KANSAS CITY - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, announced it has been granted a European patent for CTx-1301, its lead drug candidate for Attention Deficit Hyperactivity Disorder (ADHD), on Wednesday. The newly issued patent, EP Patent No. 3261625, will extend the company's intellectual property rights to include up to 30 European countries, including the United Kingdom.
The patent comes as a significant development for Cingulate as it aims to broaden its market presence beyond the United States. The company currently holds patents in Australia, Canada, and Israel, with additional applications pending in Hong Kong, the Republic of Korea, and the United States.
CTx-1301 is formulated using Cingulate’s proprietary Precision Timed Release™ (PTR™) platform. This technology allows for a multi-core tablet that delivers the active ingredient, dexmethylphenidate, in three timed releases to optimize treatment efficacy throughout the day. Dexmethylphenidate is an FDA-approved compound for ADHD, and its enhanced delivery is designed to address the need for a longer duration of action than what is currently available on the market.
ADHD is a chronic condition that affects millions worldwide, with a significant number of diagnosed individuals continuing to experience symptoms into adulthood. The disorder is characterized by patterns of inattention, hyperactivity, and impulsivity that can impact daily functioning and development.
Cingulate's PTR platform incorporates an Erosion Barrier Layer (EBL) to control drug release at specific times without premature release. This technology is expected to be employed not only for ADHD but also for other therapeutic areas where precise, multiple daily doses are beneficial.
The announcement was made in line with the company's strategy to improve treatment outcomes for conditions with burdensome daily dosing regimens. Cingulate's focus on ADHD treatment is part of a broader initiative to explore additional therapeutic areas where the PTR technology can be applied, including anxiety disorders.
This news is based on a press release statement from Cingulate Inc. and marks another step in the company's efforts to expand its clinical-stage pipeline and potential market reach.
In other recent news, Cingulate Inc. has been making significant moves to maintain its listing on the Nasdaq exchange and to boost its financial standing. In an effort to comply with Nasdaq's minimum bid price requirement, the pharmaceutical company initiated a 1-for-12 reverse stock split. This corporate action was approved by the company's stockholders and the Board of Directors, and is set to be effective from August 9, 2024.
Additionally, Cingulate Inc. has altered the terms of certain outstanding warrants, reducing the exercise price from $2.00 to $0.585 per share. The company expects this move to generate approximately $1.86 million in gross proceeds, which will be directed towards its ongoing research and development initiatives.
On the product front, Cingulate has achieved a significant milestone in its development of CTx-1301, a drug candidate for treating Attention Deficit Hyperactivity Disorder (ADHD). The company successfully completed twelve registration batches for CTx-1301, a key requirement for submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).
Despite these positive developments, Cingulate Inc. is still facing the potential risk of delisting from the Nasdaq Capital Market due to not meeting the minimum bid price requirement. The company is planning to request a hearing before the Nasdaq Hearings Panel to seek an extension to demonstrate compliance with the Bid Price Requirement Rule. These recent developments indicate the company's ongoing efforts to secure its position on the exchange.
InvestingPro Insights
Cingulate Inc. (NASDAQ: CING) has recently made headlines with its European patent grant for its ADHD drug candidate, CTx-1301, signaling a strategic move to expand its market reach. However, the company's financial health and stock performance provide a broader context for this development.
InvestingPro data reveals a market capitalization of 1.61 million USD, indicating Cingulate is a small-cap company, which often means it's more volatile and has higher growth potential compared to larger firms. The company's operating income shows a significant loss of approximately 18.7 million USD over the last twelve months as of Q2 2024, highlighting the challenges it faces in achieving profitability.
The stock's recent performance has been notably poor, with a 1-month price total return of -61.47% and a 1-year price total return of -98.76%, emphasizing the high-risk nature of investing in Cingulate at this stage. Additionally, the stock is trading near its 52-week low, at 1.85 USD per share, which could be an attractive entry point for investors if they believe in the company's long-term potential despite the current headwinds.
InvestingPro Tips suggest that Cingulate is quickly burning through cash and that analysts do not anticipate the company will be profitable this year. These insights are crucial for investors considering the company's ability to sustain operations and fund further development of its drug candidates.
For those interested in diving deeper into the company's financial health and stock performance, there are over 10 additional InvestingPro Tips available at https://www.investing.com/pro/CING. This information could provide valuable insights into whether Cingulate's recent patent news could be a turning point for the company or if the financial challenges overshadow the potential market opportunities.
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