|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OFTHE SECURITIES EXCHANGE ACT OF 1934
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|
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(State or Other Jurisdiction of
Incorporation or Organization)
|
(I.R.S. Employer
Identification No.)
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|
|
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(Address of Principal Executive Offices)
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(Zip Code)
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Title of Each Class
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Trading Symbol(s)
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Name of Each Exchange on Which Registered
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||
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|
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Large accelerated filer ☐
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Accelerated filer ☐
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Smaller reporting company
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Emerging growth company |
• |
overstatement of IPR&D by $870,000 as of both December 31, 2020 and 2021;
|
• |
overstatement of security deposits and other assets by $34,000 as of December 31, 2021;
|
• |
overstatement of total assets by $870,000 and $904,000 as of December 31, 2020 and 2021, respectively;
|
• |
overstatement of the contingent consideration liability by $20,110,000 and $19,930,000 as of December 31, 2020 and 2021, respectively;
|
• |
understatement of other liabilities by $25,000 as of December 31, 2021;
|
• |
overstatement of accumulated deficit by $19,240,000 and $19,001,000 as of December 31, 2020 and 2021, respectively;
|
• |
understatement of total stockholders’ and members’ equity by $19,240,000 and $19,001,000 as of December 31, 2020 and 2021, respectively;
|
• |
overstatement of expense related to the change in fair value of the contingent consideration by $19,240,000 for the year ended December 31, 2020 and overstatement of the credit to the
change in fair value of the contingent consideration by $180,000 for the year ended December 31, 2021;
|
• |
understatement of provision for income taxes of $59,000 for the year ended December 31, 2021;
|
• |
overstatement of net loss of $19,240,000 and $239,000 for the years ended December 31, 2020 and 2021, respectively;
|
• |
overstatement of basic and diluted net loss per common share by $1.09 for the year ended December 31, 2020 and understatement of basic and diluted net loss per common share by $0.01 for
the year ended December 31, 2021.
|
• |
overstatement of both IPR&D and total assets by $870,000 as of June 30, 2020, September 30, 2020, March 31, 2021, June 30, 2021 and
September 30, 2021;
|
• |
overstatement of both the contingent consideration liability and total liabilities by $870,000 as of June 30, 2020 and September 30, 2020;
|
• |
overstatement of the contingent consideration liability by $19,290,000 as of March 31, 2021 and June 30, 2021 and $19,360,000 as of
September 30, 2021;
|
• |
overstatement of accumulated deficit of $18,420,000 as of March 31, 2021 and June 30, 2021 and $18,490,000 as of September 30, 2021;
|
• |
understatement of total stockholders’ equity of $18,420,000 as of March 31, 2021 and June 30, 2021 and $18,490,000 as of September 30,
2021;
|
• |
overstatement of the credit to the change in fair value of the contingent consideration by $820,000 for the quarter ended March 31, 2021
and overstatement of expense related to the change in fair value of the contingent consideration of $70,000 for the quarter ended September 30, 2021;
|
• |
overstatement of net loss of $820,000 and $70,000 for the quarters ended March 31, 2021 and September 30, 2021;
|
• |
understatement of basic and diluted net loss per common share of $0.03 for the quarter ended March 31, 2021.
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Item
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Page
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Part I
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1A.
|
1 | |
Part II
|
||
7.
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32 | |
8.
|
41 | |
9A.
|
41 | |
Part IV
|
||
15.
|
43 | |
45 | ||
F-1
|
● |
potential product candidates may, upon further study, be shown to have harmful side effects or other characteristics that indicate that they are unlikely to be products that will
receive marketing approval and achieve market acceptance;
|
● |
potential product candidates may not be effective in treating their targeted diseases; or
|
● |
the acquisition or in-licensing transactions can entail numerous operational and functional risks, including exposure to unknown liabilities, disruption of our business, or incurrence
of substantial debt or dilutive issuances of equity securities to pay transaction consideration or costs, higher than expected acquisition or integration costs.
|
● |
multiple conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, anti-bribery and anti-corruption laws, regulatory requirements
and other governmental approvals, permits and licenses;
|
●
|
failure by us or our collaborators to obtain appropriate licenses or regulatory approvals for the sale or use of IRX-2 or any other product candidate we may acquire or in license;
|
● |
difficulties in managing foreign operations;
|
● |
complexities associated with managing multiple payor-reimbursement regimes or self-pay systems;
|
● |
financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable and exposure to foreign currency exchange rate fluctuations;
|
● |
reduced protection for intellectual property rights;
|
● |
natural disasters, political and economic instability, including wars, terrorism and political unrest, outbreak of disease, boycotts, curtailment of trade and other business
restrictions; and
|
● |
failure to comply with the United States Foreign Corrupt Practices Act, or FCPA, including its books and records provisions and its anti-bribery provisions, the United Kingdom Bribery
Act 2010, or U.K. Bribery Act, and similar anti-bribery and anti-corruption laws in other jurisdictions, for example by failing to maintain accurate information and control over sales or distributors’ activities.
|
● |
the timing, progress, costs and results of our INSPIRE trial for the treatment of squamous cell cancer of the head and neck;
|
● |
the costs of any other clinical trials we may initiate, including the costs to conduct the study and to produce the supply of product that may be required for our own studies or for
investigator-sponsored studies;
|
● |
the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities;
|
● |
the cost of filing, prosecuting, defending and enforcing its patent claims and other intellectual property rights;
|
● |
the cost of defending potential intellectual property disputes, including patent infringement actions brought by third parties against it or any of its current or future product
candidates;
|
● |
the effect of competing market developments;
|
● |
the cost and timing of completion of commercial-scale manufacturing activities;
|
● |
the cost of establishing sales, marketing and distribution capabilities for our products in regions where we choose to commercialize our products on our own; and
|
● |
the initiation, progress, timing and results of the commercialization of our product candidates, if approved for commercial sale.
|
● |
successfully complete pre-clinical studies and clinical trials deemed adequate by regulatory authorities and obtain and maintain regulatory approval for the marketing of our product candidates;
|
● |
receive regulatory approvals from the FDA, the EMA and other similar regulatory authorities;
|
● |
establish and maintain collaborations with third parties for the development and/or commercialization of our product candidates, or otherwise build and maintain strong development, sales, distribution and
marketing capabilities that are sufficient to develop products and launch commercial sales of any approved products, including establishing sales, marketing and distribution systems for our product candidates;
|
● |
obtain coverage and adequate reimbursement from payors such as government health care systems, pharmacy benefit managers, and insurance companies and achieve commercially attractive levels of pricing;
|
● |
secure acceptance of our product candidates from physicians, health care payors, patients and the medical community;
|
● |
produce, through a validated process, in manufacturing facilities inspected and approved by regulatory authorities, including the FDA, sufficiently large quantities of our product candidates to permit
successful commercialization;
|
● |
manage our spending as expenses increase due to government mandated post-approval clinical trials and commercialization;
|
● |
obtain and enforce sufficient intellectual property rights for any approved products and product candidates, maintain, expand and protect our intellectual property portfolio;
|
● |
add operational, financial, and management information systems; personnel, including personnel to support its clinical, manufacturing and planned future commercialization efforts and operations as a public
company;
|
● |
conduct internal or contract manufacturing meeting specifications and in compliance with applicable cGMPs; and
|
● |
initiate and continue relationships with third-party suppliers and manufacturers or continue to further develop our own manufacturing capabilities and have commercial quantities of our product candidates
manufactured at acceptable cost and quality levels and in compliance with the FDA and other regulatory requirements.
|
● |
preclinical studies and clinical trials are long, expensive and unpredictable processes that can be subject to extensive delays;
|
● |
we cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all;
|
● |
it may take several years and require significant expenditures to complete the preclinical studies and clinical trials necessary to commercialize a product candidate, and delays or failure are inherently
unpredictable and can occur at any stage.
|
● |
we may also be required to conduct additional clinical trials or other testing of our product candidates beyond the trials and testing that we contemplate, which may lead to us incurring additional
unplanned costs or result in delays in clinical development;
|
● |
we may be required to redesign or otherwise modify our plans with respect to an ongoing or planned clinical trial and changing the design of a clinical trial can be expensive and time consuming; and
|
● |
an unfavorable outcome in one or more trials would be a major setback for our product candidates and for us. It may require us to delay, reduce the scope of or eliminate one or more product development
programs, which could have a material adverse effect on our business, financial position, results of operations and future growth prospects.
|
● |
We may not be able to demonstrate that any product candidate is safe or effective as a treatment for any of our currently or future targeted indications to the satisfaction of the FDA
or other relevant regulatory authorities.
|
● |
The relevant regulatory authorities may require additional pre-approval studies or clinical trials which would increase our costs and prolong development timelines or could grant
conditional approval with a requirement to perform additional studies at a significant cost.
|
● |
The results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or other relevant regulatory authorities for marketing approval.
|
● |
The FDA or other relevant regulatory authorities may disagree with the number, design, size, conduct or implementation of our clinical trials, including the design of its future pivotal
Phase 3 clinical trials.
|
● |
Contract Research Organizations (“CROs”) that we may retain to conduct clinical trials may take actions outside of our control, or otherwise commit errors or violations of protocols,
that adversely impact our clinical trials and ability to obtain market approvals.
|
● |
The FDA or other relevant regulatory authorities may not find the data from nonclinical studies or clinical trials sufficient to demonstrate that the clinical and other benefits of
these products outweigh their safety risks.
|
●
|
The FDA or other relevant regulatory authorities may disagree with our interpretation of data or significance of results from the nonclinical studies and clinical trials of IRX - 2
or any other product candidate we may acquire or in-license or may require that it conduct additional studies.
|
●
|
The FDA or other relevant regulatory authorities may not accept data generated from our clinical trial sites.
|
● |
If our MA or other foreign application is reviewed by an advisory committee, the FDA or other relevant regulatory authority, may have difficulties scheduling an advisory committee
meeting in a timely manner or the advisory committee may recommend against approval of such application or may recommend that the FDA or other relevant regulatory authority require, as a condition of approval, additional nonclinical
studies or clinical trials, limitations on approved labeling or distribution and use restrictions.
|
● |
The FDA or other relevant regulatory authorities may require development of a REMS, or its equivalent, as a condition of approval.
|
● |
The FDA or other relevant regulatory authorities may require additional post-marketing studies and/or a patient registry, which would be costly.
|
● |
The FDA or other relevant regulatory authorities may find the chemistry, manufacturing and controls data insufficient to support the quality of IRX - 2 or any other product candidate we
may acquire or in-license.
|
● |
The FDA or other relevant regulatory authorities may identify deficiencies in the manufacturing processes or facilities of our third-party manufacturer or our own manufacturing
processes or facilities.
|
● |
The FDA or other relevant regulatory authorities may change their approval policies or adopt new regulations.
|
● |
a product candidate is ineffective or inferior to existing approved products for the same indications;
|
● |
patients may die or suffer adverse effects for reasons that may or may not be related to the product candidate being tested;
|
● |
a product candidate causes or is associated with unacceptable toxicity or has unacceptable side effects;
|
● |
the results may not confirm the positive results of earlier trials;
|
● |
we are unable to manufacture sufficient quantities of stable and qualified materials under cGMP for use in clinical studies;
|
● |
we fail to recruit a sufficient number of patients or we have slower than expected rates of patient recruitment;
|
● |
modification of clinical study protocols is necessary;
|
● |
there may be changes in regulatory requirements for clinical studies;
|
● |
there is a lack of effectiveness during clinical studies;
|
● |
there is an emergence of unforeseen safety issues;
|
● |
there may be delays, suspension, or termination of the clinical studies due to the IRB responsible for overseeing the study at a particular study site;
|
● |
there could be government or regulatory delays or “clinical holds” requiring suspension or termination of the studies; and
|
● |
our collaborators may be unable or unwilling to perform under their contracts.
|
● |
size of the patient population and process for identifying subjects;
|
● |
design of the trial protocol;
|
● |
eligibility and exclusion criteria;
|
● |
safety profile, to date, of the product candidate under study;
|
● |
perceived risks and benefits of the product candidate under study;
|
● |
perceived risks and benefits of our approach to treatment of diseases;
|
● |
availability of competing therapies and clinical trials;
|
● |
severity of the disease under investigation;
|
● |
degree of progression of the subject’s disease at the time of enrollment;
|
● |
proximity and availability of clinical trial sites for prospective subjects;
|
● |
ability to obtain and maintain subject consent;
|
● |
risks that enrolled patients will drop out before completion of the trial;
|
● |
patient referral services of physicians; and
|
● |
ability to monitor subjects adequately during and after treatment.
|
● |
decreased demand for our product candidates;
|
● |
injury to our reputation;
|
● |
withdrawal of clinical trial participants;
|
● |
costs to defend the related litigation;
|
● |
a diversion of management’s time and its resources;
|
● |
substantial monetary awards to trial participants or patients;
|
● |
product recalls, withdrawals or labeling, marketing or promotional restrictions;
|
●
|
the inability to commercialize our product candidates; and
|
● |
a decline in the value of the common stock.
|
● |
regulatory authorities may withdraw their approval of the product or seize the product;
|
● |
we, or any collaborators, may need to recall the product, or be required to change the way the product is administered or conduct additional clinical trials;
|
● |
additional restrictions may be imposed on the marketing of, or the manufacturing processes for, the product;
|
● |
we may be subject to fines, injunctions or the imposition of civil or criminal penalties;
|
● |
regulatory authorities may require the addition of labeling statements, such as a boxed warning or a contraindication;
|
● |
we, or any collaborators, may be required to create a medication guide outlining the risks of the previously unidentified side effects for distribution to patients;
|
● |
we, or any collaborators, could be sued and held liable for harm caused to patients;
|
● |
the product may become less competitive; and
|
● |
our reputation may suffer.
|
● |
the demand for our product candidates, if we obtain regulatory approval;
|
● |
our ability to set a price that we believe is fair for our products;
|
● |
our ability to generate revenue and achieve or maintain profitability;
|
● |
the level of taxes that we are required to pay; and
|
● |
the availability of capital.
|
● |
the inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
|
● |
the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future product that we may develop;
|
● |
the lack of complementary treatments to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
|
● |
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
● |
the potential efficacy and potential advantages over alternative treatments;
|
● |
the frequency and severity of any side effects, including any limitations or warnings contained in a product’s approved labeling;
|
● |
the frequency and severity of any side effects resulting from follow-up requirements for the administration of our product candidates;
|
● |
the relative convenience and ease of administration;
|
● |
the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
|
●
|
the strength of marketing and distribution support and timing of market introduction of competitive products;
|
● |
formulary acceptance;
|
● |
publicity concerning our products or competing products and treatments; and
|
● |
sufficient third-party insurance coverage and adequate reimbursement.
|
● |
collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
|
● |
collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs based on
preclinical or clinical study results, changes in the collaborators’ strategic focus or available funding, or external factors such as an acquisition that diverts resources or creates competing priorities;
|
● |
collaborators may delay clinical studies, provide insufficient funding for a clinical study program, stop a clinical study or abandon a product candidate, repeat or conduct new clinical
studies or require a new formulation of a product candidate for clinical testing;
|
● |
collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates if the collaborators believe that
competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours;
|
● |
collaborators with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;
|
● |
collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or
invalidate its intellectual property or proprietary information or expose it to potential litigation;
|
● |
collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
|
● |
disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product candidates or that result in costly litigation or
arbitration that diverts management attention and resources; and
|
● |
collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
|
ITEM 7. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
• |
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.”
|
Years Ended December 31,
|
Change
|
% Change
|
||||||||||||||
|
2021
|
2020
|
||||||||||||||
|
(As restated) |
(As restated) | ||||||||||||||
Operating expenses: | ||||||||||||||||
Research and development
|
$ |
12,705,000
|
$ |
3,951,000
|
$ |
8,754,000
|
|
222
|
%
|
|||||||
Acquired in-process research and development
|
80,538,000
|
-
|
80,538,000
|
N/A
|
||||||||||||
General and administrative
|
14,724,000
|
3,297,000
|
11,427,000
|
347
|
%
|
|||||||||||
Transaction costs
|
5,765,000
|
-
|
5,765,000
|
N/A
|
||||||||||||
Total operating expenses
|
113,732,000
|
7,248,000
|
106,484,000
|
1,469 |
%
|
|||||||||||
Loss from operations
|
(113,732,000
|
)
|
(7,248,000
|
)
|
(106,484,000
|
)
|
1,469
|
%
|
||||||||
Other expenses:
|
||||||||||||||||
Loss on sale of NTN assets
|
(9,648,000
|
)
|
-
|
(9,648,000
|
)
|
N/A
|
||||||||||
Other income (expense), net
|
899,000
|
(43,000
|
)
|
942,000
|
-2,191
|
%
|
||||||||||
Total other expense
|
(8,749,000
|
)
|
(43,000
|
)
|
(8,706,000
|
)
|
20,247
|
%
|
||||||||
Loss before income taxes
|
(122,481,000
|
)
|
(7,291,000
|
)
|
(115,190,000
|
)
|
1,580
|
%
|
||||||||
Provision for income taxes
|
(64,000
|
)
|
-
|
(64,000
|
)
|
N/A
|
||||||||||
Net loss
|
(122,545,000
|
)
|
(7,291,000
|
)
|
(115,254,000
|
)
|
1,581
|
%
|
||||||||
Series A preferred stock dividend
|
(16,000
|
)
|
-
|
(16,000
|
)
|
N/A
|
||||||||||
Net loss attributable to common stockholders
|
$
|
(122,561,000
|
)
|
$
|
(7,291,000
|
)
|
$
|
(115,270,000
|
)
|
1,581
|
%
|
|
Years Ended December 31,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
License fees
|
$
|
6,500,000
|
$
|
-
|
$
|
6,500,000
|
N/A
|
|||||||||
Stock-based compensation
|
1,597,000
|
-
|
1,597,000
|
N/A
|
||||||||||||
Clinical trials
|
1,292,000
|
412,000
|
880,000
|
214
|
%
|
|||||||||||
Payroll-related
|
2,342,000
|
1,985,000
|
357,000
|
18
|
%
|
|||||||||||
Other expenses, net
|
974,000
|
1,554,000
|
(580,000
|
)
|
-37
|
%
|
||||||||||
Total research and development expenses
|
$
|
12,705,000
|
$
|
3,951,000
|
$
|
8,754,000
|
222
|
%
|
|
Years Ended December 31,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Professional fees
|
$
|
7,351,000
|
$
|
2,352,000
|
$
|
4,999,000
|
213
|
%
|
||||||||
Stock-based compensation
|
3,638,000
|
91,000
|
3,547,000
|
3898
|
%
|
|||||||||||
Payroll-related
|
1,299,000
|
(98,000
|
)
|
1,397,000
|
-1426
|
%
|
||||||||||
Insurance
|
1,134,000
|
122,000
|
1,012,000
|
830
|
%
|
|||||||||||
Other expenses, net
|
1,302,000
|
830,000
|
472,000
|
57
|
%
|
|||||||||||
Total general and administrative expenses
|
$
|
14,724,000
|
$
|
3,297,000
|
$
|
11,427,000
|
347
|
%
|
Years Ended December 31,
|
||||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Employer retention tax credit
|
$
|
664,000
|
$
|
664,000
|
N/A
|
|||||||||||
Income from Brooklyn PPP loan forgiveness
|
310,000
|
-
|
310,000
|
N/A
|
||||||||||||
Other expenses, net
|
(1,000
|
)
|
-
|
(1,000
|
)
|
N/A
|
||||||||||
Interest expense, net
|
(74,000
|
)
|
(43,000
|
)
|
(31,000
|
)
|
72
|
%
|
||||||||
Total other income (expense), net
|
$
|
899,000
|
$
|
(43,000
|
)
|
$
|
942,000
|
-2191
|
%
|
• |
the scope, rate of progress and cost of our clinical trials and other product development activities;
|
• |
future clinical trial results;
|
• |
the terms and timing of any collaborative, licensing and other agreements that we may establish;
|
• |
the cost and timing of regulatory approvals;
|
• |
the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products;
|
• |
the cost and timing of establishing sales, marketing and distribution capabilities;
|
• |
the effect of competition and market developments; and
|
• |
the cost of filing and potentially prosecuting, defending and enforcing any patent claims and other intellectual property rights.
|
• |
Level 1 Inputs – Valued based on quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date.
|
• |
Level 2 Inputs – Valued based on inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly or indirectly. These might include
quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability
(such as interest rates, volatilities, prepayment speeds, credit risks, etc.) or inputs that are derived principally from or corroborated by market data by correlation or other means.
|
• |
Level 3 Inputs – Valued based on inputs for which there is little or no market value, which require the reporting entity to develop its own assumptions.
|
ITEM 8. |
Financial Statements and Supplementary Data
|
ITEM 9A. |
Controls and Procedures
|
•
|
hiring additional accounting personnel in a number, and with experience, to allow for proper segregation of duties and
the accurate application of GAAP, including a chief financial officer, whom we hired in May of 2022;
|
•
|
developing and implementing, and then monitoring the effectiveness of, written policies and procedures required to
achieve our financial reporting objectives in a timely manner, including policies and procedures relating to internal control over financial reporting;
|
•
|
providing additional training to accounting personnel; and
|
•
|
consulting with an accounting advisor for technical, complex and non-recurring matters.
|
ITEM 15. |
Exhibits, Financial Statement Schedules
|
Exhibit
|
Description
|
Incorporated By Reference
|
||
Agreement and Plan of Merger and Reorganization, dated August 12, 2020, among NTN Buzztime, Inc., BIT Merger Sub, Inc. and Brooklyn ImmunoTherapeutics LLC
|
Annex A to the proxy statement/prospectus/consent solicitation statement forming a part of the S-4 Registration Statement filed on January 20, 2021
|
|||
Agreement and Plan of Acquisition, dated as of July 16, 2021, by and among Brooklyn ImmunoTherapeutics, Inc., Brooklyn Acquisition Sub, Inc., Novellus LLC, Novellus, Inc., and the Sellers’ Representative.
|
Exhibit to Form 8-K filed on July 19, 2021
|
|||
Restated Certificate of Incorporation
|
Exhibit to Form 10-Q filed on August 14, 2013
|
|||
Certificate of Amendment to the Restated Certificate of Incorporation (reverse/forward split)
|
Exhibit to Form 8-K filed on June 17, 2016
|
|||
Certificate of Decrease of the Series A Convertible Preferred Stock
|
Exhibit to Form 8-K filed on April 12, 2017
|
|||
Certificate of Amendment to the Restated Certificate of Incorporation (decrease in authorized capital stock)
|
Exhibit to Form 8-K filed on June 9, 2017
|
|||
Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Reverse Stock Split)
|
Exhibit to Form 8-K filed on March 31, 2021
|
|||
Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Authorized Share Increase)
|
Exhibit to Form 8-K filed on March 31, 2021
|
|||
Certificate of Amendment to Restated Certificate of Amendment, dated March 25, 2021 (Name Change)
|
Exhibit to Form 8-K filed on March 31, 2021
|
|||
Certificate of Validation of Brooklyn ImmunoTherapeutics, Inc., as filed with the Secretary of State of the State of Delaware on September 3, 2021
|
Exhibit to Form 8-K filed on September 13, 2021
|
|||
Amended and Restated Bylaws of Brooklyn ImmunoTherapeutics, Inc.
|
Exhibit to Form 8-K filed on September 23, 2021
|
|||
Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
|
Exhibit 4.1 to Form 10-K filed on April 15, 2022
|
|||
Registration Rights Agreement, dated as of April 26, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Lincoln Park Capital Fund, LLC
|
Exhibit to Form 8-K filed on April 30, 2021
|
|||
Registration Rights Agreement, dated as of May 26, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Lincoln Park Capital Fund, LLC
|
Exhibit to Form 8-K filed on May 26, 2021
|
|||
Registration Rights Agreement, dated as of July 16, 2021, by and among Brooklyn ImmunoTherapeutics, Inc. and the individuals and entities named therein.
|
Exhibit to Form 8-K filed on July 19, 2021
|
|||
Amended and Restated Royalty Agreement and Distribution Agreement, dated March 22, 2021.
|
Exhibit to Form 8-K filed on March 31, 2021
|
|||
10.5(a)
|
Assignment and Assumption of Employment Agreement dated March 30, 2021 among Brooklyn ImmunoTherapeutics, LLC, Brooklyn ImmunoTherapeutics, Inc. and Ronald Guido.
|
Exhibit to Form 8-K filed on March 31, 2021
|
10.6(a)
|
Assignment and Assumption of Employment Agreement dated March 30, 2021 among Brooklyn ImmunoTherapeutics, LLC, Brooklyn ImmunoTherapeutics, Inc. and Lynn Sadowski Mason.
|
Exhibit to Form 8-K filed on March 31, 2021
|
||
10.7(a)
|
Executive Employment Agreement, dated as of April 1, 2021 and effective as of April 16, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Howard J. Federoff.
|
Exhibit to Form 8-K filed on April 7, 2021
|
||
10.8(a)
|
Executive Employment Agreement, dated as of June 5, 2021 and effective as of June 28, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Kevin D’Amour.
|
Exhibit to Form 8-K filed on June 10, 2021
|
||
10.9(a)
|
Executive Employment Agreement, dated as of June 16, 2021 and effective as of June 21, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Sandra Gurrola.
|
Exhibit to Form 8-K filed on June 21, 2021
|
||
10.10(a)
|
Executive Employment Agreement, dated as of July 6, 2021 and effective as of July 15, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Jay Sial.
|
Exhibit to Form 8-K filed on July 19, 2021
|
||
10.11(a)
|
Executive Employment Agreement, effective as of September 20, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Roger Sidhu.
|
Exhibit to Form 8-K filed on September 23, 2021
|
||
Form of Indemnification Agreement
|
Exhibit to Form 8-K filed on April 16, 2021
|
|||
Purchase Agreement, dated as of April 26, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Lincoln Park Capital Fund, LLC
|
Exhibit to Form 8-K filed on April 30, 2021
|
|||
Purchase Agreement, dated as of May 26, 2021, between Brooklyn ImmunoTherapeutics, Inc. and Lincoln Park Capital Fund, LLC
|
Exhibit to Form 8-K filed on May 26, 2021
|
|||
Exclusive License Agreement, dated as of April 26, 2021, between Factor Bioscience Limited, Novellus Therapeutics Limited and Brooklyn ImmunoTherapeutics LLC
|
Exhibit to Form 8-K filed on April 30, 2021
|
|||
10.16(a)
|
Brooklyn ImmunoTherapeutics, Inc. 2021 Inducement Stock Incentive Plan
|
Exhibit to Form 8-K filed on May 26, 2021
|
||
10.17(a)
|
Brooklyn ImmunoTherapeutics, Inc. Restated 2020 Stock Incentive Plan
|
Exhibit to Form 8-K filed on September 13, 2021
|
||
10.18(c)
|
Lease Agreement, made as of September 28, 2015, between Biobat, Inc. and IRX Therapeutics, LLC
|
Exhibit to Form S-4/A filed on November 25, 2020
|
||
First Amendment to Lease Agreement, dated September 28, 2015
|
Exhibit to Form S-4/A filed on November 25, 2020
|
|||
10.20(c)
|
Assignment and Assumption of Lease, made by and between IRX Therapeutics, LLC and Brooklyn, and consented to by Biobat, Inc., as landlord
|
Exhibit to Form S-4/A filed on November 25, 2020
|
||
Second Amendment to Lease Agreement, dated July 24, 2019
|
Exhibit to Form S-4/A filed on November 25, 2020
|
|||
10.22(c)
|
Sublease Agreement, dated April 18, 2019, between Brooklyn and Nezu Asia Capital Management, LLC
|
Exhibit to Form S-4/A filed on November 25, 2020
|
||
Consent to Sublease and Agreement, dated as of May 18, 2019, among 654 Madison Avenue Associates LP, Brooklyn, and Nezu Asia Capital Management, LLC
|
Exhibit to Form S-4/A filed on November 25, 2020
|
|||
Commencement Date Confirmation Agreement, made as of June 27, 2019, among Brooklyn and Nezu Asia Capital Management, LLC
|
Exhibit to Form S-4/A filed on November 25, 2020
|
|||
Lease Agreement dated June 15, 2021 between Brooklyn ImmunoTherapeutics, Inc. and Fairlane Columbia, LLC
|
Exhibit 10.25 to Form 10-K filed on April 15, 2022
|
|||
Subsidiaries of the Company.
|
Exhibit 21.1 to Form 10-K filed on April 15, 2022
|
|||
Consent of the Independent Registered Accounting Firm.
|
Filed herewith
|
Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
|||
Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
|||
Certification of Principal Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
|||
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Filed herewith
|
|||
101.INS |
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the
Inline XBRL document). |
Filed herewith |
||
101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
Filed herewith |
||
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
Filed herewith |
||
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
Filed herewith |
||
101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
Filed herewith |
||
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
Filed herewith |
||
104 |
Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
BROOKLYN IMMUNOTHERAPEUTICS, INC.
|
||
Date: June 30, 2022
|
By:
|
/s/ ANDREW JACKSON |
Andrew Jackson
|
||
Chief Financial Officer
(Principal Financial Officer)
|
Page
|
|
F-2
|
|
Consolidated Financial Statements:
|
|
|
|
F-3
|
|
|
|
F-4
|
|
|
|
F-5
|
|
F-6
|
|
F-7
|
December 31,
2021
|
December 31,
2020
|
|||||||
ASSETS
|
(as Restated) |
(as Restated) |
||||||
Current assets:
|
||||||||
Cash
|
$
|
|
$
|
|
||||
Accounts receivable
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
Total current assets
|
|
|
||||||
Property and equipment, net
|
|
|
||||||
Right-of-use assets - operating leases
|
|
|
||||||
Goodwill
|
|
|
||||||
In-process research and development
|
|
|
||||||
Investment in minority interest
|
|
|
||||||
Security deposits and other assets
|
|
|
||||||
Total assets
|
$
|
|
$
|
|
||||
LIABILITIES AND STOCKHOLDERS’ AND MEMBERS’ EQUITY
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
|
$
|
|
||||
Accrued expenses
|
|
|
||||||
Loans payable
|
|
|
||||||
PPP loan, current
|
|
|
||||||
Operating lease liabilities, current
|
|
|
||||||
Other current liabilities
|
|
|
||||||
Total current liabilities
|
|
|
||||||
Operating lease liabilities, non-current
|
|
|
||||||
PPP loan, non-current
|
|
|
||||||
Other liabilities
|
|
|
||||||
Total liabilities
|
|
|
||||||
Stockholders’ and members’ equity:
|
||||||||
Class A membership units
|
|
|
||||||
Class B membership units
|
|
|
||||||
Class C membership units
|
|
|
||||||
Common units
|
|
|
||||||
Series A preferred stock, $
|
|
|
||||||
Common stock, $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Total stockholders’ and members’ equity
|
|
|
||||||
Total liabilities and stockholders’ and members’ equity
|
$
|
|
$
|
|
Year ended December 31,
|
||||||||
2021
|
2020
|
|||||||
(as Restated) |
(as Restated) |
|||||||
Operating expenses:
|
||||||||
Research and development
|
$
|
|
$
|
|
||||
Acquired in-process research and development
|
|
|
||||||
General and administrative
|
|
|
||||||
Transaction costs
|
|
|
||||||
Total operating expenses
|
|
|
||||||
Loss from operations
|
(
|
)
|
(
|
)
|
||||
Other expenses, net:
|
||||||||
Loss on sale of NTN assets
|
(
|
)
|
|
|||||
Other income (expense), net
|
|
(
|
)
|
|||||
Total other expenses, net
|
(
|
)
|
(
|
)
|
||||
Loss before income taxes
|
( |
) | ( |
) | ||||
Provision for income taxes
|
( |
) | ||||||
Net loss
|
(
|
)
|
(
|
)
|
||||
Series A preferred stock dividend
|
(
|
)
|
|
|||||
Net loss attributable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Net loss per common share - basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted average shares outstanding - basic and diluted
|
|
|
Membership Equity
|
Common Stock
|
Series A
Preferred Stock
|
Additional
Paid-in |
Accumulated
|
||||||||||||||||||||||||||||||||||||||||
Class A
|
Class B
|
Class C
|
Common
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||||||||||||||||||||
Balances at January 1, 2021 (as Restated)
|
$
|
|
$
|
|
$
|
|
$
|
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||||||||||||||||
Brooklyn rights offerings membership units
|
|
|
|
|
-
|
|
-
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Elimination of Brooklyn’s historical members’ equity
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
-
|
|
-
|
|
|
|
|
|||||||||||||||||||||||||||||
Common stock to be retained by NTN stockholders
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Issuance of Series A preferred stock retained
by NTN stockholders
|
|
|
|
|
|
|
|
|
(
|
)
|
|
|
||||||||||||||||||||||||||||||||
Issuance of common stock to Brooklyn members
|
|
|
|
|
|
|
|
|
(
|
)
|
|
|
||||||||||||||||||||||||||||||||
Issuance of common stock to Financial Advisor upon
consummation of merger
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Issuance of common stock from the exercise of
stock options
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Issuance of common stock related to stock purchase
agreement with Lincoln Park Capital Fund, LLC, net
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Issuance of common stock in connection with
the acquisition of Novellus, Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Cash dividends to Series A preferred stockholders
|
|
|
|
|
|
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||||||||||||||
Issuance of common stock in lieu of cash
dividend to Series A preferred stockholders
|
|
|
|
|
|
|
|
|
|
(
|
)
|
|
||||||||||||||||||||||||||||||||
Forfeiture of unvested restricted stock
|
|
|
|
|
(
|
)
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||
Stock based compensation
|
|
|
|
|
-
|
|
-
|
|
|
|
|
|||||||||||||||||||||||||||||||||
Net loss
|
|
|
|
|
-
|
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||||||||||||||||||||
Balances at December 31, 2021 (as Restated)
|
$
|
|
$
|
|
$
|
|
$
|
|
|
$
|
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
Membership Equity
|
Accumulated
|
|||||||||||||||||||||||
Class A
|
Class B
|
Class C
|
Common
|
Deficit
|
Total
|
|||||||||||||||||||
Balances at January 1, 2020
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||||||||
Implementation of new accounting principle
|
|
|
|
|
|
|
||||||||||||||||||
Stock based compensation
|
|
|
|
|
|
|
||||||||||||||||||
Sale of members’ equity
|
|
|
|
|
|
|
||||||||||||||||||
Net loss
|
|
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||
Balances at December 31, 2020 (as Restated)
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
For years ended
December 31,
|
||||||||
2021
|
2020
|
|||||||
(as Restated) |
(as Restated) |
|||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Stock-based compensation
|
|
|
||||||
Amortization of right-to-use asset
|
|
|
||||||
Transaction costs - shares to Financial Advisor
|
|
|
||||||
Loss on sale of NTN assets
|
|
|
||||||
Loss on disposal of fixed assets
|
|
|
||||||
Gain on forgiveness of PPP loan
|
(
|
)
|
|
|||||
Acquired in-process research and development
|
|
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Account receivable
|
(
|
)
|
|
|||||
Prepaid expenses and other current assets
|
(
|
)
|
(
|
)
|
||||
Security deposits and other non-current assets
|
|
(
|
)
|
|||||
Accounts payable and accrued expenses
|
(
|
)
|
(
|
)
|
||||
Operating lease liability
|
(
|
)
|
|
|||||
Other liabilities
|
|
|
||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
||||
Purchase of NTN, net of cash acquired
|
|
|
||||||
Purchase of Novellus, net of common stock issued and cash acquired
|
(
|
)
|
|
|||||
Proceeds from the sale of NTN assets, net of cash disposed
|
|
|
||||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
Cash flows provided by financing activities:
|
||||||||
Net proceeds of common stock issued to Lincoln Park
|
|
|
||||||
Proceeds from sale of members’ equity
|
|
|
||||||
Proceeds from the exercise of stock options
|
|
|
||||||
Proceeds from loans payable
|
|
|
||||||
Repayment of NTN’s PPP loan
|
(
|
)
|
|
|||||
Principal payments on notes payable
|
(
|
)
|
|
|||||
Dividends paid to Series A preferred shareholders
|
(
|
)
|
|
|||||
Net cash provided by financing activities
|
|
|
||||||
Net increase (decrease) in cash and cash equivalents
|
|
(
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
|
|
||||||
Cash and cash equivalents at end of period
|
$
|
|
$
|
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Cash paid during the period for:
|
||||||||
Interest
|
$
|
|
$
|
|
||||
Income taxes
|
$
|
|
$
|
|
||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Issuance of common stock for Series A preferred stock dividend
|
$
|
|
$
|
|
||||
Issuance of common stock for business combination
|
$
|
|
$
|
|
||||
Issuance of common Stock for Novellus acquisition
|
$
|
|
$
|
|
||||
Forfeiture of unvested restricted stock
|
$
|
|
$
|
|
||||
Preferred shares issued in connection with reverse merger
|
$
|
|
$
|
|
||||
Initial measurement of ROU assets, net of tenant improvement allowance
|
$
|
|
$
|
|
||||
Initial measurement of operating lease liabilities
|
$
|
|
$
|
|
||||
Investor deposits for sale of members’ equity
|
$
|
|
$
|
|
||||
Right of use assets obtained in exchange for new operating lease liabilities
|
$
|
|
$
|
|
1) |
Organization and Description of Business Operations
|
2) |
Liquidity and Capital Resources
|
3) |
Basis of Accounting Presentation and Summary of Significant Accounting Policies
|
|
As Previously
Reported |
Adjustments
|
As Restated
|
|||||||||
|
(unaudited)
|
|||||||||||
Consolidated
Balance Sheet as of December 31, 2020
|
||||||||||||
|
||||||||||||
In-process
research and development
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Contingent consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Accumulated deficit
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
|
||||||||||||
Consolidated
Statement of Operations for the year ended December 31, 2020
|
||||||||||||
|
||||||||||||
Change in fair
value of contingent consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Net loss
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
Net loss per
common share - basic and diluted
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
|
||||||||||||
Consolidated
Statement of Cash Flows for the year ended December 31, 2020
|
||||||||||||
|
||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
Change in fair
value of contingent consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
|
||||||||||||
Consolidated
Balance Sheet as of December 31, 2021
|
||||||||||||
|
||||||||||||
In-process
research and development
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Security deposits
and other assets
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Contingent consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Other liabilities
|
$
|
|
$
|
|
$
|
|
||||||
Accumulated deficit
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
|
||||||||||||
Consolidated
Statement of Operations for the year ended December 31, 2021
|
||||||||||||
|
||||||||||||
Change in fair
value of contingent consideration
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||
Provision for income taxes
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
Net loss
attributable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
Net loss per
common share - basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
|
||||||||||||
Consolidated
Statement of Cash Flows for the year ended December 31, 2021
|
||||||||||||
|
||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
Change in fair
value of contingent consideration
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||
Security deposits
and other assets
|
$
|
(
|
)
|
$
|
|
$
|
|
|||||
Other liabilities
|
$
|
|
$
|
|
$
|
|
|
As of June 30, 2020
|
As of September 30, 2020
|
||||||||||||||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
As Previously
Reported |
Adjustments
|
As Restated
|
||||||||||||||||||
|
(in thousands)
|
(in thousands)
|
||||||||||||||||||||||
Consolidated
Balance Sheets
|
(unaudited)
|
(unaudited)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||
In-process
research and development
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Contingent
consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
|
As of March 31, 2021
|
As of June 30, 2021
|
||||||||||||||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
As Previously
Reported |
Adjustments
|
As Restated
|
||||||||||||||||||
|
(in thousands)
|
(in thousands)
|
||||||||||||||||||||||
Consolidated
Balance Sheets
|
(unaudited)
|
(unaudited)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||
In-process
research and development
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Contingent
consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Accumulated
deficit
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|
As of September 30, 2021
|
|||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
|||||||||
|
(in thousands)
|
|||||||||||
Consolidated Balance Sheets
|
(unaudited)
|
|||||||||||
|
||||||||||||
In-process
research and development
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Contingent consideration
|
$
|
|
$
|
(
|
)
|
$
|
|
|||||
Accumulated deficit
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|
Three months ended March 31, 2021
|
Three months ended September 30, 2021
|
||||||||||||||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
As Previously
Reported |
Adjustments
|
As Restated
|
||||||||||||||||||
|
(in thousands, except per share data)
|
(in thousands, except per share data)
|
||||||||||||||||||||||
Consolidated
Statement of Operations
|
(unaudited)
|
(unaudited)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||
Change in fair
value of contingent consideration
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|||||||
Net loss
attributable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|||||||
Net loss per
common share - basic and diluted
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
|
Three months ended March 31, 2021
|
Six months ended June 30, 2021
|
||||||||||||||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
As Previously
Reported |
Adjustments
|
As Restated
|
||||||||||||||||||
|
(in thousands, except per share data)
|
(in thousands, except per share data)
|
||||||||||||||||||||||
Consolidated
Statement of Cash Flows
|
(unaudited)
|
(unaudited)
|
||||||||||||||||||||||
|
||||||||||||||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
||||||
Change in fair
value of contingent consideration
|
$
|
(
|
)
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
$
|
|
|
Nine months ended September 30, 2021
|
|||||||||||
|
As Previously
Reported |
Adjustments
|
As Restated
|
|||||||||
|
(in thousands, except per share data)
|
|||||||||||
Consolidated Statement of Cash Flows
|
(unaudited)
|
|||||||||||
|
||||||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
|||
Change in fair
value of contingent consideration
|
$
|
(
|
)
|
$
|
|
$
|
|
4) |
Merger, Disposition and Acquisition Transactions
|
Historical
Balance
Sheet of
Brooklyn at
March 25, 2020
|
Fair Value
Adjustment
to Brooklyn
Pre-Merger
Assets
|
Purchase
Price
Allocation Pro
Forma
Adjustment
|
||||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
$
|
|
||||||
Accounts receivable
|
|
|
|
|||||||||
Prepaid expense and other current assets
|
|
|
|
|||||||||
Property and equipment, net
|
|
|
|
|||||||||
Software development costs
|
|
(
|
)
|
|
||||||||
Customers
|
|
|
|
|||||||||
Trade name
|
|
|
|
|||||||||
Accounts payable, accrued liabilities and other current liabilities
|
(
|
)
|
|
(
|
)
|
|||||||
Net assets acquired, excluding goodwill
|
$
|
(
|
)
|
$
|
|
$
|
(
|
)
|
||||
Total consideration
|
$
|
|
||||||||||
Net assets acquired, excluding goodwill
|
(
|
)
|
||||||||||
Goodwill
|
$
|
|
Proceeds from sale:
|
||||
Cash
|
$
|
|
||
Escrow
|
|
|||
Assume advance/loans
|
|
|||
Interest on advance/loans
|
|
|||
Carrying value of assets sold:
|
||||
Cash and cash equivalents
|
(
|
)
|
||
Accounts receivable
|
(
|
)
|
||
Prepaids and other current assets
|
(
|
)
|
||
Property and equipment, net
|
(
|
)
|
||
Software development costs
|
(
|
)
|
||
Customers
|
(
|
)
|
||
Trade name
|
(
|
)
|
||
Goodwill
|
(
|
)
|
||
Other assets
|
(
|
)
|
||
Liabilities transferred upon sale:
|
||||
Accounts payable and accrued expenses
|
|
|||
Obligations under finance leases
|
|
|||
Lease liability
|
|
|||
Deferred revenue
|
|
|||
Other current liabilities
|
|
|||
Transaction costs
|
(
|
)
|
||
Total loss on sale of assets
|
$
|
(
|
)
|
Years ended December 31,
|
||||||||
2021
|
2020
|
|||||||
(as restated) |
(as restated) |
|||||||
Net loss attributable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Basic and diluted net loss per share attributable to common stockholders
|
$
|
(
|
)
|
$
|
(
|
)
|
Fair Value of
Consideration
|
||||
Cash paid
|
$
|
|
||
Cash acquired
|
(
|
)
|
||
Unrestricted shares
|
|
|||
Restricted shares
|
|
|||
Total fair value of consideration paid
|
|
|||
Less amount of cash paid for NoveCite investment
|
(
|
)
|
||
Fair value of IPR&D acquired
|
$
|
|
5) |
Fair Value of Financial Instruments
|
6) |
Property and Equipment
|
December 31,
|
||||||||
2021
|
2020
|
|||||||
Laboratory and manufacturing equipment
|
$
|
|
$
|
|
||||
Leasehold improvements
|
|
|
||||||
Computer equipment
|
|
|
||||||
|
|
|||||||
Less: accumulated depreciation and amortization
|
(
|
)
|
(
|
)
|
||||
Property and equipment, net
|
$
|
|
$
|
|
7) |
Leases
|
Years ended December 31,
|
||||||||
2021
|
2020
|
|||||||
Operating lease expense
|
$
|
|
$
|
|
||||
Sublease income
|
(
|
)
|
(
|
)
|
||||
Variable lease expense
|
|
|
||||||
Total lease expense
|
$
|
|
$
|
|
Operating Lease
ROU Assets
|
||||
Operating lease ROU assets at January 1, 2021
|
$
|
|
||
Amortization of operating lease ROU assets
|
(
|
)
|
||
Addition of operating lease ROU assets
|
|
|||
Operating lease ROU assets at December 31, 2021
|
$
|
|
Operating Lease
Liabilities
|
||||
Operating lease liabilities at January 1, 2021
|
$
|
|
||
Principal payments on operating lease liabilities
|
(
|
)
|
||
Addition of operating lease liabilities
|
|
|||
Operating lease liabilities at December 31, 2021
|
|
|||
Less non-current portion
|
|
|||
Current portion at December 31, 2021
|
$
|
|
As of
December 31
|
||||
2022
|
$
|
|
||
2023
|
|
|||
2024
|
|
|||
2025
|
|
|||
2026
|
|
|||
Thereafter
|
|
|||
Total payments
|
|
|||
Less imputed interest
|
(
|
)
|
||
Total operating lease liabilities
|
$
|
|
As of
December 31,
2021
|
||||
2022
|
$
|
|
||
2023
|
|
|||
2024
|
|
|||
2025
|
|
|||
2026
|
|
|||
$
|
|
8) |
Goodwill and In-Process Research & Development
|
9) |
Accrued Expenses
|
As of December 31,
|
||||||||
2021
|
2020
|
|||||||
Accrued compensation
|
$
|
|
$
|
|
||||
Accrued research and development expenses
|
|
|
||||||
Accrued general and administrative expenses
|
|
|
||||||
Accrued interest
|
|
|
||||||
Total accrued expenses
|
$
|
|
$
|
|
10) |
Debt
|
11) |
Commitments and Contingencies
|
12) |
Basic and Diluted Earnings per Common Share
|
|
Year ended
December 31, 2021
|
|
||
Stock options
|
|
|
|
|
RSUs
|
|
|
|
|
Preferred stock converted into common stock
|
|
|
|
|
Total potential common shares excluded from computation
|
|
|
|
13) |
Stock-Based Compensation
|
Year ended
December 31, 2021
|
||||
Weighted average risk-free rate
|
|
%
|
||
Weighted average volatility
|
|
%
|
||
Dividend yield
|
|
%
|
||
Expected term
|
Outstanding
Options
|
Weighted
Average
Exercise
Price per Share
|
Weighted
Average
Remaining
Contractual
Life (in years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding January 1, 2021
|
|
$
|
|
-
|
$
|
|
||||||||||
Granted
|
|
|
|
|
||||||||||||
Outstanding December 31, 2021
|
|
$
|
|
|
$
|
|
||||||||||
Options vested and exercisable at December 31, 2021
|
|
$
|
|
-
|
$
|
|
Outstanding
Restricted
Stock Units
|
Weighted
Average Fair
Value per Share
|
|||||||
January 1, 2021
|
|
$
|
|
|||||
Granted
|
|
|
||||||
December 31, 2021
|
|
$
|
|
|||||
Balance expected to vest at December 31, 2021
|
|
14) |
Stockholders’ and Members’ Equity (Deficit)
|
1. |
If the Company (a) pays a dividend or makes a distribution in shares of its common stock, (b) subdivides its outstanding shares of common stock into a greater number of shares, (c) combines its outstanding
shares of common stock into a smaller number of shares, or (d) issues by reclassification of its shares of common stock any shares of its common stock (other than a change in par value, or from par value to no par value, or from no par
value to par value), then the conversion rate in effect immediately prior to the applicable event will be adjusted so that the holders of the Series A Convertible Preferred Stock will be entitled to receive the number of shares of common
stock which they would have owned or have been entitled to receive immediately following the happening of the event, had the Series A Convertible Preferred Stock been converted immediately prior to the record or effective date of the
applicable event.
|
2. |
If the outstanding shares of the Company’s common stock are reclassified (other than a change in par value, or from par value to no par value, or from no par value to par value, or as a result of a
subdivision, combination or stock dividend), or if the Company consolidates with or merge into another corporation and the Company is not the surviving entity, or if the Company sells all or substantially all of its property, assets,
business and goodwill, then the holders of the Series A Convertible Preferred Stock will thereafter be entitled upon conversion to the kind and amount of shares of stock or other equity securities, or other property or assets which would
have been receivable by such holders upon such reclassification, consolidation, merger or sale, if the Series A Convertible Preferred Stock had been converted immediately prior thereto.
|
3. |
If the Company issues common stock without consideration or for a consideration per share less than the then applicable Equivalent Preference Amount (as defined below), then the Equivalent Preference Amount
will immediately be reduced to the amount determined by dividing (A) an amount equal to the sum of (1) the number of shares of common stock outstanding immediately prior to such issuance multiplied by the Equivalent Preference Amount in
effect immediately prior to such issuance and (2) the consideration, if any, received by the Company upon such issuance, by (B) the total number of shares of common stock outstanding immediately after such issuance. The “Equivalent
Preference Amount” is the value that results when the liquidation preference of one share of Series A Convertible Preferred Stock (which is $1.00) is multiplied by the conversion rate in effect at that time; thus the conversion rate
applicable after the adjustment in the Equivalent Preference Amount as described herein will be the figure that results when the adjusted Equivalent Preference Amount is divided by the liquidation preference of one share of Series A
Convertible Preferred Stock.
|
15) |
Income Taxes
|
|
Years ended December 31,
|
|||||||
|
2021
|
2020
|
||||||
(as Restated) |
(as Restated) |
|||||||
Domestic
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Foreign
|
(
|
)
|
|
|||||
Total loss before income taxes
|
$
|
(
|
)
|
$
|
(
|
)
|
Years ended December 31,
|
||||||||
2021
|
2020
|
|||||||
Current Tax Provision
|
||||||||
Federal
|
$
|
|
$
|
|
||||
State
|
|
|
||||||
Foreign
|
||||||||
Deferred Tax Provision
|
||||||||
Federal
|
(
|
)
|
|
|||||
State
|
( |
) |
(
|
)
|
||||
Foreign
|
( |
) |
|
|||||
( |
) | ( |
) | |||||
Change in valuation allowance
|
|
|||||||
Total tax provision for income taxes
|
$
|
|
$
|
|
|
As of December 31,
|
|||||||
|
2021
|
2020
|
||||||
Deferred Tax Assets:
|
||||||||
Net operating losses
|
|
|
||||||
Foreign net operating losses
|
|
|
||||||
R&D credit carryforwards
|
|
|
||||||
Stock compensation
|
|
|
||||||
Vacation accrual
|
|
|
||||||
Contingent consideration
|
|
|
||||||
Deferred rent
|
|
|
||||||
Total gross deferred tax assets
|
|
|
||||||
Valuation allowance
|
(
|
)
|
(
|
)
|
||||
Net deferred tax assets
|
|
|
||||||
|
||||||||
Deferred Tax Liabilities:
|
||||||||
Fixed assets
|
(
|
)
|
|
|||||
Intangibles - goodwill
|
(
|
)
|
|
|||||
Total deferred tax liabilities
|
(
|
)
|
|
|||||
Net deferred taxes
|
$
|
(
|
)
|
$
|
|
As of December 31,
|
||||||||
2021 | 2020 | |||||||
Tax at federal income tax rate
|
|
%
|
% | |||||
State income tax, net of federal tax
|
|
%
|
% | |||||
Non-deductible expenses/excludable items
|
-
|
%
|
% | |||||
Pass-through loss |
% | - |
% | |||||
Change in valuation allowance
|
- |
% | - |
% | ||||
Credits
|
|
%
|
% | |||||
Other
|
-
|
% | % | |||||
Provision for income taxes
|
-
|
%
|
% |
16) |
Retirement Savings Plan
|
17) |
Subsequent Events
|