Lineage Cell Therapeutics' OpRegen® Data Ignites Hope for Geographical Atrophy Patients and Investors

Geographic atrophy (GA), a leading cause of irreversible vision loss in older adults, has long been a therapeutic dead end. But Lineage Cell Therapeutics (NASDAQ: LCTX) may have just rewritten the playbook. The company's 36-month data for its OpRegen® RPE cell therapy—presented at the Clinical Trials at the Summit (CTS) 2025—reveals durable improvements in visual acuity and retinal structure, positioning OpRegen as a potential first-in-class treatment for GA. For investors, these results could be a catalyst for a long-overdue valuation re-rating, as the therapy's transformative potential becomes undeniable.



### Durability of Visual and Anatomical Benefits: A Paradigm Shift
The 36-month data from Lineage's Phase 1/2a trial delivers the clearest evidence yet that OpRegen can counteract GA's relentless progression. Patients with extensive coverage of the RPE cell therapy (administered in a single subretinal injection) saw sustained visual gains, with a subgroup achieving a +9.0 letter improvement on the ETDRS chart at 36 months—a metric that measures visual acuity. These gains were not fleeting: mean BCVA (best corrected visual acuity) remained above baseline at every assessment point, contrasting sharply with untreated fellow eyes, which continued to deteriorate.

Structural improvements were equally compelling. Optical coherence tomography (OCT) scans showed preserved retinal layers (external limiting membrane and RPE drusen complex) in treated eyes, while untreated eyes saw progressive thinning. For instance, the mean RPEDC area in treated eyes with extensive coverage increased by +1.9 mm² at 36 months, versus a -3.8 mm² decline in untreated eyes. These findings challenge the dogma that GA-induced retinal damage is irreversible, suggesting OpRegen's allogeneic RPE cells may restore critical retinal function.

### GAlette Trial: A Strategic Lever for Commercialization
The GAlette Phase 2a trial (NCT05626114), now enrolling patients in the U.S. and Israel, is critical to scaling OpRegen's promise. Key advancements include:
- Surgical Delivery Optimization: Genentech is testing proprietary devices to improve subretinal placement accuracy, addressing a key hurdle in earlier trials where partial coverage limited efficacy.
- Thaw-and-Inject Formulation: This simplifies logistics, enabling direct shipment to clinics and eliminating the need for on-site cell preparation—a logistical and cost barrier for broader adoption.

By refining delivery methods, GAlette aims to maximize cell coverage, which the Phase 1/2a data identifies as the linchpin for therapeutic success. This focus on operational and procedural improvements reduces execution risks, making commercialization more feasible.

### Market Opportunity and Lineage's Positioning
With over 5 million GA patients globally and no FDA-approved treatments, the market is ripe for disruption. Competing therapies, such as anti-complement agents, require monthly injections and face compliance challenges. OpRegen's one-time administration and durable effects (lasting at least three years) could dominate this space.

Lineage's financials further bolster confidence:
- Cash Runway: $47.9 million as of March 2025, sufficient to fund operations into Q1 2027.
- Manufacturing Milestones: GMP-compliant doses are now feasible, reducing supply chain risks for future trials and eventual commercialization.



### Investment Implications: A Re-Rating Catalyst on the Horizon
LCTX has historically traded at a discount to peers, reflecting skepticism about OpRegen's clinical and commercial viability. The 36-month data, however, shifts the narrative:
- Reduced Risk Profile: Demonstrated durability and safety at 36 months eliminate concerns about short-lived effects or late-stage safety issues.
- Regulatory Momentum: The FDA's focus on unmet needs in GA could fast-track OpRegen, especially with Phase 2a data showing consistent benefits.
- Valuation Upside: If GAlette delivers on its goals, LCTX's pipeline (including OPC1 for spinal cord injury and ReSonance for hearing loss) could attract partnerships or M&A interest.

Investment Thesis:
- Buy: For investors seeking high-risk, high-reward opportunities in biotech. The 36-month data reduces execution risk, and GAlette's outcomes could trigger a valuation re-rating.
- Hold: For cautious investors awaiting GAlette's Phase 2a results.
- Avoid: Only for those averse to biotech's volatility or skeptical of cell therapy's scalability.

### Conclusion: A Vision for Value Creation
Lineage's OpRegen is no longer just a promising therapy—it's a potential revolution. The 36-month data confirms its ability to stabilize and improve vision in GA patients, a first in the field. With GAlette refining delivery and scalability, LCTX is primed to capitalize on a $10 billion+ market. For investors, the question is no longer if OpRegen succeeds but when the market will reward Lineage for it.

The next catalyst—GAlette's interim results—could be the spark to ignite a long-overdue revaluation of LCTX's stock. For those willing to bet on transformative science, now may be the time to set the stakes.