Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)

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 late clinical-stage medical device company focused on the advancement of innovative bioprosthetic (tissue-based) solutions to improve the standard of care for the treatment of deep 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 surgical and non-surgical replacement venous valves for patients suffering from severe CVI of the deep venous system of the leg.

The Company's lead product is the VenoValve^®, a potential first of its kind surgical replacement venous valve currently in post-enrollment follow-up of its U.S. pivotal study. The Company is also developing a second product called enVVe^®, a potential next-generation, non-surgical, transcatheter based replacement venous valve. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs.

The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed approximately three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option, although we cannot provide any assurance that either the VenoValve or enVVe will receive approval from the FDA (see the section entitled "Risk Factors" in our Annual Report on Form 10-K/A, filed with the SEC on February 28, 2025). There are currently no devices FDA approved as surgical or non-surgical replacement venous valves, and there are currently no effective treatments for deep venous CVI caused by incompetent valves.

Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. 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.

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 with venous leg ulcers (VLU) are known to miss approximately 40% more workdays than the average worker without the condition. 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 2.5 million to 3.5 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.

VenoValve

The VenoValve is a surgically implanted replacement venous valve developed by enVVeno Medical, designed for use in the deep veins of the leg to treat severe CVI caused by valvular incompetence. By lowering pressure (venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring venous leg ulcers. The VenoValve is implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh. The surgical approach for implanting the VenoValve is referred to as the SAVVE^® procedure, which enables physicians to implant the VenoValve to restore valve function in the deep veins of the leg. As our planned initial entrant to the replacement venous valve market, we estimate that approximately 2.5 million people with severe deep venous CVI in the U.S. would be candidates for the VenoValve, including approximately 1.5 million people with active venous ulcers. The VenoValve has been granted Breakthrough Device designation by the FDA.

VenoValve Clinical Status

In March of 2021 we received IDE approval from the FDA to begin the VenoValve pivotal study. An investigational device exemption or IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a Class III medical device. This approval allowed us to proceed with our U.S. pivotal study for the VenoValve, a prospective, non-blinded, single arm, multi-center clinical study. The seventy-five patient U.S. pivotal study reached full enrollment on September 1, 2023 and is now in the post-enrollment follow-up period.

The VenoValve is implanted using the SAVVE^® procedure, an open surgical approach that enables precise placement of the device within the femoral vein to restore valve function. Efficacy endpoints for the U.S. pivotal study include rVCSS scores, which are used to provide evidence of clinically meaningful benefit, as well as reflux time measurements, VAS pain scores, quality of life measurements, ulcer healing (for CEAP class C6 patients), and intra-operative and one-year vein patency and valve functionality. Safety endpoints include device related events and procedure related events including mortality, pulmonary embolism, ipsilateral deep vein thrombosis, infection and bleeding.

In November 2024, one year efficacy and safety data from the U.S. pivotal study was presented at the 51st Annual VEITH Symposium. The data indicated that eighty-five percent (85%) of the patients enrolled in the trial experienced a clinical meaningful benefit from the VenoValve, defined as a three (3) or more point improvement in revised Venous Clinical Severity Score (rVCSS), at one year, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 7.91 points. Patients in the study also experienced a seventy-five percent (75%) median reduction in pain and improvements in quality-of-life indicators. For patients with venous ulcers (CEAP C6 patients), ulcer area was reduced a median average of eighty-seven percent (87%). Over the course of the one (1) year period, there was one (1) death (unrelated to the VenoValve), zero (0) pulmonary embolisms, twelve (12) target vein thromboses, ten (10) surgical pocket hematomas, four (4) other bleeds, and seven (7) deep wound infections. Ninety-four percent (94%) of the patients that experienced a material safety event also went on to experience a clinically meaningful benefit from the VenoValve. Also, the reported target vein patency rates at thirty (30) days and one (1) year were ninety one percent (91%) and ninety seven percent (97%), respectively.

On November 19, 2024, the Company submitted the final module of its PMA application for review by the FDA.

In June 2025, the Company announced that interim two-year follow-up data on forty-two (42) subjects from the seventy-five (75) patient VenoValve U.S. pivotal trial at the Society for Vascular Surgery 2025 Vascular Annual Meeting. The data indicated that eighty-three percent (83.3%) of patients enrolled in the trial (n=35/42) maintained a clinically meaningful benefit from the VenoValve, defined as an improvement of 3 or more points in the revised Venous Clinical Severity Score (rVCSS), at year two, compared to baseline. The average rVCSS improvement in the clinically meaningful responder cohort was 9.1 points. Patients in the study also experienced a seventy-four percent (74%) median reduction in leg pain, as measured by the Visual Analog Scale (VAS). For patients with venous ulcers, wound healing outcomes in seventeen (17) patients with twenty-five (25) ulcers showed that 60% of ulcers healed completely, 24% decreased in size, and 16% increased in size. Patient-reported outcomes also demonstrated sustained improvements across all venous specific QoL indicators (VEINES-QoL/Sym). Among the patients (n=30), a 100% valve patency rate was observed at the two-year follow up. All values were calculated comparing each patient's baseline levels to the reported values at the patient's 24-month visit. The Revised Venous Clinical Severity Score (rVCSS) is a clinically validated scoring system used to track the progression or regression of venous diseases.

On August 19, 2025, the Company announced that it received a not-approvable letter from the FDA in response to its PMA application for the VenoValve. The letter indicated that the FDA completed its review of the VenoValve PMA application and determined that it is unable to approve the PMA for the VenoValve in its current form. In particular, the FDA indicated that the favorable rVCSS data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve. Without a specific hemodynamic measurement that correlates with patient improvement, the FDA raised concerns about bias and the possibility that clinical improvement occurred as a result of the patients being enrolled in a study. The FDA also focused on safety concerns which were attributed to the VenoValve open surgical procedure, and that required re-hospitalizations. The Company would not expect to see similar safety events with a non-surgical replacement valve.

On September 18, 2025, the Company filed a request for supervisory appeal of the not-approvable letter from the Center for Devices and Radiological Health (CDRH) of the FDA received on August 19, 2025, in response to its PMA application for the VenoValve. The FDA provides several internal informal and formal mechanisms to challenge staff decisions, including scientific controversies. One mechanism is a request for supervisory review in which an appeal is made to the next line of supervision. Supervisory appeals are required to be filed within 30 days of the decision being appealed, which was on or before September 18, 2025. These appeals involve a formal substantive request, an in-person meeting, and a decision. It also often includes multiple interactions even after an initial appeal decision is made. Internal Agency reviews are based on information already in the administrative file. Due to the variety of both physician reported and patient reported data generated by the VenoValve pivotal study and which is already a part of the file, the Company is confident that explaining this data to supervisory management in a focused appeal setting may lead to a positive outcome, with a decision expected by the end of 2025.

In October 2025, the Company completed an in-person meeting with the FDA. In addition to representatives from an outside firm specializing in FDA matters and appeals and representatives from the Company, the meeting also included a patient advocate from VenoValve U.S. pivotal study as well as one of the Company's primary investigators from the trial. Several employees from the FDA attended the meeting including the Director of the Center for Devices and Radiological Health, who elected to hear the appeal and who will be issuing the appeal decision. The FDA meeting provided the Company with the opportunity to put the major adverse events-those tied to the SAVVE study's safety endpoints-into the proper context. It also allowed the Company to re-emphasize the multiple physician-and patient-reported clinical benefits that comprise the totality of the evidence from the study, supported by firsthand perspectives shared by both the SAVVE study patient and investigator in attendance. Because there are no established industry or regulatory standards to determine the effectiveness for a replacement venous valve, it is necessary for the Company and the Agency to establish a new regulatory pathway for VenoValve effectiveness.

The Company worked collaboratively with the FDA over the past several years to help ensure that the Company was collecting the necessary data to support effectiveness of the VenoValve and that dialogue with respect to effectiveness is continuing as part of this appeal. There are often multiple ways to satisfactorily address a given regulatory issue, and at the meeting, the Company proposed an alternative effectiveness pathway for the VenoValve, supported by data already collected in SAVVE. The Company expects to hear from the FDA about this stage of the appeal process by the end of 2025.

Although the subject of the FDA appeal and the FDA meeting is specific to the VenoValve, the appeal does also have implications for enVVe, our next generation transcatheter replacement venous valve, and as a result, the Company is waiting for clarity from the FDA prior to filing the enVVe IDE application.

enVVe

On September 21, 2022, we announced the development of a non-surgical transcatheter based replacement venous valve called enVVe^®, for the treatment of CVI of the deep veins of the leg. Initial preliminary bench testing and pre-clinical testing for enVVe have been successfully completed.

On December 16, 2024, we announced the successful completion of the final wave of implants for the six-month pre-clinical GLP study for enVVe. The first wave of implants, for the long-term subjects, was successfully completed in October 2024, and the final wave for the shorter-term subjects was completed in December 2024. The GLP study is a prerequisite to seeking IDE approval from the FDA to begin the enVVe U.S. pivotal study. The Company is waiting until certain regulatory issues with respect to the VenoValve are resolved with the FDA before filing the IDE for enVVe, which the Company expects to file in the first quarter of 2026.

Capital

We finished 2024 with approximately $43.2 million of cash and investments and had approximately $31.0 million of cash and investments as of September 30, 2025. 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 will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per quarter as we conduct our clinical trials and work toward bringing our product candidates to market.

Nasdaq Deficiency Letter

On October 7, 2025, the Company received notification from Nasdaq notifying the Company that, because the closing bid price for the Company's common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Capital Market under Rule 5550(a)(2) of Nasdaq Listing Rules.

Nasdaq's notice has no immediate effect on the listing of the Company's common stock on the Nasdaq Capital Market.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until April 6, 2026, to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company's common stock must close at or above $1.00 per share for a minimum of 10 consecutive trading days (which period may be extended to greater than 10 consecutive trading days at the sole discretion of Nasdaq) prior to April 6, 2026.

In the event the Company does not regain compliance by April 6, 2026, the Company may be eligible for an additional 180 calendar day compliance period to demonstrate compliance with the bid price requirement. To qualify for the additional 180-day period, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. If the Nasdaq staff determines that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible for such additional compliance period, Nasdaq will provide notice that the Company's common stock will be subject to delisting. The Company would have the right to appeal a determination to delist its common stock, and the common stock would remain listed on the Nasdaq Capital Market until the completion of the appeal process.

Results of Operations

Comparison of the three months ended September 30, 2025 and 2024

Overview

We reported net losses of $4.5 million and $5.6 million for the three months ended September 30, 2025 and 2024, respectively, representing a decrease in net loss of $1.1 million, or 20%, due to a decrease in operating expenses of $1.3 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.

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 September 30, 2025, research and development expenses decreased by $0.3 million or 10%, to $2.6 million from $2.9 million for the three months ended September 30, 2024. This decrease primarily resulted from $0.4 million in lower costs related the VenoValve pivotal study as the amount of follow-up for each participant decreases over time, partially offset by $0.1 million in higher compensation costs from additional personnel.

Selling, General and Administrative Expenses

For the three months ended September 30, 2025, selling, general and administrative expenses decreased by $1.0 million or 31%, to $2.3 million from $3.3 million for the three months ended September 30, 2024. Of this decrease, $0.7 million was due to non-recurring legal costs incurred during the three months ended September 30, 2024 and $0.3 million was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest. This decrease was also due to a $0.3 million partial recovery of a non-recurring $0.6 million reserve recorded during the six months ended June 30, 2025 for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required. These decreases were partially offset by a net $0.3 million increase related to various other expenses.

Other Income

For the three months ended September 30, 2025, other income decreased $0.2 million or 35% to $0.3 million from $0.5 million for the three months ended September 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in US Treasury securities.

Comparison of the nine months ended September 30, 2025 and 2024

Overview

We reported net losses of $15.7 million and $15.6 million for the nine months ended September 30, 2025 and 2024, respectively, representing an increase in net loss of $0.1 million or 1%, due to a decrease in other income of $0.3 million, partially offset by a decrease in operating expenses of $0.2 million, as described in further detail below.

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 nine months ended September 30, 2025, research and development expenses decreased by $0.7 million or 8%, to $8.0 million from $8.7 million for the nine months ended September 30, 2024. This decrease primarily resulted from $1.3 million in lower costs related to the VenoValve study as the amount of follow-up for each participant decreases over time, partially offset by $0.6 million in higher compensation costs from additional personnel, as well as higher professional fees.

Selling, General and Administrative Expenses

For the nine months ended September 30, 2025, selling, general and administrative expenses increased $0.5 million or 6%, to $8.9 million from $8.4 million for the nine months ended September 30, 2024. Of this increase, $0.3 million was due to a non-recurring severance expense recorded in 2025 and $0.6 million related to higher compensation costs from additional personnel. This increase was also due to a non-recurring $0.3 million reserve for potentially uncollectible prepaid clinical costs resulting from payments made to a vendor that were not passed through from the vendor to clinical sites, as contractually required, and a net $0.5 million increase related to various other expenses. These increases were partially offset by $0.9 million in non-recurring legal costs incurred during the nine months ended September 30, 2024 and $0.3 million from the net effect of lower stock-based compensation cost incurred as option grants are issued and vest.

Other (Income) Expense

For the nine months ended September 30, 2025, other income decreased $0.3 million to $1.2 million from $1.5 million for the nine months ended September 30, 2024. Other income in both periods reflects realized gains, interest, and unrealized gains or losses from our program to invest excess cash in US Treasury securities.

Liquidity and Capital Resources

For the nine months ended September 30, 2025, the Company incurred losses from operations of $15.7 million and used $12.1 million cash in operating activities. The net cash used in operating activities during the 2025 period increased by $0.4 million from $11.7 million for the period ended September 30, 2024.

The losses and the uses of cash are primarily due to our product research and development activities, including clinical studies, and administrative activities. Research and development activities are for continued product development and clinical studies for our product candidates, currently the VenoValve and enVVe. Administrative functions relate to costs to support our public reporting and investor relations activities, internal administrative functions and, starting in 2024, costs to prepare for commercialization of the VenoValve. The Company will continue to incur these costs, and we anticipate these costs will increase, as we work to complete our clinical studies, enhance products, develop new products, bring those products to market, and operate as a public company.

We are not currently generating revenue and do not expect significant revenue until we successfully commercialize one or more of our product candidates after receiving FDA approval, if ever.

We do not currently have material commitments for capital expenditures or other expenditures except for our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue clinical studies, plan for commercialization of the VenoValve and continue development of enVVe.

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical studies and related product development costs and our ability to successfully bring products to market. We anticipate that our cash burn rate will increase from current levels of approximately $4 million per quarter to between $5 million and $7 million per quarter as we conduct our clinical studies and work toward bringing our product candidates to market.

We have historically funded our operations through financing activities, such as the capital raise completed in 2024, and will need to raise additional capital in the future. Any inability to raise additional financing would have a material adverse effect on us.

Based on our cash and working capital as of September 30, 2025, we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Quarterly Report and sustain operations.

Critical Accounting Estimates

The preparation of our consolidated 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.