Cingulate Inc.

Cingulate Inc. announced an update on its CTx-1301 new drug application (NDA) following a Complete Response Letter (CRL) from the FDA. The company is preparing to resubmit the NDA between December 2026 and January 2027, having substantially completed the requested chemistry, manufacturing, and controls (CMC) information. The CRL did not raise concerns about clinical safety or efficacy. Cingulate anticipates a potential commercial launch in the third quarter of 2027, pending FDA approval and classification of the resubmission.

Cingulate Inc. reported a net loss of $(5.87) million for Q2 2026 and $(15.18) million for the six months ended June 30, 2026. The company's cash and cash equivalents significantly increased to $28.4 million, and total stockholders' equity rose to $23.47 million, primarily due to financing activities. However, the FDA issued a Complete Response Letter for the CTx-1301 NDA, requesting additional CMC information, and the company expressed substantial doubt about its ability to continue as a going concern.

Cingulate Inc. reported a net loss of $5.9 million for Q2 2026, an increase from $5.0 million in Q2 2025, primarily due to higher selling, general and administrative expenses for commercial readiness. The company provided updates on its lead ADHD asset, CTx-1301, including ongoing progress for NDA resubmission to the FDA and the issuance of a new U.S. patent extending protection through December 2042. Cash and cash equivalents significantly increased to $28.4 million, expected to fund operations into mid-2027, supporting continued commercialization preparations and regulatory efforts.

Cingulate Inc. announced the publication of a peer-reviewed manuscript in CNS Drugs, detailing the comparative bioavailability of CTx-1301, its lead ADHD product candidate. The study demonstrated CTx-1301's trimodal release profile, providing rapid onset and sustained medication exposure throughout the active day, with fewer adverse events than the reference bimodal formulation. This publication, following the Phase 3 efficacy study, establishes a strong scientific foundation for CTx-1301's clinical performance and proprietary drug delivery.

Cingulate Inc. announced the publication of positive Phase 3 clinical trial results for its lead asset, CTx-1301 (dexmethylphenidate HCl), for ADHD treatment in the Journal of Child and Adolescent Psychopharmacology. The peer-reviewed publication reinforces the efficacy and safety profile of CTx-1301 and the potential of Cingulate’s Precision Timed Release™ (PTR™) platform technology. The study demonstrated clinically meaningful improvements in ADHD symptoms across all three dose groups compared to placebo, with significant p-values and strong effect sizes, moving the company closer to potential regulatory approval and commercialization.

Cingulate Inc. announced the elimination of its Chief Legal Officer position. As a result, Mr. Nilay Patel will depart as an officer of the company, effective August 3, 2026. His termination will be treated as without cause, and the company does not plan to hire a replacement for the role.

Cingulate Inc. stockholders approved an amendment to the 2021 Omnibus Equity Incentive Plan, increasing the number of shares authorized for issuance by 625,000 to a total of 2,221,126 shares. Concurrently, the Board of Directors reduced its size to five members, appointing CEO Shane Schaffer as Chairman and Jeff Hargroves as lead independent director. Stockholders also elected Jeff Hargroves as a Class II director and ratified KPMG LLP as the independent auditor for 2026.

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.