Stonegate Capital Partners Updates Coverage on Cingulate Inc. (CING) 3Q25November 18, 2025 4:27 PM EST | Source: Reportable, Inc.Dallas, Texas--(Newsfile Corp. - November 18, 2025) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate's 3Q25 results reflect continued progress toward transforming CTx-1301 into a commercial ADHD franchise. Recently the Company achieved several key milestones, including FDA acceptance of the ...

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].

Exhibit 99.1 Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update Industry Veteran Bryan Downey Named Chief Commercial Of icer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ...

Industry Veteran Bryan Downey Named Chief Commercial Officer NDA Accepted with May 2026 PDUFA Date Commercial Supply Agreement Executed KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights. Recent Highlight ...

Appointment builds on recent FDA acceptance of New Drug Application for review and advances Cingulate’s transition toward commercialization pending FDA approval Company also strengthens its cash position by completing a $6 million financing KANSAS CITY, Kan., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform ...

Once-daily formulation of dexmethylphenidate achieved primary endpoint (p < 0.001) with consistent symptom relief up to 12 hours post-doseKANSAS CITY, Kan., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, announced today that the positive Phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenid ...

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]

KANSAS CITY, Kan., Oct. 23, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that data from its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) has been selected for podium presentation at the American Academy of Child and Adolescent Psychiatry (AACAP) Annual Meeting in Chicago. This recogniti ...

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™ (PTR™) drug-delivery platform, today announced that the U.S. Food and Drug Administrati ...

Strategic Commercial Supply Agreement Positions Lead Asset CTx-1301 for Launch Pending FDA ApprovalKANSAS CITY, Kan., Sept. 17, 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 it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301(dexmethyl ...