CINGW Overview

CTx-1301 Presentation: Cingulate Inc. announced that data from its ADHD candidate CTx-1301 will be presented at the AACAP Annual Meeting, highlighting its once-daily, extended-release formulation aimed at improving treatment for ADHD patients.

Expert Presentation: Dr. Ann Childress, a leading ADHD specialist, will present the Phase 3 trial results, emphasizing CTx-1301's efficacy and safety in pediatric subjects with ADHD.

Innovative Drug Delivery: CTx-1301 utilizes Cingulate's Precision Timed Release™ platform to provide three timed releases of medication throughout the day, addressing limitations of current stimulant therapies.

Company Overview: Cingulate Inc. is focused on developing next-generation pharmaceutical products to enhance patient outcomes, with CTx-1301 in late-stage development for ADHD and other candidates targeting anxiety and neuropsychiatric conditions.

Commercial Supply Agreement: Cingulate Inc. has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301, its lead ADHD treatment, ensuring exclusive manufacturing capabilities in the U.S. through 2028, pending FDA approval.

Innovative Drug Delivery: CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology to provide a novel, extended-release formulation of dexmethylphenidate, designed to improve ADHD treatment by delivering medication in a controlled manner throughout the day.

New Drug Application Submission: Cingulate Inc. submitted a New Drug Application (NDA) to the FDA for CTx-1301, an extended-release tablet formulation of dexmethylphenidate aimed at improving ADHD treatment.

FDA Decision Timeline: The FDA is expected to make a decision on the NDA acceptance by Q4 2025, with a potential PDUFA date in mid-2026.

Financial Overview: As of June 30, 2025, Cingulate reported $8.9 million in cash and working capital of approximately $3.5 million, alongside a net loss of $4.8 million for the quarter.

Research and Development Focus: The company is increasing R&D expenses due to clinical and regulatory activities related to the NDA submission, while also exploring additional therapeutic areas for its Precision Timed Release™ platform technology.

Cingulate Inc. Submits NDA for CTx-1301: Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for its lead ADHD treatment, CTx-1301, which utilizes their proprietary Precision Timed Release™ technology to provide a once-daily, extended-release formulation of dexmethylphenidate aimed at improving patient outcomes.

Market Potential and Future Plans: The company believes that CTx-1301 could capture significant market share in the $23 billion U.S. ADHD market and plans to leverage its PTR platform technology to develop additional therapeutic candidates beyond ADHD, including anxiety disorders.

Cingulate Inc. Receives FDA Fee Waiver: Cingulate Inc. has been granted a PDUFA fee waiver from the FDA for its new drug application for CTx-1301, a treatment for ADHD, saving the company approximately $4.3 million as it prepares for submission.

CTx-1301 and PTR Technology: CTx-1301 utilizes Cingulate's Precision Timed Release™ platform to deliver dexmethylphenidate in a multi-core formulation, aiming to provide effective, once-daily dosing for ADHD patients with sustained efficacy throughout the day.

Pre-NDA Meeting Outcome: Cingulate Inc. has received formal pre-New Drug Application (NDA) meeting minutes from the FDA, indicating alignment with their plans to submit an NDA for their ADHD treatment, CTx-1301, this summer.

CTx-1301 Overview: CTx-1301 utilizes Cingulate's Precision Timed Release™ technology to provide a once-daily stimulant medication for ADHD, designed to deliver multiple doses throughout the day for optimal efficacy.