On May 12, 2026 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing "off the shelf" allogeneic cell therapies for serious medical conditions, reported its first quarter 2026 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.
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"This quarter, we continued to build on our developmental and clinical accomplishments. Most notably, we applied our proprietary cell manufacturing technology platform, AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), to launch COR1, our new, wholly-owned corneal endothelial cell therapy program. COR1 is a preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our platform. We also achieved our first milestone with our AlloSCOPE 5D manufacturing initiative, aimed at addressing the challenges of large scale production of undifferentiated pluripotent stem cells. If successful at a larger scale, the overall goal is to leverage this initiative, together with a differentiation protocol, to address the insufficient supply of islet cells needed to support a potential treatment of Type 1 Diabetes," stated Brian M. Culley, Lineage CEO.
"In parallel, we advanced our DOSED study, successfully administering OPC1 to a second chronic SCI participant using a novel delivery system. We also established a new Scientific Advisory Board with recognized and established cell therapy executive Joachim Fruebis, PhD, as its founding member. Dr. Fruebis’ extensive experience across ophthalmology, neurology, diabetes, and other key therapeutic areas will help drive the evolution of our cell therapy platform and help to translate our innovations into clinical and commercial success. We look forward to additional updates on further appointments to our SAB throughout the year."
"This will be an exciting year for Lineage. Our current cell therapy pipeline features seven separate cell types, two of which are in the clinic, and each of which is in development for a discrete indication addressing a significant unmet need. We remain focused on advancing our innovative pipeline through disciplined internal spending and support from external partners, in line with our long-term strategy of creating a leading portfolio of cell-based transplant programs, all based on our core technology and our AlloSCOPE manufacturing platform," concluded Mr. Culley.
Select Business Highlights
RG6501 (OpRegen Cell Therapy)
Positive RG6501 (OpRegen cell therapy) Phase 1/2a clinical study 3 year results encore featured at Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026, suggest evidence of sustained gains in best corrected visual acuity (BCVA) and partial structural restoration of the retina, including re-appearance of an RPE layer and features associated with recovery of photoreceptors.
Positive long-term clinical outcomes reported following a single administration of OpRegen cell therapy.
Clinical data reported at 12-, 24-, and 36-months for Cohort 4 (less advanced disease) of the Phase 1/2a study (12 patients) has continued to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients.
Notably, five patients who received extensive coverage of OpRegen cell therapy across their geographic atrophy (GA) lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement through 36 months.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech. The ongoing Phase 2a GAlette Study is currently enrolling at 17 clinical sites in the U.S. and Israel.
In addition to testing other surgical parameters, Genentech currently plans to evaluate proprietary surgical delivery devices in the Phase 2a GAlette study that have potential advantages over available off-the-shelf devices.
Ongoing efforts to further support development of OpRegen cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.
OPC1 Program (Spinal Cord Injury)
Second chronic SCI participant treated in the Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) study.
Second treated participant was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with single neurological levels of injury (NLI) at level T4 to T5, and the novel delivery system successfully administered a one-time injection of OPC1.
Opened second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center.
COR1 Program (Corneal Endothelial Disease)
Launched COR1, our corneal endothelial cell therapy (CEnC) program, a wholly-owned preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our technology platform.
Applicable indications for COR1 are expected to include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy.
Utilizing Lineage’s proprietary cell manufacturing and expansion platform, AlloSCOPE, the Company is manufacturing "off the shelf" corneal endothelial cells with identity, morphological, and functional characteristics which meet initial internal criteria and support further development.
Lineage plans to advance this new product candidate into translational models to support potential clinical testing.
ILT1 Manufacturing Initiative
Successfully met our first milestone for our ILT1 manufacturing initiative, demonstrating a highly scalable and fully suspension-based process for generating undifferentiated pluripotent cells using one of our proprietary cell lines.
Initial work accomplished at 0.5 liter scale and supports further development into a larger multi-liter format.
If successful at larger scale, Lineage may seek to demonstrate AlloSCOPE 5D scalability with one or more internal or partner-sourced hypo-immune or non hypo-immune cell lines, suitable to support potential islet cell differentiation and preclinical testing.
This initiative inverts traditional cell therapy product development by focusing on the challenge of large-scale production of a potential cell-based product candidate prior to conducting preclinical and clinical testing.
The goal of ILT1 is to establish a production modality that can support an expansion through differentiation process, entirely in a dynamic culturing system, which if successful, could potentially solve a major hurdle to production and commercialization of an islet cell therapy product candidate for the potential treatment of Type 1 Diabetes.
ReSonance (ANP1) Program (Hearing Loss)
First internally-developed program, an auditory neuron cell transplant to treat hearing loss built on our AlloSCOPE platform.
Research collaboration established in 2025 with William Demant Invest A/S (WDI) to jointly advance preclinical development of ReSonance over a term of three years.
WDI collaboration represents an important demonstration of the speed, efficiency, and value creation of the AlloSCOPE platform.
Up to $12 million of development costs was agreed to be contributed by WDI in 2025, which was intended to cover activities including, cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis.
Successfully completed 3 engineering manufacturing runs, with preparations underway for internal technology transfer to current Good Manufacturing (cGMP) team.
Established novel model of deafening to support ReSonance functional preclinical testing under the collaboration.
Scientific Advisory Board (SAB)
Established SAB to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline.
Founding member Joachim Fruebis, Ph.D., is an accomplished scientist and leader with an extensive career driving R&D innovation in biotechnology and pharma. His in-depth expertise spans small molecules, biologics, and advanced therapies across multiple therapeutic areas including ophthalmology, neurology, diabetes and obesity, cardiovascular, metabolic, and rare diseases. Dr. Fruebis’ experience includes pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines, including at Novo Nordisk, BlueRock Therapeutics, Bioverativ and Bayer.
Additional SAB members are expected to be added throughout the remainder of the year.
Appointment of Priyantha Herath, M.D., Ph.D., as Senior Vice President & Head of Clinical
Priyantha is a Board-certified specialist neurologist, with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase 3 clinical trial execution. He brings a broad clinical perspective to Lineage, having treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes, direct patient care which has contributed to a deep understanding of disease presentation, progression, and meaningful outcomes and we welcome his expertise and leadership in this new role.
Balance Sheet Highlights
Cash, cash equivalents, and marketable securities of $53.4 million as of March 31, 2026 is expected to support planned operations into Q2 2028.
First Quarter Operating Results
Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended March 31, 2026 were approximately $1.7 million, a net increase of $0.2 million as compared to $1.5 million for the same period in 2025. The increase was primarily driven by collaboration revenue recognized under our new research collaboration agreement with WDI.
Operating Expenses: Operating expenses are composed of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2026 were $9.3 million, an increase of $1.3 million as compared to $8.0 million for the same period in 2025.
R&D Expenses: R&D expenses for the three months ended March 31, 2026 were $4.2 million, an increase of $1.1 million as compared to $3.1 million for the same period in 2025. The net increase was primarily driven by $0.3 million for our OPC1 program, $0.2 million for our ReSonance program, and approximately $0.7 million for our preclinical and other undisclosed programs.
G&A Expenses: G&A expenses for the three months ended March 31, 2026 were approximately $5.1 million, an increase of $0.2 million as compared to $4.9 million for the same period in 2025. The net increase was primarily driven by personnel costs, partially offset by services provided by third parties.
Loss from Operations: Loss from operations for the three months ended March 31, 2026 was $7.6 million, an increase of $1.1 million as compared to $6.5 million for the same period in 2025.
Other Income/(Expenses): Other income/(expenses) for the three months ended March 31, 2026 reflected other income of $2.8 million, compared to other income of approximately $2.4 million for the same period in 2025. The net increase was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries and no warrant-related financing transaction costs incurred as compared to the prior year’s quarter.
Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2026 was $4.8 million, or $0.02 per share (basic) and $0.03 per share (diluted), compared to a net loss of $4.1 million, or $0.02 per share (basic and diluted), for the same period in 2025.
Conference Call and Webcast
Interested 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" (Conference ID: 9229676). 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 19, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 9229676.
About the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform
The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE "5D" describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.
(Press release, Lineage Cell Therapeutics, MAY 12, 2026, View Source [SID1234665545])