Item 1. Financial Statements
Item
1. Financial Statements
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
September 30, 2021
(Unaudited)
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 60,809
$ 32,585
Marketable equity securities
4,295
8,977
Trade accounts receivable, net
79
4
Prepaid expenses and other current assets
3,161
2,433
Total current assets
68,344
43,999
NONCURRENT ASSETS
Property and equipment, net (Notes 6 and 15)
4,728
5,630
Deposits and other long-term assets
614
616
Goodwill
10,672
10,672
Intangible assets, net
46,854
47,032
TOTAL ASSETS
$ 131,212
$ 107,949
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 6,705
$ 6,813
Lease liabilities, current portion (Note 15)
801
746
Financing lease, current portion (Note 15)
17
16
Deferred revenues
975
193
Liability classified warrants, current portion
293
1
Total current liabilities
8,791
7,769
LONG-TERM LIABILITIES
Deferred tax liability
894
2,076
Lease liability, net of current portion (Note 15)
1,887
2,514
Financing lease, net of current portion (Note 15)
12
26
Liability classified warrants, net of current portion
39
437
TOTAL LIABILITIES
11,623
12,822
Commitments and contingencies (Note 15)
-
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, 2,000 shares authorized; none issued and outstanding as of September 30, 2021 and December 31, 2020
-
-
Common shares, no par value, 250,000 shares authorized; 168,465 and 153,096 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively
432,250
393,944
Accumulated other comprehensive loss
( 3,433 )
( 3,667 )
Accumulated deficit
( 308,105 )
( 294,078 )
Lineage Cell Therapeutics, Inc. shareholders’ equity
120,712
96,199
Noncontrolling deficit
( 1,123 )
( 1,072 )
Total shareholders’ equity
119,589
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 131,212
$ 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
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
REVENUES:
Royalties
$ 1,909
$ 342
$ 2,430
$ 607
Grant revenues
68
229
237
864
Collaboration revenues
293
-
506
-
Total revenues
2,270
571
3,173
1,471
Cost of sales
( 985 )
( 102 )
( 1,222 )
( 271 )
Gross profit
1,285
469
1,951
1,200
OPERATING EXPENSES:
Research and development
2,811
3,566
9,136
9,710
General and administrative
5,317
3,628
13,788
12,055
Total operating expenses
8,128
7,194
22,924
21,765
Loss from operations
( 6,843 )
( 6,725 )
( 20,973 )
( 20,565 )
OTHER INCOME/(EXPENSES):
Interest income (expense), net
1
252
( 1 )
1,037
Gain on sale of marketable securities
-
120
6,024
3,848
Unrealized loss on marketable equity securities
( 2,450 )
( 2,003 )
( 621 )
( 7,487 )
Gain on extinguishment of debt
-
-
523
-
Unrealized gain on warrant liability
53
55
105
84
Other income (expense), net
393
351
( 318 )
175
Total other income/(expense), net
( 2,003 )
( 1,225 )
5,712
( 2,343 )
LOSS BEFORE INCOME TAXES
( 8,846 )
( 7,950 )
( 15,261 )
( 22,908 )
Deferred income tax benefit
1,012
178
1,181
178
NET LOSS
( 7,834 )
( 7,772 )
( 14,080 )
( 22,730 )
Net loss attributable to noncontrolling interest
11
12
51
49
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.
$ ( 7,823 )
$ ( 7,760 )
$ ( 14,029 )
$ ( 22,681 )
NET LOSS PER COMMON SHARE:
BASIC
$ ( 0.05 )
$ ( 0.05 )
$ ( 0.09 )
$ ( 0.15 )
DILUTED
$ ( 0.05 )
$ ( 0.05 )
$ ( 0.09 )
$ ( 0.15 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC
167,624
149,973
163,120
149,868
DILUTED
167,624
149,973
163,120
149,868
See
accompanying notes to the condensed consolidated interim financial statements.
4
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(IN
THOUSANDS)
(UNAUDITED)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
NET LOSS
$ ( 7,834 )
$ ( 7,772 )
$ ( 14,080 )
$ ( 22,730 )
Other comprehensive loss, net of tax:
Foreign currency translation adjustment, net of tax
( 382 )
( 335 )
234
( 140 )
COMPREHENSIVE LOSS
( 8,216 )
( 8,107 )
( 13,846 )
( 22,870 )
Less: Comprehensive loss attributable to noncontrolling interest
11
12
51
49
COMPREHENSIVE LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. COMMON SHAREHOLDERS
$ ( 8,205 )
$ ( 8,095 )
$ ( 13,795 )
$ ( 22,821 )
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)
Nine Months Ended September 30,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss attributable to Lineage Cell Therapeutics, Inc.
$ ( 14,029 )
$ ( 22,681 )
Net loss allocable to noncontrolling interest
( 51 )
( 49 )
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 )
( 3,848 )
Unrealized loss on marketable equity securities
621
7,487
Gain on extinguishment of debt
( 523 )
-
Depreciation expense, including amortization of leasehold improvements
504
623
Amortization of right-of-use asset
19
47
Amortization of intangible assets
178
1,080
Stock-based compensation
2,601
1,733
Common stock issued for services
202
59
Change in unrealized gain on warrant liability
( 105 )
( 84 )
Write-off of security deposit
-
150
Deferred tax benefit
( 1,181 )
( 178 )
Foreign currency remeasurement and other gain
300
( 116 )
Gain on write-off and sales of assets
( 5 )
( 154 )
Amortization of deferred license fee
-
( 200 )
Changes in operating assets and liabilities:
Accounts and grants receivable
( 104 )
51
Accrued interest receivable
-
( 1,008 )
Prepaid expenses and other current assets
( 1,229 )
1,634
Accounts payable and accrued liabilities
354
1,342
Deferred revenue and other liabilities
784
-
Net cash used in operating activities
( 17,688 )
( 14,112 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from the sale of OncoCyte common shares
10,064
10,941
Proceeds from the sale of AgeX common shares
-
1,196
Proceeds from the sale of HBL common shares
21
3
Purchase of equipment
( 208 )
( 40 )
Proceeds from the sale of equipment
14
18
Other deposits
-
18
Net cash provided by investing activities
9,891
12,136
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from employee options exercised
6,269
24,624
Common shares received and retired for employee taxes paid
( 41 )
( 19 )
Repayment of financing lease liabilities
( 13 )
( 24 )
Proceeds from Paycheck Protection Program (“PPP”) Loan
(Note 8)
-
523
Proceeds from sale of common shares
30,741
-
Payments for offering costs
( 980 )
( 53 )
Net cash provided by financing activities
35,976
25,051
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 34 )
( 36 )
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
28,145
23,039
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:
At beginning of the period
33,183
10,096
At end of the period
$ 61,328
$ 33,135
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”) (also
known as, atrophic AMD). There are currently 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 in the developed world.
●
OPC1 ,
an oligodendrocyte progenitor cell therapy currently in a Phase 1/2a multicenter clinical trial for subacute 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 September 30, 2021.
Though
our principal focus is on advancing our three cell therapy programs currently in clinical development, we may seek to create additional
value by initiating new programs using existing protocols or new protocols and cell lines, or through corporate transactions, as we have
in the past.
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.
7
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.
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. 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 any 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 September 30, 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 September 30, 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.
8
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.
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 June 30, 2021, Lineage had issued 13,859,776
common shares at a weighted average price per share of $ 2.39 for gross proceeds of $ 33.1 million. For the three months ended September
30, 2021, Lineage issued an additional 1,048,959 common shares at a weighted average price per share of $ 2.62 for gross proceeds of $ 2.7
million. As of September 30, 2021, 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 under the Sales Agreement.
As
of September 30, 2021, Lineage had an accumulated deficit of approximately $ 308.1 million, working capital of $ 59.6 million and shareholders’
equity of $ 119.6 million. Lineage has evaluated its projected cash flows and believes that its $ 65.1 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.
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.
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
(see Note 15).
9
Deferred
grant revenues currently represent grant funds received from the Israel Innovation Authority (“IIA”) for the development
of Cell Cure’s OpRegen and our bio retina program, for which the allowable expenses have not yet been incurred as of the latest
balance sheet date reported. As of September 30, 2021, deferred grant revenue was $ 82,200 , primarily comprised of remaining funds most
recently received in July 2021, June 2021 and November 2020, for their respective programs.
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. For the three and nine months
ended September 30, 2021, Lineage recorded additional royalty revenues of approximately $ 1.8 million from a certain customer, based on
the customer’s updated communication to Lineage regarding royalties due. Consequently, Lineage also recorded a corresponding 50%
of these additional royalties in cost of sales, as an accrued royalty payable to a separate royalty party. As of September 30, 2021,
the $ 1.8 million is included as a receivable within prepaid expenses and other current assets. The customer paid these royalties to Lineage
in October 2021. The additional royalty revenue for certain amounts relating to prior periods was not material to Lineage’s consolidated
financial statements, taken as a whole, for any period presented.
Collaboration
Agreements
On
April 16, 2021, Lineage entered a worldwide license and development collaboration agreement 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 a novel cancer immunotherapy agent derived from this platform utilizing an antigen provided by ITI, for the
treatment of glioblastoma multiforme. 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.
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 are typically 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.
As
part of the accounting treatment for these arrangements, 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.
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.
10
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 condensed consolidated statements of operations.
As
of September 30, 2021 we had $ 856,000 of deferred revenue on the consolidated balance sheet related to the ITI collaboration agreement,
and for the three and nine months ended September 30, 2021, we recognized $ 293,000 and $ 506,000 of revenue, respectively, related to
the ITI collaboration agreement.
Basic
and diluted net 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 and nine months ended September 30, 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
Nine Months Ended
September 30, (unaudited)
2021
2020
Stock options
17,207
16,560
Lineage Warrants (1)
-
1,090
Restricted stock units
46
108
(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
September 30,
2021
December 31,
2020
(unaudited)
Cash and cash equivalents
$ 60,809
$ 32,585
Restricted cash included in deposits and other long-term assets (see Note 15)
519
520
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
$ 61,328
$ 33,183
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 did not 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.
Revenue
Our
disaggregated revenues were as follows (in thousands):
Disaggregation
of Revenue
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
Royalties
$ 1,909
$ 342
$ 2,430
$ 607
Grant revenues
Israel Innovation Authority (“IIA”)
$ 68
$ 216
$ 237
$ 477
National Institutes of Health (“NIH”)
-
13
-
387
Total grant revenues
68
229
237
864
Revenues under collaborative agreements
Upfront license fees
36
-
72
-
Event-based development milestones
72
-
72
-
Reimbursements, cost-sharing payments
185
-
362
-
Total revenues under collaborative agreements
293
-
506
-
Total revenue
$ 2,270
$ 571
$ 3,173
$ 1,471
12
During
the three months ended September 30, 2021 we recognized $ 2.3 million in total revenue. There was no revenue related to new license agreements
granted during the period. Revenues recognized during the current period which had been included in deferred revenues at December 31,
2020 were not material.
During
the nine months ended September 30, 2021 we recognized $ 3.2 million in total revenue. We recognized $ 0.5 million in revenues from new
license agreements granted in the period, which were recorded as revenues under collaboration agreements. We recognized revenue of $ 0.1
million during the period 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:
Schedule
of Contract with Customer Contract Liability and Receivable
September 30,
2021
December 31,
2020
(unaudited)
Accounts receivable and other receivable, net (1)
$ 2,122
$ 242
Deferred revenues (1)
893
-
(1) 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 September 30, 2021, the amounts in the transaction price of our contracts with customers, including collaboration partners, and allocated
good and services not yet provided were $ 3.0 million, of which $ 2.1 million relates to unfulfilled commitments and $ 0.9 million has been
collected and is reported as deferred revenues. The unfulfilled commitments are estimated to be delivered by the end of the second quarter
of 2022. Of the total deferred revenues of $ 0.9 million, substantially all is expected to be recognized within the next 12 months.
4.
Marketable Equity Securities
As
of September 30, 2021, Lineage owned approximately 1.1 million shares of OncoCyte common stock. These shares had a fair value of approximately
$ 4.0 million, based on the closing price of OncoCyte of $ 3.56 per share on September 30, 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 September 30, 2021, Lineage 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 during the quarter. For the three months ended September 30, 2020,
Lineage recorded an unrealized loss of $ 1.9 million related to changes in the fair market value of OncoCyte’s common stock price
during the quarter.
For
the nine months ended September 30, 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 $ 0.6 million related to changes in fair market value of
OncoCyte’s common stock price during the period. For the nine months ended September 30, 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 $ 6.1 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 September 30, 2021. These securities were carried at fair
market value on our consolidated balance sheets, and the accounting transactions for the three and nine months ended were not material.
For
the three and nine months ended September 30, 2021, we did not hold any marketable securities related to AgeX. For the three and nine
months ended September 30, 2020, Lineage recorded realized gains of $ 0.1 million and $ 0.7 million, respectively, due to sales of AgeX
shares in the period. For the three and nine months ended September 30, 2020, we recorded unrealized losses of $ 0.1 million and $ 1.4
million, respectively, due to changes in fair market value of AgeX’s common stock price during the period.
13
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 .
6.
Property and Equipment, Net
At
September 30, 2021 and December 31, 2020, property and equipment, net was comprised of the following (in thousands):
Schedule of Property and Equipment, Net
September 30,
2021
December 31,
2020
(unaudited)
Equipment, furniture and fixtures
$ 3,626
$ 3,628
Leasehold improvements
2,462
2,472
Right-of-use assets
3,833
3,845
Accumulated depreciation and amortization
( 5,193 )
( 4,315 )
Property and equipment, net
$ 4,728
$ 5,630
Property
and equipment at September 30, 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 $ 165,000 and $ 200,000 for the three months ended September 30, 2021 and 2020, and $ 504,000 and $ 623,000
for the nine months ended September 30, 2021 and 2020, respectively. During the nine months ended September 30, 2021, Lineage sold non-capitalized
assets for a net gain of $ 30,000 , which was included in research and development expenses on the condensed consolidated statements of
operations. During the nine months ended September 30, 2021, Lineage sold equipment with a net book value of $ 9,000 and recognized a
gain of $ 5,000 .
During
the three and nine months ended September 30, 2020, Lineage sold equipment with a net book value of $ 39,000 and $ 52,000 , respectively,
and recognized losses of $ 32,000 and $ 34,000 , respectively. During the nine months ended September 30, 2020, Lineage sold non-capitalized
assets for a net gain of $ 67,000 , which was included in research and development expenses on the condensed consolidated statements of
operations.
14
7.
Goodwill and Intangible Assets, Net
At
September 30, 2021 and December 31, 2020, goodwill and intangible assets, net consisted of the following (in thousands):
Schedule of Goodwill and Intangible Assets, Net
September 30,
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 (3)
650
650
Total intangible assets
66,143
66,143
Accumulated amortization (4)
( 19,289 )
( 19,111 )
Intangible assets, net
$ 46,854
$ 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 in-process research and development (“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 VAC2 program, these patents are
considered to be separate long-lived intangible assets under ASC 805.
(4)
As
of September 30, 2021 the acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance
of $ 314,000 .
Amortization
expenses was $ 33,000 and $ 250,000 for the three months ended September 30, 2021 and 2020, and $ 178,000 and $ 1,080,000 for the nine months
ended September 30, 2021, and 2020, respectively.
Future
aggregate approximate amortization expense for the Company’s intangible assets are as follows (in thousands):
Schedule
of Intangible Assets Future Amortization Expense
Year Ending December 31,
2021
$ 32
2022
130
2023
130
2024
22
2025
-
Thereafter
-
Total
$ 314
15
8.
Accounts Payable and Accrued Liabilities
At
September 30, 2021 and December 31, 2020, accounts payable and accrued liabilities consisted of the following (in thousands):
Schedule of Accounts Payable and Accrued Liabilities
September 30,
2021
December 31,
2020
(unaudited)
Accounts payable
$ 3,457
$ 2,611
Accrued compensation
1,639
1,959
Accrued liabilities
1,540
1,711
PPP loan payable
-
523
Other current liabilities
69
9
Total
$ 6,705
$ 6,813
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 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 condensed 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.
We
measure cash and 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 September 30, 2021 and December 31, 2020 (in thousands):
16
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis
Fair Value Measurements Using
Balance at
September 30,
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
$ 60,809
$ 60,809
$ -
$ -
Marketable equity securities
4,295
4,295
-
-
Liabilities:
Cell Cure Warrants
332
-
-
332
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 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.
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 and Other Adjustments of Warrants
(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
( 105 )
-
( 105 )
Expiration of warrants
-
( 1 )
( 1 )
Balance as of September 30, 2021
$ 332
$ -
$ 332
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.
17
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 September
30, 2021, Lineage has incurred a total of $ 657,000 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 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 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
September 30, 2021, Lineage was authorized to issue 250,000,000 common shares, no par value. As of September 30, 2021, and December 31,
2020, Lineage had 168,465,000 and 153,095,883 issued and outstanding common shares, respectively.
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 $ 25.0 million. 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. 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 June 30, 2021, Lineage had issued 13,859,776 common shares
at a weighted average price per share of $ 2.39 for gross proceeds of $ 33.1 million. For the three months ended September 30, 2021, Lineage
issued an additional 1,048,959 common shares at a weighted average price per share of $ 2.62 for gross proceeds of $ 2.7 million. As of
September 30, 2021, 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 under the 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.
18
Reconciliation
of Changes in Shareholders’ Equity
The
following tables document the changes in shareholders’ equity for the three and nine months ended September 30, 2021 and 2020 (unaudited
and in thousands):
Schedule of Shareholders' Equity
of Shares
Amount
of Shares
Amount
Deficit
(Deficit)
Income/(Loss)
Equity
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
Shares issues for retirement of stock warrants
Shares issues for retirement of stock warrants, shares
Dissolution of BioTime Asia
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
Shares issued through ATM
-
-
2,824
7,874
-
-
-
7,874
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
10
( 15 )
-
-
-
( 15 )
Shares issued upon exercise of stock options
-
-
2,116
4,033
-
-
-
4,033
Financing related fees
-
-
-
( 26 )
-
-
-
( 26 )
Stock-based compensation
-
-
-
919
-
-
-
919
Shares issues for retirement of stock warrants
-
-
20
2
2
Foreign currency translation loss
-
-
-
-
-
-
( 960 )
( 960 )
NET LOSS
-
-
-
-
( 4,788 )
( 8 )
-
( 4,796 )
BALANCE AT JUNE 30, 2021
-
$ -
167,037
$ 428,046
$ ( 300,282 )
$ ( 1,112 )
$ ( 3,051 )
$ 123,601
Shares issued through ATM
-
-
1,049
2,667
-
-
-
2,667
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
10
( 13 )
-
-
-
( 13 )
Shares issued upon exercise of stock options
-
-
369
485
-
-
-
485
Financing related fees
-
-
-
( 79 )
-
-
-
( 79 )
Stock-based compensation
-
-
-
1,144
-
-
-
1,144
Foreign currency translation loss
-
-
-
-
-
-
( 382 )
( 382 )
NET LOSS
-
-
-
-
( 7,823 )
( 11 )
-
( 7,834 )
BALANCE AT SEPTEMBER 30, 2021
-
$ -
168,465
$ 432,250
$ ( 308,105 )
$ ( 1,123 )
$ ( 3,433 )
$ 119,589
19
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
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
13
( 11 )
-
-
-
( 11 )
Stock-based compensation
-
-
-
606
-
-
-
606
Financing related fees
-
-
-
( 10 )
-
-
-
( 10 )
Foreign currency translation loss
-
-
-
-
-
-
( 1,120 )
( 1,120 )
NET LOSS
-
-
-
-
( 6,522 )
( 8 )
-
( 6,530 )
BALANCE AT JUNE 30, 2020
-
$ -
149,831
$ 388,271
$ ( 288,343 )
$ ( 1,749 )
$ ( 486 )
$ 97,693
Beginning balance
-
$ -
149,831
$ 388,271
$ ( 288,343 )
$ ( 1,749 )
$ ( 486 )
$ 97,693
Shares issued upon vesting of restricted stock units, net of shares retired to pay employees’ taxes
-
-
10
( 6 )
-
-
-
( 6 )
Shares issued for services
-
-
150
119
-
-
-
119
Dissolution of BioTime Asia
-
-
-
( 679 )
-
679
-
-
Stock-based compensation
-
-
-
501
-
-
-
501
Financing related fees
-
-
-
( 16 )
-
-
-
( 16 )
Foreign currency translation loss
-
-
-
-
-
-
( 335 )
( 335 )
Foreign currency translation gain (loss)
-
-
-
-
-
-
( 335
( 335
NET LOSS
-
-
-
-
( 7,760 )
( 12 )
-
( 7,772 )
BALANCE AT SEPTEMBER 30, 2020
-
$ -
149,991
$ 388,190
$ ( 296,103 )
$ ( 1,082 )
$ ( 821 )
$ 90,184
Ending balance
-
$ -
149,991
$ 388,190
$ ( 296,103 )
$ ( 1,082 )
$ ( 821 )
$ 90,184
20
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”). 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 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 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
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 September 30, 2021, there were no outstanding equity awards issued under the 2021 Plan.
A
summary of Lineage’s 2012 Equity Incentive 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, 2020
15,865
93
$ 1.57
Restricted stock units vested
-
( 47 )
-
Options granted
6,245
-
2.50
Options exercised
( 3,427 )
-
1.83
Options expired/forfeited/cancelled
( 1,826 )
-
2.18
September 30, 2021
16,857
46
$ 1.80
Options exercisable at September 30, 2021
6,806
$ 1.66
At
the effective time of the Asterias Merger, Lineage assumed sponsorship of the Asterias 2013 Equity Incentive Plan, with references to
Asterias and Asterias common stock therein to be deemed references to Lineage and Lineage common shares.
21
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
Number
of Options
Outstanding
Weighted
Average
Exercise Price
December 31, 2020
350
$ 1.57
Options granted
-
-
Options exercised
-
-
Options forfeited
-
September 30, 2021
350
$ 1.57
Options exercisable at September 30, 2021
219
$ 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
Nine Months Ended
September 30, (unaudited)
2021
2020
Expected life (in years)
6.19
6.21
Risk-free interest rates
1.05 %
0.8 %
Volatility
73.2 %
67.7 %
Dividend yield
- %
- %
Operating
expenses include stock-based compensation expense as follows (in thousands):
Schedule
of Stock Based Compensation Expense
Three Months Ended
September 30, (unaudited)
Nine Months Ended
September 30, (unaudited)
2021
2020
2021
2020
Research and development
$ 235
$ 126
$ 613
$ 343
General and administrative
909
375
1,988
1,390
Total stock-based compensation expense
$ 1,144
$ 501
$ 2,601
$ 1,733
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 September 30, 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 September 30, 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.
22
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.
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 and nine months ended September 30, 2021, Lineage recorded a $ 1.0 million and $ 1.2 million deferred tax benefit, respectively,
that was primarily related to federal net operating losses generated for the three and nine months ended September 30, 2021, which was
available and indefinite in nature.
For
the three and nine months ended September 30, 2020, Lineage recorded a $ 0.2 million deferred tax benefit for income taxes.
14.
Supplemental Cash Flow Information
Supplemental
disclosure of cash flow information for the nine months ended September 30, 2021 and 2020 is as follows (in thousands):
Schedule
of Supplemental Cash Flow Information
Nine Months Ended
September 30, (unaudited)
2021
2020
Cash paid during period for interest
$ 12
$ 19
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, 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 .
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 $ 72,676
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.
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 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).
24
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 September 30, 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
2021
2020
Nine Months Ended
September 30,
2021
2020
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$ 687
$ 1,157
Operating cash flows from financing leases
12
19
Financing cash flows from financing leases
13
24
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
32
29
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
September 30,
2021
December 31,
2020
Operating leases
Right-of-use assets, net
$ 2,327
$ 2,916
Lease liabilities, current
$ 801
$ 746
Lease liabilities, noncurrent
1,887
2,514
Total operating lease liabilities
$ 2,688
$ 3,260
Financing leases
Property and equipment, gross
$ 79
$ 79
Accumulated depreciation
( 76 )
( 65 )
Property and equipment, net
$ 3
$ 14
Current liabilities
$ 17
$ 16
Long-term liabilities
12
26
Total finance lease liabilities
$ 29
$ 42
Weighted average remaining lease term
Operating leases
3.7 years
4.2 years
Finance leases
1.7 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 September 30, 2021 (in thousands):
Schedule
of Future Minimum Lease Commitments
Operating Leases
Finance Leases
Year Ending December 31,
2021
$ 248
$ 5
2022
913
19
2023
489
8
2024
460
-
2025
442
-
Thereafter
586
-
Total lease payments
$ 3,138
$ 32
Less imputed interest
( 450 )
( 3 )
Total
$ 2,688
$ 29
25
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
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.
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. Lineage believed that the claims and allegations in the action lacked 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. The court granted the stipulation and dismissed the action on August
14, 2019.
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. The parties are
currently engaged in discovery. A five-day trial before the Chancery Court is currently scheduled for October 17-21, 2022.
26
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 September 30, 2021 and December 31, 2020.
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.
27
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 September 30, 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.
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.
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 interest rate benchmark. 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, 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 additional payment obligations in the event
of any transfer outside of Israel of intellectual property related to, or the manufacture, or both, of products developed under the grant,
as defined by the IIA.
Collaboration
Agreements
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 $ 2.5 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.
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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.