Financial Performance - Net losses were $12.2 million and $27.1 million for the three and nine month periods ended September 30, 2025, with an accumulated deficit of $331.4 million[138][149]. - Total revenue for the three months ended September 30, 2025, was $132,000, down from $173,000 in the same period of 2024[158]. - Revenue for the nine months ended September 30, 2025, was $6.5 million, a significant increase from $0.5 million in the same period of 2024, primarily from royalties under the Marinus License Agreement[165]. - The net loss for the nine months ended September 30, 2025, was $27.1 million, compared to a net loss of $17.2 million in the same period of 2024[170]. - Other income for the nine months ended September 30, 2025, was $3.1 million, a decrease of $30.9 million compared to $34.0 million in 2024, primarily due to a prior year adjustment related to royalty monetization[168]. Cash and Liquidity - As of September 30, 2025, the company had $25.6 million in cash, cash equivalents, and marketable securities, and working capital of $22.0 million[138][149]. - The company expects to fund its operating plans for at least the next 12 months with available cash, cash equivalents, and marketable securities[169]. - Cash, cash equivalents, and marketable securities totaled $25.6 million as of September 30, 2025[185]. - Net cash used in operating activities was $27.9 million for the nine months ended September 30, 2025, compared to $45.9 million in 2024[178]. - Net cash provided by investing activities was $22.2 million for the nine months ended September 30, 2025, compared to $33.3 million in 2024, primarily due to the maturity of marketable securities[179]. - The company has no long-term debt and no material non-cancelable purchase commitments as of September 30, 2025[172]. Research and Development - The company has a differentiated pipeline with three novel mechanisms of action targeting seizures, with two programs currently in clinical trials and a third expected to begin in Q2 2026[137][140]. - Research and development expenses for the three months ended September 30, 2025, were $5.87 million, a decrease from $7.86 million in the same period of 2024[158]. - Research and development expenses for the nine months ended September 30, 2025, totaled $19.0 million, down $11.9 million from $30.8 million in 2024, mainly due to the pause of the OV888 (GV101) program[166]. - The company plans to initiate preclinical studies and clinical trials for additional drug candidates in the future[139]. - Positive topline Phase 1 trial data for the GABA-aminotransferase inhibitor, OV329, was announced, indicating strong inhibitory activity and a potential best-in-category safety profile[143]. Future Expectations - The company expects to incur significant expenses and operating losses for at least the next several years due to ongoing clinical trials and research and development activities[139]. - The company anticipates a gross proceeds of up to $175.1 million from a recent private placement, with initial net proceeds of $75.7 million received at closing[142]. Accounting and Compliance - There were no material changes to critical accounting policies during the three and nine month periods ended September 30, 2025, compared to the year ended December 31, 2024[184]. - The company has elected to adopt accommodations available to smaller reporting companies, including compliance exceptions from auditor attestation requirements[182]. - The company is classified as a smaller reporting company, allowing it to take advantage of scaled disclosures, including reduced executive compensation disclosures[181]. Investment Activities - The primary objectives of the company's investment activities are to ensure liquidity and preserve capital[185]. - The company intends to maintain its portfolio of cash equivalents and marketable securities in institutional market funds, including U.S. treasury and high-quality short-term corporate bonds[186]. - An immediate 100 basis point change in interest rates would not have a material effect on the fair market value of cash equivalents and marketable securities due to their short-term maturities[186]. - The company’s primary exposure to market risk is interest rate sensitivity, affected by changes in U.S. interest rates[186]. - The net cash provided by financing activities during the nine months ended September 30, 2025, resulted solely from proceeds from the exercise of stock options and employee stock purchase plan purchases[180].
Ovid Therapeutics (OVID) - 2025 Q3 - Quarterly Report