- OpRegen® Continued to Demonstrate Functional and Anatomical
Improvements in Patients with Dry AMD
- Three Cases of Retinal Tissue Restoration Reported; Longest
of Which Has Lasted 3 Years
- Company Added to Russell 3000® and Russell Microcap®
Indexes
- License Agreement Announced with Immunomic Therapeutics Inc.
to Develop New DC-Based Therapeutic
- New Chief Financial Officer Appointed
- Cash and Marketable Securities of $68.7M Expected to Support
Operations Well Into 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 second quarter 2021. Lineage will host a
conference call today at 4:30 p.m. Eastern Time to discuss its
second quarter 2021 financial results and to provide a business
update.
“Lineage continued to make significant operational and
developmental progress during the second quarter, providing
additional reports of clinically meaningful outcomes in patients
with dry-AMD with geographic atrophy, advancing our OPC1 program
for spinal cord injury, and reaching a paid milestone under our new
VAC platform alliance,” stated Brian M. Culley, Lineage CEO.
“OpRegen has generated the only known cases of retinal tissue
restoration in previously confirmed atrophic areas in humans, and
as importantly, has provided a durable functional benefit of
improved visual acuity in the treated eyes of the majority of
better vision, earlier-stage patients. We are excited that we soon
will be returning OPC1 to clinical testing in a device safety
study, which will include chronic spinal cord injury patients, and
look forward to collaborating with the SCI community as part of our
efforts to improve outcomes for individuals with this debilitating
condition. We also believe being added to the Russell 3000® Index
will improve awareness of the continued success of our cell
transplant approach and that our current cash and cash equivalents
provide funding to reach additional value-creating milestones in
the months and years ahead.”
Some of the significant events and milestones achieved to
date this year include:
- Reported a positive interim clinical update from the ongoing
Phase 1/2a study of OpRegen for the treatment of dry-AMD with GA:
83% of all Cohort 4 patients exhibited stable or improved Best
Corrected Visual Acuity at least 6 months post-treatment, while
visual acuity declined in the majority of untreated eyes; notably,
the first retinal restoration patient, with confirmed atrophy
growth at baseline has had zero progression for almost three full
years;
- Reported two additional cases of retinal tissue restoration in
dry AMD patients treated with OpRegen; restoration has now been
observed in three of four patients who received OpRegen RPE cells
across a wide area of atrophy;
- Hosted a webinar with key therapeutic area experts to discuss
the reported evidence of retinal tissue restoration findings in
detail, including a review of anatomical improvements, functional
activity, and additional results of treatment with OpRegen;
- Reported that the Company has been added to both the Russell
3000® as well as the Russell Microcap® Indexes;
- Reported that OPC1 will return to clinical testing; a Phase 1
clinical study will evaluate a novel delivery system in partnership
with Neurgain Technologies and will include treatment of chronic
spinal cord injury patients. The Phase 1 study is intended to
validate the delivery system for use in a late-stage clinical
study, expected to begin in 2022;
- Entered into a worldwide license agreement with Immunomic
Therapeutics for an allogeneic cell-based cancer immunotherapy
based on Lineage’s VAC platform with a total of $2 million in
upfront payments anticipated in the first year and the potential
for $67 million in development and commercial milestones;
- Announced an exclusive option agreement with Amasa
Therapeutics for the supply and use of clinical-grade HyStem® for
the development and commercialization of therapies for local
treatment of solid tumors; and
- Announced the appointment of Kevin L. Cook as Chief Financial
Officer. Mr. Cook brings broad expertise across a range of
financial matters and has executed over $30 billion of capital
raising and corporate development transactions, approximately half
of which involved life sciences companies.
Some of the events and milestones to look forward to
include:
- OpRegen Program
- Presentation of additional interim data from the Phase 1/2a
study, anticipated during the third and fourth quarters of
2021;
- Meeting with the U.S. Food and Drug Administration (FDA) to
discuss further clinical development, anticipated in the fourth
quarter of 2021.
- OPC1 Program
- Evaluation of the Neurgain Parenchymal Spinal Delivery (PSD)
system in preclinical and clinical testing;
- GMP production of OPC1 via an improved manufacturing process
and release testing to support a late-stage clinical trial;
- FDA interaction to discuss manufacturing improvements,
anticipated around the end of 2021 or early 2022.
- VAC Program
- Completion of enrollment in the ongoing VAC2 Phase 1 non-small
cell lung cancer study;
- Reporting results from the ongoing VAC2 Phase 1 study;
- Evaluation of opportunities for new VAC product candidates
based on internally identified or partnered tumor antigens.
- Continued evaluation of partnership opportunities and
expansion of existing external collaborations and identification of
new collaborations.
Balance Sheet Highlights
Cash, cash equivalents and marketable securities totaled $68.7
million as of June 30, 2021. Marketable securities of $6.7 million
as of June 30, 2021 include the Company’s remaining ownership in
OncoCyte and Hadasit Bio-Holdings Ltd.
Lineage added to its cash position during the second quarter of
2021 with approximately $4.0 million in proceeds from the exercise
of stock options, the majority of which were approaching
expiration.
Second Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research
grants, royalties, and licensing fees. Total revenues for the three
months ended June 30, 2021 were approximately $0.5 million, an
increase of $0.1 million as compared to $0.4 million for the same
period in 2020. The increase was primarily related to a $0.2
million increase in licensing revenues in connection with the new
collaborative agreement with Immunomic Therapeutics, and a $0.1
million increase in royalties, partially offset by a $0.2 million
decrease in grant revenues, primarily driven by the completion of
NIH grant-activities in the prior year.
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 June 30, 2021 were $7.5 million, an increase of $0.8 million
as compared to $6.7 million for the same period in 2020.
R&D Expenses: R&D expenses for the three months ended
June 30, 2021 were $2.9 million, an increase of approximately $0.1
million as compared to $2.8 million for the same period in 2020.
The increase was primarily related to increases of $0.3 million and
$0.2 million in OPC1 and VAC program expenses, respectively,
partially offset by a net decrease of $0.4 million in OpRegen and
other ophthalmic application expenses, primarily driven by
fluctuations in the timing of manufacturing activities.
G&A Expenses: G&A expenses for the three months ended
June 30, 2021 were $4.5 million, an increase of approximately $0.6
million as compared to $3.9 million for the same period in 2020.
The increase was primarily attributable to increases of $0.3
million in litigation and other expenses related to Lineage’s
merger with Asterias Biotherapeutics, Inc., $0.3 million in
investor and public relations expenses, and $0.1 million in legal
and patent expenses, partially offset by a $0.1 million decrease in
rent and utilities expenses.
Loss from Operations: Loss from operations for the three months
ended June 30, 2021 was approximately $7.1 million, an increase of
$0.7 million as compared to $6.4 million for the same period in
2020.
Other Income/(Expenses), Net: Other income/(expenses), net for
the three months ended June 30, 2021 reflected other income, net of
$2.1 million, compared to other expense, net of ($0.1) million for
the same period in 2020. The variance was primarily related to an
increase in the value of Lineage’s OncoCyte shares and the gain on
extinguishment of debt from Lineage’s Paycheck Protection Program
loan forgiveness, partially offset by no sales of marketable equity
securities as compared to the prior year’s quarter, as well as
exchange rate fluctuations related to Lineage’s international
subsidiaries.
Net loss attributable to Lineage: The net loss attributable to
Lineage for the three months ended June 30, 2021 was $4.8 million,
or $0.03 per share (basic and diluted), compared to a net loss
attributable to Lineage of $6.5 million, or $0.04 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 second
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 August 22,
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 4876810.
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 three
allogeneic (“off-the-shelf”) clinical programs are in markets with
billion dollar opportunities: (i) OpRegen®, an investigational
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 investigational oligodendrocyte progenitor cell
therapy in Phase 1/2a development for the treatment of acute spinal
cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy
platform for immuno-oncology and infectious disease, with
investigational immunotherapy VAC2 currently in 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,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” “look forward to” or
the negative version of these words and similar expressions. Such
statements include, but are not limited to, statements relating to
Lineage’s anticipated funding runway, data presentations, clinical
trial advancement and the timing thereof, Lineage’s ability to
achieve value-creating milestones, meetings and interactions with
the FDA, evaluation of the Neurgain PSD system, manufacturing
improvements, enrollment in the VAC2 Phase 1 study, announcement of
clinical study results, payments under the license agreement with
Immunomic Therapeutics, partnership evaluations and opportunities,
and market opportunity and potential for its product candidates.
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 discussed in Lineage’s filings with the Securities
and Exchange Commission (the 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 Quarterly Report on Form 10-Q 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)
June 30, 2021
(Unaudited)
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
62,001
$
32,585
Marketable equity securities
6,745
8,977
Trade accounts and grants receivable,
net
326
4
Prepaid expenses and other current
assets
2,505
2,433
Total current assets
71,577
43,999
NONCURRENT ASSETS
Property and equipment, net
5,008
5,630
Deposits and other long-term assets
610
616
Goodwill
10,672
10,672
Intangible assets, net
46,887
47,032
TOTAL ASSETS
$
134,754
$
107,949
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
5,348
$
6,813
Lease liabilities, current portion
790
746
Financing lease, current portion
17
16
Deferred revenues
613
193
Liability classified warrants, current
portion
-
1
Total current liabilities
6,768
7,769
LONG-TERM LIABILITIES
Deferred tax liability
1,907
2,076
Lease liability, net of current
portion
2,078
2,514
Financing lease, net of current
portion
16
26
Liability classified warrants, net of
current portion
384
437
TOTAL LIABILITIES
11,153
12,822
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, 2,000
shares authorized; none issued and outstanding as of June 30, 2021
and December 31, 2020
-
-
Common shares, no par value, 250,000
shares authorized; 167,037 and 153,096 shares issued and
outstanding as of June 30, 2021 and December 31, 2020,
respectively
428,046
393,944
Accumulated other comprehensive loss
(3,051
)
(3,667
)
Accumulated deficit
(300,282
)
(294,078
)
Lineage Cell Therapeutics, Inc.
shareholders’ equity
124,713
96,199
Noncontrolling deficit
(1,112
)
(1,072
)
Total shareholders’ equity
123,601
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
134,754
$
107,949
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
(UNAUDITED)
Three Months Ended
June 30,
Six Months Ended
June 30,
2021
2020
2021
2020
REVENUES:
Grant revenue
$
71
$
287
$
169
$
635
Royalties from product sales and license
fees
228
99
521
265
Collaboration revenues
213
-
213
-
Total revenues
512
386
903
900
Cost of sales
(125
)
(75
)
(237
)
(169
)
Gross profit
387
311
666
731
OPERATING EXPENSES:
Research and development
2,931
2,805
6,325
6,144
General and administrative
4,536
3,908
8,471
8,427
Total operating expenses
7,467
6,713
14,796
14,571
Loss from operations
(7,080
)
(6,402
)
(14,130
)
(13,840
)
OTHER INCOME/(EXPENSES):
Interest income (expense), net
(3
)
380
(1
)
785
Gain on sale of marketable securities
-
2,470
6,024
3,728
Unrealized gain (loss) on marketable
equity securities
590
(4,146
)
1,830
(5,484
)
Gain on extinguishment of debt
523
-
523
-
Unrealized gain (loss) on warrant
liability
35
(6
)
52
29
Other income (expense), net
970
1,174
(711
)
(176
)
Total other income/(expense), net
2,115
(128
)
7,717
(1,118
)
LOSS BEFORE INCOME TAXES
(4,965
)
(6,530
)
(6,413
)
(14,958
)
Deferred income tax benefit
169
-
169
-
NET LOSS
(4,796
)
(6,530
)
(6,244
)
(14,958
)
Net loss attributable to noncontrolling
interest
8
8
40
37
NET LOSS ATTRIBUTABLE TO LINEAGE CELL
THERAPEUTICS, INC.
$
(4,788
)
$
(6,522
)
$
(6,204
)
$
(14,921
)
NET LOSS PER COMMON SHARE:
BASIC
$
(0.03
)
$
(0.04
)
$
(0.04
)
$
(0.10
)
DILUTED
$
(0.03
)
$
(0.04
)
$
(0.04
)
$
(0.10
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC
162,914
149,821
160,831
149,814
DILUTED
162,914
149,821
160,831
149,814
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Six Months Ended June
30,
2021
2020
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to Lineage Cell
Therapeutics, Inc.
$
(6,204
)
$
(14,921
)
Net loss allocable to noncontrolling
interest
(40
)
(37
)
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
)
(3,728
)
Unrealized (gain)/loss on marketable
equity securities
(1,830
)
5,484
Gain on extinguishment of debt
(523
)
-
Depreciation expense, including
amortization of leasehold improvements
338
423
Amortization of right-of-use asset
20
18
Amortization of intangible assets
145
831
Stock-based compensation
1,458
1,232
Common stock issued for services
202
-
Change in unrealized gain on warrant
liability
(53
)
(29
)
Write-off of security deposit
-
150
Deferred tax benefit
(169
)
-
Foreign currency remeasurement and other
gain
692
236
Changes in operating assets and
liabilities:
Accounts and grants receivable, net
(353
)
125
Accrued interest receivable
-
(756
)
Prepaid expenses and other current
assets
34
1,442
Accounts payable and accrued
liabilities
(955
)
214
Deferred revenue and other liabilities
422
51
Net cash used in operating activities
(12,840
)
(9,265
)
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
-
985
Proceeds from the sale of Hadasit common
shares
21
-
Purchase of equipment and other assets
(140
)
(16
)
Proceeds from the sale of equipment and
other assets
14
-
Other deposits
-
48
Net cash provided by investing
activities
9,959
11,958
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from employee options
exercised
5,348
-
Common shares received and retired for
employee taxes paid
(27
)
(13
)
Repayment of financing lease
liabilities
-
(17
)
Proceeds from Paycheck Protection Program
(“PPP”) Loan
-
523
Proceeds from sale of common shares
27,813
-
Payments for offering costs
(877
)
-
Net cash provided by financing
activities
32,257
493
Effect of exchange rate changes on cash,
cash equivalents and restricted cash
(43
)
(38
)
NET INCREASE IN CASH, CASH EQUIVALENTS AND
RESTRICTED CASH
29,333
3,148
CASH, CASH EQUIVALENTS AND RESTRICTED
CASH:
At beginning of the period
33,183
10,096
At end of the period
$
62,516
$
13,244
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210812005745/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Solebury Trout IR Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com) (646) 378-2949
Russo Partners – Media Relations Nic Johnson or David
Schull Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com (212) 845-4242
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