U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended March 31, 2019

 

OR

 

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

 

For the transition period from ________ to ________

 

Commission file number 001-38758

 

Enochian Biosciences, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   45-2259340
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification Number)

 

Enochian Biosciences, Inc.

2080 Century Park East, Suite 906

Los Angeles, CA 90067

+1(786) 888-1685

 

(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

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

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒   No ☐.

 

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

 

  Large accelerated filer Accelerated filer
  Non-accelerated filer Smaller reporting company
  (Do not check if a smaller reporting company) Emerging growth company

 

 

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

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐   No ☒

 

Title of Each Class   Trading Symbol   Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share   ENOB   The Nasdaq Stock Market LLC

 

As of May 16, 2019, the number of shares of the registrant’s common stock outstanding was 38,789,310.

 

1

 

  

 

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

 

- INDEX -

 

    Page
PART I – FINANCIAL INFORMATION: 3
     
Item 1. Financial Statements (Unaudited): 3
     
  Condensed Consolidated Balance Sheets as of March 31, 2019 (Unaudited) and June 30, 2018 4
     
  Condensed Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended March 31, 2019 and March 31, 2018 5
     
  Condensed Consolidated Statements of Comprehensive Loss (Unaudited) for the Three and Nine Months Ended March 31, 2019 and March 31, 2018 6
     
  Condensed Consolidated Statements of Stockholders’ Equity (Unaudited) for the Nine Months Ended March 31,2019 and March 31, 2018 7
     
  Condensed Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended March 31, 2019 and March 31, 2018 9
     
  Notes to the Consolidated Financial Statements 10
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 25
     
Item 3. Quantitative and Qualitative Disclosures About Market Risk 32
     
Item 4. Controls and Procedures 32
     
PART II – OTHER INFORMATION: 33
     
Item 1. Legal Proceedings 33
     
Item 1A. Risk Factors 33
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 33
     
Item 3. Defaults Upon Senior Securities 33
     
Item 4. Mine Safety Disclosures 33
     
Item 5. Other Information 33
     
Item 6. Exhibits 34
     
Signatures 35

 

   

2

 

 

PART I – FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

The accompanying financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and in accordance with the instructions for Form 10-Q. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.

 

In the opinion of management, the financial statements contain all material adjustments, consisting only of normal recurring adjustments necessary to present fairly the financial condition, results of operations, and cash flows of the Company for the interim periods presented.

 

The results for the period ended March 31, 2019 are not necessarily indicative of the results of operations for the full year. These financial statements and related footnotes should be read in conjunction with the financial statements and footnotes thereto included in the Company’s Form 10-K for the fiscal year ended June 30, 2018, filed with the Securities and Exchange Commission on October 1, 2018, as amended.

 

 

3

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    March 31,   June 30,
    2019   2018
      (Unaudited)          
ASSETS                
Current Assets:                
Cash   $ 10,272,198     $ 15,600,865  
Other receivables     1,941       122,866  
Prepaid expenses     232,383       38,284  
Total Current Assets     10,506,522       15,762,015  
                 
Property and Equipment, Net     743,522       27,402  
                 
OTHER ASSETS                
Definite Life Intangible Assets, Net     146,277,564       152,095,459  
Deposits     138,084       137,550  
Goodwill     11,640,000       11,640,000  
Total Other Assets     158,055,648       163,873,009  
                 
TOTAL ASSETS   $ 169,305,692     $ 179,662,426  
                 
LIABILITIES AND STOCKHOLDERS’ EQUITY                
                 
CURRENT LIABILITIES:                
Accounts Payable – Trade   $ 1,035,329     $ 571,809  
Accounts Payable - Related Party     235,000       235,000  
Accrued Expenses     248,799       66,913  
Total Current Liabilities     1,519,128       873,722  
                 
Contingent Consideration Liability     23,818,000       22,891,000  
                 
Total Liabilities   $ 25,337,128     $ 23,764,722  
                 
STOCKHOLDERS’ EQUITY:                
Preferred stock, $0.0001 par value; 10,000,000 shares                
authorized; no shares issued and outstanding                
Common stock, par value $0.0001, 100,000,000 shares authorized, 38,789,310                
shares issued and outstanding at March 31, 2019; 36,163,924 issued and outstanding                 
at June 30, 2018   $ 3,878     $ 3,616  
Additional Paid-In Capital     206,361,883       193,283,798  
Accumulated Deficit     (62,596,019 )     (37,595,389 )
Other Comprehensive Income     198,822       205,679  
Total Stockholders’ Equity     143,968,564       155,897,704  
                 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY     169,305,692       179,662,426  

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

4

 

  

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES CONDENSED

CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)

 

    For the Three Months   For the Nine Months
    Ended   Ended
    March 31,   March 31,
    2019   2018   2019   2018
                 
Revenues   $ —       $ —       $ —       $ —    
                                 
Cost of Goods Sold   $ —       $ —       $ —       $ —    
                                 
Gross profit (Loss)   $ —       $ —       $ —       $ —    
                                 
Operating Expenses                                
General and Administrative Expenses     1,951,685       1,979,609       6,750,939       3,049,393  
Research and Development Expenses     730,255       137,916       2,012,778       511,537  
Depreciation and Amortization     1,979,701       761,250       5,834,817       769,150  
Consulting Expenses     —         359,783       94,760       815,881  
Total Operating Expense   $ 4,661,641     $ 3,238,558     $ 14,693,294     $ 5,145,961  
                                 
LOSS FROM OPERATIONS   $ (4,661,641 )   $ (3,238,558 )   $ (14,693,294 )   $ (5,145,961 )
                                 
Other Income (Expense)                                
Change in Fair Value of Contingent Consideration     (217,000 )     —         (10,342,390 )     —    
Interest Income (Expense)     (43 )     1,183       (130 )     (12,060 )
Interest Income (Expense) – Related Party     —         183,511       —         779,943  
Gain (Loss) on Currency Transactions     164,114       87,817       (37,347 )     87,817  
Interest and Other Income     8,724       1,153       72,531       16,081  
Total Other (Expense) Income     (44,205 )     273,664       (10,307,336 )     871,781  
                                 
Loss Before Income Taxes     (4,705,846 )     (2,964,894 )     (25,000,630 )     (4,274,180 )
                                 
Income Tax Benefit   $ —       $ (4,729 )   $ —       $ (11,301 )
                                 
NET LOSS   $ (4,705,846 )   $ (2,960,165 )   $ (25,000,630 )   $ (4,262,879 )
                                 
BASIC AND DILUTED LOSS PER SHARE   $ (0.13 )   $ (0.12 )   $ (0.67 )   $ (0.25 )
                                 
WEIGHTED AVERAGE NUMBER OF                                
COMMON SHARES                                
OUTSTANDING - BASIC AND DILUTED     37,070,152       24,790,153       37,070,152       17,303,255  

 

 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

5

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE INCOME
                 
    For the Three Months   For the Nine Months
    Ended   Ended
    March 31,   March 31,
    2019   2018   2019   2018
                 
Net Loss   $ (4,705,846 )   $ (2,960,165 )   $ (25,000,630 )   $ (4,262,879 )
Foreign Currency Translation, Adjustments     139,710       (235,960 )   $ (6,857 )   $ (620,542 )
                                 
Other Comprehensive Loss   $ (4,566,136 )   $ (3,196,125 )   $ (25,007,487 )   $ (4 ,883,421 )

 

6  
 

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF SHAREHOLDERS’ EQUITY (UNAUDITED)

 

    Common Stock   Additional Paid-In Capital   Accumulated Deficit   Accumulated Other Comprehensive Income   Total
July 1, 2018   $ 3,616     $ 193,283,798     $ (37,595,389 )   $ 205,579     $ 155,897,704  
                                      —    
Issuance of Shares     1       39,999                         40,000  
Stock-Based Compensation              46,166                         46,166  
Comprehensive Loss                                     —    
Net Loss                       (2,303,233 )              (2,303,233 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes                       —         (91,517 )     (91,517 )
September 30, 2018   $ 3,617     $ 193,369,963     $ (39,898,622 )   $ 114,062     $ 153,589,120  
                                         
Issuance of Shares     262       11,115,127       —         —         11,111,467  
Stock-Based Compensation     —         1,780,060       —         —         1,783,881  
Comprehensive Loss                                     —    
Net Loss                     (17,991,551 )             (17,991,551 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes     —         —         —         224,470       224,470  
December 31, 2018   $ 3,879     $ 206,265,150     $ (57,890,173 )   $ 338,532     $ 148,717,387  
                                         
Issuance of Shares                     —         —         —    
Stock-Based Compensation     —         96,733       —         —         96,733  
Stock issued in exchange for services                                        
Stock issued related to conversion of convertible promissory note                                        
Comprehensive Loss                                     —    
Net Loss     —         —         (4,705,846 )             (4,705,846 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes     —         —         —         (139,710 )     (139,710 )
March 31, 2019   $ 3,879     $ 206,361,883     $ (62,596,019 )   $ 198,822     $ 143,968,564  

 

  

See accompanying notes to the unaudited condensed consolidated financial statements.

 

7

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES TO SHAREHOLDERS’ EQUITY (UNAUDITED)
FOR THE NINE MONTHS ENDED MARCH 31, 2018
 
      Common Stock       Additional Paid-In Capital       Accumulated Deficit       Accumulated Other Comprehensive Income       Total  
July 1, 2017   $ 1,243     $ 29,622,183     $ (28,443,524 )   $ 352,832     $ 1,532,734  
                                      —    
Issuance of Shares     130       1,595,134                       1,595,264  
Stock-Based Compensation             112,837                       112,837  
Comprehensive Loss                                     —    
Net Loss                     (225,775 )             (225,775 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes                     —         (255,181 )     (255,181 )
September 30, 2017   $ 1,373     $ 31,330,154     $ (28,669,299 )   $ 97,651     $ 2,759,879  
Issuance of Shares     18       299,116                       299,134  
Stock-Based Compensation                                     —    
Comprehensive Loss                                     —    
Net Loss                     (1,076,346 )             (1,076,346 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes     —         —         (593 )     (129,401 )     (129,994 )
December 31, 2017   $ 1,391     $ 31,629,270     $ (29,746,238 )   $ (31,750 )   $ 1,852,673  
Issuance of Shares                                     —    
Stock-Based Compensation                                     —    
Stock issued in exchange for services     2       104,998                       105,000  
Stock issued related to conversion of convertible promissory note     8       120,292                       120,300  
Stock issued pursuant to warrants exercised     240       3,294,760                       3,295,000  
Stock issued pursuant to private placement     167       13,416,873                       13,417,040  
Stock issued pursuant to Acquistion Agreement     1,808       127,762,629                       127,764,437  
Comprehensive Loss                                        
Net Loss                     (2,960,165 )             (2,960,165 )
Other Comprehensive Loss                                     —    
Currency Translations, Net of Taxes     —         —                 (235,960 )     (235,960 )
March 31, 2018   $ 3,616     $ 176,328,822     $ (32,706,403 )   $ (267,710 )   $ 143,358,325  

 

8  
 

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

 

    For the Nine Months Ended
    March 31,
    2019   2018
         
NET LOSS   $ (25,000,630 )   $ (4,262,879 )
                 
ADJUSTMENT TO RECONCILE NET LOSS TO NET                
CASH USED IN OPERATING ACTIVITIES:                
Depreciation and Amortization     5,842,448       769,150  
Change in Contingent Consideration Liability     10,342,390       —    
Stock Based Compensation Expense     1,962,958       217,837  
Accrued Interest on Notes Receivable     —         (10,874 )
Loss on Forgiveness on Note Receivable     —         457,813  
Gain on Forgiveness of Debt, Related Party     —         (87,817 )
Accretion of Discount on Notes Payable     —         11,997  
CHANGES IN ASSETS AND LIABILITIES:                
Other Receivables     120,391       192,507  
Prepaid Expenses/Deposits     (194,101 )     (11,874 )
Accounts Payable     463,520       219,507  
Accrued Expenses     181,890       (222,111 )
NET CASH USED IN OPERATINGACTIVITIES   $ (6,281,134 )   $ (2,726,744 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
Cash held in escrow     —         2,067  
Notes receivables     —         (250,799 )
Purchase of property and equipment     (733,176 )     (30,000 )
NET CASH USED IN INVESTING ACTIVITIES   $ (733,176 )   $ (278,732 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Proceeds from stock issuances     —         16,712,715  
Proceeds from exercise of options by related party     1,700,000       —    
NET CASH PROVIDED BY FINANCING ACTIVITIES   $ 1,700,000     $ 16,712,715  
                 
(Loss) on Currency Translation   $ (14,357 )   $ (630,548 )
                 
NET CHANGE IN CASH   $ (5,328,667 )     13,076,781  
                 
CASH, BEGINNING OF PERIOD   $ 15,600,865       3,941,712  
                 
CASH, END OF PERIOD   $ 10,272,198     $ 17,018,493  
                 
                 
                 
SUPPLEMENTAL DISCLOSURES OF CASH FLOW                
INFORMATION                
Non-cash investing and financing Activities:                  
Contingent Shares issued in connection with Acquisition Agreement     9,415,388       —    
Amortization of discount on Convertible Notes Payable     —         11,997  
Stock issued in exchange for services     —         217,837  
Convertible notes payable converted to 183,356 common shares     —         401,673  
Common stock issued and contingent common shares to acquire EBI     —         127,764,437  

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

9

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARY 

NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

The accompanying financial statements are unaudited. In the opinion of management, all adjustments (which include only normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows at March 31, 2019 and 2018 and for the periods then ended have been made. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted. It is suggested that these condensed financial statements be read in conjunction with the financial statements and notes thereto included in the Company’s June 30, 2018 audited financial statements. The results of operations for the periods ended March 31, 2019 and 2018 are not necessarily indicative of the operating results for the full year.

 

Business and Basis of Presentation – Enochian BioSciences, Inc., formerly DanDrit Biotech USA, Inc. (“Enochian”, or “Registrant”, and together with its subsidiaries, the “Company”, “we” or “us”) engages in the research and development, manufacturing and clinical trials of pharmaceutical and biological products for the treatment of HIV and cancer in humans. The Registrant was originally incorporated in the State of Delaware on January 18, 2011. On March 2, 2018, the Registrant amended its articles of incorporation changing the name of the Company to Enochian BioSciences, Inc.

 

Subsidiaries

 

 Enochian Biopharma Inc. (“Enochian Biopharma”) was incorporated on May 19, 2017 in Delaware and is a 100% owned subsidiary of the Registrant. Enochian Biopharma owns a perpetual, fully paid-up, royalty-free, sub-licensable, and sole and exclusive worldwide license to research, develop, use, sell, have sold, make, have made, offer for sale, import and otherwise commercialize certain intellectual property in cellular therapies for the prevention, treatment, amelioration of and/or therapy exclusively for HIV in humans, and research and development exclusively relating to HIV in humans (the “Field”). The accompanying financial statements include the accounts of Enochian Biopharma from the date of the acquisition which was completed on February 16, 2018.

 

Enochian BioSciences Denmark ApS, formerly DanDrit BioTech ApS, a Danish corporation was incorporated on April 1, 2001 (“DanDrit Denmark”) and is a 100% owned subsidiary of the Registrant (subject to 86,490 shares of common stock of DanDrit Denmark or 2.20% of outstanding shares to be acquired with the 129,596 shares of common stock of the Registrant (“Common Stock”) held in escrow according to Danish law (the “Escrow Shares”)). DanDrit Denmark engages in the research and development, manufacturing and clinical trials of pharmaceutical and biological products for the treatment of cancer in humans. On November 15, 2018, the Company changed the name of DanDrit BioTech ApS to Enochian BioSciences Denmark ApS.

 

 Acquisition of Enochian Biopharma- On January 12, 2018, the Registrant, DanDrit Acquisition Sub, Inc., (“Acquisition Sub”), Enochian Biopharma and Weird Science, LLC (“Weird Science”) entered into an agreement to acquire Enochian Biopharma (the “Acquisition Agreement”), pursuant to which on February 16, 2018, Enochian Biopharma became a wholly owned subsidiary of the Registrant (the “Acquisition”). As consideration for the Acquisition, the stockholders of Enochian Biopharma received (i) 18,081,962 shares of the Common Stock of the Registrant and (ii) the right to receive earn-out shares of Common Stock (“Contingent Shares”) pro rata upon the exercise or conversion of warrants which were outstanding at closing. As of June 30, 2018, 6,488,122 Contingent Shares are contingently issuable in connection with the Acquisition of Enochian Biopharma. On December 27, 2018, 1,307,693 Contingent Shares were issued to the stockholders of Enochian Biopharma in accordance with the Acquisition Agreement. At March 31, 2019, 5,180,429 Contingent Shares remained unissued. No contingent share activity occurred in the quarter-end March 31, 2019.

 

Consolidation — For the three months and nine months ended March 31, 2019 and 2018, the consolidated financial statements include the accounts and operations of the Registrant, Enochian BioSciences Denmark ApS, and Enochian Biopharma. All material inter-company transactions and accounts have been eliminated in the consolidation.

    

 

10

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

 

Functional Currency / Foreign currency translation — The functional currency of Enochian BioSciences Denmark ApS is the Danish Kroner (“DKK”). The Company’s reporting currency is the U.S. Dollar for the purpose of these financial statements. The Company’s balance sheet accounts are translated into U.S. dollars at the period-end exchange rates and all revenue and expenses are translated into U.S. dollars at the average exchange rates prevailing during periods ended March 31, 2019, June 30, 2018 and March 31, 2018. Translation gains and losses are deferred and accumulated as a component of other comprehensive income in stockholders’ equity. Transaction gains and losses that arise from exchange rate fluctuations from transactions denominated in a currency other than the functional currency are included in the statements of operations as incurred. 

 

Cash and Cash Equivalents —The Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. The Company had balances held in financial institutions in Denmark and in the United States in excess of federally insured States amounts at March 31, 2019 and June 30, 2018 of $10,272,198 and $15,600,865 respectively.

 

Property and Equipment — Property and equipment are stated at cost. Expenditures for major renewals and betterments that extend the useful lives of property and equipment are capitalized, upon being placed in service. Expenditures for maintenance and repairs are charged to expense as incurred. Depreciation is computed for financial statement purposes on a straight-line basis over the estimated useful lives of the assets which range from four to ten years (See Note 2).

 

Intangible Assets —Definite life intangible assets include patents and licenses. The Company accounts for definite life intangible assets in accordance with Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 350, “Goodwill and Other Intangible Assets”. Intangible assets are recorded at cost. Patent costs consist of costs incurred to acquire the underlying patent. If it is determined that a patent will not be issued, the related remaining capitalized patent costs are charged to expense. License agreements cost represent the Fair Value of the license agreement on the date acquired. Intangible assets are amortized on a straight-line basis over their estimated useful life. The estimated useful life of patents is twenty years from the date of application.

 

Goodwill —Goodwill is not amortized but is evaluated for impairment annually in the fiscal fourth quarter or whenever events or changes in circumstances indicate the carrying value may not be recoverable.

 

We test for goodwill impairment at the reporting unit level, which is one level below the operating segment level. Our detailed impairment testing involves comparing the fair value of each reporting unit to its carrying value, including goodwill. Fair value reflects the price a market participant would be willing to pay in a potential sale of the reporting unit and is based on discounted cash flows or relative market-based approaches. If the fair value exceeds carrying value, then it is concluded that no goodwill impairment has occurred. If the carrying value of the reporting unit exceeds its fair value, a second step is required to measure possible goodwill impairment loss. The second step includes hypothetically valuing the tangible and intangible assets and liabilities of the reporting unit as if the reporting unit had been acquired in a business combination. Then, the implied fair value of the reporting unit's goodwill is compared to the carrying value of that goodwill. If the carrying value of the reporting unit's goodwill exceeds the implied fair value of the goodwill, we recognize an impairment loss in an amount equal to the excess, not to exceed the carrying value.

 

The carrying value of goodwill at March 31, 2019, was $11.6 million. We do not believe there is a reasonable likelihood that there will be a material change in the future estimates or assumptions we use to test for impairment losses on goodwill. However, if actual results are not consistent with our estimates or assumptions, we may be exposed to an impairment charge that could be material.

 

11

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

 

Impairment of Long-Lived Assets — Long-lived assets, such as property, plant, and equipment, patents and licenses are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Circumstances which could trigger a review include, but are not limited to: significant decreases in the market price of the asset; significant adverse changes in the business climate or legal factors; current period cash flow or operating losses combined with a history of losses or a forecast of continuing losses associated with the use of the asset; and current expectation that the asset will more likely than not be sold or disposed of significantly before the end of its estimated useful life.

 

Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated undiscounted future cash flows, an impairment charge is recognized by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Assets to be disposed of would be separately presented in the balance sheet and reported at the lower of the carrying amount or fair value less costs to sell and would no longer be depreciated. The depreciable basis of assets that are impaired and continue in use is their respective fair values.

Value Added Tax — In Denmark, Value Added Tax (“VAT”) of 25% of the invoice amount is collected in respect of the sales of goods on behalf of tax authorities. The VAT collected is not revenue of the Company; instead, the amount is recorded as a liability on the balance sheet until such VAT is paid to the authorities. VAT of 25% is also paid to Danish and EU vendors on invoices. These amounts are refundable from the respective governmental authority and recorded as other receivables in the accompanying financial statements.

Research and Development Expenses — The Company expenses research and development costs incurred in formulating, improving, validating and creating alternative or modified processes related to and expanding the use of the HIV and cancer therapies and technologies for use in the prevention, treatment, amelioration of and/or therapy for HIV and cancer. Research and development expenses for the three months ended March 31, 2019 and 2018, respectively amounted to $730,255 and $137,916, respectively and for the nine months ended March 31, 2019 and 2018, amounted to $2,012,778 and $511,537, respectively.

 

12

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

 

Income Taxes — The Company accounts for income taxes in accordance with FASB ASC Topic 740 Accounting for Income Taxes, which requires an asset and liability approach for accounting for income taxes.

 

Loss Per Share — The Company calculates earnings/(loss) per share in accordance with FASB ASC 260 Earnings Per Share. Basic earnings per common share (EPS) are based on the weighted average number of shares of Common Stock outstanding during each period. Diluted earnings per common share are based on shares outstanding (computed as under basic EPS) and potentially dilutive shares of Common Stock. Potential shares of Common Stock included in the diluted earnings per share calculation include in-the-money stock options that have been granted but have not been exercised. Because of the net loss for the three and nine months ended March 31, 2019 and 2018, the dilutive shares for both periods were excluded from the Diluted EPS calculation as the effect of these potential shares of Common Stock is anti-dilutive. The Company had 5,583,520 potential shares of Common Stock excluded from the Diluted EPS calculation as of March 31, 2019.

  

Fair Value of Financial Instruments — The Company accounts for fair value measurements for financial assets and financial liabilities in accordance with FASB ASC Topic 820, “Fair Value Measurements”. The authoritative guidance, which, among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is defined as the exit price, representing the amount that would either be received to sell an asset or be paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:

 

  Level 1. Observable inputs such as quoted prices in active markets for identical assets or liabilities;

 

  Level 2. Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and

 

  Level 3. Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions.

 

Unless otherwise disclosed, the fair value of the Company’s financial instruments including cash, accounts receivable, prepaid expenses, investments, accounts payable, accrued expenses, capital lease obligations and notes payable approximates their recorded values due to their short-term maturities.

 

The following table sets forth the liabilities at March 31, 2019, which is recorded on the balance sheet at fair value on a recurring basis by level within the fair value hierarchy. As required, these are classified based on the lowest level of input that is significant to the fair value measurement:

 

13

 

 

        Fair Value Measurements at Reporting Date Using
          Quoted Prices in   Significant Other   Significant Other 
    Active Markets for Observable Unobservable
  Identical Assets Inputs Inputs
        (Level 1)   (Level 2)   (Level 3)
                   
Contingent Consideration Liability            
                   
The roll forward of the contingent consideration liability is as follows:         
                   
Balance June 30, 2018                $               22,891,000
Fair value adjustment, net                $                    927,000
Balance March 31, 2019                $               23,818,000

 

The fair value adjustment, net for the nine months ended March 31, 2019 is comprised of the issuance of contingent shares pursuant to the Acquisition Agreement in the amount of $9,415,390, offset by the change in fair value for the period in the amount of $10,342, 390.  

 

Stock Options and Warrants - The Company has granted stock options to certain employees, officers and directors that were subsequently converted to Grant Warrants (see Note 5). During the three and nine month periods presented in the accompanying condensed consolidated financial statements, the Company has granted stock options and warrants. The Company accounts for options and warrants in accordance with the provisions of FASB ASC Topic 718, Compensation - Stock Compensation. Non-cash compensation costs for the vesting of options and warrants granted to officers, board members, employees and consultants for the three months ended March 31, 2019 and 2018 were $96,733 and $105,000, respectively, and for the nine months ended March 31, 2019 and 2018 were $1,962,958 and $217,837, respectively.

 

Stock-Based Compensation - The Company records stock-based compensation in accordance with ASC 718, Compensation—Stock Compensation and ASC 505 - 50 Equity-Based Payments to Non-Employees. All transactions in which goods or services are the consideration received for the issuance of equity instruments are accounted for based on the fair value of the consideration received or the fair value of the equity instrument issued, whichever is more reliably measurable. Equity instruments issued to employees and the cost of the services received as consideration are measured and recognized based on the fair value of the equity instruments issued and are recognized over the employees required service period, which is generally the vesting period.

 

14

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)

Accounting Estimates — The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimated. Significant estimates include the fair value and potential impairment of intangible assets, depreciation of fixed assets, and fair value of equity instruments issued.

Recent Accounting Pronouncements  - On January 5, 2017 FASB issued Accounting Standards Update (“ASU”) 2017-01, Clarifying the Definition of a Business. This update amended the definition of a business, which is fundamental to the determination of whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. That distinction impacts how the acquisition is treated in the financial statements, for instance, whether deal costs are capitalized or expensed. The primary goal of ASU 2017-01 was to narrow that definition, which is generally expected to result in fewer transactions qualifying as business combinations. The Company is in the process of evaluating the impact of this new guidance.

 

In February 2016, the FASB issued ASU No. 2016-02 - Leases (Topic 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply a dual approach, classifying leases as either financing or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases today. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. The standard is effective for financial statements in fiscal years beginning after December 15, 2018. The Company is in the process of evaluating the impact of this new guidance, which would take effect at the beginning of the Registrant’s fiscal year on July 1, 2019.

In August 2018, the SEC adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532,  Disclosure Update and Simplification , as updated. These amendments eliminate, modify, or integrate into other SEC requirements certain disclosure rules. Among the amendments is the requirement to present an analysis of changes in stockholders’ equity in the interim financial statements included in quarterly reports on Form 10-Q. The analysis, which can be presented as a footnote or separate statement, is required for the current and comparative quarter and year-to-date interim periods. The amendments are effective for all filings made on or after November 5, 2018. As such, the Company adopted these SEC amendments as of this period and has presented the analysis of changes in stockholders’ equity in these interim financial statements for March 31, 2019 and 2018 presented in this Quarterly Report on Form 10-Q. The Company’s adoption of these SEC amendments has no material effect on the Company’s reporting of financial position, results of operations, cash flows or stockholders’ equity.

 

On March 30, 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting.  For public business entities, the ASU is effective for annual reporting periods beginning after December 15, 2016, including interim periods within those annual reporting periods. For all other entities, the ASU is effective for annual reporting periods beginning after December 15, 2017, and interim periods within annual reporting periods beginning after December 15, 2018. The Company’s adoption of these SEC amendments has no material effect on the Company’s reporting of financial position, results of operations, cash flows or stockholders’ equity.

 

Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on the Company's present or future financial statements.

 

  Reclassification — Certain amounts in the prior period financial statements have been reclassified to conform to the current presentation.

 

15

 

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 2 — PROPERTY AND EQUIPMENT

 

    Useful Life   March 31, 2019  

June 30,

2018

Lab Equipment and Instruments     4-7     $ 499,755     $ 202,197  
Leasehold Improvements     10     $ 194,778      
Furniture Fixtures and Equipment     4-7     $ 68,643     $ 58,977  
Total           $ 763,176     $ 261,174  
Less Accumulated Depreciation           $ (19,654 )   $ (233,772 )
Net Property and Equipment           $ 743,522     $ 27,402  

 

During the nine-months end March 31, 2019, and 2018, respectively had depreciation expense of $17,056, and $1,101.

 

The Company disposed of assets valued at $231,174 in the nine months ended March 31, 2019.

 

 

16

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

  NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 NOTE 3 — DEFINITE-LIFE INTANGIBLE ASSETS

 

During February 2018, the Company acquired a License Agreement (as licensee) to the HIV therapy being developed as ENO-1001 which consists of a perpetual, fully paid-up, royalty-free, sub-licensable, and sole and exclusive worldwide license to research, develop, use, sell, have sold, make, have made, offer for sale, import and otherwise commercialize certain intellectual property in cellular therapies for the prevention, treatment, and/or amelioration of and/or therapy for HIV in humans, and research and development exclusively relating to HIV in humans (the “License”).

 

At March 31, 2019 and June 30, 2018, definite and indefinite-life intangible assets consisted of the following:  

 

                Effect of Currency
    Useful Life   March 31, 2019   Period Change   Translation   June 30, 2018
Patents   20 Years   $ 298,428             $ (12,540 ) $ 310,968
License Agreement   20 Years   $ 154,824,000             $ —     $ 154,824,000
                             
Goodwill       $ 11,640,000             $ —     $ 11,640,000
Total       $ 166,762,428     $ —       $ (12,540 ) $ 166,774,968
Less Accumulated Amortization       $ (8,844,864 )   $ (5,825,392 )   $ 20,037   $ (3,039,509)
Net Definite-Life Intangible Assets       $ 157,917,564     $ (5,825,392 )   $ 7,497   $ 163,735,459

 The Amortization expense for the three and nine months ended March 31, 2019, respectively were $3,860,712 and $5,813,864.

 

Year ending June 30,                  
2019                 $ 1,939,187
2020                 $ 7,756,790
2021                 $ 7,756,790
2022                 $ 7,756,790
2023                 $ 7,756,790
Thereafter                 $ 113,311,217
                     
                  $   146,277,564

 

Impairment – Following the fourth quarter of each year, management performs its annual test of impairment of intangible assets assessing the qualitative factors and determines if it is more than likely than not that the fair value of the asset is greater than or equal to the carrying value of the asset. 

 

17

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES

  NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 4 — LEASES

 

Operating Leases — On November 13, 2017, the Registrant entered into a Lease Agreement for a term of five years and two months from November 1, 2017 (the “Term”) with Plaza Medical Office Building, LLC, a California limited liability company (the “Landlord”), as landlord, pursuant to which the Registrant agreed to lease from the Landlord certain premises (the “Leased Premises”) located in Los Angeles.

 

The Leased Premises consist of approximately 2,325 rentable square feet. The base rent for the Leased Premises increases by 3% each year over the Term, and ranges from approximately $8,719 per month for the first year to $10,107 per month for the two months of the sixth year. The equalized monthly lease payment for the term of the lease is $8,124. The Registrant is entitled to $70,800 in tenant improvement allowance in the form of free rent applied over 10 months in equal installments beginning in January of 2018.

 

On March 21, 2018, the Registrant entered into a Sub Lease Agreement for a term of five years commencing on April 2, 2018, with Rodeo Realty, Inc., a California Corporation (the “Lessee”), as lessee, pursuant to which the Lessee agreed to lease the Leased Premises from the Registrant under the same terms and conditions for the Leased Premises between the Registrant and the Landlord. The Sub Lease Agreement was terminated on July 18, 2018.

 

On June 19, 2018, the Registrant entered into a Lease Agreement for a term of ten years from September 1, 2018 with Century City Medical Plaza Land Co., Inc., pursuant to which the Company agreed to lease approximately 2,453 rentable square feet. On February 20, 2019, the Registrant entered into an Addendum to the original Lease Agreement with an effective date of December 1, 2019, where it expanded the lease area to include another 1,101 square feet for a total rentable 3,554 square feet. The base rent increases by 3% each year, and ranges from $17,770 per month for the remainder of the first year to $23,186 per month for the tenth year. The Company is entitled to $108,168 in contributions toward tenant improvements.

 

 

For the three and nine months ended March 31, 2018, lease expense charged to general and administrative expenses amounted to $62,638 and $236,991, respectively, and $0 and $15,385 for the three and nine months ended March 31, 2018.

 

Below are the lease commitments for the next 5 years and thereafter:

  

Year Ending June 30 th   Lease Expense
  2019     $ 81,059  
  2020     $ 331,787  
  2021     $ 341,741  
  2022     $ 351,993  
  2023 and thereafter     $ 1,672,528  
  Total     $ 2,779,108  

 

 

 

18

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 5 — STOCKHOLDERS’ EQUITY

 

Acquisition of DanDrit Denmark   At March 31, 2019 and June 30, 2018, the Registrant maintained a reserve of 129,596 Escrow Shares, respectively, all of which are reflected as issued and outstanding in the accompanying financial statements. The Escrow Shares are reserved to acquire the 86,490 and 123,464 shares held by non-consenting shareholders of DanDrit Denmark at March 31, 2019 and 2018, respectively, in accordance with Section 70 of the Danish Companies Act and the Articles of Association of DanDrit Denmark. During the year ended June 30, 2018, the Registrant issued 55,457 shares of Common Stock to such non-consenting shareholders of DanDrit Denmark. On November 15, 2018, the Company changed the name of DanDrit BioTech ApS to Enochian BioSciences Denmark ApS.

 

Stock Grants  - On September 15, 2016, the Board granted the right to acquire 300,000 shares of Common Stock at a strike price of $2.00 per share in what the Board originally described as “options” (the “Grants”) to each of Eric Leire, APE Invest A/S for Aldo Petersen and N.E. Nielson in consideration of their service to the Registrant. These Grants vested immediately and expire on December 31, 2019. In October of 2017, the Registrant issued warrants to APE Invest A/S and N.E. Nielsen, and in January 2018, the Registrant issued a warrant to Eric Leire (each a “Grant Warrant” collectively the “Grant Warrants”) to evidence the Grants for an aggregate of 900,000 Grant Warrants.

 

Grant Warrants/ Plan Options

 

On February 6, 2014, the Board adopted the Registrant’s 2014 Equity Incentive Plan (the “Plan”), and the Registrant has reserved 1,206,000 shares of Common Stock for issuance in accordance with the terms of the Plan. To date the Registrant has granted options under the Plan (“Plan Options”) to purchase 403,091 shares of Common Stock.

 

On September 19, 2018, the Company increased the compensation of the Board’s existing independent directors who are members of committees of the Board to $60,000 per year, along with an increase of the annual compensation to the Chair of the Audit Committee to $15,000 per year and the addition of cash retainers in the amount of $7,500, $5,000 and $4,000 to the members of the Audit Committee, Compensation Committee and Nominating and Corporate Governance Committee, respectively. In addition, the Company granted additional options to the existing independent directors who are members of committees of the Board to increase their non-cash compensation to $75,000 per annum. All newly granted options will have exercise prices as of the market price of the Company’s common stock on the date of grant.

 

On October 30, 2018, the Company granted options to a new independent director in the amount of $75,000, with a three-year vesting period and exercisable at the market price of the Company’s common stock on the date of grant.

 

On November 21, 2018, the Company granted 300,000 fully vested options to the newly named Executive Vice-Chair of the Board exercisable at the market price of the Company’s common stock on the date of grant.

 

No options were granted, exercised or expired during the quarter-ended March 31, 2019.

 

19

 

 

A summary of the status of the Plan Options and Grant Warrants outstanding at March 31, 2019 is presented below:

 

Options Outstanding   Options Exercisable
  Exercise Prices   Number Outstanding   Weighted Average Remaining Contractual Life (years)   Weighted Average Exercise Price   Number Exercisable Weighted Average Exercise Price
   $                  8.00                    69,235                         9.07    $                  8.00                          12,350    $                         8.00
                       5.74                    15,679                         9.48                        5.74                          15,679                               5.74
                       3.95                      5,064                         9.34                        3.95                                  -                                     -   
                       2.00                  650,000                         0.75                        2.00                        650,000                               2.00
                       5.72                    13,113                         9.59                        5.72                                  -                                     -   
   $                  6.50                  300,000                         9.65    $                  6.50                        300,000    $                         6.50
Total  $                     -                  1,053,091                         4.12    $                  3.79                        978,029    $                         3.38

 

Preferred Stock — The Registrant has 10,000,000 authorized shares of Preferred Stock, par value $0.0001 per share. At March 31, 2019, and June 30, 2018 there were zero shares issued and outstanding.

 

Common Stock — The Registrant has 100,000,000 authorized shares of Common Stock, par value $0.0001 per share. At March 31, 2019, and June 30, 2018, there were 38,789,310 and 36,163,924 shares issued and outstanding, respectively.

 

Voting — Holders of Common Stock are entitled to one vote for each share held of record on each matter submitted to a vote of stockholders, including the election of directors, and do not have any right to cumulate votes in the election of directors.

 

Dividends — Holders of Common Stock are entitled to receive ratably such dividends as the Board from time to time may declare out of funds legally available.

 

Liquidation Rights — In the event of any liquidation, dissolution or winding-up of affairs of the Company, after payment of all of our debts and liabilities, the holders of Common Stock will be entitled to share ratably in the distribution of any of our remaining assets.

 

Acquisition of EBI / Contingently issuable shares On February 16, 2018, the Acquisition was completed when the Acquisition Sub merged with and into Enochian Biopharma, with Enochian Biopharma as the surviving corporation. As consideration for the Acquisition, the stockholders of Enochian Biopharma received (i) 18,081,962 shares of Common Stock, and (ii) the right to receive Contingent Shares pro rata upon the exercise or conversion of warrants which were outstanding at closing. At March 31, 2019, 5,180,429 Contingent Shares are issuable in connection with the Acquisition of Enochian Biopharma.

 

Common Stock Issuances —  On December 27, 2018, the Company issued 1,307,693 shares of Common Stock in exchange for an equal number of warrants exercisable at $1.30. Proceeds received by the Company amounted to $1.7 million. In addition, on December 27, 2018, in accordance with the Acquisition Agreement, the Company issued an equal number of shares , 1,307,693, of Common Stock to the stockholders of Enochian Biopharma. . These Contingent Shares, as defined, were valued at the closing market stock price on date of issuance of $7.20 per share. The Company recorded a charge of $9.4 million to change in fair value of contingent consideration. No Common Stock was issued during the quarter-ended March 31, 2019.

 

Recognition of Options

 

The Company recognizes compensation costs for stock option awards to employees and directors based on their grant-date fair value. The value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model. The weighted-average assumptions used to estimate the fair values of the stock options granted using the Black-Scholes option-pricing model are as follows:

 

       Recognition of Options  
        Enochian Biosciences Inc.
Expected term (in years)   3-10
Volatility   94.37-98.15%
Risk free interest rate           3.06-3.23%
Dividend yield           0%

 

The Company recognized stock-based compensation expense (excluding other non-cash compensation expense) related to the options of $96,733 and $105,000 for the three months ended March 31, 2019 and 2018, respectively, and $1,962,958 and $217,837 for the nine months ended March 31, 2019 and 2018, respectively. At March 31, 2019, the Company had approximately $201,959 of unrecognized compensation cost related to non-vested options. 

 

A summary of the status of the Plan Options and the Grant Warrants at March 31, 2019 and changes during the the three month period are presented below:

 

              Weighted Average   Average   Weighted Average
          Shares   Exercise Price   Remaining Life   Intrinsic Value
                       
Outstanding at beginning of period                1,053,091   3.79   4.36   $3,451,984
Granted                                 -                               -                                     -                                     -   
Exercised                                 -                               -                                     -                                     -   
Forfeited                                 -                               -                                     -                                     -   
Expired                                 -                               -                                     -                                     -   
Outstanding at end of period                1,053,091                        3.79                              4.12    $                3,392,952
Vested and expected to vest                   978,029                        3.38                              3.52    $                3,348,725
Exercisable end of period                     978,029                        3.38                              3.52    $                3,348,725

 

At March 31, 2019, all Grant Warrants are exercisable, and 328,029 Plan Options are exercisable. The total intrinsic value of options at March 31, 2019 was $3,392,592.  Intrinsic value is measured using the fair market value at the date of exercise (for shares exercised) at March 31, 2019 (for outstanding options), less the applicable exercise price.

 

20

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 5 — STOCKHOLDERS’ EQUITY (Continued) 

   

Common Stock Purchase Warrants

 

A summary of the status of shares of Common Stock which can be purchased underlying the warrants outstanding for the three month period at March 31, 2019 is presented below:

 

                  Weighted Average   Weighted Average
              Shares   Exercise Price   Remaining Life
                       
Outstanding at beginning of period                   4,530,429    $                        1.34   3.38
Granted                                    -                                     -                                     -   
Exercised                                    -                                     -                                     -   
Cancelled/Expired                                    -                                     -                                     -   
Outstanding at end of period                   4,530,429    $                        1.34                               3.12
Exercisable end of period                     4,530,429    $                        1.34                               1.34
                       
                       
      Equivalent Shares   Underlying Warrants   Outstanding   Equivalent Shares Exercisable
  Exercise Prices   Equivalent Shares   Weight Average Remaining Contractual Life (years)   Weight Average Exercise Price   Number Exercisable   Weighted Average Exercise Price
   $                  1.30               4,505,429   3.13    $                  1.30                     4,505,429    $                         1.30
   $                  8.00                    25,000   1.88    $                  8.00                          25,000    $                         8.00
                       
  Total               4,530,429   3.12    $                  1.34                     4,530,429    $                         1.34

 

The exercise price of certain warrants and the number of shares underlying the warrants are subject to adjustment for stock dividends, subdivisions of the outstanding shares of Common Stock and combinations of the outstanding shares of Common Stock. For so long as the warrants remain outstanding, we are required to keep reserved from our authorized and unissued shares of Common Stock a sufficient number of shares to provide for the issuance of the shares underlying the warrants.

 

21

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 6 — COMMITMENTS AND CONTINGENCIES

 

Consulting Agreements – On July 9, 2018, the Company entered into a consulting agreement with G-Tech Bio, LLC, a California limited liability company (“G-Tech”) to assist the Company with the development of the gene therapy and cell therapy modalities for the prevention, treatment, amelioration of HIV in humans, and with the development of a genetically enhanced Dendritic Cell for use as a wide spectrum platform for various diseases (including but not limited to cancers and infectious diseases) (the “ G-Tech Agreement ”). G-Tech is entitled to consulting fees for 20 months, with a monthly consulting fee of not greater than $130,000 per month. G-Tech is controlled by certain members of Weird Science. For the three and nine months ended March 31, 2019, $375,000 and $1,125,000, respectively, was charged to research and development expenses in our Condensed Consolidated Statements of Operations related to this consulting agreement.

 

On February 16, 2018, the Registrant entered into a consulting agreement with Carl Sandler, a board member and shareholder of the Registrant (through his holdings in Weird Science) for services related to clinical development and new business opportunities. In consideration for services actually rendered, the Registrant paid $10,000 per month for 6 months. For the three and nine months ended March 31, 2019, Carl Sandler was paid $0 and $15,000, respectively, for consulting services. The agreement with Mr. Sandler terminated pursuant to its terms on August 16, 2018. This amount was charged to consulting expenses in our Condensed Consolidated Statements of Operations.

  

Shares held for non-consenting shareholders In connection with the Share Exchange certain shareholders of DanDrit Denmark had not been identified or did not consent to the exchange of shares. In accordance with Section 70 of the Danish Companies Act and the Articles of Association of DanDrit Denmark, the Non-Consenting Shareholders that did not exchange the DanDrit Denmark equity interests owned by such Non-Consenting Shareholders for shares of the Company, will be entitled to receive up to 185,053 shares of Common Stock of the Company that each such Non-Consenting Shareholder would have been entitled to receive if such shareholder had consented to the Share Exchange. During the year ended June 30, 2018, the Registrant issued 55,457 shares of Common Stock to such non-consenting shareholders of DanDrit Denmark. The 129,596 remaining shares have been reflected as issued and outstanding in the accompanying financial statements. 

 

22

 

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 6 — COMMITMENTS AND CONTINGENCIES (Continued) 

Food and Drug Administration (FDA) - The FDA has extensive regulatory authority over biopharmaceutical products (drugs and biological products), manufacturing protocols and procedures and the facilities in which they will be manufactured. Any new bio product intended for use in humans is subject to rigorous testing requirements imposed by the FDA with respect to product efficacy and safety, possible toxicity and side effects. FDA approval for the use of new bio products (which can never be assured) requires several rounds of extensive preclinical testing and clinical investigations conducted by the sponsoring pharmaceutical company prior to sale and use of the product. At each stage, the approvals granted by the FDA include the manufacturing process utilized to produce the product. Accordingly, the Company’s cell systems used for the production of therapeutic or bio therapeutic products are subject to significant regulation by the FDA under the Federal Food, Drug and Cosmetic Act, as amended.

Product liability - The contract production services for therapeutic products offered exposes an inherent risk of liability as bio therapeutic substances manufactured, at the request and to the specifications of customers, could foreseeably cause adverse effects. The Company seeks to obtain agreements from contract production customers indemnifying and defending the Company from any potential liability arising from such risk. There can be no assurance, however, that the Company will be successful in obtaining such agreements in the future or that such indemnification agreements will adequately protect the Company against potential claims relating to such contract production services. The Company may also be exposed to potential product liability claims by users of its products. A successful partial or completely uninsured claim against the Company could have a material adverse effect on the Company’s operations. 

 

Employment and Service Agreements - The Company had an employment agreement with Eric Leire, the former Chief Executive Officer with a base compensation of $313,775. The Company also had a services agreement with Crossfield, Inc. an entity controlled by Robert Wolfe, the former acting Chief Financial officer with a base compensation of $240,000. The Company maintains employment agreements with other staff in the ordinary course of business. As of January 7, and 9, 2019, respectively, Eric Leire and Robert Wolfe are no longer with the Company.

 

Contingencies - The Company is from time to time involved in routine legal and administrative proceedings and claims of various types. While any proceedings or claim contains an element of uncertainty, management does not expect a material impact on our results of operations or financial position. 

 

23

 

ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS  

 

NOTE 7 — RELATED PARTY TRANSACTIONS

  

On September 15, 2016, the Registrant recorded $626,487 in stock-based compensation for the grant of 900,000 Grant Warrants to employees, officers, and certain directors of the Registrant, which were fully vested upon grant, to purchase shares of Common Stock at $2.00 per share which expire on December 31, 2019. The Grant Warrants contain certain anti-dilution provisions applicable in the discretion of the Company. At March 31, 2019, there were 650,000 Grant warrants outstanding.

 

On December 29, 2017, the Registrant entered into a consulting agreement with RS Group ApS, a company owned and controlled by 2 directors, for consulting services from October 1, 2017 through March 31, 2018. In consideration for the consulting services in connection with the negotiation and structuring of the acquisition of Enochian Biopharma, the Registrant paid RS Group ApS $367,222, this amount was charged to consulting expenses in the nine months ended March 31, 2018.

 

On February 16, 2018, the Registrant entered into a consulting agreement with Carl Sandler, who subsequently became a board member and shareholder of the Registrant (through his holdings in Weird Science) for services related to clinical development and new business opportunities. In consideration for services actually rendered, the Registrant paid $10,000 per month for 6 months. For the three and nine months ended March 31, 2019, Carl Sandler was paid $0 and $15,000, respectively, for consulting services. The agreement with Mr. Sandler terminated pursuant to its terms on August 16, 2018. This amount was charged to consulting expenses in our Condensed Consolidated Statements of Operations.

 

 Consulting Agreements – On July 9, 2018, the Company entered into a consulting agreement with G-Tech Bio, LLC, a California limited liability company (“G-Tech”) to assist the Company with the development of the gene therapy and cell therapy modalities for the prevention, treatment, amelioration of HIV in humans, and with the development of a genetically enhanced Dendritic Cell for use as a wide spectrum platform for various diseases (including but not limited to cancers and infectious diseases) (the “ G-Tech Agreement ”). G-Tech is entitled to consulting fees for 20 months, with a monthly consulting fee of not greater than $130,000 per month. G-Tech is controlled by certain members of Weird Science. For the three and nine months ended March 31, 2019, $375,000 and $1,125,000, respectively, was charged to research and development expenses in our Condensed Consolidated Statements of Operations related to this consulting agreement.

 

NOTE 8 — SUBSEQUENT EVENTS

 

In accordance with ASC 855-10, Company management reviewed all material events through the date of this report. There have been no subsequent events of a significant and reportable nature as of May 10, 2019.

 

24

 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

Forward Looking Statement Notice

 

Certain statements made in this Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements of Enochian Biosciences, Inc. formerly DanDrit Biotech USA, Inc. (“Enochian”, or “Registrant”, and together with its subsidiaries, the “Company”, “we” or “us”) to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Our actual future results and trends may differ materially depending on a variety of factors, including, but not limited to, the risks and uncertainties discussed under “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. The Company’s plans and objectives are based, in part, on assumptions involving the continued expansion of business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of the Company. Although the Company believes its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate and, therefore, there can be no assurance the forward-looking statements included in this Quarterly Report will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation by the Company or any other person that the objectives and plans of the Company will be achieved.

 

Our Business

 

We are a pre-clinical stage biotechnology company committed to using our genetically modified cellular and immune-therapy technologies to prevent or potentially cure HIV and to potentially provide life-long cancer remission of some of the deadliest cancers. We do this by genetically modifying, or re-engineering, different types of cells, depending on the therapeutic area, and then injecting or reinfusing the re-engineered cells back into the patient to provide treatment. In some of our interventions, immunotherapy is used.

 

Human Immunodeficiency Virus, or HIV, and Acquired Immunodeficiency Syndrome, or AIDS

 

HIV attacks the body’s own immune system, specifically killing off CD4+ cells, or T-cells. Left untreated, HIV reduces the number of T-cells in the body, leading to AIDs, a condition where the body cannot fight off common infections and disease.

 

Currently there are over 30 antiretroviral drugs, or ART, approved by the FDA to treat HIV patients but these drugs are expensive, require daily adherence and can have significant side effects over time. In addition, approximately 1 million people, including in high-income countries, continue to die from HIV/AIDS due to resistance to ART or lack of access. Today there are no treatments which can eliminate the reservoir of cells that contain HIV from the body. In other words, treatment is life-long.

 

There have been several efforts to cure HIV by re-engineering a person’s own T-cells so that such cells no longer express C-C chemokine receptor type 5, also known as CCR5, which is an essential co-receptor for HIV to enter T-cells. A mutation that blocks expression of CCR5 on T-cells occurs in a small percentage of people with no known adverse effects. The “Berlin patient” is an HIV-positive person who developed cancer and was treated with a bone marrow transplant with cells derived from a person with a naturally occurring deletion of CCR5. The Berlin patient seems to be effectively cured from HIV. Therefore, several researchers and companies have attempted to replicate the experience of the Berlin patient by genetically modifying the T-cells of HIV-positive patients and reinfusing them with T-cells that do not express CCR5. However, the uptake, or engraftment of the modified, reinfused cells has not been optimal, leading to a failure to achieve a cure. In addition, the transplant conditioning that has been used is myeloablative chemotherapy, wiping out the patient’s immune system, which has inherent risks and can have long term side-effects including the risk of developing cancer.

 

ENOB-HV-01 is a novel, proprietary approach with the potential to overcome the failures of recent efforts. The intervention: 1) provides gene-modified, reinfused cells with a competitive advantage over non-modified cells in the HIV-positive person, with the potential to significantly increase engraftment; and 2) avoids the need for myeloablative chemotherapy and, in fact, could potentially be given on an outpatient basis.

 

We also plan to develop ENOB-HV-11 and ENOB-HV-12 that will utilize a novel cellular- and immunotherapy approach to potentially provide for a preventative vaccine and a therapeutic vaccine, respectively.

 

Cancer

Based on learning from peer-reviewed publications of Phase I/IIa trials we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long remissions from some of the deadliest solid tumors. We plan to initially target pancreatic cancer, triple negative breast cancer, glioblastoma, and renal cell carcinoma. The platform might also allow for non-specific immune enhancement that could have impact against a broad array of solid tumors. As with HIV, our approach would potentially allow for outpatient therapy without ablating or significantly impairing the patient’s immune system, as many current approaches require.

 

To date, our operations have been funded by sales of our securities. Sales revenue will not support our current operations and we expect this to be the case until our therapies or products are approved for marketing in the United States and Europe. Even if we are successful in having our therapies or products approved for sale in the United States and Europe, we cannot guarantee that a market for the product will develop. We may never be profitable. 

 

25

 

 

Recent Developments

 

On January 7, 2019, the Company’s Board of Directors announced that the operations of the Company would be led by Dr. Mark Dybul as the Executive Vice-Chair of the Board. Dr. Dybul had previously served as Chair of the Company’s Scientific Advisory Board beginning in August of 2017, and as a director since February of 2018.

On January 7, 2019, the Board notified Dr. Eric Leire of his termination as Chief Executive Officer of the Company, effective immediately.

 

Effective January 7, 2018, the Company hired Luisa Puche as its full-time Chief Financial Officer to support the Company’s growth as an exchange listed Company. Following the appointment of Ms. Puche, on January 9, 2019 the Company terminated the consulting agreement between its wholly-owned subsidiary Enochian BioSciences Denmark ApS and Crossfield, Inc. for the services of Robert Wolfe as part-time Chief Financial Officer of the Company.

 

On December 5, 2018, the Company received confirmation that its application to list the Company’s common stock on the NASDAQ Capital Market was approved by the NASDAQ Stock Market. On December 10, 2018, the Company’s common stock began trading under the ticker symbol “ENOB”.

 

On October 30, 2018, the Board increased its size from 6 to 7 members and appointed Mr. Debruyne as a director, whom is considered independent under the listing standards of the Nasdaq Capital Market.

 

On July 18, 2018, the Company appointed David Hardy, MD to its Scientific Advisory Board (SAB). In connection with his appointment to the SAB, Dr. Hardy will be paid $30,000 per year and received options valued at $30,000 under the Company’s Equity Incentive Plan, vesting yearly over three years.

 

On July 9, 2018, the Company entered into a consulting agreement with G-Tech to assist the Company with the development of the gene therapy and cell therapy modalities for the prevention, treatment, amelioration of HIV in humans, and with the development of a genetically enhanced Dendritic Cell for use as a wide spectrum platform for various diseases (including but not limited to cancers and infectious diseases). G-Tech is entitled to service fees for 20 months, with a monthly service fee of not greater than $130,000 per month. G-Tech is controlled by certain members of Weird Science.

 

 

26

 

 

Corporate History

 

Enochian was originally incorporated in Delaware on January 18, 2011 under the name “Putnam Hills Corp.” We filed a Registration Statement on Form 10 with the U.S. Securities and Exchange Commission, or the SEC, on August 12, 2011.

    

On February 12, 2014, pursuant to the Share Exchange Agreement, the Registrant acquired 100% (including the Escrow Shares) of the issued and outstanding capital stock of DanDrit Denmark and as a result became DanDrit Denmark’s parent company. Prior to the Share Exchange, the Registrant and an existing shareholder agreed to cancel 4,400,000 out of 5,000,000 common shares of DanDrit Denmark outstanding, and the Company issued 1,440,000 shares of Common Stock for legal and consulting services related to the Share Exchange and a future public offering. At the time of the Share Exchange each outstanding share of common stock of DanDrit Denmark was exchanged for 1.498842 shares of Common Stock, for a total of 6,000,000 shares of Common Stock, resulting in 8,040,000 shares of Common Stock outstanding immediately following the Share Exchange, including the Escrow Shares, which are deemed issued and outstanding for accounting purposes.

 

In June 2015, the Board approved a change to the Registrant’s fiscal year end from March 31 to June 30. 

 

On January 12, 2018, the Registrant, Acquisition Sub, Enochian Biopharma and Weird Science entered into the Acquisition Agreement. On February 16, 2018, the Acquisition was completed when the Acquisition Sub merged with and into Enochian Biopharma, with Enochian Biopharma as the surviving corporation. As consideration for the Acquisition, the stockholders of Enochian Biopharma received (i) 50% of the number of shares of the Common Stock issued and outstanding as of the effective time of the Acquisition, in the aggregate, after giving effect to the Acquisition, and (ii) the right to receive earn-out shares of Common Stock pro rata upon the exercise or conversion of any of the Registrant’s stock options and warrants which were outstanding at closing.

 

On November 15, 2018, the Company changed the name of DanDrit BioTech ApS to Enochian BioSciences Denmark ApS.

 

Emerging Growth Company

 

 As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act, or JOBS Act, enacted in April 2012. An “emerging growth company” may take advantage of reduced reporting requirements that are otherwise applicable to public companies. These provisions include, but are not limited to:

 

  Reduced disclosure about our executive compensation arrangements;

 

  No non-binding shareholder advisory votes on executive compensation or golden parachute arrangements;

 

  Exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting; and

 

  Reduced disclosure of financial information in this prospectus, limited to two years of audited financial information and two years of selected financial information.

 

Each of the foregoing exemptions is currently available to us. We may take advantage of these exemptions until the last day of our fiscal year following the fifth anniversary of the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities Act of 1933, as amended (the “Securities Act”), which such fifth anniversary will occur on June 30, 2019 or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging growth company if we have more than $1.0 billion in annual revenues as of the end of a fiscal year, if we are deemed to be a large accelerated filer under the rules of the SEC, or if we issue more than $1.0 billion of non-convertible debt over a three-year-period. The JOBS Act permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies; provided, however, that an emerging growth company may elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. We have not elected to opt out of the transition period.

 

Because we have elected to take advantage of certain of the reduced disclosure obligations and may elect to take advantage of other reduced reporting requirements in future filings, the information that we provide to our stockholders may be different than you might receive from other public reporting companies in which you hold equity interests.

 

27

 

 

Liquidity and Capital Resources

 

We have historically satisfied our capital and liquidity requirements through funding from shareholders, the issuance of convertible notes (which over time have all been converted into shares of Common Stock) and the sale of our Common Stock and warrants. At this time, we believe we have sufficient liquidity to fund our operations for the next twelve months.

We may however need additional funds for (a) purchase of equipment, (b) research and development, specifically to open an Investigational New Drug Application (“IND”) (The first step in the drug review process by the U.S. Food and Drug Administration) for ENOB-HV-01 and to continue our research and development of ENOB-DB-01 and ENOB-DC-01 and (c) possible future strategic acquisitions of businesses, products or technologies complementary to our business. If additional funds are required, we may raise such funds from time to time through public or private sales of our equity or debt securities. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely impact our growth plans and our financial condition and results of operations.

As of March 31, 2019, the Company had $10,272,198 in cash and working capital of $8,987,394 as compared to $15,600,865 in cash and working capital of $14,888,293 as of June 30, 2018, a decrease of 34.16% and 39.6%, respectively.

 

Following is a summary of the Company’s cash flows (used in) provided by operating, investing, and financing activities:

 

        Nine Months Ended March 31, 2019   Nine Months Ended March 31, 2018
Net Cash (Used in) Operating Activities         $ 6,821,134   $(2,726,744)
Net Cash (Used by) Investing Activities           (733,176 )   (278,732)
Net Cash Provided by Financing Activities           1,700,000     16,712,715
Gain Loss on Currency Translation           ( 14,257   (630,548)
Net Change in Cash and Cash Equivalents         $ (5,328,667 )   $13,076,781

  

 Results of Operations for the three months and nine months ended March 31, 2019 compared to the three months and nine months ended March 31, 2018. The following table sets forth our revenues, expenses and net loss for the three and nine months ended March 31, 2019 and March 31, 2018. The financial information below is derived from our unaudited condensed consolidated financial statements.

 

28

 

 

  

 

    For the Three Months   For the Nine Months
    Ended   Ended
    March 31,   March 31,
    2019   2018   2019   2018
                 
Revenues   $ —       $ —       $ —       $ —    
                                 
Cost of Goods Sold   $ —       $ —       $ —       $ —    
                                 
Gross profit (Loss)   $ —       $ —       $ —       $ —    
                                 
Operating Expenses                                
General and Administrative Expenses     1,951,685       1,979,609       6,750,939       3,049,393  
Research and Development Expenses     730,255       137,916       2,012,778       511,537  
Depreciation and Amortization     1,979,701       761,250       5,834,817       769,150  
Consulting Expenses     —         359,783       94,760       815,881  
Total Operating Expense   $ 4,661,641     $ 3,238,558     $ 14,693,294     $ 5,145,961  
                                 
LOSS FROM OPERATIONS   $ (4,661,641 )   $ (3,238,558 )   $ (14,693,294 )   $ (5,145,961 )
                                 
Other Income (Expense)                                
Change in Fair Value of Contingent Consideration     (217,000 )     —         (10,342,390 )     —    
Interest Income (Expense)     (43 )     1,183       (130 )     (12,060 )
Interest Income (Expense) – Related Party     —         183,511       —         779,943  
Gain (Loss) on Currency Transactions     164,114       87,817       (37,347 )     87,817  
Interest and Other Income     8,724       1,153       72,531       16,081  
Total Other (Expense) Income     (44,205 )     273,664       (10,307,336 )     871,781  
                                 
Loss Before Income Taxes     (4,705,846 )     (2,964,894 )     (25,000,630 )     (4,274,180 )
                                 
Income Tax Benefit   $ —       $ (4,729 )   $ —       $ (11,301 )
                                 
NET LOSS   $ (4,705,846 )   $ (2,960,165 )   $ (25,000,630 )   $ (4,262,879 )
                                 
BASIC AND DILUTED LOSS PER SHARE   $ (0.13 )   $ (0.12 )   $ (0.67 )   $ (0.25 )
                                 
WEIGHTED AVERAGE NUMBER OF                                
COMMON SHARES                                
OUTSTANDING - BASIC AND DILUTED     37,070,152       24,790,153       37,070,152       17,303,255  

 

 

 

29

 

 

Revenues

 

Revenues from operations for the nine months ended March 31, 2019, and March 31, 2018 were $0 and $0, respectively. 

 

Cost of Goods Sold

 

Our cost of goods sold was $0 and $0 during the nine months ended March 31, 2019, and March 31, 2018, respectively.

 

Gross profit (Loss)

 

Gross profit for the nine months ended March 31, 2019, and March 31, 2018 was $0 and $0, respectively.

 

Expenses

 

Our operating expenses for the three months ended March 31, 2019, and March 31, 2018 were $4,661,641 and $3,238,558, respectively, representing an increase of $1,423,084, or approximately 43.94%. The largest contributors to the increase in operating expenses were the increase in depreciation and amortization of $1,218,451 associated with the amortization of intellectual property rights acquired in the Acquisition of Enochian BioPharma, the increase in stock based compensation of $96,377, and an increase in R&D of $592,339 as we continue to develop and innovate our HIV and cancer platforms.

 

Our operating expenses for the nine months ended March 31, 2019, and March 31, 2018 were $14,693,294 and $5,145,961, respectively, representing an increase of $9,547,333, or approximately 185.5%. The largest contributors to the increase in operating expenses were the increase in depreciation and amortization of $5,065,667 associated with the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma, the increase general and administrative expenses of $3,919,383 related to the development of the Company’s infrastructure to support our scientific platforms, the increase in stock based compensation and an increase in R&D as we continue to develop and innovate our HIV and cancer platforms of $1,501,241.

 

The general and administrative expenses for the three months ended March 31, 2019 and 2018 were consistent quarter over quarter.

 

 General and administrative expenses for the nine months ended March 31, 2019, and March 31, 2018 were $6,750,939 and $3,049,393, respectively, representing an increase of $3,919,383, or approximately 58.1%. The increase in general and administrative expenses is primarily due to the costs related to security expenses of $679,504 stock based compensation expenses of $1,962,958, board and committee fees of $125, 950, filing fees of $151,687, offset by the reclassification of $284,574 of service fees previously classified as Consulting to R&D to properly reflect the nature of these costs. 

Research and development expenses for the three months ended March 31, 2019 and March 31, 2018 were $730,255 and $137,916, respectively, representing an increase of $592,339 or approximately 429.5%. The increases in research and development expenses are attributable to expenditures related to the development of and studies for our genetically modified cellular and immune-therapy technologies.

 

Research and development expenses for the nine months March 31, 2019, and March 31, 2018 were $2,012,778 and $511,537, respectively, representing an increase of $1,501,241 or approximately 293.5%. The increases in research and development expenses are attributable to scientific consulting of $1,125,000, regulatory services of $373,349 and an increase in the purchase of raw material of $331,008 used in various experiment expenditures related to the development of studies for our genetically modified cellular and immune-therapy technologies.

   

Depreciation and amortization for the three months ended March 31, 2019, and March 31, 2018, were $1,979,701 and $761,250, respectively, representing an increase of $1,218,451 or approximately 160.0%. The significant increase in depreciation and amortization expenses is related to the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma.

 

30

 

 

Depreciation and amortization expenses for the nine months ended March 31, 2019, and March 31, 2018, were $5,834,817 and $769,150, respectively, representing an increase of $5,065,667 or 658.61%. The significant increase in depreciation and amortization expenses is related to the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma.

 

The Company recorded other expense of $44,205 or the three months ended March 31, 2019, compared to other income of $273,664 for the three months ended March 31, 2018, representing an decrease of $317,869. The significant increase in other expense is mainly attributable to the change in fair value of the contingent consideration liability of $217,000. This contingent consideration is related to the Contingent Shares in connection with the Acquisition of Enochian Biopharma.

 

Other income (expense) for the nine months ended March 31, 2019, and March 31, 2018, was ($10,307,336) and $871,781, respectively representing an increase of ($11,791,117). This significant increase in other expense is mainly attributable to the change in fair value of the contingent consideration of $10,342,390 related to the Contingent Shares in connection with the Acquisition of Enochian Biopharma.

  

Net Loss

 

Net loss for the three months ended March 31, 2019, and March 31, 2018, was ($4,705,846) or ($0.13) per share and ($2,960,165) or ($0.12) per share, respectively, representing an increase in loss of ($1,745,681). The net increase in loss was primarily due to the increase in the depreciation and amortization related to the Acquisition of Enochian Biopharma, which took place in February 2018, and the development of and studies for our genetically modified cellular and immune-therapy technologies, and the additional shares issued as part of the “earn-out” related to the acquisition.

 

Net loss for the nine months March 31, 2019, and March 31, 2018, was ($25,000,630) or ($0.67) per share and ($4,262,879) or ($0.25) per share, respectively, representing an increase in loss of ($20,737,751). The net increase in loss was primarily due to the increase in the general and administrative expense and depreciation and amortization related to the Acquisition of Enochian Biopharma, which took place in February 2018, and the development of and studies for our genetically modified cellular and immune-therapy technologies, the change in fair value of contingent consideration liability and the increase in loss on currency transactions.

 

  Cash Flows

 

Cash used in operating activities for the nine months ended March 31, 2019, and March 31, 2018 was ($6,281,134) and ($2,726,744), respectively. Cash used in operating activities in 2019 included several significant non-cash items that are added back to the net loss. These consisted of $5,842,448 of amortization related to our license agreement, the increase of prepaid insurance of $207,144 a $10,342,390 non-cash charge related to the fair market valuation of the contingent consideration liability and $1,962,825 non-cash stock-based compensation related the Black-Scholes valuation of our outstanding options. In addition, we received $1,700,000 of proceeds from the excercise of stock options by a related party. The net impact of these more significant items and a few others represents a decrease in cash of $5,328,667.

 

The decrease in cash of $5,328,667 is primarily attributable to $2,012,778 in research and development costs, lab expenditures of $246,486, purchasing of furniture and lab equipment of $733,176, security expenses of $679,504, and compensation and benefit expenses of $1,273,476.

 

 

For the nine months ended March 31, 2018, cash used in operating activities amounted to $2,726,744. primarily due to fund raising efforts of the Company and the operations of DanDrit Denmark, formerly named Dandrit Denmark ApS.

 

31

 

 

 

 Assets

Total assets at March 31, 2019, were $169,305,692 compared to $179,662,426 as of June 30, 2018. Total current liabilities increased to $1,519,128 at March 31, 2019 compared to $873,722 as of June 30, 2018. The decrease in total assets and increase in total current liabilities were mainly due to the growth in the Company as we continue to build the administrative and clinical infrastructure to support the development of and studies for our genetically modified cellular and immune-therapy technologies.

 

Off-Balance Sheet Arrangements

 

The Company does not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

 

Emerging Growth Company

 

As an “emerging growth company” under the JOBS Act, the Company has elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with public company effective dates.

 

Significant Accounting Policies and Critical Accounting Estimates

 

The methods, estimates, and judgments that we use in applying our accounting policies have a significant impact on the results that we report in our financial statements. Some of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates regarding matters that are inherently uncertain. In addition, Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We are not choosing to “opt out” of this provision. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable. As a result of our election, not to “opt out” of Section 107, our financial statements may not be comparable to companies that comply with public company effective dates.

 

For a full explanation of our accounting policies, see Note 1 to the unaudited condensed consolidated financial statements.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

As a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this Item.

 

Item 4. Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

Our Chief Executive Officer and Chief Financial Officer (the “Certifying Officers”) are responsible for establishing and maintaining disclosure controls and procedures for the Company.  The Certifying Officers have designed such disclosure controls and procedures to ensure that material information is made known to them, particularly during the period in which this Report was prepared.

 

The Certifying Officers are responsible for establishing and maintaining adequate internal control over financial reporting for the Company used the “Internal Control over Financial Reporting Integrated Framework” issued by Committee of Sponsoring Organizations (“COSO”) to conduct an extensive review of the Company’s “disclosure controls and procedures” (as defined in the Exchange Act, Rules 13a-15(e) and 15-d-15(e)) as of the end of each of the periods covered by this Report (the “Evaluation Date”).  Based upon that evaluation, the Certifying Officers concluded that, as of March 31, 2019, our disclosure controls and procedures were not effective in ensuring that the information we were required to disclose in reports that we file or submit under the Securities and Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms. The deficiencies are attributed to the fact that the Company does not have adequate resources to address complex accounting issues, as well as an inadequate number of persons to whom it can segregate accounting tasks within the Company so as to ensure the segregation of duties between those persons who approve and issue payment from those persons who are responsible to record and reconcile such transactions within the Company’s accounting system.  These control deficiencies will be monitored and attention will be given to the matter as we continue to accelerate through our current growth stage.

 

32

 

 

The Certifying Officers based their conclusion on the fact that the Company has identified material weaknesses in controls over financial reporting, detailed below.  In order to reduce the impact of these weaknesses to an acceptable level, the Company has contracted with consultants with expertise in U.S. GAAP and SEC financial reporting standards to review and compile all financial information prior to filing that information with the SEC.  However, even with the added expertise of these consultants, we still expect to be deficient in our internal controls over disclosure and procedures until sufficient capital is available to hire the appropriate internal accounting staff and individuals with requisite GAAP and SEC financial reporting knowledge.  There have been no significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of their evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.

 

Changes in Internal Controls

 

There have been no changes in our internal controls over financial reporting during the three and nine months ended March 31, 2019 that have materially affected or are reasonably likely to materially affect our internal controls.

 

PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings.

 

There are presently no material pending legal proceedings to which the Company or any of its subsidiaries, is a party or as to which any of its property is subject, and no such proceedings are known to the Company to be threatened or contemplated against it.

 

Item 1A. Risk Factors.

 

As a “smaller reporting company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information required by this Item.

 

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

 

None.

 

Item 3. Defaults Upon Senior Securities.

 

None.

 

Item 4. Mine Safety Disclosures.

 

Not applicable.

 

Item 5. Other Information.

 

33

 

 

Item 6. Exhibits.

 

  (a) Exhibits required by Item 601 of Regulation S-K.

 

Exhibit No.   Description
     
3.1*   Bylaws
     
31.1*   Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
     
31.2*   Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
     
32.1**   Certification of Chief Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
     
32.2**   Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
     
101.INS   XBRL Instance Document*
     
101.SCH   XBRL Taxonomy Extension Schema*
     
101.CAL   XBRL Taxonomy Extension Calculation Linkbase*
     
101.DEF   XBRL Taxonomy Extension Definition Linkbase*
     
101.LAB   XBRL Taxonomy Extension Label Linkbase*
     
101.PRE   XBRL Taxonomy Extension Presentation Linkbase*

 

 

* Filed herewith. 
** Furnished herewith.

 

34

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) 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: May 16, 2019 ENOCHIAN BIOSCIENCES, INC.
     
  By: /s/ Mark Dybul
    Mark Dybul  
    Executive Vice Chair
    (Principal Executive Officer)
     
  By: /s/ Luisa Puche
    Luisa Puche
    Chief Financial Officer
    (Principal Financial and Accounting Officer)

 

35

 

 

 

 

Exhibit 3.1

 

BY-LAWS

OF

Enochian Biosciences, Inc.

(a Delaware corporation)

(As amended January 3, 2019)

 

ARTICLE I

STOCKHOLDERS

 

Section 1. Certificates Representing Stock . (a) Certificates representing stock in the corporation shall be signed by, or in the name of, the corporation by the Chairman or Vice-Chairman of the Board of Directors, if any, or by the President or a Vice-President and by the Treasurer or an Assistant Treasurer or the Secretary or an Assistant Secretary of the corporation. Any or all the signatures on any such certificate may be a facsimile. In case any officer, transfer agent, or registrar who has signed or whose facsimile signature has been placed upon a certificate shall have ceased to be such officer, transfer agent, or registrar before such certificate is issued, it may be issued by the corporation with the same effect as if he were such officer, transfer agent, or registrar at the date of issue.

 

(b) Whenever the corporation shall be authorized to issue more than one class of stock

 

or more than one series of any class of stock, and whenever the corporation shall issue any shares of its stock as partly paid stock, the certificates representing shares of any such class or series or of any such partly paid stock shall set forth thereon the statements prescribed by the General Corporation Law. Any restrictions on the transfer or registration of transfer of any shares of stock of any class or series shall be noted conspicuously on the certificate representing such shares.

 

(c) The corporation may issue a new certificate of stock or uncertificated shares in place of any certificate theretofore issued by it, alleged to have been lost, stolen or destroyed, and the Board of Directors may require the owner of the lost, stolen or destroyed certificate, or his legal representative, to give the Corporation a bond sufficient to indemnify the corporation against any claim that may be made against it on account of the alleged loss, theft or destruction of any such certificate or the issuance of any such new certificate or uncertificated shares.

 

Section 2. Uncertificated Shares . Subject to any conditions imposed by the General Corporation Law, the Board of Directors of the corporation may provide by resolution or resolutions that some or all of any or all classes or series of the stock of the corporation shall be uncertificated shares. Within a reasonable time after the issuance or transfer of any uncertificated shares, the corporation shall send to the registered owner thereof any written notice prescribed by the General Corporation Law.

 

1  
 

 

Section 3. Fractional Share Interests . The corporation may, but shall not be required to, issue fractions of a share. If the Corporation does not issue fractions of a share, it shall (1) arrange for the disposition of fractional interests by those entitled thereto, (2) pay in cash the fair value of fractions of a share as of the time when those entitled to receive such fractions are determined, or (3) issue scrip or warrants in registered form (either represented by a certificate or uncertificated) or bearer form (represented by a certificate) which shall entitle the holder to receive a full share upon the surrender of such scrip or warrants aggregating a full share. A certificate for a fractional share or an uncertificated fractional share shall, but scrip or warrants shall not unless otherwise provided therein, entitle the holder to exercise voting rights, to receive dividends thereon, and to participate in any of the assets of the Corporation in the event of liquidation. The Board of Directors may cause scrip or warrants to be issued subject to the conditions that they shall become void if not exchanged for certificates representing the full shares or uncertificated full shares before a specified date, or subject to the conditions that the shares for which scrip or warrants are exchangeable may be sold by the corporation and the proceeds thereof distributed to the holders of scrip or warrants, or subject to any other conditions which the Board of Directors may impose.

 

Section 4. Stock Transfers . Upon compliance with provisions restricting the transfer or registration of transfer of shares of stock, if any, transfers or registration of transfers of shares of stock of the corporation shall be made only on the stock ledger of the corporation by the registered holder thereof, or by his attorney thereunto authorized by power of attorney duly executed and filed with the Secretary of the corporation or with a transfer agent or a registrar, if any, and, in the case of shares represented by certificates, on surrender of the certificate or certificates for such shares of stock properly endorsed and the payment of all taxes due thereon.

 

Section 5. Record Date For Stockholders . In order that the corporation may determine the stockholders entitled to notice of or to vote at any meeting of stockholders or any adjournment thereof, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which record date shall not be more than sixty nor less than ten days before the date of such meeting. If no record date is fixed by the Board of Directors, the record date for determining stockholders entitled to notice of or to vote at a meeting of stockholders shall be at the close of business on the day next preceding the day on which notice is given, or, if notice is waived, at the close of business on the day next preceding the day on which the meeting is held. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall apply to any adjournment of the meeting; provided, however, that the Board of Directors may fix a new record date for the adjourned meeting. In order that the corporation may determine the stockholders entitled to consent to corporate action in writing without a meeting, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted by the Board of Directors, and which date shall not be more than ten days after the date upon which the resolution fixing the record date is adopted by the Board of Directors. If no record date has been fixed by the Board of Directors, the record date for determining the stockholders entitled to consent to corporate action in writing

 

2  
 

 

without a meeting, when no prior action by the Board of Directors is required by the General Corporation Law, shall be the first date on which a signed written consent setting forth the action taken or proposed to be taken is delivered to the corporation by delivery to its registered office in the State of Delaware, its principal place of business, or an officer or agent of the corporation having custody of the book in which proceedings of meeting of stockholders are recorded. Delivery made to the corporation's registered office shall be by hand or by certified or registered mail, return receipt requested. If no record date has been fixed by the Board of Directors and prior action by the Board of Directors is required by the General Corporation Law, the record date for determining stockholders entitled to consent to corporate action in writing without a meeting shall be at the close of business on the day on which the Board of Directors adopts the resolution taking such prior action. In order that the corporation may determine the stockholders entitled to receive payment of any dividend or other distribution or allotment of any rights or the stockholders entitled to exercise any rights in respect of any change, conversion, or exchange of stock, or for the purpose of any other lawful action, the Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date is adopted, and which record date shall be not more than sixty days prior to such action. If no record date is fixed, the record date for determining stockholders for any such purpose shall be at the close of business on the day on which the Board of Directors adopts the resolution relating thereto.

 

Section 6. Meaning of Certain Terms . As used herein in respect of the right to notice of a meeting of stockholders or a waiver thereof or to participate or vote thereat or to consent or dissent in writing in lieu of meeting, as the case may be, the term "share" or "shares" or "share of stock" or "shares of stock" or "stockholder" or "stockholders" refers to an outstanding share or shares of stock and to a holder or holders of record of outstanding shares of stock when the corporation is authorized to issue only one class of shares of stock, and said reference is also intended to include any outstanding share or shares of stock and any holder or holders of record of outstanding shares of stock of any class upon which or upon whom the certificate of incorporation confers such rights where there are two or more classes or series of shares of stock or upon which or upon whom the General Corporation Law confers such rights notwithstanding that the certificate of incorporation may provide for more than one class or series of shares of stock, one or more of which are limited or denied such rights thereunder; provided, however, that no such right shall vest in the event of an increase or a decrease in the authorized number of shares of stock of any class or series which is otherwise denied voting rights under the provisions of the certificate of incorporation, except as any provision of law may otherwise require.

 

Section 7. Stockholder Meetings .

 

- Time . The annual meeting shall be held on the date and at the time fixed, from time to time, by the directors, provided that the first annual meeting shall be held on a date within thirteen months after the organization of the corporation, and each successive annual meeting shall be held on a date within thirteen months after the date of the preceding annual meeting. A special meeting shall be held on the date and at the time fixed by the directors.

 

3  
 

 

- Place . Annual meetings and special meetings shall be held at such place, within or without the State of Delaware, as the directors may, from time to time, fix. Whenever the directors shall fail to fix such place, the meeting shall be held at the registered office of the corporation in the State of Delaware.

 

- Call . Annual meetings and special meetings may be called by the directors or by any officer instructed by the directors to call the meeting.

 

- Notice or Waiver of Notice . Written notice of all meetings shall be given, stating the place, date, hour of the meeting and stating the place within the city or other municipality or community at which the list of stockholders of the corporation may be examined. The notice of an annual meeting shall state that the meeting is called for the election of directors and for the transaction of other business which may properly come before the meeting, and shall (if any other action which could be taken at a special meeting is to be taken at such annual meeting) state the purpose or purposes. The notice of a special meeting shall in all instances state the purpose or purposes for which the meeting is called. The notice of any meeting shall also include, or be accompanied by, any additional statements, information, or documents prescribed by the General Corporation Law. Except as otherwise provided by the General Corporation Law, a copy of the notice of any meeting shall be given, personally or by mail, not less than ten days nor more than sixty days before the date of the meeting, unless the lapse of the prescribed period of time shall have been waived, and directed to each stockholder at his record address or at such other address which he may have furnished by request in writing to the Secretary of the corporation. Notice by mail shall be deemed to be given when deposited, with postage thereon prepaid, in the United States Mail. If a meeting is adjourned to another time, not more than thirty days hence, and/or place is made at the meeting, it shall not be necessary to give notice of the adjourned meeting unless the directors, after adjournment, fix a new record date for the adjourned meeting. Notice need not be given to any stockholder who submits a written waiver of notice signed by him before or after the time stated therein. Attendance of a stockholder at a meeting of stockholders shall constitute a waiver of notice of such meeting, except when the stockholder attends the meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, not the purpose of, any regular or special meeting of the stockholders need be specified in any written waiver of notice.

 

- Stockholder List . The officer who has charge of the stock ledger of the corporation shall prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders, arranged in alphabetical order, and showing the address of each stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder, for any purpose germane to the meeting, during ordinary business hours, for a period of at least ten days prior to the meeting, either at a place within the city or other municipality or community where the meeting is to be held, which place shall be specified in the notice of the meeting, or if not so specified, at the place where the meeting is to be held. The list shall also be produced and kept at the time and place of the meeting during the whole time thereof, and may be inspected by any stockholder who is present. The stock ledger shall be the only evidence as to who are the stockholders entitled to examine the stock ledger, the list required by this section or the books of the corporation, or to vote at any meeting of stockholders.

 

4  
 

 

- Conduct of Meeting . Meetings of the stockholders shall be presided over by one of the following officers in the order of seniority and if present and acting-the Chairman of the Board, if any, the Vice-Chairman of the Board, if any, the President, a Vice-President, or, if none of the foregoing is in office and present and acting, by a chairman to be chosen by the stockholders. The Secretary of the corporation, or in his absence, an Assistant Secretary, shall act as secretary of every meeting, but if neither the Secretary nor an Assistant Secretary is present the Chairman of the meeting shall appoint a secretary of the meeting.

 

- Proxy Representation . Every stockholder may authorize another person or persons to act for him by proxy in all matters in which a stockholder is entitled to participate, whether by waiving notice of any meeting, voting or participating at a meeting, or expressing consent or dissent without a meeting. Every proxy must be signed by the stockholder or by his attorney-in-fact. No proxy shall be voted or acted upon after three years from its date unless such proxy provides for a longer period. A duly executed proxy shall be irrevocable if it states that is irrevocable and, if, and only as long as it is coupled with an interest sufficient in law to support an irrevocable power. A proxy may be made irrevocable regardless of whether the interest with which it is coupled is an interest in the stock itself or an interest in the corporation generally.

 

- Inspectors . The directors, in advance of any meeting, may, but need not, appoint one or more inspectors of election to act at the meeting or any adjournment thereof. If any inspector or inspectors are not appointed, the person presiding at the meeting may, but need not appoint one or more inspectors. In case any person who may be appointed as an inspector fails to appear or act, the vacancy may be filled by appointment made by the directors in advance of the meeting or at the meeting by the person presiding thereat. Each inspector, if any, before entering upon the discharge of his duties, shall take and sign an oath faithfully to execute the duties of inspectors at such meeting with strict impartiality and according to the best of his ability. The inspectors, if any, shall determine the number of shares of stock outstanding and the voting power of each, the shares of stock represented at the meeting, the existence of a quorum, the validity and effect of proxies, and shall receive votes, ballots, or consents, hear and determine all challenges and questions arising in connection with the right to vote, count and tabulate all votes, ballots, or consents, determine the result, and do such acts as are proper to conduct the election or vote with fairness to all stockholders. On request of the person presiding at the meeting, the inspector or inspectors, if any, shall make a report in writing of any challenge, question, or matter determined by him or them and execute a certificate of any fact found by him or them. Except as otherwise required by subsection (e) of Section 231 of the General Corporation Law, the provisions of that Section shall not apply to the corporation.

 

- Quorum . The holders of a majority of the outstanding shares of stock shall constitute a quorum at a meeting of stockholders for the transaction of any business. The stockholders presents may adjourn the meeting despite the absence of a quorum.

 

5  
 

 

- Voting . Each share of stock shall entitle the holder thereof to one vote. Directors shall be elected by a plurality of the votes of the shares present in person or represented by proxy at the meeting and entitled to vote on the election of directors. Any other action shall be authorized by a majority of the votes cast except where the General Corporation Law prescribes a different percentage of votes and/or a different exercise of voting power, and except as may be otherwise prescribed by the provisions of the certificate of incorporation and these Bylaws. In the election of directors, and for any other action, voting need not be by ballot.

 

Section 8. Stockholder Action Without Meetings . Any action required by the General Corporation Law to be taken at any annual or special meeting of stockholders, or any action which may be taken at any annual or special meeting of stockholders, may be taken without a meeting, without prior notice and without a vote, if a consent in writing, setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote thereon were present and voted. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing. Action taken pursuant to this paragraph shall be subject to the provisions of Section 228 of the General Corporation Law.

 

ARTICLE II

DIRECTORS

 

Section 1. Functions and Definition . The business and affairs of the corporation shall be managed by or under the direction of the Board of Directors of the corporation. The Board of Directors shall have the authority to fix the compensation of the members thereof. The use of the phrase "whole board" herein refers to the total number of directors which the corporation would have if there were no vacancies.

 

Section 2. Qualifications and Number . A director need not be a stockholder, a citizen of the United States, or a resident of the State of Delaware. The initial Board of Directors shall consist of one person. Thereafter, the number of directors may be increased or decreased from time to time by action of the stockholders or of the directors, or, if the number is not fixed, the number shall be one (1).

 

Section 3. Election and Term . The first Board of Directors, unless the members thereof shall have been named in the certificate of incorporation, shall be elected by the incorporator or incorporators and shall hold office until first annual meeting of stockholders and until their successors are elected and qualified or until their earlier resignation or removal. Any director may resign at any time upon written notice to the corporation. Thereafter, directors who are elected at an annual meeting of stockholders, and directors who are elected in the interim to fill vacancies and newly created directorships, shall hold office until the next annual meeting resignation or removal. Except as the General Corporation Law may otherwise require, in the interim between annual meetings of stockholders or of special meetings of stockholders called for the election of directors and/or for the removal of one or more directors and for the filling of any vacancy in that connection, newly created directorships and any vacancies in the Board of Directors, including unfilled vacancies resulting from the removal of directors for cause or without cause, may be filled by the vote of a majority of the remaining directors then in office, although less than a quorum, or by the sole remaining director.

 

6  
 

 

Section 4. Meetings .

 

- Time . Meetings shall be held at such time as the Board shall fix, except that the first meeting of a newly elected Board shall be held as soon after its election as the directors may conveniently assemble.

 

- Place . Meetings shall be held at such place within or without the State of Delaware as shall be fixed by the Board.

 

- Call . No call shall be required for regular meetings for which the time and place have been fixed. Special meetings may be called by or at the direction of the Chairman of the Board, if any, the Vice-Chairman of the Board, if any, of the President, or of a majority of the directors in office.

 

- Notice or Actual or Constructive Waiver . No notice shall be required for regular meetings for which the time and place have been fixed. Written, oral, or any other mode of notice of the time and place shall be given for special meetings in sufficient time for the convenient assembly of the directors thereat. Notice need not be given to any director or to any member of a committee of directors who submits a written waiver of notice signed by him before or after the time stated therein. Attendance of any such person at a meeting shall constitute a waiver of notice of such meeting, except when he attends a meeting for the express purpose of objecting, at the beginning of the meeting, to the transaction of any business because the meeting is not lawfully called or convened. Neither the business to be transacted at, nor the purpose of, any regular or special meeting of the directors need be specified in any written waiver of notice.

 

- Quorum and Action . A majority of the whole Board shall constitute a quorum except when a vacancy or vacancies prevents such majority, whereupon a majority of the directors in office shall constitute a quorum, provided, that such majority shall constitute at least one-third of the whole Board. A majority of the directors present, whether or not a quorum is present, may adjourn a meeting to another time and place. Except as herein otherwise provided, and except as otherwise provided by the General Corporation Law, the vote of the majority of the directors present at a meeting at which a quorum is present shall be the act of the Board. The quorum and voting provisions herein stated shall not be construed as conflicting with any provisions of the General Corporation Law and these Bylaws which govern a meeting of the directors held to fill vacancies and newly created directorships in the Board or action of disinterested directors.

 

Any member or members of the Board of Directors or of any committee designated by the Board, may participate in a meeting of the Board, or any such committee, as the case may be, by means of conference telephone or similar communications equipment by means of which all persons participating in the meeting can hear each other.

 

7  
 

 

- Chairman of the Meeting . The Chairman of the Board, if any and if present and acting, shall preside at all meetings. Otherwise, the Vice-Chairman of the Board, if any and if present and acting, or the President, if present and acting, or any other director chosen by the Board, shall preside.

 

Section 5. Removal of Directors . Except as may otherwise be provided by the General Corporation Law, any director or the entire Board of Directors may be removed, with or without cause, by the holders of a majority of the shares then entitled to vote at an election of directors.

 

Section 6. Committees . The Board of Directors may, by resolution passed by a majority of the whole Board, designate one or more committees, each committee to consist of one or more of the directors of the corporation. The Board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee. In the absence or disqualification of any member of any such committee or committees, the member or members thereof present at any meeting and not disqualified from voting, whether or not he or they constitute a quorum, may unanimously appoint another member of the Board of Directors to act at the meeting in the place of any such absent or disqualified member. Any such committee, to the extent provided in the resolution of the Board, shall have and may exercise the powers and authority of the Board of Directors in the management of the business and affairs of the corporation with the exception of any authority the delegation of which is prohibited by Section 141 of the General Corporation Law, and may authorize the seal of the corporation to be affixed to all papers which may require it.

 

Section 7. Written Action . Any action required or permitted to be taken at any meeting of the Board of Directors or any committee thereof may be taken without a meeting if all members of the Board or committee, as the case may be, consent thereto in writing, and the writing or writings are filed with the minutes of proceedings of the Board or committee.

 

Section 8. Board of Advisors . T he Board of Directors, in its discretion, may establish a Board of Advisors, consisting of individuals who may or may not be stockholders or directors of the Corporation. The purpose of the Board of Advisors would be to advise the officers and directors of the Corporation with respect to such matters as such officers and directors shall choose, and any other matters which the members of such Board of Advisors deem appropriate in furtherance of the best interest of the Corporation. The Board of Advisors shall meet on such basis as the members thereof may determine. The Board of Directors may eliminate the Board of Advisors at any time. No member of the Board of Advisors, nor the Board of Advisors itself, shall have any authority of the Board of Directors or any decision-making power and shall be merely advisory in nature. Unless the Board of Directors determines another method of appointment, the President shall recommend possible members of the Board of Advisors to the Board of Directors, who shall approve such appointments or reject them.

 

8  
 

 

ARTICLE III

OFFICERS

 

The officers of the corporation shall consist of a President and a Secretary who shall also be the Chief Executive Officer of the corporation unless otherwise specified by the Board of Directors, and, if deemed necessary, expedient, or desirable by the Board of Directors, a Treasurer, Chief Financial Officer, a Chair of the Board, a Vice-Chair of the Board, an Executive Vice- President, one or more other Vice-Presidents, one or more Assistant Secretaries, one or more Assistant Treasurers, and such other officers with such title as the resolution of the Board of Directors choosing them shall designate. Except as may otherwise be provided in the resolution of the Board of Directors choosing such officer, no officer other than the Chair or Vice-Chair of the Board, if any, need be a director. Any number of offices may be held by the same person, as the directors may determine.

 

The Board may designate the Chair of the Board or the Vice-Chair of the Board as an officer known as the Executive Chair or Vice-Chair of the Board. The Executive Chair (or the Executive Vice-Chair in the absence of an Executive Chair) of the Board shall, if present, perform such other powers and duties as may be assigned to him or her from time to time by the Board of Directors as an executive officer of the corporation. The Chief Executive Officer of the corporation shall report to the Executive Chair (or the Executive Vice-Chair in the absence of an Executive Chair), if present. If at any time there is no Chief Executive Officer, the Executive Chair of the Board (or the Executive Vice-Chair in the absence of an Executive Chair), if present, shall also act as the Chief Executive Officer of the corporation and shall have the powers and duties prescribed in this Article III or by resolution of the Board of Directors.

 

Unless otherwise provided in the resolution choosing such officer, each officer shall be chosen for a term which shall continue until such officer’s resignation or removal by the Board of Directors.

 

All officers of the corporation shall have such authority and perform such duties in the management and operation of the corporation as shall be prescribed in the resolutions of the Board of Directors designating and choosing such officers and prescribing their authority and duties, and shall have such additional authority and duties as are incident to their office except to the extent that such resolutions may be inconsistent therewith. The Secretary or an Assistant Secretary of the corporation shall record all of the proceedings of all meetings and actions in writing of stockholders, directors, and committees of directors, and shall exercise such additional authority and perform such additional duties as the Board shall assign to him. Any officer may be removed, with or without cause, by the Board of Directors. Any vacancy in any office may be filled by the Board of Directors.

 

ARTICLE IV

CORPORATE SEAL

 

The corporate seal shall be in such form as the Board of Directors shall prescribe.

 

ARTICLE V

FISCAL YEAR

 

The fiscal year of the corporation shall be fixed, and shall be subject to change, by the Board of Directors.

ARTICLE VI

AMENDMENT

 

These Bylaws may be adopted, amended or repealed at any time by the unanimous written consent of the Board of Directors.

 

9  

Exhibit 31.1

 

OFFICER’S CERTIFICATE

PURSUANT TO SECTION 302

 

I, Mark Dybul, certify that:

 

1.             I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2019 of Enochian Biosciences, Inc.;

 

2.             Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.             Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)             Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)             Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)             Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)             Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

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

 

(a)             All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)             Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 16, 2019 By: /s/ Mark Dybul 
  Name:  Mark Dybul
  Title: Executive Vice Chair
(Principal Executive Officer)

 

Exhibit 31.2

 

OFFICER’S CERTIFICATE

PURSUANT TO SECTION 302

 

I, Luisa Puche, certify that:

 

1.             I have reviewed this Quarterly Report on Form 10-Q for the period ended March 31, 2019 of Enochian Biosciences, Inc.;

 

2.             Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.             Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.             The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)             Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)             Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)             Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)             Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

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

 

(a)             All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)             Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 16, 2019 By: /s/ Luisa Puche
  Name: Luisa Puche
  Title:

Chief Financial Officer

(Principal Financial Officer)

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

  

In connection with the Quarterly Report of Enochian Biosciences, Inc. (the “ Company ”) on Form 10-Q for the period ended March 31, 2019 as filed with the U.S. Securities and Exchange Commission on the date hereof (the “ Report ”), the undersigned hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

 

1.          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2.          The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

 

Date: May 16, 2019 By: /s/ Mark Dybul
  Name:  Mark Dybul
  Title: Executive Vice Chair
(Principal Executive Officer)

   

A signed original of this written statement required by Section 906, or other document authentications, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the U.S. Securities and Exchange Commission or its staff upon request.

Exhibit 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

  

In connection with the Quarterly Report of Enochian Biosciences, Inc. (the “ Company ”) on Form 10-Q for the period ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission on the date hereof (the “ Report ”), the undersigned hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to his knowledge:

 

1.          The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

2.          The information contained in the Report fairly presents, in all material respects, the financial condition and results of operation of the Company.

 

Date: May 16, 2019 By: /s/ Luisa Puche  
  Name:  Luisa Puche
  Title: Chief Financial Officer
(Principal Financial Officer)

   

A signed original of this written statement required by Section 906, or other document authentications, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to the Company and will be retained by the Company and furnished to the U.S. Securities and Exchange Commission or its staff upon request.