Cingulate(CING) - 2024 Q4 - Annual Results

Financial Performance - Cingulate Inc. reported a net loss of $15.5 million for the year ended December 31, 2024, a decrease from a net loss of$23.5 million in 2023[10] - Research and development expenses were $9.4 million for the year ended December 31, 2024, down from$15.5 million in 2023, reflecting completed clinical activities[10] - Working capital increased by $17.2 million to approximately$7.5 million as of December 31, 2024, compared to a negative working capital of $9.6 million in 2023[7] - Cash and cash equivalents rose to approximately$12.2 million as of December 31, 2024, a significant increase of $12.1 million from the previous year[9] - Cingulate raised$9.4 million from a common stock offering and $8 million from a purchase agreement in 2024, strengthening its financial position[5] Product Development - Cingulate is on track for a New Drug Application (NDA) submission for CTx-1301 in mid-2025, following a scheduled pre-NDA meeting with the FDA on April 2, 2025[3] - Safety data from two Phase 3 studies for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials[3] - The company completed its final FDA-required study in January 2025, confirming that CTx-1301 can be taken with or without food[5] - Cingulate holds a European patent for CTx-1301, granted on August 14, 2024, covering up to 30 territories, including the UK[5] Strategic Initiatives - The company continues to explore licensing agreements and market expansion opportunities both domestically and internationally[5]