U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 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 9, 2023, 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 December 31, 2022 (Unaudited) and
June 30, 2022
2
Condensed Consolidated Statements of Operations for the Three and Six Months
Ended December 31, 2022, and 2021 (Unaudited)
3
Condensed Consolidated Statements of Comprehensive Loss for the Three and Six
Months Ended December 31, 2022, and 2021 (Unaudited)
4
Condensed Consolidated Statements of Stockholders’ Equity for the Six Months
Ended December 31, 2022, and 2021 (Unaudited)
5
Condensed Consolidated Statements of Cash Flows for the Six Months Ended
December 31, 2022, and 2021 (Unaudited)
7
Notes to the Condensed Consolidated Financial Statements (Unaudited)
8
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results
of Operations
25
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
33
Item 4.
Controls and Procedures
33
PART II – OTHER INFORMATION:
34
Item 1.
Legal Proceedings
34
Item 1A.
Risk Factors
35
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
35
Item 3.
Defaults Upon Senior Securities
35
Item 4.
Mine Safety Disclosures
35
Item 5.
Other Information
35
Item 6.
Exhibits
35
Signatures
36
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
December 31, 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
December 31,
June
30,
2022
2022
(Unaudited)
ASSETS
CURRENT
ASSETS:
Cash
$ 4,118,896
$ 9,172,142
Prepaids
and other assets
1,270,575
392,996
Total
Current Assets
5,389,471
9,565,138
Property
and equipment, net
555,916
586,536
OTHER
ASSETS:
Definite
life intangible assets, net
42,084
44,268
Indefinite
life intangible assets, net
61,571,000
61,571,000
Goodwill
11,640,000
11,640,000
Deposits
and other assets
61,936
68,635
Operating
lease right-of-use assets
1,013,256
1,157,086
Total
Other Assets
74,328,276
74,480,989
TOTAL
ASSETS
$ 80,273,663
$ 84,632,663
LIABILITIES
CURRENT
LIABILITIES:
Accounts
payable – trade
$ 4,555,226
$ 1,401,867
Accrued
expenses
932,603
1,031,462
Other
current liabilities
875,415
220,685
Contingent
consideration liability
—
2,343,318
Notes
payable, net
4,726,390
—
Convertible
notes payable
—
1,200,000
Current
portion of operating lease liabilities
202,370
253,636
Total
Current Liabilities
11,292,004
6,450,968
NON-CURRENT
LIABILITIES:
Convertible
notes payable
1,200,000
—
Notes
payable, net
—
4,577,148
Operating
lease liabilities, net of current portion
882,303
985,699
Total
Non-Current Liabilities
2,082,303
5,562,847
Total
Liabilities
13,374,307
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, 55,705,521 shares issued and outstanding at December 31, 2022, and 53,007,082
shares issued and outstanding at June 30, 2022
5,572
5,302
Additional
paid-in capital
283,426,764
276,989,179
Accumulated
deficit
( 216,502,705 )
( 204,345,197 )
Accumulated
other comprehensive loss
( 30,275 )
( 30,436 )
Total
Stockholders’ Equity
66,899,356
72,618,848
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 80,273,663
$ 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
For the Six Months Ended
December 31,
December 31,
2022
2021
2022
2021
Operating Expenses
General and administrative
$
4,013,063
$
3,961,764
$
8,569,903
$
8,379,268
Research and development
325,959
2,337,222
2,931,334
5,392,658
Depreciation and amortization
28,844
31,805
57,245
63,538
Total Operating Expenses
4,367,866
6,330,791
11,558,482
13,835,464
LOSS FROM OPERATIONS
( 4,367,866
)
( 6,330,791
)
( 11,558,482
)
( 13,835,464
)
Other Income (Expense)
Loss on extinguishment of contingent consideration
—
—
( 419,182
)
—
Change in fair value of contingent consideration
—
( 167,255
)
—
( 2,991,897
)
Interest expense
( 92,892
)
( 93,382
)
( 188,477
)
( 183,121
)
Gain on currency transactions
—
—
—
9
Interest and other income
3,010
8,487
8,633
15,597
Total Other Income (Expense)
( 89,882
)
( 252,150
)
( 599,026
)
( 3,159,412
)
Loss Before Income Taxes
( 4,457,748
)
( 6,582,941
)
( 12,157,508
)
( 16,994,876
)
Income Tax (Provision) Benefit
—
—
—
( 34
)
NET LOSS
$
( 4,457,748
)
$
( 6,582,941
)
$
( 12,157,508
)
$
( 16,994,910
)
BASIC AND DILUTED LOSS PER SHARE
$
( 0.08
)
$
( 0.13
)
$
( 0.22
)
$
( 0.33
)
WEIGHTED AVERAGE NUMBER OF
SHARES OF COMMON STOCK OUTSTANDING - BASIC AND DILUTED
55,509,239
52,321,982
55,304,356
52,270,821
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
For the Six Months Ended
December 31,
December 31,
2022
2021
2022
2021
Net Loss
$ ( 4,457,748 )
$ ( 6,582,941 )
$ ( 12,157,508 )
$ ( 16,994,910 )
Other Comprehensive Income (Loss)
Foreign currency translation, net
of taxes
7,915
( 3,990 )
161
( 7,983 )
Comprehensive Loss
$ ( 4,449,833 )
$ ( 6,586,931 )
$ ( 12,157,347 )
$ ( 17,002,893 )
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
Shares issued in lieu of interest
on $1.2 million note payable extension
198,439
20
204,372
—
—
204,392
Stock-based compensation
—
—
819,955
—
—
819,955
Net Loss
—
—
—
( 4,457,748 )
—
( 4,457,748 )
Foreign
currency translation adjustment
—
—
—
—
7,915
7,915
December
31, 2022
55,705,521
$ 5,572
$ 283,426,764
$ ( 216,502,705 )
$ ( 30,275 )
$ 66,899,356
See accompanying notes to the unaudited condensed
consolidated financial statements.
5
# 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
Stock issued pursuant to warrants exercised
100,000
10
129,990
—
—
130,000
Shares issued pursuant to LPC purchase agreement
277,340
28
3,048,311
—
—
3,048,339
Stock-Based Compensation
—
—
2,043,292
—
—
2,043,292
Shares issued for fully vested RSUs
1,266
—
9,811
—
—
9,811
Restricted shares converted to shares for services rendered
35,000
3
( 3 )
—
—
—
Net Loss
—
—
—
( 6,582,941 )
—
( 6,582,941 )
Foreign currency translation adjustment
—
—
—
—
( 3,990 )
( 3,990 )
December 31, 2021
52,633,267
$ 5,263
$ 273,539,732
$ ( 107,906,715 )
$ ( 18,817 )
$ 165,619,463
See accompanying notes to the unaudited condensed
consolidated financial statements.
6
ENOCHIAN BIOSCIENCES INC.
AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
For the Six Months Ended
December 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 12,157,508 )
$ ( 16,994,910 )
ADJUSTMENTS TO RECONCILE NET LOSS
TO NET CASH USED IN OPERATING ACTIVITIES:
Depreciation and amortization
57,245
63,538
Loss on extinguishment of contingent consideration liability
419,182
—
Change in contingent consideration liability
—
2,991,897
Stock based compensation expense
1,845,963
4,771,267
Amortization of discount of notes payable
149,242
148,548
Changes in assets and liabilities:
Other receivables
46
1,640
Prepaid expenses/deposits
425,233
( 11,812 )
Accounts payable
3,153,358
( 153,810 )
Accrued expenses
( 68,554 )
( 677,939 )
Other current liabilities
( 18,520 )
( 30,004 )
Operating leases, net
( 10,832 )
( 5,566 )
NET CASH USED IN OPERATING ACTIVITIES
( 6,205,145 )
( 9,897,151 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 23,633 )
( 5,156 )
NET CASH USED IN INVESTING ACTIVITIES
( 23,633 )
( 5,156 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants
1,625,000
130,000
Repayment of finance agreement
( 466,625 )
( 227,598 )
Proceeds from LPC equity agreement
—
3,048,339
NET CASH PROVIDED BY FINANCING ACTIVITIES
1,158,375
2,950,741
Effect of exchange rates on cash
17,157
( 4,937 )
NET CHANGE IN CASH
( 5,053,246 )
( 6,956,503 )
CASH, BEGINNING OF PERIOD
9,172,142
20,664,410
CASH, END OF PERIOD
$ 4,118,896
$ 13,707,907
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
INVESTING AND FINANCING ACTIVITIES
Finance agreement entered into in exchange for prepaid
assets
$ 1,139,875
$ 666,875
Shares in lieu of interest on $1.2 million notes payable
extension
$ 204,392
$ —
Common shares issued for contingent earn out liability
$ 2,762,500
$ —
See accompanying notes to the unaudited condensed
consolidated financial statement.
7
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 $ 216,502,705 as of December 31, 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 December 31, 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 December 31, 2022, and 2021 are not necessarily indicative of the
operating results for the full year.
Consolidation – For
the three and six months ended December 31, 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 and six
months ended December 31, 2021, we reclassified lab expenses of $ 193,137 and $ 242,330 , respectively from general and administrative expenses
to research and development expenses .
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 December 31, 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 December
31, 2022, and June 30, 2022, of $ 3,830,530 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 impairment is deemed necessary as of December 31, 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 additional impairment is deemed necessary as of December 31, 2022 (see Note 5.)
The carrying value of IPR&D
and goodwill at December 31, 2022, was $ 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 and six months ended
December 31, 2022, amounted to $ 325,959 and $ 2,931,334 , respectively. Research and development expenses for the three and six months
ended December 31, 2021, amounted to $ 2,337,222 , and $ 5,392,658 , 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 and six months ended December 31, 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 4,833,436 and 7,125,894 potential shares of Common Stock excluded from the Diluted EPS calculation as of December 31,
2022, and December 31, 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 and six months
ended December 31, 2022, were $ 819,955 and $ 1,845,963 , respectively. Stock-based compensation costs for the vesting of the options and
RSUs granted for the three and six months ended December 31, 2021, were $ 2,043,292 and $ 4,771,267 , 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 $ 4,457,748 and $ 12,157,508 for the three and six months
ended December 31, 2022, respectively. As of December 31, 2022, the Company had cash and cash equivalents of $ 4,118,896 and an accumulated
deficit of $ 216,502,705 . 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 measured at fair value on a recurring basis as of December 31, 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
December 31, 2022
June 30, 2022
Lab Equipment and Instruments
4 - 7
$ 570,157
$ 546,524
Leasehold Improvements
10
224,629
224,629
Furniture, Fixtures and Equipment
4 - 7
172,861
172,861
Total
967,647
944,014
Less Accumulated Depreciation
( 411,731 )
( 357,478 )
Net Property and Equipment
$ 555,916
$ 586,536
Depreciation expense amounted
to $ 27,338 , and $ 54,253 for the three and six months ended December 31, 2022, respectively, and $ 27,990 and $ 55,796 for the three and
six months ended December 31, 2021, respectively.
NOTE 5 — INTANGIBLE ASSETS
At December 31, 2022, and June
30, 2022, definite-life intangible assets, net of accumulated amortization, consisted of patents on the Company’s products and
processes of $ 42,084 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 and six months ended December 31, 2022, was $ 1,507 and $ 2,993 , respectively. Amortization expense
for the three and six months ended December 31, 2021, was $ 3,814 and $ 7,741 , respectively.
At December 31, 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 December 31, 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
December 31,
2022
Definite Life Intangible Assets
Patents
20 Years
$ 279,257
$ —
$ 6,163
$ 285,420
Less Accumulated Amortization
( 234,989 )
( 2,993 )
( 5,354 )
( 243,336 )
Net Definite-Life Intangible Assets
$ 44,268
$ ( 2,993 )
$ 809
$ 42,084
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
$ 8,883
2024
11,067
2025
11,067
2026
11,067
Total
$ 42,084
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 year ended June 30, 2022. No additional
impairment is deemed necessary as of December 31, 2022.
13
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
NOTE 6 — LEASES
Operating
Leases — On November 13, 2017, the Company 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, the Company
entered into a Lease Agreement for a term of ten years from September 1, 2018, with Century City Medical Plaza Land Co., Inc., pursuant
to which the Company agreed to lease approximately 2,453 rentable square feet. On February 20, 2019, the Company 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 expense for the term of the lease is $20,050. The Company
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 56 months. As of December
31, 2022, the weighted-average remaining term is 4.67 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 December 31, 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.
Below are the lease commitments
for the next 5 years:
Lease commitments
Year Ending June 30 th
Lease Expense
2023
$
120,002
2024
246,004
2025
253,384
2026
260,985
2027
313,836
Less imputed interest
( 109,538
)
Total
$
1,084,673
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 sublease term.
During the three and six months
ended December 31, 2022 and 2021, the net operating lease expenses were as follows:
Schedule of net operating lease expenses
For the Three Months Ended
For the Six Months Ended
December 31,
December 31,
2022
2021
2022
2021
Operating Lease Expense
$ 96,730
$ 84,113
$ 140,660
$ 168,196
Sub lease Income
( 53,310 )
—
( 106,620 )
—
Total Net Lease Expense
$ 43,420
$ 84,113
$ 34,040
$ 168,196
Lease expense charged to
general and administrative expenses for the three and six months ended December 31, 2022, amounted to $ 43,420 and $ 34,040 , respectively.
Lease expense charged to general and administrative expenses for the three and six months ended December 31, 2021, amounted to $ 84,113
and $ 168,196 , respectively.
14
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 December 31,
2022 and 2021, was $ 1,200,000 .
Effective December 30, 2022
(the “Effective Date”), 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 which is comprised of 29,419
shares for accrued interest up to the Effective Date and 169,020
shares related to the prepayment of interest through the extension date of the Amended and Restated Secured Notes using the closing
market price on that date, of $ 1.03 .
The obligations of the Company under the Amended and Restated Secured Notes were secured by a security agreement (the
“Security Agreement”). The Company evaluated the Secured Notes and conversion feature to determine
the appropriate accounting treatment based on the terms of the agreement. In accordance with ASC 480-Distinguising Liabilities from
Equity, the Company determined that the Secured Notes embody an obligation that may require the Company to settle with the issuance of
a variable number of shares, where the monetary value of the obligation is based predominantly on a fixed monetary amount $ 1,200,000 known
at inception. Accordingly, the Company recorded the Secured Note as share settled debt. The total value of the shares issued were $ 204,392
which included $ 174,090
as prepaid interest and $ 30,302
for accrued interest as of December 30, 2022.
As of December 31, 2022 and
2021, the Company recorded accrued interest in the amount of zero 0 and $ 24,181 , which is included in accrued expenses. For the
three and six months ended December 31, 2022 the interest expense related to the Convertible Notes amounted to $ 18,272 and $ 36,453
respectively. For the three and six months ended December 31, 2021 the interest expense related to the Convertible Notes amounted to
$ 18,181 and $ 36,453 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.
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 and six months ended
December 31, 2022, discount amortization of $ 74,621 and $ 149,242 was charged to interest expense. For the three and six months ended
December 31, 2021, discount amortization of $ 74,274 and $ 148,548 was charged to interest expense. The Promissory Note balance, net of
discount at December 31, 2022 is $ 4,726,390 .
Finance Agreement —
On November 30, 2022, the Company entered into a premium finance agreement (the “Agreement”) related to insurance, which
resulted into a prepaid expense with a principal amount of $ 1,139,875 at 6.69 % interest per annum. The repayment of the Agreement
will be made in nine equal monthly installments of $ 96,220 . For the three and six months ended December 31, 2022 and 2021, the
Company made repayments of $ 466,625 and $ 227,598 respectively.
For the three and six months ended
December 31, 2022, the Company recorded total interest expense in the amount of $ 2,782 . This amount is reflected in other income and
expenses.
Total interest expense recorded
for the three and six months ended December 31, 2022, was $ 92,892 and $ 188,477 , respectively. Interest expense recorded for the three
and six months ended December 31, 2021, was $ 93,382 and $ 183,121 , respectively.
15
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 December 31, 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 December 31, 2022, and June 30, 2022, there
were 55,705,521 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 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 six months ended December
31, 2022 and 2021, we did no t sell any shares of Common Stock to Lincoln Park 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.
16
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. 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 and six months ended December 31, 2022 there were 198,439 and 2,698,439 shares of Common Stock issued, respectively.
The Company recorded a loss on extinguishment of contingent consideration liability of $ 419,182 during the six months ended December
31, 2022 which reflects the difference between the fair value of the shares and the contingent consideration liability at the time of
extinguishment. As of December 31, 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 December 31, 2022, no further Contingent Shares are issuable.
Acquisition of Enochian
Denmark — At December 31, 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 December 31, 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 December 31, 2022. During the three and six
months ended December 31, 2022, the Company issued zero 0 shares of Common Stock to such non-consenting shareholders of Enochian
Denmark.
17
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 December 31, 2022:
Summary of weighted-average assumptions used to estimate the fair values of the stock options granted
Enochian
Biosciences Inc.
Expected term (in years)
5.3 – 6.5
Volatility
84.66 %- 90.75 %
Risk free interest rate
2.70 %- 4.14 %
Dividend yield
0 %
The Company recognized stock-based compensation expense related to the
options of $ 819,955 and $ 1,845,963 for the three and six months ended December 31, 2022, respectively. The Company recognized stock-based
compensation expense related to the options of $ 2,043,292 and $ 4,771,267 for the three and six months ended December 31, 2021, respectively.
At December 31, 2022, the Company had approximately $ 4,990,165 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 178,000 shares of Common Stock to employees with a three-year vesting period during the
three and six months ended December 31, 2022, respectively. For the three and six months ended December 31, 2021, the Company granted
options to purchase 120,900 and 3,130,200 shares of Common Stock to employees with a three-year vesting period, respectively.
During the three and six
months ended December 31, 2022, the Company granted options to purchase zero 0 and 184,800 shares of Common stock to employees with
a six-month vesting period, respectively. For the three and six months ended December 31, 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 and six
months ended December 31, 2022, the Company granted options to purchase zero 0 and 73,200 shares of Common stock to employees with a
one-year vesting period, respectively. For the three and six months ended December 31, 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 and six months
ended December 31, 2022, the Company granted options to purchase 159,959 and 210,917 shares of Common Stock, to the Board of Directors
and Scientific Advisory Board Members with a one-year vesting period, respectively. For the three and six months ended December 31, 2021,
the Company granted options to purchase 36,727 and 63,462 shares of Common Stock to members of the Board of Directors and Scientific
Advisory Board with a one-year vesting period, respectively.
During the three and six months
ended December 31, 2022, the Company did no t grant options to purchase shares of Common stock for consulting services. For the three
and six months ended December 2021, the Company granted options to purchase 21,979 shares of Common Stock with immediate vesting, issued
options to purchase 17,500 shares of Common Stock with a one-year vesting period, and issued options to purchase 60,000 shares
of Common Stock with a three-year vesting period for consulting services.
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 5,475,559 shares of Common Stock. At December 31,
2022 the Company has 2,310,289 options available to be issued under the 2019 Plan.
18
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 December 31, 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
$
1.00 – 4.50
860,273
8.97
$ 2.40
217,064
6.83
$ 3.21
$
4.51 – 6.50
3,169,769
8.20
$ 4.83
1,153,876
7.59
$ 5.26
$
6.51 – 8.00
803,393
7.70
$ 8.02
604,414
7.24
$ 7.94
Total
4,833,436
8.26
$ 4.93
1,975,354
7.40
$ 5.85
A summary of the status of the
Plan Options at December 31, 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
646,917
$ 2.07
Exercised
—
$ —
Forfeited
( 121,300 )
$ 5.30
Expired/Canceled
—
$ —
Outstanding
at end of period
4,833,436
$ 4.93
8.26
$ —
Exercisable
at end of period
1,975,354
$ 5.85
7.40
$ —
At December 31, 2022, the
Company had 1,975,354
exercisable Plan Options outstanding. The total intrinsic value of options exercisable at December 31, 2022, was 0 zero. Intrinsic
value is measured using the fair market value at the date of exercise (for shares exercised) and at December 31, 2022 (for
outstanding options), less the applicable exercise price.
Common Stock Purchase Warrants
A summary of the warrants outstanding
at December 31, 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
—
$ —
—
19
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 for both the three and six months ended December 31, 2022. The Company
recognized stock-based compensation expense related to the RSUs of $ 255,340 and $ 258,331 for the three and six months ended December
31, 2021, respectively.
20
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 and six months ended December 31, 2022. For the three and six months ended December 31, 2021, $75,000
and $150,000 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 and six months ended December 31, 2022 the Company paid a total of
zero 0
and during the three and six months ended December 31, 2021, the Company paid $ 433,500
and $ 867,000 ,
respectively, for scientific staffing resources, research and development and Investigational New Drug (IND) Enabling studies.
During the three and six months ended December 31, 2022, the Company paid zero 0
for any type of milestone. During the three and six months ended December 31, 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.
21
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 both the three and six months ended December 31,
2022, the Company paid zero 0 related to this License Agreement. During the three and six months ended December 31, 2021 the Company
paid $ 75,000 and $ 150,000 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).
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 and six months ended December 31, 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.
22
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.
23
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10 — RELATED PARTY TRANSACTIONS
There were no payments made
to G-Tech by the Company for the three and six months ended December 31, 2022. For the three and six months ended December 31, 2021,
the Company paid G-Tech $ 718,500 and 3,537,000 , respectively, which included payments for consulting agreements related to HIV, and
contractual costs related to the HBV License, the Development License, the ALC License (see Note 9), and security expenses.
NOTE 11 — SUBSEQUENT EVENTS
In accordance with ASC 855-10,
the Company performed a review of events subsequent to the balance sheet date through the date of this report and determined that
there were no such events requiring recognition or disclosure.
24
Item 2. Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
Forward-Looking Statement Notice
Certain statements made in this
Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform
Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance, or achievements of Enochian Biosciences Inc. (“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.
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.
25
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.
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.
26
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.
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.
27
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.
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. On March 7, 2023 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.
If we are unable to maintain 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 December 31, 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 December 31, 2022, we had cash and cash equivalents of $4,118,896, an accumulated deficit of $216,502,705, and total liabilities
of $13,374,307. 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.
28
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.
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.
29
Results of Operations for the three and six months ended December 31,
2022, compared to the three and six months ended December 31, 2021
The following table sets forth
our revenues, expenses, and net loss for the three and six months ended December 31, 2022, and 2021. The financial information below
is derived from our unaudited condensed consolidated financial statements.
For the Three Months Ended
For
the Six Months Ended
December
31,
Increase/(Decrease)
December
31,
Increase/(Decrease)
2022
2021
$
%
2022
2021
$
%
Operating
Expenses
General
and administrative
4,013,063
3,961,764
51,299
1 %
8,569,903
8,379,268
190,635
2 %
Research
and development
325,959
2,337,222
(2,011,263 )
(86 )%
2,931,334
5,392,658
(2,461,324 )
(46 )%
Depreciation
and amortization
28,844
31,805
(2,961 )
(9 )%
57,245
63,538
(6,293 )
(10 )%
Total
Operating Expenses
$ 4,367,866
$ 6,330,791
$ (1,962,925 )
(31 )%
$ 11,558,482
$ 13,835,464
$ (2,276,982 )
(16 )%
LOSS
FROM OPERATIONS
$ (4,367,866 )
$ (6,330,791 )
$ (1,962,925 )
(31 )%
$ (11,558,482 )
$ (13,835,464 )
$ 2,276,982
(16 )%
Other
Income (Expenses)
Change
in fair value of contingent consideration
—
(167,255 )
167,255
(100 )%
—
(2,991,897 )
2,991,897
(100 )%
Loss
on extinguishment of contingent consideration liability
—
—
—
0 %
(419,182 )
—
(419,182 )
(100 )%
Interest
expense
(92,892 )
(93,382 )
490
(1 )%
(188,477 )
(183,121 )
(5,356 )
3 %
Gain
(Loss) on currency transactions
—
—
—
0 %
—
9
(9 )
100 %
Interest
and other income
3,010
8,487
(5,477 )
(65 )%
8,633
15,597
(6,964 )
(45 )%
Total
Other Income (Expenses)
(89,882 )
(252,150 )
162,268
(64 )%
(599,026 )
(3,159,412 )
2,560,386
(81 )%
Loss
Before Income Taxes
$ (4,457,748 )
$ (6,582,941 )
$ 2,125,193
(32 )%
$ (12,157,508 )
$ (16,994,876 )
$ (4,837,368 )
(28 )%
Income
Tax (Expense) Benefit
$ —
$ —
$ —
0 %
$ —
$ (34 )
$ 34
100 %
NET
LOSS
$ (4,457,748 )
$ (6,582,941 )
$ (2,125,193 )
(32 )%
$ (12,157,508 )
$ (16,994,910 )
$ 4,837,402
(28 )%
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 December 31, 2022, and 2021, were $4,367,866 and $6,330,791 respectively, representing a decrease of $1,962,925, or
approximately 31%. The decrease in operating expenses primarily relates to a decrease in research and development expenses of $2,011,263
partially offset by an increase in general and administrative expenses of $51,299.
Our operating expenses for the
six months ended December 31, 2022, and 2021, were $11,558,482 and $13,835,464, respectively, representing a decrease of $2,276,982 or
approximately 16%. The decrease in operating expenses primarily relates to a decrease in research and development expenses of $2,461,324,
partially offset by an increase in general and administrative expenses of $190,635.
30
General and administrative expenses
for the three months ended December 31, 2022, and 2021, were $4,013,063 and $3,961,764, respectively, representing an increase of $51,299
or approximately 1%. The variance is related to an increase in legal expenses of $1,115,456 and compensation and related expenses of
$243,919, partially offset by a decrease in stock-based compensation of $1,223,337.
General and administrative expenses
for the six months ended December 31, 2022, and 2021, were $8,569,903 and $8,379,268, respectively, representing an increase of $190,635
or approximately 2%. The variance primarily relates to an increase in legal expenses of $2,393,807 and compensation and related expenses
of $906,299, partially offset by a decrease in stock-based compensation of $2,925,304.
Research and development expenses
for the three months ended December 31, 2022, and 2021, were $325,959 and $2,337,222, respectively, representing a decrease of $2,011,263
or approximately 86%. The variance is primarily driven by a decrease of $508,500 in expenses related to payments made to a related party
for an abandoned product candidate, and $1,273,343 in collaborating partner expenses with CDMO and CRO partners incurred in the prior
period.
Research and development expenses
for the six months ended December 31, 2022, and 2021, were $2,931,334 and $5,392,658, respectively, representing a decrease of $2,461,324
or approximately 46%. The variance is primarily driven by a decrease of $3,117,000 in expenses related to payments made to a related
party for an abandoned product candidate, $381,986 in consulting expenses, and $226,562 in lab related expenses partially offset by an
increase of $1,365,557 in collaborating partner expenses with CDMO and CRO partners.
The Company recorded other expense
of $89,882 for the three months ended December 31, 2022, compared to other expense of $252,150 for the three months ended December 31,
2021, representing a decrease in other expense of $162,268 or 64%. The variance is primarily due to the change in fair value of the contingent
consideration liability expense of $167,255 incurred in the prior period. The contingent consideration liability was settled in the period
ending September 30, 2022.
The Company recorded other expense
of $599,026 for the six months ended December 31, 2022, compared to other expense of $3,159,412 for the six months ended December 31,
2021, representing a decrease in other expense of $2,560,386 or 81%. The variance is primarily due to the change in fair value of the
contingent consideration liability expense of $2,991,897, in the prior period net of a loss of $419,182 related to the extinguishment
of the contingent consideration liability during the period ending September 30, 2022.
Net Loss
Net loss for the three months
ended December 31, 2022, and 2021, was $4,457,748 and $6,582,941, respectively, representing a decrease in loss of $2,125,193 or approximately
32%. The decrease in net loss was primarily due to a decrease in research and development expenses of $2,011,263 and a decrease in expense
related to the change in fair value of contingent consideration of $167,255.
Net loss for the six months ended
December 31, 2022, and 2021, was $12,157,508 and $16,994,910, respectively, representing a decrease in loss of $4,837,402 or approximately
28%. The decrease in net loss was primarily due to a decrease in research and development expenses of $2,461,324, and a decrease in expense
related to the change in fair value of contingent consideration of $2,991,897.
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 December 31, 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.
31
As of December 31, 2022, the Company
had $4,118,896 in cash and working capital of $(5,902,533) as compared to $9,172,142 in cash and working capital of $3,114,170 as of
June 30, 2022, a decrease of 55% and 290%, respectively.
Assets
Total assets at December 31, 2022,
were $80,273,663 compared to $84,632,663 as of June 30, 2022. The decrease in total assets was primarily due to the decrease in cash
of $5,053,246. The change in cash is primarily attributed to $2,931,334 in research and development costs related primarily to CDMO and
CRO costs, along with approximately $6,666,695 in general and administrative expenses, net of non-cash items, partially offset by an
increase in accounts payable of $3,153,358 due to the timing of cash payments and funding totaling $1,625,000 related to warrants exercised
during the period.
Liabilities
Total liabilities at December
31, 2022, were $13,374,307 compared to $12,013,815 as of June 30, 2022. The increase in total liabilities was primarily related to an
increase of $3,153,358 in accounts payable due to timing of cash payments and $654,730 in other current liabilities related to a financing
arrangement for an insurance policy partially offset by 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:
Six Months
Ended
December 31,
2022
Six Months
Ended
December 31,
2021
Net Cash Used in Operating Activities
$
(6,205,145
)
$
(9,897,151
)
Net Cash Used in Investing Activities
(23,633
)
(5,156
)
Net Cash Provided by Financing Activities
1,158,375
2,950,741
Effect of exchange rates on cash
17,157
(4,937)
Change in Cash and Cash Equivalents
$
(5,053,246
)
$
(6,956,503
)
Cash Flows
Cash used in operating activities
for the six months ended December 31, 2022, and 2021 was ($6,205,145) and ($9,897,151), respectively. Cash used in operating activities
during the current period included $2,931,334 in research and development expenses for related CDMO and CRO costs, along with approximately
$6,666,695 in general and administrative expenses, net of non-cash items, partially offset by an increase in accounts payable of $3,153,358
due to the timing of cash payments.
Cash provided by financing activities
for the six months ended December 31, 2022, was $1,158,375 as compared to cash provided by financing activities of $2,950,741 during
the six months ended December 31, 2021. During the six months ended December 31, 2022, the Company received financing from the exercise
of warrants held by shareholders of $1,625,000 that was partially offset by repayments of a financing agreement of $466,625.
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.
32
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 Chief Executive Officer
and Chief Financial Officer (the “Certifying Officers”) are responsible for establishing and maintaining disclosure controls
and procedures for the Company. The Certifying Officers have designed such disclosure controls and procedures to ensure that material
information is made known to them, particularly during the period in which this Report was prepared.
The Certifying Officers are responsible
for establishing and maintaining adequate internal control over financial reporting for the Company 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 December 31, 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 December 31, 2022, that have materially affected or are
reasonably likely to materially affect our internal controls.
33
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.
34
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
10.1
Form of Amended and Restated Senior Secured Convertible Promissory Note (incorporated by reference to Exhibit 10.1 to the Company’s Form 8-K filed with the SEC on February 23, 2023)
10.2
Amendment No. 3 to Promissory Note, effective December 30, 2022 (incorporated by reference to Exhibit 10.2 to the Company’s Form 8-K filed with the SEC on February 23, 2023)
10.3 †
Security Agreement (incorporated by reference to Exhibit 10.3 to the Company’s Form 8-K filed with the SEC on February 23, 2023)
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 , as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2**
Certification of Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the
Securities Exchange Act of 1934 , as adopted
pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1***
Certification of Principal Executive Officer pursuant
to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2***
Certification of Principal
Financial Officer pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
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.
†
Schedules and similar attachments to this Exhibit have been omitted pursuant to Item 601(a)(5)
of Regulation S-K. The Company agrees to furnish supplementally a copy of such omitted materials to the SEC upon request.
35
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 9, 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)
36
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.