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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) 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.
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.
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