KANSAS CITY, Kan., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced today that it has commenced its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). A data readout from the study ...

Core Viewpoint - Cingulate Inc. has adjourned its Special Meeting of Stockholders to allow more time for stockholders to vote on proposals due to insufficient quorum [1][2]. Company Overview - Cingulate Inc. is a biopharmaceutical company that utilizes its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop next-generation pharmaceutical products aimed at improving treatment outcomes for patients with conditions requiring frequent dosing [5]. Special Meeting Details - The adjourned Special Meeting will take place on August 28, 2024, at 11:00 a.m. Central Time, accessible via www.meetnow.global/MCZZ4DG [3][4]. - The record date for the Special Meeting is June 28, 2024 [3]. - The Board of Directors recommends that stockholders vote FOR all proposals on the agenda [4].

Core Insights - Cingulate Inc. has been granted a European patent for its lead asset CTx-1301, aimed at treating Attention Deficit Hyperactivity Disorder (ADHD) [1][2][3] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform [1][7] - The company is headquartered in Kansas City and aims to improve treatment outcomes for conditions requiring complex dosing regimens [7][8] Product Details - CTx-1301 utilizes the PTR platform to deliver dexmethylphenidate, a compound approved for ADHD treatment, in a multi-core formulation designed for optimal patient care [5][6] - The product aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [5] Market Potential - The ADHD market is significant, with approximately 6.4 million children and adolescents diagnosed in the U.S., and an estimated 11 million adults affected, indicating a large potential patient base for CTx-1301 [4] - The company is looking to expand its reach into European markets and other territories, highlighting the growing demand for ADHD treatments [3][4] Patent and Regulatory Strategy - The European patent, EP Patent No. 3261625, covers up to 30 territories, including the UK, and complements existing patents in Australia, Canada, and Israel, with pending applications in other regions [2][3] - Cingulate plans to file a new drug application with the FDA as it continues to demonstrate the clinical success of CTx-1301 [3]

Financial Performance - Research and development expenses for Q2 2024 were $1,881,093, compared to $4,455,927 in Q2 2023, reflecting a decrease of approximately 58.7%[7] - General and administrative expenses for Q2 2024 were $1,325,087, down from $1,906,442 in Q2 2023, a reduction of about 30.4%[7] - The operating loss for the six months ended June 30, 2024, was $6,154,397, compared to $10,212,364 for the same period in 2023, indicating an improvement of approximately 39.9%[7] - The net loss for Q2 2024 was $3,209,677, compared to $6,616,309 in Q2 2023, representing a decrease of about 51.6%[7] - The company reported a net loss of $6,182,154 for the six months ended June 30, 2024, compared to a net loss of $10,621,196 for the same period in 2023, indicating a 42.9% improvement in losses year-over-year[9] - The company incurred an operating loss of $3,206,180 for the three months ended June 30, 2024, compared to an operating loss of $6,362,369 for the same period in 2023, indicating a 50% reduction in operating losses[7] - The company reported a net loss per share of $5.47 for Q2 2024, compared to $6.79 for Q2 2023, showing a reduction in loss per share[7] - For the three months ended June 30, 2024, the company reported a net loss of $3,209,677, compared to a net loss of $6,616,309 for the same period in 2023, representing a 51% improvement[7] Cash Flow and Funding - The company had cash and cash equivalents of approximately $0.4 million as of June 30, 2024, with an accumulated deficit of approximately $99.1 million[12] - Net cash used in operating activities was $10,488,400 for the six months ended June 30, 2024, compared to $8,180,207 for the same period in 2023, reflecting a 28.2% increase in cash outflow[9] - Cingulate Inc. raised $10,979,443 from the issuance of common stock and pre-funded common stock purchase warrants during the financing activities[9] - The company raised approximately $1.6 million from a warrant inducement that closed on July 1, 2024, but will require additional funding for operations and development[12] - The company is exploring various strategies for additional funding, including equity offerings and potential collaborations, to support ongoing operations and development[12] Shareholder Information - The weighted average number of shares used in computing net loss per share for Q2 2024 was 586,313, compared to 974,569 for Q2 2023[7] - The Company authorized 240,000,000 shares of common stock and 10,000,000 shares of preferred stock, with 780,762 shares of common stock issued and outstanding as of June 30, 2024[27] - The Company completed a one-for-twenty reverse stock split on November 30, 2023, and a one-for-twelve reverse stock split on August 9, 2024, affecting the number of issued and outstanding shares[29][31] - Under the At-the-Market Agreement, the Company sold 23,650 shares for net proceeds of $3,115,284 in Q1 2024 and 31,858 shares for $354,259 in Q2 2024[32][35] - The Company raised $7.5 million in gross proceeds from a public offering on February 2, 2024, after deducting $750,950 in fees[36] Product Development - The company plans to develop and commercialize product candidates CTx-1301, CTx-1302, and CTx-2103, with timelines for clinical trials and NDA submissions yet to be determined[4] - The company is targeting a New Drug Application (NDA) for its ADHD treatment CTx-1301 in the first half of 2025, with ongoing clinical requirements being addressed[10] - Cingulate Inc. is actively seeking additional product candidates with significant commercial potential to align with its strategic objectives[4] - Cingulate is developing two proprietary stimulant medications, CTx-1301 and CTx-1302, aimed at treating ADHD across all patient segments[10] Expenses and Liabilities - The total accrued expenses decreased significantly to $383,313 as of June 30, 2024, from $1,651,518 at the end of 2023, indicating a reduction of 76.8%[20] - The company incurred depreciation expenses of $327,381 for the six months ended June 30, 2024, compared to $255,930 for the same period in 2023, representing a 28% increase[19] - The company recorded stock-based compensation expense of $418,906 for the six months ended June 30, 2024, compared to $421,853 for the same period in 2023, reflecting a slight decrease[41] - Cingulate's stock-based compensation expense for the six months ended June 30, 2024, was $541,349, compared to $421,855 for the same period in 2023, reflecting a 28.4% increase[9] Tax and Valuation - The Company recorded a valuation allowance of its net deferred tax assets totaling $14,270,572 as of June 30, 2024, compared to $12,631,033 at December 31, 2023[53] - The company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of June 30, 2024[54] - No deferred income tax benefit or expense was recorded for the three-month and six-month periods ended June 30, 2024, and 2023[51]

Exhibit 99.1 Cingulate Reports Second Quarter 2024 Financial Results and Provides Development Update on Major Milestones Achieved FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity Continues KANSAS CITY, Kan., August 13, 2024 -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, toda ...

FDA Clears Cingulate to File for Marketing Approval of CTx-1301 targeted in 1H 2025 Licensing Activity Continues KANSAS CITY, Kan., Aug. 13, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three months ended June 30, 2024, and provided a clinical and business up ...

KANSAS CITY, Kan., June 28, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (the "Company") (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced the entry into definitive agreements for the immediate exercise of certain outstanding Series A warrants to purchase up to an aggregate of 2,125,000 shares of common stock of the Company and Series B ...

In consideration for the immediate exercise of the warrants for cash, the Company will issue new unregistered Series C warrants to purchase up to 4,250,000 shares of common stock and new unregistered Series D warrants to purchase up to 2,125,000 shares of common stock. The new warrants will have an exercise price of $0.585 per share and will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the new warrants. The Series C warrants w ...

The event may be viewed live on Benzinga's YouTube channel, Benzinga All Access, and will also be available for viewing on Cingulate's website at cingulate.com/investors. The discussion will address the current unmet needs in Attention Deficit/Hyperactivity Disorder (ADHD), a review of the results from Cingulate's Phase 3 Fixed-Dose Study in pediatrics and adolescents, and the potential expansion of Cingulate's PTR platform into other therapeutic areas. Dr. Schaffer will also provide a company overview. Abo ...

KANSAS CITY, Kan., June 25, 2024 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced that Chairman and CEO Shane J. Schaffer, PharmD, and preeminent board-certified psychiatrist and Cingulate scientific advisor Dr. Ann Childress, MD, will participate in a live Benzinga All Access event on June 26, 20 ...