EDGAR 10-K Filing

Company CIK: 1119643
Filing Year: 2025
Filename: 1119643_10-K_2025_0001493152-25-024800.json

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ITEM 1. BUSINESS
Item 1. Business
Introduction
Nutra Pharma is a biopharmaceutical company with intellectual property for drugs that treat autoimmune disorders, viral diseases and pain. Nutra Pharma was incorporated under the laws of the state of California on February 1, 2000, under the original name of Exotic-Bird.com.
Nutra Pharma conducts drug discovery research and development (R&D) activities. In October 2009, Nutra Pharma launched its first consumer product called Cobroxin, an over-the-counter pain reliever designed to treat moderate to severe chronic pain. In May 2010, Nutra Pharma launched its second consumer product called Nyloxin, an over-the-counter pain reliever that is a stronger version of Cobroxin and is designed to treat severe chronic pain. In December 2014, we launched Pet Pain-Away, an over-the-counter pain reliever designed to treat pain in cats and dogs. In October 2019, we launched Equine Pain-Away, an over-the-counter topical pain reliever designed to treat pain in horses. In March of 2021, we launched Luxury Feet, an over-the-counter pain reliever and anti-inflammatory product that is designed for women who experience pain or discomfort due to high heels and stilettos. In October of 2021 we began manufacturing private labelled products for third party distributors.
We have conducted our operations since October 2003. We are a biopharmaceutical company that engages in the acquisition, licensing and commercialization of pharmaceutical products and technologies as well as homeopathic and ethical drugs for the management of pain, neurological disorders, cancer, autoimmune and infectious diseases. Homeopathic drugs are natural products that contain ingredients listed in the HPUS (Homeopathic Pharmacopoeia of the United States). An ethical drug is a licensed drug that has obtained Federal Drug Administration (“FDA”) approval after extensive pre-clinical and clinical testing. We seek strategic licensing partnerships to reduce the risks associated with the drug development process.
We have carried out our homeopathic and drug discovery research and clinical development and fully developed four homeopathic drugs for the relief of pain:
● Nyloxin and Nyloxin Extra Strength
● Pet Pain-Away: an over-the-counter pain reliever designed to relieve pain in cats and dogs
● Equine Pain-Away: an over-the-counter topical pain reliever designed to relieve pain in horses
● Luxury Feet: an over-the-counter pain reliever designed to relieve foot pain from high heels and stilettos
Our business plan will continue its efforts to produce, market and distribute our Nyloxin, Pet Pain-Away, Equine Pain-Away™ and Luxury Feet™ branded products both domestically and internationally.
From October 2009 until December 31, 2023, our operations centered on the marketing of Cobroxin (our discontinued product), Nyloxin and Nyloxin Extra Strength. In December of 2014, we launched Pet Pain-Away and began actively marketing the product. In October of 2021, we began manufacturing a Zeolite detoxification product and conducted some online sales. We launched Equine Pain-Away in October of 2019 and Luxury Feet officially launched distribution in March of 2021.
On March 17, 2022, we announced that we had completed the process of bringing all of our manufacturing in-house. Previously, we had utilized contract manufactures to make our products. We announced that expanding our in-house manufacturing capabilities has put Nutra Pharma in a very good position as far as reduced product costs, higher margins, faster product upgrades and an increased ability to launch new and innovative products.
On March 23, 2022, we announced that we had our first agreement to act as a formulator and contract manufacturer for the dietary supplement company, Avini Health, a related party.
Additionally, the Company has developed two drug candidates:
● RPI-78M, to treat neurological diseases and autoimmune diseases, including; Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease), Rheumatoid Arthritis (RA) and Myasthenia Gravis; and
● RPI-MN, to treat viral diseases, including HIV/AIDS and Herpes.
The Company has developed proprietary therapeutic protein products primarily for the prevention and treatment of viral and neurological diseases, including Multiple Sclerosis (MS), Adrenomyeloneuropathy (AMN), Human Immunodeficiency Virus (HIV) and pain in humans. These potential products are subject to FDA approval. In September of 2015 we were granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. The Orphan designation may greatly reduce the costs of clinical trials and shorten the timeline to potential drug approval.
The Company is also pursuing the use of our technology as a potential nerve agent countermeasure that may protect war fighters from chemical weapon attacks on the battlefield.
We continue to identify biotechnology related intellectual property and companies with which we may potentially be able to enter into arrangements, agreements or to potentially acquire.
Industry Overview of the Pain Market
Pain is the most common symptom for patients seeking medical attention. Acute and chronic pain affects large numbers of Americans. According to the US Pain Foundation (www.uspainfoundation.org) Almost 21% of the U.S. population-51.6 million adults-lives with chronic pain, defined as pain lasting more than three months. Of those, 17.1 million live with high-impact chronic pain that substantially restricts their ability to work or participate in daily activities. This costs as much as $635 billion yearly in direct healthcare costs, lost productivity and disability payments.
According to The Business Research Company, The global market for chronic pain intervention reached $78.79 billion in 2024. This is expected to exceed $117 billion by 2029. This includes prescription and over-the-counter (OTC) drugs as well as medical devices like portable nerve stimulators.
Our Products
Nyloxin/Nyloxin Extra Strength
We offer Nyloxin/Nyloxin Extra Strength as our over-the-counter (OTC) pain reliever that has been clinically proven to treat moderate to severe (Stage 2) chronic pain.
Nyloxin and Nyloxin Extra Strength are available as a two-ounce topical gel for treating joint pain and pain associated with arthritis and repetitive stress, and as a one ounce oral spray for treating lower back pain, migraines, neck aches, shoulder pain, cramps, and neuropathic pain. Both the topical gel and oral spray are packaged and sold as a one-month supply.
Nyloxin and Nyloxin Extra Strength offer several benefits as a pain reliever. With increasing concern about consumers using opioid and acetaminophen-based pain relievers, the Nyloxin products provide an alternative that does not rely on opiates or non-steroidal anti-inflammatory drugs, otherwise known as NSAIDs, for their pain-relieving effects. Nyloxin also has a well-defined safety profile. Since the early 1930s, the active pharmaceutical ingredient (API) of Nyloxin, Asian cobra venom, has been studied in more than 46 human clinical studies. The data from these studies provide clinical evidence that cobra venom provides an effective treatment for pain with few side effects and has the following benefits:
● safe and effective;
● all natural;
● long-acting;
● easy to use;
● non-narcotic;
● non-addictive; and
● analgesic and anti-inflammatory.
Potential side effects from the use of Nyloxin are rare, but may include headache, nausea, vomiting, sore throat, allergic rhinitis and coughing.
The primary difference between Nyloxin and Nyloxin Extra Strength is the dilution level of the venom. The approximate dilution levels for Nyloxin and Nyloxin Extra Strength are as follows:
Nyloxin
● Topical Gel: 30 mcg/mL
● Oral Spray: 70 mcg/mL
Nyloxin Extra Strength
● Topical Gel: 60 mcg/mL
● Oral Spray: 140 mcg/mL
In December 2011, we began marketing Nyloxin and Nyloxin Extra Strength at www.nyloxin.com. Both Nyloxin and Nyloxin Extra Strength are packaged in a roll-on container, squeeze bottle and as an oral spray. Additionally, Nyloxin topical gel is available in an 8 ounce pump bottle.
We are currently marketing Nyloxin and Nyloxin Extra Strength as treatments for moderate to severe chronic pain. Nyloxin is available as an oral spray for treating back pain, neck pain, headaches, joint pain, migraines, and neuralgia and as a topical gel for treating joint pain, neck pain, arthritis pain, and pain associated with repetitive stress. Nyloxin Extra Strength is available as an oral spray and gel application for treating the same physical indications but is aimed at treating the most severe (Stage 3) pain that inhibits one’s ability to function fully.
The Nyloxin products are available for sale on the www.Nyloxin.com website, the Nyloxin Amazon storefront at www.Amazon.com/nyloxin and on the Walmart Marketplace. Nyloxin is also sold in physician offices, clinics and small-chain pharmacies.
Nyloxin Military Strength
In December 2012, we announced the availability of Nyloxin Military Strength for sale to the United States Military and Veteran’s Administration. Over the past few years, the U.S. Department of Defense has been reporting an increase in the use and abuse of prescription medications, particularly opiates. In 2009, close to 3.8 million prescriptions for pain relievers were written in the military. This staggering number was more than a 400% increase from the number of prescriptions written in the military in 2001. But prescription drugs are not the only issue. The most common and seemingly harmless way to treat pain is with non-steroidal, anti-inflammatory drugs (NSAIDS). But there are risks. Overuse can cause nausea, vomiting, diarrhea, heartburn, ulcers and internal bleeding. In severe cases chest pain, heart failure, kidney dysfunction and life-threatening allergic reactions can occur. It is reported that approximately 7,600 people in America die from NSAID use and some 78,000 are hospitalized. Ibuprofen, also an NSAID has been of particular concern in the military. The terms “Ranger Candy” and “Military Candy” refer to the service men and women who are said to use 800mg doses of Ibuprofen to control their pain. But when taking anti-inflammatory Ibuprofen in high doses for chronic pain, there is potential for critical health risks; abuse can lead to serious stomach problems, internal bleeding and even kidney failure. There are significantly greater health risks when abuse of this drug is combined with alcohol intake. Our goal is that with Nyloxin, we can greatly reduce the instances of opiate abuse and overuse of NSAIDS in high risk groups like the US military. The Nyloxin Military Strength represents the strongest version of Nyloxin available and is approximately twice as strong as Nyloxin Extra Strength. We are working with outside consultants to register Nyloxin Military Strength and the other Nyloxin products for sale to the US government and the various arms of the military as well as the Veteran’s Administration. In February of 2018, Nyloxin was added to the Federal Supply Schedule but was subsequently removed the following week without an adequate explanation. We have continued to work with our consultants to understand why our products were improperly removed the Federal Supply Schedule and when we may be able to get re-listed on the Federal Supply Schedule for eventual sales to governmental agencies or to the US Military.
International Sales
We are pursuing international drug registrations in Canada, Mexico, India, Australia, New Zealand, Central and South America and Europe. Since European rules for homeopathic drugs are different than the rules in the US, we cannot estimate when this process will be completed. On March 25, 2013 we announced the publication of our patent and trademark for Nyloxin in India. We are actively seeking new distribution partners in India.
On May 14, 2015 we announced that we had engaged the Nature’s Clinic to begin the process of regulatory approval of our Company’s Over-the-Counter pain drug, Nyloxin for marketing and distribution in Canada. The Nature’s Clinic has already begun setting up their Chatham, Ontario warehouse. Due to lack of funding and then the subsequent COVID crisis, we have waited to complete the approval process to begin distributing Nyloxin and expect to re-engage in the process in 2026.
Additionally, we plan to complete several human clinical studies aimed at comparing the ability of Nyloxin Extra Strength to replace prescription pain relievers. We have provided protocols to several hospitals and will provide details and timelines when those protocols have been accepted. We cannot provide any timeline for these studies until adequate financing is available.
To date, our marketing efforts have been limited due to lack of funding. As sales increase, we plan to begin marketing more aggressively to increase the sales and awareness of our products.
Pet Pain-Away
During June of 2013, we announced the launch of our new homeopathic formula for the treatment of chronic pain in companion animals, Pet Pain-Away. Pet Pain-Away is a homeopathic, non-narcotic, non-addictive, over-the-counter pain reliever, primarily aimed at treating moderate to severe chronic pain in companion animals. It is specifically indicated to treat pain from hip dysplasia, arthritis pain, joint pain, and general chronic pain in dogs and cats. The initial product run was completed in December of 2014 and launched through Lumaxa Distributors on December 19, 2014.
In May of 2016, we signed a license agreement to begin the process of creating an infomercial (Direct Response) campaign for Pet Pain-Away. In November of 2016, we announced the license agreement with DEG Productions for the marketing and distribution of Pet Pain-Away globally. DEG created their own website (www.getpetpainaway.com) and began airing commercials in December of 2016.
In February of 2020, we took back the marketing of Pet Pain-Away and are currently selling the product on Amazon.com and through www.petpainaway.com
Luxury Feet
In June of 2017, we announced the creation of Luxury Feet; an over-the-counter pain reliever and anti-inflammatory product that is designed for women who experience pain or discomfort due to high heels and stilettos. We announced the official marketing launch of Luxury Feet in March of 2021. The product is currently available through www.luxuryfeet.com and on Amazon.
Equine Pain-Away (Formerly Equine Nyloxin)
In October of 2013, we announced that we were in the process of launching the newest addition to our line of homeopathic treatments for chronic pain, Equine Nyloxin. We had been working with trainers and veterinarians in the equine industry and have already identified distributors for the product. The Equine Nyloxin represents the Company’s first topical solution for the animal market. Equine Nyloxin was rebranded as Equine Pain-Away™ and officially rolled into the market in October of 2019. Equine Pain-Away is being marketed through several retailers and online at www.EquinePainAway.com and on Amazon.
Regulation
The active pharmaceutical ingredient (API) in our over the counter products, Asian cobra venom, has an approved United States monograph under the Homeopathic Pharmacopoeia of the United States (HPUS), which allowed us to register them with the FDA as homeopathic drugs. A United States monograph is a prescribed formulation for the production of any drug or product that is recognized by law for a specific application and that may be introduced into commerce. The FDA requires this registration process to maintain full compliance of companies marketing and selling medicines classified as homeopathic. In August 2009, we successfully completed submission of final packaging and labeling to the FDA to begin selling our over-the-counter pain reliever, Cobroxin. In December 2009, we completed our submission of final packaging and labeling to the FDA of Nyloxin and Nyloxin Extra Strength. In December 2016 we completed our submission of final packaging and labeling to the FDA of Pet Pain-Away.
On March 11, 2019, the United States Food and Drug Administration (FDA) sent us a warning letter regarding the claims and marketing materials of our Nyloxin line of products. On April 10, 2019 we responded to the warning letter; addressing their concerns and outlining the actions that we have taken and will take to comply with their requests for changes. The response goes on to commit to the FDA that the company will make the changes necessary to properly and legally continue to market and distribute our products. As of this date, we have made all of the committed changes to our website, social media pages and marketing material. There has been no further communication regarding this from the FDA.
Manufacturing
We oversee Nyloxin’s and Pet Pain-Away’s manufacturing activities at our Good Manufacturing Practice (“GMP”) certified facility. We are also responsible for acquiring appropriate amounts of Asian cobra venom required to manufacture Nyloxin and Pet Pain-Away.
Subject to availability of funds, we plan to begin additional clinical studies for our pain relievers. These studies will be designed to compare the efficacy of Nyloxin Extra Strength to other prescription strength pain relievers. Our study published in Toxicon, which is the journal of the International Society of Toxinology, showed that our leading drug product for the treatment of pain (RPI-78) had pain-reducing effects that lasted four times as long as morphine without the negative side effects associated with opioid-based pain relievers. Another study published in the journal Neuropharmacology showed a new mechanism on the use of Alpha-Cobratoxin as a treatment for pain. Alpha-Cobratoxin is the main component of the cobra venom used in Nyloxin and Pet Pain-Away.
The FDA requires those companies manufacturing homeopathic medicines to have their facilities certified as GMP. As of October 2005, our manufacturing and laboratory facility has been fully compliant with its GMP certification. In March 2009, we received an ISO Class 5 certification for our clean room facility. An ISO Class 5 certification is a type of classification granted for a clean room facility according to the 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. In 2023, we moved to our new facility in Boca Raton and have certified our lab for production.
Manufacturing Nyloxin and Pet Pain-Away entails a two-step process, the first of which consists of manufacturing the bulk raw materials and completing the dilution levels of the active pharmaceutical ingredient (“API”) as provided for in the Homeopathic Pharmacopeia of the United States, which is a compilation of continuously updated statements of Homeopathic Pharmacopoeia standards and monographs as recognized by that organization. Once this process is completed, the second step entails batching the ingredients into the final mixing, bottling and shipping processes.
We began limited manufacturing of Nyloxin in November 2010. We scaled up manufacturing in the first quarter of 2011. Our production level is contingent upon product demand level and we can scale up as sales demand increases. We began manufacturing Pet Pain-Away in late 2014 and completed the first run of products for distribution on December 19, 2014. We are currently expanding production capacity in our facility to allow spot production of our products and future private label brands.
In March of 2022 we announced that we had expanded our manufacturing capabilities to include liquid filling, tube filling as well as capsule production. We also announced that we had begun scaling up in-house production of dietary supplements for third-party marketers in acting as a contract manufacturer; Our first such contract was with Avini Health, a related party.
Marketing and Distribution
In August 2009, we completed an agreement with XenaCare granting them the exclusive license to market and distribute Cobroxin within the United States. To maintain this market exclusivity, XenaCare was required to meet certain minimum performance requirements. On April 1, 2011, we notified our Cobroxin Distributor, XenaCare Holdings that they were in breach of our agreement. As a result of this, the distribution agreement was terminated effective April 10, 2011. XenaCare had a large stock of the product that they had ordered from us and we have allowed them to continue to market their existing inventory of Cobroxin. In October 2011 we discontinued their website at www.Cobroxin.com. All current traffic to that website is now redirected to www.Nyloxin.com. It is our plan to eventually re-launch Cobroxin with an eventual return to retail stores.
In December of 2013, we announced an agreement with MyNyloxin.com for the exclusive rights to market and distribute Nyloxin in the Network Marketing channel. In November of 2014, MyNyloxin.com changed their name to Lumaxa. They provide a business opportunity to their Distributors to earn commissions on the sale of our products through their Distributor groups. In January of 2014, we announced the first product shipments to the MyNyloxin Independent Entrepreneurs (MIEs). Lumaxa conducts webinars, conference calls and live meetings to support recruitment of new distributors as well as to provide product and business education.
In May of 2016, we signed a license agreement to begin the process of creating an infomercial (Direct Response) campaign for Pet Pain-Away. In November of 2016, we announced the license agreement with DEG Productions for the marketing and distribution of Pet Pain-Away globally. DEG created their own website (www.getpetpainaway.com) and began airing commercials in December of 2016. In February of 2020, we took back the marketing of Pet Pain-Away and are currently selling the product on Amazon.com and through www.petpainaway.com
In late 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 site. In March of 2021, we added Luxury Feet and Equine Pain-Away to our Amazon storefront. In November of 2020, our Nyloxin line of products was added to the Walmart Marketplace and sold online at www.Walmart.com. In March of 2022, we announced that Avini Health would market our products on a non-exclusive basis while we will act as their contract manufacturer for the rest of their product line. Avini Health currently markets our products to their Distributors under the brand “Plus Relief”. In October of 2023, we launched Plus Relief for Pets through Avini Health as a private label of Pet Pain-Away. We continue to work with Avini to market these products.
We are continuing our efforts to find strategic partnerships for the promotion, marketing, registration, licensing and sales of our products domestically and internationally.
Dependence on one or a Few Major Customers
With respect to Nyloxin, Nyloxin Extra Strength and Pet Pain-Away, we have been distributing the products online and to various retailers. We are seeking both domestic and international distributors for these products. It may be that a larger distributor may require exclusivity in the US or any particular foreign market. If so, we would be dependent on that distributor for those Nyloxin sales.
International Drug Registrations
We are continuing our efforts to complete the registration process internationally. On March 25, 2013 we announced the publication of our patent and trademark for Nyloxin in India. We are currently working with potential Distributors in India. In February, 2015 we completed the first test shipments to India through our importer, S.Zhaveri Pharmakem. We are actively seeking new distribution partners in India. In April of 2015 we announced the engagement of the Vancouver Commodity Group to identify potential distribution partners in China. Later that month, we announced the acceptance of Nyloxin by the China International Exchange and Promotive Association for Medical and Healthcare (CPAM). With this approval, we have been working with several groups to find a large distributor for our products in the People’s Republic of China. On May 14, 2015 we announced that we had engaged the Nature’s Clinic to begin the process of regulatory approval of our Company’s Over-the-Counter pain drug, Nyloxin for marketing and distribution in Canada. The Nature’s Clinic has already begun setting up their Chatham, Ontario warehouse. Due to lack of funding, we have waited to complete the approval process to begin distributing Nyloxin and expect to re-engage in the process as soon as feasible. On February 1, 2018 we announced a Distribution Agreement with the Australian company, Pharmachal PTY LTD to market and distribute Nyloxin in Australia and New Zealand. Pharmachal has begun the registration process with the TGA (Therapeutic Goods Administration). We will continue to work with them through the registration process but have no current timetable for distribution in Australia.
While many countries adopt similar regulation to the United States for registering homeopathic drugs, the international application process is more complex and may be lengthier. We will continue to seek qualified, well-funded distributors for the international distribution of 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 our products internationally as we navigate the regulatory process and seek qualified distributors.
Homeopathic Drug Pain Relief Studies
Pending adequate financing or revenues, we will continue our research and development into this area, with the ultimate goal of improving product claims for Nyloxin Extra Strength, which is a treatment for stage 3 pain. We have planned the following three studies and will pursue these pending adequate financing:
MS Neuropathic Pain Phase IV
This is 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 to reinitiate this trial pending adequate funding.
Chronic Back Pain Phase I
We will continue our research and development in this area, with the ultimate goal of completing development of our future product, Recet, which is an injectable version of Cobratoxin. This is a planned 4-week patient trial period. We have thus far incurred costs of $25,000 in prior years with a total estimated budget of $250,000. We plan to reinitiate this trial pending adequate funding.
Chronic Back Pain Phase IV
We will continue our research and development, with this ultimate goal of improving product claims for Nyloxin Extra Strength, which is a 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 incurred any costs associated with the Chronic Back Pain Phase IV project. We plan to reinitiate this trial pending adequate funding.
All of these studies have been delayed due to our lack of revenues and funding. We will reassess our start and completion dates upon generating a sufficient amount of revenues, if ever.
Research and Development
We have conducted research and development of novel anticholinergic therapeutic protein products for the treatment of autoimmune and neurologic disorders, including Human Immunodeficiency Virus (HIV), Multiple Sclerosis (MS) Adrenomyeloneuropathy (AMN), Rheumatoid Arthritis (RA) and pain.
Drug Applications
We have set forth below a summary of our proposed drugs and their potential applications.
Drug
Potential Applications
RPI-78M
MS, AMN, Rheumatoid Arthritis (RA), Myasthenia Gravis (MG) and Amyotrophic Lateral Sclerosis (ALS)
RPI-MN
HIV, Herpes, general anti-viral applications
RPI-78
Pain, Arthritis
RPI-70
Pain
We believe that our pharmaceutical products have a wide range of applications in a number of chronic, inherited and/or life-threatening viral, autoimmune and neuromuscular degenerative diseases, even though none of these products have FDA or other approval for the treatment of such diseases. These disorders target nerve cells, especially one specific type of cell receptor that is sensitive to the neurotransmitter, acetylcholine, which plays an important role in the transmission of nerve impulses at synapses and myoneural (muscle-nerve) junctions.
Primary Disease Targets
Through our research program, our goal is to obtain required regulatory approvals of our HIV, MS, and AMN products, so that they can be marketed. In September of 2015 we were granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. The Orphan designation may greatly reduce the costs of clinical trials and shorten the timeline to potential drug approval. We secure confidentiality agreements prior to initiating contract research in order to protect any patentable opportunities.
Multiple Sclerosis (MS)
Multiple Sclerosis (MS) is thought to be an autoimmune disease that primarily causes central nervous system problems. In MS, the insulating fatty material surrounding the nerve fibers, also known as myelin, which functions to speed signaling from one end of the nerve cell to the other, is attacked by cells of the immune system causing problems in signal transduction. MS is the most common of demyelinating disorders, having a prevalence of approximately 1 per 1,000 persons in most of the United States and Europe. According to the American Multiple 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 in the US every year. Although MS occurs most commonly in adults, it is also diagnosed in children and adolescents. A study published by Emory University School of Medicine analyzed data from 53 countries that submitted pediatric data to the Atlas of MS during 2020-2022, and estimated that there are over 31,000 children and adolescents living with MS worldwide.
People with MS may experience diverse signs and symptoms. MS symptoms may include pain, fatigue, cognitive impairment, tremors, loss of coordination and muscle control, loss of touch sensation, slurred speech and vision impairment. The course of the disease is unpredictable and for most MS patients, the disease initially manifests a “relapsing-remitting” pattern. Periods of apparent stability are punctuated by acute exacerbations that are sudden unpredictable episodes that might involve impaired vision, diminished ability to control a limb, loss of bladder control, or a great variety of other possible neurologic deficits. In relapsing-remitting MS, some or all of the lost function returns, however, the patient sustains an unceasing, often insidious, accumulation of neuronal damage. As the burden of neural damage grows, new lesions are more likely to produce irreversible impairment of function. Typically, about eight to fifteen years after onset, MS patients enter the secondary-progressive phase. Eventually, progressive MS sufferers become wheelchair-bound, and may become blind and even incapable of speech. There is currently no FDA approved drug that reverses the course of the progressive form of MS.
RPI-78M has shown efficacy in animal models (EAE) for MS and we are planning new animal studies to gain more insight into the levels of protection that the drugs afford. In one study conducted in August 2007, all members of an untreated animal control group developed signs of disease with different levels of paralysis/muscle weakness. A similar group in the August 2007 study treated with RPI-78M showed no disease in 90% of the animals in both acute and chronic applications of the test. Moreover, there were no toxicities reported though the animals which received doses the equivalent of 280 times a human dose.
Furthermore, we believe that the ability to modulate the host immunostimulatory environment could form the basis of an effective strategy for the long-term control of autoimmunity in diseases like MS and Myasthenia gravis (MG) and is being studied as a therapeutic model for other neuromuscular diseases. Also, we believe our data suggest that it is possible that our novel therapeutic proteins could have a general application in autoimmune diseases based on human studies in Rheumatoid Arthritis and anecdotal reports from patients with Multiple Sclerosis.
In August of 1984, Biogenix applied for and received an Intrastate Investigational Drug (FSDHRS Protocol RA-1 (002)) from the Department of Health and Rehabilitation (HRS) in Florida that permitted the 4-week study of RPI-MN in 13 patients with Rheumatoid arthritis ranging in 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, early morning stiffness and stamina (this data, along with other supporting intellectual property was acquired by our wholly-owned subsidiary ReceptoPharm from Biogenix). We believe that the data obtained from the examination of clinical efficacy in these three diseases can augment information from prior clinical studies and lead to the future investigation of treatments for other chronic conditions.
We are currently planning two studies in Multiple Sclerosis:
- Study of 30 adults utilizing RPI-78M with monthly MRIs and disability testing. The goal of this small Phase IIa study would be to see if the disease modification and reversal that was seen in the rat model is replicated in humans. If sclerosing lesions in the brains of MS patients are reduced in any way, this would be a first for any MS therapy.
- Study in 30-50 children diagnosed with Pediatric MS under our Orphan Designation. The goal of this study would be to utilize the benefits of our Orphan Designation to prove efficacy in a pediatric population of MS patients.
Adrenomyeloneuropathy (AMN), Pediatric MS and other Orphan Indications
Adrenoleukodystrophy, or ALD, is a genetically determined neurological disorder that, according to the Adrenoleukodystrophy Foundation, affects 1 in every 17,900 boys worldwide. The presentation of symptoms occurs between the ages of 4 and 10, and affects the brain with demyelination, which is the stripping away of the fatty coating that keeps nerve pulses confined and maintains the integrity of nerve signals. This process inhibits the nerves’ ability to conduct properly, which causes neurological deficits, including visual disturbances, auditory discrimination, impaired coordination, dementia and seizures. Demyelination is an inflammatory response and nerve cells throughout the brain are destroyed.
Adrenomyeloneuropathy (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 itself in adolescence or adult life and may be preceded by hypoadrenalism. It is characterized by spastic paraplegia and a peripheral neuropathy, often being diagnosed as Multiple Sclerosis (MS). Nerve conduction studies in AMN show a predominant axonal neuropathy and show a loss of all axons. Lorenzo’s oil, a mixture of glyceryltrioleate and glyceryltrierucate, has been used for over a decade in an open, unblinded fashion with mixed results.
RPI-78M has been utilized in two clinical studies, which were completed at the Charles Dent Metabolic Unit located in London, England. The last trial was classified as a Phase IIb/IIIa study. These studies provided important safety data, showing RPI-78M to be well tolerated by the patients. Further study is warranted to provide data on the potential efficacy of RPI-78M to treat the symptoms of AMN.
In September of 2015, we were granted Orphan Designation by the US-FDA for the treatment of Pediatric Multiple Sclerosis. We are currently working 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 Pharma with a 7-year period of market exclusivity in the U.S. once the drug is approved. Additional benefits over conventional drug applications include: tax credits for clinical research costs, the ability to apply for grant funding, clinical trial design assistance, plus assistance from the FDA in the drug development process and the waiver of Prescription Drug User Fee Act (PDUFA) filing fees which could be in excess of $2.5 million. The granting of Orphan Drug Designation allows the Company to move forward with their preparation of an Investigative New Drug Application and proposal of clinical trials. The FDA grants Orphan Drug Designation status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. According to the FDA, the Orphan Drug program has successfully enabled the development and marketing of more than 400 drugs and biologic products for rare diseases since 1983. Evaluate Ltd., in its 2025 EvaluatePharma Orphan Drug Report, estimated that orphan drug sales will constitute more than 20% of the total share of prescription drug sales by 2030, totaling $320bn.
In December of 2015, we announced that we had applied for an Orphan Drug designation from the US-FDA for the Company’s RPI-78M drug candidate for the treatment of Myasthenia Gravis (MG). The application was subsequently rejected with an offer to re-file in the future as more data becomes available.
Pain and Arthritis
Protein or peptide-based drugs are penetrating the pain market with neurotoxins taking the lead. Botox (Allergan) and Prialt (Elan) have the potential to substitute over the long-term for morphine and other opiates in chronic pain indications. Opiates, though potent painkillers, suffer from drawbacks because they are addictive, short acting, and drug-resistance inducing. We plan to assess the effects of several peptides in animal models of pain in association with Soochow University in China. Several peptides have demonstrated positive effects and the research and development continues.
August 2007 studies at Soochow University proved the potential of our drug candidates, RPI-78 and RPI-70. When compared to Dolantin, an opiate-based drug subordinate to morphine, the effects were very encouraging. While Dolantin provided immediate pain relief it began wearing off just as RPI-70 began to take effect. The effects of RPI-70 do not seem dramatic in contrast to Dolantin, considering the quantity of drug employed in this animal model. The concentration of RPI-70 was approximately 100 times less than the opiate product. Also, RPI-70 showed real potential for combining with other pain killing medications. RPI-78 was calculated to be 150,000 times more potent than aspirin. This product can be injected systemically providing evidence of a more practical application than Prialt, which must be administered intrathecally (into the spinal cord). Opiate drugs induce tolerance and dependence. This problem is not encountered with RPI-70 and RPI-78.
In February 2009, we filed a patent application with the United States Patent and Trademark Office for the use of RPI-78 as a novel method for treating arthritis in humans. Also in February 2009, in collaboration with Soochow University in China, we published positive data from its recent animal studies on the use of RPI-78 (Cobratoxin) as a method for treating arthritis. In March of 2011, we were issued a patent for the use of cobratoxin as an analgesic (US patent #7,902,152). In February of 2012, in collaboration with Soochow University, we published another study that demonstrated a novel mechanism of action for the use of RPI-78 as a treatment for pain.
Nerve Agent Countermeasures
In February of 2018, we announced that we had filed a new provisional patent to protect our intellectual property surrounding the development of nerve agent counter measures. In much the same way that our therapies protect the nerves of patients with disease, our findings indicate that we may protect against - or at least mitigate the damage caused by - nerve agents that are utilized as chemical weapons; such as sarin gas and VX. We will be working with experts in the field to have our products in testing shortly.
Nerve agents are identified as a class of phosphorus-containing organic chemicals (organophosphates) that may disrupt the transfer of messages to organs through the nerves. This disruption is caused by the over-stimulation of certain receptors on the surface of the neurons. These same receptors are the target of Nutra Pharma’s drugs, which may block the action of the nerve agents or minimize the damage that they may cause.
The company has very encouraging preclinical data, a demonstrated molecular mechanism of action and a robust scientific rational for the continued commercial development of its nerve agent counter measure. Organophosphate nerve agents such as VX and Sarin remain a troubling threat to American service people and civilians as evidenced by the recent attacks in Syria, Malaysia and London. Supply chain issues with existing counter measures and the safety and effectiveness of these drugs is a great concern. Based on our pre-clinical studies and experience in neurobiology products, we believe that we have a superior product ready for testing in the near term.
On September 22, 2020, Dr. Dale VanderPutten, our Chief Scientific Officer was invited by the Defense Threat Reduction Agency (DTRA) to present our nerve agent countermeasure technology in a Tech Watch talk to an audience of military and civilian experts in chem/bio defense. The talk titled “A Nicotinic Acetylcholine Receptor (nAChR) Directed Organophosphate Countermeasure” was presented in a virtual internet meeting to a select expert audience invited by DTRA. The consensus of the comments and questions on the presentation supported the idea that despite past efforts, there remains an unmet need for nAChR directed defenses and that our demonstration of human safety in the clinic and pre-clinical proof of concept deserves aggressive follow up.
According to a BBC report, chemical weapons remain a real threat to the West. During the Syrian conflict there were over a thousand documented uses of chemical weapons; making this issue a major topic of concern in the US department of Defense and the United Nations. We will continue working with the Department of Defense and DTRA on potential funding for these applications.
Market Values
Multiple Sclerosis (MS)
As of 2023, MS affects an estimated 2.9 million people globally with approximately 1,000,000 sufferers in the United States. There are 15 approved drugs for the treatment of this disease. According to Precedence Research, the U.S. multiple sclerosis drugs market size accounted for $7.81 billion in 2024 and is predicted to increase from $8.44 billion in 2025 to approximately $17.15 billion by 2034, expanding at 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 to 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 growth of the market is driven by ongoing clinical trials, increasing approvals from regulatory agencies, and rising investments in R&D activities for developing new therapies. According to an April 2015 article published in the journal Neurology, the average annual cost of these drugs has increased to over $60,000 per person. According to the National Multiple Sclerosis Society, as of February 2022, the median annual price of a brand-name disease-modifying therapy was close to $94,000.
Adrenomyeloneuropathy (AMN)
AMN/ALD affects an estimated 30,000 people in the US with some estimates exceeding this number.
Pediatric Multiple Sclerosis (pediatric-MS)
According to the National Multiple Sclerosis Society, although MS occurs most commonly in adults, it is also diagnosed in children and adolescents. Estimates 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 at least one symptom suggestive of MS. Studies suggest that two to five percent of all people with MS have a history of symptom onset before age 18.
Myasthenia Gravis (MG)
According to the Myasthenia Gravis Foundation of America, the prevalence of MG in the United States is estimated to be about 64,000 patients. However, MG is probably under diagnosed and the prevalence may be higher.
Business Strategy
Pending adequate financing or revenues, we seek to develop proprietary pharmaceutical products for human illnesses that qualify for “Fast-Track” or “Orphan Drug” status under FDA regulations, which can expedite regulatory review. For some conditions, the FDA has created the “two animal rule” which permits us to collect data from ongoing animal research for human treatment applications.
We believe the results from our research will assist in getting our applications processed through the FDA’s “Fast-Track” approval process and enable us to plan the commercialization of each product independently and/or through joint ventures, partnerships and licensing arrangements. “Fast-Track” denotes life-threatening illnesses, while “Orphan” status refers to serious ailments affecting less than 200,000 individuals nationwide. AMN qualifies under both labels because it is considered an orphan disease and has no known cure. Pediatric MS and Myasthenia Gravis are also considered “Orphan” diseases because of the disease prevalence as well as the lack of effective therapies.
We believe that our proposed unique pharmaceutical products can be used alone or licensed for use in combination with other therapeutic products and may be of interest to other established pharmaceutical companies as a means of extending the patent life of their proprietary products.
Short-term Goal
Although we focused our drug development efforts from 2006 to 2008 on clinical trials for ReceptoPharm’s HIV drug, RPI-MN, our primary focus now 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 studies by the end of 2025.
Mid-term Goal
Our midterm strategy is to license our AMN, MS and HIV technologies in our attempt to bring these technologies to market within 5 years, should we obtain adequate financing.
Long-Term Goal
Our long-term goal is the use of our drugs in the field of neurological diseases, infectious diseases and autoimmune disorders. Due to our limited financial and operational resources, this goal will require us to establish strategic partners or alliances with pharmaceutical companies, academic institutions, biotechnology companies, and clinical diagnostic laboratories, which will: (a) complement our research and development efforts; (b) reduce the risks associated with undertaking the entire process of drug development and marketing; and (c) generate licensing based revenue streams. Additionally, we plan to continue identifying intellectual property and companies in the biotechnology arena as potential acquisition candidates.
Compassionate Release Programs
Certain countries, such as Canada and the United Kingdom, permit their citizens to have access to investigational medications without being approved for any applications by their respective “FDA type” agencies, and permit physicians to prescribe drugs they believe are of possible benefits to the patients. Through these “Compassionate Release Programs”, we have supplied RPI-78M, our drug under investigation for MS and AMN, to physicians in the United Kingdom. The FDA does not offer this program.
Clinical Trial Applications
We have developed Common Technical Documents (CTD) for both RPI-78M and RPI-MN that are used to support any clinical trial application. The 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 pre-clinical development work on the drug. Having these completed documents allows for expedited due diligence from regulatory bodies reviewing our applications for trials and approvals. With these documents, we successfully applied for approval to conduct a clinical investigation in the United Kingdom under the regulation of the Medicines Health and Regulatory Agency (MHRA), which is the British equivalent of the US-FDA.
Current Research and Development Projects
Neurological Studies
Pain Studies
In an effort to further support Nyloxin Extra Strength, we had planned to complete two human clinical studies aimed at comparing the ability of Nyloxin Extra Strength to replace prescription pain relievers. We originally estimated that these studies would begin during the second quarter 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 we will have adequate funding to reinitiate these trials.
AMN Phase II
We have been conducting research and development in this area since February 2006 with an original expected completion date of September 2010, which includes a 12-month patient trial period that has already been completed. We have thus far expended approximately $400,000, because we have completed our AMN Phase II project, there is no further budget for this project.
AMN Phase III
We had planned to continue research and development, with the ultimate goal of completing development of our future drug, RPI-78M. Our originally estimated start and completion dates were July 2010 and December 2011, respectively, which includes a 12-month patient trial period. We 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 we will have adequate funding to reinitiate these trials.
MS Phase II (Pediatric MS Phase I/II)
We are working with our Chief Scientific Officer, Dale Vanderputten, PhD; along with consultants to begin our Phase I/Phase II studies in pediatric Multiple Sclerosis. Pending adequate financing or revenues, we will continue our research and development, with the ultimate goal of commencing these trials with RPI-78M under our Orphan Designation. We have thus far incurred costs of $40,000. We have an estimated budget of $2,000,000. Our goal is to initiate these trials in 2026.
Currently, our total estimated costs for all of the above projects is approximately $3,000,000.
Since receiving Orphan designation for the treatment of Pediatric MS, our plans have changed. We are now working with potential sites of care to 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 trial protocols. It is our goal to begin these trials in 2026.
Dependence on one or a Few Major Customers
We have no customers with respect to our research and development projects since we have not received FDA approval for our drug candidates and have not licensed any of our technologies.
Marketing
We currently do not have a marketing program for our drug candidates because none of our products have received FDA approval. Our lack of financing has hampered our efforts to navigate the regulatory process in a timely fashion; however, if and when we have FDA-approved drug treatments, we plan to develop a marketing strategy to market our products through pharmaceutical companies, other biotechnology companies, and diagnostic laboratories. Our Chief Executive Officer will market the treatments to licensing and development officers of those companies and will otherwise direct our marketing program. Additionally, we will attempt to secure consulting agreements with marketing consultants who will actively market our products to such companies and/or provide our Chief Executive Officer with marketing guidance.
Potential Revenue Segments
Our potential revenue segments are composed of our attempt to generate revenues from license agreements, joint ventures in foreign countries and drug sales.
To date, we have not earned any revenues regarding any FDA drug candidate.
Product Liability
We maintain product liability insurance for our commercial products. Even so, product liability claims may result in significant legal costs related to our defense of such actions if damage amounts exceed our product liability insurance coverage. The design, development, and manufacture of drug products or diagnostic tests involves an inherent risk of product liability claims and corresponding damage to our brand name reputation, including claims of product failure or harm caused by the drug product.
Sources and Availability of Raw Materials
We use 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 have two US suppliers of cobra venom that we use according to product demand. In addition, there are other suppliers in China, Thailand and India. Our management is responsible for locating cobra venom suppliers on an as-needed basis, which involves obtaining a small test amount from a supplier for scientific validation of that raw material prior to purchase. Apart from cobra venom, there are no availability issues with any of the other components, excipients or compounds that we use in our products.
Compliance with Government Regulations and Need for Government Approval
The production and marketing of potential drug products as well as research and development activities generally are subject to regulation by numerous governmental authorities in the United States and other countries. In the United States, vaccines, drugs and certain diagnostic products are subject to FDA review of safety and efficacy. The Federal Food, Drug and Cosmetic Act, the Public Health Service Act and other federal statutes and regulations govern or influence the testing, manufacture, safety, labeling, storage, record keeping, approval, advertising and promotion of such products. Noncompliance with applicable requirements can result in criminal prosecution and fines, recall or seizure of products, total or partial suspension of production, or refusal of the government to approve Biological License Applications (“BLAs”), Product License Applications (“PLAs”), New Drug Applications (“NDAs”) or refusal to allow a company to enter into supply contracts. The FDA also has the authority to revoke product licenses and establishment licenses previously granted.
In order to obtain FDA approval to market a new biological or pharmaceutical product, proof of product safety, purity, potency and efficacy, and reliable manufacturing capability must be submitted. This requires companies to conduct extensive laboratory, pre-clinical and clinical tests. This testing, as well as preparation and processing of necessary applications, is expensive, time-consuming and often takes several years to complete. There is no assurance that the FDA will act favorably in making such reviews. Our potential partners, or we, may encounter significant difficulties or costs in their efforts to obtain FDA approvals, which could delay or preclude from marketing any products that may be developed. The FDA may also require post-marketing testing and surveillance to monitor the effects of marketed products or place conditions on any approvals that could restrict the commercial applications of such products. Product approvals may be withdrawn if problems occur following initial marketing, such as, compliance with regulatory standards is not maintained. Delays imposed by governmental marketing approval processes may materially reduce the period during which a company will have the exclusive right to exploit patented products or technologies. Refusals or delays in the regulatory process in one country may make it more difficult and time consuming to obtain marketing approvals in other countries.
The FDA approval process for a new biological or pharmaceutical drug involves completion of preclinical studies and the submission of the results of these studies to the FDA in an Initial New Drug application, which must be approved before human clinical trials may be conducted. The results of preclinical and clinical studies on biological or pharmaceutical drugs are submitted to the FDA in the form of a BLA, PLA or NDA for product approval to commence commercial sales. In responding to a BLA, PLA or NDA, the FDA may require additional testing or information, or may deny the application. In addition to obtaining FDA approval for each biological or chemical product, an Establishment License Application (“ELA”) must be filed and the FDA must inspect and license the manufacturing facilities for each product. Product sales may commence only when both BLA/ PLA/ NDA and ELA are approved. In certain instances in which a treatment for a rare disease or condition is concerned, the manufacturer may request the FDA to grant the drug product Orphan Drug status for a particular use. “Orphan Drug” status refers to serious ailments affecting less than 250,000 individuals. In this event, the developer of the drug may request grants from the government to defray the costs of certain expenses related to the clinical testing of such drug and be entitled to marketing exclusivity and certain tax credits.
In order to gain broad acceptance in the marketplace of a medical device, our partners or we will need to receive approval from the FDA and other equivalent regulatory bodies outside of the United States. This approval will be based upon clinical testing programs at major medical centers. Data obtained from these institutions will enable us, or our partners, to apply to the FDA for acceptance of its technology as a “device” through a 510(k) application or exemption process. Once the data have been fully gleaned, it is expected that this process would take ninety days.
According to the FDA, a “device” is: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
The FDA classifies devices as either Class I/II-exempt, Class II, or Class III.
Class III: Pre-Marketing Approval, or PMA: A Pre-Marketing Approval or PMA is the most stringent type of device marketing application required by FDA. A PMA is an application submitted to FDA to request clearance to market, or to continue marketing of a Class III medical device. A PMA is usually required for products with which FDA has little previous experience and in such cases where the safety and efficacy must be fully demonstrated on the product. The level of documentation is more extensive than for a 510(k) application and the review timeline is usually longer. Under this level of FDA approval, the manufacturing facility will be inspected as well as the clinical sites where the clinical trials are being or have been conducted. All the appropriate documents have to be compiled and available on demand by the FDA. The manufacturing facility is registered with the FDA and the product or device is registered with the FDA.
Class II: 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) is a pre-marketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre-market approval. Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims. The legally marketed device to which equivalence is drawn is known as the “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device. Under this level of approval, the manufacturing facility is registered with the FDA and the product or device is registered with the FDA. Inspections under this classification are possible. All the appropriate cGMP and clinical data backing the claims made must be on file and available on demand by the FDA.
Class I/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 notification requirements subject to the limitations on exemptions. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. However, as described above, all the appropriate documentation including cGMP and clinical data supporting the claims being made has to be on hand and available on demand by the FDA. The data must be available to support all the product claims.
Sales of biological and pharmaceutical products and medical devices outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Whether or not FDA approval has been obtained, approval of a product or a device by a comparable regulatory authority of a foreign country must generally be obtained prior to the commencement of marketing in that country.
Effect of Compliance with Federal, State, and Local Provisions for the Protection of the Environment
We have no present or anticipated direct future costs associated with environmental compliance, since we are not and will not be directly involved in manufacturing drug products as result of our research and development; however, we may be affected in the percentage licensing fees we receive, since a company may consider the environmental expense as an offset to a determination of the percentage amount we receive. We produce a drug that has limited waste issues and related costs, but handles environmentally related matters through the FDA’s Good Manufacturing Practices, the FDA mandated guidelines pertaining to the production of drugs in the United States.
Ability to Compete
The biotechnology research and development field is extremely competitive and is characterized by rapid change. Our competitors have substantially greater financial, scientific, and human resources, and as a result greater research and product development capabilities. Our competitors have competitive advantages with greater potential to develop revenue streams. Our competitors are located in the United States as well as around the world. We will attempt to compete by establishing strategic partners or alliances with pharmaceutical companies, academic institutions, biotechnology companies, and clinical diagnostic laboratories, which will enter into joint ventures, emphasizing that the drugs RPI-MN and RPI-78M possess the following properties:
● They lack measurable toxicity but are still capable of attaching to and affecting the target site on the nerve cells. This means that patients cannot overdose.
● They display no significant adverse side effects following years of investigations in humans and animals.
● The products are stable and resistant to heat, which gives the drug a long shelf life. The drugs’ stability has been determined to be over 4 years at room temperature.
RPI-78M can be administered orally; however, we have not yet developed an orally administered RPI-78M. RPI-78M has been routinely delivered by injection in a manner similar to insulin, but research over the past two years has given rise to administration by mouth. Oral delivery presents patients with additional “quality of life” benefits by eliminating or decreasing the requirements for routine injections. Should we receive adequate funding, we plan to develop an orally administered RPI-78M by initiating new trials with an oral version of that drug.
Main Competitors (Biologics)
Competition is intense among companies that develop and market products based on advanced cellular and molecular biology. Our competitors, including Amgen, Sanofi-Aventis, Biogen-Idec, Cephalon, Genetech, Genzyme, Novartis, Regeneron, Roche and Bayer, which have far superior financial, technological and operational resources. We face significant competition from these and other biotechnology and pharmaceutical firms in the United States, Europe and elsewhere. Certain specialized biotechnology firms have also entered into cooperative arrangements with major companies for development and commercialization of products, creating an additional source of competition.
Any products or technologies that successfully address viral or neurological indications could negatively impact the market potential for RPI-78M or RPI-MN. These include products that could receive approval for indications similar to those for which RPI-78M or RPI-MN seeks approval, development of biologic or pharmaceutical treatments that are more effective than existing treatments and the development of other modalities with reduced toxicity and side effects.
Interferon-based drugs and their indications represent target markets for us. Sales of interferon-based drugs annually exceed $8 billion and have attracted the participation of several major drug companies, including Bayer and Roche. Currently, there are eight interferon-based drugs licensed in Canada and the U.S.; five for the treatment of the milder Relapsing-Remitting form of MS, one for Hepatitis C, one for granulomatous disease and one for genital warts. These interferons are also used in the treatment of other conditions where treatment options are limited. The interferons for MS are Betaseron (Bayer), Avonex (Biogen), Plegridy (Biogen), Extavia (Novartis) and Rebif (EMD Serono). Since the launch of these drugs, the number of patients undergoing treatment has stabilized at current levels, indicating that there is a high turnover rate of patients in the administration of these individual drugs due to cost and side effects. Biogen developed Avonex in the early 1990’s and has been shipping the drug since late 1996. In the United Kingdom, the National Institute for Clinical Efficiency (NICE) has called for the withdrawal of Betaseron and another unrelated drug, Copaxone (Teva), from the market based on poor cost/effectiveness.
Gilead Sciences markets Harvoni as a ‘cure’ for Hepatitis C. It combines two drugs: Sovaldi (sofosbuvir) and ledipasvir. Harvoni is taking over the market as Gilead has turned Hepatitis C into a curable illness and has generated over $25B in sales.
Main Competitors (Venom-Based Drugs)
We view our main competitors as those who also engage in the development of protein-based neurotoxins as therapeutics. Employing venoms as therapeutics is not new. A large number of well-known pharmaceutical companies are developing novel therapies derived from snake venoms and other reptiles. Most of those using snake venoms employ the anticoagulant enzymes usually from viperids (adders and rattlesnakes) though elapids (cobra family) are also being investigated.
We have set forth below a summary of venom-based drugs and their potential applications.
Company
Drug
Application
Pentapharm
Batroxobin
Anticoagulant from Lancehead viper
Knoll Pharmaceutical
Ancrod
Anticoagulant from rattlesnakes
Bristol-Myers Squibb
Capoten
Antihypertensive from Brazilian Pit Viper
Medicure
Aggrastat
Antiplatelet drug from vipers
Millennium Pharmaceutical
Integrilin
Antiplatelet drug from rattlesnakes
Amylin Pharmaceuticals
Byetta
Treatment for type 2 diabetes and obesity from Gila Monster
Elan Pharmaceuticals
Prialt
Intrathecal drug from cone snails for intractable pain
Current cobra venom-based therapies include Keluoqu, a pain-killing drug on the market in China since 1978. Keluoque contains cobrotoxin as its primary ingredient and is used to control severe pain in advanced cancer patients and for post-operative pain.
Bio-Therapeutics, Inc.
On October 3, 2003, we entered into a non-assignable license agreement between Bio-Therapeutics, Inc. (“ Bio-Therapeutics”) and us, which was then amended to make the license agreement assignable. This agreement was in settlement of a lawsuit that we filed against Bio-Therapeutics alleging that Bio-Therapeutics owed us $850,000 in connection with a merger agreement between Bio-Therapeutics and us that was cancelled.
The 2003 license agreement provides that for a non-exclusive license to certain intellectual property of Bio-Therapeutics, which consists of the following two distinct technology platforms:
● Alteration of Proteins and Peptides - These include patented methods for altering the 3-Dimensional structure of certain proteins and peptides. The natural peptides bind to receptors in the body with toxic effects. This technology allows us to alter the structure of these peptides, preserving their receptor-binding characteristics, while making them non-toxic and therapeutic. Different receptors have various functions in many disease states. By the peptides binding to these receptors in a controlled fashion, certain disease symptoms may be treated. In connection with MS, binding to the acetylcholine receptor on the nerves allows for more efficient nerve conduction. With HIV, binding to chemokine receptors may prevent the virus from entering and infecting new cells.
● Non- Exclusive License for “Buccal Delivery System” (“Buccal”) - An innovative aerosolized drug delivery system that is patent pending. Many therapeutic agents cannot be effectively delivered by aerosol formulation due to their large size and/or irregular shapes. Since these therapeutic agents cannot be ingested orally without being degraded by the digestive system, patients have no alternative but to directly inject these drugs. We have a non-exclusive license to the Buccal patent pending proprietary aerosol formulation, which greatly enhances the permeability of the mucous membranes found on the roof of the mouth and the back of the throat. This allows for the easy and efficient systemic delivery into the bloodstream of a much wider variety of proteins and peptides. This non-exclusive license for “Buccal Delivery System” and patent pending application includes claims that identify the active mucosal enhancer, its combination with therapeutic agents and the mode of delivery through aerosol. This may allow for the effective and pain-free delivery of peptide and protein therapeutics for the treatment of HIV and MS.
Patents, Trademarks, Licenses and Intellectual Property
In July of 2021, we announced that we had filed a new provisional patent to protect our intellectual property surrounding our development of nerve agent counter measures. We will continue to prosecute that patent as well as several other patent applications.
We have the following patents expiring at various dates indicated below:
ReceptoPharm Patents
ReceptoPharm has three issued and several patents pending with the United States Patent and Trademark Office. These patents include:
U.S. Patent No. 8,034,777, Modified Anticholinergic Neurotoxins as Modulators of the Autoimmune Reaction was granted in October 2011with 7 claims. The patent describes a method of treatment of a human patient suffering from Multiple Sclerosis comprising the administration of a disease-mitigating amount of a composition consisting of detoxified and modified alpha-cobratoxin in a saline solution. This patent is meant to protect and support our work in the production of drugs for the treatment of auto-immune diseases. This patent expired on November 22, 2025. We have filed new patents in protection of our clinical platform for the treatment of autoimmune diseases based on manufacturing improvements.
U.S. Patent No. 7,902,152, Use of cobratoxin as an analgesic was granted in March 2011 with 16 claims. The patent describes a composition of matter for an analgesic and its method of use is disclosed. The method of use is for the treatment of chronic pain, especially to the treatment of heretofore intractable pain as associated with advanced cancer. The pain associated with neurological conditions, rheumatoid arthritis, viral infections and lesions is also contemplated. The method includes administering to a host an alpha-neurotoxin that is characterized by its ability to blocking of the action of acetylcholine at nicotinic acetylcholine receptors. Currently, this would be applied to the Company’s current and future drugs for the treatment of pain. This patent will expire on October 13, 2028. We will file additional patents in protection of our clinical platform for the treatment of pain and inflammation.
U.S. Patent No. 7,758,894, Modified elapid venoms as stimulators of the immune reaction was granted in July, 2010 with 14 claims. The patent describes a method of protection from infections by administering a detoxified and neurotropically active modified venom containing alpha-cobratoxin. Protection includes bacterial, viral and parasitic infections. This patent is meant to protect and support our work in our production of anti-infective treatments. Currently, this would be applied to RPI-MN and RPI-78. This patent will expire on September 11, 2027. We will file additional patents in protection of our clinical platform for the treatment of viral infection.
Our business is dependent upon our ability to protect our proprietary technologies and processes. Despite our efforts to protect our proprietary rights, unauthorized parties may attempt to obtain and use proprietary information. We will rely on patent and trade secret law and nondisclosure and other contractual arrangements to protect such proprietary information. We will file patent applications for our proprietary methods and devices for patient treatments. Our efforts to protect our proprietary technologies and processes are subject to significant risks, including that others may independently develop equivalent proprietary information and techniques, gain access to our proprietary information, our proprietary information being improperly disclosed, or that we may ineffectively protect our rights to unpatented trade secrets or other proprietary information.
Employees
We employ a total of 6 employees, consisting of: (a) our Chief Executive Officer (b) Our Director of Marketing (c) our Chief Scientific Officer (d) our VP of Operations (e) our Operations Manager, and (f) our Warehouse Manager. We utilize outside consultants, legal and accounting personnel as necessary and as funding permits.
Report to Security Holders
We are subject to the informational requirements of the Securities Exchange Act of 1934. Accordingly, we file annual, quarterly and other reports and information with the Securities and Exchange Commission. You may read and obtain a copy of these reports in Washington, D.C. Our filings are also available to the public from commercial document retrieval services and the Internet world wide website maintained by the Securities and Exchange Commission at www.sec.gov.

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ITEM 1A. RISK FACTORS
Item 1A. Risk Factors
You should carefully consider the risks described below regarding our operations, financial condition, financing, our common stock and other matters. If any of the following or other material risks actually occur, our business, financial condition, or results or operations could be materially adversely affected.
We have identified material weaknesses in our internal control over financial reporting, which could adversely affect our financial condition, access to capital, and the market price of our common stock
We have identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. These control deficiencies increase the risk that errors in our financial reporting may occur and remain undetected.
The existence of material weaknesses may also negatively affect our business in other ways. Investors and potential financing sources may view the presence of material weaknesses as increasing the risk of inaccurate financial reporting, which can reduce their willingness to invest in our securities or extend credit on favorable terms. As a result, our ability to raise capital, obtain debt financing, or maintain existing financing arrangements could be adversely affected. In addition, the perception of weak internal controls may negatively impact the market price of our common stock and investor confidence in our Company.
Our ability to continue as a going concern is in doubt absent obtaining adequate new debt or equity financing and achieving sufficient sales levels.
We incurred net loss of $1,393,356 and net income of $8,176,871 for the years ended December 31, 2023 and 2022, respectively. We incurred net operating losses of $886,979 and $1,907,404 for the years ended December 31, 2023 and 2022, respectively. We anticipate that these operating losses will continue for the foreseeable future. We have a significant working capital deficiency, and have not reached a profitable level of operations, which raises substantial doubt about our ability to continue as a going concern. Our continued existence is dependent upon our achieving sufficient sales levels of our Nyloxin and Pet Pain Away products and obtaining adequate financing. Unless we can begin to generate material revenue, we may not be able to remain in business. We cannot assure you that we will raise enough money or generate sufficient sales to meet our future working capital needs.
We have a limited revenue producing history with significant losses and expect losses to continue for the foreseeable future.
We incurred net loss of $1,393,356 and net income of $8,176,871 for the years ended December 31, 2023 and 2022, respectively. We incurred net operating losses of $886,979 and $1,907,404 for the years ended December 31, 2023 and 2022, respectively. As a result, at December 31, 2023, we had an accumulated deficit of $74,945,474. Our revenues have been insufficient to sustain our operations and we expect our revenues will be insufficient to sustain our operations for the foreseeable future. Our potential profitability will require the successful commercialization of our Nyloxin and Pet Pain-Away products; or a potential licensing of our therapies under development.
We will require additional financing to sustain our operations and without it will be unable to continue operations.
At December 31, 2023, we had a working capital deficit of $13,857,577. Our recurring losses from operations and working capital deficiency raise substantial doubt about our ability to continue as a going concern. We have a negative cash flow from operations of approximately $0.55 million and $0.76 million for the years ended December 31, 2023 and 2022, respectively. We have insufficient financial resources to fund our operations.
We have a history of failed distributors, which has negatively affected our revenues and may continue to do so if we fail to locate a successful distributor.
Due to poor performance, we cancelled our distribution agreement with our Cobroxin distributor, XenaCare in April 2011. We plan to re-launch Cobroxin, but we have not yet ordered product or provided planned sales. To date, we have only limited sales of Nyloxin and Pet Pain-Away through outside distributors. If we fail to improve our own marketing and distribution or fail to find a competent outside distributor our operations and financial condition will be negatively affected.
If we cannot sell a sufficient volume of our products, we will be unable to continue in business.
From October 2009 until December 31, 2023, our operations centered on the marketing of Cobroxin (our discontinued product), Nyloxin and Nyloxin Extra Strength. In December of 2014, we launched Pet Pain-Away and began actively marketing the product. In May of 2022, we began producing products for Avini Health Corporation. Avini Health distributes wellness and nutritional products through their network of independent distributors in the United States, Canada and the US Virgin Islands. The products that we provide for Avini Health include private label versions of our Nyloxin products and are sold as: Avini Plus Relief oral spray, Avini Plus Relief topical gel and Avini Plus Relief roll-on. We also provide the following products: a dietary fiber blend sold as Avini Plus Fiber, a micronized and activated colloidal suspension of zeolite that is sold as Cell Defender, a mushroom and zeolite blend sold in capsules as ZMUNITY, and a caffeine adaptogenic 2oz energy shot sold as Avini Plus Energy. During fiscal year 2022, we earned revenues of $438,274, $127,306 of it was from sales of Nyloxin and $18,494 of it was from sales of Pet Pain-Away, and $292,474 of it was from sales of Avini Products. During fiscal year 2023, we earned revenues of $594,880, $99,379 of it was from sales of Nyloxin and $67,720 of it was from sales of Pet Pain-Away, $38,465 was from sales of private label clients, and $389,316 of it was from sales of Avini Products. If we cannot achieve sufficient sales levels of our Nyloxin and Pet Pain-Away products or we are unable to secure financing our operations will be negatively affected.
We have a limited history of generating revenues on which to evaluate our potential for future success and to determine if we will be able to execute our business plan; accordingly, it is difficult to evaluate our future prospects and the risk of success or failure of our business.
You must consider our business and prospects in light of the risks and difficulties we will encounter as an early-stage revenue producing company. These risks include:
● our ability to effectively and efficiently market and distribute our products;
● our ability to obtain market acceptance of our current products and future products that may be developed by us; and
● our ability to sell our products at competitive prices which exceed our per unit costs.
We may be unable to address these risks and difficulties, which could materially and adversely affect our revenue, operating results and our ability to continue to operate our business.
Our growth strategy reflected in our business plan may be unachievable or may not result in profitability.
We may be unable to implement our growth strategy reflected in our business plan rapidly enough for us to achieve profitability. Our growth strategy is dependent on a number of factors, including market acceptance of our Nyloxin and Pet Pain-Away products and the acceptance by the public of using these products as pain relievers. We cannot assure you that our products will be purchased in amounts sufficient to attain profitability.
Among other things, our efforts to expand our sales of Nyloxin and Pet Pain-Away will be adversely affected if:
● we are unable to attract sufficient customers to the products we offer in light of the price and other terms required in order for us to attain the level of profitability that will enable us to continue to pursue our growth strategy;
● adequate penetration of new markets at reasonable cost becomes impossible limiting the future demand for our products below the level assumed by our business plan;
● we are unable to scale up manufacturing to meet product demand, which would negatively affect our revenues and brand name recognition;
● we are unable to meet regulatory requirements in the intellectual marketplace that would otherwise allow us for wider distribution; and
● we are unable to meet FDA regulatory requirements that would potentially expand our product base and potential revenues.
If we cannot manage our growth effectively, we may not become profitable.
Businesses, which grow rapidly often, have difficulty managing their growth. If we grow rapidly, we will need to expand our management by recruiting and employing experienced executives and key employees capable of providing the necessary support. We cannot assure you that our management will be able to manage our growth effectively or successfully.
Among other things, implementation of our growth strategy would be adversely affected if we were not able to attract sufficient customers to the products and services we offer or plan to offer in light of the price and other terms required in order for us to attain the necessary profitability.
If we are unable to protect our proprietary technology, our business could be harmed.
Our intellectual property, including patents, is our key asset. We currently have 3 active patents and several more in the application process. Competitors may be able to design around our patents for our Cobroxin, Nyloxin and Pet Pain-Away products and compete effectively with us. The cost to prosecute infringements of our intellectual property or the cost to defend our products against patent infringement or other intellectual property litigation by others could be substantial. We cannot assure you that:
● pending and future patent applications will result in issued patents,
● patents licensed by us will not be challenged by competitors,
● our patents, licensed and other proprietary rights from third parties will not result in costly litigation;
● pending and future patent applications will result in issued patents,
● the patents or our other intellectual property will be found to be valid or sufficiently broad to protect these technologies or provide us with a competitive advantage,
● if we are sued for patent infringement, whether we will have sufficient funds to defend our patents, and
● we will be successful in defending against future patent infringement claims asserted against our products.
Should any risks pertaining to the foregoing occur, our brand name reputation, results of operation and revenues will be negatively affected.
We are subject to substantial FDA regulations pertaining to Nyloxin and Pet Pain-Away, which may increase our costs or otherwise adversely affect our operations.
Our Nyloxin and Pet Pain-Away products are subject to FDA regulations, including manufacturing and labeling, approval of ingredients, advertising and other claims made regarding Nyloxin and Pet Pain-Away, and product ingredients disclosure. If we fail to comply with current or future regulations, the FDA could force us to stop selling Nyloxin and Pet Pain-Away or require us to incur substantial costs from adopting measures to maintain FDA compliance.
The inability to provide scientific proof for product claims may adversely affect our sales.
The marketing of Nyloxin and Pet Pain-Away involves claims that they assist in reducing Stage 2 chronic pain, while Nyloxin Extra Strength and Nyloxin Military Strength involves claims that they assist in reducing Stage 3 chronic pain. The marketing of Pet Pain-Away involves claims that they assist in relieving pain in dogs and cats. Under FDA and Federal Trade Commission (“FTC”) rules, we are required to have adequate data to support any claims we make concerning Nyloxin and Pet Pain-Away. We have scientific data for our Nyloxin and Pet Pain-Away product claims; however, we cannot be certain that these scientific data will be deemed acceptable to the FDA or FTC. If the FDA or FTC requests supporting information and we are unable to provide support that it finds acceptable, the FDA or FTC could force us to stop making the claims in question or restrict us from selling the products.
None of our ethical drug candidates have received FDA approval.
Our non-homeopathic or ethical products require a complex and costly FDA regulation process that takes several years for drug approval, if ever. None of the drug applications we have submitted to the FDA have received FDA approval. If we do not receive FDA approval for our drug applications, our operations and financial condition will be negatively affected.
If we are unable to secure sufficient cobra venom from available suppliers, our operating results will be negatively affected.
We secure cobra venom on an as-needed basis. If we do not have an available supplier to fill customer orders, there will be distribution delays and/or our failure to fulfill purchase orders, either of which will negatively affect our brand name reputation and operating results.
Our Nyloxin and Pet Pain-Away products may be unable to compete against our competitors in the pain relief market.
The pain relief market is highly competitive. We compete with companies that have already achieved product acceptance and brand recognition, including multi-billion dollar private label manufacturers and more established pharmaceutical and health products companies, or low cost generic drug manufacturers. Most such companies have far greater financial and technical resources and production and marketing capabilities than we do. Additionally, if consumers prefer our competitors’ products, or if these products have better safety, efficacy, or pricing characteristics, our results could be negatively impacted. If we fail to develop and actualize strategies to compete against our competitors we may fail to compete effectively, which will negatively affect our operations and operating results.
If we incur costs resulting from product liability claims, our operating results will be negatively affected.
If we become subject to product liability claims for Nyloxin and Pet Pain-Away that exceed our product liability policy limits, we may be subject to substantial litigation costs or judgments against us, which will negatively impact upon our financial and operating results.
Loss of any of our key personnel could have a material adverse effect on our operations and financial results.
We are dependent upon a limited number of our employees: (a) our Chief Executive Officer; (b) our Operations Manager who directs our operations and (b) our Chief Scientific Officer who conducts our research and development activities. Our success depends on the continued services of our senior management and key research and development employees as well as our ability to attract additional members to our management and research and development teams. The unexpected loss of the services of any of our management or other key personnel could have a material adverse effect upon our operations and financial results.
We may be unable to maintain and expand our business if we are not able to retain, hire and integrate key management and operating personnel.
Our success depends in large part on the continued services and efforts of key management personnel. Competition for such employees is intense and the process of locating key personnel with the combination of skills and attributes required to execute our business strategies may be lengthy. The loss of key personnel could have a material adverse impact on our ability to execute our business objectives. We do not have any key man life insurance on the lives of any of our executive officers.
Risks Related to Our Common Stock
Because the market for our common stock is limited, persons who purchase our common stock may not be able to resell their shares at or above the purchase price paid by them.
Our common stock is presently on the OTC Market Group’s Expert Market, which means that the Company’s common stock is not eligible for proprietary broker-deal quotes. There is currently only a limited public market for our common stock. We cannot assure you that an active public market for our common stock will develop or be sustained in the future. If an active market for our common stock does not develop or is not sustained, the price may decline.
Because we are subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our common stock, which adversely affects its liquidity and market price.
The SEC has adopted regulations, which generally define “penny stock” to be an equity security that has a market price of less than $5.00 per share, subject to specific exemptions. The market price of our common stock on the OTC has been substantially less than $5.00 per share and therefore we are currently considered a “penny stock” according to SEC rules. This designation requires any broker-dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from the purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker-dealers to solicit purchases of our common stock and therefore reduce the liquidity of the public market for our shares.
Because the majority of our outstanding shares are freely tradable, sales of these shares could cause the market price of our common stock to drop significantly, even if our business is performing well.
As of December 31, 2023, we had 109,150,000 outstanding shares that were subject to the limitations of Rule 144 under the Securities Act of 1933. In general, Rule 144 provides that any non-affiliates, who have held restricted common stock for at least six-months, are entitled to sell their restricted stock freely, provided that we stay current in our SEC filings. After one year, a non-affiliate may sell without any restrictions.
An affiliate may sell after one year with the following restrictions: (i) we are current in our filings, (ii) certain manner of sale provisions, (iii) filing of Form 144, and (iv) volume limitations limiting the sale of shares within any three-month period to a number of shares that does not exceed 1% of the total number of outstanding shares. A person who has ceased to be an affiliate at least three months immediately preceding the sale and who has owned such shares of common stock for at least one year is entitled to sell the shares under Rule 144 without regard to any of the limitations described above.
An investment in our common stock may be diluted in the future as a result of the issuance of additional securities or the exercise of options or warrants.
In order to raise additional capital to fund our strategic plan, we may issue additional shares of common stock or securities convertible, exchangeable or exercisable into common stock from time to time, which could result in substantial dilution to any person who purchases our common stock. Because we have a negative net tangible book value, purchasers will suffer substantial dilution. We cannot assure you that we will be successful in raising funds from the sale of common stock or other equity securities.
Since we intend to retain any earnings for development of our business for the foreseeable future, you will likely not receive any dividends for the foreseeable future.
We have not and do not intend to pay any dividends in the foreseeable future, as we intend to retain any earnings for development and expansion of our business operations. As a result, you will not receive any dividends on your investment for an indefinite period of time.
Due to factors beyond our control, our stock price may continue to be volatile.
The market price of our common stock has been and is expected to be highly volatile. Any of the following factors could affect the market price of our common stock:
● our failure to generate revenue,
● our failure to achieve and maintain profitability,
● short selling activities,
● the sale of a large amount of common stock by our shareholders including those who invested prior to commencement of trading,
● actual or anticipated variations in our quarterly results of operations,
● announcements by us or our competitors of significant contracts, new products, acquisitions, commercial relationships, joint ventures or capital commitments,
● the loss of major customers or product or component suppliers,
● the loss of significant business relationships,
● our failure to meet financial analysts’ performance expectations,
● changes in earnings estimates and recommendations by financial analysts, or
● changes in market valuations of similar companies.
In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has often been instituted. A securities class action suit against us could result in substantial costs and divert our management’s time and attention, which would otherwise be used to benefit our business.

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ITEM 1B. UNRESOLVED STAFF COMMENTS
Item 1B. Unresolved Staff Comments
None

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ITEM 2. PROPERTIES
Item 2. Properties
We lease an aggregate of 5,500 square feet of office, laboratory, and warehouse space at 1537 NW 65th Avenue, Plantation, Florida. The lease with Shelter Developers of America (“Shelter”) has been renewed through January 1, 2026. The lease calls for current monthly payments of approximately $8,500, which includes base rent, common area expenses, real estate taxes and insurance. In September of 2023, we moved our operations to 6400 Park of Commerce Blvd, Suite 1B, Boca Raton, Florida. We share 18,504 square feet with Avini Health, a private dietary supplement company. We have use of a laboratory, conference room, production suites and 3 offices. Avini Health grants us the use of the facilities as part of our contract manufacturing agreements without further payments.

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ITEM 3. LEGAL PROCEEDINGS
Item 3. Legal Proceedings
CSA 8411, LLC v. Nutra Pharma Corp., Case No. CACE 18-023150
On October 12, 2018, CSA 8411, LLC filed a lawsuit against the Company in the 17th Judicial Circuit Court in and for Broward County, Florida (Case No. CACE 18-023150) to recover $100,000 allegedly owed under an amended promissory note dated April 12, 2017. On November 1, 2018, the Company filed its Answer and Affirmative Defenses to the Complaint. The Company believes that this lawsuit is without merit. Moreover, the Company believes that it has a number of valid defenses to this claim. Among other things, the owner of CSA 8411, LLC violated the terms of a Binding Memorandum of Understanding by failing to invest in the Company and fraudulently inducing the Company to enter into the subject amended promissory note (contrary to the Get Credit Healthy lawsuit discussed above, we are certain that this individual is the majority owner of CSA 8411, LLC). Opposing counsel reached out to schedule mediation, and mediation was set for June 21, 2019 in Plantation, FL however the mediation was unsuccessful. At December 31, 2023, we owed principal balance of $91,156 and accrued interest of $73,733 (See Note 6) if the defenses and our new claims are deemed to be of no merit.
Defendant also filed affirmative claims against the Plaintiff, its owner Dan Oran and several related entities.
On May 19, 2025, the parties settled the case; fully resolving all existing disputes and conflicts between the parties. We agreed to pay $35,000 to the plaintiff(s) on or before May 19, 2025 and make nine (9) monthly payments of $10,000 each, beginning on June 19, 2025. The case was dismissed on May 20, 2025 and all payments to date have been made as agreed.
Securities and Exchange Commission v. Nutra Pharma Corporation, Erik Deitsch, and Sean Peter McManus
On September 28, 2018, the United States Securities and Exchange Commission (the “SEC”) filed a lawsuit (the “SEC Action”) in the United States District Court for the Eastern District of New York (Case No. 2:18-cv-05459) against the Company, Mr. Deitsch, and Mr. McManus. After various motions to dismiss directed to the original Complaint and the First Amended Complaint filed May 29, 2019 were disposed of in the SEC Action, the SEC filed the Second Amended Complaint against the Company and Messrs. Deitsch and McManus on April 30, 2020 which became the operative pleading seeking permanent injunctive relief, disgorgement of ill-gotten gains and prejudgment interest thereon, civil monetary penalties, a permanent officer and director bar, and a permanent penny stock bar for alleged violations between August 2013 and June 2018 of the registration, broker-dealer registration, periodic reporting, insider reporting, anti-fraud, and anti-manipulation provisions of the federal securities laws. After approximately four years of litigating the Second Amended Complaint, the Company and Messrs. Deitsch and McManus agreed to settle the case by entering into consents, without admitting or denying the allegations of the Second Amended Complaint except as to personal and subject matter jurisdiction, to entry of Final Judgments.
On March 19, 2024, the United States District Court for the Eastern District of New York in the SEC Action, approved bifurcated settlements in the form of consent judgments (the “Consent Judgments”) entered by the District Court wherein the Company and Messrs. Deitsch and McManus, without admitting or denying the allegations of the Complaint except as to personal and subject matter jurisdiction, resolved all liability issues and certain remedies as to each Defendant and left open other issues relating to remedies regarding the appropriateness and amount of disgorgement, prejudgment interest, and/or civil penalties to be paid as to all Defendants, and whether a penny stock bar shall be imposed against Defendant McManus, and if so, the length of any such bar, for later resolution by the District Court upon motion or further settlement. The Consent Judgments, among other things:
(1) Permanently enjoin Defendant Nutra Pharma from committing violations of the federal securities laws that the SEC has alleged in this case, including violations of Sections 5(a), 5(c), and 17(a) of the Securities Act of 1933 (the “Securities Act”), Sections 10(b) and 13(a) of the Securities Exchange Act of 1934 (the “Exchange Act”), and Rules 10b-5, 13a-11, and 13a-13 thereunder;
(2) Permanently enjoin Defendant Deitsch from committing violations of the federal securities laws that the SEC has alleged in this case, including violations of Sections 5(a), 5(c), and 17(a) of the Securities Act, Sections 9(a)(2), 10(b), 13(a), 13(d), and 16(d) of the Securities Exchange Act, and Rules 10b-5, 13a-14, 13d-2, and 16a-3 thereunder; impose a three-year officer-and-director bar on Deitsch, pursuant to 15 U.S.C. §§ 77t(e) and 78u(d)(2); and impose a three-year penny-stock bar on Deitsch, pursuant to 15 U.S.C. § 78u(d)(6); and
(3) Permanently enjoin Defendant McManus from committing violations of the federal securities laws that the SEC has alleged in this case, including violations of Section 17(a) of the Securities Act and Sections 10(b) and 15(a) of the Exchange Act and Rule 10b-5 thereunder.
On May 13, 2024, the remaining remedies regarding disgorgement, prejudgment interest, and civil penalties as to Defendant Deitsch and disgorgement, prejudgment interest, civil penalties, and a penny stock bar as to Defendant McManus were resolved by respective consents from each, without admitting or denying the allegations of the Complaint except as to jurisdiction and Section XIII of their respective Final Judgments that restated the permanent injunctive relief, three-year officer-and-director bar on Deitsch, the three-year penny- stock bar on Deitsch for the alleged violations described above from the Consent Judgments and imposed disgorgement of $44,046, prejudgment interest of $5,013, and a civil money penalty of $30,000 against Deitsch (a total of $79,060); and that restated the permanent injunctive relief and imposed two-year penny-stock bar against McManus, and imposed disgorgement of $5,500, prejudgment interest of $626, and a civil money penalty of $5,500 against McManus (a total of $11,626).
On August 28, 2024, the remaining remedies regarding disgorgement, prejudgment interest, and civil penalties as to the Company were resolved by consent by the Company, without admitting or denying the allegations of the Complaint except as to jurisdiction, in its Final Judgment that restated the permanent injunctive relief against the Company for the alleged violations described above from the Consent Judgment and imposed disgorgement of $520,940, prejudgment interest of $59,295, and a civil money penalty of $100,000 against Nutra Pharma (a total of $680,235).

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ITEM 4. MINE SAFETY DISCLOSURE
Item 4. Mine Safety Disclosures
None
PART II

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ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY
Item 5. Market for Registrant’s Common Equity; Related Stockholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is quoted on the over-the-counter (“OTC-Market”) under the trading symbol “NPHC.” The following table sets forth the high and low bid prices for each quarter within the last two fiscal years.
2023 Fiscal Year
High Bid Low Bid
First Quarter $ 0.0004 $ 0.0001
Second Quarter $ 0.0002 $ 0.0001
Third Quarter $ 0.0002 $ 0.0001
Fourth Quarter $ 0.0010 $ 0.0001
2022 Fiscal Year
High Bid Low Bid
First Quarter $ 0.0035 $ 0.0006
Second Quarter $ 0.0019 $ 0.0003
Third Quarter $ 0.0015 $ 0.0001
Fourth Quarter $ 0.0017 $ 0.0001
The above quotations reflect inter-dealer prices, without retail mark-up, markdown or commission and may not represent actual transactions.
Penny Stock Considerations
Our shares of common stock are “penny stocks” as that term is generally defined in the Securities Exchange Act of 1934 as equity securities with a price of less than $5.00. Our shares are subject to rules that impose sales practice and disclosure requirements on broker-dealers who engage in certain transactions involving a penny stock.
Under the penny stock regulations, a broker-dealer selling a penny stock to anyone other than an established customer or “accredited investor” must make a special suitability determination regarding the purchaser and must receive the purchaser’s written consent to the transaction prior to the sale, unless the broker-dealer is otherwise exempt. Generally, an individual with a net worth in excess of $1,000,000 or annual income exceeding $200,000 individually or $300,000 together with his or her spouse is considered an accredited investor.
In addition, under the penny stock regulations the broker-dealer is required to:
● Deliver, prior to any transaction involving a penny stock, a disclosure schedule prepared by the Securities and Exchange Commission relating to the penny stock market, unless the broker-dealer or the transaction is otherwise exempt;
● Disclose commission payable to the broker-dealer and its registered representatives and current bid and offer quotations for the securities;
● Send monthly statements disclosing recent price information pertaining to the penny stock held in a customer’s account, the account’s value and information regarding the limited market in penny stocks; and
● Make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction, prior to conducting any penny stock transaction in the customer’s account.
Because of these regulations, broker-dealers may encounter difficulties in their attempt to sell shares of our common stock, which may affect the ability of shareholders to sell their shares in the secondary market and have the effect of reducing the level of trading activity in the secondary market. These additional sales practice and disclosure requirements could impede the sale of our securities. In addition, the liquidity for our securities may be adversely affected, with a corresponding decrease in the price of our securities. Our shares are subject to such penny stock rules and our shareholders will, in all likelihood, find it difficult to sell their securities.
Holders
As of November 24, 2025, based upon records obtained from our transfer agent, there were 396 holders of record of our common stock. Our transfer agent records do not account for other holders of our common stock that are held in street name or by broker dealers as custodian for individual holders of our stock. We have one class of common stock outstanding.
Dividends
We have not declared any cash dividends on our common stock since our inception and do not anticipate paying such dividends in the foreseeable future. We plan to retain any future earnings for use in our business. Any decisions as to future payment of dividends will depend on our earnings and financial position and such other factors as our Board of Directors deems relevant. There are no restrictions contained in our bylaws or otherwise pertaining to our issuing dividends.
Equity Compensation Plans
Securities authorized per issuance under Equity Compensation Plans as of December 31, 2023 and 2022 are as follows:
Equity Compensation Plan Information
Number of
Securities
to be issued
upon exercise
of outstanding
options,
warrants and
rights
Weighted-
average
exercise
price of
outstanding
options,
warrants
and rights
Number of
Securities
Remaining
available
for future
issuance
under equity
compensation
plans (excluding
securities
reflected in
column(a))
Plan category (a) (b) (c)
Equity compensation plans approved by security holders N/A N/A
Equity compensation plans not approved by security holders $ 4.00 6,375
Total $ 4.00 6,375
The figures contained in the above chart are composed of our 2003 and 2007 Employee /Consultant Stock Compensation Plans and two (2) option agreements we have with a corporate entity and our former Chairman of the Board/Executive Chairman, as follows. The figures above reflect historical stock compensation plans and option agreements that are no longer active. These disclosures are provided for contextual completeness and do not represent ongoing obligations or current equity arrangements:
Plan
On December 3, 2003, our Board of Directors approved the Employee/Consultant Stock Compensation Plan (the “2003 Plan”). The purpose of the 2003 Plan is to further our growth by allowing us to compensate employees and consultants who have provided bona fide services to us through the award of our common stock. The maximum number of shares of common stock that may be issued under the 2003 Plan is 62,500. As of December 31, 2023 and 2022, we had issued a total of 62,375 shares under the 2003 Plan.
Plan
On June 6, 2007, our Board of Directors approved the 2007 Employee/Consultant Stock Compensation Plan (the “2007 Plan”). The purpose of the 2007 Plan is to further our growth by allowing us to compensate employees and consultants who have provided bona fide services to us through the award of our common stock. The maximum number of shares of common stock that may be issued under the 2007 Plan is 625,000. As of December 31, 2023 and 2022, we had issued a total of 618,750 shares under the 2007 Plan.
Our Board of Directors is responsible for the administration of the 2003 and 2007 Plans and has full authority to grant awards under the Plans. Awards may take the form of stock grants, options or warrants to purchase common stock. The Board of Directors has the authority to determine: (a) the employees and consultants that will receive awards under the Plan, (b) the number of shares, options or warrants to be granted to each employee or consultant, (c) the exercise price, term and vesting periods, if any, in connection with an option grant, and (d) the purchase price and vesting period, if any, in connection with the granting of a warrant to purchase shares of our common stock.
Recent Sales of Unregistered Securities
With respect to the securities issuances described below, no solicitations were made and no underwriting discounts were given or paid in connection with these transactions. The Company believes that the issuance of these securities as described below were exempt from registration with the Securities and Exchange Commission pursuant to Section 4(2) of the Securities Act of 1933.
During February 2024, we issued 35,000,000 restricted shares to a Note holder due to the default on repayments of the promissory note of $183,619 amended in February 2022. The shares were valued at a fair value of $3,500.
Pursuant to the Note agreement in the amount up to $1,000,000 signed in February 2019, in August 2023, the Noteholder received 25,000,000 shares of our restricted common stock in satisfaction of the $12,500 of the Note with a fair value of $2,500.

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ITEM 6. SELECTED FINANCIAL DATA
Item 6. Reserved
Not applicable.

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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation
Critical Accounting Policies and Estimates
In preparing the consolidated financial statements in accordance with accounting principles generally accepted in the United States of America (U.S. GAAP), we have adopted various accounting policies. Our most significant accounting policies are disclosed in Note 1 to the consolidated financial statements.
The preparation of the consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Our estimates and assumptions, including those related to the ability to continue as a going concern, the recoverability of inventory and long-lived assets, the fair value of stock-based compensation, the fair value of debt, the fair value of derivative liabilities, recognition of loss contingencies and deferred tax valuation allowances are updated as appropriate, which in most cases is at least quarterly. We base our estimates on historical experience, or various assumptions that are believed to be reasonable under the circumstances and the results form the basis for making judgments about the reported values of assets, liabilities, revenues and expenses. Actual results may materially differ from these estimates.
We believe that our critical accounting policies and estimates include our ability to continue as a going concern, revenue recognition, accounts receivable and allowance for doubtful accounts, inventory obsolescence, accounting for long-lived assets and accounting for stock based compensation.
Ability to Continue as a Going Concern: Our ability to continue as a going concern is contingent upon our ability to secure additional financing, increase ownership equity, and attain profitable operations. In addition, our ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which we operate.
Revenue Recognition: The Company accounts for revenue from contracts with customers in accordance with Financial Accounting Standard Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC Topic 606, revenue recognition has a five-step process: a) Determine whether a contract exists; b) Identify the performance obligations; c) Determine the transaction price; d) Allocate the transaction price; and e) Recognize revenue when (or as) performance obligations are satisfied.
Our revenues are primarily derived from customer orders for the purchase of our products. We recognize revenues as performance obligations are fulfilled upon shipment of products. We record revenues net of promotions and discounts. For certain product sales to a distributor, we record revenue including a portion of the cash proceeds that is remitted back to the distributor.
Accounts Receivable and Allowance for Credit Losses: We grant credit without collateral to our customers based on our evaluation of a particular customer’s credit worthiness. Accounts receivable are due 30 days after the issuance of the invoice. In addition, the Company maintains an allowance for credit losses to reflect the current expected credit losses (“CECL”) over the contractual life of the receivables. Accounts receivable are written off after collection efforts have been deemed to be unsuccessful. Accounts written off as uncollectible are deducted from the allowance for doubtful accounts, while subsequent recoveries are netted against the provision for doubtful accounts expense. We generally do not charge interest on accounts receivable. We use third party payment processors and are required to maintain reserve balances, which are included in accounts receivable.
Our accounts receivable are stated at estimated net realizable value. Accounts receivable are comprised of balances due from customers and third party payment processors, net of estimated allowances for uncollectible accounts. In determining collectability, historical trends are evaluated and specific customer issues are reviewed to arrive at appropriate allowances.
Inventory Obsolescence: Inventories are valued at the lower of cost or net realizable value. We periodically perform an evaluation of inventory for excess, impairments and obsolete items. At December 31, 2023, our inventory consisted entirely of raw materials and finished goods that are utilized in the manufacturing of finished goods. These raw materials generally have expiration dates in excess of 10 years. Commencing on October 1, 2019, we classify inventory as short-term or long-term inventory based on timing of when it is expected to be consumed.
Long-Lived Assets: The carrying value of long-lived assets is reviewed annually and when events or changes in circumstances may suggest impairment has occurred. If indicators of impairment are present, we determine whether the sum of the estimated undiscounted future cash flows attributable to the long-lived asset in question is less than its carrying amount. If less, we measure the amount of the impairment based on the amount that the carrying value of the impaired asset exceeds the discounted cash flows expected to result from the use and eventual disposal of the impaired assets.
Derivative Financial Instrument: Management evaluates all of its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported as charges or credits to income. For option-based simple derivative financial instruments, the Company uses the Black-Scholes option-pricing model to value the derivative instruments at inception and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting period. Derivative instrument liabilities are classified in the balance sheet as current or non-current based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
We do not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks.
Convertible Debt: Effective January 1, 2022, the Company adopted ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40). The update eliminates certain separation models, including the beneficial conversion feature and cash conversion models, so convertible instruments issued after adoption are generally accounted for as a single liability or equity instrument, unless a conversion feature requires separate derivative accounting under ASC 815. ASU 2020-06 also amends diluted EPS guidance.
The Fair Value Measurement Option: We have elected the fair value measurement option for convertible debt with embedded derivatives that require bifurcation, and record the entire hybrid financing instrument at fair value under the guidance of ASC Topic 815, Derivatives and Hedging (“ASC Topic 815”). The Company reports interest expense, including accrued interest, related to this convertible debt under the fair value option, within the change in fair value of convertible notes and derivatives in the accompanying consolidated statement of operations.
Derivative Accounting for Convertible Debt and Options and Warrants: The Company evaluated the terms and conditions of the convertible debt under the guidance of ASC 815, Derivatives and Hedging. The conversion terms of some of the convertible notes are variable based on certain factors, such as the future price of the Company’s common stock. The number of shares of common stock to be issued is based on the future price of the Company’s common stock. The number of shares of common stock issuable upon conversion of the debt is indeterminate. Due to the fact that the number of shares of common stock issuable could exceed the Company’s authorized share limit, the equity environment is tainted, and all additional convertible debt and options and warrants are included in the value of the derivative liabilities. Pursuant to ASC 815-15, Embedded Derivatives, the fair values of the convertible debt, options and warrants and shares to be issued were recorded as derivative liabilities on the issuance date and revalued at each reporting period.
Share-Based Compensation: We record share-based compensation in accordance with FASB ASC 718, Stock Compensation. FASB ASC 718 requires that the cost resulting from all share-based transactions are recorded in the financial statements over the respective service periods. It establishes fair value as the measurement objective in accounting for share-based payment arrangements and requires all entities to apply a fair-value-based measurement in accounting for share-based payment transactions with employees. FASB ASC 718 also establishes fair value as the measurement objective for transactions in which an entity acquires goods or services from non-employees in share-based payment transactions.
Accomplishments during 2023 & Subsequent Accomplishments
On March 22, 2024, we announced that we had reached a settlement in the civil lawsuit brought by the SEC.
Results of Operations
Status of Operations
In November 2014, we announced the recertification of our laboratory facility as the first step in re-engaging our drug development activities. In September, 2015 we received Orphan designation from the FDA for our lead drug candidate, RPI-78M for the treatment of Pediatric Multiple Sclerosis. This will allow us to shorten the timeline on clinical studies and may allow an eventual Fast Track through the approval process. We are currently working with our consultants to prepare a pre-IND meeting with the FDA in order to gain approval of a protocol for a Phase I/II clinical study in Pediatric MS. Our goal is to begin the study in early 2026.
We estimate that we will require approximately $600,000 to fund our existing operations over the next twelve months. These costs include: (i) compensation for six (6) full-time employees; (ii) compensation for various consultants who we deem critical to our business; (iii) general office expenses including rent and utilities; (iv) product liability insurance; and (v) outside legal and accounting services. These costs reflected in (i) - (v) do not include research and development costs or other costs associated with clinical studies.
We began generating revenues from the sale of Cobroxin in the fourth quarter of 2009 and from the sale of Nyloxin and Nyloxin Extra Strength in January of 2011. We began sales of Pet Pain-Away in December 2014. We began selling private label versions of our OTC products in 2021. While sales have increased year over year, they have been limited and inconsistent. Our ability to meet our future operating expenses is highly dependent on the amount of such future revenues. If future revenues from the sale of out private label products, Nyloxin and Pet Pain-Away are insufficient to cover our operating expenses we may need to raise additional equity capital, which could result in substantial dilution to existing shareholders. There can be no assurance that we will be able to raise sufficient equity capital to fund our working capital requirements on terms acceptable to us, or at all. We may also seek additional loans from our officers and directors; however, there can be no assurance that we will be successful in securing such additional loans.
Comparison of Years Ended December 31, 2023 and 2022
Net sales to unrelated customers were $205,564 for the year ended December 31, 2023, compared to $145,800 for the year ended December 31, 2022-an increase of $59,764, or approximately 40.99%. The increase primarily reflects higher sales of Nyloxin and Pet Pain-Away.
Net sales to a related party were $389,316 for the year ended December 31, 2023, compared to $292,474 for the year ended December 31, 2022-an increase of $96,842, or approximately 33.11%. The increase primarily reflects stronger demand for existing products. The prior-year same period included only initial sales following the products launch in March 2022, before full market adoption.
Cost of sales for the year ended December 31, 2023 is $177,525 compared to $162,842 for the year ended December 31, 2022. Our cost of sales includes the direct costs associated with manufacturing, shipping and handling costs. Our gross profit margin for the year ended December 31, 2023 is $367,355 or 67.42% compared to $275,432 or 62.84% for the year ended December 31, 2022. The margin improvement primarily reflects lower manufacturing costs associated with sales to a related party. In addition, we had an impairment of prepaid inventory of $20,900 and $26,410 for the years ended December 31, 2023 and 2022, respectively, related to undelivered venom and slow-moving inventory.
Selling, general and administrative expenses decreased $906,661 or 43.49% from $2,084,630 for the year ended December 31, 2022 to $1,177,969 for the year ended December 31, 2023. The decrease was primarily driven by lower professional fees, as operations were limited due to the unresolved lawsuit, partially offset by higher legal expenses. In addition, we incurred bad debt expense of $105,465 and $71,796 from the receivables from companies controlled by the Company’s former CEO for the year ended December 31, 2023 and 2022, respectively.
Other income was $73,061 and $16,215 for the year ended December 31, 2023 and 2022, respectively. For 2023, other income includes $39,667 from the gain on sale of equipment, $30,363 related to services rendered in exchange for a convertible note receivable, and $3,031 from the amortization of debt discounts on convertible notes receivable. The prior-year amount primarily relates to the amortization of debt discounts.
Interest expense, including related party interest expense, decreased $391,724 or 49.49%, from $791,483 for the year ended December 31, 2022 to $399,759 for the year ended December 31, 2023. This decrease was primarily due to decrease in amortization of loan discounts in the year ended December 31, 2023 compared to the year ended December 31, 2022.
We carry certain of our debentures and common stock warrants at fair value. Due to the fact that the number of shares of common stock issuable could exceed the Company’s authorized share limit, the equity environment is tainted, and all additional convertible debt, options and warrants are included in the value of the derivative liabilities. For the year ended December 31, 2023 and 2022, the liability related to these hybrid instruments fluctuated, resulting in a loss of $187,829 and a gain of $11,023,290, respectively. Interest expense related to these debentures is included in the fair value loss or gain in the accompanying consolidated statements of operations.
Loss on settlement of debts decreased $161,322 or 105.32%, from a loss of $153,172 for the year ended December 31, 2022 to a gain of $8,150 for the year ended December 31, 2023. This decrease in loss was primarily due to fewer debts being settled in the year ended December 31, 2023 compared to the same period in 2022.
As a result of the foregoing, our net income decreased by $9,570,227 or 117.04%, from an income of $8,176,871 for the year ended December 31, 2022 to a loss of $1,393,356 for the year ended December 31, 2023.
For the year ended December 31, 2023, net cash used in operating activities was approximately $0.55 million, an improvement from about $0.76 million in the prior year, despite a shift from net income of approximately $8.2 million in the prior year to a net loss of approximately $1.5 million in the current year. The change primarily reflects the combined effect of non-cash adjustments and favorable changes in working-capital accounts. Non-cash adjustments in 2023 included depreciation and amortization of approximately $0.2 million, bad-debt expense of approximately $0.1 million, and a non-cash loss of approximately $0.2 million related to the change in fair value of convertible instruments. In 2023, increases in accrued expenses, deferred revenue, and accrued payroll due to officers provided additional operating cash compared to the prior year. Modest increases in accounts payable and accrued interest to related parties also supported liquidity. Overall, increase in payables, accruals, and deferred revenue contributed to the reduction in cash used in operations compared with the prior year.
Net cash provided by investing activities was approximately $0.12 million for the year ended December 31, 2023, compared to net cash provided by approximately $0.03 million in 2022. Overall, investing activities generated modest net cash inflows in both periods, with the current-year increase primarily driven by proceeds from sale of equipment and the sale of StemSation stocks.
For the year ended December 31, 2023, net cash provided by financing activities was approximately $0.43 million, compared to approximately $0.64 million in the prior year. The decrease primarily reflects lower proceeds from convertible notes and reduced borrowings under other notes payable. During 2023, the Company received approximately $0.6 million in loans from an officer and $0.1 million in proceeds from convertible notes, partially offset by repayments of approximately $0.2 million on officer loans and $0.05 million on convertible notes. In addition, the Company received approximately $0.2 million in advances from other notes payable and made repayments of approximately $0.3 million on those obligations.
Liquidity and Capital Resources
During December 31, 2023 and 2022, respectively, we had negative cash from operations of approximately $0.55 million and $0.76 million. Our lack of cash, significant losses and working capital deficits and stockholders’ deficits raise substantial doubt about our ability to continue as a going concern. For the years ended December 31, 2023 and 2022, we have experienced net loss of $1,393,356 and a net income of $8,176,871, respectively, and had an accumulated deficit of $74,945,474 for the period from our inception to December 31, 2023. In addition, we had working capital and stockholders’ deficits at December 31, 2023 of $13,857,577 and $13,768,308, respectively.
Our ability to continue as a going concern is contingent upon our ability to secure additional financing, increase ownership equity and attain profitable operations. In addition, our ability to continue as a going concern must be considered in light of the problems, expenses and complications frequently encountered in established markets and the competitive environment in which we operate.
As of December 31, 2023, we had $0 in cash and owed approximately $4.44 million in vendor payables and accrued expenses. We currently do not have sufficient cash to sustain our operations for the next 12 months and will require additional financing or an increase in sales in order to execute our operating plan and continue as a going concern. Our plan is to continue to increase sales of our products and attempt to secure adequate funding to bridge the commercialization of our Nyloxin and Pet Pain-Away products. We cannot predict whether additional financing will be in the form of equity, debt, or another form and we may be unable to obtain the necessary additional capital on a timely basis, on acceptable terms, or at all. In the event that these financing sources do not materialize, or that we are unsuccessful in increasing our revenues and profits, we may be unable to implement our current plans for expansion, repay our obligations as they become due or continue as a going concern, any of which circumstances would have a material adverse effect on our business prospects, financial condition and results of operations.
Historically, we have relied upon loans from our former Chief Executive Officer Rik J Deitsch, to fund costs associated with our operations. These loans are unsecured, accrue interest at a rate of 4.0% per annum and are due on demand. At December 31, 2023, the net balance due to Rik Deitsch, the Company’s former CEO, and the companies majority owned and controlled by him (collectively referred to as “Due to Officer”) in the aggregate is $659,433, which net balance is unsecured and accruing interest at 4%. During the year ended December 31, 2023, in the aggregate, we repaid $162,100 and were advanced $599,500 on this balance. Additionally, accrued interest on the outstanding balance was $9,161 and is included in the due to officer account. The Company had fully reserved receivables from companies owned by the Company’s former CEO. The reserve was $177,261 as of December 31, 2023. The bad debt expense of $105,465 was recorded for the year ended December 31, 2023.
During the year ended December 31, 2023, we raised net cash proceeds of $127,250 and $182,200 through the issuance of convertible notes and promissory notes, respectively. Current operations are being funded through a combination of product sales, loans from our former CEO and convertible notes.
Uncertainties and Trends
Our operations and possible revenues are dependent now and in the future upon the following factors:
● Whether we successfully develop and commercialize products from our research and development activities.
● If we fail to compete effectively in the intensely competitive biotechnology area, our operations and market position will be negatively impacted.
● If we fail to successfully execute our planned partnering and out-licensing of products or technologies, our future performance will be adversely affected.
● The recent economic downturn and related credit and financial market crisis may adversely affect our ability to obtain financing, conduct our operations and realize opportunities to successfully bring our technologies to market.
● Biotechnology industry related litigation is substantial and may continue to rise, leading to greater costs and unpredictable litigation.
● The decline in sales to Avini, as Avini has begun manufacturing its own products. This shift is expected to reduce our revenues going forward and may require us to develop new customer relationships or product lines to offset the reduction.
● If we fail to comply with extensive legal/regulatory requirements affecting the healthcare industry, we will face increased costs, and possibly penalties and business losses.
Off-Balance Sheet Arrangements
We have not entered into any transaction, agreement or other contractual arrangement with an entity unconsolidated with us under whom we have:
● An obligation under a guarantee contract.
● A retained or contingent interest in assets transferred to the unconsolidated entity or similar arrangement that serves as credit, liquidity or market risk support to such entity for such assets.
● Any obligation, including a contingent obligation, under a contract that would be accounted for as a derivative instrument.
● Any obligation, including a contingent obligation, arising out of a variable interest in an unconsolidated entity that is held by us and material to us where such entity provides financing, liquidity, market risk or credit risk support to, or engages in leasing, hedging or research and development services with us.
We do not have any off-balance sheet arrangements or commitments that have a current or future effect on its financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that is material, other than those which may be disclosed in this Management’s Discussion and Analysis of Financial Condition and the audited Consolidated Financial Statements and related notes.

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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Not applicable. We have no investments in market risk sensitive instruments or in any other type securities.

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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Item 8. Financial Statements and Supplementary Data
The information required by this item begins on page and is attached hereto and incorporated herein by reference. The index to our annual consolidated financial statements as of and for the years ended December 31, 2023 and 2022 can be found under Item 15.

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ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.

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ITEM 9A. CONTROLS AND PROCEDURES
Item 9A. Controls and Procedures
Section 1.
Evaluation of Disclosure Controls and Procedures:
As of December 31, 2023, we carried out an evaluation under the supervision and the participation of our Chief Executive Officer/Chief Financial Officer, of the effectiveness of our disclosure controls and procedures as of December 31, 2023, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934 (“Exchange Act”). Based on that evaluation, our management, including our Chief Executive Officer/Chief Financial Officer, concluded that, because of the material weaknesses in internal control over financial reporting discussed in Management’s Report on Internal Control Over Financial Reporting below, our disclosure controls and procedures were not effective, at a reasonable assurance level, as of December 31, 2023. In light of this, we performed additional post-closing procedures and analyses in order to prepare the Consolidated Financial Statements included in this report. As a result of these procedures, we believe our Consolidated Financial Statements included in this report present fairly, in all material respects, our financial condition, results of operations and cash flows for the periods presented. A control system cannot provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, with the company have been detected.
Section 2.
Management’s Annual Report on Internal Control over Financial Reporting
During its evaluation of the effectiveness of internal control over financial reporting as of December 31, 2023, our management concluded that its material weaknesses in its internal controls over financial reporting include matters pertaining to: (a) lack of qualified accounting personnel; (b) inadequate segregation of duties; (c) the need to enhance the supervision, monitoring and reviewing of financial statement preparation processes due to lack of qualified accounting personnel; and (d) instances of business arrangements and transactions, with both related and unrelated parties, that were not supported by formal written agreements.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is the process designed by and under the supervision of our Chief Executive Officer/Chief Financial Officer, or the persons performing similar functions, to provide reasonable assurance regarding the reliability of our financial reporting and the preparation of our financial statements for external reporting in accordance with accounting principles generally accepted in the United States of America. Management has evaluated the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO-2013) in Internal Control over Financial Reporting - Guidance for Smaller Public Companies. Under the supervision and with the participation of our Chief Executive Officer/Chief Financial Officer, our management has assessed the effectiveness of our internal control over financial reporting as of December 31, 2023 and concluded that it is ineffective because of the material weaknesses. These identified material weaknesses included (i) an insufficient accounting staff; (ii) inadequate segregation of duties; (iii) limited checks and balances in processing cash and other transactions; and (iv) lack of independent directors and an independent audit committee.
To remedy these weaknesses, when financially able, we plan to supplement our accounting staff with additional experienced financial professionals, redefining and realigning responsibilities and by defining additional controls, reporting processes and procedures to address the accounting requirements and disclosures, and engage independent directors and a qualified independent audit committee.
In addition, until we locate and engage appropriate accounting personnel, we will engage third party consultants to assist in accounting for complex transactions and disclosures.
The material weaknesses discussed above will not be considered remediated until the necessary personnel have been engaged and the applicable remedial controls operate for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively.
Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only management’s report in this annual report.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in connection with the evaluation required by paragraph (d) of Rule 13a-15 or 15d-15 under the Exchange Act that occurred during the year ended December 31, 2023 that have materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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ITEM 9B. OTHER INFORMATION
Item 9B. Other Information
In conjunction with Item 9A above (Evaluation of Internal Controls over Financial Reporting) and following our management’s assessment and conclusion that our internal control over financial reporting as of December 31, 2023 is ineffective, because of the material weaknesses described above, we are seeking a new Chief Financial Officer pending funding. None

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ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Item 10. Directors and Executive Officers and Corporate Governance
Directors and Executive Officers
Our Board of Directors elects our executive officers annually. Directors are elected to hold office until the next annual meeting. A majority vote of the directors who are in office is required to fill vacancies of our Board of Directors not caused by removal. Each director, including a Director elected to fill a vacancy, will hold office until the expiration of the term for which the Director was elected and until a successor has been elected. Our directors and executive officers are as follows:
Listed below are our executive officers and directors as of December 31, 2023
Name
Age
Position with the Company
Director Since
Rik J. Deitsch
Chairman, President and Chief Executive Officer (2)
Stewart Lonky, M.D.
Director (1)
Garry R. Pottruck
Director (1)
July
Dale Vanderputten
Chief Scientific Officer
August
(1) Dr. Lonky and Garry R. Pottruck are members of our Audit Committee and Compensation Committee.
(2) Subsequent to the settlement with the SEC in March of 2024, Rik J Deitsch resigned as our Chairman, CEO and CFO to be replaced by Michael Flax, DDS. We also named Joe Lucas as our VP of Operations. Listed below are our executive officers and directors as of November 24,
Name
Age
Position with the Company
Director Since
Michael Flax, DDS
Chairman, President and Chief Executive Officer
Stewart Lonky, M.D.
Director (1)
Garry R. Pottruck
Director (1)
July
Dale Vanderputten
Chief Scientific Officer
August
(1) Dr. Lonky and Garry R. Pottruck are members of our Audit Committee and Compensation Committee.
Rik J. Deitsch has been our President, Chief Executive Officer and a Director since November 7, 2002 and our Chairman of the Board from December 15, 2003 until June 1, 2005 and from April 1, 2006 to March 2024. Mr. Deitsch served as our Chief Financial Officer from November 2002 until March 2012 and from September 2012 to March 2024. From February 1998 through November 2002, Mr. Deitsch served as the President of NDA Consulting Inc., a biotechnology research group that provided consulting services to the pharmaceutical industry. NDA Consulting specializes in the research of peptides derived from Cone Snail venom and Cobra venom. In October 1999, Mr. Deitsch founded Wellness Industries, a private corporation that provides formulations, research and education in the dietary supplement industry. Research conducted by Rik J Deitsch provided some of the beginning fundamentals for the development of drugs being studied for the treatment of cancer and intractable pain. Mr. Deitsch has prepared several papers and posters on rational drug design using computer simulations. Mr. Deitsch received a B.S. in Chemistry and an M.S. in Biochemistry from Florida Atlantic University in June 1997 and December 1999, respectively. Throughout 1999 and 2000, he conducted research for the Duke University Medical School Comprehensive Cancer Center. Mr. Deitsch has served as an adjunct professor and has taught several courses for Florida Atlantic University’s College of Business and Continuing Education Department. Mr. Deitsch also teaches physician CME courses internationally, lecturing on lifestyle choices in the prevention and treatment of chronic disease states. He is the co-author of two books: Are You Age-Wise, a book that reviews current research in healthy aging as it relates to lifestyle choices and supplementation and Invisible Killers, a book that outlines our exposure to environmental toxins.
Michael Flax, D.D.S., M.S., P.A. has been our Chairman, Chief Executive Office, Chief Financial Officer since March 19, 2024. Dr. Flax is a Diplomate of the American Board of Endodontics, a member of the American Association of Endodontics, and a Fellow of the American College of Dentists. He has several research papers and presentations including work on the solubility and biocompatibility of calcium hydroxide-containing root canal sealer as well as investigations into anaerobic bacteria in periapical lesions of human teeth. He also worked in medical devices and developed adhesives for pipettes during autoclave procedures. Dr. Michael Flax holds a certificate from the University of Pennsylvania School of Dental Medicine in Endodontics, 1986, a D.D.S. from Georgetown University Dental School, 1981, an M.S. in chemistry from St. John’s University, 1977, and a B.A. major in chemistry, minor in engineering from Miami University in Oxford, Ohio. He is licensed to practice dentistry in the states of Florida, Maryland, New York, Pennsylvania, and the District of Columbia.
Dr. Stewart Lonky has been our director since November 5, 2004. Dr. Lonky was a co-founder of the Trylon Corporation, a medical device firm located in Torrance, California, and served as its Chief Medical Officer from 1990-2005. Trylon Corporation developed diagnostic products for the early diagnosis of cervical and oral cancer, and in connection with that Dr. Lonky’s responsibilities included product development, the direction of clinical research and interacting with regulatory agencies, including the U.S. Food and Drug Administration (FDA). In these roles he was instrumental in successfully bringing a number of products to the medical marketplace. He has continued to be engaged in both clinical and biochemical research, and has published research articles in the peer-reviewed literature in the areas of cervical cancer and cellular pathophysiology. Since 2005, Dr. Lonky has held an advisory position with another medical device company, Histologics, LLC. Dr. Lonky has been a practicing physician in the Los Angeles Area since 1982. He is Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine. Prior to entering practice, Dr. Lonky served as a full-time faculty member at the University of California, San Diego in the Department of Medicine, Pulmonary Division, where he was engaged in research in the biochemistry of lung injury. He was a National Institutes of Health (NIH) Postdoctoral Fellow from 1974-77. He has published over twenty articles and abstracts in the peer-reviewed literature during that time, and authored two book chapters.
Garry Pottruck became our Director and Chairman of our Audit and Compensation Committees in July 2009. Since January 2011, Mr. Pottruck has been employed as a tax principal at the CPA firm of Blum and Blum. From 1997 through 2011, he was partner in the certified public accounting firm, Friedberg and Pottruck, PA, and its successor firm, located in Deerfield Beach, FL. Mr. Pottruck held financial executive positions with several companies, both public and private, from 1984 through 1994. Prior to 1984, Mr. Pottruck worked for public accounting firms after graduating with a B.S. Degree in Accounting from the C.W. Post School of Professional Accountancy at Long Island University in 1979. He is currently licensed as a Certified Public Accountant in Florida.
Dale Vanderputten, PhD became our Chief Scientific Officer on July 27, 2016. Dr. Vanderputten has been CEO and CSO of the biotechnology company Omnia Biologics, Inc., headquartered in Rockville, MD since 2003. From 1999 through 2003 he was COO and CSO of cancer gene therapy company DirectGene, Inc., headquartered in Annapolis, MD. Dr VanderPutten has held scientific and technology development positions in government, academia and industry from 1980 through 1999 including at the National Institutes of Health, University of Maryland, and Proteome Sciences, plc. Dr. VanderPutten received a Bachelor of Sciences degree in Biology and Chemistry from the American University in Washington, DC in 1982, a PhD in Genetics from the George Washington University in 1993 and an MBA from the University of Maryland in 1996. He did his doctoral and post-doctoral training in molecular neuro-biology at the National Institutes of Health. Dr. Vanderputten will begin his tenure as CSO by taking over Nutra Pharma’s clinical product development. RPI-78M, the Company’s therapy for Multiple Sclerosis, received Orphan Designation from the FDA for the treatment of Juvenile Multiple Sclerosis in September 2015. Dr. Vanderputten will work with our researchers and regulators to move RPI-78M through the clinical process for an eventual approval or licensing.
Section 16(a) Compliance of Officers and Directors
As of November 24, 2025, based on our review of Forms 3, 4, 5, and Schedule 13D furnished to us during the last fiscal year, all of our officers and directors filed the required reports.
Corporate Governance
a. Committees
(i) Audit Committee
On November 5, 2004, our Board of Directors established an Audit Committee. An audit committee charter was approved by the Board on October 14, 2012. Mr. Pottruck became the Chairman/Member of the Audit Committee as of July 29, 2009. Dr. Lonky also serves on the Audit Committee. During our 2022 Fiscal Year, our Audit Committee met two times in connection with our Fiscal Year audit, at which time the audit committee reviewed the audited financial statements and related notes. In addition, the audit committee met prior to the filing of each of the 2022 quarterly reports to review such reports. The Audit Committee addresses any questions it has to our Board members and officers, and our principal independent accountants.
(ii) Compensation Committee
On November 5, 2004, our Board of Directors established a Compensation Committee. We do not have a Compensation Committee Charter. Dr. Lonky serves on our Compensation Committee and Mr. Pottruck became our Compensation Committee’s Chairman as of July 29, 2009. During our 2022 fiscal year, our Compensation Committee met two times. Our Compensation Committee reviews all salaries, expenses, stock plans, and other compensation paid to our officers, directors, consultants, and others. Our Compensation Committee has not adopted any specific processes or procedures for considering executive and director compensation.
(iii) Nominating Committee
We do not have a Nominating Committee or similar committee performing similar functions nor a written Nominating Committee Charter. Our Board of Directors as a whole decides such matters, including those that would be performed by a standing nominating committee. We have not yet adopted a nominating committee because we have not sufficiently developed revenue-generating operations. We do not currently have any specific or minimum criteria for the election of nominees to our Board of Directors nor do we have any process or procedure for evaluating such nominees.
b. Shareholder Communications
Our Board of Directors does not have any defined policy or procedure requirements for our stockholders to send communications to our Board of Directors, including submission of recommendations for nominating directors. We have not yet adopted a process for our security holders to communicate with our Board of Directors because we have not sufficiently developed our operations and corporate governance structure. We have a toll-free number at (877) 895-5647 available on our website for our shareholders to contact us as well as a dedicated email address at investor.relations@nutrapharma.com.
c. Board of Director Meetings
We had 3 Board of Directors meetings during our 2023 Fiscal Year. Our corporate actions that were subject to Board approval were accomplished by Board resolutions. We request that all of our Directors attend our Board of Director meetings; however, we have no formal policy regarding their attendance.
d. Annual Shareholder Meetings
We held no annual shareholder meeting during 2023.
We request that all of our Directors attend our Annual Shareholder Meetings; however, we have no formal policy regarding their attendance.
e. Code of Ethics
We have a code of ethics that applies to all of our employees including its principal executive officer, principal financial officer and principal accounting officer. A copy of this code is available without charge on our website at www.nutrapharma.com. We intend to disclose any changes in or waivers from our code of ethics by posting such information on our website or by filing a Form 8-K.

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ITEM 11. EXECUTIVE COMPENSATION
Item 11. Executive Compensation
The following table summarizes compensation information for the last two fiscal years for (i) our Chief Executive Officer and (ii) the four most highly compensated executive officers other than the Chief Executive Officer who were serving as our executive officers at the end of the fiscal year (collectively, the “Named Executive Officers”).
The following executive compensation disclosure reflects all compensation awarded to, earned by or paid to the executive officers below, for the fiscal years ended December 31, 2023 and 2022.
SUMMARY COMPENSATION TABLE
Name and principal
Position Year Salary
($)(1)
Bonus
($)
Stock
Awards
($)
Option
Awards
($)
Non- Equity
Incentive
Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All Other
Compensation
($) Total
($)
Rik Deitsch 160,000 - - - - - - 160,000
Chief Executive Officer,
Chief Financial Officer,
President and
Chairman of the Board 160,000 - - - - - - 160,000
Dale Vanderputten 144,000 - - - - - - 144,000
Chief Scientific Officer 144,000 - - - - - - 144,000
The following director compensation disclosure reflects all compensation awarded to, earned by or paid to the directors below for the fiscal year ended December 31, 2023.
DIRECTOR COMPENSATION
Name Fees
Earned
or Paid
in Cash
($)
Stock
Awards
($)
Option
Awards
($)
Non-Equity
Incentive
Plan
Compensation
($)
Nonqualified
Deferred
Compensation
Earnings
($)
All Other
Compensation
($)
Total
($)
Stewart Lonky 0
Garry Pottruck 0
(1)
Represents salary accrued or paid during 2023 and 2022, respectively
Director Compensation
There are no standard arrangements to which directors are compensated for services provided to us. Should we obtain adequate funding or sufficient revenues to justify standard arrangements for director compensation, we will consider whether to adopt such a compensation plan.
Stock Option Grants in Last Fiscal Year
We did not grant incentive and non-qualified stock options in 2023 to any executive officer or director.

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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The following tables sets forth, as of November 24, 2025, certain information with respect to the beneficial ownership of our common stock by each stockholder known by us to be the beneficial owner of more than 5% of our common stock and by each of our current directors and executive officers. Each person has sole voting and investment power with respect to the shares of common stock, except as otherwise indicated. Information relating to beneficial ownership of common stock by our principal stockholders and management is based upon information furnished by each person using “beneficial ownership” concepts under the rules of the Securities and Exchange Commission. Under these rules, a person is deemed to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or direct the voting of the security, or investment power, which includes the power to vote or direct the voting of the security. The person is also deemed to be a beneficial owner of any security of which that person has a right to acquire beneficial ownership within 60 days.
Under the Securities and Exchange Commission rules, more than one person may be deemed to be a beneficial owner of the same securities, and a person may be deemed to be a beneficial owner of securities as to which he or she may not have any pecuniary beneficial interest. We are unaware of any contract or arrangement that could result in a change in control of our company.
The following table assumes based on our stock records, that there are 7,099,727,214 shares of common stocks and 12,000,000 shares of Series B Preferred Stock issued and outstanding as of November 24 2025:
Security Ownership of Management and Beneficial Owners
Name and Address of Director
or Executive Officer Number of
Common Shares
Beneficially
Owned
(1) Percent of
Common
Shares Number of Series B
Preferred Shares
Beneficially Owned
(2) Percent
of
Preferred
Shares % of Total
Votes Held
(Common &
Preferred)
(3)
Rik J. Deitsch 48,298,859 0.68 % 12,000,000 100.00 % 63.08 %
Former Chairman/Chief Executive Officer/President
6400 Park of Commerce Blvd, Suite 1B,
Boca Raton, FL
Dr. Stewart Lonky 4,755,450 0.07 % 0.00 % 0.02 %
Director
12936 Discovery Creek
Playa Vista, CA 90094
Garry Pottruck 17,198,475 0.24 % 0.00 % 0.09 %
Director
10768 NW 18 Court
Coral Springs, Florida 33071
Dale Vanderputten, PhD 2,500,000 0.04 % 0.00 % 0.01 %
Chief Scientific Officer
7120 Hialeah Ln
Parkland, FL 33067
All executive officers and directors
as a group (4) persons 72,752,784 1.03 % 12,000,000 100.00 % 63.21 %
(1) Based upon 7,099,727,214 shares of common stock issued and outstanding as of the Record Date.
(2) Based upon 12,000,000 shares of Series B Preferred Stock issued and outstanding as of the Record Date.
(3) Based upon 7,099,727,214 shares of common stock and 12,000,000 shares of Series B Preferred Stock. Each Series B Preferred Stock entitled to 1,000 votes per share or an aggregate of 12,000,000,000 votes.

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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Item 13. Certain Relationships and Related Transactions, and Director Independence
Due to(from) our Chief Executive Officer
At December 31, 2023, the net balance due to Rik Deitsch, the Company’s former CEO, and the companies majority owned and controlled by him (collectively referred to as “Due to Officer”) in the aggregate is $659,433, which net balance is unsecured and accruing interest at 4%. During the year ended December 31, 2023, in the aggregate, we repaid $162,100 and were advanced $599,500 on this balance. Additionally, accrued interest on the outstanding balance was $9,161 and is included in the due to officer account. The Company had fully reserved receivables from companies owned by the Company’s former CEO. The reserve was $177,261 as of December 31, 2023. The bad debt expense of $105,465 was recorded for the year ended December 31, 2023.
At December 31, 2022, the net balance due to Rik Deitsch, and the companies majority owned and controlled by him in the aggregate is $112,046, which net balance is unsecured and accruing interest at 4%. During the year ended December 31, 2022, in the aggregate, we repaid $267,500 and were advanced $103,385 on this balance. Additionally, accrued interest on the outstanding balance was $4,639 and is included in the due to officer account. The Company had fully reserved receivables from companies owned by the Company’s former CEO. The reserve was $71,796 as of December 31, 2022. The bad debt expense of $71,796 was recorded for the year ended December 31, 2022.
Debt owed to a Director
During 2010 we borrowed $200,000 from one of our directors. Under the terms of the loan agreement, this loan was expected to be repaid in nine months to a year from the date of the loan along with interest calculated at 10% for the first month plus 12% after 30 days from funding. We are in default regarding this loan. The loan is under personal guarantee by Mr. Deitsch. We repaid the principal balance in full as of December 31, 2016. We repaid $40,000 of the accrued interest during the first and second quarters of 2021. During October 2021, we issued 12,500,000 shares of common stock to satisfy the $10,000 accrued interest. The shares were valued at accrued payable amount due to the fact that it was a related party transaction. During the first and second quarter of 2022, we repaid $15,000 of accrued interest. At December 31, 2023 and 2022, we owed this director accrued interest of $168,724 and $149,909. The interest expense for the years ended December 31, 2023 and 2022 was $18,815 and $17,141.
Related Party Transactions
The Company acts as a product formulator and contract manufacturer for Avini Health (“Avini”). The Company’s chief executive officer is an owner of Avini and is its chief scientific officer.
Commencing in May 2022, the Company sublets a portion of its space to Avini under a one-year sublease for a monthly rent of $5,000, with the first three months rent-free. The lease was terminated on August 31, 2023.
During September 2023, the sales and manufacturing structure between the Company and Avini was revised. Avini assumed responsibility for manufacturing its own products, and the Company transferred to Avini certain raw materials and packaging supplies related to amounts previously advanced by Avini. In connection with this transition, the Company relocated its operations to a Boca Raton facility leased by Avini. Under this arrangement, the Company uses the facility rent-free, shares space and resources with Avini, and Avini pays all lease and office-related expenses.
While sales to Avini are expected to significantly decline beginning in 2024 as Avini manufactures its own products, the Company benefits from reduced operating costs and continued access to manufacturing capabilities for its own Nutra Pharma-branded products.
During 2010 we borrowed $200,000 from one of our directors. Under the terms of the loan agreement, this loan was expected to be repaid in nine months to a year from the date of the loan along with interest calculated at 10% for the first month plus 12% after 30 days from funding. We are in default regarding this loan. The loan is under personal guarantee by Mr. Deitsch. We repaid the principal balance in full as of December 31, 2016. We repaid $40,000 of the accrued interest during the first and second quarters of 2021. During October 2021, we issued 12,500,000 shares of common stock to satisfy the $10,000 accrued interest. The shares were valued at accrued payable amount due to the fact that it was a related party transaction. During the first and second quarter of 2022, we repaid $15,000 of accrued interest. At December 31, 2023 and 2022, we owed this director accrued interest of $168,724 and $149,909. The interest expense for the years ended December 31, 2023 and 2022 was $18,815 and $17,141.
As of December 31, 2023 and 2022, we had the following related party balances:
December 31, December 31,
Deferred revenue to a related party $ 366,980 $ 181,515
Due to officer 659,433 112,046
Accrued payroll due to officers 1,373,693 1,213,693
Accrued interest to a related party 168,724 149,909
For the years ended December 31, 2023 and 2022, we had the following related party transactions:
December 31,
December 31,
Net sales to a related party $ 389,316 $ 292,474
Bad debt expense - related party 105,465 71,796
Rental income from a related party 40,000 25,000
Interest expense to a related party 18,815 17,141
These transactions were not conducted at arm’s length and therefore may not reflect the terms that would have been agreed to with an unrelated third party.
Director Independence
Our common stock is quoted on the OTC-Markets; that trading medium does not have director independence requirements. Under Item 407(a) of Regulation S-K, we have adopted the definition of independence used by the NYSE American, which may be found in the guide at (s) 121(A) (2) (2007). This definition states that our Board of Directors must affirmatively determine whether any of our directors have a relationship that would interfere with the exercise of independent judgment in carrying out their responsibilities of a director. Based on this definitional standard, our Board of Directors has determined that none of our Directors are independent.

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ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
Item 14. Principal Accountant Fees and Services
Auditor Change in 2024
In 2024, the Company appointed Astra Audit and Advisory (“Astra”) as its independent auditor following a routine evaluation of audit services. The change reflects the Company’s focus on maintaining rigorous financial oversight. The Company expresses its gratitude to Rotenberg Meril Solomon Bertiger & Guttilla, P.C. (“RotenbergMeril”), which served as auditor for the 2021 annual audit and 2022 interim reviews for their contributions.
Audit Fees
The fees billed to us by our former auditor, RotenbergMeril, for the audits of our 2021 annual consolidated financial statement and the reviews of our 2022 interim condensed consolidated financial statements was $100,000.
The fees to be billed by our current auditor, Astra, for the audits of our 2021, 2022 and 2023 annual consolidated financial and for the reviews of our 2023 interim condensed consolidated financial statements is $172,500.
Audit-Related Fees
Audit-related fees represent review of registration statements or services that are normally provided in connection with statutory and regulatory filings or engagements for those fiscal years, and the aggregate fees billed for assurance and related services that are reasonably related to the performance of the audit or review of our financial statements and are not reported under Audit Fees. No such fees were billed by Astra and RotenbergMeril for 2023 or 2022, respectively.
Tax Fees
No such fees were billed by Astra and RotenbergMeril for 2023 or 2022, respectively.
All Other Fees
No such fees were billed by Astra and RotenbergMeril for 2023 or 2022, respectively.
As of December 31, 2023, the Company did not have a formal documented pre-approval policy for the fees of the principal accountant. The Company has an audit committee which reviewed all fees to the principal accountant. The percentage of hours expended on the principal accountant’s engagement to audit our financial statements for the most recent fiscal year that were attributed to work performed by persons other than the principal accountant’s full-time, permanent employees was 0%.
PART IV

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ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
Item 15. Exhibits and Financial Statement Schedules
(a) The following Financial Statements are filed as part of this report under Item 7.
Report of Independent Registered Public Accounting Firm (Astra Audit & Advisory, PC, Tampa, FL)
Consolidated Balance Sheets as of December 31, 2023 and 2022
Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022
Consolidated Statements of Changes in Stockholders’ Deficit for the Years Ended December 31, 2023 and 2022
Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022
Notes to Consolidated Financial Statements
(b) The following exhibits are filed herewith or are incorporated by reference to exhibits previously filed with the SEC:
Exhibit No.
Description
3.1
Certificate of Incorporation dated February 1, 2000 (incorporated by reference to the Company’s Registration Statement on Form SB-2/A, Registration No. 33-44398, filed on April 6, 2001)
3.2
Certificate of Amendment to Articles of Incorporation dated July 5, 2000 (incorporated by reference to the Company’s Registration Statement on Form SB-2/A, Registration No. 33-44398, filed on April 6, 2001)
3.3
Certificate of Amendment to Articles of Incorporation dated October 31, 2001 (incorporated by reference to the Company’s Registration Statement on Form SB-2/A, Registration No. 33-44398, filed on April 6, 2001)
10.1
Agreement and Plan of Merger dated April 9, 2008 by and among Nutra Pharma Corp., a California corporation (“Nutra Pharma”), NP Acquisition Corporation, a Nevada corporation wholly owned by Nutra Pharma (“Acquisition”), ReceptoPharm, Inc., a Nevada corporation (“Receptopharm”) and the stockholders of Receptopharm (incorporated by reference from Form 8-K filed on April 14, 2008).
10.18
Patent Assignment Agreement dated January 24, 2006 between Nanologix, Inc. and Nutra Pharma Corp. (incorporated by reference from Form 10-K for period ending December 31, 2006)
10.19
International License Agreement between NanoLogix, Inc. and Nutra Pharma Corp. (incorporated by reference from Form 10-K for period ending December 31, 2006)
14.1
Code of Ethics (incorporated by reference from Report on Form 10-K/A filed on May 7, 2004).
20.3
License Agreement between Bio-Therapeutics, Inc. and Nutra Pharma Corp (incorporated by reference from Form 10-KSB for the period ending December 31, 2003)
20.4
Amendment to License Agreement between Bio-Therapeutics, Inc. and Nutra Pharma Corp (incorporated by reference from Form 10-KSB for the period ending December 31, 2003)
21.1
Subsidiaries of the Registrant, Nutra Pharma Corp. (incorporated by reference from Form 10-K for the period ending December 31, 2008)
31.1
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
99.1
Form 8-K filed on April 14, 2008 under Item 1.01 regarding acquisition of ReceptoPharm, Inc. as Nutra Pharma Corp.’s wholly owned subsidiary and Exhibit 10.1 (April 10, 2008 Agreement and Plan of Merger) attached thereto (incorporated by reference to this Form 10-K for the period ending December 31, 2008).
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
Cover Page Interactive Data File (embedded within the Inline XBRL document)