Cingulate Inc 2025年季度报告

Washington, DC 20549 FORM10-Q Cingulate Inc. (Exact name of registrant as specified in its charter) Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted and postedpursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reportingcompany, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, andSection 21E of the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. In some cases, you canidentify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,”“project,” “estimate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressionsintended to identify statements about the future. These statements speak only as of the date of filing this report with the Securities andExchange Commission (SEC) and involve known and unknown risks, uncertainties and other important factors that may cause our actual ●our ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market LLC (Nasdaq); ●our lack of operating history and need for additional capital; ●our plans to develop and commercialize our product candidates; ●the timing of our planned clinical trials for CTx-1301, CTx-1302, and CTx-2103; ●the timing of our New Drug Application (NDA) submissions for CTx-1301, CTx-1302, and CTx-2103; ●the timing of and our ability to obtain and maintain regulatory approvals for CTx-1301, CTx-1302, CTx-2103, or any other futureproduct candidate; ●the clinical utility of our product candidates; ●our commercialization, marketing and manufacturing capabilities and strategy; ●our ability to identify strategic partnerships; ●our expected use of cash; ●our competitive position and projections relating to our competitors or our industry; ●our ability to identify, recruit, and retain key personnel; ●the impact of laws and regulations; ●our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business StartupsAct of 2012 (JOBS Act); ●our plans to identify additional product candidates with significant commercial potential that are consistent with our commercialobjectives; and ●our estimates regarding future revenue and expenses. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantifiedand some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The eventsand circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially fromthose projected in the forward-looking statements. You should refer to the “Risk Factors” section in our Annual Report on Form 10-K for thefiscal year ended December 31, 2024, filed with the SEC on March 27, 2025, for a discussion of important factors that may cause our actualresults to differ materially from those expressed or implied by our forward-looking statements. We operate in an evolving environment and newrisk factors and uncertainties may emerge from time to time. It is not possible for management to predict all risk factors and uncertainties. As a (1)Nature of the Business and Liquidity Organization Cingulate Inc. (Cingulate, or the Company), a Delaware corporation, is a biopharmaceutical company focused on the development of productsutilizing its drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, withan initial focus on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The Company is developing two proprietary, first-linestimulant medications, CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine), for the treatment of ADHD intended for allpatient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize a flexible core tableting technology with target product The consolidated financial statements and notes for the periods ended March 31, 2025 and 2024, represent the full consolidation of Cingulateand its subsidiaries, including Cingulate Therapeutics LLC (CTx) and all references to the Company represent this full consolidation. Liquidity The Company has incurred losses and negative cash flows from operations since inception. As a pre-revenue entity, the Com