Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 12

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1
Chunk 12
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 we are developing  a cell transplant therapy named RND1 for the treatment of an undisclosed indication. We believe this collaboration allows us to leverage our expertise to develop innovative cell transplant therapies by capitalizing on the convergence of directed cell differentiation and manufacturing with modern ex vivo gene editing technologies. Our former gene editing partner, Eterna Therapeutics, assigned this agreement to Factor in September 2024.  

We have identified, and we may seek to develop, additional product candidates based on our cell replacement approach. We may elect to conduct these activities on our own or through various collaborative arrangements. We may utilize various types of pluripotent cell lines as starting material for our product candidates. Presently, our process 

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development and manufacturing activities, including our current good manufacturing practice (“cGMP”) production of clinical trial material, are conducted at Cell Cure Neurosciences, Ltd., (“CCN”), our majority owned subsidiary.

Cell Therapy Technology Platform 

We believe we are one of the leading companies in pluripotent, cell-based non-oncology product development, as evidenced by our proprietary directed differentiation processes for multiple cellular lineages, cell manufacturing capabilities and stage of clinical development across multiple programs. Pluripotent cells, which are widely published as capable of becoming any human cell type, have potential applications in many areas of medicine with large unmet patient needs, including certain age-related degenerative diseases, degenerative conditions, or traumatic injury. Our programs are built on a proprietary, cell technology platform that integrates process development, manufacturing capabilities, formulation, and administration. Our product candidates consist of functional cells that may be able to replace faulty or absent cells, attenuate disease progression, or facilitate tissue repair. We are currently in clinical development with two pluripotent cell-derived product candidates (RPE cells and oligodendrocyte progenitor cells), and preclinical and research development for two additional candidates (auditory neurons and photoreceptor cells). In addition, we are investing in additional edited and non-edited pluripotent cell lines and are considering the differentiation of those pluripotent cells into additional cell types that may have therapeutic benefits in other areas of unmet medical need.

Cellular therapies are often aimed at regenerating or replacing affected cells or tissues and therefore may have more durable, broader, or more suitable applicability than certain traditional pharmaceutical products which seek to influence a single molecular target or a group of biological pathways. Small molecules and biologic therapies that require systemic delivery into the body can have unexpected side effects that can limit their usefulness.