Item 2. |
Management’s Discussion and
Analysis of Financial Condition and Results of Operations.
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You should read this discussion together with the
unaudited interim condensed consolidated financial statements,
related notes, and other financial information included elsewhere
in this Quarterly Report on Form 10-Q together with our audited
consolidated financial statements, related notes, and other
information contained in the Form 10-K/A filed with the
Securities and Exchange
Commission (the “SEC”) on June 30, 2022 (the “10-K/A”),
as well as the information contained
in our Annual Report on Form 10-K for the year ended December 31,
2021 (the “Original 10-K”), filed with the SEC on April 15, 2022,
to the extent the information contained in the Original 10-K was
not superseded by the information contained in the 10-K/A. The
following discussion contains assumptions, estimates and other
forward-looking statements that involve a number of risks and
uncertainties, including those discussed under “Risk Factors,” in
Part I, Item 1A of the 10-K/A and as described from time to time in
our other filings with the SEC. These risks could cause our actual
results to differ materially from those anticipated in these
forward-looking statements.
Overview
We are a
biopharmaceutical company utilizing our mRNA technology platform,
including mRNA-based cell reprogramming and gene editing
technologies, to create next generation mRNA, gene-editing and cell
therapies, including iPSC therapies for multiple therapeutic
indications. Our mRNA technology platform, which includes
novel lipid nanoparticles (“LNPs”) for mRNA delivery and targeted
transgene insertion, was acquired through a license with Factor
Bioscience Limited, or Factor, and through our acquisition of
Novellus, Inc. and Novellus, Ltd. in July 2021, which we refer to
as the Acquisition.
Merger with NTN Buzztime,
Inc.
On March 25,
2021, we completed the Merger with NTN Buzztime, Inc. In accordance
with the Merger Agreement, on March 25, 2021, Brooklyn amended its
restated certificate of incorporation in order to effect:
• prior
to the Merger, a reverse stock split of its common stock, par value
$0.005 per share, at a ratio of one-for-two; and
•
following the Merger, a change in its corporate name from “NTN
Buzztime, Inc.” to “Brooklyn ImmunoTherapeutics, Inc.”
On March 26,
2021, we sold the rights, title and interest in and to the assets
relating to the business operated under the name “NTN Buzztime,
Inc.” prior to the Merger to eGames.com Holdings LLC, or
eGames.com, in exchange for eGames.com’s payment of a purchase
price of $2.0 million and assumption of specified liabilities
relating to such pre-Merger business. This transaction, which we
refer to as the Disposition, was completed in accordance with the
terms of an asset purchase agreement dated September 18, 2020, as
amended, between us and eGames.com.
The Merger has
been accounted for as a reverse acquisition in accordance with U.S.
generally accepted accounting principles, or GAAP. Under this
method of accounting, Brooklyn LLC was deemed the “acquiring”
company and Brooklyn (then known as NTN Buzztime, Inc.) was treated
as the “acquired” company for financial reporting purposes.
Operations prior to the Merger are those of Brooklyn LLC, and the
historical financial statements of Brooklyn LLC became the
historical financial statements of Brooklyn with respect to periods
prior to the completion of the Merger.
Acquisition of Novellus
On July 16,
2021, we acquired Novellus, Inc. and Novellus, Inc.’s wholly owned
subsidiary, Novellus, Ltd. Brooklyn also acquired 25.0% of the
total outstanding equity interests of NoveCite, Inc. As
consideration for the Acquisition, we paid $22.9 million in cash
and delivered 7,022,000 shares of common stock, which under the
terms of the Acquisition Agreement, were valued at a total of
$102.0 million based on an agreed upon price of $14.5253 per
share. At the date of issuance, the fair value of the shares
was approximately $58.7 million.
mRNA, Gene-Editing, and Cellular
Medicines
We are
advancing the technology that we obtained through a license with
Factor and through the Acquisition of Novellus, Inc. and Novellus,
Ltd. in July 2021 to evaluate and develop mRNA, gene-editing, and
cellular medicines, with an initial focus on hematologic and solid
tumors. We expect that the first-generation product candidates will
include gene-editing mRNA for in vivo cell engineering and induced
pluripotent stem cell (“iPSC”)-derived cytotoxic lymphocytes
(“iCLs”) and immune-modulating cells (“iIMCs”). We expect to begin
preclinical development, including manufacturing process
development, of iCLs and iIMCs for clinical indications including
hematologic and solid tumors, as well as other indications that
require overcoming molecular cues of the tissue microenvironment.
The prior work of Novellus and NoveCite shows evidence for
preclinical efficacy of iPSC-derived cells in inflammatory
conditions (for example, acute respiratory distress syndrome, or
ARDS). Interactions with the FDA provided guidance on Chemistry,
Manufacturing and Controls (“CMC”), and manufacturing plans, which
will be undertaken in a similar manner for additional applications.
We expect that second generation products will involve more complex
gene editing, for which we anticipate using the stepwise addition
of genes provided by the in-licensed Factor Bioscience gene editing
machinery, NoveSlice, to efficiently place genes and regulatory
sequences into safe harbor locations. Development of processes to
advance CMC and manufacturing will follow the experience from first
generation products. We are also exploring opportunities to advance
in vivo mRNA cell engineering therapies for hematologic and solid
tumors by combining the NoveSlice gene editing technology with
ToRNAdoTM,
the in-licensed LNP technology.
IRX-2
IRX-2 is a
mixed, human-derived cytokine product with multiple active
constituents including Interleukin-2, or IL2, and other key
cytokines. Together, these cytokines are believed to signal,
enhance and restore immune function suppressed by the tumor, thus
enabling the immune system to attack cancer cells, unlike many
existing cancer therapies, which rely on targeting the cancer
directly. IRX-2 is prepared from the supernatant of pooled
allogeneic peripheral blood mononuclear cells, known as PBMCs, that
have been stimulated using a proprietary process employing a
specific population of cells and a specific mitogen.
Unlike
existing recombinant IL2 therapies, IRX-2 is derived from human
blood cells. We believe this may promote better tolerance, broader
targeting and a natural molecular conformation leading to greater
activity, and may permit low physiologic dosing, rather than the
high doses needed in other existing IL2 therapies.
Results of the
Phase 2b INSPIRE trial, or the INSPIRE trial, released in June
2022, showed outcomes favored IRX-2 in certain predefined subgroups
but the INSPIRE trial did not meet the primary endpoint of
Event-Free Survival (“EFS”) at two years of follow up. One hundred
and fifty patients were enrolled in the study. At two years of
follow-up in the intention-to-treat (ITT, n=105) population the
median EFS was 48.3 months and was not reached in the control arm
(Hazard Ratio 1.10 (95% Confidence Interval, 0.6-2.1; p
value=0.62)). Subgroups favoring the IRX-2 arm included patients
with later stage (III and IV) disease and those that did not
receive chemotherapy. Trends in EFS rates as defined by the
Kaplan-Meier estimate at two years of follow-up in patients with
later stage (III and IV) disease were 57.2 (40.3, 70.9) vs 49.4
(28.3, 67.4) in favor of IRX-2. In patients that did not receive
chemotherapy (radiation only) as part of adjuvant treatment, the
EFS Kaplan-Meier estimate at two years of follow-up was 76.4 (52.2,
89.4) vs 60.6 (29.4, 81.4) in favor of IRX-2. There were no new
safety signals observed with IRX-2. We currently do not have plans
to further develop the IRX-2 product candidate.
Impact of COVID-19
Pandemic
The
development of our product candidates has been, and could continue
to be, disrupted and materially adversely affected by past and
continuing impacts of the COVID-19 pandemic. This is largely a
result of measures imposed by the governments and hospitals in
affected regions, businesses and schools were suspended due to
quarantines intended to contain this outbreak. The spread of
COVID-19 from China to other countries resulted in the Director
General of the World Health Organization declaring COVID-19 a
pandemic in March 2020. Despite progress in vaccination efforts,
the longer-term impact of the COVID-19 pandemic on our development
plans and on the ability to conduct our clinical trials remains
uncertain and cannot be predicted with confidence. COVID-19 could
continue to disrupt production and cause delays in the supply and
delivery of products used in our operations, may affect our
operations, including the conduct of clinical studies, or the
ability of regulatory bodies to grant approvals or supervise our
candidates and products, may further divert the attention and
efforts of the medical community to coping with the COVID-19 and
disrupt the marketplace in which we operate and may have a material
adverse effects on our operations. COVID-19 may also affect our
employees and employees and operations at suppliers that may result
in delays or disruptions in supply. In addition, a recession or
market correction resulting from the spread of COVID-19 could
materially affect our business and the value of our common stock.
Additionally, if the COVID-19 pandemic has a significant impact on
our business and financial results for an extended period of time,
our liquidity and cash resources could be negatively impacted. The
extent to which the COVID-19 pandemic and ongoing global efforts to
contain its spread will impact our operations will depend on future
developments, which are highly uncertain, and include the duration,
severity and scope of the pandemic and the actions taken to contain
or treat the COVID-19 pandemic. Further, the specific clinical
outcomes, or future pandemic related impacts of emerging COVID-19
variants cannot be reliably predicted.
Recent
Developments
PIPE Transaction
On March 6,
2022, we entered into a Securities Purchase Agreement with an
investor (the “PIPE Investor”) providing for the private placement
(the “PIPE Transaction”) to the PIPE Investor of approximately
6,857,000 units (the “Units”), each of which consisted of (i)
one share of our common stock (or, in lieu thereof, one pre-funded
warrant (the “Pre-Funded Warrants”) to purchase one share of common
stock) and (ii) one warrant (the “Common Warrants”) to purchase one
share of common stock, for an aggregate purchase price of
approximately $12.0 million (the “Subscription Amount”). The PIPE
Transaction closed on March 9, 2022. We incurred fees of $1.0
million through June 30, 2022 related to the PIPE
Transaction.
Each
Pre-Funded Warrant has an exercise price of $0.005 per share of
common stock, was immediately exercisable and may be exercised at
any time and has no expiration date and is subject to customary
adjustments. The Pre-Funded Warrants may not be exercised if the
aggregate number of shares of common stock beneficially owned by
the holder thereof would exceed 9.99% immediately after exercise
thereof.
Each Common
Warrant has an exercise price of $1.91 per share, becomes
exercisable six months following the closing of the PIPE
Transaction, expires five-and-one-half years from the date of
issuance, and is subject to customary adjustments. The Common
Warrants may not be exercised if the aggregate number of shares of
common stock beneficially owned by the holder thereof would exceed
4.99% immediately after exercise thereof, subject to increase to
9.99% at the option of the holder.
The Common
Warrants and Pre-Funded Warrants were accounted for as liabilities
under ASC 815-40, Derivatives and
Hedging, Contracts in Entity’s Own Equity, as these warrants
provide for a cashless settlement provision that fails the
requirement of the indexation guidance under ASC 815-40. The
warrant liabilities are measured at fair value at inception and on
a recurring basis, with changes in fair value presented within the
statement of operations.
The fair
values of the Common Warrants and the Pre-Funded Warrants at the
issuance date totaled $12.6 million in the aggregate, which was
$0.6 million more than the Subscription Amount. The excess
$0.6 million represents an inducement to the PIPE Investor to enter
into the PIPE Transaction and was recorded in warrant liabilities
expense in the accompanying consolidated statement of
operations.
In connection
with the PIPE Transaction, we and the PIPE Investor also entered
into a registration rights agreement, dated March 6, 2022, pursuant
to which we agreed to prepare and file a registration statement
with the Securities and Exchange Commission (the “SEC”) to register
the resale of the shares of common stock included in the Units and
the shares of common stock issuable upon exercise of the Pre-Funded
Warrants and the Common Warrants. We agreed to use our best efforts
to have such registration statement declared effective as promptly
as possible after the filing thereof, subject to certain specified
penalties if timely effectiveness is not achieved. We filed
such registration statement on April 29, 2022, which became
effective on May 11, 2022.
Pursuant to the registration rights agreement, we are obligated to
pay the PIPE Investor liquidated damages equal to 2% of the
Subscription Amount per month, with a maximum aggregate payment of
12% of the Subscription Amount, in the event the PIPE Investor is
not permitted to use the registration statement to resell the
related securities for more than 10 consecutive calendar days or
more than an aggregate of fifteen calendar days (which need not be
consecutive calendar days) during any 12-month period.
On
May 24, 2022, we provided the PIPE Investor with notice that it was
not able to resell the securities under the registration agreement
because we did not timely file our Quarterly Report on Form 10-Q
(the “Q1 2022 10-Q”) with the SEC, and that the PIPE Investor could
not use the registration statement to resell the related securities
until we filed the Q1 2022 10-Q. Because the PIPE Investor
was unable to use the resale registration statement for at least 10
consecutive calendar days, we accrued $0.2 million during the first
quarter of 2022 for the estimated contingent loss we expect to
incur as a result of the late Q1 2022 10Q filing, which is recorded
in other expense, net for the six months ended June 30, 2022 in the
accompanying condensed consolidated statements of operations.
We paid the $0.2 million liquidated damages payment in June
2022.
On
June 30, 2022, we filed the Q1 2022 10-Q along with the 10-K/A, and
on July 1, 2022, we provided notice to the PIPE Investor that it
may resume use of the resale registration statement.
Basis of
Presentation
Revenues
We are a
development stage company and have had no revenues from product
sales to date. We will not have revenues from product sales until
such time as we receive regulatory approval of our product
candidates, successfully commercialize our products or enter into a
licensing agreement which may include up-front licensing fees, of
which there can be no assurance.
Research and Development Expenses
We expense our
research and development costs as incurred. Our research and
development expenses consist of costs incurred for
company-sponsored research and development activities, as well as
support for selected investigator-sponsored research. Upfront
payments and milestone payments for the licensing of technology are
expensed as research and development in the period in which they
are incurred if the technology is not expected to have any
alternative future uses other than the specific research and
development project for which it was intended. In-Process Research
and Development (“IPR&D”) that is acquired through an asset
acquisition and has no alternative future uses and, therefore, no
separate economic values, is expensed to research and development
costs at the time the costs are incurred.
The major
components of research and development costs include preclinical
study costs, clinical manufacturing costs, clinical study and trial
expenses, insurance coverage for clinical trials, expensed licensed
technology, consulting, scientific advisors and other third-party
costs, salaries and employee benefits, stock-based compensation
expense, supplies and materials and allocations of various overhead
costs related to our product development efforts.
In the normal
course of our business, we contract with third parties to perform
various clinical study and trial activities in the on-going
development and testing of potential products. The financial terms
of these agreements are subject to negotiation and vary from
contract to contract and may result in uneven payment flows.
Payments under the contracts depend on factors such as the
achievement of certain events or milestones, the successful
enrollment of patients, the allocation of responsibilities among
the parties to the agreement, and the completion of portions of the
clinical study or trial or similar conditions. Preclinical and
clinical study and trial associated activities such as production
and testing of clinical material require significant up-front
expenditures. We anticipate paying significant portions of a
study’s or trial’s cost before such begins and incurring additional
expenditures as the study or trial progresses and reaches certain
milestones.
General and Administrative Expenses
Our general
and administrative expenses consist primarily of salaries, benefits
and other costs, including equity-based compensation, for our
executive and administrative personnel, legal and other
professional fees, travel, insurance, and other corporate
costs.
Results of
Operations
Comparison of
the Three and Six Months Ended June 30, 2022 and 2021
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Three
months ended June 30,
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Change
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Six months
ended June 30,
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Change
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2022
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2021
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2022
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2021
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(in
thousands)
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Operating expenses:
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Research and development
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$
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1,685
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$
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5,432
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