enVVeno Medical Corp 10-Q

Item 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included herein. In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following discussion and elsewhere in this Quarterly Report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission. Forward-looking statements are statements not based on historical information and which relate to future operations, strategies, financial results or other developments. Such forward-looking statements involve significant risks and uncertainties. Forward looking statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are subject to change. These uncertainties and contingencies can affect actual results and could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on our behalf. Words such as “anticipate,” “estimate,” “plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Unless the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us” or the “Company” are to enVVeno Medical Corporation 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 (the Company received a not-approvable letter from the 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. On April 29, 2026, the Company announced that the FDA had approved the Company’s Investigational Device Exemption (“IDE”) application, authorizing the Company to commence a study of a non-surgical replacement venous valve. The Transcatheter Venous Valve Endoprosthesis (“TAVVE ® ”) pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, 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 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval. We cannot provide any assurance that the enVVe System will receive pre-market approval from the FDA to be marketed and sold in the U.S. (see the section entitled “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 26, 2026). 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. We develop and manufacture our products 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. 8 CVI Background Chronic venous disease (“CVD”) is the world’s most prevalent chronic disease. CVD is clinically classified using a standardized system known as CEAP (clinical, etiological, anatomical, and pathophysiological). The CEAP system consists of seven clinical classifications (C0 to C6) with C4, C5 and C6 being the most severe categories of CVD. Chronic Venous Insufficiency (“CVI”) is a large subset of CVD and is generally used to describe patients with C4 to C6 CVD. CVI is a debilitating condition that affects the venous system of the leg causing pain, swelling, edema, skin changes, and ulcerations. The human leg contains three vein systems: the deep vein system, the superficial vein system, and the perforator vein system which connects the deep system to the superficial system. The deep venous system is located below the muscle and facia in the center portion of the leg and is responsible for approximately 90% of the blood flow. In order for blood to return to the heart from the foot, ankle, and lower leg, the calf muscle serves as a pump and pushes the blood up the veins of the leg against gravity and through a series of one-way valves. Each valve is supposed to open as blood passes through, and then close as blood progresses up the veins of the leg to the next valve. CVI occurs when the one-way valves in the veins of the leg fail and become incompetent. When the valves fail, gravity causes the blood to flow backwards and in the wrong direction (reflux). As blood pools in the lower leg, pressure inside the veins increases (venous hypertension). Reflux, and the resulting venous hypertension, causes the leg to swell, resulting in debilitating pain, and in the most severe cases, venous ulcers. Severe CVI sufferers experience a significantly reduced quality of life. Daily activities such as preparing meals, housework, and personal hygiene (washing and bathing) become difficult due to reduced mobility. For many severe CVI sufferers, intense pain, which frequently occurs at night, prevents them from getting adequate sleep. Severe CVI sufferers are known to miss approximately 40% more workdays than the average worker. A high percentage of venous ulcer patients also experience severe itching, leg swelling, and an odorous discharge. Wound dressing changes, which occur several times a week, can be extremely painful. Venous ulcers from deep venous CVI are very difficult to heal, and a significant percentage of venous ulcers remain unhealed for more than a year. Even if healed, recurrence rates for venous ulcers are known to be high (20% to 40%) within the first year and as high as 60% after five years. Patients with severe CVI often become housebound and experience social isolation due to difficulty with ambulation. As a result, studies have shown that patients with active venous ulcers experience higher rates of anxiety and depression, with reported rates of anxiety of up to 30% and depression up to 40%. Rates of depression caused by venous ulcers among the elderly are even higher, with 48% of elderly venous ulcer patients having severe depressive symptoms. We estimate that there are approximately 3 million patients with severe deep venous CVI in the U.S. including approximately 1.5 million patients that develop venous leg ulcers (C6 patients). The average patient seeking treatment of a venous ulcer spends as much as $30,000 a year on wound care, and the total direct medical costs from venous ulcer sufferers in the U.S. has been estimated to exceed $20 billion a year. enVVe System The enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based approach. The procedure is performed without the need for open surgery or an overnight hospital stay. Built on the clinical foundation of the VenoValve program, the enVVe Valve incorporates design enhancements intended to improve performance, strength and long-term durability. The enVVe System seeks to address prior FDA concerns discerned in the clinical trial process for the VenoValve related to venous valves implanted via open surgical procedures. In addition to eliminating open surgical complications, its transcatheter approach is expected to broaden adoption by appealing to a wider range of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists. The Company has completed pre-clinical testing on the enVVe System and, on April 29, 2026, the Company announced that the FDA had approved the Company’s IDE application, authorizing the Company to commence a study of a non-surgical replacement venous valve. The TAVVE pivotal study will evaluate the Company’s minimally invasive enVVe System for patients with severe deep CVI. The first stage of the TAVVE study, which is expected to commence later this year, 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 220 th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval. Key features of the enVVe System include: ● Minimally invasive procedure requiring no general anesthesia or overnight hospital stay; ● Self-expanding frame made from a specially formulated biocompatible nickel and titanium alloy; ● Frame geometry that accommodates the natural dilation and contraction of the vein; ● 3 enVVe valve sizes to ensure a proper fit across a broad range of vein sizes; ● Unique, mono-cusp leaflet design that is laser cut from porcine pericardium tissue; ● Delivery profile of only 13 Fr (4.3 mm) when crimped, giving it the smallest profile of any replacement valve currently in use for the cardiovascular system; and ● Delivery via an over-the-wire, coaxial, single-stage pull system for ease of use. 9 VenoValve In March 2021, the Company received IDE approval from the FDA to initiate the Surgical Anti-reflux Venous Valve Endoprosthesis (“SAVVE®”) U.S. pivotal clinical study evaluating the VenoValve. The prospective, multi-center, single-arm study enrolled 75 patients with severe CVI. An application seeking pre-market approval for the VenoValve was filed in November 2024. In August 2025, the Company received a non-approvable letter from the FDA for the VenoValve and a subsequent appeal was unsuccessful. Most medical devices start out as surgical iterations and transition to less invasive, trans-catheter delivered versions over time. The Company’s strategy was to first develop the VenoValve, and then to transition to enVVe. That strategy remains intact. The enVVe System could not have been developed without the experience gained from the VenoValve. Because the VenoValve was not approved by the FDA, the Company has elected to forego any potential approval and commercialization efforts outside of the U.S. for the VenoValve and to instead focus its resources on bringing the enVVe System to market. Data from the SAVVE pivotal study has been presented at vascular conferences throughout the world and has been very well received. Clinicians recognize the need for a replacement venous valve for patients suffering from deep venous CVI and we believe that both the short-term and long-term VenoValve efficacy data has been extremely promising for this difficult to treat patient population. Although interest in a surgical replacement venous valve has been strong, clinicians recognize that long-term the large potential market is best served via a trans-catheter delivered iteration of the device. There continues to be significant interest from clinicians wanting to participate in the TAVVE pivotal study. Capital We finished 2025 with approximately $28.2 million of cash and investments and had approximately $24.9 million of cash and investments as of March 31, 2026. Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials, 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 $3 million to $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 and investments to fund operations into the third quarter of 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 March 31, 2026, we have sufficient capital resources to meet our obligations as they become due within at least one year after the date of this Quarterly Report and sustain operations. Results of Operations Comparison of the three months ended March 31, 2026 and 2025 Overview We reported net losses of $3.8 million and $4.5 million for the three months ended March 31, 2026 and 2025, respectively, representing a decrease in net loss of $0.7 million, or 15%, due to a decrease in operating expenses of $0.9 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below. 10 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 three months ended March 31, 2026, research and development expenses decreased by $0.5 million or 17%, to $2.1 million from $2.6 million for the three months ended March 31, 2025. This decrease primarily resulted from $0.7 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time and our focus has shifted to the development of the enVVe System, as well as a net decrease of $0.2 million in various other expenses. These decreases were partially offset by an increase of $0.4 million in product development, testing and other expenses related to the enVVe System being developed for approval by the FDA. Selling, General and Administrative Expenses For the three months ended March 31, 2026, selling, general and administrative expenses decreased by $0.4 million or 19%, to $2.0 million from $2.4 million for the three months ended March 31, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest, as well as a net decrease in various other expenses. Other Income For the three months ended March 31, 2026, other income decreased $0.3 million or 53% to $0.2 million from $0.5 million for the three months ended March 31, 2025. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in U.S. Treasury securities. Liquidity and Capital Resources For the three months ended March 31, 2026, the Company incurred losses from operations of $4.1 million and used $3.2 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.8 million from $4.0 million for the three months ended March 31, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of March 31, 2026, is $2.6 million. In addition, we have $22.3 million in investments, for total cash and investments of $24.9 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 the enVVe System pivotal study. 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 $3 million to $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 and investments to fund operations into the third quarter of 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 March 31, 2026, we have sufficient capital resources to meet our obligations as they become due within at least one year after the date of this Quarterly Report and sustain operations. 11 Critical Accounting Estimates The preparation of our condensed financial statements requires management to make judgments, estimates and assumptions that affect the reported amounts of expenses, assets and liabilities, and the accompanying disclosures, and the disclosure of contingent liabilities, if any. Critical accounting estimates are those for which uncertainty about the assumptions and estimates could result in outcomes that require a material adjustment to the carrying amount of assets or liabilities in future periods if the actual outcomes differ from estimates. We do not have any matters that have a significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next fiscal year. Off-Balance Sheet Arrangements None. Contractual Obligations As a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item. Item 3. Quantitative and Qualitative Disclosure About Market Risk As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item.