Company: LCTX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001193125-25-269599
Chunk: 3

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Item 2
Chunk 3
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eneic retinal pigmented epithelial (“RPE”) cell replacement therapy currently in Phase 2a development under a worldwide collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”), for the treatment of geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”).   

•OPC1, an allogeneic oligodendrocyte progenitor cell therapy currently in Phase 1/2a development for the treatment of spinal cord injuries (“SCI”). 

•ReSonanceTM (ANP1), an allogeneic auditory neuron progenitor cell transplant currently in preclinical development under a collaboration with William Demant Invest 2 Aps (“WDI”) for the potential treatment of auditory neuropathy.

•PNC1, an allogeneic photoreceptor cell transplant currently in preclinical development for the treatment of vision loss due to photoreceptor dysfunction or damage.   

•RND1, a cell transplant program for an undisclosed indication, currently being developed through a gene editing collaboration with Factor Biosciences Limited.

•A proprietary hypoimmune cell line, which may have utility in additional central nervous system indications.

•ILT1, an allogeneic islet cell transplant research program for the treatment of type 1 diabetes (T1D). We aim to deploy our manufacturing capability to address the issue of large-scale production of islet cells, with an initial goal of establishing a production modality that can support the entire production process in a dynamic culturing system, potentially solving a major hurdle to commercialization of islet cell therapy product candidates.

Our lead cell therapy program, known as OpRegen, is being developed for the treatment of ocular disorders, including GA secondary to AMD under the Collaboration and License Agreement we entered into with Roche in December 2021 (the “Roche Agreement”). OpRegen (also known as RG6501) is a suspension of human allogeneic RPE cells and is currently being evaluated in a Phase 2a multicenter clinical trial in patients with GA secondary to AMD which is referred to as the GAlette Study. OpRegen subretinal delivery has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. Under the terms of the Roche Agreement, we received a $50.0 million upfront payment