UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
OR
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from _________ to ________
Commission
file number 001-12830
Lineage
Cell Therapeutics, Inc.
(Exact
name of registrant as specified in its charter)
California
94-3127919
(State
or other jurisdiction of
incorporation
or organization)
(IRS
Employer
Identification
No.)
2173
Salk Avenue , Suite 200
Carlsbad ,
California 92008
(Address
of principal executive offices) (Zip code)
(Registrant’s
telephone number, including area code) ( 442 ) 287-8990
Securities
registered pursuant to Section 12(b) of the Act
Title
of each class
Trading
Symbol
Name
of exchange on which registered
Common
shares no par value
LCTX
NYSE
American
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). ☒ Yes ☐ No
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No
The
number of common shares outstanding as of August 4, 2023 was 174,986,671 .
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are subject to substantial risks and uncertainties.
The forward-looking statements are contained principally in Part I, Item 2. “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” of this report, but are also continued elsewhere in this report. We make such forward-looking
statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities
laws. All statements other than statements of historical facts contained in this report are forward-looking statements. In some cases,
you can identify forward-looking statements by the words “may,” “might,” “will,” “could,”
“would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,”
“believe,” “estimate,” “predict,” “project,” “potential,” “continue”
and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the
future. Forward-looking statements in this report include, but are not limited to, statements about:
●
the
potential to receive developmental, regulatory, and commercialization milestone and royalty payments under our Collaboration and
License Agreement with F. Hoffmann-La Roche Ltd and Genentech, Inc.;
●
our
plans to research, develop and commercialize our product candidates;
●
the
initiation, progress, success, cost and timing of our clinical trials and other product development activities;
●
the
therapeutic potential of our product candidates, and the indications for which we intend to develop our product candidates;
●
our
ability to successfully manufacture our product candidates for clinical development and, if approved, for commercialization, and
the timing and costs of such manufacture;
●
the
potential of our cell therapy platform;
●
our
expectations and plans regarding existing and potential future collaborations with third parties such as pharmaceutical and biotechnology
companies, government agencies, academic laboratories, and research institutes for the discovery, development, and/or commercialization
of novel cell therapy products;
●
the
size and growth of the potential markets for our product candidates and our ability to serve those markets;
●
the
potential scope and value of our intellectual property rights; and
●
the
effects on our operations of pandemics, including the recent COVID-19 pandemic, geopolitical conflicts, political and economic
instability, and rising inflation and interest rates.
2 | Page
Forward-looking
statements reflect our views and expectations as of the date of this report about future events and our future performance and condition,
and involve known and unknown risks, uncertainties and other factors that may cause our actual activities, performance, results or condition
to be materially different from those expressed or implied by the forward-looking statements. You should refer to “Item 1A. Risk
Factors” in Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 10-K”)
as filed with the Securities and Exchange Commission on March 9, 2023, for a discussion of important factors that may cause our actual
activities, performance, results and condition to differ materially from those expressed or implied by our forward-looking statements.
As a result of a variety of factors, including those discussed in Part I, Item 1A of the 2022 10-K, our forward-looking statements may
prove to be inaccurate, and the inaccuracy may be material. Accordingly, you should not place undue reliance on any forward-looking statement.
We anticipate that subsequent events and developments may cause our current views and expectations to change. However, while we may elect
to update the forward-looking statements in this report at some point in the future, we undertake no obligation to publicly update any
forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You should,
therefore, not rely on these forward-looking statements as representing our views as of any date after the date of this report.
You
should read this report completely and with the understanding that our actual future performance, results and condition may be materially
different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.
MARKET
DATA AND TRADEMARKS
This
report may also contain market data, industry forecasts and other data made by independent parties and by us relating to market size
and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to
give undue weight to such data. In addition, projections, assumptions and estimates of our future performance and the future performance
of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.
All
brand names or trademarks appearing in this report are the property of their respective owners. Solely for convenience, the trademarks
and trade names in this report are referred to without the symbols ® and TM, but such references should not be construed as any indication
that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.
******
Unless
otherwise stated or the context requires otherwise, references in this report to “Lineage,” the “Company,” “our
company,” “we,” “us,” and “our” refer collectively to Lineage Cell Therapeutics, Inc. and its
consolidated subsidiaries.
3 | Page
PART
I – FINANCIAL INFORMATION
Item
1. Financial Statements
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
June 30, 2023
December 31,
(Unaudited)
2022
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$ 33,886
$ 11,355
Marketable securities
12,039
46,520
Accounts receivable, net (Note 3)
443
297
Prepaid expenses and other current assets
2,123
1,828
Total current assets
48,491
60,000
NONCURRENT ASSETS
Property and equipment, net (Notes 6 and 14)
5,310
5,673
Deposits and other long-term assets
588
627
Goodwill
10,672
10,672
Intangible assets, net
46,627
46,692
TOTAL ASSETS
$ 111,688
$ 123,664
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities
$ 4,685
$ 8,608
Lease liabilities, current portion (Note 14)
933
916
Financing lease, current portion (Note 14)
54
36
Deferred revenues (Note 3)
10,379
9,421
Other current liabilities
1
-
Total current liabilities
16,052
18,981
LONG-TERM LIABILITIES
Deferred tax liability
273
2,076
Deferred revenues, net of current portion (Note 3)
21,688
27,725
Lease liability, net of current portion (Note 14)
2,304
2,860
Financing lease, net of current portion (Note 14)
113
84
Other long-term liabilities
-
2
TOTAL LIABILITIES
40,430
51,728
Commitments and contingencies (Note 14)
-
-
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized 2,000 shares; none issued and
outstanding as of June 30, 2023 and December 31, 2022
-
-
Common shares, no par value, 250,000 shares authorized; 174,439 and
170,093 shares issued and outstanding as of June 30, 2023 and
December 31, 2022, respectively
448,249
440,280
Accumulated other comprehensive loss
( 2,611 )
( 3,571 )
Accumulated deficit
( 372,971 )
( 363,370 )
Lineage Cell Therapeutics, Inc. shareholders’ equity
72,667
73,339
Noncontrolling deficit
( 1,409 )
( 1,403 )
Total shareholders’ equity
71,258
71,936
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 111,688
$ 123,664
See
accompanying notes to the condensed consolidated interim financial statements.
4 | Page
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN
THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
2023
2022
2023
2022
Three Months ended June 30,
Six Months ended June 30,
2023
2022
2023
2022
REVENUES:
Collaboration revenues
$ 2,871
$ 4,148
$ 4,992
$ 9,013
Royalties and license fees
354
405
619
777
Total revenues
3,225
4,553
5,611
9,790
Cost of sales
( 127 )
( 215 )
( 246 )
( 391 )
Gross profit
3,098
4,338
5,365
9,399
OPERATING EXPENSES:
Research and development
3,873
3,302
8,058
6,290
General and administrative
4,249
5,270
8,973
13,739
Total operating expenses
8,122
8,572
17,031
20,029
Loss from operations
( 5,024 )
( 4,234 )
( 11,666 )
( 10,630 )
OTHER INCOME (EXPENSES):
Interest income, net
382
51
792
51
Unrealized loss on marketable equity securities, net
( 150 )
( 709 )
( 110 )
( 1,444 )
Gain on revaluation of warrant liability
-
2
1
223
Other expenses, net
( 411 )
( 1,892 )
( 427 )
( 2,075 )
Total other income (expenses), net
( 179 )
( 2,548 )
256
( 3,245 )
LOSS BEFORE INCOME TAXES
( 5,203 )
( 6,782 )
( 11,410 )
( 13,875 )
Deferred income tax benefit
-
-
1,803
-
NET LOSS
( 5,203 )
( 6,782 )
( 9,607 )
( 13,875 )
Net (income) loss attributable to noncontrolling interest
( 26 )
19
6
25
NET LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC.
$ ( 5,229 )
$ ( 6,763 )
$ ( 9,601 )
$ ( 13,850 )
NET LOSS PER COMMON SHARE:
BASIC
$ ( 0.03 )
$ ( 0.04 )
$ ( 0.06 )
$ ( 0.08 )
DILUTED
$ ( 0.03 )
$ ( 0.04 )
$ ( 0.06 )
$ ( 0.08 )
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:
BASIC
170,592
169,731
170,361
169,689
DILUTED
170,592
169,731
170,361
169,689
See
accompanying notes to the condensed consolidated interim financial statements.
5 | Page
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(IN
THOUSANDS)
(UNAUDITED)
2023
2022
2023
2022
Three Months ended June 30,
Six Months ended June 30,
2023
2022
2023
2022
NET LOSS
$ ( 5,203 )
$ ( 6,782 )
$ ( 9,607 )
$ ( 13,875 )
Other comprehensive income, net of tax:
Foreign currency translation adjustment
446
1,730
819
1,854
Unrealized gain on marketable debt securities
50
-
141
-
COMPREHENSIVE LOSS
( 4,707 )
( 5,052 )
( 8,647 )
( 12,021 )
Less: Comprehensive (income) loss attributable to noncontrolling interest
( 26 )
19
6
25
COMPREHENSIVE LOSS ATTRIBUTABLE TO LINEAGE COMMON SHAREHOLDERS
$ ( 4,733 )
$ ( 5,033 )
$ ( 8,641 )
$ ( 11,996 )
See
accompanying notes to the condensed consolidated interim financial statements.
6 | Page
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN
THOUSANDS)
(UNAUDITED)
2023
2022
Six Months ended June 30,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss attributable to Lineage Cell Therapeutics, Inc.
$ ( 9,601 )
$ ( 13,850 )
Net loss allocable to noncontrolling interest
( 6 )
( 25 )
Adjustments to reconcile net loss attributable to Lineage Cell Therapeutics, Inc. to net cash (used in) provided by operating activities:
Accretion of income on marketable debt securities
( 516 )
-
Unrealized loss on marketable equity securities, net
110
1,444
Depreciation expense, including amortization of leasehold improvements
276
296
Change in right-of-use assets and liabilities
81
( 7 )
Amortization of intangible assets
65
65
Stock-based compensation
2,311
2,341
Gain on revaluation of warrant liability
( 1 )
( 223 )
Deferred income tax benefit
( 1,803 )
-
Foreign currency remeasurement and other gain
1,012
2,331
Changes in operating assets and liabilities:
Accounts receivable, net (Note 3)
( 147 )
50,111
Prepaid expenses and other current assets
( 270 )
594
Accounts payable and accrued liabilities (Note 7)
( 3,941 )
( 19,230 )
Deferred revenue and other liabilities (Note 3)
( 5,080 )
( 9,005 )
Net cash (used in) provided by operating activities
( 17,510 )
14,842
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of marketable debt securities
( 12,635 )
-
Maturities of marketable debt securities
47,664
-
Purchase of equipment and other assets, net
( 444 )
( 143 )
Net cash provided by (used in) investing activities
34,585
( 143 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from employee options exercised
80
388
Common shares received and retired for employee taxes paid
( 37 )
( 17 )
Proceeds from exercise of subsidiary warrants, net
-
99
Proceeds from sale of common shares
5,789
148
Payments for offering costs
( 174 )
( 57 )
Repayment of financing lease liability
( 29 )
( 15 )
Net cash provided by financing activities
5,629
546
Effect of exchange rate changes on cash, cash equivalents and restricted cash
( 192 )
( 161 )
NET INCREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
22,512
15,084
CASH, CASH EQUIVALENTS AND RESTRICTED CASH:
At beginning of the period
11,936
56,277
At end of the period
$ 34,448
$ 71,361
Reconciliation of cash, cash equivalents and restricted cash, end of period:
Cash and cash equivalents
$ 33,886
$ 70,857
Restricted cash included in deposits and other long-term assets (see Note 14 (Commitments and Contingencies))
562
504
Total cash, cash equivalents, and restricted cash
$ 34,448
$ 71,361
See
accompanying notes to the condensed consolidated interim financial statements.
7 | Page
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
NOTES
TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
1.
Organization and Business Overview
We
are a clinical-stage biotechnology company developing novel allogeneic cell therapies to address unmet medical needs. Our programs are
based on our proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform,
we design, develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or identical to
cells found naturally in the human body. The cells we manufacture are created by applying developmental biological differentiation protocols
to established, well-characterized, and self-renewing pluripotent cell lines. These cells are transplanted into patients and are designed
to (a) replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and (b) restore
or augment the patient’s functional activity.
Our
strategy is to efficiently leverage our technology platform and our development, formulation, delivery, and manufacturing capabilities
to advance our programs internally or in conjunction with strategic partners to further enhance their value and probability of success.
As one example, in December 2021 we entered into a Collaboration and License Agreement (the “Roche Agreement”) with F. Hoffmann-La
Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”),
wherein we granted to Roche exclusive worldwide rights to develop and commercialize retinal pigment epithelium (“RPE”) cell
therapies, including our proprietary cell therapy program known as OpRegen ® , for the treatment of ocular disorders, including
geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Under the terms of the Roche Agreement, Lineage received
a $ 50.0 million upfront payment and is eligible to receive up to $ 620.0 million in certain developmental, regulatory, and commercialization
milestone payments. Lineage also is eligible to receive tiered double-digit percentage royalties on net sales of OpRegen in the U.S.
and other major markets. See Note 14 (Commitments and Contingencies) for additional information regarding the Roche Agreement.
As
of June 30, 2023, we have five allogeneic, or “off-the-shelf,” cell therapy programs in development, of which three have
reached human clinical testing:
Product
Candidates
●
OpRegen ® ,
an allogeneic RPE cell replacement therapy currently in a Phase 2a multicenter clinical trial, being conducted by Roche, for the
treatment of GA secondary to AMD, also known as atrophic or dry AMD. A previous Phase 1/2a trial we conducted enrolled individuals
with dry AMD with GA. In December 2021, this program was partnered with Roche for further clinical development and commercialization.
●
OPC1 ,
an allogeneic oligodendrocyte progenitor cell therapy currently in long-term follow-up from a Phase 1/2a multicenter clinical trial
for cervical spinal cord injuries (“SCI”). To date, five patients with thoracic spinal cord injuries and 25 patients
with cervical SCI have been enrolled in clinical trials of OPC1. We recently received a response from the U.S. Food and Drug
Administration to our Type B meeting submission which will help guide our next regulatory interactions. The clinical development of
OPC1 has been partially funded by $ 14.3
million received under a grant from the California Institute for Regenerative Medicine (“CIRM”). Additional clinical
trials are being planned.
●
ANP1 ,
an allogeneic auditory neuron progenitor cell transplant currently in preclinical development
for the treatment of debilitating hearing loss (“DHL”).
●
PNC1,
an allogeneic photoreceptor cell transplant currently in preclinical development for the treatment of vision loss due to photoreceptor
dysfunction or damage.
●
VAC ,
an allogeneic cancer immunotherapy comprised of antigen-presenting dendritic cells. A Phase 1 clinical trial in non-small cell lung
cancer (“NSCLC”) of one of the VAC product candidates, VAC2, was recently completed. This clinical trial was funded and
conducted by Cancer Research UK (“CRUK”), one of the world’s largest independent cancer research charities. Another
VAC-based product candidate is in preclinical development with our partner, Immunomic Therapeutics, Inc. (“ITI”), for
the treatment of glioblastoma multiforme (“GBM”).
8 | Page
Other
Programs
We
have additional undisclosed product candidates being considered for development covering a range of therapeutic areas and unmet medical
needs. Generally, these product candidates are based on the same platform technology and employ a similar guided cell differentiation
and transplant approach as the product candidates described above, but in some cases may also include genetic modifications designed
to enhance efficacy and/or safety profiles.
In
addition to seeking to create value for shareholders by developing product candidates and advancing those candidates through clinical
development, we also may seek to create value from our intellectual property and additional related technologies and capabilities, through
partnering and/or strategic transactions.
2.
Basis of Presentation, Liquidity and Summary of Significant Accounting Policies
The
accompanying unaudited condensed consolidated interim financial statements were 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, 2022 was derived from the audited consolidated financial statements at that date but does not include all the information and footnotes
required by GAAP. These unaudited condensed consolidated interim financial statements should be read in conjunction with the audited
consolidated financial statements and notes thereto included in the 2022 10-K.
The
accompanying unaudited 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 our financial condition and results of operations. The condensed
consolidated results of operations are not necessarily indicative of the results to be expected for any other interim period or for the
entire year.
Principles
of consolidation
The
accompanying unaudited condensed consolidated interim financial statements include the accounts of our subsidiaries. All material intercompany
accounts and transactions have been eliminated in consolidation. The following table sets out Lineage’s ownership, directly or
indirectly, of the outstanding shares of its subsidiaries as of June 30, 2023.
Schedule
of Lineage’s Ownership of Outstanding Shares of its Subsidiaries
Subsidiary
Field of Business
Lineage
Ownership
Country
Cell Cure Neurosciences Ltd.
Manufacturing of Lineage’s product candidates
94 % (1) (2)
Israel
ES Cell International Pte. Ltd.
Research and clinical grade cell lines
100 %
Singapore
(1)
Includes
shares owned by Lineage and ES Cell International Pte. Ltd.
(2)
As
of December 31, 2021 our ownership percentage of Cell Cure Neurosciences Ltd. (“Cell Cure”) was approximately 99 %. In
July 2022, Hadasit Bio-Holdings Ltd exercised warrants to purchase 21,999 ordinary shares of Cell Cure. Lineage’s ownership
percentage of Cell Cure decreased as a result.
As
of June 30, 2023, 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 condensed consolidated balance sheets.
9 | Page
Liquidity
At
June 30, 2023, we had $ 45.9 million of cash, cash equivalents and marketable securities. Based on our current operating plan, we believe
that our cash, cash equivalents and marketable securities, together with our projected cash flows, will be sufficient to enable us to
carry out our planned operations through at least twelve months from the issuance date of the accompanying condensed consolidated interim
financial statements.
Capital
Resources
Since
inception we have incurred significant operating losses and have funded our operations primarily through the issuance of equity securities,
the sale of common stock of our former subsidiaries, OncoCyte and AgeX, receipt of proceeds from research grants, revenues from collaborations,
royalties from product sales, and sales of research products and services.
As
of June 30, 2023, $ 58.0 million remained available for sale under our at the market offering program (“ATM”). See Note 11
(Shareholders’ Equity) for additional information.
We
may use our marketable securities for liquidity as necessary and as market conditions allow. The market value of our marketable securities
may not represent the amount that could be realized in a sale of such securities due to various market and regulatory factors, including
trading volume, prevailing market conditions and prices at the time of any sale and subsequent sales of securities by the entities. In
addition, the value of our marketable securities may be significantly and adversely impacted by deteriorating global economic conditions
and the recent disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from the
recent pandemics, including the COVID-19 pandemic, geopolitical conflicts, rising inflation and interest rates, and other macroeconomic
factors.
Additional
Capital Requirements
Our
financial obligations primarily consist of obligations to licensors under license agreements, obligations related to grants received
from government entities, including the Israel Innovation Authority (“IIA”), obligations under contracts with vendors who
provide research services and purchase commitments with suppliers.
Our
obligations to licensors under license agreements and our obligations related to grants received from government entities require us
to make future payments, such as sublicense fees, milestone payments, redemption fees, royalties and patent maintenance costs. Sublicense
fees are payable to licensors or government entities when we sublicense the applicable intellectual property to third parties; the fees
are based on a percentage of the license fees we receive from sublicensees. Milestone payments, including those related to the Roche
Agreement, are due to licensors or government entities upon achievement of commercial, development and regulatory milestones. Redemption
fees due to the IIA under the Innovation Law are due upon receipt of milestone payments and royalties received under the Roche Agreement.
See Note 14 (Commitment and Contingencies) for additional information. Royalties, including those related to royalties we may receive
under the Roche Agreement, are payable to licensors or government entities based on a percentage of net sales of licensed products. Patent
maintenance costs are payable to licensors as reimbursement for the cost of maintaining license patents. Due to the contingent nature
of the payments, the amounts and timing of payments to licensors under our in-license agreements are uncertain and may fluctuate significantly
from period to period. As of June 30, 2023, we have not included these commitments on our condensed consolidated balance sheet because
the achievement of events that would trigger our payment obligations and the timing thereof are not fixed and determinable.
In
the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations
and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination
based on the timing of termination and the terms of the agreement. The amounts and timing of payments under these agreements are uncertain
and contingent upon the initiation and completion of the services to be provided.
10 | Page
Significant
Accounting Policies
We
describe our significant accounting policies in Note 2 to the consolidated financial statements in Item 8 of the 2022 10-K. There have
been no changes to our significant accounting policies during the six months ended June 30, 2023.
Recently
Issued and Recently Adopted Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. The Company has evaluated recently issued accounting
pronouncements and does not believe any will have a material impact on the Company’s condensed consolidated financial statements
or related financial statement disclosures.
3.
Revenue
Our
disaggregated revenues were as follows for the periods presented (in thousands):
Schedule
of Disaggregated Revenues
2023
2022
2023
2022
Three Months ended June 30,
Six Months ended June 30,
2023
2022
2023
2022
Royalties and license fees
$ 354
$ 405
$ 619
$ 777
Revenues under collaborative agreements
Upfront license fees
$ 2,871
$ 4,148
$ 4,992
$ 9,013
Total revenues under collaborative agreements
$ 2,871
$ 4,148
$ 4,992
$ 9,013
Total revenue
$ 3,225
$ 4,553
$ 5,611
$ 9,790
During
the three and six months ended June 30, 2023, we recognized $ 3.2 million and $ 5.6 million in total revenue, respectively, of which $ 2.9
million and $ 5.0 million, respectively, was recognized in collaboration revenues related to the $ 50.0 million upfront payment from Roche,
which was included in deferred revenues at December 31, 2022.
During
the three and six months ended June 30, 2022, we recognized $ 4.6 million and $ 9.8 million in total revenue, respectively, of which $ 4.1
million and $ 9.0 million, respectively, was recognized in collaboration revenues related to the $ 50.0 million upfront payment from Roche, which was
included in deferred revenues at December 31, 2021.
We
are recognizing the $ 50.0 million upfront payment under the Roche Agreement utilizing an input method of costs incurred over total estimated
costs to be incurred. At each reporting period, we update our total estimated collaboration costs, and any resulting adjustments are
recorded on a cumulative basis which would affect revenue and net income (loss) in the period of adjustment. We believe the input methodology
represents the most appropriate measure of progress towards satisfaction of the identified performance obligations.
Accounts
receivable, net, and deferred revenues (contract liabilities) from contracts with customers, including collaboration partners, consisted
of the following (in thousands):
Schedule of Contract with Customer Contract Liability and Receivable
June 30,
2023
December 31, 2022
Accounts receivable, net (1)
$ 406
$ 297
Deferred revenues
32,067
37,146
(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).
11 | Page
As
of June 30, 2023, the amounts included in the transaction price of our contracts with customers (ASU 2014-09 – Revenue from
Contracts with Customers (Topic 606)), including collaboration partners, and allocated goods and services not yet provided were $ 33.7
million, of which $ 32.1 million has been collected and is reported as deferred revenues, and $ 1.6 million relates to unfulfilled commitments
related to the ITI collaboration (see Note 14 (Commitments and Contingencies) for additional information), the latter is currently estimated
to be delivered by the end of the second quarter of 2024. Of the total deferred revenues of $ 32.1 million, approximately $ 10.4 million
is expected to be recognized within the next 12 months.
4.
Marketable Debt Securities
The
following tables are a summary of available-for-sale debt securities in cash and cash equivalents or marketable securities in the Company’s
condensed consolidated balance sheet as of June 30, 2023 and December 31, 2022 (in thousands):
Summary
of Available for Sale Debt Securities
June 30, 2023 (Unaudited)
Financial Assets:
Amortized Cost
Unrealized Gaines
Unrealized Losses
Fair Value
U.S. Treasury securities
$ 11,735
$ -
$ ( 8 )
$ 11,727
Total
$ 11,735
$ -
$ ( 8 )
$ 11,727
December 31, 2022
Financial Assets:
Amortized Cost
Unrealized Gaines
Unrealized Losses
Fair Value
U.S. Treasury securities
$ 46,247
$ 2
$ ( 152 )
$ 46,097
Total
$ 46,247
$ 2
$ ( 152 )
$ 46,097
The
Company has not recognized an allowance for credit losses on any securities in an unrealized loss position as of June 30, 2023. We believe
that the individual unrealized losses represent temporary declines resulting from changes in interest rates, and we intend to hold these
marketable securities to their maturity. The Company currently does not intend to sell these securities prior to maturity and does not
consider these investments to be other-than-temporarily impaired at June 30, 2023.
As
of June 30, 2023, the amortized cost and estimated fair value of the Company’s available-for-sale debt securities by contractual
maturity are shown below (in thousands):
Schedule
of Amortized cost And Estimated fair Value
Available-for-sale debt securities maturing:
Amortized Cost
Estimated Fair Value
In one year or less
$ 11,735
$ 11,727
Total available-for-sale debt securities
$ 11,735
$ 11,727
We
did not have any marketable debt securities classified as cash equivalents on the condensed consolidated balance sheets as of June 30,
2023 or December 31, 2022.
5.
Marketable Equity Securities
As
of June 30, 2023, Lineage owned 1.1 million shares of OncoCyte common stock, which had a fair value of $ 0.3 million as of that date,
based on the closing price of OncoCyte common stock of $ 0.23 per share on that date.
As
of December 31, 2022, Lineage owned 1.1 million shares of OncoCyte common stock, which had a fair value of $ 0.4 million as of that date,
based on the closing price of OncoCyte common stock of $ 0.32 per share on that date.
For
the three and six months ended June 30, 2023, Lineage recorded a net unrealized loss on marketable equity securities of $ 150,000 and
$ 110,000 , respectively, primarily related to changes in the fair market value of OncoCyte common stock price during the respective periods.
12 | Page
For
the three and six months ended June 30, 2022, Lineage recorded a net unrealized loss on marketable equity securities of $ 0.7 million
and $ 1.4 million, respectively, related to changes in the fair market value of OncoCyte’s common stock price during the respective
periods.
All
share prices are determined based on the closing price of OncoCyte common stock on the last day of the applicable quarter, or the last
trading day of the applicable quarter, if the last day of a quarter fell on a day that was not a trading day.
6.
Property and Equipment, Net
At
June 30, 2023 and December 31, 2022 property and equipment, net was comprised of the following (in thousands):
Schedule of Property and Equipment, Net
June 30, 2023
December 31,
(Unaudited)
2022
Equipment, furniture and fixtures
$ 3,421
$ 3,264
Leasehold improvements
2,266
2,150
Right-of-use assets
6,006
6,109
Accumulated depreciation and amortization
( 6,383 )
( 5,850 )
Property and equipment, net
$ 5,310
$ 5,673
Property
and equipment for financing leases was $ 196,000 and $ 121,000 on June 30, 2023 and December 31, 2022, respectively.
Depreciation
and amortization expense was $ 138,000 and $ 146,000 for the three months ended June 30, 2023 and 2022, respectively, and $ 276,000 and
$ 296,000 for the six months ended June 30, 2023 and 2022, respectively.
7.
Goodwill and Intangible Assets, Net
At
June 30, 2023 and December 31, 2022 goodwill and intangible assets, net consisted of the following (in thousands):
Schedule of Goodwill and Intangible Assets Net
June 30, 2023
December 31,
(Unaudited)
2022
Goodwill (1)
$ 10,672
$ 10,672
Intangible assets:
Acquired IPR&D – OPC1 (from the Asterias Merger) (2)
$ 31,700
$ 31,700
Acquired IPR&D – VAC (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)
( 19,516 )
( 19,451 )
Intangible assets, net
$ 46,627
$ 46,692
(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, see Note 14 (Commitment and Contingencies) for further discussion on the Asterias Merger.
13 | Page
(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 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 VAC platform.
(3)
Asterias
had royalty cash flows under patent families it acquired from Geron Corporation (“Geron”).
Such patent families are expected to continue to generate revenue, are not used in the OPC1
or the VAC platform, and are considered to be separate long-lived intangible assets under
Accounting Standards Codifications (“ASC”) Topic 805, Business Combinations .
(4)
As
of June 30, 2023 acquired patents were fully amortized and the acquired royalty contracts had a remaining unamortized balance of
approximately $ 87,000 .
Lineage
amortizes its intangible assets over an estimated period of 5 to 10 years on a straight-line basis. Lineage recognized approximately
$ 32,000 in amortization expense of intangible assets during each of the three months ended June 30, 2023 and 2022, and $ 65,000 during
each of the six months ended June 30, 2023 and 2022.
Amortization
of intangible assets for periods subsequent to June 30, 2023 is as follows (in thousands):
Schedule of Intangible Assets Future Amortization Expenses
Year Ending December 31,
Amortization Expense
2023
$ 65
2024
22
Total
$ 87
8.
Accounts Payable and Accrued Liabilities
At
June 30, 2023 and December 31, 2022 accounts payable and accrued liabilities consisted of the following (in thousands):
Schedule of Accounts Payable and Accrued Liabilities
June 30, 2023
December 31,
(Unaudited)
2022
Accounts payable
$ 2,187
$ 2,393
Accrued compensation
1,917
2,382
Accrued liabilities (1)
581
3,833
Total
$ 4,685
$ 8,608
(1)
The
decrease in accrued liabilities was due to a payment made in connection with the settlement of litigation in February 2023 related
to the Asterias Merger. See Note 14 (Commitment and Contingencies) for additional information.
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.
14 | Page
●
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
have not transferred any instruments between the three levels of the fair value hierarchy.
We
measure our money market fund, marketable securities and our liability classified warrants at fair value on a recurring basis. The fair
values of such assets and liabilities were as follows for June 30, 2023 and December 31, 2022 (in thousands):
Schedule of Fair Value of Assets and Liabilities Valued on Recurring Basis
Fair Value Measurements Using
Balance at June 30, 2023
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Assets:
Money market fund (1)
$ 25,641
$ 25,641
$ -
$ -
Marketable debt securities
11,727
11,727
-
-
Marketable equity securities
312
312
-
-
Total assets measured at fair value
$ 37,680
$ 37,680
$ -
$ -
Liabilities:
Warrants to purchase Cell Cure ordinary shares (2)
$ 1
$ -
$ -
$ 1
Total liabilities measured at fair value
$ 1
$ -
$ -
$ 1
Fair Value Measurements Using
Balance at December 31, 2022
Quoted Prices in Active Markets for Identical Assets
(Level 1)
Significant Other Observable Inputs
(Level 2)
Significant Unobservable Inputs
(Level 3)
Assets:
Money market fund (1)
$ 4,102
$ 4,102
$ -
$ -
Marketable debt securities
46,097
46,097
-
-
Marketable equity securities
423
423
-
-
Total assets measured at fair value
$ 50,622
$ 50,622
$ -
$ -
Liabilities:
Warrants to purchase Cell Cure ordinary shares (2)
$ 2
$ -
$ -
$ 2
Total liabilities measured at fair value
$ 2
$ -
$ -
$ 2
(1)
Included
in cash and cash equivalents in the accompanying condensed consolidated balance sheet.
(2)
Included
in other current liabilities and/or long-term liabilities in the accompanying condensed consolidated balance sheet.
Lineage’s
marketable equity securities includes the shares of stock of OncoCyte and Hadasit Bio-Holdings Ltd (“HBL”). Both securities
have readily determinable fair values and are measured at fair value and reported as current assets on the accompanying condensed consolidated
balance sheets based on the closing trading price of the security as of the date being presented.
The
carrying value of cash, restricted cash, accounts receivable, accounts payable, and accrued liabilities approximate their respective
fair values due to their relative short maturities.
15 | Page
10.
Related Party Transactions
In
connection with the putative shareholder class action lawsuits filed in February 2019 and October 2019 challenging the Asterias Merger
(see Note 14), Lineage agreed to pay the expenses for the legal defense of Neal Bradsher, a member of the Lineage board of directors,
Broadwood Partners, L.P., a shareholder of Lineage, and Broadwood Capital, Inc., which serves as the general partner of Broadwood Partners,
L.P., all of which were named defendants in the lawsuits, prior to being dismissed. Through June 30, 2023, Lineage has incurred approximately $ 625,000 in legal expenses on behalf of the foregoing parties.
11.
Shareholders’ Equity
Preferred
Shares
Lineage
is authorized to issue 2,000,000 preferred shares, no par value. The preferred shares may be issued in one or more series as the Lineage
board of directors may determine by resolution. The Lineage board of directors is authorized to fix the number of shares of any series
of preferred shares and to determine or alter the rights, preferences, privileges, and restrictions granted to or imposed on the preferred
shares as a class, or upon any wholly unissued series of any preferred shares. The Lineage board of directors may, by resolution, increase
or decrease (but not below the number of shares of such series then outstanding) the number of shares of any series of preferred shares
subsequent to the issue of shares of that series. As of June 30, 2023 and December 31, 2022, there were no preferred shares issued or
outstanding.
Common
Shares
Lineage
is authorized to issue 250,000,000 common shares, no par value. As of June 30, 2023 and December 31, 2022, there were 174,439,434 and
170,093,114 common shares issued and outstanding, respectively.
At
The Market Offering Program
In
May 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 sell its common shares from time
to time through an “at the market offering” program under the Sales Agreement.
In
March 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of $ 25.0 million of common shares
through the ATM program under the Sales Agreement (“March 2021 Prospectus Supplement”).
In
December 2021, Lineage filed a prospectus supplement with the SEC in connection with the offer and sale of up to $ 64.1 million of common
shares (which included $ 14.1 million of its common shares which then remained unsold under the March 2021 Prospectus Supplement) through
the ATM program under the Sales Agreement (“December 2021 Prospectus Supplement”). Following the filing of the December 2021
Prospectus Supplement, no further sales were made or will be made under the March 2021 Prospectus Supplement. The December 2021 Prospectus
Supplement was updated, amended and supplemented by a prospectus supplement filed with the SEC on May 18, 2023.
As
of June 30, 2023, Lineage had sold 4,345,596
common shares under the December 2021 Prospectus
Supplement at a weighted average price per share of $ 1.41
for gross proceeds of $ 6.1
million. As of June 30, 2023, $ 58.0
million remained available for sale under the
December 2021 Prospectus Supplement. During the three months ended June 30, 2023, 4,237,396 shares were sold under the December 2021
Prospectus Supplement for gross proceeds of $ 5.8 million and net proceeds of $ 5.7 million. No shares were sold in the three months ended
March 31, 2023, or the six months ended June 30, 2022.
The
shares offered under the December 2021 Prospectus Supplement are registered pursuant to Lineage’s effective shelf registration
statement on Form S-3 (File No. 333-254167), which was filed with the SEC on March 5, 2021 and declared effective on March 19, 2021.
16 | Page
Lineage
agreed to pay Cantor Fitzgerald a commission of 3.0 % of the aggregate gross proceeds from the sale of shares under the Sales Agreement,
reimburse its 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.
Reconciliation
of Changes in Shareholders’ Equity
The
following tables document the changes in shareholders’ equity for the three and six months ended June 30, 2023 and 2022 (unaudited
and in thousands):
Schedule of Shareholder’s Equity
Shares
Amount
Shares
Amount
Deficit
Deficit
Income / (Loss)
Equity
Accumulated
Preferred
Common
Other
Total
Shares
Shares
Accumulated
Noncontrolling
Comprehensive
Shareholders’
Shares
Amount
Shares
Amount
Deficit
Deficit
Income / (Loss)
Equity
BALANCE - December 31, 2022
-
$ -
170,093
$ 440,280
$ ( 363,370 )
$ ( 1,403 )
$ ( 3,571 )
$ 71,936
Shares issued upon vesting of
restricted stock units, net of shares
retired to pay employees’ taxes
-
-
53
( 37 )
-
-
-
( 37 )
Shares issued upon exercise of
stock options
-
-
28
25
-
-
-
25
Stock-based compensation
-
-
-
1,031
-
-
-
1,031
Unrealized gain on marketable securities
-
-
-
-
-
-
91
91
Foreign currency translation gain
-
-
-
-
-
-
373
373
Net loss
-
-
-
-
( 4,372 )
( 32 )
-
( 4,404 )
BALANCE - March 31, 2023
-
-
170,174
441,299
( 367,742 )
( 1,435 )
( 3,107 )
69,015
Shares issued through ATM
-
-
4,237
5,841
-
-
-
5,841
Financing related fees
-
-
-
( 193 )
-
-
-
( 193 )
Shares issued upon exercise of
stock options
-
-
28
22
-
-
-
22
Stock-based compensation
-
-
-
1,280
-
-
-
1,280
Unrealized gain on marketable securities
-
-
-
-
-
-
50
50
Foreign currency translation gain
-
-
-
-
-
-
446
446
Net income (loss)
-
-
-
-
( 5,229 )
26
-
( 5,203 )
BALANCE - June 30, 2023
-
$ -
174,439
$ 448,249
$ ( 372,971 )
$ ( 1,409 )
$ ( 2,611 )
$ 71,258
17 | Page
Accumulated
Preferred
Common
Other
Total
Shares
Shares
Accumulated
Noncontrolling
Comprehensive
Shareholders’
Shares
Amount
Shares
Amount
Deficit
Deficit
Income / (Loss)
Equity
BALANCE - December 31, 2021
-
$ -
169,477
$ 434,529
$ ( 337,097 )
$ ( 1,323 )
$ ( 5,211 )
$ 90,898
Shares
issued upon vesting of
restricted stock units, net of shares retired to pay employees’ taxes
-
-
10
( 8 )
-
-
-
( 8 )
Shares issued upon exercise of
stock options
-
-
240
189
-
-
-
189
Subsidiary warrant exercise
-
-
-
2
-
-
-
2
Stock-based compensation
-
-
-
1,106
-
-
-
1,106
Foreign currency translation gain
-
-
-
-
-
-
124
124
Net loss
-
-
-
-
( 7,087 )
( 6 )
-
( 7,093 )
BALANCE - March 31, 2021
-
-
169,727
435,818
( 344,184 )
( 1,329 )
( 5,087 )
85,218
Shares issued upon vesting of
restricted stock units, net of shares
retired to pay employees’ taxes
-
-
10
( 9 )
-
-
-
( 9 )
Shares issued upon exercise of
stock options
-
-
11
10
-
-
-
10
Subsidiary warrant exercise, net
-
-
-
97
-
-
-
97
Stock-based compensation
-
-
-
1,235
-
-
-
1,235
Foreign currency translation gain
-
-
-
-
-
-
1,730
1,730
Net loss
-
-
-
-
( 6,763 )
( 19 )
-
( 6,782 )
BALANCE - June 30, 2022
-
$ -
169,748
$ 437,151
$ ( 350,947 )
$ ( 1,348 )
$ ( 3,357 )
$ 81,499
12.
Stock-Based Awards
Equity
Incentive Plan Awards
In
September 2021, our shareholders approved the Lineage Cell Therapeutics, Inc. 2021 Equity Incentive Plan (the “2021 Plan”),
which became effective upon such approval. The 2021 Plan provides for the grant of incentive stock options, nonstatutory stock options,
stock appreciation rights, restricted stock awards, restricted stock units (“RSUs”), and other stock awards. All of our employees
(including those of 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 number of shares subject to awards granted under the Lineage Cell
Therapeutics Inc. 2012 Equity Incentive Plan (the “2012 Plan”) that were outstanding when the 2021 Plan became effective
and are not issued because such awards expire or otherwise terminate. As of June 30, 2023, there were 6,269,022 shares available for
grant under the 2021 Plan.
As
a result of the approval of the 2021 Plan by our shareholders, no additional awards will be granted under the 2012 Plan.
18 | Page
A
summary of activity under the 2021 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
Balance at December 31, 2022
6,001
$ 1.40
Options granted
5,271
$ 1.46
Options expired/forfeited/cancelled
( 160 )
$ 1.43
Balance at June 30, 2023
11,112
$ 1.43
Options exercisable at June 30, 2023
1,373
$ 1.39
Number
of RSUs
Outstanding
Balance at December 31, 2022
939
RSUs forfeited
( 100 )
RSUs vested
( 80 )
Balance at June 30, 2023
759
A
summary of activity of the 2012 Plan, and the 2018 inducement option (which was issued to a Lineage executive outside of all equity plans),
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, 2022
12,172
$ 1.83
Options exercised
( 56 )
$ 0.84
Options expired/forfeited/cancelled
( 382 )
$ 1.83
June 30, 2023
11,734
$ 1.83
Options exercisable at June 30, 2023
9,437
$ 1.79
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
Six Months ended June 30, (unaudited)
2023
2022
Expected life (in years)
6.25
6.25
Risk-free interest rates
4.2 %
2.0 %
Volatility
74.5 %
73.4 %
Dividend yield
-
-
Operating
expenses include stock-based compensation expense as follows (in thousands):
Schedule of Stock Based Compensation Expense
Three Months ended June 30, (unaudited)
Six Months ended
June 30, (unaudited)
2023
2022
2023
2022
Research and development
$ 264
$ 141
$ 469
$ 356
General and administrative
1,016
1,094
1,842
1,985
Total stock-based compensation expense
$ 1,280
$ 1,235
$ 2,311
$ 2,341
19 | Page
As
of June 30, 2023, total unrecognized compensation costs related to unvested stock options and unvested RSUs under all equity plans (including
the 2018 inducement option), were $ 11.5 million, which is expected to be recognized as expense over a weighted average period of approximately
2.9 years.
Basic
and diluted net income (loss) per share attributable to common shareholders
Basic
earnings per share is calculated by dividing net income or loss attributable to Lineage common shareholders by the weighted average number
of common shares outstanding, net of unvested restricted stock or RSUs, 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, restricted stock awards 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 six months ended June 30, 2023 and 2022, 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 Computation Of Diluted Net Loss Per Common Share
Three Months ended June 30,
Six Months ended June 30,
2023
2022
2023
2022
Stock options
22,846
18,832
22,846
18,832
Restricted stock units
759
967
759
967
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, 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.
Under
ASC 740, 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.
For
the tax years beginning on or after January 1, 2022, the Tax Cuts and Jobs Act of 2017 (“TCJA”) eliminated the option to
currently deduct research and development expenses and requires taxpayers to capitalize and amortize them over five years for research
activities performed in the United States and 15 years for research activities performed outside the United States pursuant to IRC Section
174. Although Congress is considering legislation that would repeal or defer this capitalization and amortization requirement, it is
not certain that this provision will be repealed or otherwise modified. If the requirement is not repealed or replaced, it will decrease
our tax deduction for research and development expenses in future years.
The
2017 Tax Act subjects a U.S. stockholder to Global Intangible Low-Taxed Income (“GILTI”) earned by certain foreign subsidiaries.
In general, GILTI is the excess of a U.S. stockholder’s total net foreign income over a deemed return on tangible assets. The provision
further allows a deduction of 50% of GILTI: however, this deduction is limited to the company’s pre-GILTI U.S. income. Lineage
incurred GILTI income during the years 2021 and 2022. For the three and six months ended June 30, 2023, no GILTI income was included
in the Company’s tax provision.
20 | Page
Lineage recorded
a $ 1.8
million deferred tax benefit for the six months ended June 30, 2023, due to the ability to offset certain deferred tax assets
against the deferred tax liability associated with IPR&D, and the related release of the valuation allowance. It was determined
that a portion of the deferred tax liability related to the indefinite lived assets may be realized prior to the expiration of
certain pre 2018 net operating losses. Lineage did not record a deferred tax benefit for the three months ended June 30, 2023, and
did not record a deferred tax benefit for the three and six months ended June 30, 2022.
14.
Commitments and Contingencies
Real
Property Leases
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 lease was amended in December 2022 and the term was extended for a period of thirty-seven months (the “Extended Term”)
commencing on March 1, 2023 (the “Extended Term Commencement Date”). The lease expires on March 31, 2026 , and rent was abated
for months two through four of the Extended Term. The monthly base rent was $ 24,666 through the Extended Term Commencement Date, after
which it increased to $ 25,197 . As security for the performance of its obligations under the lease, Lineage provided the landlord a security
deposit of $ 17,850 , which is included in deposits and other long-term assets on the condensed consolidated balance sheet as of June 30,
2023.
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. These pro-rata charges are expensed as incurred and excluded from the calculation of the ROU assets and lease
liabilities.
Carlsbad
Sublease
In
September 2022, Lineage entered into a sublease for approximately 4,500 square feet of rentable industrial space in Carlsbad, California
for a term that commenced on October 1, 2022 and expires on March 31, 2024 . As security for the performance of its obligations under
the sublease, Lineage provided the landlord with a security deposit of $ 22,500 . Base rent is $ 22,500 per month until the sublease expires.
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, 2027 , with an option to extend the lease for five years. Base monthly rent is NIS 39,776 (approximately $ 12,200
per month). 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. These pro-rata charges are expensed as incurred and excluded
from the calculation of the ROU assets and lease liabilities.
In
January 2018, Cell Cure entered into a lease for an additional 934 square meters (approximately 10,054 square feet) of office space in
the same facility that expires on December 31, 2027, with an option to extend the lease for five years . Base rent and construction allowance
payments are NIS 93,827 per month (approximately $ 26,000 per month). Cell Cure has a security deposit denominated in NIS with the landlord
held as restricted cash during the term of its facility lease. The value of this security deposit in USD fluctuates based upon currency
exchange rates and was $ 439,000 as of June 30, 2023, which is included in deposits and other long-term assets on the condensed consolidated
balance sheet.
In
November 2021, Cell Cure entered into a lease for an additional 133 square meters (approximately 1,432 square feet) of office space in
the same facility that commenced on December 1, 2021, and expires on December 31, 2027, with an option to extend the lease for five years .
The base monthly rent was NIS 1 1,880 (approximately US $ 3,757 ) through October 31, 2022 and increased to NIS 12,494 (approximately US
$ 3,951 ) on November 1, 2022.
In
August 2022, Cell Cure entered into a lease for 300 square meters (approximately 3,229 square feet) of office and laboratory space in
Jerusalem, Israel that expires on December 31, 2027 , with an option to extend the lease for five years. Base monthly rent is 16,350 NIS
(approximately $ 4,800 per month). When executing this lease, Cell Cure modified the expiration dates and options terms for the leases
identified above to align with this lease.
Supplemental
Information – Leases
Supplemental
cash flow information related to leases is as follows (in thousands):
Schedule
of Supplemental Cash Flow Information Related to Leases
Six Months ended June 30,
2023
2022
Cash paid for amounts included in the measurement of lease liabilities:
Operating cash flows from operating leases
$ 538
$ 508
Operating cash flows from financing leases
$ 5
$ 9
Financing cash flows from financing leases
$ 29
$ 15
Right-of-use assets obtained in exchange for lease obligations:
Operating leases
$ -
$ 33
Finance leases
$ 79
$ -
21 | Page
Supplemental
balance sheet information related to leases was as follows (in thousands, except lease term and discount rate):
Schedule
of Supplemental Balance Sheet Information Related to Leases
June 30, 2023
December 31,
(Unaudited)
2022
Operating leases
Right-of-use assets, net
$ 2,940
$ 3,517
Right-of-use lease liabilities, current
$ 933
$ 916
Right-of-use lease liabilities, noncurrent
2,304
2,860
Total operating lease liabilities
$ 3,237
$ 3,776
Financing leases
Right-of-use assets, net
$ 157
$ 105
Lease liabilities, current
$ 54
$ 29
Lease liabilities, noncurrent
113
84
Total finance lease liabilities
167
113
Other current liabilities
-
7
Total finance lease liabilities
$ 167
$ 120
Weighted average remaining lease term
Operating leases
3.9 years
4.3 years
Finance leases
3.4 years
4.1 years
Weighted average discount rate
Operating leases
6.4 %
6.3 %
Finance leases
6.8 %
6.9 %
Future
minimum lease commitments are as follows as of June 30, 2023 (in thousands):
Schedule
of Future Minimum Lease Commitments
(Unaudited)
Operating
Leases
Finance
Leases
Year Ending December 31,
2023
$ 564
$ 32
2024
942
61
2025
872
50
2026
637
26
2027
675
19
Total lease payments
3,690
188
Less imputed interest
( 453 )
( 21 )
Total
$ 3,237
$ 167
22 | Page
Collaborations
Roche
Agreement
In
December 2021, Lineage entered into the Roche Agreement, wherein Lineage granted to Roche exclusive worldwide rights to develop and commercialize
RPE cell therapies, including Lineage’s proprietary cell therapy known as OpRegen, for the treatment of ocular disorders, including
GA secondary to AMD.
Under
the terms of the Roche Agreement, Roche paid Lineage a $ 50.0 million upfront payment and Lineage is eligible to receive up to an additional
$ 620.0 million in certain developmental, regulatory and commercialization milestone payments. Lineage also is eligible for tiered double-digit
percentage royalties on net sales of OpRegen in the U.S and other major markets. All regulatory and commercial milestone payments and
royalty payments are subject to the existence of certain intellectual property rights that cover OpRegen at the time such payments would
otherwise become due, and the royalty payments on net sales of OpRegen are subject to financial offsets based on the existence of competing
products. Roche assumed responsibility for further clinical development and commercialization of OpRegen. Lineage is responsible for
completing activities related to the ongoing clinical study, for which enrollment is complete, and performing certain manufacturing and
process development activities.
Unless
earlier terminated by either party, the Roche Agreement will expire on a product-by-product and country-by-country basis upon the expiration
of all of Roche’s payment obligations under the agreement. Roche may terminate the agreement in its entirety, or on a product-by-product
or country-by-country basis, at any time with advance written notice. Either party may terminate the agreement in its entirety with written
notice for the other party’s material breach if such party fails to cure the breach or upon certain insolvency events involving
the other party.
In
January 2022, Lineage received the $ 50.0 million upfront payment from Roche. Subsequently, Lineage, via Cell Cure, paid $ 12.1 million
to the IIA, and $ 8.9 million to Hadasit Medical Research Services and Development Ltd. (“Hadasit’). Such payments were made
in accordance with obligations under the Innovation Law (as discussed below) and under the terms of Cell Cure’s agreements with
Hadasit (as discussed below). The payment to Hadasit was reduced by $ 1.9 million in accordance with the provisions of such agreements
discussed below that reduce the sublicensing fee payable to Hadasit for costs related to Lineage’s performance obligations under
the Roche Agreement. To the extent such costs are not incurred within five years after the execution of the Roche Agreement, Cell Cure
will be required to pay Hadasit 21.5 % of the amount of costs not incurred.
ITI
Collaboration Agreement
Under
Lineage’s collaborative agreement with Immunomic Therapeutics, Inc. (“ITI”), Lineage agreed to perform up to approximately
$ 2.2 million worth of certain research, development, manufacturing, and oversight activities related to the development of an allogeneic
VAC-CMV product candidate. ITI will reimburse Lineage for these costs and full-time employee costs for the manufacturing of the VAC-CMV
product candidate. As of June 30, 2023, Lineage has a remaining performance obligation of approximately $ 1.6 million for the aforementioned
activities. Upon execution of the agreement in April 2021, $ 0.5 million was paid by ITI to Lineage. Upon delivery of research-grade VAC-CMV
product generated by Lineage, ITI paid an additional $ 0.5 million in August 2021. ITI is currently evaluating its next step under the
agreement.
Agreements
with Hadasit and IIA
The
OpRegen program was supported in part with licenses to technology obtained from Hadasit, the technology transfer company of Hadassah
Medical Center, and through a series of research grants from the IIA, an independent agency created to address the needs of global innovation
ecosystems. A subset of the intellectual property underlying OpRegen was originally generated at Hadassah Medical Center and licensed
to Cell Cure for further development.
23 | Page
Under
the Encouragement of Research, Development and Technological Innovation in the Industry Law 5744, and the regulations, guidelines, rules,
procedures and benefit tracks thereunder (collectively, the “Innovation Law”), annual research and development programs that
meet specified criteria and were approved by a committee of the IIA were eligible for grants. The grants awarded were typically up to
50 % of the project’s expenditures, as determined by the IIA committee and subject to the benefit track under which the grant was
awarded.
The
terms of the grants under the Innovation Law generally require that the products developed as part of the programs under which the grants
were given be manufactured in Israel. The know-how developed thereunder may not be transferred outside of Israel unless prior written
approval is received from the IIA. Transfer of IIA-funded know-how outside of Israel is subject to approval and payment of a redemption
fee to the IIA calculated according to formulas provided under the Innovation Law. In November 2021, the IIA research committee approved
an application made by Cell Cure with respect to the grant of an exclusive license and transfer of the technological know-how for OpRegen
to Roche. Under the provisions for the redemption fee, Lineage is obligated to pay the IIA approximately 24.3 % of the upfront, milestone,
and royalty payments which may be received under the Roche Agreement, up to an aggregate cap on all payments, such cap growing over time
via interest accrual until paid in full. As of June 30, 2023, the aggregate cap amount was approximately $ 92.1 million.
Pursuant
to the Second Amended and Restated License Agreement, dated June 15, 2017, between Cell Cure and Hadasit, and a certain letter agreement
entered into on December 17, 2021, Hadasit was entitled to, and was paid, a sublicensing fee of 21.5 % of the $ 50.0 million upfront payment
under the Roche Agreement (subject to certain reductions, including for costs related to Lineage’s performance obligations under
the Roche Agreement) and of any milestone payments, and up to 50 % of all royalty payments (subject to a maximum payment of 5% of net
sales of products), Lineage receives under the Roche Agreement. The letter agreement generally terminates upon the termination of the
Roche Agreement.
Second
Amendment to Clinical Trial and Option Agreement and License Agreement with Cancer Research UK
In
May 2020, Lineage and Asterias entered into a Second Amendment to Clinical Trial and Option Agreement (the “CTOA Amendment”)
with CRUK and Cancer Research Technology (“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.
Lineage
and CRT effectuated the option by simultaneously entering into a license agreement (the “CRT License Agreement”) pursuant
to which Lineage paid a signature fee of £ 1,250,000 (approximately $ 1.6 million). For the primary licensed product for the first
indication, the CRT 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 CRT License Agreement for the uncured material breach of the other party. CRT may terminate the CRT License Agreement
in the case of Lineage’s insolvency or if Lineage ceases all development and commercialization of all products under the CRT License
Agreement.
Other
Contingent Obligations
We
have obligations under license agreements and grants received from government entities to make future payments to third parties, which
become due and payable on the achievement of certain development, regulatory and commercial milestones or on the sublicense of our rights
to another party. These commitments include sublicense fees, milestone payments, redemption fees and royalties. Sublicense fees are payable
to licensors or government entities when we sublicense underlying intellectual property to third parties; the fees are based on a percentage
of the license fees we receive from sublicensees. Milestone payments are due to licensors or government entities upon the future achievement
of certain development and regulatory milestones. Redemption fees due to the IIA under the Innovation Law are due upon receipt of any
milestone and royalties received under the Roche Agreement. Royalties are payable to licensors or government entities based on a percentage
of net sales of licensed products. As of June 30, 2023, we have not included these commitments on our condensed consolidated balance
sheet because the achievement and timing of these events are not fixed and determinable.
24 | Page
Litigation
– General
From
time to time, we are subject to legal proceedings and claims in the ordinary course of business. While management presently believes
that the ultimate outcome of these proceedings, individually and in the aggregate, will not materially harm our financial position, cash
flows, or overall trends in results of operations, legal proceedings are subject to inherent uncertainties, and unfavorable rulings or
outcomes could occur that have individually or in aggregate, a material adverse effect on our business, financial condition or operating
results. We are not currently subject to any pending material litigation, other than ordinary routine litigation incidental to our business.
Asterias
Merger
In
November 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 pursuant to which Lineage agreed to acquire all of the outstanding common stock
of Asterias in a stock-for-stock transaction (the “Asterias Merger”). The Asterias Merger closed in March 2019. In October
2019, a putative class action lawsuit was filed against the company and certain other named defendants challenging the Asterias Merger.
In
February 2023, the court approved a Stipulation and Agreement of Compromise and Settlement pursuant to which, Lineage and certain insurers
of the defendants paid $ 10.65 million (the “Settlement Amount”) into a fund created for the benefit of the purported class
and in consideration for the full and final release, settlement and discharge of all claims. Approximately $ 7.12 million of the Settlement
Amount was funded by certain insurers and approximately $ 3.53 million was paid by Lineage in cash.
Lineage
and all defendants have denied, and continue to deny, the claims alleged in the lawsuit and the settlement does not reflect or constitute
any admission, concession, presumption, proof, evidence or finding of any liability, fault, wrongdoing or injury or damages, or of any
wrongful conduct, acts or omissions on the part any defendant.
Premvia
Litigation Settlement
In
July 2019, the Company, along with other named defendants, was sued in the Superior Court of the State of California in a matter captioned
Gonzalez v. Aronowitz, M.D., et al . The plaintiff asserted medical negligence and product liability causes of action relating
to the 2017 and 2018 use in a clinical trial of a product candidate, Premvia, that the Company is no longer developing and has no plans
to pursue, and that is not related to the cell therapy candidates the Company currently is developing. In February 2023, the Company
and the other defendants each entered into settlement agreements with the plaintiff pursuant to which the defendants without admitting
any liability, which the defendants expressly denied, each agreed to pay specified amounts to the plaintiff in exchange for a full settlement
and release and discharge of claims. The Company’s insurance covered the full amount paid by the Company excluding the $ 25,000
insurance deductible.
HBL
Books and Records Request
On
April 17, 2023, Cell Cure Neurosciences Ltd. (“Cell Cure”), Lineage’s subsidiary, received a motion for disclosure
of documents pursuant to Section 198A of the Israeli Companies Law 5759-1999. The motion was filed in the district court in Tel
Aviv-Yafo by HBL Hadasit Bio-Holdings Ltd. (“HBL”), currently an approximately 5% shareholder of Cell Cure. According to
the motion, the requested production of documents is intended to allow HBL to examine the possibility of pursuing a derivative
action related to, among other things, the validity of an intercompany Collaboration and License Agreement (the “Intercompany
Agreement”) entered into between Lineage and Cell Cure pursuant to which Cell Cure conveyed certain rights and other assets to
Lineage, and Lineage agreed to undertake certain liabilities and obligations of Cell Cure relating to the OpRegen® program. In
its motion, HBL alleges, among other things, that Lineage, in its capacity as Cell Cure’s controlling shareholder, and members
of Cell Cure’s board of directors caused damage to Cell Cure because the Intercompany Agreement was an interested party
transaction that was not fairly priced and exploits Cell Cure’s resources for the benefit of Lineage. The motion seeks an
order to compel Cell Cure to disclose and deliver to HBL the documents described in the motion, such additional, cumulative, or
alternative relief as the court deems appropriate, and reimbursement of HBL’s expenses, including attorneys’ fees. Cell
Cure filed an opposition to the motion on July 9, 2023. 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.
25 | Page
Employment
Contracts
Lineage
has employment agreements with all of its 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 agree to indemnify and reimburse other parties, typically Lineage’s clinical research
organizations, investigators, clinical sites, and suppliers, 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
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 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.
Generally, Lineage has not been subject to any material claims or demands for indemnification. Lineage maintains liability insurance
policies that limit its financial exposure under the indemnification agreements. Accordingly, Lineage has not recorded any liabilities
for these agreements as of June 30, 2023 or December 31, 2022.
Royalty
Obligations and License Fees
We
have licensing agreements with research institutions, universities and other parties providing us with certain rights to use intellectual
property in conducting research and development activities in exchange for the payment of royalties on future product sales, if any.
In addition, in order to maintain these licenses and other rights, we must comply with various conditions including the payment of patent
related costs and annual minimum maintenance fees.
As
part of the Asterias Merger, Lineage acquired certain royalty revenues for cash flows generated under patent families that Asterias acquired
from Geron Corporation. Lineage continues to make royalty payments to Geron from royalties generated from these patents.
26 | Page
Item
2. Management’s Discussion and Analysis of Financial Condition and Result of Operations
The
following discussion and analysis of financial condition and results of operations should be read in conjunction with our unaudited condensed
consolidated interim financial statements and notes thereto included in this report and our audited financial statements and notes thereto
for the year ended December 31, 2022 included in the 2022 10-K. Past operating results are not necessarily indicative of results that
may occur in future periods.
The
following discussion includes forward-looking statements. See “Special Note Regarding Forward-Looking Statements,” above.
Forward-looking statements are not guarantees of future performance and our actual results may differ materially from those currently
anticipated and from historical results depending upon a variety of factors, including, but not limited to, those discussed in Part I,
Item 1A. Risk Factors of our 2022 10-K, and in our subsequent filings with the SEC, including any discussed in Part II, Item 1A of this
report under the heading “Risk Factors.”
All
information presented in this report is based on our fiscal year. Unless otherwise stated, references to particular years, quarters,
months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.
Company
and Business Overview
We
are a clinical-stage biotechnology company developing novel allogeneic cell therapies to address unmet medical needs. Our programs are
based on our proprietary cell-based technology platform and associated development and manufacturing capabilities. From this platform,
we design, develop, manufacture, and test specialized human cells with anatomical and physiological functions similar or identical to
cells found naturally in the human body. The cells we manufacture are created by applying developmental biological differentiation protocols
to established, well-characterized, and self-renewing pluripotent cell lines. These cells are transplanted into patients and are designed
to (a) replace or support cells that are absent or dysfunctional due to degenerative disease, aging, or traumatic injury, and (b) restore
or augment the patient’s functional activity.
Our
strategy is to efficiently leverage our technology platform and our development, formulation, delivery, and manufacturing capabilities
to advance our programs internally or in conjunction with strategic partners to further enhance their value and probability of success.
As one example, in December 2021 we entered into a Collaboration and License Agreement (the “Roche Agreement”) with F. Hoffmann-La
Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”),
wherein we granted to Roche exclusive worldwide rights to develop and commercialize retinal pigment epithelium (“RPE”) cell
therapies, including our proprietary cell therapy program known as OpRegen ® , for the treatment of ocular disorders, including
geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Under the terms of the Roche Agreement, Lineage received
a $50.0 million upfront payment and is eligible to receive up to $620.0 million in certain developmental, regulatory, and commercialization
milestone payments. Lineage also is eligible to receive tiered double-digit percentage royalties on net sales of OpRegen in the U.S.
and other major markets. See Note 14 (Commitments and Contingencies) for additional information regarding the Roche Agreement.
As
of June 30, 2023, we have five allogeneic, or “off-the-shelf,” cell therapy programs in development, of which three have
reached human clinical testing:
Product
Candidates
●
OpRegen ® ,
an allogeneic RPE cell replacement therapy currently in a Phase 2a multicenter clinical trial,
being conducted by Roche, for the treatment of GA secondary to AMD, also known as atrophic or dry AMD. A previous Phase 1/2a
trial we conducted enrolled individuals with dry AMD with GA. In December 2021, this program was partnered with Roche for further
clinical development and commercialization.
●
OPC1 ,
an allogeneic oligodendrocyte progenitor cell therapy currently in long-term follow-up from a Phase 1/2a multicenter clinical trial
for cervical spinal cord injuries (“SCI”). To date, five patients with thoracic spinal cord injuries and 25 patients
with cervical SCI have been enrolled in clinical trials of OPC1. We recently received a response from the U.S. Food and Drug
Administration to our Type B meeting submission which will help guide our next regulatory interactions. The clinical development of
OPC1 has been partially funded by $14.3 million received under a grant from the California Institute for Regenerative Medicine
(“CIRM”). Additional clinical trials are being planned.
27 | Page
●
ANP1 ,
an allogeneic auditory neuron progenitor cell transplant currently in preclinical development for the treatment of debilitating hearing
loss (“DHL”).
●
PNC1, an allogeneic
photoreceptor cell transplant currently in preclinical development for the treatment of vision loss due to photoreceptor dysfunction
or damage.
●
VAC , an allogeneic
cancer immunotherapy comprised of antigen-presenting dendritic cells. A Phase 1 clinical trial in non-small cell lung cancer (“NSCLC”)
of one of the VAC product candidates, VAC2, was recently completed. This clinical trial was funded and conducted by Cancer Research
UK (“CRUK”), one of the world’s largest independent cancer research charities. Another VAC-based product candidate
is in preclinical development with our partner, Immunomic Therapeutics, Inc. (“ITI”), for the treatment of glioblastoma
multiforme (“GBM”).
Other
Programs
We
have additional undisclosed product candidates being considered for development covering a range of therapeutic areas and unmet medical
needs. Generally, these product candidates are based on the same platform technology and employ a similar guided cell differentiation
and transplant approach as the product candidates described above, but in some cases may also include genetic modifications designed
to enhance efficacy and/or safety profiles.
In
addition to seeking to create value for shareholders by developing product candidates and advancing those candidates through clinical
development, we also may seek to create value from our intellectual property and additional related technologies and capabilities, through
partnering and/or strategic transactions.
Critical
Accounting Estimates
An
accounting policy is deemed critical if it requires an accounting estimate to be made based on assumptions about matters that are highly
uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that
are reasonably likely to occur could materially impact the financial statements. See Part II, Item 7 – Critical Accounting Estimates
and our consolidated financial statements and related notes in Part II, Item 8 of our 2022 10-K for accounting policies and related estimates
we believe are the most critical to understanding our condensed consolidated interim financial statements, financial condition and results
of operations and which require complex management judgment and assumptions or involve uncertainties. There have not been any changes
to our significant accounting policies or their application since we filed our 2022 10-K.
Results
of Operations
Comparison
of Three and Six Months Ended June 30, 2023 and 2022
Revenues
and Cost of Sales
The
amounts in the table below show our consolidated revenues, by source, and cost of sales for the periods presented (in thousands).
Three Months ended June 30, (unaudited)
2023
2022
$ change
% change
Collaboration revenues
$ 2,871
$ 4,148
$ (1,277 )
(31 )%
Royalties and license fees
354
405
(51 )
(13 )%
Total revenues
3,225
4,553
(1,328 )
(29 )%
Cost of sales
(127 )
(215 )
88
(41 )%
Gross profit
$ 3,098
$ 4,338
$ (1,240 )
(29 )%
28 | Page
Six Months ended June 30, (unaudited)
2023
2022
$ change
% change
Collaboration revenues
$ 4,992
$ 9,013
$ (4,021 )
(45 )%
Royalties and license fees
619
777
(158 )
(20 )%
Total revenues
5,611
9,790
(4,179 )
(43 )%
Cost of sales
(246 )
(391 )
145
(37 )%
Gross profit
$ 5,365
$ 9,399
$ (4,034 )
(43 )%
For
the three months ended June 30, 2023, the $1.3 million decrease in total revenues was due to a $1.3 million decrease in collaboration
revenues related to less current period recognition of the $50.0 million upfront licensing payment from Roche, resulting from an updated
collaboration forecast. The collaboration revenue was included in deferred revenues at December 31, 2022 (see Note 3 for further discussion).
For
the six months ended June 30, 2023, the $4.2 million decrease in total revenues was primarily due to a $4.0 million decrease in collaboration
revenues related to less current period recognition of the $50.0 million upfront licensing payment from Roche, resulting from an updated
collaboration forecast. The collaboration revenue was included in deferred revenues at December 31, 2022 (see Note 3 for further discussion).
Operating
expenses
Our
operating expenses consist of research and development expenses and general and administrative expenses.
Research
and development expenses . These expenses consist of costs incurred for company-sponsored, collaborative and contracted research
and development activities. These costs include direct expenses and indirect research-related overhead expenses including
compensation and related benefits, stock-based compensation, consulting fees, research and laboratory fees, rent of research
facilities, amortization of intangible assets, and license fees paid to third parties to acquire patents or licenses to use patents
and other technology. Research and development expenses that have an alternative future use will be capitalized as tangible assets,
and costs with no future benefit or alternative use will be expensed as incurred. Research and development expenses incurred and
reimbursed by grants from third parties approximate the grant income recognized in our consolidated statements of operations.
Royalties and sublicensing fees are recorded as research and development expenses, unless they are associated with royalties from
product sales, which we classify as cost of sales in our consolidated statements of operations. We expect our total research
and development expenses to fluctuate each reporting period based on several factors including (i) the stage of development for each
cell therapy program, (ii) the availability of resources to work on each program, and (iii) the timing of contractual
obligations.
General
and administrative expenses . These expenses include employee and director compensation and related benefits, including stock-based
compensation, for executive and corporate personnel, professional and consulting fees, and allocated overhead such as facilities rent
and equipment rent and maintenance, insurance costs allocated to general and administrative expenses, costs of patent applications, prosecution
and maintenance, stock exchange-related costs, depreciation expense, marketing costs, legal and accounting costs, and other miscellaneous.
The
amounts in the table below are our consolidated operating expenses for the periods presented (in thousands).
Three Months ended June 30, (unaudited)
2023
2022
$ change
% change
Research and development
$ 3,873
$ 3,302
$ 571
17 %
General and administrative
4,249
5,270
(1,021 )
(19 )%
Total
$ 8,122
$ 8,572
$ (450 )
(5 )%
29 | Page
Six Months ended June 30, (unaudited)
2023
2022
$ change
% change
Research and development
$ 8,058
$ 6,290
$ 1,768
28 %
General and administrative
8,973
13,739
(4,766 )
(35 )%
Total
$ 17,031
$ 20,029
$ (2,998 )
(15 )%
The
following table shows the amount of our total research and development expenses by program for the periods presented (in thousands).
Three Months ended June 30, (unaudited)
Amount
Percent of Total
2023
2022
2023
2022
OpRegen ®
$ 1,580
$ 1,137
41 %
34 %
OPC1
1,432
1,139
36 %
35 %
ANP1
697
173
18 %
5 %
PNC1
75
130
2 %
4 %
VAC platform
20
703
1 %
21 %
All other programs
69
20
2 %
1 %
Total research and development expenses
$ 3,873
$ 3,302
100 %
100 %
Six Months ended June 30, (unaudited)
Amount
Percent of Total
2023
2022
2023
2022
OpRegen ®
$ 3,100
$ 2,290
38 %
36 %
OPC1
2,833
2,065
35 %
33 %
ANP1
1,140
235
14 %
4 %
PNC1
233
245
3 %
4 %
VAC platform
306
1,430
4 %
23 %
All other programs
446
25
6 %
0 %
Total research and development expenses
$ 8,058
$ 6,290
100 %
100 %
Research
and development expenses . For the three months ended June 30, 2023, the $0.6 million increase in total research and development expenses
is mainly attributable to: (i) a $0.4 million net increase in expenses related to our OpRegen program; (ii) a $0.3 million net increase in expenses related to our OPC1 program, primarily related
to nonclinical activities; (iii) a $0.5 million increase in expenses related to our ANP1 program, primarily related to nonclinical development
activities. These increases were partially offset by a $0.7 million decrease in expense related to our VAC program, primarily related
to reduced manufacturing activities.
For
the six months ended June 30, 2023, the $1.8 million increase in total research and development expenses is mainly attributable to: (i)
a $0.8 million net increase in expenses related to our OpRegen program, which includes the work being performed on the Roche collaboration;
(ii) a $0.8 million net increase in expenses related to our OPC1 program, primarily related to nonclinical activities; (iii) a $0.9 million
increase in expenses related to our ANP1 program, primarily related to nonclinical development activities; and (iv) a $0.4 million increase
in expenses related to other programs. These increases were partially offset by a $1.1 million decrease in expense related to our VAC
program, primarily related to reduced manufacturing activities.
30 | Page
General
and administrative expenses . For the three months ended June 30, 2023, the $1.0 million year-over-year decrease in general and administrative
expenses was primarily attributable to (i) a $0.5 million decrease in legal and litigation expense, primarily related to the Asterias
litigation settlement, and an (ii) overall reduction in costs incurred for services provided by third parties, consulting costs and stock-based
compensation expense.
For
the six months ended June 30, 2023, the $4.8 million year-over-year decrease in general and administrative expenses was primarily attributable
to (i) a $4.0 million decrease in legal and litigation expense, primarily related to the Asterias litigation settlement, and an (ii)
overall reduction in costs incurred for services provided by third parties, consulting costs and stock-based compensation expense.
Other
income and (expenses), net
The
following table shows the amount of other income and (expense), net, for the periods presented (in thousands):
Three Months ended June 30, (unaudited)
Other income (expenses), net
2023
2022
$ change
% change
Interest income, net
$ 382
$ 51
$ 331
649 %
Unrealized loss on marketable
equity securities, net
(150 )
(709 )
559
(79 )%
Gain on revaluation of warrant liability
-
2
(2 )
(100 )%
Other expenses, net
(411 )
(1,892 )
1,481
(78 )%
Total
$ (179 )
$ (2,548 )
$ 2,369
(93 )%
Six Months ended June 30, (unaudited)
Other income (expenses), net
2023
2022
$ change
% change
Interest income, net
$ 792
$ 51
$ 741
1453 %
Unrealized loss on marketable
equity securities, net
(110 )
(1,444 )
1,334
(92 )%
Gain on revaluation of warrant liability
1
223
(222 )
(100 )%
Other expenses, net
(427 )
(2,075 )
1,648
(79 )%
Total
$ 256
$ (3,245 )
$ 3,501
(108 )%
Interest income, net . During the third quarter of 2022, we began to invest our excess cash in short-term U.S. Treasury securities resulting
in an increase in interest income. See Note 4 (Marketable Debt Securities) to our condensed consolidated interim financial statements
included in this report for additional information regarding our marketable debt securities.
Unrealized loss on marketable equity securities, net . We expect our total other income (expenses), net, to fluctuate each reporting period based on the changes in the
market price of the common stock of OncoCyte Corporation (“OncoCyte”), which could impact our net income or loss reported
in our condensed consolidated statements of operations for a particular reporting period. We also account for the shares we hold in HBL
as marketable equity securities. These shares are carried at fair market value on our consolidated balance sheets. The accounting transactions
for these shares were not material for either of the three and six months ended June 30, 2023. The accounting transactions for these shares were $0.7 million and $1.4 million for the three and six months ended
June 30, 2022. See Note 5 (Marketable Equity
Securities) to our condensed consolidated interim financial statements included in this report for additional information regarding our
marketable equity securities.
Other
expenses, net . Other expenses, net, for each of the three and six months ended June 30, 2023 and 2022 consisted of net
foreign currency transaction gains and losses recognized by our subsidiaries Cell Cure and ES Cell International Pte. Ltd and an employee
retention credit payroll tax refund (discussed below). Foreign currency transaction gains and losses for the periods presented are principally
related to the remeasurement of the U.S. dollar denominated notes payable and notes receivable between Cell Cure and Lineage.
31 | Page
Under
the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) ,
the Company is eligible for an employee retention credit subject to certain criteria. The employee retention credit is a payroll tax
refund per employee, which was designed by the U.S. Treasury Department to assist businesses that retained employees during the
COVID pandemic. For the six months ended June 30, 2023, we recorded an employee retention credit of $0.5 million, due to a decline
in the quarterly revenue during 2020 and 2021 as compared to the same quarterly period in 2019. We recorded the transaction within
other expenses, net on the condensed consolidated statement of operations and as a receivable within prepaid expenses and other
current assets on the condensed consolidated balance sheet. We accounted for the employee retention credit by analogy to
International Accounting Standards (IAS) 20, Accounting for Government Grants and Disclosure of Government Assistance, of
International Financial Reporting Standards (IFRS).
Income
Taxes
Under
ASC 740, Income Taxes , a valuation allowance is provided when it is more likely than not that some portion of the deferred tax
assets will not be realized. We established a full valuation allowance as of December 31, 2018, due to the uncertainty of realizing future
tax benefits from the net operating loss carryforwards and other deferred tax assets, including foreign net operating losses generated
by its subsidiaries.
For
the six months ended June 30, 2023, Lineage recorded a $1.8 million deferred tax benefit due to the ability to offset certain
deferred tax assets against the deferred tax liability associated with IPR&D, and the related release of the valuation
allowance. It was determined that a portion of the deferred tax liability related to the indefinite lived assets may be realized
prior to the expiration of certain pre 2018 net operating losses. Lineage did not record a deferred tax benefit for the three months
ended June 30, 2023, and did not record a deferred tax benefit for the three and six months ended June 30, 2022. See Note 13 (Income
Taxes) to our condensed consolidated interim financial statements included in this report for additional information.
Liquidity
and Capital Resources
Sources
of Liquidity
We
have historically funded our operations primarily through proceeds from the sale of shares of our common stock, the sale of common stock
of our former subsidiaries, research grants, revenues from collaborations, and royalties from product sales that are unrelated to our
current cell therapy product candidates.
As
of June 30, 2023, $58.0 million remained available for sale under our at the market offering program and we owned marketable securities
with a fair value of $12.0 million based on the closing price of such securities on that date. See Note 4 (Marketable Debt Securities),
Note 5 (Marketable Equity Securities) and Note 11 (Shareholders’ Equity) to our condensed consolidated interim financial statements
included in this report for additional information regarding the marketable securities we own and our at the market offering program,
respectively. We may sell shares of our common stock and the marketable securities we own for liquidity. However, when we can effect
such sales and the amount of shares we can sell depends on a variety of factors to be determined by us from time to time, including,
among others, market conditions, the trading price and volume of our common stock and of the marketable securities we own. The market
value of marketable securities we own may not represent the amount that could be realized in a sale of such securities due to various
market factors, including prevailing market conditions and prices at the time of any sale. In addition, the market value of marketable
securities we own may be significantly and adversely impacted by deteriorating global economic conditions and the recent disruptions
to and volatility in the credit and financial markets in the United States and worldwide resulting from the recent pandemics, including
the COVID-19 pandemic, geopolitical conflicts, rising inflation and interest rates, and other macroeconomic factors.
Cash
Flows
Cash
flows (used in) provided by operating activities
Net
cash used in operating activities was $17.5 million for the six months ended June 30, 2023, which primarily reflects the loss from
operations of $11.7 million plus the changes in operating assets and liabilities of $9.4 million. These items were offset by the
non-cash expenses of $2.3 million for stock-based compensation and $0.3 million for depreciation and amortization. The unrealized
loss on marketable securities, foreign currency remeasurement and deferred tax benefit had no effect on cash flows.
32 | Page
Net
cash provided by operating activities was $14.8 million for the six months ended June 30, 2022, which primarily reflects the net changes
in assets and liabilities of $22.5 million, plus the $2.7 million in non-cash expenses for stock-based compensation and depreciation
and amortization, less the loss from operations of $10.6 million. The change in assets and liabilities was impacted by the receipt of
the $50.0 million upfront payment under the Roche Agreement, and subsequent related payments to the IIA and Hadasit (see Note 14 (Commitments
and Contingencies) to the condensed consolidated interim financial statements included in this report for additional information), partially
offset by the accrual of the litigation settlement described in Note 14 (Commitments and Contingencies) to the condensed consolidated
interim financial statements included in this report. The unrealized loss on marketable equity securities and foreign currency remeasurement
had no effect on the cash flows.
Cash
flows provided by (used in) investing activities
Cash
provided by investing activities for the six months ended June 30, 2023 was $34.6 million and consisted of $47.7 million in U.S. Treasury
securities which matured during the period, partially offset by $12.6 million used to purchase U.S. Treasury securities and $0.4 million
used to purchase equipment.
Cash
used by investing activities for the six months ended June 30, 2022 consisted of $0.1 million used to purchase equipment.
Cash
flows provided by financing activities
Cash
provided by financing activities for the three months ended June 30, 2023 was $5.6 million and primarily consisted of net proceeds from
the sale of our common shares under our at the market offering program.
Cash
provided by financing activities for the six months ended June 30, 2022 was $0.5 million and consisted of $0.4 million of proceeds from
the exercise of employee stock options, $0.1 million of proceeds from the sale of our common shares under our at the market offering
program, and $0.1 million of proceeds from the exercise of warrants to purchase shares of Cell Cure. These proceeds were partially offset
by $0.1 million in financing costs.
Financial
Obligations
Our
financial obligations primarily consist of obligations to our licensors under license agreements, obligations related to grants received
from government entities, including the IIA, obligations under vendor contracts to provide research services and other purchase commitments
with suppliers.
Our
obligations to licensors under license agreements and related to grants received from government entities require us to make future payments
relating to sublicense fees, milestone payments, redemption fees, royalties and patent maintenance costs. Sublicense fees are payable
to licensors or government entities when we sublicense underlying intellectual property to third parties; the fees are based on a percentage
of the license fees we receive from sublicensees. Milestone payments, including those related to the Roche Agreement, are due to licensors
or government entities upon future achievement of certain commercial, development and regulatory milestones. Redemption fees due to the
IIA under the Innovation Law are due upon receipt of any milestone and royalties received under the Roche Agreement, see Note 14 (Commitment
and Contingencies) for additional information. Royalties, including those related to royalties we may receive under the Roche Agreement,
are payable to licensors or government entities based on a percentage of net sales of licensed products. Patent maintenance costs are
payable to licensors as reimbursement for the cost of maintaining license patents. Due to the contingent nature of the payments, the
amounts and timing of payments to licensors under our in-license agreements are uncertain and may fluctuate significantly from period
to period. As of June 30, 2023, we have not included these commitments on our consolidated balance sheet because the achievement and
timing of these events are not fixed and determinable.
33 | Page
As
discussed above, we have received grants under the Innovation Law and are required to pay royalties to the IIA from the revenues
generated from the sale of product candidates and related services developed, in whole or in part pursuant to, or as a result of, a
research and development program funded by the IIA. Under the Innovation Law, we are also required to pay redemption fees to the
IIA. To date, through a series of separate grants beginning in 2007, Cell Cure has received a total of $15.4 million from the IIA to
support the OpRegen program. We are obligated to pay approximately 24.3% of any future payments received under the Roche Agreement
to the IIA, up to an aggregate cap on all payments to IIA, such cap growing over time via interest accrual until paid in full, which
was approximately $92.1 million as of June 30, 2023. Redemption fees due to the IIA under the Innovation Law are due upon receipt of any milestone
payments and royalties received under the Roche Agreement. As of June 30, 2023, we have not included any future financial
obligations due to the IIA under the Innovation Law in our consolidated balance sheet because the achievement and timing of the
events that would require future payments to the IIA under the Innovation Law is not fixed and determinable. See Note 14
(Commitments and Contingencies) to our condensed consolidated interim financial statements included in this report for additional
information.
Under
the terms of the leases for the facilities from which Cell Cure and Lineage operate, a total of $3.8 million of rent payments will become
due, of which $0.6 million will become due in 2023.
In
the normal course of business, we enter into services agreements with contract research organizations, contract manufacturing organizations
and other third parties. Generally, these agreements provide for termination upon notice, with specified amounts due upon termination
based on the timing of termination and the terms of the agreement. The amounts and timing of payments under these agreements are uncertain
and contingent upon the initiation and completion of the services to be provided.
Future
Funding Requirements
At
June 30, 2023, we had an accumulated deficit of approximately $373.0 million. We expect to continue to incur losses for at least the
next several years. We expect that our operating expenses will continue to increase for the foreseeable future as we continue the development
of, and seek regulatory approval for, our product candidates. As a result, we will need significant additional capital to fund our operations.
Our determination as to when we will seek additional capital and the amount of additional capital that we will need will be based on
our evaluation of the progress we make in our research and development programs, changes to the scope and focus of those programs, changes
in grant funding for certain of those programs, and projection of future costs, revenues, and rates of expenditure. If we are unable
to raise additional capital when and as needed, we may be required to delay, postpone, or cancel our clinical trials or limit the number
of clinical trial sites.
We
may seek to obtain the additional capital we may need through one or more equity offerings, debt financings or other third-party funding,
including potential strategic alliances and licensing or collaboration agreements. We cannot assure that adequate additional capital
will be available on favorable terms, if at all. The issuance of additional securities, whether equity or debt, or the possibility of
such issuance, may cause the market price of our common shares to decline, and the issuance of additional equity securities could result
in the dilution of the interests of our current shareholders. If we obtain additional capital through strategic alliances and licensing
or collaboration agreements, we may be required to relinquish rights to our intellectual property, our product candidates or otherwise
agree to terms unfavorable to us. The unavailability or inadequacy of additional capital to meet future capital needs could force us
to modify, curtail, delay, or suspend some or all aspects of our current planned operations. Our ability to raise additional capital
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 recent pandemics, including the COVID-19 pandemic, the conflict in Ukraine,
rising inflation and interest rates, and other macroeconomic factors.
We
believe that our $45.9 million in cash, cash equivalents and marketable securities at June 30, 2023, provide sufficient liquidity to
carry out our current planned operations through at least twelve months from the issuance date of our condensed consolidated interim
financial statements included elsewhere in this report. We believe we will meet our longer-term expected future cash requirements and
obligations with our current cash and cash equivalents, milestone and other payments we expect to receive under our collaboration agreements,
and proceeds we receive from sales of our common shares under our at the market offering program.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Under
SEC rules and regulations, as a smaller reporting company, we are not required to provide the information required by this item.
34 | Page
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
It
is management’s responsibility to establish and maintain adequate internal control over all financial reporting pursuant to Rule
13a-15 under the Exchange Act. Our management, including our Chief Executive Officer and our Chief Financial Officer, reviewed and evaluated
the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Following this review
and evaluation , management collectively determined that our disclosure controls and procedures were effective as of the end of
the period covered by this report to ensure that information required to be disclosed by us in reports that we file or submit under the
Exchange Act: (i) is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms; and (ii)
is accumulated and communicated to management, including our chief executive officer and our chief financial officer, as appropriate
to allow timely decisions regarding required disclosure.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
We
are not currently a party to any material legal proceedings. From time-to-time we may be involved in a variety of legal proceedings.
Such proceedings may initially be viewed as immaterial but could later prove to be material. Legal proceedings are inherently unpredictable
and excessive verdicts do occur. Given the inherent uncertainties in litigation, even when we can reasonably estimate the amount of possible
loss or range of loss and reasonably estimable loss contingencies, the actual outcome may change in the future due to new developments
or changes in approach. In addition, legal proceedings could involve significant expense and diversion of management’s attention
and resources from other matters. For a discussion of legal proceedings in which we are involved, see Note 14 (Commitments and Contingencies)
in the Notes to the Condensed Consolidated Financial Statements in Part I, Item 1 of this report.
Item
1A. Risk Factors
An
investment in our common shares involves a high degree of risk. You should carefully consider the risks and uncertainties described in
the 2022 10-K, in addition to other information in this report, when evaluating our business and before deciding whether to purchase,
hold or sell our common shares. Each of these risks and uncertainties, as well as additional risks and uncertainties not presently known
to us or that we currently consider immaterial, could harm our business, financial condition, results of operations and/or growth prospects,
as well as adversely affect the market price of our common shares, in which case you may lose all or part of your investment. There have
been no material changes from the risk factors disclosed in Part I, Item 1A. Risk Factors in the 2022 10-K.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
Not
applicable.
Item
3. Default Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
35 | Page
Item
5. Other Information
(a)
None.
(b)
None.
(c)
Under SEC rules and regulations, as a smaller reporting company, we are not required to provide the information required by this
item in this report
Item
6. Exhibits
Incorporation
by Reference
Exhibit
Number
Description
Exhibit
Number
Filing
Filing
Date
File
No.
3.1
Restated Articles of Incorporation, as amended
3.1
10-Q
May 10, 2018
001-12830
3.2
Certificate of Ownership
3.1
8-K
August 12, 2019
001-12830
3.3
Amended and Restated Bylaws
3.2
8-K
August 12, 2019
001-12830
31.1*
Certification of Chief Executive Officer and Chief Financial Officer pursuant to Form of Rule 13a-14(a), as Adopted Pursuant to Section 302(a) of the Sarbanes-Oxley Act of 2002
32.1#
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101*
Interactive Data File
101.INS*
XBRL Instance Document
101.SCH*
XBRL Taxonomy Extension
Schema
101.CAL*
XBRL Taxonomy Extension
Calculation Linkbase
101.DEF*
XBRL Taxonomy Extension
Definition Document
101.LAB*
XBRL Taxonomy Extension
Label Linkbase
101.PRE*
XBRL Taxonomy Extension
Presentation Linkbase
104*
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
*
Filed herewith
#
Furnished herewith
36 | Page
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
LINEAGE CELL THERAPEUTICS, INC.
Date: August 10, 2023
/s/ Brian
M. Culley
Brian M. Culley
Chief
Executive Officer
Date: August 10, 2023
/s/ Jill
Ann Howe
Jill Ann Howe
Chief Financial Officer
37 | Page
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.