Full Press Release Details
CELL THERAPEUTICS REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
| Enrollment Continues in Phase 2a Clinical Study of RG6501 (OpRegen ) in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Under Management of Genentech, a Member of the Roche Group | ||
| Additional RG6501 (OpRegen ) Data Presented at 23 rd Annual EURETINA Congress and 2023 Eyecelerator Meetings | ||
| U.S. Patent Issued Covering Manufacturing and Differentiation Process for Retinal Pigment Epithelial (RPE) Cells | ||
| Company On Track to Submit OPC1 Investigational New Drug Amendment in Q4 2023 | ||
| Initiated Development Activities for Hypoimmune Pluripotent Cell Line for Neurology Indications Under Partnership with Eterna Therapeutics |
CA - November 9, 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 third quarter
ended September 30, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business
Lineage team has continued to advance our clinical and preclinical pipeline of differentiated cell transplant programs, supporting our
alliances and working to establish new collaborations," stated Brian M. Culley, Lineage CEO. "The most important area of
attention for our team remains our partnership with Roche and Genentech and our support for the ongoing Phase 2a clinical study of OpRegen
in patients with geographic atrophy secondary to AMD. Through presentations at medical and scientific conferences, we have broadened
awareness of OpRegen's potential to provide durable anatomical and functional improvements in patients with GA. Most recently,
additional observations of rapid improvements to outer retinal structure in the initial Phase 1/2a clinical study of OpRegen were reported;
improvements were detectable within the first three months following a single administration, suggesting that OpRegen RPE cells may provide
support to the patients' remaining retinal cells within atrophic areas. Looking forward, we are working with our partners, Roche,
and Genentech, on additional clinical data updates on the OpRegen program."
addition, our team continued the necessary work to submit our Investigational New Drug amendment for OPC1 to enable us to initiate the
DOSED clinical study in subacute and chronic spinal cord injury patients," Mr. Culley added. "In parallel, we also initiated
certain development activities under our partnership with Eterna Therapeutics, reflecting a key step in a corporate strategy to capitalize
on our existing process development capabilities by combining them with cutting-edge cell engineering and editing technologies, to create
novel and potentially superior product profiles. As always, we intend to advance our business and programs in a responsible and fiscally
conservative way, with an overarching focus on providing a meaningful impact for patients through the development of differentiated allogeneic
milestones and activities included:
cash equivalents, and marketable securities totaled $41.3 million as of September 30, 2023, which is expected to support planned operations
Quarter Operating Results
Lineage's revenue is generated primarily from licensing fees, royalties, collaboration revenues, and research grants. Total revenues
for the three months ended September 30, 2023 were $1.2 million, a net decrease of $1.8 million as compared to approximately $3.0 million
for the same period in 2022. The decrease was primarily driven by lower collaboration and licensing revenue recognized from deferred
revenues from the Collaboration and License Agreement among Lineage and Roche and Genentech entered into in December 2021.
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, 2023 were $7.8 million, a decrease
of $0.2 million as compared to $8.0 million for the same period in 2022.
Expenses: R&D expenses for the three months ended September 30, 2023 were $3.7 million, a net increase of $0.1 million as compared
to $3.6 million for the same period in 2022. The net increase was primarily driven by $0.2 million in higher OPC1 program-related expenses,
and $0.5 million in expenses to support preclinical and other research and development programs. These increases were partially offset
by a $0.5 million decrease in our VAC program, primarily related to reduced manufacturing activities.
Expenses: G&A expenses for the three months ended September 30, 2023 were $4.0 million, a net decrease of approximately $0.4
million as compared to $4.4 million for the same period in 2022. The decrease was primarily attributable to an overall reduction in costs
incurred for services by third parties, consulting costs, and recruiting related expenses.
from Operations: Loss from operations for the three months ended September 30, 2023 was $6.7 million, an increase of $1.5 million
as compared to a loss of $5.2 million for the same period in 2022.
Income/(Expenses), Net: Other income (expenses), net for the three months ended September 30, 2023 reflected other expense, net of
approximately ($0.4) million, compared to other expense, net of ($0.3) million for the same period in 2022. The net change was primarily
driven by exchange rate fluctuations related to Lineage's international subsidiaries and fair market value changes in marketable
equity securities, partially offset by interest income from our marketable debt securities.
Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2023 was $7.1 million,
or $0.04 per share (basic and diluted), compared to a net loss attributable to Lineage of $6.1 million, or $0.04 per share (basic and
diluted), for the same period in 2022.
parties may access today's conference call and webcast, 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 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number
Lineage Cell Therapeutics, Inc.
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 and preclinical 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 2a development for
the treatment of geographic atrophy secondary to age-related macular degeneration, 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 potential 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.
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 potential benefits of OpRegen and the expansion of the Phase 2a clinical study of OpRegen to additional clinical sites; that
our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the first quarter of 2025;
the timing of anticipated regulatory submissions to the FDA related to our programs, the potential future achievements of our clinical,
preclinical and development programs, the initiation of clinical trials and the timing and availability of clinical data updates related
to our programs; plans and expectations regarding existing collaborations; and the potential of our cell therapy platform and our ability
to provide an meaningful impact for patients. 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 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, 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 the feedback received
from the FDA for OPC1 may not enable further clinical development; that the ongoing Israel-Hamas war 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). 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 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.
Cell Therapeutics, Inc. IR