Cingulate Inc. Reports $3.8 Million Net Loss in Q1 2025, Increases R&D and G&A Expenses

Cingulate Inc. reported a net loss of $3.8 million for the first quarter of 2025, an increase from a loss of $3.0 million during the same period in 2024. The company's operating expenses rose to $4.7 million, up from $4.0 million year-over-year, driven primarily by increased research and development (R&D) costs, which totaled $2.2 million, a 23% increase from $1.8 million in the prior year. General and administrative expenses also saw a significant rise, reaching $1.5 million, up 30% from $1.1 million in the previous year. The increase in expenses is attributed to higher personnel costs following the reinstatement of salaries that had been reduced in late 2023, as well as increased regulatory costs in preparation for the upcoming New Drug Application (NDA) submission for CTx-1301.

In terms of financial position, Cingulate's cash and cash equivalents decreased to approximately $9.5 million as of March 31, 2025, down from $12.2 million at the end of 2024. The company’s total assets also fell to $12.5 million from $14.9 million, while total liabilities decreased to $6.5 million from $7.4 million. The reduction in liabilities was primarily due to a decrease in accounts payable and accrued expenses. Cingulate's accumulated deficit increased to $112.3 million, reflecting ongoing operational losses since its inception.

Strategically, Cingulate is focused on advancing its product pipeline, particularly CTx-1301, a treatment for Attention Deficit/Hyperactivity Disorder (ADHD). The company has initiated two Phase 3 clinical studies for CTx-1301 and plans to submit an NDA in mid-2025. Additionally, Cingulate is developing CTx-2103, aimed at treating anxiety, and has received a $3 million grant to support its clinical and manufacturing development. The company is also exploring strategic partnerships to enhance its commercialization efforts for CTx-1301.

Operationally, Cingulate has not yet generated revenue and continues to rely on capital raises to fund its operations. In the first quarter of 2025, the company raised approximately $1.9 million through the issuance of common stock under its At-the-Market (ATM) Agreement and the Lincoln Park Purchase Agreement. The company anticipates that its current cash reserves will support operations into the fourth quarter of 2025, but additional funding will be necessary to advance its product candidates and commercialization efforts.

Looking ahead, Cingulate acknowledges the need for further capital to sustain its operations and support the development of its product candidates. The company is actively seeking additional funding through equity offerings, debt financing, and potential collaborations. However, management has expressed uncertainty regarding the availability of such capital on favorable terms, which could impact the company's ability to continue its operations and achieve its strategic objectives.