected to use the extended transition period for complying with new or revised accounting standards until those
−Removed: standards would otherwise apply to private companies.
−Removed: As a result, our financial statements may not be comparable to the financial statements
−Removed: of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public
−Removed: companies, which may make our Common Stock less attractive to investors.
−Removed: In addition, if we cease to be an emerging growth company, we
−Removed: will no longer be able to use the extended transition period for complying with new or revised accounting standards.
−Removed: will remain an emerging growth company until the earliest of:
−Removed: (1) the last day of the fiscal year following the fifth anniversary of
−Removed: November 21, 2028, which was the date of the first sale of our Common Stock pursuant to an effective registration statement;
−Removed: last day of the first fiscal year in which our annual gross revenue is $1.235 billion or more;
−Removed: (3) the date on which we have, during
−Removed: the previous rolling three-year period, issued more than $1 billion in non-convertible debt securities;
−Removed: and (4) the last day of the fiscal
−Removed: year in which the market value of our Common Stock held by non-affiliates exceeded $700 million as of June 30 of such fiscal year.
−Removed: cannot predict if investors will find our Common Stock less attractive if we choose to rely on these exemptions.
−Removed: For example, if we do
−Removed: not adopt a new or revised accounting standard, our future results of operations may not be as comparable to the results of operations
−Removed: of certain other companies in our industry that adopted such standards.
−Removed: If some investors find our Common Stock less attractive as a
−Removed: result, there may be a less active trading market for our Common Stock, and our share price may be more volatile.
+Added: Any determination to declare or pay dividends in the future will be at the discretion of our Board, subject to applicable
+Added: laws and dependent upon a number of factors, including our earnings, capital requirements and overall financial conditions.
+Added: terms of any future debt or preferred securities may further restrict our ability to pay dividends on our Common Stock.
+Added: your only opportunity to achieve a return on your investment in our Common Stock may be if the market price of our Common Stock appreciates
+Added: and you sell your shares at a profit.
+Added: The market price for our Common Stock may never exceed, and may fall below, the price that you
+Added: pay for such Common Stock.
+Added: See “ Dividend Policy .”
+Added: investment in our securities is speculative and there can be no assurance of any return on any such investment.
+Added: investment in our securities is speculative and there can be no assurance that investors will obtain any return on their investment.
+Added: Investors may be subject to substantial risks involved in an investment in the Company, including the risk of losing their entire investment.
+Added: may need, but be unable, to obtain additional funding on satisfactory terms, which could dilute our stockholders or impose burdensome
+Added: financial restrictions on our business.
+Added: have relied upon cash from financing activities and in the future, we hope to rely on revenues generated from operations to fund the
+Added: cash requirements of our activities.
+Added: However, there can be no assurance that we will be able to generate any significant cash from our
+Added: operating activities in the future.
+Added: Future financing may not be available on a timely basis, in sufficient amounts or on terms acceptable
+Added: to us, if at all.
+Added: Any debt financing or other financing of securities senior to the Common Stock will likely include financial and other
+Added: covenants that will restrict our flexibility.
+Added: Any failure to comply with these covenants would have a material adverse effect on our
+Added: business, prospects, financial condition and results of operations because we could lose our existing sources of funding and impair our
+Added: ability to secure new sources of funding.
+Added: requirements of being a public company may strain our resources, divert management’s attention and affect our results of operations.
+Added: a public company in the United States, we face increased legal, accounting, administrative and other costs and expenses.
+Added: We are subject
+Added: to the reporting requirements of the Exchange Act and the Sarbanes-Oxley Act of 2002.
+Added: The Exchange Act requires, among other things,
+Added: that we file annual, quarterly and current reports with respect to our business and financial condition.
+Added: The Sarbanes-Oxley Act requires,
+Added: among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting.
+Added: example, Section 404 requires that our management report on the effectiveness of our internal controls structure and procedures for financial
+Added: Section 404 compliance may divert internal resources and will take a significant amount of time and effort to complete.
+Added: we fail to maintain compliance under Section 404, or if in the future management determines that our internal control over financial
+Added: reporting are not effective as defined under Section 404, we could be subject to sanctions or investigations by Nasdaq, the SEC or other
+Added: regulatory authorities.
+Added: Furthermore, investor perceptions of our Company may suffer, and this could cause a decline in the market price
+Added: of our Common Stock.
+Added: Any failure of our internal control over financial reporting could have a material adverse effect on our stated
+Added: results of operations and harm our reputation.
+Added: If we are unable to implement these changes effectively or efficiently, it could harm
+Added: our operations, financial reporting or financial results and could result in an adverse opinion on internal controls from our independent
+Added: We may need to hire a number of additional employees with public accounting and disclosure experience in order to meet our
+Added: ongoing obligations as a public company, particularly if we become fully subject to Section 404 and its auditor attestation requirements,
+Added: which will increase costs.
+Added: We expect these rules and regulations to increase our legal and financial compliance costs and to make some
+Added: activities more time consuming and costly, although we are currently unable to estimate these costs with any degree of certainty.
+Added: of those requirements will require us to carry out activities we have not done previously.
+Added: Our management team and other personnel will
+Added: need to devote a substantial amount of time to new compliance initiatives and to meeting the obligations that are associated with being
+Added: a public company, which may divert attention from other business concerns, which could have a material adverse effect on our business,
+Added: financial condition and results of operations.
+Added: Additionally,
+Added: the expenses incurred by public companies generally for reporting and corporate governance purposes have been increasing.
+Added: These increased
+Added: costs will require us to divert a significant amount of money that we could otherwise use to develop our business.
+Added: If we are unable to
+Added: satisfy our obligations as a public company, we could be subject to delisting of our Common Stock, fines, sanctions and other regulatory
+Added: action and potentially civil litigation.
+Added: laws, regulations and standards relating to corporate governance and public disclosure may create uncertainty for public companies, increasing
+Added: legal and financial compliance costs and making some activities more time consuming.
+Added: laws, regulations and standards are subject to varying interpretations, in many cases due to their lack of specificity, and, as a result,
+Added: may evolve over time as new guidance is provided by the courts and other bodies.
+Added: This could result in continuing uncertainty regarding
+Added: compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.
+Added: If our efforts to comply
+Added: with new laws, regulations, and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related
+Added: to their application and practice, regulatory authorities may initiate legal proceedings against us and our business may be adversely
+Added: a public company subject to these rules and regulations, we may find it more expensive for us to obtain director and officer liability
+Added: insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
+Added: These factors could
+Added: also make it more difficult in the future for us to attract and retain qualified members of our Board, particularly to serve on its audit
+Added: committee and compensation committee, and qualified executive officers.
+Added: securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price
+Added: and trading volume could decline.
+Added: trading market for our Common Stock will depend in part on the research and reports that securities or industry analysts publish about
+Added: us or our business.
+Added: Several analysts may cover our stock.
+Added: If one or more of those analysts downgrade our stock or publish inaccurate
+Added: or unfavorable research about our business, our stock price would likely decline.
+Added: If one or more of these analysts cease coverage of
+Added: our Company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading
+Added: volume to decline.
+Added: there is no active public market for our Common Stock, you may be unable to sell your shares at or above your purchase price.
+Added: our Common Stock is listed on Nasdaq, an active trading market for our shares may not be sustained following the purchase of your Common
+Added: You may be unable to sell your shares quickly or at the market price if trading in shares of our Common Stock is not active.
+Added: an inactive market may also impair our ability to raise capital by selling shares of our Common Stock and may impair our ability to enter
+Added: into strategic partnerships or acquire companies or products by using our shares of Common Stock as consideration.
+Added: may be subject to securities litigation, which is expensive and could divert our management’s attention.
+Added: market price of our securities may be volatile, and in the past companies that have experienced volatility in the market price of their
+Added: securities have been subject to securities class action litigation.
+Added: We may be the target of this type of litigation in the future.
+Added: litigation against us could result in substantial costs and divert our management’s attention from other business concerns.
+Added: ADDITION TO THE ABOVE RISKS, BUSINESSES ARE OFTEN SUBJECT TO RISKS NOT FORESEEN OR FULLY APPRECIATED BY MANAGEMENT.
+Added: IN REVIEWING THIS
+Added: FILING, POTENTIAL INVESTORS SHOULD KEEP IN MIND THAT OTHER POSSIBLE RISKS MAY ADVERSELY IMPACT OUR BUSINESS OPERATIONS AND THE VALUE
+Added: OF OUR SECURITIES.
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.