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Cingulate Inc is a clinical-stage biopharmaceutical company utilizing its proprietary precision timed-release drug delivery platform to build and advance a pipeline of next-generation pharmaceutical products designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. The company focuses on the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety, and identifying and evaluating additional therapeutic areas to use PTR technology to develop future product candidates.
Latest News: "Today we are pleased to welcome Jennifer Callahan to the C-Suite, and thank Lou Van Horn for his commitment, hard work, and guidance as Cingulate's CFO through many important milestones," stated Cingulate Chairman and CEO Shane J. Schaffer. "Jenny has worked closely with Lou and is a valued and trusted member of our management. Her leadership and expertise were instrumental during Cingulate's IPO, and we look forward to a seamless transition as we begin this new chapter." Callahan, who brings decades of accounting and financial experience to Cingulate's C-Suite, said she's excited to lead the finance team into the future and hopes to help the company raise capital in an efficient and timely manner.
"It's been a pleasure advancing the Cingulate mission for the past seven years, and I am honored to be named its next Chief Financial Officer," Callahan said. "As we move forward, capital remains imperative to the long-term success of Cingulate, and we will seek to strengthen our balance sheet through both traditional and non-dilutive transactions."
About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as "may," "could," "should," "would," "believe," "anticipate," "forecast," "estimate," "expect," "intend," "plan," "continue," "outlook," "will," "potential" and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of our Annual Report on Form 10-K filed with the SEC on March 10, 2023. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
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.
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.
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