CINGULATE THERAPEUTICS

Their unique combination of cutting-edge delivery technology and proven medications will create an unmatched release profile - allowing for rapid onset of action, reliable duration lasting the entire active day, and a favorable tolerability profile - all within a once-daily, oral dose for superior patient efficacy, safety, and convenience. CTx has executed an exclusive agreement with Catalent Pharma Solutions to develop both assets using Catalent’s patented, commercially proven OptiDose tec... hnology. OptiDose is a state-of-the-art manufacturing process that allows for faster, more efficient manufacturing (up to 100,000 units/hr), optimized drug delivery for better efficacy and significant COGm savings (approx. 75% less costly than current manufacturing technologies). IP, in the form of an existing body of patents (28 currently) – along with the filing of multiple provisional applications (beginning Q1-2015) – assure CTx and their investment partners, strong IP continuity and protection throughout development and into divestiture or commercialization. Two stimulants (both having been in clinical use for 50+ years) account for >90% of ADHD Rx’s written. These stimulants generally provide “partial-day” therapeutic efficacy, of 6-12 hours. Ongoing research suggests at least half of these patients require additional dosing to obtain “full-day” therapeutic efficacy. This “combination dosing” (taking an extended-release dose in the morning combined with an immediate release dose in the afternoon) often produces negative consequences, including insomnia, weight-loss, poor patient compliance, irritability/agitation, and overall therapeutic failure. CTx's development of these two assets – using the two aforementioned, generic stimulants –target the large, unmet need for single-dose, “full-day” therapeutic efficacy. CTx expects to have Immediate traction in both this $2-$3 Billion (projected) “combination-dose” market, as well as the “overall” $9B ADHD market.More