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]

Core Insights - Cingulate Inc. is on track to submit a New Drug Application (NDA) for its lead ADHD asset, CTx-1301, by mid-2025 following a productive Pre-NDA meeting with the FDA [2][3] - The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103, an anxiety treatment, which will be paid in three installments [5][6] - Cingulate reported a net loss of $3.8 million for Q1 2025, an increase from $3.0 million in Q1 2024, attributed to heightened development activities and reinstated salaries [11][10] Company Updates - Cingulate completed its Pre-NDA meeting with the FDA on April 2, 2025, discussing the NDA submission for CTx-1301, which is designed to treat ADHD [3] - The company announced positive results from a food effect study of CTx-1301, indicating it can be taken with or without food [4] - Cingulate's cash position as of March 31, 2025, was approximately $9.5 million, down from $12.2 million at the end of 2024, providing a cash runway into Q4 2025 [7][13] Financial Performance - Research and development expenses for Q1 2025 were $2.2 million, a 23% increase from $1.8 million in Q1 2024, primarily due to increased personnel and regulatory costs [10] - General and administrative expenses rose to $1.5 million in Q1 2025, a 30% increase from $1.1 million in Q1 2024, driven by higher professional fees and personnel costs [10] - Working capital decreased to approximately $4.9 million as of March 31, 2025, from $7.7 million at the end of 2024, reflecting cash usage for operations [8][9] Product Development - CTx-2103 has the potential to be the first once-daily formulation of buspirone, targeting the $5.5 billion U.S. anxiety market [6] - The grant received for CTx-2103 will fund development through mid-2026, with royalties contingent on future commercialization [5] - Cingulate's proprietary Precision Timed Release™ (PTR™) platform technology aims to enhance drug delivery for ADHD and anxiety treatments [19][20]

Core Insights - Cingulate Inc. announced positive top-line results from the CTx-1301-013 study, confirming that its lead candidate CTx-1301 can be taken with or without food, demonstrating a favorable tolerability profile [1][2][6] - CTx-1301 is designed to be a once-daily stimulant medication for ADHD, providing an entire active day of treatment with eight dose strengths for optimal patient care [3][9] - The study involved 27 healthy adult subjects and assessed the pharmacokinetics of a 50 mg dose of CTx-1301 in both fed and fasted states [4][5] 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][11] - The company aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [11] Product Details - CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, which is FDA-approved for ADHD treatment [1][8] - The unique formulation of CTx-1301 allows for a rapid onset and sustained efficacy throughout the day, addressing the challenge of providing an entire active-day duration of action [9][10] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion of adults experiencing symptoms that persist from childhood [7] - Current trends indicate that the prevalence of adult ADHD is growing faster than that of children and adolescents combined [7]

Core Insights - Cingulate Inc. has announced the development of CTx-2103, a once-daily formulation of buspirone aimed at addressing anxiety disorders, which represent a significant market opportunity valued at $5.5 billion in the U.S. and $11.6 billion globally [1][4] - The company has received a $3 million grant to accelerate the development of CTx-2103, which will be disbursed in three tranches based on product development milestones [2] - CTx-2103 is expected to reduce reliance on benzodiazepines, which are associated with withdrawal and dependency issues, thus providing a safer alternative for patients [1][4] 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 aims to improve treatment outcomes for patients with conditions requiring frequent dosing regimens, with an initial focus on ADHD and anxiety disorders [8] Product Details - CTx-2103 is a novel multi-release tablet of buspirone that utilizes Cingulate's PTR™ technology, designed to provide controlled drug release at specific times [4][6] - Buspirone, the active ingredient, is a non-benzodiazepine anxiolytic that may have a lower side-effect profile compared to traditional anxiolytics, with no associated risk of physical dependence [4][5] Market Context - Anxiety disorders are the most prevalent mental health issues in the U.S., affecting an estimated 31% of adults at some point in their lives, highlighting a significant unmet medical need [4][5] - The COVID-19 pandemic has exacerbated anxiety-related disorders, increasing the urgency for effective treatment options [5]

ADHD Treatment Market - The ADHD treatment market in the US is estimated to exceed $23 billion, with $18.6 billion attributed to stimulants, which accounted for approximately 88% of all ADHD medication prescriptions in the 12 months ended November 2023[18]. - Total ADHD medication sales in the United States reached over $23 billion for the 12-months ended November 2023[37]. - Stimulants accounted for approximately 88% of all ADHD medication prescriptions during the same period, with around 82 million stimulant prescriptions written[45]. - Recent stimulant medications have captured only 2.0% of total ADHD prescriptions written in the United States in 2020, indicating a significant unmet need for effective treatments[56]. Product Development and Clinical Trials - CTx-1301 and CTx-1302 are proprietary first-line stimulant medications designed to provide immediate onset of action within 30 minutes and entire active-day duration, eliminating the need for booster doses[19]. - A Phase 3 adult dose-optimization study for CTx-1301 was completed in June 2023, showing significant improvements in Clinical Global Impression Scale scores compared to placebo[22]. - The NDA submission for CTx-1301 is targeted for mid-2025, with data from completed studies being consolidated for inclusion[23]. - CTx-2103, a novel extended-release tablet of buspirone for anxiety, is expected to begin development as soon as mid-2025, pending additional capital resources[30]. - The company plans to initiate a clinical plan for CTx-1302 in 2026, pending additional capital resources[27]. - The planned Phase 1/2 studies for CTx-1302 will include approximately 100 patients, with subsequent Phase 3 trials involving around 500 patients[107]. - The Phase 3 studies for both CTx-1301 and CTx-1302 will incorporate common diagnostic tools and ADHD evaluations such as ADHD-RS-5 and CGI-S[111]. Drug Delivery Technology - The proprietary Precision Timed Release (PTR) drug delivery platform technology aims to provide true once-daily dosing with fast onset and entire active-day efficacy[60]. - CTx-1301 and CTx-1302 will be available in eight dosage strengths at launch, allowing for better titration and optimization of patient dosing needs[71]. - The new drug candidates are designed to eliminate the need for afternoon booster doses, enhancing patient compliance and reducing embarrassment for younger patients[65]. - The proprietary technology is expected to significantly improve tolerability, reducing treatment-related adverse events associated with existing stimulant therapies[70]. Regulatory and Compliance - The company plans to submit NDAs under the 505(b)(2) regulatory approval pathway, which may reduce some development burdens[140][147]. - The FDA aims to review standard review drug products within 10 months and priority review drugs within 6 months from the NDA filing date[154]. - The FDA may require Phase 4 trials to further assess a drug's safety and efficacy post-approval[159]. - The FDA may condition approval on the development of adequate controls and specifications for manufacturing and a commitment to conduct post-marketing testing[159]. - The FDA provides a five-year period of non-patent marketing exclusivity for the first applicant to gain NDA approval for a new chemical entity[168]. - The review and evaluation of an NDA by the FDA is extensive and may take longer than originally planned, potentially delaying approval[156]. Intellectual Property - The company holds six patents and three patent applications in the U.S., and 94 patents and 26 applications internationally, with expiry dates ranging from 2031 to 2043[126]. - The company has several pending patent applications and issued patents related to drug delivery systems, with patent expiry dates extending to November 2035 and February 2043[129]. - The company relies on trade secrets and proprietary know-how to protect its technology, requiring confidentiality agreements from employees and consultants[130][131]. Commercialization and Market Strategy - A joint commercialization agreement with Indegene, Inc. was established in March 2023 to provide commercialization services for CTx-1301 in the US[26]. - The company is actively seeking strategic pharmaceutical partnerships for licensing or co-promotion of CTx-1301 to ensure successful commercial launches[120]. - Manufacturing for CTx-1301 is handled by Societal CDMO, which was acquired by Bend Biosciences, ensuring compliance with cGMP regulations[122]. - The company is responsible for negotiating coverage, reimbursement, and placement decisions for its product candidates, which are influenced by existing branded drugs and clinical need[193]. Competitive Landscape - The company faces competition from both pharmaceutical and generic drug companies, with key competitors including Janssen's Concerta and Takeda's Vyvanse, which have lost exclusivity[134][135]. - The FDA's revised guidance for bioequivalence testing may limit generic competition in the methylphenidate market, potentially benefiting the company's product candidates[137]. - The company anticipates that the level of branded competition will decline with the loss of exclusivity for Vyvanse[134]. Financial Considerations - The cost of preparing and submitting a New Drug Application (NDA) is substantial, currently over $3.24 million for an NDA with clinical information, with an annual program fee of approximately $394,000[151]. - Compliance with healthcare laws and regulations involves substantial costs, and violations may lead to significant penalties, including loss of eligibility for FDA approvals[201]. Healthcare Regulations and Reimbursement - CTx-1301, CTx-1302, and CTx-2103, if approved, would likely be reimbursed under Medicare Part D, which is administered by private plans with considerable discretion in formulary decisions[194]. - The Inflation Reduction Act of 2022 has reduced government reimbursement for some drugs, indicating ongoing downward pressure on pharmaceutical product reimbursement[196]. - The company must navigate complex negotiations with third-party payors, which can significantly influence drug adoption by patients and physicians[196].

Core Viewpoint - Cingulate Inc. is progressing towards the submission of a New Drug Application (NDA) for its lead ADHD treatment, CTx-1301, with a scheduled in-person meeting with the FDA on April 2, 2025, and aims for submission in mid-2025 [1][5][2]. Financial Highlights - Cingulate reported a working capital increase of $17.5 million compared to December 31, 2023, resulting in approximately $7.5 million in working capital as of December 31, 2024 [9][8]. - Cash and cash equivalents rose to approximately $12.2 million, a $12.1 million increase from the previous year, extending the cash runway into Q4 2025 [9][8]. - The net loss for the year ended December 31, 2024, was $15.5 million, a decrease from $23.5 million in 2023, reflecting reduced development activity and personnel costs [9][10]. Clinical and Business Updates - Safety data from final Phase 3 trials for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials [5][4]. - Cingulate completed its final FDA-required food effect study for CTx-1301, demonstrating that the drug can be taken with or without food [5][4]. - A European patent for CTx-1301 was issued, covering up to 30 territories, including the UK, with additional patents pending in other regions [5][4]. Market Position and Strategy - Cingulate's managed care payor study indicated that CTx-1301 is perceived as the most valuable prospective treatment for ADHD, likely to gain coverage through contracting processes [5][4]. - The company is exploring licensing agreements both domestically and internationally to expand its market reach [5][4]. Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, designed to provide a once-daily stimulant medication for ADHD, optimizing patient care with a multi-core formulation [12][13]. - The drug aims to deliver three releases of medication throughout the day, addressing the challenge of providing effective treatment for the entire active day [12][13].

Core Insights - Cingulate Inc. is preparing for a New Drug Application (NDA) submission for its lead ADHD asset CTx-1301, targeting mid-2025, following a scheduled in-person Pre-NDA meeting with the FDA on April 2, 2025 [1][5][2] - The company reported a significant increase in working capital by $17.5 million compared to the previous year, extending its cash runway into Q4 2025, well beyond the NDA submission target date [1][9] - Safety results from final Phase 3 trials for CTx-1301 have been announced, showing no serious treatment-emergent adverse events, indicating a consistent safety profile across nine clinical trials [1][5] Financial Performance - As of December 31, 2024, Cingulate had approximately $12.2 million in cash and cash equivalents, a $12.1 million increase from the previous year, providing a strong cash runway [9] - Working capital reached approximately $7.5 million, reflecting a $17.2 million increase from December 31, 2023, indicating a strengthened balance sheet [9] - Research and development expenses decreased to $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, primarily due to completed clinical activities [9][10] Clinical and Business Updates - Cingulate completed its final FDA-required food effect study for CTx-1301, confirming that the medication can be taken with or without food [5] - A European patent for CTx-1301 was issued, covering up to 30 territories, including the UK, with additional patents pending in other regions [5] - A managed care payor study indicated that CTx-1301 is perceived as the most valuable prospective treatment for ADHD, likely to gain coverage through contracting processes [5] Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) technology, designed to deliver three releases of medication throughout the day, optimizing treatment for ADHD [12][13] - The product aims to provide a true once-daily stimulant medication that maintains efficacy throughout the entire active day, addressing a significant unmet need in ADHD treatment [12][14]