enVVeno Medical (NVNO) 10-Q 3 Aug 22 2022 Q2 Quarterly report Financial data

Cover

Cover - shares	6 Months Ended
	Jun. 30, 2022	Aug. 01, 2022
Document Type	10-Q
Amendment Flag	false
Document Quarterly Report	true
Document Transition Report	false
Document Period End Date	Jun. 30, 2022
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2022
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		9,469,850
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	Jun. 30, 2022	Dec. 31, 2021
Current Assets:
Cash and cash equivalents	$ 9,070	$ 54,728
Short-term investments	28,413
Accrued interest receivable	38
Prepaid expenses and other current assets	239	312
Total Current Assets	37,760	55,040
Property and equipment, net	606	618
Operating lease right-of-use assets, net	1,829	1,987
Long-term investments	9,706
Security deposits and other assets	31	54
Total Assets	49,932	57,699
Current Liabilities:
Accounts payable	1,034	560
Accrued expenses and other current liabilities	479	729
Current portion of operating lease liabilities	303	291
Total Current Liabilities	1,816	1,580
Long-term operating lease liabilities	1,558	1,715
Total Liabilities	3,374	3,295
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, 9,470 shares issued and outstanding as of June 30, 2022 and December 31, 2021
Additional paid-in capital	140,801	136,255
Accumulated deficit	(94,243)	(81,851)
Total Stockholders’ Equity	46,558	54,404
Total Liabilities and Stockholders’ Equity	$ 49,932	$ 57,699

Condensed Balance Sheets (Una_2

Condensed Balance Sheets (Unaudited) (Parenthetical) - $ / shares shares in Thousands	Jun. 30, 2022	Dec. 31, 2021
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	9,470	9,470
Common stock, shares outstanding	9,470	9,470

Condensed Statements of Operati

Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021
Operating Expenses:
Selling, general and administrative expenses	$ 3,913	$ 1,296	$ 7,696	$ 2,472
Research and development expenses	3,073	1,090	4,625	2,722
Loss from Operations	(6,986)	(2,386)	(12,321)	(5,194)
Other (Income) Expense:
Interest (income) expense, net	(37)	(7)	(42)	(10)
Unrealized loss from investments	113		113
Other expense		(1)		(33)
Total Other (Income) Expense	76	(8)	71	(43)
Net Loss	$ (7,062)	$ (2,378)	$ (12,392)	$ (5,151)
Net Loss Per Basic and Diluted Common Share:	$ (0.63)	$ (0.28)	$ (1.10)	$ (0.72)
Weighted Average Number of Common Shares Outstanding:
Basic and Diluted	11,229	8,512	11,229	7,160

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, 2020		$ 72,421	$ (65,323)	$ 7,098
Beginning balance, shares at Dec. 31, 2020	2,542
Share-Based Compensation		107		107
Net loss			(2,773)	(2,773)
Fair Value of Warrants Issued		212		212
Common stock issued in public offering		38,128		38,128
Common stock issued in public offering, shares	5,914
Common stock issued for exercise of warrants		240		240
Common stock issued for exercise of warrants, shares	52
Ending balance, value at Mar. 31, 2021		111,108	(68,096)	43,012
Ending balance, shares at Mar. 31, 2021	8,508
Beginning balance, value at Dec. 31, 2020		72,421	(65,323)	7,098
Beginning balance, shares at Dec. 31, 2020	2,542
Net loss				(5,151)
Ending balance, value at Jun. 30, 2021		111,348	(70,474)	40,874
Ending balance, shares at Jun. 30, 2021	8,514
Beginning balance, value at Mar. 31, 2021		111,108	(68,096)	43,012
Beginning balance, shares at Mar. 31, 2021	8,508
Share-Based Compensation		203		203
Net loss			(2,378)	(2,378)
Shares issued in satisfaction of trade payable		37		37
Shares issued in satisfaction of trade payable, shares	6
Ending balance, value at Jun. 30, 2021		111,348	(70,474)	40,874
Ending balance, shares at Jun. 30, 2021	8,514
Beginning balance, value at Dec. 31, 2021		136,255	(81,851)	54,404
Beginning balance, shares at Dec. 31, 2021	9,470
Share-Based Compensation		2,243		2,243
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, 2021		136,255	(81,851)	54,404
Beginning balance, shares at Dec. 31, 2021	9,470
Net loss				(12,392)
Ending balance, value at Jun. 30, 2022		140,801	(94,243)	46,558
Ending balance, shares at Jun. 30, 2022	9,470
Beginning balance, value at Mar. 31, 2022		138,498	(87,181)	51,317
Beginning balance, shares at Mar. 31, 2022	9,470
Share-Based Compensation		2,238		2,238
Net loss			(7,062)	(7,062)
Fair Value of Warrants Issued		65		65
Ending balance, value at Jun. 30, 2022		$ 140,801	$ (94,243)	$ 46,558
Ending balance, shares at Jun. 30, 2022	9,470

Condensed Statements of Cash Fl

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Cash Flows from Operating Activities
Net loss	$ (12,392)	$ (5,151)
Adjustments to reconcile net loss to net cash used in operating activities:
Share-based compensation	4,481	331
Issuance of warrants for services	65
Depreciation and amortization	104	59
Amortization of right of use assets	158	152
Deposit applied to consulting services	23
Unrealized loss from investments	113
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	73	(125)
Accrued interest receivable	16
Security deposit and other assets		(5)
Accounts payable	474	(1,084)
Accrued expenses and other current liabilities	(250)	(533)
Operating lease liabilities	(145)	(157)
Total adjustments	5,112	(1,362)
Net Cash Used in Operating Activities	(7,280)	(6,513)
Cash Flows from Investing Activities
Purchase of property and equipment	(92)	(151)
Purchases of investments	(38,286)
Net Cash Used in Investing Activities	(38,378)	(151)
Cash Flows from Financing Activities
Proceeds from public offering of common stock and warrants, net		38,128
Proceeds from Warrant Exercises		240
Net Cash Provided by Financing Activities		38,368
Net (Decrease) Increase in Cash	(45,658)	31,704
Cash, cash equivalents - Beginning of period	54,728	9,335
Cash, cash equivalents - End of period	9,070	41,039
Cash Received During the Period For:
Interest, net	42	5
Non-Cash Financing Activities
Fair value of common stock issued in satisfaction of trade payable		37
Fair value of warrants issued in satisfaction of trade payables and accrued expenses	$ (65)	$ (212)

Business Organization and Natur

Business Organization and Nature of Operations	6 Months Ended
	Jun. 30, 2022
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 med-tech company focused on improving the standard of care in the treatment of venous disease. We are developing tissue-based solutions that are designed to be life sustaining or life enhancing for patients with deep venous Chronic Venous Insufficiency (CVI). CVI occurs when valves inside of the veins of the leg fail, resulting in insufficient blood being returned to the heart. Our products are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially increasing the current standards of care. Our lead product is a porcine based device to be surgically implanted in our deep venous system of the leg, and is called the VenoValve®. The VenoValve is currently being evaluated in the SAVVE U.S. pivotal trial for the purpose of obtaining approval to market and sell the device from the U.S. Food and Drug Administration (“FDA”). Our team of officers and directors has been affiliated with numerous medical devices that have received FDA approval or CE marking and have been commercially successful. We currently lease a 14,507 sq. ft. manufacturing facility in Irvine, California, where we manufacture medical devices for our clinical trials, and which has capacity for commercial manufacturing.

Management_s Liquidity Plan

Management’s Liquidity Plan	6 Months Ended
	Jun. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Management’s Liquidity Plan	Note 2 – Management’s Liquidity Plan As of June 30, 2022, the Company had a cash balance of $ 9.1 38.1 35.6

Significant Accounting Policies

Significant Accounting Policies	6 Months Ended
	Jun. 30, 2022
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, 2022 and December 31, 2021, and for the three and six months ended June 30, 2022 and 2021. The results of operations for the three and six months ended June 30, 2022 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, 2021 included in the Company’s Form 10-K filed with the SEC on March 28, 2022. The condensed balance sheet as of December 31, 2021 has been derived from the Company’s audited financial statements. Investments We consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents. The fair values of these investments approximate their carrying values. Investments with original maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year are classified as long-term investments. Debt investments are classified as trading securities and realized gains and losses are recorded using the specific identification method. Changes in fair value, excluding credit losses and impairments, are recorded in unrealized gains (losses) from investments. Fair value is calculated based on publicly available market information. If the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, credit quality of debt instrument issuers, and the extent to which the fair value is less than cost. We recognize interest income based on the stated coupon rate of the investments purchased. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

Investments

Investments	6 Months Ended
	Jun. 30, 2022
Cash and Cash Equivalents [Abstract]
Investments	Note 4 – Investments The components of investments were as follows at June 30, 2022: Schedule of Investments (In thousands) Cash Equivalents Short-Term Investment Long Term Investment Fair Value Level 1 U.S. Government securities $ 2,248 $ 28,413 $ 9,706 Total debt investments $ 2,248 $ 28,413 $ 9,706 Unrealized losses from fixed-income securities 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. There were no similar investments at December 31, 2021.

Concentrations

Concentrations	6 Months Ended
	Jun. 30, 2022
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 8.8 54.5 ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

Accrued Expenses and Other Curr

Accrued Expenses and Other Current Liabilities	6 Months Ended
	Jun. 30, 2022
Payables and Accruals [Abstract]
Accrued Expenses and Other Current Liabilities	Note 6 – Accrued Expenses and Other Current Liabilities As of June 30, 2022, and December 31, 2021, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities June 30, December 31, (In thousands) 2022 2021 Accrued compensation costs $ 374 $ 525 Accrued professional fees 46 84 Accrued research and development - 60 Other accrued expenses 59 60 Total accrued expenses and other current liabilities $ 479 $ 729

Commitments and Contingencies

Commitments and Contingencies	6 Months Ended
	Jun. 30, 2022
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 24, 2022. 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, 2022. ENVVENO MEDICAL CORPORATION (unaudited)

Stockholders_ Equity

Stockholders’ Equity	6 Months Ended
	Jun. 30, 2022
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. During the six-months ended June 30, 2022, the Company granted options to employees for the purchase of thirty-thousand 6.83 4.5 0.3 10.6 1.7

Net Loss per Share

Net Loss per Share	6 Months Ended
	Jun. 30, 2022
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, 2022 and 2021: Schedule of Dilutive Net Loss Per Common Share 2022 2021 June 30, (In thousands) 2022 2021 Shares of common stock issuable upon exercise of warrants 4,578 4,402 Shares of common stock issuable upon exercise of options 3,445 386 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,023 4,788

Significant Accounting Polici_2

Significant Accounting Policies (Policies)	6 Months Ended
	Jun. 30, 2022
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, 2022 and December 31, 2021, and for the three and six months ended June 30, 2022 and 2021. The results of operations for the three and six months ended June 30, 2022 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, 2021 included in the Company’s Form 10-K filed with the SEC on March 28, 2022. The condensed balance sheet as of December 31, 2021 has been derived from the Company’s audited financial statements.
Investments	Investments We consider all highly liquid interest-earning investments with a maturity of three months or less at the date of purchase to be cash equivalents. The fair values of these investments approximate their carrying values. Investments with original maturities of greater than three months and remaining maturities of less than one year are classified as short-term investments. Investments with maturities beyond one year are classified as long-term investments. Debt investments are classified as trading securities and realized gains and losses are recorded using the specific identification method. Changes in fair value, excluding credit losses and impairments, are recorded in unrealized gains (losses) from investments. Fair value is calculated based on publicly available market information. If the cost of an investment exceeds its fair value, we evaluate, among other factors, general market conditions, credit quality of debt instrument issuers, and the extent to which the fair value is less than cost. We recognize interest income based on the stated coupon rate of the investments purchased. ENVVENO MEDICAL CORPORATION NOTES TO CONDENSED FINANCIAL STATEMENTS (unaudited)

Investments (Tables)

Investments (Tables)	6 Months Ended
	Jun. 30, 2022
Cash and Cash Equivalents [Abstract]
Schedule of Investments	The components of investments were as follows at June 30, 2022: Schedule of Investments (In thousands) Cash Equivalents Short-Term Investment Long Term Investment Fair Value Level 1 U.S. Government securities $ 2,248 $ 28,413 $ 9,706 Total debt investments $ 2,248 $ 28,413 $ 9,706

Accrued Expenses and Other Cu_2

Accrued Expenses and Other Current Liabilities (Tables)	6 Months Ended
	Jun. 30, 2022
Payables and Accruals [Abstract]
Schedule of Accrued Expenses and Other Current Liabilities	As of June 30, 2022, and December 31, 2021, accrued expenses and other current liabilities consist of the following: Schedule of Accrued Expenses and Other Current Liabilities June 30, December 31, (In thousands) 2022 2021 Accrued compensation costs $ 374 $ 525 Accrued professional fees 46 84 Accrued research and development - 60 Other accrued expenses 59 60 Total accrued expenses and other current liabilities $ 479 $ 729

Net Loss per Share (Tables)

Net Loss per Share (Tables)	6 Months Ended
	Jun. 30, 2022
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, 2022 and 2021: Schedule of Dilutive Net Loss Per Common Share 2022 2021 June 30, (In thousands) 2022 2021 Shares of common stock issuable upon exercise of warrants 4,578 4,402 Shares of common stock issuable upon exercise of options 3,445 386 Potentially dilutive common stock equivalents excluded from diluted net loss per share 8,023 4,788

Management_s Liquidity Plan (De

Management’s Liquidity Plan (Details Narrative) $ in Millions	Jun. 30, 2022 USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Cash	$ 9.1
Investments	38.1
Working capital	$ 35.6

Schedule of Investments (Detail

Schedule of Investments (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Defined Benefit Plan Disclosure [Line Items]
Short-Term Investments	$ 28,413
Long-Term Investments	9,706
Debt Securities [Member]
Defined Benefit Plan Disclosure [Line Items]
Cash Equivalents, at Carrying Value	2,248
Short-Term Investments	28,413
Long-Term Investments	9,706
Fair Value, Inputs, Level 1 [Member] | US Treasury Securities [Member] | Debt Securities [Member]
Defined Benefit Plan Disclosure [Line Items]
Cash Equivalents, at Carrying Value	2,248
Short-Term Investments	28,413
Long-Term Investments	$ 9,706

Concentrations (Details Narrati

Concentrations (Details Narrative) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Risks and Uncertainties [Abstract]
FDIC amount	$ 250
Uninsured amount	$ 8,800	$ 54,500

Schedule of Accrued Expenses an

Schedule of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021
Payables and Accruals [Abstract]
Accrued compensation costs	$ 374	$ 525
Accrued professional fees	46	84
Accrued research and development		60
Other accrued expenses	59	60
Total accrued expenses and other current liabilities	$ 479	$ 729

Stockholders_ Equity (Details N

Stockholders’ Equity (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation	$ 4,481	$ 331
Share-Based Payment Arrangement, Option [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Stock-based compensation	4,500	$ 300
Unrecognized stock-based compensation expense	$ 10,600
Weighted average remaining vesting period	1 year 8 months 12 days
Share-Based Payment Arrangement, Option [Member] | Employees [Member]
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]
Number of options granted	30,000
Weighted average exercise price	$ 6.83

Schedule of Dilutive Net Loss P

Schedule of Dilutive Net Loss Per Common Share (Details) - shares shares in Thousands	6 Months Ended
	Jun. 30, 2022	Jun. 30, 2021
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]
Potentially dilutive common stock equivalents excluded from diluted net loss per share	8,023	4,788
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	4,578	4,402
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	3,445	386