Longboard Pharmaceuticals Announces Q2 2024 Financial Results and Corporate Updates

Longboard Pharmaceuticals, Inc., a clinical-stage biopharmaceutical firm based in La Jolla, California, announced its second-quarter financial results for 2024 and provided a corporate update. The company is dedicated to developing innovative treatments for neurological diseases and has made significant strides in its clinical programs.

Kevin R. Lind, the President and CEO, highlighted the importance of the first half of the year for the company. A major milestone was achieved with bexicaserin receiving Breakthrough Therapy designation from the FDA for treating seizures associated with Developmental and Epileptic Encephalopathies (DEEs). This milestone emphasizes the urgent need for effective treatments for such devastating conditions. Lind expressed gratitude to the DEE community for their support and contributions to this achievement. He also acknowledged the FDA’s collaboration and announced plans to share details of the global Phase 3 program for bexicaserin at an R&D Day event in September.

Dr. Randall Kaye, the Chief Medical Officer, presented topline results from a Phase 1 single-ascending dose (SAD) study for LP659, a selective S1P receptor modulator. The study demonstrated that LP659 was generally safe and well-tolerated, showing a dose- and formulation-dependent reduction in lymphocytes among healthy volunteers. Dr. Kaye indicated that additional updates on a planned multiple-ascending dose trial would be provided later this year, following regulatory discussions.

Key updates and milestones include:

Bexicaserin (LP352):
- Bexicaserin is an oral, centrally acting 5-HT2C superagonist in development for treating seizures associated with DEEs.
- An Investor & Analyst Event is scheduled for September 16 in New York to discuss the global Phase 3 plan for bexicaserin.
- Interim analysis data from the PACIFIC OLE study has been accepted as a late-breaking presentation at the International League Against Epilepsy (ILAE) European Epilepsy Congress in September.
- The FDA granted Breakthrough Therapy designation for bexicaserin for patients aged two years and older.
- Phase 3 initiation for bexicaserin is expected in the second half of 2024.

LP659:
- LP659 is an oral, selective S1P receptor modulator in development for rare neuroinflammatory conditions.
- In the Phase 1 SAD study, LP659 showed a favorable safety and tolerability profile, with no serious adverse events or discontinuations due to treatment-emergent adverse events.
- The study reported no significant impacts on heart rate, electrocardiograms, pulmonary function, or infections.
- LP659 demonstrated a rapid, dose-dependent reduction in lymphocytes.

Second Quarter 2024 Financial Results:
- As of June 30, 2024, Longboard's cash, cash equivalents, and short-term investments amounted to approximately $304.9 million.
- Research and development expenses for the quarter were $20.4 million, a 63% increase from the previous year, primarily due to higher clinical trial and preclinical expenses related to bexicaserin and LP659, as well as personnel-related costs.
- General and administrative expenses totaled $5.2 million, a 67% increase from the previous year, driven by higher personnel-related costs, consulting fees, and other miscellaneous expenses.

In summary, Longboard Pharmaceuticals has made significant progress in its clinical programs and financial performance in the second quarter of 2024. The company's focus on developing treatments for neurological diseases continues to drive its efforts, with notable advancements in the development of bexicaserin and LP659. The upcoming Investor & Analyst Event and further regulatory discussions are anticipated to provide additional insights into the future of these promising therapies.

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