Lineage Cell Therapeutics Reports Second Quarter 2025 Results and Highlights Progress Across Multiple Clinical Programs
Lineage Cell Therapeutics, a clinical-stage biotechnology company focused on developing novel allogeneic, or “off-the-shelf,” cell therapies for severe neurological and ophthalmic conditions, has announced its financial results for the second quarter ended June 30, 2025, alongside a comprehensive update on its business activities. The company will hold a conference call today at 4:30 p.m. Eastern Time to discuss the results and recent developments.
CEO Commentary on Clinical Advances
Chief Executive Officer Brian M. Culley expressed optimism about the company’s lead programs, particularly following the release of long-term data from the OpRegen® retinal pigment epithelium (RPE) cell therapy program, licensed to Genentech and Roche. “The recent positive 36-month clinical update reinforces our confidence in OpRegen’s ability to address a significant unmet medical need,” Culley said.
He highlighted that patients receiving extensive one-time coverage of OpRegen cells across the area of atrophy showed meaningful anatomical and functional benefits lasting at least three years. “These outcomes challenge the long-held view that geographic atrophy (GA) is irreversible,” he added.
Beyond OpRegen, the company has achieved a key milestone in its OPC1 program for spinal cord injury, treating its first chronic patient using a new parenchymal spinal delivery system. Culley also pointed to progress in manufacturing, where Lineage has successfully produced two distinct allogeneic cell-based products in-house under cGMP standards, demonstrating the platform’s scalability.
Program Highlights
OpRegen (RG6501) – Geographic Atrophy Secondary to AMD
OpRegen, currently in clinical development through a collaboration with Roche and Genentech, continues to show promising results:
- 36-Month Phase 1/2a Data: At the 2025 Clinical Trials at the Summit (CTS), Lineage presented follow-up data showing sustained gains in Best Corrected Visual Acuity (BCVA) among patients with less advanced GA.
- In Cohort 4 patients (n=10) completing three years of follow-up, treated eyes showed a mean improvement of +6.2 ETDRS letters, up from +5.5 letters at 24 months.
- In a subgroup of five patients with extensive OpRegen coverage of their GA area, mean BCVA improvement was +9.0 ETDRS letters at 36 months (vs. +7.4 at 24 months).
- Structural and functional benefits persisted, suggesting OpRegen may counteract RPE dysfunction by supporting remaining retinal cells, even years after a single administration.
Lineage continues to support Genentech in the GAlette Phase 2a trial, which is testing OpRegen in GA patients in the U.S. and Israel. The trial will also evaluate two proprietary surgical delivery devices that could offer advantages over existing systems.
Additionally, under a services agreement signed in May 2024, Lineage is providing technical training, manufacturing support, and long-term follow-up services for OpRegen, aiding future commercial readiness.
Manufacturing Capabilities
Lineage’s in-house manufacturing platform reached a milestone in Q2 with the successful production of two different cell-based product candidates from a genetically stable master cell bank. This two-tiered cGMP system — comprising a master and working cell bank — enables consistent, scalable production from a single pluripotent cell line.
This process could yield millions of doses for single-administration therapies, reducing cost and complexity while ensuring quality across programs.
OPC1 – Spinal Cord Injury
In the DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study, Lineage treated its first chronic spinal cord injury patient — a neurologically complete case (AIS Grade A) with a thoracic injury (T1–T10). The new delivery device successfully administered a one-time injection of OPC1 cells.
The company also co-hosted the 3rd Annual Spinal Cord Injury Investor Symposium with the Christopher & Dana Reeve Foundation, strengthening ties within the SCI research and investment community.
ReSonance™ and Early-Stage Initiatives
Lineage continues to advance its ReSonance program for sensorineural hearing loss and is assessing additional early-stage opportunities that align with its strategic focus on high-impact cell therapy applications.
Financial Results for Q2 2025
Revenue
Total revenue for the quarter ended June 30, 2025, was $2.8 million, up from $1.4 million in Q2 2024. The 100% increase was primarily driven by higher collaboration revenue recognized from deferred revenues under the Roche Agreement, and from revenues recognized upon the termination of a VAC platform-related collaboration.
Operating Expenses
Total operating expenses rose sharply to $22.5 million from $7.3 million in Q2 2024. The increase was largely due to a $14.8 million non-recurring impairment charge for the intangible asset related to the VAC platform.
- R&D Expenses were $3.1 million, slightly up from $2.9 million in Q2 2024, reflecting continued investment in preclinical programs.
- G&A Expenses totaled $4.6 million, compared with $4.4 million in the prior-year quarter, driven by higher third-party service costs.
Loss from Operations
Operating loss increased to $19.8 million, compared with $5.9 million in Q2 2024, primarily due to the one-time impairment expense.
Other Income/Expense
Lineage recorded other expense of $10.6 million in Q2 2025 versus other income of $0.1 million in Q2 2024. This swing was largely due to a $12.7 million fair value remeasurement loss on warrant liabilities, driven by an increase in the company’s share price, partially offset by $1.7 million in favorable foreign exchange impacts.
Net Loss
Net loss attributable to Lineage was $30.5 million, or $0.13 per share (basic and diluted), compared with $5.8 million, or $0.03 per share, in Q2 2024. The wider loss reflects both the impairment charge and the warrant liability remeasurement.
Balance Sheet and Outlook
As of June 30, 2025, Lineage held $42.3 million in cash, cash equivalents, and marketable securities. Management expects this capital to fund planned operations into the first quarter of 2027, supporting ongoing clinical trials, manufacturing activities, and early-stage program development.
Strategic Positioning
Culley emphasized that Lineage’s pipeline progress, combined with its manufacturing expertise, enhances its position as a potential partner for larger biopharma companies. “As our cell therapy platforms gain further validation, we believe our capabilities make us an increasingly attractive partner and investment opportunity,” he said.
