Welcome to our dedicated page for Cingulate news (Ticker: CINGW), a resource for investors and traders seeking the latest updates and insights on Cingulate stock.
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company headquartered in Kansas City, Kansas, dedicated to revolutionizing the pharmaceutical landscape with its proprietary Precision Timed Release™ (PTR™) drug delivery platform. With a mission to address unmet medical needs, Cingulate focuses on developing next-generation pharmaceutical products designed to improve the lives of patients suffering from conditions characterized by suboptimal treatment outcomes and challenging daily dosing regimens. The company's innovative approach aims to provide precise, controlled drug delivery, ensuring efficacy and convenience in a single daily dose.
Core Technology: Precision Timed Release™ (PTR™) Platform
At the heart of Cingulate's operations is its PTR™ drug delivery platform, a cutting-edge technology that enables the precise, pre-defined release of active pharmaceutical ingredients at specific intervals throughout the day. The platform incorporates a proprietary Erosion Barrier Layer (EBL), which controls drug release without premature activation. This tablet-in-tablet design ensures optimized therapeutic outcomes by delivering medication at the right time, dosage, and release style. Licensed from BDD Pharma, the PTR platform is adaptable across multiple therapeutic areas, making it a versatile tool for addressing complex medical needs.
Product Pipeline and Therapeutic Focus
Cingulate's initial focus is on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), a condition affecting millions of children and adults globally. Its lead candidate, CTx-1301 (dexmethylphenidate), is a stimulant medication designed to provide rapid onset and full active-day efficacy in a single dose. By eliminating the need for booster doses, CTx-1301 addresses a significant gap in ADHD treatment. The company is also advancing CTx-2103 (buspirone) for the treatment of anxiety disorders, leveraging its PTR platform to optimize drug delivery in this therapeutic area. Beyond ADHD and anxiety, Cingulate is exploring additional indications where its technology could offer substantial improvements over existing therapies.
Market Position and Competitive Advantage
Cingulate operates in the highly competitive biopharmaceutical industry, particularly within the ADHD and anxiety treatment segments. The company's focus on once-daily dosing and its innovative PTR technology differentiate it from traditional extended-release formulations. By addressing common challenges such as suboptimal treatment adherence and fluctuating drug efficacy, Cingulate positions itself as a pioneer in precision drug delivery. The granting of patents in Europe, Australia, Canada, and Israel further underscores its commitment to global expansion and intellectual property protection.
Regulatory and Clinical Progress
Cingulate has made significant strides in advancing its clinical pipeline. The company recently completed its final FDA-required study for CTx-1301, targeting a mid-2025 submission for a New Drug Application (NDA). This milestone reflects Cingulate's adherence to rigorous regulatory standards and its readiness to bring innovative treatments to market. Additionally, its engagement with key stakeholders, including potential licensing partners and payers, highlights a strategic approach to commercialization and market access.
Future Outlook
With a robust pipeline, global patent portfolio, and innovative technology platform, Cingulate is well-positioned to address unmet medical needs in ADHD, anxiety, and beyond. The company's focus on precision drug delivery and patient-centric solutions aligns with evolving healthcare demands, offering significant potential for growth and impact in the pharmaceutical industry.
Cingulate Inc. (NASDAQ: CING) announced the completion of a study assessing the effect of food on the absorption of its lead candidate, CTx-1301, for treating ADHD. Conducted by Dr. Vince Clinical Research, the study involved 26 healthy adults in both fasted and fed states. Results are anticipated by year-end. The findings aim to enhance understanding of CTx-1301's bioavailability and support its upcoming NDA submission expected in late 2023 or early 2024. Cingulate is advancing its proprietary Precision Timed Release technology for improved ADHD treatment outcomes.
Cingulate Inc. (NASDAQ: CING) announced a Master Services Agreement (MSA) with Societal CDMO to enhance its manufacturing capabilities. Societal CDMO will produce clinical and commercial batches for CTx-1301, a leading candidate for treating ADHD, at its Gainesville, GA facility. This partnership is expected to streamline the production process as Cingulate prepares for a Phase 3 dose-optimization study for CTx-1301, set to start in December 2022. If successful, a New Drug Application (NDA) is planned for submission in early 2024.
Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, announced that Chairman & CEO Shane J. Schaffer will present at the LD Micro Main Event XV investor conference on October 26, 2022, at 10:00 a.m. PT. The event will take place at the Luxe Sunset Boulevard Hotel in Los Angeles, with live streaming available at this link. The company, utilizing its Precision Timed Release™ (PTR™) technology, focuses on developing next-generation pharmaceutical products for neurological disorders and other therapeutic areas.
Cingulate Inc. (NASDAQ: CING) announced findings from a formulation study for CTx-2103, a once-daily buspirone treatment for anxiety disorders, presented at the 2022 Psych Congress. The study demonstrated the ability of CTx-2103 to deliver a triple-release formulation, enhancing patient compliance and treatment outcomes. The CEO emphasized the importance of formulation development in achieving effective medications. CTx-2103 aims to provide benefits over existing treatments by eliminating the need for multiple daily doses.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will speak at the Benzinga All Access event on August 19, 2022, at 9 a.m. CST. The discussion will focus on unmet needs in Attention Deficit/Hyperactivity Disorder (ADHD) and the expansion of Cingulate’s Precision Timed Release™ (PTR™) platform into anxiety treatment. The event can be viewed live on Benzinga’s YouTube channel and on Cingulate’s investor website.
Cingulate is dedicated to improving treatment outcomes for patients through innovative drug delivery technology.
Cingulate Inc. (NASDAQ: CING) announced its Q2 financial results, highlighting a $5 million non-dilutive debt financing and the appointment of Scott Applebaum to its Board of Directors. As of June 30, 2022, Cingulate's cash and equivalents stood at $8.2 million. R&D expenses rose to $2.2 million, while G&A expenses increased to $1.9 million, leading to a net loss of $4 million for the quarter. The company plans to continue development of its ADHD treatment, CTx-1301, with a Phase 3 study expected to commence soon. Positive NDA filing anticipated by late 2023 requires additional capital of $16.5 million.
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company, announced that its CFO, Lou Van Horn, was honored as a 2022 CFO of the Year by the Kansas City Business Journal. This is the second time Lou has received this accolade, recognizing his financial leadership and expertise. The award ceremony took place on July 22, 2022. Lou, who played a crucial role in Cingulate's IPO in 2021, expressed gratitude for the recognition and highlighted the positive economic outlook for the Kansas City region.
Cingulate Inc. has announced the completion of the formulation study for CTx-2103, a new once-daily treatment for anxiety-related disorders using its proprietary Precision Timed Release™ (PTR™) drug delivery technology. This study, conducted in the UK, aims to improve adherence by reducing the dosing frequency of the active ingredient, buspirone. Results are anticipated in August 2022. CTx-2103 is designed to offer significant advantages over existing medications while addressing a substantial market need, as anxiety disorders affect approximately 31% of U.S. adults at some point in their lives.
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company, will present a company overview at the Diamond Equity Research 2022 Virtual Emerging Growth Invitational on June 23, 2022, at 1:40 PM EST. Chairman and CEO, Shane J. Schaffer, PharmD, will lead the presentation and follow up with a Q&A session. Investors can register for the event and access live webcasts via the provided links. Cingulate focuses on its proprietary Precision Timed Release™ (PTR™) drug delivery technology for developing next-generation products, initially targeting ADHD.
Cingulate Inc. (NASDAQ: CING) has announced that its Chairman and CEO, Shane J. Schaffer, and scientific advisor, Dr. Ann Childress, will participate in a live event on June 3, 2022, at 8:45 a.m. CST, hosted by Benzinga. The discussion will focus on unmet needs in Attention Deficit/Hyperactivity Disorder (ADHD) and the expansion of Cingulate's Precision Timed Release™ (PTR™) platform into anxiety treatments. This event can be accessed via Benzinga’s YouTube channel and Cingulate's website.
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