Financial Data and Key Metrics Changes - The company ended 2022 with $67.6 million in cash, cash equivalents, and short-term investments [27] - Operating expenses for 2022 were just under $45 million, with R&D expenses increasing to $34.6 million from $19.8 million in 2021 [27] - The net loss for 2022 was $43.9 million or $2.56 per share, compared to a net loss of $27.8 million or $1.93 per share in 2021 [28] Business Line Data and Key Metrics Changes - R&D expenses increased significantly as the company progressed both LP352 and LP659 programs [27] - G&A expenses rose to $10.2 million in 2022 from $8.1 million in 2021, reflecting the company's growth and support functions [28] Market Data and Key Metrics Changes - The company is focused on addressing the unmet medical needs in the DEE space, with a particular emphasis on syndromes like Dravet and Lennox-Gastaut [18][31] - The PACIFIC study aims to enroll 50 participants across 30 sites in the US and Australia, targeting a mix of DEE syndromes [23] Company Strategy and Development Direction - The company aims to advance its neurology assets with differentiated pharmacokinetics and pharmacodynamics, focusing on building a world-class neuroscience team [11] - There is a strong emphasis on developing LP352 and LP659, with expectations for top-line data readouts in 2023 [3][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of LP352 and LP659, highlighting the significant unmet medical needs in the DEE space [34][36] - The company anticipates that expenses will trend upwards in 2023 as it continues the development of its programs [28] Other Important Information - The company completed a $23 million follow-on public offering in February 2023, indicating strong institutional interest [29] - Expected guidance for 2023 operating expenses is in the range of $57 million to $63 million, excluding stock-based compensation [39] Q&A Session Summary Question: What should be expected regarding adverse events in the PACIFIC study? - The AE profile observed so far has been relatively benign, with headache being the most common adverse event [43] Question: Will the company pursue indications already addressed by S1P modulators? - The company sees tremendous unmet need in orphan neurological conditions and is focusing on those areas for LP659 [46] Question: Is there a need for a switch study from Fintepla to LP352? - Management believes that a switch study may not be necessary, as LP352 is expected to be safer and more effective [47] Question: Does the company have the resources to advance both programs simultaneously? - The company has built a solid team and is focused on spending responsibly while progressing both programs [48][49] Question: What are the expectations for the PACIFIC study's success? - Success is framed as safety, tolerability, and comparable seizure reduction across the DEE spectrum [75]
Longboard Pharmaceuticals(LBPH) - 2022 Q4 - Earnings Call Transcript