enVVeno Medical (NVNO) 10-Q 30 Oct 24 2024 Q3 Quarterly report Financial data

Cover

Cover - shares	9 Months Ended
	Sep. 30, 2024	Oct. 28, 2024
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Sep. 30, 2024
Document Fiscal Period Focus	Q3
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		17,536,000

Condensed Balance Sheets (Unaud

Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current Assets:
Cash and cash equivalents	$ 17,915	$ 3,620
Short-term investments	30,464	42,792
Prepaid expenses and other current assets	672	511
Total current assets	49,051	46,923
Property and equipment, net	218	334
Operating lease right-of-use assets, net	1,090	1,347
Security deposits and other assets	31	31
Total assets	50,390	48,635
Current Liabilities:
Accounts payable, accrued expenses and other current liabilities	1,872	1,033
Current portion of operating lease liabilities	357	338
Total current liabilities	2,229	1,371
Long-term operating lease liabilities	791	1,064
Total liabilities	3,020	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, 17,536 and 13,317 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively
Additional paid-in capital	192,996	176,236
Accumulated deficit	(145,626)	(130,036)
Total stockholders’ equity	47,370	46,200
Total liabilities and stockholders’ equity	$ 50,390	$ 48,635

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares shares in Thousands	Sep. 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	17,536	13,317
Common stock, shares outstanding	17,536	13,317

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Operating Expenses:
Research and development expenses	$ 2,859	$ 2,798	$ 8,736	$ 10,602
Selling, general and administrative expenses	3,311	2,551	8,391	8,358
Loss from Operations	(6,170)	(5,349)	(17,127)	(18,960)
Other Income:
Realized gain from sales of trading securities	428	148	1,215	398
Unrealized gain from trading securities	6	156	96	567
Interest income, net	94	44	226	128
Total Other Income	528	348	1,537	1,093
Net Loss	$ (5,642)	$ (5,001)	$ (15,590)	$ (17,867)
Net Loss Per Basic Common Share	$ (0.35)	$ (0.45)	$ (0.97)	$ (1.59)
Net Loss Per Diluted Common Share	$ (0.35)	$ (0.45)	$ (0.97)	$ (1.59)
Weighted Average Number of Common Shares Outstanding:
Basic	16,067	11,231	16,063	11,231
Diluted	16,067	11,231	16,063	11,231

Condensed Statements of Changes

Condensed Statements of Changes in Stockholders' Equity (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
Share-Based Compensation		4,053		4,053
Net loss			(17,867)	(17,867)
Balance at Sep. 30, 2023		149,302	(124,387)	24,915
Balance, shares at Sep. 30, 2023	9,472
Balance at Jun. 30, 2023		148,198	(119,386)	28,812
Balance, shares at Jun. 30, 2023	9,472
Share-Based Compensation		1,104		1,104
Net loss			(5,001)	(5,001)
Balance at Sep. 30, 2023		149,302	(124,387)	24,915
Balance, shares at Sep. 30, 2023	9,472
Balance at Dec. 31, 2023		176,236	(130,036)	46,200
Balance, shares at Dec. 31, 2023	13,317
Common Stock and Warrants Issued in Public Offering		13,591		13,591
Common Stock and Warrants Issued in Public Offering, shares	4,206
Share-Based Compensation		3,123		3,123
Net loss			(15,590)	(15,590)
Options exercised		46		46
Options exercised, shares	13
Balance at Sep. 30, 2024		192,996	(145,626)	47,370
Balance, shares at Sep. 30, 2024	17,536
Balance at Jun. 30, 2024		178,402	(139,984)	38,418
Balance, shares at Jun. 30, 2024	13,330
Common Stock and Warrants Issued in Public Offering		13,591		13,591
Common Stock and Warrants Issued in Public Offering, shares	4,206
Share-Based Compensation		1,003		1,003
Net loss			(5,642)	(5,642)
Balance at Sep. 30, 2024		$ 192,996	$ (145,626)	$ 47,370
Balance, shares at Sep. 30, 2024	17,536

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash Flows from Operating Activities
Net loss	$ (15,590)	$ (17,867)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	3,123	4,052
Depreciation and amortization	149	165
Amortization of right-of-use assets	257	247
Unrealized gain from investments, net	(96)	(567)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(118)	(155)
Security deposit and other assets	(43)	(8)
Accounts payable, accrued expenses and other current liabilities	839	484
Operating lease liabilities	(254)	(236)
Net Cash Used in Operating Activities	(11,733)	(13,885)
Cash Flows from Investing Activities
Purchase of property and equipment	(33)	(29)
Purchases of investments	(33,420)	(24,276)
Maturities of investments	45,844	38,581
Net Cash Provided by Investing Activities	12,391	14,276
Cash Flows from Financing Activities
Proceeds from public offering	13,591
Proceeds from stock option exercises	46
Net Cash Provided by Financing Activities	13,637
Net Increase in Cash, Cash Equivalents	14,295	391
Cash, cash equivalents - Beginning of period	3,620	4,555
Cash, cash equivalents - End of period	$ 17,915	$ 4,946

Business Organization and Natur

Business Organization and Nature of Operations	9 Months Ended
	Sep. 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 (the “Company”) 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	9 Months Ended
	Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Management’s Liquidity Plan	Note 2 – Management’s Liquidity Plan As of September 30, 2024, the Company had a cash and investment balance of $ 48.4 47.3 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

Significant Accounting Policies

Significant Accounting Policies	9 Months Ended
	Sep. 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 September 30, 2024 and December 31, 2023, and for the three and nine months ended September 30, 2024 and 2023. The results of operations for the three and nine months ended September 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

Investments	9 Months Ended
	Sep. 30, 2024
Cash and Cash Equivalents [Abstract]
Investments	Note 4 – Investments The components of investments were as follows at September 30, 2024 and December 31, 2024: Schedule of Components of Investments (In thousands) September 30, 2024 December 31, 2023 Cash Short-Term Cash Short-Term Fair Value Level 1 U.S. Government securities $ 3,794 $ 30,464 $ 3,187 $ 42,792 Total debt investments $ 3,794 $ 30,464 $ 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. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

Concentrations

Concentrations	9 Months Ended
	Sep. 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 14.9 3.4

Accounts Payable, Accrued Expen

Accounts Payable, Accrued Expenses and Other Current Liabilities	9 Months Ended
	Sep. 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 September 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) September 30, 2024 December 31, 2023 Accounts payable $ 894 $ 427 Accrued compensation costs 446 478 Other accrued expenses 532 128 Total accrued expenses and other current liabilities $ 1,872 $ 1,033

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 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. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

Stockholders_ Equity

Stockholders’ Equity	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
Stockholders’ Equity	Note 8 – Stockholders’ Equity Equity Issuance The Company consummated a public offering on September 30, 2024 whereby it raised net proceeds of $ 13.3 4.2 0.1 0.3 3.18 Transaction fees in connection with the capital raise were $ 1.4 The warrants have a fair value of $ 1.0 Schedule of Estimated Fair values and Assumptions Contractual term in years 5 Volatility 102 % Risk free interest rate 4 % Dividend yield 0 % Stock Options Stock-based compensation is reflected in selling, general and administrative expenses in the accompanying condensed statements of operations and was $ 1.0 1.1 3.1 4.1 As of September 30, 2024, there was $ 4.3 1.9

Net Loss per Share

Net Loss per Share	9 Months Ended
	Sep. 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 September 30, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share (In thousands) 2024 2023 September 30, (In thousands) 2024 2023 Shares of common stock issuable upon exercise of warrants 9,847 4,506 Shares of common stock issuable upon exercise of options 5,552 4,254 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,399 8,760

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 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 September 30, 2024 and December 31, 2023, and for the three and nine months ended September 30, 2024 and 2023. The results of operations for the three and nine months ended September 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)	9 Months Ended
	Sep. 30, 2024
Cash and Cash Equivalents [Abstract]
Schedule of Components of Investments	The components of investments were as follows at September 30, 2024 and December 31, 2024: Schedule of Components of Investments (In thousands) September 30, 2024 December 31, 2023 Cash Short-Term Cash Short-Term Fair Value Level 1 U.S. Government securities $ 3,794 $ 30,464 $ 3,187 $ 42,792 Total debt investments $ 3,794 $ 30,464 $ 3,187 $ 42,792

Accounts Payable, Accrued Exp_2

Accounts Payable, Accrued Expenses and Other Current Liabilities (Tables)	9 Months Ended
	Sep. 30, 2024
Payables and Accruals [Abstract]
Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities	As of September 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) September 30, 2024 December 31, 2023 Accounts payable $ 894 $ 427 Accrued compensation costs 446 478 Other accrued expenses 532 128 Total accrued expenses and other current liabilities $ 1,872 $ 1,033

Stockholders_ Equity (Tables)

Stockholders’ Equity (Tables)	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
Schedule of Estimated Fair values and Assumptions	Schedule of Estimated Fair values and Assumptions Contractual term in years 5 Volatility 102 % Risk free interest rate 4 % Dividend yield 0 %

Net Loss per Share (Tables)

Net Loss per Share (Tables)	9 Months Ended
	Sep. 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 September 30, 2024 and 2023: Schedule of Dilutive Net Loss Per Common Share (In thousands) 2024 2023 September 30, (In thousands) 2024 2023 Shares of common stock issuable upon exercise of warrants 9,847 4,506 Shares of common stock issuable upon exercise of options 5,552 4,254 Potentially dilutive common stock equivalents excluded from diluted net loss per share 15,399 8,760

Management_s Liquidity Plan (De

Management’s Liquidity Plan (Details Narrative) $ in Millions	Sep. 30, 2024 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash	$ 48.4
Investments	48.4
Working capital	$ 47.3

Schedule of Components of Inves

Schedule of Components of Investments (Details) - Fair Value, Inputs, Level 1 [Member] - Debt Securities [Member] - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Platform Operator, Crypto Asset [Line Items]
Cash equivalents	$ 3,794	$ 3,187
Short-term investments	30,464	42,792
US Government Debt Securities [Member]
Platform Operator, Crypto Asset [Line Items]
Cash equivalents	3,794	3,187
Short-term investments	$ 30,464	$ 42,792

Concentrations (Details Narrati

Concentrations (Details Narrative) - USD ($)	Sep. 30, 2024	Dec. 31, 2023
Risks and Uncertainties [Abstract]
FDIC amount	$ 250,000
Uninsured cash balances	$ 14,900,000	$ 3,400,000

Schedule of Accounts Payable, A

Schedule of Accounts Payable, Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
Accounts payable	$ 894	$ 427
Accrued compensation costs	446	478
Other accrued expenses	532	128
Total accrued expenses and other current liabilities	$ 1,872	$ 1,033

Schedule of Estimated Fair valu

Schedule of Estimated Fair values and Assumptions (Details)	9 Months Ended
	Sep. 30, 2024
Equity [Abstract]
Contractual term in years	5 years
Volatility	102%
Risk free interest rate	4%
Dividend yield	0%

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Accumulated Other Comprehensive Income (Loss) [Line Items]
Proceeds from issuance of common stock			$ 13,300
Payments of stock issuance costs			1,400
Warrants and rights outstanding	$ 1,000		1,000
Stock-based compensation			3,123	$ 4,052
Unrecognized stock-based compensation expense	4,300		$ 4,300
Weighted average remaining vesting period			1 year 10 months 24 days
Selling, General and Administrative Expenses [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Stock-based compensation	$ 1,000	$ 1,100	$ 3,100	$ 4,100
Pre-Funded Warrants [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of warrant shares	100		100
Underwriter [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of warrant shares	300		300
Common Stock [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Number of shares issued	4,206		4,206
Warrant [Member]
Accumulated Other Comprehensive Income (Loss) [Line Items]
Warrant exercise price	$ 3.18		$ 3.18

Schedule of Dilutive Net Loss P

Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 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	15,399	8,760
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	9,847	4,506
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	5,552	4,254