0001493152-22-021166.txt : 20220803 0001493152-22-021166.hdr.sgml : 20220803 20220803162629 ACCESSION NUMBER: 0001493152-22-021166 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 41 CONFORMED PERIOD OF REPORT: 20220630 FILED AS OF DATE: 20220803 DATE AS OF CHANGE: 20220803 FILER: COMPANY DATA: COMPANY CONFORMED NAME: enVVeno Medical Corp CENTRAL INDEX KEY: 0001661053 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 330936180 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-38325 FILM NUMBER: 221133029 BUSINESS ADDRESS: STREET 1: 70 DOPPLER CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 949-261-2900 MAIL ADDRESS: STREET 1: 70 DOPPLER CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: Hancock Jaffe Laboratories, Inc. DATE OF NAME CHANGE: 20151215 10-Q 1 form10-q.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2022

 

OR

 

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from to ___________________

 

Commission file number: 001-38325

 

enVVeno Medical Corporation

(Exact name of registrant as specified in its charter)

 

Delaware   33-0936180

(State or other jurisdiction

of incorporation or organization)

  

(I.R.S. Employer

Identification No.)

 

70 Doppler

Irvine, California 92618

(Address of principal executive offices)

 

(949) 261-2900

(Registrant’s telephone number, including area code)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class:   Name of Each Exchange on Which Registered:   Ticker Symbol
Common Stock, $0.00001 par value   The NASDAQ Stock Market LLC   NVNO
Warrant to Purchase Commons Stock   The NASDAQ Stock Market LLC   NVNOW

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer ☐ Accelerated filer ☐
  Non-accelerated filer ☒ Smaller reporting company ☒
      Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

 

As of August 1, 2022, there were 9,469,850 shares of common stock outstanding.

 

 

 

 
 

 

ENVVENO MEDICAL CORPORATION

TABLE OF CONTENTS

 

PART I  
   
FINANCIAL INFORMATION  
   
ITEM 1. Financial Statements 1
   
Condensed Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021 1
   
Unaudited Condensed Statements of Operations for the three and six months ended June 30, 2022 and 2021 2
   
Unaudited Condensed Statements of Changes in Stockholders’ Equity for the six months ended June 30, 2022 and 2021 3
   
Unaudited Condensed Statements of Cash Flows for the six months ended June 30, 2022 and 2021 4
   
Notes to Unaudited Condensed Financial Statements 5
   
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 9
   
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 14
   
ITEM 4. Controls and Procedures 14
   
PART II  
   
OTHER INFORMATION 16
   
ITEM 1. Legal Proceedings 16
   
ITEM 1A. Risk Factors 16
   
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 16
   
ITEM 3. Defaults Upon Senior Securities 16
   
ITEM 4. Mine Safety Disclosures 16
   
ITEM 5. Other Information 16
   
ITEM 6. Exhibits 17
   
Signatures 18

 

 
 

 

PART I – FINANCIAL INFORMATION

ITEM 1 – Financial Statements

 

ENVVENO MEDICAL CORPORATION

CONDENSED BALANCE SHEETS

(unaudited)

 

   June 30,   December 31, 
   2022   2021 
(In thousands except par values, unless otherwise indicated)          
Assets          
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 
           
Liabilities and Stockholders’ Equity          
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 

 

See Notes to these Unaudited Condensed Financial Statements

 

1

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

 

                 
   For the Three Months Ended   For the Six Months Ended 
   June 30,   June 30, 
   2022   2021   2022   2021 
(In thousands, except per share data)                    
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 

 

See Notes to these Unaudited Condensed Financial Statements

 

2

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

(In thousands, unless otherwise indicated)

(unaudited)

 

                      
   Common Stock   Additional Paid-in   Accumulated   

Total

Stockholders’

 
   Shares   Amount   Capital   Deficit    Equity 
Balance at January 1, 2022   9,470   $-   $136,255   $(81,851)   $  54,404 
Shared-Based Compensation   -    -    2,243    -     2,243 
Net loss   -    -    -    (5,330)    (5,330)
Balance at March 31, 2022   9,470    -    138,498    (87,181)    51,317 
Shared-Based Compensation   -    -    2,238    -     2,238 
Fair value of warrants issued             

65

          

65

 
Net loss   -         -    -    (7,062)    (7,062)
Balance at June 30, 2022   9,470   $-   $140,801   $(94,243)   $46,558 

 

   Shares   Amount   Capital   Deficit   Equity 
   Common Stock   Additional Paid-in   Accumulated   Total Stockholders’ 
   Shares   Amount   Capital   Deficit   Equity 
Balance at January 1, 2021   2,542   $         -   $72,421   $(65,323) $7,098 
Common stock issued in public offering   5,914    -    38,128    -    38,128 
Common stock issued for exercise of warrants   52    -    240    -    240 
Shared-Based Compensation   -    -    107    -    107 
Fair Value of Warrants Issued   -    -    212    -    212 
Net loss   -    -    -    (2,773)  (2,773)
Balance at March 31, 2021   8,508    -    111,108    (68,096)  43,012 
Share-Based Compensation   -    -    203    -    203 
Shares issued in satisfaction of trade payable   6    -    37    -    37 
Net loss   -    -    -    (2,378)  (2,378)
Balance at June 30, 2021   8,514   $-   $111,348   $(70,474) $40,874 

 

See Notes to these Unaudited Condensed Financial Statements

 

3

 

 

ENVVENO MEDICAL CORPORATION

CONDENSED STATEMENTS OF CASH FLOWS

(In thousands, unless otherwise indicated)

(unaudited)

 

   2022   2021 
   For the Six Months Ended 
   June, 
   2022   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 

 

  

For the Six Months Ended

June 30,

 
   2022   2021 
Supplemental Disclosures of Cash Flow Information:          
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)

 

See Notes to these Unaudited Condensed Financial Statements

 

4

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

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.

 

Note 2 – Management’s Liquidity Plan

 

As of June 30, 2022, the Company had a cash balance of $9.1 million, investments of $38.1 million and working capital of $35.6 million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that our capital resources at June 30, 2022 are sufficient to meet our obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.

 

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.

 

5

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 4 – Investments

 

The components of investments were as follows at June 30, 2022:

 

(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.

 

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 at each institution. There were aggregate uninsured cash balances of $8.8 and $54.5 million as of June 30, 2022 and December 31, 2021, respectively.

 

6

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

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:

 

   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 

 

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.

 

7

 

 

ENVVENO MEDICAL CORPORATION
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

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 shares with a weighted average exercise price of $6.83 per share. The Company recognized $4.5 million and $0.3 million of share-based compensation related to stock options during the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, there was $10.6 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.7 years.

 

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:

 

   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 

 

 

8

 

 

Item 2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion should be read in conjunction with our unaudited condensed financial statements and notes thereto included herein. In connection with, and because we desire to take advantage of, the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, we caution readers regarding certain forward-looking statements in the following discussion and elsewhere in this report and in any other statement made by, or on our behalf, whether or not in future filings with the Securities and Exchange Commission. Forward-looking statements are statements not based on historical information and which relate to future operations, strategies, financial results or other developments. Such forward-looking statements involve significant risks and uncertainties. Forward looking statements are necessarily based upon estimates and assumptions that are inherently subject to significant business, economic and competitive uncertainties and contingencies, many of which are beyond our control and many of which, with respect to future business decisions, are subject to change. These uncertainties and contingencies can affect actual results and could cause actual results to differ materially from those expressed in any forward-looking statements made by, or on our behalf. Words such as “anticipate,” “estimate,” “plan,” “continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,” “will,” “should,” “could,” and similar expressions are used to identify forward-looking statements. Such forward-looking statements also involve other factors which may cause our actual results, performance or achievements to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements and to vary significantly from reporting period to reporting period. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual future results will not be different from the expectations expressed in this Quarterly Report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

Unless the context requires otherwise, references in this document to “NVNO”, “we”, “our”, “us” or the “Company” are to EnVVeno Medical Corporation

 

Overview

 

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 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. We aim to develop products 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 the 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 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 13485-2016 certified for the design, development and manufacturing of tissue based implantable medical devices.

 

9

 

 

VenoValve

 

The VenoValve is a porcine based valve developed at enVVeno Medical to be implanted in the deep venous system of the leg to treat severe CVI. By reducing reflux and lowering pressure (venous hypertension) within the deep venous system of the leg, the VenoValve has the potential to reduce or eliminate the symptoms of severe deep venous CVI, including the potential to heal recurring venous leg ulcers. The current version of the VenoValve is designed to be implanted into the femoral vein of the patient in an open surgical procedure via a 5-to-6-inch incision in the upper thigh.

 

There are presently no FDA approved medical devices to address valvular incompetence in the deep venous system, or effective treatments for deep venous CVI. Current treatment options include compression garments, or constant leg elevation, and wound care for venous ulcers. These treatments are generally ineffective, as they attempt to alleviate the symptoms of CVI without addressing the underlying causes of the disease. In addition, we believe compliance with compression garments and leg elevation is extremely low, especially among the elderly. The premise behind the VenoValve is that by reducing the underlying causes of CVI, reflux and venous hypertension, the debilitating symptoms of CVI will decrease, resulting in improvement in the quality of the lives of CVI sufferers.

 

We estimate that there are approximately 2.4 million people in the U.S. that suffer from deep venous CVI due to valvular incompetence.

 

VenoValve Clinical Status

 

After consultation with the FDA, and as a precursor to the U.S. pivotal trial, we conducted a small first-in-human study for the VenoValve in Colombia which included eleven (11) patients. In addition to providing safety and efficacy data, the purpose of the first-in-human study was to provide proof of concept, and to provide valuable feedback to make any necessary product modifications or adjustments to our surgical implantation procedure for the VenoValve prior to conducting the U.S. pivotal trial. Endpoints for the VenoValve first-in-human study included safety (device related adverse events), reflux, measured by doppler, a VCSS score used by the clinician to measure disease severity and progress, a VAS score used by the patient to measure pain, and a quality of life measurement.

 

Final results from the one (1) year first-in-human study were presented at the Charing Cross International Symposium in April of 2021. Among the eleven (11) patients in the study, reflux improved an average of 54%, Venous Clinical Severity Scores (“VCSSs”) improved an average of 56%, and visual analog scale (VAS) scores, which are used by patients to measure pain, improved an average of 76%, all at one (1) year when compared to pre-surgery levels. VCSS scores are commonly used by clinicians in practice and in clinical trials to objectively assess outcomes in the treatment of venous disease, and include ten characteristics including pain, inflammation, skin changes such as pigmentation and induration, the number of active ulcers, and ulcer duration. The improvement in VCSS scores is significant and indicates the VenoValve patients who had severe CVI pre-surgery, had mild CVI or the complete absence of disease at one-year post surgery.

 

There were no device related safety incidences during the one (1) year first-in-human study. Non-device related safety incidences were minor and included one (1) fluid pocket (which was aspirated), intolerance from Coumadin anticoagulation therapy, three (3) minor wound infections (treated with antibiotics), and one occlusion due to patient non-compliance with anti-coagulation therapy.

 

In preparation for the VenoValve U.S. pivotal trial, on March 5, 2021, we submitted an investigational device exemption or IDE application with the FDA.

 

An IDE from the FDA is required before a medical device company can proceed with a pivotal trial for a class III medical device. On April 1, 2021, we received notification from the FDA that our IDE application was approved. We have named the U.S. pivotal trial for the VenoValve the SAVVE (Surgical Anti-reflux Veno Valve Endoprosthesis) study. It is a prospective, non-blinded, single arm, multi-center study of seventy-five (75) CVI patients to be enrolled at up to twenty (20) U.S. sites.

 

No product modifications for the VenoValve were necessary following the first-in-human study and the SAVVE trial is evaluating the same device that was used in the first-in-human study. Endpoints for the SAVVE trial mirror those endpoints used for the first-in-human study. The primary safety endpoint for the pivotal trial is a material adverse safety event (mortality, deep wound infection, major bleeding, ipsilateral deep vein thrombosis, pulmonary embolism) in no more than twenty six percent (26%) of the patients at one (1) month post implantation, and the primary effectiveness endpoint for the pivotal trial is improvement in reflux of at least thirty percent (30%), measured at six (6) months post VenoValve implantation. In the first-in-human study there were no reported material adverse safety events at one (1) month post implantation, and reflux improved an average of fifty six percent (56%) at six (6) months post implantation. VCSS scoring to measure disease manifestations, VAS scores to measure pain, and quality of life measurements will also be monitored in the study.

 

10

 

 

On August 3, 2020, we announced that the FDA granted Breakthrough Device Designation status to the VenoValve. The FDA’s Breakthrough Devices Program was established to enable priority review for devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating diseases or conditions. The goal of the FDA’s Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review, while preserving the FDA’s mission to protect and promote public health.

 

At the end of the VenoValve first-in-human study, eight (8) study participants agreed to additional monitoring. In August of 2021, longer term follow-up data was presented at the Society of Vascular Surgery Conference in San Diego, for the cohort of eight (8) patients. That data indicated no recurrences of the severe CVI that was present pre-VenoValve, including no ulcer recurrences for those patients whose venous ulcers had healed following VenoValve surgery. There were no reported safety issues from the end of one (1) year first-in-human study to the end of the two (2) year reporting period. In addition, the patients continued to improve, reporting 63%, 60%, and 93%, average improvements in reflux, VCSS, and VAS scores, respectively, at an average of two (2) years post VenoValve surgery compared to pre-VenoValve levels.

 

In October of 2021, we announced that the first patient in the SAVVE pivotal trial underwent successful VenoValve implantation surgery and had been discharged from the hospital. During April 2022 our twentieth site in the SAVVE study became active and is eligible to enroll patients.

 

The resurgence of COVID and the Omicron variant had both direct and indirect consequences on our clinical trial. Several of our clinical sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for screening. Further, as reported in the media, COVID resurgences put an enormous strain on all hospital resources including clinical staffs. In addition to caring for the influx of COVID patients, hospitals become short staffed due to their own employees’ COVID sicknesses, resulting in clinical staff being reassigned to cover the shortfall. This lack of available clinical personnel continues to slow enrollment at our clinical sites.

 

Finally, COVID impacts our patient population. Patients with COVID or who have had COVID within ninety (90) days of their screening, are excluded from our study until after the ninety (90) day period has passed. In addition, concerns about getting COVID impact the patients’ willingness to undergo an elective surgical procedure with a one-night hospital stay. As hospital clinical operations return to more normal levels, our goal is to fully enroll the SAVVE pivotal trial by the end of 2022 or the beginning of 2023. We continue to monitor the ongoing overall impact of COVID on the SAVVE clinical trial and will issue updates when appropriate.

 

In February of 2021, we raised $41.4 million of capital in a public offering of our common stock. In September of 2021, we raised $20 million dollars of capital in a registered direct offering priced at the market under Nasdaq rules and purchased by a fund managed by Perceptive Advisors, a leading life sciences investment firm. We finished 2021 with approximately $55 million of cash and had approximately $9.1 million of cash and $38.1 million of investments at June 30, 2022. At our existing cash burn rate of approximately $4 million per quarter, we should have sufficient cash to fund operations through the end of 2024 and into 2025. With primary endpoints following full enrollment in the SAVVE pivotal trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data well in advance of the need to raise additional capital.

 

11

 

 

Results of Operations

 

Comparison of the three months ended June 30, 2022 and 2021

 

Overview

 

We reported net losses of $7.1 million and $2.4 million for the three months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $4.7 million, or 197%, resulting from an increase in operating expenses and other expenses.

 

Revenues

 

As a developmental stage Company, our revenue, if any, is expected to be diminutive and dependent on our ability to commercialize our product candidates. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.

 

Selling, General and Administrative Expenses

 

For the three months ended June 30, 2022, selling, general and administrative expenses increased by $2.6 million or 202%, to $3.9 million from $1.3 million for the three months ended June 30, 2021. Of this increase, $2.1 million was due to share based compensation from grants made during 2021, which increased share-based compensation cost to $2.3 million in 2022 from $0.2 million in 2021.

 

The remaining $0.5 million increase reflects $0.2 million from consulting for reimbursement codes for the Company’s product once commercially approved, $0.1 million from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.1 million from higher information technology and other office expense to support increases in staff, and $0.1 million in compensation due to increased staff.

 

Research and Development Expenses

 

For the three months ended June 30, 2022, research and development expenses increased by $2.0 million or 182%, to $3.1 million from $1.1 million for the three months ended June 30, 2021. This increase primarily resulted from $1.4 million in costs related the SAVVE study, $0.4 million in lab costs to support the SAVVE study and VenoValve continued development, $0.1 million increase in personnel costs due to additional staff, and $0.1 million in travel costs mainly to support the SAVVE study.

 

Other (Income) Expense

 

For the three months ended June 30, 2022 other (income) expense increased $0.1 million from nil for the three months ended June 30, 2021. This change is primarily related to unrealized loss from investments which reflects changes in market value of the US Treasuries purchased by the Company. We expect the market value of these investments to fluctuate somewhat during their term, however all these Treasuries were purchased to provide a positive yield over their term.

 

Comparison of the six months ended June 30, 2022 and 2021

 

Overview

 

We reported net losses of $12.4 million and $5.2 million for the six months ended June 30, 2022 and 2021, respectively, representing an increase in net loss of $7.2 million or 141%, due to an increase in operating expenses of $7.1 million and an increase in other income and expense of $0.1 million.

 

Selling, General and Administrative Expenses

 

For the six months ended June 30, 2022, selling, general and administrative expenses increased $5.2 million or 211%, to $7.7 million from $2.5 million for the six months ended June 30, 2021. Of this increase, $4.2 million was due to share based compensation from grants made during 2021, which increased share-based compensation cost to $4.5 million in 2022 from $0.3 million in 2021.

 

The remaining $1.0 million increase in expenses is attributable to $0.3 million of consulting costs for reimbursement codes for the Company’s product to be used once the product is commercially approved, if ever, $0.2 million from higher legal costs mainly related to intellectual property, $0.2 million from higher Delaware franchise taxes in 2022 which increased due to changes in our capital structure, $0.2 million from higher information technology and other office expense to support increases in staff and $0.1 million from higher insurance costs related to increased coverages for cyber risks and higher a D&O insurance premium.

 

Research and Development Expenses

 

For the six months ended June 30, 2022, research and development expenses increased by $1.9 million or 70%, to $4.6 million from $2.7 million for the six months ended June 30, 2021.

 

This increase primarily resulted from $1.5 million in costs related the SAVVE study, $0.1 million in lab costs to support the SAVVE study and VenoValve continued development, $0.1 million increase in personnel costs due to additional staff, $0.1 million in travel costs to support the SAVVE study, and $0.1 million in costs for the preparing regulatory submissions related to SAVVE.

 

Other (Income) Expense

 

For the six months ended June 30, 2022 other (income) expense increased $0.1 million from nil for the six months ended June 30, 2021. This change is primarily related to unrealized loss from investments which reflects changes in market value of the US Treasuries purchased by the Company. We expect the market value of these investments to fluctuate somewhat during their term, however all these Treasuries were purchased to provide a positive yield over their term.

 

12

 

 

Liquidity and Capital Resources

 

For the six-months ended June 30, 2022, the Company incurred losses from operations of $12.4 million and used $7.3 million cash in operating activities. The net cash used in operating activities during the 2022 period increased by $0.8 from $6.5 million for the six-months ended June 30, 2021.

 

The losses and the uses of cash are primarily due to the Company’s administrative and product research and development activities. Administrative functions relate to costs to support the Company’s public reporting and investor relations activities as well as internal administrative functions. Research and development activities are for continued product development and clinical trials for the VenoValve, currently primarily the SAVVE study. The Company will continue to incur these costs to complete its clinical trials, enhance products, develop new products, and operate as a public company. Although we have discretion in how we use the Company’s cash resources, we expect to continue these activities for the foreseeable future as we seek to obtain regulatory approval for our lead product candidate. We are not currently generating revenue and do not expect significant revenue until we successfully commercialize our lead product candidate.

 

Our cash flows from investing activity have historically consisted of purchases of property and equipment for our lab and offices. However, during the period ending June 30, 2022, we commenced a program to invest excess cash in US Treasury bills. In the six months ended June 30, 2022, we purchased $38.3 million of these investments and expect to continue investing as the treasury bills mature and as allowed by the cash requirements of our operations. Also, during the six months ending June 30, 2022, we purchased $0.1 million of property and equipment consisting primarily of lab and test equipment.

 

We do not currently have material commitments for capital expenditures or other expenditures with the exception of our facility lease commitment of $0.4 million per year. However, we expect a modest increase in purchases of property and equipment as we continue SAVVE and plan for commercialization of the VenoValve.

 

The Company has historically funded its operations through financing activities such as the capital raises completed in 2021. During 2021, the Company raised an aggregate of $57.4 million in net proceeds in private and public placements of its securities. Our cash balance as of June 30, 2022, is $9.1 million. In addition, we have $38.1 million in investments, for total cash and investments of $47.2 million.

 

Our future capital requirements will remain dependent upon a variety of factors, especially including the success of our clinical trials and related product development costs and our ability to successfully bring products to market. At our existing cash burn rate of approximately $4 million per quarter, we should have sufficient cash to fund operations through the end of 2024 and into 2025. With primary endpoints following full enrollment in the SAVVE pivotal trial of thirty (30) days for safety, and six (6) months for effectiveness, we expect to have primary endpoint data well in advance of the need to raise additional capital. Any inability to raise additional financing would have a material adverse effect on us.

 

Based upon our cash and working capital as of June 30, 2022, we have sufficient capital resources to meet our obligations as they become due for at least one year after the date of this Report and sustain operations.

 

As of August 1, 2022, our cash balance was $5.5 million and our investment balance was $40.7 million.

 

The COVID-19 pandemic continues to disrupt the global economy and has negatively impacted large populations including people and businesses that may be directly or indirectly involved with the operation of our Company and the manufacturing, development, and testing of our product candidates. COVID with its variants continues to have both direct and indirect consequences on our clinical trial. Several of our clinical sites put elective surgeries on hold and prohibited potential study subjects from coming to the hospital for screening. Further COVID resurgences put an enormous strain on all hospital resources including clinical staffs. The lack of available clinical personnel both slows enrollment and impacts the speed at which we can activate clinical sites.

 

COVID has also impacted our patient population. Patients with COVID or who have had COVID within ninety (90) days of their screening, are excluded from our study until after the ninety (90) day period has passed. In addition, concerns about getting COVID impact the patients’ willingness to undergo an elective surgical procedure with a one-night hospital stay. As hospital clinical operations return to more normal levels, our goal is to fully enroll the SAVVE pivotal trial by the end of 2022 or the beginning of 2023. We continue to monitor the ongoing overall impact of COVID on the SAVVE clinical trial and will issue updates when appropriate.

 

13

 

 

Off-Balance Sheet Arrangements

 

None.

 

Contractual Obligations

 

As a smaller reporting company, we are not required to provide the information requested by paragraph (a)(5) of this Item.

 

Critical Accounting Policies and Estimates

 

For a description of our critical accounting policies, see Note 3 – Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q.

 

Item 3. Quantitative and Qualitative Disclosure About Market Risk

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item.

 

Item 4: Controls and Procedures

 

Disclosure Controls and Procedures

 

Our management carried out an evaluation, under the supervision and with the participation of our Chief Executive Officer (who is our Principal Executive Officer) and our Chief Financial Officer (who is our Principal Financial Officer and Principal Accounting Officer), of the effectiveness of the design of our disclosure controls and procedures (as defined by Exchange Act Rules 13a-15(e) or 15d-15(e)) as of June 30, 2022, pursuant to Exchange Act Rule 13a-15(b). Based upon that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that our disclosure controls and procedures were effective as of June 30, 2022.

 

14

 

 

Changes in Internal Control over Financial Reporting

 

During the six months ended June 30, 2022, there were no changes in our internal controls over financial reporting, or in other factors that could significantly affect these controls, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Inherent Limitations of Controls

 

Management does not expect that our disclosure controls and procedures or our internal control over financial reporting will prevent or detect all error and all fraud. Controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or deterioration in the degree of compliance with the policies or procedures. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

15

 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time we may be subject to litigation and arbitration claims incidental to its business. Such claims may not be covered by our insurance coverage, and even if they are, if claims against us are successful, they may exceed the limits of applicable insurance coverage.

 

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. The complaint asserts 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 with the Company. Mr. Rankin alleges that he was forced to resign, however, we believe that he did not give the Company notice or an opportunity to cure the allegations. The complaint seeks, inter alia, back pay, unpaid wages, compensatory damages, punitive damages, attorneys’ fees, and costs. 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 complaint asserts several causes of action, including defamation, unlawful labor code violations, sex-based discrimination, unfair competition, and seeks damages for lost wages, emotional and mental distress, consequential damages, punitive damages and attorney’s fees and costs. Mr. Rankin resigned as the Company’s Chief Financial Officer, Secretary and Treasurer on March 30, 2020. 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 October 24, 2022.

 

Item 1A. Risk Factors

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide information required by this Item. Our current risk factors are set forth in our Form 10-K, filed with the SEC on March 28, 2022.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine and Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

None.

 

16

 

 

Item 6. Exhibits

 

The following is a complete list of exhibits filed as part of this Form 10-Q. Exhibit numbers correspond to the numbers in the Exhibit Table of Item 601 of Regulation S-K.

 

Exhibit   Description
     
31.1   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act. *
31.2   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Sarbanes-Oxley Act. *
32   Certification of Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act**
101.INS   Inline XBRL Instance Document*
101.SCH   Inline XBRL Taxonomy Extension Schema Document*
101.CAL   Inline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF   Inline XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB   Inline XBRL Taxonomy Extension Label Linkbase Document*
101.PRE   Inline XBRL Taxonomy Extension Presentation Linkbase Document*
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* Filed herewith.
** Furnished herewith.

 

17

 

 

SIGNATURES

 

Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: August 3, 2022 ENVVENO MEDICAL CORPORATION
     
  By: /s/ Robert Berman
    Robert Berman
    Chief Executive Officer
    (Principal Executive Officer)
     
  By: /s/ Craig Glynn
    Craig Glynn
    Chief Financial Officer
    (Principal Financing and Accounting Officer)

 

18

 EX-31.1 2 ex31-1.htm

 

Exhibit 31.1

 

CERTIFICATION PURSUANT TO RULE 13a-14(a) OF THE
SECURITIES EXCHANGE ACT OF 1934

 

I, Robert Berman, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of enVVeno Medical Corporation;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

August 3, 2022   /s/ Robert Berman
  Name: Robert Berman
  Title: Chief Executive Officer
    (Principal Executive Officer)

 

 
 EX-31.2 3 ex31-2.htm

 

Exhibit 31.2

 

CERTIFICATION PURSUANT TO RULE 13a-14(a) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

I, Craig Glynn, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of enVVeno Medical Corporation;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

August 3, 2022   /s/ Craig Glynn
  Name: Craig Glynn
  Title: Chief Financial Officer
    (Principal Financial Officer)

 

 
 EX-32 4 ex32.htm

 

Exhibit 32

 

CERTIFICATION PURSUANT TO

18 U.S.C. §1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of enVVeno Medical Corporation (the “Company’s Quarterly Report”) on Form 10-Q for the period ended June 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), Robert Berman, as Chief Executive Officer and principal executive officer and Craig Glynn, as Chief Financial Officer and principal financial officer of the Company hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of the undersigned’s knowledge and belief, that:

 

  1. The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
  2. Information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of the dates and for the periods expressed in the Report.

 

/s/ Robert Berman  
Robert Berman  
Chief Executive Officer and Principal Executive Officer  
   
Dated: August 3, 2022  
   
/s/ Craig Glynn  
Craig Glynn  
Chief Financial Officer and Principal Financial Officer  

 

Dated: August 3, 2022

 

This certification accompanies this Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

 

 

 

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Aug. 01, 2022
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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, $0.00001 par value  
Trading Symbol NVNO  
Security Exchange Name NASDAQ  
Warrant to purchase common stock [Member]    
Title of 12(b) Security Warrant to Purchase Commons Stock  
Trading Symbol NVNOW  
Security Exchange Name NASDAQ  
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Condensed Balance Sheets (Unaudited) - USD ($)
$ 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
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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
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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
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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      
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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)
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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.

 
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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 million, investments of $38.1 million and working capital of $35.6 million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that our capital resources at June 30, 2022 are sufficient to meet our obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.

 
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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)

 
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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:

 

(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.

 
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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 at each institution. There were aggregate uninsured cash balances of $8.8 and $54.5 million as of June 30, 2022 and December 31, 2021, respectively.

 

 

ENVVENO MEDICAL CORPORATION

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 
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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:

 

   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 

 
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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
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 
XML 23 R14.htm IDEA: XBRL DOCUMENT v3.22.2
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 shares with a weighted average exercise price of $6.83 per share. The Company recognized $4.5 million and $0.3 million of share-based compensation related to stock options during the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, there was $10.6 million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of 1.7 years.

 
XML 24 R15.htm IDEA: XBRL DOCUMENT v3.22.2
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:

 

   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 

 
XML 25 R16.htm IDEA: XBRL DOCUMENT v3.22.2
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)

 
XML 26 R17.htm IDEA: XBRL DOCUMENT v3.22.2
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:

 

(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 
XML 27 R18.htm IDEA: XBRL DOCUMENT v3.22.2
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:

 

   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 
XML 28 R19.htm IDEA: XBRL DOCUMENT v3.22.2
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:

 

   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 
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.22.2
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
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.22.2
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  
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.22.2
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
XML 32 R23.htm IDEA: XBRL DOCUMENT v3.22.2
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
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.22.2
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  
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.22.2
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
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margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 1 – <span id="xdx_82F_zmCmQIcSUpR2">Business Organization and Nature of Operations</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_804_eus-gaap--SubstantialDoubtAboutGoingConcernTextBlock_z5Vrxtcn2Aye" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 2 – <span id="xdx_822_zeOlopv5C488">Management’s Liquidity Plan</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of June 30, 2022, the Company had a cash balance of $<span id="xdx_90A_eus-gaap--Cash_iI_pn5n6_c20220630_z1abydsNvAFf" title="Cash">9.1</span> million, investments of $<span id="xdx_903_eus-gaap--Investments_iI_pn5n6_c20220630_z8XqVx63jIs3" title="Investments">38.1</span> million and working capital of $<span id="xdx_904_ecustom--WorkingCapital_iI_pn5n6_c20220630_z7tnnOUrjO" title="Working capital">35.6</span> million. Although the Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products, Management believes that our capital resources at June 30, 2022 are sufficient to meet our obligations as they become due within one year after the date of this Quarterly Report, and sustain operations.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 9100000 38100000 35600000 <p id="xdx_803_eus-gaap--SignificantAccountingPoliciesTextBlock_zTuTlrmPitI3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 3 – <span id="xdx_826_zMtVNGpoMva">Significant Accounting Policies</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84F_eus-gaap--BasisOfAccountingPolicyPolicyTextBlock_z7ajPNBn8nM3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86B_z1YXIElr6ctl">Basis of Presentation</span></i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p id="xdx_84E_eus-gaap--InvestmentPolicyTextBlock_zLmxLQisPnV2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_861_zNBhCY4lPOci">Investments</span></i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i> </i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">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.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>ENVVENO MEDICAL CORPORATION</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTES TO CONDENSED FINANCIAL STATEMENTS</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(unaudited)</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_84F_eus-gaap--BasisOfAccountingPolicyPolicyTextBlock_z7ajPNBn8nM3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_86B_z1YXIElr6ctl">Basis of Presentation</span></i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"> </p> <p id="xdx_84E_eus-gaap--InvestmentPolicyTextBlock_zLmxLQisPnV2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i><span id="xdx_861_zNBhCY4lPOci">Investments</span></i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i> </i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in">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.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>ENVVENO MEDICAL CORPORATION</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTES TO CONDENSED FINANCIAL STATEMENTS</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(unaudited)</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_80F_eus-gaap--InvestmentsInDebtAndEquityInstrumentsCashAndCashEquivalentsUnrealizedAndRealizedGainsLossesTextBlock_zX4FUyNyyCnd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 4 – <span id="xdx_828_z7hFh1QDVMO">Investments</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_894_eus-gaap--InvestmentTableTextBlock_z1FzCgOnYus5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The components of investments were as follows at June 30, 2022:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B0_zeYEYdX6U5Ya" style="display: none">Schedule of Investments</span> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left; padding-bottom: 1.5pt"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Cash Equivalents</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Short-Term Investment</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Long Term Investment</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left"><b>Fair Value Level 1</b></td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt; width: 46%; text-align: left">U.S. Government securities</td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98F_eus-gaap--CashEquivalentsAtCarryingValue_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_z44mnliwSU7g" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">2,248</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_983_eus-gaap--ShortTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zs0Q7U2ht5p" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">28,413</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98C_eus-gaap--LongTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zMnxcsbX51w1" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">9,706</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt; text-align: left">Total debt investments</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_981_eus-gaap--CashEquivalentsAtCarryingValue_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zminGA7vXkOj" style="border-bottom: Black 1.5pt solid; text-align: right">2,248</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_983_eus-gaap--ShortTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zFuS2BxCQZDf" style="border-bottom: Black 1.5pt solid; text-align: right">28,413</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_989_eus-gaap--LongTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zn6qpcy1R926" style="border-bottom: Black 1.5pt solid; text-align: right">9,706</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A4_zSF3S5olJIid" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 60pt"/> <p id="xdx_894_eus-gaap--InvestmentTableTextBlock_z1FzCgOnYus5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The components of investments were as follows at June 30, 2022:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B0_zeYEYdX6U5Ya" style="display: none">Schedule of Investments</span> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td> <td colspan="2" style="font-size: 12pt"> </td><td style="font-size: 12pt"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left; padding-bottom: 1.5pt"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Cash Equivalents</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Short-Term Investment</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center; font-weight: bold">Long Term Investment</td><td style="text-align: center; padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left"><b>Fair Value Level 1</b></td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"/><td style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt; width: 46%; text-align: left">U.S. Government securities</td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98F_eus-gaap--CashEquivalentsAtCarryingValue_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_z44mnliwSU7g" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">2,248</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_983_eus-gaap--ShortTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zs0Q7U2ht5p" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">28,413</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td><td style="padding-bottom: 1.5pt; width: 2%"> </td> <td style="border-bottom: Black 1.5pt solid; width: 1%; text-align: left">$</td><td id="xdx_98C_eus-gaap--LongTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByFairValueHierarchyLevelAxis__us-gaap--FairValueInputsLevel1Member__us-gaap--InvestmentTypeAxis__us-gaap--USTreasurySecuritiesMember__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zMnxcsbX51w1" style="border-bottom: Black 1.5pt solid; width: 14%; text-align: right">9,706</td><td style="padding-bottom: 1.5pt; width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt; text-align: left">Total debt investments</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_981_eus-gaap--CashEquivalentsAtCarryingValue_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zminGA7vXkOj" style="border-bottom: Black 1.5pt solid; text-align: right">2,248</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_983_eus-gaap--ShortTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zFuS2BxCQZDf" style="border-bottom: Black 1.5pt solid; text-align: right">28,413</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left">$</td><td id="xdx_989_eus-gaap--LongTermInvestments_iI_pn3n3_c20220630__us-gaap--FairValueByAssetClassAxis__us-gaap--DebtSecuritiesMember_zn6qpcy1R926" style="border-bottom: Black 1.5pt solid; text-align: right">9,706</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> </table> 2248000 28413000 9706000 2248000 28413000 9706000 <p id="xdx_806_eus-gaap--ConcentrationRiskDisclosureTextBlock_zKp88pNnWelf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 5 – <span id="xdx_82C_zUHU35Ed9Vb8">Concentrations</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 $<span id="xdx_90A_eus-gaap--CashFDICInsuredAmount_iI_pn3n3_c20220630_zOloueewDS4i" title=" FDIC amount">250</span> at each institution. There were aggregate uninsured cash balances of $<span id="xdx_907_eus-gaap--CashUninsuredAmount_iI_pn5n6_c20220630_zqe41l7qIXKl" title="Uninsured amount">8.8</span> and $<span id="xdx_907_eus-gaap--CashUninsuredAmount_iI_pn5n6_c20211231_zBrIMfQraXph" title="Uninsured amount">54.5</span> million as of June 30, 2022 and December 31, 2021, respectively.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>ENVVENO MEDICAL CORPORATION</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTES TO CONDENSED FINANCIAL STATEMENTS</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(unaudited)</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 250000 8800000 54500000 <p id="xdx_80D_eus-gaap--AccountsPayableAccruedLiabilitiesAndOtherLiabilitiesDisclosureCurrentTextBlock_z5FVHDfYpiB8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 6 – <span id="xdx_824_zDmlGnVHtSwi">Accrued Expenses and Other Current Liabilities</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89C_eus-gaap--ScheduleOfAccruedLiabilitiesTableTextBlock_zYQGHAouDB78" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of June 30, 2022, and December 31, 2021, accrued expenses and other current liabilities consist of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B2_zg4wvlUdN0Xk" style="display: none">Schedule of Accrued Expenses and Other Current Liabilities</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_497_20220630_zbOC7IRtiJV9" style="font-weight: bold; text-align: center">June 30,</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_493_20211231_zFuGi12S5nG" style="font-weight: bold; text-align: center">December 31,</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr id="xdx_407_eus-gaap--WorkersCompensationLiabilityCurrent_iI_pn3n3_maALAOLzCZ3_zJBKdHGr2iAl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Accrued compensation costs</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">374</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">525</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--AccruedProfessionalFeesCurrent_iI_pn3n3_maALAOLzCZ3_zO2cvbsCAvu9" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Accrued professional fees</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">46</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">84</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_ecustom--AccruedResearchAndDevelopmentCurrent_iI_pn3n3_maALAOLzCZ3_zVJo5vOBSDs" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Accrued research and development</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0485">-</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">60</td><td style="text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pn3n3_maALAOLzCZ3_zT6MCtlGKGf7" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Other accrued expenses</td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">59</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">60</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--AccruedLiabilitiesAndOtherLiabilities_iTI_pn3n3_mtALAOLzCZ3_zeA1rHAd7d77" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-left: 10pt; text-align: left">Total accrued expenses and other current liabilities</td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">479</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">729</td><td style="text-align: left"> </td></tr> </table> <p id="xdx_8AB_zakPuTgtW5Of" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89C_eus-gaap--ScheduleOfAccruedLiabilitiesTableTextBlock_zYQGHAouDB78" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of June 30, 2022, and December 31, 2021, accrued expenses and other current liabilities consist of the following:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8B2_zg4wvlUdN0Xk" style="display: none">Schedule of Accrued Expenses and Other Current Liabilities</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_497_20220630_zbOC7IRtiJV9" style="font-weight: bold; text-align: center">June 30,</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_493_20211231_zFuGi12S5nG" style="font-weight: bold; text-align: center">December 31,</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr id="xdx_407_eus-gaap--WorkersCompensationLiabilityCurrent_iI_pn3n3_maALAOLzCZ3_zJBKdHGr2iAl" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Accrued compensation costs</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">374</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">525</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--AccruedProfessionalFeesCurrent_iI_pn3n3_maALAOLzCZ3_zO2cvbsCAvu9" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Accrued professional fees</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">46</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">84</td><td style="text-align: left"> </td></tr> <tr id="xdx_409_ecustom--AccruedResearchAndDevelopmentCurrent_iI_pn3n3_maALAOLzCZ3_zVJo5vOBSDs" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Accrued research and development</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right"><span style="-sec-ix-hidden: xdx2ixbrl0485">-</span></td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">60</td><td style="text-align: left"> </td></tr> <tr id="xdx_402_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pn3n3_maALAOLzCZ3_zT6MCtlGKGf7" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Other accrued expenses</td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">59</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">60</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--AccruedLiabilitiesAndOtherLiabilities_iTI_pn3n3_mtALAOLzCZ3_zeA1rHAd7d77" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-left: 10pt; text-align: left">Total accrued expenses and other current liabilities</td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">479</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">729</td><td style="text-align: left"> </td></tr> </table> 374000 525000 46000 84000 60000 59000 60000 479000 729000 <p id="xdx_80D_eus-gaap--CommitmentsAndContingenciesDisclosureTextBlock_zA1SFLEnvXC1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 7 – <span id="xdx_82C_zHS8u0Db5GNj">Commitments and Contingencies</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Litigations Claims and Assessments</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Robert Rankin Complaints</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i> </i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: center; margin-top: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>ENVVENO MEDICAL CORPORATION<br/> NOTES TO CONDENSED FINANCIAL STATEMENTS</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>(unaudited)</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-bottom: 0pt; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_801_eus-gaap--StockholdersEquityNoteDisclosureTextBlock_z4v5mzPZBs74" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 8 –<span id="xdx_825_zAVmuZkoS0o3">Stockholders’ Equity</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><i>Stock Options</i></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 <span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriodGross_pid_dc_uShares_c20220101__20220630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__srt--TitleOfIndividualAxis__custom--EmployeesMember_zTiPinQ5KO66" title="Number of options granted"><span style="-sec-ix-hidden: xdx2ixbrl0498">thirty-thousand</span></span> shares with a weighted average exercise price of $<span id="xdx_901_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_pid_c20220101__20220630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember__srt--TitleOfIndividualAxis__custom--EmployeesMember_zHYK3nV7rXx4" title="Weighted average exercise price">6.83</span> per share. The Company recognized $<span id="xdx_900_eus-gaap--ShareBasedCompensation_pn5n6_c20220101__20220630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zyvLxYR9r3Pc" title="Stock-based compensation">4.5</span> million and $<span id="xdx_90A_eus-gaap--ShareBasedCompensation_pn5n6_c20210101__20210630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zR88wqYrHGkj" title="Stock-based compensation">0.3</span> million of share-based compensation related to stock options during the six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022, there was $<span id="xdx_90A_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedStockOptions_iI_pn5n6_c20220630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zz2E1VB6PiB8" title="Unrecognized stock-based compensation expense">10.6</span> million of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of <span id="xdx_90D_eus-gaap--EmployeeServiceShareBasedCompensationNonvestedAwardsTotalCompensationCostNotYetRecognizedPeriodForRecognition1_dtY_c20220101__20220630__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zxfttCuuk2e8" title="Weighted average remaining vesting period">1.7</span> years.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 6.83 4500000 300000 10600000 P1Y8M12D <p id="xdx_801_eus-gaap--EarningsPerShareTextBlock_zr07DpugQLvk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Note 9 – <span id="xdx_824_zAkD4arOk2D3">Net Loss per Share</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_891_eus-gaap--ScheduleOfAntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareTextBlock_zeVDlRnXRJo2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B0_zRe5hXjvH9ld" style="display: none">Schedule of Dilutive Net Loss Per Common Share</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_49B_20220101__20220630_zTa3dKHvtxdk" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_495_20210101__20210630_zoxdQ3DnU60e" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">June 30,</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr id="xdx_403_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--WarrantMember_zqoLRnL566p8" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Shares of common stock issuable upon exercise of warrants</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">4,578</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">4,402</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--EmployeeStockOptionMember_zVyrimNWiNIc" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Shares of common stock issuable upon exercise of options</td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">3,445</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">386</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_zW41BLMmzzef" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Potentially dilutive common stock equivalents excluded from diluted net loss per share</td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right">8,023</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right">4,788</td><td style="text-align: left"> </td></tr> </table> <p id="xdx_8A8_zRPBMaORzxy9" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_891_eus-gaap--ScheduleOfAntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareTextBlock_zeVDlRnXRJo2" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B0_zRe5hXjvH9ld" style="display: none">Schedule of Dilutive Net Loss Per Common Share</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 100%"> <tr style="display: none; vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_49B_20220101__20220630_zTa3dKHvtxdk" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" id="xdx_495_20210101__20210630_zoxdQ3DnU60e" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">June 30,</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: left"><i>(In thousands)</i></td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="text-align: center; font-weight: bold"> </td><td style="text-align: center; font-weight: bold"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2021</td><td style="text-align: center; font-weight: bold"> </td></tr> <tr id="xdx_403_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--WarrantMember_zqoLRnL566p8" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Shares of common stock issuable upon exercise of warrants</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">4,578</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">4,402</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_409_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_hus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--EmployeeStockOptionMember_zVyrimNWiNIc" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Shares of common stock issuable upon exercise of options</td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">3,445</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">386</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pn3n3_zW41BLMmzzef" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Potentially dilutive common stock equivalents excluded from diluted net loss per share</td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right">8,023</td><td style="text-align: left"> </td><td> </td> <td style="border-bottom: Black 2.5pt double; text-align: left"> </td><td style="border-bottom: Black 2.5pt double; text-align: right">4,788</td><td style="text-align: left"> </td></tr> </table> 4578000 4402000 3445000 386000 8023000 4788000 EXCEL 36 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx M4$L#!!0 ( $V# U4'04UB@0 +$ 0 9&]C4')O<',O87!P+GAM M;$V./0L",1!$_\IQO;=!P4)B0-!2L+(/>QLOD&1#LD)^OCG!CVX>;QA&WPIG M*N*I#BV&5(_C(I(/ !47BK9.7:=N')=HI6-Y #OGDK7A.YNJQ<&4GPZ4A!0W_J=0U[R;UEA_6\#MI7E!+ P04 M " !-@P-50)%D5^X K @ $0 &1O8U!R;W!S+V-O&ULS9+! 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