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About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company headquartered in Kansas City, Kansas. The company is dedicated to transforming patient care through its proprietary Precision Timed Release™ (PTR™) drug delivery platform, which enables the development of next-generation pharmaceutical products designed to address significant unmet medical needs. Cingulate focuses on creating innovative solutions for conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes, with an initial emphasis on Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders.
Core Technology: Precision Timed Release™ (PTR™) Platform
Cingulate's PTR™ platform is a groundbreaking drug delivery technology that provides precise, pre-defined, multi-release dosing within a single tablet. This technology incorporates a proprietary Erosion Barrier Layer (EBL), which controls drug release at specific time intervals, ensuring that active pharmaceutical ingredients are delivered at optimal times throughout the day. Unlike conventional extended-release formulations, the PTR™ platform is designed to offer entire active-day efficacy, eliminating the need for additional doses or "booster" medications. The technology has been licensed from BDD Pharma and is adaptable for use in various therapeutic areas beyond ADHD and anxiety disorders.
Pipeline and Product Candidates
Cingulate's lead candidate, CTx-1301 (dexmethylphenidate), is being developed for the treatment of ADHD. Utilizing the PTR™ platform, CTx-1301 aims to provide rapid onset, entire active-day duration, and improved patient compliance. The company has completed multiple Phase 3 studies, including adult and pediatric trials, and is on track to submit a New Drug Application (NDA) to the FDA by mid-2025. Additionally, Cingulate is advancing CTx-2103 (buspirone) for the treatment of anxiety disorders, leveraging FDA's 505(b)(2) regulatory pathway to expedite development.
Market Opportunity
The global ADHD market represents a significant growth opportunity, with millions of children and adults requiring effective treatment options. Current ADHD therapies often fall short in providing consistent, all-day symptom control, leading to high demand for innovative solutions like CTx-1301. Similarly, anxiety disorders remain an underserved market, with substantial potential for improvement in treatment outcomes. Cingulate's ability to address these gaps positions it as a potential disruptor in the biopharmaceutical space.
Strategic Initiatives and Competitive Positioning
Cingulate has secured patents in multiple territories, including Europe, Australia, Canada, and Israel, with additional patents pending in the United States, Hong Kong, and South Korea. These intellectual property protections strengthen the company's competitive position and support its global expansion strategy. The company is actively engaging in licensing discussions with pharmaceutical partners in the U.S. and abroad, aiming to commercialize its products and generate non-dilutive capital. Furthermore, Cingulate's focus on regulatory compliance, such as completing FDA-required studies and manufacturing registration batches, underscores its commitment to achieving timely approvals and market entry.
Financial Sustainability and Growth
Despite operating in a capital-intensive industry, Cingulate has demonstrated financial resilience by raising significant capital through equity offerings, warrant inducements, and strategic partnerships. These efforts have extended the company's cash runway, enabling it to fund ongoing clinical, manufacturing, and regulatory activities. By prioritizing cost containment measures and exploring non-dilutive funding options, Cingulate is well-positioned to execute its strategic plan and achieve long-term growth.
Future Outlook
As Cingulate prepares for the FDA submission of its lead asset, CTx-1301, the company is poised to make a meaningful impact on the ADHD treatment landscape. With its innovative PTR™ platform, robust intellectual property portfolio, and strategic focus on addressing unmet medical needs, Cingulate is building a pipeline of next-generation pharmaceutical products that have the potential to transform patient care and improve quality of life.
Cingulate Inc. (NASDAQ: CING) has completed a Pre-NDA meeting with the FDA regarding its lead ADHD treatment asset CTx-1301 (dexmethylphenidate HCl). The company remains on schedule for a New Drug Application submission in mid-2025.
The company recently released Phase 3 safety data for CTx-1301 and results from a food effect study using a single 50-mg dose in healthy adults. The safety profile has remained consistent across nine clinical trials. CTx-1301 is positioned to be the first true once-daily stimulant medication for ADHD treatment throughout the active day, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform.
A final analysis combining both adult and pediatric safety and efficacy data will be included in the upcoming NDA submission.
Cingulate reported its full year 2024 and Q4 results, highlighting significant progress towards NDA submission for its ADHD treatment CTx-1301. The company secured a $17.5 million increase in working capital, extending cash runway into Q4 2025. Key developments include:
- Scheduled FDA Pre-NDA meeting for April 2, 2025
- Completed safety data from Phase 3 pediatric and adolescent studies with no serious adverse events
- Finished final FDA-required food effect study
- Secured European patent for CTx-1301
Financial highlights:
- Cash position: $12.2 million as of December 31, 2024
- Working capital: $7.5 million
- R&D expenses decreased to $9.4 million from $15.5 million in 2023
- Net loss reduced to $15.5 million from $23.5 million in 2023
Cingulate (NASDAQ: CING) has announced positive safety results from its final Phase 3 trials for CTx-1301, their lead ADHD treatment asset. The data encompasses two Phase 3 pediatric and adolescent studies (fixed dose and dose optimization) and a food effect study with healthy adults using a 50mg dose.
Key safety findings show no serious treatment emergent adverse events (TEAEs) or deaths, with no clinically relevant trends in TEAEs overall. The food effect study's medical findings align with previous 25mg dose results, indicating CTx-1301 can be taken with or without food.
The company has submitted these results to the FDA ahead of an in-person Pre-NDA meeting scheduled for April 2, 2025. Cingulate plans to file for FDA approval in mid-2025, positioning CTx-1301 as the first true once-daily stimulant medication for treating ADHD throughout the entire active day.
Cingulate Inc. (NASDAQ: CING) has completed its final FDA-required food effect study for CTx-1301, its lead ADHD treatment drug. The study evaluated a single 50mg dose of CTx-1301 (dexmethylphenidate) to determine if the medication can be taken with or without food, with no serious adverse events reported.
Data readout regarding bioavailability is expected in Q2 2025. A previous study in 2022 with a 25mg dose demonstrated that CTx-1301 could be taken regardless of food intake. The company is developing CTx-1301 to be the first true once-daily stimulant medication for ADHD treatment over an entire active day. Cingulate targets submission of the New Drug Application (NDA) to the FDA by mid 2025.
Cingulate Inc. (NASDAQ: CING) has secured a financing transaction worth $5 million in net proceeds through a non-convertible, unsecured promissory note of $5.48 million with an accredited investor. The note carries a 9% annual interest rate and matures in 18 months. The funds will extend the company's cash runway into Q4 2025, supporting clinical, manufacturing, and regulatory activities, including the planned NDA submission for CTx-1301 targeted for mid-2025. The private placement was made under Section 4(a)(2) of the Securities Act and/or Regulation D.
Cingulate Inc. reported Q3 2024 financial results, highlighting a $19.5M increase in working capital. The company raised $12.5M in capital during Q3, extending cash runway into Q3 2025. Net loss decreased to $3.2M from $6.0M year-over-year, with R&D expenses dropping to $1.4M from $3.9M. The company secured European patents for its lead ADHD asset CTx-1301 in up to 30 territories and regained Nasdaq compliance. Cingulate remains on track for mid-2025 New Drug Application submission of CTx-1301.
Shane J. Schaffer, Chairman and CEO of Cingulate (NASDAQ: CING), appeared on the nationally syndicated Big Biz Show to discuss Cingulate's lead Phase 3 asset, CTx-1301, for the treatment of ADHD. Schaffer highlighted the company's Precision Timed Release™ (PTR™) drug delivery platform, which aims to advance next-generation pharmaceutical products. The discussion included plans for the commercialization of CTx-1301 and potential applications of PTR™ technology in other therapeutic areas. The Big Biz Show, hosted by Bob “Sully” Sullivan, is broadcast globally through partners like iHeart Radio and the American Forces Network.
Cingulate Inc. (NASDAQ: CING) has initiated its final FDA-required study for CTx-1301, a dexmethylphenidate-based treatment for ADHD. The food effect study is expected to yield results by the end of 2024. The company has also raised over $10 million in additional capital since mid-August 2024, with 58% coming from its at-the-market facility. This capital infusion strengthens Cingulate's balance sheet and supports the advancement of CTx-1301 towards NDA submission, targeted for mid-2025. Additionally, Cingulate has received notification from Nasdaq confirming its compliance with listing requirements, addressing previous concerns about potential delisting.
Cingulate (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer, PharmD, will participate in a live Benzinga All Access event on August 28, 2024, at 10:30 a.m. CST. Schaffer will discuss the company's recent European patent, the ADHD market, and potential expansion of Cingulate’s Precision Timed Release™ (PTR™) drug delivery platform into other therapeutic areas. The event can be viewed live on Benzinga's YouTube channel and later on Cingulate's website.
Cingulate Inc. (NASDAQ:CING) has adjourned its Special Meeting of Stockholders due to insufficient quorum. The meeting is rescheduled for August 28, 2024, at 11:00 a.m. Central Time. The company's Board of Directors believes all proposals in the proxy statement are in the best interests of stockholders and recommends voting FOR all agenda items. The record date for the Special Meeting remains June 28, 2024. Stockholders can vote live by calling 1-800-652-8683 or online at www.envisionreports.com/CING-SP. Cingulate is a biopharmaceutical company using its Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products.
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