Welcome to our dedicated page for Cingulate news (Ticker: CINGW), a resource for investors and traders seeking the latest updates and insights on Cingulate stock.
Cingulate Inc. develops biopharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, with a focus on ADHD and other CNS disorders. CINGW represents Nasdaq-listed warrants exercisable for Cingulate common stock, so recurring company updates center on the operating issuer’s clinical, regulatory, financing, and governance developments.
Company news commonly covers CTx-1301, a once-daily dexmethylphenidate tablet designed for timed drug release across the day, along with pipeline work such as CTx-1302. Recurring themes include FDA submission and review updates under the 505(b)(2) pathway, Phase 3 data presentations, patent activity, commercial manufacturing arrangements, commercialization planning, financial results, private placements, debt exchanges, and board or executive changes.
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.
Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company, announced that Chairman & CEO Shane J. Schaffer will present at the LD Micro Main Event XV investor conference on October 26, 2022, at 10:00 a.m. PT. The event will take place at the Luxe Sunset Boulevard Hotel in Los Angeles, with live streaming available at this link. The company, utilizing its Precision Timed Release™ (PTR™) technology, focuses on developing next-generation pharmaceutical products for neurological disorders and other therapeutic areas.
Cingulate Inc. (NASDAQ: CING) announced findings from a formulation study for CTx-2103, a once-daily buspirone treatment for anxiety disorders, presented at the 2022 Psych Congress. The study demonstrated the ability of CTx-2103 to deliver a triple-release formulation, enhancing patient compliance and treatment outcomes. The CEO emphasized the importance of formulation development in achieving effective medications. CTx-2103 aims to provide benefits over existing treatments by eliminating the need for multiple daily doses.
Cingulate Inc. (NASDAQ: CING) announced that Chairman and CEO Shane J. Schaffer will speak at the Benzinga All Access event on August 19, 2022, at 9 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 treatment. The event can be viewed live on Benzinga’s YouTube channel and on Cingulate’s investor website.
Cingulate is dedicated to improving treatment outcomes for patients through innovative drug delivery technology.
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.