enVVeno Medical (NVNO) 10-Q 31 Jul 23 2023 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Jun. 30, 2023	Jul. 27, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Jun. 30, 2023
Document Fiscal Period Focus	Q2
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
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	true
Elected Not To Use the Extended Transition Period	true
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		9,472,000

Condensed Balance Sheets (Unaud

Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Current Assets:
Cash and cash equivalents	$ 4,714	$ 4,555
Short-term investments	25,042	34,489
Prepaid expenses and other current assets	352	392
Total Current Assets	30,108	39,436
Property and equipment, net	438	521
Operating lease right-of-use assets, net	1,509	1,673
Security deposits and other assets	31	31
Total Assets	32,086	41,661
Current Liabilities:
Accounts payable, accrued expenses and other current liabilities	1,715	1,216
Current portion of operating lease liabilities	352	314
Total Current Liabilities	2,067	1,530
Long-term operating lease liabilities	1,207	1,402
Total Liabilities	3,274	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 June 30, 2023 and December 31, 2022
Additional paid-in capital	148,198	145,249
Accumulated deficit	(119,386)	(106,520)
Total Stockholders’ Equity	28,812	38,729
Total Liabilities and Stockholders’ Equity	$ 32,086	$ 41,661

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares shares in Thousands	Jun. 30, 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 value	$ 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		6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022	Jun. 30, 2023	Jun. 30, 2022
Operating Expenses:
Selling, general and administrative expenses	$ 2,600	$ 3,913	$ 5,805	$ 7,696
Research and development expenses	4,214	3,073	7,806	4,625
Loss from Operations	(6,814)	(6,986)	(13,611)	(12,321)
Other (Income) Expense:
Realized gain from sales of trading securities	(168)		(250)
Unrealized (gain) loss from of trading securities	(133)	113	(411)	113
Interest income, net	(39)	(37)	(84)	(42)
Total Other (Income) Expense	(340)	76	(745)	71
Net Loss	$ (6,474)	$ (7,062)	$ (12,866)	$ (12,392)
Net Loss Per Basic Common Share:	$ (0.58)	$ (0.63)	$ (1.15)	$ (1.10)
Net Loss Per Diluted Common Share:	$ (0.58)	$ (0.63)	$ (1.15)	$ (1.10)
Weighted Average Number of Common Shares Outstanding:
Basic	11,231	11,229	11,231	11,229
Diluted	11,231	11,229	11,231	11,229

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
Beginning balance, value at Dec. 31, 2021		$ 136,255	$ (81,851)	$ 54,404
Balance, shares at Dec. 31, 2021	9,470
Shared-Based Compensation		4,546		4,546
Balance, shares
Net loss			(12,392)	(12,392)
Ending balance, value at Jun. 30, 2022		140,801	(94,243)	46,558
Balance, shares at Jun. 30, 2022	9,470
Beginning balance, value at Mar. 31, 2022		138,498	(87,181)	51,317
Balance, shares at Mar. 31, 2022	9,470
Shared-Based Compensation		2,303		2,303
Balance, shares
Net loss			(7,062)	(7,062)
Ending balance, value at Jun. 30, 2022		140,801	(94,243)	46,558
Balance, shares at Jun. 30, 2022	9,470
Beginning balance, value 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
Balance, shares
Net loss			(12,866)	(12,866)
Ending balance, value at Jun. 30, 2023		148,198	(119,386)	28,812
Balance, shares at Jun. 30, 2023	9,472
Beginning balance, value 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
Balance, shares
Net loss			(6,474)	(6,474)
Ending balance, value at Jun. 30, 2023		$ 148,198	$ (119,386)	$ 28,812
Balance, shares at Jun. 30, 2023	9,472

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Cash Flows from Operating Activities
Net loss	$ (12,866)	$ (12,392)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	2,949	4,546
Depreciation and amortization	109	104
Amortization of right of use assets	165	158
Deposit applied to consulting services		23
Unrealized (gain) loss from investments	(411)	113
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	40	89
Accounts payable	656	474
Accrued expenses and other current liabilities	(157)	(250)
Operating lease liabilities	(157)	(145)
Net Cash Used in Operating Activities	(9,672)	(7,280)
Cash Flows from Investing Activities
Maturities of investments	24,956
Purchase of property and equipment	(26)	(92)
Purchases of investments	(15,099)	(38,286)
Net Cash Provided by (Used in) Investing Activities	9,831	(38,378)
Net (Decrease) Increase in Cash	159	(45,658)
Cash, cash equivalents - Beginning of period	4,555	54,728
Cash, cash equivalents - End of period	4,714	9,070
Cash Received During the Period For:
Interest, net	84	42
Non-Cash Financing Activities
Fair value of warrants issued in satisfaction of trade payables and accrued expenses		$ (65)

Business Organization and Natur

Business Organization and Nature of Operations	6 Months Ended
	Jun. 30, 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. The Company develops and manufactures its products in a 14,507

Management_s Liquidity Plan

Management’s Liquidity Plan	6 Months Ended
	Jun. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Management’s Liquidity Plan	Note 2 – Management’s Liquidity Plan As of June 30, 2023, the Company had a cash balance of $ 4.7 25.0 28.0

Significant Accounting Policies

Significant Accounting Policies	6 Months Ended
	Jun. 30, 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 June 30, 2023 and December 31, 2022, and for the three and six months ended June 30, 2023 and 2022. The results of operations for the three and six months ended June 30, 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.

Investments

Investments	6 Months Ended
	Jun. 30, 2023
Cash and Cash Equivalents [Abstract]
Investments	Note 4 – Investments The components of investments were as follows at June 30, 2023 and December 31, 2022: Schedule of Components of Investments (In thousands) June 30, 2023 December 31, 2022 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 4,542 $ 25,042 $ 4,040 $ 34,489 Total debt investments $ 4,542 $ 25,042 $ 4,040 $ 34,489 Unrealized and realized gains and losses on the accompanying statement of operations result from fixed-income securities and 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, 2023
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 $ 0.25 4.5 4.3

Accounts Payable Accrued Expens

Accounts Payable Accrued Expenses and Other Current Liabilities	6 Months Ended
	Jun. 30, 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 June 30, 2023, and December 31, 2022, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities June 30, December 31, (In thousands) 2023 2022 Accounts payable $ 1,304 $ 648 Accrued compensation costs 285 391 Accrued professional fees 33 62 Other accrued expenses 93 115 Total accrued expenses and other current liabilities $ 1,715 $ 1,216

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 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 alleging 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 June 30, 2023.

Stockholders_ Equity

Stockholders’ Equity	6 Months Ended
	Jun. 30, 2023
Equity [Abstract]
Stockholders’ Equity	Note 8 – Stockholders’ Equity Stock Options During the six-months ended June 30, 2023, the Company granted options to employees for the purchase of 95,000 6.70 The Company recognized $ 2.9 4.5 As of June 30, 2023, there was $ 5.6 1.5

Net Loss per Share

Net Loss per Share	6 Months Ended
	Jun. 30, 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 June 30, 2023 and 2022: Schedule of Dilutive Net Loss Per Common Share (In thousands) 2023 2022 June 30, (In thousands) 2023 2022 Shares of common stock issuable upon exercise of warrants 4,513 4,578 Shares of common stock issuable upon exercise of options 4,269 3,445 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,782 8,023

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 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 June 30, 2023 and December 31, 2022, and for the three and six months ended June 30, 2023 and 2022. The results of operations for the three and six months ended June 30, 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.

Investments (Tables)

Investments (Tables)	6 Months Ended
	Jun. 30, 2023
Cash and Cash Equivalents [Abstract]
Schedule of Components of Investments	The components of investments were as follows at June 30, 2023 and December 31, 2022: Schedule of Components of Investments (In thousands) June 30, 2023 December 31, 2022 Cash Equivalents Short-Term Investment Cash Equivalents Short-Term Investments Fair Value Level 1 U.S. Government securities $ 4,542 $ 25,042 $ 4,040 $ 34,489 Total debt investments $ 4,542 $ 25,042 $ 4,040 $ 34,489

Accounts Payable Accrued Expe_2

Accounts Payable Accrued Expenses and Other Current Liabilities (Tables)	6 Months Ended
	Jun. 30, 2023
Payables and Accruals [Abstract]
Schedule of Accrued Expenses and Other Current Liabilities	As of June 30, 2023, and December 31, 2022, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities June 30, December 31, (In thousands) 2023 2022 Accounts payable $ 1,304 $ 648 Accrued compensation costs 285 391 Accrued professional fees 33 62 Other accrued expenses 93 115 Total accrued expenses and other current liabilities $ 1,715 $ 1,216

Net Loss per Share (Tables)

Net Loss per Share (Tables)	6 Months Ended
	Jun. 30, 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 June 30, 2023 and 2022: Schedule of Dilutive Net Loss Per Common Share (In thousands) 2023 2022 June 30, (In thousands) 2023 2022 Shares of common stock issuable upon exercise of warrants 4,513 4,578 Shares of common stock issuable upon exercise of options 4,269 3,445 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,782 8,023

Business Organization and Nat_2

Business Organization and Nature of Operations (Details Narrative)	Jun. 30, 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) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash balance	$ 4,714	$ 4,555
Investments	25,000
Working capital	$ 28,000

Schedule of Components of Inves

Schedule of Components of Investments (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Platform Operator, Crypto-Asset [Line Items]
Short-term investment	$ 25,042	$ 34,489
Fair Value, Inputs, Level 1 [Member] | Debt Securities [Member]
Platform Operator, Crypto-Asset [Line Items]
Cash equivalents	4,542	4,040
Short-term investment	25,042	34,489
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | Debt Securities [Member]
Platform Operator, Crypto-Asset [Line Items]
Cash equivalents	4,542	4,040
Short-term investment	$ 25,042	$ 34,489

Concentrations (Details Narrati

Concentrations (Details Narrative) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Risks and Uncertainties [Abstract]
FDIC amount	$ 250
Uninsured amount	$ 4,500	$ 4,300

Schedule of Accrued Expenses an

Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2023	Dec. 31, 2022
Payables and Accruals [Abstract]
Accounts payable	$ 1,304	$ 648
Accrued compensation costs	285	391
Accrued professional fees	33	62
Other accrued expenses	93	115
Total accrued expenses and other current liabilities	$ 1,715	$ 1,216

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-based compensation	$ 2,949	$ 4,546
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Share-based compensation	2,900	$ 4,500
Unrecognized stock-based compensation expense	$ 5,600
Weighted average remaining vesting period	1 year 6 months
Share-Based Payment Arrangement, Option [Member] | Employees [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of options granted	95,000
Weighted average exercise price	$ 6.70

Schedule of Dilutive Net Loss P

Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands	6 Months Ended
	Jun. 30, 2023	Jun. 30, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive common stock equivalents excluded from diluted net loss per share	8,782	8,023
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	4,513	4,578
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	4,269	3,445