Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 92

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1A
Chunk 92
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IRB”) or ethics committee (“EC”) approval at each clinical trial site;

•failure of IRB to follow FDA protocol;

•failure obtaining permission from regulatory authorities to conduct a clinical trial after review of an IND or equivalent foreign application or amendment;

•slower than anticipated rates of patient recruitment and enrollment or failure to reach the targeted number of study participants due to competition from other clinical trials or available treatment options (some potentially newly approved and marketed), or patients dropping out of our clinical studies once enrolled;

•failure by clinical sites or our CROs or other third parties to adhere to clinical trial requirements or report complete findings;

•failure to perform the clinical studies in accordance with the FDA’s good clinical practices requirements or applicable foreign regulatory guidelines;

•occurrence of serious adverse events (“SAEs”) or adverse events (“AEs”) associated with our product candidates or with product candidates of third parties that may have characteristics similar to or perceived to be similar to our product candidates;

•negative or inconclusive results from clinical trials of our product candidates or clinical trials of product candidates with characteristics similar to or perceived as similar to our product candidates, which may result in decisions by us or our collaborators, or requirements imposed by regulators, to conduct additional clinical studies or to curtail or abandon development programs for a product candidate;

•inadequate effectiveness or unacceptable side effects, possibly resulting in the FDA or other regulatory authorities denying approval of our product candidates;

•approval and introduction of new therapies or changes in standards of practice or regulatory guidance that render our clinical trial endpoints or the targeting of our proposed indications obsolete;

•inability to monitor patients adequately during or after treatment or problems with patient compliance with the clinical trial protocols;

•inability or unwillingness of medical investigators to follow our clinical trial protocols;

•inadequate supply or quality of clinical trial materials or other supplies necessary for the conduct of our clinical trials;

•delayed or unfavorable FDA or other regulatory agency inspection and review of a clinical trial site or a manufacturing facility;

•inability to use clinical trial results from foreign jurisdictions to support U.S. regulatory approval;

•changes in regulatory requirements and guidance that require amending clinical trial protocols or conducting additional clinical or nonclinical studies; and

•greater than anticipated cost of clinical studies of our product candidates.

If patients drop out of our clinical trials, miss scheduled doses or follow-up visits or otherwise fail to follow clinical trial protocols, or if our clinical trials are otherwise disrupted due to unforeseen events, such as previously occurred as a result of the COVID-19 pandemic