enVVeno Medical Reports Second Quarter 2024 Financial Results and Provides Corporate Update

Rhea-AI Summary

enVVeno Medical (NASDAQ:NVNO) reported Q2 2024 financial results and provided a corporate update. Key highlights include:

- $39.1 million in cash and investments, sufficient to fund operations through end of 2025
- Positive interim venous ulcer healing data from VenoValve pivotal trial
- On track to file VenoValve FDA approval application in Q4 2024
- Progress on enVVe transcatheter-based replacement venous valve

Financial results:
- Net loss decreased by 23.1% to $5.0 million
- Cash burn of $3.8 million, better than projected $4-5 million
- R&D expenses decreased by 33.3% to $2.8 million
- SG&A expenses remained flat at $2.6 million

Positive

• Cash and investments of $39.1 million, sufficient to fund operations through end of 2025
• 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or improved
• Net loss decreased by 23.1% to $5.0 million in Q2 2024
• Cash burn of $3.8 million, better than projected $4-5 million
• R&D expenses decreased by 33.3% to $2.8 million

Negative

• Company still operating at a net loss of $5.0 million for Q2 2024

Insights

Financial Analyst

enVVeno Medical's Q2 2024 results reveal a solid financial position with $39.1 million in cash and investments, potentially funding operations through 2025. This includes the important milestone of potential FDA approval for VenoValve. The company's cash burn of $3.8 million for the quarter was better than projected, demonstrating effective cost management.

The net loss decreased by 23.1% year-over-year, primarily due to reduced operating expenses and increased other income. R&D expenses saw a significant 33.3% decrease, mainly attributed to lower costs related to the SAVVE study as it's fully enrolled. This shift in expenses indicates a transition from the research phase towards commercialization preparation.

While SG&A expenses remained flat, the company's overall financial discipline is evident. The stable cash position and reduced burn rate suggest that enVVeno is well-positioned to fund its upcoming milestones, including the VenoValve FDA application and the initiation of the enVVe GLP study. This financial stability is important as the company approaches potential commercialization phases for its products.

Medical Research Analyst

The interim results from enVVeno's VenoValve pivotal trial are highly promising, particularly in venous ulcer healing. With 91% of patients showing fully healed or improved ulcers at one year, the data suggests significant clinical efficacy. Most notably, 100% of ulcers less than a year old have fully healed, indicating potential for early intervention benefits.

The absence of ulcer recurrences is a critical finding, as it addresses a major challenge in current venous disease treatments. This could position VenoValve as a game-changing therapy for severe chronic venous insufficiency patients who have failed conventional treatments.

The company's progress with the enVVe transcatheter-based valve is also noteworthy. The planned GLP study in Q4 2024 marks a important step towards an IDE filing in Q2 2025. This dual-product approach in both surgical and non-surgical venous valve replacement demonstrates a comprehensive strategy to address various patient needs in the venous disease market.

As the company prepares to file for FDA approval of VenoValve in Q4 2024, the positive interim data strengthens its position. However, it's important to note that final approval will depend on the complete dataset and FDA review process.

- Ended the quarter with $39.1 million cash and investments on hand sufficient to fund operations, through the end of 2025, including potential PMA approval of VenoValve®

- Positive interim venous ulcer healing data showing significant improvement from the VenoValve pivotal trial presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting

- Company on track to file application seeking VenoValve FDA approval in Q4 2024

- Continued progress toward launch of GLP study for enVVe® transcatheter-based replacement venous valve

IRVINE, CA / ACCESSWIRE / August 1, 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 second quarter 2024 and provided a corporate update.

"The past few months have been marked by a number of key data announcements from our SAVVE pivotal trial for the VenoValve. In addition to reporting a sustained clinically meaningful benefit as indicated by rVCSS for patients with an average 11-month period since receiving the VenoValve, we reported a significant improvement in venous ulcer healing for our most severe patients (C6). That data is especially impressive because all of these patients have failed conventional treatments, including many requiring years of wound care with poor results. Also important is that none of the patients with healed ulcers have experienced ulcer recurrences, putting an end to the vicious cycle often associated with conventional therapies," commented Robert Berman, CEO of enVVeno Medical. "As we look toward the remainder of this year, we look forward to completing one-year visits for the full cohort of patients, filing our application seeking PMA approval from the FDA, and reporting the definitive data."

Clinical Program Highlights

VenoValve: Surgical Replacement Venous Valve

• Positive interim venous ulcer healing data showing significant improvement from the VenoValve pivotal trial presented at the Society for Vascular Surgery 2024 Vascular Annual Meeting:

  • 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved.

  • 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed.

  • 89% of venous ulcers with a duration of more than one year prior to VenoValve surgery have fully healed or improved.

  • No ulcer recurrences.

• Company on track to file application seeking VenoValve FDA approval in Q4 2024.

enVVe®:Non-surgical Transcatheter Based Replacement Venous Valve

• Ongoing progress with manufacturing for enVVe valves and enVVe delivery systems to start a six-month chronic GLP study, which the Company expects to begin in Q4 of 2024.

• The GLP study should be the final step necessary before filing the Investigational Device Exemption (IDE) seeking FDA approval to start the enVVe pivotal study.

• The Company expects to file the IDE in Q2 2025.

Summary of Financial Results for the Second Quarter 2024
The Company ended the quarter with $39.1 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 $3.8 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 $6.5 million for the three months ended June 30, 2024 and 2023, respectively, representing a decrease in net loss of $1.5 million or 23.1%, resulting from, a decrease in operating expenses and an increase in other income as described in further detail below.

For the three months ended June 30, 2024, research and development expenses decreased by $1.4 million or 33.3%, to $2.8 million from $4.2 million for the three months ended June 30, 2023. This decrease primarily resulted from $1.7 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, partially offset by a $0.3 million increase in personnel costs to support the SAVVE study and enVVe development.

For the three months ended June 30, 2024, selling, general and administrative expenses were $2.6 million, flat from the three months ended June 30, 2023, which was also $2.6 million. This was due to the net effect of a $0.1 million decrease in share-based compensation, offset by a $0.1 million increase in legal costs.

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.

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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

What were enVVeno Medical's (NVNO) key financial results for Q2 2024?

enVVeno Medical reported a net loss of $5.0 million, a 23.1% decrease from Q2 2023. The company ended the quarter with $39.1 million in cash and investments, and had a cash burn of $3.8 million, which was better than projected.

When does enVVeno Medical (NVNO) plan to file for FDA approval of the VenoValve?

enVVeno Medical is on track to file the application seeking VenoValve FDA approval in Q4 2024.

What were the interim results of enVVeno Medical's (NVNO) VenoValve pivotal trial for venous ulcer healing?

The interim results showed that 91% of venous ulcer patients evaluated at one year have either fully healed ulcers or ulcers that have improved. 100% of venous ulcers with a duration of one year or less prior to VenoValve surgery have fully healed.

What is the status of enVVeno Medical's (NVNO) enVVe transcatheter-based replacement venous valve?

enVVeno Medical is making ongoing progress with manufacturing for enVVe valves and delivery systems to start a six-month chronic GLP study, expected to begin in Q4 of 2024. The company plans to file an IDE in Q2 2025 to start the enVVe pivotal study.