Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Lineage Cell Therapeutics Inc (LCTX, Financial) has successfully expanded its alliance with Roche and Genentech, reflecting positive developments in their OpRegen program.
- The company has opened its first ex-US clinical site for the OpRegen Phase 2 trial in Israel, enhancing the program's global reach.
- Lineage Cell Therapeutics Inc (LCTX) has a strong cash position with $38.5 million in cash, cash equivalents, and marketable securities, expected to support operations into Q4 2025.
- The company is making strategic investments in its pipeline, including promising preclinical programs like ANP1 for hearing loss and a new undisclosed neurology program.
- Lineage Cell Therapeutics Inc (LCTX) maintains a disciplined approach to fiscal management, allowing it to navigate the challenging biotech market environment effectively.
Negative Points
- The biotech sector remains in a prolonged bear market, affecting investor sentiment and capital availability for Lineage Cell Therapeutics Inc (LCTX).
- The company experienced a decrease in total revenues to $1.4 million, down from $3.2 million in the same period in 2023, primarily due to lower collaboration and licensing revenues.
- Lineage Cell Therapeutics Inc (LCTX) is facing delays in FDA review for its IND amendment related to the OPC1 program, impacting the timeline for initiating the DOSED study.
- The company reported a net loss of $5.8 million for the quarter, an increase from the $5.2 million loss in the same period in 2023.
- There is uncertainty regarding the timing and availability of clinical data from the OpRegen trial, as Lineage does not control the release of this information.
Q & A Highlights
Q: Can you provide more color on how the new services agreement with Roche has enhanced the partnership, particularly regarding manufacturing scale?
A: Brian Culley, CEO: The services agreement, entered after Genentech had time to form an opinion on the OpRegen program, includes a five-year follow-up for Phase 1/2a patients, indicating enthusiasm for the program. Lineage continues to manufacture clinical material for OpRegen, with plans for Roche/Genentech to eventually take over commercial manufacturing. The tech transfer process is lengthy, requiring personal training to ensure quality.
Q: Does your current cash guidance include future milestone payments from Roche?
A: Jill Howe, CFO: No, the current cash runway does not include potential milestone payments. We are being thoughtful and conservative with our cash management to navigate the tough environment.
Q: What activities are planned for the OPC1 study, particularly around patient identification and screening?
A: Brian Culley, CEO: We can prepare sites with training and protocol discussions but cannot involve patients until the IND is open. We hypothesize that identifying chronic injury patients will be easier than subacute ones, and we plan to use social media and community relationships to support patient outreach once permitted.
Q: How quickly could you access CIRM capital to run the DOSED study once the IND is cleared?
A: Jill Howe, CFO: There will be a delay due to CIRM's influx of applications, but we maintain good communication with them. The funding will be gradual over time as we progress through the trial.
Q: Are there plans to move preclinical programs like ANP1 into functional models or IND-enabling studies soon?
A: Brian Culley, CEO: We are making modest, impactful investments in early-stage programs while waiting for OpRegen data. Our strategy is to use OpRegen's success to advance these programs affordably in the future.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
