U.S.
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 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
45-2259340
(State or other jurisdiction
of
(I.R.S. Employer
incorporation or organization)
Identification Number)
2080 Century Park East ,
Suite 906
Los Angeles , CA
90067
(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 May 12, 2022, the number of shares of the registrant’s common stock outstanding was 52,949,967 .
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
- INDEX -
Page
PART I – FINANCIAL INFORMATION:
1
Item 1.
Financial Statements (Unaudited):
1
Condensed Consolidated Balance Sheets as of March 31, 2022 (Unaudited) and June 30, 2021
2
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended March 31, 2022, and 2021 (Unaudited)
3
Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended March 31, 2022, and 2021 (Unaudited)
4
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended March 31, 2022, and 2021 (Unaudited)
5
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended March 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
23
Item 3.
Quantitative and Qualitative Disclosures About Market Risk
30
Item 4.
Controls and Procedures
30
PART II – OTHER INFORMATION:
31
Item 1.
Legal Proceedings
31
Item 1A.
Risk Factors
31
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
31
Item 3.
Defaults Upon Senior Securities
31
Item 4.
Mine Safety Disclosures
31
Item 5.
Other Information
31
Item 6.
Exhibits
31
Signatures
32
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
March 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, 2021, filed with the Securities and Exchange Commission on September 24, 2021.
1
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
March 31,
June 30,
2022
2021
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash
$ 11,150,917
$ 20,664,410
Other receivables
—
1,640
Prepaid expenses
544,735
232,943
Total Current Assets
11,695,652
20,898,993
Property and equipment, net
640,733
719,364
OTHER ASSETS:
Definite life intangible assets, net
50,596
65,906
Indefinite life intangible assets
154,824,000
154,824,000
Goodwill
11,640,000
11,640,000
Deposits and other assets
21,742
20,984
Operating lease right-of-use assets
1,227,890
1,435,978
Total Other Assets
167,764,228
167,986,868
TOTAL ASSETS
$ 180,100,613
$ 189,605,225
LIABILITIES
CURRENT LIABILITIES:
Accounts payable – trade
$ 487,016
$ 320,559
Accrued expenses
466,324
1,182,323
Other current liabilities
277,708
90,602
Notes payable, net
4,801,936
—
Convertible notes payable
1,200,000
—
Current portion of operating lease liabilities
278,661
292,409
Total Current Liabilities
7,511,645
1,885,893
NON-CURRENT LIABILITIES:
Contingent consideration liability
10,310,836
6,037,945
Convertible notes payable
—
1,200,000
Notes payable, net
—
4,579,114
Operating lease liabilities, net of current portion
1,035,435
1,239,334
Total Liabilities
18,857,916
14,942,286
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, 52,798,267 shares issued and outstanding at March 31, 2022, and 52,219,661 shares issued and outstanding at June 30, 2021
5,280
5,222
Additional paid-in capital
275,367,091
265,580,356
Accumulated deficit
( 114,108,180 )
( 90,911,805 )
Accumulated other comprehensive loss
( 21,494 )
( 10,834 )
Total Stockholders’ Equity
161,242,697
174,662,939
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
$ 180,100,613
$ 189,605,225
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 Nine Months Ended
March 31,
March 31,
2022
2021
2022
2021
Operating Expenses
General and administrative
$ 2,790,456
$ 1,903,902
$ 11,169,724
$ 5,551,331
Research and development
1,212,380
1,119,203
6,605,038
3,574,529
Depreciation and amortization
31,720
30,825
95,258
92,043
Total Operating Expenses
4,034,556
3,053,930
17,870,020
9,217,903
LOSS FROM OPERATIONS
( 4,034,556 )
( 3,053,930 )
( 17,870,020 )
( 9,217,903 )
Other Income (Expense)
Change in fair value of contingent consideration
( 2,078,994 )
( 882,498 )
( 5,070,891 )
38,313
Interest expense
( 95,206 )
( 96,347 )
( 278,327 )
( 282,086 )
(Loss) gain on currency transactions
—
( 221 )
9
( 32,510 )
Interest and other income
7,291
1,437
22,888
8,809
Total Other Income (Expense)
( 2,166,909 )
( 977,629 )
( 5,326,321 )
( 267,474 )
Loss Before Income Taxes
( 6,201,465 )
( 4,031,559 )
( 23,196,341 )
( 9,485,377 )
Income Tax (Provision) Benefit
—
849
( 34 )
124,801
NET LOSS
$ ( 6,201,465 )
$ ( 4,030,710 )
$ ( 23,196,375 )
$ ( 9,360,576 )
BASIC AND DILUTED LOSS PER SHARE
$ ( 0.12 )
$ ( 0.09 )
$ ( 0.44 )
$ ( 0.20 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING - BASIC AND DILUTED
52,638,823
46,783,343
52,391,698
46,723,501
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 Nine Months Ended
March 31,
March 31,
2022
2021
2022
2021
Net Loss
$ ( 6,201,465 )
$ ( 4,030,710 )
$ ( 23,196,375 )
$ ( 9,360,576 )
Other Comprehensive Income (Loss)
Currency Translations
( 2,677 )
( 9,828 )
( 10,660 )
28,494
Comprehensive Loss
$ ( 6,204,142 )
$ ( 4,040,538 )
$ ( 23,207,035 )
$ ( 9,332,082 )
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, 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 )
Currency translations
—
—
—
—
( 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 )
Currency translations
—
—
—
—
( 3,990 )
( 3,990 )
December 31, 2021
52,633,267
5,263
273,539,732
( 107,906,715 )
( 18,817 )
165,619,463
Contingent shares issued pursuant to acquisition agreement
100,000
10
797,990
—
—
798,000
Shares issued pursuant to LPC purchase agreement
60,000
6
451,694
—
—
451,700
Shares issued for fully vested RSUs
5,000
1
( 1 )
—
—
—
Stock-based compensation
—
—
577,676
—
—
577,676
Net Loss
—
—
—
( 6,201,465 )
—
( 6,201,465 )
Currency translations
—
—
—
—
( 2,677 )
( 2,677 )
March 31, 2022
52,798,267
$ 5,280
$ 275,367,091
$ ( 114,108,180 )
$ ( 21,494 )
$ 161,242,697
5
# of Shares
Common Shares
Additional Paid-In Capital
Accumulated Deficit
Accumulated Other Comprehensive Income
Total
July 1, 2020
46,497,409
$ 4,650
$ 230,497,225
$ ( 64,188,198 )
$ ( 41,416 )
$ 166,272,261
Stock-based compensation
—
—
326,156
—
—
326,156
Issuance of commitment shares
139,567
14
( 14 )
—
—
—
Net Loss
—
—
—
( 2,396,570 )
—
( 2,396,570 )
Currency translations
—
—
—
—
28,389
28,389
September 30, 2020
46,636,976
4,664
230,823,367
( 66,584,768 )
( 13,027 )
164,230,236
Stock issued pursuant to warrants exercised
63,122
6
82,050
—
—
82,056
Contingent shares issued pursuant to acquisition agreement
63,122
6
192,516
—
—
192,522
Stock-based compensation
—
—
359,391
—
—
359,391
Net Loss
—
—
—
( 2,933,296 )
—
( 2,933,296 )
Currency translations
—
—
—
—
9,933
9,933
December 31, 2020
46,763,220
4,676
231,457,324
( 69,518,064 )
( 3,094 )
161,940,842
Shares issued pursuant to 2021 private placement
923,678
93
3,620,707
—
—
3,620,800
Shares issued in lieu of interest on $5 million notes payable extension
74,054
7
298,171
—
—
298,178
Restricted shares converted to shares for services rendered
35,000
4
146,996
—
—
147,000
Stock-based compensation
—
—
352,429
—
—
352,429
Net Loss
—
—
—
( 4,030,710 )
—
( 4,030,710 )
Currency translations
—
—
—
—
( 9,828 )
( 9,828 )
March 31, 2021
47,795,952
$ 4,780
$ 235,875,627
$ ( 73,548,774 )
$ ( 12,922 )
$ 162,318,711
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 Nine Months Ended
March 31,
2022
2021
CASH FLOWS FROM OPERATING ACTIVITIES :
Net loss
$ ( 23,196,375 )
$ ( 9,360,576 )
ADJUSTMENTS TO RECONCILE NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
Depreciation and amortization
95,258
92,042
Change in contingent consideration liability
5,070,891
( 38,313 )
Stock based compensation expense
5,348,943
1,184,975
Right-of-use assets
208,088
199,908
Amortization of discount of notes payable
222,822
222,231
Changes in assets and liabilities:
Other receivables
1,640
1,982
Prepaid expenses/deposits
364,078
562,295
Accounts payable
166,458
( 88,015 )
Accrued expenses
( 716,001 )
( 157,261 )
Other current liabilities
( 30,004 )
—
Operating lease liabilities
( 217,647 )
( 201,944 )
NET CASH USED IN OPERATING ACTIVITIES
( 12,681,849 )
( 7,582,676 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 5,156 )
( 10,721 )
NET CASH USED IN INVESTING ACTIVITIES
( 5,156 )
( 10,721 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants
130,000
82,057
Repayment of finance agreement
( 449,765 )
( 304,258 )
Proceeds from LPC equity agreement
3,500,039
—
Proceeds from 2021 Private Placement
—
3,620,800
NET CASH PROVIDED BY FINANCING ACTIVITIES
3,180,274
3,398,599
Effect of exchange rates on cash
( 6,762 )
24,721
NET CHANGE IN CASH
( 9,513,493 )
( 4,170,077 )
CASH, BEGINNING OF PERIOD
20,664,410
8,696,361
CASH, END OF PERIOD
$ 11,150,917
$ 4,526,284
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid during the period for:
Interest
$ 55,880
$ 36,453
Income Taxes
$ 34
$ 37
SUPPLEMENTAL DISCLOSURES OF NON-CASH INVESTING AND FINANCING ACTIVITIES
Contingent shares issued pursuant to acquisition agreement
$ 798,000
$ —
Shares issued in lieu of interest expense on $5 million note payable extension
$ —
$ 298,178
Discount on $5 million note payable related to prepaid interest paid in the form of shares issued
$ —
$ 222,231
Finance agreement entered into in exchange for prepaid assets
$ 666,875
$ —
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 human treatment of HIV, HBV, influenza and
coronavirus infections, and cancer with the intent to manufacture and commercialize said products.
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 March 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, 2021, audited financial statements. The results of operations for the periods ended March
31, 2022, and 2021 are not necessarily indicative of the operating results for the full year.
Consolidation – For the
three and nine months ended March 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 nine
months ended March 31, 2021, we reclassified lab expenses of $39,596 and $110,078, 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 – The pandemic
continues to evolve, and to date has led to the implementation of various mitigation responses, including government-imposed quarantines,
travel restrictions and other public health safety measures, as well as leading to reported adverse impacts on healthcare resources, facilities,
and providers across the United States and in other countries. COVID-19 may cause delays in our research activities. To date, it has not
materially affected our operations; however, it has caused delays in the conduct of experiments due to limitations of various organizations,
in particular those conducting experiments related to COVID-19. 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. Further
quarantines, shelter-in-place or similar restrictions and other actions taken or imposed by foreign, federal, state, and local governments
could adversely impact our or our partners’ clinical, research and development, regulatory and manufacturing operations, or timelines.
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 March 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 March 31, 2022, and June 30, 2021, of $ 10,883,620 and $ 20,287,212 , 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 3.)
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 carrying value of in-process research and development (“IPR&D”) and goodwill at March 31, 2022,
were $ 154,824,000 and $ 11,640,000 , respectively.
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. The fair value analysis performed on the license agreement, and the
annual fair value analysis performed on goodwill supported that both indefinite life intangible assets are not impaired as of June 30,
2021, and no impairment is deemed necessary as of March 31, 2022 (see Note 4.)
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 5.)
Research and Development Expenses
– The Company expenses research and development costs incurred in formulating, improving, validating, and creating alternative
or modified processes related to and expanding the use of the HIV, HBV, Coronaviruses and Oncology therapies and technologies for use
in the prevention, treatment, amelioration of and/or therapy for HIV, HBV, Coronaviruses and Oncology. Research and development expenses
for the three and nine months ended March 31, 2022, amounted to $ 1,212,380 and $ 6,605,038 , respectively. Research and development expenses
for the three and nine months ended March 31, 2021, amounted to $ 1,119,203 , and $ 3,574,529 , 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 Topic ASC 260, “Earnings Per Share”. Basic earnings
per common share (EPS) are based on the weighted average number of shares of Common Stock outstanding during each period. Diluted earnings
per common share are based on shares outstanding (computed as under basic EPS) and potentially dilutive shares of Common Stock. Potential
shares of Common Stock included in the diluted earnings per share calculation include in-the-money stock options that have been granted
but have not been exercised. Because of the net loss for the three and nine months ended March 31, 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 7,201,108 and 3,967,275 potential shares of Common Stock excluded from the Diluted EPS calculation as of March 31, 2022,
and March 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 2.)
Stock Options and
Restricted Share Units – The Company has granted stock options, restricted share units (“RSUs”) and warrants.
The Company accounts for options 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 nine months ended March 31, 2022, were $ 577,676 and $ 5,348,943 , respectively.
Stock-based compensation costs for the vesting of the options and RSUs granted for the three and nine months ended March 31, 2021,
were $ 499,428 and $ 1,184,975 , respectively. (See Note 7.)
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 — 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 or 2 liabilities as of March 31, 2022.
Level 3 liabilities held as of
March 31, 2022, consisted of a contingent consideration liability related to the February 16, 2018, acquisition of Enochian Biopharma
Inc. (the “Acquisition”). As consideration for the Acquisition, the stockholders of Enochian Biopharma received (i) 18,081,962
shares of Common Stock, and (ii) the right to receive contingent shares pro rata upon the exercise of warrants, which were outstanding
at closing. The contingent consideration liability was recorded at fair value of $ 21,516,000 at the time of acquisition and is subsequently
remeasured to fair value at the end of each reporting period. At March 31, 2022, there were 1,250,000 contingent shares issuable in connection
with the Acquisition of Enochian Biopharma.
The fair value of the contingent
consideration liability is estimated using an option-pricing model. The key inputs to the model are all contractual or observable with
the exception being volatility, which is computed, based on the Company’s underlying stock. The key inputs to valuing the contingent
consideration liability as of March 31, 2022, include the Company’s stock price on the valuation date of $ 8.25 ; the exercise price
of the warrants of $ 1.30 , the risk-free rate of 0.59 %, the expected volatility of the Company’s Common Stock of 90.7 %, the digital
call rate of 99.98 %, and the 1,250,000 contingent shares remaining at the end of the period. Fair Value measurements are highly sensitive
to changes in these inputs and significant changes in these inputs could result in a significantly higher or lower fair value.
Unless otherwise disclosed, the
fair value of the Company’s financial instruments including cash, accounts receivable, prepaid expenses, investments, accounts payable,
accrued expenses, capital lease obligations and notes payable approximate their recorded values due to their short-term maturities.
The following table sets forth
the Level 3 liability at March 31, 2022, which is recorded on the balance sheet at fair value on a recurring basis. As required, this
liability is classified based on the lowest level of input that is significant to the fair value measurement:
Summary of significant to the fair value measurement
Fair Value Measurements at
Reporting Date Using
Quoted Prices in
Active Markets for Identical Assets Inputs
Significant Other
Observable Inputs
Significant Other Unobservable Inputs
(Level 1)
(Level 2)
(Level 3)
The roll forward of the contingent consideration liability is as follows:
Balance June 30, 2021
—
—
$ 6,037,945
Contingent Shares issued pursuant to the Acquisition Agreement
—
—
( 798,000 )
Fair value adjustment
—
—
5,070,891
Contingent Consideration Liability at March 31, 2022
—
—
$ 10,310,836
12
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 — PROPERTY AND EQUIPMENT
Property and equipment consisted of the following:
Summary of property and equipment
Useful Life
March 31, 2022
June 30, 2021
Lab Equipment and Instruments
4 - 7
$ 583,421
$ 583,421
Leasehold Improvements
10
224,629
224,629
Furniture, Fixtures and Equipment
4 - 7
177,131
171,975
Total
985,181
980,025
Less Accumulated Depreciation
( 344,448 )
( 260,661 )
Net Property and Equipment
$ 640,733
$ 719,364
Depreciation expense amounted
to $ 27,990 , and $ 83,787 for the three and nine months ended March 31, 2022, respectively, and $ 26,814 and $ 80,172 for the three and nine
months ended March 31, 2021, respectively.
NOTE 4 — INTANGIBLE ASSETS
At March 31, 2022, and June 30,
2021, definite-life intangible assets, net of accumulated amortization, consisted of patents on the Company’s products and processes
of $ 50,596 and $ 65,906 , respectively. The patents are recorded at cost and amortized over twenty years from the date of application. Amortization
expense for the three and nine months ended March 31, 2022, was $ 3,730 and $ 11,471 , respectively. Amortization expense for the three and
nine months ended March 31, 2021, was $ 4,012 and $ 11,871 , respectively.
At March 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 March 31, 2022, and June 30,
2021, definite and indefinite-life intangible assets consisted of the following:
Schedule of life intangible assets
Useful Life
June 30,
2021
Period Change
Effect of Currency Translation
March 31,
2022
Definite Life Intangible Assets
Patents
20 Years
$ 316,115
$ —
$ ( 20,255 )
$ 295,860
Less Accumulated Amortization
( 250,209 )
( 11,471 )
16,416
( 245,264 )
Net Definite-Life Intangible Assets
$ 65,906
$ ( 11,471 )
$ ( 3,839 )
$ 50,596
Indefinite Life Intangible Assets
License Agreement
$ 154,824,000
—
—
$ 154,824,000
Goodwill
11,640,000
—
—
11,640,000
Total Indefinite Life Intangible Assets
$ 166,464,000
—
—
$ 166,464,000
Expected future amortization expense
is as follows:
Schedule of expected future amortization expense
Year ending June 30,
2022
$
873
2023
15,154
2024
15,154
2025
15,154
2026
4,261
Thereafter
—
Total
$
50,596
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 supported Management’s conclusion that an impairment adjustment was not required as of
June 30, 2021, and no impairment is deemed necessary as of March 31, 2022.
13
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
NOTE 5 — LEASES
Operating
Leases — On November 13, 2017, Enochian entered into a Lease Agreement for a term of five years and two months from November
1, 2017, with Plaza Medical Office Building, LLC, a California limited liability company, as landlord, (the “Landlord”), pursuant
to which the Company agreed to lease from the Landlord approximately 2,325 rentable square feet. The base rent increases by 3% each year,
and ranges from approximately $8,719 per month for the first year to $10,107 per month for the two months of the sixth year.
On June 19, 2018, Enochian entered
into a Lease Agreement for a term of ten years from September 1, 2018, with Century City Medical Plaza Land Co., Inc., pursuant to which
the Company agreed to lease approximately 2,453 rentable square feet. On February 20, 2019, the Registrant entered into an Addendum to
the original Lease Agreement with an effective date of December 1, 2019, where it expanded the lease area to include another 1,101 square
feet for a total rentable 3,554 square feet. The base rent increases by 3% each year, and ranges from $17,770 per month for the first
year to $23,186 per month for the tenth year. The equalized monthly lease payment for the term of the lease is $20,050.
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 leases have remaining lease terms between 9 months and 65 months.
As of March 31, 2022, the weighted-average remaining term is 5.11 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 March 31, 2022, the weighted-average
discount rate is 4.01 %.
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.
Lease expense charged to
general and administrative expenses for the three and nine months ended March 31, 2022, amounted to $ 85,027 and $ 253,223 , respectively.
Lease expense charged to general and administrative expenses for the three and nine months ended March 31, 2021, amounted to $ 77,345
and $ 255,719 , respectively.
Below are the lease commitments
for the next 5 years and thereafter:
Lease commitments
Year Ending June 30 th
Lease Expense
2022
$
87,692
2023
298,305
2024
246,004
2025
253,384
2026
260,985
Thereafter
313,836
Less imputed interest
( 146,110
)
Total
$
1,314,096
14
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6 — NOTES PAYABLE
Convertible Notes Payable — On February
6, 2020, the Company issued two Convertible Notes (the “Convertible Notes”) to an existing stockholder of the Company each
with a face value amount of $ 600,000 , convertible into shares of the Company’s Common Stock. The outstanding principal amount of
the Convertible Notes is 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 is 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 March 31, 2022,
and 2021 was $ 1,200,000 . As of March 31, 2022, and 2021, the Company recorded accrued interest in the amount of $ 12,030 and $ 6,000 , which
is included in accrued expenses for each period. For the three and nine months ended March 31, 2022, the interest expense related to the
Convertible Notes amounted to $ 18,151 and $ 54,604 , 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 “Unsecured Note”)
to Paseco APS, a Danish limited company, and an existing stockholder of the Company. The principal amount of the Note was originally payable
on November 30, 2021 (the “Maturity Date”) and bears 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 was 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 is being accreted over the life of the Unsecured Note.
On February 11, 2021, the Company
entered into an amendment to the Unsecured Note in the principal amount of $ 5,000,000 that extends the Maturity Date out to November 30,
2022. All other terms of the Unsecured Note remain 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 . For the three and nine
months ended March 31, 2022, respectively, discount amortization of $ 74,274 and $ 222,822 was charged to interest expense. For the three
and nine months ended March 31, 2021, discount amortization of $ 74,274 and $ 148,253 , respectively was charged to interest expense. The
Unsecured Note balance, net of discount at March 31, 2022, was $ 4,801,936 , and is reflected in current liabilities.
Finance Agreement — On November 30, 2021,
the Company entered into a premium finance agreement (the “Agreement”) with a principal amount of $ 666,875 at 3.99 % interest
per annum. The repayment of the Agreement will be made in nine equal monthly installments of $ 56,469 .
For the three and nine months
ended March 31, 2022, the Company recorded total interest expense in the amount of $ 2,782 and $ 4,977 , respectively. This amount is reflected
in other income and expenses.
Total interest expense recorded
for the three and nine months ended March 31, 2022, was $ 95,207 and $ 278,327 , respectively. Interest expense recorded for the three and
nine months ended March 31, 2021, was $ 96,347 and $ 282,086 , respectively.
15
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — STOCKHOLDERS’ EQUITY
Preferred Stock —The
Company has 10,000,000 authorized shares of Preferred Stock, par value $ 0.0001 per share. At March 31, 2022, and June 30, 2021, there
were zero shares issued and outstanding.
Common Stock —The
Company has 100,000,000 authorized shares of Common Stock, par value $ 0.0001 per share. At March 31, 2022, and June 30, 2021, there were
52,798,267 and 52,219,661 shares issued and outstanding, respectively.
Voting — Holders
of Common Stock are entitled to one vote for each share held of record on each matter submitted to a vote of stockholders, including the
election of directors, and do not have any right to cumulate votes in the election of directors.
Dividends — Holders
of Common Stock are entitled to receive ratably such dividends as the Board from time to time may declare out of funds legally available.
Liquidation Rights —
In the event of any liquidation, dissolution or winding up of affairs of the Company, after payment of all of our debts and liabilities,
the holders of Common Stock will be entitled to share ratably in the distribution of any of our remaining assets.
Purchase Agreement with Lincoln Park Capital
On July 8, 2020, we entered into
a purchase agreement (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), pursuant
to which the Company may sell and issue to Lincoln Park, and Lincoln Park is obligated to purchase, up to $ 20,000,000 of shares of our
Common Stock from time to time through August 1, 2023.
Under the Purchase Agreement,
we may direct Lincoln Park, at our sole discretion subject to certain conditions, to purchase up to 200,000 shares of Common Stock on
any business day (a “Regular Purchase”). The amount of a Regular Purchase may be increased under certain circumstances up
to 125,000 shares of Common Stock, provided that Lincoln Park’s committed obligation for Regular Purchases on any business day shall
not exceed $ 1,000,000 . In the event we direct Lincoln Park to purchase the full amount allowed for a Regular Purchase on any given
business day, we may also direct Lincoln Park to purchase additional amounts as accelerated and additional accelerated purchases. The
purchase price of shares of Common Stock related to the future funding will be based on the then prevailing market prices of such shares
at the time of sales as described in the Purchase Agreement.
Our sale of shares of Common Stock
to Lincoln Park pursuant to the Purchase Agreement is limited to 12,016,457 shares of Common Stock, representing 19.99% of the shares
of the Common Stock outstanding on the date of the Purchase Agreement unless (i) stockholder approval is obtained, (ii) the average price
of all applicable sales to Lincoln Park under the Purchase Agreement equals or exceeds the lesser of (A) the closing price of the Common
Stock on the Nasdaq Capital Market immediately preceding the date of the Purchase Agreement or (B) the average of the closing prices on
the Nasdaq Capital Market for the five Business Days immediately preceding the date of the Purchase Agreement or (iii) to the extent it
would cause Lincoln Park to beneficially own more than 9.99% of the Company’s outstanding shares of Common Stock at any given time.
In consideration for entering
into the Purchase Agreement, we issued 139,567 shares of Common Stock to Lincoln Park as a commitment fee on July 21, 2020.
During the three and nine months
ended March 31, 2022, we issued 60,000 and 337,340 shares of Common Stock to Lincoln Park under the Purchase Agreement for a purchase
price of $ 451,700 and $ 3,500,039 , respectively. At March 31, 2022, an amount of $15,278,611 remained available under the Purchase Agreement.
16
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — STOCKHOLDERS’ EQUITY (Continued)
Common Stock Issuances —
In the three and nine months ended March 31, 2022, there were 165,000 and 578,606 shares of Common Stock issued, respectively. In
the three and nine months ended March 31, 2021, there were 1,032,732 and 1,298,543 shares of Common Stock issued, respectively.
Acquisition of Enochian Biopharma
Inc. / Contingently issuable shares — On February 16, 2018, the Acquisition was completed when the subsidiary merged
with and into Enochian Biopharma, with Enochian Biopharma as the surviving corporation. As consideration for the Acquisition, the stockholders
of Enochian Biopharma received (i) 18,081,962 shares of Common Stock, and (ii) the right to receive contingent shares pro rata upon the
exercise or conversion of warrants, which were outstanding at closing. At March 31, 2022, 1,250,000 contingent shares are issuable in
connection with the Acquisition of Enochian Biopharma.
Acquisition of Enochian Denmark
— At March 31, 2022, and June 30, 2021, 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 March 31, 2022, and June 30, 2021, 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 March 31, 2022. During the three and nine months ended March 31, 2022, the Company issued zero shares of Common Stock to such non-consenting
shareholders of Enochian Denmark. There is no impact on outstanding shares as these shares are reflected as issued and outstanding.
17
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — 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:
Summary of weighted-average assumptions used to estimate the fair values of the stock options granted
Enochian
Biosciences Inc.
Expected term (in years)
5.0 – 6.5
Volatility
82.29 %- 90.21 %
Risk free interest rate
0.77 %- 1.87 %
Dividend yield
0 %
The Company recognized stock-based compensation expense related to the
options of $ 577,676 and $ 5,348,943 for the three and nine months ended March 31, 2022, respectively. The Company recognized stock-based
compensation expense related to the options of $ 499,428 and $ 1,184,975 for the three and nine months ended March 31, 2021, respectively.
At March 31, 2022, the Company had approximately $ 7,184,117 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 shareholders 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 of Common Stock, and (2) the number of shares of Common Stock available for the grant of awards as of the effective date under
the 2014 Plan that, after the effective date of the 2019 Plan, expires, or is terminated, surrendered, or forfeited for any reason without
issuance of shares. The remaining shares of Common Stock available for grant related to the 2014 Plan was 655,769 as of the effective
date; this amount along with the new 6,000,000 shares totals 6,655,769 shares of Common Stock that were available to grant immediately
after the effective date of the 2019 Plan.
Pursuant to the 2019 Plan,
the Company granted options to purchase 11,900
and 3,142,100
shares of Common Stock to employees with a 3 three-year vesting period during the three and nine months ended March 31, 2022,
respectively. For the three and nine months ended March 31, 2021, the Company granted options to purchase zero and 9,201
shares of Common Stock to employees with a 3 three-year vesting period.
During the three and nine
months ended March 31, 2022, the Company granted options to purchase 65,000
shares of Common stock to employees with a 1 one-year vesting period. For the three and nine months ended March 31, 2021, the
Company granted options to purchase zero shares of Common Stock to employees with a one-year vesting period.
During the three and nine months
ended March 31, 2022, the Company granted options to purchase 23,314 and 86,776 shares of Common stock, respectively, to the Board of
Directors and Scientific Advisory Board Members with a one-year vesting period. For the three and nine months ended March 31, 2021, the
Company granted annual options to purchase 52,500 and 140,131 shares of Common Stock, respectively to members of the Board of Directors
and Scientific Advisory Board with a one-year vesting period.
The Company issued options for
consulting services to purchase zero and 21,979 shares of Common Stock with immediate vesting, issued options to purchase zero and 24,500
shares of Common Stock with a one-year vesting period, and issued options to purchase zero and 60,000 shares of Common Stock with a three-year
vesting period during the three and nine months ended March 31, 2022, respectively.
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 Plan (“Plan Options”) to purchase 4,729,508 shares of Common Stock.
18
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — STOCKHOLDERS’ EQUITY (Continued)
A summary of the status of the
Plan Options outstanding at March 31, 2022, is presented below:
Summary of stock option activity
Options Outstanding
Options Exercisable
Exercise Price Ranges
Number Outstanding
Weighted Average Remaining Contractual Life (years)
Weighted Average Exercise Price
Number Exercisable
Weighted Average Remaining Contractual Life (years)
Weighted Average Exercise Price
$
2.00 – 4.50
279,143
8.44
$
3.23
255,637
8.40
$
3.24
$
4.51 – 6.50
3,545,722
8.97
$
4.80
471,998
6.85
$
6.17
$
6.51 – 8.00
876,242
8.59
$
7.98
556,094
7.96
$
7.93
Total
4,701,108
8.86
$
5.30
1,283,729
7.64
$
6.35
A summary of the status of the
Plan Options at March 31, 2022, and changes since July 1, 2021, 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
1,329,153
$ 6.24
8.42
$ 511,239
Granted
3,400,355
$ 4.93
—
$ —
Exercised
—
$ —
—
$ —
Forfeited
—
$ —
—
$ —
Expired
( 28,400 )
$ 2.15
—
$ —
Outstanding at end of period
4,701,108
$ 5.30
8.86
$ 9,808,104
Exercisable at end of period
1,283,729
$ 6.35
7.64
$ 1,153,019
At March 31, 2022, the Company
had 1,283,729 exercisable Plan Options outstanding. The total intrinsic value of options exercisable at March 31, 2022, was $ 1,153,019 .
Intrinsic value is measured using the fair market value at the date of exercise (for shares exercised) or at March 31, 2022 (for outstanding
options), less the applicable exercise price.
Common Stock Purchase Warrants
A summary of the warrants outstanding
at March 31, 2022, and changes since July 1, 2021, are presented below:
Summary of common stock purchase warrants outstanding
Shares
Weighted Average Exercise
Price
Weighted Average Remaining
Life
Outstanding at beginning of period
1,350,000
$ 1.30
1.02
Granted
—
$ —
—
Exercised
( 100,000 )
$ 1.30
—
Cancelled/Expired
—
$ —
—
Outstanding and exercisable at end of period
1,250,000
$ 1.30
.28
Summary of common stock purchase warrants
Underlying Warrants Outstanding
Equivalent Shares Exercisable
Exercise Prices
Equivalent Shares
Weighted Average Remaining Contractual Life (years)
Weighted Average Exercise Price
Number Exercisable
Weighted Average Exercise Price
$ 1.30
1,250,000
.28
$ 1.30
1,250,000
$ 1.30
The exercise price of certain
warrants and the number of shares underlying the warrants are subject to adjustment for stock dividends, subdivisions of the outstanding
shares of Common Stock and combinations of the outstanding shares of Common Stock. For so long as the warrants remain outstanding, we
are required to keep reserved from our authorized and unissued shares of Common Stock a sufficient number of shares to provide for the
issuance of the shares underlying the warrants.
19
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 7 — STOCKHOLDERS’ EQUITY (Continued)
Restricted Stock Units (RSUs)
The Company recognized stock-based compensation expense
related to RSUs of $ 228 and $ 258,559 for the three and nine months ended March 31, 2022, respectively. The Company recognized stock-based
compensation expense related to the RSUs of $ 147,000 for the three and nine months ended March 31, 2021, respectively.
A summary of the status of Restricted Stock Units outstanding
at March 31, 2022, and changes since July 1, 2021, is presented below:
Summary of restricted stock units outstanding
Shares
Weighted Average Issuance
Price
Weighted Average Remaining
Life
Weighted Average Intrinsic
Value
Outstanding at beginning of period
5,000
$
6.15
$
.02
$
—
Granted
36,266
—
—
—
Exercised
( 41,266
)
—
—
—
Cancelled/Expired
—
—
—
—
Outstanding at end of period
—
$
—
$
—
$
—
20
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 — COMMITMENTS AND CONTINGENCIES
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 and will continue until the services
are no longer rendered or the agreement is terminated. For the three and nine months ended March 31, 2022, $ 75,000 and $ 225,000 , respectively,
was charged to research and development expenses in our Condensed Consolidated Statements of Operations related to this consulting agreement.
For the three and nine months ended March 31, 2021, $ 75,000 and 200,000 , respectively, 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 & 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”), 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 in accordance with its agreement
in principle with G-Tech and SRI.
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.
G-Tech and SRI are each controlled by certain members of Weird Science, LLC, a shareholder of the Company.
The cash funding for research
costs pursuant to the HBV License consists of monthly payments amounting to $ 144,500 that cover scientific staffing resources to complete
the project, as well as periodic payments for materials and equipment needed to complete the project. For the three and nine months ended
March 31, 2022, the Company paid a total of $ 144,500 and $ 1,011,500 , respectively for scientific staffing resources. During the three
and nine months ended March 31, 2022, the Company paid zero and $ 1,500,000 , respectively, for the milestone completion of a Pre-Investigational
New Drug (IND) process following receipt of written comments in accordance with the HBV License. During the three and nine months ended
March 31, 2021, respectively the Company paid $ 433,500 for scientific staffing resources, and $ 275,000 and $ 675,000 , respectively, for
costs related to research studies pursuant to the HBV License.
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,
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”).
21
ENOCHIAN BIOSCIENCES INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The License Agreement was entered
into pursuant to the existing Framework Agreement between the parties dated November 15, 2019. The License Agreement states that in consideration
for the Development License, the Company shall provide cash funding for research costs and equipment and certain other in-kind funding
related to the Prevention and Treatment over a 24-month period. Additionally, the License Agreement provides for an up-front payment of
$ 10,000,000 and a $ 760,000 payment for expenditures to date prior to the effective date related to research towards the Prevention and
Treatment within 60 days of April 18, 2021. The License Agreement provides for additional payments upon the occurrence of certain benchmarks
in the development of the technology set forth in the License Agreement, in each case subject to the terms of the License Agreement.
The License Agreement provides
for cooperation related to the development of intellectual property related to the Prevention and Treatment and for a 3% royalty to G-Tech
on any net sales that may occur under the License Agreement. For the three and nine months ended March 31, 2022, the Company paid zero
and $ 150,000 , respectively, related to the Prevention and Treatment research.
G-Tech is controlled by Dr. Serhat
Gümrükcü and Anderson Wittekind, shareholders of the Company, and SRI is controlled by Dr. Serhat Gümrükcü.
G-Tech and SRI are each controlled by certain members of Weird Science, LLC, a shareholder of the Company.
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 Dr.
Gümrükcü and SRI whereby Dr. Gümrükcü granted the Company an exclusive, worldwide, perpetual, fully paid-up,
royalty-free license, with the right to sublicense, his 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 Dr. Gümrükcü 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 Dr. Gümrükcü
and SRI, 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 Dr. Gümrükcü and SRI, 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.
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 shares of Common Stock issued to such non-consenting
shareholders during the three and nine months ended March 31, 2022 (see Note 7.)
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.
Contingencies – The
Company is from time to time involved in routine legal and administrative proceedings and claims of various types. While any proceeding
or claim contains an element of uncertainty, management does not expect a material impact on our results of operations or financial position
from such proceedings or claims.
NOTE 9 — RELATED PARTY TRANSACTIONS
The Company paid G-Tech $ 354,500
and $ 3,891,500 , which included payments for consulting agreements related to HIV, contractual costs related to the HBV License and the
Development License (See Note 8), and security expenses, for the three and nine months ended March 31, 2022, respectively.
NOTE 10 — 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.
22
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations.
Forward-Looking Statement Notice
Certain statements made in this
Quarterly Report on Form 10-Q are “forward-looking statements” (within the meaning of the Private Securities Litigation Reform
Act of 1995) regarding the plans and objectives of management for future operations. Such statements involve known and unknown risks,
uncertainties and other factors that may cause actual results, performance, or achievements of Enochian Biosciences Inc. (“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 September 24, 2021. 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 pre-clinical stage biotechnology company committed to using our genetically modified cell, gene, and immune therapy technologies to
potentially prevent or cure HIV, HBV, influenza, SARS-CoV-1 and -2, and coronavirus infections, as well as to provide potentially long-term
or life-long cancer remission in some of the deadliest cancers.
Over the past several years, we
have expanded the pipeline from a single potential cure for HIV (autologous transplantation with gene-modified cells; ENOB-HV-01) to three
additional potential cures for HIV, a potential cure for Hepatitis B Virus (HBV), potential inhaled treatment and prophylaxis/prevention
of all variants of SARS-CoV-1 and -2 (the cause of the COVID-19 pandemic) and potentially other coronaviruses, and potential cures for
many solid tumors, beginning with pancreatic cancer.
Our integrated platforms encompass
innovative interventions in gene and immune therapies that provide hope for cures or life-long remissions for devastating diseases. Our
platforms can potentially streamline and accelerate pre-clinical, regulatory, clinical, and production pathways. Because of the relative
ease of administration, our potentially groundbreaking interventions could be used throughout the world.
Platforms:
Hijack RNA
Our novel approach tricks
the virus into sending suicide signals to the infected cell instead of turning the cell into a virus factory. The technology is delivered
by vectors that would allow it to rapidly treat an infection, or to lay and wait in ambush until a cell becomes infected, which would
prevent (prophylaxis, similar to taking drugs to protect from becoming infected with malaria or HIV) future infections.
The delivery mechanism
can be adapted for aerosol (e.g., respiratory infections like the virus that causes COVID-19 and influenza), intravenous or other delivery
mechanisms (e.g. for Hepatitis B Virus and HIV).
Allogeneic Cell
Therapy
The human immune system
is designed to recognize “self” and destroy “otherness” or “non-self,” such as bacteria, viruses
and cancer cells.
23
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 tumors.
In certain treatments (e.g., HIV and cancer), cells taken from healthy donors are sometimes genetically modified to further boost the
immune system to seek and kill diseases.
In addition to those
platforms, we have an innovative approach to remove cells from a person living with HIV and genetically modify them so they cannot be
infected with HIV. The unique innovation is an additional genetic alteration to increase the ability of those cells to survive and expand
when they are given back to the same person (autologous transplantation).
Respiratory Diseases
In April
2021, we acquired the exclusive license to a potential pan-SARS-Cornavirus-1 and-2 (SARS-CoV) and pan-Influenza inhaled treatment and
prophylaxis.
SARS-CoV-2
has caused the most devastating global pandemic in a century – COVID-19. Using the Hijack RNA platform technology, in vitro
and in vivo results showing rapid killing of infected cells, but not uninfected cells were presented at the important Conference
on Retroviruses and Opportunistic Infections in March 2021. Since that time, there has been substantial progress with a Pre-IND (as defined
below) submission expected in the near term.
Influenza
has caused dozens of major global pandemics; the most notable in 1918 that killed 50 to 100 million people. There was an H1N1 threat as
recently as 2009. The Hijack RNA also has shown promising in vitro results that were presented at the Annual Conference of the
American Society of Gene and Cell Therapy (ASGCT) in May 2020.
A vector
combining the SARS-CoV, and Influenza Hijack RNA has been designed.
A leading
scientist and public health expert serve on our Scientific Advisory Board focused on respiratory diseases.
Human Immunodeficiency
Virus (HIV), and Acquired Immunodeficiency Syndrome (AIDS)
HIV attacks
the human immune system, specifically killing off CD4+ cells, or T cells, which play a central, controlling role in the immune system.
Left untreated, HIV dramatically reduces the number of T cells in the body, devastates the immune system, leading to AIDS, a condition
where the immune system cannot fight off life-threatening infections and cancers.
Currently
there are over 30 antiretroviral drugs, or ART, approved by the U.S. Food and Drug Administration (“FDA”) to treat HIV but
these drugs are expensive, require daily adherence, and can have significant side effects over time. In addition, on a global basis, as
many as 1 million people, including persons in high-income countries, continue to die each year from HIV/AIDS due to drug-resistant HIV
or lack of access to treatment. To date, there are no treatments that can eliminate the reservoir of immune cells that are infected with
HIV from the body. Consequently, treatment for HIV is life-long.
There
have been several efforts to cure HIV by re-engineering a person’s own T-cells so that these cells no longer express a special protein
(C-C chemokine co-receptor type 5 or CCR5), which HIV uses to gain entry to them. A naturally occurring mutation that blocks expression
of CCR5 on T cells occurs in ~1% of persons living in or from Northern Europe with no known adverse effects. The “Berlin patient,”
and more recently the “London patient” were HIV-positive persons who developed cancer and were treated with a bone marrow
transplant with cells donated from persons with this naturally occurring mutation of CCR5. The Berlin and London patients seem to have
been effectively cured from HIV providing proof-of-concept that HIV can be cured. However, because the transplanted cells come from another
person, such transplants carry high risk and can result in death in a significant proportion of patients. Given the success with these
two patients, several researchers and companies have attempted to replicate this experience by genetically modifying T cells of HIV-positive
patients to render them unable to be infected by HIV and then returning them to the patient. Because the transplanted cells are from the
same person, the risks to the patient are much lower. The uptake, or engraftment of the modified T cells, however, has not been optimal,
leading to failure to achieve a cure. In addition, the transplant pre-treatment that has been used is bone marrow-destroying chemotherapy,
which wipes out the patient’s immune system and can have long-term side effects including the risk of developing cancer.
24
ENOB-HV-01
is a novel, proprietary approach with the potential to overcome the failures of recent efforts to develop a cure for HIV. The intervention
provides gene-modified T cells with a competitive advantage over non-modified cells in the HIV-positive person, with the potential to
significantly increase engraftment; and avoid the need for chemotherapy that substantially depletes the bone marrow and could potentially
be given as an outpatient treatment. The Company met with the FDA INTERACT team on June 2, 2020. INTERACT is the first available FDA interaction
and is a key step in the process towards a potential Investigational New Drug Application (IND) to study First-in-Human products potentially
leading to marketing authorization via Biologics License Application (BLA). The FDA Center for Biologics Evaluation and Research (CBER)
has numerous INTERACT requests and grants meetings that are deemed appropriate for this early FDA engagement. The Enochian BioSciences
management team considered the meeting to be successful with strong alignment between Enochian BioSciences’ approach to developing
ENOB-HV-01 and the comments of the FDA reviewers.
Initial
scientific findings from a mouse study on the ENOB-HV-01 approach were presented at the annual ASCGT conference in May 2020.
We are
also developing ENOB-HV-12 that will utilize a novel cellular- and immunotherapy approach that could potentially provide both preventative
and therapeutic vaccines for HIV. A non-human primate study is in process. Preliminary results could potentially be available by the latter
part of 2022.
Our co-founder and inventor, Dr.
Serhat Gümrükcü, who is also the Director of Seraph Research Institute (SRI), submitted a Pre-IND for ENOB-HV-21, an innovative
treatment of Natural Killer (NK) and Gamma Delta T-Cells (GDT) collected from another person. It is believed that the GDT cells, a small
subset of immune cells that can be infected with HIV, could be a key factor in controlling the virus. The initial scientific findings
were presented during the ASCGT Conference in May 2021. Enochian BioSciences has an exclusive license to use the underlying patent to
develop HV-21 for the prevention, treatment, and/or amelioration of and/or therapy exclusively for HIV in humans, and research and development
exclusively relating to HIV in humans.
On October 18, 2021, the Company
announced that FDA comments on an investigator-initiated Pre-IND were, from Management’s perspective, insightful and helpful with
an investigator-initiated IND submission possible in the near-term with the potential for human trial enrollment to begin in the near
to medium term in 2022.
We are
in the development phase of additional product candidates related to our HIV pipeline. ENOB-HV-31, which is in vivo gene therapy,
and ENOB-HV-32, which is a peptide drug for packaging and distribution.
Hepatitis B (HBV)
Despite the availability of an
effective vaccine and treatment that can control infection if it is taken daily for life, hepatitis B virus (HBV) is the world’s
most common serious liver infection. While vaccines are increasingly required for children, many adults have not been vaccinated. Life-long
treatment can be difficult for certain people and access can be limited.
In that regard, HBV remains the
leading cause of liver cancer and the second leading cause of cancer deaths in the world. Two billion people have been infected with HBV,
approximately 350 million have chronic HBV infection, and nearly one million people die every year.
Current efforts to develop novel
treatment or cure largely focus on approaches to deplete the pool of a certain type of HBV DNA. Enochian BioSciences has collaborated
with SRI to develop an innovative approach to co-opt HBV polymerase, a key expanding factor that the virus needs to reproduce itself,
to induce the death of liver cells infected with the virus.
On July 27, 2020, Enochian BioSciences
announced the creation of an HBV Scientific Advisory Board comprised of distinguished leaders in HBV disease, treatment, and cure. On
August 23, 2021, we announced the addition of a third leading expert with substantial experience in HBV clinical trials.
On September 27, 2021, the Company
announced the completion of a Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S. Food and
Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) for ENOB-HB-01.
25
The initial in vitro and
in vivo work was presented at the biannual HEP DART meeting in December of 2019, where it was selected as one of the best new therapies/novel
strategies. Additional data was presented at the annual ASCGT conference in May 2020. A proof-of-concept, in vivo cure study is
in advanced stages. A Pre-IND request has been completed with productive comments and insights. An IND could potentially be submitted
towards the end of 2022 with potential for enrollment in a clinical trial to begin by the end of 2022 or in 2023.
In March 2022, Enochian announced a profit-sharing
partnership with Caring Cross to use ENOB-HV-01’s “special sauce” to potentially improve the effectiveness and reduce
the cost and toxicity of a CAR-T approach to HIV Cure already in clinical trials.
Cancer
Based on learning from peer-reviewed publications of
Phase I/IIa trials, we have designed an innovative therapeutic vaccination platform that could potentially be used to induce life-long
remissions from some of the deadliest solid tumors. Initial preclinical in vitro studies have been encouraging. We initially plan
to target pancreatic cancer, triple-negative breast cancer, glioblastoma, and renal cell carcinoma. The platform might also allow for
non-specific immune enhancement that could have impact against a broad array of solid tumors. As with HIV, our approach would potentially
allow for outpatient therapy without ablating or significantly impairing the patient’s immune system, as many current approaches
require.
Through a collaboration with a leader in the field
of pancreatic cancer, our first cancer-related therapeutic target, we are developing the pipeline with in vitro and in vivo
proof-of-concept studies to evaluate the potential to induce long-term remission or cure. Results are expected in the second half
2022. If the results are promising, a potential Pre-IND and an IND with potential for enrollment in a clinical trial may begin in 2022.
To date,
our operations have been funded by sales of our securities and the issuance of debt. We have never generated any sales revenue, 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.
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.
COVID-19
The COVID-19 pandemic continues
to evolve, and to date has led to the implementation of various mitigation responses, including government-imposed quarantines, travel
restrictions and other public health safety measures, as well as leading to reported adverse impacts on healthcare resources, facilities,
and providers across the United States and in other countries. COVID-19 may cause delays in our research activities. To date, it has not
materially affected our operations; however, it has caused delays in the conduct of experiments due to limitations of various organizations,
in particular those conducting experiments related to COVID-19. 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. Further
quarantines, shelter-in-place or similar restrictions and other actions taken or imposed by foreign, federal, state, and local governments
could adversely impact our or our partners’ clinical, research and development, regulatory and manufacturing operations, or timelines.
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.
26
Results of Operations for the
three and nine months ended March 31, 2022, compared to the three and nine months ended March 31, 2021
The
following table sets forth our revenues, expenses, and net loss for the three and nine months ended March 31, 2022, and 2021. The financial
information below is derived from our unaudited condensed consolidated
For the Three Months Ended
For the Nine Months Ended
March 31,
Increase/(Decrease)
March 31,
Increase/(Decrease)
2022
2021
$
%
2022
2021
$
%
Operating Expenses
General and administrative expenses
2,790,456
1,903,902
886,554
47 %
11,169,724
5,551,331
5,618,393
101 %
Research and development expenses
1,212,380
1,119,203
93,177
8 %
6,605,038
3,574,529
3,030,509
85 %
Depreciation and amortization
31,720
30,825
895
3 %
95,258
92,043
3,215
3 %
Total Operating Expense
$ 4,034,556
$ 3,053,930
$ 980,626
32 %
$ 17,870,020
$ 9,217,903
$ 8,652,117
94 %
LOSS FROM OPERATIONS
$ (4,034,556 )
$ (3,053,930 )
$ (980,626 )
32 %
$ (17,870,020 )
$ (9,217,903 )
$ (8,652,117 )
94 %
Other Income (Expense)
Change in fair value of contingent consideration
(2,078,994 )
(882,498 )
(1,196,496 )
136 %
(5,070,891 )
38,313
(5,109,204 )
(13,335 )%
Interest expense
(95,207 )
(96,347 )
1,140
(1 )%
(278,327 )
(282,086 )
3,759
(1 )%
Gain (Loss) on currency transactions
—
(221 )
221
100 %
9
(32,510 )
32,519
100 %
Interest income
7,291
1,437
5,854
407 %
22,888
8,809
14,079
160 %
Total Other (expense) income
(2,166,909 )
(977,629 )
(1,189,280 )
122 %
(5,326,321 )
(267,474 )
(5,058,847 )
1,891 %
Loss Before Income Taxes
$ (6,201,465 )
$ (4,031,559 )
$ (2,169,906 )
54 %
$ (23,196,341 )
$ (9,485,377 )
$ (13,710,964 )
145 %
Income Tax Benefit
$ —
$ 849
$ (849 )
(100 )%
$ (34 )
$ 124,801
$ (124,835 )
(100 )%
NET LOSS
$ (6,201,465 )
$ (4,030,710 )
$ (2,170,755 )
54 %
$ (23,196,375 )
$ (9,360,576 )
$ (13,835,799 )
148 %
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 March 31, 2022, and March 31, 2021, were $4,034,556 and $3,053,930 respectively,
representing an increase of $980,626, or approximately 32% . The increase in operating expenses primarily relates to an increase
in general and administrative expenses of $886,554.
Our operating expenses for the
nine months ended March 31, 2022, and March 31, 2021, were $17,870,020 and $9,217,903, respectively, representing an increase of $8,652,117
or approximately 94%. The change is primarily related to the increase in general and administrative expenses of $5,618,393, and an increase
in R&D expenses of $3,030,509.
27
General and administrative expenses
for the three months ended March 31, 2022, and March 31, 2021, were $2,790,456 and $1,903,902, respectively, representing an increase
of $886,554 or approximately 47%. The variance is related to an increase in compensation and related expenses of $269,688, an increase
in legal expenses of $215,625, an increase in recruiting expenses of $133,007, an increase in stock-based compensation of $78,248, and
a net aggregate of immaterial increase variances of $189,985.
General and administrative expenses
for the nine months ended March 31, 2022, and March 31, 2021, were $11,169,724 and $5,551,331, respectively, representing an increase
of $5,618,393 or approximately 101%. The largest contributors to the increase in general and administrative expenses were the increases
in stock-based compensation of $4,163,968, officer compensation of $558,770, salaries expense and related costs of $395,298, and recruiting
expenses of $250,240, and a net aggregate of immaterial increases of $250,118.
Research and development expenses
for the three months ended March 31, 2022, and March 31, 2021, were $1,212,380 and $1,119,203, respectively, representing an increase
of $93,177 or approximately 8%. The variance is primarily driven by $74,470 in costs related to CV-01 and HV-12, and an increase of $56,000
in collaborating partner expenses, partially offset by a net aggregate of immaterial decreases of $37,293.
Research and development expenses
for the nine months ended March 31, 2022, and March 31, 2021, were $6,605,038 and $3,574,529, respectively, representing an increase of
$3,030,509 or approximately 85%. The largest contributors to the increase in research and development expenses were the increases in license
costs related to ENOB HB-01 of $1,500,000 for achievement of a milestone, costs incurred for ENOB HV-21 of $600,000, newly incurred costs
with CDMO and CRO partners totaling $1,447,939 and, new COVID license payments of $150,000, partially offset by HBV costs and oncology
costs that were incurred in the prior period for a total of $785,000 that was not incurred in the current period.
The Company recorded other expense
of $2,166,909 for three months ended March 31, 2022, compared to other expense of $977,629 for the three months ended March 31, 2021,
representing an increase in other expense of $1,189,280 or 122%. The variance is primarily due to the change in fair value of the contingent
consideration liability expense of $1,196,496.
The Company recorded other expense
of $5,326,321 for the nine months ended March 31, 2022, compared to other expense of $267,474 for the nine months ended March 31, 2021,
representing an increase in other expense of $5,058,847 or 1,891%. The variance is primarily due to the change in fair value of the contingent
consideration liability expense of $5,109,204.
Net Loss
Net loss for the three months
ended March 31, 2022, and 2021, was $6,201,465 and $4,030,710, respectively, representing an increase in loss of $2,170,755 or approximately
54%. The increase in net loss was primarily due to an increase in general and administrative expenses of $886,554, an increase in research
and development expenses of $93,177, and an increase in expense related to the change in fair value of contingent consideration of $1,196,496.
Net loss for the nine months ended
March 31, 2022, and 2021, was $23,196,375 and $9,360,576, respectively, representing an increase in loss of $13,835,799 or approximately
148%. The increase in net loss was primarily due to the increase in general and administrative expenses of $5,618,393, an increase in
research and development costs of $3,030,509, and an increase in expense related to the change in fair value of contingent consideration
of $5,109,204.
Liquidity and Capital Resources
We have historically satisfied
our capital and liquidity requirements through funding from shareholders, 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.
At this time, we believe we have
sufficient liquidity and access to committed funds to fund our operations for the next twelve months. We may need additional funds for
(a) the purchase of equipment, (b) increases in personnel, and (c) research and development, specifically to advance towards an Investigational
New Drug Application (IND) following Pre-IND readouts from the FDA for ENOB-CV-01, ENOB-HB-01, ENOB-HV-01, and ENOB-HV-21. We will also
require additional funding to continue our research and development of ENOB-HV-11/12, ENOB-DC-11, ENOB-FL-01 and -11 and ENOB-CV-11, to
fund the Coronavirus and Influenza Indications License Agreement in furtherance of treatment related to all coronaviruses, and for possible
future strategic acquisitions of businesses, products, or technologies complementary to our business. If additional funds are required,
we may raise such funds from time to time through public or private sales of our equity or debt securities. 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.
28
As of March 31, 2022, the Company
had $11,150,917 in cash and working capital of $4,184,007 as compared to $20,664,410 in cash and working capital of $19,013,100 as of
June 30, 2021, a decrease of 46% and 78%, respectively.
Assets
Total assets at March 31, 2022,
were $180,100,613 compared to $189,605,225 as of June 30, 2021. The decrease in total assets was primarily due to the decrease in cash
of $9,513,493. The change in cash is primarily attributed to $6,605,038 in research and development costs related to the HBV license agreement,
costs related to ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately $5,820,781 in general and
administrative expenses, net of non-cash items, partially offset by an increase in funding totaling $3,630,039 related to drawdowns from
the LPC equity line and warrants exercised during the period.
Liabilities
Total liabilities at March 31,
2022, were $18,857,916 compared to $14,942,286 as of June 30, 2021. The increase in total liabilities was primarily related to an increase
of $4,272,891 in the contingent consideration liability as a result of mark-to-market adjustment, an increase in other current liabilities
of $187,106 related to a financing arrangement for a new insurance policy and an increase in accounts payable of $166,457 due to timing,
partially offset by the reduction in accrued expenses of $715,999.
The following is a summary of
the Company’s cash flows (used by) or provided by operating, investing, and financing activities:
Nine Months
Ended
March 31,
2022
Nine Months
Ended
March 31,
2021
Net Cash (Used in) Operating Activities
$
(12,681,849
)
$
(7,582,676
)
Net Cash (Used in) Investing Activities
(5,156
)
(10,721
)
Net Cash Provided by Financing Activities
3,180,274
3,398,599
Effect of exchange rates on cash
(6,762
)
24,721
Change in Cash and Cash Equivalents
$
(9,153,493
)
$
(4,1 70,077
)
Cash Flows
Cash used in operating activities
for the nine months ended March 31, 2022, and 2021 was ($12,681,849) and ($7,582,676), respectively. Cash used in operating activities
during the current period included $6,605,038 in research and development costs related to the HBV license agreement, costs related to
ENOB-CV-01 for related CDMO and CRO costs, and ENOB-HV-21 studies along with approximately $5,820,781 in general and administrative expenses,
net of non-cash items.
Cash provided by financing activities
for the nine months ended March 31, 2022, was $3,180,274 as compared to cash provided by financing activities of $3,398,599 during the
nine months ended March 31, 2021. During the nine months ended March 31, 2022, the Company received financing from the drawdown of its
LPC equity line of $3,500,039 and the exercise of warrants held by shareholders of $130,000.
Off-Balance Sheet Arrangements
The Company does not have any
off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial
condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources
that is material to investors.
29
Significant Accounting Policies and Critical Accounting
Estimates
The methods, estimates, and judgments
that we use in applying our accounting policies have a significant impact on the results that we report in our financial statements. Some
of our accounting policies require us to make difficult and subjective judgments, often as a result of the need to make estimates regarding
matters that are inherently uncertain.
For a summary of our accounting
policies, see Note 1 to the unaudited condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures
About Market Risk.
As a “smaller reporting
company” as defined by Rule 12b-2 of the Securities Exchange Act of 1934, the Company is not required to provide the information
required by this Item.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our Principal Executive Officer
and Chief Financial Officer (the “Certifying Officers”) are responsible for establishing and maintaining disclosure controls
and procedures for the Company. The Certifying Officers have designed such disclosure controls and procedures to ensure that material
information is made known to them, particularly during the period in which this Report was prepared.
The Certifying Officers are responsible
for establishing and maintaining adequate internal control over financial reporting for the Company and used the “Internal Control
over Financial Reporting Integrated Framework” issued by the Committee of Sponsoring Organizations (“COSO”) to conduct
an extensive review of the Company’s “disclosure controls and procedures” (as defined in the Exchange Act, Rules 13a-15(e)
and 15-d-15(e)) as of the end of each of the periods covered by this Report (the “Evaluation Date”). Based upon that evaluation,
the Certifying Officers concluded that, as of March 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 fact that the Company does not have an adequate number of persons to whom it can segregate accounting tasks within the Company
so as to ensure the segregation of duties between those persons who approve and issue payment from those persons who are responsible
to record and reconcile such transactions within the Company’s accounting system. This control deficiency will be monitored, and
attention will be given to this matter as we increase our personnel.
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 March 31, 2022, that have materially affected or are reasonably
likely to materially affect our internal controls.
30
PART II — OTHER INFORMATION
Item 1. Legal Proceedings.
There are presently no material
pending legal proceedings other than in the ordinary course of business to which the Company or any of its subsidiaries, is a party or
as to which any of its property is subject, and no such proceedings are known to the Company to be threatened or contemplated against
it.
Item 1A. Risk Factors.
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, 2021, on Form 10-K (“2021 Form 10-K”) filed with the SEC on September 24, 2021. There have been no material
changes to the disclosures relating to this item from those set forth in our 2021 Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
None.
Item 6. Exhibits.
(a)
Exhibits required by Item 601 of Regulation S-K.
Exhibit No.
Description
31.1**
Certification of Principal Executive Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
31.2**
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934
32.1***
Certification of Principal Executive Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
32.2***
Certification of Chief Financial Officer pursuant to Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350
101.INS
XBRL
Instance Document
101.SCH
XBRL
Taxonomy Extension Schema
101.CAL
XBRL
Taxonomy Extension Calculation Linkbase
101.DEF
XBRL
Taxonomy Extension Definition Linkbase
101.LAB
XBRL
Taxonomy Extension Label Linkbase
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase
**
Filed herewith.
***
Furnished herewith.
31
SIGNATURES
Pursuant to the requirements of
Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Date: May 12, 2022
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)
32
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.