Lineage Cell Therapeutics (LCTX) Q2 FY26 earnings call: guidance and Q&A

What is the multi-liter scale for the islet cell program and how does it contrast with peers? What is the update on the chronic DOSED study, including any 1-year data and regulatory dialogue?

Brian declined to specify the exact multi-liter scale for the islet program due to proprietary reasons. Dr. Herath stated the DOSED study is not designed to assess functional changes, but patients are adverse event-free and stable. Anecdotal family reports of improvement (breathing, core strength) have been received, but formal neurological changes are not being assessed yet.

“So we're being intentionally unclear about exactly what vessel size, because if there were only one company in the world that makes a 4.4-liter vessel, you would know one of the many component parts and we're just not going to do that.”

asked by Mayank Mamtani · answered by Brian Culley

What is the timeline for getting COR1 into the clinic, and would Lineage seek a partner before or after clinical proof of concept?

Brian explained that COR1 benefits from established animal models and human study designs, allowing for faster clinical entry. He noted the risk profile is different due to the existing precedent of cadaveric corneal transplants. While partnership is always an option, the company can execute the plan internally, with initial animal model data expected by year-end.

“What we said today is that one of our goals is to generate initial animal model data. If we are in a position to share it before the end of the year, that's even better. That would certainly be a goal for us.”

asked by Jack Allen · answered by Brian Culley

Could Lineage elaborate on the regulatory filing for OpRegen in Ireland and its implications for Roche's European studies?

Brian clarified that the filing was for the EMA IRIS database, not Ireland specifically. He explained it's an administrative step required before engaging with European regulatory bodies, indicating Roche's continued interest and activity in the OpRegen program, though it doesn't commit them to European studies.

“As one example, OpRegen was recently registered in the EMA IRIS database, which is something that sponsors need to do before they conduct product-related activities like obtaining scientific advice or running clinical studies in Europe.”

asked by Jack Allen · answered by Brian Culley

What are the remaining commercial milestones for the OpRegen program, and does Lineage maintain commercial rights or a royalty?

Brian confirmed Lineage is eligible for $615 million in remaining developmental and commercial milestones. He stated it is a plain vanilla double-digit royalty agreement with increasing tiers, not a co-promote. The agreement covers RPE cells for any eye disorder worldwide.

“So we remain eligible for $615 million of developmental and commercial milestones. Those are not broken out publicly.”

asked by John Newman · answered by Brian Culley

Can you provide more detail on the proprietary nature of your cell manufacturing 'recipe' and its competitive impact? Also, can you comment on any increases in services or product shipments under the OpRegen agreement?

Brian stated that the OpRegen services agreement information is confidential. Regarding manufacturing, he emphasized that Lineage's intellectual property lies in methods for reproducible, scalable, and high-quality cell production. He highlighted the regulatory risk of changing processes post-Phase I for scalability, contrasting it with small molecule manufacturing, and stressed the importance of building a scalable process from day one.

“If you are making cells, and let's say it takes you randomly 45 days to run a batch of a certain kind of cell and that's good enough to do a Phase I clinical trial, but you know that it's not a commercially viable process and you just say to yourself, well, I'm going to put some steroids in here. I'm going to throw some sugar in here and I'm going to make the process, spit out more cells, I'm going to, i.e., scale it, you are changing your product in the view of the FDA.”

asked by Joseph Pantginis · answered by Brian Culley

What is the expected cadence for new patient enrollment in the DOSED study, given the safety waiting period and the dosing of the second patient? Will only chronic patients be enrolled moving forward?

Dr. Herath explained that the first four patients require a one-month DSMB break between enrollments, limiting rapid expansion. The third patient is currently being assessed, and several chronic candidates are available. He anticipates enrolling the remaining patients relatively quickly, hopefully within the next 12 months. Brian added that Lineage retains the optionality to change the protocol, potentially using subacute slots for bridging to new cells.

“So the first 4 patients in the protocol, each will have a 1-month DSMB break before the next patient can be enrolled. So there's that. So until we are done with the fourth patient, we cannot rapidly expand the recruitment.”

asked by Sean McCutcheon · answered by Priyantha Herath