Item 8. Financial Statements and Supplementary Data
ITEM 8.
FINANCIAL STATEMENTS
AND SUPPLEMENTARY DATA
Index
to consolidated financial statements
Independent
Registered Public Accounting Firm - Audit Opinion
80
Financial Statements:
Consolidated Balance Sheets
83
Consolidated Statements of Operations
84
Consolidated Statements of Comprehensive Loss
85
Consolidated Statements of Shareholders Equity
86
Consolidated Statements of Cash Flows
87
See
accompanying notes to consolidated financial statements.
79 | P a g e
Report of Independent Registered Public Accounting
Firm
To
the Shareholders and Board of Directors
Lineage
Cell Therapeutics, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheet of Lineage Cell Therapeutics, Inc. and Subsidiaries (collectively, the “Company”)
as of December 31, 2021, the related consolidated statements of operations, comprehensive loss, changes in shareholders’ equity,
and cash flows for the year ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Company at December 31, 2021, and the results of its operations and its cash flows for the year ended December 31, 2021, in conformity
with accounting principles generally accepted in the United States of America.
The
consolidated financial statements of the Company as of and for the year ended December 31, 2020 were audited by OUM & Co. LLP, who
joined WithumSmith+Brown, PC on July 15, 2021, and rendered their opinion on such statements on March 11, 2021.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that
was communicated or required to be communicated to the Audit Committee and that: (1) relates to accounts or disclosures that are material
to the consolidated financial statements; and (2) involved our especially challenging, subjective, or complex judgments. The communication
of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are
not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or
disclosures to which it relates.
Accounting
for revenue and collaboration agreements
80 | P a g e
Description
of the Matter
The
Company recorded deferred revenue and revenue from collaboration agreements of $50.4 million and $1.1 million, respectively, as of and
for the year ended December 31, 2021. As described in Note 2, the terms of the Company’s collaboration agreements may include licenses
for the Company’s technology or programs, research and development services, and services or obligations in connection with participation
in research or steering committees. Amounts received under these arrangements typically include nonrefundable upfront payments and license
fees, research funding, milestone and other contingent payments for the achievement of defined collaboration objectives and certain preclinical,
clinical, regulatory and sales-based events, as well as royalties on sales of any commercialized products.
Auditing
the Company’s accounting for revenues from collaboration arrangements was complex and required significant judgments primarily
in identifying which elements represent revenue producing performance obligations, determining the measurement and allocation of arrangement
consideration, and evaluating estimates of the total expected inputs under the input method for revenue recognized over time.
How
We Addressed the Matter in Our Audit
To
test the accounting treatment for revenue from collaboration arrangements, we evaluated, among other things, whether the identified performance
obligations were properly determined, and the transaction price was properly measured and allocated to the identified performance obligations.
To test the measurement of efforts toward satisfying the performance obligation, our audit procedures included, among others, reviewing
management’s analysis for accuracy and completeness by agreeing data to the underlying contract, inspecting communications with
the collaborative partner, evaluating the application of the input method for the recognition of revenue and testing the estimated total
inputs and actual inputs incurred.
/s/
WithumSmith+Brown, PC
We
have served as the Company’s auditor since 2014.
San
Francisco, California
March
10, 2022
PCAOB
ID Number 100
81 | P a g e
Report
of Independent Registered Public Accounting Firm
Shareholders
and Board of Directors
Lineage
Cell Therapeutics, Inc.
Carlsbad,
California
Opinion
on the Consolidated Financial Statements
We
have audited the consolidated balance sheet of Lineage Cell Therapeutics, Inc. and Subsidiaries (collectively, the “Company”)
as of December 31, 2020, and the related consolidated statements of operations, comprehensive loss, changes in shareholders’ equity,
and cash flows for the year ended December 31, 2020, and the related notes (collectively referred to as the “consolidated financial
statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position
of the Company at December 31, 2020, and the results of their operations and their cash flows for the year ended December 31, 2020 ,
in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the PCAOB
and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable
rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
/s/
OUM & CO. LLP
San
Francisco, California
March
11, 2021
We served as the Company’s auditor since 2014.
PCAOB
ID Number 252
82 | P a g e
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(IN
THOUSANDS)
December 31, 2021
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 55,742
$ 32,585
Marketable equity securities
2,616
8,977
Accounts and grants receivable, net (Note 3)
50,840
4
Prepaid expenses and other current assets
2,351
2,433
Total current assets
111,549
43,999
NONCURRENT ASSETS
Property and equipment, net (Notes 6 and 14)
4,872
5,630
Deposits and other long-term assets
630
616
Goodwill
10,672
10,672
Intangible assets, net
46,822
47,032
TOTAL ASSETS
$ 174,545
$ 107,949
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 27,969
$ 6,813
Lease liabilities, current portion (Note 14)
801
746
Financing lease, current portion (Note 14)
30
16
Deferred revenues (Note 3)
18,119
193
Liability classified warrants, current portion
197
1
Total current liabilities
47,116
7,769
LONG-TERM LIABILITIES
Deferred tax liability
2,076
2,076
Deferred revenues, net of current portion (Note 3)
32,454
-
Lease liability, net of current portion (Note 14)
1,941
2,514
Financing lease, net of current portion
30
26
Liability classified warrants and other long-term liabilities
30
437
TOTAL LIABILITIES
83,647
12,822
Commitments and contingencies (Note 14)
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of December 31, 2021 and 2020, respectively
-
-
Common shares, no par value, authorized 250,000 shares; 169,477 and 153,096 shares issued and outstanding as of December 31, 2021 and 2020, respectively
434,529
393,944
Accumulated other comprehensive loss
( 5,211 )
( 3,667 )
Accumulated deficit
( 337,097 )
( 294,078 )
Lineage Cell Therapeutics, Inc. shareholders’ equity
92,221
96,199
Noncontrolling (deficit)
( 1,323 )
( 1,072 )
Total shareholders’ equity
90,898
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 174,545
$ 107,949
See
accompanying notes to the consolidated financial statements.
83 | P a g e
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN
THOUSANDS, EXCEPT PER SHARE DATA)
2021
2020
Year Ended December 31,
2021
2020
REVENUES:
Royalties
$ 2,776
$ 773
Collaboration revenues
1,120
-
Grant revenues
445
1,053
Total revenues
4,341
1,826
Cost of sales
( 1,426 )
( 385 )
Gross profit
2,915
1,441
OPERATING EXPENSES:
Research and development
33,914
12,317
General and administrative
18,212
15,571
Total operating expenses
52,126
27,888
Loss from operations
( 49,211 )
( 26,447 )
OTHER INCOME, NET:
Interest income, net
2
1,039
Gain on sale of marketable securities
6,024
4,560
Unrealized loss on marketable equity securities
( 2,299 )
( 3,782 )
Gain on extinguishment of debt
523
-
Unrealized gain (loss) on warrant liability
205
( 174 )
Other income, net
1,486
2,880
Total other income, net
5,941
4,523
LOSS BEFORE INCOME TAXES
( 43,270 )
( 21,924 )
Income tax benefit
-
1,239
NET LOSS
( 43,270 )
( 20,685 )
Net loss attributable to noncontrolling interest
251
36
NET LOSS ATTRIBUTABLE TO LINEAGE
$ ( 43,019 )
$ ( 20,649 )
NET LOSS PER COMMON SHARE:
BASIC AND DILUTED
$ ( 0.26 )
$ ( 0.14 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC AND DILUTED
164,502
150,044
See
accompanying notes to the consolidated financial statements.
84 | P a g e
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
(IN
THOUSANDS)
2021
2020
Year Ended December 31,
2021
2020
NET LOSS
$ ( 43,270 )
$ ( 20,685 )
Other comprehensive loss, net of tax:
Foreign currency translation adjustments, net of tax
( 1,544 )
( 2,986 )
COMPREHENSIVE LOSS
( 44,814 )
( 23,671 )
Less: comprehensive loss attributable to noncontrolling interest
251
36
COMPREHENSIVE LOSS ATTRIBUTABLE TO LINEAGE COMMON SHAREHOLDERS
$ ( 44,563 )
$ ( 23,635 )
See
accompanying notes to the consolidated financial statements.
85 | P a g e
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(IN
THOUSANDS)
Number
of
Shares
Amount
Number
of
Shares
Amount
Accumulated Deficit
Interest/
(Deficit)
Comprehensive
Income/(Loss)
Shareholders’
Equity
Preferred
Shares
Common
Shares
Noncontrolling
Accumulated
Other
Total
Number
of
Shares
Amount
Number
of
Shares
Amount
Accumulated Deficit
Interest/
(Deficit)
Comprehensive
Income/(Loss)
Shareholders’
Equity
BALANCE AT DECEMBER
31, 2019
-
$ -
149,804
$ 387,062
$ ( 273,422 )
$ ( 1,712 )
$ ( 681 )
$ 111,247
Shares issued through ATM
-
-
3,095
5,404
-
-
-
5,404
Shares issued upon vesting
of restricted stock units, net of shares retired to pay employees’ taxes
-
-
47
( 27 )
-
-
-
( 27 )
Shares issued for services
-
-
150
119
-
-
-
119
Stock-based compensation
-
-
-
2,227
-
-
-
2,227
Shares issued
upon exercise of stock options
Shares issued
upon exercise of stock options, shares
Financing related fees
-
-
-
( 209 )
-
-
-
( 209 )
Dissolution of BioTime Asia
-
-
-
( 676 )
( 7 )
676
-
( 7 )
Hadasit non-cash warrant exercise
-
-
-
44
-
-
-
44
Shares issued upon exercise
of stock options
Shares issued upon exercise
of stock options, shares
Foreign currency translation
gain (loss)
-
-
-
-
-
-
( 2,986 )
( 2,986 )
NET
LOSS
-
-
-
-
( 20,649 )
( 36 )
-
( 20,685 )
BALANCE AT DECEMBER 31, 2020
-
$ -
153,096
$ 393,944
$ ( 294,078 )
$ ( 1,072 )
$ ( 3,667 )
$ 95,127
Shares issued through ATM
-
-
11,923
29,817
-
-
-
29,817
Shares issued upon vesting
of restricted stock units, net of shares retired to pay employees’ taxes
-
-
40
( 54 )
-
-
-
( 54 )
Shares issued for services
-
-
78
202
-
-
-
202
Stock-based compensation
-
-
-
3,519
-
-
-
3,519
Shares issued upon exercise of stock options
-
-
4,320
7,429
-
-
-
7,429
Financing related fees
-
-
-
( 330 )
-
-
-
( 330 )
Shares issued upon exercise of stock options
-
-
20
2
-
-
-
2
Foreign currency translation
gain (loss)
-
-
-
-
-
-
( 1,544 )
( 1,544 )
NET
LOSS
-
-
-
-
( 43,019 )
( 251 )
-
( 43,270 )
BALANCE
AT DECEMBER 31, 2021
-
$ -
169,477
$ 434,529
$ ( 337,097 )
$ ( 1,323 )
$ ( 5,211 )
$ 90,898
See
accompanying notes to the consolidated financial statements.
86 | P a g e
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN
THOUSANDS)
2021
2020
Year Ended December 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss attributable to Lineage
$ ( 43,019 )
$ ( 20,649 )
Net loss attributable to noncontrolling interest
( 251 )
( 36 )
Adjustments to reconcile net loss attributable to Lineage to net cash used in operating activities:
Gain on sale of marketable equity securities
( 6,024 )
( 4,560 )
Unrealized loss on marketable equity securities
2,299
3,782
Deferred tax benefit
-
( 1,239 )
Depreciation expense, including amortization of leasehold improvements
663
823
Amortization of right-of-use assets
14
72
Amortization of intangible assets
210
1,216
Stock-based compensation
3,519
2,227
Common stock issued for services
202
119
Change in unrealized (gain) loss on warrant liability
( 205 )
174
Write-off of security deposit
-
150
Amortization of deferred license fee
-
( 200 )
Foreign currency remeasurement and other (gain)
( 1,566 )
( 2,957 )
Loss (gain) on sale of assets
24
( 20 )
Realized loss on warrant exercise
-
44
Gain on extinguishment of debt
( 523 )
-
Changes in operating assets and liabilities:
Accounts and grants receivable
( 857 )
287
Accrued interest receivable
-
( 1,008 )
Receivables from affiliates, net of payables
-
7
Prepaid expenses and other current assets
( 72 )
1,575
Accounts payable and accrued liabilities
21,645
308
Deferred revenue and other liabilities
380
132
Net cash used in operating activities
( 23,561 )
( 19,753 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of OncoCyte common shares
10,064
10,941
Proceeds from the sale of AgeX common shares
-
1,290
Proceeds from the sale of HBL common shares
21
830
Purchase of property and equipment
( 354 )
( 64 )
Proceeds from sale of assets
14
23
Security deposit paid and other
-
18
Net cash provided by investing activities
9,745
13,038
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from employee options exercised
7,240
-
Proceeds from payment of Juvenescence promissory note
-
24,624
Common shares received and retired for employee taxes paid
( 54 )
( 27 )
Proceeds from sale of common shares
30,865
5,127
Payments for offering costs
( 1,101 )
( 356 )
Repayment of financing lease liabilities
( 20 )
( 26 )
Proceeds from Paycheck Protection Program (“PPP”) Loan (Note 8)
-
523
Net cash provided by financing activities
36,930
29,865
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 20 )
( 63 )
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
23,094
23,087
At beginning of year
33,183
10,096
At end of year
$ 56,277
$ 33,183
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Cash paid during year for interest
$ 13
$ 20
SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES:
Receivable from sale of common shares in at the market offering
$ 147
$ 269
Receivable from exercise of stock options
$ 189
$ -
See
accompanying notes to the consolidated financial statements.
87 | P a g e
LINEAGE
CELL THERAPEUTICS, INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
1.
Organization, Basis of Presentation and Liquidity
Lineage Cell Therapeutics,
Inc. (“Lineage,” “we,” “us,” or “our”) is a clinical-stage biotechnology company developing
novel cell therapies to address unmet medical needs. Our programs are based on our proprietary cell-based technology and associated development
and manufacturing capabilities. From this platform, we design, develop, and manufacture specialized human cells with anatomical and physiological
functions which are similar or identical to cells found naturally in the human body. These cells which we manufacture are created by
developmental differentiation protocols applied to established and well-characterized, pluripotent, and self-renewing cell lines. These
functional cells are transplanted into patients to either replace or support cells that are dysfunctional or absent due to degenerative
disease or traumatic injury, or are administered as a means of helping the body mount a more robust and effective immune response to
cancer or infectious diseases.
Our
strategy is to efficiently leverage our technology platform and manufacturing capabilities to develop and advance our programs internally
or in conjunction with strategic partners to further enhance their value. As one example, on December 17, 2021, we entered into a Collaboration
and License Agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively, “Roche”),
wherein Lineage granted to Roche exclusive worldwide rights to develop and commercialize retinal pigment epithelium cell therapies, including its proprietary cell therapy known as OpRegen®, for the treatment of ocular disorders, including advanced
dry age-related macular degeneration with geographic atrophy. Roche has paid Lineage a $ 50.0 million upfront payment under this alliance
and Lineage is eligible to receive up to an additional $ 620.0 million in certain developmental, regulatory, and commercialization milestone
payments. Lineage also is eligible for tiered double-digit percentage royalties on net sales of OpRegen.
Currently,
Lineage is working with Roche in support of the dry age-related macular degeneration (OpRegen) program and is clinically testing
therapies to treat spinal cord injuries and non-small cell lung cancer, as well as conducting research and preclinical development activities
intended to advance our pipeline into other therapeutic indications and target tissues or organs.
Product
Candidates & Other Programs
We
have several allogeneic, or “off-the-shelf,” cell therapy programs in development:
●
OpRegen ® ,
a retinal pigment epithelium (“RPE”) cell replacement therapy currently in a Phase 1/2a multicenter clinical trial for
the treatment of advanced dry age-related macular degeneration (“AMD”) with geographic atrophy (“GA”) (also
known as atrophic AMD). There are currently no therapies approved by the U.S. Food and Drug Administration (“FDA”) for
dry AMD. As of December 17, 2021 this program has been partnered with Roche for further clinical development and commercialization.
●
OPC1 ,
an oligodendrocyte progenitor cell therapy currently in long-term follow-up for a Phase 1/2a multicenter clinical trial for spinal
cord injuries (“SCI”). This clinical trial has been partially funded by the California Institute for Regenerative Medicine
(“CIRM”).
●
VAC ,
an allogeneic cancer immunotherapy of antigen-presenting dendritic cells. One of the VAC product candidates, VAC2, is currently in
a Phase 1 clinical trial in non-small cell lung cancer (“NSCLC”). This clinical trial is being funded and conducted by
Cancer Research UK, one of the world’s largest independent cancer research charities. We also have another VAC-based product
candidate in preclinical development with our partner, Immunomic Therapeutics, Inc. (“ITI”), for the treatment of glioblastoma
multiforme (“GBM”).
●
Other.
We have other product candidates
in preclinical development covering a range of therapeutic areas and target tissues or organs. Generally, these
candidates are based on the same pluripotent platform technology and employ a similar guided cell differentiation and transplant
approach as our current clinical-stage products.
In
addition to seeking to create value for shareholders by developing product candidates and other technologies through our clinical development
programs, we also seek to create value from our technologies through partnering and strategic transactions. We founded two companies
that later became publicly traded companies: OncoCyte Corporation (“OncoCyte”) and AgeX Therapeutics, Inc. (“AgeX”).
We continue to hold common stock in OncoCyte as of December 31, 2021.
During
the year ended December 31, 2021, we received approximately $ 10.1 million in gross proceeds in connection with our sale of shares of
OncoCyte. In August 2020, we also received $ 24.6 million from Juvenescence Limited (“Juvenescence”), representing principal
and accrued interest under a promissory note we received in connection with our sale of AgeX shares to Juvenescence in August 2018.
88 | P a g e
Asterias
Merger
On
November 7, 2018, Lineage, Asterias Biotherapeutics, Inc. (“Asterias”) and Patrick Merger Sub, Inc., a wholly owned subsidiary
of Lineage, entered into an Agreement and Plan of Merger (the “Merger Agreement”) whereby Lineage agreed to acquire all of
the outstanding common stock of Asterias in a stock-for-stock transaction (the “Asterias Merger”).
On
March 7, 2019, the shareholders of each of Lineage and Asterias approved the Merger Agreement. Prior to the Asterias Merger, Lineage
owned approximately 38 % of Asterias’ issued and outstanding common stock and accounted for Asterias as an equity method investment.
On
March 8, 2019, the Asterias Merger closed with Asterias surviving as a wholly owned subsidiary of Lineage. The former stockholders of
Asterias (other than Lineage) received 0.71 common shares of Lineage for every share of Asterias common stock they owned. Lineage issued
24,695,898 common shares, including 58,085 shares issued in respect of restricted stock units issued by Asterias that immediately vested
in connection with the closing of the Asterias Merger. The aggregate dollar value of such shares, based on the closing price of Lineage
common shares on March 8, 2019, was $ 32.4 million. The total purchase price was $ 52.6 million. Lineage also assumed warrants to purchase
shares of Asterias common stock.
The
Asterias Merger was accounted for using the acquisition method of accounting in accordance with Accounting Standards Codification (“ASC”)
Topic 805, Business Combinations , which requires, among other things, that the assets and liabilities assumed be recognized at
their fair values as of the acquisition date.
Use
of estimates
The
preparation of consolidated financial statements in conformity with accounting principles generally accepted in the U.S. (“GAAP”)
requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during
the reporting period with consideration given to materiality. Significant estimates and assumptions which are subject to significant
judgment include those related to going concern assessment of consolidated financial statements, useful lives associated with long-lived
assets, including evaluation of asset impairment, allowances for uncollectible accounts receivables, loss contingencies, deferred income
taxes and tax reserves, including valuation allowances related to deferred income taxes, and assumptions used to value stock-based awards,
debt or other equity instruments. Actual results could differ materially from those estimates.
Principles
of consolidation
Lineage’s
consolidated financial statements include the accounts of its subsidiaries. The following table reflects Lineage’s ownership, directly
or through one or more subsidiaries, of the outstanding shares of its operating subsidiaries as of December 31, 2021.
89 | P a g e
Schedule
of Lineage’s Ownership of Outstanding Shares of its Subsidiaries
Subsidiary
Field of Business
Lineage
Ownership
Country
Asterias BioTherapeutics, Inc. (1)
Cell
based therapeutics to treat neurological conditions and cancer
100 %
USA
Cell Cure Neurosciences Ltd (“Cell Cure”)
Manufacturing
of Lineage’s cell replacement platform technology
99 % (2)
Israel
ES Cell International Pte. Ltd. (“ESI”) (3)
Research
and clinical grade cell lines
100 %
Singapore
OrthoCyte Corporation (“OrthoCyte”)
Research
in orthopedic diseases and injuries
99.8 %
USA
(1)
Asterias
was acquired by Lineage in March 2019.
(2)
Includes shares
owned by Lineage and ESI.
(3)
The operating activities and fields of business listed
under these subsidiaries are conducted primarily by Lineage as the parent company.
All
material intercompany accounts and transactions have been eliminated in consolidation. As of December 31, 2021, Lineage consolidated
its direct and indirect wholly owned or majority-owned subsidiaries because Lineage has the ability to control their operating and financial
decisions and policies through its ownership, and the noncontrolling interest is reflected as a separate element of shareholders’
equity on Lineage’s consolidated balance sheets.
Liquidity
Lineage
has incurred significant operating losses and in recent years has funded its operations primarily through sale of common stock of AgeX
and OncoCyte, both former subsidiaries, sale of common stock of Hadasit Bio-Holdings Ltd (“HBL”), receipt of research grants,
royalties from product sales, license revenues, sales of research products and issuance of equity securities.
On
May 1, 2020, Lineage entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with
Cantor Fitzgerald & Co., as sales agent (“Cantor Fitzgerald”), pursuant to which Lineage may offer and sell, from time
to time, through Cantor Fitzgerald, common shares of Lineage (“ATM Shares”) having an aggregate offering price of up to $ 25.0
million. Lineage is not obligated to sell any ATM Shares. Subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald
will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules
and regulations, and the rules of the NYSE American, to sell the ATM Shares from time to time based upon Lineage’s instructions,
including any price, time or size limits specified by Lineage. Under the Sales Agreement, Cantor Fitzgerald may sell the ATM Shares by
any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended,
or by any other method permitted by law, including in privately negotiated transactions. Cantor Fitzgerald’s obligations to sell
the ATM Shares are subject to satisfaction of certain conditions, including the continued effectiveness of Lineage’s Registration
Statement on Form S-3 (File No. 333-237975), which was filed with the Commission on May 1, 2020 and was declared effective on May 8,
2020. The Sales Agreement replaced the previous sales agreement with Cantor that had been entered into in April 2017.
On
March 5, 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of an additional $ 25.0 million
of common shares under the Sales Agreement increasing the total offering to $ 50.0 million. As of December 21, 2021, $ 14.1 million remained
available for sale under the Sales Agreement. On December 21, 2021, Lineage filed a prospectus supplement with the SEC in connection
with the offering and sale of up to $ 64.1 million of common shares (the “New Sales Agreement”), with Cantor Fitzgerald as
the sales agent, no additional sales will be made under the Sales Agreement. The $ 64.1 million under the New Sales Agreement which may
be issued are registered pursuant to Lineage’s effective shelf registration on Form S-3 (File
No. 333-237975), as filed with the SEC on May 1, 2020 and declared effective on May 8, 2020 (the “May 2020 Registration Statement”),
and Lineage’s effective shelf registration statement on Form S-3 (File No. 333-254167), which was filed with the SEC on March 5,
2021 and declared effective on March 19, 2021. As of December 31, 2021, under the Sales Agreement, Lineage had issued 14,908,735 common
shares at a weighted average price per share of $ 2.41 for gross proceeds of $ 35.9 million. As of December 31, 2021, under the New Sales
Agreement, Lineage had issued 108,200 common shares at a weighted average price per share of $ 2.55 for gross proceeds of $ 0.3 million
(which includes $ 0.2 million of cash in transit related to a 2021 transaction that settled in early 2022). As a result, as of December
31, 2021, $ 63.9 million remained available for sale under the New Sales Agreement.
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As
of December 31, 2021, Lineage had an accumulated deficit of approximately $ 337.1 million, working capital of $ 64.4 million and shareholders’
equity of $ 90.9 million. Lineage has evaluated its projected cash flows and believes that its $ 58.4 million of cash, cash equivalents
and marketable equity securities are sufficient to fund Lineage’s planned operations for at least the next twelve months from the
issuance date of the consolidated financial statements included herein. If Lineage needs near term working capital or liquidity to supplement
its cash and cash equivalents for its operations, Lineage may sell some, or all, of its marketable equity securities, as necessary.
In
January 2022, Lineage received a $ 50.0 million upfront payment related to the Roche Agreement. Lineage made a subsequent payment of $ 12.1
million to the IIA, pursuant to Lineage’s obligations under the Innovation Law. Additionally, Lineage made a subsequent
payment of $ 8.9 million to Hadasit, pursuant to Lineage’s obligations under the Second Amended and Restated License Agreement.
See Note 14 for a description of the Roche Agreement and related payment obligations.
Lineage’s
projected cash flows are subject to various risks and uncertainties, and the unavailability or inadequacy of financing to meet future
capital needs could force Lineage to modify, curtail, delay, or suspend some or all aspects of its planned operations. Lineage’s
determination as to when it will seek new financing and the amount of financing that it will need will be based on Lineage’s evaluation
of the progress it makes in its research and development programs, any changes to the scope and focus of those programs, any changes
in grant funding for certain of those programs, and projection of future costs, revenues, and rates of expenditure. Lineage’s ability
to raise additional funds may be adversely impacted by deteriorating global economic conditions and the disruptions to and volatility
in the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. Lineage may be required
to delay, postpone, or cancel clinical trials or limit the number of clinical trial sites, unless it is able to obtain adequate financing.
Lineage cannot assure that adequate financing will be available on favorable terms, if at all. Sales of additional equity securities
by Lineage or its subsidiaries and affiliates could result in the dilution of the interests of current shareholders.
2.
Summary of Significant Accounting Policies
Marketable
equity securities -
Lineage accounts for the shares it holds in OncoCyte and HBL as marketable equity securities in accordance with ASC 320-10-25, Investments
– Debt and Equity Securities , as amended by Accounting Standards Update (“ASU”) 2016-01, Financial Instruments–Overall:
Recognition and Measurement of Financial Assets and Financial Liabilities, further discussed below.
OncoCyte
shares have readily determinable fair values quoted on the NYSE American under trading symbol “OCX”. The HBL shares have
a readily determinable fair value quoted on the Tel Aviv Stock Exchange (“TASE”) under the trading symbol “HDST”
where share prices are denominated in New Israeli Shekels (NIS).
Revenue
recognition - Lineage recognizes revenue in accordance with Financial Accounting Standards Board (“FASB”) ASU 2014-09 ,
Revenues from Contracts with Customers (Topic 606) , and in a manner that depicts the transfer of control of a product or a service
to a customer and reflects the amount of the consideration it is entitled to receive in exchange for such product or service. In doing
so, Lineage follows a five-step approach: (i) identify the contract with a customer; (ii) identify the performance obligations in the
contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations; and (v) recognize
revenue when (or as) the customer obtains control of the product or service. Lineage considers the terms of a contract and all relevant
facts and circumstances when applying the revenue recognition standard. Lineage applies the revenue recognition standard, including the
use of any practical expedients, consistently to contracts with similar characteristics and in similar circumstances.
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In
applying the provisions of ASU 2014-09, Lineage has determined that government grants are out of the scope of ASU 2014-09 because the
government entities do not meet the definition of a “customer,” as defined by ASU 2014-09, as there is not considered to
be a transfer of control of goods or services to the government entities funding the grant. In the absence of applicable guidance under
U.S. GAAP, the Company’s policy is to recognize grant revenue when the related costs are incurred and the right to payment is realized.
Costs incurred are recorded in research and development and general and administrative expenses on the accompanying statements of operations .
Deferred grant revenues represent grant funds received from the governmental funding agencies for which the allowable expenses have
not yet been incurred as of the balance sheet date reported.
Royalties
from product sales and license fees -
For agreements that include sales-based royalties, including commercial milestone payments based on the level of sales, and the license
is deemed to be the predominant item to which the royalties relate, Lineage recognizes revenue at the later of (i) when the related sales
occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially
satisfied). Lineage estimates and recognizes royalty revenues based on all available information, including estimates provided by the
customer or licensee from which Lineage obtains such estimates directly for each reporting period. Actual revenues ultimately received
may differ from those estimates recorded and are adjusted in the period when information to actuals is available to Lineage.
Collaborative
agreements -
On April 16, 2021, Lineage entered a worldwide license and collaboration agreement with ITI for the development and commercialization
of the VAC platform. Under the terms of this agreement, Lineage is entitled to upfront licensing fees totaling $ 2.0
million paid over the first year, and up to $ 67.0
million in development and commercial milestones
across multiple indications. Lineage will also be eligible to receive royalties up to 10 %
on net sales of future products. On December 17, 2021, we entered into an exclusive worldwide collaboration and license agreement with
Roche, for the development and commercialization of OpRegen. Roche paid a $ 50.0
million upfront payment and we are eligible to
receive up to $ 620.0
million in additional development, approval,
and sales milestone payments, in addition to tiered double-digit royalties.
We
review collaborative agreements to determine if the accounting treatment falls under Accounting Standards Codification, Topic 606 ,
Revenue from Contracts with Customers (“ASC 606”) , or Accounting Standards Codification Topic 808, Collaborative
Arrangements (“ASC 808”). While these agreements may be within the scope of ASC 808, we may analogize to ASC 606 for
some aspects of the agreements.
The
terms of our collaborative agreements typically include one or more of the following: (i) upfront fees; (ii) milestone payments related
to achievement of development or commercial goals; (iii) royalties on net sales of licensed products; and (iv) reimbursement of cost-sharing
of research and development (“R&D”) expenses. Each of these payments eventually result in collaboration revenues. When
a portion of non-refundable upfront fees or other payments received are allocated to continuing performance obligations under the terms
of a collaborative arrangement, they are recorded as deferred revenue and recognized as collaboration revenue when (or as) the underlying
performance obligation is satisfied.
To
identify the performance obligations within the collaboration agreements, we first identify all the promises in the contract (i.e. explicit
and implicit), which may include a customer option to acquire additional goods or services for free or at a discount. We exclude any
immaterial promises from the assessment of identifying performance obligations. When an option is identified as providing a customer
with a material right, the option is identified as a performance obligation. A portion of the transaction price is then allocated to
the option and recognized when (or as) the future goods or services related to the option are provided, or when the option expires.
As
part of the accounting treatment for these agreements, we must develop estimates and assumptions that require judgement to determine
the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among
the performance obligations. The following items are estimated in the calculation of the stand-alone selling price: forecasted revenues
and development costs, development timelines, discount rates and probabilities of technical and regulatory success. We evaluate each
performance obligation to determine if they can be satisfied at a point in time or over time, and we measure the services delivered to
our collaboration partners each reporting period, which is based on the progress of the related program. If necessary, we adjust the
measure of performance and related revenue recognition. Any such adjustments are recorded on a cumulative catch-up basis which would
affect revenue and net income (loss) in the period of adjustment. In addition, variable consideration (e.g., milestone payments) must
be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
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Upfront
fees - If a license to our intellectual property is determined to be distinct from the other performance obligations identified in
the arrangement, we recognize collaboration revenues from the transaction price allocated to the license when the license is transferred
to the licensee, and the licensee is able to use and benefit from the license. When the license is determined to be non-distinct, we
utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation
is satisfied over time or at a point in time, and, if over time, the appropriate method of measuring progress for purposes of recognizing
collaboration revenue from the allocated transaction price. For example, when we receive upfront fees for the performance of research
and development services, or when research and development services are not considered to be distinct from a license, we recognize collaboration
revenue for those units of account over time using a measure of progress. We evaluate the measure of progress at each reporting period
and, if necessary, adjust the measure of performance and related revenue as a change in estimate.
Milestone
payments - At the inception of each collaboration agreement that includes milestone payments (variable consideration), we evaluate
whether the milestones are considered probable of being reached and estimate the amount to be included in the transaction price using
the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value
is included in the transaction price. Milestone payments that are not within our or the collaboration partner’s control, such as
non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals
are received. At the end of each reporting period, we re-evaluate the probability of achievement of milestones that are within our or
the collaboration partner’s control, such as operational developmental milestones and any related constraint, and if necessary,
adjust our estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect
collaboration revenues and net income (loss) in the period of adjustment. Revisions to our estimate of the transaction price may also
result in negative collaboration revenues and net income (loss) in the period of adjustment.
Royalties
- For collaboration agreements that include sales-based royalties, including commercial milestone payments based on the level of
sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (i) when
the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied
(or partially satisfied).
Reimbursement,
cost-sharing payments - Under certain collaborative agreements, we will receive reimbursement for a portion of our R&D expenses.
Such reimbursements are reviewed for gross versus net reporting considerations and reflected either as a reduction of R&D expense
or as reimbursement revenue in our consolidated statements of operations.
As
of December 31, 2021, we recorded $ 49.7
million and $ 0.8
million of deferred revenue on the consolidated
balance sheet, related to the Roche and ITI collaboration agreements. For the year ended December 31, 2021, we recognized $ 0.3
million and $ 0.8
million of revenue on the statement of operations,
related to the Roche and ITI collaboration agreements, respectively.
Basic
and diluted net income (loss) per share attributable to common shareholders -
Basic earnings per share is calculated by dividing net
income or loss attributable to Lineage common shareholders by the weighted average number of common shares outstanding, net of unvested
restricted stock or restricted stock units, subject to repurchase by Lineage, if any, during the period. Diluted earnings per share is
calculated by dividing the net income or loss attributable to Lineage common shareholders by the weighted average number of common shares
outstanding, adjusted for the effects of potentially dilutive common shares issuable under outstanding stock options and warrants, using
the treasury-stock method, convertible preferred stock, if any, using the if-converted method, and treasury stock held by subsidiaries,
if any.
For
the years ended December 31, 2021 and 2020, respectively, Lineage reported a net loss attributable to common shareholders, and therefore,
all potentially dilutive common shares were considered antidilutive for those periods.
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The
following common share equivalents were excluded from the computation of diluted net income (loss) per common share for the periods presented
because including them would have been antidilutive (in thousands):
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
Years
Ended December 31,
2021
2020
Stock options
14,883
16,215
Lineage Warrants
-
1,090
Restricted stock units (1)
31
93
(1)
On February 11, 2022, the
Board of Directors of Lineage, approved restricted stock unit awards for an aggregate of 694,424 (see Note 12).
Restricted
cash -
In accordance with ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , Lineage explains the change during the period
in the total of cash, cash equivalents and restricted cash, and includes restricted cash with cash and cash equivalents when reconciling
the beginning-of-period and end-of-period total amounts shown on the consolidated statements of cash flows.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the consolidated balance sheet
dates that comprise the total of the same such amounts shown in the consolidated statements of cash flows for all periods presented herein
(in thousands):
Schedule of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
December
31, 2021
December
31, 2020
Cash and cash equivalents
$ 55,742
$ 32,585
Restricted cash included in deposits and other long-term assets (see Note 14)
535
520
Restricted cash included in prepaid expenses and other current assets (see Note 14)
-
78
Total cash, cash equivalents, and restricted cash as shown in the consolidated statements of cash flows
$ 56,277
$ 33,183
Accounts
and grants receivable, net – Net accounts receivables amounted to $ 50,640,000
and $ 4,000
and grants receivable amounted to $ 200,000
and $ 61,000
as of December 31, 2021 and 2020, respectively.
Net trade receivables include an allowance for doubtful accounts of approximately $ 74,000
and $ 44,000
as of December 31, 2021 and 2020, respectively,
for those amounts deemed uncollectible by Lineage. Lineage establishes an allowance for doubtful accounts based on the evaluation of
the collectability of its receivables on a variety of factors, including the length of time receivables are past due, significant events
that may impair the customer’s ability to pay, such as a bankruptcy filing or deterioration in the customers operating results
or financial position, and historical experience. If circumstances related to customers change, estimates of the recoverability of receivables
would be further adjusted.
Leases
- We account for leases in accordance with ASC 842, Leases . We determine if an arrangement is a lease at inception. Leases
are classified as either financing or operating, with classification affecting the pattern of expense recognition in the consolidated
statements of operations. Under the available practical expedients for the adoption of ASC 842, we account for the lease and non-lease
components as a single lease component. We recognize right-of-use (“ROU”) assets and lease liabilities for leases with terms
greater than twelve months in the condensed consolidated balance sheet. ROU assets represent our right to use an underlying asset during
the lease term and lease liabilities represent our obligation to make lease payments arising from the lease. Operating and finance lease
ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. As most
of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at commencement
date in determining the present value of lease payments. We use the implicit rate when readily determinable. The operating and finance
lease ROU assets also includes any lease payments made and excludes lease incentives. Our lease terms may include options to extend or
terminate the lease when it is reasonably certain that we will exercise that option. Lease expense for operating lease payments is recognized
on a straight-line basis over the lease term. Lease expense for finance lease payments is recognized as amortization of ROU assets and
related interest. Operating and finance leases are included as ROU assets in property and equipment, and ROU lease liabilities, current
and long-term, in the consolidated balance sheets.
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Goodwill
and IPR&D – Goodwill is calculated as the difference between the acquisition date fair value of the consideration transferred
and the values assigned to the assets acquired and liabilities assumed. Goodwill is tested for impairment in accordance with ASU 2017-04,
Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment . In-process research and development
(“IPR&D”) assets are indefinite-lived intangible assets until the completion or abandonment of the associated research
and development (“R&D”) efforts. Once the R&D efforts are completed or abandoned, the IPR&D will either be amortized
over the asset’s estimated life as a finite-lived intangible asset or be impaired, respectively, in accordance with ASC 350, Intangibles
– Goodwill and Other . In accordance with ASC 350, goodwill and acquired IPR&D are determined to have indefinite lives and,
therefore, are not amortized. Instead, they are tested for impairment at least annually and between annual tests if we become aware of
an event or a change in circumstances that would indicate the asset may be impaired.
Going
concern assessment – Lineage assesses going concern uncertainty for its consolidated financial statements to determine if Lineage
has sufficient cash and cash equivalents on hand and working capital to operate for a period of at least one year from the date the consolidated
financial statements are issued or are available to be issued, which is referred to as the “look-forward period” as defined
by FASB’s ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to Lineage, Lineage
will consider various scenarios, forecasts, projections, and estimates, and Lineage will make certain key assumptions, including the
timing and nature of projected cash expenditures or programs, and its ability to delay or curtail those expenditures or programs, if
necessary, among other factors. Based on this assessment, as necessary or applicable, Lineage makes certain assumptions concerning its
ability to curtail or delay research and development programs and expenditures within the look-forward period in accordance with ASU
No. 2014-15.
Cash
and cash equivalents – Lineage considers all highly liquid investments purchased with an original maturity of three months
or less to be cash equivalents. As of December 31, 2021 and 2020, Lineage had $ 52.3 million and $ 28.8 million in money market funds,
respectively, considered to be cash equivalents.
Concentrations
of credit risk and significant sources of supply – Financial instruments that potentially subject Lineage to significant concentrations
of credit risk consist primarily of cash and cash equivalents. Lineage limits the amount of credit exposure of cash balances by maintaining
its accounts in high credit quality financial institutions. Cash equivalent deposits with financial institutions may occasionally exceed
the limits of insurance on bank deposits; however, Lineage has not experienced any losses on such accounts.
Lineage
relies on single-source, third-party suppliers for a few key components of our product candidates. If these single-source, third-party
suppliers are unable to continue providing a key component, the initiation or progress of any clinical studies of its product candidates
may be impeded.
Property
and equipment, net – Property and equipment is stated at cost and is being depreciated using the straight-line method over
their estimated useful lives ranging from 3 to 10 years. Leasehold improvements are amortized over the shorter of the useful life or
the lease term (see Note 6).
Long-lived
intangible assets – Long-lived intangible assets, consisting primarily of acquired patents, patent applications, and licenses
to use certain patents are stated at acquired cost, less accumulated amortization. Amortization expense is computed using the straight-line
method over the estimated useful lives of the assets, generally over 5 to 10 years.
Impairment
of long-lived assets – Long-lived assets, including long-lived intangible assets, are reviewed annually for impairment and
whenever events or changes in circumstances indicate that the carrying amount of an asset may not be fully recoverable. If an impairment
indicator is present, Lineage evaluates recoverability by a comparison of the carrying amount of the assets to future undiscounted net
cash flows expected to be generated by the assets. If the assets are impaired, the impairment recognized is measured by the amount by
which the carrying amount exceeds the estimated fair value of the assets.
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Accounting
for warrants – Lineage determines the accounting classification of warrants that it or its subsidiaries issue, as either liability
or equity, by first assessing whether the warrants meet liability classification in accordance with ASC 480-10, Accounting for Certain
Financial Instruments with Characteristics of both Liabilities and Equity , and then in accordance with ASC 815-40, Accounting
for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company’s Own Stock . Under ASC 480-10, warrants
are considered liability classified if the warrants are mandatorily redeemable, obligate the issuer to settle the warrants or the underlying
shares by paying cash or other assets, or warrants that must or may require settlement by issuing variable number of shares. If warrants
do not meet liability classification under ASC 480-10, Lineage assesses the requirements under ASC 815-40, which states that contracts
that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood
of the transaction occurring that triggers the net cash settlement feature. If the warrants do not require liability classification under
ASC 815-40, in order to conclude equity classification, Lineage assesses whether the warrants are indexed to its common stock or its
subsidiary’s common stock, as applicable, and whether the warrants are classified as equity under ASC 815-40 or other applicable
GAAP. After all relevant assessments are made, Lineage concludes whether the warrants are classified as liability or equity. Liability
classified warrants are required to be accounted for at fair value both on the date of issuance and on subsequent accounting period ending
dates, with all changes in fair value after the issuance date recorded in the consolidated statements of operations as a gain or loss.
Equity classified warrants are accounted for at fair value on the issuance date with no changes in fair value recognized subsequent to
the issuance date.
Transactions
with noncontrolling interests of subsidiaries - Lineage accounts for a change in ownership interests in its subsidiaries that does
not result in a change of control of the subsidiary by Lineage under the provisions of ASC 810-10-45-23,
Consolidation – Other Presentation Matters, which prescribes the accounting for changes in ownership interest that
do not result in a change in control of the subsidiary, as defined by GAAP, before and after the transaction . Under this guidance,
changes in a controlling shareholder’s ownership interest that do not result in a change of control, as defined by GAAP, in the
subsidiary are accounted for as equity transactions. Thus, if the controlling shareholder retains control, no gain or loss is recognized
in the statements of operations of the controlling shareholder. Similarly, the controlling shareholder will not record any additional
acquisition adjustments to reflect its subsequent purchases of additional shares in the subsidiary if there is no change of control.
Only a proportional and immediate transfer of carrying value between the controlling and the noncontrolling shareholders occurs based
on the respective ownership percentages.
Research
and development expenses - Research and development expenses consist of costs incurred for company-sponsored, collaborative and contracted
research and development activities. These costs include direct and research-related overhead expenses including compensation and related
benefits, stock-based compensation, consulting fees, research and laboratory fees, rent of research facilities, amortization of intangible
assets, and license fees paid to third parties to acquire patents or licenses to use patents and other technology. Research and development
costs which have an alternative future use will be capitalized as tangible assets, and costs with no future benefit or alternative use
will be expensed as incurred. Research and development expenses incurred and reimbursed by grants from third parties approximate the
grant income recognized in the consolidated statements of operations. Royalty expenses or sublicensing fees are recorded as research
and development costs, unless these costs are associated with royalties from product sales, which we classify as cost of sales on our
consolidated statements of operations.
General
and administrative expenses - General and administrative expenses consist of compensation and related benefits, including stock-based
compensation, for executive and corporate personnel; professional and consulting fees; and allocated overhead such as facilities and
equipment rent and maintenance, insurance costs allocated to general and administrative expenses, costs of patent applications, prosecution
and maintenance, stock exchange-related costs, depreciation expense, marketing costs, and other miscellaneous expenses which are allocated
to general and administrative expense.
Foreign
currency translation adjustments and other comprehensive income or loss - In countries in which Lineage operates where the functional
currency is other than the U.S. dollar, assets and liabilities are translated using published exchange rates in effect at the consolidated
balance sheet date. Revenues and expenses and cash flows are translated using an approximate weighted average exchange rate for the period.
Resulting foreign currency translation adjustments are recorded as other comprehensive income or loss, net of tax, in the consolidated
statements of comprehensive income or loss and included as a component of accumulated other comprehensive income or loss on the consolidated
balance sheets. Foreign currency translation adjustments are primarily attributable to Cell Cure and ESI, Lineage’s consolidated
foreign subsidiaries. For the years ended December 31, 2021 and 2020, comprehensive loss includes foreign currency translation adjustments,
net of tax, of $ 1.5 million and $ 3.0 million, respectively.
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Foreign
currency transaction gains and losses - For transactions denominated in other than the functional currency of Lineage or its subsidiaries,
Lineage recognizes transaction gains and losses in the consolidated statements of operations and classifies the gain or loss based on
the nature of the item that generated it. The majority of Lineage’s foreign currency transaction gains and losses are generated
by Cell Cure’s intercompany debt due to Lineage, which are U.S. dollar-denominated, while Cell Cure’s functional currency
is the Israeli New Shekel (“ILS”). At each balance sheet date, Lineage remeasures the intercompany debt using the current
exchange rate at that date pursuant to ASC 830, Foreign Currency Matters. These foreign currency remeasurement gains and losses
are included in other income and expenses, net.
Income
taxes - Lineage accounts for income taxes in accordance with ASC 740, Income Taxes , which prescribe the use of the asset and
liability method, whereby deferred tax asset or liability account balances are calculated at the balance sheet date using current tax
laws and rates in effect. Valuation allowances are established when necessary to reduce deferred tax assets when it is more likely than
not that a portion or all of the deferred tax assets will not be realized. ASC 740 guidance also prescribes a recognition threshold and
a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax
return. For benefits to be recognized, a tax position must be more-likely-than-not sustainable upon examination by taxing authorities.
Lineage files a U.S. federal income tax return as well as various state and foreign income tax returns. Lineage’s judgments regarding
future taxable income may change over time due to changes in market conditions, changes in tax laws, tax planning strategies or other
factors. If Lineage assumptions, and consequently the estimates, change in the future with respect to Lineage’s own deferred tax
assets and liabilities, the valuation allowance may be increased or decreased, which may have a material impact on Lineage’s consolidated
financial statements. Lineage recognizes accrued interest and penalties related to unrecognized tax benefits, if any, as income tax expense;
however, no amounts were accrued for the payment of interest and penalties as of December 31, 2021 and 2020.
On
December 22, 2017, the United States enacted major federal tax reform legislation, Public Law No. 115-97, commonly referred to as the
2017 Tax Cuts and Jobs Act (“2017 Tax Act”), which enacted a broad range of changes to the Internal Revenue Code. Beginning
in 2018, the 2017 Tax Act subjects a U.S. stockholder to tax on Global Intangible Low Tax Income (“GILTI”) earned by certain
foreign subsidiaries. In general, GILTI is the excess of a U.S. shareholder’s total net foreign income over a deemed return on
tangible assets. The provision further allows a deduction of 50% of GILTI, however this deduction is limited to the Company’s pre-GILTI
U.S. income. For the year ended December 31, 2020, our foreign subsidiaries operated at a loss, as a result there was no income inclusion.
For the year ended December 31, 2021, Lineage’s foreign subsidiaries generated income arising from an intercompany transaction.
As a result, there was in inclusion of $ 15.0 million included in federal income for 2021. The income was fully offset by our federal
net operating loss carryforwards
Current
interpretations under ASC 740 state that an entity can make an accounting policy election to either recognize deferred taxes for temporary
basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax
is incurred as a period expense. We have elected to account for GILTI as a current period expense when incurred.
On
January 1, 2021, Lineage adopted ASU 2019-12, Simplifying the Accounting for Income Taxes . The ASU enhances and simplifies various
aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments,
performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in
certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. The Company’s
adoption of ASU 2019-12 did not have a material impact on the Consolidated Financial Statements.
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Stock-based
compensation - Lineage follows accounting standards governing share-based payments in accordance with ASC 718, Compensation –
Stock Compensation , which require the measurement and recognition of compensation expense for all share-based payment awards made
to directors and employees, including employee stock options, based on estimated fair values. Lineage utilizes the Black-Scholes option
pricing model for valuing share-based payment awards. Lineage’s determination of fair value of share-based payment awards on the
date of grant using that option-pricing model is affected by Lineage’s stock price as well as by assumptions regarding a number
of complex and subjective variables. These variables include, but are not limited to, expected stock price volatility over the term of
the awards, and the expected term of options granted, which is derived using the simplified method, which is an average of the contractual
term of the option and its vesting period, as we do not have sufficient historical exercise data. The risk-free rate is based on the
U.S. Treasury yield in effect at the time of grant for zero coupon U.S. Treasury notes with maturities similar to the expected term of
the awards. Forfeitures are accounted for as they occur.
Although
the fair value of employee stock options is determined in accordance with FASB guidance, changes in the assumptions can materially affect
the estimated value and therefore the amount of compensation expense recognized in the consolidated financial statements.
Recently
Adopted Accounting Pronouncements
In
August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework – Changes to the Disclosure
Requirements for Fair Value Measurement , which modifies certain disclosure requirements for reporting fair value measurements. ASU
2018-13 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. Lineage adopted
this standard on January 1, 2020 and it did not have a significant impact on its consolidated financial statements.
In
December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes . The ASU enhances and simplifies various
aspects of the income tax accounting guidance in ASC 740 and removes certain exceptions for recognizing deferred taxes for investments,
performing intraperiod allocation and calculating income taxes in interim periods. The ASU also adds guidance to reduce complexity in
certain areas, including recognizing deferred taxes for tax goodwill and allocating taxes to members of a consolidated group. This ASU
is effective for fiscal years beginning after December 15, 2020, and interim periods within those fiscal years with early adoption permitted.
Lineage adopted this standard as of January 1, 2021 and it did not have a material impact on its consolidated financial statements.
In
January 2017, the FASB issued ASU 2017-04, Intangibles – Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment ,
which simplifies the accounting for goodwill impairments by eliminating the requirement to compare
the implied fair value of goodwill with its carrying amount as part of step two of the goodwill impairment test referenced in ASC 350,
Intangibles - Goodwill and Other . As a result, an entity should perform its annual, or interim, goodwill impairment test by comparing
the fair value of a reporting unit with its carrying amount. An impairment charge should be recognized for the amount by which the carrying
amount exceeds the reporting unit’s fair value. However, the impairment loss recognized should not exceed the total amount of goodwill
allocated to that reporting unit. ASU 2017-04 is effective for smaller reporting companies for annual reporting periods beginning after
December 15, 2022, including any interim impairment tests within those annual periods, with early application permitted. On January 1,
2021, we elected to early adopt ASU 2017-04, and the adoption had no impact on our consolidated financial statements. We will perform
goodwill impairment tests in accordance with ASU 2017-04.
Recently
Issued Accounting Pronouncements Not Yet Adopted - The following accounting standards, which are not yet effective, are presently
being evaluated by Lineage to determine the impact that they might have on its consolidated financial statements.
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments . ASU 2016-13 is intended to provide financial statement users with more decision-useful information about the expected
credit losses on financial instruments and other commitments and requires consideration of a broader range of reasonable and supportable
information to inform credit loss estimates. ASU 2016-13 is effective for Lineage beginning January 1, 2023. Lineage has not yet completed
its assessment of the impact of the new standard on its consolidated financial statements.
98 | P a g e
3.
Revenue
Our
disaggregated revenues were as follows (in thousands):
Schedule
of Disaggregated Revenues
Year Ended December 31,
2021
2020
Royalties
$ 2,776
$ 773
Grant revenues
Israel Innovation Authority (“IIA”)
$ 445
$ 666
National Institutes of Health (“NIH”)
-
387
Total grant revenues
445
1,053
Revenues under collaborative agreements
Upfront license fees
452
-
Event-based development milestones
123
-
Reimbursements, cost-sharing payments
545
-
Total revenues under collaborative agreements
1,120
-
Total revenue
$ 4,341
$ 1,826
During
the year ended December 31, 2021 we recognized $ 4.3 million in total revenue. We recognized $ 1.1 million in revenues from new license
agreements granted in the period, which were recorded as revenues under collaboration agreements. This amount represents upfront license
fees and reimbursement revenues earned in the current year, as well as $ 0.1 million of variable consideration where development milestones
were achieved. We also recognized revenue of $ 0.1 million during the period for grant revenues which had been included in deferred revenues
at December 31, 2020.
Accounts
receivable and other receivable, net, and deferred revenues (contract liabilities) from contracts with customers, including collaboration
partners, consisted of the following (in thousands):
Schedule
of Contract With Customer Asset and Liability
December
31, 2021
December
31, 2020
(unaudited)
Accounts receivable
and other receivable, net (1 )(2)
$ 50,640
$ 242
Deferred revenues (1) (2)
50,500
-
(1)
Increase in accounts receivable due to accrual of $ 50.0
million upfront payment related to Roche Agreement, offset to deferred revenues.
(2)
Excludes government grants
as Lineage has determined government grants are outside the scope of ASU 2014-09 - Revenue from Contracts with Customers (Topic 606).
As
of December 31, 2021, the amounts in the transaction price of our contracts with customers, including collaboration partners, and allocated
good and services not yet provided were $ 52.1
million, of which $ 0.8
million has been collected and is reported as
deferred revenues, $ 49.7
million was accrued to deferred revenues, and
$ 1.7 million
relates to unfulfilled commitments. The unfulfilled commitments are estimated to be delivered by the end of the fourth quarter of 2022.
Of the total deferred revenues of $ 50.5 million,
approximately $ 18.0
million is expected to be recognized within the next 12 months.
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The
following table presents amounts under our collaboration agreements included in the transaction price (i.e., cumulative amounts
triggered or probable) as of December 31, 2021 (in thousands):
Schedule
of Collaboration Agreements
Upfront (1)
Development (2)
Reimbursements (3)
Total
Collaboration partner and agreement date:
ITI (April 2021) (4)
$ 500
$ 500
$ 2,220
$ 3,220
Roche
(December 2021) (5)
50,000
-
-
50,000
Total amounts under our collaboration agreements included in the transaction price
$ 50,500
$ 500
$ 2,220
$ 53,220
(1)
Upfront license fees.
(2)
Event-based development
and regulatory milestones amounts.
(3)
Reimbursements and costs-sharing
payments.
(4)
Regarding the accounting treatment for the collaborative
agreement, the license and related development deliverables were determined to be highly interdependent and interrelated and have
been combined as one performance obligation. Delivery is determined to be over time and revenue will be recognized utilizing an input
method of costs incurred over total estimated costs in the work plan. The regulatory milestones are variable consideration that are
fully constrained until the uncertainty of each milestone has been resolved. Sales-based milestones and royalties are variable consideration
that will not be included in the transaction price until the related commercialization and sales have occurred. The cost reimbursements
are considered variable consideration and are included in the transaction price. Revenues related to the cost reimbursements are
presented gross on the consolidated statement of operations instead of a reduction to the costs being reimbursed. We currently estimate
the unsatisfied performance obligations within the contract to be completed by December 31, 2022.
(5)
Regarding the accounting treatment for the collaborative
agreement, the license, technology transfer and related clinical deliverables were determined to be highly interdependent and interrelated
and have been combined as one performance obligation. Delivery is determined to be over time and revenue will be recognized utilizing
an input method of costs incurred over total estimated costs to complete the performance obligation. A material customer option for
additional goods and services was included in the transaction price, and $ 12.0 million of the transaction price was allocated to
the second performance obligation. The option will be recognized when the customer exercises the option or when the option expires.
Regulatory and development milestones are variable consideration that are fully constrained until the uncertainty of each milestone
has been resolved. Sales-based milestones and royalties are variable consideration that will not be included in the transaction price
until the related commercialization milestones and sales targets have occurred. We currently estimate the unsatisfied performance
obligations within the contract to be completed by December 31, 2026.
4.
Marketable Equity Securities
As
of December 31, 2021, Lineage owned approximately 1.1 million shares of OncoCyte common stock. These shares had a fair value of approximately
$ 2.4 million, based on the closing price of OncoCyte of $ 2.17 per share on December 31, 2021. As of December 31, 2020, Lineage owned
approximately 3.6 million shares of OncoCyte common stock. These shares had a fair value of approximately $ 8.7 million, based on the
closing price of OncoCyte of $ 2.39 per share on December 31, 2020.
For
the year ended December 31, 2021, Lineage recorded a realized gain of $ 6.0 million due to sales of OncoCyte shares in the period. Lineage
also recorded a net unrealized loss on marketable equity securities of $ 2.2 million related to changes in fair market value of OncoCyte’s
common stock price during the period. For the year ended December 31, 2020, Lineage recorded a realized gain of $ 3.1 million due to sales
of OncoCyte shares in the period. Lineage also recorded a net unrealized loss on marketable equity securities of $ 2.5 million related
to changes in fair market value of OncoCyte’s common stock price in the period.
All
share prices are determined based on the closing price of OncoCyte common stock on the NYSE American on the applicable dates, or the
last day of trading of the applicable quarter, if the last day of a quarter fell on a weekend.
We account
for the shares we hold in HBL as marketable equity securities as of December 31, 2021. These securities were carried at fair market value
on our consolidated balance sheets, and the accounting transactions for the year ended December 31, 2021 were not material.
For
the year ended December 31, 2021, we did not hold any marketable securities related to AgeX. For the year ended December 31, 2020, Lineage
recorded realized gains of $ 0.8
million, due to sales of AgeX shares in the
period. For the year ended December 31, 2020, we recorded unrealized losses of $ 1.3
million, respectively, due to changes in fair market
value of AgeX’s common stock price during the period.
100 | P a g e
5.
Sale of Significant Ownership Interest in AgeX to Juvenescence Limited
On
August 30, 2018, Lineage entered into a Stock Purchase Agreement with Juvenescence and AgeX, pursuant to which Lineage sold 14.4 million
shares of common stock of AgeX to Juvenescence for $ 3.00 per share, or an aggregate purchase price of $ 43.2 million (the “Purchase
Price”). Juvenescence paid $ 10.8 million of the Purchase Price at closing, issued an unsecured convertible promissory note dated
August 30, 2018 in favor of Lineage for $ 21.6 million (the “Promissory Note”), and paid $ 10.8 million on November 2, 2018.
The Stock Purchase Agreement contains customary representations, warranties and indemnities from Lineage relating to the business of
AgeX, including an indemnity cap of $ 4.3 million, which is subject to certain exceptions. In connection with the sale, Lineage also entered
into a Shared Facilities Agreement with AgeX.
The
Promissory Note bore interest at 7 % per annum, with principal and accrued interest payable at maturity on August 30, 2020. The Promissory
Note was paid in full on August 28, 2020 .
6.
Property and Equipment, Net
At
December 31, 2021 and 2020, property and equipment, net were comprised of the following (in thousands):
Schedule of Property and Equipment, Net
December 31,
2021
2020
Equipment, furniture and fixtures
$ 3,472
$ 3,628
Leasehold improvements
2,539
2,472
Right-of-use assets
4,163
3,845
Accumulated depreciation and amortization
( 5,302 )
( 4,315 )
Property and equipment, net
$ 4,872
$ 5,630
Property
and equipment at December 31, 2021 and December 31, 2020 includes $ 79,000 in financing leases. In September 2020, Lineage terminated
its leases in Alameda and entered into a new lease for a reduced amount of square footage. This resulted in a reduction to right-of-use
assets of approximately $ 1.4 million. See additional information in Note 14.
Depreciation
and amortization expense amounted to $ 663,000 and $ 823,000 for the years ended December 31, 2021 and 2020, respectively. During the year
ended December 31, 2021, Lineage sold non-capitalized assets for a net gain of $ 30,000 , which was included in R&D expenses on the
consolidated statements of operations. During the year ended December 31, 2021, Lineage sold equipment with a net book value of $ 9,000
and recognized a gain of $ 5,000 . Additionally, Lineage wrote off assets with a net book value of $ 29,000 .
During
the year ended December 31, 2020, Lineage sold equipment with a net book value of $ 32,000 and recognized a loss of $ 9,000 . Lineage also
wrote off assets with a net book value of $ 156,000 , with $ 104,000 of this amount related to the termination of its leases in Alameda.
Additionally, Lineage sold non-capitalized assets for a net gain of $ 72,000 .
101 | P a g e
7.
Goodwill and Intangible Assets, Net
At
December 31, 2021 and 2020, goodwill and intangible assets, net consisted of the following: (in thousands):
Schedule of Goodwill and Intangible Assets, Net
December 31,
2021
2020
Goodwill (1)
$ 10,672
$ 10,672
Intangible assets:
Acquired IPR&D – OPC1 (from the Asterias Merger) (2)
$ 31,700
$ 31,700
Acquired IPR&D – VAC2 (from the Asterias Merger) (2)
14,840
14,840
Intangible assets subject to amortization:
Acquired patents
18,953
18,953
Acquired royalty contracts (3)
650
650
Total intangible assets
66,143
66,143
Accumulated amortization (4)
( 19,321 )
( 19,111 )
Intangible assets, net
$ 46,822
$ 47,032
(1)
Goodwill represents the
excess of the purchase price over the fair value of the net tangible and identifiable intangible assets acquired and liabilities
assumed in the Asterias Merger.
(2)
Asterias
had two IPR&D intangible assets that were valued at $ 46.5 million as part of the purchase price allocation that was performed
in connection with the Asterias Merger. The fair value of these assets consisted of $ 31.7 million pertaining to the OPC1 program
and $ 14.8 million pertaining to the VAC2 program.
(3)
Asterias
had royalty cash flows under certain specific patent families that Asterias previously acquired from Geron Corporation (“Geron”).
The Geron patents are expected to continue to generate revenue and are not used in the OPC1 or the VAC platform, these patents are
considered to be separate long-lived intangible assets under ASC 805.
(4)
As of December 31, 2021
the acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of $ 282,000 .
Lineage
amortizes its intangible assets over an estimated period of 5 to 10 years on a straight-line basis. Lineage recognized $ 0.2 million and
$ 1.2 million in amortization expense of intangible assets during the years ended December 31, 2021 and 2020, respectively.
Amortization
of intangible assets for periods subsequent to December 31, 2021 is as follows (in thousands):
Schedule of Intangible Assets Future Amortization Expense
Year
Ended December 31,
Amortization
Expense
2022
$
130
2023
130
2024
22
Total
$
282
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8.
Accounts Payable and Accrued Liabilities
At
December 31, 2021 and 2020, accounts payable and accrued liabilities consist of the following (in thousands):
Schedule of Accounts Payable and Accrued Liabilities
2021
2020
December 31,
2021
2020
Accounts payable
$ 3,543
$ 2,611
Accrued compensation
2,162
1,959
Accrued liabilities (1)
22,086
1,711
PPP loan payable
-
523
Other current liabilities
178
9
Total
$ 27,969
$ 6,813
(1) Includes $ 21.0
million of royalty and redemption fee expense to Hadasit and the IIA, respectively, pursuant to Lineage’s financial obligations
related to the Roche Agreement (see Note 14) .
PPP
Loan Payable
In
April 2020, Lineage received a loan for $ 523,000 from Axos Bank under the Paycheck Protection Program (“PPP”) contained within
the Coronavirus Aid, Relief and Economic Security (“CARES”) Act. The PPP loan had a term of two years, was unsecured, and
was guaranteed by the U.S. Small Business Administration (“SBA”). The loan carried a fixed interest rate of one percent per
annum, of which the first six months of interest was deferred. Under the CARES Act and Paycheck Protection Program Flexibility Act, Lineage
was eligible to apply for forgiveness of all loan proceeds used to pay payroll costs, rent, utilities and other qualifying expenses during
the 24-week period following receipt of the loan, provided that Lineage maintains its employment and compensation within certain parameters
during such period. Not more than 40 % of the forgiven amount may be for non-payroll costs. If the conditions outlined in the PPP loan
program were adhered to by Lineage, all or part of such loan could be forgiven. Lineage applied for forgiveness of the PPP loan on September
30, 2020, and on May 13, 2021, received notice that the entire PPP loan principal balance and interest charges were forgiven in full,
which the Company recorded as a gain on debt extinguishment in the consolidated statements of operations. The PPP loan forgiveness amount
was excluded from Lineage’s taxable income for federal and California purposes. However, for California income taxes, public companies
cannot deduct expenses from loan proceeds which were forgiven.
9.
Fair Value Measurements
Fair
value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes
the inputs to valuation methodologies used to measure fair value (ASC 820-10-50), Fair Value Measurements and Disclosures :
●
Level 1 – Inputs
to the valuation methodology are quoted prices for identical assets or liabilities in active markets.
●
Level 2 – Inputs
other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially
the full term of the assets or liabilities.
●
Level 3 – Inputs
to the valuation methodology are unobservable; that reflect management’s own assumptions about the assumptions market participants
would make and significant to the fair value.
103 | P a g e
We
measure cash, cash equivalents, marketable securities and our liability classified warrants at fair value on a recurring basis. The fair
values of such assets were as follows for December 31, 2021 and 2020 (in thousands):
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis
Fair Value Measurements Using
Balance at
December 31, 2021
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant
Other
Observable Inputs
(Level 2)
Significant
Unobservable Inputs
(Level 3)
Assets:
Cash and cash equivalents
$ 55,742
$ 55,742
$ -
$ -
Marketable securities
2,616
2,616
-
-
Liabilities:
Lineage Warrants
-
-
-
-
Cell Cure Warrants
227
-
-
227
Fair Value Measurements Using
Balance at
December 31, 2020
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Significant
Unobservable Inputs
(Level 3)
Assets:
Cash and cash equivalents
$ 32,585
$ 32,585
$ -
$ -
Marketable securities
8,977
8,977
-
-
Liabilities:
Lineage Warrants
1
-
-
1
Cell Cure Warrants
437
-
-
437
We
have not transferred any instruments between the three levels of the fair value hierarchy.
In
determining fair value, Lineage utilizes a Black-Scholes pricing model that maximizes the use of observable inputs and minimize the use
of unobservable inputs to the extent possible, and also considers counterparty credit risk in its assessment of fair value. The significant
unobservable inputs used in the fair value measurement of the Company’s Level 3 Cell Cure warrant liabilities are volatility and
share value. A significant increase or decrease in these Level 3 inputs could result in a significantly higher or lower fair value measurements.
104 | P a g e
The
following table sets forth the establishment of the Company’s Level 3 liabilities, as well as a summary of the changes in the fair
value and other adjustments:
Schedule
of Changes In Fair Value
(Dollars in thousands)
Cell Cure
Warrants
Lineage
Warrants
Total
Balance as of December 31, 2020
$ 437
$ 1
$ 438
Change in fair value and other adjustments
( 210 )
-
( 210 )
Expiration of warrants
-
( 1 )
( 1 )
Balance as of December 31, 2021
$ 227
$ -
$ 227
Marketable
equity securities include our positions in OncoCyte, and HBL. Both of these securities have readily determinable fair values quoted on
the NYSE American or TASE stock exchanges. These securities are measured at fair value and reported as current assets on the consolidated
balance sheets based on the closing trading price of the security as of the date being presented.
The
fair value of Lineage’s assets and liabilities, which qualify as financial instruments under FASB guidance regarding disclosures
about fair value of financial instruments, approximate the carrying amounts presented in the accompanying consolidated balance sheets.
The carrying amounts of accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and other
current liabilities approximate fair values because of the short-term nature of these items.
10.
Related Party Transactions
Lineage
incurred costs of $ 5,050
per month for the use of approximately 900
square feet of office space in New York City,
which was made available to Lineage on a month-by-month basis by one of its directors at an amount that approximates his cost (see Note
14). In March
2021 , Lineage terminated without penalty its
leasing term related to the New York City office lease.
In
connection with the putative shareholder class action lawsuits filed in February 2019 and October 2019 challenging the Asterias Merger
(see Note 14), Lineage has agreed to pay for the legal defense of Neal Bradsher, director, Broadwood Partners, L.P., a shareholder of
Lineage, and Broadwood Capital, Inc., which manages Broadwood Partners, L.P., all of which were named in the lawsuits. Through December
31, 2021, Lineage has incurred a total of $ 593,782 in legal expenses on behalf of the director, shareholder and the manager of the shareholder.
As
part of financing transactions in which there were multiple other purchasers, Broadwood Partners, L.P. purchased 623,090 shares of OncoCyte
common stock from Lineage in January 2020.
11.
Shareholders’ Equity
Preferred
Shares
Lineage
is authorized to issue 2,000,000 shares of preferred stock. The preferred shares may be issued in one or more series as the board of
directors may by resolution determine. The board of directors is authorized to fix the number of shares of any series of preferred shares
and to determine or alter the rights, preferences, privileges, and restrictions granted to or imposed on the preferred shares as a class,
or upon any wholly unissued series of any preferred shares. The board of directors may, by resolution, increase or decrease (but not
below the number of shares of such series then outstanding) the number of shares of any series of preferred shares subsequent to the
issue of shares of that series. As of December 31, 2021, no shares of preferred stock were issued or outstanding.
Common
Shares
At
December 31, 2021, Lineage was authorized to issue 250,000,000 common shares, no par value. As of December 31, 2021 and 2020, Lineage
had 169,477,347 and 153,095,883 issued and outstanding common shares, respectively.
During
the years ended December 31, 2021 and 2020, Lineage issued 40,000 and 47,000 common shares, net of shares withheld and retired for employee
taxes paid, respectively, for vested restricted stock units (see Note 12).
105 | P a g e
At-the-Market
(“ATM”) Offering
On
May 1, 2020, Lineage entered into the Sales Agreement, pursuant to which Lineage may offer and sell, from time to time, through
Cantor Fitzgerald, common shares of Lineage (“ATM Shares”) having an aggregate offering price of up to $ 25.0 million.
Lineage is not obligated to sell any ATM Shares. Subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald will
use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules
and regulations, and the rules of the NYSE American, to sell the ATM Shares from time to time based upon Lineage’s
instructions, including any price, time or size limits specified by Lineage. Under the Sales Agreement, Cantor Fitzgerald may sell
the ATM Shares by any method deemed to be an “at-the-market” offering as defined in Rule 415(a)(4) under the Securities
Act of 1933, as amended, or by any other method permitted by law, including in privately negotiated transactions. Cantor
Fitzgerald’s obligations to sell the ATM Shares are subject to satisfaction of certain conditions, including the continued
effectiveness of Lineage’s Registration Statement on Form S-3 (File No. 333-237975), which was filed with the Commission on
May 1, 2020 and was declared effective on May 8, 2020. The Sales Agreement replaced the previous sales agreement with Cantor that
had been entered into in April 2017.
On
March 5, 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of an additional $ 25.0 million
of common shares under the Sales Agreement increasing the total offering to $ 50.0 million. As of December 21, 2021, $ 14.1 million remained
available for sale under the Sales Agreement. On December 21, 2021, Lineage filed a prospectus supplement with the SEC in connection
with the New Sales Agreement, with Cantor Fitzgerald as the sales agent, and no additional sales will be made under the Sales Agreement.
The $ 64.1 million under the New Sales Agreement which may be issued are registered pursuant to the May
2020 Registration Statement, and Lineage’s effective shelf registration statement on Form S-3 (File No. 333-254167), which was
filed with the SEC on March 5, 2021 and declared effective on March 19, 2021. As of December 31, 2021, under the Sales Agreement, Lineage
had issued 14,908,735 common shares at a weighted-average price per share of $ 2.41 for gross proceeds of $ 35.9 million. As of December
31, 2021, under the New Sales Agreement, Lineage had issued 108,200 common shares at a weighted-average price per share of $ 2.55 for
gross proceeds of $ 0.3 million (which includes $ 0.2 million of cash in transit related to a 2021 transaction that settled in early 2022).
As a result, as of December 31, 2021, $ 63.9 million remained available for issuance under the New Sales Agreement.
Lineage
agreed to pay Cantor Fitzgerald a commission of 3.0 % of the aggregate gross proceeds from each sale of shares, reimburse legal fees and
disbursements and provide Cantor Fitzgerald with customary indemnification and contribution rights. The Sales Agreement may be terminated
by Cantor Fitzgerald or Lineage at any time upon notice to the other party, or by Cantor Fitzgerald at any time in certain circumstances,
including the occurrence of a material and adverse change in Lineage’s business or financial condition that makes it impractical
or inadvisable to market the shares or to enforce contracts for the sale of the shares.
Warrants
Lineage
(previously Asterias) Warrants – Liability Classified
In
March 2019, in connection with the closing of the Asterias Merger, Lineage assumed outstanding Asterias Warrants. The total number of
common shares of Lineage subject to warrants that were assumed by Lineage in connection with the Asterias Merger was 1,089,900 ,
which were converted to Lineage Warrants 30
days after the closing of the Asterias Merger,
with similar terms and conditions retained under the Lineage Warrants as per the original Warrant Agreements. The Lineage Warrants had
an exercise price of $ 6.15
per warrant share and expired on May
13, 2021 .
Cell
Cure Warrants – Liability Classified
Cell
Cure has two sets of issued warrants (the “Cell Cure Warrants”). Warrants to purchase 24,566 Cell Cure ordinary shares at
an exercise price of $ 40.5359 were issued to HBL in July 2017. These warrants expire in July 2022 . Warrants to purchase 13,738 Cell Cure
ordinary shares at exercise prices ranging from $ 32.02 to $ 40.00 per share were issued to consultants. 11,738 of these warrants were
cashless exercised in October 2020. The expense related to the cashless exercise was approximately $ 44,000 and it was recorded as other
income/(expense), net on the statements of operations. The remaining 2,000 warrants have an exercise price of $ 40.00 and expire in January
2024.
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ASC
815 requires freestanding financial instruments, such as warrants, with exercise prices denominated in currencies other than the functional
currency of the issuer to be accounted for as liabilities at fair value, with all subsequent changes in fair value after the issuance
date to be recorded as gains or losses in the consolidated statements of operations. Because the exercise price of the Cell Cure Warrants
is U.S. dollar-denominated and settlement is not expected to occur in the next twelve months, Cell Cure classified the Cell Cure Warrants
as a long-term liability in accordance with ASC 815.
The
fair value of the Cell Cure Warrants at the time of issuance was determined by using the Black-Scholes option pricing model using the
respective contractual term of the warrants. In applying this model, the fair value is determined by applying Level 3 inputs, as defined
by ASC 820; these inputs are based on certain key assumptions including the fair value of the Cell Cure ordinary shares, adjusted for
lack of marketability, as appropriate, and the expected stock price volatility over the term of the Cell Cure Warrants. The fair value
of the Cell Cure ordinary shares is determined by Cell Cure’s Board of Directors, which may engage a valuation specialist to assist
it in estimating the fair value, or may use recent transactions in Cell Cure shares, if any, as a reasonable approximation of fair value,
or may apply other reasonable methods to determining the fair value, including a discount for lack of marketability. In connection with
the cashless exercise in October 2020, Cell Cure had an independent third-party update the fair value of the Cell Cure shares. Lineage
determines the stock price volatility using historical prices of comparable public company common stock for a period equal to the remaining
term of the Cell Cure Warrants. The Cell Cure Warrants are revalued each reporting period using the same methodology described above,
with changes in fair value included as gains or losses in other income and expenses, net, in the consolidated statements of operations.
For
the years ended December 31, 2021 and 2020, Lineage recorded a noncash gain of $ 0.2 million and a noncash loss of $ 0.2 million, respectively,
for the increase/decrease in the fair value of the Cell Cure Warrants included in other income and expenses, net for each period. The
decrease in the fair value of the Cell Cure Warrants was mainly attributable to the time premium amortization, due to the shorter duration
of the warrants. As of December 31, 2021 and 2020, the Cell Cure Warrants, valued at $ 0.2 million and $ 0.4 million, respectively, were
included in current and long-term liabilities on the consolidated balance sheets.
12.
Stock-Based Awards
Equity
Incentive Plan Award s
On
September 13, 2021, the shareholders of Lineage approved the 2021 Equity Incentive Plan (the “2021 Plan”), and the plan became
effective. The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options, stock appreciation rights, restricted
stock awards, restricted stock units awards (“RSUs”), and other stock awards. All of our employees (including our affiliates’),
non-employee directors and consultants are eligible to participate in the 2021 Plan.
Subject
to adjustment for certain changes in our capitalization, the aggregate number of our common shares that may be issued under the 2021
Plan will not exceed the sum of (i) 15,000,000 shares and (ii) the Prior Plan Returning Shares (“Prior Plan Returning Shares”).
The Prior Plan Returning Shares are defined as an award granted under the Lineage Cell Therapeutics Inc. 2012 Equity Incentive Plan (the
“2012 Plan”), which were outstanding when the 2021 Plan became effective, and are not issued because such Prior Plan Award
or any option thereof expires or otherwise terminates without all of the shares covered by such Prior Plan Award having been issued.
Given the approval of the 2021 Plan, no additional awards will be granted from the 2012 Plan or the Asterias 2013 Equity Incentive Award
(the “Asterias Equity Plan”). As of December 31, 2021, there were no outstanding equity awards issued under the 2021 Plan.
As of December 31, 2021, there were 16,382,385 shares available for grant under the 2021 Plan.
On
February 11, 2022, the Board of Directors at Lineage, approved restricted stock unit awards for an aggregate amount of 694,424 . The awards
were issued under the 2021 Plan, which defines restricted stock units as a full value award, which reduce the Plan’s common shares
available for grant by 1.50 shares for each share issued.
107 | P a g e
A
summary of Lineage’s 2012 Plan activity and other stock option awards granted outside of the 2012 Plan related information is as
follows (in thousands, except per share amounts):
Schedule of Share-based Compensation, Employee Stock Purchase Plan, Activity
Number
of Options
Outstanding
Number
of RSUs
Outstanding
Weighted
Average
Exercise Price
December 31, 2019
14,710
166
$ 2.17
Options granted
5,256
-
0.71
Options forfeited
( 4,101 )
-
2.61
Restricted stock units vested
-
( 73 )
-
December 31, 2020
15,865
93
$ 1.57
Options granted
6,245
-
2.50
Options exercises
( 4,321 )
-
1.72
Options forfeited
( 3,146 )
-
1.99
Restricted units vested
-
( 62 )
-
December 31, 2021
14,643
31
$ 1.84
Options exercisable at December 31, 2021
6,391
$ 1.68
As
of December 31, 2021, options outstanding and options exercisable under the 2012 Plan have a weighted-average remaining contractual term
of 7.3 years and 5.3 years, respectively, and intrinsic value of $ 9.6 million and $ 5.2 million, respectively.
In
connection with the vested RSUs during the year ended December 31, 2021, Lineage paid $ 54,000 in minimum employee withholding taxes in
exchange for 21,000 vested Lineage common shares issuable to the employees and immediately retired those shares. For the year ended December
31, 2021, Lineage recorded a noncash stock-based compensation expense of $ 0.1 million, in connection with the vested RSUs, included in
consolidated stock-based compensation expense.
In
connection with the vested RSUs during the year ended December 31, 2020, Lineage paid $ 27,000 in minimum employee withholding taxes in
exchange for 26,000 vested Lineage common shares issuable to the employees and immediately retired those shares. For the year ended December
31, 2020, Lineage recorded a noncash stock-based compensation expense of $ 0.1 million, in connection with the vested RSUs, included in
consolidated stock-based compensation expense.
108 | P a g e
A
summary of activity under the Asterias Equity Plan from the closing date of the Asterias Merger through December 31, 2021 is as follows
(in thousands, except per share amounts):
Schedule of Share-based Compensation, Employee Stock Purchase Plan, Activity
Number
of Options
Outstanding
Number
of RSUs
Outstanding
Weighted
Average
Exercise Price
December 31, 2019
350
-
$ 1.57
Options granted
-
-
-
Options forfeited
-
-
-
December 31, 2020
350
-
$ 1.57
Options granted
-
-
-
Options forfeited
( 109 )
-
1.57
December 31, 2021
241
-
$ 1.57
Options exercisable at December 31, 2021
241
$ 1.57
As
of December 31, 2021, options outstanding and options exercisable under the Asterias Equity Plan both have a weighted-average remaining
contractual term of 0.3 years and intrinsic value of $ 212,000 and $ 212,000 , respectively.
Stock-based
compensation expense
The
fair value of each option award is estimated on the date of grant using a Black-Scholes option pricing model applying the weighted-average
assumptions noted in the following table:
Schedule of Weighted Average Assumptions to Calculate Fair Value of Stock Options
Year Ended December 31,
2021
2020
Expected life (in years)
6.2
6.2
Risk-free interest rates
1.0 %
0.8 %
Volatility
73.2 %
67.7 %
Dividend yield
- %
- %
The
weighted-average estimated fair value of stock options granted under the 2012 Plan and other stock option awards granted outside of the
2012 Plan, during the years ended December 31, 2021 and 2020 was $ 1.62 and $ 0.43 per share, respectively.
Operating
expenses include stock-based compensation expense as follows (in thousands):
Schedule of Stock Based Compensation Expense
2021
2020
Year Ended December 31,
2021
2020
Research and development
$ 833
$ 464
General and administrative
2,686
1,763
Total stock-based compensation expense
$ 3,519
$ 2,227
As
of December 31, 2021, total unrecognized compensation costs related to unvested stock options under Lineage’s 2012 Plan and the
Asterias Equity Plan was $ 8.5 million, which is expected to be recognized as expense over a weighted average period of approximately
2.5 years.
109 | P a g e
13.
Income Taxes
For
the year ended December 31, 2021, Lineage did no t
record a tax provision or deferred tax benefit. For the year ended December 31, 2020, Lineage recorded a $ 1.2 million
deferred tax benefit for income taxes.
The
domestic and foreign breakout of loss before net income tax benefit was as follows:
Schedule of Income before Income Tax, Domestic and Foreign
2021
2020
December 31,
2021
2020
Domestic
$ ( 16,998 )
( 17,500 )
Foreign
( 26,272 )
( 4,424 )
Loss before net income tax benefit
$ ( 43,270 )
( 21,924 )
Income
taxes differed from the amounts computed by applying the indicated current U.S. federal income tax rate to pretax losses from operations
as a result of the following:
Schedule of Income Tax Rate Reconciliation
2021
2020
Year Ended December 31,
2021
2020
Computed tax benefit at federal statutory rate
21 %
21 %
Research and development and other credits
1 %
1 %
Permanent differences
( 1 )%
- %
Change in valuation allowance
( 16 )%
( 17 )%
State tax benefit
8 %
3 %
GILTI inclusion
( 12 )%
- %
Foreign rate differential and other
( 1 )%
( 2 )%
Income tax benefit
- %
6 %
The
primary components of the deferred tax assets and liabilities at December 31, 2021 and 2020 were as follows (in thousands):
Schedule of Components of Deferred Tax Assets and Liabilities
Deferred tax assets/(liabilities):
2021
2020
December 31,
Deferred tax assets/(liabilities):
2021
2020
Net operating loss carryforwards
$ 68,766
$ 63,941
Research and development and other credits
9,466
8,878
Patents and licenses
1,403
1,178
Stock options
1,717
2,131
Operating lease liability
134
242
Other
1,608
1,523
Total deferred tax assets
83,094
77,893
Valuation allowance
( 70,967 )
( 64,069 )
Deferred assets, net of valuation allowance
12,127
13,824
Operating lease ROU assets
( 115 )
( 215 )
Intangibles
( 13,299
)
( 13,226
)
Equity method investments and marketable securities at fair value
( 789 )
( 2,459 )
Total deferred tax liabilities
( 14,203 )
( 15,900
)
Net deferred tax liabilities
$ ( 2,076 )
$ ( 2,076 )
110 | P a g e
A valuation allowance is provided
when it is more likely than not that some portion of the deferred tax assets will not be realized. Lineage established a full valuation
allowance as of December 31, 2018 due to the uncertainty of realizing future tax benefits from its net operating loss carryforwards and
other deferred tax assets, including foreign net operating losses generated by its subsidiaries. During the year ended December 31, 2021,
Lineage had taxable income and therefore did not generate any indefinite lived deferred tax assets as tax provision benefit. As
new indefinite lived deferred tax assets are generated, we will continue to book provision benefits until the deferred tax liability
position is exhausted, barring any new developments.
As
of December 31, 2021, Lineage has gross net operating loss carryforwards of approximately $ 155.6
million for federal purposes. As of December
31, 2021, Lineage’s foreign subsidiaries have net operating loss carryforwards of approximately $ 60.2
million which carryforward indefinitely.
As
of December 31, 2021, Lineage has net operating losses of $ 151.8
million for state tax purposes.
As
of December 31, 2021, Lineage has research tax credit carryforwards for federal and state tax purposes of $ 3.7
million and $ 5.8
million, respectively. These tax credits reflect
the amounts for Lineage, Asterias and OrthoCyte as of December 31, 2021. For federal purposes, the
credits generated each year have a carryforward period of 20 years .
The federal tax credits expire in varying amounts between
2021 and 2041 , while the state tax credits have
no expiration period.
On
August 5, 2020, Lineage began the liquidation of its foreign subsidiary BioTime Asia. At the time of the liquidation, BioTime Asia had
an intercompany payable due to Lineage. For book purposes, the corresponding balances eliminate in consolidation. For federal purposes,
the activities of their foreign subsidiaries are not included in the consolidated tax return. Accordingly, the payable was written off
for tax purposes by Lineage, creating a $ 3.6 million bad debt deduction increasing its NOL carryover. For California, the activities
of its foreign subsidiaries, including BioTime Asia, are included in the combined tax return. As such, the corresponding intercompany
balances are eliminated.
On
December 17, 2021, Lineage and its subsidiary, Cell Cure, entered into a Collaboration and License Agreement with Roche, wherein Lineage
granted to Roche exclusive worldwide rights to develop and commercialize RPE cell therapies. Under the agreement Roche will pay Lineage
a $ 50.0 million upfront payment. This payment was received in January of 2022 (see further discussion at Note 14).
During
December 2021, in an intercompany transaction, Lineage acquired the economic rights to Cell Cure’s interest in certain intellectual
property. This transaction generated a gain to Cell Cure of $ 31.7
million which was fully offset by net operating
loss carryforwards in Israel. For book and California income tax purposes, this transaction eliminates in consolidation. For federal
income tax purposes, the activities of our foreign subsidiaries are not included in the consolidated tax return. However, under
the provisions of GILTI the profits of our foreign subsidiaries may be included, see further discussion below.
Beginning
in 2018, the 2017 Tax Act subjects a U.S. stockholder to GILTI earned by certain foreign subsidiaries. In general, GILTI is the excess
of a U.S. shareholder’s total net foreign income over a deemed return on tangible assets. The provision further allows a deduction
of 50 %
of GILTI, however this deduction is limited to the company’s pre-GILTI U.S. income. For the year ended December 31, 2020, our foreign
subsidiaries generated losses, as a result there was no inclusion. For the year ended December 31, 2021, Lineage’s combined foreign
entities generated a profit arising from intercompany transactions. As a result, there was an inclusion of $ 24.8
million for GILTI purposes for 2021. The
resulting net income for federal income tax purposes was fully offset by their federal net operating loss carryforwards.
Other
Transactions and Related Impact on Income Taxes
The
market value of the respective shares Lineage holds in OncoCyte and Asterias (through the merger date of March 8, 2019) creates a deferred
tax liability to Lineage based on the closing price of the security, less the tax basis of the security Lineage has in such shares. The
deferred tax liability generated by shares that Lineage holds as of December 31, 2021 and 2020, is a source of future taxable income
to Lineage, as prescribed by ASC 740-10-30-17, that will more likely than not result in the realization of its deferred tax assets to
the extent of those deferred tax liabilities. This deferred tax liability is determined based on the closing price of those securities
as of December 31, 2021 and 2020.
111 | P a g e
Other
Income Tax Matters
Internal
Revenue Code Section 382 places a limitation (“Section 382 Limitation”) on the amount of taxable income that can be offset
by NOL carryforwards after a change in control (generally greater than 50 % change in ownership within a three-year period) of a loss
corporation. California has similar rules. Generally, after a change in control, a loss corporation cannot deduct NOL carryforwards in
excess of the Section 382 Limitation. Due to these “change in ownership” provisions, utilization of the NOL and tax credit
carryforwards may be subject to an annual limitation regarding their utilization against taxable income in future periods.
Lineage
files a U.S. federal income tax return as well as various state and foreign income tax returns. In general, Lineage is no longer subject
to tax examination by major taxing authorities for years before 2016. Although the statute is closed for purposes of assessing additional
income and tax in these years, the taxing authorities may still make adjustments to the NOL and credit carryforwards used in open years.
Therefore, the statute should be considered open as it relates to the NOL and credit carryforwards used in open years.
Lineage
may be subject to potential examination by U.S. federal, U.S. states or foreign jurisdiction authorities in the areas of income taxes.
These potential examinations may include questioning the timing and amount of deductions, the nexus of income among various tax jurisdictions
and compliance with U.S. federal, U.S. state and foreign tax laws. Based on Lineage’s assessment, no liabilities for uncertain
tax positions should be recorded as of December 31, 2021 and 2020. Lineage’s management does not expect that the total amount
of unrecognized tax benefits will materially change over the next twelve months.
Lineage’s
practice is to recognize interest and penalties related to income tax matters in tax expense. As of December 31, 2021 and 2020, Lineage
has no accrued interest and penalties.
14.
Commitments and Contingencies
Carlsbad
Lease
In
May 2019, Lineage entered into a lease for approximately 8,841 square feet of rentable space in an office park in Carlsbad, California
(the “Carlsbad Lease”). The term of the Carlsbad Lease commenced on August 1, 2019 and expires on October 31, 2022.
Base
rent under the Carlsbad Lease, beginning on August 1, 2021, is $ 23,959 per month and increases by 3 % on August 1, 2022 . Base rent for
the first twenty-four months of the lease was based upon a deemed rentable area of 7,000 square feet. Base rent was abated for months
two through five of the lease.
In
addition to base rent, Lineage pays a pro rata portion of increases in certain expenses, including real property taxes, utilities (to
the extent not separately metered to the leased space) and the landlord’s operating expenses, over the amounts of those expenses
incurred by the landlord. As security for the performance of its obligations under the Carlsbad Lease, Lineage provided the landlord
with a security deposit of $ 17,850 .
Alameda
Leases and Alameda Sublease
In
December 2015, Lineage entered into leases of office and laboratory space located in two buildings in Alameda, California (the “Alameda
Leases”) comprised of 22,303 square feet (the “1010 Atlantic Premises”) and 8,492 square feet (the “1020 Atlantic
Premises”). Base rent under the Alameda Leases beginning on February 1, 2020 was $ 72,676 per month with annual increases of approximately
3 %. In addition to base rent, Lineage paid a pro rata portion of increases in certain expenses,
including real property taxes, utilities (to the extent not separately metered to the leased space) and the landlord’s operating
expenses, over the amounts of those expenses incurred by the landlord. As security for its obligations, Lineage provided the landlord
with a security deposit of approximately $ 424,000 , which was reduced to $ 78,000 on January 24, 2019 in accordance with the terms of the
lease. The security deposit was returned to Lineage in March 2021.
112 | P a g e
In
April 2020, Lineage entered into a sublease with Industrial Microbes, Inc. (“Industrial Microbes”) for the use of 10,000
square feet in the 1010 Atlantic Premises (the “Industrial Microbes Sublease”). Base rent under the Industrial Microbes Sublease
was $ 28,000 per month with annual increases of approximately 3 %. Base rent for the first month
was abated. In addition to base rent and utilities, Industrial Microbes paid a pro-rata portion of increases in operating expenses, after
an abatement period of one year.
On
September 11, 2020, Lineage entered into a Lease Termination Agreement with the landlord terminating the Alameda Leases effective as
of August 31, 2020 for the 1020 Atlantic Premises and September 30, 2020 for the 1010 Atlantic Premises. In
consideration for the termination of the leases, Lineage paid a termination fee of $ 130,000 and other amounts due under the terms of
the Alameda Leases through the applicable effective termination dates, except that no rent was due with respect to the 1020 Atlantic
Premises after July 31, 2020. Lineage’s security deposit was received in March 2021. Lineage
paid a separate termination fee of $ 30,000 to Industrial Microbes in connection with the termination of the Industrial Microbes Sublease
and returned the $ 56,000 security deposit paid by Industrial Microbes. For the period of sublease from mid-April 2020 through
September 2020, Lineage received $ 119,000 in rental income from Industrial Microbes.
Lineage
continues to occupy approximately 2,432 square feet of the 1010 Atlantic Premises under a new sublease agreement (the “Alameda
Sublease”). The term of the Alameda Sublease is
from October 1, 2020 through January 31, 2023 . Base rent under the Alameda Sublease is $ 14,592 per month with annual increases of 3 %
each October 1 thereafter during the lease term. Base rent for the first month was abated. Lineage paid a security deposit of $ 16,000
under the Alameda Sublease; this amount is included in deposits and other long-term assets as of September 30, 2021 (see Note 2).
Based
on the smaller footprint, and after taking into consideration the fees disclosed above, Lineage has reduced its contractual obligations
by approximately $ 780,000 over the remaining life of the original leases through January 31, 2023.
New
York Leased Office Space
Lineage
incurred costs of $ 5,050 per month for the use of approximately 900 square feet of office space in New York City, which was made available
to Lineage for use in conducting meetings and other business affairs, on a month-by-month basis, by one of its directors at an amount
that approximates his cost. In March 2021, Lineage terminated without penalty its leasing term related to the New York City office lease.
The lease was not in the scope of ASC 842 because it is a month-to-month lease.
Cell
Cure Leases
Cell
Cure leases 728.5 square meters (approximately 7,842 square feet) of office and laboratory space in Jerusalem, Israel under a lease that
expires December 31, 2025 , with an option to extend the lease for five years each (the “Original Cell Cure Lease”). Base
monthly rent is NIS 39,776 (approximately $ 12,200 per month using the December 7, 2020 exchange rate). In addition to base rent, Cell
Cure pays a pro-rata share of real property taxes and certain costs related to the operation and maintenance of the building in which
the leased premises are located.
On
January 28, 2018, Cell Cure entered into another lease agreement for an additional 934 square meters (approximately 10,054 square feet)
of office space in the same facility in Jerusalem, Israel under a lease that expires on December 31, 2025 , with two five-year extension
options (the “January 2018 Lease”). The January 2018 Lease commenced on April 1, 2018 and included a leasehold improvement
construction allowance of up to NIS 4,000,000 (approximately up to US $ 1.1 million using the December 31, 2018 exchange rate) from the
landlord. The leasehold improvements were completed in December 2018 and the entire allowance was used. Beginning on January 1, 2019,
combined base rent and construction allowance payments for the January 2018 Lease are NIS 93,827 per month (approximately $ 26,000 per
month). In December 2018, Cell Cure made a $ 420,000 deposit required under the January 2018 Lease, which is included in deposits and
other long-term assets on the consolidated balance sheet as of December 31, 2021, to be held as restricted cash during the term of the
January 2018 Lease.
113 | P a g e
On
November 30, 2021, Cell Cure entered into a lease agreement for an additional 133 square meters (approximately 1,432 square feet) of
office space in the same facility in Jerusalem, Israel under a lease that expires on December 31, 2025 , with one five year and one approximate
three-year extension options (the “November 2021 Lease”). The November 2021 Lease commenced on December 1, 2021, with a twelve-month
base rent of NIS 11,880 (approximately US $ 3,757 using the November 30, 2021 exchange rate). On November 1, 2022, the base monthly rent
increases to NIS 12,494 (approximately US $ 3,951 using the November 30, 2021 exchange rate).
Adoption
of ASC 842
The
below tables provide the amounts recorded in connection with the adoption of ASC 842 as of, and for the years ended December 31, 2021
and 2020, for Lineage’s operating and financing leases, as applicable.
Supplemental
cash flow information related to leases was as follows (in thousands):
Schedule of Supplemental Cash Flow Information Related to Leases
2021
2020
Year Ended December 31,
2021
2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$ 935
$ 1,356
Operating cash flows from financing leases
13
20
Financing cash flows from financing leases
20
26
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
213
1,047
Financing leases
39
-
Supplemental
balance sheet information related to leases was as follows (in thousands, except lease term and discount rate):
Schedule of Supplemental Balance Sheet Information Related to Leases
2021
2020
December 31,
2021
2020
Operating leases
Right-of-use assets, net
$ 2,372
$ 2,916
Right-of-use lease liabilities, current
$ 801
$ 746
Right-of-use lease liabilities, noncurrent
1,941
2,514
Total operating lease liabilities
$ 2,742
$ 3,260
Financing leases
Right-of-use assets, net
$ 36
$ -
Property and equipment, gross
$ 79
$ 79
Accumulated depreciation
( 79 )
( 65 )
Property and equipment, net
$ -
$ 14
Lease liabilities, current
$ 13
$ -
Lease liabilities, noncurrent
23
-
Total finance lease liabilities
$ 36
$ -
Other current liabilities
$ 17
$ 16
Long-term liabilities
7
26
Total finance lease liabilities
$ 24
$ 42
Weighted average remaining lease term
Operating leases
3.5 years
4.2 years
Finance leases
2.2 years
2.4 years
Weighted average discount rate
Operating leases
7.7 %
8.0 %
Finance leases
5.7 %
10.0 %
114 | P a g e
Future
minimum lease commitments are as follows (in thousands):
Schedule of Future Minimum Lease Commitments
Operating
Leases
Finance
Leases
Year Ending December 31,
2022
$
1,042
$
33
2023
583
22
2024
551
10
2025
532
-
2026
447
-
Total lease payments
$
3,155
$
65
Less imputed interest
( 413
)
( 5
)
Total
$
2,742
$
60
Roche
Collaboration Agreement
On
December 17, 2021, Lineage and its subsidiary, Cell Cure, entered into the Roche Agreement, wherein Lineage granted to Roche exclusive
worldwide rights to develop and commercialize RPE cell therapies, including its proprietary cell therapy known as OpRegen. Roche paid
Lineage a $ 50.0 million upfront payment and Lineage is eligible to receive up to an additional $ 620.0 million in certain developmental,
regulatory and commercialization milestone payments. Lineage is also eligible for tiered double-digit percentage royalties on net sales
of OpRegen. All regulatory and commercial milestone payments, and royalty payments, are subject to the existence of certain intellectual
property rights related to OpRegen once such payments become due.
The
OpRegen program has been supported in part with contributions made by Hadasit, the technology transfer company of Hadassah Medical Center,
and the IIA, an independent agency created to address the needs of global innovation ecosystems. A significant portion of early
development on the OpRegen program occurred at Cell Cure. Cell Cure was established by the Hadassah Medical Center, where the intellectual
property underlying the differentiation and manufacture of RPE cells originated. In addition, significant monetary support for the OpRegen
program was provided by the IIA through a series of separate research grants, beginning in 2007. Under the Encouragement of Research,
Development and Technological Innovation in the Industry Law 5744, and the regulations, guidelines, rules, procedures and benefit tracks
thereunder (collectively, the “Innovation Law”), annual research and development programs that meet specified criteria and
were approved by a committee of the IIA which were eligible for grants. The grants awarded were typically up to 50 % of the project’s
expenditures, as determined by the IIA committee and subject to the benefit track under which the grant was awarded.
The
terms of the grants under the Innovation Law generally require that the products developed as part of the programs under which the grants
were given be manufactured in Israel. The know-how developed thereunder may not be transferred outside of Israel unless prior written
approval is received from the IIA. Transfer of IIA-funded know-how outside of Israel is subject to approval and payment of a redemption
fee, to the IIA calculated according to the relevant formulas provided under the Innovation Law. In November 2021, an application made
by Cell Cure to the research committee of the IIA, was approved granting an exclusive license and transfer of the technological know-how
for OpRegen to Roche. Under the provisions for the redemption fee, Lineage is obligated to pay the IIA a portion of the upfront, milestone,
and royalty payments which may be received under the Agreement. Lineage is obligated to pay approximately 24.3 % of the upfront, milestone,
and royalty payments it receives from Roche to the IIA, up to an aggregate cap on all payments. As of December 31, 2021, the IIA cap
amount was calculated to be approximately $ 102.7 million.
115 | P a g e
In
addition, pursuant to the Second Amended and Restated License Agreement, dated June 15, 2017, between Cell Cure and Hadasit, as amended,
and a certain letter agreement entered into on December 17, 2021, by and between Cell Cure and Hadasit, Cell Cure is obligated to pay
to Hadasit a sublicensing fee of 21.5% of the upfront payment (subject to certain reductions) and any milestone payments, and up to 50%
of all royalty payments (subject to a maximum payment of 5% of net sales of products) , Lineage receives from Roche. The letter agreement
generally terminates upon the termination of the Agreement.
In
January 2022, Lineage received the $ 50.0
million upfront payment from Roche. Lineage made
a subsequent payment of $ 12.1
million to the IIA, pursuant to Lineage’s
obligations under the Innovation Law. Additionally, Lineage made a subsequent payment of $ 8.9
million to Hadasit, pursuant to Lineage’s
obligations under the Second Amended and Restated License Agreement. Lineage reduced the Hadasit payment by $ 1.9
million, due to a $ 8.6
million budgetary commitment under the Agreement.
Lineage
is required to pay Hadasit 21.5% of any portion of the commitment not incurred within five years after the execution of the Agreement .
Both the IIA and Hadasit payments were accrued as research and development expenses incurred, upon the execution of the Agreement within
the company’s year-end consolidated statement of operations.
Unless
earlier terminated by either party, the Agreement will expire on a product-by-product and country-by-country basis upon the expiration
of all of Roche’s payment obligations under the Agreement. Roche may terminate the Agreement in its entirety, or on a product-by-product
or country-by-country basis, at any time with advance written notice. Either party may terminate the Agreement in its entirety with written
notice for the other party’s material breach if such party fails to cure the breach. Either party also may terminate the Agreement
in its entirety upon certain insolvency events involving the other party.
ITI
Collaboration Agreement
Under
our collaborative agreement with ITI we agreed to perform certain research, development, manufacturing, and oversight activities related
to a VAC-CMV product up to a budgeted amount of approximately $ 2.2 million. ITI will reimburse the Company for material costs and full-time
employee costs with no markup related to the manufacturing of the VAC-CMV product.
Second
Amendment to Clinical Trial and Option Agreement and License Agreement with Cancer Research UK
On
May 6, 2020, Lineage and its wholly owned subsidiary Asterias entered into a Second Amendment to Clinical Trial and Option Agreement
(the “CTOA Amendment”) with Cancer Research UK (“CRUK”) and Cancer Research Technology Limited (“CRT”),
which amends the Clinical Trial and Option Agreement entered into between Asterias, CRUK and CRT dated September 8, 2014, as amended
September 8, 2014. Pursuant to the CTOA Amendment, Lineage assumed all obligations of Asterias and exercised early its option to acquire
data generated in the Phase 1 clinical trial of VAC2 in non-small cell lung cancer being conducted by CRUK. CRUK will continue conducting
the VAC2 study.
Lineage
and CRT effectuated the option by simultaneously entering into a license agreement (the “License Agreement”) pursuant to
which Lineage agreed to pay the previously agreed signature fee of £ 1,250,000 (approximately $ 1.6 million). In consideration of
Lineage’s agreement to exercise the option prior to completion of the study, the parties agreed to defer the signature fee as follows:
£ 500,000 in September 2020, £ 500,000 in February 2021 and £ 250,000 in April 2021. For the primary licensed product
for the first indication, the License Agreement provides for milestone fees of up to £ 8,000,000 based upon initiation of a Phase
3 clinical trial and the filing for regulatory approval and up to £ 22,500,000 in sales-based milestones payments. Additional milestone
fees and sales-based milestone payments would be payable for other products or indications, and mid-single-digit royalty payments are
payable on sales of commercial products.
Either
party may terminate the License Agreement for the uncured material breach of the other party. CRT may terminate the License Agreement
in the case of Lineage’s insolvency or if Lineage ceases all development and commercialization of all products under the License
Agreement.
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Research
and Option Agreement
On
January 5, 2019, Lineage and Orbit Biomedical Limited (“Orbit”) entered into a Research and Option Agreement, which was assigned
by Orbit to Gyroscope Therapeutics Limited (“Gyroscope”) and amended on May 7, 2019, January 30, 2020, May 1, 2020 and September
4, 2020 (the “Gyroscope Agreement”). As amended, the Gyroscope Agreement provided Lineage access to Gyroscope’s vitrectomy-free
subretinal injection device (the “Orbit Device”) as a means of delivering OpRegen in Lineage’s ongoing Phase 1/2a clinical
trial through the earlier of: (i) December 1, 2020; or (ii) or treatment of three additional patients with the Orbit Device between September
4, 2020 and December 1, 2020 (the “Access Period”). Following the Access Period, Lineage also had an exclusive right to negotiate
a definitive agreement to distribute and sell the Orbit Device for the subretinal delivery of RPE cells for the treatment of dry AMD
(the “Option Period”), which was initially set to expire in February 2021. Pursuant to the terms of the Gyroscope Agreement,
Lineage paid access fees totaling $ 2.5 million: (i) $ 1.25 million in January 2019 upon execution of the Gyroscope Agreement; and (ii)
$ 1.25 million in August 2019 upon completion of certain collaborative research activities using the Gyroscope technology for the OpRegen
Phase 1/2a clinical trial. These access fees of $ 2.5 million were amortized on a straight-line basis throughout 2019 and included in
research and development expenses. Lineage also agreed to reimburse Gyroscope for costs of consumables, training services, travel costs
and other out of pocket expenses incurred by Gyroscope for performing services under the Gyroscope Agreement. In January 2020, Lineage
agreed to pay an additional $ 0.5 million to extend the Access Period to July 5, 2020, $ 0.2 million of which was paid in February 2020
and $ 0.3 million of which was paid in November 2020. The Access Period was subsequently extended two additional times at no cost and
ended in accordance with the terms of the Gyroscope Agreement in November 2020. In February 2021, Lineage exercised its right to extend
the initial Option Period for $ 0.5 million. During the extended Option Period, Lineage determined not to pursue a definitive agreement
to distribute and sell the Orbit Device, and the Gyroscope Agreement terminated on May 11, 2021 upon expiration of the Option Period.
Litigation
– General
From
time to time, we are subject to legal proceedings and claims in the ordinary course of business. While management presently believes
that the ultimate outcome of these proceedings, individually and in the aggregate, will not materially harm our financial position, cash
flows, or overall trends in results of operations, legal proceedings are subject to inherent uncertainties, and unfavorable rulings or
outcomes could occur that have individually or in aggregate, a material adverse effect on our business, financial condition or operating
results. Except as described below, we are not currently subject to any pending material litigation, other than ordinary routine litigation
incidental to our business, as described above.
On
October 14, 2019, a putative class action lawsuit was filed challenging the Asterias Merger. This action (captioned Ross v. Lineage
Cell Therapeutics, Inc., et al. , C.A. No. 2019-0822) was filed in Delaware Chancery Court and names Lineage, the Asterias board of
directors, one member of Lineage’s board of directors, and certain stockholders of both Lineage and Asterias as defendants. The
action was brought by a purported stockholder of Asterias, on behalf of a putative class of Asterias stockholders, and asserts breach
of fiduciary duty and aiding and abetting claims under Delaware law. The complaint alleges, among other things, that the process leading
up to the Asterias Merger was conflicted, that the Asterias Merger consideration was inadequate, and that the proxy statement filed by
Asterias with the Commission omitted certain material information, which allegedly rendered the information disclosed materially misleading.
The complaint seeks, among other things, that a class be certified, the recovery of monetary damages, and attorneys’ fees and costs.
On December 20, 2019, the defendants moved to dismiss the complaint. On February 10, 2020, the plaintiff filed an opposition. Defendants
filed their replies on March 13, 2020. On June 23, 2020, a hearing on the motions to dismiss occurred. On September 21, 2020, the Chancery
Court denied the motion to dismiss as to Lineage and certain members of the Asterias board of directors, and it granted the motion to
dismiss as to all other defendants. On October 30, 2020, the remaining defendants filed an answer to the complaint. The parties are currently
engaged in discovery. A five-day trial before the Chancery Court is currently scheduled for October 17-21, 2022.
Lineage
believes the allegations in the action lack merit and intends to vigorously defend the claims asserted. It is impossible at this time
to assess whether the outcome of this proceeding will have a material adverse effect on Lineage’s consolidated results of operations,
cash flows or financial position. Therefore, in accordance with ASC 450, Contingencies, Lineage has not recorded any accrual for
a contingent liability associated with this legal proceeding based on its belief that a liability, while possible, is not probable nor
estimable, and any range of potential contingent liability amounts cannot be reasonably estimated at this time. Lineage records legal
expenses as incurred.
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Employment
Contracts
Lineage
has entered into employment agreements with certain executive officers. Under the provisions of the agreements, Lineage may be required
to incur severance obligations for matters relating to changes in control, as defined in the agreements, and involuntary terminations.
Indemnification
In
the normal course of business, Lineage may provide indemnifications of varying scope under Lineage’s agreements with other companies
or consultants, typically Lineage’s clinical research organizations, investigators, clinical sites, suppliers and others. Pursuant
to these agreements, Lineage will generally agree to indemnify, hold harmless, and reimburse the indemnified parties for losses and expenses
suffered or incurred by the indemnified parties arising from claims of third parties in connection with the use or testing of Lineage’s
products and services. Indemnification provisions could also cover third party infringement claims with respect to patent rights, copyrights,
or other intellectual property pertaining to Lineage products and services. The term of these indemnification agreements will generally
continue in effect after the termination or expiration of the particular research, development, services, or license agreement to which
they relate. The potential future payments Lineage could be required to make under these indemnification agreements will generally not
be subject to any specified maximum amount. Historically, Lineage has not been subject to any claims or demands for indemnification.
Lineage also maintains various liability insurance policies that limit Lineage’s financial exposure. As a result, Lineage believes
the fair value of these indemnification agreements is minimal. Accordingly, Lineage has not recorded any liabilities for these agreements
as of December 31, 2021 and 2020.
Royalty
obligations and license fees
Lineage
and its subsidiaries or affiliates are parties to certain licensing agreements with research institutions, universities and other parties
for the rights to use those licenses and other intellectual property in conducting research and development activities. These licensing
agreements provide for the payment of royalties by Lineage or the applicable party to the agreement on future product sales, if any.
In addition, in order to maintain these licenses and other rights during the product development, Lineage or the applicable party to
the contract must comply with various conditions including the payment of patent related costs and annual minimum maintenance fees. Annual
minimum maintenance fees are expected to be approximately $ 30,000 to $ 60,000 per year.
As
part of the Asterias Merger, Lineage acquired certain royalty revenues for cash flows that were generated under certain specific patent
families that Asterias previously acquired from Geron. Asterias paid Geron a royalty for all royalty revenues received from these contracts.
Lineage continues to make royalty payments to Geron for royalties generated from these patents.
15.
Employee Benefit Plan
We
have a defined contribution 401(k) plan for all employees. Under the terms of the plan, employees may make voluntary contributions as
a percentage or defined amount of compensation. We provide a safe harbor contribution of up to 5.0 % of the employee’s compensation,
not to exceed eligible limits, and subject to employee participation. For the years ended December 31, 2021 and 2020, we incurred approximately
$ 164,000 and $ 149,000 , respectively, in expenses related to the safe harbor contribution.
16.
Segment Information
Lineage’s
executive management team, as a group, represents the entity’s chief operating decision makers. Lineage’s executive management
team views Lineage’s operations as one segment that includes the research and development of therapeutic products for retinal diseases,
neurological diseases and disorders and oncology. As a result, the financial information disclosed materially represents all the financial
information related to Lineage’s sole operating segment.
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17.
Enterprise-Wide Disclosures
Geographic
Area Information
The
following table presents consolidated revenues, including license fees, royalties, grant income, and other revenues, disaggregated by
geography, based on the billing addresses of customers, or in the case of grant revenues based on where the governmental entities that
fund the grant are located (in thousands).
Schedule of Geographic Area Information
Geographic Area
2021
2020
Year Ended December 31,
Geographic Area
2021
2020
United States
$ 3,895
$ 1,160
Foreign (1)
446
666
Total revenues
$ 4,341
$ 1,826
(1)
Foreign revenues are primarily
generated from grants in Israel.
The
composition of Lineage’s long-lived assets, consisting of plant and equipment, net, between those in the United States and in foreign
countries, as of December 31, 2021 and 2020, is set forth below (in thousands):
2021
2020
December 31,
2021
2020
Domestic
$ 548
$ 1,035
Foreign (1)
4,324
4,595
Total
$ 4,872
$ 5,630
(1)
Assets in foreign countries
principally include laboratory equipment and leasehold improvements in Israel.
Major
Sources of Revenues
The
following table presents Lineage’s consolidated revenues disaggregated by source (in thousands).
Schedule of Revenues Disaggregated by Source
2021
2020
Year Ended December 31,
2021
2020
REVENUES:
Royalties
$ 2,776
$ 773
Collaboration revenues
1,120
-
Grant revenues
445
1,053
Total revenues
$ 4,341
$ 1,826
Prepaid
expenses and other current assets at December 31, 2021 includes $ 0.1 million of receivables related to cash in transit for sales of ATM
Shares in 2021 that settled in 2022, and $ 0.2 million of receivables related to cash in transit for the exercise of stock options in
2021 that settled in 2022.
The
following table shows Lineage’s major sources of revenues, as a percentage of total revenues, that were recognized during the years
ended December 31, 2021 and 2020:
Schedule of Sources of Revenues
Sources of Revenues
2021
2020
Year Ended December 31,
Sources of Revenues
2021
2020
Royalties
63.9 %
42.3 %
Collaboration revenues
25.8 %
- %
Grant revenues
10.3 %
57.7 %
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18.
Selected Quarterly Financial Information (UNAUDITED, in thousands, except per share data)
Lineage
has derived this data from the unaudited consolidated interim financial statements that, in Lineage’ s opinion, have been prepared
on substantially the same basis as the audited consolidated financial statements contained herein and include all normal recurring adjustments
necessary for a fair presentation of the financial information for the periods presented. These unaudited consolidated quarterly results
should be read in conjunction with the consolidated financial statements and notes thereto included herein. The consolidated operating
results in any quarter are not necessarily indicative of the consolidated results that may be expected for any future period.
Schedule of Selected Quarterly Financial Information
Year Ended December 31, 2021
First
Quarter
Second
Quarter
Third
Quarter
Fourth
Quarter
Revenues, net
$ 391
512
2,270
1,168
Operating expenses
7,329
7,467
8,128
29,202
Loss from operations
( 7,050 )
( 7,080 )
( 6,843 )
( 28,238 )
Net loss attributable to Lineage
( 1,416 )
( 4,788 )
( 7,823 )
( 28,992 )
Basic net income (loss) per share
$ ( 0.01 )
$ ( 0.03 )
$ ( 0.05 )
$ ( 0.17 )
Year Ended December 31, 2020
Revenues, net
$ 514
386
571
355
Operating expenses
7,858
6,713
7,194
6,123
Loss from operations
( 7,438 )
( 6,402 )
( 6,725 )
( 5,882 )
Net income (loss) attributable to Lineage
( 8,399 )
( 6,522 )
( 7,760 )
2,032
Basic net income (loss) per share
$ ( 0.06 )
$ ( 0.04 )
$ ( 0.05 )
$ 0.01
Quarterly
and year-to-date computations of net income (loss) per share amounts are calculated using the respective period weighted average shares
outstanding. Therefore, the sum of the per share amounts for the quarters may not agree with the per share amounts for the year.
19.
Subsequent Events
Receipt
of Roche Upfront Payment
In
January 2022, Lineage received a $ 50.0 million upfront payment related to the Roche Agreement. Lineage made a subsequent payment of $ 12.1
million to the IIA, pursuant to Lineage’s obligations under the Innovation Law. Additionally, Lineage made a subsequent
payment of $ 8.9 million to Hadasit, pursuant to Lineage’s obligations under the Hadasit License. Lineage reduced the Hadasit payment
by $ 1.9 million, due to a $ 8.6 million budgetary commitment under the Roche Agreement. Lineage is required to pay Hadasit 21.5% of any
portion of the commitment not incurred within five years after the execution of the Roche Agreement . The IIA and Hadasit payments were
expensed on the consolidated statement of operations as of December 31, 2021, offset with an accrued liability on the consolidated balance
sheet.
Restricted
Stock Unit Awards
On
February 11, 2022, the Board of Directors at Lineage, approved restricted stock unit awards for an aggregate amount of 694,424 . The awards
were issued under the 2021 Plan, which defines restricted stock units as a full value award, which reduce the Plan’s common shares
available for grant by 1.50 shares for each share issued. As of December 31, 2021, there were 16,382,385 shares available for grant under
the 2021 Plan.
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ITEM 9.
CHANGES IN AND DISAGREEMENTS
WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not
applicable.