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Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company dedicated to improving patient outcomes through its proprietary Precision Timed Release™ (PTR™) drug delivery platform. Headquartered in Kansas City, Kansas, the company is focused on developing next-generation pharmaceutical products that address conditions requiring burdensome daily dosing regimens and that often yield suboptimal treatment outcomes.
Cingulate’s lead candidates target Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders, with a particular emphasis on their flagship product, CTx-1301. CTx-1301 utilizes dexmethylphenidate, a compound approved by the FDA, to provide a rapid onset and entire active-day efficacy through three precisely timed medication releases. This approach aims to eliminate the need for booster doses and improve overall patient compliance and satisfaction. The product has already demonstrated significant promise in Phase 3 trials, with impressive clinical effect sizes that suggest broad potential impact.
Another key product in the pipeline is CTx-2103, a novel extended-release formulation of buspirone designed for the treatment of anxiety. CTx-2103 leverages the PTR platform to deliver three timed doses in one tablet, potentially offering substantial benefits over current multi-dose regimens. This product is currently progressing through clinical trials, with positive feedback from the FDA on its regulatory pathway.
In recent months, Cingulate has achieved several milestones: they announced successful Phase 3 trial data for CTx-1301, closed a $4 million public offering, and converted $5.8 million of debt into equity. These financial maneuvers have strengthened their balance sheet, enabling continued investment in their clinical programs. Additionally, Cingulate recently welcomed new executive leadership and independent directors, further fortifying their capabilities as they navigate the complexities of drug development and commercialization.
Cingulate is committed to ongoing research and development, leveraging its PTR platform not only for ADHD and anxiety but also exploring other therapeutic areas. This innovative platform integrates an Erosion Barrier Layer (EBL), which controls the drug release at precise times without premature release, enhancing the effectiveness and convenience of treatment.
For more information, visit their official website at Cingulate.com.
Cingulate announced the exercise of outstanding Series A and B warrants at a reduced price of $0.585 per share, generating gross proceeds of approximately $1.86 million. Originally issued in February 2023 with an exercise price of $2.00, the warrants allow the purchase of up to 3,187,500 shares of common stock. The transaction, facilitated by H.C. Wainwright & Co., is expected to close by July 1, 2024. In return, Cingulate will issue new Series C and D warrants to purchase up to 6,375,000 shares at the same reduced price, exercisable upon shareholder approval. Proceeds will fund R&D, commercialization of CTx-1301, and general corporate needs.
Cingulate, a biopharmaceutical company listed on NASDAQ under the symbol CING, will host a live event featuring CEO Shane J. Schaffer and ADHD expert Dr. Ann Childress. The event will be held on June 26, 2024, at 10:30 a.m. CST, and will be accessible via Benzinga’s YouTube channel and Cingulate’s website. During the event, the discussion will cover unmet needs in ADHD, results from Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents, and potential expansion of the company's Precision Timed Release™ platform into other therapeutic areas. Dr. Schaffer will also provide a company overview.
Cingulate announced a significant achievement in the development of its ADHD drug, CTx-1301, by completing twelve required registration batches. This milestone meets the U.S. Food and Drug Administration (FDA) manufacturing requirements necessary for New Drug Application (NDA) submission. The company is using its Precision Timed Release™ (PTR™) technology to develop CTx-1301, intended to offer a reliable manufacturing process and acceptable shelf life. Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025, marking a important step towards FDA marketing clearance.
Cingulate has received FDA confirmation on the requirements for filing a New Drug Application (NDA) for its Phase 3 candidate, CTx-1301, aimed at treating ADHD in patients aged six and older. The FDA has agreed that data from ongoing Phase 3 studies are sufficient for submission under the 505(b)(2) pathway, eliminating the need for further fixed dose and onset/duration studies. Cingulate will also conduct a brief Phase 1 fed/fast study to include in the NDA. The company aims to submit the NDA in the first half of 2025. Cingulate is also negotiating with potential commercialization partners and payers to maximize market access for CTx-1301, which may benefit over 60% of ADHD patients currently using booster doses. The drug has shown promising results, with patients expressing a desire to continue its use post-trial.
Cingulate Inc. reported its first quarter 2024 financial results, showing positive trends with $10 million increase in stockholders' equity and capital raising efforts totaling $10.7 million. The company is on track to file for Marketing Approval with the FDA for CTx-1301 in the first half of 2025. R&D expenses decreased, and total stockholders' equity saw a $10 million increase from the end of 2023.
Cingulate Inc. announced that Peter J. Werth, a successful pharma entrepreneur and investor, will be featured with Chairman and CEO Shane J. Schaffer on a live Benzinga event. Werth will discuss his background and vision for Cingulate, while Schaffer will provide company updates. The event will take place on May 3, 2024, at 12:10 p.m. EST.
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