In This Article:
Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Lineage Cell Therapeutics Inc (LCTX) has extended its cash runway to support operations into Q1 2026, indicating strong fiscal discipline.
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The company has made significant progress with the FDA regarding the OPC1 dose study, obtaining a clear path to commence enrollment.
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Lineage's partnership with Genentech for the Opgen program shows promising signs, with Genentech maintaining and investing in the program despite industry cutbacks.
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The company has achieved RMAT designation for its Opgen program, which could provide regulatory advantages.
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Lineage is advancing its manufacturing capabilities, aiming to achieve commercial-scale production of allogeneic cell therapies, which could position it as a leader in the field.
Negative Points
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Lineage Cell Therapeutics Inc (LCTX) does not have access to interim data from the ongoing Opgen phase two study, creating uncertainty about the program's progress.
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The company is still awaiting FDA review completion for the OPC1 IND amendment, which has been a lengthy process.
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There is a lack of clarity on the timeline for potential milestone payments from the Roche and Genentech collaboration.
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The company faces challenges in ensuring the purity, potency, and yield necessary for commercial-scale manufacturing.
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Lineage's financial results show a net loss of $3 million for the quarter, indicating ongoing financial challenges.
Q & A Highlights
Q: Can you clarify the timeline for the OPC1 study and when it might return to the clinic? A: Brian Culley, CEO: We recently had a meeting with the FDA where we presented top-line information about the device. The FDA indicated that the information appeared sufficient, but they want to see the full data. We expect to submit this data in the next few weeks, and the FDA typically takes 30 to 60 days to review. During this time, we can advance site activation activities, but we won't dose a patient until the review is complete. We anticipate the FDA will complete its review in Q1 2025, and we plan to commence enrollment shortly thereafter.
Q: How do you ensure full coverage of cells in the cochlea for the A&P1 program, given the differences from the eye? A: Brian Culley, CEO: In preclinical studies, we observed that transplanted cells migrated through and around the cochlea's curves, which is encouraging. While we can't precisely measure coverage like in dry AMD, the migration suggests potential benefits. The cochlea's complexity means we can't yet determine exact coverage, but early results are promising.