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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 announced the exercise of outstanding Series A and B warrants at a reduced price of $0.585 per share, generating gross proceeds of approximately $1.86 million. Originally issued in February 2023 with an exercise price of $2.00, the warrants allow the purchase of up to 3,187,500 shares of common stock. The transaction, facilitated by H.C. Wainwright & Co., is expected to close by July 1, 2024. In return, Cingulate will issue new Series C and D warrants to purchase up to 6,375,000 shares at the same reduced price, exercisable upon shareholder approval. Proceeds will fund R&D, commercialization of CTx-1301, and general corporate needs.
Cingulate, a biopharmaceutical company listed on NASDAQ under the symbol CING, will host a live event featuring CEO Shane J. Schaffer and ADHD expert Dr. Ann Childress. The event will be held on June 26, 2024, at 10:30 a.m. CST, and will be accessible via Benzinga’s YouTube channel and Cingulate’s website. During the event, the discussion will cover unmet needs in ADHD, results from Cingulate’s Phase 3 Fixed-Dose Study in pediatrics and adolescents, and potential expansion of the company's Precision Timed Release™ platform into other therapeutic areas. Dr. Schaffer will also provide a company overview.
Cingulate announced a significant achievement in the development of its ADHD drug, CTx-1301, by completing twelve required registration batches. This milestone meets the U.S. Food and Drug Administration (FDA) manufacturing requirements necessary for New Drug Application (NDA) submission. The company is using its Precision Timed Release™ (PTR™) technology to develop CTx-1301, intended to offer a reliable manufacturing process and acceptable shelf life. Cingulate plans to submit the NDA for CTx-1301 in the first half of 2025, marking a important step towards FDA marketing clearance.
Cingulate has received FDA confirmation on the requirements for filing a New Drug Application (NDA) for its Phase 3 candidate, CTx-1301, aimed at treating ADHD in patients aged six and older. The FDA has agreed that data from ongoing Phase 3 studies are sufficient for submission under the 505(b)(2) pathway, eliminating the need for further fixed dose and onset/duration studies. Cingulate will also conduct a brief Phase 1 fed/fast study to include in the NDA. The company aims to submit the NDA in the first half of 2025. Cingulate is also negotiating with potential commercialization partners and payers to maximize market access for CTx-1301, which may benefit over 60% of ADHD patients currently using booster doses. The drug has shown promising results, with patients expressing a desire to continue its use post-trial.
Cingulate Inc. reported its first quarter 2024 financial results, showing positive trends with $10 million increase in stockholders' equity and capital raising efforts totaling $10.7 million. The company is on track to file for Marketing Approval with the FDA for CTx-1301 in the first half of 2025. R&D expenses decreased, and total stockholders' equity saw a $10 million increase from the end of 2023.
Cingulate Inc. announced that Peter J. Werth, a successful pharma entrepreneur and investor, will be featured with Chairman and CEO Shane J. Schaffer on a live Benzinga event. Werth will discuss his background and vision for Cingulate, while Schaffer will provide company updates. The event will take place on May 3, 2024, at 12:10 p.m. EST.
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