NEPHROS INC
For the period ended Dec 31, 2025. Filed Mar 12, 2026.
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FY2025 · Filed Mar 12, 2026
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
For the fiscal year ended December 31,2025
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
For the transition period from to
Commission File Number 001-32288
(Exact name of registrant specified in its charter)
| Delaware | 13-3971809 |
|---|---|
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
380 Lackawanna Place
South Orange, NJ 07079
(Address of Principal Executive Offices)
(201) 343-5202
(Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol | Name of exchange on which registered |
|---|---|---|
| Common stock, par value $0.001 per share | NEPH | The Nasdaq Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Exchange Act:None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Exchange Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:
| Large accelerated filer ☐ | Accelerated filer ☐ |
|---|---|
| Non-accelerated filer ☒ | Smaller reporting company ☒ |
| Emerging growth company ☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No☒
The aggregate market value of the voting stock held by non-affiliates of the registrant, as of June 30, 2025, was $27,317,372. Such aggregate market value was computed by reference to the closing price of the common stock as reported on the Nasdaq Stock Market on June 30, 2025. For purposes of making this calculation only, the registrant has defined affiliates as including only directors and executive officers and stockholders holding greater than 10% of the voting stock of the registrant as of June 30, 2025.
As of March 12, 2026, there were 10,644,268 shares of the registrant’s common stock, $0.001 par value, outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Certain portions of the registrant’s proxy statement to be filed with the Securities and Exchange Commission in connection with the 2026 Annual Meeting of Stockholders (the “2026 Proxy Statement”) are incorporated by reference into Part III of this Annual Report on Form 10-K. The 2026 Proxy Statement will be filed within 120 days of December 31, 2025.
TABLE OF CONTENTS
| PART I | 4 | |
|---|---|---|
| Item 1. Business | 4 | |
| Item 1A. Risk Factors | 11 | |
| Item 1B. Unresolved Staff Comments | 21 | |
| Item 1C. Cybersecurity | 21 | |
| Item 2. Properties | 23 | |
| Item 3. Legal Proceedings | 23 | |
| Item 4. Mine Safety Disclosures | 23 | |
| PART II | 24 | |
| Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 24 | |
| Item 6. Reserved | 24 | |
| Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 24 | |
| Item 7A. Quantitative and Qualitative Disclosures About Market Risk | 28 | |
| Item 8. Financial Statements and Supplementary Data | 29 | |
| Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 51 | |
| Item 9A. Controls and Procedures | 51 | |
| Item 9B. Other Information | 51 | |
| PART III | 52 | |
| Item 10. Directors, Executive Officers and Corporate Governance | 52 | |
| Item 11. Executive Compensation | 52 | |
| Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 52 | |
| Item 13. Certain Relationships and Related Transactions, and Director Independence | 52 | |
| Item 14. Principal Accounting Fees and Services | 52 | |
| PART IV | 52 | |
| Item 15. Exhibits, Financial Statement Schedules | 52 | |
| Item 16. Form 10K Summary | 55 | |
| SIGNATURES | 56 |
FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain statements in this Annual Report on Form 10-K constitute “forward-looking statements.” Such statements include statements regarding the efficacy and intended use of our technologies under development, the timelines and strategy for bringing such products to market, the timeline for regulatory approval of our products, the availability of funding sources for continued development of such products, and other statements that are not historical facts, including statements that may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include, but are not limited to, the risks that:
| ● | we face significant challenges in obtaining market acceptance of our products, which, if not obtained, could adversely affect our potential sales and revenues; |
|---|---|
| ● | product-related deaths or serious injuries or product malfunctions could trigger recalls, class action lawsuits and other events that could cause us to incur expenses and may also limit our ability to generate revenues from such products; |
| ● | we face potential liability associated with the production, marketing and sale of our products, and the expense of defending against claims of product liability could materially deplete our assets and generate negative publicity, which could impair our reputation; |
| ● | to the extent our products or marketing materials are found to violate any provisions of the U.S. Food, Drug and Cosmetic Act (the “FDC Act”) or any other statutes or regulations, we could be subject to enforcement actions by the U.S. Food and Drug Administration (the “FDA”) or other governmental agencies; |
| ● | we may not be able to obtain funding when needed or on terms favorable to us in order to continue operations; |
| ● | we may not have sufficient capital to successfully implement our business plan; |
| ● | we may not be able to effectively market and sell our products in new or existing markets; |
| ● | we may not be able to sell our water filtration products at competitive prices or profitably; |
| ● | we may experience increased costs and/or disruptions in our supply chain due to the imposition of U.S. tariffs; |
| ● | we may encounter unanticipated internal control deficiencies or weaknesses or ineffective disclosure controls and procedures; |
| ● | we may not be able to obtain appropriate or necessary regulatory approvals to achieve our business plan; |
| ● | we may not be able to secure or enforce adequate legal protection, including patent protection, for our products; and |
| ● | we may not be able to achieve sales growth in key geographic markets. |
More detailed information about us and the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements in this Annual Report on Form 10-K, is set forth in our filings with the U.S. Securities and Exchange Commission (the “SEC”), including our other periodic reports filed with the SEC. We urge investors and security holders to read those documents free of charge at the SEC’s web site at www.sec.gov. We do not undertake to publicly update or revise our forward-looking statements because of new information, future events or otherwise, except as required by law.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.