NutriBand (NTRB) risk factors, FY2026 10-K

NutriBand's FY2026 10-K, filed Apr 29, 2026, lists 23 risk factors. Against the prior year's 35: 12 dropped, 4 substantially reworded.

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Risk factors listed
230 groups
New this year
0vs 35 last year
Dropped
12since the prior 10-K
Substantially reworded
4of those kept
Section length
6k wordsItem 1A

What the changes say

  • No new standalone risks were added, while 12 prior risks covering FDA, development, manufacturing, commercialization, distributors and shareholder matters were dropped.
  • The revised business-risk language adds Iran-war, tariff, healthcare-market and AI-driven stock-market concerns affecting margins, liquidity and capital raising.
  • Management ownership is now reported at 49.88%, down from 54%, while the prior dilution and financing warning was removed.

What changed since the prior 10-K

Dropped

  • Dropped

    There is economic uncertainty concerning economic policies being pursued by the new administration in the United States that may affect the costs and timing of the process of bringing our products to market through approvals with the FDA

  • Dropped

    Our failure to develop our abuse deterrent fentanyl transdermal system will impair our ability to continue in business

    U.S. economic and political uncertainty affecting FDA approval timing, product costs, pricing, promotions and margins.

  • Dropped

    Risk of delays at FDA due to restructuring and layoffs

    Failure to finance, obtain approval for or successfully commercialize the abuse-deterrent fentanyl patch threatening business continuity.

  • Dropped

    We may encounter delays in completing clinical trials, which would increase our costs and delay market entry

  • Dropped

    Since we do not have commercial manufacturing capability, if we are unable to establish manufacturing facilities, we may have to enter into a manufacturing agreement with a manufacturer that has been approved by the FDA

    FDA restructuring, hiring freezes and layoffs potentially delaying clinical development and disrupting agency operations.

  • Dropped

    Our products will continue to be subject to FDA review after FDA approval is given

  • Dropped

    We may decide not to continue developing or commercializing any products at any time during development or after approval, which would reduce or eliminate our potential return on investment for those product candidates

    Clinical-trial delays increasing costs and postponing FDA approval and market entry.

  • Dropped

    If any of our potential products are approved for marketing but fail to achieve the broad degree of physician or market acceptance necessary for commercial success, our operating results and financial condition will be adversely affected

  • Dropped

    If we seek to expand our business through acquisition, we may not be successful in identifying acquisition targets or integrating their businesses with our existing business

    Lack of commercial manufacturing capability requiring an FDA-approved contract manufacturer or facility.

  • Dropped

    We are dependent on third party distributors for the international marketing of our consumer products and complying with applicable laws

  • Dropped

    The market price for our common stock may be volatile and your investment in our common stock could suffer a decline in value

  • Dropped

    We may issue preferred stock whose terms could adversely affect the voting power or value of our common stock

    Post-approval FDA review discovering product or manufacturing problems that could restrict or withdraw products.

Reworded

  • 100% rewritten

    Risks Concerning our Business

    Adds the Iran war, potential tariff and healthcare-product changes, and AI-focused market trends as threats to margins, liquidity and capital raising.

  • 82% rewritten

    Because of our executive officers’ stock ownership and stock ownership of certain other stockholders that have invested in the company, these stockholders have the power to elect all directors and to approve any action requiring stockholder approval

    Reports officer and director ownership falling from approximately 54% to 49.88% and removes the prior warning about financing dilution and working-capital restrictions.

  • 52% rewritten

    We and our senior executive officers settled an SEC investigation, which may affect the market for and the market price of our common stock and our ability to list on a stock exchange

    The SEC investigation and cease-and-desist settlement description is substantively unchanged, aside from minor wording edits.

  • 37% rewritten

    Healthcare reforms by governmental authorities, court decisions affecting health care policies and related reductions in pharmaceutical pricing, reimbursement and coverage by third-party payors may adversely affect our business

    Retains reimbursement, pricing and coverage concerns but removes the prior discussion of rising U.S. healthcare expenditures attracting public attention.

All 23 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Risks Concerning our Business100% rewritten
  2. 02Before we can market in the United States any product which is classified by the FDA as a drug, we must obtain FDA marketing approval
  3. 03Risk of increased tariffs on foreign goods
  4. 04Our ability to finance our operations and generate revenues depends on the clinical and commercial success of our abuse deterrent fentanyl transdermal system and our other related product candidates, and failure to achieve such success will negatively impact our business
  5. 05If we or any third-party manufacturer fails to comply with FDA current good manufacturing practices, we may not be able to sell our products until and unless the manufacturer becomes compliant
  6. 06If the FDA implements Risk Evaluation and Mitigation Strategies policies for any of our proposed products, we will need to comply with such policies before we can obtain FDA approval or the product
  7. 07We must continually monitor the safety of our products once approved and marketed for potential adverse events which could jeopardize our ability to continue marketing the products
  8. 08If we obtain FDA approval to market our products, we expect to spend considerable time and money complying with federal and state laws and regulations governing their sale, and, if we are unable to fully comply with such laws and regulations, we could face substantial penalties
  9. 09Before we can market our products outside of the United States, we will need to obtain regulatory approval in each country in which we propose to sell our products
  10. 10If we do not have sufficient product liability insurance, we may be subject to claims that are in excess of our net worth
  11. 11Because some of the patches we are developing, such as our abuse deterrent fentanyl patch, have potential severe side effects, we may face liability in the event patients suffer serious, possibly life-threatening, side effects from our products
  12. 12The drug delivery industry is subject to rapid technological change, and our failure to keep up with technological developments may impair our ability to market our products
  13. 13If we obtain FDA approval, we may face significant competition from better known and better capitalized companies
  14. 14Healthcare reforms by governmental authorities, court decisions affecting health care policies and related reductions in pharmaceutical pricing, reimbursement and coverage by third-party payors may adversely affect our business37% rewritten
  15. 15It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection
  16. 16We are dependent upon our chief executive officer, our president and our chief operating officer
  17. 17If we are unable to attract, train and retain technical and financial personnel, our business may be materially and adversely affected
  18. 18Our lack of internal controls over financial reporting may affect the market for and price of our common stock
  19. 19Stockholders may experience significant dilution as a result of future equity offerings and other issuances of our common stock or other securities
  20. 20Our failure to meet the continued listing requirements of Nasdaq could result in a de-listing of our common stock
  21. 21We and our senior executive officers settled an SEC investigation, which may affect the market for and the market price of our common stock and our ability to list on a stock exchange52% rewritten
  22. 22Because of our executive officers’ stock ownership and stock ownership of certain other stockholders that have invested in the company, these stockholders have the power to elect all directors and to approve any action requiring stockholder approval82% rewritten
  23. 23Raising funds by issuing equity or convertible debt securities could dilute the net tangible book value of the common stock and impose restrictions on our working capital

Other NutriBand 10-Ks

  • FY2025 10-K risk factors
    35 risks

    NutriBand is entirely dependent on developing and winning FDA approval for its lead abuse-deterrent fentanyl transdermal system. Operations face significant risks from FDA restructuring and tariff increases on foreign raw materials. The company has a history of ineffective internal controls and an SEC settlement regarding past disclosure issues.

    Filed Apr 28, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.