• Cash Position: $47.8 million in cash, cash equivalents, and marketable securities as of December 31, 2024.
• Revenue (Q4 2024): $2.9 million, an increase from $2.1 million in Q4 2023.
• Operating Expenses (Q4 2024): $7.8 million, a decrease from $8.2 million in Q4 2023.
• R&D Expenses (Q4 2024): $3.4 million, a decrease from $3.9 million in Q4 2023.
• G&A Expenses (Q4 2024): $4.4 million, consistent with Q4 2023.
• Loss from Operations (Q4 2024): $5.1 million, a decrease from $6.4 million in Q4 2023.
• Net Loss (Q4 2024): $3.3 million or $0.02 per share, compared to $4.8 million or $0.03 per share in Q4 2023.
• Total Revenue (Full Year 2024): $5.9 million, compared to $8.9 million in 2023.
• Total Operating Expenses (Full Year 2024): $31 million, a decrease from $33.7 million in 2023.
• R&D Expenses (Full Year 2024): $12.5 million, a decrease from $15.7 million in 2023.
• G&A Expenses (Full Year 2024): $18.2 million, an increase from $17.3 million in 2023.
• Net Loss (Full Year 2024): $18.6 million or $0.09 per share, compared to $21.5 million or $0.12 per share in 2023.

• Warning! GuruFocus has detected 4 Warning Signs with LCTX.

Release Date: March 10, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Lineage Cell Therapeutics Inc (LCTX) reported that their lead candidate, OpRegen, is progressing well in the Phase 2a GAlette study, with no impact from Roche's recent pipeline reductions.
• The company has secured RMAT designation for OpRegen, indicating a positive regulatory outlook.
• Lineage's manufacturing capabilities are highlighted as a competitive advantage, with scalable GMP production processes in place.
• The company has extended its cash runway into Q1 2027, supported by a recent financing strategy that includes milestone warrants.
• Lineage's OPC1 program for spinal cord injury is advancing with a new delivery device and improved manufacturing process, potentially expanding its clinical applications.

Negative Points

• Lineage Cell Therapeutics Inc (LCTX) has not received interim data from Roche's ongoing Phase 2a trial, creating uncertainty about the timing of future updates.
• The company's revenue increase is primarily driven by deferred collaboration revenue, indicating potential reliance on partnerships for financial growth.
• Operating expenses remain high, with a total of $31 million for the year, despite a decrease from the previous year.
• The net loss for the year was $18.6 million, reflecting ongoing financial challenges.
• There is significant competition in the RPE transplant space, with multiple companies reporting positive data, which could impact Lineage's market position.

Q & A Highlights

Q: What steps is Lineage Cell Therapeutics taking to maintain market leadership in RPE cell replacements amidst increasing competition? A: Brian Culley, CEO, emphasized the importance of having the right attributes for success, highlighting the "triumvirate" of Lineage's manufacturing, Genentech's product development capabilities, and Roche's commercialization expertise. He expressed confidence that these partnerships position Lineage ahead of competitors in the RPE cell replacement field.

Q: When can we expect the updated three-year data for OpRegen? A: Brian Culley stated that inquiries about the three-year data should be directed to Genentech, as they decide on the timing and venue for announcements. However, he noted that the effects of OpRegen continue to persist, and any announcements will be communicated to stakeholders.

Q: How does Lineage view the broader implications of positive early results from RPE cell replacement therapies? A: Brian Culley sees the positive results from multiple companies as validation of the cell therapy modality. He believes the growth opportunity lies in non-oncology areas, where cell transplantation can address conditions not fully solved by small molecules or antibodies, such as spinal cord injuries and Parkinson's disease.

Q: What are the logistics and improvements in the OPC1 program for spinal cord injuries? A: Brian Culley explained that the OPC1 program will involve a mix of new and experienced clinical sites. Improvements include a new immediate-use formulation that simplifies cell preparation, reducing the burden on patients and providers. The program aims to enhance delivery and manufacturing processes.

Q: What is the status of the DOSED study and the introduction of the new OPC1 formulation? A: Brian Culley stated that the DOSED study will initially focus on thoracic injuries with a safety run-in phase. The new OPC1 formulation, which has undergone comparability testing, will be introduced in a staged manner to ensure safety and efficacy. The company plans to use forthcoming sites for the new formulation.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.