Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 54

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1A
Chunk 54
---
.’s Syfovre® (pegcetacoplan injection) and Iveric bio, Inc.’s IZERVAY™ (avacincaptad pegol intravitreal solution);

•Roche may not dedicate the resources necessary to carry OpRegen through clinical development, regulatory approval, or commercialization; 

•Roche may conclude that the commercial potential of OpRegen does not meet its internal thresholds or yield a timely return on its investment in OpRegen; 

•Roche may choose not to develop and commercialize OpRegen in certain, or any, markets or for one or more indications, if at all; 

•Roche may change the focus of its development or commercialization efforts or prioritize other programs and, accordingly, reduce the efforts and resources allocated to OpRegen; 

•Roche may be unable to obtain regulatory clearances or approvals to continue clinical development or commercialization of OpRegen in a timely manner, or at all; 

•the failure to develop a formulation and/or manufacturing process for OpRegen that Roche believes is commercially viable in a timely manner, or at all; or 

•the loss or impairment of intellectual property rights related to OpRegen.

If Roche terminates the collaboration:

•we would no longer have the right to receive any milestone payments or royalties thereunder; 

•further development of OpRegen, if any, would be significantly delayed or terminated; 

•we would bear all risks and costs related to any further clinical development, manufacturing, regulatory approval and commercialization OpRegen, if any; 

•we might determine that the commercial potential of OpRegen does not warrant further development of OpRegen; 

•we would need to raise additional capital if we were to choose to pursue OpRegen development on our own, or we would need to establish alternative collaborations with third parties, which might not be possible in a timely manner, or at all; 

•if we were to choose to pursue OpRegen development independently, we would need to work collaboratively with Roche to transfer the OpRegen program back to us, and such a transfer might take significant amounts of time, would be resource intensive and costly, and might not be feasible; and

•it may adversely affect the interest of other third parties in pursuing strategic collaborations relating to our product candidates, including OpRegen, or technology or the terms of any such potential collaboration. 

Any loss or termination of rights under the collaboration will cause us to lose a