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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 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.
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. completed a $25 million Initial Public Offering (IPO) of Common Stock, facilitated by Aegis Capital Corp. as the Lead Bookrunning Manager. The company is focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) technology, particularly for treating Attention Deficit/Hyperactivity Disorder (ADHD). Their products aim to offer improved treatment outcomes and daily dosing regimens. Cingulate's pipeline includes innovative formulations like CTx-1301 and CTx-1302, designed for rapid onset and extended efficacy.
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