LCTX hits first OpRegen milestone, unlocking $5M from Roche deal

Rhea-AI Filing Summary

Lineage Cell Therapeutics announced that it has achieved the first development milestone under its collaboration and license agreement with Genentech and F. Hoffmann-La Roche for OpRegen, its lead cell therapy program for geographic atrophy secondary to age-related macular degeneration. Meeting this milestone on November 20, 2025, based on manufacturing and clinical progress in the Phase 2a GAlette trial, triggers a $5 million milestone payment to Lineage, expected within 30 days. Lineage reports that approximately 24.1% of this payment will be paid to the Israel Innovation Authority and 21.5% to Hadasit Medical Research and Development Ltd., under existing Israeli research and collaboration agreements tied to its subsidiary Cell Cure Neuroscience Ltd.

Positive

• First Roche development milestone achieved, confirming predefined progress for the OpRegen GA program under the collaboration agreement.
• $5 million milestone payment expected within 30 days, providing non-dilutive funding, with the remainder retained by Lineage after contractual payments to Israeli partners.

Negative

• None.

Insights

Biotech & partnerships analyst

Lineage gains $5M from Roche after OpRegen hits its first development milestone.

The company reports achieving the first development milestone in its OpRegen collaboration with Genentech and F. Hoffmann-La Roche. This milestone is tied to manufacturing and clinical advancements in the Phase 2a GAlette trial for geographic atrophy secondary to age-related macular degeneration, indicating that the program has progressed to a predefined performance or development threshold under the agreement.

The milestone triggers a $5 million payment to Lineage, expected within 30 days. The company states that approximately 24.1% of the payment will go to the Israel Innovation Authority and 21.5% to Hadasit Medical Research and Development Ltd., reflecting pre-existing funding and collaboration arrangements involving its subsidiary Cell Cure Neuroscience Ltd. The remainder stays with Lineage, representing non-equity, milestone-based funding.

This event confirms that OpRegen continues to advance within the Roche collaboration framework and that at least one key contractual benchmark has been met. Future disclosures in company filings may describe additional milestones or clinical results as the GAlette trial and broader development plans progress.

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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

Date of Report (Date of earliest event reported): November 20, 2025

Lineage Cell Therapeutics, Inc.

(Exact name of Registrant as Specified in Its Charter)

California			001-12830	94-3127919
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
2173 Salk Avenue, Suite 200
Carlsbad, California				92008
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (442) 287-8990

(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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common shares		LCTX		NYSE American LLC

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, in December 2021, Lineage Cell Therapeutics, Inc. (“we,” “us,” “our,” the “Company,” or “Lineage”), entered into a collaboration and license agreement with Genentech, Inc. and F. Hoffmann-La Roche Ltd. (the “Roche Agreement”) under which our lead cell therapy program known as OpRegen® (also known as RG6501) is being developed for the treatment of ocular disorders, including geographic atrophy (“GA”) secondary to age-related macular degeneration (“AMD”). OpRegen is currently being evaluated in a Phase 2a multicenter clinical trial, known as “GAlette”, in patients with GA secondary to AMD.

On November 20, 2025, the first development milestone under the Roche Agreement was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program. This event triggered a $5 million milestone payment to Lineage, which is expected to be received by us within 30 days.

As previously reported, approximately 24.1% and 21.5% of the milestone payment will be paid to the Israel Innovation Authority and to Hadasit Medical Research and Development Ltd. (“Hadasit”), respectively, in accordance with the Israeli Encouragement of Research, Development and Industrial Initiative Technology Law, 5744-1984, as amended, and in accordance with agreements between our subsidiary, Cell Cure Neuroscience Ltd., and Hadasit, respectively.

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.

			Lineage Cell Therapeutics, Inc.
Date:	November 24, 2025	By:	/s/ George A. Samuel III
		Name: Title:	George A. Samuel III General Counsel and Corporate Secretary

FAQ

What milestone did Lineage Cell Therapeutics (LCTX) announce with Roche?

Lineage Cell Therapeutics announced that on November 20, 2025, it achieved the first development milestone under its collaboration and license agreement with Genentech and F. Hoffmann-La Roche for the OpRegen cell therapy program.

How much is the milestone payment Lineage (LCTX) will receive from Roche?

Achieving the first development milestone triggers a $5 million milestone payment to Lineage Cell Therapeutics, which the company expects to receive within 30 days.

Which program triggered the $5 million milestone payment to Lineage Cell Therapeutics?

The payment is tied to OpRegen (also known as RG6501), Lineage’s lead cell therapy program being developed with Roche for geographic atrophy secondary to age-related macular degeneration, currently in a Phase 2a GAlette trial.

How will the $5 million milestone payment be shared with Lineage’s Israeli partners?

Lineage states that approximately 24.1% of the milestone payment will be paid to the Israel Innovation Authority and 21.5% to Hadasit Medical Research and Development Ltd., under existing Israeli research and collaboration agreements related to Cell Cure Neuroscience Ltd.

What stage of clinical development is OpRegen in according to the 8-K?

OpRegen is being evaluated in a Phase 2a multicenter clinical trial called GAlette in patients with geographic atrophy secondary to age-related macular degeneration.

What does this milestone mean for the Lineage and Roche collaboration?

The milestone confirms that manufacturing and clinical advancements required under the Roche agreement have been met for OpRegen, activating a contractual payment and demonstrating continued progress in the collaboration.