Lineage Cell Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
-- Enrollment Continues in Phase 2a Clinical Study of RG6501 (OpRegen$(R)$) 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(R)) Data Presented at 23rd 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 CARLSBAD, Calif.--(BUSINESS WIRE)--November 09, 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 update.
"The 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."
"In 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 cell transplants."
Recent milestones and activities included:
-- RG6501 (OpRegen)
-- Continued execution under our collaboration with Roche and
Genentech across multiple functional areas, including support for
the ongoing Phase 2a multi-center clinical study in patients with
GA secondary to AMD. Additional sites expected to come online for
the Phase 2a study.
-- Results of imaging analyses demonstrating rapid improvement in
outer retinal structure from patients enrolled in the prior Phase
1/2a clinical study, were presented at the 23rd EURETINA
Congress:
-- All five patients who had extensive coverage of the GA
lesion with the surgical bleb containing OpRegen in
suspension demonstrated evidence of improvement in outer
retinal structure as assessed by optical coherence
tomography $(OCT.AU)$ within the first three months after
treatment.
-- Retinal structural improvements were initially
observed on day 1 (n=1), day 14 (n=1), month 1 (n=2),
and month 3 (n=1).
-- Structural improvement on OCT was qualitatively
defined as meeting all pre-specified criteria on at
least two non-adjacent B scans including: 1)
reduction in outer plexiform layer $(OPL.AU)$ and/or
inner nuclear layer $(INL.UK)$ subsidence; 2)
reappearance of external limiting membrane $(ELM.UK)$;
and 3) increased hyperreflectivity and/or thickness
of RPE and/or Bruch's membrane or reduction of
hypertransmission on at least two non-adjacent B
scans.
-- Structural improvement was only observed within GA
lesions with extensive coverage with the surgical
bleb, suggesting that OpRegen RPE cells provide
support to the remaining retinal cells within
atrophic areas.
-- These five patients had an average of 4.4 letter
best corrected visual acuity (BCVA) gain by 3 months
and 12.8 letter BCVA gain by 1 year compared to
baseline.
-- U.S. Patent No.11,746,324 entitled "Large Scale Production of
Retinal Pigment Epithelial Cells," issued.
-- Investigational New Drug $(IND.AU)$ amendment preparation for clinical
testing of novel OPC1 spinal cord delivery system continues
-- Company remains on track to submit IND amendment to FDA in Q4
2023 to enable initiation of the DOSED clinical study in subacute
and chronic spinal cord injury patients.
-- Initiated Development Activities for Hypoimmune Pluripotent Cell Line
for Neurology Indications Under Partnership with Eterna Therapeutics
-- Lineage evaluated its development strategy with a group of
leading neurology experts in the U.S. and abroad and following an
assessment of the competitive landscape, finalized its selection
of specific gene edits for the initial cell lines to be developed
by Eterna.
-- The edits include: the targeted deletion of the B2M gene,
designed to reduce the immunogenicity of product candidates
derived from the lines by inhibiting rejection by CD8+ T
cells; the targeted insertion of the HLA-E gene, designed
to overexpress HLA-E and prevent the allogeneic NK cell
response; and a third undisclosed edit intended to confer
clinical differentiation and a competitive advantage in the
applicable indications.
-- Positive ANP1 initial proof of concept results from collaboration with
the University of Michigan
-- Initial results demonstrated delivery, engraftment, and survival
of ANP1 cells into specific target areas.
-- Results support advancement of the ANP1 program into functional
preclinical testing.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities totaled $41.3 million as of September 30, 2023, which is expected to support planned operations into Q1 2025.
Third Quarter Operating Results
Revenues: 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.
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, 2023 were $7.8 million, a decrease of $0.2 million as compared to $8.0 million for the same period in 2022.
R&D 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.
G&A 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.
Loss 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.
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