{"url_path":"/sec/cik-0001119643/10-k/2026/item-1a","section_key":"item-1a","section_title":"Item 1A Risk Factors**","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-05-20","source_url":"https://www.sec.gov/Archives/edgar/data/1119643/0001493152-26-024641-index.html","accession_number":"0001493152-26-024641","cik":"0001119643","ticker":null,"issuer_name":"NUTRA PHARMA CORP","edgar_url":"https://www.sec.gov/Archives/edgar/data/1119643/0001493152-26-024641-index.html","primary_entity_key":"0001119643","primary_entity_name":"NUTRA PHARMA CORP"},"word_count":3595,"has_tables":true,"body_markdown":"**Item\n1A. Risk Factors**\n\n \n\nYou\nshould carefully consider the risks described below regarding our operations, financial condition, financing, our common stock and other\nmatters. If any of the following or other material risks actually occur, our business, financial condition, or results or operations\ncould be materially adversely affected.\n\n \n\n**We\nhave identified material weaknesses in our internal control over financial reporting, which could adversely affect our financial condition,\naccess to capital, and the market price of our common stock**\n\n \n\nWe\nhave identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination\nof deficiencies, in internal control such that there is a reasonable possibility that a material misstatement of our annual or interim\nfinancial statements will not be prevented or detected on a timely basis. These control deficiencies increase the risk that errors in\nour financial reporting may occur and remain undetected.\n\n \n\nThe\nexistence of material weaknesses may also negatively affect our business in other ways. Investors and potential financing sources may\nview the presence of material weaknesses as increasing the risk of inaccurate financial reporting, which can reduce their willingness\nto invest in our securities or extend credit on favorable terms. As a result, our ability to raise capital, obtain debt financing, or\nmaintain existing financing arrangements could be adversely affected. In addition, the perception of weak internal controls may negatively\nimpact the market price of our common stock and investor confidence in our Company.\n\n \n\n**Our\nability to continue as a going concern is in doubt absent obtaining adequate new debt or equity financing and achieving sufficient sales\nlevels.**\n\n \n\nWe\nincurred net losses of $2,047,392 and $1,285,663 for the years ended December 31, 2025 and 2024, respectively. We incurred net operating\nlosses of $1,462,338 and $878,421 for the years ended December 31, 2025 and 2024, respectively. We anticipate that these operating losses\nwill continue for the foreseeable future. We have a significant working capital deficiency, and have not reached a profitable level of\noperations, which raises substantial doubt about our ability to continue as a going concern. Our continued existence is dependent upon\nour achieving sufficient sales levels of our Nyloxin and Pet Pain Away products and obtaining adequate financing. Unless we can begin\nto generate material revenue, we may not be able to remain in business. We cannot assure you that we will raise enough money or generate\nsufficient sales to meet our future working capital needs.\n\n \n\n**We\nhave a limited revenue producing history with significant losses and expect losses to continue for the foreseeable future.**\n\n \n\nWe\nincurred net losses of $2,047,392 and $1,285,663 for the years ended December 31, 2025 and 2024, respectively. We incurred net operating\nlosses of $1,462,338 and $878,421 for the years ended December 31, 2025 and 2024, respectively. As a result, at December 31, 2025, we\nhad an accumulated deficit of $78,278,529. Our revenues have been insufficient to sustain our operations and we expect our revenues will\nbe insufficient to sustain our operations for the foreseeable future. Our potential profitability will require the successful commercialization\nof our Nyloxin and Pet Pain-Away products; or a potential licensing of our therapies under development.\n\n \n\n**We\nwill require additional financing to sustain our operations and without it will be unable to continue operations.**\n\n \n\nAt\nDecember 31, 2025, we had a working capital deficit of $16,813,637. Our recurring losses from operations and working capital deficiency\nraise substantial doubt about our ability to continue as a going concern. We have a negative cash flow from operations of approximately\n$1.16 million and $0.42 million for the years ended December 31, 2025 and 2024, respectively. We have insufficient financial resources\nto fund our operations.\n\n \n\n**We\nhave a history of failed distributors, which has negatively affected our revenues and may continue to do so if we fail to locate a successful\ndistributor.**\n\n \n\nDue\nto poor performance, we cancelled our distribution agreement with our Cobroxin distributor, XenaCare in April 2011. We plan to re-launch\nCobroxin, but we have not yet ordered product or provided planned sales. To date, we have only limited sales of Nyloxin and Pet Pain-Away\nthrough outside distributors. If we fail to improve our own marketing and distribution or fail to find a competent outside distributor\nour operations and financial condition will be negatively affected.\n\n \n\n21\n\n \n\n \n\n**If\nwe cannot sell a sufficient volume of our products, we will be unable to continue in business.**\n\n \n\nFrom\nOctober 2009 until December 31, 2025, our operations centered on the marketing of Cobroxin (our discontinued product), Nyloxin and Nyloxin\nExtra Strength. In December of 2014, we launched Pet Pain-Away and began actively marketing the product. In May of 2022, we began producing\nproducts for Avini Health Corporation. Avini Health distributes wellness and nutritional products through their network of independent\ndistributors in the United States, Canada and the US Virgin Islands. The products that we provide for Avini Health include private label\nversions of our Nyloxin products and are sold as: Avini Plus Relief oral spray, Avini Plus Relief topical gel, Avini Plus Relief roll-on,\nand Avini Plus Relief for Pets. We also provided the following products: a dietary fiber blend sold as Avini Plus Fiber, a micronized\nand activated colloidal suspension of zeolite that is sold as Cell Defender, a mushroom and zeolite blend sold in capsules as ZMUNITY,\nand a caffeine adaptogenic 2oz energy shot sold as Avini Plus Energy. During fiscal year 2024, we earned revenues of $392,150, $77,217\nof it was from sales of Nyloxin and $52,750 of it was from sales of Pet Pain-Away, $116,342 of it was from sales of private label clients,\nand $145,841 of it was from sales to Avini of products manufactured by the Company, including both Nutra-branded products and Avini-branded\nproducts. If we cannot achieve sufficient sales levels of our Nyloxin and Pet Pain-Away products, or if we are unable to secure financing,\nour operations will be negatively affected. During fiscal year 2025, we earned revenues of $385,307, $58,309 of it was from sales of\nNyloxin and $55,185 of it was from sales of Pet Pain-Away, $144,118 of it was from sales of private label clients, and $127,695 of it\nwas from sales to Avini of products manufactured by the Company, including both Nutra-branded products and Avini-branded products. If\nwe cannot achieve sufficient sales levels of our Nyloxin and Pet Pain-Away products, or if we are unable to secure financing, our operations\nwill be negatively affected.\n\n \n\n**We\nhave a limited history of generating revenues on which to evaluate our potential for future success and to determine if we will be able\nto execute our business plan; accordingly, it is difficult to evaluate our future prospects and the risk of success or failure of our\nbusiness.**\n\n \n\nYou\nmust consider our business and prospects in light of the risks and difficulties we will encounter as an early-stage revenue producing\ncompany. These risks include:\n\n \n\n \n●\nour\nability to effectively and efficiently market and distribute our products;\n\n \n●\nour\nability to obtain market acceptance of our current products and future products that may be developed by us; and\n\n \n●\nour\nability to sell our products at competitive prices which exceed our per unit costs.\n\n \n\nWe\nmay be unable to address these risks and difficulties, which could materially and adversely affect our revenue, operating results and\nour ability to continue to operate our business.\n\n \n\n**Our\ngrowth strategy reflected in our business plan may be unachievable or may not result in profitability.**\n\n \n\nWe\nmay be unable to implement our growth strategy reflected in our business plan rapidly enough for us to achieve profitability. Our growth\nstrategy is dependent on a number of factors, including market acceptance of our Nyloxin and Pet Pain-Away products and the acceptance\nby the public of using these products as pain relievers. We cannot assure you that our products will be purchased in amounts sufficient\nto attain profitability.\n\n \n\nAmong\nother things, our efforts to expand our sales of Nyloxin and Pet Pain-Away will be adversely affected if:\n\n \n\n \n●\nwe\nare unable to attract sufficient customers to the products we offer in light of the price and other terms required in order for us\nto attain the level of profitability that will enable us to continue to pursue our growth strategy;\n\n \n●\nadequate\npenetration of new markets at reasonable cost becomes impossible limiting the future demand for our products below the level assumed\nby our business plan;\n\n \n●\nwe\nare unable to scale up manufacturing to meet product demand, which would negatively affect our revenues and brand name recognition;\n\n \n●\nwe\nare unable to meet regulatory requirements in the intellectual marketplace that would otherwise allow us for wider distribution;\nand\n\n \n●\nwe\nare unable to meet FDA regulatory requirements that would potentially expand our product base and potential revenues.\n\n \n\n22\n\n \n\n \n\n**If\nwe cannot manage our growth effectively, we may not become profitable.**\n\n \n\nBusinesses,\nwhich grow rapidly often, have difficulty managing their growth. If we grow rapidly, we will need to expand our management by recruiting\nand employing experienced executives and key employees capable of providing the necessary support. We cannot assure you that our management\nwill be able to manage our growth effectively or successfully.\n\n \n\nAmong\nother things, implementation of our growth strategy would be adversely affected if we were not able to attract sufficient customers to\nthe 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\nprofitability.\n\n \n\n**If\nwe are unable to protect our proprietary technology, our business could be harmed.**\n\n \n\nOur\nintellectual property, including patents, is our key asset. We currently have 3 active patents and several more in the application process.\nCompetitors may be able to design around our patents for our Cobroxin, Nyloxin and Pet Pain-Away products and compete effectively with\nus. The cost to prosecute infringements of our intellectual property or the cost to defend our products against patent infringement or\nother intellectual property litigation by others could be substantial. We cannot assure you that:\n\n \n\n \n●\npending\nand future patent applications will result in issued patents,\n\n \n●\npatents\nlicensed by us will not be challenged by competitors,\n\n \n●\nour\npatents, licensed and other proprietary rights from third parties will not result in costly litigation;\n\n \n●\npending\nand future patent applications will result in issued patents,\n\n \n●\nthe\npatents or our other intellectual property will be found to be valid or sufficiently broad to protect these technologies or provide\nus with a competitive advantage,\n\n \n●\nif\nwe are sued for patent infringement, whether we will have sufficient funds to defend our patents, and\n\n \n●\nwe\nwill be successful in defending against future patent infringement claims asserted against our products.\n\n \n\nShould\nany risks pertaining to the foregoing occur, our brand name reputation, results of operation and revenues will be negatively affected.\n\n \n\n**We\nare subject to substantial FDA regulations pertaining to Nyloxin and Pet Pain-Away, which may increase our costs or otherwise adversely\naffect our operations.**\n\n \n\nOur\nNyloxin and Pet Pain-Away products are subject to FDA regulations, including manufacturing and labeling, approval of ingredients, advertising\nand other claims made regarding Nyloxin and Pet Pain-Away, and product ingredients disclosure. If we fail to comply with current or future\nregulations, the FDA could force us to stop selling Nyloxin and Pet Pain-Away or require us to incur substantial costs from adopting\nmeasures to maintain FDA compliance.\n\n \n\n**The\ninability to provide scientific proof for product claims may adversely affect our sales.**\n\n \n\nThe\nmarketing of Nyloxin and Pet Pain-Away involves claims that they assist in reducing Stage 2 chronic pain, while Nyloxin Extra Strength\nand Nyloxin Military Strength involves claims that they assist in reducing Stage 3 chronic pain. The marketing of Pet Pain-Away involves\nclaims that they assist in relieving pain in dogs and cats. Under FDA and Federal Trade Commission (“FTC”) rules, we are\nrequired to have adequate data to support any claims we make concerning Nyloxin and Pet Pain-Away. We have scientific data for our Nyloxin\nand Pet Pain-Away product claims; however, we cannot be certain that these scientific data will be deemed acceptable to the FDA or FTC.\nIf the FDA or FTC requests supporting information and we are unable to provide support that it finds acceptable, the FDA or FTC could\nforce us to stop making the claims in question or restrict us from selling the products.\n\n \n\n**None\nof our ethical drug candidates have received FDA approval.**\n\n \n\nOur\nnon-homeopathic or ethical products require a complex and costly FDA regulation process that takes several years for drug approval, if\never. None of the drug applications we have submitted to the FDA have received FDA approval. If we do not receive FDA approval for our\ndrug applications, our operations and financial condition will be negatively affected.\n\n \n\n23\n\n \n\n \n\n**If\nwe are unable to secure sufficient cobra venom from available suppliers, our operating results will be negatively affected.**\n\n \n\nWe\nsecure cobra venom on an as-needed basis. If we do not have an available supplier to fill customer orders, there will be distribution\ndelays and/or our failure to fulfill purchase orders, either of which will negatively affect our brand name reputation and operating\nresults.\n\n \n\n**Our\nNyloxin and Pet Pain-Away products may be unable to compete against our competitors in the pain relief market.**\n\n \n\nThe\npain relief market is highly competitive. We compete with companies that have already achieved product acceptance and brand recognition,\nincluding multi-billion dollar private label manufacturers and more established pharmaceutical and health products companies, or low\ncost generic drug manufacturers. As a result, many of our competitors have significantly greater financial strength, technical expertise,\nproduction capacity, and marketing reach than we do. Additionally, if consumers prefer our competitors’ products, or if these products\nhave better safety, efficacy, or pricing characteristics, our results could be negatively impacted. If we fail to develop and actualize\nstrategies to compete against our competitors we may fail to compete effectively, which will negatively affect our operations and operating\nresults.\n\n \n\n**If\nwe incur costs resulting from product liability claims, our operating results will be negatively affected.**\n\n \n\nIf\nwe become subject to product liability claims for Nyloxin and Pet Pain-Away that exceed our product liability policy limits, we may be\nsubject to substantial litigation costs or judgments against us, which will negatively impact upon our financial and operating results.\n\n \n\n**Loss\nof any of our key personnel could have a material adverse effect on our operations and financial results.**\n\n \n\nWe\nare dependent upon a limited number of our employees: (a) our Chief Executive Officer; (b) our Operations Manager who directs our operations\nand (c) our Chief Scientific Officer who conducts our research and development activities. Our success depends on the continued services\nof our senior management and key research and development employees as well as our ability to attract additional members to our management\nand research and development teams. The unexpected loss of the services of any of our management or other key personnel could have a\nmaterial adverse effect upon our operations and financial results.\n\n \n\n**We\nmay be unable to maintain and expand our business if we are not able to retain, hire and integrate key management and operating personnel.**\n\n \n\nOur\nsuccess depends in large part on the continued services and efforts of key management personnel. Competition for such employees is intense\nand the process of locating key personnel with the combination of skills and attributes required to execute our business strategies may\nbe lengthy. The loss of key personnel could have a material adverse impact on our ability to execute our business objectives. We do not\nhave any key man life insurance on the lives of any of our executive officers**.**\n\n \n\n**Cybersecurity\nRisk Management, Strategy, and Governance**\n\n \n\nThe\nCompany maintains processes designed to assess, identify, and manage material risks from cybersecurity threats, including routine system\nmonitoring, access controls, data backup procedures, and periodic evaluation of system vulnerabilities. Cybersecurity risks are considered\nas part of the Company’s overall risk management framework, including risks associated with third-party service providers. Management\nis responsible for the day-to-day oversight of cybersecurity risk management, and the Board of Directors provides oversight as part of\nits general risk oversight responsibilities. To date, the Company has not experienced any cybersecurity incidents that have materially\naffected the Company’s business, results of operations, or financial condition; however, no assurance can be provided that such\nincidents will not occur in the future.\n\n \n\n**Risks\nRelated to Our Common Stock**\n\n \n\n**Because\nthe market for our common stock is limited, persons who purchase our common stock may not be able to resell their shares at or above\nthe purchase price paid by them.**\n\n \n\nOur\ncommon stock is presently on the OTC Market Group’s Expert Market, which means that the Company’s common stock is not eligible\nfor proprietary broker-dealer quotes. There is currently only a limited public market for our common stock. We cannot assure you that\nan active public market for our common stock will develop or be sustained in the future. If an active market for our common stock does\nnot develop or is not sustained, the price may decline.\n\n \n\n24\n\n \n\n \n\n**Because\nwe are subject to the “penny stock” rules, brokers cannot generally solicit the purchase of our common stock, which adversely\naffects its liquidity and market price.**\n\n \n\nThe\nSEC has adopted regulations, which generally define “penny stock” to be an equity security that has a market price of less\nthan $5.00 per share, subject to specific exemptions. The market price of our common stock on the OTC has been substantially less than\n$5.00 per share and therefore we are currently considered a “penny stock” according to SEC rules. This designation requires\nany broker-dealer selling these securities to disclose certain information concerning the transaction, obtain a written agreement from\nthe purchaser and determine that the purchaser is reasonably suitable to purchase the securities. These rules limit the ability of broker-dealers\nto solicit purchases of our common stock and therefore reduce the liquidity of the public market for our shares.\n\n \n\n**Because\nthe majority of our outstanding shares are freely tradable, sales of these shares could cause the market price of our common stock to\ndrop significantly, even if our business is performing well.**\n\n \n\nAs\nof December 31, 2025, we had 109,150,000 outstanding shares that were subject to the limitations of Rule 144 under the Securities Act\nof 1933. In general, Rule 144 provides that any non-affiliates, who have held restricted common stock for at least six-months, are entitled\nto sell their restricted stock freely, provided that we stay current in our SEC filings. After one year, a non-affiliate may sell without\nany restrictions.\n\n \n\nAn\naffiliate may sell after one year with the following restrictions: (i) we are current in our filings, (ii) certain manner of sale provisions,\n(iii) filing of Form 144, and (iv) volume limitations limiting the sale of shares within any three-month period to a number of shares\nthat 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\npreceding 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\nwithout regard to any of the limitations described above.\n\n \n\n**An\ninvestment in our common stock may be diluted in the future as a result of the issuance of additional securities or the exercise of options\nor warrants.**\n\n \n\nIn\norder to raise additional capital to fund our strategic plan, we may issue additional shares of common stock or securities convertible,\nexchangeable or exercisable into common stock from time to time, which could result in substantial dilution to any person who purchases\nour common stock. Because we have a negative net tangible book value, purchasers will suffer substantial dilution. We cannot assure you\nthat we will be successful in raising funds from the sale of common stock or other equity securities.\n\n \n\n**Since\nwe intend to retain any earnings for development of our business for the foreseeable future, you will likely not receive any dividends\nfor the foreseeable future.**\n\n \n\nWe\nhave not and do not intend to pay any dividends in the foreseeable future, as we intend to retain any earnings for development and expansion\nof our business operations. As a result, you will not receive any dividends on your investment for an indefinite period of time.\n\n \n\n**Due\nto factors beyond our control, our stock price may continue to be volatile.**\n\n \n\nThe\nmarket price of our common stock has been and is expected to be highly volatile. Any of the following factors could affect the market\nprice of our common stock:\n\n \n\n \n●\nour\nfailure to generate revenue,\n\n \n●\nour\nfailure to achieve and maintain profitability,\n\n \n●\nshort\nselling activities,\n\n \n●\nthe\nsale of a large amount of common stock by our shareholders including those who invested prior to commencement of trading,\n\n \n●\nactual\nor anticipated variations in our quarterly results of operations,\n\n \n●\nannouncements\nby us or our competitors of significant contracts, new products, acquisitions, commercial relationships, joint ventures or capital\ncommitments,\n\n \n●\nthe\nloss of major customers or product or component suppliers,\n\n \n●\nthe\nloss of significant business relationships,\n\n \n●\nour\nfailure to meet financial analysts’ performance expectations,\n\n \n●\nchanges\nin earnings estimates and recommendations by financial analysts, or\n\n \n●\nchanges\nin market valuations of similar companies.\n\n \n\n25\n\n \n\n \n\nIn\nthe past, following periods of volatility in the market price of a company’s securities, securities class action litigation has\noften been instituted. A securities class action suit against us could result in substantial costs and divert our management’s\ntime and attention, which would otherwise be used to benefit our business."}