- Ended the quarter with $42.9 million cash and investments on hand sufficient to fund current operations, including multiple value driving milestones, through the end of 2025 - Positive 11-month topline efficacy data presented at the 46th Annual Charing Cross Symposium - Company on track to file PMA Application seeking VenoValve? FDA approval in Q4 2024
IRVINE, CA / ACCESSWIRE / May 8, 2024 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of venous disease, today reported financial results for the first quarter 2024.
"We continue to generate and present extremely encouraging data for the VenoValve at leading vascular conferences throughout the world and are in the final stages of accumulating the data necessary to file for PMA approval later this year. We recently added Andrew Cormack to our senior management team as our Chief Commercial Officer and will continue to make changes and additions to prepare for commercialization and what we hope will be FDA approval for the VenoValve," commented Robert Berman, CEO of enVVeno Medical. "Importantly, we have maintained our strong financial position and moving forward, have the capital that we need to take the Company through several key milestones."
Recent Corporate Highlights
Appointed Andrew Cormack as its Chief Commercial Officer.
Positive 11-month topline efficacy data from SAVVE showing significant clinical improvement from SAVVE U.S. pivotal trial presented at the 46th Annual Charing Cross Symposium:
Overall, 8.46 average revised Venous Clinical Severity Score (rVCSS) Improvement per patient for patients showing Clinical Meaningful Benefit (rVCSS Improvement 3 Points) including:
9.29 points for patients at the two-year milestone
8.08 points for patients at the one-year milestone
8.71 points for patients at the six-month milestone
94% of the study patients receiving the VenoValve have shown clinical improvement as measured by rVCSS at a weighted-average patient follow-up of 11.04 months.
72% of the study patients have improved the three or more rVCSS points needed to demonstrate the VenoValve's Clinical Meaningful Benefit, at a weighted-average patient follow-up of 11.64 months.
Total patient follow-up was 762 months and 582 months, respectively, for the two patient cohorts.
Company on Track to File Application Seeking VenoValve FDA Approval in Q4 2024.
enVVe?:Non-surgical Transcatheter Based Replacement Venous Valve and Delivery System
Initial bench testing and acute pre-clinical testing for the enVVe valve were very successful.
The Company is now making final adjustments to make it easier to load the enVVe valve into the enVVe delivery system.
enVVe valves and enVVe delivery systems are currently being manufactured to start a six-month chronic GLP study, which the Company expects to begin in Q3 of 2024.
The GLP study should be the final step necessary before filing the IDE seeking FDA approval to start the enVVe pivotal study.
The Company expects to file the IDE in Q2 of 2025.
Summary of Financial Results for the First Quarter 2024
The Company ended the quarter with $42.9 million in cash and investments. Based on management's current expectations, this capital has the potential to fund the Company through several significant milestones, 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 $3.5 million, better than the Company's projected cash burn rate of approximately $4-5 million per quarter.
The Company reported net losses of $5.0 million and $6.4 million for the three months ended March 31, 2024 and 2023, respectively, representing a decrease in net loss of $1.4 million or 22%, resulting from, as described in further detail below, a decrease in operating expenses of $1.3 million, and an increase in other income of $0.1 million.
For the three months ended March 31, 2024, selling, general and administrative expenses decreased $0.7 million or 22%, to $2.5 million from $3.2 million for the three months ended March 31, 2023. This was due to share-based compensation, which decreased to $1.2 million in 2024 from $1.9 million in 2023, primarily because of the expense associated with grants made in 2021, which was $0.7 million lower in 2024 than in 2023.
For the three months ended March 31, 2024, research and development expenses decreased by $0.5 million or 14%, to $3.1 million from $3.6 million for the three months ended March 31, 2023. This decrease primarily resulted from $0.9 million in lower costs related the SAVVE study as the study was fully enrolled during 2023 resulting in the reduction of outreach and enrollment related activities and related costs. This decrease was offset by $0.3 million increase in personnel costs to support SAVVE and enVVe development, and $0.2 million in lab costs related to enVVe development.
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 potential 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 trial 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.
