OTC: NPHC
NUTRA PHARMA CORPCIK 0001119643 · SIC 2833 · Pharmaceutical Preparations
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. About this business →
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Latest financial statements
From 10-Q filed Aug 19, 2026 (period ending Jun 30, 2026). As printed on the EDGAR/iXBRL face — not generated by the model.
Condensed Consolidated Statements of Operations (Unaudited)
| Description | Three months ended June 30, 2026 | Three months ended June 30, 2025 | Six months ended June 30, 2026 | Six months ended June 30, 2025 |
|---|---|---|---|---|
| Net sales | 34,463 | 84,532 | 61,709 | 158,506 |
| Net sales to a related party | 23,459 | 37,611 | 44,427 | 74,031 |
| Cost of sales | (25,297) | (58,715) | (54,536) | (104,978) |
| Reserve for supplier advances for purchases | - | - | - | (5,000) |
| Gross profit | 32,625 | 63,428 | 51,600 | 122,559 |
| Operating expenses: | ||||
| Payroll, benefits and related taxes | 184,743 | 174,554 | 355,031 | 354,143 |
| Professional fees | 171,850 | 75,406 | 289,350 | 187,224 |
| Consulting expenses | 81,246 | 76,167 | 167,232 | 163,726 |
| Other selling, general and administrative costs | 30,250 | 27,830 | 54,700 | 57,814 |
| Total operating expenses | 468,089 | 353,957 | 866,313 | 762,907 |
| Loss from operations | (435,464) | (290,529) | (814,713) | (640,348) |
| Other income (expenses) | ||||
| Other income | 2,305 | 8,750 | 2,305 | 58,750 |
| Interest expense | (103,922) | (101,242) | (198,282) | (193,452) |
| Interest expense to related parties | (6,248) | (5,550) | (12,250) | (11,135) |
| Change in fair value of convertible notes and derivatives | (3,405,443) | 704,622 | (3,526,007) | (302,687) |
| Net gain on settlement of debt and accrued expenses | - | 53,526 | 140,500 | 53,526 |
| Total other expenses, net | (3,513,308) | 660,106 | (3,593,734) | (394,998) |
| Loss before income taxes | (3,948,772) | 369,577 | (4,408,447) | (1,035,346) |
| Provision for income taxes | - | - | - | - |
| Net (loss) income | (3,948,772) | 369,577 | (4,408,447) | (1,035,346) |
| Net loss per share basic and diluted | (0.00) | 0.00 | (0.00) | (0.00) |
| Weighted average number of shares outstanding during the period basic | 8,066,882,434 | 7,743,036,280 | 8,039,312,159 | 7,710,251,385 |
| Weighted average number of shares outstanding during the period diluted | 8,066,882,434 | 37,727,786,152 | 8,039,312,159 | 7,710,251,385 |
Condensed Consolidated Balance Sheets
| Description | June 30, 2026 | December 31, 2025 |
|---|---|---|
| ASSETS | ||
| Current assets: | ||
| Cash | - | 12,181 |
| Accounts receivable | 26,454 | 26,060 |
| Accounts receivable related party, net | 21,567 | 24,385 |
| Inventory, current portion | 23,509 | 19,535 |
| Other receivable | 133,906 | 133,906 |
| Convertible notes receivable, net of discount | 30,500 | 30,500 |
| Receivable from sale of Stemsation stocks, net | - | - |
| Investment in Stemsation stocks | 17,600 | 17,600 |
| Settlement receivables | 160,084 | 160,084 |
| Prepaid expenses and other current assets | 49,499 | 35,332 |
| Total current assets | 463,119 | 459,583 |
| Inventory, less current portion | 91,244 | 99,170 |
| Due from employee related party, net | 47,554 | 38,043 |
| Property and equipment, net | 20,946 | 25,805 |
| Total assets | 622,863 | 622,601 |
| LIABILITIES AND STOCKHOLDERS’ DEFICIT | ||
| Current liabilities: | ||
| Accounts payable | 889,624 | 853,581 |
| Accrued expenses | 2,314,136 | 2,186,283 |
| Accrued payroll due to officers | 2,027,893 | 1,892,845 |
| Accrued interest to related parties | 215,081 | 202,831 |
| Due to related parties | 1,773,851 | 1,592,794 |
| Derivative liabilities | 2,037,134 | 960,382 |
| Notes payable Unrelated third parties, net | 1,114,321 | 1,129,247 |
| Convertible notes payable Unrelated third parties, net | 6,589,684 | 6,209,306 |
| Convertible notes payable, at fair value | 4,495,723 | 2,046,469 |
| Other advances from an unrelated third party | 225,000 | 225,000 |
| SBA notes payable, current portion | 14,361 | 12,525 |
| Total current liabilities | 21,696,808 | 17,311,263 |
| SBA notes payable, less current portion | 134,808 | 136,644 |
| Total liabilities | 21,831,616 | 17,447,907 |
| Commitments and Contingencies (Note 11) | ||
| Stockholders’ deficit: | ||
| Preferred stock, $0.001 par value, 20,000,000 shares authorized and 12,000,000 Series B Preferred shares authorized, issued and outstanding | 12,000 | 12,000 |
| Common stock, $0.001 par value, 12,000,000,000 shares authorized; 7,159,727,214 and 7,099,727,214 shares issued and outstanding, respectively | 7,159,727 | 7,099,727 |
| Common stock to be issued | 514,678 | 501,678 |
| Additional paid-in capital | 53,791,818 | 53,839,818 |
| Accumulated deficit | (82,686,976) | (78,278,529) |
| Total stockholders’ deficit | (21,208,753) | (16,825,306) |
| Total liabilities and stockholders’ deficit | 622,863 | 622,601 |
Condensed Consolidated Statements of Cash Flows (Unaudited)
| Description | Six months ended June 30, 2026 | Six months ended June 30, 2025 |
|---|---|---|
| Cash flows from operating activities: | ||
| Net loss | (4,408,447) | (1,035,346) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Change in reserve for supplier advances for purchases | - | 5,000 |
| Net gain on settlement of debt and accrued expenses | (140,500) | (53,526) |
| Depreciation | 4,859 | 5,308 |
| Stock-based compensation | 14,833 | 1,667 |
| Amortization of convertible notes receivable discount | - | (3,750) |
| Change in fair value of convertible notes and derivatives | 3,526,007 | 302,687 |
| Amortization of loan discount | 132,175 | 126,085 |
| Amortization of operating lease right-of-use assets | - | 44,462 |
| Changes in operating assets and liabilities: | ||
| Increase in accounts receivable | (394) | (11,469) |
| Decrease (increase) in accounts receivable related party, net | 2,818 | (3,655) |
| Decrease in inventory | 3,952 | 9,038 |
| Increase in other receivable | - | (100,000) |
| Increase in due from employee related party, net | (9,511) | - |
| Increase in prepaid expenses and other current assets | (16,000) | (102,500) |
| (Decrease) increase in accounts payable | 36,043 | (8,678) |
| Increase in accrued expenses | 127,853 | 66,402 |
| Increase in accrued payroll due to officers | 135,048 | 99,291 |
| Increase in due to a related party | - | 9,584 |
| Increase (decrease) in accrued interest to related parties | 12,250 | 1,798 |
| Decrease in operating lease obligations | - | (45,774) |
| Net cash used in operating activities | (579,014) | (693,376) |
| Cash flows from investing activities: | ||
| Purchase of property and equipment | - | (26,052) |
| Convertible notes receivable advances | - | (25,000) |
| Net cash used in investing activities | - | (51,052) |
| Cash flows from financing activities: | ||
| Advances from related parties | 254,057 | 290,258 |
| Repayments to related parties | (73,000) | (145,352) |
| Proceeds from convertible notes | 463,001 | 810,056 |
| Repayment of convertible notes | (37,825) | (28,000) |
| Advances from notes payable | 83,250 | - |
| Repayments of notes payable | (122,650) | (139,912) |
| Net cash provided by financing activities | 566,833 | 787,050 |
| Net change in cash | (12,181) | 42,622 |
| Cash beginning of period | 12,181 | 36,447 |
| Cash end of period | - | 79,069 |
| Supplemental Cash Flow Information: | ||
| Cash paid for interest | 3,816 | 46,222 |
| Cash paid for income taxes | - | - |
| Non Cash Financing and Investing: | ||
| Common stock to be issued for stock based compensation | 13,000 | - |
| Common stock issued for settlement of debt | 12,000 | - |
Amounts as printed on the EDGAR/iXBRL face. Labels, columns, and figures are the filing face, not a GAAP stencil. Interactive statements & notes on EDGAR ↗
About NUTRA PHARMA CORP
Source: Item 1 (Business) from the 10-K filed May 20, 2026. Description as filed by the company with the SEC.
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.
Read full description ↓
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, 2025, our operations centered on the marketing of Cobroxin, which was discontinued in 2013 and is expected
to be reintroduced later in 2026, as well as 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.
3
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.
4
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. In December 2025, the Company entered into a business collaboration agreement with a third-party service provider
to support its expansion into the Indian market. Under the agreement, the service provider will assist with business development activities,
including identifying potential customers, facilitating negotiations, and supporting market entry efforts.
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. 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.
5
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, Chewy.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 United States Food and Drug Administration
(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 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.
6
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 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. In early 2025, we moved all Avini Health
manufacturing over to Avini Health. Nutra Pharma retains unlimited rights to the use of the production facilities and access to the Avini
production crew for the manufacturing of all of the Nutra Pharma products. Throughout 2025, we also produced products under private labels
for other third party customers. This included a variety of dietary supplements, which were transitioned to Avini Health beginning
in the fourth quarter of 2025, while the Company retained ownership of its cobra venom technology under individual brands.
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. The arrangement is no longer material to the Company’s current operations.
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, Chewy.com, and through www.petpainaway.com.
7
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.
In
addition to our own brands, we have several private label customers that market our pain relievers under their own brands. 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. At present, the Company’s international efforts
are primarily focused on India, where the Company previously obtained patent and trademark protections for Nyloxin and continues to evaluate
potential distribution opportunities.
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.
8
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.
9
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.
10
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.
11
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 in later 2026.
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 have engaged a third-party agency to assist in identifying and pursuing
potential funding opportunities and 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.
12
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 in later 2026.
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.
13
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 later 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.
14
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 Operations Manager 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.
15
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 has 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.
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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 a 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.
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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.
The
global sales of drugs for the treatment of Multiple Sclerosis reached over $30 billion in 2025 and is expected to grow to over $46 billion
by 2033 according to Nova Advisor. The main category are interferon-based drugs, which account for over 90% of sales. Ocrevus leads the
category with over $7 billion in sales, followed by Kesimpta with $2.7 billion in sales. The main attraction for Ocrevus is dosing by
infusion of only twice annually.There has been little innovation in the treatment of MS in over 30 years. More recently, BTK inhibitors
have been studied as an alternative to the interferon-type drugs. This class of drug still faces challenges that include side effects
– some severe; including liver failure in some patients. Sanofi’s drug, tolebrutinib, failed late stage trials in 2025; placing
doubt on future drugs of this mechanism.
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
(Defibrase)
Anticoagulant
from Lancehead viper
Knoll
Pharmaceutical
Ancrod
(Viprinex)
Anticoagulant
from Malayan pit viper
Bristol-Myers
Squibb
Capoten
(Captopril)
Antihypertensive
from Brazilian Pit Viper
Medicure
Tirofiban
(Aggrastat)
Antiplatelet
drug from Saw-scaled viper
Millennium
Pharmaceutical
Eptifibatide
(Integrilin)
Antiplatelet
drug from Pygmy rattlesnake
Amylin
Pharmaceuticals
Exanatidfe
(Byetta)
Treatment
for type 2 diabetes and obesity from Gila Monster venom
Elan
Pharmaceuticals
Ziconotide
(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.
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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.
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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 7 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, (f) our Quality Systems Manager and (g) 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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