Lineage Achieves First Milestone Under Worldwide Collaboration Agreement with Genentech

Lineage Cell Therapeutics, Inc. today announced it had achieved the first milestone available under its worldwide collaboration with Roche and Genentech, a member of the Roche Group, for OpRegen^® (RG6501), a suspension of human allogeneic retinal pigment epithelial (RPE) cells, currently in development for the treatment of geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD). The milestone was achieved based on manufacturing and clinical advancements related to the OpRegen cell therapy program.

“We are excited to have achieved the first of the $620 million of milestone payments available under our collaboration with Roche and Genentech. The achievement of this milestone is rooted in our manufacturing expertise, which we deployed with the OpRegen cell therapy program, and reflects years of investment to optimize our in-house production processes and highlights the importance of having in-house control of complex manufacturing processes,” stated Brian M. Culley, Lineage CEO. “Roche and Genentech are established leaders in ophthalmology, with a demonstrated and longstanding commitment to patients, innovative research, and successful product development, and we are proud to have reached this manufacturing milestone to support the Genentech team’s clinical efforts.”

“Long-term clinical outcomes following a single administration of OpRegen cell therapy is challenging the view that GA causes irreversible damage. Clinical data reported at 12-, 24-, and 36-months for Cohort 4 of the Phase 1/2a study (12 patients) continues to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients with less advanced disease. Notably, five patients who received significant coverage of OpRegen cell therapy across their GA lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement,” added Mr. Culley. 

RG6501 (OpRegen) is a suspension of human allogeneic retinal pigment epithelial (RPE) cells currently in development for the treatment of GA secondary to AMD. Subretinal delivery of OpRegen cell therapy has the potential to counteract RPE cell loss in areas of GA lesions by supporting retinal cell health and improving retinal structure and function. It is being developed under an exclusive worldwide collaboration between Lineage, Roche, and Genentech, a member of the Roche Group, and is currently being evaluated in a Phase 2a clinical study, GAlette, in patients with GA secondary to AMD (ClinicalTrials.gov Identifier: NCT05626114). 

Additional information is available at: https://investor.lineagecell.com/financial-information/sec-filings.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained above, are forward-looking statements. In some cases, forward-looking statements, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “suggest,” or the negative version of these words and similar expressions. Such forward-looking statements include, but are not limited to, statements relating to: the potential therapeutic benefits of OpRegen cell therapy in patients with GA secondary to AMD; the significance of the Phase 1/2a clinical study data of OpRegen reported to date; and expectations regarding the achievement of any future milestones under Lineage’s collaboration with Roche and Genentech. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following risks: that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that Roche and Genentech may not successfully advance OpRegen cell therapy or be successful in completing further clinical trials for OpRegen cell therapy and/or obtaining regulatory approval for OpRegen cell therapy in any particular jurisdiction; that competing alternative therapies may adversely impact the commercial potential of OpRegen cell therapy; that the ongoing Israeli regional conflict may materially and adversely impact our manufacturing processes, including cell banking and product manufacturing for our cell therapy product candidates, all of which are conducted by our subsidiary in Jerusalem, Israel; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect.  Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other subsequent reports, which are available on the SEC’s website at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. All forward-looking statements are expressly qualified in their entirety by these cautionary statements.  Lineage undertakes no obligation to update any forward-looking statement to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.