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Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Monday, August 14, 2023
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KANSAS CITY, Kan., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended June 30, 2023, as well as a clinical and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase 3 pediatric and adolescent studies.

Key Points: 
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • As part of that effort:
    Cingulate completed a Phase 3 adult dose-optimization study in June 2023 and announced top-line results in July 2023.
  • Assuming positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
  • Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures into September 2023.

Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD

Retrieved on: 
Tuesday, July 11, 2023
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Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.

Key Points: 
  • Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness.
  • After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo.
  • In addition to the Phase 3 adult dose-optimization study, Cingulate plans to initiate its pivotal Phase 3 fixed-dose pediatric and adolescent study this month and a dose-optimization onset and duration trial in pediatric patients in August 2023.
  • Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.