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Cingulate Inc. (NASDAQ: CING) is a clinical-stage biopharmaceutical company dedicated to improving patient outcomes through its proprietary Precision Timed Release™ (PTR™) drug delivery platform. Headquartered in Kansas City, Kansas, the company is focused on developing next-generation pharmaceutical products that address conditions requiring burdensome daily dosing regimens and that often yield suboptimal treatment outcomes.
Cingulate’s lead candidates target Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety disorders, with a particular emphasis on their flagship product, CTx-1301. CTx-1301 utilizes dexmethylphenidate, a compound approved by the FDA, to provide a rapid onset and entire active-day efficacy through three precisely timed medication releases. This approach aims to eliminate the need for booster doses and improve overall patient compliance and satisfaction. The product has already demonstrated significant promise in Phase 3 trials, with impressive clinical effect sizes that suggest broad potential impact.
Another key product in the pipeline is CTx-2103, a novel extended-release formulation of buspirone designed for the treatment of anxiety. CTx-2103 leverages the PTR platform to deliver three timed doses in one tablet, potentially offering substantial benefits over current multi-dose regimens. This product is currently progressing through clinical trials, with positive feedback from the FDA on its regulatory pathway.
In recent months, Cingulate has achieved several milestones: they announced successful Phase 3 trial data for CTx-1301, closed a $4 million public offering, and converted $5.8 million of debt into equity. These financial maneuvers have strengthened their balance sheet, enabling continued investment in their clinical programs. Additionally, Cingulate recently welcomed new executive leadership and independent directors, further fortifying their capabilities as they navigate the complexities of drug development and commercialization.
Cingulate is committed to ongoing research and development, leveraging its PTR platform not only for ADHD and anxiety but also exploring other therapeutic areas. This innovative platform integrates an Erosion Barrier Layer (EBL), which controls the drug release at precise times without premature release, enhancing the effectiveness and convenience of treatment.
For more information, visit their official website at Cingulate.com.
Cingulate Inc. (NASDAQ: CING) announced that its Chairman and CEO, Shane J. Schaffer, will speak at a live Benzinga All Access event on April 18, 2023, at 10 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 treatments. Schaffer will provide a company overview and recap recent clinical and business updates. The event will be available for viewing on Benzinga's YouTube channel and on Cingulate's website.
Cingulate is a biopharmaceutical company focused on developing next-generation pharmaceutical products aimed at improving treatment outcomes for patients with ADHD and potentially anxiety disorders through its PTR platform.
Cingulate Inc. (NASDAQ: CING) has completed the first cohort of its Phase 3 trial for CTx-1301, a treatment for adult ADHD, with results expected in 3Q 2023. This trial assesses the onset and duration of CTx-1301 in adults aged 18-55. Following this, Cingulate plans a pivotal Phase 3 fixed-dose trial for pediatric and adolescent patients slated to begin mid-2023. If successful, a New Drug Application (NDA) could be submitted in early 2024. CTx-1301 aims to provide entire active-day efficacy with once-daily dosing, enhancing the ADHD treatment landscape as no current stimulant medication offers this benefit.
Cingulate Inc. has announced a commercial agreement with Indegene to support the launch of its ADHD treatment, CTx-1301. This novel medication aims to provide a true, once-daily dose with efficacy lasting up to 16 hours, targeting a significant unmet need in the $20 billion ADHD market. The agreement includes comprehensive commercialization strategies designed to drive revenue and support Cingulate during its Phase 3 clinical trials, with results anticipated in Q3 2023. This partnership is expected to enhance Cingulate's operational efficiency and mitigate resource risks, positioning the company for a successful FDA approval and market entry.
Cingulate Inc. (NASDAQ: CING) announced financial results for the year ending December 31, 2022, highlighting progress in its clinical development. Major updates include the ongoing Phase 3 Adult Dose-Optimization Study for CTx-1301, expected to yield results in Q3 2023, and plans to initiate a pediatric study in mid-2023. The company had $5.4 million in cash at year-end, down from $16.5 million the previous year, which could fund operations into Q2 2023. Cingulate reported a net loss of $17.7 million for 2022, an improvement from $20.7 million in 2021, driven by lower one-time charges and increased development activity.
Cingulate Inc. (NASDAQ: CING) announced positive results from its CTx-1301-003 trial, demonstrating that its ADHD treatment, CTx-1301, can be taken with or without food. This investigational drug utilizes the Precision Timed Release™ platform for effective drug delivery. The trial involved 23 adults and measured pharmacokinetic parameters, confirming the drug's favorable tolerability profile. The company plans to initiate its pivotal Phase 3 trials in mid-2023, focusing on pediatric and adult populations. The results underscore the potential of CTx-1301 to meet critical needs in ADHD treatment, promising a single daily dose with enhanced efficacy.
Cingulate Inc. (NASDAQ: CING) announced the initiation of its first Phase 3 clinical trial for CTx-1301, a novel, extended-release tablet for treating ADHD, expected to yield initial results in the first half of 2023. The trial aims to evaluate both efficacy and safety compared to a placebo, targeting adults aged 18 to 55. CTx-1301 seeks to provide a single dose with effects lasting up to 16 hours, eliminating the need for booster doses that many patients currently require. The company plans to submit a New Drug Application (NDA) to the FDA in the first half of 2024.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will participate in a Benzinga All Access event on December 16, 2022, at 9:20 a.m. CST, discussing unmet needs in ADHD and expansion into anxiety treatments. This event was initially scheduled for December 2, 2022. The session will highlight Cingulate’s proprietary Precision Timed Release™ (PTR™) drug delivery platform. Viewers can access the event live on Benzinga’s YouTube channel or Cingulate’s website.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will participate in a Benzinga All Access event on December 2, 2022, at 10 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 therapeutics. The event will be live-streamed on Benzinga’s YouTube channel and Cingulate’s website. Cingulate's mission is to develop next-generation treatments that improve patient outcomes in ADHD and potentially anxiety disorders.
Cingulate Inc. (NASDAQ: CING) reported its Q3 2022 financial results, highlighting key advancements in its drug development pipeline. The company initiated a food effect study of its ADHD candidate, CTx-1301, and plans to start a Phase 3 adult dose-optimization study in December 2022. Cingulate executed a Master Services Agreement with Societal CDMO for manufacturing support. The firm has $9.8 million in cash as of September 30, 2022, down from $16.5 million at year-end 2021, and expects to fund operations through Q1 2023. Q3 net loss narrowed to $4 million from $15.3 million in 2021.
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.
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