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]

Core Viewpoint - Cingulate Inc. is preparing for a New Drug Application (NDA) submission for its lead ADHD treatment, CTx-1301, with a scheduled in-person meeting with the FDA on April 2, 2025, and aims for submission by mid-2025 [1][5][2]. Financial Highlights - Cingulate reported a $17.5 million increase in working capital compared to December 31, 2023, resulting in approximately $7.5 million in working capital as of December 31, 2024 [10][9]. - The company had approximately $12.2 million in cash and cash equivalents as of December 31, 2024, a $12.1 million increase from the previous year, extending its cash runway into Q4 2025 [10][9]. - Research and development expenses decreased to $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities [10][11]. - General and administrative expenses were $6.2 million for the year ended December 31, 2024, compared to $7.3 million in 2023, primarily due to reduced personnel costs [10][11]. Clinical and Business Updates - Cingulate released safety data from two Phase 3 studies for CTx-1301, confirming no serious treatment-emergent adverse events and a consistent safety profile across nine clinical trials [5][10]. - The company completed its final FDA-required food effect study for CTx-1301, demonstrating that the medication can be taken with or without food [5][10]. - A European patent for CTx-1301 was issued on August 14, 2024, covering up to 30 territories, including the UK, with additional patents pending in other regions [5][10]. - 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][10]. Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform to deliver dexmethylphenidate, designed for once-daily dosing to optimize patient care [13][14]. - The product aims to provide a rapid onset and sustained efficacy throughout the active day, addressing a significant need in ADHD treatment [13][14]. Market Context - ADHD affects over 20 million patients in the U.S., with a growing prevalence among adults, highlighting the market potential for effective treatments like CTx-1301 [12].

Financial Performance - Cingulate Inc. reported a net loss of $15.5 million for the year ended December 31, 2024, a decrease from a net loss of $23.5 million in 2023[10] - Research and development expenses were $9.4 million for the year ended December 31, 2024, down from $15.5 million in 2023, reflecting completed clinical activities[10] - Working capital increased by $17.2 million to approximately $7.5 million as of December 31, 2024, compared to a negative working capital of $9.6 million in 2023[7] - Cash and cash equivalents rose to approximately $12.2 million as of December 31, 2024, a significant increase of $12.1 million from the previous year[9] - Cingulate raised $9.4 million from a common stock offering and $8 million from a purchase agreement in 2024, strengthening its financial position[5] Product Development - Cingulate is on track for a New Drug Application (NDA) submission for CTx-1301 in mid-2025, following a scheduled pre-NDA meeting with the FDA on April 2, 2025[3] - Safety data from two Phase 3 studies for CTx-1301 indicated no serious treatment-emergent adverse events, confirming a consistent safety profile across nine clinical trials[3] - The company completed its final FDA-required study in January 2025, confirming that CTx-1301 can be taken with or without food[5] - Cingulate holds a European patent for CTx-1301, granted on August 14, 2024, covering up to 30 territories, including the UK[5] Strategic Initiatives - The company continues to explore licensing agreements and market expansion opportunities both domestically and internationally[5]

Core Insights - Cingulate Inc. has completed its final FDA-required food effect study for CTx-1301, a medication aimed at treating ADHD, with no serious adverse events reported [2][3][4] - The company plans to submit a New Drug Application (NDA) to the FDA by mid-2025, marking a significant milestone in the development of CTx-1301 [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 [2][12] - The company is headquartered in Kansas City and aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD [12] Product Development - CTx-1301 is designed to be a once-daily stimulant medication that provides effective treatment for ADHD throughout the day, regardless of food intake [4][10] - The drug utilizes a multi-core formulation of dexmethylphenidate, which is part of the stimulant class of medications known for their efficacy in treating ADHD [9][10] Study Details - The food effect study involved administering a single 50mg dose of CTx-1301 to subjects in both fed and fasted states, with results expected in Q2 2025 [3][9] - Previous studies indicated that CTx-1301 could be taken with or without food, demonstrating its versatility [3] ADHD Context - ADHD affects approximately 6.4 million children and adolescents in the U.S., with a significant portion continuing to experience symptoms into adulthood [8] - The adult ADHD population is estimated at around 11 million, with only about 20% receiving treatment [8] Technology Platform - Cingulate's PTR technology allows for precise control of drug release, aiming to enhance patient care by providing a tailored dosing experience [11] - The platform is designed to deliver medication at specific intervals, improving upon existing therapies for ADHD and potentially other conditions [11]

Company Overview - Cingulate Inc. (NASDAQ:CING) is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology [2][7] - The company aims to improve treatment outcomes for patients with conditions that require burdensome daily dosing regimens, initially focusing on ADHD and exploring additional therapeutic areas such as anxiety disorders [2] Financial Transaction - Cingulate has completed a financing transaction with an accredited investor, resulting in net proceeds of $5 million [7] - The transaction involved a non-convertible, unsecured promissory note with a principal amount of $5,480,000, accruing interest at a rate of 9% per annum and maturing 18 months after issuance [7] Use of Proceeds - The net proceeds from the financing will be utilized for working capital and general corporate purposes, providing the company with a cash runway to fund clinical, manufacturing, and regulatory activities, as well as operating costs into the fourth quarter of 2025 [3] - The company plans to file a New Drug Application (NDA) for potential FDA approval of CTx-1301, targeting mid-2025 for this filing [3]

Financial Performance - Operating loss for the three months ended September 30, 2024, was $3,282,087, a decrease from $5,749,674 for the same period in 2023[10] - Net loss for the three months ended September 30, 2024, was $3,231,604, compared to a net loss of $5,979,054 for the same period in 2023[10] - The net loss for the three months ended September 30, 2023, was $5,979,054, compared to a net loss of $16,600,250 for the nine months ended September 30, 2023[16] - The company incurred a net loss of $9,413,758 for the nine months ended September 30, 2024, compared to $16,600,250 for the same period in the previous year[16] - The accumulated deficit increased to $(102,357,201) as of September 30, 2024, from $(92,943,443) on December 31, 2023, reflecting a rise of approximately 10%[8] - The company reported a net cash used in operating activities of $14,371,857 for the nine months ended September 30, 2024[16] - The company reported interest and other income of $50,483 for the three months ended September 30, 2024, compared to an expense of $(229,380) in the same period of 2023, indicating a positive shift[10] Assets and Liabilities - Total current assets increased significantly to $11,343,611 as of September 30, 2024, compared to $578,594 at the end of December 31, 2023[8] - Cash and cash equivalents decreased to $10,040,149 as of September 30, 2024, from $52,416 at the end of December 31, 2023[8] - Total liabilities decreased to $1,542,541 as of September 30, 2024, from $10,360,865 at the end of December 31, 2023[8] - Total stockholders' equity increased to $12,037,563 as of September 30, 2024, from a deficit of $(6,869,429) at the end of December 31, 2023[8] - Accrued expenses totaled $402,152 as of September 30, 2024, significantly down from $1,651,518 as of December 31, 2023, reflecting a decrease of approximately 75.7%[30] Research and Development - Research and development expenses for the nine months ended September 30, 2024, totaled $5,116,582, down from $10,508,395 in the same period of 2023[10] - Research and development expenses for the three months ended September 30, 2024, were $1,428,504, down from $3,923,852 in the same period of 2023, reflecting a decrease of about 64%[10] - The company plans to develop and commercialize product candidates, with ongoing clinical trials for CTx-1301, CTx-1302, and CTx-2103[6] - The company is targeting a New Drug Application (NDA) for its ADHD treatment CTx-1301 in mid-2025, with ongoing clinical requirements[18] - The company has a third product, CTx-2103, in the formulation stage for treating anxiety[18] Stock and Financing - The company raised approximately $24.4 million from the issuance of common stock and pre-funded common stock purchase warrants during the nine months ended September 30, 2024[16] - The company issued common stock in connection with various offerings, raising a total of approximately $11,791,624 during the three months ended September 30, 2024[14] - The Company completed a public offering on February 2, 2024, resulting in gross proceeds of $7.5 million before deducting $750,950 in fees[51] - The Company sold 902,300 shares of common stock under the ATM Agreement for net proceeds of $5,804,393 during the three months ended September 30, 2024[48] - The Company sold 1,092,337 shares under the Lincoln Park Purchase Agreement during the three months ended September 30, 2024, for net proceeds of $6,081,814[50] Stock-Based Compensation - Stock-based compensation expense for the three months ended September 30, 2023, was $236,251[13] - Stock-based compensation expense was recorded at $812,691 for the nine months ended September 30, 2024, compared to $658,105 for the same period in 2023[56] - The fair value of stock options granted during the three months ended September 30, 2024, was $5.04, while the range for the nine months ended September 30, 2024, was from $4.00 to $14.00[61] - As of September 30, 2024, there was $1,219,737 of unrecognized compensation cost related to nonvested share-based compensation arrangements, expected to be recognized over the next one to four years[56] Tax and Valuation - The Company recorded a valuation allowance for deferred tax assets totaling $16,121,058 as of September 30, 2024, compared to $12,631,033 at December 31, 2023[74] - No deferred income tax benefit or expense was recorded for the three-month periods ended September 30, 2024 and 2023, or for the nine-month periods ended September 30, 2024 and 2023[71] - The total income tax expense for the nine months ended September 30, 2024, was $0, consistent with the previous year[72] - The Company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of September 30, 2024[76] Corporate Actions - The company completed a one-for-twelve reverse stock split on August 9, 2024, reducing the number of issued and outstanding shares[41] - The Company has authorized 240,000,000 shares of common stock and 10,000,000 shares of preferred stock, with 3,044,165 shares of common stock issued and outstanding as of September 30, 2024[38] - The maximum aggregate offering price of shares under the ATM Agreement was increased from $15.2 million to $19.7 million[78] - The Company approved an amendment to the 2021 Plan, increasing the number of shares authorized for issuance by 104,167 shares to a total of 125,577 shares[55]