Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 06, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-38325 | |
Entity Registrant Name | enVVeno Medical Corporation | |
Entity Central Index Key | 0001661053 | |
Entity Tax Identification Number | 33-0936180 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 70 Doppler | |
Entity Address, City or Town | Irvine | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92618 | |
City Area Code | (949) | |
Local Phone Number | 261-2900 | |
Title of 12(b) Security | Common Stock, $0.00001 par value | |
Trading Symbol | NVNO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 13,330,000 |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Current Assets: | ||
Cash and cash equivalents | $ 2,314 | $ 3,620 |
Short-term investments | 40,628 | 42,792 |
Prepaid expenses and other current assets | 306 | 511 |
Total Current Assets | 43,248 | 46,923 |
Property and equipment, net | 289 | 334 |
Operating lease right-of-use assets, net | 1,261 | 1,347 |
Security deposits and other assets | 31 | 31 |
Total Assets | 44,829 | 48,635 |
Current Liabilities: | ||
Accounts payable, accrued expenses and other current liabilities | 1,143 | 1,033 |
Current portion of operating lease liabilities | 344 | 338 |
Total Current Liabilities | 1,487 | 1,371 |
Long-term operating lease liabilities | 973 | 1,064 |
Total Liabilities | 2,460 | 2,435 |
Commitments and Contingencies | ||
Stockholders’ Equity: | ||
Preferred stock, par value $0.00001, 10,000 shares authorized: no shares issued or outstanding | ||
Common stock, par value $0.00001, 250,000 shares authorized, 13,330 and 13,317 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | ||
Additional paid-in capital | 177,397 | 176,236 |
Accumulated deficit | (135,028) | (130,036) |
Total Stockholders’ Equity | 42,369 | 46,200 |
Total Liabilities and Stockholders’ Equity | $ 44,829 | $ 48,635 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 250,000,000 | 250,000,000 |
Common stock, shares issued | 13,330,000 | 13,317,000 |
Common stock, shares outstanding | 13,330,000 | 13,317,000 |
Condensed Statements Of Operati
Condensed Statements Of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Operating Expenses: | ||
Research and development expenses | $ 3,052 | $ 3,595 |
Selling, general and administrative expenses | 2,451 | 3,202 |
Loss from Operations | (5,503) | (6,797) |
Other Income: | ||
Realized gain from sales of trading securities | 408 | 82 |
Unrealized gain from trading securities | 44 | 278 |
Interest income, net | 59 | 45 |
Total Other Income | 511 | 405 |
Net Loss | $ (4,992) | $ (6,392) |
Net Loss Per Basic Common Share: | $ (0.31) | $ (0.57) |
Net Loss Per Diluted Common Share: | $ (0.31) | $ (0.57) |
Weighted Average Number of Common Shares Outstanding: | ||
Basic | 16,057 | 11,231 |
Diluted | 16,057 | 11,231 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity (Deficiency) (Unaudited) - USD ($) shares in Thousands, $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balance at Dec. 31, 2022 | $ 145,249 | $ (106,520) | $ 38,729 | |
Balance, shares at Dec. 31, 2022 | 9,472 | |||
Stock-based compensation | 1,792 | 1,792 | ||
Net loss | (6,392) | (6,392) | ||
Balance at Mar. 31, 2023 | 147,041 | (112,912) | 34,129 | |
Balance, shares at Mar. 31, 2023 | 9,472 | |||
Balance at Dec. 31, 2023 | 176,236 | (130,036) | 46,200 | |
Balance, shares at Dec. 31, 2023 | 13,317 | |||
Stock-based compensation | 1,115 | 1,115 | ||
Options exercised | 46 | 46 | ||
Options exercised, shares | 13 | |||
Net loss | (4,992) | (4,992) | ||
Balance at Mar. 31, 2024 | $ 177,397 | $ (135,028) | $ 42,369 | |
Balance, shares at Mar. 31, 2024 | 13,330 |
Condensed Statements Of Cash Fl
Condensed Statements Of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Cash Flows from Operating Activities | ||
Net loss | $ (4,992) | $ (6,392) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 1,115 | 1,792 |
Depreciation and amortization | 55 | 54 |
Amortization of right of use assets | 86 | 82 |
Unrealized gain from Investments | (43) | (277) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 205 | 80 |
Accounts payable, accrued expenses and other current liabilities | 110 | (369) |
Operating lease liabilities | (85) | (79) |
Net Cash Used in Operating Activities | (3,549) | (5,109) |
Cash Flows from Investing Activities | ||
Maturities of investments | 17,342 | 11,460 |
Purchase of investments | (15,135) | (8,628) |
Purchase of property and equipment | (10) | (5) |
Net Cash Provided by Investing Activities | 2,197 | 2,827 |
Cash Flows from Financing Activities | ||
Proceeds from Stock Option Exercises | 46 | |
Net Cash Provided by Financing Activities | 46 | |
Net Decrease in Cash | (1,306) | (2,282) |
Cash, cash equivalents - Beginning of period | 3,620 | 4,555 |
Cash, cash equivalents - End of period | $ 2,314 | $ 2,273 |
Business Organization and Natur
Business Organization and Nature of Operations | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Business Organization and Nature of Operations | Note 1 – Business Organization and Nature of Operations enVVeno Medical Corporation is a 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 is developing surgical and non-surgical replacement venous valves for patients suffering from severe Chronic Venous Insufficiency (“CVI”) of the deep venous system of the leg. The Company’s lead product is the VenoValve®, which is a potential first-in-class surgical replacement venous valve that is currently being evaluated in a U.S. pivotal study. The Company is also developing a second product called enVVe®, which is a potential first-in-class, non-surgical, transcatheter based replacement venous valve system consisting of the enVVe valve, the enVVe delivery system, and the delivery system accessories. The Company is currently conducting pre-clinical testing on enVVe. Both the VenoValve and enVVe are designed to act as one-way valves, to help assist in propelling blood up the veins of the leg, and back to the heart and lungs. The VenoValve and enVVe are being developed first for approval by the U.S. Food and Drug Administration (FDA). We expect the VenoValve to be eligible for FDA approval first, followed two to three years later by enVVe. If approved, we expect the VenoValve and enVVe to co-exist, with the VenoValve as a surgical replacement venous valve option and enVVe as a non-surgical replacement venous valve option. |
Management_s Liquidity Plan
Management’s Liquidity Plan | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Management’s Liquidity Plan | Note 2 – Management’s Liquidity Plan As of March 31, 2024, the Company had a cash and investment balance of $ 42.9 41.8 |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Note 3 – Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of March 31, 2024 and December 31, 2023, and for the three months ended March 31, 2024 and 2023. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 29, 2024. The accompanying condensed balance sheet as of December 31, 2023 has been derived from the Company’s audited financial statements. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) |
Investments
Investments | 3 Months Ended |
Mar. 31, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Investments | Note 4 – Investments The components of investments were as follows at March 31, 2024 and December 31, 2023: Schedule of Components of Investments (In thousands) March 31, 2024 December 31, 2023 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,655 $ 40,628 $ 3,187 $ 42,792 Total debt investments $ 1,655 $ 40,628 $ 3,187 $ 42,792 Unrealized and realized gains and losses on the accompanying statement of operations result from fixed-income securities and are primarily attributable to changes in interest rates. Management does not believe any remaining unrealized losses represent impairments based on our evaluation of available evidence. |
Concentrations
Concentrations | 3 Months Ended |
Mar. 31, 2024 | |
Risks and Uncertainties [Abstract] | |
Concentrations | Note 5 – Concentrations The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $ 250,000 2.1 3.4 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 6 – Property and Equipment As of March 31, 2024 and December 31, 2023, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) March 31, 2024 December 31, 2023 Laboratory equipment $ 554 $ 548 Computer equipment and software 486 482 Leasehold improvements, furniture and fixtures 373 373 Total property and equipment 1,413 1,403 Less: accumulated depreciation (1,124 ) (1,069 ) Property and equipment, net $ 289 $ 334 Depreciation expense amounted to $ 0.1 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) |
Accounts Payable Accrued Expens
Accounts Payable Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Accounts Payable Accrued Expenses and Other Current Liabilities | Note 7 – Accounts Payable Accrued Expenses and Other Current Liabilities As of March 31, 2024, and December 31, 2023, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities (In thousands) March 31, 2024 December 31, 2023 Accounts payable $ 604 $ 427 Accrued compensation costs 396 478 Other accrued expenses 143 128 Total accrued expenses and other current liabilities $ 1,143 $ 1,033 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 8 – Commitments and Contingencies Litigations Claims and Assessments In the normal course of business, the Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements. Robert Rankin Complaints On July 9, 2020, the Company was served with a civil complaint filed in the Superior Court for the State of California, County of Orange by a former employee, Robert Rankin, who resigned his employment on or about March 30, 2020. The case is entitled Rankin v. Hancock Jaffe Laboratories, Inc. et al., Case No. 30-2020-01146555-CU-WR-CJC and was filed on May 27, 2020. On September 3, 2020 the Company and its Chief Executive Officer were served with a second complaint filed in the Superior Court for the State of California, County of Orange by Mr. Rankin. The case is entitled Rankin v. Hancock Jaffe Laboratories, Inc. et al., Case No. 30-2020-01157857 and was filed on August 31, 2020. The complaints assert several causes of action including a cause of action for failure to timely pay Mr. Rankin’s accrued and unused vacation and three months’ severance under his July 16, 2018 employment agreement, defamation, unlawful labor code violations, sex-based discrimination, and unfair competition, and seeks damages for lost wages, emotional and mental distress, consequential damages, punitive damages and attorney’s fees and costs. The Company has denied all claims in both matters (which have now been consolidated) and has filed a counterclaim asserting that Rankin has breached his employment agreement with the Company to the Company’s damage. The Company continues to believe it has meritorious defenses to both matters which are currently set for trial on July 22, 2024. As of the date of these financial statements, the amount of loss associated with these complaints, if any, cannot be reasonably estimated. Accordingly, no amounts related to these complaints are accrued as of March 31, 2024. ENVVENO MEDICAL CORPORATION (unaudited) |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 9 – Stockholders’ Equity Stock Options Stock-based compensation is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $ 1.1 million and $ 1.8 million during the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, there was $ 5.9 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.9 years. |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Note 10 – Net Loss per Share The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of March 31, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share 2024 2023 (In thousands) March 31, 2024 2023 Shares of common stock issuable upon exercise of warrants 14,384 4,589 Shares of common stock issuable upon exercise of options 5,159 4,206 Potentially dilutive common stock equivalents excluded from diluted net loss per share 19,543 8,795 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States of America for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the unaudited condensed financial statements of the Company as of March 31, 2024 and December 31, 2023, and for the three months ended March 31, 2024 and 2023. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of the operating results for the full year. These unaudited condensed financial statements should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 29, 2024. The accompanying condensed balance sheet as of December 31, 2023 has been derived from the Company’s audited financial statements. |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Components of Investments | The components of investments were as follows at March 31, 2024 and December 31, 2023: Schedule of Components of Investments (In thousands) March 31, 2024 December 31, 2023 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,655 $ 40,628 $ 3,187 $ 42,792 Total debt investments $ 1,655 $ 40,628 $ 3,187 $ 42,792 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | As of March 31, 2024 and December 31, 2023, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) March 31, 2024 December 31, 2023 Laboratory equipment $ 554 $ 548 Computer equipment and software 486 482 Leasehold improvements, furniture and fixtures 373 373 Total property and equipment 1,413 1,403 Less: accumulated depreciation (1,124 ) (1,069 ) Property and equipment, net $ 289 $ 334 |
Accounts Payable Accrued Expe_2
Accounts Payable Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities | As of March 31, 2024, and December 31, 2023, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities (In thousands) March 31, 2024 December 31, 2023 Accounts payable $ 604 $ 427 Accrued compensation costs 396 478 Other accrued expenses 143 128 Total accrued expenses and other current liabilities $ 1,143 $ 1,033 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
Schedule of Dilutive Net Loss Per Common Share | The following table summarizes the number of potentially dilutive common stock equivalents excluded from the calculation of diluted net loss per common share as of March 31, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share 2024 2023 (In thousands) March 31, 2024 2023 Shares of common stock issuable upon exercise of warrants 14,384 4,589 Shares of common stock issuable upon exercise of options 5,159 4,206 Potentially dilutive common stock equivalents excluded from diluted net loss per share 19,543 8,795 |
Management_s Liquidity Plan (De
Management’s Liquidity Plan (Details Narrative) $ in Millions | Mar. 31, 2024 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash | $ 42.9 |
Investments | 42.9 |
Working capital | $ 41.8 |
Schedule of Components of Inves
Schedule of Components of Investments (Details) - Fair Value, Inputs, Level 1 [Member] - Debt Securities [Member] - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Platform Operator, Crypto Asset [Line Items] | ||
Cash equivalents | $ 1,655 | $ 3,187 |
Short-term investment | 40,628 | 42,792 |
US Government Debt Securities [Member] | ||
Platform Operator, Crypto Asset [Line Items] | ||
Cash equivalents | 1,655 | 3,187 |
Short-term investment | $ 40,628 | $ 42,792 |
Concentrations (Details Narrati
Concentrations (Details Narrative) - USD ($) | Mar. 31, 2024 | Dec. 31, 2023 |
Risks and Uncertainties [Abstract] | ||
FDIC amount | $ 250,000 | |
Uninsured amount | $ 2,100,000 | $ 3,400,000 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,413 | $ 1,403 |
Less: accumulated depreciation | (1,124) | (1,069) |
Property and equipment, net | 289 | 334 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 554 | 548 |
Software Development [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 486 | 482 |
Leasehold Improvements Furniture And Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 373 | $ 373 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 0.1 | $ 0.1 |
Schedule of Accounts Payable Ac
Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 604 | $ 427 |
Accrued compensation costs | 396 | 478 |
Other accrued expenses | 143 | 128 |
Total accrued expenses and other current liabilities | $ 1,143 | $ 1,033 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Share-Based Payment Arrangement, Noncash Expense | $ 1,115 | $ 1,792 |
Share-Based Payment Arrangement, Option [Member] | ||
Share-Based Payment Arrangement, Nonvested Award, Option, Cost Not yet Recognized, Amount | $ 5,900 | |
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition | 1 year 10 months 24 days | |
Selling, General and Administrative Expenses [Member] | ||
Share-Based Payment Arrangement, Noncash Expense | $ 1,100 | $ 1,800 |
Schedule of Dilutive Net Loss P
Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 19,543 | 8,795 |
Warrant [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 14,384 | 4,589 |
Share-Based Payment Arrangement, Option [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 5,159 | 4,206 |