Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 26, 2023 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2023 | |
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 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Elected Not To Use the Extended Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 9,472,000 | |
Common stock 0.00001 par value [Member] | ||
Title of 12(b) Security | Common Stock, $0.00001 par value | |
Trading Symbol | NVNO | |
Security Exchange Name | NASDAQ | |
Warrant to purchase common stock [Member] | ||
Title of 12(b) Security | Warrant to Purchase Commons Stock | |
Trading Symbol | NVNOW | |
Security Exchange Name | NASDAQ |
Condensed Balance Sheets (Unaud
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 2,273 | $ 4,555 |
Short-term investments | 31,934 | 34,489 |
Prepaid expenses and other current assets | 312 | 392 |
Total Current Assets | 34,519 | 39,436 |
Property and equipment, net | 472 | 521 |
Operating lease right-of-use assets, net | 1,591 | 1,673 |
Security deposits and other assets | 31 | 31 |
Total Assets | 36,613 | 41,661 |
Current Liabilities: | ||
Accounts payable, accrued expenses and other current liabilities | 847 | 1,216 |
Current portion of operating lease liabilities | 320 | 314 |
Total Current Liabilities | 1,167 | 1,530 |
Long-term operating lease liabilities | 1,317 | 1,402 |
Total Liabilities | 2,484 | 2,932 |
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, 9,472 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | ||
Additional paid-in capital | 147,041 | 145,249 |
Accumulated deficit | (112,912) | (106,520) |
Total Stockholders’ Equity | 34,129 | 38,729 |
Total Liabilities and Stockholders’ Equity | $ 36,613 | $ 41,661 |
Condensed Balance Sheets (Una_2
Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares shares in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.00001 | $ 0.00001 |
Preferred stock, shares authorized | 10,000 | 10,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par or stated value per share | $ 0.00001 | $ 0.00001 |
Common stock, shares authorized | 250,000 | 250,000 |
Common stock, shares issued | 9,472 | 9,472 |
Common stock, shares outstanding | 9,472 | 9,472 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating Expenses: | ||
Selling, general and administrative expenses | $ 3,202 | $ 3,783 |
Research and development expenses | 3,595 | 1,552 |
Loss from Operations | (6,797) | (5,335) |
Other Income: | ||
Realized gain from sales of trading securities | (82) | |
Unrealized gain from trading securities | (278) | |
Interest income, net | (45) | (5) |
Total Other Income | (405) | (5) |
Net Loss | $ (6,392) | $ (5,330) |
Net Loss Per Basic and Diluted Common Share: | $ (0.57) | $ (0.47) |
Weighted Average Number of Common Shares Outstanding: | ||
Basic and Diluted | 11,231 | 11,229 |
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 |
Beginning balance, value at Dec. 31, 2021 | $ 136,255 | $ (81,851) | $ 54,404 | |
Beginning balance, shares at Dec. 31, 2021 | 9,470 | |||
Shared-Based Compensation | 2,243 | 2,243 | ||
Shared-Based Compensation, shares | ||||
Net loss | (5,330) | (5,330) | ||
Ending balance, value at Mar. 31, 2022 | 138,498 | (87,181) | 51,317 | |
Ending balance, shares at Mar. 31, 2022 | 9,470 | |||
Beginning balance, value at Dec. 31, 2022 | 145,249 | (106,520) | 38,729 | |
Beginning balance, shares at Dec. 31, 2022 | 9,472 | |||
Shared-Based Compensation | 1,792 | 1,792 | ||
Shared-Based Compensation, shares | ||||
Net loss | (6,392) | (6,392) | ||
Ending balance, value at Mar. 31, 2023 | $ 147,041 | $ (112,912) | $ 34,129 | |
Ending balance, shares at Mar. 31, 2023 | 9,472 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash Flows from Operating Activities | ||
Net loss | $ (6,392) | $ (5,330) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Share-based compensation | 1,792 | 2,243 |
Depreciation and amortization | 54 | 51 |
Amortization of right of use assets | 82 | 78 |
Unrealized gain from Investments | (277) | |
Deposit applied to consulting services | 25 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 80 | |
Accounts payable | (268) | (3) |
Accrued expenses and other current liabilities | (101) | (313) |
Operating lease liabilities | (79) | (72) |
Total adjustments | 1,283 | 2,009 |
Net Cash Used in Operating Activities | (5,109) | (3,321) |
Cash Flows from Investing Activities | ||
Maturities of investments | 11,460 | |
Purchase of property and equipment | (5) | (69) |
Purchase of investments | (8,628) | |
Net Cash Provided by (Used in) Investing Activities | 2,827 | (69) |
Net Decrease in Cash | (2,282) | (3,390) |
Cash, cash equivalents - Beginning of period | 4,555 | 54,728 |
Cash, cash equivalents - End of period | 2,273 | 51,338 |
Cash Received During the Period For: | ||
Interest, net | $ 45 | $ 5 |
Business Organization and Natur
Business Organization and Nature of Operations | 3 Months Ended |
Mar. 31, 2023 | |
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 med-tech 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. CVI most often occurs when valves inside 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. The Company’s lead product is the VenoValve® which is currently being evaluated in a U.S. pivotal study. The Company is also developing a second product called enVVe™, which is a transcatheter based replacement venous valve. 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. Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and that have been commercially successful. We develop and manufacture our products in a 14,507 sq. ft. leased manufacturing facility in Irvine, California, which has been ISO 13485-2020 certified for the design, development and manufacturing of tissue based implantable medical devices. |
Management_s Liquidity Plan
Management’s Liquidity Plan | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Management’s Liquidity Plan | Note 2 – Management’s Liquidity Plan As of March 31, 2023, the Company had a cash and investment balance of $ 34.2 33.4 |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and December 31, 2022, and for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2023. The accompanying condensed balance sheet as of December 31, 2022 has been derived from the Company’s audited financial statements. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited) |
Concentrations
Concentrations | 3 Months Ended |
Mar. 31, 2023 | |
Risks and Uncertainties [Abstract] | |
Concentrations | Note 4 – 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 2.0 million 4.3 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 5 – Property and Equipment As of March 31, 2023 and December 31, 2022, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) March 31, December 31, 2023 2022 Laboratory equipment $ 524 $ 524 Furniture and fixtures 160 160 Computer equipment 227 222 Leasehold improvements 213 213 Software 251 251 Total property and equipment 1,375 1,370 Less: accumulated depreciation (903 ) (849 ) Property and equipment, net $ 472 $ 521 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, 2023 | |
Payables and Accruals [Abstract] | |
Accounts Payable Accrued Expenses and Other Current Liabilities | Note 6 – Accounts Payable Accrued Expenses and Other Current Liabilities As of March 31, 2023, and December 31, 2022, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities (In thousands) March 31, December 31, 2023 2022 Accounts payable $ 380 $ 648 Accrued compensation costs 362 391 Accrued professional fees 22 62 Accrued research and development - 56 Other accrued expenses 83 59 Total accrued expenses and other current liabilities $ 847 $ 1,216 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 7 – 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 October 30, 2023. 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, 2023. ENVVENO MEDICAL CORPORATION (unaudited) |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders’ Equity | Note 8 – Stockholders’ Equity Stock Options From time to time, the Company issues options for the purchase of its common stock to employees and others. The Company recognized $ 1.8 2.2 6.6 1.7 |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | Note 9 – 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, 2023 and 2022: Schedule of Dilutive Net Loss Per Common Share 2023 2022 (In thousands) March 31, 2023 2022 Shares of common stock issuable upon exercise of warrants 4,589 4,553 Shares of common stock issuable upon exercise of options 4,206 3,454 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,795 8,007 |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and December 31, 2022, and for the three months ended March 31, 2023 and 2022. The results of operations for the three months ended March 31, 2023 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, 2022 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2023. The accompanying condensed balance sheet as of December 31, 2022 has been derived from the Company’s audited financial statements. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | As of March 31, 2023 and December 31, 2022, property and equipment consist of the following: Schedule of Property and Equipment (In thousands) March 31, December 31, 2023 2022 Laboratory equipment $ 524 $ 524 Furniture and fixtures 160 160 Computer equipment 227 222 Leasehold improvements 213 213 Software 251 251 Total property and equipment 1,375 1,370 Less: accumulated depreciation (903 ) (849 ) Property and equipment, net $ 472 $ 521 |
Accounts Payable Accrued Expe_2
Accounts Payable Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | As of March 31, 2023, and December 31, 2022, accounts payable, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities (In thousands) March 31, December 31, 2023 2022 Accounts payable $ 380 $ 648 Accrued compensation costs 362 391 Accrued professional fees 22 62 Accrued research and development - 56 Other accrued expenses 83 59 Total accrued expenses and other current liabilities $ 847 $ 1,216 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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, 2023 and 2022: Schedule of Dilutive Net Loss Per Common Share 2023 2022 (In thousands) March 31, 2023 2022 Shares of common stock issuable upon exercise of warrants 4,589 4,553 Shares of common stock issuable upon exercise of options 4,206 3,454 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,795 8,007 |
Business Organization and Nat_2
Business Organization and Nature of Operations (Details Narrative) | Mar. 31, 2023 ft² |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Area of Land | 14,507 |
Management_s Liquidity Plan (De
Management’s Liquidity Plan (Details Narrative) $ in Millions | Mar. 31, 2023 USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Cash and investment balance | $ 34.2 |
Working capital | $ 33.4 |
Concentrations (Details Narrati
Concentrations (Details Narrative) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 |
Risks and Uncertainties [Abstract] | ||
FDIC amount | $ 250,000 | |
Uninsured amount | $ 2,000,000 | $ 4,300,000 |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,375 | $ 1,370 |
Less: accumulated depreciation | (903) | (849) |
Property and equipment, net | 472 | 521 |
Laboratory Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 524 | 524 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 160 | 160 |
Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 227 | 222 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 213 | 213 |
Software Development [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 251 | $ 251 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation expense | $ 0.1 | $ 0.1 |
Schedule of Accrued Expenses an
Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 380 | $ 648 |
Accrued compensation costs | 362 | 391 |
Accrued professional fees | 22 | 62 |
Accrued research and development | 56 | |
Other accrued expenses | 83 | 59 |
Total accrued expenses and other current liabilities | $ 847 | $ 1,216 |
Stockholders_ Equity (Details N
Stockholders’ Equity (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock-based compensation | $ 1,792 | $ 2,243 |
Share-Based Payment Arrangement, Option [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Stock-based compensation | 1,800 | $ 2,200 |
Unrecognized stock-based compensation expense | $ 6,600 | |
Weighted average remaining vesting period | 1 year 8 months 12 days |
Schedule of Dilutive Net Loss P
Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive common stock equivalents excluded from diluted net loss per share | 8,795 | 8,007 |
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 | 4,589 | 4,553 |
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 | 4,206 | 3,454 |