enVVeno Medical Corp

Note 1 –Business Organization and Nature of Operations

The Company

enVVeno Medical Corporation (the “Company”) is a medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of venous disease. The Company is developing a replacement venous valve for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg.

The Company first developed the VenoValve®, which was a potential first-in-class surgical replacement venous valve (the Company received a not-approvable letter from the U.S. Food and Drug Administration (“FDA”) in response to its PMA application for the VenoValve in August 2025). The Company is now focused on its next-generation, non-surgical venous valve product, called the enVVe® system. The enVVe System consists of the enVVe Valve, enVVe Delivery System, enVVe Nose Cone, the enVVe Delivery System Accessories, and the enVVe Crimping System. The enVVe Valve is a first-in-class, non-surgical, transcatheter based replacement venous valve being developed for the treatment of severe CVI. The enVVe Valve is designed to act as a one-way valve, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The Company has completed pre-clinical testing on the enVVe System and has begun discussions with the FDA regarding the enVVe pivotal trial, which it expects to begin in 2026.

The enVVe System is being developed for approval by the FDA.

At the annual meeting of the Company’s stockholders held on December 11, 2025 (the “2025 Annual Meeting”), the Company’s stockholders approved an amendment to the Company’s Restated Certificate of Incorporation, as amended (the “Restated Certificate of Incorporation”), to effect a reverse stock split of our common stock, at a ratio betweenone-for-five (1:5) and one-for-thirty-five (1:35).

On January 2, 2026, the Company’s board of directors (the “Board”) approved aone-for-thirty-five (1:35) reverse stock split of the outstanding shares of our common stock (the “Reverse Stock Split”). On January 16, 2026, the Company filed an amendment to the Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the Reverse Stock Split, which became effective on January 20, 2026. The amendment did not change the number of authorized shares of our common stock.

Except as the context otherwise requires, all common stock share numbers, share price amounts (including exercise prices, conversion prices, and closing market prices) and shares issued upon the exercise of warrants contained in the audited consolidated financial statements and notes thereto have been retroactively adjusted to reflect the Reverse Stock Split.

Note 2 –Management’s Liquidity Plan

As of December 31, 2025, the Company had a cash balance of $3.1 million, investments of $25.1 million and working capital of $26.7 million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that our capital resources are sufficient to meet our obligations as they become due within one year after the date of this Annual Report.

Note 3 –Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates.

Investments

We consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents. The fair values of these investments approximate their carrying values. Investments with original maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year are classified as long-term investments.

Debt investments are classified as trading securities and realized gains and losses are recorded using the specific identification method. Changes in fair value, excluding credit losses and impairments, are recorded in unrealized gains (losses) from investments. Fair value is calculated based on publicly available market information. If the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, credit quality of debt instrument issuers, and the extent to which the fair value is less than cost. We recognize interest income based on the stated coupon rate of the investments purchased.

Property and Equipment, Net

Property and equipment are stated at cost, net of accumulated depreciation using the straight-line method over their estimated useful lives, which range from 5 to 7 years. Leasehold improvements are amortized over the lesser of (a) the useful life of the asset; or (b) the remaining lease term. Expenditures for maintenance and repairs, which do not extend the economic useful life of the related assets, are charged to operations as incurred, and expenditures, which extend the economic life are capitalized. When assets are retired, or otherwise disposed of, the costs and related accumulated depreciation or amortization are removed from the accounts and any gain or loss on disposal is recognized.

Impairment of Long-lived Assets

The Company reviews for the impairment of long-lived assets whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount.

Income Taxes

The Company follows the asset and liability method of accounting for income taxes under ASC 740, “Income Taxes.” Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that included the enactment date. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.

ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest and penalties related to unrecognized tax benefits as income tax expense. There were no unrecognized tax benefits and no amounts accrued for interest and penalties as of December 31, 2025 or December 31, 2024. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position.

Fair Value of Financial Instruments

The Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

FASB ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

Financial instruments, including accounts payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

Net Loss per Share

The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common shares outstanding during the period including warrants exercisable for little or no cash consideration. Basic and diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and options, would have been anti-dilutive.

Stock-Based Compensation

The Company has an Equity Incentive Plan under which the Board of Directors may grant restricted stock or stock options to employees and nonemployees. The accounting treatment for stock-based payments to employees and non-employees is substantially equivalent.

Stock-based compensation cost is recorded for all option grants and awards of non-vested stock based on the grant date fair value of the award, and is recognized over the service period required for the award.

The fair value of the Company’s stock options is estimated at the date of grant using the Black-Scholes based option valuation model. For the expected term, the Company uses SEC Staff Accounting Bulletin No. 107 simplified method for “plain vanilla” options with following characteristics: (i) the share options are granted at the market price on the grant date; (ii) exercisability is conditional on performing service through the vesting date on most options; (iii) if an employee terminates service prior to vesting, the employee would forfeit the share options; (iv) if an employee terminates service after vesting, the employee would have 30 to 90 days to exercise the share options; and (v) the share options are nontransferable and nonhedgeable.

The Company uses its stock’s historical market information to calculate volatility used in estimating fair value of options granted. The volatility assumption is based on the historical volatility of the Company’s common stock with an equivalent remaining expected term. The risk-free interest rate is based on the implied yield available on U.S. treasury zero-coupon issues with an equivalent remaining expected term. The dividend yield assumption is based on the Company’s history and expectation of future dividend payouts on the common stock.

For option grants without performance conditions, the Company recognizes compensation expense over the requisite service period ratably, recognizing expense for each tranche of each grant starting on the grant date. For grants that have both service and performance conditions, the Company recognizes compensation expense using the graded attribution method. Compensation expense for grants with performance conditions is recognized only for those awards expected to vest.

Forfeitures of unvested stock options are recorded when they occur.

Loss Contingencies

The Company will accrue an estimated loss if information available before the consolidated financial statements are issued or are available to be issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the consolidated financial statements and the amount of loss can be reasonably estimated.

Recently Adopted Accounting Standards

In December 2023, the FASB issued ASU No. 2023-09,Income Taxes (Topic 740 – Improvements to Income Tax Disclosures (ASU 2023-09). ASU 2023-09 was effective for annual periods beginning after December 15, 2024, and required enhanced disclosures related to the income tax rate reconciliation and income taxes paid to improve the transparency of income tax disclosures by requiring (1) consistent categories and greater disaggregation of information in the rate reconciliation and (2) income taxes paid disaggregated by jurisdiction. We adopted ASU 2023-09 effective on January 1, 2025, and have prospectively applied it to all periods presented.

Recent Accounting Standards

In December 2024, the FASB issued ASU No. 2024-03,Income Statement - Reporting Comprehensive Income- Expense Disaggregation Disclosures(ASU 2024-03). ASU 2024-03 requires disclosure of specific information about certain costs and expenses in the notes to its financial statements for interim and annual reporting periods. The objective of the disclosure requirements is to provide disaggregated information to help financial statement users (a) better understand the Company’s performance, (b) better assess the Company’s prospects for future cash flows, and (c) compare the Company’s performance over time and with that of other entities. ASU 2024-03 is effective for annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. We are currently evaluating the impact that this guidance will have on our consolidated financial statements.

Note 4 –Concentrations

The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $1.1 million as of December 31, 2025.

Note 5 –Investments

The components of investments were as follows:

Unrealized losses of $0.4 million and $22,000 for the year ended December 31, 2025 and 2024, respectively, from fixed-income securities are primarily attributable to changes in interest rates.

Note 6 –Property and Equipment

Property and equipment consist of the following:

Depreciation expense was $0.1 million and $0.2 million for the years ended December 31, 2025 and 2024, respectively, and is reflected in general and administrative expenses in the accompanying statements of operations.

Note 7 –Right-of-Use Assets and Liabilities

The Company leases its facility in Irvine, California under an operating lease which it amended in November 2021 to extend the lease term an additional 60 months through September 30, 2027. The lease rate at the date of the amendment was approximately $30,000 per month with escalating payments adjusting annually. In connection with the lease, the Company is obligated to pay approximately $7,000 monthly for operating expenses for building repairs and maintenance. The Company has no other operating or financing leases with terms greater than 12 months.

Lease liabilities were determined using the Company’s estimated incremental borrowing rate of 3.95% to estimate the present value of the remaining monthly lease payments.

Our operating lease cost is as follows:

Supplemental cash flow information related to our operating lease is as follows:

Remaining lease term and discount rate for our operating lease is as follows:

Maturity of our lease liabilities by fiscal year for our operating lease is as follows:

Note 8 –Accounts payable, accrued expenses and other current liabilities

Accounts payable, accrued expenses and other current liabilities consist of the following:

Note 9 –Income Taxes

The domestic and foreign components of net loss before income taxes are as follows:

The following summarizes the Company’s income tax provision (benefit):

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures by requiring more granular disaggregation in the effective tax rate (“ETR”) reconciliation and providing expanded information regarding income taxes paid, categorized by jurisdiction. The Company adopted the provisions of ASU 2023-09 on a prospective basis effective January 1, 2025.

In accordance with this guidance, the following table provides a disaggregated reconciliation of the Company’s effective income tax rate to the U.S. statutory federal income tax rate:

The reconciliation between the U.S. statutory federal income tax rate and the Company’s effective tax rate for the year ended December 31, 2024 is as follows in accordance with the guidance prior to adoption of ASU 2023-09:

The Company’s state and local income tax expense is primarily driven by its operations in California. For the year ended December 31, 2025, California represents greater than 50% of the state and local income tax component of the effective tax rate reconciliation. No other individual state or local jurisdiction accounted for more than 50% of the aggregate state and local tax effect for the year ended December 31, 2025.

Significant components of the Company’s deferred tax assets are as follows:

On July 4, 2025 the One Big Beautiful Bill Act, or OBBBA, was enacted. The legislation includes several changes to the U.S. federal corporate income tax law, among other things, reinstating 100% bonus depreciation on qualified fixed assets, immediate expensing of domestic research and development expenditures, and favorable rules for determining the limitation on business interest expense. These changes were retroactively enacted for tax years beginning after December 31, 2024 with certain provisions effective after January 19, 2025 and were reflected in the income tax provision for the year ended December 31, 2025. The provisions of the OBBBA did not have a material impact on the effective income tax rate.

ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is “more likely than not.” Realization of any future tax benefit is dependent on the Company’s ability to generate sufficient taxable income within the carryforward period. Because of the Company’s history of operating losses, management believes that recognition of the deferred tax assets arising from the above listed future tax benefits is currently not more likely than not to be realized and, accordingly, has provided a full valuation allowance. The valuation allowance increased by $4.2 million and $5.4 million during the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025 and 2024, the Company net operating loss carryforwards for federal income tax purposes of approximately $95.6 million and $72.2 million, respectively. Of this, pre-2018 federal NOLs of approximately $12.0 million may be carried forward for twenty years and begin to expire in 2029. The remaining post 2018 federal NOLs of approximately $83.6 million can be carried forward indefinitely and could be used to offset up to 80% of taxable income in all the future years.

As of December 31, 2025 and 2024, the Company had net operating loss carryforwards for state income tax purposes of approximately $114.0 million and $97.7 million, respectively, which can be carried forward for twenty years and begin to expire in 2029.

To the extent the Company utilizes its NOL carryforward in the future, the tax years in which the attribute was generated may still be adjusted upon examination by the Internal Revenue Service or state tax authorities of the future period tax return in which the attribute is utilized. The Company also has federal research and development tax credit carryforwards of approximately $0.2 million which begin to expire in 2027.

The utilization of the Company’s net operating loss carryforwards and research tax credit carryovers could be subject to annual limitations under Section 382 and 383 of the Internal Revenue Code of 1986, as amended (the “Code”), due to ownership change limitations that may have occurred previously or that could occur in the future. These ownership changes limit the amount of net operating loss carryforwards and other deferred tax assets that can be utilized to offset future taxable income and tax, respectively. In general, an ownership change, as defined by Section 382 and 383 of the Code, results from transactions increasing ownership of certain stockholders or public groups in the stock of the corporation by more than 50 percent points over a three-year period. The Company has not completed an analysis of an ownership change under Section 382 of the Code. To the extent that a study is completed and an ownership change is deemed to occur, the Company’s net operating losses and tax credits could be limited.

The Company files income tax returns in the U.S. federal jurisdiction as well as California and local jurisdictions and is subject to examination by those taxing authorities. The statute of limitations for assessment by the IRS and state tax authorities is open for tax years ending December 31, 2025, 2024, 2023, 2022 and 2021, although carryforward attributes that were generated for tax years prior to 2021 may still be adjusted upon examination by the IRS or state tax authorities if they either have been, or will be, used in future period. No tax audits were initiated during 2025 or 2024. For the fiscal year ended December 31, 2025, the Company did not make any payments for federal or state income taxes, net of refunds received.

Management has evaluated and concluded that there were no material uncertain tax positions requiring recognition in the Company’s consolidated financial statements as of December 31, 2025 and 2024. The Company does not expect any significant changes in its unrecognized tax benefits within twelve months of the reporting date. The Company’s policy is to classify assessments, if any, for tax related interest as interest expense and penalties as general and administrative expenses in the statements of operations.

Note 10 –Commitments and Contingencies

Litigation Claims and Assessments

In the normal course of business, the Company may be involved in legal proceedings, claims and assessments. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

Note 11 –Stockholders’ Equity

Equity Issuances

The Company completed equity transactions during the years ended December 31, 2025 and 2024. The following table provides an overview of those transactions:

(In thousands)

The 2025 transaction is a result of the sale the common stock under an At-the-Market Agreement (“ATM”), entered into on October 30, 2025 to create an at-the-market equity program under which the Company may sell up to $50 million of shares of its common stock from time to time.

The 2024 transaction included approximately 2,000 pre-funded warrants and approximately 9,000 warrants to the underwriter with a weighted average exercise price of the warrants is $140.88 and a fair value of $1.0 million based on the Black Scholes method and the following weighted average input assumptions:

Warrants

A summary of warrant activity is presented below:

Note 12 –Stock-based Compensation

Omnibus Incentive Plan

The Company issues stock-based awards under its Company’s 2016 Omnibus Incentive Plan, as amended, which enables the Company to grant stock options, stock appreciation rights, restricted stock, restricted stock units, unrestricted stock, other stock-based awards and cash awards to associates, directors, consultants, and advisors of the Company and its affiliates, and to improve the ability of the Company to attract, retain, and motivate individuals upon whom the Company’s sustained growth and financial success depend, by providing such persons with an opportunity to acquire or increase their proprietary interest in the Company. Stock options granted under the 2016 Plan may be non-qualified stock options or incentive stock options, within the meaning of Section 422(b) of the Internal Revenue Code of 1986, except that stock options granted to outside directors and any consultants or advisers providing services to the Company or an affiliate shall in all cases be non-qualified stock options. The option price must be at least 100% of the fair market value on the date of grant and if issued to a 10% or greater shareholder must be 110% of the fair market value on the date of the grant.

The 2016 Plan is to be administered by the Board, which has discretion over the awards and grants thereunder. No awards may be issued after April 26, 2028.

The number of shares authorized to be issued under the Plan is automatically adjusted from time to time when the Company issues additional shares of common stock or securities that are convertible or exercisable into shares of common stock (other than pursuant to the Plan) such that shares authorized under the plan after such issuance shall be equal to at least 20% of the issued and outstanding shares of the Company on a fully diluted basis. As of December 31, 2025 there are 220,150 shares authorized to be issued and 33,678 remaining available for future issuance under the Plan.

Stock Options

The fair value of each option grant is estimated at the grant date using the Black Scholes method. The following assumptions were used in estimating fair value:

A summary of the option activity is presented below:

The Company includes stock-based compensation expense in selling, general and administrative expenses, and recognized $3.4 million and $4.1 million during the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, there was $3.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.6 years.

Restricted Stock Units

The Company also issues restricted shares and restricted stock units under the 2016 Plan. As of December 31, 2024, there were 11,428 restricted stock units issued and outstanding. As of December 31, 2025, vesting conditions required for the restricted stock units was not achieved and the restricted stock units were cancelled.

Note 13 –Net Loss Per Share

The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share:

Note 14 –Segment Reporting

The Company has determined that it currently operates in asingle segment, Medical Device development, located in a single geographic location, the United States. The accounting policies of the segment are the same as those described in the summary of significant accounting policies. Since the Company operates in a single segment, the measure of segment total assets and loss from operations is the same as that reported on the accompanying balance sheets as total assets, and the accompanying statement of operations as loss from operations, respectively.

The Company’s chief operating decision maker (“CODM”) is the chief executive officer. The CODM uses operating expenses to measure performance against progress in its clinical trials and its product development. The following table sets forth segment expenses.

Adjustments and reconciling items in the above table consist of interest income and realized and unrealized gains and losses related to our investments in U.S. Treasury securities.

Note 15 –Subsequent Events

On December 11, 2025, the Company completed its 2025 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, the Company’s stockholders, among other things, granted authority to the Company’s Board of Directors to effectuate a reverse stock split of the Company’s common stock at a ratio of betweenone-for-five and one-for-thirty-five, with such ratio to be determined at the sole discretion of the Company’s Board of Directors (the “Board”) and with such reverse stock split to be effected at such time and date, if at all, as determined by the Board in its sole discretion.

On January 20, 2026, the Company effected aone-for-thirty-five (1:35) reverse stock split (the “Reverse Stock Split”) of the shares of the Company’s common stock, par value $0.00001 per share (the “Common Stock”). As a result of the Reverse Stock Split, every thirty-five (35) shares of issued and outstanding Common Stock was automatically combined into one (1) issued and outstanding share of Common Stock, without any change in the par value per share. No fractional shares were issued as a result of the Reverse Stock Split and any fractional shares resulting from the Reverse Stock Split were rounded down to the nearest whole share and remitted cash payments in lieu of fractional shares. Following the Reverse Stock Split, the number of shares of Common Stock outstanding was reduced from 22,946,223 shares to 655,606 shares.

Pursuant to their terms, proportional adjustments were also made to the Company’s outstanding stock options and warrants such that the number of shares of Common Stock underlying such securities were reduced by a factor of 35 and the exercise prices of such securities were increased by a factor of 35 (by way of example, if prior to the Reverse Stock Split there was an outstanding warrant to purchase 3,500 shares of Common Stock at an exercise price of $0.30 per share, such warrant has now been adjusted following the Reverse Stock Split and is now a warrant to purchase 100 shares of Common Stock at an exercise price of $10.50). The number of authorized shares of Common Stock under the Certificate of Incorporation will remain unchanged at 250,000,000 shares.

Nasdaq Minimum Price Bid Compliance

On February 4, 2026, the Company announced that it has received formal notice from the Listings Qualifications staff of The Nasdaq Stock Market LLC (“Nasdaq”) that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), which requires a minimum bid price of $1.00 per share. Nasdaq confirmed that for the 10 consecutive business days, from January 20, 2026 through February 2, 2026, the closing bid price of the Company’s common stock was at or above $1.00, and as a result, the matter was closed.