Lineage Cell Therapeutics’ Earnings Call Highlights Progress and Challenges

Lineage Cell Therapeutics, Inc. ((LCTX)) has held its Q1 earnings call. Read on for the main highlights of the call.

Lineage Cell Therapeutics’ recent earnings call painted a picture of both progress and challenges. The company expressed optimism due to significant advancements in their OpRegen and OPC1 programs, alongside achieving a major manufacturing milestone. However, uncertainties linger around Genentech’s decision-making timeline and potential enrollment challenges for the OPC1 program, which could impact future developments.

OpRegen Program Progress

The OpRegen program, focused on an allogeneic RPE cell transplant for dry AMD, is showing promising results. The treatment has demonstrated anatomical and functional benefits lasting up to two years from a one-time surgical delivery. The Phase 2a GAlette Study is advancing well, with Genentech’s continued investment, including acquiring RMAT designation and proprietary surgical delivery devices, underscoring the program’s potential.

Manufacturing Milestone Achieved

Lineage has reached a significant manufacturing milestone by completing a GMP production run capable of producing millions of doses from a single starting cell line. This achievement demonstrates the company’s capability across multiple cell types and lines, positioning Lineage for new partnership opportunities and enhancing its growth prospects.

OPC1 Program Advancements

The OPC1 program is making strides with the testing of a new delivery device designed to enhance safety and usability. This device allows cell administration without interrupting patient respiration, improving the procedure’s overall safety. The company anticipates beginning enrollment for the DOSED study in June, marking a critical step forward.

Financial Stability

Lineage reported a robust financial position with a cash reserve of $47.9 million as of March 31, 2025, expected to support operations into Q1 2027. The company also has approximately $37 million in warrant capital and is actively pursuing additional funding sources, ensuring financial stability as it advances its programs.

Delayed Decision on OpRegen Advancement

A notable concern is the lack of a timeline for Genentech’s decision to advance OpRegen into a controlled study. This delay creates uncertainty about the program’s next steps and could impact its future trajectory.

Limited Access to GAlette Study Data

Lineage currently lacks access to data from the ongoing GAlette Study, relying on Genentech for updates. This limitation poses challenges in assessing the study’s progress and making informed decisions.

OPC1 Trial Enrollment Challenges

Enrollment for the OPC1 DOSED study may face challenges, as the initial requirement for thoracic injury patients could slow the study’s pace. This potential hurdle highlights the complexities involved in advancing clinical trials.

Forward-Looking Guidance

Lineage Cell Therapeutics provided guidance on several key metrics during the first quarter of 2025. The company reported a slight increase in total revenues to $1.5 million, with operating expenses slightly reduced to $8 million. The net loss was reduced to $4.1 million, or $0.02 per share. Cash reserves are expected to support operations until Q1 2027. The company emphasized its manufacturing capabilities, potential partnerships, and upcoming clinical data for the OpRegen program, alongside advancements in the OPC1 program.

In summary, Lineage Cell Therapeutics’ earnings call conveyed a mix of optimism and caution. While significant progress in key programs and financial stability are promising, uncertainties around decision-making timelines and enrollment challenges present notable concerns. Investors and stakeholders will be keenly watching how these elements unfold in the coming months.