Lineage Cell Therapeutics

What Lineage Cell Therapeutics does

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic cell therapies for serious medical conditions with significant unmet needs, including dry age-related macular degeneration, spinal cord injury, sensorineural hearing loss, corneal endothelial disease, and Type 1 Diabetes. The company is publicly traded on NYSE American under ticker LCTX, headquartered in Carlsbad, California with a 94%-owned cGMP manufacturing subsidiary (CellCure Neurosciences) in Jerusalem, Israel. Its proprietary AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform applies directed differentiation protocols to established pluripotent stem cell lines to produce ready-to-inject, off-the-shelf cell therapies without requiring genetic editing of the base platform, with optional gene editing capacity (e.g., the RND1 hypoimmune iPSC line developed with Factor Bioscience).

The company's product portfolio comprises seven programs: OpRegen (RG6501), an RPE cell replacement therapy for geographic atrophy secondary to dry AMD in Phase 2a development under a worldwide collaboration with Roche and Genentech; OPC1, an oligodendrocyte progenitor cell therapy for spinal cord injury in Phase 1/2a clinical trials; ReSonance (ANP1), an auditory neuron progenitor cell therapy in preclinical development with William Demant Invest; COR1, a corneal endothelial cell therapy in preclinical development; and research-stage programs ILT1 (Type 1 Diabetes), RND1 (hypoimmune iPSC), and PNC1 (photoreceptors). OpRegen and OPC1 both hold FDA RMAT designations; OPC1 additionally holds Orphan Drug designation, and OpRegen holds Fast Track designation, providing expedited regulatory pathways.

Lineage generates revenue primarily through collaboration and milestone payments rather than product sales, as no therapies are yet commercially approved. FY 2025 revenue of $14.6 million (up 54% YoY from $9.5M) was driven by the first milestone achievement under the Roche/Genentech collaboration and research funding from William Demant Invest. The company expects its $55.8M cash position (end of FY 2025) to fund operations into Q2 2028. Distribution for future approved products will primarily flow through partner infrastructure (Roche/Genentech for OpRegen globally; potentially WDI's audiology network for ReSonance), with clinical trial site networks serving as the current channel for investigational product distribution.

Name

Lineage Cell Therapeutics

Legal name

Lineage Cell Therapeutics, Inc.

Website

https://lineagecell.com

Company type

Public

Founded year

1990

Operating status

Operating

Headcount range

11–50 employees

Short description

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing allogeneic cell therapies from its proprietary AlloSCOPE platform to treat dry AMD, spinal cord injury, hearing loss, and corneal disease, with OpRegen partnered globally with Roche/Genentech.

Ownership category

akta.pro rank

Product category

Cell Therapy / Regenerative Medicine

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Stem Cell Therapies (MSC/iPSC/HSC-derived) (HLAAABAE), Stem Cell–Based Regenerative Therapies (HLAAAGAA), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC)

Keywords

• Allogeneic cell therapy
• Regenerative medicine
• Pluripotent stem cell
• Cell therapy manufacturing
• Biopharmaceutical pipeline

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Others

Revenue model

1. Collaboration and Milestone Revenue: Revenue generated from milestone payments and collaboration agreements with pharmaceutical partners, primarily Roche/Genentech for OpRegen (RG6501). The company achieved its first milestone under the Roche/Genentech worldwide collaboration in 2025, contributing to revenue growth of 54% year-over-year to $14.6 million in 2025.
2. Research Collaboration Funding: Non-dilutive research funding received from strategic partners for specific development programs. William Demant Invest (WDI) is funding up to $12 million over approximately 3 years for the ReSonance (ANP1) hearing loss program. CIRM provided a $50,000 grant for the Spinal Cord Injury Investor Symposium.
3. Government Grants: Grants from governmental and non-profit bodies supporting specific programs and initiatives, such as the CIRM grant for the Spinal Cord Injury Investor Symposium.

Go-to-market motion1 record

Distribution channels4 records

Marketing channels6 records

Core offering

Lineage Cell Therapeutics develops and manufactures allogeneic cell therapies from pluripotent stem cell lines using its proprietary AlloSCOPE platform. The company produces ready-to-inject, off-the-shelf cell therapy products designed to replace or support cells absent or dysfunctional due to degenerative disease, aging, or traumatic injury. Programs address geographic atrophy (dry AMD), spinal cord injury, hearing loss, corneal endothelial disease, and Type 1 Diabetes.

Product overview

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing a portfolio of allogeneic cell therapies based on its proprietary AlloSCOPE™ platform. The platform enables scalable, consistent, off-the-shelf cell therapy manufacturing from pluripotent stem cell lines. The product portfolio includes: OpRegen® (RG6501), an RPE cell replacement therapy for geographic atrophy secondary to dry AMD in Phase 2a development with Roche/Genentech; OPC1, an oligodendrocyte progenitor cell therapy for spinal cord injury in clinical trials; ReSonance (ANP1), an auditory neuron progenitor cell therapy for hearing loss in preclinical development; COR1, a corneal endothelial cell therapy for Fuchs dystrophy and bullous keratopathy in preclinical stage; and research initiatives including ILT1 (Type 1 Diabetes), RND1 (hypoimmune iPSC), and PNC1 (photoreceptors).

Differentiator

Problem solved

Functional benefit

Brands

• AlloSCOPE: Proprietary allogeneic cell manufacturing platform (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) for developing cell-based products
• ReSonance
• COR1
• ILT1

Products and services

• OpRegen (RG6501) Allogeneic retinal pigmented epithelial (RPE) cell replacement therapy for geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD), administered as a single subretinal transplantation of RPE cells. Being co-developed and commercialized with Roche/Genentech under a worldwide collaboration.
• OPC1 Allogeneic oligodendrocyte progenitor cell therapy designed to improve recovery following spinal cord injury (SCI) by replacing or supporting cells in the injured spinal cord that are absent or dysfunctional due to traumatic injury. In Phase 1/2a DOSED clinical study treating both subacute (21-42 days post-injury) and chronic (1-5 years post-injury) SCI.
• ReSonance (ANP1) Allogeneic auditory neuron progenitor cell transplant in preclinical development for the treatment of sensorineural hearing loss. Being developed in collaboration with William Demant Invest.
• COR1 Preclinical corneal endothelial cell therapy program targeting Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy, utilizing the proprietary AlloSCOPE platform to develop an off-the-shelf allogeneic cell therapy.
• ILT1 Research-stage islet cell transplant initiative for Type 1 Diabetes (T1D), targeting large-scale production of undifferentiated pluripotent cells for eventual islet cell therapy.
• RND1 Novel hypoimmune iPSC cell line with proprietary gene edits (B2M deletion, HLA-E overexpression, and a third undisclosed edit) developed in collaboration with Factor Bioscience for potential cell transplant candidates for CNS diseases and other indications.
• PNC1 Photoreceptor research initiative focused on directing differentiation of human pluripotent cells into clinical-grade transplantable photoreceptor precursors for treatment of photoreceptor degeneration conditions such as retinitis pigmentosa.

Quantifiable outcome

• OpRegen Phase 1/2a Cohort 4 (n=10): +6.2 ETDRS letters mean BCVA gain at 36 months (sustained from +5.5 at 24 months); extensive coverage subgroup (n=5): +9.0 ETDRS letters mean BCVA gain at 36 months (sustained from +7.4 at 24 months)
• +3 more outcomes

Named customers1 record

Segments5 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered major, minor and flagship / core.

• Factor Bioscience Inc.majorTechnology or Integration · 6 January 2026Lineage entered into an option and license agreement with Factor Bioscience (as assigned from Eterna) to develop an engineered hypoimmune iPSC cell line (RND1) for differentiation into cell transplant product candidates for CNS diseases. The partnership involves specific gene edits to reduce immunogenicity and prevent adverse immune responses. In January 2026, Lineage took delivery of the novel gene-edited hypoimmune iPSC line, triggering a success payment to Factor. Lineage retains an option to obtain an exclusive license for preclinical, clinical, and commercial use of the cell line. Factor remains eligible for an additional payment subject to Lineage entering an exclusive license.
• William Demant Invest 2 Aps (WDI)majorStrategic or Co-development Partner · 26 August 2025Lineage entered into a research collaboration with William Demant Invest to develop ReSonance (ANP1), an allogeneic auditory neuron progenitor cell transplant for sensorineural hearing loss. WDI will fund up to $12 million in planned research collaboration costs over the approximately three-year term of the agreement. The joint effort aims to advance preclinical development including manufacturing, proof-of-concept, and regulatory strategies to support future clinical trials. WDI's investment leverages its presence in the hearing healthcare market.
• California Institute for Regenerative Medicine (CIRM)minorOthers · 9 May 2023Lineage received a $50,000 grant from CIRM to support the inaugural Spinal Cord Injury Investor Symposium scheduled for June 29, 2023, in La Jolla, CA. The conference was designed to facilitate discussions on advancements and challenges in spinal cord injury treatment and foster collaboration among healthcare companies, researchers, and policymakers as part of broader efforts to accelerate stem cell therapies for unmet medical needs.
• Roche and Genentech (Member of the Roche Group)flagship / coreStrategic or Co-development Partner · 14 November 2022Lineage entered into an exclusive worldwide collaboration with Roche and Genentech for the development and commercialization of OpRegen (RG6501), an allogeneic RPE cell replacement therapy for geographic atrophy secondary to dry AMD. The collaboration leverages Roche/Genentech's global ophthalmology development and commercial infrastructure. Lineage achieved the first milestone under this collaboration in 2025, triggering collaboration revenue. The partnership includes potential milestone and royalty consideration payable to Lineage. Under the collaboration, Genentech leads global clinical development and the companies jointly oversee commercialization activities.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Century Therapeutics: Clinical-stage biotech developing allogeneic iPSC-derived cell therapies (NK and T cell platforms) for oncology. Directly comparable to Lineage as both are iPSC-based allogeneic cell therapy developers with similar scientific platforms and clinical-stage assets.
• BlueRock Therapeutics: Bayer-owned clinical-stage company developing engineered cell therapies from iPSCs, including programs in neurology, cardiology, and ophthalmology. Highly comparable to Lineage's AlloSCOPE platform and overlapping indications (e.g., retinal disease via acquired programs).
• Fate Therapeutics: Clinical-stage biotech developing off-the-shelf iPSC-derived NK and T cell immunotherapies. Directly comparable to Lineage as both use iPSC-based allogeneic platforms to create scalable, off-the-shelf cellular medicines.
• ViaCyte: Clinical-stage company developing stem cell-derived islet cell replacement therapies for Type 1 diabetes. Directly comparable to Lineage's ILT1 program and shares the pluripotent stem cell-derived allogeneic cell therapy approach.
• Sana Biotechnology: Clinical-stage biotech developing engineered cell therapies including hypoimmune iPSC-derived cells for type 1 diabetes and other indications. Highly comparable to Lineage's RND1 hypoimmune platform and overlapping T1D focus.
• Mesoblast: Commercial-stage company developing allogeneic cell therapies from mesenchymal lineage cells for inflammatory and degenerative diseases. Comparable as an allogeneic cell therapy developer with similar commercial readiness profile and indication overlap.
• Pluristem Therapeutics: Clinical-stage company developing allogeneic cell therapies from placental-derived stem cells for various indications. Comparable as a clinical-stage allogeneic cell therapy developer with similar pipeline-stage assets and platform technology orientation.
• Athersys: Clinical-stage biotech developing MultiStem cell therapy for neurological, inflammatory, and cardiovascular conditions. Comparable as a clinical-stage allogeneic cell therapy developer with similar size and pipeline-stage positioning.

Broad incumbents

• Vertex Pharmaceuticals: Large-cap pharmaceutical company that has advanced VX-880, an allogeneic stem cell-derived islet cell therapy for Type 1 diabetes. Directly comparable to Lineage's ILT1 program and represents a well-capitalized competitor in the cell therapy for T1D space.
• Astellas Pharma: Large-cap Japanese pharma that markets Izervay for geographic atrophy (via acquisition of Iveric Bio) and has a portfolio in cell and gene therapy via Universal Cells. Comparable as a broad incumbent in the cell therapy and ophthalmology spaces where Lineage competes.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/lineagecell
• YouTubeyoutube.com/@LineageCell/featured
• Facebookfacebook.com/LineageCell
• LinkedInlinkedin.com/company/lineagecell

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries1 record

Funding overview

Funding rounds15 records

Investors3 records

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M&A4 records

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lineage Cell Therapeutics