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RENOVARO BIOSCIENCES INC. - Quarter Report: 2019 March (Form 10-Q)

 

 

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.

 

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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.

 

 

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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.

 

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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.

 

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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)

 

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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.

 

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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 

 

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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.

 

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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.

   

 

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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 30th  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.

 

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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 shareholdersIn 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. 

 

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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. 

 

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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.

 

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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.

 

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   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 

 

 

 

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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.

 

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 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.

 

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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.

 

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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.

 

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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)

 

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