Longboard Pharmaceuticals(US:LBPH)2024-11-07 21:12Financial Performance - The company reported net losses of $24.5 million for the three months ended September 30, 2024, compared to $12.9 million for the same period in 2023, representing a 90% increase in losses [119]. - Total operating expenses for the three months ended September 30, 2024, were $28.1 million, compared to $13.6 million for the same period in 2023, marking a 107% increase [119]. - The company incurred a net loss of $61.3 million for the nine months ended September 30, 2024, compared to a net loss of $39.4 million for the same period in 2023 [138]. - Net cash used in operating activities was $54.9 million for the nine months ended September 30, 2024, compared to $39.8 million for the same period in 2023 [138]. - Net cash used in investing activities was $218.6 million for the nine months ended September 30, 2024, compared to net cash provided of $25.8 million for the same period in 2023 [139]. Research and Development - Research and development expenses increased by 105% to $21.5 million for the three months ended September 30, 2024, up from $10.5 million in the same period of 2023 [120]. - Research and development expenses increased by $23.5 million, or 75%, to $55.1 million for the nine months ended September 30, 2024, compared to $31.6 million for the same period in 2023 [121]. - The FDA has granted Breakthrough Therapy designation for the product candidate bexicaserin for the treatment of seizures associated with developmental and epileptic encephalopathies [104]. - The company initiated a global Phase 3 program for bexicaserin, named the DEEp Program, in Q3 2024 [104]. - The proposed Phase 1 multiple-ascending dose study for LP659 is currently on full clinical hold by the FDA [104]. Financial Position and Funding - The company has raised approximately $288.4 million in cash, cash equivalents, and short-term investments as of September 30, 2024 [105]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments of $288.4 million, up from $48.5 million as of December 31, 2023 [124]. - Net cash provided by financing activities was $287.0 million for the nine months ended September 30, 2024, primarily from a follow-on offering that raised $226.5 million [140]. - The company expects to finance its cash needs through public or private equity offerings, debt financings, or other capital sources until it can generate significant revenue from product sales [109]. - The company expects existing cash and short-term investments to fund operations for at least the next 12 months [133]. Internal Controls and Compliance - The company maintains disclosure controls and procedures designed to ensure timely reporting of required information [151]. - As of September 30, 2024, the company's management concluded that disclosure controls and procedures were effective at the reasonable assurance level [152]. - There were no changes in internal control over financial reporting during the quarter ended September 30, 2024, that materially affected internal control [153]. - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to delay the adoption of new accounting standards [147]. - The company is also classified as a "smaller reporting company," enabling it to take advantage of scaled disclosures as long as certain thresholds are met [148]. Legal Matters - There are no material legal proceedings involving the company, although litigation can have adverse impacts due to costs and reputational harm [155]. Market and Future Outlook - The company has an accumulated deficit of $201.9 million as of September 30, 2024 [106]. - Future capital requirements will depend on various factors, including the progress and costs of research programs and regulatory reviews [134]. - As of September 30, 2024, a hypothetical 10.0 percent increase in accrued research and development expenses would have resulted in an increase to the net loss of approximately $1.1 million [146]. - The market value of common stock held by non-affiliates exceeded $700.0 million as of June 30, 2024, leading to the company ceasing to be an emerging growth company effective December 31, 2024 [149]. - The company will no longer qualify as a smaller reporting company beginning with the first Quarterly Report on Form 10-Q for the quarterly period ending March 31, 2025 [149].