Cingulate Inc 2026年季度报告

FORM 10-Q Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Actof 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to 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 was 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 If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complyingwith any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ As of May 12, 2026, 13,276,022 shares of the registrant’s common stock, $0.0001 par value, were issued and outstanding. 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, and Section 21Eof the Securities Exchange Act of 1934, as amended, that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,”, “believe,”“estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions intended to identify statements about thefuture. These statements speak only as of the date of filing this report with the Securities and Exchange Commission (SEC) and involve known andunknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different ●our ability to maintain compliance with the continued listing requirements of The Nasdaq Stock Market LLC (Nasdaq); ●our ability to obtain approval for CTx-1301 and the timing of any such approval;●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 our product candidates;●the timing of our New Drug Application (NDA) submissions for our product candidates;●the timing of and our ability to obtain and maintain regulatory approvals for our product candidates;●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 Startups Actof 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 quantified and someof which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. The events andcircumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from thoseprojected in the forward-looking statements. You should refer to the “Risk Factors” section in our Annual Report on Form 10-K for the fiscal yearended December 31, 2025, filed with the SEC on March 18, 2026 (Form 10-K), 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 new riskfactors and uncertainties may emerge from time to time. It is not possible for management to predict all risk factors and uncertainties. As a result of (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, with aninitial focus on the treatm