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

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1
Chunk 10
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 nervous system indications.

Other Programs and Technologies

Although we have to date focused on neurological and ophthalmic cell types, the pluripotent cells which our platform is based on are capable of becoming any of the cell types of the human body. We currently maintain a list of additional undisclosed product candidates which may be considered for development, or partnership in the future, and which altogether cover a range of therapeutic areas and conditions. Generally, these product candidates are based on the same platform technology and employ a similar guided cell differentiation and transplant approach as the product candidates detailed above, but in some cases may also include genetic modifications designed to enhance efficacy and/or safety profiles. We may elect not to develop or partner any of these product candidates.

In addition to seeking to create value for shareholders by developing product candidates through clinical development, we also may seek to create value from our intellectual property or related technologies and capabilities, through licensing collaborations and/or other strategic transactions.

Select Business Highlights

We and our partners have achieved numerous clinical, strategic and operational milestones.

•Ongoing execution of Lineage’s contributions to our collaboration with Roche and Genentech for the development of OpRegen (RG6501) across multiple functional areas.

•Entered into a separate Services Agreement with Genentech to further support development of OpRegen (RG6501), including: (i) activities to support the ongoing Phase 1/2a study and currently enrolling Phase 2a GAlette study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.

•OpRegen (RG6501) Phase 1/2a clinical study 24-month visual acuity results featured at 2024 Retinal Cell & Gene Therapy Innovation Summit.

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•Roche announced receipt of RMAT designation from the U.S. FDA for OpRegen, for the treatment of GA secondary to AMD.

•Submitted an IND amendment for OPC1 for the treatment of chronic and subacute spinal cord injury, and initiated activities to enroll SCI patients in the DOSED clinical study; currently targeting enrollment to commence in the second quarter of 2025.

•Closed two separate financings totaling $44 million in gross proceeds; potential to receive an additional $36 million in gross proceeds upon the full exercise in cash of OpRegen clinical milestone-linked warrants, which each have an exercise price of $0.91 per share.

•Created and hosted the 2nd Annual Spinal Cord Injury Investor Symposium in partnership with the Christopher & Dana Reeve