enVVeno Medical Corp

(unaudited)

Note 1 –Business Organization and Nature of Operations

The Company

enVVeno Medical Corporation (the “Company”) is a late-stage 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 is focused on its next-generation, non-surgical replacement venous valve, 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 transcatheter based replacement venous valve being developed for the treatment of severe, deep venous 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.

In April 2026, the U.S. Food and Drug Administration (“FDA”) awarded the Company an Investigational Device Exemption (“IDE”) approval to proceed with a U.S. pivotal study of the enVVe System. The Transcatheter Venous Valve Endoprosthesis (“TAVVE”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe CVI.

The IDE approval positions the Company to advance what could become the first effective treatment option for the approximately 3 million U.S. patients who suffer from the debilitating impact of severe CVI due to malfunctioning valves in the deep veins of the leg.

The first stage of the TAVVE® study, which is expected to commence in the fourth quarter of 2026, will consist of 10 patients, whose 30-day safety results will be submitted to the FDA for review. This group of 10 patients will continue to be followed as a separate cohort throughout the study, and their safety and efficacy data will be reported publicly from time to time. The second stage of the study, which will begin immediately after the 30-day safety results for the first group are reported to the FDA, will enroll 220 patients, with 165 patients receiving the enVVe valve, and 55 patients randomized into a control arm who will receive standard of care treatment. The results from the patients who receive the enVVe valve will be compared to the results from the patients in the control arm of the study. The TAVVE study will enroll patients at up to 40 U.S. clinical sites and will include vascular surgeons, interventional radiologists and interventional cardiologists. One year after the 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

2026 Reverse Stock Split

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 unaudited condensed financial statements and notes hereto have been retroactively adjusted to reflect the Reverse Stock Split.

Note 2 –Management’s Liquidity Plan

As of September 30, 2026, the Company had a cash and investment balance of $18.5 million and working capital of $16.4 million. Although the Company expects to continue incurring losses for the foreseeable future and will 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 the Company’s capital resources are sufficient to meet its obligations as they become due within one year after the date of this Quarterly Report, and sustain operations. The timing and extent of pursuing its product development initiatives and penetrating markets for the sale of its products are subject to management’s decisions regarding discretionary spending. This discretion relates to the incremental spending, rather than all operating costs.

Note 3 –Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting of normal recurring items) which are considered necessary for a fair presentation of the Company’s unaudited condensed financial statements of the Company as of and for the three and nine months ended September 30, 2026 and 2025, and as of December 31, 2025.

The results of operations for the three and nine months ended September 30, 2026 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2025 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2026. The accompanying condensed balance sheet as of December 31, 2025 has been derived from the Company’s audited financial statements.

Note 4 –Investments

The components of investments were as follows:

Unrealized losses of $23,000 and $39,000 for the three months ended September 30, 2026 and 2025, respectively, and $0.1 million and $0.3 million for the nine months ended September 30, 2026 and 2025, respectively, are from fixed-income securities and are primarily attributable to changes in interest rates.

Note 5 –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 $2.0 million and $1.1 million as of September 30, 2026 and December 31, 2025, respectively.

Note 6 –Accounts Payable Accrued Expenses and Other Current Liabilities

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

Note 7 –Commitments and Contingencies

Litigations Claims and Assessments

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

Note 8 –Stockholders’ Equity

Omnibus Incentive Plan

Stock Options

Stock-based compensation expense is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $0.4 million and $0.7 million during the three months ended September 30, 2026 and 2025, respectively, and $1.3 million and $2.8 million during the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, there was $1.2 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.23 years.

There wereno options granted during the three and nine months ended September 30, 2026. There wereno options granted during the three months ended September 30, 2025 and 17,142 options granted during the nine months ended September 30, 2025 in connection with entering into certain employment and consulting agreements.

There wereno options exercised during the three and nine months ended September 30, 2026 and 2025.

There were 6,569 and 18,885 option grants forfeited during the three and nine months ended September 30, 2026, respectively. There wereno option grants forfeited during the three months ended September 30, 2025 and there were 15,110 option grants forfeited during the nine months ended September 30, 2025.

Warrants

There wereno warrants issued during the three and nine months ended September 30, 2026 and 2025.

Pre-funded warrants issued in 2021 were exercised for 25,972 shares of common stock during the three months ended September 30, 2025, at an exercise price of $0.0001 per share. Pre-funded warrants issued in 2023 and 2021 were exercised for 74,862 shares of common stock during the nine months ended September 30, 2025, at an exercise price of $0.0001 per share.

There wereno warrants that expired during the three months ended September 30, 2026. There were warrants exercisable for 8,990 shares of common stock that expired during the three months ended September 30, 2025. There were warrants exercisable for 85,219 and 20,380 shares of common stock that expired during the nine months ended September 30, 2026 and 2025, respectively.

Warrants issued in 2024 were exercised for 1,714 shares of common stock during the three and nine months ended September 30, 2025, at an exercise price of $140.875 per share.

A warrant issued in 2021 was exercised during the three and nine months ended September 30, 2025, at an exercise price of $245.00 per share.

Equity Issuances

There were approximately 22,000 and 39,000 shares of common stock issued during the three and nine months ended September 30, 2026, respectively, under our at-the-market equity program resulting in proceeds of $0.2 million and $0.3 million during the three and nine months ended September 30, 2026, respectively, net of transaction fees.

Note 9 –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 10 –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 set forth in the Company’s Form 10-K, filed with the SEC on March 26, 2026. 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 between loss from operations and net loss consist of interest income and realized and unrealized gains and losses related to the Company’s investments in U.S. Treasury securities.