GuruFocus - Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Lineage Cell Therapeutics Inc (LCTX) has extended its cash runway to support operations into Q1 2026, indicating strong fiscal discipline.
- The company has made significant progress with the FDA regarding the OPC1 dose study, obtaining a clear path to commence enrollment.
- Lineage's partnership with Genentech for the Opgen program shows promising signs, with Genentech maintaining and investing in the program despite industry cutbacks.
- The company has achieved RMAT designation for its Opgen program, which could provide regulatory advantages.
- 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.
- 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.
- The company is still awaiting FDA review completion for the OPC1 IND amendment, which has been a lengthy process.
- There is a lack of clarity on the timeline for potential milestone payments from the Roche and Genentech collaboration.
- The company faces challenges in ensuring the purity, potency, and yield necessary for commercial-scale manufacturing.
- Lineage's financial results show a net loss of $3 million for the quarter, indicating ongoing financial challenges.
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 (NASDAQ:AMD), the migration suggests potential benefits. The cochlea's complexity means we can't yet determine exact coverage, but early results are promising.
Q: Can you provide details on your activities under the services agreement with Genentech and whether they indicate progress?
A: Brian Culley, CEO: One notable activity is following patients in the lineage phase 12a trial for an additional five years. This suggests that if patients are experiencing benefits, it makes sense to continue monitoring them. This elective follow-up, not required by the FDA, along with other actions and statements by Genentech, indicates supportive progress.
Q: What are your current views on business development around the OPC1 program as the study progresses?
A: Brian Culley, CEO: The optimal point for partnering is crucial. For OPC1, having the option to partner is valuable, but not obligatory. We believe modest investments to achieve important milestones, like improving delivery and cell production, will enhance partnership value. While we could partner now, achieving these milestones first would likely yield better economics.
Q: How does the A&P1 program differentiate from other hearing loss treatments, and what are the next steps to reach IND status?
A: Brian Culley, CEO: Unlike single-pathway treatments, A&P1 aims to replace lost auditory neurons, potentially addressing a broader patient population. We plan to conduct a pre-IND meeting to understand FDA expectations, especially regarding animal models. The program's differentiation lies in its potential to replace lost cells, unlike gene therapies targeting specific mutations.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.