UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended JuneSeptember 30, 20182020

 

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

 

Hancock Jaffe Laboratories, Inc.

(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

Warrant to Purchase Commons Stock

The NASDAQ Stock Market LLC

The NASDAQ Stock Market LLC

HJLI

HJLW

 

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 [X] No [  ] No [X]

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).

Yes [x][X] 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[  ]X](Do not check if a smaller reporting company)Smaller reporting company[X]
 Emerging growth company[X]

 

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. [X]

 

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

Yes [  ] No [X]

 

As of August 10, 2018,November 16, 2020, there were 11,717,30749,775,443 shares of common stock outstanding.

 

 

 

 
 

 

HANCOCK JAFFE LABORATORIES, INC.

TABLE OF CONTENTS

 

PART I 
  
FINANCIAL INFORMATION 
  
ITEM 1. Financial Statements
Condensed Balance Sheets as of June 30, 2018 (unaudited) and December 31, 20171
  
Unaudited Condensed StatementsBalance Sheets as of Operations for the ThreeSeptember 30, 2020 (unaudited) and Six Months Ended June 30, 2018 and 2017December 31, 20192
Unaudited Condensed Statement of Changes in Stockholders’ Deficiency for the Three and Six Months Ended June 30, 201831
  
Unaudited Condensed Statements of Operations for the three and nine months ended September 30, 2020 and 20192
Unaudited Condensed Statements of Changes in Stockholders’ Equity (Deficiency) for the nine months ended September 30, 2020 and 20193
Unaudited Condensed Statements of Cash Flows for the Threenine months ended September 30, 2020 and Six Months Ended June 30, 2018 and 201720194
  
Notes to Unaudited Condensed Financial Statements6
 ��
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations2421
  
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk3326
  
ITEM 4. Controls and Procedures3326
  
PART II 
  
OTHER INFORMATION28
  
ITEM 1. Legal Proceedings3428
  
ITEM 1A. Risk Factors3428
  
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds3430
  
ITEM 3. Defaults Upon Senior Securities3431
  
ITEM 4. Mine Safety Disclosures3431
  
ITEM 5. Other Information3431
  
ITEM 6. Exhibits3532
  
Signatures3633

 

 
 

 

PART I – FINANCIAL INFORMATION

ITEM 1 – Financial Statements

 

HANCOCK JAFFE LABORATORIES, INC.

CONDENSED BALANCE SHEETS

 

  June 30,  December 31, 
  2018  2017 
  (unaudited)    
Assets        
Current Assets:        
Cash $5,942,424  $77,688 
Accounts receivable, net  28,964   35,181 
Prepaid expenses and other current assets  137,632   57,544 
Total Current Assets  6,109,020   170,413 
Property and equipment, net  19,084   23,843 
Intangible assets, net  1,047,756   1,109,410 
Deferred offering costs  -   880,679 
Security deposits and other assets  29,843   30,543 
Total Assets $7,205,703  $2,214,888 
         
Liabilities, Temporary Equity and Stockholders’ Equity (Deficiency)        
Current Liabilities:        
Accounts payable $1,361,288  $1,451,244 
Accrued expenses and other current liabilities  1,184,796   903,594 
Accrued interest - related parties  -   20,558 
Convertible notes payable, net of debt discount  -   1,574,832 
Convertible note payable - related party  -   499,000 
Notes payable  -   275,000 
Notes payable - related party  -   270,038 
Deferred revenue  49,000   103,400 
Derivative liabilities  -   3,076,918 
Total Liabilities  2,595,084  8,174,584 
         
Redeemable Convertible Series A Preferred Stock, par value $0.00001, 0 and 1,005,700 shares issued and outstanding and liquidation preference of $0 and $10,801,863 at June 30, 2018 and December 31, 2017, respectively  -   3,935,638 
Redeemable Convertible Series B Preferred Stock, par value $0.00001, 0 and 253,792 shares issued and outstanding and liquidation preference of $0 and $3,103,416 at June 30, 2018 and December 31, 2017, respectively  -   1,235,117 
Commitments and Contingencies        
Stockholders’ Equity (Deficiency):        
Preferred stock, par value $0.00001, 10,000,000 shares authorized: no shares issued or outstanding  -   - 
Common stock, par value $0.00001, 50,000,000 shares authorized, 11,717,307 and 6,133,678 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively  117   61 
Additional paid-in capital  49,923,221   24,389,307 
Accumulated deficit  (45,312,719)  (35,519,819)
Total Stockholders’ Equity (Deficiency)  4,610,619   (11,130,451)
Total Liabilities, Temporary Equity and Stockholders’ Equity (Deficiency) $7,205,703  $2,214,888 
  September 30,  December 31, 
  2020  2019 
   (unaudited)     
Assets        
Current Assets:        
Cash and cash equivalents $5,629,003  $1,307,231 
Prepaid expenses and other current assets  348,653   116,647 
Total Current Assets  5,977,656   1,423,878 
Property and equipment, net  425,526   344,027 
Restricted Cash  -   810,055 
Operating lease right-of-use assets, net  609,656   826,397 
Security deposits and other assets  29,843   29,843 
Total Assets $7,042,681  $3,434,200 
         
Liabilities and Stockholders’ Equity        
Current Liabilities:        
Accounts payable $974,229  $1,221,189 
Accrued expenses and other current liabilities  287,672   333,438 
Note Payable  312,700   - 
Deferred revenue - related party  33,000   33,000 
Current portion of operating lease liabilities  307,823   288,685 
Total Current Liabilities  1,915,424   1,876,312 
Long-term operating lease liabilities  332,296   567,948 
Total Liabilities  2,247,720   2,444,260 
         
Commitments and Contingencies  -   - 
Stockholders’ Equity:        
Convertible preferred stock, par value $0.00001, 10,000,000 shares authorized: 4,205,406 and 0 shares issued or outstanding as of September 30, 2020 and December 31, 2019, respectively  42   - 
Common stock, par value $0.00001, 250,000,000 shares authorized, 40,242,734 and 17,931,857 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively  403   179 
Additional paid-in capital  65,743,924   57,177,686 
Accumulated deficit  (60,949,408)  (56,187,925)
Total Stockholders’ Equity  4,794,961   989,940 
Total Liabilities and Stockholders’ Equity $7,042,681  $3,434,200 

 

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

 

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
             
Revenues:                
Product sales $-  $-  $-  $152,400 
Royalty income  28,963   38,800   60,028   66,708 
Contract research - related party  54,400   -   54,400   - 
Total Revenues  83,363   38,800   114,428   219,108 
Cost of revenues  -   -   -   188,734 
Gross Profit  83,363   38,800   114,428   30,374 
                 
Selling, general and administrative expenses  2,914,723   1,085,624   4,161,731   2,135,167 
Research and development expenses  280,419   184,919   520,912   257,579 
Loss from Operations  (3,111,779)  (1,231,743)  (4,568,215)  (2,362,372)
                 
Other Expense (Income):                
Amortization of debt discount  2,005,479   23,634   6,575,236   23,634 
Loss (gain) on extinguishment of convertible notes payable  43,474   -   (1,481,317)  - 
Interest expense, net  111,960   15,682   322,422   24,934 
Change in fair value of derivative liabilities  (227,279)  (22,147)  (191,656)  1,622 
Total Other Expense  1,933,634   17,169   5,224,685   50,190 
                 
Net Loss  (5,045,413)  (1,248,912)  (9,792,900)  (2,412,562)
Deemed dividend to preferred stockholders  (3,180,860)  (113,779)  (3,310,001)  (214,911)
Net Loss Attributable to Common Stockholders $(8,226,273) $(1,362,691) $(13,102,901) $(2,627,473)
                 
Net Loss Per Basic and Diluted Common Share: $(1.06) $(0.22) $(1.88) $(0.43)
                 

Weighted Average Number of Common Shares Outstanding:

                
Basic and Diluted  7,781,603   6,123,482   6,962,193   6,062,082 

  For the Three Months Ended  For the Nine Months Ended 
  September 30,  September 30, 
  2020  2019  2020  2019 
             
Revenues:                
Royalty income $-  $-  $-  $31,243 
Total Revenues  -   -   -   31,243 
                 
Selling, general and administrative expenses  1,164,089   1,157,064   3,001,720   3,989,274 
Research and development expenses  758,198   676,970   1,974,995   1,418,293 
Loss from Operations  (1,922,287)  (1,834,034)  (4,976,715)  (5,376,324)
                 
Other (Income) Expense:                
Interest (income) expense, net  (564)  (19,139)  (3,425)  (41,680)
Change in fair value of derivative liabilities  53,046   -   (211,807)  - 
Total Other (Income) Expense  52,482   (19,139)  (215,232)  (41,680)
Net Loss  (1,974,769)  (1,814,895)  (4,761,483)  (5,334,644)
Deemed dividend to Series C Preferred Stockholders  (23,859)  -   (23,859)  - 
Net Loss Attributable to Common Stockholders $(1,998,628)  $(1,814,895)  $(4,785,342) $(5.334,644)
                 
Net Loss Per Basic and Diluted Common Share: $(0.06) $(0.10) $(0.19) $(0.35)
                 
Weighted Average Number of Common Shares Outstanding:                
Basic and Diluted  36,145,494   17,922,129   25,460,490   15,029,969 

 

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIENCY)

(unaudited)

 

              Total 
        Additional     Stockholders’ 
  Common Stock  Paid-in  Accumulated  Equity 
  Shares  Amount  Capital  Deficit  (Deficiency) 
Balance at January 1, 2018  6,133,678  $61  $24,389,307  $(35,519,819) $(11,130,451)
Common stock issued in initial public offering[1]  1,725,000   17   6,070,135   -   6,070,152 
Derivative liabilities reclassified to equity  -   -   3,594,002   -   3,594,002 
Preferred stock converted to common stock  1,743,231   18   5,170,737   -   

5,170,755

 
Common stock issued in connection with May Bridge Notes  55,000   1   228,965   -   228,966 
Common stock issued in satisfaction of Advisory Board fees payable  30,000   -   90,000   -   90,000 
Common stock issued upon conversion of convertible debt and interest  1,650,537   17   8,252,669   -   8,252,686 
Common stock issued upon conversion of related party convertible debt and interest  120,405   1   517,741   -   517,742 
Common stock issued upon exchange of related party notes payable and interest  35,012   -   150,553   -   150,553 
Common stock issued in satisfaction of deferred salary  44,444   -   200,000   -   200,000 
Stock-based compensation:                    
Amortization of stock options  -   -   278,435   -   278,435 
Common stock granted to consultants  180,000   2   801,677   -   801,679 
Warrants granted to consultants  -   -   179,000   -   179,000 
Net loss  -   -   -   (9,792,900)  (9,792,900)
Balance at June 30, 2018  11,717,307  $

117

  $49,923,221  $(45,312,719) $

4,610,619

 
        Additional     Total 
  Common Stock  Paid-in  Accumulated  Stockholders 
  Shares  Amount  Capital  Deficit  Equity 
Balance at January 1, 2019  11,722,647  $117  $50,598,854  $(48,562,528) $2,036,443 
Common stock issued in private placement offering [1]  2,347,997   24   2,317,252   -   2,317,276 
Stock-based compensation:                    
Amortization of stock options  -   -   82,720   -   82,720 
Common stock issued to consultants  85,000   -   -   -   - 
Warrants granted to consultants  -   -   2,334   -   2,334 
Net loss  -   -   -   (1,573,726)  (1,573,726)
Balance at March 31, 2019  14,155,644  $141  $53,001,160  $(50,136,254) $2,865,047 
Common stock issued in public offering [2]  3,615,622   36   3,319,620   -   3,319,656 
Stock-based compensation:                    
Amortization of stock options  -   -   86,870   -   86,870 
Common stock issued to consultants/settlement, net [3]  150,863   2   298,298   -   298,300 
Warrants granted to consultants/settlement  -   -   28,165   -   28,165 
Net loss  -   -   -   (1,946,023)  (1,946,023)
Balance at June 30, 2019  17,922,129  $179  $56,734,113  $(52,082,277) $4,652,015 
Stock-based compensation:                    
Amortization of stock options  -   -   159,864   -   159,864 
Common stock issued to consultants  -   -   87,014   -   87,014 
Net loss  -   -   -   (1,814,895)  (1,814,895)
Balance at September 30, 2019  17,922,129  $179  $56,980,991  $(53,897,172) $3,083,998 

 

[1] net of offering costs of $2,554,848$386,724.

[2] net of offering costs of $549,060.

[3] net of forfeiture of 6,137 shares.

  Series C Convertible Preferred Stock  Common Stock  Additional Paid-in  Accumulated  Total Stockholders 
  Shares  Amount  Shares  Amount  Capital  Deficit  Equity 
Balance at January 1, 2020  -   -   17,931,857  $179  $57,177,686  $(56,187,925) $989,940 
Common stock issued in private placement offering [4]  -   -   1,300,000   13   24,292   -   24,305 
Stock-based compensation:                            
Amortization of stock options  -   -   -   -   116,820   -   116,820 
Warrants granted to consultants  -   -   -   -   14,070   -   14,070 
Net loss  -   -   -   -   -   (1,159,758)  (1,159,758)
Balance at March 31, 2020  -   -   19,231,857  $192  $57,332,868  $(57,347,683) $(14,623)
Common stock issued in public offering [5]          4,817,195   48   1,973,260   -   1,973,308 
Stock-based compensation:                            
Amortization of stock options          -   -   37,717   -   37,717 
Net loss          -   -   -   (1,626,956)  (1,626,956)
Balance at June 30, 2020          24,049,052  $240  $59,343,845  $(58,974,639) $369,446 
Common stock issued in public offering [6]          14,375,000   144   3,881,763       

3,881,907

 
Preferred stock issued in private placement[7]  4,205,406   42           1,358,060       

1,358,102

 
Common stock issued for exercise of warrants          

1,818,682

   19   631,607       631,626 
Reclassification of Warrant Derivatives to Equity                  334,229       334,229 
Stock-based compensation:                            
Amortization of stock options          -   -   194,420   -   194,420 
Net loss                 -   -   -   (1,974,769)  (1,974,769)
Balance at September 30, 2020  4,205,406  $42   

40,242,734

  $403  $ 65,743,924  $(60,949,408) $4,794,961 

[4] net of offering costs of $79,658.

[5] net of offering costs of $360,026.

[6] net of offering costs of $718,093.

[7] net of offering costs of $197,901.

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

  For the Nine Months Ended 
  September 30, 
  2020  2019 
Cash Flows from Operating Activities        
Net loss $(4,761,483) $(5,334,644)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock-based compensation  363,027   745,269 
Depreciation and amortization  71,252   85,060 
Amortization of right-of-use assets  216,741   206,618 
Change in fair value of derivatives  (211,807)  - 
Changes in operating assets and liabilities:        
Accounts receivable  -   32,022 
Prepaid expenses and other current assets  (232,006)  (52,547)
Accounts payable  (246,960)  134,205 
Accrued expenses  (45,766)  109,768 
Payments on lease liabilities  (216,514)  (198,930)
Total adjustments  (302,033)  1,061,465 
Net Cash Used in Operating Activities  (5,063,516)  (4,273,179)
         
Cash Flows from Investing Activities        
Purchase of property and equipment  (152,751)  (350,934)
Net Cash Used in Investing Activities  (152,751)  (350,934)
         
Cash Flows from Financing Activities        
Proceeds from private placements of common stock and warrants, net [1]  570,341   2,317,276 
Preferred stock issued in private placement [2]  1,358,102   - 
Proceeds from public offerings, net [3]  5,855,215   3,319,656 
Proceeds from issuance of note payable  312,700   - 
Proceeds from Warrant Exercises  631,626   - 
Net Cash Provided by Financing Activities  8,727,984   5,636,932 
         
Net Increase in Cash, Cash Equivalent, and Restricted Cash  3,511,717   1,012,819 
Cash, cash equivalents and restricted cash - Beginning of period  2,117,286   2,740,645 
Cash, cash equivalents and restricted cash - End of period $5,629,003  $3,753,464 

[1] Net of cash offering costs of $79,568 and $386,724 in 2020 and 2019, respectively.

[2] Net of cash offering costs of $197,901.

[3] Net of cash offering costs of $1,078,119 and $549,060 in 2020 and 2019, respectively.

 

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS OF CASH FLOWS

(unaudited)

 

  For the Six Months Ended 
  June 30, 
  2018  2017 
Cash Flows from Operating Activities        
Net loss $(9,792,900) $(2,412,562)
Adjustments to reconcile net loss to net cash used in operating activities:        
Amortization of debt discount  6,575,236   23,634 
Gain on extinguishment of convertible notes payable  (1,481,317)  - 
Stock-based compensation  1,259,114   274,752 
Depreciation and amortization  66,413   72,912 
Change in fair value of derivatives  (191,656)  1,622 
Changes in operating assets and liabilities:        
Accounts receivable, net  6,217   (15,300)
Inventory  -  90,908 
Prepaid expenses and other current assets  

(80,088

)  (69,650)
Security deposit and other assets  700   (1,000)
Accounts payable  (9,956)  249,373 
Accrued expenses  536,156   63,602 
Deferred revenues  (54,400)  - 
Total adjustments  6,626,419   690,853 
Net Cash Used in Operating Activities  (3,166,481)  (1,721,709)
         
Cash Flows from Investing Activities        
Collection of receivable for sale of assets  -   166,250 
Issuance of note receivable to related party  -   (160,000)
Advances to related party  -   (31,350)
Purchase of property and equipment  -   (2,265)
Net Cash Used in Investing Activities  -   (27,365)
         
Cash Flows from Financing Activities        
Proceeds from initial public offering, net[1]  7,657,427   - 
Initial public offering costs paid in cash  (706,596)  (40,002)
Repayments of notes payable  (1,125,000)  - 
Proceeds from issuance of note payable to related party  -   311,000 
Repayments of notes payable - related party  (120,864)  (87,852)
Proceeds from issuance of notes payable, net of commission  722,500   - 
Proceeds from issuance of convertible notes, net of cash offering costs  2,603,750   892,430 
Net proceeds from issuance of redeemable Series B preferred stock and warrant  -   632,900 
Net Cash Provided by Financing Activities  9,031,217   1,708,476 
         
Net Increase (Decrease) in Cash  5,864,736   (40,598)
Cash - Beginning of period  77,688   56,514 
Cash - End of period $5,942,424  $15,916 

[1] Net of offering costs paid from escrow of $967,573

  For the Nine Months Ended 
  September 30, 
  2020  2019 
Supplemental Disclosures of Cash Flow Information:      
Cash Paid (Received) During the Years For:        
Interest, net $(3,425) $933
         
Non-Cash Financing Activities:        
Fair value of warrants issued in connection with common stock included in derivative liabilities $513,534  $- 
Fair value of placement agent warrants issued in connection with common stock included in derivative liabilities $32,502  $- 
Reclassification of warrant derivatives to equity $(334,229)  - 

 

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS - continued

(unaudited)

  For the Six Months Ended 
  June 30, 
  2018  2017 
Supplemental Disclosures of Cash Flow Information:        
Cash Paid During the Years For:        
Interest $307,340  $27,148 
         
Non-Cash Financing Activities        
Conversion of convertible note payable - related party and accrued interest into common stock $517,742  $- 
Exchange of note payable - related party and accrued interest into common stock $150,553  $- 
Fair value of placement agent warrants issued in connection with
preferred stock offering included in derivative liabilities
 $-  $2,130 
Fair value of warrants issued in connection with convertible debt
included in derivative liabilities
 $1,046,763  $307,060 
Embedded conversion option in convertible debt
included in derivative liabilities
 $1,239,510  $426,379 
Derivative liabilities reclassified to equity $6,059,823  $- 
Conversion of convertible notes payable and accrued interest into common stock $5,743,391  $- 
Conversion of preferred stock into common stock $5,170,755  $- 

See Notes to these Unaudited Condensed Financial Statements

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 1 – Business Organization and Nature of Operations

 

Hancock Jaffe Laboratories, Inc. (“Hancock Jaffe”we”, “us”, “our”, “HJLI” or the “Company”) develops and sells biological tissueis a medical device company developing tissue-based solutions that are designed to treat patients with coronary, vascular, end stage renal and peripheral arterial diseases in the United States and Europe. Hancock Jaffe was incorporated in the State of Delaware on December 22, 1999.

The Company develops and manufactures implantable cardiovascular bioprosthetic devicesbe life sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease, and end stage renal disease, and has manufactured anddisease. The Company’s products are being developed to address large unmet medical needs by either offering treatments where none currently exist or by substantially increasing the following medical devices that have, orcurrent standards of care. Our two lead products which we are developing are: the VenoValve®, a porcine based device to be surgically implanted in the processdeep venous system of seeking Class IIIthe leg to treat a debilitating condition called chronic venous insufficiency (“CVI”); and the CoreoGraft®, a bovine based conduit to be used to revascularize the heart during coronary artery bypass graft (“CABG”) surgeries. Both of our current products are being developed for approval by the U.S. Food and Drug Administration (“FDA”) approval:

. We currently receive tissue for development of our products from one domestic suppliers and one international supplier. Our current business model is to license, sell, or enter into strategic alliances with large medical device companies with respect to our products, either prior to or after FDA approval. Our current senior management team has been affiliated with more than 50 products that have received FDA approval or CE marking. We currently lease a 14,507 sq. ft. manufacturing facility in Irvine, California, where we manufacture products for our clinical trials, and which has previously been FDA certified for commercial manufacturing of product.

 

ProCol® Vascular Bioprosthesis;
Bioprosthetic Heart Valve;

Coronary Artery Bypass Graft, an “off the shelf” device, Coreograft™; and

Bioprosthetic Venous Valve, the VenoValve™.

The Company also realizes sub-contract manufacturingEach of our product candidates will be required to successfully complete clinical trials and royalty revenue from salesother testing to demonstrate the safety and efficacy of the ProCol® Vascular Bioprosthesis for hemodialysis patients with end stage renal disease, which has beenproduct candidate before it will be approved by the FDA, as well as revenue from researchFDA. The completion of these clinical trials and development services performed on behalftesting will require a significant amount of Hancock Jaffe Laboratory Aesthetics, Inc. (“HJLA”), pursuant to a Developmentcapital and Manufacturing Agreement dated April 1, 2016.the hiring of additional personnel.

 

On October 31, 2017, our Board of Directors approvedSeptember 15, 2020, at a 1 for 2 reverse stock split ofspecial stockholders meeting, the Company’s common stock, which was effected on December 14, 2017. Per share and share amounts presented herein have been adjusted for all periods presented to give retroactive effect tostockholders approved the aforementioned stock splits.

Note 2 - Initial Public Offering

On May 30, 2018, the Company’s registration statement on Form S-1 relating to its initial public offeringincrease of its authorized common shares to 250,000,000 for a sufficient authorized number to settle all outstanding stock (the “IPO”) was declared effective by the Securitiesoptions, warrants and Exchange Commission (“SEC”). The Company completed its initial public offering of 1,500,000 units (the “Units”) at $5.00 per unit on June 4, 2018, each consisting of one share of the Company’s common stock, par value $0.00001 per share (the “Common Stock”), and a warrant to purchase one share of common stock with an exercise price of $6.00 per share. Aggregate gross proceeds from the IPO were $7,500,000, before underwriting discounts and commissions.

In connection with the IPO, on June 1, 2018, the Company filed an Amended and Restated Certificate of Incorporation (the “Restated Certificate”) with the Secretary of State of the State of Delaware and adopted Amended and Restated Bylaws (the “Restated Bylaws”). The Company’s Board of Directors and stockholders previously approved the Restated Certificate and the Restated Bylaws to be effective immediately prior to the closing of the IPO.convertible preferred stock.

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

On June 8, 2018, the underwriters notified the Company of their exercise in full of their option to purchase an additional 225,000 Units (the “Additional Units”) to cover over-allotments. On June 12, 2018, the underwriters purchased the Additional Units at the IPO price of $5.00 per Unit, generating $1,125,000 in gross proceeds before underwriting discounts and commissions.

Pursuant to the Restated Certificate, the Company is authorized to issue an aggregate of 60,000,000 shares of stock, of which 50,000,000 shares are designated as common stock, and 10,000,000 shares are designated as preferred stock (see Note 9 – Temporary Equity and Stockholders’ Equity (Deficiency)).

 

Note 32 – Going Concern and Management’s Liquidity Plan

 

The accompanying unaudited condensed financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should the Company be unable to continue as a going concern.concern for the next twelve months from the filing of this Form 10-Q. The Company incurred a net loss of $9,792,900 during$4,761,483 and $5,334,644 for the sixnine months ended JuneSeptember 30, 20182020 and 2019, respectively, and had an accumulated deficit of $45,312,719$60,949,408 at JuneSeptember 30, 2018.2020. Cash used in operating activities was $3,166,481$5,063,516 and $4,273,179 for the sixnine months ended JuneSeptember 30, 2018.2020 and 2019, respectively. The aforementioned factors raise substantial doubt about the Company’s ability to continue as a going concern within one year after the issuance date of the financial statements.

 

As of June 30, 2018, Hancock Jaffe had a cash balance of $5,942,424 and working capital of $3,513,936.

The Company expects to continue incurring losses for the foreseeable future and willrecognizes the need to raise additional capital to sustain its operations, pursue its product development initiatives and penetrate markets for the sale of its products.

Historically, Toward that end, the Company has been successfulcompleted five separate equity sales in 2020 through the filing date of this report raising fundsaggregate net proceeds of approximately $12,200,000 (see Notes 10 and 11). As of September 30, 2020, the Company had cash balances of $5,629,003 and working capital of $4,062,232. Management believes the proceeds from these transactions should provide sufficient cash to support its capital needs. Managementsustain the Company’s operations at least one year after the issuance date of these financial statements.

If necessary, after one year, management believes that the Company hascould have access to additional capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however,means. However, there is a material risk that the Company cannot provide any assurance that it will be ableunable to raise additional capital or obtain new financing when needed on commercially acceptable terms. Such aterms, if at all, or if it will be successful in implementing its business plan couldand developing its medical devices. Further, the COVID-19 pandemic has disrupted the global economy and eroded capital markets which makes it more difficult to obtain the financing that we need to fund and continue our operations. The inability of the Company to raise needed capital would have a material adverse effect on the Company’s business, financial condition and results of operations, and ultimately the Company could be forced to curtail or discontinue its operations, liquidate and/or seek reorganization in bankruptcy. These financial statements do not include any adjustments that might result from the outcome of this uncertainty.

7

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 43 – 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 JuneSeptember 30, 2018,2020 and December 31, 2019, and for the three and sixnine months ended JuneSeptember 30, 20182020 and 2017.2019. The results of operations for the three and sixnine months ended JuneSeptember 30, 20182020 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, 20172019 included in the Company’s Form S-1/A10-K filed with the SEC on May 30, 2018.March 18, 2020. The condensed balance sheet as of December 31, 20172019 has been derived from the Company’s audited financial statements.

 

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include the valuation allowance related to the Company’s deferred tax assets, and the valuation of warrants and derivative liabilities.

Deferred Offering Costs

Deferred offering costs, which primarily consist of direct, incremental professional fees relating to pending initial public offerings, are capitalized within non-current assets and are offset against the proceeds upon the consummation of the offering. Deferred offering costs of $2,554,848, consisting primarily of legal, accounting and underwriting fees, werecharged to additional paid in capital upon the consummation of the IPO on June 4, 2018.

Investments

Equity investments over which the Company exercises significant influence, but does not control, are accounted for using the equity method, whereby investment accounts are increased (decreased) for the Company’s proportionate share of income (losses), but investment accounts are not reduced below zero.

The Company holds a 28.5% ownership investment, consisting of founders’ shares acquired at nominal cost, in Hancock Jaffe Laboratory Aesthetics, Inc. (“HJLA”). To date, HJLA has recorded cumulative losses. Since the Company’s investment is recorded at $0, the Company has not recorded its proportionate share of HJLA’s losses. If HJLA reports net income in future years, the Company will apply the equity method only after its share of HJLA’s net income equals its share of net losses previously incurred.

8

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Fair Value of Financial Instruments

 

The Company measures the fair value of financial assets and liabilities based on the guidance of Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) ASC 820 “Fair Value Measurements and Disclosures” (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

 

FASB ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

 

Level 1Quoted prices available in active markets for identical assets or liabilities trading in active markets.
  
Level 2Observable inputs other than quoted prices included in Level 1, such as quotable prices for similar assets and liabilities in active markets; quoted prices for identical or similar assets and liabilities in markets that are not active; or other inputs that are observable or can be corroborated by observable market data.
  
Level 3Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. This includes certain pricing models, discounted cash flow methodologies and similar valuation techniques that use significant unobservable inputs.

 

Financial instruments, including accounts receivable and accounts payable are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments. The Company’s other financial instruments include notes payable, the carrying value of which approximates fair value, as the notes bear terms and conditions comparable to market for obligations with similar terms and maturities. Derivative liabilities are accounted for at fair value on a recurring basis.

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

TheOn September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved the increase of its authorized shares of capital stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock). Accordingly, there is no fair value of derivative liabilities as of JuneSeptember 30, 2018 and December 31, 2017, by level within the fair value hierarchy appears below:2020.

Description: Quoted Prices in
Active Markets for
Identical Assets or
Liabilities
(Level 1)
  Significant
 Other
Observable
Inputs
(Level 2)
  Significant Unobservable Inputs
(Level 3)
 
Derivative liabilities - Preferred Stock Series A Warrants            
June 30, 2018 $-  $-  $- 
December 31, 2017 $-  $-  $541,990 
Derivative liabilities - Preferred Stock Series B Warrants            
June 30, 2018 $-  $-  $- 
December 31, 2017 $-  $-  $60,551 
Derivative liabilities - Convertible Debt Warrants            
June 30, 2018 $-  $-  $- 
December 31, 2017 $-  $-  $1,298,012 
Derivative liabilities - Convertible Debt Embedded Conversion Feature            
June 30, 2018 $-  $-  $- 
December 31, 2017 $-  $-  $1,176,365 

 

The following table sets forth a summary of the changes in the fair value of Level 3 derivative liabilities that are measured at fair value on a recurring basis:

 

  Derivative 
  Liabilities 
Balance - January 1, 2018 $3,076,918 
Issuance of derivative liabilities - convertible debt warrants  1,942,362 
Issuance of derivative liabilities - convertible debt embedded conversion feature  3,652,588 
Extinguishment of derivative liabilities upon debt modification  (2,420,390)
Change in fair value of derivative liabilities  (191,656)
Extinguishment of derivative liabilities upon conversion of debt  (2,465,820)
Reclassification of warrant derivatives to equity  (3,594,002)
Balance - June 30, 2018 $- 

10
 Derivative
Liabilities
Balance – January 1, 2020$-
Derivative liabilities associated with the issuance of common stock warrants513,534
Derivative liabilities associated with the issuance of placement agent warrants32,502
Change in fair value of derivative liabilities(346,129)
Balance – March 31,2020199,907
Change in fair value of derivative liabilities81,276
Balance June 30, 2020281,183
Change in fair value of derivative liabilities53,046
Reclassification of warrant derivatives to equity(334,229)
Balance – September 30, 2020$-

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Preferred Stock

The Company applies the accounting standards for distinguishing liabilities from equity under U.S. GAAP when determining the classification and measurement of its Series A and Series B Preferred Stock (together, the “Preferred Stock”). Preferred stock subject to mandatory redemption is classified as a liability instrument and is measured at fair value. Conditionally redeemable preferred stock (including preferred shares that feature redemption rights that are either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) is classified as temporary equity. At all other times, preferred stock is classified as permanent equity. As of the issuance date, the carrying amount of the Preferred Stock was less than the redemption value. If the Company were to determine that redemption was probable, the carrying value would be increased by periodic accretions such that the carrying value would equal the redemption amount at the earliest redemption date. Such accretion would be recorded as a preferred stock dividend (see Note 9 – Temporary Equity and Stockholders’ Equity (Deficiency)).

 

Derivative Liabilities

 

On February 25, 2020 in connection with a private placement of its securities (Note 10), the Company issued warrants to purchase 1,430,000 shares of its common stock. The Company determined these warrants were derivative financial instruments when issued.

Derivative financial instruments are recorded as a liability at fair value and are marked-to-market as of each balance sheet date. The change in fair value at each balance sheet date is recorded as a change in the fair value of derivative liabilities on the statement of operations for each reporting period. The fair value of the derivative liabilities was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification of the financial instruments at each balance sheet date. If the classification changes as a result of events during the period, the financial instrument is marked to market and reclassified as of the date of the event that caused the reclassification.

On June 4, 2018, in connection with the Company’s IPO,all of its previously issued convertible notes were converted and paid in full (as discussed in Note 6 - Convertible Notes and Convertible Note – Related Party), and the embedded conversion options and warrants no longer qualified as derivatives; accordingly, the derivative liabilities were remeasured to fair value on June 4, 2018 andSeptember 15, 2020, the fair value of derivative liabilities of $3,594,002 was reclassified to additional paid inequity when the Company’s stockholders approved the increase of its authorized shares of capital (see Fair Value of Financial Instruments, above)stock. (See Note 10 –Stockholders’ Equity (Deficiency) Common Stock).

 

The Company recorded a gain (loss) on the change in fair value of derivative liabilities of $227,279 and $191,656$211,807 during the three and sixnine months ended JuneSeptember 30, 2018, respectively,2020 and $22,147 and $(1,622)a loss on the change in fair value of derivative liabilities of $53,046 during the three and six monthsquarter ended JuneSeptember 30, 2017, respectively.2020.

Convertible NotesSequencing Policy

 

The convertible notes payable discussedOn July 15, 2020, the Company adopted a sequencing policy, whereby, in Note 6 – Convertible Notes and Convertible Note – Related Party, had a conversion pricethe event that couldreclassification of contracts from equity to assets or liabilities is necessary pursuant to ASC 815 due to the Company’s inability to demonstrate it has sufficient authorized shares, shares will be adjusted basedallocated on the Company’s stock price, which resulted in the conversion feature being recorded as a derivative liability and a debt discount. The debt discount was amortized to interest expense over the lifebasis of the respective note, usingearliest issuance date of potentially dilutive instruments, with the effective interest method.

On June 4, 2018, principalearliest grants receiving the first allocation of $10,000 owed on the Convertible Notes was paid in cash, and allshares. Pursuant to ASC 815, issuances of the remaining principal and interest owed pursuantsecurities to the Convertible Notes were converted into common stockCompany’s employees and directors, or to compensate grantees in connection witha share-based payment arrangement, are not subject to the Company’s IPO. The conversion of the Convertible Notes was deemed to be a debt extinguishment; accordingly, the warrant and embedded conversion option derivative liabilities were remeasured to fair value on June 4, 2018 and reclassified to additional paid in capital (See Derivative Liabilities, above).

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)sequencing policy.

 

Net Loss per Share

 

The Company computes basic and diluted loss per share by dividing net loss attributable to common stockholders by the weighted average number of common stock outstanding during the period. Net loss income attributable to common stockholders consists of net loss, adjusted for the convertible preferred stock deemed dividend resulting from the 8% cumulative dividend on the Preferred Stock and the beneficial conversion feature recorded in connection with the conversion of the(see Note 10 - Stockholders Equity (Deficiency) Series C Convertible Preferred Stock (see Note 9 – Temporary Equity and Stockholders’ Equity (Deficiency)).

Basic and diluted net loss per common share are the same since the inclusion of common stock issuable pursuant to the exercise of warrants and options, plus the conversion of preferred stock or convertible notes, in the calculation of diluted net loss per common shares would have been anti-dilutive.

The following table summarizes net loss attributable to common stockholders used in the calculation of basic and diluted loss per common share:

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
Net loss $(5,045,413) $(1,248,912) $(9,792,900) $(2,412,562)
Deemed dividend to Series A and B preferred stockholders  (3,180,860)  (113,779)  (3,310,001)  (214,911)
Net loss attributable to common stockholders $(8,226,273) $(1,362,691) $(13,102,901) $(2,627,473)

 

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 JuneSeptember 30, 20182020 and 2017:2019:

 

  June 30, 
  2018  2017 
Shares of common stock issuable upon conversion of preferred stock  -   566,413 
Shares of common stock issuable upon exercise of preferred stock warrants and the subsequent conversion of the preferred stock issued therewith  -   51,902 
Shares of common stock issuable upon the conversion of convertible debt  -   83,334 
Shares of common stock issuable upon exercise of warrants  3,792,047   266,903 
Shares of common stock issuable upon exercise of options  1,502,000   1,296,000 
Potentially dilutive common stock equivalents excluded from diluted net loss per share  5,294,047   2,264,552 

12

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Revenue Recognition

In March 2016, the FASB issued ASU No. 2016-08, “Revenue from Contracts with Customers - Principal versus Agent Considerations”, in April 2016, the FASB issued ASU No. 2016-10, “Revenue from Contracts with Customers (Topic 606) - Identifying Performance Obligations and Licensing” and in May 9, 2016, the FASB issued ASU No. 2016-12, “Revenue from Contracts with Customers (Topic 606)”, or ASU 2016-12. This update provides clarifying guidance regarding the application of ASU No. 2014-09 - Revenue From Contracts with Customers which is not yet effective. These new standards provide for a single, principles-based model for revenue recognition that replaces the existing revenue recognition guidance. In July 2015, the FASB deferred the effective date of ASU 2014-09 until annual and interim periods beginning on or after December 15, 2017. It has replaced most existing revenue recognition guidance under U.S. GAAP. The ASU may be applied retrospectively to historical periods presented or as a cumulative-effect adjustment as of the date of adoption. The Company adopted Topic 606 using a modified retrospective approach and will be applied prospectively in the Company’s financial statements from January 1, 2018 forward. Revenues under Topic 606 are required to be recognized either at a “point in time” or “over time”, depending on the facts and circumstances of the arrangement, and will be evaluated using a five-step model. The adoption of Topic 606 did not have a material impact on the Company’s financial statements, at initial implementation nor will it have a material impact on an ongoing basis.

The Company recognizes revenue when goods or services are transferred to customers in an amount that reflects the consideration which it expects to receive in exchange for those goods or services. In determining when and how revenue is recognized from contracts with customers, the Company performs the following five-step analysis: (i) identification of contract with customer; (ii) determination of performance obligations; (iii) measurement of the transaction price; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

The following table summarizes the Company’s revenue recognized in the accompanying condensed statements of operations:

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
Product sales $-  $-  $-  $152,400 
Royalty income  28,963   38,800   60,028   66,708 
Contract research - related party  54,400   -   54,400   - 
Total Revenues $83,363  $38,800  $114,428  $219,108 

Revenue from sales of products is recognized at the point where the customer obtains control of the goods and the Company satisfies its performance obligation, which generally is at the time the product is shipped to the customer. Royalty revenue, which is based on resales of ProCol Vascular Bioprosthesis to third-parties, will be recorded when the third-party sale occurs and the performance obligation has been satisfied. Contract research and development revenue is recognized over time using an input model, based on labor hours incurred to perform the research services, since labor hours incurred over time is thought to best reflect the transfer of service.

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Information on Remaining Performance Obligations and Revenue Recognized from Past Performance

Information about remaining performance obligations pertaining to contracts that have an original expected duration of one year or less is not disclosed. The transaction price allocated to remaining unsatisfied or partially unsatisfied performance obligations with an original expected duration exceeding one year was not material at June 30, 2018.

Contract Balances

The timing of our revenue recognition may differ from the timing of payment by our customers. A receivable is recorded when revenue is recognized prior to payment and the Company has an unconditional right to payment. Alternatively, when payment precedes the provision of the related services, deferred revenue is recorded until the performance obligations are satisfied. The Company had deferred revenue of $49,000 and $103,400 as of June 30, 2018 and December 31, 2017, respectively, related to cash received in advance for contract research and development services. The Company expects to satisfy its remaining performance obligations for contract research and development services and recognize the deferred revenue over the next twelve months.

  September 30, 
  2020  2019 
Shares of common stock issuable upon exercise of warrants  34,022,068   4,366,960 
Shares of common stock issuable upon exercise of options  5,315,540   1,517,000 
Potentially dilutive common stock equivalents excluded from diluted net loss per share  39,337,608   5,883,960 

 

Stock-Based Compensation

 

The Company measures the cost of services received in exchange for an award of equity instruments based on the fair value of the award. The fair value of the award is measured on the grant date and recognized over the period services are required to be provided in exchange for the award, usually the vesting period. Forfeitures of unvested stock options are recorded when they occur.

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Concentrations

The Company maintains cash with major financial institutions. Cash held in United States bank institutions is currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to $250,000 at each institution. There were aggregate uninsured cash balances of $5,692,424 at June$5,379,003 and $1,867,286 as of September 30, 2018. There were no cash balances in excess of federally insured amounts at2020 and December 31, 2017.2019, respectively. The Company periodically evaluates the financial stability of the financial institutions with whom it maintains its cash balances. As of September 30, 2020, and as of the date of filing this report, the Company is not aware of any circumstances which would indicate they are not financially sound.

 

DuringFor the three and sixnine months ended JuneSeptember 30, 2017,2019, all of the Company’s revenues from continuing operations were from royalties as a result of the sub-contract manufacture of product to forthree-year Post-Acquisition Supply Agreement with LeMaitre Vascular, Inc. (“LeMaitre”), and royalties earnedthat was effective from the sale of product by LeMaitre, with whom the Company entered a Post-Acquisition Supply Agreement effective March 18, 2016. During the three and six months ended June 30, 2018, 35% and 52% of the Company’s revenues from continuing operations were from royalties earned from the sale of product by LeMaitre.2016 to March 18, 2019. The Company did not recognizehave any subcontract manufacturing revenues duringsimilar revenue in the three and sixnine months ended JuneSeptember 30, 2018. During the three and six months ended June 30, 2018, 65% and 48%, respectively, of the Company’s revenues were earned from contract research and development services performed for HJLA.2020.

 

14

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Subsequent Events

 

The Company evaluated events that have occurred after the balance sheet date through the date the financial statements were issued. Based upon the evaluation and transactions, the Company did not identify any other subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed in Note 1011 - Subsequent Events.

 

Recent Accounting Pronouncements

In February 2016,December 2019, the FASB issued ASU No. 2016-02, “Leases (Topic 842),” (“2019-12,Simplifying the Accounting for Income Taxes, which is intended to simplify various aspects of the income tax accounting guidance, including requirements such as tax basis step-up in goodwill obtained in a transaction that is not a business combination, ownership changes in investments, and interim-period accounting for enacted changes in tax law. ASU 2016-02”). ASU 2016-02 requires an entity to recognize assets and liabilities arising from a lease for both financing and operating leases. ASU 2016-02 will also require new qualitative and quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-022019-12 is effective for public business entities for fiscal years beginning after December 15, 2018, with early adoption permitted. The Company is currently evaluating ASU 2016-02 and its impact on its financial statements

In August 2016, the FASB issued ASU 2016-15, “Statement of Cash Flows - Classification of Certain Cash Receipts and Cash Payments (Topic 230)” (“ASU 2016-15”). ASU 2016-15 will make eight targeted changes to how cash receipts and cash payments are presented and classified in the statement of cash flows. ASU 2016-15 is effective for fiscal years beginning after December 15, 2017. ASU 2016-15 requires adoption on a retrospective basis unless it is impracticable to apply, in which case the Company would be required to apply the amendments prospectively as of the earliest date practicable. The adoption of ASU 2016-15 did not have a material impact on the Company’s financial statements.

In May 2017, the FASB issued ASU No. 2017-09, Compensation—Stock Compensation (Topic 718); Scope of Modification Accounting. The amendments in this ASU provide guidance that clarifies when changes to the terms or conditions of a share-based payment award must be accounted for as modifications. If the value, vesting conditions or classification of the award changes, modification accounting will apply. The guidance is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The adoption of ASU 2017-09 did not have a material impact on the Company’s financial statements.

On June 20, 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718) - Improvements to Nonemployee Share-Based Payment Accounting, which simplifies accounting for share-based payment transactions resulting for acquiring goods and services from nonemployees. ASU 2018-07 is effective for fiscal years, and2020, including interim periods within those fiscal years, beginning after December 15, 2018. Earlyand early adoption is permitted. The new standard was adopted effective April 1, 2018,usingWe are currently evaluating the modified retrospective approach; however,impact that this guidance will have on our condensed financial statements.

Note 4 – Restricted Cash

As of September 30, 2020, the Company did not identify or recordhave any adjustmentsrestricted cash. Previously, the Company had maintained a restricted cash balance in connection with a vendor litigation matter with ATSCO, Inc. (see Note 9 - Commitments and Contingencies - Litigations Claims and Assessments). The matter was resolved on July 20, 2020, and on August 28, 2020 ATSCO took possession of the restricted cash as full settlement of the dispute.

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported in the balance sheet as of September 30, 2019 and that sum to the openingtotal of the same amounts shown in the statement of cash flows for the nine months ending September 30, 2019 with the comparative cash balance without restricted cash as of retained earnings on adoption.The new standard did not have a material impact on the Company’s financial statements.September 30, 2020.

 

15

  As of September 30, 
  2020  2019 
Cash and cash equivalents $5,629,003  $2,943,409 
Restricted cash  -   810,055 
Total cash, cash equivalents, and restricted cash in the balance sheets $5,629,003  $3,753,464 

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 5 – Accrued ExpensesProperty and Accrued Interest – Related PartyEquipment

 

As of JuneSeptember 30, 20182020 and December 31, 2017, accrued expenses2019, property and equipment consist of the following:

 

  June 30,  December 31, 
  2018  2017 
Accrued compensation costs $652,185  $556,118 
Accrued professional fees  184,232   235,654 
Deferred rent  14,934   4,978 
Accrued interest  -   101,050 
Accrued franchise taxes  25,607   - 

Accrued stock-based compensation

  255,062   - 
Other accrued expenses  52,776   5,794 
Accrued expenses $1,184,796  $903,594 
  September 30,  December 31, 
  2020  2019 
Laboratory equipment $332,126  $214,838 
Furniture and fixtures  93,417   93,417 
Computer software and equipment  61,771   50,403 
Leasehold improvements  158,092   158,092 
Construction Work in Progress – Software  244,479   220,384 
   889,885   737,134 
Less: accumulated depreciation  (464,359)  (393,107)
Property and equipment, net $425,526  $344,027 

 

Accrued interest - related parties consisted of accrued interest on notes payableDepreciation expense amounted to $66,857 and $26,828 for the majority stockholdernine months ended September 30, 2020 and to Leman Cardiovascular S.A. (see Note 7 - Notes Payable2019, respectively. Depreciation expense is reflected in general and Note Payable – Related Party) totaling,administrative expenses in the aggregate, $0 and $20,558 at June 30, 2018 and December 31, 2017, respectively.

Asaccompanying statements of June 30, 2018, the termination of employment of the Company’s chief financial officer (the “CFO”) was deemed to be probable and, as a result, the Company accrued severance expense of $313,650 pursuant to the terms of his employment agreement, which is included in accrued compensation costs in the table above. The employment of the CFO was terminated effective July 20, 2018.

operations.

 

Note 6 - Convertible Notes– Right-of-Use Assets and Convertible Note – Related PartyLease Liability

 

Convertible Notes

During the period from June 15, 2017 through December 7,On September 20, 2017, the Company issued senior secured convertible promissory notes aggregating $2,750,500.renewed its operating lease for its manufacturing facility in Irvine, California, effective October 1, 2017, for five years with an option to extend the lease for an additional 60-month term at the end of lease term. The Company incurred cash offering costs of $186,100 (including $129,030 of placement agent fees) resulting in net cash proceeds of $2,564,400. The notes, as amended on December 29, 2017 (the “2017 Convertible Notes”), matured on February 28, 2018, and bore interest at 15%initial lease rate was $26,838 per annum. The principal and interest due on the 2017 Convertible Notes were convertible into shares of common stock at a conversion price equal to the lesser of (i) $12.00 per share, or (ii) 70% of the highest price per common stock sold in an initial public offering (the “2017 Conversion Price”). The 2017 Convertible Notes included warrants exercisable for the number of shares of common stock equal to 75% of the total shares issuable upon the conversion of the related 2017 Convertible Note, at a price equal to the lesser of (i) $14.40 per share or (ii) 120% of the 2017 Conversion Price.month with escalating payments. In connection with the sale of the 2017 Convertible Notes,lease, the Company issued five-year warrantsis obligated to pay $7,254 monthly for operating expenses for building repairs and maintenance. The Company has no other operating or financing leases with terms greater than 12 months.

The Company adopted Accounting Standards Codification (“ASC”) Topic 842, Leases (Topic 842) effective January 1, 2019 using the placement agentmodified-retrospective method and elected the package of transition practical expedients for expired or existing contracts, which does not require reassessment of previous conclusions related to contracts containing leases, lease classification and initial direct costs, and therefore the financing forcomparative periods presented are not adjusted. In addition, the purchaseCompany elected to adopt the short-term lease exception and not apply Topic 842 to arrangements with lease terms of 15,339 shares12 months or less. On January 1, 2019, upon adoption of common stock at an exercise priceTopic 842, the Company recorded right-of-use assets of $15.84 per share (see Note 9 – Temporary Equity$1,099,400, lease liabilities of $1,121,873 and Stockholders’ Deficiency – Warrants).eliminated deferred rent of $22,473. The fairCompany determined the lease liabilities using the Company’s estimated incremental borrowing rate of 8.5% to estimate the present value of the conversion option and warrants issued in connection with the 2017 Convertible Notes had an issuance date value of $1,175,668 and $397,211, respectively, and the aggregate of $1,572,879 was recorded as a debt discount and a derivative liability.remaining monthly lease payments.

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

From January 5, 2018 through January 16, 2018, the Company issued senior secured convertible notes (the “2018 Convertible Notes”) in the aggregate amount of $2,897,500. The Company incurred cash offering costs of $293,750 (including $289,750 of placement agent fees) resulting in net cash proceeds of $2,603,750. The 2018 Convertible Notes bore interest at 15% per annum and were due on February 28, 2018 (the “Maturity Date”). The 2018 Convertible Notes were convertible into shares of common stock at a conversion price equal to the lesser of (i) $12.00 per share, or (ii) 70% of the highest price per common share sold in an initial public offering (the “2018 Conversion Price”). The 2018 Convertible Notes include five-year warrants exercisable for the number of common stock equal to 50% of the total shares issuable upon the conversion of the 2018 Convertible Note, at a price equal to the lesser of (i) $14.40 per share or (ii) 120% of the 2018 Conversion price. The 2018 Convertible Notes (and accrued interest) are convertible at any time at the option of the holder; however, if the Company consummates an IPO on or prior to the Maturity Date, the principal and interest due under the then-outstanding 2018 Convertible Notes will be automatically converted into shares of the Company’s common stock. In connection with the sale of the 2018 Convertible Notes, the Company agreed to issue a five-year warrant to the placement agent for the financing for the purchase of 24,146 shares of common stock, exercisable at a price equal to the 110% of the greater of (i) the price at which the securities are issued, or (ii) the exercise price of the debt holder warrants. The fair value of the conversion option and the warrants issued in connection with the 2018 Convertible Notes had an issuance date value of $1,239,510 and $1,046,763, respectively, and the aggregate of $2,286,273 was recordedOur operating lease cost is as a debt discount and a derivative liability.

follows:

 

  

For the Three Months Ended

September 30,

  

For the Nine

Months Ended

September 30,

 
  2020  2020 
Operating lease cost $85,492  $256,475 

The 2017 Convertible Notes and the 2018 Convertible Notes are together, the “Convertible Notes”.

Supplemental cash flow information related to our operating lease is as follows:

 

  

For the Three Months Ended

September 30,

  

For the Nine

Months Ended

September 30,

 
  2020  2020 
Operating Cash Flow Information:        
Cash paid for amounts in the measurement of lease liabilities $85,416  $256,248 

On February 28, 2018, the Convertible Notes were amended such that the maturity date was extended to May 15, 2018, the 2017 Convertible Note warrants became exercisable

Remaining lease term and discount rate for our operating lease is as follows:

September 30,

2020

Remaining lease term2 years
Discount rate8.5%

Maturity of our lease liabilities by fiscal year for the number of shares of common stock equal to 100% of the total shares issuable upon the conversion of the 2017 Convertible Notes and the 2018 Convertible Note Warrants become exercisable for the number of shares of common stock equal to 75% of the total shares issuable upon the conversion on the 2018 Convertible Notes. The amendment of the Convertible Notes was deemed to be a debt extinguishment and,our operating lease is as a result, during the six months ended June 30, 2018, the Company recognized a $1,524,791 gain on extinguishment of convertible notes payable within the accompanying statement of operations consisting of the extinguishment of $2,420,390 of derivative liabilities associated with the embedded conversion option of the extinguished Convertible Notes, partially offset by the issue date value of additional warrants issued (deemed to be a derivative liability) in the amount of $895,599. Additionally, the embedded conversion option within the re-issued Convertible Notes was deemed to be a derivative liability and the relative fair value was recorded as a discount in the amount of $2,413,079.follows:

 

On June 4, 2018, principal and interest of $10,000 and $267, respectively, were paid in cash and all remaining principal and accrued interest balances of the Convertible Notes were automatically converted into 1,650,537 shares of common stock upon the closing of the IPO at a conversion price of $3.50 per share. The conversion of the Convertible Notes was deemed to be a debt extinguishment and, as a result, the Company recognized a $43,474 loss on extinguishment of convertible notes payable within the accompanying statement of operations consisting of the fair value of the common stock issued upon the conversion of the Convertible Notes of $8,252,685, less the extinguishment of $5,743,391 of principal and interest converted and $2,465,820 of derivative liabilities associated with the embedded conversion option of the extinguished Convertible Notes.

For the three months ended June 30, 2018 and 2017, interest expense incurred in connection with the Convertible Notes was $105,658 and $6,164, respectively. Interest expense incurred in connection with the Convertible Notes was $305,452 and $6,164 during the six months ended June 30, 2018 and 2017, respectively.

17

Three months ended December 31, 2020 $87,981 
Year ended December 31, 2021  354,561 
Year Ended December 31, 2022  271,854 
Total $714,396 
Less: Imputed Interest  (74,277)
Present value of our lease liability $640,119 

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 7 – Accrued Expenses and Accrued Interest

As of September 30, 2020, and December 31, 2019, accrued expenses consist of the following:

  September 30,  December 31, 
  2020  2019 
Accrued compensation costs $233,428  $151,858 
Accrued professional fees  23,000   141,310 
Accrued franchise taxes  25,607   30,270 
Accrued research and development  5,637   - 
Other accrued expenses  -   10,000 
Accrued expenses $287,672  $333,438 

Convertible Note 8 Related PartyNote Payable

 

On June 30, 2015,April 12, 2020, the Company entered into aobtained loan agreement with its then-majority (78%) common stock shareholder, (the “2015 Note”). The 2015 Note had a maximum borrowing capacity of $2,200,000 and bore interest at 3% per annum. On April 1, 2016, the 2015 Note was amended such that the 2015 Note became convertible into shares of common stock at the option of the lender at a conversion price of $10.00 per share. During the six months ended June 30, 2018 and 2017, the Company borrowed $0 and $311,000, respectively, under the 2015 Note. On April 26, 2018, the outstanding principal balance and accrued interest of the 2015 Note was converted into 120,405 shares of common stock at a conversion price of $4.30 per share. The Company incurred interest expense related to the 2015 Note of $4,613 and $6,235 during the six months ended June 30, 2018 and 2017, respectively. For the three months ended June 30, 2018 and 2017, the Company incurred interest expense in connection with the 2015 Note was $879 and $3,622, respectively.

Note 7 - Notes Payable and Note Payable – Related Party

Notes Payable

During December 2017, the Company borrowed an aggregate of $275,000 pursuant to two promissory notes, which bore interest at 10% per annum. The notes were repaid in full during January 2018. The Company incurred interest expense of $0 and $958 during the three and six months ended June 30, 2018 in connection with these notes.

On May 15, 2018, the Company received aggregate proceeds of $722,500 in exchange for certain promissory notes (the “May Notes”“Loan”) in the aggregate principal amount of $850,000 and 55,000 shares$312,700, pursuant to the Paycheck Protection Program (the “PPP”) under Division A, Title I of the Company’s common stock, net of commissions of $27,500. The $27,500 commission and the original issue discount of $100,000 were recorded as debt discount, and the relative fair value of the common stock issued in connection with the May Notes of $228,966CARES Act, which was recorded as a debt discount with a corresponding credit to additional paid-in capital. The May Notes bore interest between 0-10% per annum and were repaid in full upon the consummation of the IPO on June 4, 2018. The Company incurred $4,911 of interest expense during the three and six months ended June 30, 2018 in connection with the May Notes.

Note Payable – Related Partyenacted March 27, 2020.

 

The Loan, which was in the form of a Note dated April 12, 2020, matures on April 12, 2022 and bears interest at a rate of 1% per annum, payable monthly commencing on November 12, 2020. The Note may be prepaid at any time before maturity with no prepayment penalties. Funds from the Loan may only be used for payroll costs, costs used to continue group health care benefits, mortgage payments, rent, utilities, and interest on other debt obligations incurred before February 15, 2020. The Company had abelieves it has used the entire Loan amount for qualifying expenses. Under the terms of the PPP, certain amounts of the Loan may be forgiven if they are used for qualifying expenses as described in the CARES Act.

As of September 30, 2020, the note payable to a related party (the “Related Party Note”), of which the Company’s Former President and Vice President of Operations were officers, and of which a member of the Company’s Board of Directors is a shareholder. The Related Party Note, as amended, bore interest at 6% per annum and matured on May 10, 2018. On April 26, 2018, the outstanding principal balance and accrued interest of the Related Party Note was amended such that the note became convertible into common stock at a conversion price of $4.30, and on the same day, principal and interest in the aggregate of $150,553 due in connection with the Related Party Note was converted into 35,012 shares of common stock. The Company incurred $632 and $5,978 of interest expense during the three months ended June 30, 2018 and 2017, respectively, and incurred interest expense of $4,078 and $12,621 during the six months ended June 30, 2018 and 2017, respectively, in connection with the Related Party Note.$312,700.

18

HANCOCK JAFFE LABORATORIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Note 89 – 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 is not currently a party to any legal proceedings nor is it aware of any threatened legal proceedings which are expected to have a material adverse effect on the Company’s financial statements. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.

 

On September 21, 2018, ATSCO, Inc., a vendor, filed a lawsuit with the Superior Court seeking payment of $809,520 plus legal costs for disputed invoices to the Company dated from 2015 to June 30, 2018. The Company had entered into a Services and Material Supply Agreement (“Agreement”), dated March 4, 2016 for ATSCO to supply porcine and bovine tissue to the Company. On January 18, 2019, the Orange County Superior Court granted a Right to Attach Order and Order for Issuance of Writ of Attachment in the amount of $810,055 (the “Disputed Amount”) and on March 21, 2019, the Santa Clara, CA sheriff department served the Writ of Attachment and took custody of and was holding the Disputed Amount (see Note 4 – Restricted Cash). On July 20, 2020, the Company and ATSCO agreed to settle the dispute. Pursuant to the terms of the settlement, the Company agreed to release the Disputed Amount of restricted cash in exchange for a full release from all claims made by ATSCO related to this matter. On August 28, 2020, ATSCO took possession of the Restricted Cash. Accordingly, as of September 30, 2020, the Company has removed the restricted cash and related accounts payable from its financial statements.

The Company has replaced ATSCO and has entered into new supply relationships with two domestic and one international company to supply porcine and bovine tissues.

On October 8, 2018, Gusrae Kaplan Nusbaum PLLC (“Gusrae”) filed a complaint with the Supreme Court of the State of New York seeking payment of $178,926 plus interest and legal costs for invoices to the Company dated from November 2016 to December 2017. In July 2016, the Company retained Gusrae to represent the Company in connection with certain specific matters. The Company believes that Gusrae has not applied all of the payments made by the Company along with billing irregularities and errors and is disputing the amount owed. The Company recorded the disputed invoices in accounts payable and as of June 30, 2020, the Company has fully accrued for the outstanding claim against the Company.

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 as the Company’s Chief Financial Officer, Secretary and Treasurer on March 30, 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. The complaint seeks, among other things, back pay, unpaid wages, compensatory damages, punitive damages, attorneys’ fees, and costs. The Company intends to vigorously defend the claims, investigate the allegations, and assert counterclaims.

Employment AgreementsHANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

Note 10 –Stockholders’ Equity (Deficiency)

 

On March 20, 2018,September 15, 2020, the Company completed a special meeting of stockholders (the “Special Meeting”). At the Special Meeting, the Company’s stockholders, among other things, (i) approved an amendment to the Company’s Amended and Restated Certificate of Incorporation (the “A&R Certificate of Incorporation”) to increase the aggregate number of authorized shares of common stock by 200,000,000 shares from 50,000,000 to 250,000,000 shares; (ii) approved an amendment to the A&R Certificate of Incorporation to reduce the vote required to amend, repeal, or adopt any provisions of the A&R Certificate of Incorporation from the approval of 66 2/3% of the voting power of the shares of the then outstanding voting stock of the Company entitled to vote to a majority of such shares; and (iii) approved a reverse stock split of the Company’s common stock at a ratio of between one-for-five and one-for-twenty-five, with such ratio to be determined at the sole discretion of the Company’s Board of Directors (the “Board”) and with such reverse stock split to be effected at such time and date, if at all, as determined by the Board in its sole discretion.

Common Stock

On February 25, 2020, the Company raised $650,000 in gross proceeds through a private placement bridge offering of its common stock and warrants to purchase its common stock to certain accredited investors (the “Bridge Offering”). The Company sold an aggregate of 1,300,000 shares of common stock and warrants to purchase 1,300,000 shares of common stock in the Bridge Offering pursuant to a securities purchase agreement between the Company and each of the investors in the Bridge Offering (the “Purchase Agreement”). The warrants are exercisable for a the period commencing the date the Company’s stockholders approve either an increase in the number of the Company’s authorized shares or a reverse stock split and ending on February 25, 2025 and have an exercise price of $0.79 per share. Pursuant to the terms of the Purchase Agreement, the Company agreed to hold a meeting of its stockholders on or prior to May 25, 2020 for the purpose of seeking approval of either an increase in the number of shares of common stock the Company is authorized to issue or a reverse split of the Company’s common stock (a “Capital Event”). The Company did not hold a meeting until September 15, 2020, at which time the Company’s stockholders approved various measures including those comprising a Capital Event.

On April 24, 2020, the Company entered into a Securities Purchase Agreement (the “April 2020 Purchase Agreement”) with certain investors for the purpose of raising approximately $1.0 million in gross proceeds for the Company. Pursuant to the terms of the April 2020 Purchase Agreement, the Company agreed to sell, in a registered direct offering, an aggregate of 1,886,793 shares of the Company’s common stock, at a purchase price of $0.405 per share, and in a concurrent private placement, warrants to purchase up to 1,886,793 shares of common stock, at a purchase price of $0.125 per warrant, for a combined purchase price per share and warrant of $0.53. The warrants are exercisable immediately on the date of issuance at an exercise price of $0.405 per share and will expire five years following the date of issuance.

The closing of the sales of these securities under the April 2020 Purchase Agreement occurred on April 28, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were $811,641.

On June 1, 2020, the Company entered into a Securities Purchase Agreement (the “June 2020 Purchase Agreement”) with certain investors for the purpose of raising approximately $1,333,000 in gross proceeds for the Company. Pursuant to the terms of the June 2020 Purchase Agreement, the Company agreed to sell, in a registered direct offering, an aggregate of 2,930,402 shares of the Company’s common stock at a purchase price of $0.33 per share, and in a concurrent private placement, warrants to purchase up to 2,930,402 shares of common stock at a purchase price of $0.125 per warrant, for a combined purchase price per share and warrant of $0.455. The warrants are exercisable immediately on the date of issuance at an exercise price of $0.33 per share and will expire five years following the date of issuance.

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

The closing of the sales of these securities under the June 2020 Purchase Agreement occurred on June 3, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were $1,161,667.

On July 17, 2020, the Company entered into an AmendmentUnderwriting Agreement relating to Employmenta firm commitment public offering (the “Public Offering”) of 12,500,000 units (the “Units”), consisting of an aggregate of 12,500,000 shares of common stock and warrants to purchase up to 12,500,000 shares of common stock at a public offering price of $0.32 per Unit. Pursuant to the terms of the Underwriting Agreement, (the “Employment Amendment”) with the CEO, pursuantunderwriters also exercised their overallotment option in full, purchasing an additional 1,875,000 shares of common stock and warrants to which the CEO was removedpurchase up to 1,875,000 shares of common stock for an aggregate purchase of 14,375,000 shares and warrants to purchase up to 14,375,000 shares of common stock. The warrants have an initial exercise price of $0.32 per share, subject to customary adjustments, and will expire seven years from the positiondate of CEO andissuance. Exercisability of the warrants was appointedsubject to servestockholder approval of an increase in the number of authorized shares of common stock or a reverse stock split, in either case, in an amount sufficient to permit exercise in full of the warrants, which was obtained on September 15, 2020.

Pursuant to the Underwriting Agreement, the Company also issued to the underwriters as compensation a warrant to purchase up to 750,000 shares of common stock with substantially the same terms as the warrants issued in the Public Offering.

The closing of this transaction occurred on July 21, 2020. Net proceeds to the Company, after deducting the underwriters and placement agent’s fees and expenses, including the Company’s Chief Medical Officer Outsideestimated offering expenses, and excluding the proceeds, if any, from the exercise of the United States. The Employment Amendment represented a changewarrants issued in position only; all other terms and conditionsthe Public Offering, were $3,882,000. As of the CEO Agreement remain in effect. Further, on March 20, 2018, the employment of the Company’s Co-CEO was terminated without cause,July 21, 2020 closing, did not have sufficient authorized common shares to share settle all outstanding stock options and warrants.

On February 7, 2019, the Company entered into an agreementAgreement (“MZ Agreement”) with MZHCI, LLC a new Chief Executive Officer (the “New CEO”MZ Group Company (“MZ”), which provides for MZ to provide investor relations advisory services. The MZ Agreement was for an annual base salaryinitial term of $400,000 as well as standard employee insurancetwelve (12) months with six-month automatic extension periods. MZ received cash compensation of $8,000 per month and other benefitseighty-five thousand (85,000) restricted shares which vested quarterly over the initial twelve-month term. Effective on July 24, 2020, the Company and MZ terminated the agreement.

Series C Convertible Preferred Stock

In a private placement occurring concurrently with the Public Offering, the Company entered into a Securities Purchase Agreement with certain investors pursuant to which the Company agreed to sell 4,205,406 shares of its Series C Convertible Preferred Stock (the “New CEO Agreement”“Preferred Stock”). and warrants to purchase up to 6,078,125 shares of its common stock for a combined purchase price per share and warrant of $0.37. Pursuant to this agreement,its terms, the New CEO is eligible for annual salary increases atPreferred Stock may convert into 6,078,125 shares of common stock. The warrants issued have an initial per share exercise price of $0.32, subject to customary adjustments, and will expire seven years from the discretiondate of issuance.

The gross proceeds were $1,556,000 and the net proceeds to the Company from the transaction, after deducting the underwriters and placement agent’s fees and expenses, including the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the boardwarrants issued in the private placement, were $1,358,000.

The holders of directorsthe Company’s Preferred Stock vote with holders of the Common Stock, and with any other shares of preferred stock that vote with the Common Stock, with each holder of Preferred Stock being entitled to one vote per share of Preferred Stock, and are entitled to receive 8% non-compounding cumulative dividends, payable when, as well as annual bonus payments of up to 50% of base salary, as determinedand if declared by the Compensation Committee of the Board of Directors. The New CEO Agreement provides for severance payments equalSeries C Preferred Stock ranks senior to six monthsthe common stock as to dividends and the distribution of base salaryassets in the event of termination without cause, severance paymentsany liquidation, dissolution, or winding up of the Company, either voluntary or involuntary or any sale of the Company.

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

In the event of any liquidation, dissolution, or winding up of the Company, either voluntary or involuntary, or any sale of the Company, the holders of Preferred Stock are entitled to receive, before and in preference to any distribution of any of the assets to the holders of the common stock, or any other series of the Company’s preferred stock that is junior to the Preferred Stock, an amount per share equal to one year$0.37 for each outstanding share of base salary ifPreferred Stock (the “Original Series C Issue Price”), plus all accrued but unpaid dividends thereon through the date of such termination occurs on or afterevent.

As of September 30, 2020, the two-year anniversaryholders of Preferred Stock are entitled to receive a liquidation preference payment of $0.37 per share, plus accrued and unpaid dividends totaling, in the aggregate, $23,859. During the three and nine months ended September 30, 2020, the Company recognized the $23,859 as a deemed dividend for the purpose of calculating loss attributable to common stockholders and loss per share. The liquidation preference of the Preferred Stock is subordinate and ranks junior to all indebtedness of the Company.

The Company may elect to convert the Preferred Stock to common stock in the event the Company either (i) consummates a merger, or (ii) raises an aggregate of at least $8,000,000 in gross proceeds in a transaction or series of transactions within any twelve (12) month period. In the event the Company elects to effect such a conversion, each share of Series C Preferred Stock is convertible into 1.445 shares of common stock.

The Company determined that the Preferred Stock represented permanent equity due to the absence of a redemption feature and the embedded conversion option was clearly and closely related to the equity host and did not require bifurcation. The $2,431,250 fair value of the warrants was calculated using the Black-Scholes option pricing model, using the $0.44 stock price, an expected term of 7.0 years, volatility of 118.7%, a risk-free rate of 0.47% and expected dividends of 0.00%. The $1,556,000 of gross proceeds were allocated on a relative fair value basis of $607,220 to the Preferred Stock and $948,781 to the warrants. The Preferred Stock includes a contingent beneficial conversion feature (“BCF”) which was valued at its $2,067,155 intrinsic value using the commitment date stock price of $0.44 per share and the effective conversion price of $0.10 per share, but was limited to the $607,220 of proceeds that were allocated to the Preferred Stock. The contingent BCF will be recognized when the contingency is resolved. If the BCF is recognized, it will be recorded as a deemed dividend for the purposes of calculating earnings per share. In addition, since the Company does not have retained earnings, the dividend will be recorded against additional paid-in capital.

Warrants

Certain investors in the Public Offering agreed with the underwriter to enter into a lock-up and voting agreement (the “Lock-Up and Voting Agreements”) whereby each such investor was subject to a lock-up period through July 21, 2020 and agreed to vote all shares of common stock each beneficially owned on the closing date of the New CEO Agreement and severance payments equalPublic Offering with respect to two years of base salary if such termination occurs within 24 months of a change in controlany proposals presented to the stockholders of the Company. In addition,Additionally, certain investors that agreed to enter into the Lock-Up and Voting Agreements, as consideration for their waiver of certain rights described in connectionthe April 2020 Purchase Agreement and June 2020 Purchase Agreement, were issued unregistered warrants (the “Waiver Warrants”) to purchase an aggregate of 3,495,000 shares of common stock. These warrants were substantially similar to the warrants issued in the concurrent private placement, except that they warrants have a term of five (5) years, an exercise price equal to $0.37 per share and carry piggy-back registration rights.

Exercisability of the warrants issued in the February 25 transaction was subject to stockholder approval of a Capital Event. The warrants issued in the April and June transactions were immediately exercisable. Exercisability of the warrants issued in the July Public Offering and Private Placement was subject to the later to occur of (i) date that the Company files an amendment to its amended and restated certificate of incorporation to reflecting stockholder approval of either an increase in the number of our authorized shares of Common Stock or a reverse stock split (in either case in an amount sufficient to permit the conversion in full of the Preferred Stock and exercise in full of the warrants), and (ii) the date of approval as may be required by the applicable rules and regulations of The Nasdaq Stock Market LLC (or any successor entity) from the stockholders of the Company with respect to the New CEOtransactions contemplated by the Securities Purchase Agreement, including the New CEOissuance of all of the shares issuable upon conversion of the Preferred Stock and warrants in excess of 19.99% of the issued and outstanding common stock on the closing date of the private placement.

On June 15, 2020, the Company filed a registration statement covering the warrants issued in the April and June transactions. The registration statement was declared effective on June 23, 2020. At the Special Meeting held on September 15, 2020, the Company’s stockholders approved measures comprising a Capital Event, as defined in the February transaction, increasing the authorized common shares by an amount sufficient to cover the exercise of warrants purchased in that transaction as well as the Public Offering and Private Placement, and including common shares issuable upon conversion of the Company’s Series C Preferred Stock. The Company filed its amended and restated certificate of incorporation on September 17, 2020 and filed a registration statement covering the warrants issued in the February and July transactions. This registration statement became effective on October 22, 2020, such that all of the warrants issued in 2020 are now exercisable.

On January 3, 2019, the Company entered into an Agreement (“Alere Agreement”) with Alere Financial Partners, a division of Cova Capital Partners LLC (“Alere”) for Alere to provide capital markets advisory services. The Alere Agreement is on a month to month basis that can be cancelled by either party with thirty (30) days advance notice. The Company will receivepay a monthly fee of $7,500 and issued to Alere five-year warrants to purchase 35,000 shares of the Company’s common stock at an option forexercise price of $1.59, equal to the purchase of up to 6.5%closing price of the Company’s common stock on February 7, 2019, the date of approval by the Company’s board of directors. On June 11, 2019, both parties agreed to terminate the Alere Agreement as of June 30, 2019 and the unvested warrants as of June 30, 2019, totaling 17,500, were forfeited.

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

In addition to the warrants issued to investors in the Bridge Offering described above, the placement agent received a fully-diluted basiswarrant to purchase 130,000 shares of the Company’s common stock containing substantially the same terms as the warrant issued to investors in that transaction. The Company determined that all of the warrants issued in connection with the Bridge Offering were derivative instruments because the Company did not have control of the obligation to obtain shareholder approval by May 25, 2020 to increase the number of authorized shares or to approve a reverse stock split. The accounting treatment of derivative financial instruments requires that the Company record the warrants as a liability at fair value and mark-to-market the instruments at fair values as of each subsequent balance sheet date. Any change in fair value is recorded as a change in the fair value of derivative liabilities for each reporting period at each balance sheet date.

The fair value of the warrants was determined using a Monte Carlo simulation, incorporating observable market data and requiring judgment and estimates. The Company reassesses the classification at each balance sheet date. If the classification changes as a result of events during the period, the contract will be reclassified as of the date of the IPO. The New CEO’s employment withevent that causes the Company is “at-will”, and may be terminated at any time, with or without cause and with or without notice by either the New CEO or the Company.reclassification.

 

Note 9 – Temporary EquityThe warrant derivatives were valued as of the February 25, 2020 issuance date, as of the quarter ended March 31, 2020, as of June 30, 2020, and Stockholders’ Equity (Deficiency)as of September 15, 2020 when the Company’s stockholders approved an increase in authorized shares in an amount sufficient to allow full exercise of these warrants. The value at issuance was $546,036 and was recorded as a derivative liability. The value of the derivative liability was $199,907 at March 31, 2020, $281,183 at June 30, 2020, and $334,229 at September 15, 2020.

 

Common StockThe derivative liability increased $53,046 and decreased $211,807 during the three and nine months ended September 30, 2020, respectively. The changes in derivative liability is reflected in Other Income on the Condensed Statement of Operations.

On September 15, 2020, the fair value of derivative liabilities was reclassified to equity when the Company’s stockholders approved items comprising a Capital Event. Accordingly, there is no fair value of derivative liabilities as of September 30, 2020.

The following inputs and assumptions were used for the valuation of the derivative liability:

  February 25, 2020  March 31, 2020  June 30, 2020  September 15, 2020 
Stock Price $0.70  $0.295  $0.3859  $0.4346 
Projected Volatility  97.1%  102.7%  102.7%  110.7%
Risk-Free Rate  1.36%  0.38%  0.29%  0.31%

It was assumed the stock price would fluctuate with the Company’s projected volatility.
The projected volatility was based on the historical volatility of the Company.
If the Company was required to pay the fair value of the warrant in cash as of May 25, 2020, the obligation was discounted at the Company’s estimated cost of debt based on short-term C-CCC bond ratings of 19.5% and 28.5%.
The likelihood of the Company calling a shareholder meeting and achieving shareholder approval was 90% as of February 25, 2020.
As June 30, 2020, the Company projected shareholder approval would not be obtained until approximately 8/31/20. No mandatory exercise was allowed prior to that date.
Until the Company obtained shareholder approval to increase the authorized shares on September 15, 2020, we assumed the warrant holders have an option to require the Company to pay the fair value of the warrants. The derivative value at that date was $334,229.

 

The Company completed the initial public offering of its common stock on June 4, 2018. See Note 2 - Initial Public Offering.

On April 26, 2018, the Company issued 44,444 shares of common stock with an aggregate value of $200,000, in satisfaction of deferred salary to its Chief Medical Officer Outside the United States. During June 2018, the Company issued 30,000 shares of common stock with an aggregate value of $90,000, in satisfaction of fees payable to its Medical Advisory Board, and granted 160,000 shares of immediately vested common stock with an aggregate value of $798,400 and 20,000 shares of common stock which will vest monthly over next twelve months to certain consultants. As of June 30, 2018, there was $96,521 of unrecognized stock-based compensation expense related to the unvested shares of common stock that will be recognized over the remaining vesting period of one year.

19
 

 

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

 

Preferred Stock

The Company’s preferred stock had certain redemption rights that were considered by the Company to be outside of the Company’s control. Accordingly, the Series A Preferred Stock and Series B Preferred Stock are presented as temporary equity on the Company’s condensed balance sheets.

The Series A and Series B Preferred Stock were convertible at the option of the holder at a conversion price of $10.00 and $12.00 per share, respectively, which was reduced to $4.50 and $4.30 per share, respectively, if the conversion resulted from a mandatory IPO conversion. On June 4, 2018, all Series A and Series B Preferred Stock and dividends in arrears of $911,151 and $107,556, respectively, were mandatorily converted into 1,743,231 shares of common stock, upon the completion of the IPO (see Note 2 – Initial Public Offering).In connection with the mandatory conversion of the Preferred Stock, the Company recorded a deemed dividend equal to the number of additional shares of common stock issued upon conversion of the Preferred Stock resulting from the reduction in the conversion price upon the mandatory IPO conversion, multiplied times the fair value of the common stock on the commitment date.

WarrantsWarrant Exercises

 

During the sixthree and nine months ended Juneending September 30, 2018, the Company issued five-year2020, warrants (“Investor Warrants”) for theto purchase of 1,269,3841,818,682 shares of common stock with an exercise price equalwere exercised resulting in proceeds to the lesserCompany of (i) $12.00 per share, or (ii) 70% of the highest price per common stock sold in an initial public offering, to investors in connection with the sale of the Convertible Notes, and issued five-year warrants for the purchase of 123,285 shares of common stock to with an exercise price equal to 110% of the Investor Warrants exercise price to the placement agent, in connection with the issuance of the Convertible Notes and as a result of the increase in warrant coverage in connection with the amendment to the Convertible Notes (see Note 6 - Convertible Notes and Convertible Note – Related Party). In connection with the IPO, the exercise price of the warrants issued to investors and the placement agent in connection with the Convertible Notes became fixed at $4.20 per share and $4.62 per share, respectively, pursuant to the terms of the warrants.

On June 4, 2018, the Company issued five-year warrants for the purchase of 1,725,000 shares of common stock at an exercise price of $6.00 per share to purchasers of Units in the IPO and issued five-year warrants for the purchase of 86,250 shares of common stock at an exercise price of $6.25 to the underwriter for the IPO. Further, in connection with the IPO, warrants for the purchase of 100,570 shares of Series A Preferred Stock were amended such that they became exercisable for the purchase of 116,912 shares of common stock at an exercise price of $4.30 per share.

On June 18, 2018, the Company issued five-year warrants for the purchase 100,000 shares of common stock to certain consultants. The warrants vested immediately, were exercisable at $5.00 per share and had a grant date value of $179,000 using the Black-Scholes Model pricing model, with the following assumptions used: stock price of $4.93, risk free interest rate of 2.67-2.80%, expected term of 3-5 years, volatility of 42.6% and an annual rate of quarterly dividends of 0%. A summary of warrant activity during the six months ended June 30, 2018 is presented below:

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

  Series A Preferred Stock  Common Stock 
  Number of Warrants  Weighted
Average
Exercise
Price
  Weighted
Average
Remaining
Life in
Years
  Intrinsic Value  Number of Warrants  Weighted Average Exercise Price  Weighted Average Remaining Life in Years  Intrinsic Value 
Outstanding, January 1, 2018  100,570  $5.00           371,216  $13.21         
Issued  -   -           3,303,919   6.02         
Exercised  -   -           -   -         
Cancelled  -   -           -   -         
Amendment of placement agent warrants[1]        (100,570)  5.00                  116,912   4.30         
Outstanding, June 30, 2018  -  $-        -  $     -   3,792,047  $5.48[2]  4.6  $      - 
                                 
Exercisable, June 30, 2018  -  $-   -  $-   3,792,047  $5.48   4.6  $- 

[1]

In connection with the IPO, placement agent warrants for the purchase of Series A Preferred Stock were amended such that the warrants became exercisable for the number of common stock that would have been issued upon the exercise of the Series A warrant and subsequent conversion to common stock upon the consummation of the IPO. The exercise price was amended to the price equal to the total proceeds that would have been required upon the exercise of the original warrant, divided by the amended number of warrant shares.

[2]

Pursuant to the terms of the warrant, the exercise price of the warrants issued to investors and the placement agent in connection with the sale of the Convertible Notes became fixed at $4.20 per share and $4.62 per share, respectively, at the date of the IPO, based upon the price of stock issued in the IPO.

A summary of outstanding and exercisable warrants as of June 30, 2018 is presented below:

Warrants Outstanding  Warrants Exercisable 
Exercise
Price
  Exercisable
Into
 Outstanding Number of Warrants  Weighted
Average
Remaining
Life in Years
  Exercisable Number of Warrants 
$12.00  Common Stock  183,963   5.0   183,963 
$4.30  Common Stock  116,912   2.7   116,912 
$6.25  Common Stock  86,250   4.9   86,250 
$6.00  Common Stock  1,725,000   4.9   1,725,000 
$5.00  Common Stock  100,000   5.0   100,000 
$4.62  Common Stock  138,624   4.4   138,624 
$4.20  Common Stock  1,441,298   4.3   1,441,298 
       3,792,047       3,792,047 

21

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)$631,626.

 

Stock Options

On June 18, 2018,From time to time, the Company granted non-qualified stockissues options for the purchase of 80,000 shares ofits common stock at anto employees and others. On July 18, 2020, the Company granted 100,000 options to each of its four independent directors and a total of 2,650,000 options to various executive officers, other employees and a consultant. The exercise price of $4.93 to members of its Medical Advisory Board. Thefor these stock options have a ten-year term and vest monthly over two years. The options had grant date value of $2.21is $0.40 per share, for an aggregate grant date value of $176,800, using the Black Scholes method with the following assumptions used: stockclosing price of $4.93, risk-free interest rate of 2.85%, volatility of 42.6%, annual rate of quarterly dividends of 0%, and a contractual term of six years. A summary of the option activity duringCompany’s stock on the six months ended June 30, 2018 is presented below:

        Weighted    
     Weighted  Average    
     Average  Remaining  Aggregate 
  Number of  Exercise  Life  Intrinsic 
  Options  Price  In Years  Value 
Outstanding, January 1, 2018  1,422,000  $10.16         
Granted  80,000   4.93         
Forfeited  -   -         
Outstanding, June 30, 2018  1,502,000  $9.88   8.4  $              - 
                 
Exercisable, June 30, 2018  1,250,871  $10.17   8.4  $- 

A summary of outstanding and exercisable options as of June 30, 2018 is presented below:

Options Outstanding  Options Exercisable 
Exercise Price  Exercisable Into Outstanding
Number of Options
  Weighted Average
Remaining Life In
Years
  Exercisable
Number of
Options
 
$10.00  Common Stock  1,296,000   8.3   1,123,204 
$12.00  Common Stock  120,000   9.2   120,000 
$7.00  Common Stock  6,000   9.4   6,000 
$4.93  Common Stock  80,000   10.0   1,667 
    Total  1,502,000       1,250,871 

business day preceding the grant date. The Company recognized $141,059$194,421 and $137,376$159,865 of stock-based compensation related to stock options during the three months ended JuneSeptember 30, 20182020 and 2017,2019, respectively, and recognized $363,027 and $329,454 of stock-based compensation related to stock options of $278,435 and $274,752 during the sixnine months ended JuneSeptember 30, 20182020 and 2017,2019, respectively. As of JuneSeptember 30, 2018,2020, there was $447,869$1,138,934 of unrecognized stock-based compensation expense related to outstanding stock options that will be recognized over the weighted average remaining vesting period of one year.2.5 years.

HANCOCK JAFFE LABORATORIES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)Restricted Stock Units

 

In connection with the New CEO Agreement, the New CEO is entitled to receive an option for the purchase of up to 6.5% ofOn September 13, 2019, under the Company’s commonnonemployee director compensation program, the Company granted two of its independent directors 78,125 restricted a stock on a fully-diluted basis as of the date of the IPO which vest 20% on the date of grant, and the remainder vest ratably over the following twenty-four months. The Company accrued stock-based compensation expense of $255,062 related to the vesting of stock options to be granted to the New CEO, for the three and six months ended June 30, 2018. As of June 30, 2018, there is $1,041,186 of unrecognized stock-based compensation related to stock options to be issuedunits each in connection with their appointment to the New CEO Agreement.Board in accordance with the Option Plan, which, based on the Company’s closing stock price on the grant date were valued at $0.96 per unit for an aggregate grant date value of $150,000. These units vest in equal annual portions on the anniversary of their grant.

 

Note 1011 – Subsequent Events

 

Chief Financial Officer

On July 16, 2018,October 7, 2020, the Company entered into an employment agreementa Securities Purchase Agreement (the “CFO“October 2020 Purchase Agreement”) with certain investors for the Company’s new chief financial officer (the “New CFO”). In connection withpurpose of raising approximately $5,100,000 million in gross proceeds for the CFOCompany. Pursuant to the terms of the October 2020 Purchase Agreement, the New CFO receivedCompany agreed to sell, in a ten-year option for the purchaseregistered direct offering, an aggregate of 150,0009,532,709 shares of the Company’s common stock at a purchase price of $0.41 per share, and in a concurrent private placement, warrants to purchase up to 9,532,709 shares of common stock at a purchase price of $0.125 per warrant, for a combined purchase price per share and warrant of $0.535. The warrants are exercisable immediately on the date of issuance at an exercise price of $2.98$0.41 per share and will expire five years following the date of which 50,000 option shares vest July 16, 2019 and the remaining option shares will vest on a quarterly basis over the following two-year period.issuance.

 

Stock OptionsThe closing of the sales of these securities under the October 2020 Purchase Agreement occurred on October 9, 2020. Net proceeds to the Company from the transactions, after deducting the placement agent’s fees and expenses but before paying the Company’s estimated offering expenses, and excluding the proceeds, if any, from the exercise of the warrants, were approximately $4,450,000.

 

On August 1, 2018,November 10, 2020 the Company granted ten-year options for theagreed to pay Spartan Capital Securities LLC $355,000 in cash, and warrants to purchase of an aggregate of 120,000440,449 shares of the Company’s common stock to the non-employee membersat a purchase price of the Board of directors. The options are exercisable at $2.95$0.32 per share, and vest monthly overwarrants to purchase 451,402 shares of common stock at a twelve-month period.purchase price of $0.41 per share. These amounts were in dispute and were paid pursuant to an investment banking agreement dated February 12, 2020 in connection with financings which occurred in July and October. The investment banking agreement has now been terminated with no further obligations.

 

On August 1, 2018, the Company approved the grant of a ten-year option for the purchase of 1,080,207 shares of the Company’s common stock to the New CEO, pursuant to the New CEO Agreement (see Note 9 – Temporary Equity and Stockholders’ Equity (Deficiency) – Stock Options), which are exercisable at $4.99 per share.

20 


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 disclaim anyundertake no obligation to publicly update any forward-looking statements.statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

The independent registered public accounting firm’s report on the Company’s financial statements as of December 31, 2017,2019, and for each of the years in the two-year period then ended, includes a “going concern” explanatory paragraph, that describes substantial doubt about the Company’s ability to continue as a going concern.

 

Unless the context requires otherwise, references in this document to “HJLI”, “we”, “our”, “us” or the “Company” are to Hancock Jaffe Laboratories, Inc.

 

Overview

 

We areHancock Jaffe Laboratories, Inc. is a development stage medical device company developing biologic-basedtissue-based solutions that are designed to be life-enhancinglife sustaining or life enhancing for patients with cardiovascular disease, and peripheral arterial and venous disease, and end stage renal disease,disease. The Company’s products are being developed to address large unmet medical needs by either offering treatments where none currently exist or ESRD. Each product candidate we are developing is designedby substantially increasing the current standards of care. Our two lead products are: the VenoValve®, a porcine based device to allow vascular and cardiothoracic surgeons to achieve effectiveness while improving current procedures and healthcare for a variety of patients. We arebe surgically implanted in the processdeep venous system of developingthe leg to treat a debilitating condition called chronic venous insufficiency (“CVI”); and obtainingthe CoreoGraft®, a bovine based conduit to be used to revascularize the heart during coronary artery bypass graft (“CABG”) surgeries. Both of our current products are being developed for approval by the U.S. Food and Drug Administration (“FDA”). We currently receive tissue for our products from one domestic supplier and one international supplier. Our current business model is to license, sell, or enter into strategic alliances with large medical device companies with respect to our products, either prior to or after FDA approval. Our current senior management team has been affiliated with more than 50 products that have received FDA approval or CE marking. We currently lease a 14,507 sq. ft. manufacturing facility in Irvine, California, where we manufacture products for the following three product candidates: the Bioprosthetic Heart Valve,our clinical trials and which we refer to as BHV, the Bioprosthetic Coronary Artery Bypass Graft, which we refer to as CoreoGraft, and the Bioprosthetic Venous Valve, which we refer to as the VenoValve. We havehas previously manufactured, developed and obtainedbeen FDA pre-market approvalcertified for the ProCol Vascular Bioprosthesis, a product for hemodialysis vascular access in patients with ESRD, which we sold to LeMaitre Vascular, Inc., or LMAT, in March 2016.commercial manufacturing of product.

 

Each of our product candidatesproducts will be required to successfully complete significant clinical trials to demonstrate the safety and efficacy of the product candidate before it will be able to be approved by the FDA. The completion

We are in the process of these clinical trials will require a significant amount of capitaldeveloping the following bioprosthetic implantable devices for peripheral vascular and the hiring of additional personnel.cardiovascular disease:

Recent Developments and TrendsVenoValve

 

The VenoValve is a porcine based valve developed at HJLI to be implanted in the deep venous system of the leg to treat severe CVI. By reducing reflux, and lowering venous hypertension, the VenoValve has the potential to reduce or eliminate the symptoms of deep venous, severe CVI, including venous leg ulcers. The current version of the VenoValve is designed to be surgically implanted into the patient via a 5 to 6 inch incision in the upper thigh.

There are presently no FDA approved medical devices to address valvular incompetence, or effective treatments for deep venous CVI. Current treatment options include compression garments, or constant leg elevation. 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 that compliance with compression garments and leg elevation is extremely low, especially among the elderly. Valve transplants from other parts of the body have been attempted, but with very-poor results. Many attempts to create substitute valves have also failed, usually resulting in early thromboses. 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.

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, as a precursor to the U.S. pivotal trial, we are conducting a small first-in-man study for the VenoValve in Colombia. The first phase of the first-in-man Colombian trial included 11 patients. In addition to providing safety and efficacy data, the purpose of the first-in-man study is to provide proof of concept, and to provide valuable feedback to make any necessary product modifications or adjustments to our surgical implantation procedures for the VenoValve prior to conducting the U.S. pivotal trial. In December of 2018, we received regulatory approval from Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”), the Colombian equivalent of the FDA. On February 19, 2019, we announced that the first VenoValve was successfully implanted in a patient in Colombia. Between April of 2019 and December of 2019, we successfully implanted VenoValves in 10 additional patients, completing the implantations for the first phase of the Colombian first-in-man study. Overall, VenoValves have been implanted in 11 patients. Endpoints for the VenoValve first-in-man study include reflux, measured by doppler, a VCSS score used by the clinician to measure disease severity, and a VAS score used by the patient to measure pain.

Reverse Stock SplitNine of 11 patients have now completed the one-year first-in-man trial. For those nine patients, reflux has improved an average of 50%, Venous Clinical Severity Scores (“VCSSs”) have improved an average of 58%, and VAS scores, which are used by patients to measure pain, have improved an average of 70%, all when compared to pre-surgery levels. VCSS scores are commonly used 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 improvements in VCSS scores is significant and indicates that VenoValve patients who had severe CVI pre-surgery, now have mild CVI or the complete absence of disease at one-year post surgery.

VenoValve safety incidences have been minor and include 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, we have submitted a Pre-IDE filing with the FDA requesting a Pre-IDE meeting. An investigational device exemption or IDE form the FDA is required for a medical device company to proceed with a pivotal trial for a class III medical device. Next steps for the VenoValve include the Pre-IDE meeting with the FDA, the continued monitoring of the two remaining VenoValve patients in our first-in-human trial, and the completion of a series of functional tests and an animal safety study mandated by the FDA, which are pre-requisites for the filing of an IDE application. We expect to be in a position to file our IDE application with the FDA, seeking approval to proceed with the VenoValve U.S. pivotal trial, in Q1 of 2021.

CoreoGraft

 

A one-for-two reverse stock splitThe CoreoGraft is a bovine based off the shelf conduit that could potentially be used to revascularize the heart, instead of our common stock was effected on December 14, 2017. Withharvesting the exceptionsaphenous vein from the patient’s leg in a Saphenous Vein Graft (SVG). In addition to avoiding the invasive and painful SVG harvest process, HJLI’s CoreoGraft closely matches the size of the securitiescoronary arteries, eliminating graft failures that are not affected byoccur due to size mismatch. In addition, with no graft harvest needed, the reverse stock split, all shareCoreoGraft could also reduce or eliminate the inner thickening that burdens and per share information has been retroactively adjustedleads to give effect to the reverse stock split for all periods presented, unless otherwise indicated.

Convertible Notes and Warrants

During the period from June 15, 2017 through December 7, 2017, we received aggregate proceeds of $2,750,500. We incurred cash offering costs of $186,100 (including $129,030 of placement agent fees) resulting in net cash proceeds of $2,564,400, pursuant to the issuance of convertible promissory notes, or the 2017 Notes, and five-year warrants, or the 2017 Investor Warrants, exercisable for the number of shares of common stock equal to 50%failure of the total shares issuable upon the conversion of the related 2017 Note. The 2017 Notes, as amended, were convertible into shares of common stock at a price per share equal to the lesser of $12.00 per share or 70% of the price per share in our initial public offering, bore interest at 15% per annum, payable quarterly, and were due on February 28, 2018.

From January 5, 2018 through January 16, 2018, we issued convertible notes, or the 2018 Notes, in the aggregate principal amount of $2,897,500 for net cash proceeds of $2,603,750. The 2018 Notes were convertible into shares of common stock at a price per share equal to the lesser of $12.00 per share or 70% of the price per share in our initial public offering, bore interest at 15% and were originally due on February 28, 2018. In connection with the issuance of the 2018 Notes, we also issued five-year warrants (the “2018 Investor Warrants”) exercisable for the number of shares of common stock equal to 50% of the total shares issuable upon the conversion of the 2018 Notes.

On February 28, 2018, we amended and restated the 2017 Notes and the 2018 Notes to, among other things, (i) extend the maturity date to May 15, 2018 and (ii) increase the warrant coverage of the 2017 Investor Warrants and the 2018 Investor Warrants to 100% and 75%, respectively, of the number of shares of common stock issuable upon the conversion of the related notes.

On June 4, 2018, upon the consummation of our IPO, principal and interest of $2,740,500 and $51,807, respectively, owed in connection with the 2017 Notes was converted into 802,345 shares of our common stock at a conversion price of $3.50 per share, and principal and interest of $10,000 and $267, respectively was paid in cash. Principal and interest of $2,897,500 and 53,584, respectively owed in connection with the 2018 Notes was converted into 848,192 shares of our common stock at a conversion price of $3.50 per share. As of June 30, 2018, there is no balance owed on the 2017 Notes or the 2018 Notes.

Exchange of Debt for Equity

On April 26, 2018 the convertible note held by the then majority (78%) common stock shareholder (“2015 Note”) was amended to reduce the conversion price to $4.30 per share, and a note held by another related party (the “Related Party Note”), was amended such that the Related Party Note became convertible at a conversion price of $4.30 per share. On the same date, the entire principal balance of $499,000 and $18,742 of related interest owed in connection with the 2015 Note was converted into 120,405 shares of our common stock and the entire principal balance of $148,905 and $1,648 of related interest owed in connection with the Related Party Note was converted into 35,012 shares of our common stock.

Conversion of Deferred Compensation

On April 30, 2018, we issued 44,444 shares of our common stock at a value of $4.50 per share in satisfaction of $200,000 in deferred compensation to our Chief Medical Officer Outside the United States.

Promissory NotesSVGs.

 

In addition on May 15, 2018, we issued five promissory notes (the “May Bridge Notes”)to providing a potential alternative to SVGs, the CoreoGraft could be used when making grafts from the patients’ own arteries and veins is not an option. For example, patients with aggregate proceedssignificant arterial and vascular disease often do not have suitable vessels to be used as grafts. For other patients, such as women who have undergone radiation treatment for breast cancer and have a higher incidence of $722,500heart disease, using the LIMA may not be an option if it was damaged by the radiation. Another example are patients undergoing a second CABG surgery. Due in large part to early SVG failures, patients may need a second CABG surgery. If the SVG was used for the first CABG surgery, the patient may have insufficient veins to harvest. While the CoreoGraft may start out as a product for patients with no other options, if the CoreoGraft establishes good short term and a principal balance amountlong term patency rates, it could become the graft of $850,000 and,choice for all CABG patients in connection therewith, issued 55,000 shares of our common stockaddition to the holders of the May Bridge Notes. The proceeds from the May Bridge Notes were used for working capital purposes. All of the principal and accrued interest on the May Bridge Notes were paid in full upon the consummation of the Company’s initial public offering (“IPO”) on June 4, 2018.LIMA.

 

Initial Public OfferingCoreoGraft Clinical Status

On May 30, 2018, the Company’s registration statement on Form S-1/A relating to its initial public offering of its common stock was declared effective by the Securities and Exchange Commission (“SEC”). The Company completed its initial public offering of 1,500,000 units (the “Units”) at $5.00 per unit on June 4, 2018, each Unit consisting of one share of the Company’s common stock, par value $0.00001 per share (the “Common Stock”), and a warrant to purchase one share of common stock at $6.00 per share. Aggregate gross proceeds from the IPO were $7,500,000, before underwriting discounts and commissions.

On June 8, 2018, the underwriters notified the Company of their exercise in full of their option to purchase an additional 225,000 Units (the “Additional Units”) to cover over-allotments. On June 12, 2018, the underwriters purchased the Additional Units at the initial public offering price of $5.00 per Unit, generating $1,125,000 in gross proceeds before underwriting discounts and commissions.

 

In connectionJanuary of 2020, we announced the results of a six-month, nine sheep, animal feasibility study for the CoreoGraft. Bypasses were accomplished by attaching the CoreoGrafts from the ascending aorta to the left anterior descending artery, and surgeries were preformed both on-pump and off-pump. Partners for the feasibility study included the Texas Heart Institute, and American Preclinical Services.

Test subjects were evaluated via angiograms and flow monitors during the study, and a full pathology examination of the CoreoGrafts and the surrounding tissue was performed post necropsy.

The results from the feasibility study demonstrated that the CoreoGrafts remained patent (open) and fully functional at 30, 90, and 180 day intervals after implantation. In addition, pathology examinations of the grafts and surrounding tissue at the conclusion of the study showed no signs of thrombosis, infection, aneurysmal degeneration, changes in the lumen, or other problems that are known to plague and lead to failure of SVGs.

In addition to exceptional patency, pathology examinations indicated full endothelialization for grafts implanted for 180 days both throughout the CoreoGrafts and into the left anterior descending arteries. Endothelium is a layer of cells that naturally exist throughout healthy veins and arteries and that that act as a barrier between blood and the surrounding tissue, which helps promote the smooth passage of blood. Endothelium are known to produce a variety anti-clotting and other positive characteristics that are essential to healthy veins and arteries. The presence of full endothelialization within the longer term CoreoGrafts indicates that the graft is being accepted and assimilated in a manner similar to natural healthy veins and arteries that exist throughout the vascular system and is an indication of long-term biocompatibility.

In May of 2020, we announced that we had received approval from the Superintendent of Health of the National Health Counsel for the Republic of Paraguay to conduct a first-in-human trial for the CoreoGraft. Up to 5 patients that need coronary artery bypass graft surgery will receive CoreoGraft implants as part of the first-in-human study. In July of 2020, we announced that we had received permission to proceed with the IPO,first-in-human study, which had been put on June 1, 2018, the Company filed an Amended and Restated Certificate of Incorporation (the “Restated Certificate”) with the Secretary of State of the State of Delaware and adopted Amended and Restated Bylaws (the “Restated Bylaws”). The Company’s Board of Directors and stockholders previously approved the Restated Certificate and the Restated Bylaws to be effective immediately priorhold due to the closingCOVID-19 pandemic, and in August of 2020 we announced that the Initial Public Offering.

Pursuant tofirst two patients had been enrolled for the Restated Certificate, the Company is authorized to issue an aggregate of 60,000,000 shares of stock, of which 50,000,000 shares are designated as common stock and 10,000,000 shares are designated as preferred stock.first-in-human CoreoGraft trial.

 

Preferred Stock

On June 4, 2018, all Series A and Series B Preferred Stock and dividends in arrears of $911,151 and $107,556, respectively, were mandatorily converted into 1,743,231 shares of common stock, uponOctober 28, 2020, we announced the completionfirst successful implantation of the IPO (see Note 2 – Initial Public Offering). The Series A and Series B Preferred Stock were convertible at the option of the holder atCoreoGraft in a conversion price of $10.00 and $12.00 per share, respectively, except that the price was reduced to $4.50 and $4.30 per share, respectively, if the conversion resulted from a mandatory IPO conversion.In connection with the mandatory conversion of the Preferred Stock, the Company recorded a deemed dividend equal to the number of additional shares of common stock issued upon conversion of the Preferred Stock resulting from the reductionpatient in the conversion price upon the mandatory IPO conversion, multiplied times the fair value of the common stock on the commitment date.Colombia.

26

Results of Operations

The following table represents selected items in our statements of operations for the three and six months ended June 30, 2018 and 2017:

  For the Three Months Ended  For the Six Months Ended 
  June 30,  June 30, 
  2018  2017  2018  2017 
Revenues:                
Product sales $-  $-  $-  $152,400 
Royalty income  28,963   38,800   60,028   66,708 
Contract research - related party  54,400   -   54,400   - 
Total Revenues  83,363   38,800   114,428   219,108 
Cost of revenues  -   -   -   188,734 
Gross Profit  83,363   38,800   114,428   30,374 
                 
Selling, general and administrative expenses  2,914,723   1,085,624   4,161,731   2,135,167 
Research and development expenses  280,419   184,919   520,912   257,579 
Loss from Operations  (3,111,779)  (1,231,743)  (4,568,215)  (2,362,372)
                 
Other Expense (Income):                
Amortization of debt discount  2,005,479   23,634   6,575,236   23,634 
Loss (gain) on extinguishment of convertible notes payable  43,474   -   (1,481,317)  - 
Interest expense, net  111,960   15,682   322,422   24,934 
Change in fair value of derivative liabilities  (227,279)  (22,147)  (191,656)  1,622 
Total Other Expense  1,933,634   17,169   5,224,685   50,190 
                 
Net Loss  (5,045,413)  (1,248,912)  (9,792,900)  (2,412,562)
Deemed dividend to preferred stockholders  (3,180,860)  (113,779)  (3,310,001)  (214,911)
Net Loss Attributable to Common Stockholders $(8,226,273) $(1,362,691) $(13,102,901) $(2,627,473)
                 
Net Loss Per Basic and Diluted Common Share: $(1.06) $(0.22) $(1.88) $(0.43)
                 
Weighted Average Number of Common Shares Outstanding:                
Basic and Diluted  7,781,603   6,123,482   6,962,193   6,062,082 

Comparison of the three months ended JuneSeptember 30, 20182020 and 20172019

Overview

 

We reported net losses of $5,045,413$1,974,769 and $1,248,912$1,814,895 for the three months ended JuneSeptember 30, 20182020 and 2017,2019, respectively, representing an increase in net loss of $3,796,501,$159,874 or 304%9%, resulting primarily fromdue to an increase in operating expenses of $1,924,599,$88,253, and ana net increase in amortizationother income and expense of debt discount of $1,981,845 (see below).$71,621.

 

Revenues

Revenues earned during the three months ended June 30, 2018 consist of royalty income and income from contract research – related party of $28,963 and $54,400, respectively. Revenues earned during the three months ended June 30, 2017 were generated through royalty income of $38,800.

Royalty income is earned pursuant to the terms of our March 2016 asset sale agreement with LMAT. The decrease in royalty income results from a decrease in LMAT sales volume for the three months ended June 30, 2018, versus three months ended June 30, 2017. The contract research revenue earned during the three months ended June 30, 2018 is related to research and development services performed on behalf of Hancock Jaffe Laboratory Aesthetics, Inc. (“HJLA”), pursuant to a Development and Manufacturing Agreement dated April 1, 2016.

 

As a developmental stage Company, our revenue, if any, is expected to be diminutive. The Company may license one or more of its products resulting in royalty revenues.diminutive and dependent on our ability to commercialize our product candidates.

 

Selling, General and Administrative Expenses

 

For the three months ended JuneSeptember 30, 2018,2020, selling, general and administrative expenses increased by $1,829,099$7,025 or 168%1%, to $2,914,723$1,164,089 from $1,085,624$1,157,064 for the three months ended JuneSeptember 30, 2017.2019. The small net increase reflects increases in legal, consulting and insurance expenses totaling approximately $170,000, partially offset by decreases in travel, compensation and other administrative expenses totaling approximately $152,000.

Legal expenses increased approximately $57,000 mainly due to the Company’s increased level of public filing activity not directly related to funding transactions in 2020 when compared to 2019, partially offset by lower ATSCO litigation related expenses. Consulting expenses increased $58,000 primarily due to placement agent fees for the Company’s research and development director. Compensation cost was approximately $95,000 lower due mainly to the change in classification of $65,000 employee benefits charged to research and development expenses in 2020 that were previously included in Selling, General and Administrative Expenses, lower travel expenses of approximately $43,000 in 2020 due to COVID-19 travel restrictions, and approximately $22,000 in lower facility and office related expenses.

Research and Development Expenses

For the three months ended September 30, 2020, research and development expenses increased by $81,228 or 12%, to $758,198 from $676,970 for the three months ended September 30, 2019. The increase is primarily due to increases of $95,000 in non-cash stock compensation and related costs due to a larger team, $41,000 in lab cost related to our APS study, partially offset by $19,000 in lower tissue purchases in 2020 due to stay-at home work orders related to COVID-19, and $11,000 in lower consulting expense of approximately $1,239,000, increasesdue to the external cost being replaced with an employee in severance expenses of approximately $300,000 and increases of approximately $385,000 in legal, professional fees and consulting fees during the period.2020.

 

ResearchInterest Income

Interest income of $564 and Development Expenses

For the three months ended June 30, 2018, research and development expenses increased by $95,500 or 52%, to $280,419 from $184,919 for the three months ended June 30, 2017. The increase is primarily due to increased labor costs, benefits and supplies and materials associated with research and development activities incurred by us in developing techniques to manufacture the Bioprosthetic Heart Valve and the pediatric bioprosthetic venous valves. We have not manufactured any product for LMAT during 2018, allowing us to increase our research and development activities.

Loss on Extinguishment of Convertible Notes Payable

For the three months ended June 30, 2018, we recorded a loss on extinguishment of convertible notes of $43,474. On June 4, 2018, upon the consummation of our initial public offering, principal and interest of $2,740,500 and $51,807, respectively, owed in connection with the 2017 Notes, were converted into 802,345 shares of our common stock at a conversion price of $3.50 per share, and principal and interest of $10,000 and $267, respectively$19,139 was paid in cash. Principal and interest of $2,897,500 and 53,584, respectively, owed in connection with the 2018 Notes, were converted into 848,192 shares of our common stock at a conversion price of $3.50 per share. The conversion of the 2017 Notes and 2018 Notes (together, the “Notes”) was deemed to be a debt extinguishment and, as a result,earned during the three months ended JuneSeptember 30, 2018, we recognized a $43,474 loss on extinguishment of convertible notes payable, consisting of the fair value of the common stock issued upon the conversion of the Notes of $8,252,685, less the extinguishment of $5,743,391 of principal2020 and interest converted and $2,465,820 of derivative liabilities associated with the embedded conversion option of the extinguished Notes.

Interest Expense

For the three months ended June 30, 2018, interest expense increased by $96,278, or 614%, as compared to the three months ended June 30, 2017, due to an increase in the average balance of loans payable outstanding, principally from the issuance of the Notes during the during the period from June 2017 through January 2018.

28

Amortization of Debt Discount

During the three months ended June 30, 2018, non-cash amortization of debt discount expense increased by $1,981,845 to $2,005,479 from $23,634 for the three months ended June 30, 2017. The increase is related to amortization of debt discount related to the embedded conversion option in the Notes, as well as the warrants issued with the Notes during the period from June 2017 through January 2018.2019, respectively.

 

Change in Fair Value of Derivative Liability

 

For the three monthsquarter ended JuneSeptember 30, 2018 and 2017,2020, we recorded a gainloss on the change in fair value of derivative liabilities of $227,279 and $22,147, respectively.$53,046. Our derivative liabilities are related to warrants issued in connection with our Series A preferred stock and Series B preferred stock financings, plus warrants issuedBridge Offering in connection with the Notes, as well as the embedded conversion options in the Notes.

Deemed Dividend

We recorded a deemed dividend of $3,180,860 and $113,779 for the three months ended June 30, 2018 and 2017, respectively, of which $93,269 and $113,779, respectively, resulted from the 8% cumulative dividend on the Preferred Stock and $3,087,591 and $0, respectively, resulted from the beneficial conversion feature recorded in connection with the conversion of the Preferred Stock (see Recent Developments - Preferred Stock, above).

February 2020.

 

Comparison of the sixnine months ended JuneSeptember 30, 20182020 and 20172019

 

Overview

 

We reported net losses of $9,792,900$4,761,483 and $2,412,562$5,334,644 for the sixnine months ended JuneSeptember 30, 20182020 and 2017,2019, respectively, representing an increasea decrease in net loss of $7,380,338,$573,161, or 306%11%, resulting primarily from increasesdue to a decrease in operating expenses of $2,289,897, increases$399,609, and an increase in non-cash amortizationother income and expense of debt discount of $6,551,602, partially offset by a $1,481,317 gain on extinguishment of convertible notes payable.$173,552.

 

Revenues

 

RevenuesRevenue earned during the sixnine months ended JuneSeptember 30, 2018 consist2019 was $31,243 and consisted entirely of royalty income and contract research - related party of $60,028 and 54,400, respectively. Revenues earned during the six months ended June 30, 2017 were generated through product sales of the ProCol Vascular Bioprosthesis of $152,400, and royalty income of $66,708. Sale of the ProCol Vascular Bioprosthesis during the six months ended June 30, 2017 resulted from our contract manufacturing supply arrangement with LMAT, which we entered in connection with the sale of the ProCol Vascular Bioprosthesis to LMAT in 2016. There were no orders for product from LMAT during the six months ended June 30, 2018.

Royalty income is earned pursuant to the terms of our March 2016 asset sale agreement with LMAT. The increaseLeMaitre Vascular, Inc., which three-year term ended on March 18, 2019. With the agreement reaching the end of its term in royalty income results from royalties earned on LMAT sales for the six months ended June 30, 2018, versus six months ended June 30, 2017.

The contract research2019, there was not any similar revenue is related to research and development services performed on behalf of HJLA, pursuant to a Development and Manufacturing Agreement dated April 1, 2016.in 2020.

 

As a developmental stage Company, our revenue, if any, is expected to be diminutive. The Company may license one or more of its products resulting in royalty revenues.

Until any ofdiminutive and dependent on our ability to commercialize our product candidates are approved, if at all, our revenue will be substantially dependent upon LMAT’s sales efforts of the ProCol Vascular Bioprosthesis.

29

Gross Profit (Loss)

Cost of sales were $0 and $188,734 for the six months ended June 30, 2018 and 2017, respectively, consisting primarily of labor costs and the costs of materials used for the sub-contract manufacture of the vascular bioprosthesis. The gross loss on product sales of the ProCol Vascular Bioprosthesis is primarily the result of (i) lower than expected product sales, and (ii) high fixed costs which result from a fixed volume contract with the supplier of our raw materials. We intend to negotiate with suppliers such that during periods of low demand, the suppliers will provide materials that can be used for research and development purposes, however, we may not be successful in these negotiations.

candidates.

Selling, General and Administrative Expenses

 

For the sixnine months ended JuneSeptember 30, 2018,2020, selling, general and administrative expenses decreased by $987,554 or 25%, to $3,001,720 from $3,989,274 for the nine months ended September 30, 2019. The decrease is primarily due to decreases of approximately $382,000 in stock-based compensation expense primarily from the settlement of a legal dispute in 2019 and from lower expense related to awards of common stock options to employees and consultants in 2020, $67,000 in legal fees due to lower costs related to the ATSCO litigation, $140,000 in lower consulting and outside services cost related to recruiting fees in 2019 that were not incurred in 2020 and reductions in other consulting, $142,000 in lower travel costs due to COVID-19 travel restrictions, and in facility and other office expenses which were $104,000 lower due to the office closure related to stay-at home work orders, partially offset by $134,000 in higher insurance costs in 2020.

Research and Development Expenses

For the nine months ended September 30, 2020, research and development expenses increased by $2,026,564$556,702 or 95%39%, to $4,161,731$1,974,995 from $2,135,167$1,418,293 for the sixnine months ended JuneSeptember 30, 2017.2019. The increase is primarily due to increases of approximately $1,239,000$272,000 in non-cash stock compensation expense, increases of approximately $573,000 in legal, professional fees and consulting fees and increases in severance expenses of $300,000 during the period.

Research and Development Expenses

For the six months ended June 30, 2018, research and development expenses increased by $263,333 or 102%, to $520,912 from $257,579 for the six months ended June 30, 2017. The increase is primarilyrelated costs due to increased labor costs, benefitsa larger team, $271,000 in lab cost related to our APS study, and supplies and materials associated with research and development activities incurred by us$39,000 in developing techniquesconsulting related to manufacture the Bioprosthetic Heart Valve and the pediatric bioprosthetic venous valves. We did not manufacture any productsupport for LMAT during 2018, allowing us to increase our research and development activities.

Net Gain on Extinguishment of Convertible Notes Payable

For the six months ended June 30, 2018, we recorded a gain on extinguishment of convertible notes of $1,481,317. On February 28, 2018, the NotesGLP protocol. These increases were amended such that the maturity date was extended to May 15, 2018, the 2017 Investor Warrants became exercisable for the number of shares of common stock equal to 100% of the total shares issuable upon the conversion of the 2017 Notes, and the 2018 Investor Warrants become exercisable for the number of shares of common stock equal to 75% of the total shares issuable upon the conversion on the 2018 Notes. The amendment of the Notes was deemed to be a debt extinguishment and, as a result, we recognized a $1,524,791 gain on extinguishment of convertible notes payable within the accompanying statement of operations consisting of the extinguishment of $2,420,390 of derivative liabilities associated with the embedded conversion options of the extinguished Notes, partially offset by the value of additional warrants issued (deemedapproximately 26,000 in lower tissue purchases due to be a derivative liability) in the amount of $895,599.COVID-19.

Further, on June 4, 2018, upon the consummation of our IPO, principal and interest of $2,740,500 and $51,807, respectively, owed in connection with the 2017 Notes was converted into 802,345 shares of our common stock at a conversion price of $3.50 per share, and principal and interest of $10,000 and $267, respectively was paid in cash. Principal and interest of $2,897,500 and 53,584, respectively owed in connection with the 2018 Notes was converted into 848,192 shares of our common stock at a conversion price of $3.50 per share. The conversion of the Notes was deemed to be a debt extinguishment and, as a result, during the six months ended June 30, 2018, we recognized a $43,474 loss on extinguishment of convertible notes payable, consisting of the fair value of the common stock issued upon the conversion of the Notes of $8,252,685, less the extinguishment of $5,743,391 of principal and interest converted and $2,465,820 of derivative liabilities associated with the embedded conversion option of the extinguished Notes. The loss on extinguishment partially offset the gain on extinguishment described above.

Interest ExpenseIncome

 

ForInterest income of $3,425 and $41,680 was earned during the sixnine months ended JuneSeptember 30, 2018, interest expense increased by $297,488, as compared to the six months ended June 30, 2017, due to an increase in the average balance of loans payable outstanding, principally from the issuance of the Notes during the period from June 2017 through January 2018.

Amortization of Debt Discount

During the three months ended June 30, 2018, amortization of debt discount expense increased by $6,551,602, to $6,575,236 from $23,634 for the three months ended June 30, 2017. The increase is related to amortization of debt discount related to the embedded conversion option in the Notes, as well as the Warrants issued with the Notes during the period from June 2017 through January 2018.2020 and 2019, respectively.

 

Change in Fair Value of Derivative Liability

 

For the sixnine months ended JuneSeptember 30, 2018 and 2017,2020, we recorded a gain and loss on the change in fair value of derivative liabilities of $191,656 and $1,622, respectively.$211,807. Our derivative liabilities arewere related to warrants issued in connection with our Series A preferred stock and Series B preferred stock financings, plus warrants issued in connection with the Notes, as well as the embedded conversion options in the Notes.

Deemed Dividend

We recorded a deemed dividend of $3,310,001 and $214,911 for the six months ended June 30, 2018 and 2017, respectively, of which $222,410 and $214,911, respectively, resulted from the 8% cumulative dividend on the Preferred Stock and $3,087,591 and $0, respectively, resulted from the beneficial conversion feature recorded in connection with the conversion of the Preferred Stock (see Recent Developments - Preferred Stock, above).Bridge Offering.

 

Liquidity and Capital Resources

 

We have incurred losses since inception and negative cash flows from operating activities for the sixnine months ended JuneSeptember 30, 2018.2020. As of JuneSeptember 30, 2018,2020, we had an accumulated deficit of $45,312,719.$60,949,408. These factors, among others, raise substantial doubt about our ability to continue as a going concern. Since inception, we have funded our operations primarily through our IPO, public and private placements of equity, and private placements of convertible debt securities as well as modest revenues from royalties, contract research and sales of the ProCol Vascular Bioprosthesis. To-date in 2020, including the October 2020 offering, we have closed five financings providing aggregate net proceeds of approximately $12,200,000.

As of August 7, 2018,November 10, 2020, we had a cash balance of $5,271,263.$8,841,899.

We measure our liquidity in a variety of ways, including the following:

 

 

June 30,
2018

 

December 31,
2017

  September 30
2020
 December 31,
2019
 
 (unaudited)     (unaudited)   
Cash $5,942,424  $77,688  $5,629,003 $1,307,231 
Restricted Cash - 810,055 
Working capital (deficiency) $3,513,936  $(8,004,171)  4,062,232  (452,434)

 

Based upon our cash and working capital as of JuneSeptember 30, 2018,2020, and after giving effect to the transactions completed on October 9, 2020, we expectbelieve we have sufficient cash to require additional equity and or debt financing in order to meet our obligations as they become due withinsustain the Company’s operations at least one year after the date of filing this filingReport.

The COVID-19 pandemic has disrupted the global economy and sustain operations. These factors, among others, raise substantial doubt abouthas negatively impacted large populations including people and businesses that may be directly or indirectly involved with the operation of our ability to continueCompany and the manufacturing, development, and testing of our product candidates. The full scope and economic impact of COVID-19 is still unknown and there are many risks from the COVID-19 that could generally and negatively impact economies and healthcare providers in the countries where we do business, the medical device industry as a going concern.

We will require significant amounts of additional capital to continue to fund our operations and complete our researchwhole, and development activities. If we are not able to obtain additional cash resources, we will not be able to continue operations. We will continue seeking additional financing sources to meet our working capital requirements, to make continued investment in research and development and to make capital expenditures needed for us to maintain and expand our business. We may not be able to obtain additional financing on terms favorable to us, if at all. If we are unable to obtain adequate financing or financing on terms satisfactory to us when we require it, or if we expend capital on projects that are not successful, our ability to continue to support our business growth, continue research and to respond to business challenges could be significantly limited, or we may have to cease our operations. If we raise additional funds through further issuances of equity or convertible debt securities, our existing stockholders could suffer significant dilution, and any new equity securities we issue could have rights, preferences and privileges superior to those of holders of our common stock, including the Units sold in our IPO.

For the Six Months Ended June 30, 2018 and 2017

For the six months ended June 30, 2018 and 2017, we used cash of $3,166,481 and $1,721,709, respectively, in operations. Cash used during the six months ended June 30, 2018 was primarily attributable to our net loss of $9,792,900, adjusted for net non-cash expenses in the aggregate amount of $6,227,790 and by $398,629 of net cash provided by changes in the levels of operating assets and liabilities. Cash used during the six months ended June 30, 2017 was primarily attributable to our net loss of $2,412,562, adjusted for net non-cash expenses in the aggregate amount of $372,920, partially offset by $317,933 of net cash provided by changes in the levels of operating assets and liabilities.

During the six months ended June 30, 2018, there were no cash flows from investing activities. During the six months ended June 30, 2017, cash used in investing activities was $27,365 of which $160,000 represented an issuance of a note receivable to a related party, $31,350 of net advances paid to a related party and $2,265 for purchases of property and equipment partially offset by $166,250 represented cash proceeds received in connection with the asset sale to LMAT.

During the six months ended June 30, 2018, cash provided by financing activities was $9,031,217, of which $7,657,427 was provided in connection with net proceeds from our initial public offering, $2,603,750 from the issuance of convertible notes and warrants, $722,500 of proceeds from issuances of notes payable, partially offset by the repayments of notes payable of $1,125,000, repayments of notes payable – related party of $120,864 and payment of initial public offering costs of $706,596. During the six months ended June 30, 2017, cash provided by financing activities was $1,708,476, of which $311,000 was provided with the issuance of a note payable to the then majority stockholder, net proceeds from the issuance of convertible notes of $892,430 and net proceeds from the issuance of Series B preferred stock of $632,900, partially offset by the repayments of notes payable – related party of $87,852 and payment of initial public offering costs of $40,002.

stage, pre-revenue companies such as HJLI.

 

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.

 

32

Critical Accounting Policies and Estimates

 

For a description of our critical accounting policies, see Note 4 – 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, 2018,2020, pursuant to Exchange Act Rule 13a-15(b). Based uponon that evaluation, our PrincipalChief Executive Officer and PrincipalChief Financial Officer concluded that our disclosure controls and procedures were not effective as of June 30, 2018.2020 because of the material weakness in internal control over financial reporting discussed below.

Notwithstanding the material weakness in internal control over financial reporting described below, our management has concluded that our consolidated financial statements included in the Quarterly Report on Form 10-Q are fairly stated in all material respects in accordance with accounting principles generally accepted in the United States of America.

Material Weakness

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

We did not maintain effective controls over accounting for warrants issued in connection with our February 25, 2020 financing, and, as a result, did not record an associated derivative liability on a timely basis. At the time of issuance, the Company sought and received technical accounting guidance on the accounting treatment for the derivative liability. However, due to personnel changes, the existence of the guidance was not known to new finance personnel. This deficiency did not result in the revision of any of our previously issued financial statements. However, if not addressed, the deficiency could result in material misstatement in the future. Accordingly, our management has determined that this control deficiency constitutes a material weakness.

Remediation Plan

We are in the process of developing a detailed plan for remediation of the material weakness, including developing and maintaining a transition process for new finance executives to review existing critical accounting policies and judgments. We will continue to assess the effectiveness of our remediation efforts in connection with our future assessments of the effectiveness of internal control over financial reporting and disclosure controls and procedures.

 

Changes in Internal Control over Financial Reporting

 

DuringOther than the three monthsmaterial weakness discussed above, there was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act) identified in connection with the evaluation of our internal control that occurred during the quarter ended June 30, 2018, there were no changes in our internal controls over financial reporting, or in other factors2020 that could significantly affect these controls, thathas materially affected, or areis 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.

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 itsour insurance coverage, and even if they are, if claims against us are successful, they may exceed the limits of applicable insurance coverage. We are

On October 8, 2018, Gusrae Kaplan Nusbaum PLLC (“Gusrae”) filed a complaint with the Supreme Court of the State of New York seeking payment of $178,926 plus interest and legal costs for invoices to the Company dated from November 2016 to December 2017. In July 2016, the Company retained Gusrae to represent the Company in connection with certain specific matters. The Company believes that Gusrae has not currently awareapplied all of any threatened or pending litigationthe payments made by the Company along with billing irregularities and errors and is disputing the amount owed. The Company recorded the disputed invoices in accounts payable and as of June 30, 2019, the Company has fully accrued for the outstanding claim against the Company.

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 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. The complaint seeks, among other things, back pay, unpaid wages, compensatory damages, punitive damages, attorneys’ fees, and costs. The Company intends to vigorously defend the claims, investigate the allegations, and assert counterclaims. Mr. Rankin resigned as the Company’s Chief Financial Officer, Secretary and Treasurer on March 30, 2020.

 

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. However, in addition to our current risk factors are set forth in our Form S-1,10-K, filed with the SEC on June 12, 2018.March 18, 2020, we have also identified the following additional risks to our company.

Risks Related to COVID-19

The COVID-19 pandemic has significantly negatively impacted our business.

The COVID-19 pandemic has disrupted 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. The full scope and economic impact of COVID-19 is still unknown and there are many risks from COVID-19 that could generally and negatively impact economies and healthcare providers in the countries where we do business, the medical device industry as a whole, and development stage, pre-revenue companies such as HJLI. At this time, we have identified the following COVID-19 related risks that we believe have a greater likelihood of negatively impacting our company specific, including, but not limited to:

Federal, State and local shelter-in-place directives which limit our employees from accessing our facility to manufacture, develop and test our product candidates.
Travel restrictions and quarantine requirements which prevent us from initiating and continuing animal studies and patient trial both inside and outside of the United States.
The burden on hospitals and medical personnel resulting in the cancellation of non-essential medical procedures such as surgical procedures needed to implant our product candidates for pre-clinical and clinical trials.
Delays in the procurement of certain supplies and equipment that are needed to develop and test our product candidates.
Erosion of the capital markets which make it more difficult to obtain the financing that we need to fund and continue our operations.
Potential back-log at regulatory agencies such as the FDA which may result in delays in obtaining regulatory approvals.
Travel restrictions which prevent patients from participating and continuing the participation in clinical trials.

Risks Related to our Material Weakness

If we fail to maintain an effective system of internal controls, we may not be able to accurately report financial results or prevent fraud. If we identify a material weakness in our internal control over financial reporting, our ability to meet our reporting obligations and the trading price of our stock could be negatively affected.

As described in Part I, Item 4 - Controls and Procedures, in connection with our issuance of warrants in the Bridge Offering, we identified a material weakness in our internal control over financial reporting with regard to our failure to record an associated derivative liability on a timely basis. This deficiency did not result in the revision of any of our issued financial statements. If we are unable to remediate this material weakness, or if we do not have these controls operating effectively for a sufficient amount of time, management may conclude that we did not maintain effective internal control over financial reporting as of December 31, 2020.

Effective internal controls are necessary to provide reliable financial reports and to assist in the effective prevention of fraud. Any inability to provide reliable financial reports or prevent fraud could harm our business. We regularly review and update our internal controls, disclosure controls and procedures, and corporate governance policies. In addition, we are required under the Sarbanes-Oxley Act of 2002 to report annually on our internal control over financial reporting. Any system of internal controls, however well designed and operated, is based in part on certain assumptions and can provide only reasonable, not absolute, assurances that the objectives of the system are met. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. Accordingly, a material weakness increases the risk that the financial information we report contains material errors.

While we are in the process of developing a detailed plan for remediation of the material weakness, including developing and maintaining a transition process for new finance executives to review existing critical accounting policies and judgments, we can offer no assurance that our remediation plan will ultimately have the intended effects. Any failure to maintain such internal controls could adversely impact our ability to report our financial results on a timely and accurate basis. If our financial statements are not accurate, investors may not have a complete understanding of our operations or may lose confidence in our reported financial information. Likewise, if our financial statements are not filed on a timely basis as required by the SEC and The Nasdaq Stock Market, we could face severe consequences from those authorities. In either case, it could result in a material adverse effect on our business or have a negative effect on the trading price of our common stock. Further, if we fail to remedy this deficiency (or any other future deficiencies) or maintain the adequacy of our internal controls, we could be subject to regulatory scrutiny, civil or criminal penalties or shareholder litigation. We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weakness identified or that any additional material weaknesses will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of those controls.

Further, in the future, if we cannot conclude that we have effective internal control over our financial reporting, investors could lose confidence in the reliability of our financial statements, which could lead to a decline in our stock price. Failure to comply with reporting requirements could also subject us to sanctions and/or investigations by the SEC, The Nasdaq Stock Market or other regulatory authorities.

 

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

 

On June 18, 2018, we issued 160,000November 10, 2020 the Company agreed to pay Spartan Capital Securities LLC warrants to purchase 440,449 shares of common stock at a purchase price of $0.32 per share, and 20,000warrants to purchase 451,402 shares of restricted common stock at $4.99a purchase price of $0.41 per shareshare. These warrants were issued as consideration pursuant to certain consultants. For these sales of securities,an investment banking agreement dated February 12, 2020 in connection with financings which occurred in July and October. The investment banking agreement has now been terminated with no general solicitation was used, and the Company relied on thefurther obligations. The warrant shares were issued pursuant to an exemption from registration available under Section 4(a)(2) of the Securities Act of 1933, as amended, or the Securities Act, with respect to transactions by an issuer not involving any public offering.amended.

On June 18, 2018, we granted warrants to purchase 100,000 shares of common stock at an exercise price of $4.93 to certain consultants. For these sales of securities, no general solicitation was used, and the Company relied on the exemption from registration available under Section 4(a)(2) of the Securities Act.

Use of Proceeds from Offering of Registered Securities

On May 30, 2018, our Registration Statement on Form S-1, as amended (Reg. No. 333-220372) was declared effective by the SEC, and on May 31, 2018, our Registration Statement on Form S-1 (Reg. No. 333-225296) became effective upon filing with the SEC. Each such Registration Statement was filed in connection with our IPO, pursuant to which we sold 1,725,000 Units, each consisting of one share of our common stock and a warrant to purchase one share of our common stock, at a price to the public of $5.00 per Unit, which amount includes the full exercise of the underwriter’s option to purchase additional Units. The common stock and warrants comprising each Unit were immediately separable and traded separately. Each warrant is exercisable for a share of our common stock at a price of $6.00 per share. The IPO closed on June 4, 2018 and the underwriters exercised their overallotment option as of June 8, 2018, as a result of which we raised net proceeds of approximately $6.5 million after deducting approximately $750,000 in underwriting discounts, commissions and expenses and approximately $1,222,569 in offering expenses payable by us. Network 1 Financial Securities was the underwriter for the offering. No payments were made by us to directors, officers or persons owning ten percent or more of our common stock or to their associates, or to our affiliates, other than payments in the ordinary course of business to officers for salaries and to non-employee directors as compensation for board or board committee service.

There has been no material change in the planned use of proceeds from our initial public offering as described in the final prospectus filed with the SEC pursuant to Rule 424(b) under the Securities Act on June 1, 2018.

Item 3. Defaults upon Senior Securities

 

None.

 

Item 4. Mine and Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

None.

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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
  
3.1Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 6, 2018).
3.2Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 of the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 6, 2018). 
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 XBRL Instance Document*
101.SCH XBRL Taxonomy Extension Schema Document*
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEF XBRL Taxonomy Extension Definition Linkbase Document*
101.LAB XBRL Taxonomy Extension Label Linkbase Document*
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document*

 

*Filed herewith.
**Furnished and not filed herewith.

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 10, 2018November 17, 2020HANCOCK JAFFE LABORATORIES, INC.
   
 By:/s/Robert Berman
  Robert Berman
  Chief Executive Officer
  (Principal Executive Officer)
   
 By:/s/ Robert RankinCraig Glynn
  Robert RankinCraig Glynn
  Interim Chief Financial Officer
  (Principal Financing and Accounting Officer)

 

33