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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 9, 2023
Lineage
Cell Therapeutics, Inc.
(Exact
name of registrant as specified in charter)
California |
|
001-12830 |
|
94-3127919 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
2173
Salk Avenue, Suite 200
Carlsbad,
California |
|
92008 |
(Address of principal executive
offices) |
|
(Zip Code) |
(442)
287-8990
Registrant’s
telephone number, including area code
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common shares |
|
LCTX |
|
NYSE American |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item
2.02. Results of Operations and Financial Condition.
On
November 9, 2023, Lineage Cell Therapeutics, Inc. issued a press release announcing financial results for the quarter ended September
30, 2023, a copy of which is furnished as Exhibit 99.1.
The
information under this Item 2.02 and in Exhibit 99.1 is being furnished and is not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), and is not to be incorporated by reference into any
filing of the registrant under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof,
regardless of any general incorporation language in any such filing, except as shall be expressly set forth by specific reference in
such a filing.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
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 hereunto duly authorized.
|
Lineage Cell Therapeutics, Inc. |
|
|
|
Date: November 9, 2023 |
By: |
/s/ George
A. Samuel III |
|
Name: |
George A. Samuel III |
|
Title: |
General Counsel and Corporate Secretary |
Exhibit
99.1
LINEAGE
CELL THERAPEUTICS REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
|
● |
Enrollment
Continues in Phase 2a Clinical Study of RG6501 (OpRegen®) in Patients with Geographic Atrophy (GA) Secondary to Age-Related
Macular Degeneration (AMD) Under Management of Genentech, a Member of the Roche Group |
|
|
|
|
● |
Additional
RG6501 (OpRegen®) Data Presented at 23rd Annual EURETINA Congress and 2023 Eyecelerator Meetings |
|
|
|
|
● |
U.S.
Patent Issued Covering Manufacturing and Differentiation Process for Retinal Pigment Epithelial (RPE) Cells |
|
|
|
|
● |
Company
On Track to Submit OPC1 Investigational New Drug Amendment in Q4 2023 |
|
|
|
|
● |
Initiated
Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications Under Partnership with Eterna Therapeutics |
CARLSBAD,
CA – November 9, 2023 - Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology
company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the third quarter
ended September 30, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business
update.
“The
Lineage team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs, supporting our
alliances and working to establish new collaborations,” stated Brian M. Culley, Lineage CEO. “The most important area of
attention for our team remains our partnership with Roche and Genentech and our support for the ongoing Phase 2a clinical study of OpRegen
in patients with geographic atrophy secondary to AMD. Through presentations at medical and scientific conferences, we have broadened
awareness of OpRegen’s potential to provide durable anatomical and functional improvements in patients with GA. Most recently,
additional observations of rapid improvements to outer retinal structure in the initial Phase 1/2a clinical study of OpRegen were reported;
improvements were detectable within the first three months following a single administration, suggesting that OpRegen RPE cells may provide
support to the patients’ remaining retinal cells within atrophic areas. Looking forward, we are working with our partners, Roche,
and Genentech, on additional clinical data updates on the OpRegen program.”
“In
addition, our team continued the necessary work to submit our Investigational New Drug amendment for OPC1 to enable us to initiate the
DOSED clinical study in subacute and chronic spinal cord injury patients,” Mr. Culley added. “In parallel, we also initiated
certain development activities under our partnership with Eterna Therapeutics, reflecting a key step in a corporate strategy to capitalize
on our existing process development capabilities by combining them with cutting-edge cell engineering and editing technologies, to create
novel and potentially superior product profiles. As always, we intend to advance our business and programs in a responsible and fiscally
conservative way, with an overarching focus on providing a meaningful impact for patients through the development of differentiated allogeneic
cell transplants.”
Recent
milestones and activities included:
| ○ | Continued
execution under our collaboration with Roche and Genentech across multiple functional
areas, including support for the ongoing Phase 2a multi-center clinical study in patients
with GA secondary to AMD. Additional sites expected to come online for the Phase 2a study. |
| ○ | Results
of imaging analyses demonstrating rapid improvement in outer retinal structure from patients
enrolled in the prior Phase 1/2a clinical study, were presented at the 23rd
EURETINA Congress: |
| ● | All
five patients who had extensive coverage of the GA lesion with the surgical bleb containing
OpRegen in suspension demonstrated evidence of improvement in outer retinal structure as
assessed by optical coherence tomography (OCT) within the first three months after treatment. |
| ● | Retinal
structural improvements were initially observed on day 1 (n=1), day 14 (n=1), month 1 (n=2),
and month 3 (n=1). |
| ● | Structural
improvement on OCT was qualitatively defined as meeting all pre-specified criteria on at
least two non-adjacent B scans including: 1) reduction in outer plexiform layer (OPL) and/or
inner nuclear layer (INL) subsidence; 2) reappearance of external limiting membrane (ELM);
and 3) increased hyperreflectivity and/or thickness of RPE and/or Bruch’s membrane
or reduction of hypertransmission on at least two non-adjacent B scans. |
| | |
| ● | Structural
improvement was only observed within GA lesions with extensive coverage with the surgical
bleb, suggesting that OpRegen RPE cells provide support to the remaining retinal cells within
atrophic areas. |
| ● | These
five patients had an average of 4.4 letter best corrected visual acuity (BCVA) gain by 3
months and 12.8 letter BCVA gain by 1 year compared to baseline. |
| ○ | U.S.
Patent No.11,746,324 entitled “Large Scale Production of Retinal Pigment Epithelial
Cells,” issued. |
| - | Investigational
New Drug (IND) amendment preparation for clinical testing of novel OPC1 spinal cord delivery
system continues |
| ○ | Company
remains on track to submit IND amendment to FDA in Q4 2023 to enable initiation of the DOSED
clinical study in subacute and chronic spinal cord injury patients. |
| - | Initiated
Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications
Under Partnership with Eterna Therapeutics |
| ○ | Lineage
evaluated its development strategy with a group of leading neurology experts in the U.S.
and abroad and following an assessment of the competitive landscape, finalized its selection
of specific gene edits for the initial cell lines to be developed by Eterna. |
| | |
| ● | The
edits include: the targeted deletion of the B2M gene, designed to reduce the immunogenicity
of product candidates derived from the lines by inhibiting rejection by CD8+ T cells; the
targeted insertion of the HLA-E gene, designed to overexpress HLA-E and prevent the allogeneic
NK cell response; and a third undisclosed edit intended to confer clinical differentiation
and a competitive advantage in the applicable indications. |
| - | Positive
ANP1 initial proof of concept results from collaboration with the University of Michigan |
| | |
| ○ | Initial
results demonstrated delivery, engraftment, and survival of ANP1 cells into specific target
areas. |
| | |
| ○ | Results
support advancement of the ANP1 program into functional preclinical testing. |
Balance
Sheet Highlights
Cash,
cash equivalents, and marketable securities totaled $41.3 million as of September 30, 2023, which is expected to support planned operations
into Q1 2025.
Third
Quarter Operating Results
Revenues:
Lineage’s revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues
for the three months ended September 30, 2023 were $1.2 million, a net decrease of $1.8 million as compared to approximately $3.0 million
for the same period in 2022. The decrease was primarily driven by lower collaboration and licensing revenue recognized from deferred
revenues from the Collaboration and License Agreement among Lineage and Roche and Genentech entered into in December 2021.
Operating
Expenses: Operating expenses are comprised of research and development (“R&D”) expenses and general and administrative
(“G&A”) expenses. Total operating expenses for the three months ended September 30, 2023 were $7.8 million, a decrease
of $0.2 million as compared to $8.0 million for the same period in 2022.
R&D
Expenses: R&D expenses for the three months ended September 30, 2023 were $3.7 million, a net increase of $0.1 million as compared
to $3.6 million for the same period in 2022. The net increase was primarily driven by $0.2 million in higher OPC1 program-related expenses,
and $0.5 million in expenses to support preclinical and other research and development programs. These increases were partially offset
by a $0.5 million decrease in our VAC program, primarily related to reduced manufacturing activities.
G&A
Expenses: G&A expenses for the three months ended September 30, 2023 were $4.0 million, a net decrease of approximately $0.4
million as compared to $4.4 million for the same period in 2022. The decrease was primarily attributable to an overall reduction in costs
incurred for services by third parties, consulting costs, and recruiting related expenses.
Loss
from Operations: Loss from operations for the three months ended September 30, 2023 was $6.7 million, an increase of $1.5 million
as compared to a loss of $5.2 million for the same period in 2022.
Other
Income/(Expenses), Net: Other income (expenses), net for the three months ended September 30, 2023 reflected other expense, net of
approximately ($0.4) million, compared to other expense, net of ($0.3) million for the same period in 2022. The net change was primarily
driven by exchange rate fluctuations related to Lineage’s international subsidiaries and fair market value changes in marketable
equity securities, partially offset by interest income from our marketable debt securities.
Net
Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2023 was $7.1 million,
or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $6.1 million, or $0.04 per share (basic and
diluted), for the same period in 2022.
Conference
Call and Webcast
Interested
parties may access today’s conference call and webcast, by dialing (800) 715-9871 from the U.S. and Canada and should request the
“Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors
section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone
replay will be available through November 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number
2323932.
About
Lineage Cell Therapeutics, Inc.
Lineage
Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s
programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities.
With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor
cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent
due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to
cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic
(“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for
the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration
with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development
for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform
for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer;
(iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor
neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please
visit www.lineagecell.com or follow the company on Twitter @LineageCell.
Forward-Looking
Statements
Lineage
cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.
Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “design,” “intend,”
“expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,”
“should,” “would,” “contemplate,” “project,” “target,” “tend to,”
or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating
to: the potential benefits of OpRegen and the expansion of the Phase 2a clinical study of OpRegen to additional clinical sites; that
our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the first quarter of 2025;
the timing of anticipated regulatory submissions to the FDA related to our programs, the potential future achievements of our clinical,
preclinical and development programs, the initiation of clinical trials and the timing and availability of clinical data updates related
to our programs; plans and expectations regarding existing collaborations; and the potential of our cell therapy platform and our ability
to provide an meaningful impact for patients. Forward-looking statements involve known and unknown risks, uncertainties and other factors
that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance
or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following
risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash, cash equivalents and marketable
securities more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may
not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that OpRegen may never be proven to
provide durable anatomical functional improvements in dry-AMD patients, that competing alternative therapies may adversely impact the
commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further
clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that the feedback received
from the FDA for OPC1 may not enable further clinical development; that the ongoing Israel-Hamas war may materially and adversely impact
our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are
conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product
candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business
and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking
statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All
forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these
and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including
Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s
website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were
made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date
on which they were made, except as required by law.
Lineage
Cell Therapeutics, Inc. IR
Ioana
C. Hone
(ir@lineagecell.com)
(442)
287-8963
LifeSci
Advisors
Daniel
Ferry
(daniel@lifesciadvisors.com)
(617)
430-7576
Russo
Partners – Media Relations
Nic
Johnson or David Schull
(Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com)
(212)
845-4242
Tables
to follow
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
| |
September
30, 2023 | | |
December
31, | |
| |
(Unaudited) | | |
2022 | |
ASSETS | |
| | | |
| | |
CURRENT ASSETS | |
| | | |
| | |
Cash and cash
equivalents | |
$ | 31,474 | | |
$ | 11,355 | |
Marketable securities | |
| 9,858 | | |
| 46,520 | |
Accounts receivable, net | |
| 432 | | |
| 297 | |
Prepaid
expenses and other current assets | |
| 1,717 | | |
| 1,828 | |
Total current assets | |
| 43,481 | | |
| 60,000 | |
| |
| | | |
| | |
NONCURRENT ASSETS | |
| | | |
| | |
Property and equipment,
net | |
| 4,854 | | |
| 5,673 | |
Deposits and other long-term
assets | |
| 552 | | |
| 627 | |
Goodwill | |
| 10,672 | | |
| 10,672 | |
Intangible
assets, net | |
| 46,594 | | |
| 46,692 | |
TOTAL
ASSETS | |
$ | 106,153 | | |
$ | 123,664 | |
| |
| | | |
| | |
LIABILITIES AND SHAREHOLDERS’
EQUITY | |
| | | |
| | |
CURRENT LIABILITIES | |
| | | |
| | |
Accounts payable and accrued
liabilities | |
$ | 5,030 | | |
$ | 8,608 | |
Lease liabilities, current
portion | |
| 881 | | |
| 916 | |
Financing lease, current
portion | |
| 55 | | |
| 36 | |
Deferred
revenues | |
| 9,915 | | |
| 9,421 | |
Total current liabilities | |
| 15,881 | | |
| 18,981 | |
| |
| | | |
| | |
LONG-TERM LIABILITIES | |
| | | |
| | |
Deferred tax liability | |
| 273 | | |
| 2,076 | |
Deferred revenues, net
of current portion | |
| 21,195 | | |
| 27,725 | |
Lease liability, net of
current portion | |
| 2,047 | | |
| 2,860 | |
Financing lease, net of
current portion | |
| 97 | | |
| 84 | |
Other
long-term liabilities | |
| - | | |
| 2 | |
TOTAL LIABILITIES | |
| 39,493 | | |
| 51,728 | |
| |
| | | |
| | |
| |
| | | |
| | |
SHAREHOLDERS’ EQUITY | |
| | | |
| | |
Preferred shares, no par value, authorized
2,000 shares; none issued and outstanding as of September 30, 2023 and December 31, 2022 | |
| - | | |
| - | |
Common shares, no par value, 450,000 and
250,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; 174,987 and 170,093 shares issued
and outstanding as of September 30, 2023 and December 31, 2022, respectively | |
| 450,282 | | |
| 440,280 | |
Accumulated other comprehensive
loss | |
| (2,084 | ) | |
| (3,571 | ) |
Accumulated
deficit | |
| (380,081 | ) | |
| (363,370 | ) |
Lineage Cell Therapeutics, Inc. shareholders’
equity | |
| 68,117 | | |
| 73,339 | |
Noncontrolling
deficit | |
| (1,457 | ) | |
| (1,403 | ) |
Total shareholders’
equity | |
| 66,660 | | |
| 71,936 | |
TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY | |
$ | 106,153 | | |
$ | 123,664 | |
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(IN
THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
| |
Three Months ended
September 30, | | |
Nine
Months ended
September
30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
REVENUES: | |
| | | |
| | | |
| | | |
| | |
Collaboration
revenues | |
$ | 957 | | |
$ | 2,592 | | |
$ | 5,949 | | |
$ | 11,605 | |
Royalties
and license fees | |
| 289 | | |
| 406 | | |
| 908 | | |
| 1,183 | |
Total revenues | |
| 1,246 | | |
| 2,998 | | |
| 6,857 | | |
| 12,788 | |
| |
| | | |
| | | |
| | | |
| | |
Cost of sales | |
| (169 | ) | |
| (235 | ) | |
| (415 | ) | |
| (626 | ) |
| |
| | | |
| | | |
| | | |
| | |
Gross profit | |
| 1,077 | | |
| 2,763 | | |
| 6,442 | | |
| 12,162 | |
| |
| | | |
| | | |
| | | |
| | |
OPERATING EXPENSES: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 3,741 | | |
| 3,592 | | |
| 11,799 | | |
| 9,883 | |
General
and administrative | |
| 4,041 | | |
| 4,422 | | |
| 13,014 | | |
| 18,160 | |
Total
operating expenses | |
| 7,782 | | |
| 8,014 | | |
| 24,813 | | |
| 28,043 | |
Loss from operations | |
| (6,705 | ) | |
| (5,251 | ) | |
| (18,371 | ) | |
| (15,881 | ) |
OTHER INCOME (EXPENSES): | |
| | | |
| | | |
| | | |
| | |
Interest income, net | |
| 433 | | |
| 384 | | |
| 1,225 | | |
| 435 | |
Loss on marketable equity
securities, net | |
| (60 | ) | |
| (233 | ) | |
| (170 | ) | |
| (1,677 | ) |
Gain on revaluation of
warrant liability | |
| - | | |
| - | | |
| 1 | | |
| 223 | |
Other
expenses, net | |
| (826 | ) | |
| (475 | ) | |
| (1,253 | ) | |
| (2,550 | ) |
Total
other income (expenses), net | |
| (453 | ) | |
| (324 | ) | |
| (197 | ) | |
| (3,569 | ) |
LOSS BEFORE INCOME TAXES | |
| (7,158 | ) | |
| (5,575 | ) | |
| (18,568 | ) | |
| (19,450 | ) |
| |
| | | |
| | | |
| | | |
| | |
Provision
for income tax benefit (expense) | |
| - | | |
| (541 | ) | |
| 1,803 | | |
| (541 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS | |
| (7,158 | ) | |
| (6,116 | ) | |
| (16,765 | ) | |
| (19,991 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net
loss attributable to noncontrolling interest | |
| 48 | | |
| 47 | | |
| 54 | | |
| 72 | |
| |
| | | |
| | | |
| | | |
| | |
NET
LOSS ATTRIBUTABLE TO LINEAGE CELL THERAPEUTICS, INC. | |
$ | (7,110 | ) | |
$ | (6,069 | ) | |
$ | (16,711 | ) | |
$ | (19,919 | ) |
| |
| | | |
| | | |
| | | |
| | |
NET LOSS PER COMMON SHARE: | |
| | | |
| | | |
| | | |
| | |
Basic
and Diluted | |
$ | (0.04 | ) | |
$ | (0.04 | ) | |
$ | (0.10 | ) | |
$ | (0.12 | ) |
| |
| | | |
| | | |
| | | |
| | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: | |
| | | |
| | | |
| | | |
| | |
Basic
and Diluted | |
| 174,868 | | |
| 169,786 | | |
| 171,880 | | |
| 169,722 | |
LINEAGE
CELL THERAPEUTICS, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN
THOUSANDS)
(UNAUDITED)
| |
Nine Months ended
September 30, | |
| |
2023 | | |
2022 | |
CASH FLOWS FROM OPERATING
ACTIVITIES: | |
| | | |
| | |
Net loss attributable to Lineage
Cell Therapeutics, Inc. | |
$ | (16,711 | ) | |
$ | (19,919 | ) |
Net loss allocable to noncontrolling interest | |
| (54 | ) | |
| (72 | ) |
Adjustments to reconcile net loss attributable
to Lineage Cell Therapeutics, Inc. to net cash (used in) provided by operating activities: | |
| | | |
| | |
Loss on marketable equity
securities, net | |
| 170 | | |
| 1,677 | |
Accretion of income on
marketable debt securities | |
| (647 | ) | |
| (186 | ) |
Depreciation expense, including
amortization of leasehold improvements | |
| 419 | | |
| 441 | |
Change in right-of-use
assets and liabilities | |
| 86 | | |
| (24 | ) |
Amortization of intangible
assets | |
| 98 | | |
| 113 | |
Stock-based compensation | |
| 3,580 | | |
| 3,328 | |
Gain on revaluation of
warrant liability | |
| (1 | ) | |
| (223 | ) |
Deferred income tax benefit | |
| (1,803 | ) | |
| - | |
Foreign currency remeasurement
and other loss | |
| 1,893 | | |
| 2,668 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable, net | |
| (141 | ) | |
| 50,206 | |
Prepaid expenses and other
current assets | |
| 56 | | |
| 517 | |
Accounts payable and accrued
liabilities | |
| (3,456 | ) | |
| (17,573 | ) |
Deferred
revenue and other liabilities | |
| (6,036 | ) | |
| (11,591 | ) |
Net cash (used in) provided
by operating activities | |
| (22,547 | ) | |
| 9,362 | |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING
ACTIVITIES: | |
| | | |
| | |
Proceeds from the sale
of marketable equity securities | |
| 196 | | |
| - | |
Purchases of marketable
debt securities | |
| (16,403 | ) | |
| (40,628 | ) |
Maturities of marketable
debt securities | |
| 53,497 | | |
| - | |
Purchase of equipment | |
| (583 | ) | |
| (429 | ) |
Net cash provided by
(used in) investing activities | |
| 36,707 | | |
| (41,057 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING
ACTIVITIES: | |
| | | |
| | |
Proceeds from employee
options exercised | |
| 88 | | |
| 506 | |
Common shares received
and retired for employee taxes paid | |
| (37 | ) | |
| (17 | ) |
Proceeds from exercise
of subsidiary warrants, net | |
| - | | |
| 991 | |
Proceeds from sale of common
shares | |
| 6,625 | | |
| 148 | |
Payments for offering costs | |
| (199 | ) | |
| (95 | ) |
Repayment
of financing lease liability | |
| (41 | ) | |
| (23 | ) |
Net cash provided by
financing activities | |
| 6,436 | | |
| 1,510 | |
Effect of exchange rate
changes on cash, cash equivalents and restricted cash | |
| (532 | ) | |
| (795 | ) |
NET INCREASE IN CASH, CASH
EQUIVALENTS AND RESTRICTED CASH | |
| 20,064 | | |
| (30,980 | ) |
| |
| | | |
| | |
CASH, CASH EQUIVALENTS AND RESTRICTED CASH: | |
| | | |
| | |
At beginning of the
period | |
| 11,936 | | |
| 56,277 | |
At end of the period | |
$ | 32,000 | | |
$ | 25,297 | |
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