Core Insights - Cingulate Inc. is making significant progress in transforming CTx-1301 into a commercial ADHD franchise, with key milestones achieved [1][5] - The FDA has accepted the NDA for CTx-1301, with a PDUFA date set for May 31, 2026, indicating a potential launch in 2026 pending approval [5] - The company has secured a commercial supply agreement with Bend Bio Sciences to ensure U.S. manufacturing capacity ahead of the product launch [1][5] Financial Position - As of the end of the quarter, Cingulate reported approximately $6.1 million in cash [5] - A $6 million financing post-quarter has extended the company's runway into the second quarter of 2026 [5] Commercial Strategy - The commercial build is advancing with the appointment of Bryan Downey as Chief Commercial Officer [5] - Partnerships with Indegene and Bend Bio Sciences are part of the strategy to secure manufacturing and commercial capabilities [5]

Financial Performance - The net loss for the nine months ended September 30, 2025, was $16,177,001, compared to a net loss of $10,328,505 for the same period in 2024, reflecting a 56.5% increase in losses[15]. - The company reported an operating loss of $5,995,835 for the three months ended September 30, 2025, compared to an operating loss of $3,282,087 for the same period in 2024, indicating a 82.5% increase in operating losses[15]. - The net loss for the three months ended September 30, 2025, was $7,341,062, compared to a net loss of $4,125,643 for the same period in 2024, representing an increase of 78%[38]. - The operating loss for the nine months ended September 30, 2025, was $14,351,844, compared to a loss of $9,436,484 for the same period in 2024, reflecting a 52% increase in losses[38]. - The total general and administrative expenses for the nine months ended September 30, 2025, were $6,579,735, up from $4,319,902 for the same period in 2024, marking a 52% increase[38]. Assets and Liabilities - Total current assets decreased from $12,660,803 as of December 31, 2024, to $7,433,310 as of September 30, 2025, representing a decline of approximately 41.5%[13]. - Total liabilities decreased slightly from $7,408,984 as of December 31, 2024, to $7,045,206 as of September 30, 2025, a reduction of about 4.9%[13]. - Cash and cash equivalents decreased significantly from $12,211,321 as of December 31, 2024, to $6,118,710 as of September 30, 2025, a decline of approximately 50.1%[13]. - The company's total assets decreased to $10,518,892 as of September 30, 2025, from $14,864,489 at December 31, 2024, reflecting a decline of approximately 29%[13]. - The total current liabilities increased to $5,882,285 as of September 30, 2025, compared to $4,972,105 at December 31, 2024, reflecting an increase of approximately 18%[13]. Research and Development - Research and development expenses for the three months ended September 30, 2025, increased to $2,848,544, up 99.2% from $1,428,504 in the same period of 2024[15]. - Research and development expenses for the nine months ended September 30, 2025, were $7,772,109, up from $5,116,582 in the same period of 2024, indicating a year-over-year increase of about 52%[15]. - The company is developing two proprietary stimulant medications, CTx-1301 and CTx-1302, for the treatment of ADHD[22]. - The company is also developing CTx-2103, a product aimed at treating anxiety, which is currently in the formulation stage[22]. Stock and Financing - The weighted average number of shares used in computing net loss per share increased from 1,766,362 in Q3 2024 to 5,431,206 in Q3 2025, indicating a significant dilution effect[15]. - The balance of common stock increased to 5,977,358 shares by September 30, 2025, from 3,826,199 shares at the end of March 2025[18]. - The company raised $7,565,637 from the issuance of common stock and pre-funded common stock purchase warrants, net of fees, during the nine months ended September 30, 2025[20]. - The Company has authorized 240,000,000 shares of common stock, with 5,977,358 shares issued and outstanding as of September 30, 2025[50]. - The Company sold 82,048 shares of common stock under the At-the-Market Agreement during the three months ended September 30, 2025, generating net proceeds of $412,996[56]. Cash Flow and Funding - The company reported a net cash used in operating activities of $13,647,893 for the nine months ended September 30, 2025[20]. - The company reported a net cash provided by financing activities of $7,561,207 for the nine months ended September 30, 2025[20]. - The company has incurred losses and negative cash flows from operations since inception, indicating a need for additional funding for operations and development[24]. - The company is evaluating various strategies to obtain additional funding, which may include equity offerings, debt issuance, or collaborations with other companies[24]. - The consolidated financial statements have been prepared on a going concern basis, reflecting substantial doubt about the company's ability to continue operations within one year[24]. Accounting and Valuation - The accumulated deficit increased from $109,925,120 as of December 31, 2024, to $126,102,121 as of September 30, 2025, reflecting a growth in losses of approximately 14.7%[13]. - The valuation allowance for deferred tax assets totaled $20,898,141 as of September 30, 2025, compared to $17,405,569 at December 31, 2024, indicating an increase of about 20%[12]. - The company recorded a change in fair value of derivatives amounting to $1,016,682 for the nine months ended September 30, 2025[20]. - The company has not recognized any impairment losses during the nine-month periods ended September 30, 2025 or 2024[28]. - The company has not identified any material uncertain tax positions requiring recognition in the consolidated financial statements as of September 30, 2025[74].

Financial Performance - Cingulate Inc. reported a net loss of $7.3 million for Q3 2025, an increase of 77.6% compared to a net loss of $4.1 million in Q3 2024[12]. - General and administrative expenses increased by 69.7% to $3.1 million in Q3 2025, up from $1.9 million in Q3 2024, primarily due to personnel and commercial costs[11]. Research and Development - Research and development expenses rose to $2.8 million in Q3 2025, a 99.5% increase from $1.4 million in Q3 2024, driven by higher personnel, manufacturing, and regulatory costs[10]. - Positive Phase 3 trial results for CTx-1301 were presented, showing significant improvements in ADHD symptoms with once-daily dosing[5]. Cash Position and Financing - As of September 30, 2025, Cingulate had approximately $6.1 million in cash and cash equivalents, down from $12.2 million at the end of 2024[14]. - Cingulate completed a $6 million financing transaction to strengthen its balance sheet, structured as a non-convertible promissory note with a 9% interest rate[4]. - The company expects to raise approximately $7.0 million in additional capital to support commercialization efforts leading up to the May 31, 2026 PDUFA date for CTx-1301[9]. Regulatory Developments - Cingulate's NDA for CTx-1301 was accepted by the FDA, with a PDUFA target action date set for May 31, 2026[2]. - A commercial supply agreement was established with Bend Bio Sciences for the exclusive manufacturing of CTx-1301 in the U.S. through 2028, contingent on FDA approval[7]. - The company received a PDUFA fee waiver from the FDA, saving approximately $4.3 million[8].

Core Insights - Cingulate Inc. has made significant progress with the acceptance of its New Drug Application (NDA) for CTx-1301 by the FDA, with a target action date set for May 31, 2026 [2][20] - The company appointed Bryan Downey as Chief Commercial Officer, bringing over 25 years of experience in the pharmaceutical industry [3][6] - A $6 million financing transaction was completed to strengthen the company's balance sheet ahead of potential commercialization [3][4] Recent Highlights - The FDA accepted the NDA for CTx-1301, a once-daily extended-release therapy for ADHD, confirming the submission is complete and ready for review [2][20] - Positive Phase 3 trial results for CTx-1301 were presented at the AACAP Annual Meeting, showing significant improvements in ADHD symptoms [5][6] Financial Overview - As of September 30, 2025, Cingulate reported approximately $6.1 million in cash and cash equivalents, a decrease from $12.2 million at the end of 2024 [10][15] - The company incurred a net loss of $7.3 million for the third quarter of 2025, compared to a loss of $4.1 million in the same period of 2024, primarily due to increased R&D and G&A expenses [13][11] Operational Developments - A commercial supply agreement was established with Bend Bio Sciences for the manufacturing of CTx-1301, ensuring exclusive supply through 2028 if FDA approved [7] - Cingulate received a PDUFA fee waiver from the FDA, saving approximately $4.3 million [8][9] Research and Development - R&D expenses for the third quarter of 2025 were $2.8 million, a 99.5% increase from the previous year, driven by higher personnel and manufacturing costs [11] - General and administrative expenses rose to $3.1 million, a 69.7% increase from the same quarter in 2024, largely due to personnel costs related to the NDA submission [12]

Core Insights - Cingulate Inc. has appointed Bryan Downey as Chief Commercial Officer to advance the commercialization of CTx-1301, following FDA acceptance of its New Drug Application (NDA) with a target action date of May 31, 2026 [1][12] - The company has completed a $6 million financing transaction to strengthen its cash position and extend its cash runway into the second quarter of 2026, supporting its commercialization efforts pending FDA approval [2][8] Company Developments - Bryan Downey brings over 25 years of experience in commercial strategy and product launches, having held senior roles at Alfasigma USA, Jubilant Pharma, and Sanofi [3][4] - Cingulate's CTx-1301 is designed to provide rapid onset and all-day ADHD symptom control with a single daily dose, differentiating it from existing medications that often require multiple doses [5][12] - The company has partnered with Indegene to establish the commercial infrastructure and market access strategies necessary for the successful launch of CTx-1301 [5] Financial Overview - The $6 million financing was structured as a non-convertible, unsecured promissory note with a 9% annual interest rate, maturing in 18 months, allowing for monthly redemptions post-PDUFA date [8] - The proceeds from the financing will be utilized for working capital and general corporate purposes [8] Product Information - CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) platform, enabling three timed releases of medication from a single tablet to maintain focus throughout the day [5][12] - The global ADHD market is valued at over $23 billion annually, indicating significant market potential for Cingulate's innovative product [5]

Core Insights - Cingulate Inc. announced positive Phase 3 results for CTx-1301, a once-daily formulation of dexmethylphenidate for pediatric ADHD, achieving primary endpoints with significant symptom relief [1][3] - The ADHD market is valued at $23 billion, with CTx-1301 offering a potential advantage through its once-daily dosing, which may improve patient adherence [3] Group 1: Clinical Trial Results - CTx-1301 demonstrated dose-dependent improvements on ADHD ratings scale and Clinical Global Impression-Severity scales, providing symptom relief for up to 12 hours post-dose [1] - The randomized, double-blind, placebo-controlled study showed rapid onset of effect and sustained efficacy, with a safety profile consistent with other stimulant medications [2] Group 2: Product and Market Potential - The 37.5mg dose of CTx-1301 showed the largest effect size in symptom reduction, indicating substantial efficacy [3] - Cingulate's partnership with Indegene is structured to align commercial execution with growth milestones as the company approaches product launch [3] Group 3: Regulatory and Financial Aspects - The New Drug Application for CTx-1301 was accepted by the FDA, with a target PDUFA date of May 31, 2026, and a waiver of the standard PDUFA filing fee saving the company approximately $4.3 million [4] - Cingulate plans to share additional details from the Phase 3 study in future scientific publications and investor communications [6] Group 4: Company Overview - Cingulate Inc. utilizes its Precision Timed Release™ platform to develop next-generation pharmaceutical products aimed at improving patient outcomes in conditions requiring complex dosing [9] - CTx-1301 is in late-stage development for ADHD, with additional candidates targeting anxiety and other neuropsychiatric conditions [9]

Core Insights - Cingulate Inc. announced that data from its lead ADHD candidate CTx-1301 has been selected for podium presentation at the AACAP Annual Meeting, indicating significant scientific interest in the product [1][2][3] - CTx-1301 is designed as a once-daily, extended-release formulation aimed at improving treatment for ADHD by addressing limitations of current stimulant therapies [3][5] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform [1][6] - The company is headquartered in Kansas City, Kansas, and is advancing a pipeline that includes candidates for ADHD and other neuropsychiatric conditions [6] Product Details - CTx-1301 (dexmethylphenidate HCl) utilizes the PTR™ platform to provide three precisely timed releases of medication throughout the day, aiming for rapid onset and full-day symptom control [5] - The product is currently being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment [5] ADHD Context - ADHD affects an estimated 20 million individuals in the U.S., including around 8 million children and 12 million adults, characterized by inattention, hyperactivity, and impulsivity [4] - Current stimulant medications, while the gold standard, often require multiple daily doses and may not provide consistent coverage throughout the day [4]

Core Insights - Cingulate Inc. announced that data from its lead ADHD candidate CTx-1301 has been selected for podium presentation at the AACAP Annual Meeting, indicating growing scientific interest in the product [1][3] - CTx-1301 is a once-daily, extended-release formulation designed to simplify ADHD treatment for millions [1][4] Company Overview - Cingulate Inc. is a biopharmaceutical company focused on developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform [1][6] - The company is headquartered in Kansas City, Kansas, and is advancing a pipeline that includes candidates for ADHD, anxiety, and other neuropsychiatric conditions [6] Product Details - CTx-1301 (dexmethylphenidate HCl) utilizes the PTR™ platform to deliver three precisely timed releases of medication throughout the day, aiming for rapid onset and full-day efficacy [5] - The product is currently being evaluated under the FDA's 505(b)(2) pathway for ADHD treatment [5] Clinical Presentation - The Phase 3 data for CTx-1301 will be presented by Dr. Ann Childress, a leading ADHD specialist, at the AACAP Annual Meeting [2][3] - The presentation will focus on the efficacy and safety of CTx-1301 in pediatric subjects with ADHD [2] ADHD Context - ADHD affects an estimated 20 million individuals in the U.S., including approximately 8 million children and 12 million adults, characterized by inattention, hyperactivity, and impulsivity [4] - Current stimulant medications often require multiple daily doses and may not provide consistent coverage throughout the day [4]

Core Insights - Cingulate Inc. announced that the FDA has accepted the New Drug Application (NDA) for CTx-1301, a treatment for ADHD, with a target action date of May 31, 2026 [1][3] - The NDA is being reviewed under the FDA's 505(b)(2) pathway, allowing Cingulate to leverage existing data on dexmethylphenidate while demonstrating novel clinical benefits [2][10] - CTx-1301 has shown significant improvements in ADHD symptoms during Phase 3 trials, indicating its potential to address gaps in current ADHD management [4][6] Regulatory Milestone - The acceptance of the NDA marks a significant regulatory milestone for Cingulate and the CTx-1301 program, validating the completeness of their submission [3][5] - The FDA's review will assess the efficacy, safety, and overall risk-benefit profile of CTx-1301 [7] Clinical Results - Phase 3 trials demonstrated that CTx-1301 provides rapid onset of effect and sustained efficacy throughout the day, addressing issues with current stimulant therapies [4][6] - No serious treatment-emergent adverse events were reported, indicating a favorable safety profile [6] Commercial Strategy - Cingulate is preparing for a timely launch of CTx-1301, having completed process transfer and scale-up production with its manufacturing partner [7] - The company is leveraging an AI-driven omnichannel platform to optimize prescriber reach and patient support, with early research indicating strong formulary receptivity for CTx-1301 [8] Market Context - ADHD affects approximately 20 million individuals in the U.S., with stimulant medications being the gold standard for treatment [9] - Current extended-release formulations often require multiple doses, highlighting the need for a once-daily solution like CTx-1301 [9][10]

Core Insights - Cingulate Inc. has entered into a strategic commercial supply agreement with Bend Bio Sciences for the manufacturing of its lead asset CTx-1301, pending FDA approval [1][3] - CTx-1301 is a novel, extended-release formulation of dexmethylphenidate aimed at addressing limitations of current ADHD therapies, with an NDA submitted to the FDA on July 31, 2025 [2][3] - The agreement ensures Bend Bio Sciences will be the exclusive manufacturer of CTx-1301 in the U.S. through 2028, contingent on FDA approval, providing manufacturing security and operational efficiency for Cingulate [3][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][9] - The company aims to improve treatment outcomes for patients with conditions requiring complex dosing regimens, starting with ADHD and potentially expanding to anxiety disorders [9] Product Details - CTx-1301 utilizes Cingulate's PTR technology to deliver dexmethylphenidate in a multi-core formulation designed for precise release at defined intervals, addressing the challenge of providing an entire active-day duration of action [6][7] - The formulation is designed to enhance patient care by delivering medication in a single tablet, improving adherence and treatment efficacy [6][8] Market Context - ADHD affects over 20 million patients in the U.S., with a significant portion being adults; current treatment options are often inadequate, highlighting the need for innovative therapies like CTx-1301 [5][6] - The prevalence of adult ADHD is growing faster than that of children and adolescents, indicating a substantial market opportunity for effective treatment solutions [5]