Financial Performance - The company reported a net loss of approximately $8.4 million, or $0.25 per share, for Q3 2024, compared to a net loss of approximately $11.3 million, or $0.48 per share, for the same period in 2023[7]. - For the nine months ended September 30, 2024, the company reported a net loss of approximately $23.7 million, or $0.75 per share, compared to a net loss of approximately $29.9 million, or $1.32 per share, for the same period in 2023[8]. - The net loss for the three months ended September 30, 2024, was $8,365,798, compared to a net loss of $11,345,936 for the same period in 2023, representing a 26.1% improvement[17]. - Basic and diluted net loss per share for the three months ended September 30, 2024, was $(0.25), an improvement from $(0.48) in the same period of 2023[17]. - Total other income, net for the nine months ended September 30, 2024, was $869,739, compared to $248 for the same period in 2023[17]. - The company reported a gain on remeasurement of warrant liabilities of $728,771 for the nine months ended September 30, 2024, compared to a loss of $(305,972) in the prior year[17]. - Interest income for the nine months ended September 30, 2024, was $313,956, a decrease from $341,854 in the same period of 2023[17]. - The company incurred interest expense of $(13,786) for the nine months ended September 30, 2024, compared to $(20,414) in the same period of 2023[17]. - Provision for income taxes for the nine months ended September 30, 2024, was $14,781, down from $21,531 in the same period of 2023[17]. Cash and Liabilities - As of September 30, 2024, the company's cash totaled approximately $5.6 million, down from approximately $23.4 million as of December 31, 2023[8]. - Total liabilities as of September 30, 2024, were approximately $17.6 million, compared to $18.0 million as of December 31, 2023[16]. Operating Expenses - For the three months ended September 30, 2024, total operating expenses were $8,462,534, a decrease of 26.5% compared to $11,563,954 for the same period in 2023[17]. - Research and development expenses for the nine months ended September 30, 2024, were $18,226,497, down 21.7% from $23,312,661 in the prior year[17]. - Total operating expenses for the nine months ended September 30, 2024, were $24,514,283, down 18.1% from $29,884,290 in the prior year[17]. Clinical Trials and Drug Development - The ongoing 1-year open-label extension (OLE) trial for brilaroxazine has 108 patients who have completed 1 year of treatment, which is a requirement for New Drug Application (NDA) submission[4]. - Topline data from the OLE trial is expected in December 2024, with full data analysis including long-term safety and efficacy expected in Q1 2025[6]. - The company is targeting a potential NDA submission for brilaroxazine in schizophrenia in Q2 2026[6]. - The company presented positive speech latency data for brilaroxazine from the Phase 3 RECOVER trial, supporting its efficacy for negative symptoms of schizophrenia[5]. - The initiation of the registrational Phase 3 RECOVER-2 trial for brilaroxazine is expected in Q1 2025, subject to additional financing[6]. - The company has received Orphan Drug Designation from the U.S. FDA for brilaroxazine for the treatment of pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF)[11].
Reviva Pharmaceuticals (RVPH) - 2024 Q3 - Quarterly Results