RENOVARO BIOSCIENCES INC. - Quarter Report: 2018 December (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 December 31, 2018
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 000-54478
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(510) 203-4857
(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 and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ 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 ☒
As of February 12, 2019, the number of shares of the registrant’s common stock outstanding was 38,789,310.
1 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
- INDEX -
2 |
PART I – FINANCIAL INFORMATION
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 December 31, 2018 are not necessarily indicative of the results of operations for the full year. These financial statements and related footnotes should be read in conjunction with the financial statements and footnotes thereto included in the Company’s Form 10-K for the fiscal year ended June 30, 2018, filed with the Securities and Exchange Commission on October 1, 2018, as amended.
3 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
December 31, | June 30, | |||||||
2018 | 2018 | |||||||
(Unaudited) | ||||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash | $ | 13,240,240 | $ | 15,600,865 | ||||
Other receivables | 3,093 | 122,866 | ||||||
Prepaid expenses | 25,613 | 38,284 | ||||||
Total Current Assets | 13,268,946 | 15,762,015 | ||||||
Property and Equipment, Net | 654,830 | 27,402 | ||||||
OTHER ASSETS | ||||||||
Definite Life Intangible Assets, Net | 148,255,481 | 152,095,459 | ||||||
Deposits | 137,550 | 137,550 | ||||||
Goodwill | 11,640,000 | 11,640,000 | ||||||
Total Other Assets | 160,033,031 | 163,873,009 | ||||||
TOTAL ASSETS | $ | 173,956,807 | $ | 179,662,426 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts Payable – Trade | $ | 518,927 | $ | 571,809 | ||||
Accounts Payable - Related Party | 235,000 | 235,000 | ||||||
Accrued Expenses | 884,493 | 66,913 | ||||||
Total Current Liabilities | 1,638,420 | 873,722 | ||||||
Contingent Consideration Liability | 23,601,000 | 22,891,000 | ||||||
Total Liabilities | $ | 25,239,420 | $ | 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 December 31, 2018; 36,163,924 issued and outstanding at June 30, 2018 | $ | 3,878 | $ | 3,616 | ||||
Additional Paid-In Capital | 206,265,150 | 193,283,798 | ||||||
Accumulated Deficit | (57,890,173 | ) | (37,595,389 | ) | ||||
Other Comprehensive Income, Net | 338,532 | 205,679 | ||||||
Total Stockholders’ Equity | 148,717,387 | 155,897,704 | ||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 173,956,807 | $ | 179,662,426 |
See accompanying notes to the unaudited condensed consolidated financial statements.
4 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
For the Three Months Ended | For the Six Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Revenues | $ | — | $ | — | $ | — | $ | — | ||||||||
Cost of Goods Sold | — | — | — | — | ||||||||||||
Gross profit (Loss) | — | — | — | — | ||||||||||||
Operating Expenses | ||||||||||||||||
General and Administrative Expenses | 1,767,321 | 668,231 | 2,933,029 | 956,947 | ||||||||||||
Stock-Based Compensation Expense | 1,780,059 | — | 1,866,225 | 112,837 | ||||||||||||
Research and Development Expenses | 788,968 | 219,969 | 1,282,523 | 373,621 | ||||||||||||
Depreciation and Amortization | 1,896,554 | 3,954 | 3,855,116 | 7,900 | ||||||||||||
Consulting Expenses | 32,725 | 388,888 | 94,760 | 456,098 | ||||||||||||
Total Operating Expense | 6,265,627 | 1,281,042 | 10,031,653 | 1,907,403 | ||||||||||||
LOSS FROM OPERATIONS | (6,265,627 | ) | (1,281,042 | ) | (10,031,653 | ) | (1,907,403 | ) | ||||||||
Other Income (Expense) | ||||||||||||||||
Change in Fair Value of Contingent Consideration | (11,593,390 | ) | — | (10,125,390 | ) | — | ||||||||||
Interest (Expense) | (43 | ) | — | (87 | ) | (62 | ) | |||||||||
Interest (Expense) – Related Party | — | (12,289 | ) | — | (13,181 | ) | ||||||||||
(Loss) Gain on Currency Transactions | (169,483 | ) | 209,023 | (201,461 | ) | 596,432 | ||||||||||
Interest and Other Income | 36,992 | 6,028 | 63,807 | 14,928 | ||||||||||||
Total Other (Expense) Income | (11,725,924 | ) | 202,762 | (10,263,131 | ) | 598,117 | ||||||||||
Loss Before Income Taxes | (17,991,551 | ) | (1,078,280 | ) | (20,294,784 | ) | (1,309,286 | ) | ||||||||
Income Benefit | — | (1,934 | ) | _-_ | (6,572 | ) | ||||||||||
NET LOSS | $ | (17,991,551 | ) | $ | (1,076,346 | ) | $ | (20,294,784 | ) | $ | (1,302,714 | ) | ||||
BASIC AND DILUTED LOSS PER SHARE | $ | (0.50 | ) | $ | (0.08 | ) | $ | (0.56 | ) | $ | (0.10 | ) | ||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 36,172,403 | 13,847,118 | 36,229,259 | 12,711,029 |
See accompanying notes to the unaudited condensed consolidated financial statements
5 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OTHER COMPREHENSIVE LOSS (UNAUDITED)
For the Three Months | For the Six Months | |||||||||||||||
Ended December 31, | Ended December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Net Loss | $ | (17,991,551 | ) | $ | (1,076,346 | ) | $ | (20,294,784 | ) | $ | (1,302,714 | ) | ||||
Currency Translation, Net of Taxes | 226,391 | (129,993 | ) | 130,832 | (384,582 | ) | ||||||||||
Other Comprehensive Loss | $ | (17,765,160 | ) | $ | (1,206,339 | ) | $ | (20,163,952 | ) | $ | (1,687,296 | ) |
See accompanying notes to the unaudited condensed consolidated financial statements.
6 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
For the Six Months Ended December 31, | ||||||||
2018 | 2017 | |||||||
NET LOSS | $ | (20,294,784 | ) | $ | (1,302,714 | ) | ||
ADJUSTMENT TO RECONCILE NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES: | ||||||||
Depreciation and Amortization | 3,855,115 | 7,900 | ||||||
Change in Contingent Consideration Liability | 10,125,390 | — | ||||||
Stock Based Compensation Expense | 1,866,225 | 112,837 | ||||||
Accrued Interest on Notes Payable - Related Party | — | 1,183 | ||||||
Accretion of Discount on Notes Payable | — | 11,997 | ||||||
Accrued Interest on Notes Receivable | — | (10,874 | ) | |||||
CHANGES IN ASSETS AND LIABILITIES: | ||||||||
Other Receivables | 119,773 | 119,277 | ||||||
Prepaid Expenses/Deposits | 12,671 | 12,026 | ||||||
Accounts Payable | (52,882 | ) | 263,843 | |||||
Accounts Payable – Related Party | — | — | ||||||
Accrued Expenses | 817,578 | (210,050 | ) | |||||
NET CASH PROVIDED BY (USED) IN OPERATING ACTIVITIES | (3,550,914 | ) | (994,575 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Cash held in escrow | — | (4,811,766 | ) | |||||
Notes receivables | — | (250,799 | ) | |||||
Purchase of property and equipment | (640,544 | ) | — | |||||
NET CASH USED IN INVESTING ACTIVITIES | (640,544 | ) | (5,062,565 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Net proceeds from advances to purchase common shares | — | 3,211,411 | ||||||
Proceeds from exercise of options by related party | 1,700,000 | 1,601,029 | ||||||
NET CASH PROVIDED BY FINANCING ACTIVITIES | 1,700,000 | 4,812,440 | ||||||
Gain (Loss) on Currency Translation | 130,833 | (390,833 | ) | |||||
NET CHANGE IN CASH | (2,360,625 | ) | (1,635,583 | ) | ||||
CASH, BEGINNING OF PERIOD | 15,600,865 | 3,941,712 | ||||||
CASH, END OF PERIOD | $ | 13,240,240 | $ | 2,306,129 | ||||
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION | ||||||||
Cash paid during the periods for: | ||||||||
Interest | $ | — | $ | — | ||||
Income Taxes | $ | — | $ | — | ||||
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 | ||||
Disposition of fully depreciated assets | $ | 231,174 | $ | — | ||||
Convertible notes payable converted to 183,356 common shares | $ | — | $ | 293,370 |
See accompanying notes to the unaudited condensed consolidated financial statements.
7 |
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 December 31, 2018 and 2017 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 December 31, 2018 and December 31, 2017 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, sublicensable, 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.
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 December 31, 2018, 5,180,429 Contingent Shares remained unissued.
Year End – In June 2015, DanDrit USA’s Board of Directors (the “Board”) approved a change to its fiscal year end from December 31 to June 30.
Consolidation — For the three months and six months ended December 31, 2018 and 2017, 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.
8 |
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 December 31, 2018, June 30, 2018 and December 31, 2017. 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 December 31, 2018 and June 30, 2018 of $12,990,240 and $15,350,865 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 December 31, 2018, was $11.64 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.
9 |
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 December 31, 2018 and 2017, respectively amounted to $788,968 and $219,969, respectively and for the six months ended December 31, 2018 and 2017, amounted to $1,282,523 and $373,621, respectively.
10 |
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 six months ended December 31, 2018 and December 31, 2017, 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 December 31, 2018.
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 December 31, 2018, 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:
11 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Continued)
Fair Value Measurements at Reporting Date Using | ||||||||||||||||
December 31, 2018 | Quoted Prices in Active Markets for Identical Assets |
Significant Other Observable Inputs |
Significant Unobservable Inputs |
|||||||||||||
(Level 1) | (Level 2) | (Level 3) | ||||||||||||||
Contingent Consideration Liability | $ | 23,601,000 | $ | - | $ | - | $ | 23,601,000 |
The roll forward of the contingent consideration liability is as follows:
Balance June 30, 2018 | $ | 22,891,000 | |
Fair value adjustment | 710,000 | ||
Balance December 31, 2018 | $ | 23,601,000 |
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 six 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 December 31, 2018 and 2017 were $1,780,059 and $0, respectively, and for the six months ended December 31, 2018 and 2017 were $1,866,225 and $112,837, 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.
12 |
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 on January 1, 2019, however early adoption is permitted. The Company is in the process of evaluating the impact of this new guidance.
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—There are no reclassifications for the periods presented.
13 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 — PROPERTY AND EQUIPMENT
Property and equipment consisted of the following at December 31, 2018 and June 30, 2018:
December 31, | June 30, | |||||||||
Useful Life | 2018 | 2018 | ||||||||
Lab Equipment and Instruments | 4-7 | $ | 417,113 | $ | 202,197 | |||||
Leasehold Improvements | 10 | 194,778 | _ | |||||||
Furniture Fixtures and Equipment | 4-7 | 58,653 | 58,977 | |||||||
Total | 670,544 | 261,174 | ||||||||
Less Accumulated Depreciation | (15,714 | ) | (233,772 | ) | ||||||
Net Property and Equipment | $ | 654,830 | $ | 27,402 |
Depreciation expense amounted to $11,605 and $13,117 for the three and six months ended December 31, 2018, respectively, and $0 for both the three months and six months ended December 31, 2017.
14 |
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, sublicensable, 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 in the Field (the “License”).
At December 31, 2018 and June 30, 2018, definite and indefinite-life intangible assets consisted of the following:
Useful Life |
December 31, 2018 |
Period Change |
Effect of Currency Translation |
June 30, 2018 | ||||||||||||||
Patents | 20 Years | $ | 304,440 | — | $ | (6,528 | ) | $ | 310,968 | |||||||||
License Agreement | 20 Years | 154,824,000 | — | — | 154,824,000 | |||||||||||||
Goodwill | 11,640,000 | — | — | 11,640,000 | ||||||||||||||
Total | 166,768,440 | — | (6,528 | ) | 166,774,968 | |||||||||||||
Less Accumulated Amortization | (6,872,959 | ) | (3,841,999 | ) | 8,459 | (3,039,509 | ) | |||||||||||
Net Definite-Life Intangible Assets | $ | 159,895,481 | (3,841,999 | ) | (2,021 | ) | $ | 163,735,459 |
At December 31, 2018 the expected future amortization expense for the years ended are as follows:
Year ending June 30, | ||||
2019 | 3,923,340 | |||
2020 | 7,756,790 | |||
2021 | 7,756,790 | |||
2022 | 7,756,790 | |||
2023 | 7,756,790 | |||
Thereafter | 113,304,981 | |||
$ | 148,255,481 |
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.
15 |
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. The base rent increases by 3% each year, and ranges from $12,265 per month for the first year to $16,003 per month for the tenth year. The Company is entitled to $108,168 in contributions toward tenant improvements.
For the three and six months ended December 31, 2018, lease expense charged to general and administrative expenses amounted to $166,621 and $168,848, respectively, and $0 and $1,450 for the three and six months ended December 31, 2017.
Below are the lease commitments for the next 10 years:
Year Ending June 30th | Lease Expense | ||
2019 | 127,484 | ||
2020 | 267,140 | ||
2021 | 275,154 | ||
2022 | 283,408 | ||
2023 and thereafter | 1,224,943 | ||
Total | $ | 2,178,129 |
16 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 5 — STOCKHOLDERS’ EQUITY
Preferred Stock — The Registrant has 10,000,000 authorized shares of Preferred Stock, par value $0.0001 per share. At December 31, 2018, 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 December 31, 2018, 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.
Common Stock Issuances — On December 27, 2018, the Company issued 1,307,693 shares 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, the Company issued 1,307,693 common shares to the stockholders of Enochian Biopharma in accordance with the Acquisition Agreement. These Contingent Shares were valued at the closing market stock price of $7.20 per share. The Company recorded a charge of $9.4 million to change in fair value of contingent consideration.
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 December 31, 2018, 5,180,429 Contingent Shares are issuable in connection with the Acquisition of Enochian Biopharma.
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:
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 $1,780,059 and $0 for the three months ended December 31, 2018 and 2017, respectively, and $1,866,225 and $112,837 for the six months ended December 31, 2018 and 2017, respectively. At December 31, 2018, the Company had approximately $298,689 of unrecognized compensation cost related to non-vested options.
17 |
ENOCHIAN BIOSCIENCES,
INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 5 — STOCKHOLDERS’ EQUITY (Continued)
Acquisition of DanDrit Denmark — At December 31, 2018 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 December 31, 2018 and 2017, 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.
A summary of the status of the Plan Options and Grant Warrants outstanding at December 31, 2018 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 | 9.32 | $ | 8.00 | - | - | |||||||||||||||
5.74 | 15,679 | 9.72 | 5.74 | - | - | |||||||||||||||||
3.95 | 5,064 | 9.54 | 3.95 | - | - | |||||||||||||||||
2.00 | 650,000 | 1.00 | 2.00 | 650,000 | 2.00 | |||||||||||||||||
5.72 | 13,113 | 9.84 | 5.72 | - | - | |||||||||||||||||
$ | 6.50 | 300,000 | 9.90 | $ | 6.50 | 300,000 | $ | 6.50 | ||||||||||||||
Total | - | 1,053,091 | 4.36 | $ | 3.79 | 950,000 | $ | 3.42 |
18 |
ENOCHIAN BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 5 — STOCKHOLDERS’ EQUITY (Continued)
A summary of the status of the Plan Options and the Grant Warrants at December 31, 2018 and changes during the period are presented below:
Shares |
Weighted Average Exercise Price |
Average Remaining Life |
Weighted Average Intrinsic Value |
|||||||||||||
Outstanding at beginning of period | 690,621 | $ | 2.00 | 2.50 | $ | - | ||||||||||
Granted | 362,470 | 6.52 | 10 | - | ||||||||||||
Exercised | - | - | - | - | ||||||||||||
Forfeited | - | - | - | - | ||||||||||||
Expired | - | - | - | - | ||||||||||||
Outstanding at end of period | 1,053,091 | $ | 3.79 | 4.36 | $ | 3,451,984 | ||||||||||
Vested and expected to vest | 950,000 | $ | 3.42 | 3.81 | $ | 3,400,000 | ||||||||||
Exercisable end of period | 950,000 | $ | 3.42 | 3.81 | $ | 3,400,000 |
At December 31, 2018, all Grant Warrants are exercisable, and 300,000 Plan Options are exercisable. The total intrinsic value of options at December 31, 2018 was $3,435,006. Intrinsic value is measured using the fair market value at the date of exercise (for shares exercised) at December 31, 2018 (for outstanding options), less the applicable exercise price.
Common Stock Purchase Warrants
A summary of the status of shares of Common Stock which can be purchased underlying the warrants outstanding at December 31, 2018 is presented below:
Shares |
Weighted Average Exercise Price |
Weighted Average Remaining Life | |||||||||
Outstanding at beginning of period | 5,838,122 | $ | 1.33 | - | |||||||
Granted | - | - | - | ||||||||
Exercised | (1,307,693 | ) | - | 1.30 | |||||||
Cancelled/Expired | - | - | - | ||||||||
Outstanding at end of period | 4,530,429 | $ | 1.30 | 3.38 | |||||||
Exercisable end of period | 4,530,429 | $ | 1.30 | 3.34 |
Equivalent Shares Underlying Warrants Outstanding | Equivalent Shares Exercisable | |||||||||||||||||||||||
Exercise Prices | Equivalent Shares |
Weighted Average Remaining Contractual Life (years) |
Weighted Average Exercise Price |
Number Exercisable |
Weighted Average Exercise Price |
|||||||||||||||||||
$ | 1.30 | 4,505,429 | 3.37 | $ | 1.30 | 4,505,429 | $ | 1.30 | ||||||||||||||||
$ | 8.00 | 25,000 | 2.12 | $ | 8.00 | 25,000 | $ | 8.00 | ||||||||||||||||
Total | 4,530,429 | 3.37 | $ | 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.
19 |
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 six months ended December 31, 2018, $375,000 and $750,000, 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 six months ended December 31, 2018, Carl Sandler was paid $0 and $15,000, respectively, for consulting services. The agreement with Mr. Sandler terminated pursuant to its terms on August 16, 2018. This amount was charged to consulting expenses in our Condensed Consolidated Statements of Operations.
Shares held for non-consenting shareholders – In connection with the Share Exchange certain shareholders of DanDrit Denmark had not been identified or did not consent to the exchange of shares. In accordance with Section 70 of the Danish Companies Act and the Articles of Association of DanDrit Denmark, the Non-Consenting Shareholders that did not exchange the DanDrit Denmark equity interests owned by such Non-Consenting Shareholders for shares of the Company, will be entitled to receive up to 185,053 shares of Common Stock of the Company that each such Non-Consenting Shareholder would have been entitled to receive if such shareholder had consented to the Share Exchange. During the year ended June 30, 2018, the Registrant issued 55,457 shares of Common Stock to such non-consenting shareholders of DanDrit Denmark. The 129,596 remaining shares have been reflected as issued and outstanding in the accompanying financial statements.
20 |
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 Agreements - The Company had an employment agreement with Eric Leire, the Chief Executive Officer with a base compensation of $313,775. The Company had a services agreement with Crossfield, Inc. an entity controlled by Robert Wolfe, the Chief Financial officer with a base compensation of $240,000. The Company maintains employment agreements with other staff in the ordinary course of business.
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.
21 |
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 and expire on December 31, 2019. The Grant Warrants contain certain anti-dilution provisions applicable in the discretion of the Company. At December 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.
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 six months ended December 31, 2018, Carl Sandler was paid $15,000 and $0, 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.
On July 9, 2018, the Company entered into 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 six months ended December 31, 2018, $375,000 and $750,000, respectively, was charged to research and development expenses in our Condensed Consolidated Statements of Operations.
NOTE 8 — SUBSEQUENT EVENTS
In accordance with ASC 855-10, Company management reviewed all material events through the date of this report. The following subsequent events occurred:
On January 4, 2019, the Company entered into a consulting agreement, effective July 28, 2018, with DCA Advisory Services, LLC (“DCA”). The agreement is for advisory and management services related to all Intellectual Property (IP) activities, as well as business development and strategic advice at a monthly fee of $12,500. DCA is wholly owned by Christine Mikail, a shareholder of Enochian Biosciences, Inc. No services were rendered for this agreement until after January 4, 2019.
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 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.
The Company has recorded 377,000 in severance payments related to the foregoing terminations as accrued expenses as of December 31, 2018.
22 |
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.
23 |
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 10th , 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 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.
On April 9, 2018, the Company announced the appointment of Hans-Peter Kiem to its Scientific Advisory Board (“SAB”).
On March 22, 2018, the Board established an Audit Committee, Nominating and Corporate Governance Committee and Compensation Committee each comprised solely of independent directors. The Audit Committee is chaired by Ms. Evelyn D’An, who qualifies as an audit committee financial expert under the listing standards of the NASDAQ Capital Market; the Nominating and Corporate Governance Committee is chaired Luc Dubryne; and the Compensation Committee is chaired by Mr. James Sapirstein.
On March 6, 2018, the Board increased its size from 4 to 6 members and appointed Mr. Sapirstein and Ms. D’An as directors, each of whom is considered independent under the listing standards of the Nasdaq Capital Market; and
On February 28, 2018, the Board increased its size from 2 to 4 members and appointed Carl Sandler, formerly the Chief Executive Officer of Enochian Biopharma, and Dr. Dybul.
On February 16, 2018, we completed the acquisition of Enochian Biopharma pursuant to the Acquisition Agreement, with Enochian Biopharma surviving as a wholly owned subsidiary of the Registrant.
On February 16, 2018, the Company entered into a consulting agreement with Weird Science under which Weird Science provided services related to the development of the Company’s products for the treatment of HIV and cancer, which terminated on July 9, 2018.
On January 18, 2018, the Company announced the appointment of Ambassador Mark R. Dybul, MD and Steven G. Deeks, MD to its Scientific Advisory Board. Dr. Dybul also serves as the Chairman of the Scientific Advisory Board.
On January 12, 2018, the Registrant, its wholly owned subsidiary Acquisition Sub, Enochian Biopharma and Weird Science entered into an Acquisition Agreement (the “Acquisition Agreement”) for the acquisition of Enochian Biopharma from Weird Science and most notably, the License with Enochian Biopharma as licensee and Weird Science as licensor.
24 |
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 December 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.
25 |
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 ENO-1001 and to continue our research and development of ENO-4001 and ENO-4002 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 December 31, 2018, the Company had $13,240,240 in cash and working capital of $11,755,526 as compared to $15,600,865 in cash and working capital of $14,888,293 as of June 30, 2018, a decrease of 15% and 21%, respectively.
Following is a summary of the Company’s cash flows (used in) provided by operating, investing, and financing activities:
Six Months Ended December 31, 2018 |
Six Months Ended December 31, 2017 | |||||||
Net Cash Provided by (Used by) Operating Activities | $ | 3,550,914 | $ | (994,575 | ) | |||
Net Cash (Used by) Investing Activities | (640,544 | ) | (5,062,565 | ) | ||||
Net Cash Provided by Financing Activities | 1,700,000 | 4,811,766 | ||||||
Gain (Loss) on Currency Translation | 130,833 | (390,883 | ) | |||||
Net (Decrease) in Cash and Cash Equivalents | $ | (2,360,625 | ) | $ | (1,635,583 | ) |
26 |
Results of Operations for the three months and six months ended December 31, 2018 compared to the three months and six months ended December 31, 2017
The following table sets forth our revenues, expenses and net loss for the three and six months ended December 31, 2018 and December 31, 2017. The financial information below is derived from our unaudited condensed consolidated financial statements.
For the Three Months Ended |
For the Six Months Ended |
|||||||||||||||
December 31, | December 31, | |||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||
Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
Cost of Goods Sold | - | - | - | - | ||||||||||||
Gross profit (Loss) | - | - | - | - | ||||||||||||
Operating Expenses | ||||||||||||||||
General and Administrative Expenses | 1,767,321 | 668,231 | 2,933,029 | 956,947 | ||||||||||||
Stock-Based Compensation Expense | 1,780,059 | - | 1,866,225 | 112,837 | ||||||||||||
Research and Development Expenses | 788,968 | 219,969 | 1,282,523 | 373,621 | ||||||||||||
Depreciation and Amortization | 1,896,554 | 3,954 | 3,855,116 | 7,900 | ||||||||||||
Consulting Expenses | 32,275 | 388,888 | 94,760 | 456,098 | ||||||||||||
Total Operating Expense | 6,265,627 | 1,281,042 | 10,031,653 | 1,907,403 | ||||||||||||
LOSS FROM OPERATIONS | (6,265,627 | ) | (1,281,042 | ) | (10,031,653 | ) | (1,907,403 | ) | ||||||||
Other Income (Expense) | ||||||||||||||||
Change in Fair Value of Contingent Consideration | (11,593,390) | - | (10,125,390) | - | ||||||||||||
Interest (Expense) | (43) | - | (87 | ) | (62 | ) | ||||||||||
Interest (Expense) – Related Party | - | (12,289) | - | (13,181 | ) | |||||||||||
(Loss) Gain on Currency Transactions | (169,483) | 209,023 | (201,461) | 596,432 | ||||||||||||
Interest and Other Income | 36,992 | 6,028 | 63,807 | 14,928 | ||||||||||||
Total Other (Expense) Income | (11,725,924) | 202,762 | (10,263,131) | 598,117 | ||||||||||||
Loss Before Income Taxes | (17,991,551 | ) | (1,078,280 | ) | (20,294,784 | ) | (1,309,286 | ) | ||||||||
Income Benefit | - | (1,934 | ) | _-_ | (6,572 | ) | ||||||||||
NET LOSS | $ | (17,991,551 | ) | $ | (1,076,346 | ) | $ | (20,294,784 | ) | $ | (1,302,714 | ) | ||||
BASIC AND DILUTED LOSS PER SHARE | $ | (0.50 | ) | $ | (0.08 | ) | $ | (0.56 | ) | $ | (0.10 | ) | ||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED | 36,172,403 | 13,847,118 | 36,229,259 | 12,711,029 |
27 |
Revenues
Revenues from operations for the six months ended December 31, 2018, and December 31, 2017 were $0 and $0, respectively.
Cost of Goods Sold
Our cost of goods sold was $0 and $0 during the six months ended December 31, 2018, and December 31, 2017, respectively.
Gross profit (Loss)
Gross profit for the six months ended December 31, 2018, and December 31, 2017 was $0 and $0, respectively.
Expenses
Our operating expenses for the three months ended December 31, 2018, and December 31, 2017 were $6,265,627 and $1,281,042, respectively, representing an increase of $4,984,585, or approximately 389.1%. The largest contributors to the increase in operating expenses were the increase in depreciation and amortization associated with the amortization of intellectual property rights acquired in the Acquisition of Enochian BioPharma, the increase in stock based compensation, and the increase in general and administrative expenses related to the development of the Company’s infrastructure to support the scientific platforms and an increase in R&D as we continue to develop and innovate our HIV and cancer platforms.
Our operating expenses for the six months ended December 31, 2018, and December 31, 2017 were $10,031,653 and $1,907,403, respectively, representing an increase of $8,124,250, or approximately 425.9%. The largest contributors to the increase in operating expenses were the increase in depreciation and amortization associated with the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma, the increase in general and administrative expenses 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.
General and administrative expenses for the three months ended December 31, 2018 and 2017 were $1,767,321 and $668,231, respectively, representing an increase of $1,099,090 or 164.5%. The increase in general and administrative expenses is primarily due to costs related to security of $342,377 compensation expense of $677,343, board committee fees of $218,282 and filing fees of $83,675.
General and administrative expenses for the six months ended December 31, 2018, and December 31, 2017 were $2,933,029 and $956,947, respectively, representing an increase of $1,976,082, or approximately 206.5%. The increase in general and administrative expenses is primarily due to the costs related to security expenses of $462,803, compensation expenses of $927,328, board and committee fees of $256,418 and filing fees of $86,938.
Research and development expenses for the three months ended December 31, 2018 and December 31, 2017 were $788,968 and $219,969, respectively, representing an increase of $568,999 or approximately 258.7%. The increases in research and development expenses are attributable to expenditures related to the development of studies for our genetically modified cellular and immune-therapy technologies.
Research and development expenses for the six months December 31, 2018, and December 31, 2017 were $1,282,523 and $373,621, respectively, representing an increase of $908,902 or approximately 243.3%. 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.
Depreciation and amortization for the three months ended December 31, 2018, and December 31, 2017, were $1,896,554 and $3,954, respectively, representing an increase of $1,892,600. The significant increase in depreciation and amortization expenses is related to the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma.
28 |
Depreciation and amortization expenses for the six months ended December 31, 2018, and December 31, 2017, were $3,855,116 and $7,900, respectively, representing an increase of $3,847,216. The significant increase in depreciation and amortization expenses is related to the amortization of intellectual property rights acquired in the Acquisition of Enochian Biopharma.
Other (expense) income for the three months ended December 31, 2018, and December 31, 2017, was ($11,725,924) and $202,762, respectively, representing an increase of $11,928,686. The significant increase in other expense is mainly attributable to the change in fair value of the contingent consideration liability of $11,593,390. This contingent consideration is related to the Contingent Shares in connection with the Acquisition of Enochian Biopharma.
Other (expenses) income for the six months ended December 31, 2018, and December 31, 2017, was ($10,263,131) and $598,117, respectively representing an increase of ($10,861,248). This significant increase in other expense is mainly attributable to the change in fair value of the contingent consideration of $10,125,390. This contingent consideration is related to the Contingent Shares in connection with the Acquisition of Enochian Biopharma.
Net Loss
Net loss for the three months ended December 31, 2018, and December 31, 2017, was ($17,991,551) or ($0.50) per share and ($1,076,346) or ($0.08) per share, respectively, representing an increase in loss of ($16,915,205). 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, and the additional shares issued as part of the “earn-out” related to the acquisition.
Net loss for the six months December 31, 2018, and December 31, 2017, was ($20,294,784) or ($0.56) per share and ($1,302,714) or ($0.10) per share, respectively, representing an increase in loss of $18,992,070. 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, and the additional shares issued as contingent consideration related to the Acquisition of Enochian Biopharma.
Cash Flows
Cash provided (used) by operating activities for the six months ended December 31, 2018, and December 31, 2017 was ($3,550,914) and ($994,575), respectively. Cash provided by operating activities in 2018 included several significant non-cash items that are added back to the net loss. These consisted of $3,855,115 of amortization related to our license agreement, a $10,125,390 non-cash charge related to the fair market valuation of the contingent consideration liability and $1,866,225 non-cash stock-based compensation related the Black-Scholes valuation of our outstanding options. In addition, we received $1,700,000 of proceeds from stock issuances. The net impact of these more significant items and few others represents a decrease in cash of $2,360,625.
The decrease in cash is primarily attributable to $1,257,528 in research and development costs, security expenses of $462,803 and compensation and benefit expenses of $927,328.
For the six months ended December 31, 2017, cash used by operating activities amounted to $994,575 and was primarily attributable to fund raising efforts of the Company and the operations of our Danish subsidiary Enochian BioSciences Denmark, formerly named Dandrit Denmark.
29 |
Assets
Total assets at December 31, 2018 were $173,956,807 compared to $179,662,426 as of June 30, 2018. Total current liabilities increased to $1,638,420 at December 31, 2018 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 December 31, 2018, 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.
30 |
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 six months ended December 31, 2018 that have materially affected or are reasonably likely to materially affect our internal controls.
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.
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.
31 |
(a) | Exhibits required by Item 601 of Regulation S-K. |
Exhibit No. | Description | |
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. |
32 |
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: February 13, 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) |
33 |