Cosmos Health Inc.: Form 10-K for the period ended Dec 31, 2025

The Company

Cosmos Health Inc. was incorporated in 2009 in Nevada and is a diversified, vertically integrated global healthcare group, owner of proprietary pharmaceutical and nutraceutical brands, generics, manufacturer and distributor of healthcare products, engaged in research & development of innovative medicines and repurposing drugs as well as operator of a telehealth platform.

As a global company we are harnessing our expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern pharmaceutical and nutraceutical products.

Our Markets

We operate in the healthcare sector and particularly in the Pharmaceutical and Nutraceutical businesses. We cover vertically several process phases within the abovementioned sectors, such as research & development, manufacturing, marketing, sales and distribution of products and services. More specifically, we operate in generic medicines, nutraceuticals, biocides, medical devices, novel oncology drugs, drug repurposing and telehealth services.

Generic medicines are the pharmaceutical and therapeutic equivalents of branded pharmaceutical products and are generally marketed under their generic (chemical) names rather than by brand names. Typically, a generic drug may not be marketed until the expiration of applicable patent(s) on the corresponding branded product, unless a resolution of patent litigation results in an earlier opportunity to enter the market. Generic drugs are the same as branded products in dosage form, safety, efficacy, route of administration, quality, performance characteristics and intended use, but they are sold generally at prices below those of the corresponding branded products. Generic drugs provide a cost-effective alternative for consumers, while maintaining the same high quality, efficacy, safety profile, purity and stability of the branded product.

The Company also conducts its business within the global nutraceuticals market with our own brand which we consider to be highly qualitative and competitive. Nutraceuticals are defined as products that contain at least one dietary ingredient within them and can be consumed orally. Some of the purposes of nutraceuticals are used for immune system defense, energy, stress, bones and joints.

According to a study published by Towards Healthcare, the global generic drugs market was valued at $424.98 billion in 2025 and is projected to reach $874.63 billion by 2033, representing a Compound Annual Growth Rate (CAGR) of 8.35% throughout the forecasted period. The rise in patent expiration, increasing demand for cost-effective and efficient medicines and less complex approval process for generics drive the market growth.

The global nutraceuticals market size was valued at USD 591.15 billion in 2024, grew to USD 636.31 billion in 2025, and is projected to reach approximately USD 1,234 billion by 2034, expanding at a CAGR of 7.64% between 2025 and 2034 (Towards Healthcare, Nutraceuticals Market Projected to Hit USD 1,234.34 Billion by 2034, Preventive Health Trends Propel Global Demand, GlobeNewswire, October 30, 2025). This growth reflects a sustained and growing consumer interest in products that promote wellness and help prevent illness. This shift toward preventive health is a key driver of increasing market demand.

According to the Towards Healthcare study, the global obesity & weight management market size is calculated at USD 163.13 billion in 2025 and is expected to be worth USD 362.1 billion by 2034, expanding at a CAGR of 8.3% from 2024 to 2034, driven by the increasing prevalence of obesity and its associated health risks, including diabetes, hypertension, and orthopedic conditions.

According to Future Market Insights, the global hospital disinfectant products and services market size is expected to reach $75.6 billion in value by 2033. This reflects a compound annual growth rate (CAGR) of 7.7% during the forecast period, with the EU and UK market playing a significant role.

The global oncology drugs market size was valued at USD 256.46 billion in 2025 and is projected to grow from USD 286.36 billion in 2026 to USD 697.59 billion by 2034, exhibiting a CAGR of 11.77% during the forecast period (Fortune Business Insights, Oncology Drugs Market Size, Share & Growth Forecast, 2025). This growth is primarily driven by the increasing prevalence of cancer globally, continuous advancements in targeted therapies and immunotherapies, and a strong pipeline of innovative drug launches.

The global drug repurposing market size is anticipated to reach USD 30.1 billion by 2028, up from USD 24.5 billion in 2021, reflecting a CAGR of 2.9% over the 2022-2028 period. Drug repurposing, often referred to as re-profiling, is the process of identifying new therapeutic applications for approved and marketed drugs that have already been through safety and efficacy testing and has emerged as a key strategy by the vast majority of pharmaceutical and biopharmaceutical companies to fuel significant business expansion. Notably, between 2007 and 2009, 30-40% of all biologics approved in the U.S. were either repurposed or repositioned drugs.

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Growth Strategy

Our main strategy initiative is focused on continuing our progress in becoming a global healthcare company through the development of a lean, efficient and vertically integrated operating model, as well as, to expand our portfolio of our own branded nutraceutical and pharmaceutical products, grow our customer base and achieve our growth stabilization in this new market and gain an adequate size in the global pharmaceutical market. We are committed to serving our customers while continuing to innovate and provide products that make a difference in the lives of individuals. We strive to maximize our shareholders’ value by adapting to market realities and customer needs. Our strategy involves the enhancement of our manufacturing capacities and building a multinational network or wholesalers, distributors, and pharmacies and simultaneously continuing to expand the portfolio of innovative products that we distribute to that network.

We are committed to driving organic growth at attractive margins by improving execution, optimizing cash flow and leveraging our strong market position, while maintaining a streamlined cost structure throughout each of our businesses. We continue to further align our organization to our customers’ needs in a more seamless and unified way, while supporting corporate strategy and accelerating growth.

In 2025, we continued to execute on the core elements of our “Growth Strategy”, which remains as follows:

• High Marking Segments: delivering on our growth areas and high-margin segments, we continued to show strong performance of our key proprietary brands such as Sky Premium Life® (“SPL”), Mediterranation® and C-Sept® / C-Scrub® with launches into new fast growing geographical regions.
• Generic Pharmaceuticals: focusing on our generic medicines’ capital with a view on a global commercial reach, focused portfolio and pipeline footprint, we continued to optimize our generics business and build a strong pipeline that will allow us to leverage our assets, know-how and sales network.
• Manufacturing of Pharmaceuticals: directing our manufacturing business by optimizing our production facilities and establishing a global footprint in the pharmaceutical fields of contract manufacturing organization (CMO) and contract development and manufacturing organization (CDMO).
• Global Networks, leveraging our extensive global network to access new markets and business segments, amplifying our reach and impact. We aim to expand and consort our sales distribution networks of our proprietary brands through strategic agreements in new regions and territories, such as the UAE and other GCC countries, Eastern Europe etc., while strengthening our market share in core markets.
• Corporate Reorganization: through vertical integration and efficiency, a corporate reorganization is underway to streamline costs and enhance asset and resource utilization through the integration of business units. A key component of this plan is to achieve operational efficiencies and economies of scale through organic growth and a cost optimization initiative aimed at significantly reducing recurring operating expenses and while maintaining the Company's growth outlook.
• Innovation: stepping up innovation through taken steps to deliver innovative products pipeline, by accelerating our R&D efforts on IP-driven products such as the CCX0722 obesity and weight management pill, CCDL24 an innovative treatment for gastrointestinal disorders, CNS, Prostate, Ovarian and Colorectal cancer treatments. Finally, our recently acquired AI-driven drug repurposing platform “Cloudscreen®”, aims to address major health challenges in various treatment areas.

We have made several strategic acquisitions of companies, products and technologies to complement our internal growth and expertise. These acquisitions have strengthened our core product technology infrastructure by providing additional manufacturing, marketing, and research and development capabilities, including the ability to manufacture our products, other product components and services.

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Product Portfolio

Our product portfolio includes generics and over-the-counter (“OTC”) pharmaceutical products, innovative medicines, as well as nutraceuticals and biocides. This structure enables strong alignment and integration between manufacturing, operations, commercial regions, research & development and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas and physical wellbeing.

Generic Medicines:

Generic medicines are the chemical and therapeutic equivalents of originator medicines and are typically more affordable in comparison to the originator’s products. Generic medicines are required to meet similar governmental requirements as their brand-name equivalents, such as those relating to current Good Manufacturing Practices (“GMP”), manufacturing processes and health authorities’ inspections, and must receive regulatory approval prior to their sale in any given country. Generic medicines may be manufactured and marketed if relevant patents on their brand-name equivalents (and any additional government-mandated market exclusivity periods) have expired.

We develop, manufacture and sell generic medicines in a variety of dosage forms, including tablets, capsules, liquids, ointments and creams.

Our portfolio of generic medicines includes: 1) ASTO-CHOL (Pravastatin); 2) Diorium (Omeprazole); 3) HEART-FREE (Clopidogrel); 4) the LIPICHOL (Atorvastatin); 5) Miltus (Donepezil); 6) Newzypra (Olanzapine); 7) the PNEUMO-KAST (Montelukast); 8) Sahar (Pioglitazone); 9) VIVALCID (Leucovorin); and 10) the Diabit-is (Sitagliptin). The table below presents all the generics, the medication uses purpose and the active ingredient of each product:

Nutraceuticals

Nutraceuticals is referring to a broad range of products derived from food sources that provide health benefits in addition to their basic nutritional value. While nutraceuticals are not classified as drugs, they are often used for their therapeutic effects in a manner similar to pharmaceuticals.

Our proprietary nutraceutical brands are Sky Premium Life® (“SPL”) and Mediterranation®. Our portfolio currently includes around 165 SKUs and more specifically product codes such as Vitamins and Minerals, Amino Acids, Botanical and other Herbal extracts used for health prevention and care needs.

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Our products are classified into two main categories, “Products per Benefit” and “Products per Nutrient” as follows:

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Biocides

Our proprietary portfolio of branded biocides and antiseptic soaps comprises of our brands C-Sept® and C-Scrub®. The biocide C-Sept Pro 2% has a broad-spectrum antimicrobial formulation that combines 76% Isopropyl Alcohol and 2% chlorhexidine digluconate as active substances. On the other hand, our antiseptic soap, C-Scrub Wash 4% CHG, contains chlorhexidine digluconate as its active antiseptic substance, which is approved by the World Health Organization for human use. The broad antimicrobial spectrum of C-Scrub Wash 4% CHG encompasses Gram-positive and Gram-negative microbes, fungi, and viruses, and its efficacy has been demonstrated in numerous published clinical studies. C-Scrub Wash 4% CHG significantly reduces bacterial load on the skin with long lasting.

Other Pharmaceutical Products:

Our portfolio of other pharmaceutical products includes brands such as:

• Melatonin Spray®;
• Otikon™; and
• Bio-bebe®.

Melatonin Spray®, is recommended for addressing insomnia and jet lag, offering a peaceful sleep. It is manufactured using nanonemulsification technology and primarily contains melatonin, a lipophilic molecule. To increase the absorption of such molecules, nanoemulsification is one of the most effective methods. The absorption of the ingredient increases proportionally with the reduction of the micelle diameter. The diameter of a nanoemulsion micelle ranges between 50 and 300nm.

Otikon™ ear drops, is a class II medical device in the form of ear drops for spray application and contains natural ingredients used to relieve ear pain, remove excess ear wax (cerumen) and improve hearing. The efficacy and safety of Otikon™ ear drops, or naturopathic drops, has been studied in children with ear pain associated with otitis media. Among other ingredients, it contains olive oil, mullein olive oil extract (Verbascum Thapsus), marigold oil extract (Calendula officinalis), St. John’s wort oil extract (Hypericum perforatum) and lavender oil (Lavandula officinalis).

Bio-bebe® is an organic infant care and nutrition brand. All product lines are made exclusively of 100% organic, high-quality ingredients, and are produced with minimal environmental impact. The range includes a variety of baby foods such as organic powder milk, pear, carrot and banana purée, pasta with minced meat, whole grain rice cereals, whole grain cereal porridges and organic rice creams with vanilla milk. Additional brand extensions include baby cosmetics, liquid dish soaps and detergents.

In line with our growth strategy, we are constantly evaluating and optimizing our products portfolio, including through the sale of certain product rights in our operating or entering areas.

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Below is an analysis per category of our inventory as of December 31, 2025:

Business Offerings

Manufacturing

By being licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), we are competent to produce our own pharmaceutical products as well as ramping up revenue generation from manufacturing for third parties. Our facilities can accommodate a wide range of pharmaceuticals products in the form of tablets, capsules, syrups, nasal sprays, creams, gels, ointments and a broad range of other products such as nutraceuticals, cosmetics, biocides, and medical devices.

Full Line Wholesaler

As a full line pharmaceutical wholesaler, we distribute a comprehensive range of pharmaceutical products, including prescription medications, (OTC) drugs, medical devices, food supplements, nutraceuticals, cosmetics and other healthcare products, to various businesses within the healthcare sector such as retail pharmacies, hospitals, private clinics and other wholesale pharmaceutical distributors.

We utilize the latest technology in pharmaceutical storage and retrieval systems to ensure the quality and accuracy of its distribution. Our facility utilizes robotic technologies such as ROWA™ and SSI SCHAEFER A-Frame to automate our processes in the inventory management, procurement, order execution and tracking. Therefore, we achieve a zero-error rate, faster order picking, automated order picking process, higher cost-efficiency. We stay in the forefront of quality assurance and accuracy by investing in the most innovative machinery and software available to pharmaceutical distributors.

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Telehealth services

We provide telehealth services through ZipDoctor, which is a direct-to-consumer subscription-based telemedicine platform that provides its customers affordable, unlimited, 24/7 access to board certified physicians and licensed mental and behavioural health counsellors and therapists. ZipDoctor’s online telemedicine platform is available to customers across the United States and offers English and Spanish coverage with virtual visits taking place either by telephone or through a secured video chat platform.

Drug Repurposing

Cloudscreen® (Cloudscreen) is a multimodal platform for drug repositioning and repurposing. It integrates both 1D and 3D data types into its AI algorithm, which thoroughly analyzes the druggable proteome and variome, offering accurate predictions for repurposing of existing drugs toward new indications. The platform is accompanied by in vitro validation for both toxicity and effectiveness.

Finding new therapeutic applications for previously researched drugs can offer patients quicker access to novel treatments. Such a strategy not only benefits developers by reducing time and costs but also retains the original IP protection. Especially for high-cost conditions like cancer, exploring anti-cancer potentials in a vast array of off-patent drugs, which have already established their safety profiles, is a powerful tactic preferred by most leading pharmaceutical enterprises.

We have built on promising preclinical discoveries, predictive insights, and simulations generated by Cosmos Health's AI-powered Cloudscreen® drug repurposing platform. Recent in vitro studies have validated the therapeutic potential of a repurposed marketed drug for both indications, with inventors establishing a novel mechanism of action unique to each of the following disease. For instance:

• Multiple sclerosis (MS) is a chronic autoimmune disorder that affects the central nervous system, leading to a broad spectrum of symptoms and potentially significant disability. The global prevalence of MS has shown a sustained upward trend over recent decades, with approximately 2.9 million people currently living with the condition worldwide, reflecting a significant increase from 2.3 million in 2013 (Kapica-Topczewska et al., Multiple Sclerosis: An Ethnically Diverse Disease with Worldwide Equity Challenges Accessing Care, MDPI Brain Sciences, December 2025).
• Gliomas are a diverse group of primary brain and spinal cord tumors originating from glial cells. In oncology, gliomas account for approximately 30% of all central nervous system tumors and about 80% of all malignant brain tumors.
• Hematologic malignancies encompass a diverse group of cancers affecting the blood, bone marrow, and lymphatic system, including leukemia, lymphoma, and multiple myeloma. These diseases account for a significant portion of cancer diagnoses worldwide, with varying incidence rates across different regions.

Our patent application for multiple sclerosis was filed under application number N2039644, while the application pertaining to glioma was submitted under number N2039647. Additionally, a third application, focusing on hematologic malignancies including multiple myeloma was filed under number N2039645. All three applications were officially filed on February 10, 2025.

These advancements build on promising preclinical discoveries, predictive insights, and simulations generated by Cosmos Health's AI-powered Cloudscreen drug repurposing platform. Recent in vitro studies have validated the therapeutic potential of a repurposed marketed drug for both indications, with inventors establishing a novel mechanism of action unique to each cancer type.

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Research & Development

Our R&D activities are focused on novel medicines development activities that are World Intellectual Property Organization (“WIPO”) patented. Specifically, they includes preclinical assessment (including toxicology, pharmacokinetics, pharmacodynamics and pharmacology studies), clinical development (including pharmacology and the design, execution and analysis of global safety and efficacy trials), as well as regulatory strategy to deliver registration of our pipeline products. We develop novel innovative medicines in our core therapeutic and disease focus areas, such as CNS cancer, prostate, ovarian and colorectal cancer, and finally obesity and weight management.

In line with our growth strategy and our focus on internal growth that leverages our R&D capabilities, we have entered, and expect to pursue, in-licensing, acquisition, collaboration, funding and other partnership opportunities to supplement and expand our existing pipeline.

Obesity & Weight Management (CCX0722)

By employing novel amino acid-based cross-linkers, a series of water-absorbent polymeric networks, known as superabsorbent hydrogels (SAHs), our obesity product, CCX0722, has emerged as promising candidates for weight management and obesity. Spatial fillers are hydrophilic biopolymer grids capable of absorbing and retaining large amounts of water or biological fluids. CCX0722 is expected to reduce food intake by increasing satiety and reducing appetite. The product is being optimized in terms of its physicochemical properties and its effects on gut microflora through a series of in vitro studies and simulations

We are currently finalizing the scale-up production phase of CCX0722, paving the way for human clinical trials and targeting a market launch in the third or fourth quarter of 2026. Building on the successful completion of pilot production and previous development milestones, the Company is now actively engaging with contract research organizations (CROs) to complete the technical dossier, and clinical trials are set to be completed between the end of 2025 and the beginning of 2026. This strategic progress marks a critical step in positioning CCX0722 for regulatory submission and potential classification as a class III medical device.

CNS Cancer

We have acquired all rights arising from the patent filed with the WIPO under reference code PCT/EP2023/071865, related to CNS cancer treatment. The patent filing describes the repurposing of an existing drug to act on the Mucosa-associated lymphoid tissue lymphoma translocation protein 1 (MALT1), a key target in various diseases. This innovation proposes the use of the repurposed drug in addressing certain central nervous system (CNS) cancers, hematological cancers, allergic inflammation, and autoimmune diseases. Existing preclinical data are promising for the further development of these findings.

Prostate, Ovarian and Colorectal Cancers

The Company has secured buy-out rights and exclusive licensing for two patented anticancer drugs targeting, among others, prostate, ovarian, and colorectal cancers.

Both of these innovative anticancer therapies, developed through cutting-edge oncology research, are protected by international patents and set to commence Clinical Phase I trials. The first therapy is safeguarded by WIPO patent WO 2017/001439A1 and the second by WIPO patent WO 2018/011414 A1, with a focus on major markets such as the USA, EU, Canada, Japan, China, and Australia.

The innovation on the first novel drug development task provides novel hybrid esters of steroidal lactams and alkylating agents (LSEs, steroids that contain lactam group -NHC=O- into steroid ring/s conjugated with alkylating agents). The compounds are esters of steroidal lactams with derivatives of bis(2-chloroethyl) aminophenoxypropanoic acid. These compounds exhibit: 1. higher antitumor activity, 2. lower acute toxicity in comparison with non-lactam steroid alkylating esters and conventional alkylators.

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Through the important cytotoxic anticancer activity against several human cancer cell lines and tumor systems in vitro and in vivo and their well-tolerated toxicity, these new molecules seems to hold a quite unique multi-targeting profile of biological and pharmacological effects on tumor cells, fairly different of the conventional and currently used anticancer drugs.

With regard to the status of the studies, they have been conducted for the lead molecules: in silico studies, in vitro and in vivo evaluation, in 38 human cancer cell lines and in 14 human cancer xenograft models, optimized drug synthesis, acute toxicity evaluation in mice, primary pharmacokinetic (PK) study in mice.

On the other hand, novel pharmacologically active 1,2,4-triazolo-[3,4-b]-1,3,4-thiadiazole derivatives (TADs) were prepared and tested in vitro and in vivo for multi-targeted anticancer activity. TADs demonstrated: (1) High cytostatic and cytotoxic activity against human cancer cell lines, in vitro. (2) High antitumor effects against human tumor xenografts in vivo. (3) Well tolerated systemic toxicity and relatively low acute toxicities, in vivo. (3) High effectiveness against cancer cells resistant to chemotherapeutics as, platinum complexes (cisplatin, carboplatin, oxaliplatin), doxorubicin, irinotecan, paclitaxel). (4) High activity against colon and pancreatic cancer cells that bear K-RAS and/or TP53 mutations. (5) High effectiveness against hormone refractory prostate cancer. (6) High effectiveness against hormone-therapy resistant breast cancer. (7) They induce strong inhibition of phosphorylation and activity of Topoisomerase IIa. (8) They induce strong inhibition of PI3K-AKT-mTOR signal transduction cellular pathway. (9) High activity against tumors that bear KRAS, BRAF, MEK1, PIK3CA mutations. (10) Very high effectiveness against cancer tumors that present defective mismatch repair system (dMMR) with high microsatellite instability (MSI-H). (11) They significantly enhance microsatellite instability in MSI-H cancer cells, as well as in MSI stable (MSS) cancer cells. (12) They trigger the expression of PDL-1 on cancer cells, inducing a dose dependent increment of 80-100% in 2-4 days after treatment. In silico computational and primary in vitro and in vivo studies confirm that TADs act as multi-targeted agents with a novel panel of pharmacological activity.

Studies have been conducted for the lead molecules: In Silico studies, in Vitro and in vivo evaluation (in 28 human cancer cell lines and in 10 human cancer xenograft models), Optimized drug synthesis, Acute toxicity evaluation in mice.

Product Insurance

We maintain insurance coverage for our warehouses and inventory against risks such as damage or theft. However, we do not insure products after the point of sale, as transactions are conducted under an Ex-Works (EXW) basis, whereby customers assume responsibility for transportation and any associated risks, including insurance coverage. Looking ahead, we will continue to reassess this approach and may consider obtaining product liability insurance to mitigate part or all of our exposure to product-related risks.

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Customers

Through our subsidiaries, we primarily sell pharmaceutical products directly to pharmacies and a limited number of large wholesale drug distributors who, in turn, supply-sell the products to other wholesalers, hospitals, pharmacies, and governmental agencies across the European Union member state. No customer accounted for 10% or more of our total consolidated revenues during the years ended December 31, 2025 and 2024.

We have a diverse customer base that includes wholesalers and retail healthcare providers. We make a significant amount of our sales to a relatively small number of pharmaceutical wholesalers. These customers represent an essential part of the distribution chain of our products. Pharmaceutical wholesalers have undergone, and are continuing to undergo, significant consolidation on a worldwide basis. This consolidation resulted in these groups gaining additional purchasing leverage and consequently increasing the product pricing pressures facing our business.

Geographic Markets

The majority of our revenues are generated from operations in the European Union and UK, with growing contributions from the UAE and North America, all earned outside of the U.S. during 2025 and with initial US operations commencing in 2026. All of our foreign operations are subject to risks inherent in conducting business abroad, including price and currency exchange controls, fluctuations in the relative values of currencies, political and economic instability and restrictive governmental actions. Our geographical market sales distribution of our total consolidated revenues during the years ended December 31, 2025 and 2024 are as follows:

Competition

Our pharmaceutical businesses are conducted in intensely competitive and often highly regulated markets. Many of our trading of pharmaceutical products face competition in the form of branded or generic drugs that treat similar diseases or indications. The principal forms of competition include efficacy, safety, ease of use, and cost effectiveness. The means of competition vary across product categories and business groups, demonstrating that the value of our trading products is a critical factor for success in all of our principal businesses.

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Our competitors include other pharmaceutical companies, and smaller companies with generic drug and consumer healthcare products. We compete with other companies that manufacture and sell products that treat diseases or indications similar to those treated by our trading pharmaceutical products.

Our competitive position in pharmaceutical sector is affected by several factors including among others, the amount and effectiveness of our and our competitors’ promotional resources, customer acceptance, product quality, our and our competitors’ introduction of new products, ingredients, claims, dosage forms, or other forms of innovation, and pricing, regulatory and legislative matters (such as product labeling, patient access and prescription).

The branded pharmaceutical industry is highly competitive. Our products compete with products manufactured by many other companies in highly competitive markets throughout the EU territory and internationally as well. Competitors include many of the major brand name and generic manufacturers of pharmaceutical products. If competitors introduce new products, delivery systems or processes with therapeutic or cost advantages, our products can be subject to progressive price reductions or decreased volume of sales, or both.

In the generic pharmaceutical market, we might face intense competition from other generic drug manufacturers, brand name pharmaceutical companies, existing brand equivalents and manufacturers of therapeutically similar drugs.

By specializing in high barrier to entry products, we endeavor to market more profitable and longer-lived products relative to commodity generic products. We believe that our competitive advantages include our integrated team-based approach to product development that combines our formulation, regulatory, legal and commercial capabilities; our ability to introduce new generic equivalents for brand-name drugs; our ability to meet customer expectations; and the breadth of our existing generic product portfolio offering.

Newly introduced generic products with limited or no other generic competition typically garner higher prices. At the expiration of the exclusivity period, other generic distributors may enter the market, resulting in a significant price decline for the drug. Consequently, the maintenance of profitable operations in generic pharmaceuticals depends, in part, on our ability to select, develop and launch new generic products in a timely and cost-efficient manner and to maintain efficient, high quality business capabilities.

We compete in the nutritional industry with our own branded nutraceutical products against companies that sell through retail stores, as well as against other direct selling companies. We compete against manufacturers and retailers of nutraceutical products which are distributed through supermarkets, drug stores, health food stores, vitamin outlets and mass market retailers, among others. We believe that the principal components of competition in nutraceutical products are expertise and service, high product quality, diversification and differentiation, price and brand recognition.

Operating conditions have become more challenging under the mounting global pressures of competition, industry regulation and cost containment. We continue to take measures to evaluate, adapt and improve our organization and business practices to better meet customer and public needs. We also seek to continually enhance the organizational effectiveness of all of our functions, including efforts to accurately and ethically launch and promote our products.

Information Systems

Our wholesale operations are managed through a primary enterprise resource planning (“ERP”) system, which supports key functions including electronic order entry by customers, invoice processing, purchasing, and inventory tracking. Our Greek subsidiaries—SkyPharm S., Cosmofarm S.A., and Cana S.A.—operate on separate ERP systems. In addition, our UK subsidiary and our U.S. parent company each utilize their own distinct ERP platforms.

We are in the process of implementing a centralized platform that will consolidate data from all these systems to ensure accurate and efficient financial reporting across the group. We aim to finalize this implementation by the end of 2026. This system integration is intended to strengthen data accuracy, streamline consolidation processes, and support timely reporting in accordance with applicable regulatory requirements.

Additionally, we are improving our entity-wide infrastructure to enhance efficiency, capabilities, and speed to market. We continue to invest in advanced information systems and automated warehouse technology. For example, to comply with future pedigree and other supply chain custody requirements, we have made significant investments in secure supply chain information systems.

The Company processes a substantial portion of its purchase orders, invoices, and payments electronically and continues to invest in expanding its electronic interface with suppliers. The Company has also integrated warehouse operating systems to manage the majority of transactional volume. These systems have improved distribution productivity and operating leverage.

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Government Regulations

Government authorities in the EU and in other countries extensively regulate, among other things, the research, development, testing, approval, manufacturing, labeling, post-approval monitoring and reporting, packaging, advertising and promotion, storage, distribution, marketing and export and import of pharmaceutical products. As such, our branded pharmaceutical products and the generic product candidates are subject to extensive regulation both before and after approval. The process of obtaining regulatory approvals and the subsequent compliance with applicable state, local and foreign statutes and regulations require the expenditure of substantial time and financial resources. Failure to comply with these regulations could result in, among other things, warning letters, civil penalties, delays in approving or refusal to approve a pharmaceutical product.

A major part of our business relates to the trading of branded and generic pharmaceutical products and medicines within the EU member states. In order to be able to operate our business, we need to comply with EU regulations, as well as EU member states regulations that govern various operations of our business. The Greek government regulation that applies to our business requires the granting to our operating subsidiaries of the Authorization for Wholesale Distribution of Medicinal Products for human use. In order for this Authorization to be granted, the companies need to always comply with certain Good Distribution Practices (“GDP”) that mainly assure the proper storage, handling, distribution and trade of the pharmaceutical products.

On July 22, 2015, the National Medicines Agency in Greece approved the license of wholesale sale of pharmaceutical products under the name SkyPharm SA with set validity at five years and an expiration date of July 22, 2020. Subsequently, on June 15, 2020, SkyPharm legally and timely submitted the application for renewal of the wholesale license of pharmaceutical products to the National Medicines Agency. The National Medicines Agency did not respond, therefore the Company asked for an immediate decision on the renewal. Two months after the filing of the no. 3459 / 15.01.2021 letter and almost nine months after the no. 627615.06.2020 company application for the renewal, the National Medicines Agency replied by rejecting the renewal request on March 9, 2021 (ref. 62769 / 20-25.02.2021). In addition, document No. 127351-16.12.2021 of EOF (Greek National Medicines Organization) to SkyPharm states that after an inspection of EOF at the premises of Doc Pharma, we did not have a wholesale license in violation of article 106 par. 1b and par. 1c of the ministerial decision D.YG3a / GP.32221 / 29-4-2019. The National Medicines Agency imposed a fine of €15,000 ($16,225) on SkyPharm for the above case, which was included in “General and administrative” expense on the accompany statement of operations and comprehensive loss for the 12-month period ended December 31, 2024.

Decahedron received its Wholesale Distribution Authorization for human use on February 5, 2021, from the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) in accordance with Regulation 18 of the Human Medicines Regulations 2012 (SI 2012/1916) and it is subject to the provisions of those Regulations and the Medicines Act 1971. This License will continue to remain in force from the date of issue by the Licensing Authority unless cancelled, suspended, revoked or varied as to the period of its validity or relinquished by the authorization holder.

Cosmofarm received its Wholesale Distribution Authorization for human use on February 15, 2019, issued by the National Organization for Medicines. The license is valid for a period of five years in accordance with EU Directive 2013/C343/01 and was renewed on February 14, 2024. Furthermore, Cosmofarm was granted a GDP (Good Distribution Practice) certificate on November 11, 2019.

Our subsidiary, Cana SA, is a holder of Good Manufacturing Practices license (GMP), which means that it is certified for fulfilling the minimum standards that a medicines manufacturer must meet in the production processes.

Our subsidiaries are ISO 9001 certified for a management system for the trade and distribution of pharmaceuticals. As part of the certification process by the International Organization for Standardization, we need to be compliant with the General Data Protection Regulation (“GDPR”) adopted by the European Union in May 2018. GDPR applies to the processing of personal data of persons in the EU by a controller or processor.

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Research and Development

The Company entered into a Research & Development agreement with Doc Pharma S.A. on May 17, 2021. Under this agreement, Doc Pharma is responsible for the research, development, design, registration, copy rights and licenses of 250 nutritional supplements for the final products called Sky Premium Life®. More specifically, Doc Pharma is responsible for the product development and the Company has added 165 of such products codes in its portfolio as of December 31, 2025. The licenses purchased by Doc Pharma SA are capitalized and included in “Goodwill and intangible assets, net” of the Company’s Consolidated Balance Sheets as of December 31, 2025. Thus, no relevant R&D expense had been charged to the Company’s Consolidated Statements of Operations and Comprehensive Loss, concerning this agreement.

On June 25, 2022, the Company signed a research and development (“R&D”) agreement with a third party (CloudPharm PC), through which the Company assigned to the third party the development of new products and services in the field of health, focusing on the human intestinal microbiome. The project includes two phases. Phase 1 has a 20-month duration and its cost amounts to EUR 758,000 ($838,450) and phase 2, has a 22-month duration and a cost of EUR 820,000 ($907,084). The amount will be due and payable upon completion of the corresponding phases. The Company records the corresponding R&D expense based on the project’s progress, which is invoiced by the third party in the relevant period. For the 12-month periods ended December 31, 2025 and 2024, the Company incurred $22,996 and $0 of such costs respectively included in “Research and Development costs” in the Company’s Consolidated Statements of Operations and Comprehensive Loss.

On January 23, 2024, the Company completed the acquisition of Cloudscreen, a cutting-edge Artificial Intelligence (AI) powered platform. The acquisition is pursuant to a purchase agreement announced on October 11, 2023. Cloudscreen is a multimodal platform specialized in drug repurposing, a process that involves uncovering new target proteins or indications for existing drugs for use in treating different diseases. The total purchase price amounted to $637,080 incorporating both cash and stock consideration. The platform is included in “Goodwill and intangible assets, net” in the Company’s Consolidated Balance Sheets.

On December 3, 2024, the Company entered into a Research Study Agreement with the National Hellenic Research Foundation (“NHRF” or the “Contractor”) for an in vitro study supporting modifications to an existing invention. This study is conducted under a prior agreement between the Company, NHRF, and CloudPharm PC, originally signed on June 15, 2022. Under the agreement, while conducting the study, NHRF will ensure scientific rigor, provide periodic updates, and maintain confidentiality. Cosmos Health will supply the necessary documentation and support to the research. Ownership of the research protocol is shared among CloudPharm PC, NHRF and Cosmos Health, while NHRF retains control over its methodologies. NHRF is prohibited from publishing findings without Cosmos Health’s approval or using the study for any other purpose. The total contract value is €60,000 plus VAT, payable in three installments. For the 12-month period ended December 31, 2025, the Company incurred €45,000 ($50,052) in costs related to this agreement, which were recorded under “Research and Development costs” in the Company’s Consolidated Statements of Operations and Comprehensive Loss.

On December 6, 2024, the Company signed an Independent Contractor Agreement with a third-party contractor (the “Contractor”). The Contractor will provide oncology research and development services exclusively to the Company. The contract lasts three years (December 5, 2024 – December 5, 2027) and may be extended by mutual agreement. The Company may terminate the contract immediately for specific causes, including felony conviction, fraud, or loss of medical license. Either party may terminate the contract with a 30-day written notice. Certain compensation obligations will remain effective after termination. The monthly consideration to be paid to the Contractor is based on the commencement of the Clinical Trials (as defined in the agreement) and New Drugs Applications (as defined in the agreement) and additional cash and stock consideration is payable based on certain milestones. None of the milestones were met as of December 31, 2025, and thus the Company has incurred no expenses as of the end of the period.

On December 31, 2024, the Company signed an agreement with a related party, DocPharma SA (the “Licensor”), through which the Company obtained a royalty-bearing, exclusive worldwide license to actively commercialize the patents owned by the Licensor, through research and preclinical and clinical trials for the useful life of the patents, or for 20 years, whichever is longer. The patents, filed in 2016 and 2017 respectively, cover innovative treatments for cancer. The terms of the agreement include an initial payment of EUR 500,000 due by the end of 2025, followed by fixed annual payments of EUR 350,000 during the five-year Start-Up Term from 2025 to 2030. After the Start-Up Term, the Company will pay a 1.5% royalty on annual net sales of licensed products covered by an issued patent. Moreover, the Company retains an optional buy-out right for a total amount of EUR 7,500,000, which can be exercised with a 60 day-notice and a 60-day close period. The Company also has the right to sublicense the patents. For the 12-month period ended December 31, 2025, the Company incurred EUR 350,000 ($410,760) in royalties concerning this agreement, which were included in “Research and Development costs” in the Company’s Consolidated Statements of Operations and Comprehensive Loss.

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Distribution & Trade Agreements

On November 25, 2021, SkyPharm SA signed a trade agreement with a wholesaler which operates in the storage, distribution, trading and promotion of pharmaceutical products (“Distributor C”). Based on the agreement, Distributor C is appointed as the exclusive representative for the promotion and distribution of our proprietary nutraceutical products Sky Premium Life® in Greece.

During July 2021, the Company’s subsidiary Decahedron Ltd created a distribution page on Amazon UK, through which it sells, advertises and promotes our own proprietary branded nutraceutical product line Sky Premium Life®, directly to final consumers.

On September 22, 2022, the Company entered into a distribution agreement with a third party in order to become the distributor of Monkeypox Virus Real-Time PCR Detection Kits. Cosmos has exclusive distribution rights for Greece and Cyprus, with the opportunity to distribute the test kits across Europe on a non-exclusive basis.

On June 27, 2024, the Company entered into an exclusive distribution agreement (the “Agreement”) with Pharmalink for the distribution of its Sky Premium Life® products in the United Arab Emirates (UAE). Under the Agreement, Pharmalink is responsible for all key functions, including sales and marketing, regulatory affairs, logistics, supply, and distribution of the Sky Premium Life® product line within the UAE. The Company has received an initial purchase order from Pharmalink for 130,000 units and expects to receive orders exceeding 500,000 units during 2026, and more than 3,000,000 units over the next five years. However, as of the filing date, no additional orders have been executed.

On September 28 and October 28, 2025, the Company entered into two separate exclusive distribution agreements for the distribution of its branded nutraceutical products under the “Sky Premium Life” brand in Kuwait and Jordan, respectively. Under the terms of the agreements, the distributors are required to pay 50% of the total order value upon placement of an order, with the remaining 50% payable upon notification by the Company that the order is ready and no later than five (5) days prior to the expected shipment date.

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Employees & Human Capital

As of December 31, 2025, we had a total of 163 full-time employees. Of these, 13 were engaged in sales, 4 in procurement, 47 in warehouse services, 24 in logistics and transportation, 3 in quality assurance, 14 in finance and accounting, 2 in management, 4 in cleaning services, 18 in the call center, 9 in research and development, 24 in administrative support services, and 1 in information technology. None of our employees are represented by labor unions. We consider our employee relations to be good and have not experienced any work stoppages, slowdowns, or other serious labor issues that have materially impeded our business operations.

We have a team with a significant track record in the pharmaceutical business. In order to achieve our strategic objectives, we have, and will remain, focused on hiring and retaining a highly skilled management team that has extensive experience and specific skill sets relating to the sales, selection, development and commercialization of pharmaceutical products. We intend to continue our efforts to build and expand this team as we grow our business. No assurances can be given that the Company will be able to retain any additional persons.

Our human capital resources objectives include, as applicable, identifying, recruiting, retaining, incentivizing and integrating our existing and additional employees. The principal purposes of our equity incentive plans are to attract, retain and motivate selected employees, consultants and directors through the granting of stock-based compensation awards and cash-based performance bonus awards.

Attracting and retaining top talent is an integral part to our success. We intentionally build a workforce of people with viewpoints and backgrounds as diverse as the customers we serve around Europe. As a responsibility to our team and in an evolving effort, we engage employees with meaningful careers and development opportunities to grow and succeed.

Available Information

Our internet address is https://www.cosmoshealthinc.com/. We post links on our website to the following filings as soon as reasonably practicable after they are electronically filed or furnished to the SEC: annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements on Schedule 14D, and any amendment to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended. All such filings are available through our website free of charge. The information on our Internet website is not incorporated by reference into this Form 10-K or our other securities filings and is not a part of such filings.

Information about the operation of the Public Reference Room can be obtained by calling the SEC at 1-800-SEC-0330 or 1-202-551-8090. You can also access our filings through the SEC’s internet address site: www.sec.gov (http://www.sec.gov), under our Nasdaq ticker “COSM”.

The Company is not required to provide the information called for in this item due to its status as a Smaller Reporting Company, however we describe below some of the risks we believe are material to our business. You should carefully consider the following risks in evaluating us and our business. You should also refer to the other information set forth in this report, including the information set forth in “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” as well as in our consolidated financial statements and the related notes. Our business prospects, financial condition or results of operations could be adversely affected by any of the following risks.

Regulatory and Litigation Risks

Laws and regulations regarding our business may prohibit or restrict our ability to sell our products in some markets or require us to make changes to our business model in some markets. Our products, business practices and manufacturing activities are subject to extensive government regulations and could be subject to additional laws and regulations.

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Taxation and transfer pricing could adversely affect our results of operations and financial condition

We are subject to foreign tax and intercompany pricing laws, including those relating to the flow of funds between our U.S. parent company and our foreign subsidiaries. These pricing laws are designed to ensure that appropriate levels of income and expense are reported by our U.S. and foreign entities, and that they are taxed appropriately. Regulators in the United States and in foreign markets closely monitor our corporate structures, intercompany transactions, and how we effectuate intercompany fund transfers. Our effective tax rate could increase, and our results of operations and financial condition could be materially adversely affected if regulators challenge our corporate structures, transfer pricing methodologies or intercompany transfers. We are eligible to receive foreign tax credits in the United States for certain foreign taxes actually paid abroad. In the event any audits or assessments are concluded adversely to us, we may not be able to offset the consolidated effect of foreign income tax assessments through the use of U.S. foreign tax credits. Because the laws and regulations governing U.S. foreign tax credits are complex and subject to periodic legislative amendment, we may not be able to take advantage of any foreign tax credits in the future. In addition, changes in the amount of our total and foreign source taxable income may also limit our ability to take advantage of foreign tax credits in the future. The various customs, exchange control and transfer pricing laws are continually changing, and are subject to the interpretation of governmental agencies. We collect and remit value-added taxes and sales taxes in jurisdictions and states in which we have determined that nexus exists. Despite our efforts to be aware of and to comply with such laws and changes to the interpretations thereof, we may not be able to continue to operate in compliance with such laws. We may need to adjust our operating procedures in response to these interpretational changes, and such changes could have a material adverse effect on our results of operations and financial condition.

Changes in consumer behavior

Consumer behavior in recent years shows an increasing trend in the health-medicines sector, especially during the period of health crisis. It is observed that shopping habits and consumer behavior in general have changed since the coronavirus pandemic. The coronavirus pandemic and the responses thereto around the world could adversely impact our business and operating results. Consumers have turned to basic necessities and digital channels and e-commerce while physical networks are underperforming.

Management of further developments

In recent years, the Company has been steadily increasing its turnover, while expanding its range of products and its own branded nutraceutical products, has acquired the latest technology drug storage systems to ensure quality and accuracy (zero error rates) in their distribution. The further increase of the Company’s operations may lead, among other things, to increased capital needs, new investments in equipment and information systems, and requirements for capacity building. Failure to raise new capital will have a significant impact on the non-implementation of the required investments necessary to increase sales. Under these conditions, the growth of the Company’s activity, its financial results and its financial situation will be negatively affected.

Currency exchange rate fluctuations could adversely affect our results of operation and financial condition

In 2025, we recognized more than 98% of our net sales in markets outside the United States, while we commenced initial sales in the US through our Sky Premium Life nutraceutical brand, with the majority of revenues still generated outside the US., the majority of which were recognized in each market’s respective local currency. We purchase inventory from companies in foreign markets, some of them in U.S. dollars. In preparing our financial statements, we translate net sales and expenses in foreign countries from their local currencies into U.S. dollars using average annual exchange rates. Because our sales are in foreign countries, exchange rate fluctuations may have a significant effect on net sales and earnings. Our reported earnings have been significantly affected by fluctuations in currency exchange rates, with net sales and earnings generally increasing with a weaker U.S. dollar and decreasing with a strengthening U.S. dollar.

Geopolitical issues, conflicts and other global events could adversely affect our results of operations and financial condition

Because our business is conducted outside of the United States, it is subject to global political issues and conflicts such as the current war in the Ukraine or the conflict in the Middle East. Such political issues and conflicts could have a material adverse effect on our results of operations and financial condition if they escalate in areas in which we do business. In addition, changes in and adverse actions by governments in foreign markets in which we do business could have a material adverse effect on our results of operations and financial condition.

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Climate change and related legislation or regulations may adversely impact our business, including potential financial, operational and physical impacts.

The nature of our business has not required any material capital expenditures to comply with federal, state or local provisions enacted or adopted regulating the discharge of materials into the environment. No material capital expenditures to meet such provisions are anticipated. Such regulatory provisions did not have a material effect upon our results of operations or competitive position during the year ended December 31, 2025.

Cybersecurity risks and the failure to maintain the integrity of data could expose us to data loss, litigation and liability, which could adversely affect our results of operations and financial condition.

We collect and retain large volumes of data from employees and independent consultants, including credit card numbers and other personally identifiable information, for business purposes, including transactional and promotional purposes. Our various information technology systems enter, process, summarize and report such data. The integrity and protection of this data are critical to our business. We are subject to significant security and privacy regulations, as well as requirements imposed by the credit card industry. Similarly, a failure to adhere to the payment card industry’s data security standards could cause us to incur penalties from payment card associations, termination of our ability to accept credit or debit card payments, litigation and adverse publicity, any of which could have a material adverse effect on our business and financial condition. Maintaining compliance with these evolving regulations and requirements could be difficult and may increase costs. In addition, a penetrated or compromised data system or the intentional, inadvertent, or negligent release or disclosure of data could result in theft, loss or fraudulent or unlawful use of company, employee, consultant or guest data which could adversely affect our reputation, disrupt our operations, or result in remedial and other costs, fines or lawsuits, which could have a material adverse effect on our results of operations and financial condition. Although we take measures to protect the security, integrity and confidentiality of our data systems, we experience cyber-attacks of varying degrees and types on a regular basis. Our infrastructure may be vulnerable to these attacks, and in some cases, it could take time to discover them. Breaches of our data systems, or those of our vendors, whether from circumvention of security systems, denial-of-service attacks or other cyber-attacks, hacking, “phishing” attacks, computer viruses, ransomware or malware, employee or insider error, malfeasance, social engineering, vendor software supply chain compromises, physical breaches or other actions, could result in material interruptions or malfunctions in our or such vendors’ websites, applications, data processing, or disruption of other business operations. For various reasons or circumstances, our employees may work remotely from time to time. Additionally, outside parties may attempt to fraudulently induce employees, users, or customers to disclose sensitive information to gain access to our data or our users’ or customers’ data. Any such breach or unauthorized access could result in unauthorized disclosure, misuse or loss of sensitive information and lead to significant legal and financial exposure, regulatory inquiries or investigations, loss of confidence by our sales force, disruption of our operations and damage to our reputation. These risks are heightened as we work with third-party partners and as our sales force uses social media, as the partners and social media platforms could be vulnerable to the same types of breaches.

We may be required to expend significant capital and other resources to protect against and remedy any potential or existing security breaches and their consequences. A cyber-attack could also lead to litigation, fines, other remedial action, heightened regulatory scrutiny and diminished customer confidence. In addition, our remediation efforts may not be successful, and we may not have adequate insurance to cover these losses. The unavailability of the information systems or the failure of these systems to perform as anticipated for any reason could disrupt our business and could have a material adverse effect on our business, results of operations, cash flows and financial condition. Moreover, cyber-attacks against the Ukrainian government and other countries in the region have been reported in connection with the recent conflicts between Russia and Ukraine and in the Middle East, including Iran. To the extent such attacks have collateral effects on global critical infrastructure, financial institutions or us, such developments could adversely affect our business, operating results and financial condition. At this time, it is difficult to assess the likelihood of such threat and any potential impact at this time.

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Inflation and rising interest rates in the EU

In December 2025, the annual inflation rate in the European Union was approximately 2.3%, reflecting a continued moderation compared to the elevated inflation levels observed in prior years. The annual average change in the Harmonized Index of Consumer Prices (HICP) in the EU during the ten-year period from 2016 to 2025 was approximately 2.6%.

Inflationary pressures in recent years have adversely affected our business due to higher costs for raw materials, increased transportation expenses, and higher overall operating costs. Although inflation has moderated during 2024 and 2025, cost levels across several categories remain elevated compared to historical averages.

In addition, the significant increase in global benchmark interest rates in recent years has adversely affected our business, as substantially all of our loan facilities carry floating interest rates, which may result in increased financing costs and higher cash outflows. During 2025, we observed a modest decline in floating benchmark rates following monetary policy easing by major central banks, including the Federal Reserve and the European Central Bank. However, interest rates remain, on average, higher than levels observed during most periods prior to the recent tightening cycle, which may continue to result in higher financing costs for the Company.

Inflation Reduction Act of 2022 in the U.S.

The U.S. Inflation Reduction Act of 2022 (the “IRA”), includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025 (now effective), thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the U.S. Department of Health and Human Services (HHS) rebate rule that would have limited the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one rare disease designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it may not qualify for the orphan drug exemption. Although we currently have limited sales in the United States, the effects of the IRA, including any regulatory action by the Trump Administration pertaining to the IRA, on any future business of ours and the healthcare industry in general is not yet known.

Most-Favoured-Nation (MFN) Pricing and Section 232 Tariffs

The U.S. Inflation Reduction Act of 2022 (the "IRA"), includes several provisions that may impact our business to varying degrees, including provisions that reduce the out-of-pocket spending cap for Medicare Part D beneficiaries from $7,050 to $2,000 starting in 2025 (now effective), thereby effectively eliminating the coverage gap; impose new manufacturer financial liability on certain drugs under Medicare Part D, allow the U.S. government to negotiate Medicare Part B and Part D price caps for certain high-cost drugs and biologics without generic or biosimilar competition; require companies to pay rebates to Medicare for certain drug prices that increase faster than inflation; and delay until January 1, 2032 the implementation of the U.S. Department of Health and Human Services (HHS) rebate rule that would have limited the fees that pharmacy benefit managers can charge. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one rare disease designation and for which the only approved indication is for that disease or condition. If a product receives multiple rare disease designations or has multiple approved indications, it may not qualify for the orphan drug exemption. The administration has also pursued Most-Favoured-Nation (MFN) pricing agreements, which seek to tie U.S. drug prices to the lowest prices paid by other developed nations. If implemented, MFN pricing could significantly reduce the prices we are able to charge for our products in the U.S. market, which could have a material adverse effect on our revenues and results of operations. Additionally, based on a Commerce Department investigation into national security risks arising from reliance on foreign-manufactured drugs, the administration is applying Section 232 of the Trade Expansion Act of 1962 to impose tariffs on pharmaceutical imports beginning in 2026. These tariffs could increase our cost of goods and disrupt our supply chain. We are continuing to monitor these developments and assess their potential impact on our business, financial condition, and results of operations.

Development, regulatory approval & marketing of products

The discovery and development of drugs, vaccines and biological products are time consuming, costly and unpredictable. The outcome is inherently uncertain and involves a high degree of risk due to the following factors, among others:

• The process from early discovery to design and adequate implementation of clinical trials to regulatory approval can take many years and have high costs.
• We may have difficulties recruiting and enrolling patients for clinical trials on a consistent basis.
• Product candidates can and do fail at any stage of the process, including as the result of unfavorable pre-clinical and clinical trial results, or unfavorable new pre-clinical or clinical data and further analyses of existing pre-clinical or clinical data, including results that may not support further clinical development of the product candidate or indication.
• We may need to amend our clinical trial protocols or conduct additional clinical trials under certain circumstances, for example, to further assess appropriate dosage or collect additional safety data.
• We may not be able to meet anticipated pre-clinical or clinical endpoints, commencement and/or completion dates for our pre-clinical or clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates.
• We may not be able to successfully address all the comments received from regulatory authorities such as the FDA and the EMA, or be able to obtain approval for new products and indications from regulators.

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Regulatory approvals of our products depend on myriad factors, including regulatory determinations as to the product’s safety and efficacy. In the context of public health emergencies like the COVID-19 pandemic, regulators evaluate various factors and criteria to potentially allow for marketing authorization on an emergency or conditional basis.

Additionally, clinical trial and other product data are subject to differing interpretations and assessments by regulatory authorities. As a result of regulatory interpretations and assessments or other developments that may occur during the review process, or even after a product is authorized or approved for marketing, a product’s commercial potential could be adversely affected by potential emerging concerns or regulatory decisions regarding or impacting the scope of indicated patient populations, labeling or marketing, manufacturing processes, safety issues and/or other matters, including decisions relating to emerging developments regarding potential product impurities. Finally, certain of our products have received and may in the future receive approvals under accelerated approval pathways where continued approval may be contingent upon confirmatory studies demonstrating the anticipated clinical benefit and/or safety profile.

The Company’s cybersecurity principles, goals and targets are defined in a policy approved by the Board of Directors (the “Policy”). This Policy is anchored in a risk-based approach based on industry standards to balance the level of cybersecurity against the risks faced by the Company. Material risks are managed by both internal resources and third-party contractors, with cybersecurity risk monitoring integrated into our overall risk management program. The Company believes that effective information security management is necessary for the secured sharing and protection of information within the Company’s cyberspace.

The Policy applies to all directors, officers, employees and contractors of the Company and any parent, holding companies and subsidiaries regardless of their contract terms, who use the Company’s technological devices.

The Board of Directors is responsible for leading the Company to minimize the risk of unauthorized and malicious use, disclosure, potential theft, alteration or damaging effects on the Company’s operations while concurrently enabling the sharing of information in cyberspace. The Board of Directors is committed to ensuring that risks to the confidentiality, integrity or availability of Company-owned information assets are managed appropriately by implementing an information security risk management approach.

The Audit Committee oversees the Policy and its implementation of the Company’s oversight, programs, procedures, and policies related to cybersecurity, cybersecurity risks, information security, and data privacy. Team leads from various departments of the Company have been identified under the Policy to report to the Company’s CFO on annual basis overseeing the cybersecurity strategy as defined in the Policy.

The management team includes members with IT backgrounds and relevant experience to guide our cybersecurity efforts. Management ensures that employees are provided with adequate resources and training to fully understand cybersecurity guidelines and expectations. In the event of a Policy breach, members of the management team may be asked by the IT Department to assist with security investigations. If any member of management is unaware of the best course of action in dealing with an IT-related matter, the manager shall immediately contact the Company’s third-party IT representative. Upon discovering a potential violation of the Policy or a cybersecurity breach, the member of management must document the incident and request the individual surrender possession of any devices that may have suffered a security breach.

Additionally, the Company’s management reports to the Audit Committee on the Company’s and its subsidiaries’ strategies, risks, metrics and operations relating to cybersecurity and information security matters, including significant cybersecurity and information security-related projects and initiatives and related progress, the integration and alignment of such strategy with the Company’s overall business and strategy, and trends that may affect such strategy or operations. We consider cybersecurity, along with other significant risks that we face, within our overall enterprise risk management framework.

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In 2025, we did not identify any cybersecurity threats that have materially affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However, despite our efforts, we cannot eliminate all risks from cybersecurity threats, or provide assurances that we have not experienced an undetected cybersecurity incident.

The Company rents and owns the following corporate offices and facilities:

• The U.S. corporate office is located at 141 W. Jackson Blvd, Suite 4236, Chicago, Illinois 60604. The initial lease commenced in 2015 and has been amended several times since inception. The most recent amendment was executed on March 17, 2025 and extends the lease term through October 31, 2028. The monthly rent is $1,280.
• Our Greece office, as well as the office of SkyPharm S.A., is located at 5 Agiou Georgiou Street, 55438, Pilea, Thessaloniki, Greece. The Company entered into a new three-year lease commencing on October 1, 2024, at a monthly rate of €2,202 ($2,383).
• The offices of Decahedron are located at Unit 14, Spice Green Centre, Flex Meadow, Harlow, CM19 5TR, Essex, United Kingdom. The lease commenced on September 25, 2020, at a monthly rate of £3,500 ($4,473).
• CANA S.A. previously leased corporate office space located at Konstantinoupoleos 19, 14122, Irakleio, Athens, Greece. In late 2025, the company relocated its administrative offices to its wholly owned facility located at Irakleiou Street 443, Neo Irakleio, Athens, Greece, and no longer leases the Konstantinoupoleos premises. The owned facility includes approximately 54,000 square feet of production and administrative space and is licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA) for the manufacture of pharmaceuticals, food supplements, cosmetics, biocides, and medical devices.
• The offices of Cosmofarm are located at Gonata Stylianou 15, Peristeri, Attiki, Greece 12133. The Company purchased this building on April 24, 2023 for a total cash consideration of $1,054,872.

Each of the above facilities is adequate for the Company’s current needs.

We are aware of certain legal proceedings, which are disclosed in Note 15 – Commitments and Contingencies to the financial statements. Other than the matters described therein, we are not aware of any pending legal proceedings to which any of our officers, directors, or beneficial holders of 5% or more of our voting securities are adverse to us or have a material interest adverse to us.

Forward-Looking Statements

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions.

We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain.

Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.

Presentation of Information

As used in this prospectus, the terms “we,” “us” “our” “Cosmos”, “Cosmo Health” and the “Company” mean Cosmos Health Inc. unless the context requires otherwise. The following discussion and analysis should be read in conjunction with our audited (and unaudited) financial statements and the related notes that appear elsewhere in this prospectus. All dollar amounts in this registration statement refer to U.S. dollars unless otherwise indicated.

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Overview

Summary

We are diversified, vertically integrated global healthcare group, owner of proprietary pharmaceutical and nutraceutical brands, generics, manufacturer and distributor of healthcare products, engaged in research & development of innovative medicines and repurposing drugs as well as operator of a telehealth platform. The Company, through its subsidiaries, is operating within the pharmaceutical industry and in order to compete successfully in the healthcare industry, must demonstrate that its products offer medical benefits as well as cost advantages. Currently, most of the products that the Company is trading, compete with other products already on the market in the same therapeutic category, and are subject to potential competition from new products that competitors may introduce in the future.

Revenue sources

Full Line Wholesaler

As a full line pharmaceutical wholesaler, we distribute a comprehensive range of pharmaceutical products, including prescription medications, over-the-counter (OTC) drugs, medical devices, food supplements, nutraceuticals, cosmetics and other healthcare products, to various businesses within the healthcare sector such as retail pharmacies, hospitals, private clinics and other wholesale pharmaceutical distributors.

Branded Pharmaceuticals & Generics

We are engaged in the production, promotion, distribution and sale of licensed branded generics and OTC products throughout Europe by our subsidiaries in Greece and UK. Our capital efficient business model is based on infrastructure, efficiency and scale. We believe that there is a significant growth on opportunities through product additions and geographic expansion.

Healthcare Distribution

We conduct direct distribution and sales of pharmaceuticals, medical devices, branded generics and OTC products. Our automated and GDP licensed distribution facilities ensure all medications reach their destination daily on an efficient and secure way. Our network exceeds over 1,500 pharmacies in Greece. We have created an upgraded and high-end distribution center in Greece due to our Robotic systems and integrated automations (“ROWA” robotics).

Nutraceutical

We have created and developed our own proprietary branded nutraceutical products, named “Sky Premium Life®” which was launched in 2018 and “Mediterranation®” which was launched in 2022. Utilizing unique formulations, and specialized extraction processes which follow strict pharmaceutical standards, our proprietary lines of nutraceuticals aim for excellence. We have a full portfolio of fast-moving and specialty formulas with more than 160 product codes including vitamins, minerals and other herbal extracts. Our nutraceutical products are manufactured exclusively by Doc Pharma. We focus on nutraceutical products because we foresee it as a market with high growth opportunities due to its large market size and margin contribution as the demand for nutraceutical products is increasing globally.

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General Risks

Supply chain disruption is a growing concern for the European pharmaceutical industry as it increasingly looks to cut costs by relying on ‘emerging markets’, where standards can be lower in terms of compliance, ethics and health and safety. Our business depends on the timely supply of materials, services and related products to meet the demands of our customers, which depends in part on the timely delivery of materials and services from suppliers and contract manufacturers. Significant or sudden increases in demand for our products, as well as worldwide demand for the raw materials and services we require to manufacture and sell our products, may result in a shortage of such materials or may cause shipment delays due to transportation interruptions or capacity constraints. Such shortages or delays could adversely impact our suppliers’ ability to meet our demand requirements. Difficulties in obtaining sufficient and timely supply of materials or services can have an adverse impact on our manufacturing operations and our ability to meet customer demand.

We may also experience significant interruptions of our manufacturing operations, delays in our ability to deliver products, increased costs or customer order cancellations as a result of:

• the failure or inability to accurately forecast demand and obtain sufficient quantities of quality raw materials on a cost-effective basis;
• volatility in the availability and cost of materials or services, including rising prices due to inflation;
• difficulties or delays in obtaining required import or export approvals;
• shipment delays due to transportation interruptions or capacity constraints, such as reduced availability of air or ground transport or port closures;
• information technology or infrastructure failures, including those of a third-party supplier or service provider; and
• natural disasters or other events beyond our control (such as earthquakes, utility interruptions, tsunamis, hurricanes, typhoons, floods, storms or extreme weather conditions, fires, regional economic downturns, regional or global health epidemics, geopolitical turmoil, increased trade restrictions between the U.S. and China and other countries, social unrest, political instability, terrorism, or acts of war) in locations where we or our customers or suppliers have manufacturing or other operations.

Hikes in the price of medicine and their impact on the sustainability of the healthcare systems are garnering more and more attention. European regulators are willing to play their part in safeguarding continued access to safe and effective medicines. Regulators can speed up the approval of branded pharmaceuticals and biosimilars to boost competition and drive down prices.

Cuts in healthcare spending have been frequently occurring since the financial crises of the late of 2000’s. Europe’s slow recovery has been uneven, with austerity and economic uncertainty, especially in the EU’s poorer member states, such as Greece.

Results of Operations

Year ended December 31, 2025 versus December 31, 2024

For the year ended December 31, 2025, the Company had a net loss of $19,144,998 on revenue of $65,271,815, versus a net loss of $16,183,018 on revenue of $54,426,402, for the year ended December 31, 2024.

Revenue

For the twelve-month period ended December 31, 2025, the Company's total revenue increased by 19.9%, reaching $65,271,815, compared to $54,426,402 for the prior year period ended December 31, 2024. This growth was primarily driven by the following factors:

• Wholesale Revenue Growth: The revenue increase was largely attributable to our subsidiary Cosmofarm S.A., which experienced higher sales following the expansion into new distribution channels added during 2024 and 2025, contributing to an approximately 15% increase in wholesale revenues. This growth was further supported by higher demand and an expanded customer base during the period.
• Pharmaceutical Manufacturing Expansion: Our pharmaceutical manufacturing subsidiary, CANA S.A., nearly doubled its revenues, growing from approximately $865,000 to approximately $1.7 million in 2025, as the Company continued to realize returns on its investment in the manufacturing facility since the acquisition on June 30, 2023.
• UK Subsidiary Growth: Our UK subsidiary, Decahedron Ltd., significantly increased its revenues from approximately $815,000 to approximately $2.6 million in 2025, primarily driven by expanded Amazon sales of branded nutraceutical products as well as the sale of certain pharmaceutical products into the Greek market.

The combination of these factors contributed to the overall revenue growth for the period. Our future revenue growth will continue to be affected by various factors such as industry growth trends, including drug utilization, the introduction of new innovative brand therapies, the likely increase in the number of generic drugs available over the next few years as a result of the expiration of certain drug patents held by brand-name pharmaceutical manufacturers, price increases and price deflation, general economic conditions in the member states of the European Union, competition within the industry, customer consolidation, changes in pharmaceutical manufacturer pricing and distribution policies and practices, increased downward pressure on government and other third-party reimbursement rates to our customers, and changes in government rules and regulations.

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Cost of Goods Sold

For the year ended December 31, 2025, our cost of goods sold ("COGS") was $57,376,240, representing a 14.5% increase compared to $50,115,079 for the prior fiscal year ended December 31, 2024.

While COGS increased in absolute terms, it grew at a slower pace than revenue (14.5% vs. 19.9%), reflecting a favourable shift in our revenue mix. Specifically, our higher-margin business lines — pharmaceutical manufacturing through CANA S.A. and own-branded nutraceutical sales through Decahedron Ltd. (UK) and SkyPharm S.A. (Greece) — grew at a faster rate than our wholesale operations during the period. This mix shift contributed to meaningful gross margin expansion, with gross margin improving to 12.1% for the year ended December 31, 2025, compared to 7.9% for the year ended December 31, 2024.

Our wholesale subsidiary, Cosmofarm S.A., continues to represent approximately 90% of total revenues and COGS. While wholesale operations are characterized by lower gross margins relative to our manufacturing and own-branded segments, the strong volume growth at Cosmofarm S.A. remains a critical driver of overall revenue scale. As our manufacturing and own-branded nutraceutical segments continue to grow as a proportion of total revenues, we expect this favourable mix shift to continue to positively impact our consolidated gross margins over time.

Gross Profit

For the year ended December 31, 2025, our gross profit was $7,895,575, representing an increase of $3,584,252, or 83.1%, compared to $4,311,323 for the prior fiscal year ended December 31, 2024.

The significant improvement in gross profit was primarily attributable to revenue growing at a faster pace than COGS (19.9% vs. 14.5%), driven by a favourable shift in our revenue mix toward higher-margin business lines. Our pharmaceutical manufacturing subsidiary, CANA S.A., and our own-branded nutraceutical operations conducted through Decahedron Ltd. (UK) and Skypharm S.A. (Greece), grew disproportionately faster than our wholesale segment during the period, contributing to meaningful margin expansion. As a result, gross margin improved to 12.1% for the year ended December 31, 2025, compared to 7.9% for the year ended December 31, 2024.

Operating Expenses

For the year ended December 31, 2025, total operating expenses were $24,599,179, compared to $19,856,153 for the prior fiscal year ended December 31, 2024, representing an increase of $4,743,026, or 23.9%. The change in operating expenses was primarily attributable to the following factors:

General and Administrative Expenses

General and administrative expenses increased by $3,885,923, or 33.1%, to $15,619,160 for the year ended December 31, 2025, compared to $11,733,237 for the prior year. The increase was primarily driven by the following:

• Provisions for doubtful accounts and expected credit losses totalled $5,882,393 in 2025, comprising the following:
• A full allowance of $3,949,085 recorded against the outstanding loan receivable due from Doc Pharma S.A., a related party, reflecting approximately 18 months of non-payment and management's assessment that collectability was uncertain as of year-end (see Note 9 — Related Party Transactions).
• A provision of $1,400,020 recorded against advances made in connection with the Montreal land and building acquisition, representing the portion of the total advances of $2,000,020 for which no repayment had been received as of the filing date. As the Company continues to pursue collection of the full outstanding balance, the advance has been classified as a provision for credit losses.
• The remaining provision of $533,288 relates to allowances established against accounts receivable and prepaid balances where collection or realization was assessed as uncertain.
• Stock-based compensation increased to $2,312,241 from $1,689,712 in the prior year, reflecting higher equity grants to employees and consultants.
• Management bonuses increased to approximately $2.0 million from approximately $615,000 in the prior year, reflecting performance-based compensation awarded to senior management.
• Investor relations expenses increased to approximately $688,000 from approximately $183,000 in the prior year, reflecting the Company's increased efforts in capital markets outreach and shareholder communications.

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Salaries and Wages

Salaries and wages increased by $1,084,842, or 19.1%, to $6,778,278 for the year ended December 31, 2025, compared to $5,693,436 for the prior year. The increase was primarily driven by our pharmaceutical manufacturing subsidiary, CANA S.A., which continued to expand its workforce during the period — hiring both production personnel to strengthen manufacturing capacity and management personnel to support the subsidiary's ongoing growth phase.

Sales and Marketing Expenses

Sales and marketing expenses decreased by $204,729, or 57.7%, to $150,240 for the year ended December 31, 2025, compared to $354,969 for the prior year. The decline reflects a strategic reduction in promotional investment related to the Company's own-branded nutraceutical products during the period.

Research and Development Costs

Research and development costs remained relatively stable at $519,363 for the year ended December 31, 2025, compared to $533,293 for the prior year, a decrease of $13,930, or 2.6%, as no new R&D agreements were entered into during 2025.

Depreciation and Amortization

Depreciation and amortization expense was $1,369,353 for the year ended December 31, 2025, compared to $1,249,238 for the prior year, an increase of $120,115, or 9.6%, remaining broadly consistent with the prior year level.

Impairment Charges

For the year ended December 31, 2025, the Company recorded total impairment charges of $162,785, compared to $291,980 for the prior year. The current year charges related to the following:

• Cosmofarm S.A. e-commerce platform ($90,450): The Company fully impaired the carrying value of an e-shop operated by its wholesale subsidiary, Cosmofarm S.A., which had not generated profits and was deemed no longer recoverable.
• Pharmaceutical licenses ($72,335): The Company recorded an impairment charge on certain pharmaceutical licenses that have not yet been commercially launched and for which no near-term revenue generation is anticipated.

Loss from Operations

As a result of the foregoing, our loss from operations for the year ended December 31, 2025 was $16,703,604, representing an increase of $1,158,774, or 7.5%, compared to a loss from operations of $15,544,830 for the year ended December 31, 2024.

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Other Income (expense), net

For the year ended December 31, 2025, the Company recorded other expense, net of $233,443, compared to other income, net of $86,737 for the year ended December 31, 2024.

The current year expense of $233,443 primarily relates to prior period expense adjustments recorded by our subsidiaries Cosmofarm S.A. and SkyPharm S.A. The prior year other income of $86,737 was primarily attributable to the reversal of a previously recorded adjustment related to cumulative discounted sales to Medihelm S.A., the exclusive distributor of the Company's proprietary line of nutraceutical products, which management determined was no longer required given the significant allowance already recorded and the limited level of new sales activity with Medihelm during that period.

Interest Income & Expenses

For the year ended December 31, 2025, interest expense totalled $1,899,872, representing an increase of $887,558, or 87.7%, compared to $1,012,314 for the prior year ended December 31, 2024. The increase was primarily driven by new debt facilities entered into during 2025, specifically: (i) a bond loan facility with CrediaBank S.A. (formerly Attica Bank S.A., renamed following its merger with Pancreta Bank in 2025) entered into by our wholesale subsidiary, Cosmofarm S.A.; and (ii) the convertible note facilities entered into by Cosmos Health Inc. at the parent company level. For further details on the convertible notes, refer to Note 12 — Convertible Debt in the accompanying consolidated financial statements.

Interest income for the year ended December 31, 2025 was $396,413, remaining relatively stable compared to $406,449 for the prior year ended December 31, 2024, a decrease of $10,036, or 2.5%. The modest decline reflects the ordinary repayment of existing loan receivable balances during the period, with no new loan agreements entered into, and consequently a slight reduction in outstanding balances generating interest income.

Gain on Extinguishment of Debt

For the year ended December 31, 2025, the Company recognized a gain on extinguishment of debt of $68,610, with no comparable amount in the prior year. The gain arose from the debt exchange of the outstanding balance owed under the Promissory Note related to the acquisition of Cloudscreen, an AI-powered drug repurposing platform acquired on January 23, 2024. During 2025, the Company repaid $22,421 of the outstanding balance and converted the remaining balance of $293,400 into shares of common stock pursuant to a debt exchange agreement. The gain represents the difference between the carrying value of the extinguished debt and the fair value of the shares issued in settlement, reflecting the conversion price of $0.65 per share agreed under the exchange agreement compared to the market price of $0.498 per share on the date of the exchange.

Non-Cash Interest Expense

For the year ended December 31, 2025, the Company recorded non-cash interest expense of $722,763, with no comparable amount in the prior year. This amount represents the amortization of debt discounts recorded in connection with the convertible note facilities entered into by the Company during 2025, including the debt discount attributable to the bifurcated derivative liability recognized at issuance. This is a non-cash charge with no impact on the Company's operating cash flows.

Change in Fair Value of Derivative Liability

For the year ended December 31, 2025, the Company recorded a gain on the change in fair value of its derivative liability of $1,525,020, with no comparable amount in the prior year. The derivative liability relates to embedded derivatives identified within the convertible note agreement entered into with ATW Partners in August 2025. The gain reflects the favourable mark-to-market remeasurement of these embedded derivatives as of December 31, 2025. Given that the full-year gain of $1,525,020 compares to a gain of $311,778 recorded through September 30, 2025, the favourable movement accelerated significantly in the fourth quarter of 2025, primarily reflecting changes in the Company's stock price and other valuation inputs used in the fair value measurement.

Gain/(Loss) on Digital Assets

For the year ended December 31, 2025, the Company recorded a net loss on digital assets of $588,916, with no comparable amount in the prior year. During 2025, the Company invested approximately $2,000,000 in digital assets, primarily Ethereum (ETH). The loss reflects the net change in fair value of the Company's digital asset holdings during the period. This item is non-cash in nature to the extent it relates to unrealized fair value movements, and is presented separately given the growing significance of the Company's digital asset strategy.

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Change in Fair Value of Convertible Notes

For the year ended December 31, 2025, the Company recorded a loss on the change in fair value of its convertible notes of $1,347,658, with no comparable amount in the prior year. The Company elected the fair value option for its convertible notes issued during 2025, and accordingly remeasures these instruments at fair value at each reporting date with changes recognized in the consolidated statements of operations. The loss reflects the mark-to-market remeasurement of the convertible instruments issued in the second and third quarters of 2025 through the December 31, 2025 measurement date. Given that the loss through September 30, 2025 was $2,317,631, the full-year loss of $1,347,658 reflects a favourable reversal in the fourth quarter of 2025, primarily driven by changes in the Company's stock price and other inputs used in the valuation model.

Unrealized Foreign Currency Losses & Deemed Dividends

For the year ended December 31, 2025, the Company recorded a total comprehensive loss of $16,678,564, compared to a total comprehensive loss of $24,093,129 for the year ended December 31, 2024. The improvement was primarily attributable to the following factors:

• Foreign Currency Translation Adjustment: For the year ended December 31, 2025, the Company recorded an unrealized foreign currency translation gain of $2,466,434, compared to an unrealized foreign currency translation loss of $1,715,087 for the year ended December 31, 2024. This favorable swing of $4,181,521 was primarily driven by the strengthening of both the Euro and British Pound against the US Dollar during 2025. The EUR/USD closing rate strengthened to 1.1736 as of December 31, 2025 from 1.0351 as of December 31, 2024, representing an appreciation of approximately 13.1%. Similarly, the GBP/USD closing rate strengthened to 1.3447 as of December 31, 2025 from 1.2521 as of December 31, 2024, representing an appreciation of approximately 7.4%. These currency movements resulted in favorable translation adjustments on the net assets of the Company's Greek and UK subsidiaries, as well as on intercompany loan balances denominated in Euros and British Pounds. For the detailed foreign exchange rates used to translate these balances, please refer to Note 2 – Summary of Significant Accounting Policies under the section "Foreign Currency Translation and Other Comprehensive Income/(Loss)."
• Deemed Dividends: No deemed dividends were recorded for the year ended December 31, 2025, compared to deemed dividends of $6,195,024 recorded for the year ended December 31, 2024, which were primarily associated with the Warrant Inducement Letter dated September 26, 2024. For further details, please refer to Note 17 – Stock Options and Warrants.
• Net Loss: The net loss increased from $16,183,018 in 2024 to $19,144,998 in 2025, representing an increase of $2,961,980, which partially offset the improvements noted above.

The combination of the above factors, most notably the elimination of deemed dividends and the favorable foreign currency translation swing, drove the overall improvement in total comprehensive loss year-over-year. For a comprehensive understanding of the key accounting policies and assumptions underlying these changes, readers are encouraged to review the relevant Notes to the Financial Statements as indicated above.

Going Concern

The Company's consolidated financial statements are prepared in conformity with accounting principles generally accepted in the United States of America ("U.S. GAAP"), which contemplates the continuation of the Company as a going concern.

For the year ended December 31, 2025, the Company had revenue of $65,271,815, a net loss of $19,144,998, and net cash used in operations of $8,447,614. Additionally, as of December 31, 2025, the Company had cash and cash equivalents of $715,674 and restricted cash of $2,744,219, the latter designated for the purchase of digital assets (Ethereum) pursuant to the Convertible Note Agreement dated August 5, 2025. The Company had positive working capital of $116,412, an accumulated deficit of $133,167,273, and stockholders' equity of $18,424,629.

The Company's revenues are not able to sustain its operations, and concerns exist regarding the Company's ability to meet its obligations as they become due. The Company is subject to a number of risks similar to those of smaller commercial companies, including dependence on key individuals and products, the difficulties inherent in the development of a commercial market, the need to obtain additional capital, competition from larger companies, and other pharmaceutical and health care companies.

Management evaluated the above conditions which raise substantial doubt about the Company's ability to continue as a going concern to determine if it can meet its obligations for the subsequent 12 months from the date of this filing. Management considered its ability to access future capital, curtail expenses if needed, expand product lines, and acquire new products. Management's plans include expansion of brand name products to the market, expanding the current product portfolio, and evaluating acquisition targets to expand distribution. The exclusive distribution agreement signed for its Sky Premium Life products in the United Arab Emirates ("UAE") and the significant orders already received are expected to substantially strengthen its operating cash flow. Furthermore, the Company intends to vertically integrate its supply chain distribution network.

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With respect to capital markets activities, the Company has undertaken and intends to continue pursuing the following initiatives:

• ATM Sales Program: During the period from September 22 to December 31, 2025, the Company issued an aggregate of 5,997,256 shares of its common stock under its At-the-Market ("ATM") sales program, pursuant to the Company's Shelf Registration Statement on Form S-3 (File No. 333-267550), for gross proceeds of $5,417,396 and net proceeds of $5,254,875, after deducting underwriter commissions and other offering expenses. The Company intends to continue utilizing the ATM program as a source of ongoing equity capital as market conditions permit.
• ATW Convertible Note Facility: On August 5, 2025, the Company entered into a Securities Purchase Agreement for the issuance of up to $300 million of senior secured convertible promissory notes, with an initial closing of $8 million completed on August 6, 2025. The proceeds are primarily intended for digital asset acquisition and working capital. While the Company does not currently intend to draw additional tranches, it may pursue subsequent closings of up to $292 million available under this facility in the event additional capital needs arise, subject to the satisfaction of certain conditions.
• New Shelf Registration Statement: On November 7, 2025, the Company filed a new Registration Statement on Form S-3 (the "New S-3") with the Securities and Exchange Commission, pursuant to which the Company registered up to $200,000,000 of securities, including shares of common stock, preferred stock, warrants, units, and subscription rights, on a shelf basis. The New S-3 was filed as a replacement registration statement pursuant to Rule 415(a)(6) under the Securities Act, with respect to securities remaining unsold under the Prior Registration Statement (File No. 333-267550). The Company intends to utilize the New S-3 to raise additional equity capital as and when needed, subject to the registration statement becoming effective.

Management's plans also include postponing certain debt repayments through achieving favourable amendments to its debt facilities and making substantial efforts to secure additional debt financing. Additionally, the Company's management is considering postponing certain repayments to suppliers and creditors as necessary.

However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described herein and eventually secure other sources of financing and attain profitable operations.

Considering the above, management is of the view that substantial doubt exists for the Company's ability to continue as a going concern. The consolidated financial statements do not include any adjustments to reflect the possible future effect on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from the outcome of this uncertainty.

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Liquidity and Capital Resources

Working Capital

As of December 31, 2025, the Company had positive working capital of $116,412, compared to negative working capital of $296,193 as of December 31, 2024. The improvement in working capital was primarily attributable to the significant growth in current assets during 2025, particularly accounts receivable, inventory, restricted cash, and prepaid expenses, reflecting the expansion of the Company's wholesale and other business operations, as well as the proceeds received from the ATM equity program and the ATW convertible note facility. These increases were partially offset by higher current liabilities, including the classification of the convertible notes payable and the associated derivative liability as current obligations, and higher lines of credit and accrued expenses. The Company continues to closely manage its working capital to ensure adequate liquidity for operations and strategic investments.

Cash Flow from Operating Activities

As of December 31, 2025, the Company had cash and cash equivalents of $715,674, compared to $315,105 as of December 31, 2024, with restricted cash of $2,744,219 also held at year end, designated for digital asset acquisition pursuant to the ATW Convertible Note Agreement. For the year ended December 31, 2025, the Company used net cash of $8,447,614 in operating activities, compared to net cash used of $7,717,034 for the year ended December 31, 2024, representing an increase in cash outflows of $730,580.

The increase in net cash used in operating activities was primarily driven by the following factors:

• Net loss: The Company recorded a net loss of $19,144,998 for the year ended December 31, 2025, compared to a net loss of $16,183,018 for the prior year. The increase in net loss year-over-year was the primary driver of operating cash outflows.
• Higher interest expense: Interest expense increased to $1,899,872 in 2025 from $1,012,314 in 2024, reflecting the new debt facilities entered into during 2025, including the CrediaBank bond loan at the Cosmofarm S.A. level and the 2025 convertible notes. Additionally, non-cash interest expense of $722,763 relating to the amortization of debt discounts on the convertible instruments was recorded in 2025 with no prior year equivalent.
• Higher salaries and wages: Salaries and wages increased to $6,778,278 from $5,693,436 in the prior year, primarily driven by continued headcount expansion at CANA S.A. to support its growing manufacturing operations.
• Working capital movements: Accounts receivable increased significantly, reflecting the strong revenue growth at Cosmofarm S.A. and other subsidiaries, resulting in a cash outflow of $4,939,952 from trade receivables and $1,169,856 from related party receivables. These outflows were partially offset by an increase in accounts payable and accrued expenses of $2,041,168 and related party payables of $2,426,867, reflecting the corresponding growth in the Company's purchasing activity.
• Non-cash items: Several significant non-cash adjustments partially offset the operating cash outflows, including depreciation and amortization of $1,369,353, stock-based compensation of $2,312,241, bad debt expense of $5,882,393, impairment charges of $162,785, and the change in fair value of convertible notes of $1,347,658.

The Company anticipates that as its operational investments in manufacturing capacity, distribution channels, and own-branded products mature, they will contribute to improved operating profitability and positive operating cash flows in future periods.

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Cash Flow from Investing Activities

For the year ended December 31, 2025, the Company used $2,014,855 in net cash for investing activities, compared to $798,269 in the prior year. The higher outflow in 2025 was primarily driven by the purchase of $2,000,000 in digital assets, specifically Ethereum (ETH), pursuant to the ATW Convertible Note Agreement dated August 5, 2025, under which the Company deployed a portion of the initial $8 million tranche proceeds into ETH as part of its digital asset strategy.

These outflows were partially offset by $137,963 in proceeds received from repayments of outstanding loans receivable. Capital expenditures during 2025 were modest, consisting of $55,675 in property and equipment purchases and $97,143 in intangible asset acquisitions, compared to the prior year which included approximately $849,168 in nutraceutical license acquisitions and $418,075 in machinery and equipment purchases, primarily related to CANA S.A.'s manufacturing facility expansion. The Company's investment strategy continues to focus on expanding its business through organic growth, selective acquisitions of licenses and technology, and its digital asset program.

Cash Flow from Financing Activities

For the year ended December 31, 2025, the Company generated $14,056,091 in net cash from financing activities, compared to $5,046,684 for the year ended December 31, 2024, representing an increase of $9,009,407. The higher financing inflows in 2025 were primarily driven by the following:

• Convertible Notes: The Company received aggregate gross proceeds of $9,839,347 from the issuance of senior secured convertible promissory notes during the year ended December 31, 2025. This amount includes proceeds from multiple convertible financing arrangements. Among these, the Company entered into a Securities Purchase Agreement with ATW Partners on August 5, 2025, providing for the issuance of up to $300 million of senior secured convertible promissory notes, of which an initial tranche of $8,000,000 was funded on August 6, 2025. The remaining proceeds relate to additional convertible note issuances completed during the year under separate arrangements. This represents a new financing source compared to the prior year, during which no comparable convertible note financings were in place. For further details, refer to Note 12 — Convertible Debt.
• ATM Equity Program: During the period from September 22 to December 31, 2025, the Company issued 5,997,256 shares of common stock under its ATM sales program for gross proceeds of $5,417,396 and net proceeds of $5,254,875, after deducting underwriter commissions and other offering expenses. The Company intends to continue utilizing the ATM program as an ongoing source of equity capital.
• CrediaBank Bond Loan: Cosmofarm S.A., the Company's wholesale subsidiary, entered into a new bond loan facility with CrediaBank S.A. (formerly Attica Bank S.A.) during 2025, contributing to proceeds from notes payable of $1,316,435 during the year.
• Lines of Credit: The Company had net proceeds from lines of credit of $1,211,938 (gross proceeds of $27,909,048 less repayments of $26,697,110), reflecting the revolving nature of Cosmofarm S.A.'s working capital credit facilities.
• Debt repayments: The Company repaid $1,882,080 of outstanding notes payable during the year, compared to $1,092,121 in the prior year, reflecting the continued payments of existing debt obligations.
• Financing fees: The Company incurred $1,830,470 in financing fees during 2025, compared to $391,575 in the prior year, primarily related to the issuance costs associated with the ATM underwriter’s fees and the convertible note facilities.

In contrast, the prior year financing activities of $5,046,684 were primarily driven by $4,240,977 in proceeds from the exercise of warrants pursuant to the Warrant Inducement Agreement entered into in September 2024, modest ATM proceeds, and net proceeds from lines of credit and notes payable, partially offset by debt repayments and financing fees.

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Liquidity Outlook

The Company’s financing activities in 2025 have enabled it to access additional funds through debt and equity financing, which will support its ongoing investments and operational growth. The Company continues to manage its liquidity position carefully and is committed to maintaining sufficient resources to support its strategic objectives, including expanding its operations through both organic growth and selective acquisitions.

Management is confident that the Company’s current liquidity position, along with its ongoing financing and investment strategies, will enable it to meet its financial obligations and continue its growth trajectory in the coming periods.

Debt Obligations

June 23, 2020 Debt Agreement

On June 23, 2020, the Company’s subsidiary, Cosmofarm, entered into an agreement with the National Bank of Greece S.A. (the “Bank”) to borrow a maximum of €500,000 ($611,500). The note has a maturity date of 60 months from the date of the first disbursement, which includes a grace period of nine months. The total amount of the initial proceeds was received in three equal monthly installments. The note is interest bearing from the date of receipt and is payable every three months at an interest rate of 3.06% plus 3-month Euribor (2.06% as of December 31, 2025). The outstanding balance was €0 ($0) and €88,235 ($91,332) as of December 31, 2025 and 2024, respectively, of which $0 and $91,332 was classified as “Notes payable – long-term portion” respectively, on the accompanying consolidated balance sheets. During the year ended December 31, 2025, the Company repaid €88,235 ($103,553) of the principal balance.

November 19, 2020 Debt Agreement

On November 19, 2020, the Company entered into an agreement with a third-party lender in the principal amount of €500,000 ($611,500). The note matures on November 18, 2025 and bears an annual interest rate, based on a 360-day year, of 3% plus 0.6% plus 6-month Euribor when Euribor is positive (2.12% as of December 31, 2025). The principal is to be repaid in 18 quarterly installments of €27,778 ($30,333). During the year ended December 31, 2025, the Company repaid €111,111 ($130,400) of the principal and as of December 31, 2025, the Company had accrued interest of €3,387 ($3,975) related to this note and an outstanding principal balance of €0 ($0) and €111,111 ($115,011) as of December 31, 2025 and December 31 2024, respectively.

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July 30, 2021 Debt Agreement

On July 30, 2021, the Company entered into an agreement with a third-party lender in the principal amount of €500,000 ($578,850). The note matures on August 5, 2026 and bears an annual interest rate that applies to 60% of the principal of the note that is based on a 365-day year, of 5.84% plus 3-month Euribor when Euribor is positive (2.06% as of December 31, 2025). Pursuant to the terms of the agreement, there is a nine-month grace period for principal repayment during which interest is accrued. The principal is to be repaid in 18 quarterly installments of €27,778 commencing three months from the end of the grace period During the year ended December 31, 2025, the Company repaid €105,747 ($109,459) of the principal. As of December 31, 2025, the Company had accrued interest of €20,038 ($23,517), principal of €90,345 ($106,029), of which $0 is classified as “Notes payable – long term portion” on the accompanying consolidated balance sheets. As of December 31, 2024, the Company had accrued interest of €15,778 ($16,332), principal of €206,343 ($213,585). During the year ended December 31, 2025, the Company repaid €115,998 ($136,135) of the principal.

June 9, 2022 Debt Agreement

On June 9, 2022, the Company entered into an agreement with a third-party lender in the principal amount of €320,000 ($335,008). The note matures on June 16, 2027 and bears an annual interest rate of 2.64% plus an additional rate of 0.60%, plus the 3-month Euribor (2.06% as of December 31, 2025). Pursuant to the agreement, there is a 12-month grace period for principal repayment during which interest is accrued. The principal is to be repaid in 17 equal quarterly installments of €18,824. During the year ended December 31, 2025, the Company repaid €80,000 ($93,888) of the principal. As of December 31, 2025 the Company had accrued interest of €4,262 ($5,002) and an outstanding balance of €100,000 ($117,360) of which $23,472 is classified as “Notes payable – long term portion” on the accompanying consolidated balance sheets. As of December 31, 2024 the outstanding balance was €180,000 ($186,318).

July 14, 2023 Debt Agreement

On July 14, 2023, the Company entered into an agreement with a third-party lender in the principal amount of €1,000,000 ($1,123,700). The note matures on July 31, 2028, and bears an annual interest rate of 4.1% plus the 3-month Euribor (2.06% as of December 31, 2025). Pursuant to the agreement, there is a nine-month grace period for interest and principal repayment. The principal is to be repaid in 18 equal quarterly installments of €55,556 commencing on May 2, 2024. During the year ended December 31, 2025, the Company repaid €217,267 ($254,984) of the principal. As of December 31, 2025, the Company has accrued interest of €19,879 ($23,330) and an outstanding balance of €597,483 ($701,206) of which $446,405 is classified as “Notes payable – long term portion” on the accompanying consolidated balance sheets. As of December 31, 2024 the outstanding balance was €814,750 ($843,348).

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Cloudscreen

On January 23, 2024, the Company completed the acquisition of Cloudscreen, a cutting-edge Artificial Intelligence (AI)-powered platform, pursuant to the purchase agreement announced on October 11, 2023. Cloudscreen is a multimodal platform specialized in drug repurposing, a process that involves identifying new target proteins or indications for existing drugs for use in treating different diseases. The total purchase price amounted to $637,080 and consisted of 280,000 shares of the Company's common stock with a fair value of $319,200 and $317,880 to be settled in cash pursuant to the Promissory Note signed on October 10, 2023.

During the year ended December 31, 2025, the Company repaid $22,421 of the outstanding balance. The remaining balance of $293,400 was converted into shares of the Company's common stock pursuant to a debt exchange agreement. The number of shares issued was determined using a contractually agreed conversion price of $0.65 per share, while the market price of the Company's common stock on the date of the exchange was $0.498 per share. As a result of this conversion, the Company recognized a gain on extinguishment of debt of $68,610, representing the difference between the carrying value of the extinguished obligation and the fair value of the shares issued in settlement. As of December 31, 2025, the Company had no remaining outstanding balance related to this obligation, compared to an outstanding balance of $279,348 as of December 31, 2024.

July 29, 2024 Debt Agreement

On July 29, 2024 the Company entered into an agreement with a third-party lender in the principal amount of €400,000 ($432,760). The note matures on July 31, 2029 and bears an annual interest rate of 2.58% plus the 3-month Euribor (2.06% as of December 31, 2025). Pursuant to the agreement, there is a six-month grace period for principal and interest repayment. The principal is to be repaid in 18 equal quarterly installments of €22,222 commencing on April 30, 2025. During the year ended December 31, 2025, the Company repaid principal of €44,444 ($52,160). As of December 31, 2025, and December 31, 2024, the Company had an outstanding balance of €355,556 ($417,080) and €400,000 ($414,040) of which $312,960 is classified as “Notes payable - long term portion” on the accompanying consolidated balance sheets.

December 20, 2024 Debt Agreement

On December 20, 2024 the Company entered into an agreement with a third-party lender in the principal amount of €400,000 ($414,040). The note matures on December 20, 2027 and bears an annual interest rate of 2.5% plus an additional rate of 0.60% plus the 3-month Euribor (2.06% as of December 31, 2025). Pursuant to the agreement, there is a six-month grace period for principal repayment. The principal is to be repaid in 6 equal semiannual installments of €66,667 commencing on June 20, 2025. During the 12 months ended December 2025, the Company repaid principal of €133,333($156,480). As of December 31, 2025, and December 31, 2024, the Company an outstanding balance of €266,667 ($312,960) and €400,000 ($414,040), of which $156,480 is classified as “Notes payable - long term portion” on the accompanying consolidated balance sheets.

January 27, 2025 Debt Agreement

On January 27, 2025, the Company entered into a bond loan agreement with Attica Bank, providing for maximum borrowings of up to €2,200,000 ($2,357,120). Under the terms of the facility, the Company received initial proceeds of €700,000 ($881,520), which were classified as Notes Payable in the Company’s consolidated financial statements. The remaining borrowing capacity of €1,500,000 ($1,619,400) is available to the Company on a revolving basis, subject to the provision of qualifying checks receivable as security for each drawing. These subsequent drawdowns are classified as Lines of Credit due to their secured and contingent nature. The facility bears interest at a floating rate of 2.95% plus the applicable 6-month Euribor (2.12% as of December 31, 2025). The Note Payable portion of the facility is to be repaid in 10 equal semiannual installments of €70,000 commencing on July 27, 2026. During the year ended December 31, 2025, the Company repaid principal of €70,000 ($82,152). As of December 31, 2025 the Company has accrued interest of €28,702 ($33,685) and an outstanding balance of €630,000 ($739,368), of which $575,064 (€490,000), is classified as “Notes payable - long term portion” on the accompanying consolidated balance sheets.as of December 31, 2025. The loan is further secured by a preliminary mortgage of €2,640,000 ($3,098,304) registered on Company’s owned warehouse facilities.

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May 29, 2025 Debt agreement

On May 29, 2025, the Company entered into a business loan agreement (the “Note”) with a third-party lender in the principal amount of $525,000. The Note carried debt issuance fees of $25,000, which are being amortized over the life of the loan. The loan is short-term in nature, as it was scheduled to be fully repaid by December 15, 2025, through weekly installments. The Note bears fixed total interest of $231,000, which is being accrued evenly over the term of the loan and is payable together with the principal installments. During the year ended December 31, 2025, the Company made aggregate principal and interest repayments totaling $756,000. As of December, 31, 2025 the Company had an outstanding balance of $0.

Trade Facility Agreements

On May 12, 2017, SkyPharm entered into a Trade Finance Facility Agreement (the “SkyPharm Facility”) with Synthesis Structured Commodity Trade Finance Limited (the “Lender”) as amended on November 16, 2017 and May 16, 2018.

On October 17, 2018, the Company entered into a further amended agreement with Synthesis whereby the current balance on the TFF as of October 1, 2018, which was €4,866,910 ($5,629,555) and related accrued interest of €453,094 ($524,094) would be split into two principal balances of Euro €2,000,000 ($2,316,000), (the “EURO Loan”) and USD $4,000,000 (the “USD Loan”). Interest on both the EURO Loan and USD Loan commenced on October 1, 2018, at 6% per annum plus one-month Euribor (3.869% as of December 31, 2024), and 6% plus one-month LIBOR (5.47% as of date of December 31, 2024), respectively.

On December 30, 2020, the Company transferred the EURO Loan to a new third-party lender. The terms remained the same except interest accrues at 5.5% per annum plus one-month Euribor 3.869% as of December 31, 2024. The principal was scheduled to be repaid in a total of five quarterly installments beginning October 31, 2021 of €50,000 ($54,600) each with a final repayment of €1,800,000 ($1,965,600) payable on October 31, 2022.

On March 3, 2022, the Company entered into a modification agreement to extend the maturity date to January 10, 2023, and payments under the USD Loan. During June 2022, the Company agreed with the Lender to postpone the repayment of an installment of $500,000 due on June 30, 2022 (based on the modification agreement signed on March 3, 2022) until January 2023. During September 2022, the Company entered into an agreement with the Lender to postpone the repayment of the outstanding balance on the USD Loan of $3,950,000, plus unpaid accrued interest until January 2023. The Company capitalized fees paid upon modification of €200,000 ($221,060) that are being amortized over the life of the loan. The Company incurred non-cash interest expense of $216,182 during the year ended December 31, 2022, concerning the above capitalized fees.

During the year ended December 31, 2022, the Company repaid €175,000 ($191,100) of the EURO Loan and $2,593,363 of the USD Loan such that as of December 31, 2022, the Company had principal balances of €1,775,000 ($1,898,895) and $1,406,637 under the agreements, respectively. As of December 31, 2022, the Company had accrued $309,365 in interest expense related to these agreements.

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On December 21, 2022, the USD Loan was assigned to GIB Fund Solutions ICAV (the “Fund”). On January 31, 2023, the Company paid $1,100,000 to the Fund under a full and final settlement agreement for the USD Loan, recording a gain on extinguishment of debt of $306,637 relating to the waiver of the unpaid balance. Additionally, the Company repaid €50,000 ($50,310) of the EURO Loan during the year ended December 31, 2024.

On December 22, 2022 SkyPharm signed an agreement for the extension of the payments and an increase in interest rate due under the EURO loan that was extended to be repaid with a balloon payment now due on October 31, 2025. This extension was agreed upon in writing on December 22, 2022, with a retroactive modification date to October 31, 2022 (the original maturity date).

As of December 31, 2024, the Company had an outstanding principal balance of €1,350,000 ($1,397,385) all of which $1,327,440 was classified as “Notes payable - long term portion” on the consolidated balance sheets.

The Company repaid €300,000 ($352,080) of the EURO Loan during the 12 months ended December 31, 2025. As of December 31, 2025, the Company had an outstanding principal balance of €1,050,000 ($1,232,280), all of which is classified as “Notes payable” on the consolidated balance sheets. For the year ended December 31, 2025, the Company had accrued $113,962, in interest expense related to these agreements.

COVID-19 Government Loans

May 12, 2020 Loan

On May 12, 2020, the Company’s subsidiary, SkyPharm, was granted loan from the Greek government and, on May 22, 2020, received the amount of €300,000 ($366,900). The loan would be repaid in 40 equal monthly installments beginning on July 29, 2022. As a condition to the loan, the Company was required to retain the same number of employees until October 31, 2020. As of December 31, 2025, the principal balance was €87,500 ($102,690). During the year ended December 31, 2025, the Company repaid €15,625 ($18,338) of the principal balance. The outstanding balance as of December 31, 2024 was €103,125 ($106,745).

June 24, 2020 Debt Agreement

On June 24, 2020, the Company’s subsidiary, Decahedron, received a loan £50,000 ($68,310) from the UK government. The loan has a ten-year maturity and bears interest at a rate of 2.5% per annum beginning 12 months after the initial disbursement, which was on July 10, 2020. The Company may prepay this loan without penalty at any time. As of December 31, 2025, the principal balance was £34,330 ($46,164). As of December 31, 2024, the principal balance was £38,144 ($47,761).

As of December 31, 2025, the Company was in compliance with all financial and non-financial covenants under its outstanding debt agreements, including but not limited to all notes payable, credit facilities, and other borrowing arrangements. There were no events of default, nor any conditions or events that, with the passage of time or the giving of notice, would reasonably be expected to constitute an event of default, with respect to any of the Company's debt obligations as of such date.

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Related Party Indebtedness

Grigorios Siokas

From time to time, Grigorios Siokas loans the Company funds in the form of non-interest bearing, no-term loans.

During the 12-month period ended December 31, 2024, the Company had an outstanding principal balance under these loans of $13,257 in loans payable to Grigorios Siokas. As of December 31, 2025, the Company had an outstanding principal balance of $0 related to this payable. During the 12-month period ended December 31, 2025, there were no additional receipts regarding this loan.

Grigorios Siokas is the Company’s CEO and a principal shareholder and is hence considered a related party to the Company.

Dimitrios Goulielmos

On November 21, 2014, the Company entered into an agreement with Dimitrios Goulielmos, as amended on November 4, 2016. Pursuant to the amendment, this loan has no maturity date and is non-interest bearing. As of December 31, 2024 and 2023, the Company had a principal balance of €10,200 ($11,971) and €10,200 ($10,558), respectively. The above balances are adjusted for the foreign currency rate as of the balance sheet date.

Significant Equipment

We do not intend to purchase any significant equipment for the next 12 months aside from a few pieces of IT equipment. Nevertheless, we will replace essential equipment for operations if it is required within the year.

Employees

In order to achieve our strategic objectives, we have, and will remain, focused on hiring and retaining a highly skilled management team that has extensive experience and specific skill sets relating to the sales, selection, development and commercialization of pharmaceutical products. We intend to continue our efforts to build and expand this team as we grow our business. We have plans to increase the number of our employees by adding more salespeople during the next 12 months.

Off Balance Sheet Arrangements

As of December 31, 2025, there were no off-balance sheet arrangements.

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Critical Accounting Policies and Estimates

In December 2001, the SEC requested that all registrants list their most “critical accounting polices” in the Management’s 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.

Income Taxes. The Company accounts for income taxes under the asset and liability method, as required by the accounting standard for income taxes, ASC 740 “Accounting for Income Taxes.” Under this method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis, as well as net operating loss carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.

The Company is liable for income taxes in Greece and the United Kingdom. The corporate income tax rate is 22% in Greece (tax losses are carried forward for five years effective January 1, 2013) and 25% in the United Kingdom. Losses may also be subject to limitation under certain rules regarding change of ownership.

We regularly review deferred tax assets to assess their potential realization and establish a valuation allowance for portions of such assets to reduce the carrying value if we do not consider it to be more likely than not that the deferred tax assets will be realized. Our review includes evaluating both positive (e.g., sources of taxable income) and negative (e.g., recent historical losses) evidence that could impact the realizability of our deferred tax assets.

We recognize the impact of an uncertain tax position in our financial statements if, in management’s judgment, the position is not more-likely-then-not sustainable upon audit based on the position’s technical merits. This involves the identification of potential uncertain tax positions, the evaluation of applicable tax laws and an assessment of whether a liability for an uncertain tax position is necessary. We operate and are subject to audit in multiple taxing jurisdictions.

We record interest and penalties related to income taxes as a component of interest and other expense, respectively.

Potential benefits of income tax losses are not recognized in the accounts until realization is more likely than not. The Company has adopted ASC 740 “Accounting for Income Taxes” as of its inception. Pursuant to ASC 740, the Company is required to compute tax asset benefits for net operating losses carried forward. The potential benefits of the U.S. net operating losses have not been recognized in this financial statement because the Company cannot be assured it is more likely than not it will utilize the net operating losses carried forward in future years.

The Company has net operating loss carry-forwards in our parent, Cosmos Health Inc., which are applicable to future taxable income in the United States (if any). Additionally, the Company has income tax liabilities in the United Kingdom and Greece. The income tax assets and liabilities are not able to be netted. We therefore reserve the income tax assets applicable to the United States but recognize the income tax liabilities in Greece and the United Kingdom. Losses may also be subject to limitation under certain rules regarding change of ownership.

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Accounts Receivable and Allowance for Credit Losses

The Company follows ASC Topic 326, Financial Instruments – Credit Losses (“ASC 326”) to estimate the allowance for doubtful accounts. The Company is required to estimate credit losses on accounts receivable balances held at amortized cost. ASC 326 introduces a new methodology for measuring credit losses, replacing the previous incurred loss model with an expected credit loss model. The Company measures credit losses on accounts receivable using an expected credit loss model, which considers historical experience, current conditions, and reasonable and supportable forecasts. Credit losses are measured as the difference between the present value of contractual cash flows expected to be collected and the present value of expected cash flows discounted at the financial instrument’s original effective interest rate. The Company reviews individually each trade receivable for collectability and performs on-going credit evaluations of its customers and adjusts credit limits based upon payment history and the customer’s current credit worthiness, as determined by the review of their current credit information; and determines the allowance for doubtful accounts based on historical write-off experience, customer specific facts and general economic conditions that may affect a client’s ability to pay. Bad debt expense is included in general and administrative expenses, if any.

Inventory

Our merchandise inventories are made up of finished goods, manufacturing products, raw materials and other products and are valued at the lower of cost or market using the weighted-average cost method. However, the net realizable value (“NRV”) will always be higher than our inventory’s cost, once most of our inventory is fast moving and the vast majority of our products is pharmaceuticals, which have standard selling prices that could not result to the NRV being higher than the average cost. Moreover, our efficient inventory management which has led to minimum obsolete and slow-moving inventory also indicates that the NRV is higher than its average cost. Thus, an NRV assessment would have no material, if any, to our inventory’s cost. Average cost includes the direct purchase price, net of vendor allowances and cash discounts, of merchandise inventory. We record valuation reserves on an annual basis for merchandise damage, expired and defective returns and merchandise items with slow-moving or obsolescence exposure. These reserves are estimates of a reduction in value to reflect inventory valuation at the lower of cost or market. The reserve for merchandise returns is based upon the determination of the historical net realizable value of products sold from our returned goods inventory or returned to vendors for credit. Our reserve for merchandise returns includes amounts for returned product on-hand as well as for new merchandise on-hand that we estimate will ultimately become returned goods inventory after being sold based on historical return rates.

Below is an analysis per category of our inventories as of December 31, 2025 and 2024:

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Recently Issued Accounting Pronouncements

In December 2023, the Financial Accounting Standards Board issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments enhance the transparency and decision usefulness of income tax disclosures by requiring additional information about the effective tax rate reconciliation and income taxes paid by jurisdiction. The amendments are effective for public business entities for annual periods beginning after December 15, 2024. The Company adopted this guidance on January 1, 2025. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements.

In March 2024, the Financial Accounting Standards Board issued ASU 2024-02, Codification Improvements—Amendments to Remove References to the Concepts Statements. The amendments remove references to certain Concepts Statements and make other minor technical corrections to the Codification. The Company adopted this guidance during fiscal year 2025, and the adoption did not have a material impact on its consolidated financial statements.

In November 2024, the Financial Accounting Standards Board issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40). The standard requires public entities to disclose additional information about specific expense categories presented in the income statement, including purchases of inventory, employee compensation, depreciation, and amortization. The amendments are effective for public business entities for annual periods beginning after December 15, 2026, and interim periods thereafter. The Company is currently evaluating the impact that the adoption of this guidance will have on its consolidated financial statement disclosures.

In September 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2025-06, Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software (“ASU 2025-06”), which modernizes the accounting for internal-use software. ASU 2025-06 removes all references to software development stages and requires capitalization of software costs when management has committed to the software project and it is probable the software will be completed and perform its intended use. ASU 2025-06 will be effective for the Company in its first quarter of 2029, and early adoption is permitted. The Company is currently evaluating the timing and method of its adoption of ASU 2025-06.

Disclosure Controls and Procedures

The Company maintains disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act) that are designed to ensure that information required to be disclosed in the Company’s Securities Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to the Company’s management, including its Principal Executive Officer/Principal Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Evaluation of Disclosure Controls and Procedures

The Company’s management, with the participation of the Company’s Principal Executive Officer and Principal Financial Officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures as of the end of the period covered by this report. Based upon that evaluation, the Principal Executive Officer and the Principal Financial Officer have concluded that, as of the end of the period covered by this report, the Company’s disclosure controls and procedures were ineffective due to material weaknesses stated in Management’s Report on Internal Control over Financial Reporting set forth below.

Management’s Report on Internal Control over Financial Reporting

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) under the Exchange Act. This rule defines internal control over financial reporting as a process designed by, or under the supervision of, the Company’s Chief Executive Officer and Chief Financial Officer, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and procedures that:

• Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions;
• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of management and directors of the Company; and
• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of our assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

With the participation of the Chief Executive Officer and Chief Financial Officer, our management conducted an evaluation of the effectiveness of our internal control over financial reporting. Based on this evaluation, our management has concluded that our internal control over financial reporting was ineffective as of December 31, 2025, as the result of the below weaknesses.

AS 2201 and the SEC define the term “material weakness” as “a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.” We had the following material weaknesses at December 31, 2024 set forth below:

• The Company has a lack of proper segregation of duties.
• The Company’s internal control structure lacks multiple levels of review and oversight and does not have appropriate IT General Controls (ITGCs) for the applications used in the Financial Reporting process, caused by lack of design of relevant controls and overall IT risk management.

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Remediation of Deficiencies and Material Weaknesses

We are in the process of remediating all material weaknesses present in our internal controls.

• The Company has a lack of proper segregation of duties.

We are in the process of updating the organizational chart in order to reallocate roles among personnel and emphasize sharing the responsibilities of key business processes by distributing the discrete functions of these processes to multiple people and departments. Specifically, we have delegated the following processes to different personnel; authorization, custody, recordkeeping, and reconciliation. For example, a manager authorizing discount sales is not responsible for maintaining accounts receivable records or handling cash receipts. In addition, we have set access rights at the data and our software based on the job responsibilities and level of the personnel, therefore unauthorized users are not able to change any data on the system or process to bank transactions.

• The Company’s internal control structure lacks multiple levels of review and oversight and does not have appropriate IT General Controls (ITGCs) for the applications used in the Financial Reporting process, caused by lack of design of relevant controls and overall IT risk management.

Enhancements to Internal Controls and Financial Reporting Systems

The Company is actively refining its internal control framework by implementing multiple levels of review tailored to job responsibilities and personnel hierarchy. Key enhancements include:

• Bank Reconciliation Oversight: Management conducts timely reviews to ensure bank reconciliations are prepared accurately and on schedule. Discrepancies between the general ledger and bank statements are promptly identified and addressed.
• Review and Authorization of Financial Information: The Chief Financial Officer (CFO) reviews management accounting information and authorizes material transactions and adjustments, ensuring compliance with financial policies and procedures.
• Payroll Process Controls: Payroll is processed by an external service provider, subsequently reviewed by the accountant, and formally approved by the CFO before payment authorization.
• Financial Reporting System Assessment: The Company is evaluating the implementation of a new financial reporting application across all subsidiaries. This system is expected to enhance financial data processing, reporting accuracy, and integration of key financial controls, thereby strengthening IT General Controls (ITGCs) within a unified and more reliable platform.

These initiatives reflect the Company’s ongoing commitment to improving financial reporting processes, internal controls, and operational efficiency in alignment with best practices and regulatory requirements.

Limitations on the Effectiveness of Internal Controls

Our management, including our Chief Executive Officer and our Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal control over financial reporting are or will be capable of preventing or detecting all errors or all fraud. Any control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. The design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Further, because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements, due to error or fraud will not occur or that all control issues and instances of fraud, if any, within the company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns may occur because of simple error or mistake. Controls can also be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of controls. The design of any system of controls is based in part on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Projections of any evaluation of controls effectiveness to future periods are subject to risk.

This annual report does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit us to provide only management’s report in this annual report.

Changes in Internal Control Over Financial Reporting

During the most recently completed fiscal year, there has been no change in our internal control over financial reporting that has materially affected or is reasonably likely to materially affect, our internal control over financial reporting.