- Reported RG6501 (OpRegen®) Clinical Results at 2022 ARVO
Meeting; Outer Retinal Structure Improvement Observed in Five Dry
AMD Patients
- Expanded Pipeline with Two New Cell Therapy Development
Programs; Auditory Neurons and Photoreceptors
- Announced Completion of Enrollment in VAC2 Phase 1 NSCLC
Study by Cancer Research UK
- Cash and Cash Equivalents of $78.1 Million as of March 31,
2022
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 first quarter of 2022. Lineage management
will host a conference call and webcast today at 4:30 p.m. Eastern
Time/1:30 p.m. Pacific Time to discuss its first quarter 2022
financial and operating results and to provide a business
update.
“The first quarter of this year was highlighted by the rapid
launch of new cell therapy programs in hearing loss and vision
disorders and conducting tech transfer activities to support our
alliance with Roche and Genentech for our dry AMD program,” stated
Brian M. Culley, Lineage CEO. “Our broad strategic plan is to
position Lineage as a leader in regenerative medicine through the
transplant of specific cell types to treat significant unmet
medical needs. As part of that plan, we have expanded our cell
therapy pipeline to five distinct programs, each offering an
opportunity to impact various diseases. We believe our ability to,
in just a matter of months, advance from a product concept to
generating new intellectual property to support the manufacture of
specific cell types, is not only illustrative of the power and
efficiency of our platform but also a competitive advantage
compared to others in this field. Looking forward, our focus is on
clinical and regulatory execution across our portfolio. We are
working to advance OPC1 and VAC2 into their next phases of clinical
testing, in spinal cord injury and oncology, respectively, as well
as advancing our auditory neuron and photoreceptor programs through
preclinical development and toward pre-IND meetings with FDA. We
believe the combination of our disciplined use of capital and
current balance sheet will support multiple years of progress,
during which we anticipate reaching significant events with each of
our clinical and preclinical programs.”
Recent milestones include:
- Reported RG6501 (OpRegen) Phase 1/2a clinical results at 2022
Association for Research in Vision and Ophthalmology, Inc. (ARVO)
annual meeting: 12-month primary endpoint data support the
potential for OpRegen to slow, stop or reverse disease progression
in geographic atrophy (GA) secondary to age-related macular
degeneration (AMD); outer retinal structure improvement observed in
five dry AMD patients;
- Announced expansion of pipeline with addition of new cell
therapy program: allogeneic photoreceptor neural cell (PNC1)
transplants for the treatment of diseases which may lead to
blindness; dynamic culturing process offers path to clinical- and
industrial-scale production of photoreceptors; data generated
further demonstrated that a single cell suspension of photoreceptor
precursor cells has the potential to survive and mature
post-transplantation in a rodent model of retinal
degeneration;
- Announced completion of patient enrollment in Phase 1 clinical
study of VAC2 for the treatment of non-small cell lung cancer
(NSCLC) by Cancer Research UK; Lineage has now assumed
responsibility for further clinical development of VAC2 and any
future development opportunities derived from the VAC platform;
and
- Announced expansion of pipeline with addition of new cell
therapy program: auditory neuronal cells (ANP1) for the treatment
of hearing loss; intellectual property filed covering composition
and methods for generating auditory neuronal progenitors.
Some of the events and milestones anticipated by Lineage in
the rest of 2022 include:
- Investigational New Drug (“IND”) amendment submission to enable
clinical performance and safety testing of a novel parenchymal
spinal delivery system for OPC1, in Q4 2022;
- FDA interaction to discuss recent manufacturing improvements
made to OPC1, anticipated in Q4 2022;
- Clinical data update from the ongoing VAC2 Phase 1 non-small
cell lung cancer study; anticipated from CRUK in 2H 2022;
- An IND submission for VAC2 to support US-based clinical testing
in 2H 2022;
- Preclinical activities for both ANP1 and PNC1 programs; ongoing
throughout 2022;
- Additional OPC1 publications, including full clinical study
results from the SCiStar clinical study and an MRI findings paper;
anticipated in 2H 2022;
- Continued development of a cell-based therapeutic for
glioblastoma with our strategic partner, Immunomic Therapeutics;
ongoing throughout 2022;
- Evaluation of opportunities for new VAC product candidates
based on internally identified or partnered tumor antigens; ongoing
throughout 2022;
- Evaluation of new funded partnership opportunities and/or
expansion of existing collaborations; ongoing throughout 2022;
and
- Continued participation in numerous investor and partnering
meetings and medical and industry conferences to broaden awareness
of our mission and accomplishments.
Balance Sheet Highlights
Cash and cash equivalents totaled $78.1 million as of March 31,
2022.
First Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research
grants, royalties, and licensing fees. Total revenues for the three
months ended March 31, 2022 were $5.2 million, an increase of $4.8
million as compared to $0.4 million for the same period in 2021.
The increase was primarily related to licensing fees recognized
from deferred revenues in connection with the $50.0 million upfront
licensing payment received in the first quarter of 2022 from
Roche.
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 March 31, 2022 were $11.5 million, an increase of $4.2
million as compared to $7.3 million for the same period in 2021,
primarily attributable to a $3.5 million non-recurring expense
related to the potential settlement of the litigation concerning
our 2019 acquisition of Asterias (“Asterias Litigation”).
R&D Expenses: R&D expenses for the three months ended
March 31, 2022 were $3.0 million, a decrease of $0.4 million as
compared to $3.4 million for the same period in 2021. The decrease
was driven by $0.7 million in lower expenses for the OPC1 program,
partially offset by $0.2 million and $0.1 million in higher
expenses to support the VAC program and OpRegen related expenses to
support the Roche Collaboration, respectively. Another $0.1 million
of the offsetting increase was related to initial costs to support
the new auditory neuron cell therapy program.
G&A Expenses: G&A expenses for the three months ended
March 31, 2022 were $8.5 million, an increase of $4.6 million as
compared to $3.9 million for the same period in 2021. The increase
was primarily attributable to the $3.5 million non-recurring
expense related to the potential settlement of the Asterias
Litigation, and $0.5 million in share-based compensation.
Loss from Operations: Loss from operations for the three months
ended March 31, 2022 was $6.4 million, a decrease of $0.7 million
as compared to $7.1 million for the same period in 2021.
Other Income/(Expenses), Net: Other income (expenses), net for
the three months ended March 31, 2022 reflected other expense, net
of ($0.7) million, compared to other income, net of $5.6 million
for the same period in 2021. The net change of ($6.3) million was
primarily related to the gain on sale of marketable securities in
the prior year.
Net Loss Attributable to Lineage: The net loss attributable to
Lineage for the three months ended March 31, 2022 was $7.1 million,
or $0.04 per share (basic and diluted), compared to a net loss
attributable to Lineage of $1.4 million, or $0.01 per share (basic
and diluted), for the same period in 2021.
Conference Call and Webcast
Interested parties may access today’s conference call by dialing
(866) 888-8633 from the U.S. and Canada and (636) 812-6629 from
elsewhere outside 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 May 20, 2022, by dialing (855) 859-2056 from the U.S. and
Canada and (404) 537-3406 from elsewhere outside the U.S. and
Canada and entering conference ID number 1875641.
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
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 1/2a
development for the treatment of geographic atrophy secondary to
age-related macular degeneration, which 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 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 collaboration and license agreement with Roche and
Genentech, activities expected to occur thereunder, the potential
to receive upfront, milestone and royalty consideration payable to
Lineage thereunder; the potential benefits of treatment with
OpRegen; the power and efficiency of Lineage’s platform and its
competitive advantages; the ability of Lineage’s resources to
support multiple years of progress; the potential future
achievements of Lineage’s clinical and preclinical programs; the
timing of potential FDA interactions, and of anticipated clinical
trials and clinical data updates; and plans and expectations of
Lineage’s products in development. 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 risk 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; the risk that competing alternative
therapies may adversely impact the commercial potential of OpRegen;
the risk that Roche and Genentech may not be successful in
completing further clinical trials for OpRegen and/or obtaining
regulatory approval for OpRegen in any particular jurisdiction; the
risk that Lineage may not be able to manufacture sufficient
clinical quantities of its product candidates in accordance with
current good manufacturing practice; 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 and Quarterly Report on Form 10-Q
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. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS)
March 31, 2022
(Unaudited)
December 31, 2021
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
78,062
$
55,742
Marketable equity securities
1,882
2,616
Accounts and grants receivable, net
515
50,840
Prepaid expenses and other current
assets
1,413
2,351
Total current assets
81,872
111,549
NONCURRENT ASSETS
Property and equipment, net
4,548
4,872
Deposits and other long-term assets
639
630
Goodwill
10,672
10,672
Intangible assets, net
46,789
46,822
TOTAL ASSETS
$
144,520
$
174,545
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
8,957
$
27,969
Lease liabilities, current portion
719
801
Financing lease, current portion
31
30
Deferred revenues
14,885
18,119
Liability classified warrants, current
portion
1
197
Total current liabilities
24,593
47,116
LONG-TERM LIABILITIES
Deferred tax liability
2,076
2,076
Deferred revenues, net of current
portion
30,821
32,454
Lease liability, net of current
portion
1,781
1,941
Financing lease, net of current
portion
26
30
Liability classified warrants and other
long-term liabilities
5
30
TOTAL LIABILITIES
59,302
83,647
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized
2,000 shares; none issued and outstanding as of March 31, 2022 and
December 31, 2021
-
-
Common shares, no par value, 250,000
shares authorized; 169,727 and 169,477 shares issued and
outstanding as of March 31, 2022 and December 31, 2021,
respectively
435,818
434,529
Accumulated other comprehensive loss
(5,087
)
(5,211
)
Accumulated deficit
(344,184
)
(337,097
)
Lineage Cell Therapeutics, Inc.
shareholders’ equity
86,547
92,221
Noncontrolling (deficit)
(1,329
)
(1,323
)
Total shareholders’ equity
85,218
90,898
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
144,520
$
174,545
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
(UNAUDITED)
Three Months Ended March
31,
2022
2021
REVENUES:
Collaboration revenues
$
4,865
$
-
Royalties
372
293
Grant revenues
-
98
Total revenues
5,237
391
Cost of sales
(176
)
(112
)
Gross profit
5,061
279
OPERATING EXPENSES:
Research and development
2,988
3,394
General and administrative
8,469
3,935
Total operating expenses
11,457
7,329
Loss from operations
(6,396
)
(7,050
)
OTHER INCOME/(EXPENSES):
Interest income, net
1
2
Gain on sale of marketable securities
-
6,024
Unrealized (loss) gain on marketable
equity securities
(735
)
1,239
Unrealized gain on warrant liability
221
18
Other (expenses), net
(184
)
(1,681
)
Total other income (expenses), net
(697
)
5,602
LOSS BEFORE INCOME TAXES
(7,093
)
(1,448
)
Deferred income tax benefit
-
-
NET LOSS
(7,093
)
(1,448
)
Net loss attributable to noncontrolling
interest
6
32
NET LOSS ATTRIBUTABLE TO LINEAGE CELL
THERAPEUTICS, INC.
$
(7,087
)
$
(1,416
)
NET LOSS PER COMMON SHARE:
BASIC
$
(0.04
)
$
(0.01
)
DILUTED
$
(0.04
)
$
(0.01
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC
169,647
158,725
DILUTED
169,647
158,725
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Three Months Ended March
31,
2022
2021
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to Lineage Cell
Therapeutics, Inc.
$
(7,087
)
$
(1,416
)
Net loss allocable to noncontrolling
interest
(6
)
(32
)
Adjustments to reconcile net loss
attributable to Lineage Cell Therapeutics, Inc. to net cash used in
operating activities:
Gain on sale of marketable securities
-
(6,024
)
Unrealized loss/(gain) on marketable
equity securities
735
(1,239
)
Depreciation expense, including
amortization of leasehold improvements
150
174
Amortization of right-of-use asset
(4
)
10
Amortization of intangible assets
32
112
Stock-based compensation
1,106
539
Common stock issued for services
-
102
Change in unrealized gain on warrant
liability
(221
)
(18
)
Foreign currency remeasurement and other
gain
75
1,712
Changes in operating assets and
liabilities:
Accounts and grants receivable
50,321
(135
)
Prepaid expenses and other current
assets
573
(92
)
Accounts payable and accrued
liabilities
(18,905
)
(1,031
)
Deferred revenue and other liabilities
(4,865
)
(86
)
Net cash provided by (used in) operating
activities
21,904
(7,424
)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from the sale of OncoCyte common
shares
-
10,064
Proceeds from the sale of HBL common
shares
-
21
Purchase of equipment and other assets
(46
)
(11
)
Net cash (used in) provided by investing
activities
(46
)
10,074
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from employee options
exercised
379
1,717
Common shares received and retired for
employee taxes paid
(8
)
(13
)
Proceeds from exercise of subsidiary
warrants
2
-
Proceeds from sale of common shares
148
19,873
Payments for offering costs
-
(614
)
Repayment of lease liability
(8
)
-
Net cash provided by financing
activities
513
20,963
Effect of exchange rate changes on cash,
cash equivalents and restricted cash
(42
)
(80
)
NET INCREASE IN CASH, CASH EQUIVALENTS AND
RESTRICTED CASH
22,329
23,533
CASH, CASH EQUIVALENTS AND RESTRICTED
CASH:
At beginning of the period
56,277
33,183
At end of the period
$
78,606
$
56,716
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005185/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Justin Frantz
(jfrantz@soleburytrout.com ) (617) 221-9100
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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