Cingulate Appoints Nilay Patel as Chief Legal Officer to Support Growth ahead of New Drug Application
Pharma Vet brings 20+ years of Legal, Compliance, and Commercialization Expertise as Company prepares ADHD Drug Filing
KANSAS CITY, Kan., July 09, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, has named Nilay Patel, JD, as Chief Legal Officer. Patel’s appointment comes as Cingulate plans to submit a new drug application to the FDA in coming weeks for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Mr. Patel brings more than two decades of legal and compliance leadership in the pharmaceutical industry, having advised companies across every stage of drug development, launch, and commercialization. He most recently served as Chief Legal Officer, Chief Compliance Officer and Corporate Secretary at Ironshore Pharmaceuticals.
“We are pleased to welcome Nilay Patel to Cingulate at such a pivotal time in our company’s progression,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “As we file to seek approval for CTx-1301, Nilay brings an extensive knowledge of the ADHD landscape and a rare blend of deep legal expertise, operational insight, and proven leadership in navigating the complexities of pharmaceutical commercialization.”
Before joining Ironshore, Mr. Patel held senior legal roles at Grifols, where he served as Assistant General Counsel for the company’s U.S. Bioscience division, and at Life Sciences Law PLLC, where he represented both emerging biotech firms and global pharmaceutical clients in licensing, mergers and acquisitions, and intellectual property matters.
“I’m honored to join Cingulate at an exciting and inflectional stage in its growth,” Patel stated. “I was drawn to Cingulate because of its seasoned management team and innovative approach to addressing long-standing challenges in ADHD treatment through science-driven, patient-focused solutions, and I look forward to advancing the company’s vision and long-term success as we move closer to commercialization.”
On July 8, 2025, the Company granted non-qualified stock options to Nilay Patel to purchase a total of 30,000 shares of the Company’s common stock at an exercise price per share of $4.51, which was the closing price per share of the Company’s common stock as reported by NASDAQ on July 8, 2025. The grant was approved by the Compensation Committee of the Company’s Board of Directors as an inducement award in accordance with Nasdaq Listing Rule 5635(c)(4). The options will vest over four years, with 25% of the shares underlying the option vesting on the one-year anniversary of the grant date and the remaining 75% vesting in approximately equal monthly installments over the following thirty-six months, subject to the employee being continuously employed by the Company through each vesting date.
About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, OralogiK™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Investor & Media Relations:
Thomas Dalton
Vice President, Corporate Communications, Cingulate
tdalton@cingulate.com
(913) 942-2301
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