Cingulate Inc. reported its financial results for the quarter ended June 30, 2025, showcasing key financial metrics and developments.
The company submitted a New Drug Application (NDA) for lead asset CTx-1301 to the FDA, signaling a significant milestone in its pipeline.
Recent highlights include positive study results and a strategic purchase agreement with Lincoln Park Capital.
NDA Submission for CTx-1301
Submitted NDA to FDA for CTx-1301, a novel extended-release tablet formulation addressing ADHD limitations.
Strategic Purchase Agreement
Entered into a purchase agreement with Lincoln Park Capital to raise up to $25.0 million of common stock over 36 months.
Financial Highlights
$8.9 million in cash as of June 30, 2025, supporting pre-commercial activities for CTx-1301.
- Cingulate's NDA submission for CTx-1301 represents a significant step towards potential FDA approval and commercialization.
- The positive study results and financial position indicate a focus on advancing key assets and securing capital for growth.
Overall, Cingulate Inc.'s second quarter results reflect progress in drug development, financial stability, and strategic partnerships, positioning the company for future growth and potential FDA approval.