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 enrollment in a clinical study for CTx-2103, a novel buspirone formulation aimed at treating anxiety disorders. This study, initiated in May 2022 with 12 participants, is set to yield results in July 2022. CTx-2103 employs Cingulate's proprietary Precision Timed Release™ (PTR™) technology, enabling once-daily dosing. The formulation could address issues of nonadherence prevalent with current treatments, offering potential for improved patient outcomes in a significant $5.5B U.S. anxiety market.
Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company, will present an overview at the H.C. Wainwright Global Investment Conference on May 25, 2022, from 3:00-3:30 p.m. ET in Miami, FL. The presentation will feature insights from CEO Shane J. Schaffer and CMO Matthew Brams, M.D. Interested investors can access the live webcast and later view a replay on Cingulate’s investor website for 90 days. The company focuses on its proprietary Precision Timed Release™ (PTR™) technology, primarily targeting ADHD treatment while exploring other therapeutic areas like anxiety disorders.
Cingulate Inc. (NASDAQ: CING) announced its financial results for Q1 2022 and dosed the first subject in a human formulation study of CTx-2103 for anxiety. The company aims to provide a single-dose therapeutic solution due to current treatment limitations. CTx-2103 could capture a segment of the U.S. anxiety market, valued over $5.5 billion. Cingulate reported a net loss of $5 million for the quarter and incurred R&D expenses of $2.8 million, reflecting an increase due to clinical activities. Cingulate seeks $21.5 million in additional capital to advance its projects.
Cingulate Inc. (NASDAQ: CING) presented a company overview at NobleCon18, highlighting its proprietary Precision Timed Release™ (PTR™) drug delivery platform. CEO Shane J. Schaffer detailed the company's focus on developing next-generation pharmaceuticals, particularly for Attention Deficit/Hyperactivity Disorder (ADHD). The presentation is available to view on the company’s website and will be archived for 90 days. Cingulate aims to improve treatment outcomes for patients with burdensome dosing regimens, with potential future applications in anxiety disorders.
Cingulate Inc. has successfully completed its Initial Public Offering, raising gross proceeds of $25 million. This funding aims to advance its lead investigational drug, CTx-1301, for treating ADHD, with plans to file a New Drug Application with the FDA in late 2023. The company has updated its clinical program to streamline research, potentially reducing costs and approval time. As of December 31, 2021, cash reserves stood at $16.5 million, enabling funding through late 2022.
KANSAS CITY, Kan., Feb. 15, 2022 – Cingulate Inc. (NASDAQ: CING) has announced that CEO Shane J. Schaffer will present at the Aegis Capital Corp. Virtual Conference on February 24, 2022, at 10:30 a.m. ET. Cingulate's presentation will be available for viewing from February 23 to February 25. The clinical-stage biopharmaceutical company focuses on its Precision Timed Release™ (PTR™) drug delivery technology to develop products addressing ADHD and other conditions. A webcast of the presentation will be available for 30 days after the event on Cingulate’s website.
Cingulate Inc. (NASDAQ: CING) has announced an expedited 2022 clinical program for its lead candidate, CTx-1301, aimed at treating ADHD. The company plans to initiate Phase 3 studies, including pediatric safety and efficacy assessments, in the second quarter of 2022. This acceleration, based on FDA feedback, is expected to lower capital requirements and expedite the New Drug Application filing anticipated in the latter half of 2023. Cingulate aims to enhance patient outcomes through its proprietary Precision Timed Release technology.
Cingulate Inc., a clinical-stage biopharmaceutical company, announced the appointment of Curt Medeiros and Gregg Givens to its Board of Directors following its IPO. Medeiros brings expertise in healthcare growth and market access, while Givens has over 35 years of finance experience. Both will contribute to the company’s vision of enhancing ADHD treatment and addressing unmet patient needs. Their backgrounds aim to strengthen Cingulate's leadership and business strategy as it advances its product pipeline, particularly targeting behavioral health and ADHD management.
Cingulate Inc. has successfully completed its initial public offering, selling 4,166,666 shares of common stock along with warrants, generating approximately $25 million in gross proceeds. The shares and warrants now trade on the Nasdaq under the symbols ‘CING’ and ‘CINGW’, respectively. The funds will primarily support research and development for their product candidates, including CTx-1301 and CTx-1302, and cover various financial obligations. An over-allotment option was partially exercised, allowing for the sale of additional shares and warrants.
Cingulate Inc. has priced its initial public offering (IPO) of 4,166,666 shares at $6.00 per share, paired with warrants at the same price. The offering will yield gross proceeds of approximately $25 million, aimed at advancing its clinical products, including CTx-1301 and CTx-1302, focused on ADHD treatment. The shares and warrants are set to trade on Nasdaq under the symbols ‘CING’ and ‘CINGW’ starting December 8, 2021. The transaction is expected to close on December 10, 2021, if standard conditions are met.
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