Company: LCTX
Filing Date: 2025-03-10
Form Type: 10-K
Source: 0000950170-25-036309
Chunk: 27

Company: Lineage Cell Therapeutics, Inc.
Filing Date: 2025-03-10
Form: 10-K
Item: Item 1
Chunk 27
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 to apply even after the repayment of royalties in full by the grant recipient.

Part of CCN’s research and development efforts have been financed, partially, through grants that it has received from the IIA and when we acquired our holdings in CCN, we undertook in writing, vis-à-vis the IIA, to comply with, and to ensure the compliance by CCN with, the Innovation Law. We therefore must comply with the requirements of the Innovation Law and related regulations. To date, through a series of separate grants beginning in 2007, CCN received a total of $15.4 million from the IIA to support the OpRegen program. See Note 13 (Commitments and Contingencies) to our consolidated financial statements included in this report for additional information.

Grants from the California Institute for Regenerative Medicine

The clinical development of OPC1 has been supported by $14.3 million of funding from CIRM, a state agency established to fund stem cell research and development of new stem cell-based treatments. The terms of our grant award from CIRM require royalty payments to the California State General Fund based on net commercial revenue from the sale of any product, drug or service arising from CIRM-funded research as follows: 0.1% per $1.0 million of funds granted for the earlier of 10 years or nine times the award amount that has been paid. In addition, a 1% royalty will be owed on net commercial revenue in excess of $500 million per year until the last to expire patent covering a CIRM-funded invention, if any, contributed towards the commercialization of the product.

In February 2024, we applied for clinical program funding from CIRM to support the DOSED clinical study. Later in February 2024, CIRM’s governing board determined to postpone acceptance of clinical funding applications submitted after January 31, 2024, in response to an unprecedented influx of applications and resulting review and budgetary issues. CIRM has announced that they anticipate opportunities for clinical funding to be re-opened in Spring 2025 and at that time we would plan to submit our grant applicant in support of our DOSED clinical study as part of that clinical funding program.  However, no assurances can be given as to when CIRM will accept new clinical program funding applications or, if it does, that CIRM will accept our application for review or that it will award us any additional funding for the OPC1 program. See the risk factor titled, “We have relied on grant