Jun. 22 at 7:36 PM
$LCTX OpRegen recap
Entering a major inflection window:
1. EU registration/listing by Roche/Genentech partner activity is another validation point.
2. Duke shows open enrollment expected soon. Device upgrade appears to be nearing completion, removing a key bottleneck.
3. Final quarter of Ph2: ~45/50 patients treated, with final cohorts moving through treatment.
4. Multiple paths forward:
Ph2/3 pivot or expanded pivotal pathway
Potential accelerated regulatory strategy discussions if data supports
5. Roche commitment remains a major de-risking factor with continued investment in manufacturing, clinical execution & development.
6. Interim Roche update this summer (per Canaccord commentary).
7. SAB expansion expected any new high-caliber members could signal growing confidence.
8. Upcoming catalysts: enrollment restart, mature data, durability, regulatory clarity, and strategic optionality.
The setup, Big Pharma partner, and multiple paths to value creation.
