Stonegate Capital Partners Initiates Coverage on Cingulate Inc. (CING) June 18, 2025 8:00 AM EDT | Source: Reportable, Inc. Dallas, Texas--(Newsfile Corp. - June 18, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners initiates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 1Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on leveraging its proprietary Precision Timed Release (PTR) plat ...

Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5 New Drug Application on Schedule for this Summer CING CEO Shares Insights and Strategic Outlook on "Unboxing Biotech" Podcast KANSAS CITY, Kan., May 20, 2025 (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 the efficacy results from an ...

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]

Pre-NDA Meeting for CTx-1301(dexmethylphenidate) Held April 2, 2025; New Drug Application Submission Targeted for Mid-2025 Non-Dilutive Funding to Accelerate Development of CTx-2103 (buspirone) KANSAS CITY, Kan., May 08, 2025 (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 f ...

Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD About CTx-1301 KANSAS CITY, Kan., April 29, 2025 (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 positive top-line results from the CTx-1301-013 study, an ...

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]