KANSAS CITY, Kan. - Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, has announced the completion of twelve registration batches for CTx-1301, its leading product candidate aimed at treating Attention Deficit Hyperactivity Disorder (ADHD). This step is crucial for meeting U.S. Food and Drug Administration (FDA) prerequisites for a New Drug Application (NDA).
The successful production of these batches is a significant milestone in the chemical, manufacturing, and control (CMC) process, demonstrating a reliable manufacturing method and acceptable shelf life for CTx-1301.
Laurie Myers, Chief Operating Officer of Cingulate, stated that this accomplishment brings the company closer to complying with FDA guidelines for submitting an NDA. The company anticipates submitting its application in the first half of 2025.
CTx-1301, which utilizes Cingulate’s proprietary Precision Timed Release™ (PTR™) drug delivery platform, is designed to deliver three doses of dexmethylphenidate at specific times throughout the day. Dexmethylphenidate is an FDA-approved compound for ADHD treatment, and CTx-1301 aims to provide a rapid onset and full-day efficacy in a single tablet.
ADHD is a chronic condition affecting millions, characterized by inattention and/or hyperactivity-impulsivity that disrupts functioning or development. In the U.S., an estimated 6.4 million children and adolescents are diagnosed with ADHD, with a significant number continuing to experience symptoms into adulthood. Despite the high prevalence, only a fraction of adults with ADHD receive treatment.
Cingulate’s PTR technology, which includes an Erosion Barrier Layer (EBL) and is licensed from BDD Pharma, allows for controlled drug release at predetermined times without drug leakage before the intended release. The company aims to utilize this technology to enhance its clinical-stage pipeline and explore additional therapeutic areas beyond ADHD and anxiety disorders.
This announcement is based on a press release statement from Cingulate Inc. and contains forward-looking statements that involve potential risks, as detailed in the company’s SEC filings. The completion of the registration batches represents a step forward for Cingulate in its efforts to bring CTx-1301 to market, pending regulatory approval.
In other recent news, pharmaceutical firm Cingulate Inc. is facing potential delisting from the Nasdaq Capital Market due to not meeting the minimum bid price requirement. This information was made public in a recent filing with the Securities and Exchange Commission. Already under a discretionary panel monitor until May 2025, the company did not receive additional time to regain compliance.
Cingulate plans to request a hearing before the Nasdaq Hearings Panel to seek an extension to demonstrate compliance with the Bid Price Requirement Rule. This move will delay any possible delisting until the conclusion of the hearing and any further extension period granted.
The company is also contemplating measures such as a reverse stock split to address the compliance issue. Still, it is uncertain whether the Panel will permit the company to maintain its listing or if Cingulate can meet the bid price requirement within any granted extension period and comply with other Nasdaq listing standards. These are recent developments in the company's efforts to secure its position on the exchange.
InvestingPro Insights
As Cingulate Inc. (NASDAQ: CING) progresses towards its goal of submitting a New Drug Application for CTx-1301, investors are closely monitoring the company's financial health and market performance. Here are some key insights from InvestingPro that may be of interest:
InvestingPro Data shows a concerning financial outlook for Cingulate, with an operating income of -21.86M USD and a return on assets of -355.56% for the last twelve months as of Q1 2024. These numbers reflect challenges the company faces in reaching profitability. Moreover, the gross profit for the same period stands at 0.32M USD, which may raise questions about the company's ability to sustain its operations without significant improvements in revenue.
The stock has experienced a tumultuous period, with a 6-month price total return of -70.82% and a staggering 1-year price total return of -96.72%. The market cap, adjusted to 4.19M USD, further underscores the volatility and the small size of the company within the biopharmaceutical industry.
InvestingPro Tips suggest a mixed picture: while Cingulate holds more cash than debt on its balance sheet, it is quickly burning through cash and has weak gross profit margins. The company's stock price often moves in the opposite direction of the market, which could indicate a lack of investor confidence or a disconnect from broader market trends. Investors should also note that analysts do not anticipate the company will be profitable this year.
For those interested in further analysis and additional InvestingPro Tips, a visit to https://www.investing.com/pro/CING will provide a deeper dive into Cingulate's financials and market performance. There are 12 additional tips available to help investors make more informed decisions. To enhance your investing strategy, consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.