Lineage Cell Therapeutics(LCTX) - 2020 Q4 - Annual Report

Financial Performance and Profitability - The company has incurred operating losses since inception and is uncertain about when it will achieve profitability[18] - The company has incurred operating losses since inception and is uncertain about achieving profitability[2] Research and Development - The company plans to continue spending a substantial amount on research and development, but success in developing useful products is not guaranteed[18] - A substantial amount of capital will continue to be spent on research and development, with no guarantee of success in developing useful medical products and technologies[2] Funding and Capital Requirements - The ability to conduct clinical trials and obtain regulatory approvals is dependent on the availability of funds[18] - The pace of research and development and the ability to commence clinical trials depend on the available funds[2] - Additional equity or debt securities may need to be issued to raise capital for operating expenses[18] - Additional equity or debt securities will need to be issued to raise capital for operating expenses[2] Regulatory Compliance - The company is subject to federal and state healthcare fraud and abuse laws, and non-compliance could result in substantial penalties[18] - The company may face substantial penalties if unable to comply with federal and state healthcare fraud and abuse laws[2] - Regulatory approvals are necessary for the company to sell its therapeutic and medical device products[18] - Without regulatory approvals, the company will not be permitted to sell its therapeutic and medical device products[2] Product Development and Market Potential - The company is focused on advancing its product candidates through clinical trials and commercialization[10] - The potential markets for the company's product candidates are significant, but the ability to serve those markets is uncertain[10] - The company aims to protect its intellectual property rights, which are crucial for its product candidates[10] Impact of External Factors - The ongoing effects of the COVID-19 pandemic may impact the company's operations[10]