Cingulate Inc.

Cingulate Inc. announced its inclusion in the Russell 3000E® Index, a significant achievement that is expected to enhance its visibility with institutional investors and expand market awareness. CEO Shane J. Schaffer highlighted that this inclusion further positions the company for long-term growth. Cingulate remains committed to advancing its lead ADHD product candidate, CTx-1301, and developing its proprietary Precision Timed Release™ (PTR™) platform.

Cingulate Inc. announced the issuance of U.S. Patent No. 12,653,791 by the USPTO for its lead ADHD asset, CTx-1301. This patent covers key aspects of CTx-1301's formulation and method of use, extending exclusivity through December 2042. This marks the company's first wholly-owned U.S. patent for CTx-1301, significantly strengthening its intellectual property portfolio and supporting its path toward potential commercialization.

Cingulate Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl) for the treatment of ADHD. The FDA's feedback primarily focused on Chemistry, Manufacturing and Controls (CMC) information requests, with no current concerns identified regarding the clinical safety or efficacy of CTx-1301. Cingulate plans a prompt resubmission of the requested information and stated it is well-capitalized with nearly $30 million in cash, which is expected to fund operations and pre-commercial activities into 2027.

Cingulate Inc. announced its Annual Meeting of Stockholders will be held virtually on July 9, 2026. Stockholders will vote on the election of Jeff Hargroves as a Class II director, the ratification of KPMG LLP as the independent auditor, and a proposal to increase the authorized shares under the 2021 Omnibus Equity Incentive Plan by 625,000 to a total of 2,221,126 shares. The Board also plans to reduce its size from seven to five directors, with two current Class II directors not seeking re-election.

Cingulate Inc. announced that Class II directors Jeff Ervin and Jay Roberts will not seek re-election at the 2026 Annual Meeting of Stockholders, as the company aims to reduce its Board size to five directors. The Board also intends to appoint a new chairman. Additionally, Jeff Hargroves resigned as a Class I director and was immediately re-appointed as a Class II director to ensure proper class balance, and he has been nominated for election at the upcoming Annual Meeting.

Cingulate Inc. reported a net loss of $(9.31) million for Q1 2026, significantly wider than the $(3.85) million loss in Q1 2025. The company's cash and cash equivalents increased to $25.9 million as of March 31, 2026, primarily due to $21.91 million in net cash provided by financing activities, including common stock issuances. Despite the increased cash, the company continues to incur losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern. The NDA for its lead asset CTx-1301 was accepted with a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

Cingulate Inc. reported its first-quarter 2026 financial results, showing a strengthened balance sheet with cash and cash equivalents growing to $25.9 million as of March 31, 2026, an increase of $14.9 million from year-end 2025. This was driven by a $12.0 million private placement. The company is actively engaging with the FDA on its CTx-1301 NDA for ADHD, with a PDUFA target action date of May 31, 2026, and is advancing commercial readiness efforts. Despite an increased net loss of $9.3 million, management believes current capital funds operations into 2027.