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 September
30, 2022
OR
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________
Commission file number 001-38758
Enochian Biosciences Inc.
(Exact name of registrant as specified in its
charter)
Delaware
45-2559340
(State or other jurisdiction of
(I.R.S. Employer
incorporation or organization)
Identification Number)
1927 Paseo Rancho Castillo
Los Angeles , CA
90032
(Address of principal executive offices)
(Zip Code)
+1 (305) 918-1980
(Registrant’s telephone number, including
area code)
N/A
(Former name, former address and former fiscal
year, if changed since last report)
Securities registered pursuant to Section 12(b)
of the Act:
Title of Each Class
Trading Symbol
Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share
ENOB
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant
(1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☐ No ☒
Indicate by check mark whether the registrant
has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405
of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☐ No ☒
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definitions of
“large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging
growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
Emerging growth company
☐
If an emerging growth company, indicate by
check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of March
7 , 2 023 , the number of shares of the registrant’s common stock outstanding was 55,705,521 .
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
- INDEX -
Page
PART I – FINANCIAL INFORMATION:
1
Item 1.
Financial Statements (Unaudited):
1
Condensed Consolidated Balance Sheets as of September 30, 2022 (Unaudited) and June 30, 2022
2
Condensed Consolidated Statements of Operations for the Three Months Ended September 30, 2022, and 2021 (Unaudited)
3
Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended September 30, 2022, and 2021 (Unaudited)
4
Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended September 30, 2022, and 2021 (Unaudited)
5
Condensed Consolidated Statements of Cash Flows for the Three Months Ended September 30, 2022, and 2021 (Unaudited)
6
Notes to the Condensed Consolidated Financial Statements (Unaudited)
7
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
26
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
34
Item 4.
Controls and Procedures
34
PART II – OTHER INFORMATION:
35
Item 1.
Legal Proceedings
35
Item 1A.
Risk Factors
36
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
36
Item 3.
Defaults Upon Senior Securities
36
Item 4.
Mine Safety Disclosures
36
Item 5.
Other Information
36
Item 6.
Exhibits
36
Signatures
37
i
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements.
The accompanying financial
statements have been prepared in accordance with generally accepted accounting principles for interim financial information and
in accordance with the instructions for Form 10-Q. Accordingly, they do not include all of the information and footnotes required
by generally accepted accounting principles for complete financial statements.
In the opinion of management,
the financial statements contain all material adjustments, consisting only of normal recurring adjustments necessary to present
fairly the financial condition, results of operations, and cash flows of the Company for the interim periods presented.
The results for the periods
ended September 30, 2022, 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, 2022, filed with the Securities and Exchange Commission on February 27, 2023.
1
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30,
June 30,
2022
2022
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash
$ 7,971,918
$ 9,172,142
Prepaids and other assets
160,629
392,996
Total Current Assets
8,132,547
9,565,138
Property and equipment, net
559,621
586,536
OTHER ASSETS:
Definite life intangible assets, net
39,953
44,268
Indefinite life intangible assets, net
61,571,000
61,571,000
Goodwill
11,640,000
11,640,000
Deposits and other assets
65,285
68,635
Operating lease right-of-use assets
1,062,150
1,157,086
Total Other Assets
74,378,388
74,480,989
TOTAL ASSETS
$ 83,070,556
$ 84,632,663
LIABILITIES
CURRENT LIABILITIES:
Accounts payable – trade
$ 4,682,745
$ 1,401,867
Accrued expenses
1,042,242
1,031,462
Contingent consideration liability
—
2,343,318
Other current liabilities
35,540
220,685
Convertible notes payable
1,200,000
1,200,000
Current portion of operating lease liabilities
198,557
253,636
Total Current Liabilities
7,159,084
6,450,968
NON-CURRENT LIABILITIES:
Notes payable, net
4,651,769
4,577,148
Operating lease liabilities, net of current portion
934,861
985,699
Total Non-Current Liabilities
5,586,630
5,562,847
Total Liabilities
12,745,714
12,013,815
Commitments and Contingencies
—
—
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, 55,507,082 shares issued and outstanding at September 30, 2022, and 53,007,082 shares issued and outstanding at June 30, 2022
5,552
5,302
Additional paid-in capital
282,402,437
276,989,179
Accumulated deficit
( 212,044,957 )
( 204,345,197 )
Accumulated other comprehensive loss
( 38,190 )
( 30,436 )
Total Stockholders’ Equity
70,324,842
72,618,848
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 83,070,556
$ 84,632,663
See accompanying notes to the unaudited condensed
consolidated financial statements.
2
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
For the Three Months Ended
September 30,
2022
2021
Operating Expenses
General and administrative
$ 4,556,840
$ 4,417,505
Research and development
2,605,375
3,055,435
Depreciation and amortization
28,401
31,733
Total Operating Expenses
7,190,616
7,504,673
LOSS FROM OPERATIONS
( 7,190,616 )
( 7,504,673 )
Other Income (Expenses)
Loss on extinguishment of contingent consideration liability
( 419,182 )
—
Change in fair value of contingent consideration
—
( 2,824,642 )
Interest expense
( 95,585 )
( 89,739 )
Gain on currency transactions
—
9
Interest and other income
5,623
7,110
Total Other Income (Expenses)
( 509,144 )
( 2,907,262 )
Loss Before Income Taxes
( 7,699,760 )
( 10,411,935 )
Income Tax (Expense) Benefit
—
( 34 )
NET LOSS
$ ( 7,699,760 )
$ ( 10,411,969 )
BASIC AND DILUTED NET LOSS PER SHARE
$ ( 0.14 )
$ ( 0.20 )
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING - BASIC AND DILUTED
55,099,473
52,219,661
See accompanying notes to the unaudited condensed
consolidated financial statements.
3
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(UNAUDITED)
For the Three Months Ended
September 30,
2022
2021
Net Loss
$ ( 7,699,760 )
$ ( 10,411,969 )
Other Comprehensive Loss
Foreign Currency Translation, net of taxes
( 7,754 )
( 3,993 )
Comprehensive Loss
$ ( 7,707,514 )
$ ( 10,415,962 )
See accompanying notes to the unaudited condensed
consolidated financial statements.
4
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY
(UNAUDITED)
# of Shares
Common Shares
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income
Total
July 1, 2022
53,007,082
$ 5,302
$ 276,989,179
$ ( 204,345,197 )
$ ( 30,436 )
$ 72,618,848
Stock issued pursuant to warrants exercised
1,250,000
125
1,624,875
1,625,000
Shares issued for Earn-out
1,250,000
125
2,762,375
2,762,500
Stock-based Compensation
—
—
1,026,008
—
—
1,026,008
Net Loss
—
—
—
( 7,699,760 )
—
( 7,699,760 )
Foreign Currency Translation Adjustment
—
—
—
—
( 7,754 )
( 7,754 )
September 30, 2022
55,507,082
$ 5,552
$ 282,402,437
$ ( 212,044,957 )
$ ( 38,190 )
$ 70,324,842
# of Shares
Common Shares
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income
Total
July 1, 2021
52,219,661
$ 5,222
$ 265,580,356
$ ( 90,911,805 )
$ ( 10,834 )
$ 174,662,939
Stock-based Compensation
—
—
2,727,975
—
—
2,727,975
Net Loss
—
—
—
( 10,411,969 )
—
( 10,411,969 )
Foreign Currency Translation Adjustment
—
—
—
—
( 3,993 )
( 3,993 )
September 30, 2021
52,219,661
$ 5,222
$ 268,308,331
$ ( 101,323,774 )
$ ( 14,827 )
$ 166,974,952
See accompanying notes to the unaudited condensed
consolidated financial statements.
5
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
(UNAUDITED)
For the Three Months Ended
September 30,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$
( 7,699,760
)
$
( 10,411,969
)
ADJUSTMENTS TO RECONCILE NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Depreciation and amortization
28,401
31,733
Loss on extinguishment of contingent consideration liability
419,182
—
Change in contingent consideration liability
—
2,824,642
Stock based compensation expense
1,026,008
2,727,975
Amortization of discount of notes payable
74,621
74,274
Changes in assets and liabilities:
Other receivables
( 3,988
)
1,640
Prepaid expenses/deposits
239,703
157,799
Accounts payable
3,280,877
227,306
Accrued expenses
10,783
( 817,554
)
Other current liabilities
( 185,145
)
( 90,602
)
Operating leases, net
( 10,981
)
( 1,931
)
NET CASH USED IN OPERATING ACTIVITIES
( 2,820,299
)
( 5,276,687
)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
—
( 5,156
)
NET CASH USED IN INVESTING ACTIVITIES
—
( 5,156
)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants
1,625,000
—
NET CASH PROVIDED BY FINANCING ACTIVITIES
1,625,000
—
Effect of exchange rates on cash
( 4,925
)
( 5,517
)
NET CHANGE IN CASH
( 1,200,224
)
( 5,287,360
)
CASH, BEGINNING OF PERIOD
9,172,142
20,664,410
CASH, END OF PERIOD
$
7,971,918
$
15,377,050
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest
$
30,332
$
36,462
Income Taxes
$
—
$
34
SUPPLEMENTAL DISCLOSURES OF NON-CASH FINANCING ACTIVITIES
Common shares issued for contingent earn out liability
$
2,762,500
$
—
See accompanying notes to the unaudited condensed
consolidated financial statements.
6
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTE 1 — THE BUSINESS AND SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
Business – Enochian
Biosciences Inc., (“Enochian,” or “Registrant”, and together with its subsidiaries, the “Company”,
“we” or “us”) engages in the research and development of pharmaceutical and biological products for the
treatment of Cancer, HIV, and HBV with the intent to manufacture said products.
Going Concern - These
financial statements have been prepared on a going concern basis, which assumes that the Company will continue to realize its assets
and discharge its liabilities in the normal course of business. The Company has not generated any revenue, has incurred substantial
recurring losses from continuing operations and has an accumulated deficit of $ 212,044,957 as of September 30, 2022. The continuation
of the Company as a going concern is dependent upon (i) its ability to successfully obtain FDA approval of its product candidates,
(ii) its ability to obtain any necessary debt and/or equity financing, and (iii) its ability to generate profits from the Company’s
future operations. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year from the issuance of these financial statements.
These financial statements do not include any adjustments to the recoverability and classification of recorded asset amounts and
classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Basis of Presentation
– The Company prepares consolidated financial statements in accordance with accounting principles generally accepted
in the United States of America (“U.S. GAAP”) and follows the rules and regulations of the U.S. Securities and Exchange
Commission (“SEC”). 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 September 30, 2022, and 2021 and for the periods then ended have been made. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted. The accompanying
unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto
included in the Company’s June 30, 2022, audited financial statements. The results of operations for the periods ended September
30, 2022, and 2021 are not necessarily indicative of the operating results for the full year.
Consolidation –
For the three months ended September 30, 2022, and 2021, the condensed consolidated financial statements include the accounts and
operations of the Registrant and its subsidiaries. All material inter-company transactions and accounts have been eliminated in
the consolidation.
Reclassification –
Certain amounts in the prior period financial statements, have been reclassified to conform to the current presentation. For
the three months ended September 2021, we reclassified lab expenses of $ 49,192 , from general and administrative expenses
to research and development expenses .
7
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, and fair value of equity instruments issued.
COVID-19 Update
The COVID-19 pandemic continues
to evolve. COVID-19 may cause delays in our research activities. To date, the COVID-19 pandemic has not materially affected our
operations. However, it has caused delays in the conduct of experiments due to limitations in resources and supply chain issues,
in particular for those third-parties conducting experiments. There have also been increases in the cost to conduct animal studies
due to staffing and other limitations.
The full extent to which
the COVID-19 pandemic may impact our business and operations is subject to future developments, which are uncertain and difficult
to predict. We continue to monitor the impact of the COVID-19 pandemic on our business and operations and will seek to adjust our
activities as appropriate.
In addition, the pandemic
could result in significant and prolonged disruption of global financial markets, reducing our ability to access capital, which
could in the future negatively affect the financial resources available to us.
Functional Currency &
Foreign Currency Translation – The functional currency of Enochian Denmark 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 the periods ended September 30, 2022, and 2021. 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 statement of operations as incurred.
8
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — THE BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES (Continued)
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 amounts at September 30, 2022, and June 30, 2022, of $ 7,622,223 and $ 8,805,495 , 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 and depreciated 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 4.)
Intangible Assets –
The Company has both definite and indefinite life intangible assets.
Definite life intangible
assets include patents. 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. 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.
Indefinite life intangible
assets include license agreements and goodwill. The Company accounts for indefinite life intangible assets in accordance with ASC
350, “Goodwill and Other Intangible Assets”. License agreement costs represent the fair value of the license agreement
on the date acquired and are tested annually for impairment, as well as whenever events or changes in circumstances indicate the
carrying value may not be recoverable.
Goodwill –
Goodwill is not amortized but is evaluated for impairment annually as of June 30 th of each fiscal year or whenever events
or changes in circumstances indicate the carrying value may not be recoverable.
Impairment
of Goodwill and Indefinite Lived Intangible Assets – 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 carrying
value of the reporting unit exceeds its fair value, we record an impairment loss for such excess. The annual fair value analysis
performed on goodwill supported that goodwill was not impaired as of June 30, 2022, and no additional impairment is deemed necessary
as of September 30, 2022 (see Note 5.)
For indefinite-lived intangible
assets, such as licenses acquired as an IPR&D asset, on an annual basis we determine the fair value of the asset and record
an impairment loss, if any, for the excess of the carrying value of the asset over its fair value. For the year ended June 30,
2022, the carrying value of the licenses acquired as an IPR&D asset exceeded its fair value. Therefore, the Company recorded
an impairment loss of $ 93,253,000 during the year ended June 30, 2022. No impairment is deemed necessary as of September 30, 2022
(see Note 5.)
The carrying value of IPR&D
and goodwill at September 30, 2022, were $ 61,571,000 and $ 11,640,000 , respectively.
9
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — THE BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES (Continued)
Impairment of Long-Lived
Assets – Long-lived assets, such as property and equipment, definite and indefinite life intangible assets 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 expectations 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 for 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 are their respective fair values.
Leases – In
accordance with ASC Topic 842, the Company determined the initial classification and measurement of its right-of-use assets and
lease liabilities at the lease commencement date and thereafter. The lease terms include any renewal options and termination options
that the Company is reasonably assured to exercise, if applicable. The present value of lease payments is determined by using the
implicit interest rate in the lease, if that rate is readily determinable; otherwise, the Company develops an incremental borrowing
rate based on the information available at the commencement date in determining the present value of the future payments.
Rent expense for operating
leases is recognized on a straight-line basis, unless the operating lease right of use assets have been impaired, over the reasonably
assured lease term based on the total lease payments and is included in operating expenses in the condensed consolidated statements
of operations. For operating leases that reflect impairment, the Company will recognize the amortization of the operating lease
right-of-use assets on a straight-line basis over the remaining lease term with rent expense still included in general and administrative
expenses in the unaudited condensed consolidated statements of operations.
The Company has elected
the practical expedient to not separate lease and non-lease components. The Company’s non-lease components are primarily
related to property maintenance, insurance, and taxes, which vary based on future outcomes, and thus are recognized in general
and administrative expenses when incurred (see Note 6.)
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 Oncology, HIV and HBV therapies and technologies for use
in the prevention, treatment, amelioration of and/or therapy for Oncology, HIV and HBV. Research and development expenses for the
three months ended September 30, 2022 and 2021, amounted to $ 2,605,375 , and $ 3,055,435 , respectively.
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 Topic 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 months ended September 30, 2022, and 2021, 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 4,495,477
and 7,116,667
potential shares of Common Stock excluded from the Diluted EPS calculation as of September 30, 2022, and September 30, 2021,
respectively.
10
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 — THE BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES (Continued)
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, 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 (see Note 3.)
Stock
Options and Restricted Share Units – The Company has granted stock options, restricted share units
(“RSUs”) and warrants. The Company accounts for stock-based awards in accordance with the provisions of FASB ASC Topic
718, “Compensation - Stock Compensation”.
Stock-Based Compensation
– The Company records stock-based compensation in accordance with ASC Topic 718, “Compensation - Stock Compensation”.
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 consultants 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 required service
period, which is generally the vesting period. Stock based compensation costs for the vesting of options and RSUs granted for the
three months ended September 30, 2022 and 2021 were $ 1,026,008 and $ 2,727,975 , respectively (See Note 8.)
Recently Adopted Accounting
Pronouncements – Recent accounting pronouncements issued by the FASB do not or are not believed by management to have
a material impact on the Company’s present or future financial statements.
11
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – GOING CONCERN
The Company’s
consolidated financial statements are prepared using the generally accepted accounting principles applicable to a going concern,
which contemplates the realization of assets and liquidation of liabilities in the normal course of business. However, the Company
has incurred substantial recurring losses from continuing operations, has used cash in the Company’s continuing operations,
and is dependent on additional financing to fund operations. The Company incurred a net loss of approximately $ 7,699,760
and $ 10,411,969
for the quarters ended September 30, 2022 and 2021, respectively. As of September 30, 2022, the Company had cash and cash
equivalents of $ 7,971,918
and an accumulated deficit of $ 212,044,957 .
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for one year after the
date the financial statements are issued. The condensed consolidated financial statements do not include any adjustments relating to
the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the
Company be unable to continue in existence. Management intends to raise additional funds for (a) research and development, (b)
increases in personnel, and (c) the purchase of equipment, specifically to advance the Company’s potential products through
the regulatory process. The Company may raise such funds from time to time through public or private sales of equity or debt
securities. Such financing may not be available on acceptable terms, or at all, and the failure to raise capital when needed could
materially adversely affect the Company’s growth plans and its financial condition and results of operations.
NOTE 3 — FAIR VALUE
MEASUREMENTS – 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 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 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.
There were no Level 1, 2
or 3 assets, nor any Level 1, 2 or 3 liabilities as of September 30, 2022.
12
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 4 — PROPERTY AND EQUIPMENT
Property and equipment consisted of the following:
Summary of property and equipment
Useful Life
September 30, 2022
June 30, 2022
Lab Equipment and Instruments
4 - 7
$ 546,524
$ 546,524
Leasehold Improvements
10
224,629
224,629
Furniture, Fixtures and Equipment
4 - 7
172,861
172,861
Total
944,014
944,014
Less Accumulated Depreciation
( 384,393 )
( 357,478 )
Net Property and Equipment
$ 559,621
$ 586,536
Depreciation expense amounted
to $ 26,915 , and $ 27,806 for the three months ended September 30, 2022 and 2021, respectively.
NOTE 5 — INTANGIBLE ASSETS
At September 30, 2022, and
June 30, 2022, definite-life intangible assets, net of accumulated amortization, consisted of patents on the Company’s products
and processes of $ 39,953 and $ 44,268 , respectively. The patents are recorded at cost and amortized over twenty years from the date
of application. Amortization expense for the three months ended September 30, 2022, and September 30, 2021, was $ 1,486 and $ 3,927 ,
respectively.
At September 30, 2022, and
2021, indefinite life intangible assets consisted of a license agreement classified as In-Process Research and Development (“IPR&D”)
intangible assets, which are not amortizable until the intangible asset provides economic benefit, and goodwill.
At September 30, 2022, and
June 30, 2022, definite and indefinite-life intangible assets consisted of the following:
Schedule of life intangible assets
Useful Life
June 30,
2022
Period Change
Effect of Currency Translation
September 30,
2022
Definite Life Intangible Assets
Patents
20 Years
$ 279,257
$ —
$ ( 18,103 )
$ 261,154
Less Accumulated Amortization
( 234,989 )
( 1,486 )
15,274
( 221,201 )
Net Definite-Life Intangible Assets
$ 44,268
$ ( 1,486 )
$ ( 2,829 )
$ 39,953
Indefinite Life Intangible Assets
License Agreement
$ 61,571,000
—
—
$ 61,571,000
Goodwill
11,640,000
—
—
11,640,000
Total Indefinite Life Intangible Assets
$ 73,211,000
—
—
$ 73,211,000
Expected future amortization
expense is as follows:
Schedule of expected future amortization expense
Year ending June 30,
2023
$ 6,752
2024
11,067
2025
11,067
2026
11,067
Total
$ 39,953
During February 2018, the
Company acquired a License Agreement (as licensee) to an HIV therapy which consists of a perpetual, fully paid-up, royalty-free,
sub-licensable, and sole and exclusive worldwide license to research, develop, use, sell, have sold, make, have made, offer for
sale, import and otherwise commercialize certain intellectual property in cellular therapies for the prevention, treatment, amelioration
of and/or therapy exclusively for HIV in humans, and research and development exclusively relating to HIV in humans. Because the
HIV License Agreement is considered an IPR&D intangible asset it is classified as an indefinite life asset that is tested annually
for impairment.
Impairment – Following
the fourth quarter of each year, management performs its annual test of impairment of intangible assets by performing a quantitative
assessment and determines if it is more likely than not that the fair value of the asset is greater than or equal to the carrying
value of the asset. The results of the quantitative assessment indicated that the carrying value of the licenses acquired as an
IPR&D asset exceeded its fair value, due to the sublicensing of ENOB HV-01, which required a different valuation approach and
changes in other factors impacting the fair value of the asset. Therefore, an impairment adjustment of $ 93,253,000
was recorded in the three months ended June 30, 2022.
13
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED
FINANCIAL STATEMENTS
NOTE 6 — LEASES
Operating
Leases — On
November 13, 2017, Enochian entered into a Lease Agreement for a term of five years and two months from November 1, 2017, with Plaza
Medical Office Building, LLC, a California limited liability company, as landlord, (the “Landlord”) pursuant to which
the Company agreed to lease from the Landlord approximately 2,325 rentable square feet. The base rent increased by 3% each year, and
ranged from approximately $8,719 per month for the first year to $10,107 per month for the two months of the sixth year. The lease
was terminated early without penalties or additional costs as of September 30, 2022, that released an accrual
of $ 70,800
related to leasehold improvements that was not utilized.
On June 19, 2018, Enochian
entered into a Lease Agreement for a term of ten years from September 1, 2018, with Century City Medical Plaza Land Co., Inc.,
pursuant to which the Company agreed to lease approximately 2,453 rentable square feet. On February 20, 2019, Enochian entered
into an Addendum to the original Lease Agreement with an effective date of December 1, 2019, where it expanded the lease area to
include another 1,101 square feet for a total rentable 3,554 square feet. The base rent increases by 3% each year, and ranges from
$17,770 per month for the first year to $23,186 per month for the tenth year. The equalized monthly lease payment for the term
of the lease is $20,050. Enochian subleased the space as of June 25, 2022 (see subsection below “ Sublease Agreement ”
for details.)
The Company identified and
assessed the following significant assumptions in recognizing the right-of-use asset and corresponding liabilities:
Expected lease term
— The expected lease term includes both contractual lease periods and, when applicable, cancelable option periods when it
is reasonably certain that the Company would exercise such options. The Company’s lease has a remaining lease term of 59
months. As of September 30, 2022, the weighted-average remaining term is 4.92 years.
Incremental borrowing
rate — The Company’s lease agreements do not provide an implicit rate. As the Company does not have any external
borrowings for comparable terms of its leases, the Company estimated the incremental borrowing rate based on the U.S. Treasury
Yield Curve rate that corresponds to the length of each lease. This rate is an estimate of what the Company would have to pay if
borrowing on a collateralized basis over a similar term in an amount equal to the lease payments in a similar economic environment.
As of September 30, 2022, the weighted-average discount rate is 4.03 %.
Lease and non-lease
components — In certain cases the Company is required to pay for certain additional charges for operating costs,
including insurance, maintenance, taxes, and other costs incurred, which are billed based on both usage and as a percentage of
the Company’s share of total square footage. The Company determined that these costs are non-lease components, and they are
not included in the calculation of the lease liabilities because they are variable. Payments for these variable, non-lease components
are considered variable lease costs and are recognized in the period in which the costs are incurred.
14
Below are the lease commitments
for the next 5 years:
Lease commitments
Year Ending June 30 th
Lease Expense
2023
180,003
2024
246,004
2025
253,384
2026
260,985
2027
313,836
Less imputed interest
( 120,794 )
Total
$ 1,133,418
Sublease Agreement
On June 20, 2022, the Company
entered into a sublease Agreement with One Health Labs (the “Subtenant”), whereby the Subtenant agreed to lease 3,554
square feet of space currently rented by the Company in Century City Medical Plaza as of June 25, 2022, for a period of 3.5 years
with an option to renew for the remaining term of the lease that ends as of June 19, 2028. The base rent is $17,770 per month plus
$750 towards utility fees that are part of the original lease agreement and will increase by 3% each year over the term of the
sub-lease. The Company received a total of $57,022 on July 1, 2022 after execution of the sublease to cover the first month
rent, utility fee and deposit. The first sublease payment began on August 1, 2022.
In accordance with ASC Topic
842, the Company treats the sublease as a separate lease, as the Company was not relieved of the primary obligation under the original
lease. The Company continues to account for the Century City Medical Plaza lease as a lessee and in the same manner as prior to
the commencement date of the sublease. The Company accounts for the sublease as a lessor of the lease. The sublease is classified
as an operating lease, as it does not meet the criteria of a sales-type or direct financing lease.
The Company will recognize
operating income from the sublease on a straight-line basis in its statements of operations over the lease term.
For the three months ended September 30, 2022,
and 2021, the net operating lease expenses were as follows:
Schedule of net operating lease expenses
Three Months Ended September 30,
2022
2021
Operating Lease Expense
$ 43,930
$ 84,083
Sublease Income
( 53,310 )
—
Total Net Lease Expense (Income)
$ ( 9,380 )
$ 84,083
Lease expense (income)
charged to general and administrative expenses for the three months ended September 30, 2022, and 2021, amounted to $ ( 9,380 )
and $ 84,083 ,
respectively.
15
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — NOTES PAYABLE
Convertible Notes Payable — On
February 6, 2020, the Company issued two Convertible Notes (the “Convertible Notes”) to Paseco APS (the “Holder”),
a Danish limited company and an existing stockholder of the Company each with a face value amount of $ 600,000 , convertible into
shares of Common Stock, $ 0.0001 par value per share. The outstanding principal amount of the Convertible Notes was due and payable
on February 6, 2023 . Interest on the Convertible Notes commenced accruing on the date of issuance at six percent ( 6 %) per annum,
computed on the basis of twelve 30-day months, and is compounded monthly on the final day of each calendar month based upon the
principal and all accrued and unpaid interest outstanding as of such compound date. The interest was payable in cash on a semi-annual
basis.
The holder of the Convertible
Notes had the right at any time prior to the date that is twelve months from issuance to convert all or any part of the outstanding
and unpaid principal and all unpaid interest into shares of the Company’s Common Stock. The conversion price was equal to
$ 12.00 per share of Common Stock. The Holder did not exercise the conversion feature that expired on February 6, 2021. The Company
evaluated the Convertible Notes in accordance with ASC 470-20 and identified that they each contain an embedded conversion feature
that shall not be bifurcated from the host document (i.e., the Convertible Notes) as they are not deemed to be readily convertible
into cash. All proceeds received from the issuance have been recognized as a liability on the balance sheet. The Convertible Notes
balance as of September 30, 2022 and 2021, was $ 1,200,000 .
Effective December 30, 2022,
the Company amended and restated the Convertible Notes (the “Amended and Restated Secured Notes”). Pursuant to the
Amended and Restated Secured Notes, the due date was extended to February 28, 2024 , and the interest was increased to twelve percent
( 12 %) per annum, which was prepaid by the Company in full on the date of amendment through the issuance of 198,439 shares of the
Company’s Common Stock based on the closing market price on that date, of $ 1.03 , which included 29,419 shares for interest
accrued through December 30, 2022, and the obligations of the Company under the Amended and Restated Secured Notes were secured
by a security agreement (the “Security Agreement”).
As of September 30, 2022
and 2021, the Company recorded accrued interest in the amount of $ 12,030 and $ 6,000 , which is included in accrued expenses. For
the three months ended September 30, 2022 and 2021, the interest expense related to the Convertible Notes amounted to $ 18,182 and
$ 18,272 respectively.
Note Payable —
On March 30, 2020 (the “Issuance Date”), the Company issued a Promissory Note in the principal amount of $ 5,000,000
(the “Promissory Note”) to the Holder. The principal amount of the Promissory Note was originally payable on
November 30, 2021 (the “Maturity Date”). The Promissory Note bore interest at a fixed rate of 6 % per annum, computed
based on the number of days between the Issuance Date and the Maturity Date, which was prepaid by the Company in full on the Issuance
Date through the issuance of 188,485 shares of the Company’s Common Stock based on the closing market price on that date
for a total value of $ 501,370 . The Company evaluated the Unsecured Note and PIK interest in accordance with ASC 470-Debt and ASC
835-Interest, respectively. Pursuant to ASC 470-20, proceeds received from the issuance are to be recognized at their relative
fair value, thus the liability is shown net of the corresponding discount of $ 493,192 , which is the relative fair value of the
shares issued for the PIK interest on the closing date using the effective interest method. The discount of $ 493,192 will be accreted
over the life of the Promissory Note.
16
On February 11, 2021, the Company
entered into an amendment to the Promissory Note that extended the Maturity Date to November
30, 2022 . All other terms of the Promissory Note remained the same. The change in Maturity Date required an additional
year of interest at the fixed rate of 6 %
per annum, which was prepaid by the Company in full on the date of the amendment through the issuance of 74,054
shares of the Company’s Common Stock based on the closing market price on that date for a total value of $ 298,178 .
On May 17, 2022, the Company
entered into a second amendment to the Promissory Note that extended the Maturity Date to November 30, 2023 and increased the
interest rate from 6 % to 12 % per annum. All other terms of the Promissory Note remained the same. The change in Maturity Date required
an additional year of interest at the fixed rate of 12% per annum. Pursuant to the amendment, the Company prepaid interest for
the period November 30, 2022 until May 30, 2023 on the date of the amendment through the issuance of 47,115 shares of the Company’s
Common Stock based on the closing market price on that date for a total value of $ 299,178 . All other accrued interest payable from
May 30, 2023 to the Maturity Date shall be payable by the Company on May 30, 2023, at the option of the Holder either (i) in cash
or (ii) in non-assessable shares of the Company’s Common Stock, valued at the closing sale price of the Common Stock of the
Nasdaq Capital Market on May 30, 2023.
Effective December 30, 2022,
the Company entered into a third amendment to the Promissory Note. Pursuant to the third amendment, the Company’s obligations
under the Promissory Note were secured by the Security Agreement. To secure the Company’s obligations under each of the Amended
and Restated Secured Notes and the Promissory Note, the Company entered into a Security Agreement with the Holder, pursuant to
which the Company granted a lien on all assets of the Company (the “Collateral”) for the benefit of the Holder. Upon
an Event of Default (as defined in the Amended and Restated Secured Notes and Promissory Note, respectively) the Holder may, among
other things, collect or take possession of the Collateral, proceed with the foreclosure of the security interest in the Collateral
or sell, lease, or dispose of the Collateral.
For the three months ended
September 30, 2022 and 2021, discount amortization of $ 74,621 and $ 74,274 was charged to interest expense. The Promissory Note
balance, net of discount at September 30, 2022 is $ 4,651,769 .
Finance Agreement —
On November 30, 2021, the Company entered into a premium finance agreement (the “Agreement”) with a principal amount of
$ 666,875
at 3.99 %
interest per annum. The repayment of the Agreement was made in nine equal monthly installments of $ 56,469 .
For the three months ended September 30, 2022 and 2021, the Company recorded total interest expense in the amount of $ 2,782
and $ 1,267 ,
respectively. This amount is reflected in other income and expenses.
Total interest expense
recorded for the three months ended September 30, 2022 and 2021, was $ 95,585 and $ 89,739 , respectively.
17
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — STOCKHOLDERS’ EQUITY
Preferred Stock —The
Company has 10,000,000 authorized
shares of Preferred Stock, par value $ 0.0001 per
share. At September 30, 2022, and June 30, 2022, there were zero 0 shares
issued and outstanding.
Common Stock —The
Company has 100,000,000 authorized shares of Common Stock, par value $ 0.0001 per share. At September 30, 2022, and June 30, 2022,
there were 55,507,082 and 53,007,082 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 debts and liabilities,
the holders of Common Stock will be entitled to share ratably in the distribution of any of the remaining assets.
Purchase Agreement with Lincoln Park Capital
On July 8, 2020, we entered
into a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”),
pursuant to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $ 20,000,000
of shares of our Common Stock from time to time through August 1, 2023 .
In consideration for entering
into the Purchase Agreement, we issued 139,567 shares of Common Stock to Lincoln Park as a commitment fee on July 21, 2020.
During the three months
ended September 30, 2022 and 2021, we did no t sell any shares of Common Stock to Lincoln Park under the Purchase Agreement. At
September 30, 2022, an amount of $ 14,102,251 remained available under the Purchase Agreement. As of October 17, 2022, we no longer
have access to this Purchase Agreement as we are no longer able to use the registration statement on Form S-3 that registered the shares issuable to Lincoln Park under the Purchase
Agreement.
18
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — STOCKHOLDERS’ EQUITY
(Continued)
Common Stock Issuances
On July 14, 2022, certain of our
warrant holders exercised warrants to purchase 1,250,000
shares of Common Stock for total proceeds to the Company of $ 1,625,000 ,
with corresponding earn-out distribution of the same number of shares in connection with the acquisition of Enochian BioPharma, Inc.,
based on the share price on that date of $ 2.21 .
This non-cash earn-out distribution impacted stockholders’ equity in the amount of $ 2,762,500
based on the share price on July 14, 2022 of $ 2.21 .
In the three months ended September 30, 2022 and 2021 there were 2,500,000
and zero 0
shares of Common Stock issued, respectively. For the period ending September 30, 2022, the Company recorded a loss on extinguishment
of contingent consideration liability of $ 419,182 which reflects the difference between the fair value of the shares and the contingent
consideration liability at the time of issuance. As of September 30, 2022, all outstanding warrants have been exercised and there is
no further contingent consideration liability balance remaining as of the end of this period.
Acquisition of Enochian
Biopharma Inc. / Contingently issuable shares — On February 16, 2018, the acquisition of Enochian Biopharma was
completed. As part of the acquisition, the stockholders of Enochian Biopharma received (i) 18,081,962 shares of Common Stock, and
(ii) the right to receive Contingent Shares of Common Stock pro rata upon the exercise or conversion of warrants, which were outstanding
at closing. As of September 30, 2022, no further Contingent Shares are issuable.
Acquisition of Enochian
Denmark — At September 30, 2022, and June 30, 2022, the Company maintained a reserve of 17,414 shares
of Common Stock of the Registrant held in escrow according to Danish law (the “Escrow Shares”), all of which are
reflected as issued and outstanding in the accompanying financial statements. The Escrow Shares are reserved to acquire the shares
of Enochian Denmark held by non-consenting shareholders of Enochian Denmark on both September 30, 2022, and June 30, 2022, in
accordance with Section 70 of the Danish Companies Act and the Articles of Association of DanDrit Denmark. There have been 167,639 shares
of Common Stock issued to non-consenting shareholders of Enochian Denmark as of September 30, 2022. During the three months ended
September 30, 2022, the Company issued zero 0 shares
of Common Stock to such non-consenting shareholders of Enochian Denmark. There is no impact on outstanding shares as these shares
are reflected as issued and outstanding.
19
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — STOCKHOLDERS’ EQUITY (Continued)
Stock-based Compensation
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 in the three months ended September 30, 2022:
Summary of weighted-average assumptions used to estimate the fair values of the stock options granted
Enochian
Biosciences Inc.
Expected term (in years)
5.25 – 5.5
Volatility
86.78 % – 88.48 %
Risk free interest rate
2.70 % – 3.05 %
Dividend yield
0 %
The Company recognized stock-based compensation expense related
to the options of $ 1,026,008 and $ 2,727,975 for the three months ended September 30, 2022 and 2021, respectively. At September
30, 2022, the Company had approximately $ 5,485,468 of unrecognized compensation cost related to non-vested options.
Plan Options
On February 6, 2014, the
Board adopted the Company’s 2014 Equity Incentive Plan (the “2014 Plan”), and the Company had reserved 1,206,000
shares of Common Stock for issuance in accordance with the terms of the 2014 Plan.
On October 30, 2019,
the Board approved and on October 31, 2019, the Company’s stockholders adopted Enochian’s 2019 Equity Incentive Plan
(the “2019 Plan”), which replaced the 2014 Plan. The 2019 Plan authorized options to be awarded to not exceed the sum
of (1) 6,000,000 new shares, and (2) the number of shares available for the grant of awards as of the effective date under the
2014 Plan plus any options related to awards that expire, are terminated, surrendered, or forfeited for any reason without issuance
of shares under the 2014 Plan after the effective date of the 2019 Plan.
Pursuant to the 2019 Plan,
the Company granted options to purchase zero 0 and 3,009,300 shares
of Common Stock to employees with a three-year vesting period during the three months ended September 30, 2022 and 2021,
respectively.
During the three months
ended September 30, 2022, the Company granted options to purchase 184,800 shares of Common stock to employees with a six-month
vesting period. For the three months ended September 30, 2021, the Company did no t grant options to purchase shares of Common Stock
to employees with a six-month vesting period.
During the three months
ended September 30, 2022, the Company granted options to purchase 73,200 shares of Common stock to employees with a one-year vesting
period. For the three months ended September 30, 2021, the Company did no t grant options to purchase shares of Common Stock to
employees with a one-year vesting period.
During the three months
ended September 30, 2022, the Company granted options to purchase 50,958 shares of Common Stock, to the Board of Directors and
Scientific Advisory Board Members with a one-year vesting period. For the three months ended September 30, 2021, the Company granted
options to purchase 26,735 shares of Common Stock to members of the Board of Directors and Scientific Advisory Board with a one-year
vesting period.
During the three months ended
September 30, 2022, the Company did no t
grant options to purchase shares of Common stock for consulting services with immediate vesting. For the three months ended
September 30, 2021, the Company granted options to purchase 21,979
shares of Common Stock to consultants with immediate vesting.
During the three months ended
September 30, 2022, the Company did no t
grant options to purchase shares of Common stock for consulting services with a one-year vesting period. For the three months ended September
30, 2021, the Company granted options to purchase 24,500
shares of Common Stock to for consulting services with a one-year vesting period.
All of the above options
are exercisable at the market price of the Company’s Common Stock on the date of the grant.
To date the Company has
granted options under the 2014 Plan and 2019 Plan (“Plan Options”) to purchase 5,106,000
shares of Common Stock. At September 30, 2022, the Company has 2,679,848 options available to be issued under the Plan.
20
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — STOCKHOLDERS’ EQUITY
(Continued)
A summary of the status
of the Plan Options outstanding at September 30, 2022, is presented below:
Summary of stock options outstanding
Options Outstanding
Options Exercisable
Exercise Price Ranges
Number Outstanding
Weighted Average Remaining Contractual Life (years)
Weighted Average Exercise Price
Number Exercisable
Weighted Average Remaining Contractual Life (years)
Weighted Average Exercise Price
$ 2.00 – 4.50
522,315
8.64
$ 2.80
217,065
7.08
$ 3.21
$ 4.51 – 6.50
3,169,769
8.46
$ 4.83
1,153,876
7.84
$ 5.26
$ 6.51 – 12.00
803,393
7.95
$ 8.02
543,067
7.31
$ 7.92
Total
4,495,477
8.39
$ 5.16
1,914,007
7.60
$ 5.78
A summary of the status
of the Plan Options at September 30, 2022, and changes since July 1, 2022, are presented below:
Summary of stock option activity
Shares
Weighted Average Exercise
Price
Average Remaining Life
Weighted Average Intrinsic
Value
Outstanding at beginning of period
4,307,820
$ 5.37
8.55
$ —
Granted
308,958
$ 2.36
$
Exercised
—
$
$
Forfeited
—
$
$
Expired/Canceled
( 121,300 )
$ 5.30
$
Outstanding at end of period
4,495,477
$ 5.16
8.39
$ —
Exercisable at end of period
1,914,007
$ 5.78
7.60
$ —
At September 30, 2022, the
Company had 1,914,007 exercisable
Plan Options outstanding. The total intrinsic value of options exercisable at September 30, 2022, was 0 zero .
Intrinsic value is measured using the fair market value at the date of exercise (for shares exercised) and at September 30, 2022
(for outstanding options), less the applicable exercise price.
Common Stock Purchase Warrants
A summary of the warrants
outstanding at September 30, 2022, and changes since July 1, 2022, are presented below:
Summary of common stock purchase warrants outstanding
Shares
Weighted Average Exercise
Price
Weighted Average Remaining
Life
Outstanding at beginning of period
1,250,000
$ 1.30
1.02
Granted
—
$ —
—
Exercised
( 1,250,000 )
$ 1.30
—
Cancelled/Expired
—
$ —
—
Outstanding and exercisable at end of period
—
$ —
—
21
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — STOCKHOLDERS’ EQUITY
(Continued)
Restricted Stock Units (RSUs)
The Company recognized
stock-based compensation expense related to RSUs of zero 0 and
$ 2,991 for
the three months ended September 30, 2022 and 2021, respectively.
The Company had zero 0 Restricted
Stock Units outstanding at September 30, 2022.
22
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 9 — COMMITMENTS AND CONTINGENCIES
Commitments
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, and 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 was entitled
to consulting fees for 20 months, with a monthly consulting fee of not greater than $ 130,000 per month. Upon the completion of
the 20 months, the monthly consulting fee of $25,000 continued for scientific consulting and knowledge transfer on existing HIV
experiments until the services were no longer being rendered or the G-Tech Agreement is terminated. As of May 25, 2022, the consultant
was no longer able to render services, therefore no expense was incurred for the three months ended September 30, 2022. For the
three months ended September 30, 2021, $75,000 was charged to research and development expenses in our Condensed Consolidated
Statements of Operations related to this consulting agreement.
On January 31, 2020, the
Company entered into a Statement of Work and License Agreement (the “HBV License Agreement”) by and among the Company, G-Tech, and G Health Research Foundation, a not for profit entity organized under the laws of California doing business as
Seraph Research Institute (“SRI”) (collectively the “Licensors”), whereby the Company acquired a perpetual,
sublicensable, exclusive license (the “HBV License”) for a treatment under development (the “Treatment”)
aimed to treat Hepatitis B Virus (HBV) infections.
The HBV License Agreement
states that in consideration for the HBV License, the Company shall provide cash funding for research costs and equipment and certain
other in-kind funding related to the Treatment over a 24 month period, and provides for an up-front payment of $ 1.2 million within
7 days of January 31, 2020, along with additional payments upon the occurrence of certain benchmarks in the development of the
technology set forth in the HBV License Agreement, in each case subject to the terms of the HBV License Agreement. Additionally,
the HBV License Agreement provides for cooperation related to the development of intellectual property related to the Treatment
and for a 2 % royalty to G-Tech on any net sales that may occur under the HBV License. On February 6, 2020, the Company paid the
$ 1.2 million up-front payment. The HBV License Agreement contains customary representations, warranties, and covenants of the parties
with respect to the development of the Treatment and the HBV License.
The cash funding for research
costs pursuant to the HBV License Agreement consisted of monthly payments amounting to $144,500 that
covered scientific staffing resources to complete the project as well as periodic payments for materials and equipment needed to
complete the project. There were no payments made after January 31, 2022. During the three months ended September 30, 2022 and 2021,
the Company paid a total of zero 0 and
$ 433,500 ,
respectively, for scientific staffing resources, research and development and Investigational New Drug ("IND") Enabling studies.
During the three months ended September 30, 2022, and 2021, the Company paid zero 0 and
$ 1,500,000 ,
respectively, for the milestone completion of a Pre-IND process following receipt of written comments in accordance the HBV License
Agreement. The Company has filed a claim against the Licensors, which includes certain payments it made related to this license (see
Contingencies sub-section below).
On April 18, 2021, the Company
entered into a Statement of Work and License Agreement (the “License Agreement”), by and among the Company, G-Tech
and SRI (collectively, the “Licensors”), whereby the Company acquired a perpetual sublicensable, exclusive license
(the “Development License”) to research, develop, and commercialize certain formulations which are aimed at preventing
and treating pan-coronavirus or the potential combination of the pan-coronavirus and pan-influenza, including the SARS-coronavirus
that causes COVID-19 and pan-influenza (the “Prevention and Treatment”).
The License Agreement was
entered into pursuant to the existing Framework Agreement between the parties dated November 15, 2019. The License Agreement states
that in consideration for the Development License, the Company shall provide cash funding for research costs and equipment and
certain other in-kind funding related to the Prevention and Treatment over a 24-month period. Additionally, the License Agreement
provides for an up-front payment of $ 10,000,000 and a $ 760,000 payment for expenditures to date prior to the effective date related
to research towards the Prevention and Treatment within 60 days of April 18, 2021. The License Agreement provides for additional
payments upon the occurrence of certain benchmarks in the development of the technology set forth in the License Agreement, in
each case subject to the terms of the License Agreement.
The License Agreement
provides for cooperation related to the development of intellectual property related to the Prevention and Treatment and for a 3%
royalty to G-Tech on any net sales that may occur under the License Agreement. For the three months ended September 30, 2022, and
2021, the Company paid zero 0 and
$ 75,000 related
to the Prevention and Treatment research. The Company is no longer pursuing any product candidates that relate to this license. The
Company has filed a claim against the Licensors to recover all monies it paid related to this license (see Contingencies sub-section
below).
23
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
On August 25, 2021, the
Company entered into an ALC Patent License and Research Funding Agreement in the HIV Field (the “ALC License Agreement”)
with Serhat Gümrükcü and SRI (collectively, the “Licensors”) whereby the Licensors granted the Company
an exclusive, worldwide, perpetual, fully paid-up, royalty-free license, with the right to sublicense, proprietary technology
subject to a U.S. patent application, to make, use, offer to sell, sell or import products for use solely for the prevention, treatment,
amelioration of or therapy exclusively for HIV in humans, and research and development exclusively relating to HIV in humans; provided
the Licensors retained the right to conduct HIV research in the field. Pursuant to the ALC License Agreement, the Company granted
a non-exclusive license back to the Licensors, under any patents or other intellectual property owned or controlled by the Company,
to the extent arising from the ALC License, to make, use, offer to sell, sell or import products for use in the diagnosis, prevention,
treatment, amelioration or therapy of any (i) HIV Comorbidities and (ii) any other diseases or conditions outside the HIV Field.
The Company made an initial payment to SRI of $ 600,000 and agreed to fund future HIV research conducted by the Licensors, as mutually
agreed to by the parties. On September 10, 2021, pursuant to the ALC License Agreement, the Company paid the initial payment of
$ 600,000 .
G-Tech and SRI are controlled
by Serhat Gümrükcü and Anderson Wittekind, shareholders of the Company.
Shares held for
non-consenting shareholders – The 17,414 remaining
shares of Common Stock related to the Acquisition of Enochian Denmark have been reflected as issued and outstanding in the
accompanying financial statements. There were zero 0 shares
of Common Stock issued to such non-consenting shareholders during the three months ended September 30, 2022 (see Note
8.)
Service Agreements
– The Company has a consulting agreement for services of a Senior Medical Advisor for up to $210,000 per year on a
part-time basis. This consulting agreement was terminated as of October 31, 2022. The Company maintains employment agreements with
other staff in the ordinary course of business.
Contingencies
Securities Class Action
Litigation . On July 26, 2022 and July 28, 2022, securities class action complaints were filed by purported stockholders of
ours in the United States District Court for the Central District of California against us and certain of our current and former
officers and directors. The complaints allege, among other things, that the defendants violated Sections 10(b) and 20(a) of the
Securities Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions
of material fact in connection with the Company’s relationship with Serhat Gümrükcü and its commercial prospects.
The complaints seek unspecified damages, interest, fees, and costs. The defendants have not yet responded to the complaints.
Federal Derivative Litigation .
On September 22, 2022, Samuel E. Koenig filed a shareholder derivative action in the United States District Court for the Central
District of California. On January 19, 2023, John Solak filed a substantially similar shareholder derivative action in the United
States District Court for the District of Delaware. Both derivative actions recite similar underlying facts as those alleged in
the Securities Class Action Litigation. The actions, filed on behalf of the Company, name Serhat Gümrükcü and certain
of the Company’s current and former directors as defendants. The actions also name the Company as a nominal defendant. The
actions allege violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934 and also set out claims for breach
of fiduciary duty, contribution and indemnification, aiding and abetting, and gross mismanagement. Plaintiffs do not quantify any
alleged injury, but seek damages, disgorgement, restitution, and other costs and expenses. On January 24, 2023, the United States
District Court for the Central District of California stayed the Koenig matter pending resolution of the defendants’ anticipated
motion to dismiss in the Securities Class Action Litigation. The defendants have not yet responded to either complaint.
24
State Derivative Litigation .
On October 20, 2022, Susan Midler filed a shareholder derivative action in the Superior Court of California, Los Angeles County,
reciting similar underlying facts as those alleged in the Securities Class Action Litigation. The action, filed on behalf of the
Company, names Serhat Gümrükcü and certain of the Company’s current and former directors as defendants. The
action also names the Company as a nominal defendant. The action sets out claims for breaches of fiduciary duty, contribution,
and indemnification, aiding and abetting, and gross mismanagement. Plaintiff does not quantify any alleged injury, but seeks damages,
disgorgement, restitution, and other costs and expenses. The defendants have not yet responded to the complaint.
On October 21, 2022, the
Company filed a Complaint in the Superior Court of the State of California for the County of Los Angeles against Serhat Gümrükcü,
William Anderson Wittekind, G-Tech Bio LLC, SG & AW Holdings LLC, and Seraph Research Institute. The Complaint alleges that
the defendants engaged in a “concerted, deliberate scheme to alter, falsify, and misrepresent to the Company the results
of multiple studies supporting its [Hepatitis B] and SARS-CoV-2/influenza pipelines.” Specifically, “Defendants manipulated
negative results to reflect positive outcomes from various studies, and even fabricated studies out of whole cloth.” As a
result of the defendants’ conduct, the Company claims that it “paid approximately $25 million to Defendants and third-parties
that it would not otherwise have paid.” The defendants have not yet answered the allegations set forth in the Company’s
Complaint.
On December 28, 2022, the
Company received a demand letter on behalf of Weird Science LLC (“Weird Science”), William Anderson Wittekind, the
William Anderson Wittekind 2020 Annuity Trust, the William Anderson Wittekind 2021 Annuity Trust, the Dybul 2020 Angel Annuity
Trust, and the Ty Mabry 2021 Annuity Trust alleging that the Company breached the February 16, 2018 Investor Rights Agreement between
the Company, Weird Science, and RS Group ApS. Specifically, the demand letter alleges that the Company “breached its obligations
under the Investor Rights Agreement to provide the requisite thirty days’ notice” to Holders of Registrable Securities
in connection with SEC Form S-3 filings on July 13, 2020 and February 11, 2022 and demands over $64 million in damages. The Company
denies these allegations and intends to vigorously defend against this claim.
On March 1, 2021, former
Enochian BioSciences Chief Financial Officer, Robert Wolfe and his company, Crossfield, Inc., filed a Complaint in the U.S. District
Court for the District of Vermont against the Company, Enochian BioSciences Denmark ApS, and certain directors and officers. In the
Complaint, Mr. Wolfe and Crossfield, Inc. asserted claims for abuse of process and malicious prosecution, alleging, inter alia, that
the Company lacked probable cause to file and prosecute an earlier action, and sought millions of dollars of compensatory damages,
as well as punitive damages. The allegations in the Complaint relate to an earlier action filed by the Company and Enochian
BioSciences Denmark ApS in the Vermont Superior Court, Orange Civil Division. On March 3, 2022, the court partially granted the
Company’s motion to dismiss, dismissing the abuse of process claim against all defendants and all claims against Mark Dybul
and Henrik Grønfeldt-Sørensen. On November 29, 2022, the Company filed a motion for summary judgment with respect to the
sole remaining claim of malicious prosecution. The Company denies the allegations set forth in the Complaint and will continue to
vigorously defend against the remaining claim.
NOTE 10 — RELATED PARTY TRANSACTIONS
The
Company paid G-Tech zero 0 and
$ 2,218,500 which
included payments for consulting agreements related to HIV, and contractual costs related to the HBV License, the Development
License and the ALC License (see Note 9), and security expenses, for the three months ended September 30, 2022 and 2021,
respectively.
NOTE 11 — SUBSEQUENT EVENTS
Subsequent to September 30, 2022, the Company
became involved in a number of legal proceedings. Please see Note 9 above and Part II, Item 1 - Legal Proceedings for details of
such matters.
As of December 30, 2022,
the Company entered into amended and restated secured convertible promissory notes (see Note 7.)
On December 30, 2022, the
Company entered into a security agreement with the Holder (see Note 7.)
25
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. (“Enochian,” 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 in Part I, Item 1A, “Risk Factors” in our Annual Report on Form 10-K as filed with
the SEC on February 27, 2023. The Company’s plans and objectives are based, in part, on assumptions involving the continued
expansion of the 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 biotechnology company committed to developing advanced allogeneic cell and gene therapies to promote stronger immune system
responses potentially for long-term or life-long cancer remission in some of the deadliest cancers, and potentially to treat or
cure serious infectious diseases such as Human Immunodeficiency Virus (HIV) and Hepatitis B virus (HBV) infection.
Our
Product Development strategy is anchored in the use of “non-self” or allogeneic cells that enhance the immune response
that we seek to elicit .
Over the past several years,
Enochian BioSciences has evolved from a company with a single product candidate as a potential cure for HIV (ENOB-HV-01), adding
two additional pipeline candidates for HIV (ENOB-HV-12 and ENOB-HV-21), a pipeline for Hepatitis B Virus (HBV) (ENOB-HB-01), and
with a significant expansion into cancer immune therapies to address high unmet needs from difficult-to- treat solid tumors (ENOB-DC-11.)
The oncology platform is
now at the forefront of our development activities, beginning with pancreatic cancer.
Many operational aspects
of our platforms can be quickly adapted to multiple disease states from a single therapeutic approach, potentially streamlining
and accelerating development, and regulatory process, as well as manufacturing operations. Moreover, because our product candidates
do not require specialized delivery devices and surgical procedures, our potentially groundbreaking interventions could have worldwide
applicability.
The Company responds quickly
to new data and perceived development opportunities and risks assessments. Based on the maturation of our pipelines, the Company
makes business decisions to prioritize the programs that could move more rapidly through development and commercial processes.
26
Therapeutic Platforms
The Company’s general
approach with gene- and/or cell-therapy is to enhance the immune system to allow a person to better fight diseases. The Company
is leveraging general principals and advances in the knowledge of the immune response to engineer cells with enhanced attributes
to promote the recognition and elimination of diseased cells.
Advanced Allogeneic Cell
Therapy
The strategic benefit of
cell therapy platforms is to potentially allow for manufacture of large, “off-the-shelf” banks of therapeutic cells
that could be accessed on demand by health care professionals to potentially decrease the time between diagnosis and treatment.
In addition, because we
focus on cells from donors the strategy could potentially enhance the ability of the therapeutic candidates to induce a more robust
response once injected into patients. The human immune system is designed to recognize and distinguish “self” from
“non-self” and destroy “otherness” such as bacteria, viruses, and damaged or diseased cells such as cancer
cells. Alloreactivity (reacting against another person’s cells) is the most powerful response the immune system generates.
Several of our technologies take advantage of the alloreactivity to hyper stimulate a person’s immune response to better
attack a chronic infection (e.g., HIV) or solid tumor.
In certain treatments (e.g.,
HIV and cancer), cells taken from healthy donors are sometimes genetically modified to introduce signaling molecules that are designed
to enhance the ability of specific immune cells to recognize diseased cells, and to help recruit other cells that will destroy
cancer or virus infected cells.
The Company believes that
the combination of off-the-shelf allogeneic cells, combined with genetic modifications designed to enhance immune signaling, could
potentially generate therapeutic candidates that have unique attributes that will increase the likelihood of success.
Cell Therapy enabling
technology
In addition to the platform
described above, Enochian BioSciences has an innovative gene therapy approach to enhance the selection and engraftment (uptake)
of cells carrying therapeutic attributes. Enhanced uptake or engraftment could play a critical role in some cases to increase the
likelihood of therapeutic benefit. This technology was initially developed for autologous cell therapy from a person living with
HIV, and genetically modifying those cells so they cannot be infected with most variants of HIV plus a gene modification to enhance
uptake. We have sublicensed under a profit-sharing agreement our technology to potentially increase engraftment for potential use
in CAR-T therapy as a potential cure for HIV.
HBV Gene Therapy
Enochian BioSciences is
exploring various approaches for gene therapy design elements to potentially eliminate virus-infected cells with an innovative
molecular mechanism that co-opts the virus’ machinery to induce the death of infected cells rather than reproducing and causing
more infection to exacerbate disease.
27
Oncology:
ENOB-DC-11: Genetically
modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Solid Tumors – Starting
with Pancreatic Cancer
Allogeneic Cell Therapy
Platform –moderately Advanced Pre-Clinical
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 remission from some of the deadliest solid tumors. The survival rate in pancreatic
cancer is currently only 5 to 10 percent at 5 years.
Initial
preclinical in vitro and proof of concept in vivo studies have been encouraging. The platform might also allow for
non-specific immune enhancement that could have impact against a broad array of solid tumors. We initially plan to target pancreatic
cancer. Other potential targets for later development could include triple-negative breast cancer, glioblastoma, or renal cell
carcinoma. As with HIV, our approach would potentially allow for outpatient therapy without wiping out or significantly impairing
the patient’s immune system, as many current approaches require.
Enochian BioSciences has
initiated a collaboration with Dr. Anahid Jewett from UCLA to study further the in vitro and in vivo effectiveness
of the approach in pancreatic cancer. Dr. Jewett created an innovative pancreatic cancer mouse model that mimics the human immune
system in combination with implanted human cancer cells. Early results show promising substantial tumor size reduction. We are
now fully committed to process development/improvements and hope to have confirmatory in vivo data by early 2023 with potential
Pre-IND submission early/mid 2023. If successful, clinical trials in humans could be possible by the first half
of 2024.
ENOB-DC-12--XX: Genetically
modified Allogeneic Dendritic Cell Therapeutic Vaccine as Potential Product for Long-term Remission of Additional Indications
The technology is a platform
that could potentially be adapted to other solid tumors first line and/or salvage therapy, by itself or, potentially, in combination
with other cancer treatments. Additional indications are being evaluated strategically to balance risk and opportunity to advance
therapeutic development quickly in cancer indications with few treatment options.
Infectious Diseases:
HIV:
ENOB-HV 12: HIV Therapeutic Vaccines for Potential
Long-term Remission/Cure
Allogeneic Cell Therapy
Platform - Advanced Pre-Clinical Stage; Non-Human Primate Studies Ongoing.
In persons living with HIV
who are controlling the spread of virus with anti-retroviral (ARV) treatment, boosting the immune system in a different way than
the virus already has through infection, could allow for control of HIV after stopping ARVs.
Enochian
BioSciences is developing ENOB-HV-12 that utilizes a novel cellular and immunotherapy approach that could potentially provide therapeutic
vaccines for HIV (ENOB-HV-12). A non-human primate study of the therapeutic vaccine in primates at the Fred Hutchinson Cancer Research
Center is ongoing. Animals began receiving the first injections of the potential therapeutic vaccine in August, 2022. Preliminary
results could potentially be available in the first half of 2023. A Pre-IND request could be submitted by mid-2023, with IND submission and
the beginning of Phase I clinical trials by mid- to end-2024.
28
ENOB-HV-01: Autologous Transplant with Genetically
Modified Cells :
FDA INTERACT Meeting Held February 2020 -
Advanced Pre-Clinical Stage
We have pioneered a novel
enabling technology (ALDH gene modification) that we believe will allow sufficient engraftment of the CCR5 gene-modified Hematopoietic
Stem Cell (HSC) to eliminate the need for Antiretroviral Treatment (ART.)
Management conducted a successful
FDA INTERACT Meeting in alignment with the Company’s experimental plan. Although in vitro and in vivo studies
have demonstrated promising results, further development of ENOB-HV-01 at this time was deemed costly and a long-term undertaking.
While the Company plans to return to full development of the approach when resources are available, it has become less attractive
and been deprioritized for business reasons, while pipelines that could move more quickly have been prioritized (e.g., DC-11).
Therefore, a business decision was made to sub-license the ALDH gene modification.
ENOB-HV-01 was sub-licensed
to Caring Cross with a profit share arrangement. Caring Cross is developing a CAR-T approach that they believe, when combined with
Enochian Biosciences ALDH gene modification, could enhance engraftment of their CAR-T cell therapy and enhance their likelihood
of success.
ENOB-HV-21: Immunotherapy with Allogeneic
NK/GDT Cells
Allogeneic Cell Therapy Platform -Pre-IND
conducted - Advanced Pre-Clinical with Human Data through a Collaboration
We
are also exploring ENOB-HV-21, an innovative treatment for HIV with allogeneic Natural Killer (NK) and Gamma Delta T-Cells (GDT).
It is believed that the GDT cells, a small subset of immune cells that can be infected with HIV, could both be infected by, and
be a key factor in controlling the virus. The initial scientific findings were presented during the American Society of Gene &
Cell Therapy (ASCGT) Annual Meeting in 2021. Enochian BioSciences has an exclusive license to use the underlying patent to develop
ENOB-HV-21 for potential treatment or cure of HIV. A successful investigator-initiated Pre-IND was completed in October
2021 . However, due to a shift in priorities to the Oncology pipeline, Enochian BioSciences does not
plan to pursue the IND and potential clinical trial in the near to medium-term.
HBV:
ENOB-HB-01: Potential
Cure for HBV
HBV Gene Therapy -Pre-Clinical
ENOB-HB-01 is in an early
pre-clinical phase as we explore various approaches for gene therapy design elements. If those explorations are successful, it
is possible we could begin the regulatory process at the earliest in the first half of 2024. However, our highest priority is currently
the oncology platform, beginning with pancreatic cancer.
Corporate History
We were incorporated under
the laws of the State of Delaware on January 18, 2011, under the name Putnam Hills Corp. and in 2014 we merged with and changed
our name to DanDrit Biotech USA, Inc. In 2018, we acquired Enochian Biopharma and changed our name to Enochian BioSciences Inc.
29
Regaining Compliance with Nasdaq Listing Requirements
On each of October 17, 2022,
November 23, 2022, and February 16, 2022, we received a notice, or the Notices, from the Listing Qualifications Department of Nasdaq
stating that we were not in compliance with Nasdaq Listing Rule 5250(c)(1), or the “Rule”, because we did not timely
file our Form 10-K for the period ended June 30, 2022 and our Forms 10-Q for the periods ended September 30, 2022 and December 31,
2022 with the SEC. The Rule requires listed companies to timely file all required periodic financial reports with the SEC. On February
27, 2023, we filed our Form 10-K. Today we filed our Form 10-Q for the period ended September 30, 2022 but have not yet filed our
Form 10-Q for the period ended December 31, 2022, and therefore we have not regained compliance with the Rule. We were unable to
file the Annual Report on Form 10-K for the period ended June 30, 2022 and the Quarterly Report on Form 10-Q for the periods ended
September 30, 2022 and December 31, 2022 by their initial deadlines, due to the reasons described in the Notifications of Late
Filing on Form 12b-25, filed with the SEC on September 29, 2022 and November 15, 2022. While we were able to file the Annual Report
on Form 10-K for the period ended June 30, 2022 and the Quarterly Report on Form 10-Q for the period ended September 30, 2022 within
the extension period provided pursuant to Nasdaq rules, we have not yet filed the Form 10-Q for the period ended December 31, 2022,
and there can be no assurance that we will be able to remain in compliance with the Rule or with other Nasdaq listing requirements
in the future.
If we are unable to regain
compliance with the Rule or with any of the other continued listing requirements, Nasdaq may take steps to delist our securities,
which could have adverse consequences, including a limited availability of market quotations for our securities, reduced liquidity
for our securities, a limited amount of news and analyst coverage and a decreased ability to issue additional securities or obtain
additional financing in the future.
Going Concern and Management’s Plans
The financial statements
included elsewhere herein for the period ended September 30, 2022, were prepared under the assumption that we would continue our
operations as a going concern, which contemplates the realization of assets and the satisfaction of liabilities during the normal
course of business. As of September 30, 2022, we had cash and cash equivalents of $7,971,918, an accumulated deficit of $212,044,957,
and total liabilities of $12,745,714. We have incurred losses from continuing operations, have used cash in our continuing operations,
and are dependent on additional financing to fund operations. These conditions raise substantial doubt about our ability to continue
as a going concern for one year after the date the financial statements are issued. The financial statements included elsewhere
herein do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets
or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
Management has reduced
overhead and administrative costs by streamlining the organization to focus around two of its therapies (oncology and a HIV
therapeutic vaccine). The Company has tailored its workforce to focus on these therapies. In addition, management has extended its
$1.2 million convertible notes 12 months out to be payable on February 28, 2024, and the Company intends to attempt to secure
additional required funding through equity or debt financing. However, there can be no assurance that the Company will be able to
obtain any sources of funding. Such additional funding may not be available or may not be available on reasonable terms, and, in the
case of equity financing transactions, could result in significant additional dilution to our stockholders. If we do not obtain
required additional equity or debt funding, our cash resources will be depleted and we could be required to materially reduce or
suspend operations, which would likely have a material adverse effect on our business, stock price and our relationships with third
parties with whom we have business relationships, at least until additional funding is obtained. If we do not have sufficient funds
to continue operations, we could be required to seek bankruptcy protection or other alternatives that could result in our
stockholders losing some or all of their investment in us.
Funding that we may receive
during fiscal 2023 is expected to be used to satisfy existing and future obligations and liabilities and working capital needs,
to support commercialization of our products and conduct the clinical and regulatory work to develop our product candidates, and
to begin building working capital reserves.
30
COVID-19
The COVID-19 pandemic continues
to evolve. COVID-19 may cause delays in our research activities. To date, the COVID-19 pandemic has not materially affected
our operations. However, it has caused delays in the conduct of experiments due to limitations in resources and supply chain issues,
in particular for those conducting experiments. There have also been increases in the cost to conduct animal studies due to staffing
and other limitations.
The full extent to which
the COVID-19 pandemic may impact our business and operations is subject to future developments, which are uncertain and difficult
to predict.
We continue to monitor the
impact of the COVID-19 pandemic on our business and operations and will seek to adjust our activities as appropriate.
Results of Operations
for the three months ended September 30, 2022 and 2021
The following table sets
forth our revenues, expenses and net loss for the three months ended September 30, 2022 and 2021. The financial information below
is derived from our unaudited condensed consolidated financial statements.
For the Three Months Ended
September 30,
Increase/(Decrease)
2022
2021
$
%
Operating Expenses
General and administrative
$ 4,556,840
$ 4,417,505
$ 139,335
3 %
Research and development
2,605,375
3,055,435
(450,060 )
(15 )%
Depreciation and amortization
28,401
31,733
(3,332 )
(11 )%
Total Operating Expenses
7,190,616
7,504,673
(314,057 )
(4 )%
LOSS FROM OPERATIONS
(7,190,616 )
(7,504,673 )
314,057
(4 )%
Other Income (Expenses)
Loss on
extinguishment of contingent consideration liability
(419,182 )
(419,182 )
100 %
Change in fair value of contingent consideration
(2,824,642 )
2,824,624
(100 )%
Interest expense
(95,585 )
(89,739 )
(5,846 )
7 %
Gain on currency transactions
9
(9 )
(100 )%
Interest and other income
5,623
7,110
(1,487 )
(21 )%
Total Other Income (Expenses)
(509,144 )
(2,907,262 )
2,398,118
(82 )%
Loss Before Income Taxes
(7,699,760 )
(10,411,935 )
2,712,175
(26 )%
Income Tax (Expense) Benefit
(34 )
34
(100 )%
NET LOSS
$ (7,699,760 )
$ (10,411,969 )
$ 2,712,209
(26 )%
Revenues
We are a pre-revenue, pre-clinical
biotechnology company. We have never generated revenues and have incurred losses since inception. We do not anticipate earning
any revenues until our therapies or products are approved for marketing and sale.
Expenses
Our operating expenses for
the three months ended September 30, 2022, and September 30, 2021, were $7,190,616 and $7,504,673
respectively, representing a decrease of $314,057, or approximately 4% . The decrease in operating expenses primarily relates
to the decrease in research and development expenses of $450,060 offset by the increase in general and administrative expenses
of $139,335.
31
General and administrative expenses
for the three months ended September 30, 2022, and September 30, 2021, were $4,556,840 and $4,417,505, respectively, representing an increase
of $139,335 or approximately 3%. The variance is related to an increase in legal expenses of $1,278,351, compensation and related expenses
of $662,380, offset by a decrease in stock-based compensation of $1,701,968.
Research and development
expenses for the three months ended September 30, 2022, and September 30, 2021, were $2,605,375 and $3,055,435, respectively, representing
a decrease of $450,060 or approximately 15%. The variance is primarily driven by a decrease of $2,683,500 in expenses related to payments made to a related party for abandoned product candidate ENOB-CV-01, offset by an increase of $2,303,615 in
collaborating partner expenses with CDMO and CRO partners .
The Company recorded other expense
of $509,144 for the three months ended September 30, 2022, compared to other expense of $2,907,262 for the three months ended September
30, 2021, representing a decrease in other expense of $2,398,118 or 82%. The variance is primarily due to the change in fair value of
the contingent consideration liability expense of $2,824,624 offset by the loss on extinguishment of contingent consideration liability
of 419,182. As of September 30, 2022, the contingent consideration liability has been settled.
Net Loss
Net loss for the three months
ended September 30, 2022, and 2021, was $7,699,760 and $10,411,969, respectively, representing a decrease in net loss of $2,712,209
or approximately 26%. The decrease in net loss was primarily due to a decrease in research and development expenses of $450,060, a
decrease in expense related to the change in fair value of contingent consideration of $2,824,642, offset by loss on extinguishment
of contingent consideration liability of 419,182 and offset by an increase in general and administrative expenses of $139,335.
Liquidity and Capital Resources
We have historically satisfied
our capital and liquidity requirements through funding from stockholders, the sale of our Common Stock and warrants, and debt financing.
We have never generated any sales revenue to support our operations and we expect this to continue until our therapies or products
are approved for marketing in the United States and/or Europe. Even if we are successful in having our therapies or products approved
for sale in the United States and/or Europe, we cannot guarantee that a market for the therapies or products will develop. We may
never be profitable.
As noted above under the
heading “Going Concern and Management’s Plans,” through September 30, 2022, we have incurred substantial losses.
We will need additional funds for (a) research and development, (b) increases in personnel, and (c) the purchase of equipment, specifically
to advance towards an Investigational New Drug Application (IND) following Pre-IND readouts from the FDA for ENOB-DC11, ENOB-HV-12,
ENOB-HV-01, ENOB-HV-21 and ENOB-HB-01. The availability of any required additional funding cannot be assured. In addition, an adverse
outcome in legal or regulatory proceedings in which we are currently involved or in the future may be involved could adversely
affect our liquidity and financial position. 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. Such financing may not be available on acceptable terms, or at all, and
our failure to raise capital when needed could materially adversely affect our growth plans and our financial condition and results
of operations.
32
As of September 30, 2022,
the Company had $7,971,918 in cash and working capital of $973,463 as compared to $9,172,142 in cash and working capital of $3,114,170
as of June 30, 2022, a decrease of 13% and 69%, respectively.
Assets
Total assets at September 30,
2022, were $83,070,556 compared to $84,632,663 as of June 30, 2022. The decrease in total assets was primarily due to the decrease in
cash of $1,200,224. The change in cash is primarily attributed to $2,605,375 in research and development costs related primarily to CDMO
and CRO costs, along with approximately $3,502,431 in general and administrative expenses, net of non-cash items, partially offset by
an increase in accounts payable of $3,280,878 due to the timing of cash payments and funding totaling $1,625,000 related to warrants exercised
during the period.
Liabilities
Total liabilities at September
30, 2022, were $12,745,714 compared to $12,013,815 as of June 30, 2022. The increase in total liabilities was primarily related
to an increase of $3,280,878 in accounts payable due to timing, offset by a decrease in other current liabilities of $185,145 related
to a financing arrangement for an insurance policy and the reduction in the contingent consideration liability of $2,343,318.
The following is a summary
of the Company’s cash flows (used in) or provided by operating, investing, and financing activities:
Three Months
Ended
September 30,
2022
Three Months
Ended
September 30,
2021
Net Cash Used in Operating Activities
$ (2,820,299 )
$ (5,276,687 )
Net Cash Used in Investing Activities
—
(5,156 )
Net Cash Provided by Financing Activities
1,625,000
—
Effect of exchange rates on cash
(4,925 )
(5,517 )
Change in Cash and Cash Equivalents
$ (1,200,224 )
$ (5,287,360 )
Cash Flows
Cash used in operating activities
for the three months ended September 30, 2022, and 2021 was ($2,820,299) and ($5,276,687), respectively. Cash used in operating
activities during the current period included $2,605,375 in research and development for related CDMO and CRO costs, along with
approximately $3,502,431 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts
payable of $3,280,878 due to the timing of cash payments.
Cash provided by financing
activities for the three months ended September 30, 2022, was $1,625,000 as compared to cash provided by financing activities of
zero during the three months ended September 30, 2021. During the three months ended September 30, 2022, the Company received financing
from the exercise of warrants held by shareholders of $1,625,000.
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.
33
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.
For a summary 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 Principal 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 and used the
“Internal Control over Financial Reporting Integrated Framework” issued by the 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 September 30, 2022, 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 deficiency is attributed to the Company not having adequate resources to address complex
accounting matters. This control deficiency will be monitored, and attention will be given to this matter as we grow.
The Certifying Officers
based their conclusion on the fact that the Company has identified a material weakness in controls over financial reporting, detailed
above. We expect to be deficient in our disclosure controls and procedures until sufficient capital is available to hire the appropriate
internal accounting staff.
Changes in Internal Controls
There have been no changes
in our internal controls over financial reporting during the three months ended September 30, 2022, that have materially affected
or are reasonably likely to materially affect our internal controls.
34
PART II — OTHER INFORMATION
Item 1. Legal Proceedings.
Securities Class Action
Litigation . On July 26, 2022 and July 28, 2022, securities class action complaints were filed by purported stockholders of ours
in the United States District Court for the Central District of California against us and certain of our current and former officers
and directors. The complaints allege, among other things, that the defendants violated Sections 10(b) and 20(a) of the Securities
Exchange Act of 1934, as amended, and Rule 10b-5 thereunder, by making false and misleading statements and omissions of material
fact in connection with the Company’s relationship with Serhat Gümrükcü and its commercial prospects. The
complaints seek unspecified damages, interest, fees, and costs. The defendants have not yet responded to the complaints.
Federal Derivative Litigation .
On September 22, 2022, Samuel E. Koenig filed a shareholder derivative action in the United States District Court for the Central
District of California. On January 19, 2023, John Solak filed a substantially similar shareholder derivative action in the United
States District Court for the District of Delaware. Both derivative actions recite similar underlying facts as those alleged in
the Securities Class Action Litigation. The actions, filed on behalf of the Company, name Serhat Gümrükcü and certain
of the Company’s current and former directors as defendants. The actions also name the Company as a nominal defendant. The
actions allege violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934 and also set out claims for breach
of fiduciary duty, contribution and indemnification, aiding and abetting, and gross mismanagement. Plaintiffs do not quantify any
alleged injury, but seek damages, disgorgement, restitution, and other costs and expenses. On January 24, 2023, the United States
District Court for the Central District of California stayed the Koenig matter pending resolution of the defendants’ anticipated
motion to dismiss in the Securities Class Action Litigation. The defendants have not yet responded to either complaint.
State Derivative Litigation .
On October 20, 2022, Susan Midler filed a shareholder derivative action in the Superior Court of California, Los Angeles County,
reciting similar underlying facts as those alleged in the Securities Class Action Litigation. The action, filed on behalf of the
Company, names Serhat Gümrükcü and certain of the Company’s current and former directors as defendants. The
action also names the Company as a nominal defendant. The action sets out claims for breaches of fiduciary duty, contribution and
indemnification, aiding and abetting, and gross mismanagement. Plaintiff does not quantify any alleged injury, but seeks damages,
disgorgement, restitution, and other costs and expenses. The defendants have not yet responded to the complaint.
On October 21, 2022, the
Company filed a Complaint in the Superior Court of the State of California for the County of Los Angeles against Serhat Gümrükcü,
William Anderson Wittekind, G Tech Bio LLC, SG & AW Holdings LLC, and Seraph Research Institute. The Complaint alleges that
the defendants engaged in a “concerted, deliberate scheme to alter, falsify, and misrepresent to the Company the results
of multiple studies supporting its [Hepatitis B] and SARS-CoV-2/influenza pipelines.” Specifically, “Defendants manipulated
negative results to reflect positive outcomes from various studies, and even fabricated studies out of whole cloth.” As a
result of the defendants’ conduct, the Company claims that it “paid approximately $25 million to Defendants and third-parties
that it would not otherwise have paid.” The defendants have not yet answered the allegations set forth in the Company’s
Complaint.
On December 28, 2022, the
Company received a demand letter on behalf of Weird Science LLC (“Weird Science”), William Anderson Wittekind, the
William Anderson Wittekind 2020 Annuity Trust, the William Anderson Wittekind 2021 Annuity Trust, the Dybul 2020 Angel Annuity
Trust, and the Ty Mabry 2021 Annuity Trust alleging that the Company breached the February 16, 2018 Investor Rights Agreement between
the Company, Weird Science, and RS Group ApS. Specifically, the demand letter alleges that the Company “breached its obligations
under the Investor Rights Agreement to provide the requisite thirty days’ notice” to Holders of Registrable Securities
in connection with SEC Form S-3 filings on July 13, 2020 and February 11, 2022 and demands over $64 million in damages. The Company
denies these allegations and intends to vigorously defend against this claim.
On March 1, 2021, former
Enochian BioSciences Chief Financial Officer, Robert Wolfe and his company, Crossfield, Inc., filed a Complaint in the U.S. District
Court for the District of Vermont against the Company, Enochian BioSciences Denmark ApS, and certain directors and officers. In the
Complaint, Mr. Wolfe and Crossfield, Inc. asserted claims for abuse of process and malicious prosecution, alleging, inter alia, that
the Company lacked probable cause to file and prosecute an earlier action, and sought millions of dollars of compensatory damages,
as well as punitive damages. The allegations in the Complaint relate to an earlier action filed by the Company and Enochian
BioSciences Denmark ApS in the Vermont Superior Court, Orange Civil Division. On March 3, 2022, the court partially granted the
Company’s motion to dismiss, dismissing the abuse of process claim against all defendants and all claims against Mark Dybul
and Henrik Grønfeldt-Sørensen. On November 29, 2022, the Company filed a motion for summary judgment with respect to the
sole remaining claim of malicious prosecution. The Company denies the allegations set forth in the Complaint and will continue to
vigorously defend against the remaining claim.
35
Item 1A. Risk Factors.
Risk factors that may affect
our business and financial results are discussed within Item 1A ”Risk Factors” of our annual report for the fiscal
year ended June 30, 2022, on Form 10-K (“2022 Form 10-K”) filed with the SEC on February 27, 2023. There
have been no material changes to the disclosures relating to this item from those set forth in our 2022 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits .
(a)
Exhibits required by Item 601 of Regulation S-K.
Exhibit No.
Description
31.1**
Certification of Principal 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 Principal 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.
36
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date: March 7, 2023
ENOCHIAN BIOSCIENCES INC.
By:
/s/ Mark Dybul
Mark Dybul
Chief Executive Officer
(Principal Executive Officer)
By:
/s/ Luisa Puche
Luisa Puche
Chief Financial Officer
(Principal Financial and Accounting Officer)
37
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.