Lineage Cell Therapeutics Inc. filed SEC Form 8-K: Other Events

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Lineage Cell Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

As previously reported, Lineage Cell Therapeutics, Inc. (the “Company”) applied for a Clinical Trial (CLIN2) award (the “CIRM Grant”) from the California Institute for Regenerative Medicine (“CIRM”) in June 2025 to support continued clinical development of OPC1 for the treatment of spinal cord injuries (“SCI”). On November 28, 2025, the Company elected to withdraw its application for the CIRM Grant following comments to the application received by the Company from CIRM on November 24, 2025. There were no specific content deficiencies identified by CIRM in the Company’s grant application, and based on discussions between the Company and CIRM representatives held on November 25, 2025, the Company intends to respond to the feedback it 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 Company’s current application nor the planned resubmission of a revised application impact the Company’s current and planned development of OPC1 or the ongoing DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study to evaluate the safety and utility of a novel spinal cord delivery device designed to administer OPC1 to the spinal parenchyma in both subacute (between 21 to 42 days following injury) and chronic (between 1 to 5 years following injury) SCI participants.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.