- Established Exclusive Worldwide Collaboration and License
Agreement with Roche and Genentech for the Development and
Commercialization of RG6501 (OpRegen®) in Transaction Worth up to
$670 Million
- Retinal Tissue Restoration and Visual Improvements Reported
in Four Patients Treated with RG6501 (OpRegen) for Dry Age-Related
Macular Degeneration
- Non-Clinical Testing Initiated to Support New Delivery
Device for OPC1 Clinical Trials
- Worldwide License Agreement Secured for a Cancer
Immunotherapy Product Candidate Based on the Lineage VAC
Platform
- Cash and Cash Equivalents of Approximately $83 Million as of
January 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 fourth quarter and full year 2021.
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 fourth
quarter and full year 2021 financial and operating results and to
provide a business update.
“2021 was a transformative year for Lineage, in part because we
entered into a worldwide corporate partnership with Roche and
Genentech for our OpRegen program for the treatment of ocular
disorders,” stated Brian M. Culley, Lineage CEO. “We have continued
to execute on our strategic plan to position Lineage as a leader in
the allogeneic cell transplant revolution, supported by our
regenerative medicine technology; manufacturing and differentiation
of specific cell types. These cells are transplanted into the body
to restore or improve function lost due to aging, injury, or
disease. We believe the collaboration of our lead asset with a
world-class pharmaceutical partner with extensive ophthalmology
capabilities brings significant validation to our technology
platform and our approach to product development. As importantly,
this transaction adds significant new capital to help support the
advancement of our OPC1 program, VAC platform, and the expansion of
our regenerative medicine pipeline into new disease settings. Our
corporate objectives in 2022 will be focused on the continued
advancement of our current clinical programs and making responsible
investments in the expansion of our novel approach to cell
transplant medicine in disease settings where we believe we can
make a meaningful impact. We look forward to announcing our new,
internally developed pipeline candidate later this quarter.”
Some of the more significant milestones we achieved in 2021
include:
- Established an exclusive worldwide collaboration and license
agreement with Roche and Genentech (the “Roche Collaboration”), for
the development and commercialization of OpRegen, a retinal pigment
epithelium (“RPE”) cell therapy, for the treatment of ocular
disorders, including advanced dry age-related macular degeneration
(“dry AMD”) with geographic atrophy (“GA”), in a transaction worth
up to $670 million in addition to double digit royalties;
- Reported a fourth case of retinal restoration with OpRegen;
notably, four patients with dry AMD were observed to have areas of
GA which diminished or remained unchanged relative to baseline for
a period of at least 12 months;
- Announced a worldwide license agreement with Immunomic
Therapeutics, Inc. for an allogeneic cell-based cancer
immunotherapy based on our VAC platform; Lineage received $2
million upfront and may receive up to $67 million in development
and commercial milestones plus royalties;
- Entered into an exclusive agreement with Neurgain Technologies
to evaluate a novel delivery system for OPC1 to treat Spinal Cord
Injury;
- Expanded our management team with the additions of Chief
Financial Officer, Kevin L. Cook, as well as General Counsel,
George A. Samuel, III; and
- Expanded our Board of Directors with the appointments of Drs.
Anula Jayasuriya, M.D., Ph.D., M.B.A. and Dipti Amin, MBBS, FFPM,
MRCGP, DCPSA, DCH, DRCOG, DGM.
Some of the events and milestones anticipated by Lineage in
2022 include:
- Announcement of a new pipeline program from our regenerative
medicine cell therapy platform anticipated in March;
- Completion of 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 Q3 2022;
- Initiation of clinical performance and safety testing of the
novel Parenchymal Spinal Delivery system device for OPC1, with an
anticipated Investigational New Drug (“IND”) amendment submission
in Q3 2022;
- Updates from the ongoing VAC2 Phase 1 non-small cell lung
cancer study; anticipated in Q2 2022;
- An anticipated IND submission for VAC2 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 partnership opportunities and expansion of
existing collaborations; ongoing throughout 2022; and
- Continued participation in numerous investor and partnering
meetings and medical and industry conferences to broaden the
knowledge of our work.
Balance Sheet Highlights
Cash and cash equivalents totaled $55.7 million as of December
31, 2021. In January 2022, we received a $50.0 million upfront
payment related to the Roche Collaboration and made subsequent
payments pursuant to Lineage’s downstream obligations.
Fourth Quarter Operating Results
Revenues: Lineage’s revenue is generated primarily from research
grants, royalties, and licensing fees. Total revenues for the three
months ended December 31, 2021 were approximately $1.2 million, an
increase of $0.8 million as compared to $0.4 million for the same
period in 2020. The increase was related to royalties and licensing
fees, which was primarily driven by licensing revenues in
connection with collaboration agreements entered into in 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 December 31, 2021 were $29.2 million, an increase of $23.1
million as compared to $6.1 million for the same period in 2020.
The overall increase was substantially driven by $20.6 million in
higher OpRegen-related expenses, mainly due to accruals for future
financial obligations payable to the Israel Innovation Authority
(“IIA”) and Hadasit Medical Research Services and Development Ltd
(“Hadasit”), related to the receipt of the $50.0 million upfront
payment under the Roche Collaboration.
R&D Expenses: R&D expenses for the three months ended
December 31, 2021 were $24.8 million, an increase of $22.2 million
as compared to $2.6 million for the same period in 2020. The
increase was substantially driven by the $21.0 million accrual for
future financial obligations payable to IIA and Hadasit. Other
drivers of the increased variance were related to $1.0 million and
$0.6 million in higher expenses to support the development of the
OPC1 and VAC programs, respectively.
G&A Expenses: G&A expenses for the three months ended
December 31, 2021 were $4.4 million, an increase of $0.9 million as
compared to $3.5 million for the same period in 2020. The increase
was primarily attributable to increases of $0.3 million in legal
and litigation expenses, $0.3 million in salaries and related
benefits, and $0.3 million in share-based compensation expense.
Loss from Operations: Loss from operations for the three months
ended December 31, 2021 was $28.2 million, an increase of $22.3
million as compared to $5.9 million for the same period in 2020,
principally owing to collaboration-related expense accruals of
$21.0 million which were not deferrable expenses, and as such, do
not align with current period revenues due to revenue deferral
accounting standards.
Other Income, Net: Other income, net for the three months ended
December 31, 2021 was $0.2 million, compared to other income, net
of $6.9 million for the same period in 2020. The variance was
primarily related to changes in the value of marketable equity
securities for the applicable periods.
Net Income/(Loss) Attributable to Lineage: The net loss
attributable to Lineage for the three months ended December 31,
2021 was ($29.0) million, or ($0.17) per share (basic and diluted),
compared to a net income attributable to Lineage of $2.0 million,
or $0.01 per share (basic and diluted), for the same period in
2020. The large year-over-year change was principally due to the
collaboration-related expense accruals amounting to ($0.12) per
share which were not deferrable expenses, and as such, do not align
with current period revenues due to revenue deferral accounting
standards.
Full Year Operating Results
Revenues: Lineage’s revenue is generated primarily from research
grants, royalties, and licensing fees. Total revenues for the year
ended December 31, 2021 were $4.3 million, an increase of $2.5
million as compared to $1.8 million for the same period in 2020.
The increase was primarily related to a $2.0 million increase in
royalty revenues, and a $1.1 million increase in licensing revenues
in connection with collaboration agreements, partially offset by a
$0.6 million decrease in grant revenues.
Operating Expenses: Operating expenses are comprised of R&D
expenses and G&A expenses. Total operating expenses for the
year ended December 31, 2021 were $52.1 million, an increase of
$24.2 million as compared to $27.9 million for the same period in
2020. The overall increase was substantially driven by $19.9
million in higher OpRegen-related expenses, mainly due to accruals
for future financial obligations payable to IIA and Hadasit,
related to the receipt of the $50.0 million upfront payment under
the Roche Collaboration.
R&D Expenses: R&D expenses for the year ended December
31, 2021 were $33.9 million, an increase of $21.6 million as
compared to $12.3 million for the same period in 2020. The increase
was substantially driven by the $21.0 million accrual for future
financial obligations payable to the IIA and Hadasit. Other drivers
of the net increase variance were $2.2 million in higher
manufacturing and device development costs to support the OPC1
program, offset by $0.3 million in lower VAC program expenses.
G&A Expenses: G&A expenses for the year ended December
31, 2021 were $18.2 million, an increase of approximately $2.6
million as compared to $15.6 million for the same period in 2020.
The increase was primarily related to increases of $1.3 million in
legal, litigation and patent expenses, $0.9 million in share-based
compensation expenses, and $0.3 million in payroll and related
benefits expense.
Loss from Operations: Loss from operations for the year ended
December 31, 2021 was $49.2 million, an increase of $22.8 million
as compared to $26.4 million for the same period in 2020,
principally owing to collaboration-related expense accruals of
$21.0 million which were not deferrable expenses, and as such, do
not align with current period revenues due to revenue deferral
accounting standards.
Other Income, Net: Other income, net for the year ended December
31, 2021 was $5.9 million, compared to other income, net of $4.5
million for the same period in 2020. The net variance was primarily
related to the changes in the value of marketable equity securities
for the applicable periods.
Net Loss Attributable to Lineage: The net loss attributable to
Lineage for the year ended December 31, 2021 was $43.0 million, or
$0.26 per share (basic and diluted), compared to a net loss
attributable to Lineage of $20.6 million, or $0.14 per share (basic
and diluted), for 2020. The large year-over-year change is
principally due to collaboration-related expense accruals amounting
to $0.13 per share which were not deferrable expenses, and as such,
do not align with current period revenues due to revenue deferral
accounting standards.
Conference Call and Webcast
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 March 18, 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 7718167.
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, which is now 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; 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,” “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 and activities expected to occur thereunder, the
milestone and royalty consideration payable to Lineage and
Lineage’s planned use of proceeds therefrom, the potential benefits
of treatment with OpRegen, the potential success of other existing
partnerships and collaborations, the broad potential for Lineage’s
regenerative medicine platform and Lineage’s ability to expand the
same, Lineage’s plans to advance its spinal cord injury and
oncology programs and announce new disease settings where it plans
to deploy its technology, 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 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 generate
clinical outcomes beyond the reach of traditional methods and
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, but not limited to, the risk that
competing alternative therapies may adversely impact the commercial
potential of OpRegen, which could materially adversely affect the
milestone and royalty payments payable to Lineage under the
collaboration and license agreement, 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 might not
succeed in developing products and technologies that are useful in
medicine and demonstrate the requisite safety and efficacy to
achieve regulatory approval in accordance with its projected
timing, or at all; the risk that, even if one or more of Lineage’s
product candidates are approved and commercialized, Lineage may
never attain profitability; the risk that Lineage is unable to
raise sufficient additional capital to fund its operations; the
risk that Lineage may not be able to manufacture sufficient
clinical and, if approved, commercial quantities of its product
candidates in accordance with current good manufacturing practice;
the risks related to Lineage’s dependence on other third parties,
and Lineage’s ability to establish and maintain its collaborations
with these third parties; the risk that government-imposed bans or
restrictions and religious, moral, and ethical concerns about the
use of hES cells could prevent Lineage or its partners from
developing and successfully marketing its stem cell product
candidates; the risk that Lineage’s intellectual property may be
insufficient to protect its products; the risk that the COVID-19
pandemic or geopolitical events may directly or indirectly cause
significant delays in and substantially increase the cost of
development of Lineage’s product candidates, as well as heighten
other risks and uncertainties related to Lineage’s business and
operations; 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.
Tables to follow
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS)
December 31, 2021
December 31, 2020
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
55,742
$
32,585
Marketable equity securities
2,616
8,977
Trade accounts and grants receivable,
net
50,840
4
Prepaid expenses and other current
assets
2,351
2,433
Total current assets
111,549
43,999
NONCURRENT ASSETS
Property and equipment, net
4,872
5,630
Deposits and other long-term assets
630
616
Goodwill
10,672
10,672
Intangible assets, net
46,822
47,032
TOTAL ASSETS
$
174,545
$
107,949
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
27,969
$
6,813
Lease liabilities, current portion
801
746
Financing lease, current portion
30
16
Deferred revenues
18,119
193
Liability classified warrants, current
portion
197
1
Total current liabilities
47,116
7,769
LONG-TERM LIABILITIES
Deferred tax liability
2,076
2,076
Deferred revenues, net of current
portion
32,454
-
Lease liability, net of current
portion
1,941
2,514
Financing lease, net of current
portion
30
26
Liability classified warrants and other
long-term liabilities
30
437
TOTAL LIABILITIES
83,647
12,822
-
-
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, authorized
2,000 shares; none issued and outstanding as of December 31, 2021
and 2020, respectively
-
-
Common shares, no par value, authorized
250,000 shares; 169,477 and 153,096 shares issued and outstanding
as of December 31, 2021 and 2020, respectively
434,529
393,944
Accumulated other comprehensive loss
(5,211
)
(3,667
)
Accumulated deficit
(337,097
)
(294,078
)
Lineage Cell Therapeutics, Inc.
shareholders’ equity
92,221
96,199
Noncontrolling (deficit)
(1,323
)
(1,072
)
Total shareholders’ equity
90,898
95,127
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
174,545
$
107,949
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
(IN THOUSANDS, EXCEPT PER
SHARE DATA)
Year Ended December
31,
2021
2020
REVENUES:
Royalties
$
2,776
$
773
Collaboration revenues
1,120
-
Grant revenues
445
1,053
Total revenues
4,341
1,826
Cost of sales
(1,426
)
(385
)
Gross profit
2,915
1,441
OPERATING EXPENSES:
Research and development
33,914
12,317
General and administrative
18,212
15,571
Total operating expenses
52,126
27,888
Loss from operations
(49,211
)
(26,447
)
OTHER INCOME, NET:
Interest income, net
2
1,039
Gain on sale of marketable securities
6,024
4,560
Unrealized loss on marketable equity
securities
(2,299
)
(3,782
)
Gain on extinguishment of debt
523
-
Unrealized gain (loss) on warrant
liability
205
(174
)
Other income, net
1,486
2,880
Total other income, net
5,941
4,523
LOSS BEFORE INCOME TAXES
(43,270
)
(21,924
)
Income tax benefit
-
1,239
NET LOSS
(43,270
)
(20,685
)
Net loss attributable to noncontrolling
interest
251
36
NET LOSS ATTRIBUTABLE TO
LINEAGE
$
(43,019
)
$
(20,649
)
NET LOSS PER COMMON SHARE:
BASIC AND DILUTED
$
(0.26
)
$
(0.14
)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES
OUTSTANDING:
BASIC AND DILUTED
164,502
150,044
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
CASH FLOWS
(IN THOUSANDS)
Year Ended December
31,
2021
2020
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to Lineage
$
(43,019
)
$
(20,649
)
Net loss attributable to noncontrolling
interest
(251
)
(36
)
Adjustments to reconcile net loss
attributable to Lineage to net cash used in operating
activities:
Gain on sale of marketable equity
securities
(6,024
)
(4,560
)
Unrealized loss on marketable equity
securities
2,299
3,782
Deferred tax benefit
-
(1,239
)
Depreciation expense, including
amortization of leasehold improvements
663
823
Amortization of right-of-use assets
14
72
Amortization of intangible assets
210
1,216
Stock-based compensation
3,519
2,227
Common stock issued for services
202
119
Change in unrealized (gain) loss on
warrant liability
(205
)
174
Write-off of security deposit
-
150
Amortization of deferred license fee
-
(200
)
Foreign currency remeasurement and other
(gain)
(1,566
)
(2,957
)
Loss (gain) on sale of assets
24
(20
)
Realized loss on warrant exercise
-
44
Gain on extinguishment of debt
(523
)
-
Changes in operating assets and
liabilities:
Accounts and grants receivable
(857
)
287
Accrued interest receivable
-
(1,008
)
Receivables from affiliates, net of
payables
-
7
Prepaid expenses and other current
assets
(72
)
1,575
Accounts payable and accrued
liabilities
21,645
308
Deferred revenue and other liabilities
380
132
Net cash used in operating activities
(23,561
)
(19,753
)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from sale of OncoCyte common
shares
10,064
10,941
Proceeds from the sale of AgeX common
shares
-
1,290
Proceeds from the sale of HBL common
shares
21
830
Purchase of property and equipment
(354
)
(64
)
Proceeds from sale of assets
14
23
Security deposit paid and other
-
18
Net cash provided by investing
activities
9,745
13,038
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from employee options
exercised
7,240
-
Proceeds from payment of Juvenescence
promissory note
-
24,624
Common shares received and retired for
employee taxes paid
(54
)
(27
)
Proceeds from sale of common shares
30,865
5,127
Payments for offering costs
(1,101
)
(356
)
Repayment of financing lease
liabilities
(20
)
(26
)
Proceeds from Paycheck Protection Program
(“PPP”) Loan
-
523
Net cash provided by financing
activities
36,930
29,865
Effect of exchange rate changes on cash,
cash equivalents and restricted cash
(20
)
(63
)
NET INCREASE (DECREASE) IN CASH, CASH
EQUIVALENTS AND RESTRICTED CASH
23,094
23,087
At beginning of year
33,183
10,096
At end of year
$
56,277
$
33,183
SUPPLEMENTAL DISCLOSURE OF CASH FLOW
INFORMATION:
Cash paid during year for interest
$
13
$
20
SUPPLEMENTAL SCHEDULE OF NON-CASH
FINANCING AND INVESTING ACTIVITIES:
Receivable from sale of common shares in
at the market offering
$
147
$
269
Receivable from exercise of stock
options
$
189
$
-
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220310005347/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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