NVNO 10-K & 10-Q changes, risk factors and insider trading

We currently depend entirely on the successful and timely regulatory approval and commercialization of our current product candidates,candidate, and any future product candidates, which may not receive regulatory approval or, if any of our product candidates do receive regulatory approval, we may not be able to successfully commercialize them.

We currently have twoone product candidates,candidate, the VenoValveenVVe and the enVVe,System, and our business presently depends entirely on our success with thesethis product product candidates.candidate. In order for our product candidatescandidate to succeed theyit needneeds to be approved by regulatory authorities, which may never happen. Our product candidatescandidate areis based on technologies that have not been used previously in the manner we propose. Market acceptance of our product candidates will largely depend on our ability to demonstrate their relative safety, efficacy, cost-effectiveness and ease of use. We may not be able to successfully develop and commercialize our product candidates.candidate. If we fail to do so, we will not be able to generate substantial revenues, if any.

We are subject to rigorous and extensive regulation by the FDA in the United States and by comparable agencies in other jurisdictions, including the European Medicines Agency, or EMA, in the European Union, or EU. Our product candidatescandidate areis currently in development, and we have not not received FDA approval for them.it. Our product candidatescandidate may not be marketed in the United States until they have been approved by the FDA and may not be marketed in other jurisdictions until they have received approval from the appropriate foreign regulatory agencies. A Each product candidate requires significant research, development, preclinicalpre-clinical testing and extensive clinical investigation before submission of any regulatory application for marketing approval. For example, on August 19, 2025, the Company received a not-approvable letter from the FDA in response to its PMA application for the VenoValve. While the enVVe System is different than the VenoValve in that it is a non-surgical, transcatheter based replacement venous valve, the enVVe System may also not receive FDA approval.

Obtaining regulatory approval requires substantial time, effort and financial resources, and we may not be able to obtain approval of any of our product candidates on a timely basis, or at all. The number, size, design and focus of preclinicalpre-clinical and clinical trials that will be required required for approval by the FDA, the EMA or any other foreign regulatory agency varies depending on the device, the disease or condition that that the product candidates are designed to address and the regulations applicable to particular products. PreclinicalPre-clinical and clinical data can be interpreted in different ways, which could delay, limit or preclude regulatory approval. The FDA, the EMA and other foreign regulatory regulatory agencies can delay, limit or deny approval of a product for many reasons, including, but not limited to:

If our current and future product candidates are not approved at all or quickly enough to provide net revenues to defray our operating expenses, our business, financial condition, operating results and prospects could be harmed.

If we successfully develop product candidates, which at this time will likely take several years at a minimum, we will have to demonstrate the efficacy and financial viability of our products to doctors, hospitals, insurance companies, and other stakeholders.

In the United States, in order for surgeons to use our product candidates, the hospital facilities where these surgeons treat patients will will typically require that the product candidates receive approval from the facility’s value analysis committee (“VAC”). VACs VACs typically review the comparative effectiveness and cost of medical devices used in the facility. The makeup and evaluation processes for VACs vary considerably, and it can be a lengthy, costly and time-consuming effort to obtain approval by the relevant VAC. For example, example, even if we have an agreement with a hospital system for the purchase of a product, in most cases, they must obtain VAC approval by each hospital within the system to sell at that particular hospital. Additionally, hospitals typically require separate VAC approval for each specialty in which a product is used, which may result in multiple VAC approval processes within the same hospital even if such product has already been approved for use by a different specialty group. VAC approval is often needed for each different product to be used by the surgeons in that specialty. In addition, hospital facilities and group purchasing organizations, or GPOs, which manage purchasing for multiple facilities, may also require us to enter into a purchasing agreement and satisfy numerous elements of their administrative procurement process, which can also be a lengthy, costly and time-consuming effort. If we do not receive access to hospital facilities in a timely manner, or at all, via these VAC and purchasing contract processes, or otherwise, or if we are unable to secure contracts on commercially reasonable terms in a timely manner, or at all, our costs may increase, our sales may decrease and our operating results may be harmed.

The Company has incurred significant operating losses which have generated significant net operating loss carry-forwards for both federal and state purposes. Other than federal NOL carryforwards generated after 2017, our NOL carryforwards will expire if not used over the next fivefour years. Our ability to realize the benefits of these NOL carryforwards will depend on our ability to generate income.

Further, our ability to realize the benefits of NOL carryforwards are limited because of ownership changes. In general, a corporation that undergoes undergoes an “ownership change” (generally defined as a greater than 50% change (by value) in its equity ownership over a rolling three-yearthree (3) year period) may be subject to limitations on its ability to utilize its NOLs and certain credit carryforwards to offset future taxable income and taxes. We have analyzed the tax impacts of ownership changes that occurred in 2018, 2021, 20232023, 2024, and in 2024.2025. While those ownership changes may have resulted in limits to the amount of NOLs that maycan be used in a given year, these are all post 2017 NOLs and are carried forward indefinitely.

Our product candidates maywill be subject to extensive governmental regulation in foreign jurisdictions, such as the EEA, and our failure to comply with applicable requirements could cause our business, results of operations and financial condition to suffer.

In the United States, our product candidates are regulated as medical devices. Before our medical device product candidates may be marketed marketed in the United States, we must submit, and the FDA must approve a PMA application. For the PMA approval process, the FDA must determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing and labeling data. In addition, modifications to products that are approved through a PMA application generally require FDA approval. The time required to obtain approval, clearance or license by the FDA to market a new therapy is unpredictable but typically takes years and depends upon many factors, including the substantial discretion of the FDA.FDA, especially after the Company received a not-approvable letter from the FDA related to the VenoValve. This timeline may be further extended as a result of the recent reduction in workforce that has taken place within the federal government, including at the FDA.

In addition, other legislative changes have been proposed and adopted in the United States since the PPACA was enacted. On August 2, 2011, 2011, the Budget Control Act of 2011 created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers up to 2% per fiscal year, which went into effect on April 1, 2013,2013. The and2% will remainreduction in effectMedicare payments to providers, originally triggered by the Budget Control Act of 2011, has been extended multiple times. Most recently, the Consolidated Appropriations Act, 2023 extended this 2% sequester through 2024 unlessfiscal additionalyear Congressional action is taken.2032. On January 2, 2013, the American Taxpayer Relief Act of 2012, or the ATRA, was signed into law which further reduced Medicare payments to certain providers, including hospitals.

We have filed patent applications for our products and related intellectual property with the U.S. Patent and Trademark Office and in other jurisdictions. As of the December 31, 2024,2025, we have been granted thirty-nineforty-two (3942) patents including eightnine (89) in the United States and have have another twenty-fourtwenty-one (2421) applications in various stages of review including fivesix (56) in the United States].States.

Our patents may not have, or our pending patent applications that mature into issued patents may not include, claims with a scope sufficient to protect our products, any additional features we develop for our current products or any new products. Other parties may have developed technologies that may be related or competitive to our products, may have filed or may file patent applications and may have received or may receive patents that overlap or conflict with our patent applications, either by claiming the same methods or devices or by claiming subject matter that could dominate our patent position. The patent positions of medical device companies, including our patent position, may involve complex legal and factual questions, and, therefore, the scope, validity and enforceability of any patent claims that we may obtain cannot be predicted with certainty. Patents, if issued, may be challenged, deemed unenforceable, invalidated or circumvented. Proceedings challenging our patents could result in either loss of the patent or denial of the patent application or loss or reduction in the scope of one or more of the claims of the patent or patent application. In addition, such proceedings may be costly. Thus, any patents that we may own may not provide any protection against competitors. Furthermore, an adverse decision in an interference proceeding can result in a third party receiving the patent right sought by us, which in turn could affect our ability to commercialize our implant systems.

The medical device industry is characterized by frequent and extensive litigation regarding patents and other intellectual property rights. Many medical device companies with substantially greater resources than us have employed intellectual property litigation as a way to gain a competitive advantage. We may become involved in litigation, interference proceedings, oppositions, reexamination, protest or other potentially adverse intellectual property proceedings as a result of alleged infringement by us of the rights of others or as a result of priority of invention disputes with third parties, either in the United States or internationally. We may also become a party to patent infringement claims and litigation or interference proceedings declared by the USPTO to determine the priority of inventions. Third parties may also challenge the validity of any of our issued patents and we may initiate proceedings to enforce our patent rights and prevent others from infringing on our intellectual property rights. Any claims relating to the infringement of third-party proprietary rights or proprietary determinations, even if not meritorious, could result in costly litigation, lengthy governmental proceedings, diversion of our management’s attention and resources, or entrance into royalty or license agreements that are not advantageous to us. In any of these circumstances, we may need to spend significant amounts of money, time and effort defending our position. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on our ability to raise the funds necessary to continue our operations.

As of theMarch date24, of this Annual Report,2026, we have issued and outstanding options to purchase 5,921,699181,996 shares of our common stock with a weighted average exercise price of $7.17, 400,000 restricted stock units subject to vesting,$220.41 and warrants to purchase 12,662,953177,921 shares of our common stock with a weighted average exercise price of $6.11.$278.26. Further, we have 828,79838,154 shares available for issuance under our Amended and Restated 2016 Omnibus Incentive Plan.

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 venous disease. Chronic Venous Disease (“CVD”) is the world’s most prevalent 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, cases, venous ulcers that are difficult to heal. The Company is developing surgical and non-surgicala replacement venous valvesvalve for patients suffering from severe CVI of the deep venous system of the leg.

The Company’sCompany leadfirst product isdeveloped the VenoValve®, which iswas a first-in-class surgical replacement venous valvevalve. thatOn isAugust currently19, being2025, the Company evaluatedreceived a not-approvable letter from the U.S. Food and Drug Administration (“FDA”) in aresponse U.S.to pivotalits study.PMA application for the VenoValve. The Company is alsonow developingfocused aon secondits productnext-generation, non-surgical venous valve product, called the enVVe®, whichsystem. 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.valve being developed for the treatment of severe CVI. The CompanyenVVe Valve is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as a one-way valves,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.

TheenVVe VenoValve and enVVe areis being developed first for approval by the U.S. Food and Drug Administration (FDA).FDA. We expect the VenoValve to be eligible for FDA approval first, followed two to 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 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.

OurWe 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.

For the year ended December 31, 2024,2025, other income increaseddecreased $0.3$0.6 million to $2.0$1.4 million from $1.7$2.0 million for the year ended SeptemberDecember 30,31, 2024 2023.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 gainslosses from our program to invest excess cash in U.S. Treasury securities.

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 arewere for continued product development and clinical trials for the VenoValve VenoValve and for enVVe.the enVVe System. The Company will continue to incur these costs to complete its clinical trials,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 $0.3$0.4 million per year. We expect a modestnominal increase in purchases of property and equipment and in facility lease costs as we continuecommence SAVVE, commence TAVVE, and plan for commercialization of the VenoValve.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 willmay increase from current levels of approximately $4 million per quarter to between $4 million and $5 million per quarter to $5 million to $6 million per quarter in 2025.2026. Even Even after considering this increase, we should have sufficient cash to fund operations through mid-2026.mid-2027.

We have historically funded our operations through financing activities such as the capital raises completed in 2024 and 2023.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.

Overview enVVeno Medical Corporation 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. 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 becomepermanently 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 anon-surgical 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 replacement venous valve product,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,first-in-class non-surgical, transcatheter based replacement venous valve being developed for the treatment of severesevere, 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. The Company has completed pre-clinical testing on the enVVe System.

On AprilThe 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 laterin thisthe year,second half of 2026, will consist of 10 patients, whose 30-day safety 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 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 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. 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 FDA post-marketing approval.

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.permanently damaged. 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.

The enVVe System is designed to treat severe deep CVI through a minimally invasive, catheter-based approach.procedure. The procedure is performed without without the need for open surgery or an overnight hospital stay. Built on the clinical foundation of the VenoValve® surgical replacement venous valve program, which demonstrated significant clinical improvement in severe CVI patients, the enVVe Valve incorporatesSystem 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 venousthe valves implanted viaVenoValve’s open surgical procedures.implantation procedure. In addition to to eliminating open surgical complications, itsthe enVVe System’s transcatheter approach is expected to broaden adoption by appealing to a wider range of implanting physicians including vascular surgeons, interventional radiologists, and interventional cardiologists.

TheOn 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 pivotal study offor athe non-surgicalenVVe replacement venous valve.System. The TAVVE pivotal study will evaluate the Company’s 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 220th patient is enrolled in the second stage of the study, the Company would be eligible to file for FDA post-marketing approval.

We finished 2025 with approximately $28.2 million of cash and investments and had approximately $24.9$21.5 million of cash and investments as as of MarchJune 31,30, 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 the second half of 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.raises and an at-the-market equity program. 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 MarchJune 31,30, 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.

Comparison of the three months ended MarchJune 31,30, 2026 and 2025

We reported net losses of $3.8$3.6 million and $4.5$6.7 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, representing a decrease in net loss of $0.7$3.1 million, or 15%,46%, due to a decrease in operating expenses of $0.9$3.3 million, partially offset by a decrease in other income of $0.2 million, as described in further detail below.

For the three months ended MarchJune 31,30, 2026, research and development expenses decreased by $0.5$0.8 million or 17%,28%, to $2.1 million from $2.6$2.9 million million for the three months ended MarchJune 31,30, 2025. This decrease primarily resulted from $0.7$1.1 million in lower costs related to 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,time, as well as a net decrease of $0.2$0.1 million in various other expenses. These decreases were partially offset by an increase of $0.4 million inas our focus has shifted to product development, testing and other expenses related to the enVVe System being developed for approval by the FDA.

For the three months ended MarchJune 31,30, 2026, selling, general and administrative expenses decreased by $0.4$2.5 million or 19%,59%, to $2.0$1.7 million from $2.4$4.2 million for the three months ended MarchJune 31,30, 2025. The decrease was due to the net effect of lower stock-based compensation cost incurred as option grants are issued and vest,vest representing $1.0 million, as well as a non-recurring $0.6 million reserve for potentially uncollectible prepaid clinical costs and a non-recurring severance expense of $0.3 million recorded during the three months ended June 30, 2025, and a net decrease$0.6 inmillion related to various other expenses.

For the three months ended MarchJune 31,30, 2026, other income decreased $0.3$0.2 million or 53%45% to $0.2 million from $0.5$0.4 million for the three months ended MarchJune 31,30, 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.

For the threesix months ended MarchJune 31,30, 2026, the Company incurred losses from operations of $4.1$7.9 million and used $3.2$6.8 million cash in operating activities. The net cash used in operating activities during the 2026 period decreased by $0.8$0.9 million from $4.0$7.7 million for the threesix months ended MarchJune 31,30, 2025 primarily due to the decrease in research and development expenses from 2025 to 2026. Our cash balance as of MarchJune 31,30, 2026, is $2.6$2.8 million. In addition, we have $22.3$18.7 million in investments, for total cash and investments of $24.9$21.5 million.

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 rate may increase from current levels of approximately $3 million to $4 million per quarter to between $4 million and $5 million per quarter quarterin inthe second half of 2026. Even after considering this increase, we should have sufficient cash and investments to fund operations into the the third quarter of 2027.

We have historically funded our operations through financing activities such as the capital raises.raises and an at-the-market equity program. 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 MarchJune 31,30, 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.