Full Press Release Details
CELL THERAPEUTICS REPORTs FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
| Additional RG6501 (OpRegen ) Phase 1/2a Clinical Study Results Presented at ARVO 2023 | ||
| Enrolling Phase 2a Clinical Study of RG6501 (OpRegen) in Patients with GA Secondary to AMD Under Management of Genentech, a Member of the Roche Group | ||
| Awarded CIRM Grant to Support 1 st Annual Spinal Cord Injury Investor Symposium | ||
| Signed Option and License Agreement with Eterna Therapeutics to Develop Hypoimmune iPSC Lines | ||
| Initiated Preclinical Testing of ANP1 for Treatment of Hearing Loss |
CA - May 11, 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 first quarter ended
March 31, 2023 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results.
the first quarter of this year, the Lineage team executed on multiple fronts, advancing our clinical and preclinical cell transplant
programs while continuing support of our existing alliances and establishing new ones," stated Brian M. Culley, Lineage CEO. "A
key area of focus was our partnership with Roche and Genentech and supporting the ongoing Phase 2a clinical study of OpRegen in patients
with GA secondary to AMD, which is enrolling and treating patients at multiple sites in the U.S. Through presentations at various medical
and scientific conferences, we also broadened our efforts to enhance awareness of OpRegen's potential to provide durable anatomical
and functional improvements in dry AMD patients. In addition, we established new collaborations with CIRM and the Christopher & Dana
Reeve Foundation to support a new SCI conference which aims to identify, discuss, and address gaps
in the product development process and elevate the patient's voice in the treatment process. Looking ahead, we will be working
on regulatory interactions for OPC1 while continuing to maintain our commitment to disciplined spending and making responsible investments
in disease settings where we believe the use of differentiated cell transplants can provide a meaningful impact for patients."
milestones and activities included:
of the events anticipated by Lineage include:
| - | Type B Meeting with FDA to discuss a proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system. | |
| - | Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system. | |
| - | Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury. | |
| - | Updates from ongoing ANP1 preclinical testing at the University of Michigan Kresge Hearing Research Institute under a collaboration with the University of Michigan. |
cash equivalents, and marketable securities totaled $46.8 million as of March 31, 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 March 31, 2023 were approximately $2.4 million, a net decrease of $2.8 million as compared to $5.2 million
for the same period in 2022. The decrease was driven by less collaboration and licensing revenue recognized from deferred revenues from
the Roche Agreement.
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 March 31, 2023 were $8.9 million, a decrease of
$2.5 million as compared to $11.4 million for the same period in 2022.
Expenses: R&D expenses for the three months ended March 31, 2023 were $4.2 million, a net increase of $1.2 million as compared to
$3.0 million for the same period in 2022. The net increase was primarily driven by $0.5 million for nonclinical-related expenses to support
the OPC1 program, and $0.2 million in OpRegen program expenses to support the Roche collaboration. Another $0.4 million and $0.2 million
of the increase was related to R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively.
Expenses: G&A expenses for the three months ended March 31, 2023 were $4.7 million, a net decrease of $3.7 million as compared to
approximately $8.4 million for the same period in 2022. The decrease was primarily driven by $3.5 million in lower litigation and legal
expenses, mostly due to the Asterias litigation settlement expense accrued in the prior year, and $0.2 million in lower expense for accounting
from Operations: Loss from operations for the three months ended March 31, 2023 was $6.6 million, an increase of $0.2 million as compared
to $6.4 million for the same period in 2022.
Income/(Expenses), Net: Other income (expenses), net for the three months ended March 31, 2023 reflected other income, net of $0.4 million,
compared to other expense, net of ($0.7) million for the same period in 2022. The net income was primarily driven by fair market value
changes in marketable equity securities, interest income from our marketable debt securities, and other income recorded in the current
period related to the employee retention credit program, partially offset by exchange rate fluctuations related to Lineage's international
Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2023 was $4.4 million, or $0.03
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 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 May 18, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 8339383.
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 significance of the Phase 2a clinical study of OpRegen; that our cash, cash equivalents and marketable securities is sufficient
to support our planned operations into the third quarter of 2024; the timing and nature of events and milestones anticipated to occur
in 2023, including plans and expectations regarding publications and presentations related to our programs, 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 availability of clinical data updates related to our programs; plans and expectations
regarding existing collaborations, including our plans to develop new cell lines into differentiated cell transplant therapies and potential
product candidates, and the potential indications thereof as a result of the Agreement with Eterna; our ability to broaden awareness
of our mission, programs and accomplishments; 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 planned regulatory interaction with FDA for OPC1 may
not enable further clinical development; that the SCIIS will not accelerate SCI research, clinical trials or product development; 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
Partners - Media Relations
Johnson or David Schull