EBIT: As of FY2025 Q2, the actual value is USD -4.65 M.

Cash and Working Capital

As of June 30, 2025, Cingulate had approximately $8.9 million in cash and cash equivalents, a decrease of $3.3 million from December 31, 2024. The company expects its cash will satisfy its capital needs into late 2025 under the current business plan. To advance the commercialization efforts for CTx-1301 into early 2026, the company will need to raise approximately $1.5 million of additional capital.

Research and Development Expenses

Research and development expenses were $2.7 million for the three months ended June 30, 2025, an increase of $0.8 million or 43.6% from the same period in 2024. This increase was due to higher clinical and regulatory costs related to the NDA submission of CTx-1301, partially offset by a decrease in manufacturing costs.

General and Administrative Expenses

General and administrative expenses were $1.9 million for the three months ended June 30, 2025, an increase of $0.6 million or 47.1% from the same period in 2024, primarily due to higher legal and financial advisory fees.

Net Loss

Net loss was $4.8 million for the three months ended June 30, 2025, compared to $3.2 million for the same period in 2024. The increase in net loss was primarily due to increased research and development costs.

Outlook / Guidance

Cingulate anticipates an FDA decision in Q4 2025 regarding the NDA acceptance for CTx-1301, with a potential PDUFA date in mid-2026. The company plans to prioritize pre-commercial activities in anticipation of the launch of CTx-1301 in mid-2026, pending FDA approval.