Lineage Cell Therapeutics: Navigating Key Contradictions in Manufacturing, Trials, and FDA Communication in 2025Q2 Earnings Call

Manufacturing capabilities and partnership strategy, spinal cord injury trial design and patient enrollment, FDA communication and timeline for OPC1 study, platform-based partnerships and manufacturing strategy, enrollment strategy and challenges in spinal cord injury studies are the key contradictions discussed in Lineage Cell Therapeutics' latest 2025Q2 earnings call.



OpRegen Program Progress:
- Lineage's partner, Roche and Genentech, reported that patients treated in the Phase I/IIa clinical trial of OpRegen showed a mean gain of vision of 9 letters in the treated eyes, compared to a loss of 11 letters in the untreated eyes.
- This trend suggests a 20-letter difference in mean visual acuity between treated and untreated eyes in individuals who received OpRegen cells across their geographic atrophy.
- The positive results are attributed to the anatomical and functional benefits of the RPE transplant, which have lasted for 3 years and are validated by similar findings from other independent studies.

Manufacturing Capabilities and Strategic Focus:
- The company reported the development of a GMP banking and production platform capable of generating millions of doses of its product candidates in a xeno-free 3D culturing system.
- Lineage has shifted strategic focus to capitalize on its investments in manufacturing and directed differentiation to advance existing and new programs.
- The company aims to reduce dependency on equity capital markets through non-equity dilutive transactions and partnerships, emphasizing a cost-conscious approach to pipeline advancement.

OPC1 Study Milestones:
- Lineage successfully administered OPC1 for the first time in a chronic injury participant in the DOSED study, marking a significant milestone in the field of spinal cord injury treatment.
- The use of a novel delivery system designed to administer cells without stopping ventilation has shown promising results, enhancing the safety and ease of the procedure.
- These advancements are part of efforts to ready OPC1 for later-stage clinical testing, with the company planning to introduce a new cell manufacturing process and formulation into ongoing trials.

Financial Performance and Cash Position:
- As of June 30, 2025, Lineage's overall cash position was $42.3 million, expected to support planned operations into Q1 of 2027.
- The company reported total revenues of $2.8 million for Q2 2025, a net increase of $1.4 million compared to $1.4 million for the same period in 2024.
- The increase in revenue was primarily driven by more collaboration revenue recognized from deferred revenues under the Roche agreement, despite a $19.8 million loss from operations due to a nonrecurring impairment expense related to the VAC platform.