Management's Discussion and Analysis of Financial Condition and Results of Operations

The following discussion should be read in conjunction with our consolidated financial statements and the related notes contained elsewhere in this Annual Report on Form 10-K and in our other Securities and Exchange Commission filings. The following discussion may contain predictions, estimates, and other forward-looking statements that involve a number of risks and uncertainties, including those discussed under "Risk Factors" and elsewhere in this Annual Report on Form 10-K. These risks could cause our actual results to differ materially from any future performance suggested below.

Overview

enVVeno Medical Corporation 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. Chronic Venous Disease ("CVD") is the world's most prevalent chronic disease, impacting approximately 70% of the adult population of the U.S. Chronic Venous Insufficiency ("CVI"), is a large subset of CVD, which most often occurs when valves inside of the veins of the leg become damaged, resulting in the backwards flow of blood (reflux), blood pooling in the lower leg, increased pressure in the veins of the leg (venous hypertension) and in severe cases, venous ulcers that are difficult to heal. The Company is developing a replacement venous valve for patients suffering from severe CVI of the deep venous system of the leg.

The Company first developed the VenoValve®, which was a first-in-class surgical replacement venous valve. On August 19, 2025, 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. 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.

enVVe is being developed for approval by the FDA. We cannot provide any assurance that either enVVe will receive approval from the FDA (see the section entitled "Risk Factors" in this Annual Report on Form 10-K). There are currently no devices approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

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.

We develop and manufacture our products in connection with our clinical trials in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

Recent Developments

2026 Reverse Stock Split

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 amended and restated certificate of incorporation to effect a reverse stock split of our common stock, at a ratio between one-for-five (1:5) and one-for-thirty-five (1:35).

On January 2, 2026, the Company's board of directors approved a one-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 amended and 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 this Annual Report on Form 10-K have been retroactively adjusted to reflect the Reverse Stock Split.

Results of Operations

Comparison of the year ended December 31, 2025 to the year ended December 31, 2024

Overview

We reported net losses of $19.5 million and $21.8 million for the years ended December 31, 2025 and 2024, respectively, representing a decrease in net loss of $2.3 million or 11%, resulting from, as described in further detail below, a decrease in operating expenses of $2.9 million, and a decrease in other income of $0.6 million.

Revenues

As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate after receiving FDA approval, if ever.

Research and Development Expenses

For the year ended December 31, 2025, research and development expenses decreased by $2.2 million or 19%, to $10.0 million from $12.2 million for the year ended December 31, 2024. The decrease primarily resulted from $2.4 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.2 million in higher compensation costs from additional personnel. We expect a moderate overall increase in expenses from current levels as costs related to the VenoValve pivotal study continue and costs related to the enVVe pivotal study would begin if IDE approval from the FDA is received.

Selling, General and Administrative Expenses

For the year ended December 31, 2025, selling, general and administrative expenses decreased by $0.7 million or 6%, to $10.9 million from $11.6 million for the year ended December 31, 2024. This decrease is primarily driven by $1.1 million in non-recurring legal costs incurred during the year ended December 31, 2024 and $0.7 million from the net effect of lower stock-based compensation cost incurred as option grants are issued and vest. These decreases were partially offset by a $0.3 million non-recurring severance expense recorded in 2025, $0.4 million related to higher compensation costs from additional personnel, and a net $0.4 million increase related to various other expenses.

Other Income

For the year ended December 31, 2025, other income decreased $0.6 million to $1.4 million from $2.0 million for the year ended December 31, 2024 as a result of the Company holding less U.S. Treasury securities in 2025 than 2024. Other income in both periods reflects net realized gains, interest, and unrealized losses from our program to invest excess cash in U.S. Treasury securities.

Liquidity and Capital Resources

For the year ended December 31, 2025, the Company incurred losses from operations of $20.9 million and used $15.6 million cash in operating activities. The net cash used in operating activities during 2025 decreased by $1.2 million from $16.8 million for the year ended December 31, 2024, primarily due to the decrease in research and development expenses from 2024 to 2025. Our cash balance as of December 31, 2025, is $3.1 million. In addition, we have $25.1 million in investments, for total cash and investments of $28.2 million.

The operating losses and the uses of cash are primarily due to the Company's product research and development and administrative activities. Administrative functions relate to costs to support the Company's public reporting and investor relations activities as well as internal administrative functions. Research and development activities were for product development and clinical trials for the VenoValve and for the enVVe System. The Company will continue to incur these costs to complete its clinical trials for the VenoValve and the enVVe System, enhance products, develop new products, and operate as a public company for the foreseeable future as we seek to obtain regulatory approval for our studies and product candidates.

We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.4 million per year. We expect a nominal increase in purchases of property and equipment and in facility lease costs as we commence TAVVE.

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate may increase from current levels of approximately $4 million per quarter to between $4 million and $5 million per quarter in 2026. Even after considering this increase, we should have sufficient cash to fund operations through mid-2027.

We have historically funded our operations through financing activities such as the capital raises. We will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

Based upon our cash and working capital as of December 31, 2025, we have sufficient capital resources to meet our obligations as they become due within at least one year after the date of this Annual Report and sustain operations.

Contractual Obligations

As a "smaller reporting company" as defined by Item 10 of Regulation S-K, we are not required to provide the information requested by paragraph (a)(5) of this Item.