- Successful completion of Pre-NDA meeting with FDA for CTx-1301, maintaining mid-2025 submission timeline
- Secured $3 million non-dilutive grant for CTx-2103 development
- Q1 2025 net loss increased to $3.8 million with $9.5 million cash position remaining
Cingulate Inc. (CING), a biopharmaceutical company, reported its financial results for the first quarter of 2025 and shared significant updates on its drug development pipeline. On April 2, 2025, the company completed a Pre-NDA meeting with the FDA for its lead ADHD treatment candidate, CTx-1301. This milestone ensures that Cingulate remains on track to submit its New Drug Application (NDA) by mid-2025. Recent Phase 3 safety data and food effect studies demonstrated positive outcomes for CTx-1301.
The company also secured a $3 million non-dilutive grant to expedite the development of CTx-2103 (buspirone), aimed at treating anxiety. This grant, structured to be paid in three $1 million installments, is expected to cover the development costs through mid-2026, with a future royalty obligation capped at $3.5 million. As of March 31, 2025, Cingulate reported $9.5 million in cash, ensuring operational runway into the fourth quarter of 2025.
Financially, Cingulate faced a net loss of $3.8 million in Q1 2025, an increase from $3.0 million in Q1 2024. The rise in net loss is attributed to increased research and development expenses of $2.2 million, up by 23% year-over-year, and general and administrative expenses of $1.5 million, marking a 30% rise. Despite these financial pressures, the company's cash position positions it to sustain its strategic initiatives, especially the anticipated NDA submission for CTx-1301.
