SKINVISIBLE, INC. 10-Q

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations Forward-Looking Statements This Quarterly Report on Form 10-Q contains forward-looking statements. Forward-looking statements are projections of events, revenues, income, future economic performance or management’s plans and objectives for our future operations. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” and the risks set out below, any of which may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and not in limitation: • the uncertainty of profitability based upon our history of losses; • legislative or regulatory changes concerning skincare research and therapies; • risks related to failure to obtain adequate financing on a timely basis and on acceptable terms to continue as going concern; • risks related to our operations and uncertainties related to our business plan and business strategy; • changes in economic conditions; • uncertainty with respect to intellectual property rights, protecting those rights and claims of infringement of other’s intellectual property; • competition; and • cybersecurity concerns. This list is not an exhaustive list of the factors that may affect any of our forward-looking statements. These and other factors should be considered carefully, including those contained in our Annual Report on Form 10-K under “Risk Factors” for the year ended December 31, 2024, and readers should not place undue reliance on our forward-looking statements. Forward looking statements are made based on management’s beliefs, estimates and opinions on the date the statements are made, and we undertake no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results. Our financial statements are stated in United States dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles. 4 Table of Contents Company Overview We, through our wholly owned subsidiary Skinvisible Pharmaceuticals Inc., are a pharmaceutical research and development (“R&D”) company that has developed and patented an innovative polymer delivery system, Invisicare® and formulated over forty topical skin products, which we out-license globally. We were incorporated in 1998 and target an estimated $80 billion global skincare and dermatology market and a $30 billion global over-the-counter market as well as other healthcare / medical and consumer goods markets. The Company is also exploring new opportunities in large medical markets outside of the dermatology market such as obesity and other potential markets where a topical or transdermal solution would be a viable alternative. With the research and development complete on forty products and numerous patents issued (technology and product patents), we are ready to monetize our investment. Our business model will continue to be to out-license our patented prescription and over-the-counter (“OTC”) products featuring Invisicare to established manufacturers and marketers of brands internationally and to maximize profits from the products we have already out-licensed. The opportunity for us to license our products continues to be a viable model as the need for pharmaceutical companies to access external R&D companies for new products due to their own downsizing or elimination of internal R&D departments. The demand for our products is enhanced due to the granting of key US and international patents and the completed development of a number of unique products. Our Flagship Product Pivotal to our success is our patented polymer delivery system technology Invisicare. Invisicare is a patented polymer delivery system that enhances the delivery of active ingredients for topically applied skin care products. Its patented technology has a unique formula and process for combining active ingredients with a delivery system that extends the duration of time the product remains on the skin and active. Invisicare is specifically formulated to carry water insoluble active and certain cationic active ingredients in water-based products without the use of alcohol, silicones, waxes, or other organic solvents. Products utilizing Invisicare have the proven ability to bond active ingredients to the skin for up to four hours and longer. They are non-occlusive and allow normal skin respiration and perspiration while moisturizing and protecting against exposure from a wide variety of environmental irritants. When topically applied, these formulated products adhere to the skin's outer layers, forming a protective bond, resisting wash-off, and delivering targeted levels of therapeutic or cosmetic skincare agents to the skin. They allow enhanced delivery performance for a variety of skincare agents resulting in improved efficacy, longer duration of action, reduced irritation and lower dosage of active agent required. The "invisible" polymer compositions wear off as part of the natural exfoliation process of the skin's outer layer cells. The advantage of products formulated with Invisicare is (1) Invisicare’s ability to bind active ingredients (the drug) to the skin, forming a protective bond on the skin, for extended periods of time; (2) Invisicare can deliver targeted levels (high or low) of therapeutic or cosmetic ingredients to the skin in a controlled release; (3) Invisicare can help to reduce the irritation of some active ingredients due to how it controls the slower release of that active ingredient; and (4) Invisicare science proves that it provides a protective skin barrier which helps retain the natural moisture content of the skin, while still allowing it to breathe. These benefits present an excellent opportunity for clear scientific advantages and marketing messages which resonate with physicians and consumers. 5 Table of Contents We generate revenue by: • LICENSING : We develop topical prescription and over-the-counter products enhanced with Invisicare to license to pharmaceutical and consumer goods companies around the world for an upfront fee and ongoing royalties. • CO-DEVELOPMENT : We assist pharmaceutical clients in the early development of the most optimal formulation, which they then take forward into clinical testing. • LIFE CYCLE MANAGEMENT : We provide cost-effective solutions to global pharmaceutical companies by reformulating their products coming off patent with a new Invisicare patent and new product benefits and line extensions. Pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the revenue loss from their drugs coming off patent. License Agreement with Quoin On October 17, 2019, we entered an Exclusive License Agreement with Quoin Pharmaceuticals, Inc., a Delaware corporation (“Quoin”) pursuant to which we granted Quoin a license to certain patents for the development of products for commercial sale. In exchange for the license, Quoin paid us a license fee of one million USD dollars (USD $1,000,000) (the “License Fee”) and will additionally pay a single digit royalty interest of all net sales on the licensed products subject to adjustment in certain situations. The agreement also requires that Quoin make a milestone payment of $5 million to us upon achieving the first to occur of either FDA or European Union regulatory approval for one product licensed. In addition, and upon the successful approval in the US or European Union, whichever occurs first, Skinvisible is entitled to receive a single digit royalty percentage of Quoins net sales revenues for any licensed product covered by the patent rights licensed under the License Agreement. Plus, Quoin also agreed to pay Skinvisible 25% of any revenues they receive as royalties in the event that they sublicense any licensed products to a third party. On June 6, 2022, the Company announced that its licensee Quoin and its product QRX003, was the first Invisicare delivery technology product to receive U.S. FDA Acceptance of Investigational New Drug Application and that Quoin was actively working towards obtaining necessary FDA and other regulatory approvals for marketing the product in the United States and other countries. On February 14, 2024, the Company announced that there was significant progress in Quoin's clinical trials for product formulations containing Invisicare targeting Netherton Syndrome. The trials focus on the innovative formulation "QRX003," powered by Skinvisible’s Invisicare® proprietary drug delivery technology. The updates include: • Positive Initial Data and Clean Safety Profile: The trials have demonstrated positive initial data and a clean safety profile, leading to the implementation of an optimization plan. • Optimization Plan Implementation: Quoin has increased the size of both clinical trials significantly and adjusted dosing frequency to twice-daily from once-daily for both trials. • Elimination of Lower Dose: In the blinded trial, a lower dose has been eliminated based on the positive outcomes observed. • Protocol Amendments: Quoin's press release highlights protocol amendments aimed at enhancing the data set and potentially expediting regulatory approval. We believe these protocol amendments could ultimately result in the generation of a highly compelling data set, which could support regulatory filings and approval for QRX003 as the first treatment for Netherton Syndrome. 6 Table of Contents On March 4, 2024, Quoin announced a further milestone: it received FDA Clearance to recruit teen subjects into both ongoing Netherton Syndrome clinical studies. We believe this announcement is important as: • Clearance to include teen patients in both Quoin’s open label and placebo-controlled studies are expected to significantly expand the number of eligible subjects, potentially expedite recruitment and lead to a more robust data set. • This development represents the first ever inclusion of non-adult subjects in Netherton Syndrome clinical studies conducted under an open Investigational New Drug Application. • It is believed that the inclusion of this patient population in Quoin’s studies will be a critical component of the development of a robust data set that could result in regulatory approval with a broad label as QRX003 is being tested both as monotherapy and in conjunction with off-label treatments. On June 27, 2024, Quoin announced an International Expansion of ongoing clinical trials for Netherton Syndrome in Saudia Arabia. The site is currently treating Netherton patients who are eligible for recruitment into Quoin studies. On October 22, 2024, Quoin announced further International Expansion of ongoing clinical trials for Netherton Syndrome with two additional clinical sites to be opened in the United Kingdom where both sites are recognized Centers of Excellence for Netherton Syndrome in the UK. On November 5, 2024, Quoin Pharmaceuticals initiated clinical testing of its lead product in a pediatric Netherton Syndrome patient. This clinical assessment is being performed on a pediatric patient at children’s health Ireland in Dublin; the first evaluation of QRX003, powered by Skinvisible’s Invisicare technology, in a pediatric patient. On December 19, 2024, Quoin Pharmaceuticals announced FDA clearance to initiate a new additional Netherton Syndrome (NS) clinical study for QRX003. The company further announced that the study will be conducted by Dr. Amy Paller, of Northwestern University. It is planned that up to eight subjects will be enrolled into the study and will have QRX003 applied twice daily to greater than 80% of their entire body surface area (BSA) over a 12-week period. By comparison, in Quoin’s ongoing open-label and double-blind clinical studies, QRX003 is applied to approximately 20% of the subject’s BSA, typically the arms and lower leg. This new study, designed to mimic how NS patients will use QRX003 if approved, represents the most extensive use of QRX003 in a clinical setting to date. It is anticipated that the data generated from this study will be used to supplement the data package to support the potential regulatory approval of QRX003 as a treatment for NS. Quoin also announced other key developments, including: • Significant clinical improvements in both open label and pediatric studies including subject's disease classification improved from "severe" to "mild" after 6 weeks dosing; • No adverse events or safety concerns reported to date from each of Quoin's ongoing clinical studies in Netherton Syndrome subjects; and • License of Netherton Syndrome product QRX003 with Invisicare delivery technology in 60 countries. On May 20, 2025, Quoin announced that it has been granted an Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for its lead product QRX003 in Netherton Syndrome. Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved, QRX003 will be granted 10 years of market exclusivity in Europe for the treatment of Netherton Syndrome. On June 24, 2025, Quoin announced that the FDA granted a Rare Pediatric Disease (RPD) Designation for QRX003, for the treatment of Netherton Syndrome. 7 Table of Contents The designation reinforces the potential of QRX003 as a therapeutic candidate for a profoundly underserved pediatric population. The FDA’s Rare Pediatric Disease Designation program is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for QRX003 is approved, upon reauthorization of the program Quoin may be eligible to receive a Priority Review Voucher (PRV), which can be redeemed to receive priority review for another marketing application or may be sold or transferred. License Agreement with Ovation Science On February 3, 2020, we entered into a License Agreement with Ovation Science Inc. pursuant to which Skinvisible granted to Ovation Science Inc. a license for the manufacture and distribution rights to its hand sanitizer product, DermSafe. In exchange for the license, Ovation Science Inc. agreed to pay to Skinvisible a royalty percentage on all net sales on the licensed products subject to adjustment in certain situations plus a license fee payable in year 3 of the agreement if it chooses to continue the license. On June 10, 2020, Ovation Science paid us the fee otherwise due in year 3 and in exchange we extended the term of Ovation Science’s license to 6-years and granted Ovation additional rights to its hand sanitizer products and assigned Canadian Identification Numbers 02310589 and 02355558, all DermSafe Trademarks, DermSafe clinical data and the right to patent DermSafe where not currently patented. In exchange for these rights, Ovation Science paid a $100,000 license fee. We completed the required assignments during the year ending December 31, 2020 and recognized $100,000 in revenue. On September 18, 2025, the Company signed a new agreement with Ovation Science. Ovation Science retains exclusive global rights to use Skinvisible’s Invisicare® technology with cannabinoids for topical/transdermal products, including new formulations with THC-V targeting obesity and metabolic health. The agreement covers confidential know-how and a pending PCT patent application for transdermal delivery of glucose-controlling agents. The collaboration aims to address gastrointestinal side effects in obesity treatments and capitalize on a projected $150 billion market by 2035 (Morgan Stanley, 2025). Patent Applications for Transdermal Delivery for Obesity and Glucose-Controlling Agents In May and June of 2024, we filed provisional patent applications covering formulations that leverage Invisicare for the transdermal administration of obesity drugs and glucose-controlling agents for diseases such as diabetes. The patents are titled "Transdermal Delivery Composition for Delivery of CB-1 Receptor Antagonists and/or GLP-1 Receptor Agonists, and Method of Delivery” and “Transdermal Delivery Composition for Delivery of at Least One Glucose Controlling Agent, and Method of Delivering at Least One Glucose Controlling Agent.” The patent applications focus on the use of Invisicare in a transdermal delivery technology designed to incorporate CB-1 receptor antagonists and/or GPL-1 receptor agonists, with drugs known for their potential in obesity management and for glucose-controlling agents, into a lotion that is applied topically to the skin using a metered applicator. Studies have demonstrated the superior transdermal penetration and controlled release of other active compounds using Invisicare's innovative technology, with certain actives exhibiting up to a tenfold increase in transdermal delivery effectiveness. By utilizing Invisicare, we aim to not only offer patients a convenient and effective alternative to traditional oral or injectable therapies but to also enhance drug efficacy and potentially significantly reduce side effects as transdermal delivery avoids first-pass metabolism. Additionally, for long-term treatment of obesity and glucose controlling agents, a transdermal delivery system could feasibly provide a convenient method for administering maintenance doses for these medications. We are actively pursuing strategic partnerships with pharmaceutical and/or biotech companies to facilitate the introduction of the first transdermal obesity therapies to market and to explore the application of its delivery platform across diverse disease domains. 8 Table of Contents Results of Operations for the Three and Nine Months Ended September 30, 2025 and 2024 Revenues Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $5,000 for the three months ended September 30, 2025 as compared with $5,000 for the same period ended September 30, 2024. Our revenue, which we combine from product sales, royalties on patent licenses and license fees (product development fees), was $15,000 for the nine months ended September 30, 2025 as compared with $15,000 for the same period ended September 30, 2024. We hope to generate more revenues from our licenses with Quoin and Ovation for the second half of 2025. We also plan to enter into commercial arrangements with pharma and biotech companies to exploit our patent applications that were recently filed, and we hope to generate revenue from these efforts in the future. Gross Profit We had $0 in cost of revenues for the three and nine months ended September 30, 2025, compared with $0 in cost of revenues for the three and nine months ended September 30, 2024, so our gross profit was $5,000 and $5,000 for the three months ended September 30, 2025 and 2024, respectively, and $15,000 and $15,000 for the nine months ended September 30, 2025 and 2024, respectively. Operating Expenses Operating expenses decreased to $111,057 for the three months ended September 30, 2025, from $129,969 for the same period ended September 30, 2024. Operating expenses decreased to $397,146 for the nine months ended September 30, 2025, from $405,846 for the same period ended September 30, 2024. Our operating expenses for all periods consisted mainly of selling, general and administrative expenses, which, consisted mainly of accrued salaries and wages and audit and accounting fees. Our selling, general and administrative expenses for the nine months ended September 30, 2025, consisted mainly of accrued salaries and wages of $259,950 and audit and accounting of $39,828.50. In comparison, our selling, general and administrative expenses for the nine months ended September 30, 2024, consisted mainly of accrued salaries and wages of $262,827 and audit and accounting of $37,747. We expect our operating expenses will increase in the future as the Company begins to generate more licensing revenue. Other Expense We had other expense of $144,188 for the three months ended September 30, 2025, as compared with other expenses of $161,635 for the three months ended September 30, 2024. We had other expense of $423,531 for the nine months ended September 30, 2025, as compared with other expenses of $489,579 for the nine months ended September 30, 2024. Our other expense for the three and nine months ended September 30, 2025 consisted mainly of interest expense netted against other income related to the sale of polymer. Our other expense for the three and nine months ended September 30, 2024 consisted mainly of interest expense, netted against a gain on settlement of debt and gain on derivative liability changes. Net Loss We recorded a net loss of $250,245 for the three months ended September 30, 2025, as compared with a net loss of $286,604 for the three months ended September 30, 2024. We recorded a net loss of $805,677 for the nine months ended September 30, 2025, as compared with a net loss of $880,425 for the nine months ended September 30, 2024. 9 Table of Contents Liquidity and Capital Resources Going concern – The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred cumulative net losses of $40,751,819 since its inception and requires capital for its contemplated operational and marketing activities to take place. The Company’s ability to generate the necessary funds through licensing of its core products or the ability to raise additional capital through the future issuances of common stock or debt is unknown. The obtainment of additional financing, the successful development of the Company’s contemplated plan of operations, and its transition, ultimately, to the attainment of profitable operations are necessary for the Company to continue operations. These factors, among others, raises substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements of the Company do not include any adjustments that may result from the outcome of these aforementioned uncertainties. As of September 30, 2025, we had total current assets of $28,469 and total assets in the amount of $133,623. Our total current liabilities as of September 30, 2025 were $4,765,644. We had a working capital deficit of $4,737,175 as of September 30, 2025, compared with a working capital deficit of $3,615,238 as of December 31, 2024. Operating activities used $40,385 in cash for the nine months ended September 30, 2025, as compared with $52,922 used for the nine months ended September 30, 2024. Our negative operating cash flows for 2024 and 2025 were largely the result of our net loss for those quarters, mainly offset by changes in operating assets and liabilities and the amortization of debt discount and amortization. We used $4,086 in cash for the purchase of intangible assets in investing activities for the nine months ended September 30, 2025, and used $9,218 in cash in the same period ended 2024. Cash flow provided from financing activities was $34,780 for the nine months ended September 30, 2025, as compared with $61,864 provided by cash flows for financing activities during the nine months ended September 30, 2024. The features of the debt instruments and payables concerning our financing activities are detailed in the footnotes to our financial statements. Based upon our current financial condition, we do not have sufficient cash to operate our business at the current level for the next twelve months. We intend to fund operations through increased sales and debt and/or equity financing arrangements, which may be insufficient to fund expenditures or other cash requirements. We plan to seek additional financing in a private equity offering to secure funding for operations. There can be no assurance that we will be successful in raising additional capital. Off Balance Sheet Arrangements As of September 30, 2025, there were no off-balance sheet arrangements. Critical Accounting Policies In December 2001, the SEC requested that all registrants list their most “critical accounting polices” in the Management Discussion and Analysis. The SEC indicated that a “critical accounting policy” is one which is both important to the portrayal of a company’s financial condition and results, and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. 10 Table of Contents Product sales – Revenues from the sale of products (Invisicare® polymers) are recognized when title to the products are transferred to the customer and only when no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive reasonably assured payments for products sold and delivered. Royalty sales – We also recognize royalty revenue from licensing our patented product formulations only when earned, with no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments. Distribution and license rights sales – We also recognize revenue from distribution and license rights only when earned (and are amortized over a five-year period), with no further contingencies or material performance obligations are warranted, and thereby have earned the right to receive and retain reasonably assured payments. Costs of Revenue – Cost of revenue includes raw materials, component parts, and shipping supplies. Shipping and handling costs is not a significant portion of the cost of revenue. Accounts Receivable – Accounts receivable is comprised of uncollateralized customer obligations due under normal trade terms requiring payment within 30 days from the invoice date. The carrying amount of accounts receivable is reviewed periodically for collectability. If management determines that collection is unlikely, an allowance that reflects management’s best estimate of the amounts that will not be collected is recorded. Management reviews each accounts receivable balance that exceeds 30 days from the invoice date and, based on an assessment of creditworthiness, estimates the portion, if any, of the balance that will not be collected. As of September 30, 2025, we had not recorded a reserve for doubtful accounts. Recently Issued Accounting Pronouncements In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendments in this ASU require disclosures, on an annual and interim basis, of significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”), as well as the aggregate amount of other segment items included in the reported measure of segment profit or loss. This ASU requires that a public entity disclose the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. This ASU is effective for fiscal years beginning after December 15, 2023, including interim periods within those fiscal years, with early adoption permitted. The amendments in this ASU should be applied retrospectively to all prior periods presented in the financial statements. The Company adopted the ASU and determined that its adoption did not have a material impact on the Company’s condensed consolidated financial statements and related disclosures. As defined in the ASU, operating segments are components of an enterprise about which discrete financial information is regularly provided to the CODM in making decisions on how to allocate resources and assess performance for the organization. The Company operates and manages its business as one reportable and operating segment. The Company’s CODM is the Chief Executive Officer. The Company’s CODM reviews condensed consolidated operating results to make decisions about allocating resources and assessing performance for the entire Company. In July 2025, the FASB issued Accounting Standards Update 2025-05, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets ("ASU 2025-05"). ASU 2025-05 provides a practical expedient that all entities can use when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC 606, Revenue from Contracts with Customers. Under this practical expedient, an entity is allowed to assume that the current conditions it has applied in determining credit loss allowances for current accounts receivable and current contract assets remain unchanged for the remaining life of those assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025, and interim reporting periods in those years. Entities that elect the practical expedient and, if applicable, make the accounting policy election are required to apply the amendments prospectively. The Company is currently evaluating the impact of ASU 2025-05 on its financial statements and disclosures. The Company does not believe that other standards, which have been issued but are not yet effective, will have a significant impact on its financial statements. 11 Table of Contents Item 3. Quantitative and Qualitative Disclosures About Market Risk A smaller reporting company is not required to provide the information required by this Item.