Lineage Cell Therapeutics, Inc. (NYSE: LCTX)

Lineage Cell Therapeutics, Inc., a clinical-stage biotechnology company, operates in the field of developing novel allogeneic, or "off-the-shelf," cell therapies to address unmet medical needs (Lineage Cell Therapeutics, Inc.). The company's main business activities revolve around creating cell therapies for various diseases and conditions, including age-related macular degeneration (AMD), spinal cord injury, and hearing loss. Lineage Cell Therapeutics' primary products and services include OpRegen, a suspension of human allogeneic retinal pigmented epithelial (RPE) cells, and OPC1, an allogeneic oligodendrocyte progenitor cell therapy.

The company's neuroscience-focused cell therapy pipeline includes several product candidates, most notably RG6501 (OpRegen), an allogeneic RPE cell replacement therapy in Phase 2a development for the treatment of geographic atrophy (GA) secondary to AMD. OpRegen has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal structure and function (Lineage Cell Therapeutics, Inc.). This cell replacement therapy is derived from the company's pluripotent cell technology, which converts pluripotent stem cells into nearly pure populations of RPE cells, and is designed to replace damaged or lost RPE cells with healthy, functional RPE cells manufactured from a well-characterized, allogeneic cell line.

Lineage Cell Therapeutics distinguishes itself within the industry as a leader in pluripotent, cell-based asset development, with a proprietary directed differentiation protocol and cell manufacturing capabilities. The company's cell therapy approach varies from other investigational agents and FDA-approved drugs for AMD, which necessitate repeated, frequent intravitreal injections. The company's position within the industry is further solidified by its collaboration with Roche and Genentech, under which OpRegen is being developed for the treatment of GA secondary to AMD. This collaboration provides access to Roche's and Genentech's expertise and resources, as well as their global reach and commercial capabilities.

The company's customers include Roche and Genentech, with whom it has a collaboration agreement to develop OpRegen for the treatment of GA secondary to AMD. Lineage Cell Therapeutics aims to address unmet medical needs by developing and advancing allogeneic, or "off-the-shelf," treatments comprised of functional cells delivered to the body. The company's biological therapies are derived from the differentiation of pluripotent stem cells from established and self-renewing cell lines (Lineage Cell Therapeutics, Inc.).

The company's strategies include leveraging its cell therapy platform to develop innovative treatments for various diseases and conditions and broadening the application of its cell therapy platform to support long-term growth. An example of this is the strategic collaboration with Eterna Therapeutics Inc. to develop iPSC lines for potential neurology indications (Lineage Cell Therapeutics, Inc.).

In addition to OpRegen, Lineage Cell Therapeutics has developed the VAC platform, an immuno-oncology platform using dendritic cells loaded with antigens for the treatment of cancer. VAC2, an allogeneic, or non-patient specific, cancer vaccine candidate, is designed to stimulate patient immune responses to an antigen, human telomerase reverse transcriptase ("hTERT"), which is commonly expressed in cancerous cells but is not usually found in normal adult cells. The company has entered into a worldwide license and development collaboration agreement with Immunomic Therapeutics, Inc. (ITI) to develop a novel cancer immunotherapy agent derived from the VAC platform utilizing an antigen provided by ITI (Lineage Cell Therapeutics, Inc.).

The company's collaborations and grants from government entities, such as the Israeli Innovation Authority (IIA) and the California Institute for Regenerative Medicine (CIRM), support the development of its cell therapies. Lineage Cell Therapeutics is required to comply with the terms of the grants, including royalty payments to the IIA and CIRM based on net commercial revenue from the sale of any product, drug, or service arising from the grants (Lineage Cell Therapeutics, Inc.). The company's competitive position is strengthened by its proprietary technology and collaboration agreements, including the agreements with Roche and Genentech, ITI, and Eterna Therapeutics Inc. Lineage Cell Therapeutics, Inc. continues to develop novel allogeneic, or "off-the-shelf," cell therapies to address unmet medical needs.