Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301

Core Insights - Cingulate Inc. has appointed Bryan Downey as Chief Commercial Officer to advance the commercialization of CTx-1301, following FDA acceptance of its New Drug Application (NDA) with a target action date of May 31, 2026 [1][12] - The company has completed a $6 million financing transaction to strengthen its cash position and extend its cash runway into the second quarter of 2026, supporting its commercialization efforts pending FDA approval [2][8] Company Developments - Bryan Downey brings over 25 years of experience in commercial strategy and product launches, having held senior roles at Alfasigma USA, Jubilant Pharma, and Sanofi [3][4] - Cingulate's CTx-1301 is designed to provide rapid onset and all-day ADHD symptom control with a single daily dose, differentiating it from existing medications that often require multiple doses [5][12] - The company has partnered with Indegene to establish the commercial infrastructure and market access strategies necessary for the successful launch of CTx-1301 [5] Financial Overview - The $6 million financing was structured as a non-convertible, unsecured promissory note with a 9% annual interest rate, maturing in 18 months, allowing for monthly redemptions post-PDUFA date [8] - The proceeds from the financing will be utilized for working capital and general corporate purposes [8] Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, enabling three timed releases of medication from a single tablet to maintain focus throughout the day [5][12] - The global ADHD market is valued at over $23 billion annually, indicating significant market potential for Cingulate's innovative product [5]