Lineage Cell Therapeutics(LCTX)2025-03-10 20:15Financial Performance and Profitability - The company has incurred operating losses since inception and is uncertain when it will attain profitability[20] - The company anticipates needing to raise substantial additional capital to fund operations and product development, which may dilute existing shareholders[20] Product Development and Regulatory Risks - The company relies on third-party collaboration with F. Hoffmann-La Roche Ltd and Genentech, Inc. for the development and commercialization of RG6501 (OpRegen), which is critical for potential revenue[20] - The FDA granted orphan drug designation to OPC1 for the treatment of acute spinal cord injuries, but maintaining this designation is not guaranteed[21] - The company has limited experience in manufacturing its product candidates on a commercial scale, which poses risks for clinical development and regulatory approval[21] Market and Competitive Landscape - The commercial success of product candidates will depend on market acceptance by physicians, patients, and third-party payors[21] - The company faces significant competition, which may impact its ability to successfully commercialize its product candidates[21] - The company has no marketing and sales force or distribution capabilities currently in place[21] Stock Market and Geopolitical Risks - The market price of the company's common shares has been and may continue to be volatile[21] - The company is exposed to geopolitical risks that could disrupt operations, particularly at its facility in Jerusalem, Israel[20]