Item 1. Financial Statements
Item
1. Financial Statements
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
March 31, 2021
(Unaudited)
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 56,210
$ 32,585
Marketable equity securities
6,154
8,977
Trade accounts and grants receivable, net
109
4
Prepaid expenses and other current assets
2,149
2,433
Total current assets
64,622
43,999
NONCURRENT ASSETS
Property and equipment, net (Notes 6 and 15)
5,114
5,630
Deposits and other long-term assets
601
616
Goodwill
10,672
10,672
Intangible assets, net
46,919
47,032
TOTAL ASSETS
$ 127,928
$ 107,949
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 5,733
$ 6,813
Financing lease and right of use lease liabilities, current portion (Note 15)
786
762
Deferred revenues
101
193
Liability classified warrants, current portion
1
1
Total current liabilities
6,621
7,769
LONG-TERM LIABILITIES
Deferred tax liability
2,076
2,076
Right-of-use lease liability, net of current portion (Note 15)
2,217
2,514
Financing lease, net of current portion
26
26
Liability classified warrants, net of current portion
418
437
TOTAL LIABILITIES
11,358
12,822
Commitments and contingencies (Note 15)
-
-
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of March 31, 2021 and December 31, 2020
-
-
Common shares, no par value, 250,000 shares authorized; 162,067 and 153,096 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively
415,259
393,944
Accumulated other comprehensive loss
( 2,091 )
( 3,667 )
Accumulated deficit
( 295,494 )
( 294,078 )
Lineage Cell Therapeutics, Inc. shareholders’ equity
117,674
96,199
Noncontrolling interest (deficit)
( 1,104 )
( 1,072 )
Total shareholders’ equity
116,570
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 127,928
$ 107,949
See
accompanying notes to the condensed consolidated interim financial statements.
3
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN
THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
Three Months Ended
March 31,
2021
2020
REVENUES:
Grant revenue
$ 98
$ 348
Royalties from product sales and license fees
293
166
Total revenues
391
514
Cost of sales
( 112 )
( 94 )
Gross profit
279
420
OPERATING EXPENSES:
Research and development
3,394
3,339
General and administrative
3,935
4,519
Total operating expenses
7,329
7,858
Loss from operations
( 7,050 )
( 7,438 )
OTHER INCOME/(EXPENSES):
Interest income, net
2
405
Gain on sale of marketable securities
6,024
1,258
Unrealized gain (loss) on marketable equity securities
1,239
( 1,338 )
Unrealized gain on warrant liability
18
35
Other expenses, net
( 1,681 )
( 1,350 )
Total other income (expenses), net
5,602
( 990 )
LOSS BEFORE INCOME TAXES
( 1,448 )
( 8,428 )
Deferred income tax benefit
-
-
NET LOSS
( 1,448 )
( 8,428 )
Net loss attributable to noncontrolling interest
32
29
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.
$ ( 1,416 )
$ ( 8,399 )
NET LOSS PER COMMON SHARE:
BASIC
$ ( 0.01 )
$ ( 0.06 )
DILUTED
$ ( 0.01 )
$ ( 0.06 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC
158,725
149,807
DILUTED
158,725
149,807
See
accompanying notes to the condensed consolidated interim financial statements.
4
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS)/INCOME
(IN
THOUSANDS)
(UNAUDITED)
Three Months Ended
March 31,
2021
2020
NET LOSS
$ ( 1,448 )
$ ( 8,428 )
Other comprehensive income, net of tax:
Foreign currency translation adjustment, net of tax
1,576
1,315
COMPREHENSIVE (LOSS)/INCOME
128
( 7,113 )
Less: Comprehensive loss attributable to noncontrolling interest
32
29
COMPREHENSIVE (LOSS)/INCOME ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.
COMMON SHAREHOLDERS
$ 160
$ ( 7,084 )
See
accompanying notes to the condensed consolidated interim financial statements.
5
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN
THOUSANDS)
(UNAUDITED)
Three Months Ended
March 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss attributable to Lineage Cell Therapeutics, Inc.
$ ( 1,416 )
$ ( 8,399 )
Net loss allocable to noncontrolling interest
( 32 )
( 29 )
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash used in operating activities:
Gain on sale of marketable securities
( 6,024 )
( 1,258 )
Unrealized (gain)/loss on marketable equity securities
( 1,239 )
1,338
Depreciation expense, including amortization of leasehold improvements
174
212
Amortization of right-of-use asset
10
9
Amortization of intangible assets
112
498
Stock-based compensation
539
626
Common stock issued for services
102
-
Change in unrealized gain on warrant liability
( 18 )
( 35 )
Foreign currency remeasurement and other gain
1,712
1,424
Changes in operating assets and liabilities:
Accounts and grants receivable, net
( 135 )
66
Accrued interest receivable
-
( 378 )
Receivables from OncoCyte and AgeX, net of payables
-
( 40 )
Prepaid expenses and other current assets
( 92 )
911
Accounts payable and accrued liabilities
( 1,031 )
( 138 )
Deferred revenue and other liabilities
( 86 )
167
Net cash used in operating activities
( 7,424 )
( 5,026 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from the sale of OncoCyte common shares
10,064
4,963
Proceeds from the sale of AgeX common shares
-
258
Proceeds from the sale of Hadasit common shares
21
-
Purchase of equipment and other assets
( 11 )
( 10 )
Other deposits
-
45
Net cash provided by investing activities
10,074
5,256
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from employee options exercised
1,717
-
Common shares received and retired for employee taxes paid
( 13 )
( 2 )
Repayment of financing lease liabilities
-
( 8 )
Proceeds from sale of common shares
19,873
-
Payments for offering costs
( 614 )
-
Net cash provided by (used in) financing activities
20,963
( 10 )
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 80 )
73
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
23,533
293
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:
At beginning of the period
33,183
10,096
At end of the period
$ 56,716
$ 10,389
See
accompanying notes to the condensed consolidated interim financial statements.
6
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization and Business Overview
Lineage
Cell Therapeutics, Inc. (“Lineage,” “we,” “us,” or “our”) is a clinical-stage
biotechnology company developing novel cell therapies for unmet medical needs. Our focus is to develop therapies for degenerative
retinal diseases, neurological conditions associated with demyelination, and that aid the body in detecting and combating
cancer. Specifically, Lineage is testing therapies to treat dry age-related macular degeneration, spinal cord injuries, and non-small
cell lung cancer. Our programs are based on our proprietary cell-based technology platform and associated development and manufacturing
capabilities. From this platform, we develop and manufacture specialized, terminally or functionally differentiated human cells
from established and well-characterized pluripotent cell lines. These differentiated cells are transplanted into a patient either
to 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.
We
have three allogeneic, or “off-the-shelf,” cell therapy programs in clinical 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”). There
currently are no therapies approved by the U.S. Food and Drug Administration (“FDA”) for dry AMD, which accounts for
approximately 85-90% of all AMD cases and is one of the leading causes of blindness in people over the age of 60.
●
OPC1 ,
an oligodendrocyte progenitor cell therapy currently in a Phase 1/2a multicenter clinical trial for acute spinal cord injuries (“SCI”).
This clinical trial has been partially funded by the California Institute for Regenerative Medicine (“CIRM”).
●
VAC2 ,
an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in a Phase 1 clinical trial in non-small cell
lung cancer. This clinical trial is being funded and conducted by Cancer Research UK, one of the world’s largest independent
cancer research charities.
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 March 31, 2021.
Though
our principal focus is on advancing our three cell therapy programs currently in clinical development, we may seek to create additional
value through corporate transactions, as we have in the past, or by initiating new programs using existing protocols or new protocols
and cell lines.
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.
See
Note 3 for a discussion of the Asterias Merger.
Investment
in OncoCyte
Lineage
has an equity position in OncoCyte, a publicly traded molecular diagnostic company (NYSE American: OCX), which Lineage
founded and, in the past, was a majority-owned consolidated subsidiary until February 17, 2017, when Lineage deconsolidated OncoCyte’s
financial statements. OncoCyte is focused on developing and commercializing laboratory-developed tests to serve unmet medical needs across
the cancer care continuum. As of March 31, 2021, Lineage owned approximately 1.1
million shares of OncoCyte common stock, or 1.3 %
of its outstanding shares (see Note 4).
7
2.
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies
The
unaudited condensed consolidated interim financial statements presented herein, and discussed below, have been prepared in accordance
with generally accepted accounting principles in the United States (“GAAP”) for interim financial information and with the
instructions to Form 10-Q and Article 8 of Regulation S-X. In accordance with those rules and regulations certain information and footnote
disclosures normally included in comprehensive consolidated financial statements have been condensed or omitted. The condensed consolidated
balance sheet as of December 31, 2020 was derived from the audited consolidated financial statements at that date, but does not include
all the information and footnotes required by GAAP. These condensed consolidated interim financial statements should be read in conjunction
with the audited consolidated financial statements and notes thereto included in Lineage’s Annual Report on Form 10-K for the year
ended December 31, 2020, as filed with the Securities and Exchange Commission (the “Commission”) on March 11, 2021.
The
accompanying condensed consolidated interim financial statements, in the opinion of management, include all adjustments, consisting only
of normal recurring adjustments, necessary for a fair presentation of Lineage’s financial condition and results of operations.
The condensed consolidated results of operations are not necessarily indicative of the results to be expected for any other interim period
or for the entire year.
Principles
of consolidation
Lineage’s
condensed consolidated interim financial statements include the accounts of its subsidiaries. All material intercompany accounts and
transactions have been eliminated in consolidation. The following table reflects Lineage’s ownership, directly or through one or
more subsidiaries, of the outstanding shares of its operating subsidiaries as of March 31, 2021.
Schedule
of Lineage's Ownership of Outstanding Shares of its Subsidiaries
Subsidiary
Field
of Business
Lineage
Ownership
Country
Asterias
BioTherapeutics, Inc.
Cell
therapy clinical development programs in spinal cord injury and oncology
100
%
USA
Cell
Cure Neurosciences Ltd. (“Cell Cure”)
Development
and manufacturing of Lineage’s cell replacement platform technology
99
% (1)
Israel
ES
Cell International Pte. Ltd. (“ESI”)
Stem
cell products for research, including clinical grade cell lines produced under cGMP
100
%
Singapore
OrthoCyte
Corporation (“OrthoCyte”)
Developing
bone grafting products for orthopedic diseases and injuries
99.8
%
USA
(1)
Includes
shares owned by Lineage and ESI.
As
of March 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.
8
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 (“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, but is not obligated to,
raise up to $ 25.0 million through the sale of common shares from time to time in at-the-market transactions under the Sales Agreement.
As of March 31, 2021, Lineage had issued 11,035,444 common shares at a weighted average price per share of $ 2.27 for gross proceeds of
$ 25.0 million under the Sales Agreement. 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.
No sales of the additional $25.0 million shares have been conducted as of May 7, 2021.
As
of March 31, 2021, Lineage had an accumulated deficit of approximately $ 295.5 million, working capital of $ 58.0 million and shareholders’
equity of $ 116.6 million. Lineage has evaluated its projected cash flows and believes that its $ 62.4 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 condensed consolidated interim 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.
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.
Business
Combinations
Lineage
accounts for business combinations, such as the Asterias Merger completed in March 2019, in accordance with ASC Topic 805, which requires
the purchase price to be measured at fair value. When the purchase consideration consists entirely of Lineage common shares, Lineage
calculates the purchase price by determining the fair value, as of the acquisition date, of shares issued in connection with the closing
of the acquisition. Lineage recognizes estimated fair values of the tangible assets and intangible assets acquired, including in-process
research and development (“IPR&D”), and liabilities assumed as of the acquisition date, and records as goodwill any amount
of the fair value of the tangible and intangible assets acquired and liabilities assumed in excess of the purchase price.
9
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.
Lineage’s
largest source of revenue is currently related to government grants. 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. Lineage has, and will continue to, account for grants received to perform research and development services in accordance
with ASC 730-20, Research and Development Arrangements, which requires an assessment, at the inception of the grant, of whether the grant
is a liability or a contract to perform research and development services for others. If Lineage or a subsidiary receiving the grant
is obligated to repay the grant funds to the grantor regardless of the outcome of the research and development activities, then Lineage
is required to estimate and recognize that liability. Alternatively, if Lineage or a subsidiary receiving the grant is not required to
repay, or if it is required to repay the grant funds only if the research and development activities are successful, then the grant agreement
is accounted for as a contract to perform research and development services for others, in which case, grant revenue is recognized when
the related research and development expenses are incurred (see Note 15).
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 latest balance sheet date reported. As of March 31, 2021, deferred grant revenue was $ 101,000 .
10
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 three months ended March 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.
The
following common share equivalents were excluded from the computation of diluted net 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
Three Months Ended
March 31,
(unaudited)
2021
2020
Stock options
19,257
17,959
Lineage Warrants (1) (Note 3)
1,090
1,090
Restricted stock units
77
145
(1)
Although
the Lineage Warrants (as defined below) are classified as liabilities, the Lineage Warrants are considered for dilutive earnings
per share calculations in accordance with ASC 260, Earnings Per Share, and determined to be antidilutive for the period presented.
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 condensed consolidated statements of cash flows.
The
following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance
sheet dates that comprise the total of the same such amounts shown in the condensed consolidated statements of cash flows for all periods
presented herein (in thousands):
Schedule
of Reconciliation of Cash, Cash Equivalents, and Restricted Cash
March 31,
2021
December 31,
2020
March 31,
2020
December 31,
2019
(unaudited)
(unaudited)
Cash and cash equivalents
$ 56,210
$ 32,585
$ 9,832
$ 9,497
Restricted cash included in deposits and other long-term assets (see Note 15)
506
520
557
599
Restricted cash included in prepaid expenses and other current assets (see Note 15)
-
78
-
-
Total cash, cash equivalents, and restricted cash as shown in the condensed consolidated statements of cash flows
$ 56,716
$ 33,183
$ 10,389
$ 10,096
11
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 condensed 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 is not expected to have a material impact on its condensed consolidated financial
statements.
Recently
Issued Accounting Pronouncements Not Yet Adopted - The recently issued accounting pronouncements applicable to Lineage that are not yet
effective should be read in conjunction with the recently issued accounting pronouncements, as applicable and disclosed in Lineage’s
Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Commission on March 11, 2021.
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 condensed consolidated financial statements.
3.
Asterias Merger
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.
Asterias
has 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 consists of $ 31.7 million pertaining to the OPC1 program that is
currently in a Phase 1/2a clinical trial for SCI, which has been partially funded by the California Institute for Regenerative Medicine
and $ 14.8 million pertaining to the VAC2 program, which is an allogeneic, or “off-the-shelf,” cancer immunotherapy derived
from pluripotent stem cells for which a clinical trial in non-small cell lung cancer is being funded and sponsored by Cancer Research
UK.
Asterias
also has certain royalty revenues for “research only use” culture media for pre-clinical research applications under certain,
specific patent families under contracts which preclude the customers to sell for commercial use or for clinical trials. These royalty
cash flows are generated under certain specific patent families that Asterias previously acquired from Geron Corporation (“Geron”).
Asterias pays Geron a royalty for all royalty revenues received from these contracts. Because these patents are expected to continue
to generate revenues for Asterias and are not to be used in the OPC1 or the VAC2 programs, these patents are considered to be separate
long-lived intangible assets under ASC 805.
12
In
connection with the closing of the Asterias Merger, Lineage assumed outstanding warrants to purchase shares of Asterias common stock,
as further discussed below and in Note 11, and assumed sponsorship of the Asterias 2013 Equity Incentive Plan (see Note 12). All stock
options to purchase shares of Asterias common stock outstanding immediately prior to the closing of the Asterias Merger were canceled
at the closing for no consideration.
Asterias
Merger Related Litigation - See Note 15 Commitments and Contingencies for discussion regarding litigation related to the Asterias Merger.
4.
Accounting for Common Stock of OncoCyte, at Fair Value
As
of March 31, 2021, Lineage owned approximately 1.1 million shares of OncoCyte common stock. These shares had a fair value of approximately
$ 5.8 million, based on the closing price of OncoCyte of $ 5.19 per share on March 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 three months ended March 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 gain on marketable equity securities of $ 1.2 million related to changes in fair market value of
OncoCyte’s common stock price during the quarter.
For
the three months ended March 31, 2020, Lineage recorded a realized gain of $ 1.1 million due to sales of OncoCyte shares in the period.
Lineage also recorded a net unrealized loss on marketable equity securities of $ 0.3 million related to changes in fair market value of
OncoCyte’s common stock price in the quarter.
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.
5.
Sale of Significant Ownership Interest in AgeX to Juvenescence Limited
On
August 30, 2018, Lineage entered into a Stock Purchase Agreement with Juvenescence Limited (“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 .
13
6.
Property and Equipment, Net
At
March 31, 2021 and December 31, 2020, property and equipment, net was comprised of the following (in thousands):
Schedule
of Property and Equipment, Net
March 31, 2021
December 31, 2020
(unaudited)
Equipment, furniture and fixtures
$ 3,448
$ 3,628
Leasehold improvements
2,392
2,472
Right-of-use assets
3,746
3,845
Accumulated depreciation and amortization
( 4,472 )
( 4,315 )
Property and equipment, net
$ 5,114
$ 5,630
Property
and equipment at March 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 15.
Depreciation
and amortization expense amounted to $ 174,000 and $ 212,000 for the three months ended March 31, 2021 and 2020, respectively. During the
three months ended March 31, 2021 and 2020, Lineage sold non-capitalized assets for a net gain of $ 16,000 and $ 30,000 , respectively,
which was included in research and development expenses on the condensed consolidated statements of operations. During the three months
ended March 31, 2020, Lineage sold equipment with a net book value of $ 13,000 and recognized a gain of $ 2,000 , which was included in
research and development expenses on the condensed consolidated statement of operations.
7.
Goodwill and Intangible Assets, Net
At
March 31, 2021, and December 31, 2020, goodwill and intangible assets, net consisted of the following (in thousands):
Schedule of Goodwill and Intangible Assets, Net
March
31, 2021
December 31,2020
(unaudited)
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 (2)
650
650
Total intangible assets
66,143
66,143
Accumulated amortization
( 19,224 )
( 19,111 )
Intangible assets, net
$ 46,919
$ 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)
See
Note 3 for information on the Asterias Merger which was consummated on March 8, 2019.
Amortization
recognized in research and development expenses was $ 0.1 million and $ 0.5 million for the three months ended March 31, 2021 and 2020,
respectively.
14
8.
Accounts Payable and Accrued Liabilities
At
March 31, 2021 and December 31, 2020, accounts payable and accrued liabilities consisted of the following (in thousands):
Schedule of Accounts Payable and Accrued Liabilities
March 31, 2021
December
31, 2020
(unaudited)
Accounts payable
$ 2,797
$ 2,611
Accrued compensation
1,246
1,959
Accrued liabilities
988
1,711
PPP loan payable
523
523
Other current liabilities
179
9
Total
$ 5,733
$ 6,813
As
of March 31, 2021, accrued liabilities includes $ 0.3 million related to the signature fee owed to Cancer Research UK, as described in
Note 15.
PPP
Loan Payable
In
April 2020, Lineage received a loan for $ 523,000
from Axos Bank under the PPP contained
within the Coronavirus Aid, Relief and Economic Security (“CARES”) Act. The PPP loan has a term of two years, is unsecured,
and is guaranteed by the U.S. Small Business Administration (“SBA”). The loan carries a fixed interest rate of one
percent per annum, with the first six months of interest deferred. Under the CARES Act and Paycheck Protection Program Flexibility
Act, Lineage will be 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 are adhered to by Lineage, all or part of such loan could be forgiven.
Lineage believes that all or a substantial portion of the PPP loan is eligible for forgiveness within one year and classifies
the loan as a short-term liability. On December 27, 2020, the Consolidated Appropriations Act, 2021 (CAA) was signed
into law, retroactively allowing a deduction of the expenses that gave rise to the PPP loan forgiveness, that was previously denied
under the CARES Act. California has partially adopted the federal tax treatment. On February 17, 2021, California issued an Immediate
Action Agreement, allowing companies to deduct up to $ 150,000
in expenses covered by the PPP loan. Any forgiven amounts will not be included in Lineage’s taxable income
for federal or California purposes. Lineage applied for forgiveness of the PPP loan on September 30, 2020, and on May 13, 2021,
received notice that the PPP loan was forgiven in full.
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.
15
We
measure cash, cash equivalents, marketable equity securities and our liability classified warrants at fair value on a recurring basis.
The fair values of such assets were as follows for March 31, 2021 and December 31, 2020 (in thousands):
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis
Fair Value Measurements Using
Balance at March 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
$ 56,210
$ 56,210
$ -
$ -
Marketable equity securities
6,154
6,154
-
-
Liabilities:
Lineage Warrants
1
-
-
1
Cell Cure Warrants
418
-
-
418
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 equity 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 valuation techniques that maximize 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.
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 condensed
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.
16
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 15). 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 15), 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 March
31, 2021, Lineage has incurred a total of $ 375,000 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 1,000,000 shares, 2,000,000
shares and 623,090 shares of OncoCyte common stock from Lineage in July 2019, September 2019 and January 2020, respectively.
11.
Shareholders’ Equity
Preferred
Shares
Lineage
is authorized to issue 2,000,000 preferred shares. The preferred shares may be issued in one or more series as our board of directors
may determine by resolution. Our 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. Our 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. There are no preferred shares issued and outstanding.
Common
Shares
At
March 31, 2021, Lineage was authorized to issue 250,000,000 common shares, no par value. As of March 31, 2021, and December 31, 2020,
Lineage had 162,066,897 and 153,095,883 issued and outstanding common shares, respectively.
17
At-The-Market
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 having an aggregate offering price of up to $ 25,000,000 . Lineage is not obligated to sell any shares
under the Sales Agreement. 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 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 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 shares under the Sales Agreement 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. As of March 31, 2021, Lineage had issued 11,035,444
common shares at a weighted average price per share of $ 2.27 for gross proceeds of $ 25.0 million under the Sales Agreement. 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. No sales of the additional $25.0 million shares have been conducted as of May 7, 2021.
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.
18
Reconciliation
of Changes in Shareholders’ Equity
The
following tables document the changes in shareholders’ equity for the three months ended March 31, 2021 and 2020 (unaudited and
in thousands):
Schedule of Shareholders' Equity
1
2
3
4
5
6
7
8
Preferred Shares
Common Shares
Noncontrolling
Accumulated Other
Total
Number
Number
Accumulated
Interest/
Comprehensive
Shareholders’
of Shares
Amount
of Shares
Amount
Deficit
(Deficit)
Income/(Loss)
Equity
BALANCE AT DECEMBER 31, 2020
-
$ -
153,096
$ 393,944
$ ( 294,078 )
$ ( 1,072 )
$ ( 3,667 )
$ 95,127
Shares issued through ATM
-
-
7,941
19,008
-
-
-
19,008
Shares issued for services
-
-
78
202
-
-
-
202
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
10
( 12 )
-
-
-
( 12 )
Shares issued upon exercise of stock options
-
-
942
1,751
1,751
Financing related fees
-
-
-
( 173 )
-
-
-
( 173 )
Stock-based compensation
-
-
-
539
-
-
-
539
Foreign currency translation gain
-
-
-
-
-
-
1,576
1,576
NET LOSS
-
-
-
-
( 1,416 )
( 32 )
-
( 1,448 )
BALANCE AT MARCH 31, 2021
-
$ -
162,067
$ 415,259
$ ( 295,494 )
$ ( 1,104 )
$ ( 2,091 )
$ 116,570
Preferred Shares
Common Shares
Noncontrolling
Accumulated Other
Total
Number
Number
Accumulated
Interest/
Comprehensive
Shareholders’
of Shares
Amount
of Shares
Amount
Deficit
(Deficit)
Income/(Loss)
Equity
BALANCE AT DECEMBER 31, 2019
-
$ -
149,804
$ 387,062
$ ( 273,422 )
$ ( 1,712 )
$ ( 681 )
$ 111,247
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
14
( 2 )
-
-
-
( 2 )
Stock-based compensation
-
-
-
626
-
-
-
626
Foreign currency translation gain
-
-
-
-
-
-
1,315
1,315
NET LOSS
-
-
-
-
( 8,399 )
( 29 )
-
( 8,428 )
BALANCE AT MARCH 31, 2020
-
$ -
149,818
$ 387,686
$ ( 281,821 )
$ ( 1,741 )
$ 634
$ 104,758
19
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 “Lineage
Warrants”). As of March 31, 2021, 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
have an exercise price of $ 6.15 per share and expire 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 per share 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 have been issued to consultants. Of these warrants,
11,738 were cashless exercised in October 2020. The remaining 2,000 warrants have an exercise price of $ 40.00 per share and expire in
January 2024 .
12.
Stock-Based Awards
Equity
Incentive Plan Awards
Effective
November 8, 2019, Lineage adopted an amendment changing the name of the BioTime, Inc. 2012 Equity Incentive Plan to the Lineage Cell
Therapeutics, Inc. 2012 Equity Incentive Plan (the “2012 Plan”). The 2012 Plan provides for the grant of stock options, restricted
stock, restricted stock units (“RSUs”) and stock appreciation rights. As of March 31, 2021, a maximum of 24,000,000 common
shares were available for grant under the 2012 Plan. Recipients of stock options are eligible to purchase common shares at an exercise
price equal to the fair market value of such shares on the date of grant. The maximum term of options granted under the 2012 Plan is
10 years. Stock options generally vest over a four-year period based on continuous service; however, the 2012 Plan allows for other vesting
periods. Upon the expiration of the restrictions applicable to an RSU, Lineage will either issue to the recipient, without charge, one
common share per RSU or cash in an amount equal to the fair market value of one common share. RSUs granted from the 2012 Plan reduce
the shares available for grant by two shares for each RSU granted.
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
Shares
Available
for Grant
Number
of Options
Outstanding
Number
of RSUs
Outstanding
Weighted
Average
Exercise Price
December 31, 2020
8,002
15,865
93
$ 1.57
Restricted stock units vested
-
-
( 16 )
-
Options granted
( 4,175 )
4,175
-
2.43
Options exercised
-
( 942 )
-
1.86
Options expired/forfeited/cancelled
191
( 191 )
-
2.76
March 31, 2021
4,018
18,907
77
$ 1.74
Options exercisable at March 31, 2021
8,741
$ 1.95
20
At
the effective time of the Asterias Merger, Lineage assumed sponsorship of the Asterias 2013 Equity Incentive Plan (the “Asterias
Equity Plan”), with references to Asterias and Asterias common stock therein to be deemed references to Lineage and Lineage common
shares. There were 7,309,184 shares available under the Asterias Equity Plan immediately before the closing of the Asterias Merger, which
became 5,189,520 shares immediately following the Asterias Merger. The shares available under the Asterias Equity Plan will be for awards
granted to those former Asterias employees who continued as Lineage employees upon consummation of the Asterias Merger.
A
summary of activity under the Asterias Equity Plan is as follows (in thousands, except per share amounts):
Schedule
of Share-based Compensation, Employee Stock Purchase Plan, Activity
Shares
Available
for Grant
Number
of Options
Outstanding
Weighted
Average
Exercise Price
December 31, 2020
4,840
350
$ 1.57
Options granted
-
-
-
Options exercised
-
-
-
Options forfeited
-
-
March 31, 2021
4,840
350
$ 1.57
Options exercisable at March 31, 2021
176
$ 1.57
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
Three Months Ended
March 31, (unaudited)
2021
2020
Expected life (in years)
6.25
6.25
Risk-free interest rates
1.06 %
0.8 %
Volatility
73.0 %
67.5 %
Dividend yield
- %
- %
Operating
expenses include stock-based compensation expense as follows (in thousands):
Schedule of Stock Based Compensation Expense
Three Months Ended
March 31, (unaudited)
2021
2020
Research and development
$ 134
$ 96
General and administrative
405
530
Total stock-based compensation expense
$ 539
$ 626
21
13.
Income Taxes
The
provision for income taxes for interim periods is generally determined using an estimated annual effective tax rate as prescribed by
ASC 740-270, Income Taxes, Interim Reporting. The effective tax rate may be subject to fluctuations during the year as new information
is obtained, which may affect the assumptions used to estimate the annual effective tax rate, including factors such as valuation allowances
and changes in valuation allowances against deferred tax assets, the recognition or de-recognition of tax benefits related to uncertain
tax positions, if any, and changes in or the interpretation of tax laws in jurisdictions where Lineage conducts business. ASC 740-270
also states that if an entity is unable to reliably estimate some or a part of its ordinary income or loss, the income tax provision
or benefit applicable to the item that cannot be estimated shall be reported in the interim period in which the item is reported.
For
items that Lineage cannot reliably estimate on an annual basis (principally unrealized gains or losses generated by changes in the market
prices of OncoCyte shares), Lineage uses the actual year to date effective tax rate rather than an estimated annual effective tax rate
to determine the tax effect of each item, including the use of all available net operating losses and other credits or deferred tax assets.
The
market value of the shares of OncoCyte common stock Lineage holds creates a deferred tax liability to Lineage based on the closing prices
of the shares, less Lineage’s tax basis in the shares. The deferred tax liability generated by the OncoCyte shares that Lineage
holds as of March 31, 2021, 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 the deferred tax liability. This deferred tax liability
is determined based on the closing prices of the OncoCyte shares as of March 31, 2021. Due to the inherent unpredictability of future
prices of those shares, Lineage cannot reliably estimate or project those deferred tax liabilities on an annual basis. Therefore, the
deferred tax liability pertaining to OncoCyte shares, determined based on the actual closing prices on the last stock market trading
day of the applicable accounting period, and the related impacts to the valuation allowance and deferred tax asset changes, are recorded
in the accounting period in which they occur.
Prior
to the Asterias Merger discussed in Note 3, the Asterias shares Lineage held generated similar deferred tax liabilities to Lineage as
the OncoCyte shares discussed above. As of the Asterias Merger date and due to Asterias becoming a wholly owned subsidiary of Lineage,
the Asterias deferred tax liabilities were eliminated with a corresponding adjustment to Lineage’s valuation allowance, resulting
in no tax provision or benefit from this adjustment.
In
connection with the Asterias Merger, a deferred tax liability of $ 10.8 million was recorded as part of the acquisition accounting. The
deferred tax liability (“DTL”) is related to fair value adjustments for the assets and liabilities acquired in the Asterias
Merger, principally consisting of IPR&D. This estimate of deferred taxes was determined based on the excess of the estimated fair
values of the acquired assets and liabilities over the tax basis of the assets and liabilities acquired. The statutory tax rate was applied,
as appropriate, to the adjustment based on the jurisdiction in which the adjustment is expected to occur. Because the IPR&D (prior
to completion or abandonment of the R&D) is considered an indefinite-lived asset for accounting purposes, the fair value of the IPR&D
on the acquisition date created a deferred income tax liability in accordance with ASC 740. This DTL is computed using the fair value
of the IPR&D assets on the acquisition date multiplied by Lineage’s respective federal and state income tax rates. While this
DTL would reverse on impairment or sale or commencement of amortization of the related intangible assets, those events are not anticipated
under ASC 740 for purposes of predicting reversal of a temporary difference to support the realization of deferred tax assets, except
for certain deferred tax assets and credit carryforwards that are also indefinite in nature as of the Asterias Merger date, which may
be considered for reversal under ASC 740 as further discussed below.
22
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, 2020, a portion of the valuation allowance was released as it relates to Lineage’s indefinite lived assets that
can be used against the indefinite lived liabilities. The amount of the valuation allowance released was $ 1.2 million; 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.
For
the three months ended March 31, 2021, and 2020, Lineage did not record any provision or benefit for income taxes, as Lineage had taxable
income related to a gain on the sale of OncoCyte common stock in the periods. This taxable income was offset by net operating loss carryforwards.
14.
Supplemental Cash Flow Information
Supplemental
disclosure of cash flow information for the three months ended March 31, 2021 and 2020 is as follows (in thousands):
Schedule of Supplemental Cash Flow Information
Three Months Ended
March 31, (unaudited)
2021
2020
Cash paid during period for interest
$ 3
$ 7
15.
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, 2020 is $ 18,386 per month and increases by 3 % annually on every August 1 thereafter
during the lease term. Base rent for the first twenty-four months of the lease is 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 .
23
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 $ 72,636 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.
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 considered restricted cash and is included in deposits and other long-term assets as of March
31, 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.
24
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 US $ 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 options
to extend the lease for five years each (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 amount is included in deposits and
other long-term assets on the consolidated balance sheet as of March 31, 2021, to be held as restricted cash during the term of
the January 2018 Lease.
The
below table provides supplemental cash flow information related to leases as follows (in thousands):
Schedule
of Supplemental Cash Flow Information Related to Leases
Three Months Ended
March 31,
2021
2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$ 208
$ 398
Operating cash flows from financing leases
3
7
Financing cash flows from financing leases
-
8
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
-
29
Financing leases
-
-
25
Supplemental
balance sheet information related to leases is as follows (in thousands, except lease term and discount rate):
Schedule of Supplemental Balance Sheet Information Related to Leases
March 31, 2021
December 31, 2020
Operating leases
Right-of-use assets, net
$ 2,648
$ 2,916
Right-of-use lease liabilities, current
771
746
Right-of-use lease liabilities, noncurrent
2,217
2,514
Total operating lease liabilities
$ 2,988
$ 3,260
Financing leases
Property and equipment, gross
$ 79
$ 79
Accumulated depreciation
( 68 )
( 65 )
Property and equipment, net
$ 11
$ 14
Current liabilities
$ 16
$ 16
Long-term liabilities
26
26
Total finance lease liabilities
$ 42
$ 42
Weighted average remaining lease term
Operating leases
4.0 years
4.2 years
Finance leases
2.2 years
2.4 years
Weighted average discount rate
Operating leases
8.0 %
8.0 %
Finance leases
10.0 %
10.0 %
Future
minimum lease commitments are as follows as of March 31, 2021 (in thousands):
Schedule
of Future Minimum Lease Commitments
Operating
Leases
Finance
Leases
Year
Ending December 31,
2021
$
724
$
14
2022
912
19
2023
480
8
2024
454
-
2025
442
-
Thereafter
531
-
Total
lease payments
$
3,543
$
41
Less
imputed interest
( 555
)
( 4
)
Total
$
2,988
$
37
26
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 January 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
Lineage
is subject to various claims and contingencies in the ordinary course of its business, including those related to litigation,
business transactions, employee-related matters, and others. When Lineage is aware of a claim or potential claim, it assesses
the likelihood of any loss or exposure. If it is probable that a loss will result and the amount of the loss can be reasonably
estimated, Lineage will record a liability for the loss. If the loss is not probable or the amount of the loss cannot be reasonably
estimated, Lineage will disclose the claim if the likelihood of a potential loss is reasonably possible and the amount involved
could be material. Lineage is not aware of any claims likely to have a material adverse effect on its financial condition or results
of operations.
On
February 19, 2019, a putative shareholder class action lawsuit was filed (captioned Lampe v. Asterias Biotherapeutics, Inc.
et al ., Case No. RG19007391) in the Superior Court of the State of California, County of Alameda challenging the Asterias
Merger. On March 1, 2019, Asterias made certain amendments and supplements to its public disclosures regarding the Asterias Merger
(the “Supplemental Disclosures”). On May 3, 2019, an amended class action complaint (the “Amended Complaint”)
was filed. The Amended Complaint named Lineage, Patrick Merger Sub, Inc., the Asterias board of directors, one member of Lineage’s
board of directors, and certain stockholders of both Lineage and Asterias. The action was brought by two purported stockholders
of Asterias, on behalf of a putative class of Asterias stockholders, and asserted breach of fiduciary duty and aiding and abetting
claims under Delaware law. The Amended Complaint alleged, among other things, that the process leading up to the Asterias Merger
was conflicted and 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 Amended Complaint sought, among other things, that
a class be certified, the recovery of monetary damages, and attorneys’ fees and costs.
27
On
June 3, 2019, defendants filed demurrers to the Amended Complaint. On August 13, 2019, the parties submitted a stipulation to
the court seeking dismissal of the action with prejudice as to the named Plaintiffs and without prejudice as to the unnamed putative
class members, and disclosed to the court the parties’ agreement to resolve, for $ 200,000 , Plaintiffs’ claim for an
award of attorneys’ fees and expenses in connection with the purported benefit conferred on Asterias stockholders by the
Supplemental Disclosures. The court granted the stipulation and dismissed the action August 14, 2019. Lineage continues to believe
that the claims and allegations in the action lack merit, but believed that it was in Lineage’s shareholders’ best
interest for the action to be dismissed and to resolve the fee claim in a timely manner without additional costly litigation expenses.
On
October 14, 2019, another 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.
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.
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 provide Lineage with insurance against claims or demands for indemnification in specified circumstances. 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 March 31, 2021 and December 31, 2020.
28
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.
Second
Amended and Restated License Agreement
On
June 15, 2017, Cell Cure entered into a Second Amended and Restated License Agreement (the “License Agreement”) with
Hadasit Medical Research Services and Development Ltd. (“Hadasit”), the commercial arm and a wholly owned subsidiary
of Hadassah Medical Organization. Pursuant to the License Agreement, Hadasit granted Cell Cure an exclusive, worldwide, royalty
bearing license (with the right to grant sublicenses) in its intellectual property portfolio of materials and technology related
to human stem cell derived photoreceptor cells and retinal pigment epithelial cells (the “Licensed IP”), to use, commercialize
and exploit any part thereof, in any manner whatsoever in the fields of the development and exploitation of: (i) human stem cell
derived photoreceptor cells, solely for use in cell therapy for the diagnosis, amelioration, prevention and treatment of eye disorders;
and (ii) human stem cell derived retinal pigment epithelial cells, solely for use in cell therapy for the diagnosis, amelioration,
prevention and treatment of eye disorders.
As
consideration for the Licensed IP, Cell Cure will pay a small one-time lump sum payment, a royalty in the mid-single digits of
net sales from sales of Licensed IP by any invoicing entity, and a royalty of 21.5 % of sublicensing receipts. In addition, Cell
Cure will pay Hadasit an annual minimal non-refundable royalty, which will become due and payable the first January 1 following
the completion of services to Cell Cure by a research laboratory.
Cell
Cure will pay Hadasit non-refundable milestone payments upon the recruitment of the first patient for the first Phase 2b clinical
trial, upon the enrollment of the first patient in the first Phase 3 clinical trials, upon delivery of the report for the first
Phase 3 clinical trials, upon the receipt of an NDA or marketing approval in the European Union, whichever is the first to occur,
and upon the first commercial sale in the United States or European Union, whichever is the first to occur. Such milestones, in
the aggregate, may be up to $ 3.5 million. As of March 31, 2021, Cell Cure had not accrued any milestone payments under the License
Agreement.
The
License Agreement terminates upon the expiration of Cell Cure’s obligation to pay royalties for all licensed products, unless
earlier terminated. In addition to customary termination rights of both parties, Hadasit may terminate the License Agreement if
Cell Cure fails to continue the clinical development of the Licensed IP or fails to take actions to commercialize or sell the
Licensed IP over any consecutive 12 month period. The License Agreement also contains mutual confidentiality obligations of Cell
Cure and Hadasit, and indemnification obligations of Cell Cure.
29
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.
Grants
Under
the terms of the grant agreement between Cell Cure and Israel Innovation Authority (“IIA”) (formerly the Office of
the Chief Scientist of Israel) of the Ministry of Economy and Industry, for the development of OpRegen, Cell Cure will be required
to pay royalties on future product sales, if any, up to the amounts received from the IIA, plus interest indexed to LIBOR. Cell
Cure’s research and product development activities under the grant are subject to substantial risks and uncertainties and
performed on a best efforts basis. As a result, Cell Cure is not required to make any payments under the grant agreement unless
it successfully commercializes OpRegen. Accordingly, pursuant to ASC 730-20, the grant is considered a contract to perform research
and development services for others and grant revenue is recognized as the related research and development expenses are incurred
(see Note 2).
Israeli
law pertaining to such government grants contain various conditions, including substantial penalties and restrictions on the transfer
of intellectual property, or the manufacture, or both, of products developed under the grant outside of Israel, as defined by
the IIA.
16.
Subsequent Events
Immunomic
Therapeutics Inc. License Agreement
On
April 16, 2021, Lineage entered a worldwide license and development collaboration with Immunomic Therapeutics, Inc (ITI). Lineage
is the sole and exclusive owner of the rights to the VAC platform and has licensed to ITI patents and materials for the development
and commercialization of novel cancer immunotherapy agent derived from this platform utilizing an antigen provided by ITI.
Under
terms of the 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.
PPP
Loan
On
May 13, 2021, Lineage received notice that its PPP loan was forgiven in full. See Note 8 for additional information.
30
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.