Cingulate names Nilay Patel as chief legal officer ahead of FDA filing

KANSAS CITY - Biopharmaceutical company Cingulate Inc. (NASDAQ:CING), a micro-cap firm valued at $19.15 million, has appointed Nilay Patel as Chief Legal Officer as the company prepares to submit a new drug application to the FDA for its ADHD treatment candidate. According to InvestingPro data, the company currently maintains a weak financial health score of 1.65.

Patel, who previously served as Chief Legal Officer at Ironshore Pharmaceuticals, brings over 20 years of legal and compliance experience in the pharmaceutical industry. His appointment comes as Cingulate plans to file for regulatory approval of CTx-1301, a dexmethylphenidate HCl formulation for Attention Deficit Hyperactivity Disorder.

"I’m honored to join Cingulate at an exciting and inflectional stage in its growth," Patel said in the press release statement.

The company granted Patel non-qualified stock options to purchase 30,000 shares at an exercise price of $4.51, with vesting over four years. The grant was approved as an inducement award under Nasdaq rules. Notably, analyst price targets for Cingulate range from $8 to $61 per share, suggesting potential upside from current levels. InvestingPro subscribers can access 8 additional key insights about the company’s valuation and performance metrics.

Cingulate’s lead candidate utilizes the company’s Precision Timed Release drug delivery platform, designed to deliver three precisely timed doses of medication in a single daily tablet. The technology aims to provide rapid onset and full-day efficacy for ADHD patients.

ADHD affects over 20 million patients in the U.S., including 12 million adults and more than 8 million children under 17, according to information provided in the company announcement.

Cingulate is headquartered in Kansas City and focuses on developing pharmaceutical products for conditions requiring multiple daily doses, with an initial focus on ADHD and potential expansion into anxiety disorders. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates rapid cash burn, with negative free cash flow of $14.44 million in the last twelve months.

In other recent news, Cingulate Inc. announced the expansion of its equity incentive plan following stockholder approval, adding 800,000 shares to the plan for a total of 1,141,826 authorized shares. This decision was made during the company’s 2025 Annual Meeting of Stockholders, where other key proposals, such as the election of Peter J. Werth as a Class I director and the ratification of KPMG LLP as the independent auditor, were also approved. Additionally, stockholders adopted an amendment for a reverse stock split, which the Board of Directors can execute at any time before the one-year anniversary of the meeting. In another development, Cingulate Inc. received formal feedback from the U.S. Food and Drug Administration (FDA) for its lead ADHD treatment candidate, CTx-1301. The company plans to submit a New Drug Application (NDA) for CTx-1301 during the upcoming summer, with the FDA indicating that the drug may rely on existing efficacy and safety data of the listed drug, Focalin XR. Cingulate’s proprietary Precision Timed Release™ technology aims to provide once-daily dosing for ADHD, potentially making CTx-1301 the first such medication to treat ADHD for the entire active day. The company is also considering the application of its technology in other therapeutic areas, including anxiety disorders.

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