Ovid Therapeutics (US:OVID)2024-11-12 13:07Financial Performance - Total revenue for the three months ended September 30, 2024, was $173,000, an increase of $64,000 (approximately 58.7%) compared to $109,000 for the same period in 2023[96]. - Total revenue for the nine months ended September 30, 2024, was $490,000, an increase of $240,000 (approximately 96%) compared to $250,000 for the same period in 2023[104]. - Other income for the nine months ended September 30, 2024, was $34.0 million, an increase of $29.9 million compared to $4.1 million in the same period in 2023, primarily due to an adjustment to the royalty monetization liability[107]. - Net loss for the three months ended September 30, 2024, was $14.0 million, an increase of $2.8 million (approximately 24.7%) compared to a net loss of $11.3 million in the same period in 2023[108]. - The net loss for the nine months ended September 30, 2024, was $17.2 million, primarily due to a non-cash fair value adjustment resulting in a $29.0 million gain[115]. Cash and Securities - The company had $62.7 million in cash, cash equivalents, and marketable securities, with an accumulated deficit of $295.0 million as of September 30, 2024[83]. - As of September 30, 2024, the company had total cash, cash equivalents, and marketable securities of $62.7 million, expected to fund operations for at least the next 12 months[108]. - Cash, cash equivalents, and marketable securities totaled $62.7 million as of September 30, 2024[121]. - Net cash used in operating activities was $45.9 million for the nine months ended September 30, 2024, compared to $33.9 million for the same period in 2023[115]. - Net cash provided by investing activities was $33.3 million for the nine months ended September 30, 2024, primarily due to the maturity of marketable securities[116]. Research and Development - The company expects to submit an IND application for OV350 in Q4 2024 and initiate clinical trials in Q1 2025[87]. - The company is developing a library of KCC2 direct activators and anticipates multiple clinical development programs in the next 2-3 years[87]. - Research and development expenses are expected to increase significantly as the company advances its drug candidates through clinical trials[91]. - Research and development expenses for the three months ended September 30, 2024, were $7.9 million, up $2.5 million (approximately 47.2%) from $5.3 million in the same period in 2023, primarily due to accelerated preclinical and clinical research[99]. - Research and development expenses for the nine months ended September 30, 2024, were $30.8 million, an increase of $12.9 million (approximately 71.8%) from $17.9 million in the same period in 2023, driven by costs related to multiple clinical programs[104]. Organizational Changes - The company announced an organizational restructuring in June 2024, including workforce reduction to prioritize programs and extend cash runway[109]. - General and administrative expenses decreased to $5.5 million for the three months ended September 30, 2024, down $1.3 million (approximately 18.5%) from $6.8 million in 2023, attributed to organizational restructuring[100]. - General and administrative expenses for the nine months ended September 30, 2024, were $20.8 million, down $2.6 million (approximately 11.1%) from $23.4 million in 2023, due to cost reduction strategies[106]. - The company may incur additional charges related to organizational restructuring expected to be completed by the second quarter of 2025[114]. Market and Economic Conditions - The company is subject to risks including global economic conditions, inflation, and challenges in obtaining regulatory approvals[90]. - Increased inflation rates and interest rate hikes by the U.S. Federal Reserve may adversely affect the company's operating costs and liquidity[114]. Future Financing - The company expects to finance its cash needs through equity offerings, debt financings, and additional funding from collaborations[114]. - The company filed a shelf registration statement allowing the sale of up to $250.0 million of common stock, including $75.0 million available under an at-the-market offering program[112]. Product Development and Sales - The company has not generated revenue from commercial drug sales and does not expect to until regulatory approval is obtained[91]. - The company has no products approved for commercial sale and has not generated any revenue from product sales to date[114]. - The company paused the initiation of the Phase 2 proof-of-concept study of OV888/GV101 to evaluate insights from competitor trials[88]. - The company sold rights to soticlestat to Takeda, which did not meet primary endpoints in two pivotal Phase 3 trials[89].