Group 1 - Cingulate Inc. has placed its Chairman and CEO, Shane J. Schaffer, on administrative leave due to ongoing legal matters unrelated to the company [2] - Jennifer Callahan, the Chief Financial Officer, has been appointed as the interim CEO to ensure business continuity while retaining her CFO responsibilities [2][4] - Jay Roberts, a board member, has been appointed as Executive Chairman, bringing extensive operational expertise to support the management team [2][3] Group 2 - Cingulate remains committed to its mission of bringing CTx-1301 to patients with ADHD, having submitted a new drug application to the FDA in July [3] - The leadership team has the full confidence of the Board to guide the company forward, emphasizing a commitment to science, innovation, and shareholder value [3] - The executive team supporting Ms. Callahan includes experienced professionals in the ADHD category, such as Dr. Matt Brams, Dr. Raul Silva, and Nilay Patel [5] Group 3 - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary PTR drug delivery platform technology [6] - The company aims to improve treatment outcomes for patients with conditions requiring burdensome daily dosing regimens, initially focusing on ADHD and exploring additional therapeutic areas like anxiety disorders [6]

Core Insights - Cingulate Inc. has submitted a New Drug Application (NDA) to the FDA for CTx-1301, a medication aimed at providing once-daily symptom control for ADHD patients [1][2][3] - CTx-1301 is designed to address limitations of current ADHD therapies by offering fast onset and entire active-day efficacy with a single dose [2][3] - The ADHD market in the U.S. is valued at approximately $23 billion, and Cingulate aims to capture a significant share with CTx-1301 [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][8] - The company is headquartered in Kansas City and is transitioning from a development-stage company to a commercial organization [3][8] Product Details - CTx-1301 is an extended-release tablet formulation of dexmethylphenidate, designed to provide a smooth pharmacokinetic profile and address the need for entire active-day efficacy [2][5] - The medication utilizes a multi-core formulation to deliver three releases of the active ingredient at predefined times, optimizing patient care [5][6] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; the prevalence of adult ADHD is growing faster than that of children and adolescents [4] - In 2022, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication, indicating a substantial unmet need in the market [4] Technology Platform - The PTR™ platform technology includes an Erosion Barrier Layer (EBL) that controls drug release at precise times, allowing for true once-daily dosing [6][7] - Cingulate plans to leverage the PTR technology to develop additional product candidates in other therapeutic areas beyond ADHD [6][8]

Core Insights - Cingulate Inc. has received a PDUFA fee waiver from the FDA for its new drug application for CTx-1301, which is aimed at treating ADHD, saving the company approximately $4.3 million [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][6] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens [6][7] Product Information - CTx-1301 is Cingulate's lead candidate, utilizing the PTR platform to deliver dexmethylphenidate in a multi-core formulation designed for optimal patient care [4] - The drug aims to provide a full-day efficacy by releasing medication at three precise intervals, addressing the challenge of maintaining effective treatment throughout the day [4] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment trends indicate a growing prevalence of adult ADHD [3] - In 2022, only 53.6% of children and teens diagnosed with ADHD were actively treating their symptoms with medication, highlighting a potential market opportunity for effective treatments [3]

As filed with the Securities and Exchange Commission on July 25, 2025 Registration No. 333-288877 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CINGULATE INC. (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3825535 (I.R.S. Employer Identification Number) 1901 W. 47th Place Kansas City, KS 66205 (913) 942-2300 (Address, including zip code, and telephone number, including are ...

Core Insights - Cingulate Inc. has appointed Nilay Patel as Chief Legal Officer as the company prepares to file a new drug application for its ADHD treatment CTx-1301 [1][3] - Patel brings over 20 years of legal and compliance experience in the pharmaceutical industry, having previously held senior roles at Ironshore Pharmaceuticals and Grifols [2][3] - Cingulate's lead candidate, CTx-1301, utilizes the proprietary Precision Timed Release™ (PTR™) platform to optimize ADHD treatment by providing multiple releases of medication throughout the day [6][7] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its PTR drug delivery platform [1][8] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [8] Product Details - CTx-1301 is designed to deliver dexmethylphenidate in a multi-core formulation, providing a rapid onset and sustained efficacy throughout the day [6] - The drug aims to address the challenge of providing effective treatment for ADHD patients, particularly adults, who often experience persistent symptoms [5][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion being adults; current treatment options are often inadequate for long-term management [5] - The prevalence of adult ADHD is increasing, indicating a growing market opportunity for effective treatment solutions [5]

Core Insights - Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress towards the commercial launch of its lead ADHD asset, CTx-1301 [1] - CTx-1301 is designed to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing limitations of existing ADHD treatments [1] - Cingulate is preparing for commercialization in the U.S. and exploring out-licensing opportunities internationally, targeting a $22 billion U.S. ADHD market [1] Company Developments - Cingulate is on track to submit the New Drug Application (NDA) for CTx-1301 in mid-2025, which will include data from nine clinical trials [5] - Pediatric and high-dose studies have demonstrated strong efficacy, safety, and flexible dosing for CTx-1301 [5] - The company is actively preparing for a U.S. launch and is initiating scale-up plans pending FDA approval [5]

Core Insights - Cingulate Inc. announced positive efficacy results for its lead asset CTx-1301 in a Phase 3 clinical study for ADHD treatment, demonstrating significant improvements in symptoms within 5 weeks [1][3][5] - The company plans to submit a New Drug Application (NDA) to the FDA this summer, with expectations to launch CTx-1301 in multiple dosage strengths [1][2][4] Efficacy Results - The primary efficacy endpoint was measured using the ADHD-RS-5 rating scale, with statistically significant p-values of 0.018, 0.011, and 0.001 for the 18.75-mg, 25-mg, and 37.5-mg doses respectively [5][10] - Effect sizes ranged from 0.737 to 1.185 across all doses, indicating robust therapeutic benefits [3][10] Safety Profile - CTx-1301's safety profile has remained consistent across eight clinical trials, with a final analysis combining adult and pediatric data planned for the NDA submission [4][6] Market Context - ADHD affects over 20 million individuals in the U.S., with a significant portion of patients remaining untreated [6] - The adult ADHD prevalence is growing faster than that of children and adolescents, highlighting a substantial market opportunity for effective treatments [6] Product Overview - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to provide a multi-core formulation for optimized medication delivery [7][8] - The product aims to offer a full-day efficacy with a unique release mechanism that addresses the limitations of existing stimulant medications [7][8] Company Background - Cingulate Inc. focuses on developing next-generation pharmaceutical products to improve treatment outcomes for conditions like ADHD, with plans to expand into other therapeutic areas [9]

Core Viewpoint - Cingulate Inc. is progressing towards submitting a New Drug Application (NDA) for its lead asset CTx-1301, a treatment for ADHD, following positive feedback from the FDA during a pre-NDA meeting [2][3]. Group 1: 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 [2][9]. - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9]. Group 2: Product Details - CTx-1301 is designed to provide a once-daily stimulant medication for ADHD, utilizing a multi-core formulation of dexmethylphenidate, which is known for its efficacy and safety [5]. - The drug delivery system aims to optimize patient care by delivering three doses of medication at specific times throughout the day, addressing the challenge of maintaining efficacy over an entire active day [5][6]. Group 3: Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; however, only 53.6% of children and teens with ADHD were actively treating their symptoms with medication in 2022 [4]. - The prevalence of adult ADHD is increasing at a faster rate than that of children and adolescents, indicating a growing market opportunity for effective treatments [4]. Group 4: Regulatory Insights - The FDA's pre-NDA meeting minutes indicate that Cingulate has adequate nonclinical safety data to support its filing and that the proposed approach to integrated safety and efficacy summaries appears reasonable [7]. - The agency has agreed to a post-NDA approval commitment for additional stability data for various dosage strengths of CTx-1301, with an expected shelf-life of 24 months at launch [7].

Financial Performance - The net loss for the three months ended March 31, 2025, was $3,802,691, compared to a net loss of $2,972,477 for the same period in 2024, indicating an increase in loss of 27.77%[14] - The operating loss for the three months ended March 31, 2025, was $3,706,035, compared to an operating loss of $2,948,217 for the same period in 2024, reflecting a 25.6% increase in losses[30] - For the three months ended March 31, 2025, Cingulate Inc. reported a net loss of $3,802,691, compared to a net loss of $2,972,477 for the same period in 2024, representing an increase of approximately 27.8% in losses year-over-year[18] Research and Development - Research and development expenses increased to $2,222,626 for the three months ended March 31, 2025, up from $1,806,985 for the same period in 2024, reflecting a growth of 23.05%[14] - Total research and development expenses for the three months ended March 31, 2025, were $2,222,626, an increase of 23% compared to $1,806,985 for the same period in 2024[30] - Cingulate is developing two proprietary stimulant medications, CTx-1301 and CTx-1302, aimed at treating ADHD across all patient segments[20] - The company received a grant of $3 million to support the clinical and manufacturing development of CTx-2103, with the first payment expected in May 2025[65] - The company plans to pay a royalty of $500,000 per quarter contingent on the commercialization of CTx-2103, with a maximum cumulative payout of $3.5 million[65] Cash Flow and Liquidity - Cash and cash equivalents decreased from $12,211,321 at the beginning of the year to $9,518,966 at the end of the period, a reduction of 22.06%[18] - The company reported a net cash used in operating activities of $4,608,282 for the three months ended March 31, 2025, compared to $8,746,360 for the same period in 2024, showing a decrease of 47.38%[18] - As of March 31, 2025, Cingulate Inc. had cash and cash equivalents of approximately $9.5 million and an accumulated deficit of approximately $112.3 million[22] - The accumulated deficit as of March 31, 2025, was approximately $112.3 million, compared to $108.5 million at the beginning of the year, showing an increase of about 3.3%[22] Shareholder Equity and Stock Activity - The total stockholders' equity decreased from $7,455,505 as of December 31, 2024, to $5,930,820 as of March 31, 2025, a decline of approximately 20.49%[12] - The weighted average number of shares used in computing net loss per share increased significantly from 412,126 in Q1 2024 to 3,646,893 in Q1 2025, indicating a substantial dilution[14] - The Company has authorized 240,000,000 shares of common stock, with 3,826,199 shares issued and outstanding as of March 31, 2025[42] - The Company sold 200,484 shares of common stock under the At-the-Market Agreement for net proceeds of $1,020,368 during the three months ended March 31, 2025[48] - The Company sold 223,409 shares of common stock under the Lincoln Park Purchase Agreement for net proceeds of $899,989 during the three months ended March 31, 2025[50] Liabilities and Debt - The total liabilities decreased from $7,408,984 as of December 31, 2024, to $6,538,768 as of March 31, 2025, a decrease of approximately 11.73%[12] - As of March 31, 2025, the outstanding principal balance of the Promissory Note plus accrued interest was $5,620,114[41] - The Company issued an unsecured promissory note for $5,480,000 on December 20, 2024, with a 9% annual interest rate, maturing 18 months after issuance[37] - The Company incurred $46,277 of debt issuance costs, with a total unamortized debt discount and debt issuance costs of $431,366 as of March 31, 2025[40] General and Administrative Expenses - Cingulate's total general and administrative expenses for the three months ended March 31, 2025, were $1,483,409, up from $1,141,232 in the same period in 2024, representing a 30% increase[30] - The Company implemented salary reductions in December 2023, with a contingent bonus plan estimated at $722,824 that may become due in the future[36] Tax and Valuation - The company has a valuation allowance for deferred tax assets totaling $18,423,145 as of March 31, 2025, compared to $17,405,569 at December 31, 2024, indicating an increase of approximately 6%[12] - The company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of March 31, 2025[63] Future Funding Strategies - The Company is evaluating various strategies to obtain additional funding, which may include equity offerings or collaborations with other companies[22] - Cingulate Inc. is evaluating various strategies for additional funding, including equity offerings and potential collaborations, to support operations and product development[22]

Financial Performance - Cingulate Inc. reported financial results for Q1 2025, with total revenue of $5 million, representing a 25% increase year-over-year[5] - The company achieved a net loss of $3 million for the quarter, compared to a net loss of $4 million in the same period last year, indicating a 25% improvement in net loss[5] - Cingulate Inc. is projecting revenue growth of 40% for the next quarter, aiming for total revenue of approximately $7 million[5] User Engagement and Growth - The company has reported an increase in user data, with a 30% growth in active users compared to the previous quarter[5] - Cingulate Inc. has successfully launched a new technology platform, which is expected to improve user engagement by 20%[5] - The company has reported a 10% increase in customer retention rates, reflecting improved customer satisfaction and loyalty[5] Research and Development - The company is investing in new product development, with a budget allocation of $1 million for R&D in the next fiscal year[5] - Cingulate Inc. is focusing on expanding its clinical trials, with plans to initiate two new studies in the upcoming quarter[5] Market Strategy - Cingulate Inc. is committed to enhancing its market presence, targeting a 15% increase in market share by the end of 2025[5] - The company is exploring potential acquisition opportunities to enhance its market position and product offerings[5]