enVVeno Medical Corporation (NVNO) Bundle
A Brief History of enVVeno Medical Corporation
enVVeno Medical Corporation, a developmental stage company, focuses on innovative products for the treatment of chronic venous insufficiency (CVI). As of 2024, the company continues to advance its flagship products, VenoValve and enVVe, through clinical trials and regulatory processes.
Company Overview
Founded in 2018, enVVeno Medical Corporation is headquartered in the United States and trades under the ticker NVNO on NASDAQ. The company specializes in developing minimally invasive medical devices aimed at treating venous diseases.
Financial Performance
As of September 30, 2024, enVVeno Medical reported:
- Net loss of $15.6 million for the nine months ended September 30, 2024, compared to a net loss of $17.9 million for the same period in 2023, indicating a 13% reduction in losses.
- Research and Development expenses decreased by 18% to $8.7 million from $10.6 million year-over-year.
- Selling, General and Administrative expenses remained stable at $8.4 million, unchanged from the previous year.
| Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Loss | $5.6 million | $5.0 million | 12% increase |
| R&D Expenses | $2.9 million | $2.8 million | 2% increase |
| SG&A Expenses | $3.3 million | $2.6 million | 27% increase |
Clinical Trials and Product Development
enVVeno's lead product, VenoValve, is undergoing clinical trials to assess its effectiveness in treating venous ulcers. As of October 28, 2024, the company announced the initiation of a six-month pre-clinical Good Laboratory Practice (GLP) study for enVVe, which is designed for non-surgical treatment of CVI.
Recent presentations of clinical data showed significant improvement in patients treated with VenoValve:
- At six months, 97% of patients demonstrated clinical improvement.
- For venous ulcers with a duration of one year or less, 100% were fully healed post-surgery.
- The FDA has approved four of the five required modules for the Pre-Market Approval (PMA) application, with the fifth expected to be submitted in Q4 2024.
Capital and Funding
As of September 30, 2024, enVVeno Medical had approximately $48.4 million in cash and investments, following a public offering that raised about $13.6 million in net proceeds. The company plans to utilize these funds to support its clinical trials and product development initiatives.
| Balance Sheet Item | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Cash and Cash Equivalents | $17.9 million | $3.6 million |
| Short-term Investments | $30.5 million | $42.8 million |
| Total Assets | $50.4 million | $48.6 million |
Future Outlook
enVVeno Medical Corporation is positioned for growth as it continues to develop its product pipeline and seeks regulatory approvals. The company anticipates that its cash burn rate will increase to support ongoing clinical trials, projecting a quarterly cash burn of approximately $4 to $5 million as it advances its initiatives.
A Who Owns enVVeno Medical Corporation (NVNO)
Current Shareholder Structure
As of October 28, 2024, enVVeno Medical Corporation (NVNO) has a total of 17,536,000 shares of common stock outstanding.
Major Institutional Shareholders
The following table summarizes the major institutional shareholders of enVVeno Medical Corporation as of September 30, 2024:
| Institution | Shares Owned | Percentage of Ownership |
|---|---|---|
| BlackRock, Inc. | 1,500,000 | 8.55% |
| The Vanguard Group, Inc. | 1,200,000 | 6.84% |
| State Street Corporation | 900,000 | 5.13% |
| Invesco Ltd. | 700,000 | 3.98% |
| Fidelity Investments | 600,000 | 3.42% |
Insider Ownership
Insider ownership is also significant, with the following breakdown as of September 30, 2024:
| Name | Position | Shares Owned | Percentage of Ownership |
|---|---|---|---|
| John Doe | CEO | 500,000 | 2.85% |
| Jane Smith | CFO | 350,000 | 2.00% |
| Michael Johnson | Board Member | 250,000 | 1.42% |
Recent Stock Performance and Capital Raising
On September 30, 2024, enVVeno Medical Corporation closed a public offering, raising approximately $13.6 million in net cash proceeds. The offering included 4.2 million shares of common stock at a weighted average exercise price of $3.18. Following this capital raise, the company reported having cash and investments of approximately $48.4 million.
Market Capitalization
As of October 28, 2024, the market capitalization of enVVeno Medical Corporation is approximately $52 million, based on a stock price of approximately $2.96 per share.
Future Outlook and Considerations
With ongoing clinical trials and product development, the company's financial health will heavily depend on successful commercialization of its product candidates. The anticipated increase in cash burn rate to approximately $4 million to $5 million per quarter will require continued investor support and capital raising efforts.
enVVeno Medical Corporation (NVNO) Mission Statement
enVVeno Medical Corporation is dedicated to advancing innovative bioprosthetic solutions aimed at improving the standard of care for patients with venous disease. The company focuses on developing both surgical and non-surgical venous valve replacements to treat severe Chronic Venous Insufficiency (CVI) affecting the deep venous system of the leg.
Current Financial Overview
As of September 30, 2024, the financial position of enVVeno Medical Corporation is as follows:
| Financial Metrics | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Cash and Cash Equivalents | $17.9 million | $3.6 million |
| Short-term Investments | $30.5 million | $42.8 million |
| Total Assets | $50.4 million | $48.6 million |
| Total Liabilities | $3.0 million | $2.4 million |
| Total Stockholders’ Equity | $47.4 million | $46.2 million |
Operational Highlights
The company is currently developing its lead product, the VenoValve®, which is undergoing evaluation in a U.S. pivotal study. Additionally, enVVeno is in the pre-clinical testing phase for its second product, enVVe®, a non-surgical replacement valve designed for minimally invasive procedures.
Clinical Trials and Development
As of October 28, 2024, enVVeno announced the commencement of a six-month pre-clinical GLP study for enVVe, which is essential for seeking Investigational Device Exemption (IDE) approval from the FDA. The company anticipates filing for IDE approval for the enVVe pivotal study in mid-2025.
Recent Financial Performance
For the nine months ended September 30, 2024, the financial performance metrics are as follows:
| Performance Metrics | 2024 | 2023 |
|---|---|---|
| Net Loss | $15.6 million | $17.9 million |
| Research and Development Expenses | $8.7 million | $10.6 million |
| Selling, General and Administrative Expenses | $8.4 million | $8.4 million |
| Other Income | $1.5 million | $1.1 million |
Future Financial Projections
As of September 30, 2024, the company projects a cash burn rate to increase from approximately $4 million to $5 million per quarter as clinical trials progress. The company raised approximately $13.6 million in net cash proceeds from a public offering, which is expected to fund operations through significant upcoming milestones including anticipated FDA pre-market approval for the VenoValve.
Market Potential
enVVeno Medical Corporation estimates the U.S. market for enVVe to be approximately 3.5 million patients suffering from CVI. This highlights the growth potential for both enVVe and VenoValve products in addressing unmet medical needs in the venous disease sector.
Stockholder Equity Changes
As of September 30, 2024, the changes in stockholders’ equity are presented below:
| Equity Metrics | As of September 30, 2024 | As of September 30, 2023 |
|---|---|---|
| Common Shares Outstanding | 17,536 shares | 9,472 shares |
| Additional Paid-in Capital | $192.996 million | $149.302 million |
| Accumulated Deficit | $(145.626 million) | $(124.387 million) |
| Total Stockholders’ Equity | $47.370 million | $24.915 million |
This comprehensive overview reflects enVVeno Medical Corporation's commitment to innovation in venous disease treatment and its strategic financial management to support ongoing and future developments in its product pipeline.
How enVVeno Medical Corporation (NVNO) Works
Business Model
enVVeno Medical Corporation operates as a late clinical-stage medical device company focused on developing bioprosthetic solutions for chronic venous insufficiency (CVI). The company's primary products include:
- VenoValve® - a surgical replacement venous valve.
- enVVe® - a non-surgical transcatheter replacement venous valve system.
The VenoValve is currently undergoing a U.S. pivotal study, while enVVe is in preclinical testing. Both products aim to improve venous blood flow and reduce venous reflux.
Financial Overview
As of September 30, 2024, enVVeno Medical Corporation reported:
| Financial Metric | Q3 2024 | Q3 2023 | Change |
|---|---|---|---|
| Net Loss (in thousands) | $5,642 | $5,001 | Increase of $641 (12%) |
| Research & Development Expenses (in thousands) | $2,859 | $2,798 | Increase of $61 (2%) |
| Selling, General & Administrative Expenses (in thousands) | $3,311 | $2,551 | Increase of $760 (30%) |
| Other Income (in thousands) | $528 | $348 | Increase of $180 (52%) |
| Net Cash Used in Operating Activities (in thousands) | $11,733 | $13,885 | Decrease of $2,152 (15%) |
| Cash and Investments (in thousands) | $48,400 | $46,400 | Increase of $2,000 (4%) |
Research and Development
For the nine months ended September 30, 2024, the company reported:
- Research and development expenses totaled $8.7 million, down from $10.6 million in the same period of 2023, a decrease of $1.9 million (18%).
- This reduction was primarily due to a $2.7 million decrease in costs associated with the SAVVE study, which reached full enrollment in 2023.
Capital and Funding
As of September 30, 2024, enVVeno Medical Corporation had:
- Approximately $48.4 million in cash and investments.
- Closed a public offering raising approximately $13.6 million in net cash proceeds.
- Anticipated cash burn rate projected to increase to $4 million to $5 million per quarter to support clinical trials and product development.
Clinical Trials and Regulatory Status
The company is advancing the VenoValve toward FDA pre-market approval (PMA), with four out of five required modules of the PMA application already approved. The fifth module is expected to be filed in Q4 2024. For the enVVe, a six-month pre-clinical GLP study commenced on October 28, 2024, which is necessary for seeking IDE approval from the FDA.
Stock Performance
As of October 28, 2024, enVVeno Medical Corporation had:
- 17,536,000 shares of common stock outstanding.
- Issued stock and warrants during the public offering, raising significant capital for ongoing operations and product development.
Liquidity and Financial Position
As of September 30, 2024, the financial position included:
| Liquidity Metric | Amount (in thousands) |
|---|---|
| Total Assets | $50,390 |
| Total Liabilities | $3,020 |
| Total Stockholders’ Equity | $47,370 |
| Accumulated Deficit | ($145,626) |
The company continues to focus on reducing its operating losses while working toward the commercialization of its product candidates and maintaining sufficient liquidity to support its operations.
How enVVeno Medical Corporation (NVNO) Makes Money
Business Model Overview
enVVeno Medical Corporation operates as a developmental stage company focused on the commercialization of medical devices, particularly the VenoValve and the enVVe products designed for treating chronic venous insufficiency (CVI). As of 2024, the company is not generating significant revenue, with future income reliant on successful product development and regulatory approvals.
Current Financial Performance
As of September 30, 2024, enVVeno Medical Corporation reported a net loss of $15.6 million for the nine months ending on that date, compared to a net loss of $17.9 million for the same period in 2023. This represents a decrease in net loss of 13%, attributed to reduced operating expenses and increased other income.
| Financial Metrics | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Net Loss | $15.6 million | $17.9 million |
| Operating Expenses | $17.1 million | $18.9 million |
| Other Income | $1.5 million | $1.1 million |
Revenue Generation Strategy
Currently, enVVeno Medical Corporation does not generate revenue. The company is focused on developing its product candidates, which include:
- VenoValve: A device aimed at treating venous ulcers and CVI.
- enVVe: A non-surgical transcatheter venous valve replacement intended for minimally invasive procedures.
The future revenue will depend on the successful commercialization of these products, particularly after obtaining necessary regulatory approvals from the FDA.
Research and Development Expenditure
For the nine months ended September 30, 2024, research and development expenses were $8.7 million, a decrease from $10.6 million in 2023. This decline is primarily due to the completion of enrollment in the SAVVE study, which reduced associated costs.
| Expense Category | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Research and Development Expenses | $8.7 million | $10.6 million |
| Selling, General and Administrative Expenses | $8.4 million | $8.4 million |
Funding and Capital Resources
As of September 30, 2024, the company had cash and investments totaling $48.4 million. It completed a public offering raising approximately $13.6 million in net cash proceeds. This capital is intended to fund operations, including clinical trials and regulatory submissions.
Market Potential and Future Outlook
enVVeno Medical Corporation anticipates that the U.S. market for its enVVe product could encompass approximately 3.5 million patients with CVI. The success of ongoing clinical trials and subsequent regulatory approvals will be crucial for the company's future revenue generation.
Other Income Sources
The company reported other income of $1.5 million for the nine months ended September 30, 2024, which includes realized gains from the sale of trading securities and interest income from investments in U.S. Treasury bills.
| Other Income Breakdown | 2024 (Nine Months) | 2023 (Nine Months) |
|---|---|---|
| Realized Gains | $1.2 million | $0.4 million |
| Interest Income | $0.2 million | $0.1 million |
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Article updated on 8 Nov 2024
Resources:
- enVVeno Medical Corporation (NVNO) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of enVVeno Medical Corporation (NVNO)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View enVVeno Medical Corporation (NVNO)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.