Cingulate Business Summary

Cingulate Inc. (CING) is a clinical-stage biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) platform to develop next-generation treatments for Central Nervous System (CNS) disorders, primarily Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety. The company’s business model is centered on the clinical development and eventual commercialization of its lead asset, CTx-1301 (dexmethylphenidate), which is currently awaiting a PDUFA target action date of May 31, 2026. Revenue is projected to be generated through direct product sales, strategic licensing agreements, and potential commercial partnerships following FDA approval. Cingulate competes in the high-growth ADHD market against established players and emerging biotech firms such as Citius Pharmaceuticals, Heron Therapeutics, and Ironshore Pharmaceuticals. The company distinguishes itself by leveraging its Erosion Barrier Layer (EBL) technology to provide a true once-daily dosing profile, aiming to solve the common industry challenge of suboptimal therapeutic coverage and mid-day dosing requirements. The leadership team is led by Co-founder and CEO Shane J. Schaffer, PharmD, a 25-year industry veteran with prior experience at Pfizer, Novartis, and Sanofi. He is supported by Chief Financial Officer Jennifer Callahan, who previously served as Interim CEO, and Chief Commercial Officer Bryan Downey, who joined in late 2025 to spearhead the commercial launch of CTx-1301. The scientific foundation of the company is managed by Co-founders Dr. Raul Silva (Chief Scientific Officer) and Dr. Matt Brams (Chief Medical Officer), both of whom bring extensive clinical expertise in neuropsychiatry. The Board of Directors is chaired by John A. (Jay) Roberts and includes notable industry figures such as Peter J. Werth, founder of ChemWerth Inc. Recent institutional backing is highlighted by a $12 million PIPE financing led by Falcon Creek Capital Advisor LLC in February 2026, which also granted the firm the right to designate Jeff Hargroves to the company’s board.