☑
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
31-1103425
|
|
(State of incorporation)
|
(I.R.S. Employer Identification No.)
|
140 58th Street, Suite 2100, Brooklyn, New York
|
11220
|
|
(Address of principal executive offices)
|
(Zip Code)
|
Title of each class
|
Trading symbol
|
Name of each exchange on which registered
|
||
Common stock, $0.005 par value per share
|
BTX
|
The Nasdaq Stock Market LLC
|
Large accelerated filer
|
☐ |
Accelerated filer
|
☐
|
Non-accelerated filer
|
☒ |
Smaller reporting company
|
☒
|
Emerging growth company
|
☐
|
Page
|
||
PART I – FINANCIAL INFORMATION
|
||
Item 1.
|
Financial Statements (unaudited)
|
|
1
|
||
2
|
||
3
|
||
4
|
||
5 | ||
Item 2.
|
22 | |
Item 3.
|
34 | |
Item 4.
|
34 | |
PART II – OTHER INFORMATION
|
||
Item 1.
|
35 | |
Item 1A.
|
35 | |
Item 2.
|
36
|
|
Item 6.
|
37 | |
38 |
|
September 30,
2021
|
December 31,
2020
|
||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets:
|
||||||||
Cash
|
$
|
24,381,831
|
$
|
1,630,455
|
||||
Tax receivable
|
23,303
|
-
|
||||||
Prepaid expenses and other current assets
|
1,353,183
|
102,322
|
||||||
Total current assets
|
25,758,317
|
1,732,777
|
||||||
Property and equipment, net
|
547,006
|
594,106
|
||||||
Right-of-use assets - operating leases
|
2,665,828
|
2,092,878
|
||||||
Goodwill
|
2,043,747
|
2,043,747
|
||||||
In-process research and development
|
6,860,000
|
6,860,000
|
||||||
Investment in NoveCite
|
1,000,000 | - | ||||||
Security deposits and other assets
|
519,467
|
453,252
|
||||||
Total assets
|
$
|
39,394,365
|
$
|
13,776,760
|
||||
LIABILITIES AND STOCKHOLDERS’ AND MEMBERS’ EQUITY (DEFICIT)
|
||||||||
Current liabilities:
|
||||||||
Accounts payable
|
$
|
996,262
|
$
|
1,275,223
|
||||
Accrued expenses
|
2,128,493
|
1,051,020
|
||||||
Loans payable
|
410,000
|
410,000
|
||||||
PPP Loan, current
|
-
|
115,972
|
||||||
Operating lease liabilities, current
|
408,125
|
273,217
|
||||||
Other current liabilities |
617,661
|
-
|
||||||
Total current liabilities
|
4,560,541
|
3,125,432
|
||||||
Contingent consideration
|
19,360,000
|
20,110,000
|
||||||
Operating lease liabilities, non-current
|
2,410,667
|
1,905,395
|
||||||
PPP Loan, non-current
|
-
|
193,933
|
||||||
Other liabilities
|
22,863
|
22,863
|
||||||
Total liabilities
|
26,354,071
|
25,357,623
|
||||||
Stockholders’ and members’ equity (deficit):
|
||||||||
Class A membership units
|
-
|
23,202,005
|
||||||
Class B membership units
|
-
|
1,400,000
|
||||||
Class C membership units
|
-
|
1,000,000
|
||||||
Common units
|
-
|
197,873
|
||||||
Series A convertible preferred stock | 781 | - | ||||||
Common stock, $0.005 par value, 100,000,000 shares authorized; 52,043,818
shares issued and outstanding at September 30, 2021; no shares issued and outstanding at December 31, 2020.
|
260,219
|
-
|
||||||
Additional paid-in capital
|
164,010,804
|
-
|
||||||
Accumulated deficit
|
(151,231,510
|
)
|
(37,380,741
|
)
|
||||
Total stockholders’ and members’ equity (deficit)
|
13,040,294
|
(11,580,863
|
)
|
|||||
Total liabilities and stockholders’ and members’ equity (deficit)
|
$
|
39,394,365
|
$
|
13,776,760
|
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
1,466,652
|
923,529
|
8,379,062
|
2,299,669
|
||||||||||||
Acquired in-process research and development
|
80,537,551 | - | 80,537,551 |
-
|
||||||||||||
General and administrative
|
4,258,178
|
1,084,057
|
10,515,088
|
2,741,652
|
||||||||||||
Transaction costs
|
-
|
-
|
5,765,407
|
-
|
||||||||||||
Change in fair value of contingent consideration
|
70,000
|
-
|
(750,000
|
)
|
-
|
|||||||||||
Total operating expenses
|
86,332,381
|
2,007,586
|
104,447,108
|
5,041,321
|
||||||||||||
Loss from operations
|
(86,332,381
|
)
|
(2,007,586
|
)
|
(104,447,108
|
)
|
(5,041,321
|
)
|
||||||||
Other income (expenses):
|
||||||||||||||||
Loss on sale of NTN assets
|
-
|
|
-
|
(9,648,173
|
)
|
-
|
||||||||||
Other income (expense), net
|
277,069
|
|
(12,559
|
)
|
252,318
|
|
(31,482
|
)
|
||||||||
Total other income (expenses), net
|
277,069
|
|
(12,559
|
)
|
(9,395,855
|
)
|
(31,482
|
)
|
||||||||
Net loss
|
(86,055,312
|
)
|
(2,020,145
|
)
|
(113,842,963
|
)
|
(5,072,803
|
)
|
||||||||
Series A convertible preferred stock dividend
|
-
|
|
-
|
(7,806
|
)
|
-
|
||||||||||
Net loss attributable to common stockholders
|
$ |
(86,055,312
|
)
|
$
|
(2,020,145
|
)
|
$
|
(113,850,769
|
)
|
$ |
(5,072,803
|
)
|
||||
Net loss per common share - basic and diluted
|
$ |
(1.70
|
)
|
$ |
(0.11
|
)
|
$ |
(2.82
|
)
|
$ |
(0.29
|
)
|
||||
Weighted average shares outstanding - basic and diluted
|
50,543,982
|
17,626,806
|
40,362,440
|
17,570,973
|
|
|
Membership Equity
|
Common
Stock
|
Series A Convertible
Preferred Stock
|
Additional
Paid-in
|
Accumulated | |||||||||||||||||||||||||||||||||||||||
|
Class A
|
Class B
|
Class C
|
Common
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
|||||||||||||||||||||||||||||||||
Balances at July 1, 2021
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
44,707,382
|
$
|
223,537
|
156,112
|
$
|
781
|
$
|
100,134,743
|
$
|
(65,176,198
|
)
|
$
|
35,182,863
|
|
||||||||||||||||||||||
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net
|
-
|
-
|
-
|
-
|
340,048
|
1,700
|
-
|
-
|
3,498,796
|
-
|
3,500,496
|
|||||||||||||||||||||||||||||||||
Issuance of common stock in connection with the acquisition of Novellus, Inc.
|
-
|
-
|
-
|
-
|
7,022,230
|
35,111
|
-
|
-
|
58,648,832
|
-
|
|
58,683,943
|
||||||||||||||||||||||||||||||||
Forfeiture of unvested restricted stock
|
-
|
-
|
-
|
-
|
(25,842
|
)
|
(129
|
)
|
-
|
-
|
129
|
-
|
-
|
|||||||||||||||||||||||||||||||
Stock based compensation
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
1,728,304
|
-
|
1,728,304
|
|||||||||||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(86,055,312
|
)
|
(86,055,312
|
)
|
|||||||||||||||||||||||||||||||
Balances at September 30, 2021
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
52,043,818
|
$
|
260,219
|
156,112
|
$
|
781
|
$
|
164,010,804
|
$
|
(151,231,510
|
)
|
$
|
13,040,294
|
|||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||
Balances at January 1, 2021
|
$
|
23,202,005
|
$
|
1,400,000
|
$
|
1,000,000
|
$
|
197,873
|
-
|
$
|
-
|
-
|
$
|
-
|
$
|
-
|
$
|
(37,380,741
|
)
|
$
|
(11,580,863
|
)
|
||||||||||||||||||||||
Brooklyn rights offerings membership units
|
10,500,000
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
10,500,000
|
|||||||||||||||||||||||||||||||||
Elimination of Brooklyn’s historical members’ equity
|
(33,702,005
|
)
|
(1,400,000
|
)
|
(1,000,000
|
)
|
(197,873
|
)
|
-
|
-
|
-
|
-
|
36,299,878
|
-
|
-
|
|||||||||||||||||||||||||||||
Common stock to be retained by NTN stockholders
|
-
|
-
|
-
|
-
|
1,514,373
|
7,572
|
-
|
-
|
8,169,885
|
-
|
8,177,457
|
|||||||||||||||||||||||||||||||||
Issuance of Series A convertible preferred stock retained by NTN stockholders
|
-
|
-
|
-
|
-
|
-
|
-
|
156,112
|
781
|
(781
|
)
|
-
|
-
|
||||||||||||||||||||||||||||||||
Issuance of common stock to Brooklyn members
|
-
|
-
|
-
|
-
|
38,923,957
|
194,620
|
-
|
-
|
(194,620
|
)
|
-
|
-
|
||||||||||||||||||||||||||||||||
Issuance of common stock to Financial Advisor upon consummation of merger
|
-
|
-
|
-
|
-
|
1,067,668
|
5,338
|
-
|
-
|
5,760,069
|
-
|
5,765,407
|
|||||||||||||||||||||||||||||||||
Issuance of common stock from the exercise of stock options
|
-
|
-
|
-
|
-
|
1,300
|
6
|
-
|
-
|
10,196
|
-
|
10,202
|
|||||||||||||||||||||||||||||||||
Issuance of common stock related to stock purchase agreement with Lincoln Park Capital Fund, LLC, net
|
-
|
-
|
-
|
-
|
3,551,990
|
17,760
|
-
|
-
|
52,007,654
|
-
|
52,025,414
|
|||||||||||||||||||||||||||||||||
Issuance of common stock in connection with the acquisition of Novellus, Inc. | - | - | - | - | 7,022,230 | 35,111 | - | - | 58,648,832 | - | 58,683,943 | |||||||||||||||||||||||||||||||||
Issuance of common stock in lieu of cash dividend to Series A convertible preferred stockholders
|
-
|
-
|
-
|
-
|
202
|
1
|
-
|
-
|
7,805
|
(7,806
|
)
|
-
|
||||||||||||||||||||||||||||||||
Forfeiture of unvested restricted stock
|
-
|
-
|
-
|
-
|
(37,902
|
)
|
(189
|
)
|
-
|
-
|
189
|
-
|
-
|
|||||||||||||||||||||||||||||||
Stock based compensation
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
3,301,697
|
-
|
3,301,697
|
|||||||||||||||||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
-
|
(113,842,963 | ) |
(113,842,963
|
)
|
|||||||||||||||||||||||||||||||
Balances at September 30, 2021
|
$
|
-
|
$
|
-
|
$
|
-
|
$
|
-
|
52,043,818
|
$
|
260,219
|
156,112
|
$
|
781
|
$
|
164,010,804
|
$
|
(151,231,510
|
)
|
$
|
13,040,294
|
Membership Equity
|
Accumulated
|
|||||||||||||||||||||||
|
Class A | Class B |
Class C
|
Common
|
Deficit
|
Total | ||||||||||||||||||
Balances at July 1, 2020
|
$
|
23,202,005
|
$
|
1,400,000
|
$
|
1,000,000
|
$
|
152,405
|
$
|
(13,994,184
|
)
|
$
|
11,760,226
|
|||||||||||
Stock based compensation:
|
- | - | - | 22,734 | - | 22,734 | ||||||||||||||||||
Net loss
|
-
|
-
|
-
|
-
|
(2,020,145
|
)
|
(2,020,145
|
)
|
||||||||||||||||
Balances at September 30, 2020
|
$
|
23,202,005
|
$
|
1,400,000
|
$
|
1,000,000
|
$
|
175,139
|
$
|
(16,014,329
|
)
|
$
|
9,762,815
|
|||||||||||
Balances at January 1, 2020
|
$
|
18,177,692 |
$
|
1,400,000 |
$
|
1,000,000 |
$
|
106,937 |
$
|
(10,941,526 | ) |
$
|
9,743,103 | |||||||||||
Stock based compensation
|
- | - | - | 68,202 | - | 68,202 | ||||||||||||||||||
Sale of members’ equity
|
5,024,313 | - | - | - | - | 5,024,313 | ||||||||||||||||||
Net loss
|
- | - | - | - | (5,072,803 | ) | (5,072,803 | ) | ||||||||||||||||
Balances at September 30, 2020
|
$
|
23,202,005 |
$
|
1,400,000 |
$
|
1,000,000 |
$
|
175,139 |
$
|
(16,014,329 | ) |
$
|
9,762,815 |
For the nine months ended
September 30,
|
||||||||
2021
|
2020
|
|||||||
Cash flows used in operating activities:
|
||||||||
Net loss
|
$
|
(113,842,963
|
)
|
$
|
(5,072,803
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation and amortization
|
92,754
|
72,909
|
||||||
Stock-based compensation
|
3,301,697
|
68,202
|
||||||
Amortization of right-to-use asset
|
242,849
|
-
|
||||||
Transaction costs - shares to Financial Advisor
|
5,765,407
|
-
|
||||||
Loss on sale of NTN assets
|
9,648,173
|
-
|
||||||
Loss on disposal of fixed assets
|
12,626 | - | ||||||
Gain on forgiveness of PPP Loan
|
(309,905 | ) | - | |||||
Acquired in-process research and development
|
80,537,551 | - | ||||||
Change in fair value of contingent consideration
|
(750,000
|
)
|
-
|
|||||
Changes in operating assets and liabilities:
|
||||||||
Account receivable
|
4,680
|
-
|
||||||
Prepaid expenses and other current assets
|
(1,109,270
|
)
|
(69,240
|
)
|
||||
Security deposits and other non-current assets
|
(31,496
|
)
|
(84,914
|
)
|
||||
Accounts payable and accrued expenses
|
5,881
|
(1,392,925
|
)
|
|||||
Operating lease liability
|
(225,618
|
)
|
(2,356
|
)
|
||||
Other liabilities
|
-
|
17,842
|
||||||
Net cash used in operating activities
|
(16,657,634
|
)
|
(6,463,285
|
)
|
||||
Cash flows used in investing activities:
|
||||||||
Purchase of property and equipment
|
(6,860
|
)
|
(26,177
|
)
|
||||
Purchase of NTN, net of cash acquired
|
147,262
|
-
|
||||||
Purchase of Novellus, net cash acquired
|
(22,853,608 | ) | - | |||||
Proceeds from the sale of NTN assets, net of cash disposed
|
118,594
|
-
|
||||||
Net cash used in investing activities
|
(22,594,612
|
)
|
(26,177
|
)
|
||||
Cash flows provided by financing activities:
|
||||||||
Net proceeds of common stock issued to Lincoln Park
|
52,025,414 | - | ||||||
Proceeds from the exercise of stock options
|
10,202 | - | ||||||
Proceeds from loans payable
|
- | 309,905 | ||||||
Proceeds from the collection of subscription receivable
|
- | 275,000 | ||||||
Repayment of NTN’s PPP loan
|
(531,994
|
)
|
-
|
|||||
Proceeds from sale of members’ equity
|
10,500,000
|
3,858,750
|
||||||
Net cash provided by financing activities
|
62,003,622
|
4,443,655
|
||||||
Net increase (decrease) in cash and cash equivalents
|
22,751,376
|
(2,045,807
|
)
|
|||||
Cash and cash equivalents at beginning of period
|
1,630,455
|
5,100,819
|
||||||
Cash and cash equivalents at end of period
|
$
|
24,381,831
|
$
|
3,055,012
|
||||
Supplemental disclosures of cash flow information:
|
||||||||
Cash paid during the period for:
|
||||||||
Interest
|
$
|
12,796
|
$
|
-
|
||||
Income taxes
|
$
|
-
|
$
|
-
|
||||
Supplemental disclosure of non-cash investing and financing activities:
|
||||||||
Issuance of common stock for Series A convertible preferred stock dividend
|
$ | 7,806 | $ | - | ||||
Issuance of common stock for business combination
|
$
|
8,177,457
|
$
|
-
|
||||
Issuance of common stock for Novellus acquisition
|
$ | 58,683,943 | $ | - | ||||
Forfeiture of unvested restricted stock
|
$
|
(189
|
)
|
$
|
-
|
|||
Preferred shares issued in connection with reverse merger
|
$
|
781
|
$
|
-
|
||||
Initial measurement of ROU assets, net of tenant improvement allowance
|
$ | 815,799 | $ | - | ||||
Initial measurement of operating lease liabilities
|
$ |
865,799
|
$ | - |
1) |
DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
|
2) |
LIQUIDITY AND CAPITAL RESOURCES
|
3)
|
MERGER, DISPOSITION AND ACQUISITION TRANSACTIONS
|
Number of shares of common stock owned by
Brooklyn stockholders immediately before the Merger
|
1,514,373
|
|||
Multiplied by the fair value per share of common stock (i)
|
$
|
5.40
|
||
Total purchase price
|
$
|
8,177,614
|
(i) |
Based on the closing price per share (post
reverse stock split) of the common stock of Brooklyn as reported on the NYSE American stock exchange on March 25, 2021, immediately before the Merger.
|
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
|
$
|
147,728
|
$
|
-
|
$
|
147,728
|
||||||
Accounts receivable
|
102,517
|
-
|
102,517
|
|||||||||
Prepaid expense and other current assets
|
329,596
|
-
|
329,596
|
|||||||||
Property and equipment, net
|
1,015,370
|
-
|
1,015,370
|
|||||||||
Software development costs
|
1,296,460
|
(368,460
|
)
|
928,000
|
||||||||
Customers
|
-
|
548,000
|
548,000
|
|||||||||
Trade name
|
-
|
299,000
|
299,000
|
|||||||||
Accounts payable, accrued liabilities and other current liabilities
|
(3,781,173
|
)
|
-
|
(3,781,173
|
)
|
|||||||
Net assets acquired, excluding goodwill
|
$
|
(889,502
|
)
|
$
|
478,540
|
$
|
(410,962
|
)
|
||||
Total consideration
|
$
|
8,177,614
|
||||||||||
Net assets acquired, excluding goodwill
|
(410,962
|
)
|
||||||||||
Goodwill
|
$
|
8,588,576
|
Proceeds from sale:
|
||||
Cash
|
$
|
132,055
|
||
Escrow
|
50,000
|
|||
Assume advance/loans
|
1,700,000
|
|||
Interest on advance/loans
|
67,945
|
|||
Carrying value of assets sold:
|
||||
Cash and cash equivalents
|
(13,461
|
)
|
||
Accounts receivable
|
(75,153
|
)
|
||
Prepaids and other current assets
|
(123,769
|
)
|
||
Property and equipment, net
|
(1,013,950
|
)
|
||
Software development costs
|
(927,368
|
)
|
||
Customers
|
(548,000
|
)
|
||
Trade name
|
(299,000
|
)
|
||
Goodwill
|
(8,588,576
|
)
|
||
Other assets
|
(103,173
|
)
|
||
Liabilities transferred upon sale:
|
||||
Accounts payable and accrued expenses
|
113,156
|
|||
Obligations under finance leases
|
16,676
|
|||
Lease liability
|
25,655
|
|||
Deferred revenue
|
54,803
|
|||
Other current liabilities
|
148,987
|
|||
Transaction costs
|
(265,000
|
)
|
||
Total loss on sale of assets
|
$
|
(9,648,173
|
)
|
|
Shares
Issued
|
Fair Value
Per Share
|
Fair Value of
Consideration
|
|||||||||
Cash paid
|
$
|
22,882,181
|
||||||||||
Cash acquired
|
(28,573
|
)
|
||||||||||
Unrestricted shares
|
3,644,540
|
$
|
10.05
|
36,627,627
|
||||||||
Restricted shares
|
3,377,690
|
6.53
|
22,056,316
|
|||||||||
Total fair value of consideration paid
|
81,537,551
|
|||||||||||
Less amount of cash paid for NoveCite investment
|
(1,000,000
|
)
|
||||||||||
Fair value of IPR&D acquired
|
$
|
80,537,551
|
4)
|
FAIR VALUE OF FINANCIAL INSTRUMENTS
|
As of September 30, 2021
|
||||||||||||
Description
|
Level 1
|
Level 2
|
Level 3
|
|||||||||
Liabilities:
|
||||||||||||
Contingent consideration
|
-
|
-
|
$
|
19,360,000
|
||||||||
Total
|
$
|
-
|
$
|
-
|
$
|
19,360,000
|
As of December 31, 2020
|
||||||||||||
Description
|
Level 1
|
Level 2
|
Level 3
|
|||||||||
Liabilities:
|
||||||||||||
Contingent consideration
|
-
|
-
|
$
|
20,110,000
|
||||||||
Total
|
$
|
-
|
$
|
-
|
$
|
20,110,000
|
|
Three months ended
September 30, 2021
|
Nine months ended
September 30, 2021
|
||||||
Balance as of beginning of period
|
$
|
19,290,000
|
$
|
20,110,000
|
||||
Fair value adjustments included in operating expenses
|
70,000
|
(750,000
|
)
|
|||||
Balance as of end of period
|
$
|
19,360,000
|
$
|
19,360,000
|
5) |
LEASES
|
Three months ended
September 30, 2021
|
Nine months ended
September 30, 2021
|
|||||||
Operating lease expense
|
$
|
187,498
|
$
|
501,097
|
||||
Sublease income
|
(21,045
|
)
|
(62,116
|
)
|
||||
Variable lease expense
|
5,625
|
15,977
|
||||||
Total lease expense
|
$
|
172,078
|
$
|
454,958
|
Operating Lease
ROU Assets
|
||||
Operating lease ROU assets at
January 1, 2021
|
$
|
2,092,878
|
||
Amortization of operating lease
ROU assets
|
(242,849
|
)
|
||
Addition of operating lease ROU
assets
|
815,799
|
|||
Operating lease ROU assets at
September 30, 2021
|
$
|
2,665,828
|
Operating Lease
Liabilities
|
||||
Operating lease liabilities at
January 1, 2021
|
$
|
2,178,612
|
||
Principal payments on operating
lease liabilities
|
(225,618
|
)
|
||
Addition of operating lease
liabilities
|
865,798
|
|||
Operating lease liabilities at
September 30, 2021
|
2,818,792
|
|||
Less non-current portion
|
2,410,667
|
|||
Current portion at September 30,
2021
|
$
|
408,125
|
As of
September 30, 2021
|
||||
2021
|
$
|
183,877
|
||
2022
|
750,335
|
|||
2023
|
767,154
|
|||
2024
|
784,504
|
|||
2025
|
802,358
|
|||
Thereafter
|
512,534
|
|||
Total payments |
|
3,800,762
|
||
Less imputed interest | (981,970 | ) | ||
Total operating lease liabilities | $ | 2,818,792 |
As of
September 30, 2021
|
||||
2021
|
$
|
20,458
|
||
2022
|
82,419
|
|||
2023
|
84,194
|
|||
2024
|
86,010
|
|||
2025
|
87,867
|
|||
Thereafter
|
74,590
|
|||
$
|
435,538
|
6)
|
GOODWILL AND IN-PROCESS RESEARCH & DEVELOPMENT
|
7)
|
ACCRUED EXPENSES
|
September 30,
2021
|
|
|
December 31,
2020
|
|||||
Accrued compensation
|
$
|
589,652
|
$
|
293,534
|
||||
Accrued research and development expenses
|
718,764
|
207,468
|
||||||
Accrued general and administrative expenses
|
625,487
|
399,893
|
||||||
Accrued interest
|
194,590
|
150,125
|
||||||
Total accrued expenses
|
$
|
2,128,493
|
$
|
1,051,020
|
8) |
DEBT
|
9)
|
COMMITMENTS AND CONTINGENCIES
|
10)
|
STOCK-BASED COMPENSATION
|
|
Three months ended
September 30, 2021
|
Nine months ended
September 30, 2021
|
||||||
Weighted average risk-free rate
|
0.97 | % | 1.06 | % | ||||
Weighted average volatility
|
143.29 | % | 134.88 | % | ||||
Dividend yield
|
0 | % | 0 | % | ||||
Expected term
|
6.08 years
|
6.08 years
|
11) |
STOCKHOLDERS’ AND MEMBERS’ EQUITY (DEFICIT)
|
12)
|
RECENT ACCOUNTING PRONOUNCEMENTS
|
13) |
SUBSEQUENT EVENTS
|
Item 2. |
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.”
|
•
|
Advance our product candidate IRX-2 through clinical development. IRX-2 is a human blood-based IL 2 therapy being studied for
multiple types of cancer, including squamous cell cancer of the head and neck. Treatment of patients in the INSPIRE trial has been completed, and patients who participated in the trial are currently being monitored for event-free
survival with top-line data estimated to be available in the first half of 2022.
|
•
|
Advance combination trials with checkpoint inhibitors. Once INSPIRE trial data are released, we plan to use those results as a
catalyst in addition to data from the other clinical trials in the program with multiple data read-outs anticipated in 2022 and later.
|
•
|
Pursue partnerships to advance the IRX-2 clinical program. We are pursuing partnering opportunities with leading biopharmaceutical companies for the development and
commercialization of IRX-2.
|
•
|
Regulatory strategy. We believe that our assets may present opportunities for potential breakthroughs in the treatment of cancer and other indications. We will
endeavor to seek breakthrough therapy designation with regulatory agencies for IRX-2 for one or more indications. We cannot, however, assure that we will receive breakthrough therapy designation for any future indications or that any
breakthrough therapy designation we do receive will necessarily lead to a faster approval time.
|
•
|
Intellectual Property. We continue to pursue additional intellectual property based on data from IRX clinical studies.
|
•
|
Monotherapy studies:
|
•
|
BR-101 - A study involving 16 patients with neoadjuvant breast cancer performed at the Providence Portland Medical Center. Details of this trial can be found at clinicaltrials.gov (NCT02950259).
|
•
|
CIN-201 - An open label single arm Phase 2 trial of the IRX‑2 regimen in women with cervical squamous intraepithelial neoplasia 3 or squamous vulvar intraepithelial
neoplasia 3. Details of this trial can be found at clinicaltrials.gov (NCT03267680).
|
•
|
Combination studies:
|
•
|
BAS-104 - A basket study originally intended to enroll 100 patients with metastatic bladder, renal, non-small cell lung cancer, or NSCLC, melanoma, and head and neck
cancer being held at the Moffitt Cancer Center, using IRX‑2 in conjunction with Opdivo (Nivolumab), an immunotherapy cancer treatment marketed by Bristol-Myers Squibb Company. This trial was discontinued after 11 subjects were enrolled
due to insurance reimbursement challenges. Details of this trial can be found on clinicaltrials.gov (NCT03758781).
|
•
|
HCC-107 - A study involving 28 patients with metastatic hepatocellular carcinoma, or HCC, being held at City of Hope Medical Center, HonorHealth Research Institute, and
Texas Oncology at Baylor Charles A. Simmons Cancer Center using IRX‑2 in conjunction with Opdivo, a cancer treatment marketed by Bristol-Myers Squibb Company. Details of this trial can be found at clinicaltrials.gov
(NCT03655002).
|
•
|
GI-106 - A study involving 20 patients with metastatic gastric and gastroesophageal junction cancers (GI) being held at City of Hope Medical Center, HonorHealth Research
Institute, and Texas Oncology at Baylor Charles A. Simmons Cancer Center using IRX‑2 in conjunction with Keytruda (Pembrolizumab), an immunotherapy cancer treatment marketed by Merck. Details of this trial can be found at clinicaltrials.gov (NCT03918499).
|
•
|
MHN-102 - A study involving 15 patients with metastatic head and neck cancer being held at the H. Lee Moffitt Cancer Center and Research Institute and University of
Michigan Health System using IRX‑2 in conjunction with Imfinzi (Durvalumab), a cancer treatment marketed by AstraZeneca plc. Details of this trial can be found at clinicaltrials.gov
(NCT03381183).
|
•
|
BR-202 - A study involving 30 patients with neoadjuvant triple negative breast cancer, held at the Providence Portland Medical Center using IRX‑2 in conjunction with a
programmed cell death protein 1, or PD1, and chemotherapy treatments. Details of this trial can be found at clinicaltrials.gov (NCT04373031).
|
•
|
Brooklyn acquired all of the outstanding equity interests of Novellus, Inc. as the result of the merger of Brooklyn Acquisition Sub, Inc. with and into Novellus, Inc., following which Novellus, Inc., as the
surviving corporation, became Brooklyn’s wholly owned subsidiary and Novellus Ltd. became Brooklyn’s indirectly owned subsidiary.
|
•
|
Brooklyn acquired 25.0% of the total outstanding equity interests of NoveCite, Inc., a corporation focused on developing an MSC product for patients with acute respiratory distress syndrome, including from
COVID-19.
|
Three months ended September 30,
|
||||||||||||||||
2021
|
2020
|
Change
|
% Change
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
1,466,652
|
$
|
923,529
|
$
|
543,123
|
59
|
%
|
||||||||
Acquired IPR&D
|
80,537,551
|
-
|
80,537,551
|
N/A
|
||||||||||||
General and administrative
|
4,258,178
|
1,084,057
|
3,174,121
|
293
|
%
|
|||||||||||
Change in fair value of contingent consideration
|
70,000
|
-
|
70,000
|
N/A
|
|
|||||||||||
Total operating expenses
|
86,332,381
|
2,007,586
|
84,324,795
|
4,200
|
%
|
|||||||||||
Loss from operations
|
(86,332,381
|
)
|
(2,007,586
|
)
|
(84,324,795
|
)
|
4,200
|
%
|
||||||||
Other income (expenses):
|
||||||||||||||||
Other income (expense), net
|
277,069
|
(12,559
|
)
|
289,628
|
2,306
|
%
|
||||||||||
Total other income (expenses), net
|
277,069
|
(12,559
|
)
|
289,628
|
2,306
|
%
|
||||||||||
Net loss
|
$
|
(86,055,312
|
)
|
$
|
(2,020,145
|
)
|
$
|
(84,035,167
|
)
|
4,160
|
%
|
Nine months ended September 30,
|
||||||||||||||||
2021
|
2020
|
Change
|
% Change
|
|||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development
|
$
|
8,379,062
|
$
|
2,299,669
|
$
|
6,079,393
|
264
|
%
|
||||||||
Acquired IPR&D
|
80,537,551
|
-
|
80,537,551
|
N/A
|
||||||||||||
General and administrative
|
10,515,088
|
2,741,652
|
7,773,436
|
284
|
%
|
|||||||||||
Transaction costs
|
5,765,407
|
-
|
5,765,407
|
N/A
|
||||||||||||
Change in fair value of contingent consideration
|
(750,000
|
)
|
-
|
(750,000
|
)
|
N/A
|
||||||||||
Total operating expenses
|
104,447,108
|
5,041,321
|
99,405,787
|
1,972
|
%
|
|||||||||||
Loss from operations
|
(104,447,108
|
)
|
(5,041,321
|
)
|
(99,405,787
|
)
|
1,972
|
%
|
||||||||
Other expenses:
|
||||||||||||||||
Loss on sale of NTN assets
|
(9,648,173
|
)
|
-
|
(9,648,173
|
)
|
N/A
|
||||||||||
Other income (expense), net
|
252,318
|
(31,482
|
)
|
283,800
|
901
|
%
|
||||||||||
Total other expenses
|
(9,395,855
|
)
|
(31,482
|
)
|
(9,364,373
|
)
|
29,745
|
%
|
||||||||
Net loss
|
(113,842,963
|
)
|
(5,072,803
|
)
|
(108,770,160
|
)
|
2,144
|
%
|
||||||||
Series A convertible preferred stock dividend
|
(7,806
|
)
|
-
|
(7,806
|
)
|
N/A
|
||||||||||
Net loss attributable to common stockholders
|
$
|
(113,850,769
|
)
|
$
|
(5,072,803
|
)
|
$
|
(108,777,966
|
)
|
2,144
|
%
|
|
Three months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Payroll-related
|
$
|
743,528
|
$
|
433,435
|
$
|
310,093
|
72
|
%
|
||||||||
Stock-based compensation
|
447,780
|
-
|
447,780
|
N/A
|
||||||||||||
Other expenses, net
|
275,344
|
490,094
|
(214,750
|
)
|
-44
|
%
|
||||||||||
Total research and development expense
|
$
|
1,466,652
|
$
|
923,529
|
$
|
543,123
|
59
|
%
|
|
Nine months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
License fees
|
$
|
4,000,000
|
$
|
-
|
$
|
4,000,000
|
N/A
|
|||||||||
Payroll-related
|
1,797,317
|
1,291,038
|
506,279
|
39
|
%
|
|||||||||||
Stock-based compensation
|
1,018,428
|
-
|
1,018,428
|
N/A
|
||||||||||||
Other expenses, net
|
1,563,317
|
1,008,631
|
554,686
|
55
|
%
|
|||||||||||
Total research and development expense
|
$
|
8,379,062
|
$
|
2,299,669
|
$
|
6,079,393
|
264
|
%
|
|
Three months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Professional fees
|
$
|
1,587,573
|
$
|
779,119
|
$
|
808,454
|
104
|
%
|
||||||||
Stock-based compensation
|
1,280,524
|
22,734
|
1,257,790
|
5,533
|
%
|
|||||||||||
Payroll-related
|
540,769
|
28,513
|
512,256
|
1,797
|
%
|
|||||||||||
Insurance
|
366,986
|
39,709
|
327,277
|
824
|
%
|
|||||||||||
Other expenses, net
|
482,326
|
213,982
|
268,344
|
125
|
%
|
|||||||||||
Total general and administrative expense
|
$
|
4,258,178
|
$
|
1,084,057
|
$
|
3,174,121
|
293
|
%
|
|
Nine months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Professional fees
|
$
|
5,553,661
|
$
|
1,827,002
|
$
|
3,726,659
|
204
|
%
|
||||||||
Stock-based compensation
|
2,283,269
|
68,202
|
2,215,067
|
3,248
|
%
|
|||||||||||
Payroll-related
|
706,066
|
86,553
|
619,513
|
716
|
%
|
|||||||||||
Insurance
|
766,951
|
83,627
|
683,324
|
817
|
%
|
|||||||||||
Other expenses, net
|
1,205,141
|
676,268
|
528,873
|
78
|
%
|
|||||||||||
Total general and administrative expense
|
$
|
10,515,088
|
$
|
2,741,652
|
$
|
7,773,436
|
284
|
%
|
|
Three months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Income from Brooklyn PPP Loan forgiveness
|
$
|
309,905
|
$
|
-
|
$
|
309,905
|
N/A
|
|||||||||
Interest expense, net
|
(20,210
|
)
|
(12,559
|
)
|
(7,651
|
)
|
61
|
%
|
||||||||
Other expenses, net
|
(12,626
|
)
|
-
|
(12,626
|
)
|
N/A
|
||||||||||
Total other income (expense), net
|
$
|
277,069
|
$
|
(12,559
|
)
|
$
|
289,628
|
-2,306
|
%
|
|
Nine months ended September 30,
|
|||||||||||||||
|
2021
|
2020
|
Change
|
% Change
|
||||||||||||
Income from Brooklyn PPP Loan forgiveness
|
$
|
309,905
|
$
|
-
|
$
|
309,905
|
N/A
|
|||||||||
Interest expense, net
|
(55,974
|
)
|
(31,482
|
)
|
(24,492
|
)
|
78
|
%
|
||||||||
Other expenses, net
|
(1,613
|
)
|
-
|
(1,613
|
)
|
N/A
|
||||||||||
Total other income (expense), net
|
$
|
252,318
|
$
|
(31,482
|
)
|
$
|
283,800
|
-901
|
%
|
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk.
|
Item 4. |
Controls and Procedures.
|
|
• |
hiring and employing additional accounting personnel in a number, and with experience, to allow for proper segregation of duties; and
|
|
• |
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.
|
Item 1. |
Legal Proceedings.
|
Item 1A. |
Risk Factors.
|
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds.
|
Item 6. |
Exhibits.
|
Exhibit
|
Description
|
|
Incorporated By Reference
|
|
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
|
||
(q) 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
|
||
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
|
||
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
|
||
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
|
||
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
|
||
Schedule identifying agreements substantially identical to the form of indemnification agreement filed as Exhibit 10.4(a)
|
|
Filed herewith
|
||
Brooklyn ImmunoTherapeutics, Inc. Restated 2020 Stock Incentive Plan
|
Exhibit to Form 8-K filed on September 13, 2021
|
|||
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
|
|
Furnished herewith
|
||
Certification of Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
Furnished 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).
|
|
|
* |
Certain information redacted and replaced with “[***]”.
|
+ |
Indicates management contract or compensatory plan.
|
† |
Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Brooklyn ImmunoTherapeutics, Inc. hereby undertakes to furnish supplementally copies of any of the omitted schedules and
exhibits upon request by the Securities and Exchange Commission.
|
BROOKLYN IMMUNOTHERAPEUTICS, INC.
|
||
Date: November 12, 2021
|
By:
|
/s/ Howard J. Federoff
|
Howard J. Federoff
|
||
Chief Executive Officer and President
|
Indemnitee
|
Date of Agreement
|
Charles Cherington
|
April 14, 2021
|
Kevin D’Amour
|
September 23, 2021
|
George P. Denny III
|
April 14, 2021
|
Howard J. Federoff
|
April 20, 2021
|
Luba Greenwood
|
April 14, 2021
|
Ronal Guido
|
April 14, 2021
|
Sandra Gurrola
|
June 21, 2021
|
Lynn Sadowski Mason
|
April 15, 2021
|
Erich Mohr
|
May 7, 2021
|
Yiannis Monovoukas
|
April 14, 2021
|
Ajay Sial
|
September 23, 2021
|
Roger Sidhu
|
September 23, 2021
|
Nicholas Singer
|
April 14, 2021
|
Date: November 12, 2021
|
/s/ Howard J. Federoff
|
Howard J. Federoff
|
|
Chief Executive Officer and President
|
|
|
(Principal Executive Officer)
|
Date: November 12, 2021
|
/s/ Sandra Gurrola
|
Sandra Gurrola
|
|
Vice President of Finance
|
|
(Principal Financial Officer)
|
Date: November 12, 2021
|
/s/ Howard J. Federoff
|
Howard J. Federoff
|
|
Chief Executive Officer and President
|
|
(Principal Executive Officer)
|
Date: November 12, 2021
|
/s/ Sandra Gurrola
|
Sandra Gurrola
|
|
Vice President of Finance
|
|
(Principal Financial Officer)
|