Press Release: Lineage Cell Therapeutics Reports Second Quarter 2025 Financial Results and Provides Business Update

Dow Jones
08/13
   --  Positive RG6501 (OpRegen(R)) Phase 1/2a Clinical Study 36 Month Results 
      Featured at Clinical Trials at the Summit 2025 
 
   --  Successfully Reduced-to-Practice Critical Aspect of Commercial-Scale, 
      Cell-Based, GMP Production Processes 
 
   --  First Chronic Patient Treated in New Clinical Study of OPC1 in Patients 
      with Subacute and Chronic Spinal Cord Injury 
 
   --  Hosted the 3rd Annual SCI Investor Symposium 
CARLSBAD, Calif.--(BUSINESS WIRE)--August 12, 2025-- 

Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel allogeneic, or "off the shelf", cell therapies for serious neurological and ophthalmic conditions, today reported its second quarter 2025 financial and operating results and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and provide a business update.

"Following the recent positive 36-month clinical data update with the OpRegen RPE cell therapy program, which is licensed by Genentech and Roche, we continue to remain confident in its potential to address a significant medical need, especially because long term clinical outcomes following a single administration of OpRegen cell therapy are challenging the long-held view that GA is an irreversible condition," stated Brian M. Culley, Lineage CEO. "It is notable that among patients who received extensive one-time coverage of OpRegen RPE cells across the area of atrophy, anatomical and functional benefits have lasted for at least three years, outcomes consistent with meaningful disease stabilization and even improvement."

"In addition to supporting our partners in advancing the OpRegen program, we are equally excited to have reached a milestone with our OPC1 program for the treatment of spinal cord injury, treating our first-ever chronic patient with a new parenchymal spinal delivery system. We also solidified our position as a leader in allogeneic cell process development and manufacturing by reporting in-house GMP production for each of two separate cell-based product candidates from a master and working cell bank system which, in its current form, can support a production capability of several million doses for a single-administration product. This is in addition to continuing to advance our ReSonance$(TM)$ program for the treatment of sensorineural hearing loss and evaluating other strategically selected early-stage initiatives. As our cell therapy platforms gain further validation, we believe our pipeline and cell manufacturing and related expertise continue to position us as a compelling partner and investment opportunity," added Mr. Culley.

Select Business Highlights

   --  RG6501 (OpRegen Cell Therapy) 
 
          --  Positive RG6501 (OpRegen) Phase 1/2a Clinical Study 36 Month 
             Results featured at Clinical Trials at the Summit $(CTS)$ 2025. 2025 
             CTS highlights: 
 
                 --  Gains in Best Corrected Visual Acuity (BCVA) in patients 
                    in Cohort 4 (less advanced GA) measured at month 12 remain 
                    evident through month 36 following subretinal 
                    administration of OpRegen cell therapy; 
 
                 --  Mean change in BCVA among treated eyes for patients 
                    (n=10) completing 3-year follow up was +6.2 letters 
                    (compared to +5.5 letters at 24 months) (Early Treatment 
                    Diabetic Retinopathy Study (ETDRS) assessment); 
 
                 --  Improvement in BCVA and outer retinal structure in 
                    patients with extensive OpRegen bleb coverage of their GA 
                    area was greater than in patients with limited coverage and 
                    persisted through month 36 
 
                 --  Effects were greater on average in the five (5) patients 
                    with extensive OpRegen cell therapy coverage of atrophic 
                    areas at the time of surgical delivery 
 
                        --  In these patients' treated eyes, the mean change 
                           in BCVA was +9.0 ETDRS letters for those completing 
                           3-year follow-up (compared to +7.4 ETDRS letters at 
                           24 months) (n=5) 
 
 
 
                 --  These data suggest that OpRegen cell therapy may 
                    counteract RPE cell dysfunction and loss in GA by providing 
                    support to the remaining retinal cells within atrophic 
                    areas, and these effects appear durable through at least 36 
                    months after a single administration 
 
 
 
          --  Ongoing execution of Lineage's contributions to its 
             collaboration with Roche and Genentech across multiple functional 
             areas, including support for the ongoing Phase 2a clinical study 
             (the "GAlette Study") in patients with geographic atrophy (GA) 
             secondary to age-related macular degeneration $(AMD)$ at sites in 
             the U.S. and Israel. 
 
                 --  In addition to testing of other surgical parameters, 
                    Genentech currently plans to evaluate two proprietary 
                    surgical delivery devices that have potential advantages 
                    over available off-the-shelf devices in the GAlette Study. 
 
 
 
 
          --  Ongoing efforts to further support development of OpRegen RPE 
             cell therapy under a separate services agreement with Genentech, 
             signed May 2024, including: (i) activities to support the ongoing 
             Phase 1/2a study long term follow-up and the currently enrolling 
             Phase 2a GAlette Study; and (ii) additional technical training and 
             materials related to our cell therapy technology platform to 
             support commercial manufacturing strategies. 
 
 
 
   --  Manufacturing Capability 
 
          --  Successfully completed a production run for two different 
             product candidates, each produced from a customized, two-tiered 
             current Good Manufacturing Practice ("cGMP") cell banking system, 
             highlighting the application of the Lineage platform across 
             multiple programs. 
 
                 --  This production process utilizes a genetically-stable 
                    master cell bank created from a single, well-characterized 
                    pluripotent cell line, to generate a working cell bank, 
                    which then provides the source material for a final 
                    cell-based product candidate. 
 
                 --  This demonstrated cGMP production process should enable 
                    the ability to produce millions of doses of a 
                    cost-effective, scalable and consistent supply of an 
                    allogeneic, cell-based product derived from a single 
                    initial cell line, that can be applied across multiple 
                    programs. 
 
 
 
 
 
   --  OPC1 
 
          --  First chronic spinal cord injury patient treated in the DOSED 
             (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord 
             Injury: Evaluation of a Novel Device) clinical study. 
 
                 --  First chronic SCI patient treated in DOSED was a 
                    neurologically complete SCI injury (American Spinal Injury 
                    Association Impairment Scale [AIS] grade A), with a single 
                    neurological level of injury (NLI) from levels T1 to T10, 
                    and the novel delivery system successfully administered a 
                    one-time injection of OPC1. 
 
 
 
          --  Hosted the 3rd Annual Spinal Cord Injury Investor Symposium (3rd 
             SCIIS) in partnership with the Christopher & Dana Reeve 
             Foundation. 
 
 

Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $42.3 million as of June 30, 2025, is expected to support planned operations into Q1 2027.

Second Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended June 30, 2025 were $2.8 million, a net increase of $1.4 million as compared to $1.4 million for the same period in 2024. The increase was primarily driven by more collaboration revenue recognized from deferred revenues under the Roche Agreement, as well as deferred revenues recognized upon termination of the VAC platform-related collaboration agreement.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended June 30, 2025 were $22.5 million, an increase of $15.2 million as compared to $7.3 million for the same period in 2024. The overall increase was driven by the $14.8 million expense recognized for the loss on impairment for the intangible asset related to the VAC platform.

R&D Expenses: R&D expenses for the three months ended June 30, 2025 were $3.1 million, an increase of $0.2 million as compared to $2.9 million for the same period in 2024. The net increase was primarily driven by ongoing activities within our preclinical programs.

G&A Expenses: G&A expenses for the three months ended June 30, 2025 were $4.6 million, an increase of $0.2 million as compared to $4.4 million for the same period in 2024. The net increase was primarily driven by more costs incurred for services provided by third parties.

Loss from Operations: Loss from operations for the three months ended June 30, 2025 were $19.8 million, an increase of $13.9 million as compared to $5.9 million for the same period in 2024. This increase in loss was primarily driven by the impairment expense related to the VAC platform of $14.8 million, which is a non-recurring transaction.

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August 12, 2025 16:01 ET (20:01 GMT)

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