Cingulate Inc. reported significant financial challenges in its latest 10-Q filing for the quarter ending September 30, 2025, with a net loss of $7.34 million, compared to a loss of $4.13 million in the same period last year. This represents a 77.9% increase in net loss year-over-year. For the nine months ending September 30, 2025, the company recorded a total net loss of $16.18 million, up from $10.33 million in the prior year, reflecting a 56.6% increase. The company's accumulated deficit has now reached approximately $126.1 million.
Operating expenses for the third quarter of 2025 totaled $8.99 million, a 76.5% increase from $5.09 million in the same quarter of 2024. This increase was driven primarily by a 99.5% rise in research and development expenses, which reached $2.85 million, and a 69.7% increase in general and administrative expenses, totaling $3.15 million. The rise in R&D costs was attributed to increased personnel expenses and manufacturing costs associated with the preparation for the New Drug Application (NDA) submission for CTx-1301, the company's lead product candidate for ADHD.
Cingulate has made strategic advancements, including the submission of its NDA for CTx-1301 to the U.S. Food and Drug Administration (FDA) on July 31, 2025, which was accepted for review with a target action date of May 31, 2026. The company is also developing CTx-2103 for anxiety and plans to initiate clinical trials for CTx-1302, another ADHD treatment, pending additional funding. The company has entered into a commercial supply agreement with CoreRx, Inc. to support the manufacturing of CTx-1301.
As of September 30, 2025, Cingulate reported cash and cash equivalents of $6.12 million, a decrease from $12.21 million at the end of 2024. The company has indicated that it will need to raise approximately $9 million in additional capital to support its operations and advance its commercialization efforts for CTx-1301. The company has been actively pursuing various funding strategies, including equity offerings and potential collaborations, to secure the necessary capital for its ongoing development and operational needs.
Looking ahead, Cingulate anticipates continued operating losses as it seeks regulatory approval for its product candidates and prepares for commercialization. The company has expressed concerns about its ability to continue as a going concern, emphasizing the need for additional funding to sustain its operations and development activities.
About Cingulate Inc.
Cingulate Inc. is a biopharmaceutical company developing innovative drugs using its proprietary Precision Timed Release platform to improve treatment of conditions like ADHD and anxiety. Its pipeline includes next-generation stimulant medications and non-stimulant therapies designed for once-daily dosing, faster onset, and better tolerability. The company focuses on clinical development, strategic partnerships, licensing, and leveraging its intellectual property to address unmet medical needs in large markets.
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