Business
Cingulate Inc. Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update
Phase 3 Trial Initiation for Lead ADHD Candidate CTx-1301 in December 2022 Executed Manufacturing Agreement with Societal CDMO 2022 Psych Congress
About this update from Cingulate Inc.
[{"type":"text","content":"Phase 3 Trial Initiation for Lead ADHD Candidate CTx-1301 in December 2022 Executed Manufacturing Agreement with Societal CDMO 2022 Psych Congress Presentation Demonstrated Ability of Anxiety Candidate CTx-2103 to Deliver a Single Administration of Triple-Release Buspirone KANSAS CITY, Kan., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), 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 announced its financial results for the quarter ended September 30, 2022 and provided a clinical and business update. Highlights include a newly executed Master Services Agreement (MSA) and multiple clinical program updates on its lead Attention Deficit / Hyperactivity Disorder (ADHD) candidate, CTx-1301 (dexmethylphenidate), as well as anxiety asset CTx-2103 (buspirone HCl). “The third quarter of 2022 marked multiple inflection points for Cingulate, during which we initiated and completed a food effect study to meet the New Drug Application pharmacology requirement for our lead ADHD candidate, CTx-1301, and finalized plans for a Phase 3 adult dose-optimization study that will commence in the coming weeks,” said Shane J. Schaffer, Cingulate Chairman and CEO. “Our agreement with Societal CDMO secures the manufacturing capacity and operational expertise to support our products at each and every scale as we advance our clinical trial activities toward the commercialization of these next-generation products designed to improve patient outcomes .” Cingulate Announces Partnership with Societal CDMO Cingulate announced it has executed an MSA with Societal CDMO, Inc. (NASDAQ: SCTL), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges in small molecule therapeutic development. With capabilities spanning pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms, Societal CDMO will manufacture all clinical, registration, and commercial batches of Cingulate’s lead ADHD candidate CTx-1301, an investigational medication for the treatment of ADHD. Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, GA facility a...