Company: LCTX
Filing Date: 2025-06-23
Form Type: 8-K
Source: 0000950170-25-088738
Chunk: 1

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-06-23
Form: 8-K
Item: Item 8.01
Chunk 1
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Item 8.01 Other Events.

As previously reported, RG6501 (OpRegen®) is being evaluated in a Phase 1/2a clinical study in patients with GA secondary to AMD. OpRegen retinal pigment epithelium (RPE) cell therapy 36-month visual acuity results from patients enrolled in the study were presented at CTS 2025 on June 20, 2025. The presentation included that:

• Improvement in visual acuity in Cohort 4 patients (patients with less advanced GA than in other cohorts) was present at 12 months (primary endpoint), 24 months, and has now persisted through 36 months.

• Gains in best corrected visual acuity (BCVA) in Cohort 4 patients (less advanced GA) measured at 12 months remain evident through 36 months following subretinal administration of OpRegen cell therapy.

• Mean change in BCVA among treated eyes for patients (n=10) completing 3-year follow up was +6.2 letters (compared to +5.5 letters at 24 months) (Early Treatment Diabetic Retinopathy Study (ETDRS) assessment).

• Improvement in BCVA and outer retinal structure in patients with extensive OpRegen bleb coverage of their GA area was greater than in patients with limited coverage and persisted through month 36

• Effects were greater on average in the five (5) patients with extensive OpRegen cell therapy coverage of atrophic areas at the time of surgical delivery.

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In these patients’ treated eyes, the mean change in BCVA was +9.0 ETDRS letters for those completing 3-year follow-up (compared to +7.4 ETDRS letters at 24 months) (n=5).

• Sustained evidence of retinal structural improvement by a quantitative Optical Coherence Tomography (OCT) analysis through 36 months was observed in treated eyes of Cohort 4 patients (less advanced GA than in other cohorts) following a single subretinal administration of OpRegen cell therapy.

• At month 36, sustained evidence of retinal structure improvements in external limiting membrane (ELM) and RPE drusen complex (RPEDC) layers on OCT was observed in the subgroup of five patients in Cohort 4 with extensive OpRegen cell therapy bleb coverage of atrophic areas at the time of surgical delivery.

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Mean improvement of RPEDC area compared with baseline was