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OFFON

ENOCHIAN BIOSCIENCES, INC.

(ENOB)
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ENOCHIAN BIOSCIENCES : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K)

09/24/2021 | 05:29pm EDT
The following discussion of our financial condition and results of operations
should be read in conjunction with our financial statements, and the related
notes to those statements included elsewhere in this report. In addition to the
historical financial information, the following discussion and analysis contain
forward-looking statements that involve risks and uncertainties. Our actual
results may differ materially from those anticipated in these forward-looking
statements.



Our Business



Enochian BioSciences, Inc. is a biopharmaceutical company focused on developing
innovative platforms for gene-modified cellular and immune therapies to
potentially cure and treat deadly diseases. The company's gene-modified cell and
immune therapy platforms can potentially be applied to multiple indications,
including HIV/AIDS, Hepatitis B, all Corona and Influenza viruses, and Oncology.



To date, our operations have been funded by sales of our securities and debt
financing. 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.



Recent Developments


On August 11, 2021, and with an effective date of July 1, 2021, the Company and
Dr. Dybul entered into an Employment Agreement, the form of which was approved
and recommended by the Board on October 30, 2019 and approved by stockholders of
the Company with a majority of the voting power of all shares of the Company's
capital stock entitled to vote on the matter on October 31, 2019. The material
terms of the Employment Agreement are as set forth in the Company's Information
Statement filed with the Securities and Exchange Commission on November 12,
2019.



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.



36







RESULTS OF OPERATIONS


Year ended June 30, 2021 compared to the year ended June 30, 2020.




The following table sets forth our revenues, expenses and net income for the
years ended June 30, 2021 and 2020. The financial information below is derived
from our audited consolidated financial statements included elsewhere in this
Annual Report.



                                            For the Year Ended
                                                 June 30,                        Increase/(Decrease)
                                         2021               2020                 $                  %
Operating Expenses
General and administrative
expenses                            $   7,740,130$   7,120,835$     619,295                9 %
Research and development
expenses                               15,538,122          4,694,349         10,843,773              231 %
Depreciation and amortization             123,535            108,584             14,951               14 %
Total Operating Expenses               23,401,787         11,923,768         11,478,019               96 %
LOSS FROM OPERATIONS                  (23,401,787 )      (11,923,768 )      (11,478,019 )            (96 )%
Other Income (Expenses)
Change in fair value of
contingent consideration               (3,048,033 )          274,566         (3,322,599 )         (1,210 )%
Interest expense                         (379,608 )         (104,280 )         (275,328 )            264 %
Gain (Loss) on currency
transactions                              (32,634 )          146,828           (179,462 )           (122 )%
Gain on settlement                              -            140,000           (140,000 )           (100 )%
Interest income                            13,179             50,296            (37,117 ))           (74 )%
Total Other Income (Expenses)          (3,447,096 )          507,410         (3,954,506 )           (779 )%
Loss Before Income Taxes              (26,848,883 )      (11,416,358 )     
(15,432,525 )            135 %
Income Tax Benefit                        125,276                  -            125,276              100 %
NET LOSS                            $ (26,723,607 )$ (11,416,358 )$ (15,307,249 )            134 %




37







                                                              For the Year Ended
                                                                   June 30,
                                                         2021                   2020

Net Loss                                            $ (26,723,607 )$ (11,416,358 )
Other Comprehensive Income (Loss)
Foreign Currency Translation Gain (Loss),
Net of Taxes                                               30,582               (143,234 )

Comprehensive Loss                                  $ (26,693,025 )$ (11,559,592 )




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.




Operating Expenses



Our operating expenses for the years ended June 30, 2021 and 2020 were $23,401,787 and $11,923,768, respectively, representing an increase of $11,478,019, or 96%. The largest contributor to the increase in operating expenses for the year ended June 30, 2021, was the increase in research and development expenses of $10,843,773 in connection with the continued growth in our research and development efforts, and an increase in general and administrative expenses of $619,295.




General and administrative expenses for the years ended June 30, 2021 and 2020
were $7,740,130 and $7,120,835, respectively, representing an increase of
$619,295, or 9%. General and administrative expenses include audit fees,
non-cash compensation expenses, consulting expenses, board compensation, filing
fees, corporate taxes, security expenses, legal fees, office leases, insurance,
patent fees, salaries, investor relations, travel expenses and other general and
administrative expenses. The increase in general and administrative expenses are
primarily related to increases of $416,076 in stock-based compensation, $254,512
in salaries, $179,363 related to insurance, and $99,880 in investor relations,
partially offset by decreases in legal and security fees and laboratory costs
totaling approximately $420,862.



Research and development expenses for the years ended June 30, 2021, and June
30, 2020, were $15,538,122 and $4,694,349, respectively, representing an
increase of $10,843,773 or 231%. Overall research and development expenses
remained consistent with the exception of the $10 million upfront fees related
to the Coronavirus and Influenza License Agreement discussed above, and
approximately $657,000 in collaboration partner costs in the development of our
product lines ENOB-HV-12 and DC-11 in the year ended June 30, 2021.



Other Income (Expense)



Net other income (expense) for the years ended June 30, 2021 and 2020 was
$(3,447,096) and $507,410, respectively, representing an increase of 3,954,506
or 779%. The increase in other expense was due primarily to the change in the
fair value of contingent consideration of $3,322,000, which is impacted by
contingent shares issued during the period and the mark to market adjustments on
the remaining contingent consideration liability, as well as an increase in
interest expense of approximately $275,000.



Net Loss



Net loss for the years ended June 30, 2021 and June 30, 2020 was $26,723,607 and
$11,416,358, respectively, representing an increase in net loss of $15,307,249,
or 134%. The increase in net loss was primarily due to the upfront fees of $10
million related to the Coronavirus and Influenza License Agreement recorded in
research and development costs, an approximate increase in the change in fair
value of contingent consideration of $3,332,599 and $619,295 increase in general
and administrative expenses.



38






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-HV11/12 and ENOB-DC11 and
ENOB-FL-01 and -11 and ENOB-CV-11, to fund the Coronavirus and Influenza
Indications License Agreement in furtherance of the 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.



As of June 30, 2021, the Company had $20,664,410 in cash and working capital of
$19,013,100 as compared to $8,696,361 in cash and working capital of $7,606,411
as of June 30, 2020. The increase in cash of $11,968,049 is primarily due to the
proceeds from the various equity raises throughout the year that totaled
approximately $33,066,148, partially offset by the cost of operations primarily
related to research and development costs of $15,500,000 (see Note 8 of the
Financial Statements.)



Equity



On July 8, 2020, we entered into a purchase agreement (the "LPC Purchase
Agreement") with Lincoln Park Capital Fund, LLC, ("LPC"), pursuant to which LPC
is committed to buy, and we have the right, but not the obligation, to sell to
LPC up to an aggregate of $20,000,000 of our Common Stock, subject to certain
limitations and conditions set forth in the LPC Purchase Agreement, including a
limitation on the number of shares of Common Stock we can put to LPC and the
pricing parameters for the sales. For the year ended June 30, 2021, the Company
issued 200,000 shares of Common Stock for proceeds of $1,221,350 (see Note
7 of
the Financial Statements.)



Pursuant to a private placement offering, the Company issued 1,275,719 shares of
Common Stock resulting in proceeds of $5,000,800. The Company effected the
issuances of the shares of Common Stock from March 15, 2021 to June 9, 2021. The
private placement was made directly by the Company in reliance upon Regulation S
of the Securities Act of 1933. No underwriter or placement agent was engaged by
the Company for this private placement (see Note 7 of the Financial Statements.)



On June 14, 2021, the Company and certain institutional investors entered into a
securities purchase agreement (the "Purchase Agreement"), pursuant to which the
Company agreed to sell to such investors an aggregate of 3,866,668 shares of
Common Stock, in a registered direct offering, for gross proceeds of
approximately $29 million (the "Financing"). The purchase price for each share
of Common Stock was $7.50. The Company agreed not to issue or enter into any
agreement to issue Common Stock from June 14, 2021 until ninety (90) days after
the closing of the Financing. The Company entered into a letter agreement dated
June 14, 2021 (the "Letter Agreement") with H.C. Wainwright & Co., LLC, as
exclusive placement agent (the "Placement Agent"), pursuant to which the
Placement Agent agreed to act as the exclusive placement agent for the
Financing. The Company agreed to pay the Placement Agent an aggregate fee equal
to 7.0% of the gross proceeds raised in the Financing. The Company also agreed
to pay the Placement Agent certain expenses. The Company paid $2,090,000 in
commissions and incurred offering expenses, and issuance costs of $66,011,
resulting in net proceeds of $26,843,999 in connection with the Financing. The
Financing closed on June 16, 2021 (see Note 7 of the Financial Statements.)


Warrant Exercises



On July 3, 2019, certain of our warrant holders exercised warrants to purchase
500,000 shares of Common Stock for total proceeds to the Company of $1,000,000.
For the year ended June 30, 2021, the Company issued 63,122 shares of Common
Stock for total proceeds of $82,056 upon the exercise of warrants.



Debt



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 Common Stock. The holder did not
exercise the conversion feature that expired on February 6, 2021. 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. For
the years ended June 30, 2021 and 2020, the interest expense amounted to $72,967
and $30,302, respectively (see Note 5 to the Financial Statements.)



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 (the
"Holder"), a Danish limited company and an existing stockholder of the Company.
The principal amount of the Unsecured Note will be payable on November 30, 2021,
and bears interest at a fixed rate of 6% per annum, which was prepaid by the
Company in full on the date of issuance through the issuance of 188,485 shares
of the Company's Common Stock based on the closing market price on that date,
valued at $501,370. On February 11, 2021, the Company and the Holder amended the
original Unsecured Note to extend the maturity date to November 30, 2022. The
Company prepaid in full all accrued interest from November 30, 2021 to the new
maturity date November 30, 2022, through the issuance of 74,054 shares of Common
Stock based on the closing market price on that date, valued at $299,178. (See
Note 5 to the Financial Statements).



39







Cash Flows


Year ended June 30, 2021 compared to the year ended June 30, 2020

Following is a summary of the Company's cash flows provided by (used by) operating, investing, and financing activities:



                                                   For the Year Ended
                                                        June 30,
                                                 2021              2020

Net Cash Used by Operating Activities $ (20,610,723 )$ (10,459,422 )Net Cash Used by Investing Activities

             (48,892 )        (184,463 )

Net Cash Provided by Financing Activities 32,601,553 7,200,000 Effect of exchange rates on cash

                   26,111          (141,978 )
Net Increase (Decrease) in Cash             $  11,968,049     $  (3,585,863
)




At June 30, 2021, we had cash and cash equivalents of $20,664,410, an increase
of $11,968,049, when compared to the June 30, 2020 balance of $8,696,361. This
increase was primarily due to cash provided by financing activities, primarily
from equity sale transactions, partially offset by cash used in operating
activities.



We plan to use our cash and cash equivalents to fund research and development,
specifically to open an Investigational New Drug Application (IND) (the first
step in the drug review process by the FDA) for ENOB CV-01, ENOB-HB01,
ENOB-HV01, and ENOB-HV21, to continue our research and development of
ENOB-HV11/12 and ENOB-DC11, and to fund the Coronavirus and Influenza
Indications License Agreement in furtherance of the Treatment, and possible
future strategic acquisitions of businesses, products or technologies
complementary to our business. These activities will require an increase in
staffing and possible additional property, plant and equipment purchases to
support the expected growth.



Cash used by operating activities represents the cash receipts and disbursements
related to all of our activities other than investing and financing activities.
Operating cash flow is derived by adjusting our net income for non-cash items
and changes in operating assets and liabilities. Net cash used by operating
activities for the years ended June 30, 2021 and 2020 was $20,610,723 and
$10,459,422, respectively, representing an increase of $10,151,301. The increase
is primarily related to the increase in our net loss as adjusted for non-cash
items, partially offset by changes in our operating assets and liabilities
of
$932,133.


Net cash used by investing activities for the years ended June 30, 2021 and 2020
was $48,892 and $184,463, respectively, representing a decrease of $135,571. The
decrease is primarily due to lower costs incurred in purchases of equipment
in
the current year.


Net cash provided by financing activities for the years ended June 30, 2021 and
2020 was $32,601,553 and $7,200,000, respectively, representing an increase of
$25,401,553. The net cash provided by financing activities in the current year
consists primarily of $26,843,998 of net proceeds from the issuance of Common
Stock as part of a direct offering, $5,000,800 of proceeds from the issuance of
Common Stock through a private placement, and $1,221,350 proceeds from issuance
of Common Stock related to equity line draws. The prior year net cash from
financing activities primarily consisted of $1,200,000 related to a convertible
note payable, $5,000,000 related to a long-term note payable, and $1,000,000
related to warrants exercised.



40






Off-Balance Sheet Arrangements

As of June 30, 2021, and 2020, we had no off-balance sheet arrangements. We are not aware of any material transactions, which are not disclosed in our consolidated financial statements.

Significant Accounting Policies and Critical Accounting Estimates




Our management's discussion and analysis of our financial condition and results
of operations is based on our consolidated financial statements, which have been
prepared in accordance with accounting principles generally accepted in the U.S.
The preparation of these financial statements requires us to make estimates and
assumptions that affect the reported amounts of assets, liabilities and
expenses. On an on-going basis, we evaluate our critical accounting policies and
estimates. We base our estimates on historical experience and on various other
assumptions that we believe to be reasonable in the circumstances, the results
of which form the basis for making judgments about the carrying values of assets
and liabilities that are not readily apparent from other sources. Actual results
may differ from these estimates under different assumptions and conditions. Our
most critical accounting estimates are detailed below, and our significant
accounting policies are more fully described in Note 1 of the accompanying
consolidated financial statements.



Intangible Assets - The Company has both Definite and Indefinite life intangible assets.

Definite life intangible assets relate to 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 capitalized 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. Definite life
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
acquired in a business combination. The Company accounts for indefinite life
intangible assets in accordance with ASC 350, License agreement costs represent
the fair value of the license agreement on the date acquired and are tested
annually for impairment.



Goodwill - Goodwill is not amortized but is evaluated for impairment annually as
of June 30 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 IPR&D and goodwill at June 30, 2021, 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 less, 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 (see
Note
3.)



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. Under the authoritative guidance, 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 established 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.




41






There were no assets that use Level 1, 2 or 3 inputs, nor any liabilities that use Level 1 or 2 inputs as of June 30, 2021.

Liabilities that use Level 3 inputs held as of June 30, 2021 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
the Acquisition and is subsequently remeasured to fair value at each reporting
date. At June 30, 2021, 1,350,000 contingent shares are issuable in connection
with the Acquisition.


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
value of the Company's underlying stock. The key inputs to valuing the
contingent consideration liability on the date of acquisition and as of June 30,
2021 include the Company's stock price, the exercise price of the warrants of
$1.30 per share, the risk-free rate, the expected volatility of the Company's
common stock and the digital call rate. The 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.



Stock-Based Compensation - The Company has granted stock options, restricted
share units ("RSUs") and warrants to certain employees, officers, directors and
consultants. The Company accounts for options in accordance with the provisions
of FASB ASC Topic 718, Compensation - Stock Compensation. Stock based
compensation costs for the vesting of options and RSUs granted to certain
employees, officers, directors and consultants for the years ended June 30, 2021
and 2020 were $1,444,798 and $1,028,721, respectively (see Note 7 to the
Financial Statements).



The Company recognizes compensation costs for stock option awards to employees,
officers 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 the expected term of the award, the underlying stock price volatility, the
risk-free interest rate and the expected dividend yield.



The Company records stock-based compensation for services received from
non-employees in accordance with ASC 718, Compensation-Stock Compensation
Non-Employees. All transactions in which goods or services are the consideration
received for the issuance of equity instruments are accounted for based on the
fair value of the consideration received or the fair value of the equity
instrument issued, whichever is more reliably measurable. Equity instruments
issued to 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 consultants' required service period, which is
generally the vesting period (see Note 7 to the Financial Statements.)



Recently Enacted Accounting Standards




For a description of accounting changes and recent accounting standards,
including the expected dates of adoption and estimated effects, if any, on our
consolidated financial statements, see "Note 1: Recent Accounting
Pronouncements" in the financial statements included elsewhere in this Annual
Report.

© Edgar Online, source Glimpses

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Financials (USD)
Sales 2021 - - -
Net income 2021 -26,7 M - -
Net cash 2021 13,3 M - -
P/E ratio 2021 -8,77x
Yield 2021 -
Capitalization 431 M 431 M -
EV / Sales 2020 -
EV / Sales 2021 -
Nbr of Employees 11
Free-Float 38,5%
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Managers and Directors
Mark Richard Dybul Executive Vice Chairman & Chief Executive Officer
Luisa Puche Chief Financial Officer
Rene Sindlev Chairman
Joseph R. Cohen Director-Research & Discovery
Carl Sandler Independent Director
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