Full Press Release Details
CELL THERAPEUTICS REPORTs FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
| Phase 2a Clinical Study of RG6501 (OpRegen ) in Patients with GA Secondary to AMD Initiated by Genentech, a Member of the Roche Group | ||
| Submitted RMAT and Pre-IND Materials to Support OPC1 and VAC2 Programs in Spinal Cord Injury and Oncology, Respectively | ||
| Launched Two New Cell Therapy Programs for the Treatment of Hearing and Vision Loss | ||
| Established New R&D Facility and Expanded Existing cGMP Manufacturing Facility |
CA - March 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 fourth quarter
and full year ended December 31, 2022 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results.
marked a year of clinical and regulatory execution for the Lineage team, as we worked alongside our partners and internally to advance
our clinical and preclinical programs," stated Brian M. Culley, Lineage CEO. "A significant area of focus last year was our
alliance with Roche and Genentech, including supporting the initiation of a Phase 2a clinical study of OpRegen in patients with GA secondary
to AMD. We believe we have selected the most capable partner to advance OpRegen and we anticipate that the findings from the Phase 2a
study will be highly informative to the OpRegen development program in any future larger, comparative trials. We also made considerable
progress expanding and diversifying our pipeline, primarily through the addition of two new cell transplant programs. We believe the
learnings from our dry AMD program may prove valuable to our newer product opportunities, which are similarly based on our differentiated
cell transplant technology."
also completed key regulatory activities for our OPC1 and VAC2 programs, which help provide insights into their continued development,"
Mr. Culley added. "Our corporate objectives for 2023 will be to emphasize the further progression of our allogeneic cell therapy
programs, 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, and the continued support of both our newly established and existing collaborations, all
in support of our overarching vision of building Lineage into a leading cell therapy company."
significant milestones achieved in 2022 include:
| Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). | ||
| Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen: |
| Completed verification and validation and preclinical testing activities for a novel parenchymal spinal delivery (PSD) system to support planned regulatory submissions. | ||
| Key data from OPC1, a Phase 1 clinical study in acute thoracic spinal cord injury and a Phase 1/2a clinical study in subacute cervical spinal cord injury, were published in the Journal of Neurosurgery: Spine. |
| Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation. | ||
| Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates continued. |
| Pre-Investigational New Drug (IND) application briefing package submitted to the FDA to support U.S. clinical development for immuno-oncology. | ||
| Reported completion of enrollment in VAC2 Phase 1 non-small cell lung cancer (NSCLC) Study by Cancer Research UK. | ||
| Following technology transfer of the program from Cancer Research UK to Lineage and improvement of manufacturing processes, production scale increased and accordingly the cost of goods was reduced significantly, along with marked improvements in the purity and functionality of the manufactured material. |
| - | Established new U.S. R&D facility and expanded current GMP manufacturing facility in Israel. | |
| - | Strengthened intellectual property portfolio with Notice of Allowance for various patent applications including but not limited to covering oligodendrocyte progenitor cells. | |
| - | Announced appointment of Jill Howe as Chief Financial Officer. |
of the events and milestones anticipated by Lineage in 2023 include:
| - | Results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 ( OpRegen ), to be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting. | |
| - | Type B Meeting with FDA to discuss our proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system, anticipated in the second quarter. | |
| - | Clinical data update from the ongoing VAC2 Phase 1 NSCLC study, pending release from Cancer Research UK, anticipated in the second quarter. | |
| - | Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system. | |
| - | Initiation of DOSED ( D elivery of O ligodendrocyte Progenitor Cells for S pinal Cord Injury: E valuation of a Novel D evice) clinical study of OPC1. | |
| - | Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury. | |
| - | Submission of a grant application to CIRM for the continued support of the clinical development of OPC1. | |
| - | Development update on hypo immune induced pluripotent stem cell (iPSC) lines for neurology indications, under collaboration with Eterna Therapeutics. | |
| - | Updates from ongoing ANP1 preclinical testing at the University of Michigan Kresge Hearing Research Institute under a collaboration with the University of Michigan. | |
| - | Evaluation of new partnership opportunities and/or expansion of existing collaborations. | |
| - | Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission, programs, and accomplishments. |
cash equivalents, and marketable securities totaled $57.9 million as of December 31, 2022, which is expected to support planned operations
Quarter Operating Results
Lineage's revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues
for the three months ended December 31, 2022 were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million
for the same period in 2021. The increase was related to the recognition of deferred collaboration revenues in connection with a Collaboration
and License Agreement (the "Roche Agreement") we entered into with F. Hoffmann-La Roche Ltd. and Genentech, Inc., a member
of the Roche Group (collectively or individually, "Roche" or "Genentech"), in 2021, partially offset by lower
royalty and grant revenues.
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, 2022 were $8.5 million, a decrease
of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease
in R&D expenses under the Roche Agreement.
Expenses: R&D expenses for the three months ended December 31, 2022 were $4.1 million, a decrease of $20.7 million as compared to
$24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial
obligations payable to the Israel Innovation Authority ("IIA") and Hadasit Medical Research Services and Development Ltd
("Hadasit"), in connection with the $50.0 million upfront payment received under the Roche Agreement. This decrease was partially
offset by $0.1 million and $0.2 million in higher expenses to support the development of the new photoreceptor and auditory neuron cell
therapy program, respectively.
Expenses: G&A expenses for the three months ended December 31, 2022 were $4.3 million, a decrease of $0.1 million as compared to
$4.4 million for the same period in 2021. The decrease was primarily attributable to a decrease of $0.4 million in legal and litigation
expenses, partially offset by approximately $0.1 million in higher salaries and related benefit fees, and $0.1 million in higher share-based
compensation expense.
from Operations: Loss from operations for the three months ended December 31, 2022 was $6.6 million, a decrease of $21.6 million as compared
to $28.2 million for the same period in 2021, principally owing to collaboration-related expense accruals of $21.0 million under the
Income, Net: Other income, net for the three months ended December 31, 2022 was $0.3 million, compared to other income, net of $0.2 million
for the same period in 2021. The net variance was primarily related to offsetting variances between the changes in the value of marketable
equity securities, as well as exchange rate fluctuations related to Lineage's international subsidiaries for the applicable periods.
Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2022 was $6.4 million, or
$0.03 per share (basic and diluted), compared to a net loss attributable to Lineage of $29.0 million, or $0.17 per share (basic and diluted),
for the same period in 2021.
Year Operating Results
Lineage's revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues
for the year ended December 31, 2022 were $14.7 million, an increase of $10.4 million as compared to $4.3 million for the same period
in 2021. The increase was primarily related to a $12.2 million increase in collaboration revenues recognized from deferred revenues stemming
from the $50.0 million upfront payment under the Roche Agreement, partially offset by lower royalty and grant revenues.
Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December
31, 2022 were $36.5 million, a decrease of $15.6 million as compared to $52.1 million for the same period in 2021.
Expenses: R&D expenses for the year ended December 31, 2022 were $14.0 million, a decrease of $19.9 million as compared to $33.9
million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial obligations
payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory
neuron and photoreceptor cell therapy programs, respectively.
Expenses: G&A expenses for the year ended December 31, 2022 were $22.5 million, an increase of approximately $4.3 million as compared
to $18.2 million for the same period in 2021. The increase was primarily attributable to increases of $2.1 million in litigation and
legal expenses, $1.3 million in salaries and related benefit fees, $0.9 million in share-based compensation expenses, and $0.4 million
in audit and tax services, partially offset by $0.5 million in lower investor relations expense.
from Operations: Loss from operations for the year ended December 31, 2022 was $22.5 million, a decrease of $26.7 million as compared
to $49.2 million for the same period in 2021.
Income/(Expenses), Net: Other income (expenses), net for the year ended December 31, 2022 reflected other expense, net of ($3.3) million,
compared to other income, net of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain
on sale of marketable equity securities, as well exchange rate fluctuations related to Lineage's international subsidiaries for
the applicable periods.
Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2022 was $26.3 million, or $0.15 per
share (basic and diluted), compared to a net loss attributable to Lineage of $43.0 million, or $0.26 per share (basic and diluted), for
parties may access today's conference call 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 March 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering
conference ID number 5707771.
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.