Precision Timed Release™ (PTR™) platform
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Cingulate Announces the Closing of a $12 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2026-02-17 13:00
Core Viewpoint - Cingulate Inc. successfully closed a $12 million PIPE financing, indicating strong validation of its strategy and technology in the ADHD treatment market [1][2]. Financing Details - The PIPE financing was led by Falcon Creek Capital and completed at a price of $5.04 per share, with 80% warrant coverage [2][9]. - All investors in the PIPE financing are subject to a 180-day lock-up period, aligning long-term interests [3][9]. - The financing proceeds will support general operations and the commercial launch of CTx-1301, pending FDA approval [4][9]. Product Information - CTx-1301 is a once-daily, multi-core tablet designed to provide consistent symptom control for ADHD, utilizing Cingulate's Precision Timed Release™ platform [8][11]. - The FDA accepted Cingulate's NDA for CTx-1301 in October 2025, with a PDUFA target action date set for May 31, 2026 [9]. Company Overview - Cingulate Inc. focuses on developing next-generation pharmaceutical products for ADHD and other CNS disorders, leveraging its proprietary technology [11]. - The company is headquartered in Kansas City, Kansas, and aims to improve therapeutic outcomes for conditions with suboptimal treatment coverage [11]. Investor Relations - Falcon Creek Capital, a specialized investment firm, will designate up to two members to Cingulate's board, enhancing governance and strategic execution [4][12].
Cingulate's Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting
Globenewswire· 2025-10-23 20:45
Core Insights - Cingulate Inc. announced that data from its lead ADHD candidate CTx-1301 has been selected for podium presentation at the AACAP Annual Meeting, indicating growing scientific interest in the product [1][3] - CTx-1301 is a once-daily, extended-release formulation designed to simplify ADHD treatment for millions [1][4] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform [1][6] - The company is headquartered in Kansas City, Kansas, and is advancing a pipeline that includes candidates for ADHD, anxiety, and other neuropsychiatric conditions [6] Product Details - CTx-1301 (dexmethylphenidate HCl) utilizes the PTR™ platform to deliver three precisely timed releases of medication throughout the day, aiming for rapid onset and full-day efficacy [5] - The product is currently being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment [5] Clinical Presentation - The Phase 3 data for CTx-1301 will be presented by Dr. Ann Childress, a leading ADHD specialist, at the AACAP Annual Meeting [2][3] - The presentation will focus on the efficacy and safety of CTx-1301 in pediatric subjects with ADHD [2] ADHD Context - ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, characterized by inattention, hyperactivity, and impulsivity [4] - Current stimulant medications often require multiple daily doses and may not provide consistent coverage throughout the day [4]