Cingulate Inc. Reports $4.8 Million Net Loss in Q2 2025, Submits NDA for CTx-1301

Cingulate Inc. reported a net loss of $4.8 million for the three months ended June 30, 2025, compared to a loss of $3.2 million for the same period in 2024, marking a 49.2% increase in losses year-over-year. For the six months ending June 30, 2025, the company recorded a net loss of $8.6 million, up from $6.2 million in the prior year, reflecting a 39.0% increase. The company's operating expenses also rose significantly, with research and development costs increasing by 43.6% to $2.7 million in the second quarter, driven by heightened clinical operations and regulatory activities related to its lead product candidate, CTx-1301.

Cingulate's total assets decreased to approximately $13.5 million as of June 30, 2025, down from $14.9 million at the end of 2024. The decline in cash and cash equivalents was notable, dropping to $8.9 million from $12.2 million. The company’s accumulated deficit reached approximately $117.1 million, underscoring its ongoing financial challenges as a pre-revenue entity. The increase in liabilities, particularly a rise in current liabilities from $4.97 million to $6.73 million, was primarily due to a significant increase in the current portion of a note payable.

Strategically, Cingulate has made significant progress in its product development pipeline. The company submitted a New Drug Application (NDA) for CTx-1301 to the FDA on July 31, 2025, following the completion of necessary clinical studies. Additionally, Cingulate is advancing its second product candidate, CTx-1302, and has initiated development for CTx-2103, aimed at treating anxiety. The company has also entered into a master services agreement with Indegene, Inc. to assist in the commercialization of CTx-1301.

Operationally, Cingulate's workforce has seen changes, with the termination of its Chief Operating Officer in August 2025 and the appointment of Jennifer Callahan as interim CEO. The company has also been active in raising capital, having sold shares under its At-the-Market Agreement and a purchase agreement with Lincoln Park Capital, generating approximately $6.1 million in net proceeds during the first half of 2025. However, Cingulate anticipates needing an additional $1.5 million to support its commercialization efforts for CTx-1301 into early 2026.

Looking ahead, Cingulate faces substantial challenges in securing the necessary funding to continue its operations and product development. The company has indicated that it will need to raise additional capital through equity or debt financing to support its ongoing research and development activities. The management remains optimistic about the potential of its product candidates but acknowledges the uncertainty surrounding future capital availability and the regulatory approval process.