$46.4 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025
Topline efficacy data for VenoValve? U.S. pivotal trial to be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024
Continued progress toward launch of GLP study for enVVe? transcatheter-based replacement venous valve
IRVINE, CA / ACCESSWIRE / February 29, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today provided a corporate update and reported financial results for the fourth quarter and year-end of 2023.
"We made significant progress over the course of the past year and are poised to reach multiple value driving milestones in 2024. We look forward to reporting topline efficacy results from the SAVVE pivotal trial on March 6th. Additionally, we are executing on our plans to launch the pre-clinical GLP study for enVVe which is on track to begin in the first quarter of this year," commented Robert Berman, CEO of enVVeno Medical. "In addition to the progress with our development programs, we have significantly bolstered our strong financial position and moving forward, have the capital that we need to focus our efforts towards our expected PMA approval for the VenoValve."
Corporate Highlights
Closed $28 million private placement led by Perceptive Advisors with participation from Nantahala Capital, Kingdon Capital Management, Velan Capital, L1 Capital and other new and existing institutional investors.
Achieved completion of enrollment in the SAVVE U.S. pivotal trial.
Positive preliminary device-related Material Adverse Event (MAE) safety data from the SAVVE U.S. pivotal trial for the VenoValve was presented at the 50th Annual VEITH symposium. The preliminary device related MAE rate for the fully enrolled 75 subject study is reported to be eight percent (8%).
Topline efficacy data from SAVVE to be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024.
PMA eligibility to file for FDA approval of the VenoValve is expected to occur in Q3 of 2024.
enVVe?:Non-surgical Transcatheter Based Replacement Venous Valve
Ongoing progress toward expedited development plan including six (6) month pre-clinical GLP study of enVVe, which the Company expects to begin in Q1 2024 and which is an FDA prerequisite and final step before seeking approval for the enVVe pivotal trial.
Investigational Device Exemption (IDE) seeking approval for the enVVe pivotal trial expected to be filed in Q4 2024.
Approval of enVVe pivotal trial expected in early 2025.
Summary of Financial Results for the Full Year 2023
The Company ended the year with $46.4 million in cash and investments. Based on management's current expectations, this capital is expected to fund operations through late 2025, including the release of initial topline efficacy data from SAVVE, anticipated FDA pre-market approval of the VenoValve, the beginning of preparations for VenoValve commercialization, and accelerated plans for the pivotal trial for enVVe.
Cash burn for the quarter was $5 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter. The Company anticipates that its cash burn rate will increase from current levels of approximately $4 million to $5 million per quarter to $5 million to $6 million per quarter in 2025.
The Company reported net losses of $23.5 million and $24.7 million for the years ended December 31, 2023 and 2022, respectively, representing a decrease in net loss of $1.2 million or 5%, resulting from, as described in further detail below, an increase in operating expenses of $0.3 million, and an increase in other income of $1.4 million.
For the year ended December 31, 2023, selling, general and administrative expenses decreased by $3.3 million or 22%, to $11.7 million from $15.0 million for the year ended December 31, 2022. This decrease is primarily driven by share-based compensation. Expense related to grants made in 2021 was $4.2 million lower in 2023 than in 2022. This decrease was partially offset by the expense from grants made in 2022, resulting in a net reduction of $3.6 million in share-based compensation from 2022 to 2023. Selling, general and administrative expenses also decreased $0.2 million from warrants issued to a vendor in 2022 with no similar warrants issued in 2023, and $0.1 million from lower insurance cost in 2023. These decreases were partially offset by $0.6 million of higher cash compensation related to management bonuses paid during 2023 compared to 2022 when no bonus was paid.
For the year ended December 31, 2023, research and development expenses increased by $3.7 million or 37%, to $13.6 million from $9.9 million for the year ended December 31, 2022. The increase is due to an increase of $2.7 million in costs for the SAVVE trial from $3.5 million in 2022 to $6.2 million in 2023, and $1.1 million in compensation from the increases in staffing also to support the SAVVE trial, partially offset by a decrease of $0.1 million in other lab costs for development and other preparation for the enVVe trials.
About enVVeno Medical Corporation
enVVeno Medical (NASDAQ:NVNO) is an Irvine, California-based, 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. The Company's lead product, the VenoValve?, is a first-in-class surgical replacement venous valve being developed for the treatment of deep venous Chronic Venous Insufficiency (CVI). The Company is also developing a non-surgical, transcatheter based replacement venous valve for the treatment of deep venous CVI called enVVe?. CVI 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 and become chronic. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the leg, and back to the heart and lungs. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal study and the Company is currently performing the final testing necessary to seek approval for the enVVe pivotal trial.
Cautionary Note on Forward-Looking Statements
This press release and any statements of stockholders, directors, employees, representatives and partners of enVVeno Medical Corporation (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results and timing (may differ significantly from those set forth or implied in the forward-looking statements. Forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations or otherwise, except as required by applicable law.
