Business
Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update
Werth Family Investment Associates Provides Additional Capital InvestmentPhase 3 Adult Efficacy and Safety Trial of CTx-1301 Data ReleasedCTx-1301 Phase 3
About this update from Cingulate Inc.
[{"type":"text","content":"Werth Family Investment Associates Provides Additional Capital InvestmentPhase 3 Adult Efficacy and Safety Trial of CTx-1301 Data ReleasedCTx-1301 Phase 3 Pediatric and Adolescent Studies Underway 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. “We believe the Phase 3 adult efficacy and safety trial is a significant clinical milestone and validation of what Cingulate has set out to accomplish: create the only ADHD medication that overcomes the major unmet needs of currently available treatments with clear and unmatched differentiation,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. Dr. Raul Silva, MD, Chief Science Officer added, “We are pleased with the results from this trial and believe they will be replicated in the ongoing Phase 3 pediatric and adolescent trials.” Werth Family Investment Associates Provides $1 Million InvestmentOn August 11, 2023, Cingulate entered into a Securities Purchase Agreement with WFIA and issued, in a private placement priced at the market under Nasdaq rules, 1,823,155 shares of the Company’s common stock, par value $0.0001 per share at a purchase price per share of $0.5485, for aggregate gross proceeds to the Company of approximately $1.0 million. Clinical Update 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. Full results from the study, including safety data and patient reported outcomes from a pre- and post-trial questionnaire, have been accepted for presen...