enVVeno Medical Reports Fourth Quarter and Year-End 2023 Financial Results and Provides Corporate Update

Rhea-AI Summary

enVVeno Medical Corporation (NVNO) reports $46.4 million in cash, achieving milestones in venous disease treatment. Topline efficacy data for VenoValve U.S. pivotal trial to be disclosed at VENOUS2024 American Venous Forum Annual Meeting. Strong financial position with funds to last through 2025.

Positive

• Company has $46.4 million in cash and investments to fund operations till late 2025
• Topline efficacy data for VenoValve U.S. pivotal trial to be revealed at VENOUS2024 American Venous Forum Annual Meeting
• Progress towards GLP study for enVVe transcatheter-based replacement venous valve
• Completed $28 million private placement led by Perceptive Advisors with other institutional investors
• Positive preliminary safety data from SAVVE U.S. pivotal trial presented at 50th Annual VEITH symposium
• PMA eligibility for FDA approval of VenoValve expected in Q3 2024
• Progress towards pre-clinical GLP study of enVVe expected to begin in Q1 2024
• Approval of enVVe pivotal trial anticipated in early 2025
• Net losses decreased by 5% from 2022 to 2023
• Selling, general and administrative expenses decreased by 22% in 2023 compared to 2022
• Research and development expenses increased by 37% in 2023 compared to 2022

Negative

• Cash burn rate expected to rise from $4-5 million per quarter to $5-6 million per quarter in 2025
• Net losses reported for the years ended December 31, 2023 and 2022
• Increase in operating expenses and other income affecting net loss
• Reduction in share-based compensation from 2022 to 2023
• Increase in research and development expenses due to SAVVE trial costs

Insights

Financial Analyst

The reported cash and investments position of $46.4 million is a critical indicator of enVVeno Medical Corporation's financial health, providing a runway that extends through late 2025. This runway is particularly significant considering the upcoming milestones, such as the release of topline efficacy data from the SAVVE trial and the anticipated FDA pre-market approval of the VenoValve. It is also noteworthy that the company has managed to reduce its net loss year-over-year by 5%, despite an increase in research and development expenses, which reflects a strategic allocation of resources towards its clinical programs.

The private placement of $28 million is an essential liquidity event that signals confidence from institutional investors and provides the necessary capital to advance enVVeno's product pipeline. The cash burn rate, currently at $4-5 million per quarter, is projected to increase slightly in 2025. This anticipated increase in cash burn aligns with the company's transition from a development phase to a potential commercialization phase, assuming successful clinical trial outcomes and regulatory approvals.

Medical Research Analyst

The progression of enVVeno's clinical programs is of paramount importance for the company's future. The completion of enrollment in the SAVVE U.S. pivotal trial and the positive preliminary safety data with an 8% MAE rate indicates a promising outlook for the VenoValve, a surgical replacement venous valve. The upcoming presentation of topline efficacy data at the VENOUS2024 meeting will be a significant determinant of the product's clinical viability and market potential.

The development of enVVe, a non-surgical transcatheter-based replacement venous valve, is also a critical aspect of enVVeno's portfolio. The commencement of a six-month pre-clinical GLP study as an FDA prerequisite marks a decisive step towards the pivotal trial. The anticipated IDE filing in Q4 2024 and expected approval in early 2025 could position enVVeno as a frontrunner in the venous disease treatment space, pending positive trial outcomes.

Market Research Analyst

From a market perspective, the venous disease treatment sector represents a significant opportunity for enVVeno Medical Corporation. The company's strategic focus on both surgical and non-surgical venous valve replacements positions it to cater to a broad patient population. The commercialization potential of the VenoValve, following expected PMA approval, could disrupt the current standard of care and open up a new revenue stream for enVVeno.

Moreover, the company's anticipation of increased operational expenses aligns with the typical lifecycle of a biotech firm transitioning from research to commercialization. The successful advancement of the VenoValve and enVVe could catalyze investor interest and potentially enhance enVVeno's market capitalization, subject to clinical and regulatory validations.

• $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 6^th. 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.

Clinical Program Highlights

VenoValve: Surgical Replacement Venous Valve

• 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 50^th 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.

INVESTOR CONTACT:

Jenene Thomas, JTC Team, LLC
NVNO@jtcir.com
(833) 475-8247

SOURCE: enVVeno Medical Corporation

View the original press release on accesswire.com

FAQ

How much cash and investments does enVVeno Medical Corporation have on hand?

enVVeno Medical Corporation has $46.4 million in cash and investments.

When will the topline efficacy data for the VenoValve U.S. pivotal trial be presented?

The topline efficacy data for the VenoValve U.S. pivotal trial will be presented at the VENOUS2024 American Venous Forum Annual Meeting on March 6, 2024.

What is the expected timeline for PMA eligibility to file for FDA approval of the VenoValve?

PMA eligibility to file for FDA approval of the VenoValve is expected to occur in Q3 of 2024.

What is the progress update on the pre-clinical GLP study for enVVe?

The Company expects to begin the pre-clinical GLP study of enVVe in Q1 2024.

When is the approval of the enVVe pivotal trial expected?

The approval of the enVVe pivotal trial is expected in early 2025.

What was the net loss reported by enVVeno Medical Corporation for the year ended December 31, 2023?

enVVeno Medical Corporation reported net losses of $23.5 million for the year ended December 31, 2023.

Why did research and development expenses increase in 2023 compared to 2022?

Research and development expenses increased due to costs for the SAVVE trial and compensation for staffing to support the trial.

What was the decrease in selling, general and administrative expenses in 2023 compared to 2022?

Selling, general and administrative expenses decreased by 22% in 2023 primarily due to a reduction in share-based compensation.

What was the cash burn rate for enVVeno Medical Corporation in the quarter?

Cash burn for the quarter was $5 million, consistent with the Company's projected cash burn rate of approximately $4-5 million per quarter.

Who led the $28 million private placement for enVVeno Medical Corporation?

$28 million private placement was led by Perceptive Advisors with participation from other institutional investors.