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NUTRA PHARMA CORP

CIK: 11196431 Annual ReportLatest: 2026-05-20

10-K / May 20, 2026

Nutra Pharma Corporation

Company overview

  • Incorporated in California on February 1, 2000 (originally Exotic-Bird.com).
  • Business focus: discovery, development, licensing and commercialization of pharmaceutical products and technologies, including homeopathic and ethical drugs. Primary therapeutic areas include pain, autoimmune and infectious diseases, and neurological disorders.
  • Core intellectual property and programs center on cobra venom–based products and protein-based therapeutics for autoimmune and viral diseases. Several programs are in preclinical or clinical development.
  • Strategic approach: pursue licensing partnerships, collaborations and contract manufacturing to reduce development risk.

Products and brands

  • Nyloxin and Nyloxin Extra Strength (OTC topical gel and oral spray)

    • Indications: moderate to severe chronic pain (Nyloxin Stage 2; Nyloxin Extra Strength Stage 3).
    • Formulations and concentrations:
      • Nyloxin Topical Gel: 30 mcg/mL
      • Nyloxin Oral Spray: 70 mcg/mL
      • Nyloxin Extra Strength Topical Gel: 60 mcg/mL
      • Nyloxin Extra Strength Oral Spray: 140 mcg/mL
    • Packaging: 2-ounce topical formats; 1-ounce oral spray; larger container options available.
    • Distribution channels: nyloxin.com, Amazon (Nyloxin store), Walmart Marketplace; physician offices, clinics, and small-chain pharmacies.
    • Military version: Nyloxin Military Strength (approximately twice as strong as Nyloxin Extra Strength); pursued for U.S. government/military sales.
  • Cobroxin

    • OTC pain reliever; previously marketed, discontinued in 2013; planned reintroduction in 2026.
  • Pet Pain-Away

    • Homeopathic OTC pain reliever for cats and dogs; launched in 2014.
    • Distribution history: Lumaxa Distributors (2014); DEG Productions (2016) for global marketing; current marketing via Amazon, Chewy, and petpainaway.com after re-acquisition of marketing rights in 2020.
    • Private label/partnerships: Plus Relief for Pets via Avini Health (private-label product launched Oct 2023).
  • Equine Pain-Away

    • OTC topical pain reliever for horses; launched 2019.
    • Marketed via retailers and online (equinepainaway.com and Amazon).
  • Luxury Feet

    • OTC pain relief and anti-inflammatory product for pain from high heels and stilettos; launched March 2021.
    • Available at luxuryfeet.com and on Amazon.
  • Zeolite detox product

    • Private-label/contract manufacturing context; initiated Oct 2021 with some online sales.

Manufacturing, operations and regulation

  • In-house manufacturing capability completed March 17, 2022; prior reliance on contract manufacturers.
  • Facility: GMP-certified manufacturing, with prior ISO Class 5 clean room certification. In 2023 the company moved to a new facility in Boca Raton, Florida (6400 Park of Commerce Blvd, Suite 1B) occupying 18,504 sq ft shared with Avini Health.
  • Suppliers: cobra venom sourced from two U.S. suppliers, with additional suppliers in China, Thailand and India.
  • Contract manufacturing and partnerships:
    • March 2022: agreement to act as formulator and contract manufacturer for Avini Health (related party).
    • 2025: Avini manufacturing moved entirely to Avini Health; Nutra Pharma retains unlimited rights to its production facilities and access to Avini’s production crew for Nutra Pharma products.
  • Regulatory status:
    • Active in homeopathic regulation (HPUS monographs) and FDA compliance for homeopathic OTC products.
    • FDA communications: received a warning letter in 2019 regarding Nyloxin marketing claims; the company responded and reports no further FDA communication.
    • Orphan Drug designation: FDA Orphan Drug designation for pediatric multiple sclerosis (RPI-78M) granted Sept 2015.
    • Ethical (non-homeopathic) drug candidates: none have FDA approval; regulatory pathways and clinical studies are planned contingent on financing.

Intellectual property

  • Patents (active or referenced)
    • US 8,034,777 — Modified Anticholinergic Neurotoxins as Modulators of the Autoimmune Reaction (expired Nov 22, 2025).
    • US 7,902,152 — Use of cobratoxin as an analgesic (expires Oct 13, 2028).
    • US 7,758,894 — Modified elapid venoms as stimulators of the immune reaction (expires Sept 11, 2027).
  • Additional patents and applications cover cobratoxin, venom-derived therapeutics and nerve-agent countermeasures; ReceptoPharm patents are referenced.
  • Protection strategy: combination of patents and trade secrets; ongoing patent filings for manufacturing improvements and clinical platforms.

Markets, customers and distribution

  • Domestic channels: direct-to-consumer online sales, select retailers, physician offices, clinics and small-chain pharmacies.
  • Government/military: Nyloxin Military Strength targeted for potential U.S. government and military procurement and Federal Supply Schedule opportunities.
  • International efforts: pursuing registrations and approvals in Canada, Mexico, India, Australia, New Zealand, Central and South America, and Europe. India market entry supported by third-party services; Canada regulatory engagement planned with Nature’s Clinic (re-engagement planned for 2026).
  • Product channel details:
    • Nyloxin: nyloxin.com, Amazon Nyloxin storefront, Walmart Marketplace; physician offices, clinics and small-chain pharmacies.
    • Pet Pain-Away: Amazon, Chewy and petpainaway.com; private-label arrangements with Avini (Plus Relief for Pets).
    • Equine Pain-Away and Luxury Feet: sold via company sites and Amazon.
    • Avini Health collaboration: Nutra Pharma acts as contract manufacturer for Avini’s Plus Relief branded products and other private-label orders; Avini handles broader distribution.

Financial performance (selected figures)

  • Revenue
    • 2025: $385,307
    • 2024: $392,150
    • 2024 product breakdown: Nyloxin $77,217; Pet Pain-Away $52,750; private label $116,342; Avini-related product sales $145,841.
    • 2025 product breakdown: Nyloxin $58,309; Pet Pain-Away $55,185; private label $144,118; Avini-related product sales $127,695.
  • Income and profitability
    • Net loss: 2025 net loss $2,047,392; 2024 net loss $1,285,663.
    • Net operating loss: 2025 $1,462,338; 2024 $878,421.
    • Accumulated deficit: $78,278,529 as of December 31, 2025.
  • Liquidity and capitalization
    • Working capital deficit: $16,813,637 as of December 31, 2025.
    • Negative cash flow from operations: approximately $1.16 million in 2025; approximately $0.42 million in 2024.
    • Outstanding shares: 109,150,000 shares outstanding subject to Rule 144 as of December 31, 2025.

Employment and facilities

  • Employees: 7 (CEO, Director of Marketing, CSO, VP of Operations, Operations Manager, Quality Systems Manager, Warehouse Manager).
  • Use of outside consultants, lawyers and accountants as needed and as funding permits.
  • Facilities:
    • Previous facility: 5,500 sq ft in Plantation, FL; lease renewed through December 31, 2025.
    • Current facility: 18,504 sq ft shared with Avini Health at 6400 Park of Commerce Blvd, Boca Raton, FL, including lab, conference room, production suites and offices.

Risks and regulatory matters

  • Key risk factors include dependence on limited revenue streams, the need to raise financing, the ability to scale manufacturing, competition, regulatory approvals for non-homeopathic drug candidates, and going-concern risk due to operating losses and working capital deficiency.
  • SEC litigation matters were resolved through consent judgments and settlements (2024–2025), including disgorgement and penalties.

Strategic and organizational notes

  • In-house manufacturing was pursued to reduce costs and enable faster product upgrades, while retaining production capacity rights for private-label and partner programs.
  • Orphan Drug designation for pediatric MS provides potential development incentives if development proceeds.
  • Business model centers on a core set of pain-relief products and niche autoimmune/neurological programs, with emphasis on licensing, partnerships and contract manufacturing to support operations.