- OpRegen® Granted Regenerative Medicine Advanced Therapy
(RMAT) Designation From FDA
- ReSonance™ (ANP1) Preclinical Results Presented at 59th
Annual Inner Ear Biology Workshop
- Added to 2024 Russell 3000® Index
Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX),
a clinical-stage biotechnology company developing allogeneic cell
therapies for unmet medical needs, today reported its third quarter
2024 financial and operating results. The Company will host a
conference call today at 4:30 p.m. Eastern Time to discuss these
results and to provide a business update.
“We were delighted to see our partners’ continued commitment to
the OpRegen program, in this instance by seeking and successfully
obtaining RMAT designation,” stated Brian M. Culley, Lineage CEO.
“We believe OpRegen continues to showcase itself as an asset with
the potential to be ‘a transformational medicine’ and view the
recent RMAT designation as additional positive progress for this
pioneering cell transplant program. As we worked to return our
second cell transplant program, OPC1 for spinal cord injury, back
into the clinic, we also presented promising preclinical results
from our third program, ReSonance, for sensorineural hearing loss.
We look forward to continuing to create value through the
advancement of our clinical and preclinical pipelines, applying
both our technology and extensive manufacturing expertise to
validate our cell transplant approach.”
Recent Operational Highlights
- RG6501 (OpRegen)
- Roche and Genentech, a member of the Roche Group, announced
receipt of RMAT designation from the U.S. FDA for OpRegen, for the
treatment of geographic atrophy (GA) secondary to age-related
macular degeneration (AMD).
- Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including support for
the ongoing Phase 2a clinical study (the “GAlette Study”) in
patients with GA secondary to AMD.
- Continued activities under the separate services agreement with
Genentech to support ongoing development of OpRegen. Lineage has
been providing additional clinical, technical, training and
manufacturing services funded by Genentech, that further support
the ongoing advancement and optimization of the OpRegen program and
include: (i) activities to support the ongoing Phase 1/2a study and
currently-enrolling Phase 2a study; and (ii) additional technical
training and materials related to Lineage’s cell therapy technology
platform to support commercial manufacturing strategies.
- OPC1
- DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal
Cord Injury: Evaluation of a Novel Device) clinical study for the
treatment of subacute and chronic spinal cord patient start-up
activities and FDA interactions continue.
- ReSonance (ANP1)
- Preclinical results presented at 59th Annual Inner Ear Biology
Workshop
- ReSonance manufactured by a proprietary process, developed
in-house, at clinical scale, with relevant in-vitro functional
activity
- Immediate-use, thaw-and-inject formulation durably engrafted in
multiple preclinical hearing loss models
- ReSonance is currently being evaluated in a functional model of
hearing loss through a collaboration with the University of
Michigan Kresge Hearing Research Institute.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities of $32.7
million as of September 30, 2024 is expected to support planned
operations into Q1 2026.
Third Quarter Operating Results
Revenues: Revenue is generated primarily from collaboration
revenues, royalties, and other revenues. Total revenues for the
three months ended September 30, 2024 were $3.8 million, a net
increase of approximately $2.5 million as compared to approximately
$1.2 million for the same period in 2023. The increase was
primarily driven by more collaboration revenue recognized from
deferred revenues under the collaboration and license agreement
with 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 September 30, 2024 were $7.6 million, a decrease of $0.3
million as compared to $7.9 million for the same period in
2023.
R&D Expenses: R&D expenses for the three months ended
September 30, 2024 were $3.2 million, a net decrease of
approximately $0.6 million as compared to $3.7 million for the same
period in 2023. The net decrease was primarily driven by $0.6
million for our OPC1 program, $0.4 million for our preclinical
programs, and partially offset by $0.5 million for our OpRegen
program.
G&A Expenses: G&A expenses for the three months ended
September 30, 2024 were $4.4 million, a net increase of $0.4
million as compared to $4.0 million for the same period in 2023.
The net increase was primarily driven by $0.3 million for personnel
costs and $0.1 million for stock-based compensation expense.
Loss from Operations: Loss from operations for the three months
ended September 30, 2024 were $3.8 million, a decrease of $2.9
million as compared to $6.7 million for the same period in
2023.
Other Income/(Expenses): Other income (expenses) for the three
months ended September 30, 2024 reflected other income of $0.8
million, compared to other expenses of approximately ($0.4) million
for the same period in 2023. The change was primarily driven by
exchange rate fluctuations related to our international
subsidiaries.
Net Loss Attributable to Lineage: The net loss attributable to
Lineage for the three months ended September 30, 2024 was $3.0
million, or $0.02 per share (basic and diluted), compared to a net
loss attributable to Lineage of $7.1 million, or $0.04 per share
(basic and diluted), for the same period in 2023.
Conference Call and Webcast
Interested parties may access the conference call on November
14th, 2024, 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 21st, 2024, by dialing (800)
770-2030 from the U.S. and Canada and entering conference ID number
2238934.
About Lineage Cell Therapeutics, Inc.
Lineage Cell Therapeutics is a clinical-stage biotechnology
company developing novel, “off-the-shelf,” cell therapies to
address unmet medical needs. Lineage’s programs are based on its
proprietary cell-based technology platform and associated
development and manufacturing capabilities. From this platform,
Lineage designs, develops, manufactures, and tests specialized
human cells with anatomical and physiological functions similar or
identical to cells found naturally in the human body. These cells
are created by applying directed differentiation protocols to
established, well-characterized, and self-renewing pluripotent cell
lines. These protocols generate cells with characteristics
associated with specific and desired developmental lineages. Cells
derived from such lineages are transplanted into patients in an
effort to replace or support cells that are absent or dysfunctional
due to degenerative disease, aging, or traumatic injury, and to
restore or augment the patient’s functional activity. Lineage’s
neuroscience focused pipeline currently includes: (i) OpRegen, a
retinal pigment epithelial cell therapy in Phase 2a development
under a worldwide collaboration with Roche and Genentech, a member
of the Roche Group, for the treatment of geographic atrophy
secondary to age-related macular degeneration; (ii) OPC1, an
oligodendrocyte progenitor cell therapy in Phase 1/2a development
for the treatment of spinal cord injuries; (iii) ReSonance (ANP1),
an auditory neuronal progenitor cell therapy for the potential
treatment of auditory neuropathy; (iv) PNC1, a photoreceptor neural
cell therapy for the potential treatment of vision loss due to
photoreceptor dysfunction or damage; and (v) RND1, a novel
hypoimmune induced pluripotent stem cell line being developed in
collaboration with Factor Bioscience Limited. For more information,
please visit www.lineagecell.com or follow the company on X/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.
Lineage’s forward-looking statements are based upon its current
expectations and beliefs and involve assumptions that may never
materialize or may prove to be incorrect. Such statements include,
but are not limited to, statements relating to: the potential
therapeutic benefits of OpRegen in patients with GA secondary to
AMD and the potential impacts of RMAT designation on Roche and
Genentech’s development of OpRegen or OpRegen’s ultimate success;
the benefits of our new services agreement with Genentech and its
impact on advancing the OpRegen program; the commencement of the
DOSED clinical study for OPC1; that our cash, cash equivalents and
marketable securities is sufficient to support our planned
operations into the first quarter of 2026; the impacts to Lineage
of our continued inclusion within the Russell 3000 Index; the broad
potential for Lineage’s regenerative medicine platform and our
ability to develop additional product candidates; and the potential
of our platform technology and/or manufacturing capabilities to
validate our approach or create value. 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 development activities, preclinical activities, and
clinical trials of our product candidates may not commence,
progress or be completed as expected due to many factors within and
outside of our control; 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 or become a ‘transformational medicine’, 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 OPC1 may not advance further in any
clinical trials, and if it does, that any such clinical trials may
not be successful; that the ongoing Israel-Hamas war and broader
regional conflict 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). 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 subsequent 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. All forward-looking statements are
expressly qualified in their entirety by these cautionary
statements.
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE
SHEETS
(IN THOUSANDS)
(UNAUDITED)
September 30, 2024
December 31, 2023
ASSETS
CURRENT ASSETS
Cash and cash equivalents
$
27,750
$
35,442
Marketable securities
4,961
50
Accounts receivable, net
405
745
Prepaid expenses and other current
assets
1,285
2,204
Total current assets
34,401
38,441
NONCURRENT ASSETS
Property and equipment, net
2,013
2,245
Operating lease right-of-use assets
2,362
2,522
Deposits and other long-term assets
606
577
Goodwill
10,672
10,672
Intangible assets, net
46,540
46,562
TOTAL ASSETS
$
96,594
$
101,019
LIABILITIES AND SHAREHOLDERS’
EQUITY
CURRENT LIABILITIES
Accounts payable and accrued
liabilities
$
4,477
$
6,270
Operating lease liabilities, current
portion
1,083
830
Finance lease liabilities, current
portion
54
52
Deferred revenues, current portion
8,250
10,808
Total current liabilities
13,864
17,960
LONG-TERM LIABILITIES
Deferred tax liability
273
273
Deferred revenues, net of current
portion
16,050
18,693
Operating lease liabilities, net of
current portion
1,533
1,979
Finance lease liabilities, net of current
portion
80
91
TOTAL LIABILITIES
31,800
38,996
SHAREHOLDERS’ EQUITY
Preferred shares, no par value, 2,000
shares authorized; none issued and outstanding as of September 30,
2024 and December 31, 2023
—
—
Common shares, no par value, 450,000
shares authorized as of September 30, 2024 and December 31, 2023;
188,837 and 174,987 shares issued and outstanding as of September
30, 2024 and December 31, 2023, respectively
469,268
451,343
Accumulated other comprehensive loss
(2,890
)
(3,068
)
Accumulated deficit
(400,192
)
(384,856
)
Lineage's shareholders’ equity
66,186
63,419
Noncontrolling deficit
(1,392
)
(1,396
)
Total shareholders’ equity
64,794
62,023
TOTAL LIABILITIES AND SHAREHOLDERS’
EQUITY
$
96,594
$
101,019
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,
2024
2023
2024
2023
REVENUES:
Collaboration revenues
$
3,386
$
957
$
5,671
$
5,949
Royalties, license and other revenues
393
289
960
908
Total revenues
3,779
1,246
6,631
6,857
OPERATING EXPENSES:
Cost of sales
38
169
180
415
Research and development
3,171
3,741
9,049
11,799
General and administrative
4,410
4,041
13,770
13,014
Total operating expenses
7,619
7,951
22,999
25,228
Loss from operations
(3,840
)
(6,705
)
(16,368
)
(18,371
)
OTHER INCOME (EXPENSES):
Interest income
397
433
1,322
1,225
Loss on marketable equity securities,
net
(6
)
(60
)
(21
)
(170
)
Foreign currency transaction gain (loss),
net
448
(827
)
(284
)
(1,796
)
Other income (expense)
—
1
19
544
Total other income (expenses)
839
(453
)
1,036
(197
)
LOSS BEFORE INCOME TAXES
(3,001
)
(7,158
)
(15,332
)
(18,568
)
Provision for income tax benefit
—
—
—
1,803
NET LOSS
(3,001
)
(7,158
)
(15,332
)
(16,765
)
Net (income) loss attributable to
noncontrolling interest
(33
)
48
(4
)
54
NET LOSS ATTRIBUTABLE TO
LINEAGE
$
(3,034
)
$
(7,110
)
$
(15,336
)
$
(16,711
)
Net loss per common share attributable to
Lineage basic and diluted
$
(0.02
)
$
(0.04
)
$
(0.08
)
$
(0.10
)
Weighted-average common shares used to
compute basic and diluted net loss per common share
188,835
174,868
186,860
171,880
LINEAGE CELL THERAPEUTICS,
INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
Nine Months Ended September
30,
2024
2023
CASH FLOWS FROM OPERATING
ACTIVITIES:
Net loss attributable to Lineage
$
(15,336
)
$
(16,711
)
Net loss attributable to noncontrolling
interest
4
(54
)
Adjustments to reconcile net loss
attributable to Lineage Cell Therapeutics, Inc. to net cash used in
operating activities:
Loss on marketable equity securities,
net
21
170
Accretion of income on marketable debt
securities
(184
)
(647
)
Depreciation and amortization expense
436
419
Change in right-of-use assets and
liabilities
(31
)
86
Amortization of intangible assets
22
98
Stock-based compensation
3,762
3,580
Deferred income tax benefit
—
(1,803
)
Foreign currency remeasurement and other
loss
309
1,892
Changes in operating assets and
liabilities:
Accounts receivable
339
(141
)
Prepaid expenses and other current
assets
891
56
Accounts payable and accrued
liabilities
(1,778
)
(3,456
)
Deferred revenue
(5,201
)
(6,036
)
Net cash used in operating activities
(16,746
)
(22,547
)
CASH FLOWS FROM INVESTING
ACTIVITIES:
Proceeds from the sale of marketable
equity securities
18
196
Purchases of marketable debt
securities
(8,761
)
(16,403
)
Maturities of marketable debt
securities
4,000
53,497
Purchase of equipment
(200
)
(583
)
Net cash (used in) provided by investing
activities
(4,943
)
36,707
CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from employee options
exercised
229
88
Common shares received and retired for
employee taxes paid
(23
)
(37
)
Proceeds from sale of common shares
14,070
6,625
Payments for offering costs
(113
)
(199
)
Repayment of finance lease liabilities
(40
)
(41
)
Net cash provided by financing
activities
14,123
6,436
Effect of exchange rate changes on cash,
cash equivalents and restricted cash
(120
)
(532
)
NET (DECREASE) INCREASE IN CASH, CASH
EQUIVALENTS AND RESTRICTED CASH
(7,686
)
20,064
CASH, CASH EQUIVALENTS AND RESTRICTED
CASH:
At beginning of the period
35,992
11,936
At end of the period
$
28,306
$
32,000
SUPPLEMENTAL DISCLOSURES:
Cash paid for interest
$
6
$
8
SUPPLEMENTAL SCHEDULE OF NON-CASH
FINANCING AND INVESTING ACTIVITIES:
Property and equipment expenditures in
accounts payable
$
11
$
8
Reconciliation of cash, cash
equivalents and restricted cash, end of period:
Cash and cash equivalents
$
27,750
$
31,474
Restricted cash included in deposits and
other long-term assets (see Note 13 (Commitments and
Contingencies))
556
526
Total cash, cash equivalents, and
restricted cash
$
28,306
$
32,000
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241114288784/en/
Lineage Cell Therapeutics, Inc. IR Ioana C. Hone
(ir@lineagecell.com) (442) 287-8963
Russo Partners – Media Relations Nic Johnson or David
Schull (Nic.johnson@russopartnersllc.com)
(David.schull@russopartnersllc.com) (212) 845-4242
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