8-K: Lineage Withdraws CIRM Grant, Plans January Resubmission

Lineage Cell Therapeutics, Inc. withdrew its CIRM grant application for OPC1 spinal cord injury treatment but plans to resubmit in January 2026 without impacting current development.

Summary

• Lineage Cell Therapeutics, Inc. (the Company) withdrew its Clinical Trial (CLIN2) award application (CIRM Grant) from the California Institute for Regenerative Medicine (CIRM) on November 28, 2025.
• The grant was intended to support the clinical development of OPC1 for treating spinal cord injuries (SCI).
• The withdrawal followed comments received from CIRM on November 24, 2025, though no specific content deficiencies were identified.
• The Company plans to respond to CIRM's feedback and submit a revised application in the next available grant cycle, scheduled for January 2026.
• The withdrawal and planned resubmission do not impact the Company's current and planned development of OPC1 or the ongoing DOSED clinical study.

Sentiment

Score: 5

Explanation: The withdrawal of a grant application is a negative event, indicating a temporary setback in funding. However, the immediate plan to resubmit, the absence of specific content deficiencies, and the assurance that current development is unaffected mitigate the negative impact, resulting in a neutral to slightly negative sentiment.

Positives

• No specific content deficiencies were identified by CIRM in the initial grant application, suggesting the feedback is addressable.
• The Company intends to promptly resubmit a revised application in January 2026, indicating a proactive approach to securing funding.
• The withdrawal and planned resubmission will not impact the ongoing DOSED clinical study or the overall development timeline for OPC1.

Negatives

• The Company's application for the CIRM Grant was withdrawn, delaying potential non-dilutive funding for the OPC1 program.
• There is a temporary setback in the grant application process, requiring additional effort and time for resubmission.

Risks

• The revised grant application may not be successful in the January 2026 cycle, leading to further delays in securing CIRM funding.
• Unforeseen challenges or additional feedback from CIRM could arise during the resubmission process, prolonging the funding timeline.
• Reliance on grant funding introduces uncertainty, as approval is not guaranteed and can be subject to external review processes.

Future Outlook

The Company plans to address feedback from CIRM and resubmit its revised grant application in January 2026. This strategy aims to secure funding for OPC1's clinical development without impacting the ongoing DOSED study or overall program timelines.

Management Comments

• The Company intends to respond to the feedback received from CIRM on its application and submit a revised application in the next available CIRM grant application cycle, currently scheduled for January 2026.
• Neither the withdrawal of the current application nor the planned resubmission of a revised application impact the Company's current and planned development of OPC1 or the ongoing DOSED clinical study.

Industry Context

This announcement reflects the competitive and often iterative nature of securing non-dilutive funding for clinical-stage biotechnology companies, particularly in complex fields like regenerative medicine for spinal cord injuries. Grant applications, even for promising therapies like OPC1, frequently undergo rigorous review and may require revisions based on reviewer feedback. The ability to quickly adapt and resubmit is crucial for maintaining development momentum in the biopharma sector.

Stakeholder Impact

• Shareholders may experience short-term uncertainty regarding the timing of non-dilutive funding for the OPC1 program.
• The Company's employees and research teams involved in OPC1 development are assured that current clinical studies and development plans remain unaffected.

Next Steps

• Respond to feedback received from CIRM on the grant application.
• Submit a revised grant application in the next available CIRM grant application cycle, scheduled for January 2026.

Key Dates

Recommendation

While the withdrawal of a grant application is a negative development, the Company's swift plan to resubmit in January 2026, coupled with the assurance that current clinical development of OPC1 and the DOSED study are not impacted, suggests this is a temporary setback rather than a fundamental issue. Investors should hold to observe the outcome of the resubmission and continued progress of the clinical program, as the long-term value proposition remains largely intact despite this short-term funding delay.

Keywords

Lineage Cell Therapeutics, LCTX, CIRM Grant, OPC1, Spinal Cord Injury, SCI, Clinical Trial, Regenerative Medicine, Biotechnology, DOSED study