{"url_path":"/sec/cik-0001119643/10-k/2026/item-1","section_key":"item-1","section_title":"Item 1 Business**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-05-20","source_url":"https://www.sec.gov/Archives/edgar/data/1119643/0001493152-26-024641-index.html","accession_number":"0001493152-26-024641","cik":"0001119643","ticker":null,"issuer_name":"NUTRA PHARMA CORP","edgar_url":"https://www.sec.gov/Archives/edgar/data/1119643/0001493152-26-024641-index.html","primary_entity_key":"0001119643","primary_entity_name":"NUTRA PHARMA CORP"},"word_count":11441,"has_tables":true,"body_markdown":"**Item\n1. Business**\n\n \n\n**Introduction**\n\n \n\nNutra\nPharma is a biopharmaceutical company with intellectual property for drugs that treat autoimmune disorders, viral diseases and pain.\nNutra Pharma was incorporated under the laws of the state of California on February 1, 2000, under the original name of Exotic-Bird.com.\n\n \n\nNutra\nPharma conducts drug discovery research and development (R&D) activities. In October 2009, Nutra Pharma launched its first consumer\nproduct called Cobroxin, an over-the-counter pain reliever designed to treat moderate to severe chronic pain. In May 2010, Nutra Pharma\nlaunched its second consumer product called Nyloxin, an over-the-counter pain reliever that is a stronger version of Cobroxin and is\ndesigned to treat severe chronic pain. In December 2014, we launched Pet Pain-Away, an over-the-counter pain reliever designed to treat\npain in cats and dogs. In October 2019, we launched Equine Pain-Away, an over-the-counter topical pain reliever designed to treat pain\nin horses. In March of 2021, we launched Luxury Feet, an over-the-counter pain reliever and anti-inflammatory product that is designed\nfor women who experience pain or discomfort due to high heels and stilettos. In October of 2021 we began manufacturing private labelled\nproducts for third party distributors.\n\n \n\nWe\nhave conducted our operations since October 2003. We are a biopharmaceutical company that engages in the acquisition, licensing and commercialization\nof pharmaceutical products and technologies as well as homeopathic and ethical drugs for the management of pain, neurological disorders,\ncancer, autoimmune and infectious diseases. Homeopathic drugs are natural products that contain ingredients listed in the HPUS (Homeopathic\nPharmacopoeia of the United States). An ethical drug is a licensed drug that has obtained Federal Drug Administration (“FDA”)\napproval after extensive pre-clinical and clinical testing. We seek strategic licensing partnerships to reduce the risks associated with\nthe drug development process.\n\n \n\nWe\nhave carried out our homeopathic and drug discovery research and clinical development and fully developed four homeopathic drugs for\nthe relief of pain:\n\n \n\n \n●\nNyloxin\nand Nyloxin Extra Strength\n\n \n●\nPet\nPain-Away: an over-the-counter pain reliever designed to relieve pain in cats and dogs\n\n \n●\nEquine\nPain-Away: an over-the-counter topical pain reliever designed to relieve pain in horses\n\n \n●\nLuxury\nFeet: an over-the-counter pain reliever designed to relieve foot pain from high heels and stilettos\n\n \n\nOur\nbusiness plan will continue its efforts to produce, market and distribute our Nyloxin, Pet Pain-Away, Equine Pain-Away™ and Luxury\nFeet™ branded products both domestically and internationally.\n\n \n\nFrom\nOctober 2009 until December 31, 2025, our operations centered on the marketing of Cobroxin, which was discontinued in 2013 and is expected\nto be reintroduced later in 2026, as well as Nyloxin and Nyloxin Extra Strength. In December of 2014, we launched Pet Pain-Away and began\nactively marketing the product. In October of 2021, we began manufacturing a Zeolite detoxification product and conducted some online\nsales. We launched Equine Pain-Away in October of 2019 and Luxury Feet officially launched distribution in March of 2021.\n\n \n\nOn\nMarch 17, 2022, we announced that we had completed the process of bringing all of our manufacturing in-house. Previously, we had utilized\ncontract manufactures to make our products. We announced that expanding our in-house manufacturing capabilities has put Nutra Pharma\nin a very good position as far as reduced product costs, higher margins, faster product upgrades and an increased ability to launch new\nand innovative products.\n\n \n\nOn\nMarch 23, 2022, we announced that we had our first agreement to act as a formulator and contract manufacturer for the dietary supplement\ncompany, Avini Health, a related party.\n\n \n\nAdditionally,\nthe Company has developed two drug candidates:\n\n \n\n \n●\nRPI-78M,\nto treat neurological diseases and autoimmune diseases, including; Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), Amyotrophic\nLateral Sclerosis (ALS or Lou Gehrig’s disease), Rheumatoid Arthritis (RA) and Myasthenia Gravis; and\n\n \n●\nRPI-MN,\nto treat viral diseases, including HIV/AIDS and Herpes.\n\n \n\nThe\nCompany has developed proprietary therapeutic protein products primarily for the prevention and treatment of viral and neurological diseases,\nincluding Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV) and pain in humans. These potential\nproducts are subject to FDA approval. In September of 2015 we were granted Orphan Designation by the US-FDA for the treatment of Pediatric\nMultiple Sclerosis. The Orphan designation may greatly reduce the costs of clinical trials and shorten the timeline to potential drug\napproval.\n\n \n\nThe\nCompany is also pursuing the use of our technology as a potential nerve agent countermeasure that may protect war fighters from chemical\nweapon attacks on the battlefield.\n\n \n\nWe\ncontinue to identify biotechnology related intellectual property and companies with which we may potentially be able to enter into arrangements,\nagreements or to potentially acquire.\n\n \n\n3\n\n \n\n \n\n**Industry\nOverview of the Pain Market**\n\n \n\nPain\nis the most common symptom for patients seeking medical attention. Acute and chronic pain affects large numbers of Americans. According\nto the US Pain Foundation (www.uspainfoundation.org) almost 21% of the U.S. population—51.6 million adults—lives with chronic\npain, defined as pain lasting more than three months. Of those, 17.1 million live with high-impact chronic pain that substantially restricts\ntheir ability to work or participate in daily activities. This costs as much as $635 billion yearly in direct healthcare costs, lost\nproductivity and disability payments.\n\n \n\nAccording\nto The Business Research Company, the global market for chronic pain intervention reached $78.79 billion in 2024. This is expected to\nexceed $117 billion by 2029. This includes prescription and over-the-counter (OTC) drugs as well as medical devices like portable nerve\nstimulators.\n\n \n\n**Our\nProducts**\n\n \n\n**Nyloxin/Nyloxin\nExtra Strength**\n\n \n\nWe\noffer Nyloxin/Nyloxin Extra Strength as our over-the-counter (OTC) pain reliever that has been clinically proven to treat moderate to\nsevere (Stage 2) chronic pain.\n\n \n\nNyloxin\nand Nyloxin Extra Strength are available as a two-ounce topical gel for treating joint pain and pain associated with arthritis and repetitive\nstress, and as a one ounce oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps, and neuropathic pain.\nBoth the topical gel and oral spray are packaged and sold as a one-month supply.\n\n \n\nNyloxin\nand Nyloxin Extra Strength offer several benefits as a pain reliever. With increasing concern about consumers using opioid and acetaminophen-based\npain relievers, the Nyloxin products provide an alternative that does not rely on opiates or non-steroidal anti-inflammatory drugs, otherwise\nknown as NSAIDs, for their pain-relieving effects. Nyloxin also has a well-defined safety profile. Since the early 1930s, the active\npharmaceutical ingredient (API) of Nyloxin, Asian cobra venom, has been studied in more than 46 human clinical studies. The data from\nthese studies provide clinical evidence that cobra venom provides an effective treatment for pain with few side effects and has the following\nbenefits:\n\n \n\n \n●\nsafe\nand effective;\n\n \n●\nall\nnatural;\n\n \n●\nlong-acting;\n\n \n●\neasy\nto use;\n\n \n●\nnon-narcotic;\n\n \n●\nnon-addictive;\nand\n\n \n●\nanalgesic\nand anti-inflammatory.\n\n \n\nPotential\nside effects from the use of Nyloxin are rare, but may include headache, nausea, vomiting, sore throat, allergic rhinitis and coughing.\n\n \n\nThe\nprimary difference between Nyloxin and Nyloxin Extra Strength is the dilution level of the venom. The approximate dilution levels for\nNyloxin and Nyloxin Extra Strength are as follows:\n\n \n\nNyloxin\n\n \n\n \n●\nTopical\nGel: 30 mcg/mL\n\n \n●\nOral\nSpray: 70 mcg/mL\n\n \n\nNyloxin\nExtra Strength\n\n \n\n \n●\nTopical\nGel: 60 mcg/mL\n\n \n●\nOral\nSpray: 140 mcg/mL\n\n \n\nIn\nDecember 2011, we began marketing Nyloxin and Nyloxin Extra Strength at www.nyloxin.com. Both Nyloxin and Nyloxin Extra Strength are\npackaged in a roll-on container, squeeze bottle and as an oral spray. Additionally, Nyloxin topical gel is available in an 8 ounce pump\nbottle.\n\n \n\n4\n\n \n\n \n\nWe\nare currently marketing Nyloxin and Nyloxin Extra Strength as treatments for moderate to severe chronic pain. Nyloxin is available as\nan oral spray for treating back pain, neck pain, headaches, joint pain, migraines, and neuralgia and as a topical gel for treating joint\npain, neck pain, arthritis pain, and pain associated with repetitive stress. Nyloxin Extra Strength is available as an oral spray and\ngel application for treating the same physical indications but is aimed at treating the most severe (Stage 3) pain that inhibits one’s\nability to function fully.\n\n \n\nThe\nNyloxin products are available for sale on the www.Nyloxin.com website, the Nyloxin Amazon storefront at www.Amazon.com/nyloxin and on\nthe Walmart Marketplace. Nyloxin is also sold in physician offices, clinics and small-chain pharmacies.\n\n \n\n**Nyloxin\nMilitary Strength**\n\n \n\nIn\nDecember 2012, we announced the availability of Nyloxin Military Strength for sale to the United States Military and Veteran’s\nAdministration. Over the past few years, the U.S. Department of Defense has been reporting an increase in the use and abuse of prescription\nmedications, particularly opiates. In 2009, close to 3.8 million prescriptions for pain relievers were written in the military. This\nstaggering number was more than a 400% increase from the number of prescriptions written in the military in 2001. But prescription drugs\nare not the only issue. The most common and seemingly harmless way to treat pain is with non–steroidal, anti–inflammatory\ndrugs (NSAIDS). But there are risks. Overuse can cause nausea, vomiting, diarrhea, heartburn, ulcers and internal bleeding. In severe\ncases chest pain, heart failure, kidney dysfunction and life–threatening allergic reactions can occur. It is reported that approximately\n7,600 people in America die from NSAID use and some 78,000 are hospitalized. Ibuprofen, also an NSAID has been of particular concern\nin the military. The terms “Ranger Candy” and “Military Candy” refer to the service men and women who are said\nto use 800mg doses of Ibuprofen to control their pain. But when taking anti–inflammatory Ibuprofen in high doses for chronic pain,\nthere is potential for critical health risks; abuse can lead to serious stomach problems, internal bleeding and even kidney failure.\nThere are significantly greater health risks when abuse of this drug is combined with alcohol intake. Our goal is that with Nyloxin,\nwe can greatly reduce the instances of opiate abuse and overuse of NSAIDS in high risk groups like the US military. The Nyloxin Military\nStrength represents the strongest version of Nyloxin available and is approximately twice as strong as Nyloxin Extra Strength. We are\nworking with outside consultants to register Nyloxin Military Strength and the other Nyloxin products for sale to the US government and\nthe various arms of the military as well as the Veteran’s Administration. In February of 2018, Nyloxin was added to the Federal\nSupply Schedule but was subsequently removed the following week without an adequate explanation. We have continued to work with our consultants\nto understand why our products were improperly removed the Federal Supply Schedule and when we may be able to get re-listed on the Federal\nSupply Schedule for eventual sales to governmental agencies or to the US Military.\n\n \n\n**International\nSales**\n\n \n\nWe\nare pursuing international drug registrations in Canada, Mexico, India, Australia, New Zealand, Central and South America and Europe.\nSince European rules for homeopathic drugs are different than the rules in the US, we cannot estimate when this process will be completed.\nOn March 25, 2013 we announced the publication of our patent and trademark for Nyloxin in India. We are actively seeking new distribution\npartners in India. In December 2025, the Company entered into a business collaboration agreement with a third-party service provider\nto support its expansion into the Indian market. Under the agreement, the service provider will assist with business development activities,\nincluding identifying potential customers, facilitating negotiations, and supporting market entry efforts.\n\n \n\nOn\nMay 14, 2015 we announced that we had engaged the Nature’s Clinic to begin the process of regulatory approval of our Company’s\nOver–the–Counter pain drug, Nyloxin for marketing and distribution in Canada. Due to lack of funding and then the subsequent COVID crisis, we have waited to complete\nthe approval process to begin distributing Nyloxin and expect to re-engage in the process in 2026.\n\n \n\nAdditionally,\nwe plan to complete several human clinical studies aimed at comparing the ability of Nyloxin Extra Strength to replace prescription pain\nrelievers. We have provided protocols to several hospitals and will provide details and timelines when those protocols have been accepted.\nWe cannot provide any timeline for these studies until adequate financing is available.\n\n \n\nTo\ndate, our marketing efforts have been limited due to lack of funding. As sales increase, we plan to begin marketing more aggressively\nto increase the sales and awareness of our products.\n\n \n\n5\n\n \n\n \n\n**Pet\nPain–Away**\n\n \n\nDuring\nJune of 2013, we announced the launch of our new homeopathic formula for the treatment of chronic pain in companion animals, Pet Pain–Away.\nPet Pain–Away is a homeopathic, non–narcotic, non–addictive, over–the–counter pain reliever, primarily\naimed at treating moderate to severe chronic pain in companion animals. It is specifically indicated to treat pain from hip dysplasia,\narthritis pain, joint pain, and general chronic pain in dogs and cats. The initial product run was completed in December of 2014 and\nlaunched through Lumaxa Distributors on December 19, 2014.\n\n \n\nIn\nMay of 2016, we signed a license agreement to begin the process of creating an infomercial (Direct Response) campaign for Pet Pain–Away.\nIn November of 2016, we announced the license agreement with DEG Productions for the marketing and distribution of Pet Pain–Away\nglobally. DEG created their own website (www.getpetpainaway.com) and began airing commercials in December of 2016.\n\n \n\nIn\nFebruary of 2020, we took back the marketing of Pet Pain-Away and are currently selling the product on Amazon.com, Chewy.com and through\nwww.petpainaway.com.\n\n \n\n**Luxury\nFeet**\n\n \n\nIn\nJune of 2017, we announced the creation of *Luxury Feet*; an over–the–counter pain reliever and anti–inflammatory\nproduct that is designed for women who experience pain or discomfort due to high heels and stilettos. We announced the official marketing\nlaunch of Luxury Feet in March of 2021. The product is currently available through www.luxuryfeet.com and on Amazon.\n\n \n\n**Equine\nPain-Away (Formerly Equine Nyloxin)**\n\n \n\nIn\nOctober of 2013, we announced that we were in the process of launching the newest addition to our line of homeopathic treatments for\nchronic pain, *Equine Nyloxin*. We had been working with trainers and veterinarians in the equine industry and have already identified\ndistributors for the product. The *Equine Nyloxin*represents the Company’s first topical solution for the animal market.\nEquine Nyloxin was rebranded as Equine Pain-Away™ and officially rolled into the market in October of 2019. Equine Pain-Away is\nbeing marketed through several retailers and online at www.EquinePainAway.com and on Amazon.\n\n \n\n**Regulation**\n\n \n\nThe\nactive pharmaceutical ingredient (API) in our over the counter products, Asian cobra venom, has an approved United States monograph under\nthe Homeopathic Pharmacopoeia of the United States (HPUS), which allowed us to register them with the United States Food and Drug Administration\n(FDA) as homeopathic drugs. A United States monograph is a prescribed formulation for the production of any drug or product that is recognized\nby law for a specific application and that may be introduced into commerce. The FDA requires this registration process to maintain full\ncompliance of companies marketing and selling medicines classified as homeopathic. In August 2009, we successfully completed submission\nof final packaging and labeling to the FDA to begin selling our over-the-counter pain reliever, Cobroxin. In December 2009, we completed\nour submission of final packaging and labeling to the FDA of Nyloxin and Nyloxin Extra Strength. In December 2016 we completed our submission\nof final packaging and labeling to the FDA of Pet Pain-Away.\n\n \n\nOn\nMarch 11, 2019, the FDA sent us a warning letter regarding the claims and marketing materials of our Nyloxin line of products. On April\n10, 2019 we responded to the warning letter; addressing their concerns and outlining the actions that we have taken and will take to\ncomply with their requests for changes. The response goes on to commit to the FDA that the company will make the changes necessary to\nproperly and legally continue to market and distribute our products. As of this date, we have made all of the committed changes to our\nwebsite, social media pages and marketing material. There has been no further communication regarding this from the FDA.\n\n \n\n6\n\n \n\n \n\n**Manufacturing**\n\n \n\nWe\noversee Nyloxin’s and Pet Pain-Away’s manufacturing activities at our Good Manufacturing Practice (“GMP”) certified\nfacility. We are also responsible for acquiring appropriate amounts of Asian cobra venom required to manufacture Nyloxin and Pet Pain-Away.\n\n \n\nSubject\nto availability of funds, we plan to begin additional clinical studies for our pain relievers. These studies will be designed to compare\nthe efficacy of Nyloxin Extra Strength to other prescription strength pain relievers. Our study published in *Toxicon*, which is\nthe journal of the International Society of Toxinology, showed that our leading drug product for the treatment of pain (RPI-78) had pain-reducing\neffects that lasted four times as long as morphine without the negative side effects associated with opioid-based pain relievers. Another\nstudy published in the journal Neuropharmacology showed a new mechanism on the use of Alpha-Cobratoxin as a treatment for pain. Alpha-Cobratoxin\nis the main component of the cobra venom used in Nyloxin and Pet Pain-Away.\n\n \n\nThe\nFDA requires those companies manufacturing homeopathic medicines to have their facilities certified as GMP. As of October 2005, our manufacturing\nand laboratory facility has been fully compliant with its GMP certification. In March 2009, we received an ISO Class 5 certification\nfor our clean room facility. An ISO Class 5 certification is a type of classification granted for a clean room facility according to\nthe number and size of particles permitted per volume of air. An ISO Class 5 clean room has at most, 3,500 particles per square meter.\nIn 2023, we moved to our new facility in Boca Raton and have certified our lab for production.\n\n \n\nManufacturing\nNyloxin and Pet Pain-Away entails a two-step process, the first of which consists of manufacturing the bulk raw materials and completing\nthe dilution levels of the active pharmaceutical ingredient (“API”) as provided for in the Homeopathic Pharmacopeia of the\nUnited States, which is a compilation of continuously updated statements of Homeopathic Pharmacopoeia standards and monographs as recognized\nby that organization. Once this process is completed, the second step entails batching the ingredients into the final mixing, bottling\nand shipping processes.\n\n \n\nWe\nbegan limited manufacturing of Nyloxin in November 2010. We scaled up manufacturing in the first quarter of 2011. Our production level\nis contingent upon product demand level and we can scale up as sales demand increases. We began manufacturing Pet Pain-Away in late 2014\nand completed the first run of products for distribution on December 19, 2014. We are currently expanding production capacity in our\nfacility to allow spot production of our products and private label brands.\n\n \n\nIn\nMarch of 2022 we announced that we had expanded our manufacturing capabilities to include liquid filling, tube filling as well as capsule\nproduction. We also announced that we had begun scaling up in-house production of dietary supplements for third-party marketers in acting\nas a contract manufacturer; Our first such contract was with Avini Health, a related party. In early 2025, we moved all Avini Health\nmanufacturing over to Avini Health. Nutra Pharma retains unlimited rights to the use of the production facilities and access to the Avini\nproduction crew for the manufacturing of all of the Nutra Pharma products. Throughout 2025, we also produced products under private labels\nfor other third party customers. This included a variety of dietary supplements, which were transitioned to Avini Health beginning\nin the fourth quarter of 2025, while the Company retained ownership of its cobra venom technology under individual brands.\n\n \n\n**Marketing\nand Distribution**\n\n \n\nIn\nAugust 2009, we completed an agreement with XenaCare granting them the exclusive license to market and distribute Cobroxin within the\nUnited States. To maintain this market exclusivity, XenaCare was required to meet certain minimum performance requirements. On April\n1, 2011, we notified our Cobroxin Distributor, XenaCare Holdings that they were in breach of our agreement. As a result of this, the\ndistribution agreement was terminated effective April 10, 2011. XenaCare had a large stock of the product that they had ordered from\nus and we have allowed them to continue to market their existing inventory of Cobroxin. In October 2011 we discontinued their website\nat www.Cobroxin.com. All current traffic to that website is now redirected to www.Nyloxin.com. It is our plan to eventually re-launch\nCobroxin with an eventual return to retail stores.\n\n \n\nIn\nDecember of 2013, we announced an agreement with MyNyloxin.com for the exclusive rights to market and distribute Nyloxin in the Network\nMarketing channel. The arrangement is no longer material to the Company’s current operations.\n\n \n\nIn\nMay of 2016, we signed a license agreement to begin the process of creating an infomercial (Direct Response) campaign for Pet Pain-Away.\nIn November of 2016, we announced the license agreement with DEG Productions for the marketing and distribution of Pet Pain-Away globally.\nDEG created their own website (www.getpetpainaway.com) and began airing commercials in December of 2016. In February of 2020, we took\nback the marketing of Pet Pain-Away and are currently selling the product on Amazon.com, Chewy.com, and through www.petpainaway.com.\n\n \n\n7\n\n \n\n \n\nIn\nlate 2019 we created our own storefront on Amazon at www.Amazon.com/nyloxin. In August of 2020, we added Pet Pain-Away to the Amazon\nsite. In March of 2021, we added Luxury Feet and Equine Pain-Away to our Amazon storefront. In November of 2020, our Nyloxin line of\nproducts was added to the Walmart Marketplace and sold online at www.Walmart.com. In March of 2022, we announced that Avini Health would\nmarket our products on a non-exclusive basis while we will act as their contract manufacturer for the rest of their product line. Avini\nHealth currently markets our products to their Distributors under the brand “Plus Relief”. In October of 2023, we launched\nPlus Relief for Pets through Avini Health as a private label of Pet Pain-Away. We continue to work with Avini to market these products.\n\n \n\nIn\naddition to our own brands, we have several private label customers that market our pain relievers under their own brands. We are continuing\nour efforts to find strategic partnerships for the promotion, marketing, registration, licensing and sales of our products domestically\nand internationally.\n\n \n\n**Dependence\non one or a Few Major Customers**\n\n \n\nWith\nrespect to Nyloxin, Nyloxin Extra Strength and Pet Pain-Away, we have been distributing the products online and to various retailers.\nWe are seeking both domestic and international distributors for these products. It may be that a larger distributor may require exclusivity\nin the US or any particular foreign market. If so, we would be dependent on that distributor for those Nyloxin sales.\n\n \n\n**International\nDrug Registrations**\n\n \n\nWe\nare continuing our efforts to complete the registration process internationally. At present, the Company’s international efforts\nare primarily focused on India, where the Company previously obtained patent and trademark protections for Nyloxin and continues to evaluate\npotential distribution opportunities.\n\n \n\nWhile\nmany countries adopt similar regulation to the United States for registering homeopathic drugs, the international application process\nis more complex and may be lengthier. We will continue to seek qualified, well-funded distributors for the international distribution\nof Cobroxin, Nyloxin and Pet Pain-Away. At this time, we have no way of knowing when we may begin the process of marketing and distributing\nour products internationally as we navigate the regulatory process and seek qualified distributors.\n\n \n\n**Homeopathic\nDrug Pain Relief Studies**\n\n \n\nPending\nadequate financing or revenues, we will continue our research and development into this area, with the ultimate goal of improving product\nclaims for Nyloxin Extra Strength, which is a treatment for stage 3 pain. We have planned the following three studies and will pursue\nthese pending adequate financing:\n\n \n\n*MS\nNeuropathic Pain Phase IV*\n\n \n\nThis\nis a planned 10-week patient trial period. We have thus far incurred costs of $5,000 with a total estimated budget of $130,000. We plan\nto reinitiate this trial pending adequate funding.\n\n \n\n8\n\n \n\n \n\n*Chronic\nBack Pain Phase I*\n\n \n\nWe\nwill continue our research and development in this area, with the ultimate goal of completing development of our future product, Recet,\nwhich is an injectable version of Cobratoxin. This is a planned 4-week patient trial period. We have thus far incurred costs of $25,000\nin prior years with a total estimated budget of $250,000. We plan to reinitiate this trial pending adequate funding.\n\n \n\n*Chronic\nBack Pain Phase IV*\n\n \n\nWe\nwill continue our research and development, with this ultimate goal of improving product claims for Nyloxin Extra Strength, which is\na treatment for stage 3 pain. This is a planned 4-week patient trial period. We have an estimated budget of $250,000. We have not yet\nincurred any costs associated with the Chronic Back Pain Phase IV project. We plan to reinitiate this trial pending adequate funding.\n\n \n\nAll\nof these studies have been delayed due to our lack of revenues and funding. We will reassess our start and completion dates upon generating\na sufficient amount of revenues, if ever.\n\n \n\n**Research\nand Development**\n\n \n\nWe\nhave conducted research and development of novel anticholinergic therapeutic protein products for the treatment of autoimmune and neurologic\ndisorders, including Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) Adrenomyeloneuropathy (AMN), Rheumatoid Arthritis (RA)\nand pain.\n\n \n\n**Drug\nApplications**\n\n \n\nWe\nhave set forth below a summary of our proposed drugs and their potential applications.\n\n \n\n \n**Drug**\n \n**Potential\nApplications**\n\n \nRPI-78M\n \nMS,\nAMN, Rheumatoid Arthritis (RA), Myasthenia Gravis (MG) and Amyotrophic Lateral Sclerosis (ALS)\n\n \nRPI-MN\n \nHIV,\nHerpes, general anti-viral applications\n\n \nRPI-78\n \nPain,\nArthritis\n\n \nRPI-70\n \nPain\n\n \n\nWe\nbelieve that our pharmaceutical products have a wide range of applications in a number of chronic, inherited and/or life-threatening\nviral, autoimmune and neuromuscular degenerative diseases, even though none of these products have FDA or other approval for the treatment\nof such diseases. These disorders target nerve cells, especially one specific type of cell receptor that is sensitive to the neurotransmitter,\nacetylcholine, which plays an important role in the transmission of nerve impulses at synapses and myoneural (muscle-nerve) junctions.\n\n \n\n**Primary\nDisease Targets**\n\n \n\nThrough\nour research program, our goal is to obtain required regulatory approvals of our HIV, MS, and AMN products, so that they can be marketed.\nIn September of 2015 we were granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. The Orphan designation\nmay greatly reduce the costs of clinical trials and shorten the timeline to potential drug approval. We secure confidentiality agreements\nprior to initiating contract research in order to protect any patentable opportunities.\n\n \n\n9\n\n \n\n \n\n*Multiple\nSclerosis (MS)*\n\n \n\nMultiple\nSclerosis (MS) is thought to be an autoimmune disease that primarily causes central nervous system problems. In MS, the insulating fatty\nmaterial surrounding the nerve fibers, also known as *myelin*, which functions to speed signaling from one end of the nerve cell\nto the other, is attacked by cells of the immune system causing problems in signal transduction. MS is the most common of demyelinating\ndisorders, having a prevalence of approximately 1 per 1,000 persons in most of the United States and Europe. According to the American\nMultiple Sclerosis Society, 1,000,000 people in the US are affected by MS and another 2.8 million globally, with 10,000 new cases diagnosed\nin the US every year. Although MS occurs most commonly in adults, it is also diagnosed in children and adolescents. A study published\nby Emory University School of Medicine analyzed data from 53 countries that submitted pediatric data to the Atlas of MS during 2020-2022,\nand estimated that there are over 31,000 children and adolescents living with MS worldwide.\n\n \n\nPeople\nwith MS may experience diverse signs and symptoms. MS symptoms may include pain, fatigue, cognitive impairment, tremors, loss of coordination\nand muscle control, loss of touch sensation, slurred speech and vision impairment. The course of the disease is unpredictable and for\nmost MS patients, the disease initially manifests a “relapsing-remitting” pattern. Periods of apparent stability are punctuated\nby acute exacerbations that are sudden unpredictable episodes that might involve impaired vision, diminished ability to control a limb,\nloss of bladder control, or a great variety of other possible neurologic deficits. In relapsing-remitting MS, some or all of the lost\nfunction returns, however, the patient sustains an unceasing, often insidious, accumulation of neuronal damage. As the burden of neural\ndamage grows, new lesions are more likely to produce irreversible impairment of function. Typically, about eight to fifteen years after\nonset, MS patients enter the secondary-progressive phase. Eventually, progressive MS sufferers become wheelchair-bound, and may become\nblind and even incapable of speech. There is currently no FDA approved drug that reverses the course of the progressive form of MS.\n\n \n\nRPI-78M\nhas shown efficacy in animal models (EAE) for MS and we are planning new animal studies to gain more insight into the levels of protection\nthat the drugs afford. In one study conducted in August 2007, all members of an untreated animal control group developed signs of disease\nwith different levels of paralysis/muscle weakness. A similar group in the August 2007 study treated with RPI-78M showed no disease in\n90% of the animals in both acute and chronic applications of the test. Moreover, there were no toxicities reported though the animals\nwhich received doses the equivalent of 280 times a human dose.\n\n \n\nFurthermore,\nwe believe that the ability to modulate the host immunostimulatory environment could form the basis of an effective strategy for the\nlong-term control of autoimmunity in diseases like MS and Myasthenia gravis (MG) and is being studied as a therapeutic model for other\nneuromuscular diseases. Also, we believe our data suggest that it is possible that our novel therapeutic proteins could have a general\napplication in autoimmune diseases based on human studies in Rheumatoid Arthritis and anecdotal reports from patients with Multiple Sclerosis.\n\n \n\nIn\nAugust of 1984, Biogenix applied for and received an Intrastate Investigational Drug (FSDHRS Protocol RA-1 (002)) from the Department\nof Health and Rehabilitation (HRS) in Florida that permitted the 4-week study of RPI-MN in 13 patients with Rheumatoid arthritis ranging\nin age from 49 to 81. Patients were enrolled for a period of 4 weeks; the results showed 30% to 49% improvement in range of joint motion,\nearly morning stiffness and stamina (this data, along with other supporting intellectual property was acquired by our wholly-owned subsidiary\nReceptoPharm from Biogenix). We believe that the data obtained from the examination of clinical efficacy in these three diseases can\naugment information from prior clinical studies and lead to the future investigation of treatments for other chronic conditions.\n\n \n\nWe\nare currently planning two studies in Multiple Sclerosis:\n\n \n\n \n-\nStudy\nof 30 adults utilizing RPI-78M with monthly MRIs and disability testing. The goal of this small Phase IIa study would be to see if\nthe disease modification and reversal that was seen in the rat model is replicated in humans. If sclerosing lesions in the brains\nof MS patients are reduced in any way, this would be a first for any MS therapy.\n\n \n-\nStudy\nin 30-50 children diagnosed with Pediatric MS under our Orphan Designation. The goal of this study would be to utilize the benefits\nof our Orphan Designation to prove efficacy in a pediatric population of MS patients.\n\n \n\n10\n\n \n\n \n\n*Adrenomyeloneuropathy\n(AMN), Pediatric MS and other Orphan Indications*\n\n \n\nAdrenoleukodystrophy,\nor ALD, is a genetically determined neurological disorder that, according to the Adrenoleukodystrophy Foundation, affects 1 in every\n17,900 boys worldwide. The presentation of symptoms occurs between the ages of 4 and 10, and affects the brain with demyelination, which\nis the stripping away of the fatty coating that keeps nerve pulses confined and maintains the integrity of nerve signals. This process\ninhibits the nerves’ ability to conduct properly, which causes neurological deficits, including visual disturbances, auditory discrimination,\nimpaired coordination, dementia and seizures. Demyelination is an inflammatory response and nerve cells throughout the brain are destroyed.\n\n \n\nAdrenomyeloneuropathy\n(AMN) is the most common form of X-ALD, a maternally inherited type of ALD. AMN affects about 40-45% of X-ALD patients and usually presents\nitself in adolescence or adult life and may be preceded by hypoadrenalism. It is characterized by spastic paraplegia and a peripheral\nneuropathy, often being diagnosed as Multiple Sclerosis (MS). Nerve conduction studies in AMN show a predominant axonal neuropathy and\nshow a loss of all axons. Lorenzo’s oil, a mixture of glyceryltrioleate and glyceryltrierucate, has been used for over a decade\nin an open, unblinded fashion with mixed results.\n\n \n\nRPI-78M\nhas been utilized in two clinical studies, which were completed at the Charles Dent Metabolic Unit located in London, England. The last\ntrial was classified as a Phase IIb/IIIa study. These studies provided important safety data, showing RPI-78M to be well tolerated by\nthe patients. Further study is warranted to provide data on the potential efficacy of RPI-78M to treat the symptoms of AMN.\n\n \n\nIn\nSeptember of 2015, we were granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. We are currently\nworking with potential sites of care to conduct a Phase I/II in Pediatric MS. The designation of RPI-78M as an Orphan Drug provides Nutra\nPharma with a 7-year period of market exclusivity in the U.S. once the drug is approved. Additional benefits over conventional drug applications\ninclude: tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, plus assistance\nfrom the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees which could be in excess\nof $2.5 million. The granting of Orphan Drug Designation allows the Company to move forward with their preparation of an Investigative\nNew Drug Application and proposal of clinical trials. The FDA grants Orphan Drug Designation status to products that treat rare diseases,\nproviding incentives to sponsors developing drugs or biologics. According to the FDA, the Orphan Drug program has successfully enabled\nthe development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. Evaluate Ltd., in its 2025 EvaluatePharma\nOrphan Drug Report, estimated that orphan drug sales will constitute more than 20% of the total share of prescription drug sales by 2030,\ntotaling $320bn.\n\n \n\nIn\nDecember of 2015, we announced that we had applied for an Orphan Drug designation from the US-FDA for the Company’s RPI-78M drug\ncandidate for the treatment of Myasthenia Gravis (MG). The application was subsequently rejected with an offer to re-file in the future\nas more data becomes available.\n\n \n\n*Pain\nand Arthritis*\n\n \n\nProtein\nor peptide-based drugs are penetrating the pain market with neurotoxins taking the lead. Botox (Allergan) and Prialt (Elan) have the\npotential to substitute over the long-term for morphine and other opiates in chronic pain indications. Opiates, though potent painkillers,\nsuffer from drawbacks because they are addictive, short acting, and drug-resistance inducing. We plan to assess the effects of several\npeptides in animal models of pain in association with Soochow University in China. Several peptides have demonstrated positive effects\nand the research and development continues.\n\n \n\nAugust\n2007 studies at Soochow University proved the potential of our drug candidates, RPI-78 and RPI-70. When compared to Dolantin, an opiate-based\ndrug subordinate to morphine, the effects were very encouraging. While Dolantin provided immediate pain relief it began wearing off just\nas RPI-70 began to take effect. The effects of RPI-70 do not seem dramatic in contrast to Dolantin, considering the quantity of drug\nemployed in this animal model. The concentration of RPI-70 was approximately 100 times less than the opiate product. Also, RPI-70 showed\nreal potential for combining with other pain killing medications. RPI-78 was calculated to be 150,000 times more potent than aspirin.\nThis product can be injected systemically providing evidence of a more practical application than Prialt, which must be administered\nintrathecally (into the spinal cord). Opiate drugs induce tolerance and dependence. This problem is not encountered with RPI-70 and RPI-78.\n\n \n\n11\n\n \n\n \n\nIn\nFebruary 2009, we filed a patent application with the United States Patent and Trademark Office for the use of RPI-78 as a novel method\nfor treating arthritis in humans. Also in February 2009, in collaboration with Soochow University in China, we published positive data\nfrom its recent animal studies on the use of RPI-78 (Cobratoxin) as a method for treating arthritis. In March of 2011, we were issued\na patent for the use of cobratoxin as an analgesic (US patent #7,902,152). In February of 2012, in collaboration with Soochow University,\nwe published another study that demonstrated a novel mechanism of action for the use of RPI-78 as a treatment for pain.\n\n \n\n*Nerve\nAgent Countermeasures*\n\n \n\nIn\nFebruary of 2018, we announced that we had filed a new provisional patent to protect our intellectual property surrounding the development\nof nerve agent counter measures. In much the same way that our therapies protect the nerves of patients with disease, our findings indicate\nthat we may protect against – or at least mitigate the damage caused by - nerve agents that are utilized as chemical weapons; such\nas sarin gas and VX. We will be working with experts in the field to have our products in testing in later 2026.\n\n \n\nNerve\nagents are identified as a class of phosphorus-containing organic chemicals (organophosphates) that may disrupt the transfer of messages\nto organs through the nerves. This disruption is caused by the over-stimulation of certain receptors on the surface of the neurons. These\nsame receptors are the target of Nutra Pharma’s drugs, which may block the action of the nerve agents or minimize the damage that\nthey may cause.\n\n \n\nThe\ncompany has very encouraging preclinical data, a demonstrated molecular mechanism of action and a robust scientific rational for the\ncontinued commercial development of its nerve agent counter measure. Organophosphate nerve agents such as VX and Sarin remain a troubling\nthreat to American service people and civilians as evidenced by the recent attacks in Syria, Malaysia and London. Supply chain issues\nwith existing counter measures and the safety and effectiveness of these drugs is a great concern. Based on our pre-clinical studies\nand experience in neurobiology products, we believe that we have a superior product ready for testing in the near term.\n\n \n\nOn\nSeptember 22, 2020, Dr. Dale VanderPutten, our Chief Scientific Officer was invited by the Defense Threat Reduction Agency (DTRA) to\npresent our nerve agent countermeasure technology in a Tech Watch talk to an audience of military and civilian experts in chem/bio defense.\nThe talk titled “A Nicotinic Acetylcholine Receptor (nAChR) Directed Organophosphate Countermeasure” was presented in a virtual\ninternet meeting to a select expert audience invited by DTRA. The consensus of the comments and questions on the presentation supported\nthe idea that despite past efforts, there remains an unmet need for nAChR directed defenses and that our demonstration of human safety\nin the clinic and pre-clinical proof of concept deserves aggressive follow up.\n\n \n\nAccording\nto a BBC report, chemical weapons remain a real threat to the West. During the Syrian conflict there were over a thousand documented\nuses of chemical weapons; making this issue a major topic of concern in the US department of Defense and the United Nations. We have engaged a third-party agency to assist in identifying and pursuing\npotential funding opportunities and will\ncontinue working with the Department of Defense and DTRA on potential funding for these applications.\n\n \n\n**Market\nValues**\n\n \n\n*Multiple\nSclerosis (MS)*\n\n \n\nAs\nof 2023, MS affects an estimated 2.9 million people globally with approximately 1,000,000 sufferers in the United States. There are 15\napproved drugs for the treatment of this disease. According to Precedence Research, the U.S. multiple sclerosis drugs market size accounted\nfor $7.81 billion in 2024 and is predicted to increase from $8.44 billion in 2025 to approximately $17.15 billion by 2034, expanding\nat a CAGR of 8.18% from 2025 to 2034. The global multiple sclerosis drugs market size accounted for $21.26 billion in 2024 and is predicted\nto increase from $22.96 billion in 2025 to approximately $45.90 billion by 2034, expanding at a CAGR of 8.00% from 2025 to 2034. The\ngrowth of the market is driven by ongoing clinical trials, increasing approvals from regulatory agencies, and rising investments in R&D\nactivities for developing new therapies. According to an April 2015 article published in the journal *Neurology*, the average annual\ncost of these drugs has increased to over $60,000 per person. According to the National Multiple Sclerosis Society, as of February 2022,\nthe median annual price of a brand-name disease-modifying therapy was close to $94,000.\n\n \n\n12\n\n \n\n \n\n*Adrenomyeloneuropathy\n(AMN)*\n\n \n\nAMN/ALD\naffects an estimated 30,000 people in the US with some estimates exceeding this number.\n\n \n\n*Pediatric\nMultiple Sclerosis (pediatric-MS)*\n\n \n\nAccording\nto the National Multiple Sclerosis Society, although MS occurs most commonly in adults, it is also diagnosed in children and adolescents.\nEstimates suggest that 8,000-10,000 children (up to 18 years old) in the United States have MS, and another 10,000-15,000 have experienced\nat least one symptom suggestive of MS. Studies suggest that two to five percent of all people with MS have a history of symptom onset\nbefore age 18.\n\n \n\n*Myasthenia\nGravis (MG)*\n\n \n\nAccording\nto the Myasthenia Gravis Foundation of America, the prevalence of MG in the United States is estimated to be about 64,000 patients. However,\nMG is probably under diagnosed and the prevalence may be higher.\n\n \n\n**Business\nStrategy**\n\n \n\nPending\nadequate financing or revenues, we seek to develop proprietary pharmaceutical products for human illnesses that qualify for “Fast-Track”\nor “Orphan Drug” status under FDA regulations, which can expedite regulatory review. For some conditions, the FDA has created\nthe “two animal rule” which permits us to collect data from ongoing animal research for human treatment applications.\n\n \n\nWe\nbelieve the results from our research will assist in getting our applications processed through the FDA’s “Fast-Track”\napproval process and enable us to plan the commercialization of each product independently and/or through joint ventures, partnerships\nand licensing arrangements. “Fast-Track” denotes life-threatening illnesses, while “Orphan” status refers to\nserious ailments affecting less than 200,000 individuals nationwide. AMN qualifies under both labels because it is considered an orphan\ndisease and has no known cure. Pediatric MS and Myasthenia Gravis are also considered “Orphan” diseases because of the disease\nprevalence as well as the lack of effective therapies.\n\n \n\nWe\nbelieve that our proposed unique pharmaceutical products can be used alone or licensed for use in combination with other therapeutic\nproducts and may be of interest to other established pharmaceutical companies as a means of extending the patent life of their proprietary\nproducts.\n\n \n\n*Short-term\nGoal*\n\n \n\nAlthough\nwe focused our drug development efforts from 2006 to 2008 on clinical trials for ReceptoPharm’s HIV drug, RPI-MN, our primary focus\nnow is on RPI-78M for the treatment of MS and MG. With the Orphan designation for Pediatric MS, we expect to move into Phase I/II clinical\nstudies in later 2026.\n\n \n\n*Mid-term\nGoal*\n\n \n\nOur\nmidterm strategy is to license our AMN, MS and HIV technologies in our attempt to bring these technologies to market within 5 years,\nshould we obtain adequate financing.\n\n \n\n*Long-Term\nGoal*\n\n \n\nOur\nlong-term goal is the use of our drugs in the field of neurological diseases, infectious diseases and autoimmune disorders. Due to our\nlimited financial and operational resources, this goal will require us to establish strategic partners or alliances with pharmaceutical\ncompanies, academic institutions, biotechnology companies, and clinical diagnostic laboratories, which will: (a) complement our research\nand development efforts; (b) reduce the risks associated with undertaking the entire process of drug development and marketing; and (c)\ngenerate licensing based revenue streams. Additionally, we plan to continue identifying intellectual property and companies in the biotechnology\narena as potential acquisition candidates.\n\n \n\n13\n\n \n\n \n\n**Compassionate\nRelease Programs**\n\n \n\nCertain\ncountries, such as Canada and the United Kingdom, permit their citizens to have access to investigational medications without being approved\nfor any applications by their respective “FDA type” agencies, and permit physicians to prescribe drugs they believe are of\npossible benefits to the patients. Through these “Compassionate Release Programs”, we have supplied RPI-78M, our drug under\ninvestigation for MS and AMN, to physicians in the United Kingdom. The FDA does not offer this program.\n\n \n\n**Clinical\nTrial Applications**\n\n \n\nWe\nhave developed Common Technical Documents (CTD) for both RPI-78M and RPI-MN that are used to support any clinical trial application.\nThe CTD is a complete history of the individual drug, including all of the in-vitro and in-vivo work accomplished to date, as well as\npre-clinical development work on the drug. Having these completed documents allows for expedited due diligence from regulatory bodies\nreviewing our applications for trials and approvals. With these documents, we successfully applied for approval to conduct a clinical\ninvestigation in the United Kingdom under the regulation of the Medicines Health and Regulatory Agency (MHRA), which is the British equivalent\nof the US-FDA.\n\n \n\n**Current\nResearch and Development Projects**\n\n \n\n**Neurological\nStudies**\n\n \n\n*Pain\nStudies*\n\n \n\nIn\nan effort to further support Nyloxin Extra Strength, we had planned to complete two human clinical studies aimed at comparing the ability\nof Nyloxin Extra Strength to replace prescription pain relievers. We originally estimated that these studies would begin during the second\nquarter of 2010; however, these studies have been delayed because of lack of funding. We have no way of knowing at this time, if or when\nwe will have adequate funding to reinitiate these trials.\n\n \n\n*AMN\nPhase II*\n\n \n\nWe\nhave been conducting research and development in this area since February 2006 with an original expected completion date of September\n2010, which includes a 12-month patient trial period that has already been completed. We have thus far expended approximately $400,000,\nbecause we have completed our AMN Phase II project, there is no further budget for this project.\n\n \n\n*AMN\nPhase III*\n\n \n\nWe\nhad planned to continue research and development, with the ultimate goal of completing development of our future drug, RPI-78M. Our originally\nestimated start and completion dates were July 2010 and December 2011, respectively, which includes a 12-month patient trial period.\nWe have thus far incurred costs of $5,000. We have an estimated budget of $500,000. We have no way of knowing at this time, if or when\nwe will have adequate funding to reinitiate these trials.\n\n \n\n*MS\nPhase II (Pediatric MS Phase I/II)*\n\n \n\nWe\nare working with our Chief Scientific Officer, Dale Vanderputten, PhD; along with consultants to begin our Phase I/Phase II studies in\npediatric Multiple Sclerosis. Pending adequate financing or revenues, we will continue our research and development, with the ultimate\ngoal of commencing these trials with RPI-78M under our Orphan Designation. We have thus far incurred costs of $40,000. We have an estimated\nbudget of $2,000,000. Our goal is to initiate these trials in later 2026.\n\n \n\nCurrently,\nour total estimated costs for all of the above projects is approximately $3,000,000.\n\n \n\nSince\nreceiving Orphan designation for the treatment of Pediatric MS, our plans have changed. We are now working with potential sites of care\nto initiate a Phase I/II clinical trial in Pediatric MS. Our next step is to have a pre-IND meeting with the FDA to go over the proposed\ntrial protocols. It is our goal to begin these trials in 2026.\n\n \n\n14\n\n \n\n \n\n**Dependence\non one or a Few Major Customers**\n\n \n\nWe\nhave no customers with respect to our research and development projects since we have not received FDA approval for our drug candidates\nand have not licensed any of our technologies.\n\n \n\n**Marketing**\n\n \n\nWe\ncurrently do not have a marketing program for our drug candidates because none of our products have received FDA approval. Our lack of\nfinancing has hampered our efforts to navigate the regulatory process in a timely fashion; however, if and when we have FDA-approved\ndrug treatments, we plan to develop a marketing strategy to market our products through pharmaceutical companies, other biotechnology\ncompanies, and diagnostic laboratories. Our Operations Manager will market the treatments to licensing and development officers of those\ncompanies and will otherwise direct our marketing program. Additionally, we will attempt to secure consulting agreements with marketing\nconsultants who will actively market our products to such companies and/or provide our Chief Executive Officer with marketing guidance.\n\n \n\n**Potential\nRevenue Segments**\n\n \n\nOur\npotential revenue segments are composed of our attempt to generate revenues from license agreements, joint ventures in foreign countries\nand drug sales.\n\n \n\nTo\ndate, we have not earned any revenues regarding any FDA drug candidate.\n\n \n\n**Product\nLiability**\n\n \n\nWe\nmaintain product liability insurance for our commercial products. Even so, product liability claims may result in significant legal costs\nrelated to our defense of such actions if damage amounts exceed our product liability insurance coverage. The design, development, and\nmanufacture of drug products or diagnostic tests involves an inherent risk of product liability claims and corresponding damage to our\nbrand name reputation, including claims of product failure or harm caused by the drug product.\n\n \n\n**Sources\nand Availability of Raw Materials**\n\n \n\nWe\nuse the raw material, cobra venom, for the drugs that we study and in the production of all of our over-the-counter products. We currently\nhave two US suppliers of cobra venom that we use according to product demand. In addition, there are other suppliers in China, Thailand\nand India. Our management is responsible for locating cobra venom suppliers on an as-needed basis, which involves obtaining a small test\namount from a supplier for scientific validation of that raw material prior to purchase. Apart from cobra venom, there are no availability\nissues with any of the other components, excipients or compounds that we use in our products.\n\n \n\n**Compliance\nwith Government Regulations and Need for Government Approval**\n\n \n\nThe\nproduction and marketing of potential drug products as well as research and development activities generally are subject to regulation\nby numerous governmental authorities in the United States and other countries. In the United States, vaccines, drugs and certain diagnostic\nproducts are subject to FDA review of safety and efficacy. The Federal Food, Drug and Cosmetic Act, the Public Health Service Act and\nother federal statutes and regulations govern or influence the testing, manufacture, safety, labeling, storage, record keeping, approval,\nadvertising and promotion of such products. Noncompliance with applicable requirements can result in criminal prosecution and fines,\nrecall or seizure of products, total or partial suspension of production, or refusal of the government to approve Biological License\nApplications (“BLAs”), Product License Applications (“PLAs”), New Drug Applications (“NDAs”) or refusal\nto allow a company to enter into supply contracts. The FDA also has the authority to revoke product licenses and establishment licenses\npreviously granted.\n\n \n\n15\n\n \n\n \n\nIn\norder to obtain FDA approval to market a new biological or pharmaceutical product, proof of product safety, purity, potency and efficacy,\nand reliable manufacturing capability must be submitted. This requires companies to conduct extensive laboratory, pre-clinical and clinical\ntests. This testing, as well as preparation and processing of necessary applications, is expensive, time-consuming and often takes several\nyears to complete. There is no assurance that the FDA will act favorably in making such reviews. Our potential partners, or we, may encounter\nsignificant difficulties or costs in their efforts to obtain FDA approvals, which could delay or preclude from marketing any products\nthat may be developed. The FDA may also require post-marketing testing and surveillance to monitor the effects of marketed products or\nplace conditions on any approvals that could restrict the commercial applications of such products. Product approvals may be withdrawn\nif problems occur following initial marketing, such as, compliance with regulatory standards is not maintained. Delays imposed by governmental\nmarketing approval processes may materially reduce the period during which a company will have the exclusive right to exploit patented\nproducts or technologies. Refusals or delays in the regulatory process in one country may make it more difficult and time consuming to\nobtain marketing approvals in other countries.\n\n \n\nThe\nFDA approval process for a new biological or pharmaceutical drug involves completion of preclinical studies and the submission of the\nresults of these studies to the FDA in an Initial New Drug application, which must be approved before human clinical trials may be conducted.\nThe results of preclinical and clinical studies on biological or pharmaceutical drugs are submitted to the FDA in the form of a BLA,\nPLA or NDA for product approval to commence commercial sales. In responding to a BLA, PLA or NDA, the FDA may require additional testing\nor information, or may deny the application. In addition to obtaining FDA approval for each biological or chemical product, an Establishment\nLicense Application (“ELA”) must be filed and the FDA must inspect and license the manufacturing facilities for each product.\nProduct sales may commence only when both BLA/ PLA/ NDA and ELA are approved. In certain instances in which a treatment for a rare disease\nor condition is concerned, the manufacturer may request the FDA to grant the drug product Orphan Drug status for a particular use. “Orphan\nDrug” status refers to serious ailments affecting less than 250,000 individuals. In this event, the developer of the drug may request\ngrants from the government to defray the costs of certain expenses related to the clinical testing of such drug and be entitled to marketing\nexclusivity and certain tax credits.\n\n \n\nIn\norder to gain broad acceptance in the marketplace of a medical device, our partners or we will need to receive approval from the FDA\nand other equivalent regulatory bodies outside of the United States. This approval will be based upon clinical testing programs at major\nmedical centers. Data obtained from these institutions will enable us, or our partners, to apply to the FDA for acceptance of its technology\nas a “device” through a 510(k) application or exemption process. Once the data has been fully gleaned, it is expected that\nthis process would take ninety days.\n\n \n\nAccording\nto the FDA, a “device” is: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or\nother similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or\nthe United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the\ncure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of\nthe body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on\nthe body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended\npurposes.”\n\n \n\nThe\nFDA classifies devices as either Class I/II-exempt, Class II, or Class III.\n\n \n\nClass\nIII: Pre-Marketing Approval, or PMA: A Pre-Marketing Approval or PMA is the most stringent type of device marketing application required\nby FDA. A PMA is an application submitted to FDA to request clearance to market, or to continue marketing of a Class III medical device.\nA PMA is usually required for products with which FDA has little previous experience and in such cases where the safety and efficacy\nmust be fully demonstrated on the product. The level of documentation is more extensive than for a 510(k) application and the review\ntimeline is usually longer. Under this level of FDA approval, the manufacturing facility will be inspected as well as the clinical sites\nwhere the clinical trials are being or have been conducted. All the appropriate documents have to be compiled and available on demand\nby the FDA. The manufacturing facility is registered with the FDA and the product or device is registered with the FDA.\n\n \n\n16\n\n \n\n \n\nClass\nII: 510(k). This is one level down from the PMA and it is applied to devices with which the FDA has had previous experience. A 510(k)\nis a pre-marketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially\nequivalent, to a legally marketed device that is not subject to pre-market approval. Applicants must compare their 510(k) device to one\nor more similar devices currently on the U.S. market and make and support their substantial equivalency claims. The legally marketed\ndevice to which equivalence is drawn is known as the “predicate” device. Applicants must submit descriptive data and, when\nnecessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability,\nthat is, substantial equivalency (SE) of a new device to a predicate device. Under this level of approval, the manufacturing facility\nis registered with the FDA and the product or device is registered with the FDA. Inspections under this classification are possible.\nAll the appropriate cGMP and clinical data backing the claims made must be on file and available on demand by the FDA.\n\n \n\nClass\nI/II Exemption: This is the lowest level of scrutiny. Most Class I devices and a few Class II devices are exempt from the pre-marketing\nnotification requirements subject to the limitations on exemptions. However, these devices are not exempt from other general controls.\nAll medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged\nand properly labeled, and have establishment registration and device listing forms on file with the FDA. However, as described above,\nall the appropriate documentation including cGMP and clinical data supporting the claims being made has to be on hand and available on\ndemand by the FDA. The data must be available to support all the product claims.\n\n \n\nSales\nof biological and pharmaceutical products and medical devices outside the United States are subject to foreign regulatory requirements\nthat vary widely from country to country. Whether or not FDA approval has been obtained, approval of a product or a device by a comparable\nregulatory authority of a foreign country must generally be obtained prior to the commencement of marketing in that country.\n\n \n\n**Effect\nof Compliance with Federal, State, and Local Provisions for the Protection of the Environment**\n\n \n\nWe\nhave no present or anticipated direct future costs associated with environmental compliance, since we are not and will not be directly\ninvolved in manufacturing drug products as a result of our research and development; however, we may be affected in the percentage licensing\nfees we receive, since a company may consider the environmental expense as an offset to a determination of the percentage amount we receive.\nWe produce a drug that has limited waste issues and related costs, but handles environmentally related matters through the FDA’s\nGood Manufacturing Practices, the FDA mandated guidelines pertaining to the production of drugs in the United States.\n\n \n\n**Ability\nto Compete**\n\n \n\nThe\nbiotechnology research and development field is extremely competitive and is characterized by rapid change. Our competitors have substantially\ngreater financial, scientific, and human resources, and as a result greater research and product development capabilities. Our competitors\nhave competitive advantages with greater potential to develop revenue streams. Our competitors are located in the United States as well\nas around the world. We will attempt to compete by establishing strategic partners or alliances with pharmaceutical companies, academic\ninstitutions, biotechnology companies, and clinical diagnostic laboratories, which will enter into joint ventures, emphasizing that the\ndrugs RPI-MN and RPI-78M possess the following properties:\n\n \n\n \n●\nThey\nlack measurable toxicity but are still capable of attaching to and affecting the target site on the nerve cells. This means that\npatients cannot overdose.\n\n \n●\nThey\ndisplay no significant adverse side effects following years of investigations in humans and animals.\n\n \n●\nThe\nproducts are stable and resistant to heat, which gives the drug a long shelf life. The drugs’ stability has been determined\nto be over 4 years at room temperature.\n\n \n\nRPI-78M\ncan be administered orally; however, we have not yet developed an orally administered RPI-78M. RPI-78M has been routinely delivered by\ninjection in a manner similar to insulin, but research over the past two years has given rise to administration by mouth. Oral delivery\npresents patients with additional “quality of life” benefits by eliminating or decreasing the requirements for routine injections.\nShould we receive adequate funding, we plan to develop an orally administered RPI-78M by initiating new trials with an oral version of\nthat drug.\n\n \n\n17\n\n \n\n \n\n**Main\nCompetitors (Biologics)**\n\n \n\nCompetition\nis intense among companies that develop and market products based on advanced cellular and molecular biology. Our competitors, including\nAmgen, Sanofi-Aventis, Biogen-Idec, Cephalon, Genetech, Genzyme, Novartis, Regeneron, Roche and Bayer, which have far superior financial,\ntechnological and operational resources. We face significant competition from these and other biotechnology and pharmaceutical firms\nin the United States, Europe and elsewhere. Certain specialized biotechnology firms have also entered into cooperative arrangements with\nmajor companies for development and commercialization of products, creating an additional source of competition.\n\n \n\nAny\nproducts or technologies that successfully address viral or neurological indications could negatively impact the market potential for\nRPI-78M or RPI-MN. These include products that could receive approval for indications similar to those for which RPI-78M or RPI-MN seeks\napproval, development of biologic or pharmaceutical treatments that are more effective than existing treatments and the development of\nother modalities with reduced toxicity and side effects.\n\n \n\n \n\nThe\nglobal sales of drugs for the treatment of Multiple Sclerosis reached over $30 billion in 2025 and is expected to grow to over $46 billion\nby 2033 according to Nova Advisor. The main category are interferon-based drugs, which account for over 90% of sales. Ocrevus leads the\ncategory with over $7 billion in sales, followed by Kesimpta with $2.7 billion in sales. The main attraction for Ocrevus is dosing by\ninfusion of only twice annually.There has been little innovation in the treatment of MS in over 30 years. More recently, BTK inhibitors\nhave been studied as an alternative to the interferon-type drugs. This class of drug still faces challenges that include side effects\n– some severe; including liver failure in some patients. Sanofi’s drug, tolebrutinib, failed late stage trials in 2025; placing\ndoubt on future drugs of this mechanism.\n\n \n\nGilead\nSciences markets Harvoni as a ‘cure’ for Hepatitis C. It combines two drugs: Sovaldi (sofosbuvir) and ledipasvir. Harvoni\nis taking over the market as Gilead has turned Hepatitis C into a curable illness and has generated over $25B in sales.\n\n \n\n**Main\nCompetitors (Venom-Based Drugs)**\n\n \n\nWe\nview our main competitors as those who also engage in the development of protein-based neurotoxins as therapeutics. Employing venoms\nas therapeutics is not new**.** A large number of well-known pharmaceutical companies are developing novel therapies derived from\nsnake venoms and other reptiles. Most of those using snake venoms employ the anticoagulant enzymes usually from viperids (adders and\nrattlesnakes) though elapids (cobra family) are also being investigated.\n\n \n\nWe\nhave set forth below a summary of venom-based drugs and their potential applications.\n\n \n\n**Company**\n \n**Drug**\n \n**Application**\n\nPentapharm\n \nBatroxobin\n(Defibrase)\n \nAnticoagulant\nfrom Lancehead viper\n\nKnoll\nPharmaceutical\n \nAncrod\n(Viprinex)\n \nAnticoagulant\nfrom Malayan pit viper\n\nBristol-Myers\nSquibb\n \nCapoten\n(Captopril)\n \nAntihypertensive\nfrom Brazilian Pit Viper\n\nMedicure\n \nTirofiban\n(Aggrastat)\n \nAntiplatelet\ndrug from Saw-scaled viper\n\nMillennium\nPharmaceutical\n \nEptifibatide\n(Integrilin)\n \nAntiplatelet\ndrug from Pygmy rattlesnake\n\nAmylin\nPharmaceuticals\n \nExanatidfe\n(Byetta)\n \nTreatment\nfor type 2 diabetes and obesity from Gila Monster venom\n\nElan\nPharmaceuticals\n \nZiconotide\n(Prialt)\n \nIntrathecal\ndrug from cone snails for intractable pain\n\n \n\nCurrent\ncobra venom-based therapies include Keluoqu, a pain-killing drug on the market in China since 1978. Keluoque contains cobrotoxin as its\nprimary ingredient and is used to control severe pain in advanced cancer patients and for post-operative pain.\n\n \n\n18\n\n \n\n \n\n**Bio-Therapeutics,\nInc.**\n\n \n\nOn\nOctober 3, 2003, we entered into a non-assignable license agreement between Bio-Therapeutics, Inc. (“ Bio-Therapeutics”)\nand us, which was then amended to make the license agreement assignable. This agreement was in settlement of a lawsuit that we filed\nagainst Bio-Therapeutics alleging that Bio-Therapeutics owed us $850,000 in connection with a merger agreement between Bio-Therapeutics\nand us that was cancelled.\n\n \n\nThe\n2003 license agreement provides that for a non-exclusive license to certain intellectual property of Bio-Therapeutics, which consists\nof the following two distinct technology platforms:\n\n \n\n \n●\nAlteration\nof Proteins and Peptides - These include patented methods for altering the 3-Dimensional structure of certain proteins and peptides.\nThe natural peptides bind to receptors in the body with toxic effects. This technology allows us to alter the structure of these\npeptides, preserving their receptor-binding characteristics, while making them non-toxic and therapeutic. Different receptors have\nvarious functions in many disease states. By the peptides binding to these receptors in a controlled fashion, certain disease symptoms\nmay be treated. In connection with MS, binding to the acetylcholine receptor on the nerves allows for more efficient nerve conduction.\nWith HIV, binding to chemokine receptors may prevent the virus from entering and infecting new cells.\n\n \n \n \n\n \n●\nNon-\nExclusive License for “Buccal Delivery System” (“Buccal”) – An innovative aerosolized drug delivery\nsystem that is patent pending. Many therapeutic agents cannot be effectively delivered by aerosol formulation due to their large\nsize and/or irregular shapes. Since these therapeutic agents cannot be ingested orally without being degraded by the digestive system,\npatients have no alternative but to directly inject these drugs. We have a non-exclusive license to the Buccal patent pending proprietary\naerosol formulation, which greatly enhances the permeability of the mucous membranes found on the roof of the mouth and the back\nof the throat. This allows for the easy and efficient systemic delivery into the bloodstream of a much wider variety of proteins\nand peptides. This non-exclusive license for “Buccal Delivery System” and patent pending application includes claims\nthat identify the active mucosal enhancer, its combination with therapeutic agents and the mode of delivery through aerosol. This\nmay allow for the effective and pain-free delivery of peptide and protein therapeutics for the treatment of HIV and MS.\n\n \n\n**Patents,\nTrademarks, Licenses and Intellectual Property**\n\n \n\nIn\nJuly of 2021, we announced that we had filed a new provisional patent to protect our intellectual property surrounding our development\nof nerve agent counter measures. We will continue to prosecute that patent as well as several other patent applications.\n\n \n\nWe\nhave the following patents expiring at various dates indicated below:\n\n \n\n*ReceptoPharm\nPatents*\n\n \n\nReceptoPharm\nhas three issued and several patents pending with the United States Patent and Trademark Office. These patents include:\n\n \n\nU.S.\nPatent No. 8,034,777, Modified Anticholinergic Neurotoxins as Modulators of the Autoimmune Reaction was granted in October 2011with 7\nclaims. The patent describes a method of treatment of a human patient suffering from Multiple Sclerosis comprising the administration\nof a disease-mitigating amount of a composition consisting of detoxified and modified alpha-cobratoxin in a saline solution. This patent\nis meant to protect and support our work in the production of drugs for the treatment of auto-immune diseases. This patent expired on\nNovember 22, 2025. We have filed new patents in protection of our clinical platform for the treatment of autoimmune diseases based on\nmanufacturing improvements.\n\n \n\n19\n\n \n\n \n\nU.S.\nPatent No. 7,902,152, Use of cobratoxin as an analgesic was granted in March 2011 with 16 claims. The patent describes a composition\nof matter for an analgesic and its method of use is disclosed. The method of use is for the treatment of chronic pain, especially to\nthe treatment of heretofore intractable pain as associated with advanced cancer. The pain associated with neurological conditions, rheumatoid\narthritis, viral infections and lesions is also contemplated. The method includes administering to a host an alpha-neurotoxin that is\ncharacterized by its ability to blocking of the action of acetylcholine at nicotinic acetylcholine receptors. Currently, this would be\napplied to the Company’s current and future drugs for the treatment of pain. This patent will expire on October 13, 2028. We will\nfile additional patents in protection of our clinical platform for the treatment of pain and inflammation.\n\n \n\nU.S.\nPatent No. 7,758,894, Modified elapid venoms as stimulators of the immune reaction was granted in July, 2010 with 14 claims. The patent\ndescribes a method of protection from infections by administering a detoxified and neurotropically active modified venom containing alpha-cobratoxin.\nProtection includes bacterial, viral and parasitic infections. This patent is meant to protect and support our work in our production\nof anti-infective treatments. Currently, this would be applied to RPI-MN and RPI-78. This patent will expire on September 11, 2027. We\nwill file additional patents in protection of our clinical platform for the treatment of viral infection.\n\n \n\nOur\nbusiness is dependent upon our ability to protect our proprietary technologies and processes. Despite our efforts to protect our proprietary\nrights, unauthorized parties may attempt to obtain and use proprietary information. We will rely on patent and trade secret law and nondisclosure\nand other contractual arrangements to protect such proprietary information. We will file patent applications for our proprietary methods\nand devices for patient treatments. Our efforts to protect our proprietary technologies and processes are subject to significant risks,\nincluding that others may independently develop equivalent proprietary information and techniques, gain access to our proprietary information,\nour proprietary information being improperly disclosed, or that we may ineffectively protect our rights to unpatented trade secrets or\nother proprietary information.\n\n \n\n**Employees**\n\n \n\nWe\nemploy a total of 7 employees, consisting of: (a) our Chief Executive Officer (b) Our Director of Marketing (c) our Chief Scientific\nOfficer (d) our VP of Operations (e) our Operations Manager, (f) our Quality Systems Manager and (g) our Warehouse Manager. We utilize\noutside consultants, legal and accounting personnel as necessary and as funding permits.\n\n \n\n**Report\nto Security Holders**\n\n \n\nWe\nare subject to the informational requirements of the Securities Exchange Act of 1934. Accordingly, we file annual, quarterly and other\nreports and information with the Securities and Exchange Commission. You may read and obtain a copy of these reports in Washington, D.C.\nOur filings are also available to the public from commercial document retrieval services and the Internet world wide website maintained\nby the Securities and Exchange Commission at www.sec.gov.\n\n \n\n20"}