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Cingulate Inc. (CING+5.26%) has submitted its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing outlines Cingulate's focus on developing its proprietary Precision Timed Release (PTR) drug delivery platform, with an emphasis on treatments for ADHD and anxiety. The company's lead candidates, CTx-1301 and CTx-1302, target ADHD, while CTx-2103 is aimed at anxiety.
Cingulate reported ongoing Phase 3 clinical trials for CTx-1301, with plans to submit a New Drug Application (NDA) in mid-2025. The company has completed a Phase 1/2 study demonstrating bioavailability and dose proportionality of CTx-1301 compared to Focalin XR.
The report discusses the company's strategic partnership with Indegene for commercialization services in the United States, should Cingulate receive FDA approval for CTx-1301. The company is also seeking additional partnerships for international markets.
Cingulate's intellectual property portfolio includes patents and patent applications in the United States and other countries, covering its PTR platform and product candidates.
The filing highlights risks such as reliance on third-party manufacturers, regulatory approval uncertainties, and potential competition from other pharmaceutical companies.
The company acknowledges its dependence on additional capital to continue operations and develop its product pipeline, with a focus on securing strategic partnerships and financing.
Cingulate's management team brings experience from leading biopharmaceutical companies, with a focus on developing and commercializing next-generation pharmaceutical products.
The report includes a cautionary note about forward-looking statements, emphasizing the risks and uncertainties involved in drug development and commercialization.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Cingulate Inc. annual 10-K report dated March 27, 2025. To report an error, please email earnings@qz.com.