Company: LCTX
Filing Date: 2025-06-23
Form Type: 8-K
Source: 0000950170-25-088738
Chunk: 2

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-06-23
Form: 8-K
Item: Item 8.01
Chunk 2
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 maintained in treated eyes from 24 months (+2.6 mm2; n=4) to 36 months (+1.9 mm2; n=5).

• In comparison, mean change in RPEDC area decreased in untreated fellow eyes from 24 months (-2.8 mm
2; n=4) to 36 months (-3.8 mm
2; n=5).

o

Mean change in ELM area was maintained in treated eyes from 24 months (+0.8 mm2; n=4) to 36 months (+0.3 mm2; n=5).

• In comparison, mean change in ELM area decreased in untreated fellow eyes from 24 months (-1.9 mm
2; n=4) to 36 months (-3.4 mm
2; n=5).

• These data suggest that OpRegen cell therapy may counteract RPE cell dysfunction and loss in GA by providing support to the remaining retinal cells within atrophic areas, and these effects appear durable through at least 36 months after a single administration.

RG6501 (OpRegen) is being developed under an exclusive worldwide collaboration between Lineage, Roche and Genentech. A Phase 2a clinical study, known as the “ GAlette” study, evaluating the success of subretinal delivery of OpRegen cell therapy to target areas of GA in patients with GA secondary to AMD is currently enrolling (ClinicalTrials. gov Identifier: NCT05626114). In addition to evaluating other surgical parameters, the GAlette study will test proprietary surgical devices in development for subretinal delivery of OpRegen cell therapy that have potential advantages over currently available devices and procedures.

Forward-Looking Statements

This report contains forward-looking statements. All statements, other than statements of historical facts, contained in this report are forward-looking statements. In some cases, forward-looking statements can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to: statements relating to the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD