Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Longboard Pharmaceuticals Inc (LBPH, Financial) reported positive top line data from their Phase 1b/2a PACIFIC study, showing a 60% median reduction in motor seizures for Bexicaserin in highly refractory DEE patients.
- The FDA granted Breakthrough Therapy designation for Bexicaserin for seizures associated with DEEs, making Longboard the first company to receive this designation for DEEs.
- LP659, a selective S1P receptor modulator, demonstrated promising preclinical results with high oral bioavailability and targeted action on CNS glial cell S1P receptors.
- The company has a strong financial position with approximately $305 million in cash and investments, providing a runway into 2027.
- Longboard is preparing to initiate a global Phase 3 program for Bexicaserin, including two pivotal studies, indicating progress towards addressing unmet medical needs in DEEs.
Negative Points
- The patent life for LP659 is limited, with composition matter protection only until 2031, which may impact long-term commercial strategies.
- The company is still under a partial clinical hold for LP659, which needs to be resolved before advancing to the multiple ascending dose study.
- There is uncertainty regarding the final indication selection for LP659, as the decision is pending further data from the Phase 1 MAD study.
- The market size for DEEs is still being evaluated, with potential challenges in accurately assessing the patient population due to overlapping diagnoses.
- Increased R&D expenses are expected to continue, which may impact financial performance in the short term as the company scales its operations for Phase 3 programs.
Q & A Highlights
Q: Can you expand on the sizing of the Bexicaserin Phase 3 studies and the representation of different DEEs?
A: Kevin Lind, President and CEO, stated that they plan to disclose full details at the R&D Day on September 16. The focus is on ensuring a comprehensive rollout rather than piecemeal information.
Q: How large is the DEE opportunity following the breakthrough therapy designation for Bexicaserin?
A: Kevin Lind mentioned that while exact numbers will be shared later, they believe the market is substantial. They are excited about addressing DEEs and providing access to patients who currently lack it.
Q: What is the decision matrix for selecting indications for LP659?
A: Kevin Lind explained that the decision involves commercial opportunity, clinical feasibility, and translational science. They are expanding potential indications based on ongoing learnings and plan to finalize decisions after the MAD study.
Q: Can you comment on discussions with global regulators regarding the broad DEE path for Bexicaserin?
A: Randall Kaye, Chief Medical Officer, stated that they have initiated discussions with global regulatory authorities. The breakthrough therapy designation sets a precedent, and they expect positive discussions globally.
Q: What is the status of the partial clinical hold on LP659, and what needs to be resolved?
A: Randall Kaye mentioned that the partial clinical hold is still in place. They plan to submit a complete response along with the proposal for the multiple ascending dose study to resolve it soon.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
