- OpRegen® Continues to Demonstrate Functional and Anatomical
Improvements in Patients with Dry AMD
- Performance Testing Underway to Support New Delivery Device
for OPC1 Clinical Trials
- Cash, Cash Equivalents, and Marketable Securities of $65.1
Million
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 2021. Lineage will host a
conference call today at 4:30 p.m. Eastern Time to discuss its
third quarter 2021 financial results and to provide a business
update.
“Lineage’s approach is to produce specific types of human cells
and stably transplant those cells as a treatment for serious
medical conditions. We believe our approach, in certain settings,
can generate clinical outcomes beyond the reach of traditional
methods, as evidenced by the restoration of retinal tissue in
patients in our dry AMD trial and the restoration of a tissue
matrix in patients in our spinal cord injury trial,” stated Brian
M. Culley, Lineage CEO. “During the third quarter, we reported
positive interim outcomes in patients with dry AMD with geographic
atrophy, initiated performance testing of our OPC1 delivery device
for spinal cord injury, and we expanded our executive team with the
appointment of a new General Counsel. Looking ahead, we are
preparing for engagement with FDA for our OpRegen program to
discuss aspects of product designation, manufacturing plans, and
later-stage clinical development. In parallel, we look forward to
the initiation of our OPC1 and novel delivery device clinical
safety study early next year. We believe our technology platform
has broad potential beyond even the indications we currently are
pursuing and while we continue to advance our three clinical-stage
programs, we also are evaluating new applications of our
technology, either on our own or through strategic alliances.”
Some of the milestones achieved in the third quarter
include:
- Presented OpRegen clinical data at the 54th Annual Scientific
Meeting of the American Retina Society from the ongoing Phase 1/2a
study of OpRegen for the treatment of dry-AMD with GA;
statistically significant evidence of a treatment effect with
OpRegen was observed in Cohort 4 better vision patients.
- Reported continued positive interim clinical data with
OpRegen: 8/12 (67%) of the Cohort 4 patients’ treated eyes were at
or above baseline visual acuity at their last assessment, based on
per protocol scheduled visits ranging from 9 months to over 3 years
post-transplant, while visual acuity predictably declined in the
majority of untreated eyes; notably, three patients with evidence
of retinal restoration and confirmed history of GA growth continued
to demonstrate areas of retinal restoration as of their last per
protocol assessments, ranging from 9 months to 33 months following
treatment.
- Announced the appointment of George A. Samuel III as General
Counsel and Corporate Secretary. Mr. Samuel brings extensive
corporate, transactional, intellectual property and commercial
expertise which spans nearly 15 years across the life sciences and
technology sectors as well as in private practice.
- Featured in the B. Riley Securities Fall 2021 “Growth Biotech
Best Idea” Virtual Series as well as the 2021 Cantor Fitzgerald
Virtual Global Healthcare Conference.
Some of the events and milestones anticipated by Lineage
include:
- OpRegen Program
- Additional interim data from the Phase 1/2a clinical study to
be featured at the 2021 American Academy of Ophthalmology Annual
Meeting in a presentation on November 13, 2021, as part of the Gene
and Cell-Based Therapies Session, by Michael S. Ip, M.D.,
Professor, Department of Ophthalmology at the David Geffen School
of Medicine at the University of California, Los Angeles.
- Multiple interactions with the U.S. Food and Drug
Administration (FDA) planned to discuss product designation,
manufacturing plans, and later-stage clinical development,
anticipated to begin in Q4 2021 and continue in Q1 2022.
- OPC1 Program
- Complete evaluation of a novel Parenchymal Spinal Delivery
(PSD) system in non-clinical testing; anticipated in Q4 2021.
- Complete GMP production of OPC1 via an improved and
larger-scale manufacturing process and a new thaw-and-inject
formulation; anticipated in Q1 2022.
- FDA interaction to discuss recent manufacturing improvements
made to OPC1; anticipated in Q1 2022.
- Initiation of clinical performance and safety testing of the
novel PSD device for OPC1; anticipated Investigational New Drug
(IND) amendment submission in Q1 2022.
- VAC Programs
- Completion of enrollment by Cancer Research UK in the ongoing
VAC2 Phase 1 non-small cell lung cancer study; anticipated in Q1
2022.
- Continued development of a dendritic cell-based therapeutic for
glioblastoma with our strategic partner; ongoing throughout
2022.
- Evaluation of opportunities for new VAC product candidates
based on internally identified or partnered tumor antigens; ongoing
throughout 2022.
- Business Development
- Evaluation of partnership opportunities and expansion of
existing collaborations; ongoing throughout 2022.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled $65.1
million as of September 30, 2021. Marketable securities of $4.3
million as of September 30, 2021 include the Company’s remaining
ownership in OncoCyte Corporation (“OncoCyte”) and Hadasit
Bio-Holdings Ltd.
Third Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research
grants, royalties, and licensing fees. Total revenues for the three
months ended September 30, 2021 were approximately $2.3 million, an
increase of $1.7 million as compared to $0.6 million for the same
period in 2020. The increase was primarily related to a $1.6
million increase in royalty revenues, and a $0.3 million increase
in licensing revenues in connection with a collaboration agreement,
partially offset by a $0.2 million decrease in grant revenues.
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, 2021 were $8.1 million, an increase of $0.9
million as compared to $7.2 million for the same period in
2020.
R&D Expenses: R&D expenses for the three months ended
September 30, 2021 were $2.8 million, a decrease of approximately
$0.8 million as compared to $3.6 million for the same period in
2020. The decrease was primarily driven by lower VAC program
expenses, related to a non-recurring prior year accrual of a $1.6
million signature fee to Cancer Research UK, partially offset by an
increase in OPC1 expenses resulting from a return of unspent
project funds of approximately $0.8 million in the prior year
period from a former Asterias BioTherapeutics, Inc. (“Asterias”)
service provider.
G&A Expenses: G&A expenses for the three months ended
September 30, 2021 were $5.3 million, an increase of approximately
$1.7 million as compared to $3.6 million for the same period in
2020. The increase was primarily attributable to increases of $0.8
million in litigation and other expenses related to Lineage’s
merger with Asterias, and $0.5 million in share-based
compensation.
Loss from Operations: Loss from operations for the three months
ended September 30, 2021 was approximately $6.8 million, an
increase of $0.1 million as compared to $6.7 million for the same
period in 2020.
Other Income/(Expenses), Net: Other income/(expenses), net for
the three months ended September 30, 2021 reflected other expense,
net of ($2.0) million, compared to other expense, net of ($1.2)
million for the same period in 2020. The variance was primarily
related to a decrease in the value of Lineage’s OncoCyte shares, a
decrease in interest income following settlement of the
Juvenescence Limited note receivable in the prior year, and no
sales of marketable equity securities as compared to the prior
year’s quarter.
Net loss attributable to Lineage: The net loss attributable to
Lineage for the three months ended September 30, 2021 was $7.8
million, or $0.05 per share (basic and diluted), compared to a net
loss attributable to Lineage of $7.8 million, or $0.05 per share
(basic and diluted), for the same period in 2020.
Conference Call and Webcast
Lineage will host a conference call and webcast today, at 4:30
p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third
quarter 2021 financial results and to provide a business update.
Interested parties may access the 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 November 18,
2021, 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 9352189.
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 three allogeneic (“off-the-shelf”) product candidates: (i)
OpRegen®, a retinal pigment epithelium transplant therapy in Phase
1/2a development for the treatment of dry age-related macular
degeneration, a leading cause of blindness in the developed world;
(ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a
development for the treatment of acute spinal cord injuries; and
(iii) VAC2, an allogeneic 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. 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,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,”
“would,” “contemplate,” “project,” “target,” “tend to,” ‘suggest,”
or the negative version of these words and similar expressions.
Such statements include, but are not limited to, the ability of
Lineage’s approach to generate clinical outcomes beyond the reach
of traditional methods, the broad potential for Lineage’s
technology platform, the projected timing of milestones of future
studies, including their initiation and completion, the projected
timing of interactions with the FDA to discuss product designation,
manufacturing plans and improvements, and later-stage clinical
development, the continued development of its product candidates,
the potential opportunities for the establishment or expansion of
strategic partnerships and collaborations and the timing thereof,
and the potential for Lineage’s investigational allogeneic cell
therapies to provide safe and effective treatment for multiple,
diverse serious or life threatening conditions. 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 risks
and uncertainties inherent in Lineage’s business and other risks 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.
Tables to follow
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS)
September 30, 2021
(Unaudited)
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
60,809
$
32,585
Marketable equity securities
4,295
8,977
Trade accounts receivable, net
79
4
Prepaid expenses and other current
assets
3,161
2,433
Total current assets
68,344
43,999
NONCURRENT ASSETS
Property and equipment, net
4,728
5,630
Deposits and other long-term assets
614
616
Goodwill
10,672
10,672
Intangible assets, net
46,854
47,032
TOTAL ASSETS
$
131,212
$
107,949
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
6,705
$
6,813
Lease liabilities, current portion
801
746
Financing lease, current portion
17
16
Deferred revenues
975
193
Liability classified warrants, current
portion
293
1
Total current liabilities
8,791
7,769
LONG-TERM LIABILITIES
Deferred tax liability
894
2,076
Lease liability, net of current
portion
1,887
2,514
Financing lease, net of current
portion
12
26
Liability classified warrants, net of
current portion
39
437
TOTAL LIABILITIES
11,623
12,822
-
-
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, 2,000
shares authorized; none issued and outstanding as of September 30,
2021 and December 31, 2020
-
-
Common shares, no par value, 250,000
shares authorized; 168,465 and 153,096 shares issued and
outstanding as of September 30, 2021 and December 31, 2020,
respectively
432,250
393,944
Accumulated other comprehensive loss
(3,433
)
(3,667
)
Accumulated deficit
(308,105
)
(294,078
)
Lineage Cell Therapeutics, Inc.
shareholders’ equity
120,712
96,199
Noncontrolling deficit
(1,123
)
(1,072
)
Total shareholders’ equity
119,589
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
131,212
$
107,949
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
(UNAUDITED)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2021
2020
2021
2020
REVENUES:
Royalties
$
1,909
$
342
$
2,430
$
607
Grant revenues
68
229
237
864
Collaboration revenues
293
-
506
-
Total revenues
2,270
571
3,173
1,471
Cost of sales
(985
)
(102
)
(1,222
)
(271
)
Gross profit
1,285
469
1,951
1,200
OPERATING EXPENSES:
Research and development
2,811
3,566
9,136
9,710
General and administrative
5,317
3,628
13,788
12,055
Total operating expenses
8,128
7,194
22,924
21,765
Loss from operations
(6,843
)
(6,725
)
(20,973
)
(20,565
)
OTHER INCOME/(EXPENSES):
Interest income (expense), net
1
252
(1
)
1,037
Gain on sale of marketable securities
-
120
6,024
3,848
Unrealized loss on marketable equity
securities
(2,450
)
(2,003
)
(621
)
(7,487
)
Gain on extinguishment of debt
-
-
523
-
Unrealized gain on warrant liability
53
55
105
84
Other income (expense), net
393
351
(318
)
175
Total other income/(expense), net
(2,003
)
(1,225
)
5,712
(2,343
)
LOSS BEFORE INCOME TAXES
(8,846
)
(7,950
)
(15,261
)
(22,908
)
Deferred income tax benefit
1,012
178
1,181
178
NET LOSS
(7,834
)
(7,772
)
(14,080
)
(22,730
)
Net loss attributable to noncontrolling
interest
11
12
51
49
NET LOSS ATTRIBUTABLE TO LINEAGE CELL
THERAPEUTICS, INC.
$
(7,823
)
$
(7,760
)
$
(14,029
)
$
(22,681
)
NET LOSS PER COMMON SHARE:
BASIC
$
(0.05
)
$
(0.05
)
$
(0.09
)
$
(0.15
)
DILUTED
$
(0.05
)
$
(0.05
)
$
(0.09
)
$
(0.15
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC
167,624
149,973
163,120
149,868
DILUTED
167,624
149,973
163,120
149,868
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Nine Months Ended September
30,
2021
2020
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to Lineage Cell
Therapeutics, Inc.
$
(14,029
)
$
(22,681
)
Net loss allocable to noncontrolling
interest
(51
)
(49
)
Adjustments to reconcile net loss
attributable to Lineage Cell Therapeutics, Inc. to net cash used in
operating activities:
Gain on sale of marketable securities
(6,024
)
(3,848
)
Unrealized loss on marketable equity
securities
621
7,487
Gain on extinguishment of debt
(523
)
-
Depreciation expense, including
amortization of leasehold improvements
504
623
Amortization of right-of-use asset
19
47
Amortization of intangible assets
178
1,080
Stock-based compensation
2,601
1,733
Common stock issued for services
202
59
Change in unrealized gain on warrant
liability
(105
)
(84
)
Write-off of security deposit
-
150
Deferred tax benefit
(1,181
)
(178
)
Foreign currency remeasurement and other
gain
300
(116
)
Gain on write-off and sales of assets
(5)
(154
)
Amortization of deferred license fee
-
(200
)
Changes in operating assets and
liabilities:
Accounts and grants receivable
(104
)
51
Accrued interest receivable
-
(1,008
)
Prepaid expenses and other current
assets
(1,229
)
1,634
Accounts payable and accrued
liabilities
354
1,342
Deferred revenue and other liabilities
784
-
Net cash used in operating activities
(17,688
)
(14,112
)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from the sale of OncoCyte common
shares
10,064
10,941
Proceeds from the sale of AgeX common
shares
-
1,196
Proceeds from the sale of HBL common
shares
21
3
Purchase of equipment
(208
)
(40
)
Proceeds from the sale of equipment
14
18
Other deposits
-
18
Net cash provided by investing
activities
9,891
12,136
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from employee options
exercised
6,269
24,624
Common shares received and retired for
employee taxes paid
(41
)
(19
)
Repayment of financing lease
liabilities
(13
)
(24
)
Proceeds from Paycheck Protection Program
(“PPP”) Loan
-
523
Proceeds from sale of common shares
30,741
-
Payments for offering costs
(980
)
(53
)
Net cash provided by financing
activities
35,976
25,051
Effect of exchange rate changes on cash,
cash equivalents and restricted cash
(34
)
(36
)
NET INCREASE IN CASH, CASH EQUIVALENTS AND
RESTRICTED CASH
28,145
23,039
CASH, CASH EQUIVALENTS AND RESTRICTED
CASH:
At beginning of the period
33,183
10,096
At end of the period
$
61,328
$
33,135
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211110006231/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Mike Biega (Mbiega@soleburytrout.com)
(617) 221-9660
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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