enVVeno Medical (NVNO) 10-Q 31 Jul 24 2024 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Jun. 30, 2024	Jul. 29, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Jun. 30, 2024
Document Fiscal Period Focus	Q2
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	Jun. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 2,380	$ 3,620
Short-term investments	36,687	42,792
Prepaid expenses and other current assets	469	511
Total Current Assets	39,536	46,923
Property and equipment, net	252	334
Operating lease right-of-use assets, net	1,176	1,347
Security deposits and other assets	31	31
Total Assets	40,995	48,635
Current Liabilities:
Accounts payable, accrued expenses and other current liabilities	1,344	1,033
Current portion of operating lease liabilities	351	338
Total Current Liabilities	1,695	1,371
Long-term operating lease liabilities	882	1,064
Total Liabilities	2,577	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 June 30, 2024 and December 31, 2023, respectively
Additional paid-in capital	178,402	176,236
Accumulated deficit	(139,984)	(130,036)
Total Stockholders’ Equity	38,418	46,200
Total Liabilities and Stockholders’ Equity	$ 40,995	$ 48,635

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares shares in Thousands	Jun. 30, 2024	Dec. 31, 2023
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 value	$ 0.00001	$ 0.00001
Common stock, shares authorized	250,000	250,000
Common stock, shares issued	13,330	13,317
Common stock, shares outstanding	13,330	13,317

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Operating Expenses:
Selling, general and administrative expenses	$ 2,629	$ 2,600	$ 5,080	$ 5,805
Research and development expenses	2,825	4,214	5,877	7,806
Loss from Operations	(5,454)	(6,814)	(10,957)	(13,611)
Other Income:
Realized gains from sales of trading securities	379	168	787	250
Unrealized gains from of trading securities	46	133	90	411
Interest income, net	73	39	132	84
Total Other Income	498	340	1,009	745
Net Loss	$ (4,956)	$ (6,474)	$ (9,948)	$ (12,866)
Net Loss Per Basic Common Share	$ (0.31)	$ (0.58)	$ (0.62)	$ (1.15)
Net Loss Per Diluted Common Share	$ (0.31)	$ (0.58)	$ (0.62)	$ (1.15)
Weighted Average Number of Common Shares Outstanding:
Basic	16,067	11,231	16,062	11,231
Diluted	16,067	11,231	16,062	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
Shared-Based Compensation		2,949		2,949
Net loss			(12,866)	(12,866)
Balance at Jun. 30, 2023		148,198	(119,386)	28,812
Balance, shares at Jun. 30, 2023	9,472
Balance at Mar. 31, 2023		147,041	(112,912)	34,129
Balance, shares at Mar. 31, 2023	9,472
Shared-Based Compensation		1,157		1,157
Net loss			(6,474)	(6,474)
Balance at Jun. 30, 2023		148,198	(119,386)	28,812
Balance, shares at Jun. 30, 2023	9,472
Balance at Dec. 31, 2023		176,236	(130,036)	46,200
Balance, shares at Dec. 31, 2023	13,317
Shared-Based Compensation		2,120		2,120
Net loss			(9,948)	(9,948)
Options exercised		46		46
Options exercised, shares	13
Balance at Jun. 30, 2024		178,402	(139,984)	38,418
Balance, shares at Jun. 30, 2024	13,330
Balance at Mar. 31, 2024		177,397	(135,028)	42,369
Balance, shares at Mar. 31, 2024	13,330
Shared-Based Compensation		1,005		1,005
Net loss			(4,956)	(4,956)
Balance at Jun. 30, 2024		$ 178,402	$ (139,984)	$ 38,418
Balance, shares at Jun. 30, 2024	13,330

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Cash Flows from Operating Activities
Net loss	$ (9,948)	$ (12,866)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	2,120	2,949
Depreciation and amortization	106	109
Amortization of right of use assets	171	165
Unrealized (gain) loss from investments	(90)	(411)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	42	40
Accounts payable	271	656
Accrued expenses and other current liabilities	40	(157)
Operating lease liabilities	(169)	(157)
Net Cash Used in Operating Activities	(7,457)	(9,672)
Cash Flows from Investing Activities
Maturities of investments	31,263	24,956
Purchase of property and equipment	(24)	(26)
Purchases of investments	(25,068)	(15,099)
Net Cash Provided by Investing Activities	6,171	9,831
Cash Flows from Financing Activities
Proceeds from Stock Option Exercises	46
Net Cash Provided by Financing Activities	46
Net (Decrease) Increase in Cash	(1,240)	159
Cash, cash equivalents - Beginning of period	3,620	4,555
Cash, cash equivalents - End of period	$ 2,380	$ 4,714

Business Organization and Natur

Business Organization and Nature of Operations	6 Months Ended
	Jun. 30, 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	6 Months Ended
	Jun. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Management’s Liquidity Plan	Note 2 – Management’s Liquidity Plan As of June 30, 2024, the Company had a cash and investment balance of $ 39.1 37.8

Significant Accounting Policies

Significant Accounting Policies	6 Months Ended
	Jun. 30, 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 June 30, 2024 and December 31, 2023, and for the three and six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 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	6 Months Ended
	Jun. 30, 2024
Cash and Cash Equivalents [Abstract]
Investments	Note 4 – Investments The components of investments at June 30, 2024 and December 31, 2023 were as follows: Schedule of Components of Investments (In thousands) June 30, 2024 December 31, 2023 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,661 $ 36,687 $ 3,187 $ 42,792 Total debt investments $ 1,661 $ 36,687 $ 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	6 Months Ended
	Jun. 30, 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 0.9 3.4 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

Accounts Payable Accrued Expens

Accounts Payable Accrued Expenses and Other Current Liabilities	6 Months Ended
	Jun. 30, 2024
Payables and Accruals [Abstract]
Accounts Payable Accrued Expenses and Other Current Liabilities	Note 6 – Accounts Payable Accrued Expenses and Other Current Liabilities As of June 30, 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) June 30, 2024 December 31, 2023 Accounts payable $ 698 $ 427 Accrued compensation costs 517 478 Other accrued expenses 129 128 Total accrued expenses and other current liabilities $ 1,344 $ 1,033

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 2024
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 allege 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 and fiduciary duty to the Company’s damage. The Company continues to believe it has meritorious defenses to both matters which are currently set for trial on August 12, 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 June 30, 2024. ENVVENO MEDICAL CORPORATION (unaudited)

Stockholders_ Equity

Stockholders’ Equity	6 Months Ended
	Jun. 30, 2024
Equity [Abstract]
Stockholders’ Equity	Note 8 – Stockholders’ Equity Stock Options Stock-based compensation is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $ 1.0 1.2 2.1 3.0 5.3 1.5

Net Loss per Share

Net Loss per Share	6 Months Ended
	Jun. 30, 2024
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 June 30, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share 2024 2023 (In thousands) June 30, 2024 2023 Shares of common stock issuable upon exercise of warrants 9,546 4,513 Shares of common stock issuable upon exercise of options 5,554 4,269 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,100 8,782

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 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 June 30, 2024 and December 31, 2023, and for the three and six months ended June 30, 2024 and 2023. The results of operations for the three and six months ended June 30, 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)	6 Months Ended
	Jun. 30, 2024
Cash and Cash Equivalents [Abstract]
Schedule of Components of Investments	The components of investments at June 30, 2024 and December 31, 2023 were as follows: Schedule of Components of Investments (In thousands) June 30, 2024 December 31, 2023 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 1,661 $ 36,687 $ 3,187 $ 42,792 Total debt investments $ 1,661 $ 36,687 $ 3,187 $ 42,792

Accounts Payable Accrued Expe_2

Accounts Payable Accrued Expenses and Other Current Liabilities (Tables)	6 Months Ended
	Jun. 30, 2024
Payables and Accruals [Abstract]
Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities	As of June 30, 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) June 30, 2024 December 31, 2023 Accounts payable $ 698 $ 427 Accrued compensation costs 517 478 Other accrued expenses 129 128 Total accrued expenses and other current liabilities $ 1,344 $ 1,033

Net Loss per Share (Tables)

Net Loss per Share (Tables)	6 Months Ended
	Jun. 30, 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 June 30, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share 2024 2023 (In thousands) June 30, 2024 2023 Shares of common stock issuable upon exercise of warrants 9,546 4,513 Shares of common stock issuable upon exercise of options 5,554 4,269 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,100 8,782

Management_s Liquidity Plan (De

Management’s Liquidity Plan (Details Narrative) $ in Millions	Jun. 30, 2024 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Investments	$ 39.1
Cash	39.1
Working capital	$ 37.8

Schedule of Components of Inves

Schedule of Components of Investments (Details) - Fair Value, Inputs, Level 1 [Member] - Debt Securities [Member] - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Platform Operator, Crypto Asset [Line Items]
Cash equivalents	$ 1,661	$ 3,187
Short-term investment	36,687	42,792
US Government Debt Securities [Member]
Platform Operator, Crypto Asset [Line Items]
Cash equivalents	1,661	3,187
Short-term investment	$ 36,687	$ 42,792

Concentrations (Details Narrati

Concentrations (Details Narrative) - USD ($)	Jun. 30, 2024	Dec. 31, 2023
Risks and Uncertainties [Abstract]
FDIC amount	$ 250,000
Uninsured amount	$ 900,000	$ 3,400,000

Schedule of Accounts Payable Ac

Schedule of Accounts Payable Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accounts payable	$ 698	$ 427
Accrued compensation costs	517	478
Other accrued expenses	129	128
Total accrued expenses and other current liabilities	$ 1,344	$ 1,033

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023	Jun. 30, 2024	Jun. 30, 2023
Stock-based compensation			$ 2,120	$ 2,949
Share-Based Payment Arrangement, Option [Member]
Unrecognized stock-based compensation expense	$ 5,300		$ 5,300
Weighted average remaining vesting period			1 year 6 months
Selling, General and Administrative Expenses [Member]
Stock-based compensation	$ 1,000	$ 1,200	$ 2,100	$ 3,000

Schedule of Dilutive Net Loss P

Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands	6 Months Ended
	Jun. 30, 2024	Jun. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive common stock equivalents excluded from diluted net loss per share	15,100	8,782
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	9,546	4,513
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	5,554	4,269