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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. reported Q3 2024 financial results, highlighting a $19.5M increase in working capital. The company raised $12.5M in capital during Q3, extending cash runway into Q3 2025. Net loss decreased to $3.2M from $6.0M year-over-year, with R&D expenses dropping to $1.4M from $3.9M. The company secured European patents for its lead ADHD asset CTx-1301 in up to 30 territories and regained Nasdaq compliance. Cingulate remains on track for mid-2025 New Drug Application submission of CTx-1301.
Shane J. Schaffer, Chairman and CEO of Cingulate (NASDAQ: CING), appeared on the nationally syndicated Big Biz Show to discuss Cingulate's lead Phase 3 asset, CTx-1301, for the treatment of ADHD. Schaffer highlighted the company's Precision Timed Release™ (PTR™) drug delivery platform, which aims to advance next-generation pharmaceutical products. The discussion included plans for the commercialization of CTx-1301 and potential applications of PTR™ technology in other therapeutic areas. The Big Biz Show, hosted by Bob “Sully” Sullivan, is broadcast globally through partners like iHeart Radio and the American Forces Network.
Cingulate Inc. (NASDAQ: CING) has initiated its final FDA-required study for CTx-1301, a dexmethylphenidate-based treatment for ADHD. The food effect study is expected to yield results by the end of 2024. The company has also raised over $10 million in additional capital since mid-August 2024, with 58% coming from its at-the-market facility. This capital infusion strengthens Cingulate's balance sheet and supports the advancement of CTx-1301 towards NDA submission, targeted for mid-2025. Additionally, Cingulate has received notification from Nasdaq confirming its compliance with listing requirements, addressing previous concerns about potential delisting.
Cingulate (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer, PharmD, will participate in a live Benzinga All Access event on August 28, 2024, at 10:30 a.m. CST. Schaffer will discuss the company's recent European patent, the ADHD market, and potential expansion of Cingulate’s Precision Timed Release™ (PTR™) drug delivery platform into other therapeutic areas. The event can be viewed live on Benzinga's YouTube channel and later on Cingulate's website.
Cingulate Inc. (NASDAQ:CING) has adjourned its Special Meeting of Stockholders due to insufficient quorum. The meeting is rescheduled for August 28, 2024, at 11:00 a.m. Central Time. The company's Board of Directors believes all proposals in the proxy statement are in the best interests of stockholders and recommends voting FOR all agenda items. The record date for the Special Meeting remains June 28, 2024. Stockholders can vote live by calling 1-800-652-8683 or online at www.envisionreports.com/CING-SP. Cingulate is a biopharmaceutical company using its Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products.
Cingulate Inc. (NASDAQ: CING) has been granted a European patent for its lead asset CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The patent, issued on August 14, 2024, as EP Patent No. 3261625, covers up to 30 European territories, including the United Kingdom. This adds to Cingulate's existing patents in Australia, Canada, and Israel, with pending patents in Hong Kong, the Republic of Korea, and the United States.
The company views this as a significant milestone in its efforts to expand beyond the US market and make an impact on the growing ADHD markets in Europe and other territories. Cingulate utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to develop next-generation pharmaceutical products.
Cingulate Inc. (NASDAQ: CINGW) reported its Q2 2024 financial results and development updates. Key highlights include:
1. FDA clearance to file for marketing approval of CTx-1301 for ADHD, targeting NDA submission in 1H 2025.
2. Completion of registration batches for CTx-1301.
3. Ongoing licensing activity and positive payer study results for CTx-1301.
4. $1.6 million capital raised through warrant inducement.
5. One-for-twelve reverse stock split to maintain Nasdaq listing.
6. Q2 2024 financials: $0.4 million cash on hand, $3.1 million in stockholders' equity, and net loss of $3.2 million.
The company continues to progress towards CTx-1301's NDA submission while exploring licensing opportunities and addressing Nasdaq compliance requirements.
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.
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