Company: LCTX
Filing Date: 2025-05-01
Form Type: 8-K
Source: 0000950170-25-061466
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Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-05-01
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events.

Lineage Cell Therapeutics, Inc. (the “ Company,” “we,” “us,” or “our”) has successfully completed a production run for two different product candidates, each produced from a customized, two-tiered current Good Manufacturing Practice (“cGMP”) cell banking system. This production process utilizes a genetically-stable master cell bank created from a single, well-characterized pluripotent cell line, to generate a working cell bank, which then provides the source material for a final cell-based product candidate. This demonstrated cGMP production process should enable the ability to produce millions of doses of a cost-effective, scalable, and consistent supply of an allogeneic, cell-based product derived from a single initial cell line, that can be applied across multiple programs.

The following risk factor supplements the risk factors set forth in “ Item 1A. Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent reports we file with the SEC. The risk factor below should be read with the other risk factors described in the Company’s prior filings with the SEC.

No assurances can be given that we will be able to consistently continue to manufacture clinical quantities of our product candidates in accordance with current Good Manufacturing Practice (cGMP) from a master and working cell bank system, or at a cost-effective or commercially viable scale, for one or more of our product candidates.

The manufacture and supply of our cell therapy product candidates involve novel processes that are generally more complex than those required for small molecule drugs and accordingly present significant challenges and are subject to multiple risks. These complex processes involve the expansion and differentiation of pluripotent or embryonic stem cells to produce a master cell bank from which a renewable working cell bank can be obtained in order to produce the desired cell product candidate. Establishing a line of cells from stem cells that can proliferate without differentiating and remain well characterized, including being free of potentially deleterious genetic mutations, is challenging and requires a significant amount of time and resources. In May 2025, we announced that we successfully completed a production run for two different product candidates, each produced from a customized, two-tiered cGMP cell banking system. However, at this time, no assurances can be given that we will be able to consistently continue to produce cGMP production lots in the future or do so at a cost-effective or commercially viable scale. See also the risk factor titled, “ The manufacture of our cell