CING

Cash Position Grows to $25.9 Million KANSAS CITY, Kan., May 14, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended March 31, 2026, and provided a corporate update. “Cingulate remains focused on disciplined execution in 2026 and we believe we are well positioned to bring our lead ADHD asset, CTx-1301, to market,” said Cingulate CEO Shane J. Schaffer. “We continue to engage constructively with the FDA on our new drug application while advancing commercial readiness and manufacturing capabilities, and believe our current resources provide an extended cash runway into 2027.” Strengthened Balance Sheet Cingulate enters the second quarter of 2026 with a meaningfully stronger financial position, having grown its cash and cash equivalents to $25.9 million as of March 31, 2026 — a $14.9 million increase from December 31, 2025 — driven by the successful close of a $12.0 million at-the-market private placement in February 2026 alongside opportunistic usage of the Company’s at-the-market and stock purchase agreements. Working capital increased to $17.0 million from $1.7 million at year-end, reflecting the Company's significantly improved liquidity. Management believes this capital base is sufficient to fund operations into 2027, supporting key value-creating milestones including the pursuit of regulatory approval and launch readiness for CTx-1301. Regulatory Update Cingulate is actively collaborating with the FDA to provide responses to information requests related to the manufacturing and CMC elements of its CTx-1301 NDA. The Company remains committed to working efficiently with the Agency and will provide updates as the review process progresses. Commercial Readiness Update Cingulate continues to advance its commercialization preparations, with dedicated teams established across all key functional areas. The Company’s launch strategy leverages a commercialization strategy augmented by AI-driven tools designed to optimize targeting, decision-making, and performance measurement — positioning Cingulate for a rapid commercial launch contingent upon FDA approval. Key areas of focus include: Market Access and Payer Engagement: Advancing payer strategy and re...

U.S. Patent Notice of Allowance for CTx-1301 Received; Additional European Patents Granted Recent $12M Private Placement Closed At-the-Market Pricing KANSAS CITY, Kan., March 18, 2026 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to develop a pipeline of next-generation products, today reported financial results for the quarter ended December 31, 2025, and provided a corporate update. Highlights include recent U.S. and European patent developments, the closing of a $12 million private investment, and the acceptance of a New Drug Application (NDA) for its lead candidate, CTx-1301 (dexmethylphenidate HCl). Cingulate CEO Shane J. Schaffer stated, “Cingulate delivered on key inflection points throughout 2025 and this continues into 2026. Cingulate is proud to announce that CTx-1301 has strengthened its patent estate. We have demonstrated that CTx-1301 utilizing the PTR™ Platform does something meaningfully different in the treatment of ADHD, and these improvements are now recognized by patent offices in the United States as well as major territories around the world. We’ve spent years building the PTR™ platform which exclusively delivers medication how and when patients need it most, and we’re continuing to work constructively with the FDA as it evaluates our application for approval. While we advance CTx-1301 through the regulatory review process, our Company has strengthened its financial and operational foundation,” Schaffer continued. “At the same time, we are advancing our commercial readiness and manufacturing scale-up, so we’re well positioned to support commercial launch, pending approval. With the support of our recent financing and the addition of experienced commercial leadership, we believe we’re taking the right steps to build long-term value for both patients and shareholders.” Operational Highlights U.S. Patent Notice of Allowance On Tuesday, March 17th, 2026, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a patent application covering Cingulate’s lead ADHD candidate, CTx-1301, indicating that the agency has completed its examination and determined that the claims are allowable. Upon issuance, the patent is expected to provide protection through May 2042 for key aspects of CTx-1301’s formulation...

By John Vandermosten, CFA NASDAQ:CING READ THE FULL CING RESEARCH REPORT Cingulate, Inc. (NASDAQ:CING) reported third quarter 2025 results on November 13th, 2025. No revenues were recorded and operating expense totaled $6.0 million. The new drug application (NDA) to the FDA was accepted and a PDUFA date of May 31st, 2026 was given. Cingulate also saw changes in its management ranks as the company’s focus shifts to pre-commercialization activities which included the appointment of Bryan Downey as Chief Commercial Officer. Company representatives have participated in investor and medical conferences, highlighted by Dr. Ann Childress’ podium presentation at AACAP and attendance at the Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) conference. In the financing sphere, a purchase agreement was signed with Lincoln Park Capital, which is expected to augment the in place at-the-market (ATM) facility and support the crescendo of activities leading up to the anticipated approval next year. 3Q:25 Financial and Operational Results Cingulate reported third quarter results in a press release and Form 10-Q filing with the SEC on November 13th. For the quarter ending September 30th, 2025, the company reported a net loss of ($7.3) million or ($1.359) per share. For 3Q:25 versus the same prior year period: Research and development expenses were $2.8 million, nearly doubling from $1.4 million. The change was attributable to an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel costs were further broken down into separation costs for an executive recognized in August 2025 and the payment of a contingent bonus plan that were payable upon acceptance of the NDA by the FDA. Manufacturing costs were related to preparation for product validation batches of CTx-1301. Regulatory costs were up as the team prepared to submit the NDA; General & administrative expenses rose 70% to $3.1 million from $1.9 million on account of increased personnel and other expenses, higher costs related to the arrangement with Indegene and personnel expenses related to the contingent bonus plan earned upon FDA acceptance of the NDA; Net interest and other expense were ($1.3) million compared to ($844,000) related to derivative change in fair value issued to Lincoln Park and its share purchase commitment and interest expense incurred on the promissor...

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 Highlights (Post-Q3) FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026 In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate’s New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to optimize ADHD treatment. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, confirming the NDA is complete and ready for review. Industry Veteran Bryan Downey Named Chief Commercial Officer; $6 Million Financing Completed On November 3, 2025, Cingulate appointed Bryan Downey as Chief Commercial Officer, and announced the completion of a $6 million financing transaction, further strengthening its balance sheet as the company prepares for potential commercialization. Downey brings over 25 years of experience in commercial strategy, leadership, and successful pharmaceutical launches, having held senior executive roles at Alfasigma USA, Jubilant Pharma, and Sanofi. In conjunction with Downey’s appointment, Cingulate completed a financing transaction with an accredited investor, providing net proceeds of $6 million. The transaction was structured as a $6,570,000 non-convertible, unsecured promissory note accruing interest at 9% per annum and maturing 18 months from issuance. The note provides the flexibility for Cingulate to begin monthly redemptions on the note subsequent to the CTx-1301 PDUFA date of May 31, 2026, subject to the terms of the note and other conditions. Cingulate intends to use the proceeds for working capital and other general corporate purposes. The summary of the financing terms herein is qualified in its entirety by the definitive agreements filed with the SEC. Positive Phase 3 Results Presented at Annual AACAP Conference The positive Phase 3 results from Cingulate’s pivotal trial of CTx-1301 were recently presented by Ann Chil...

Once-daily formulation of dexmethylphenidate achieved primary endpoint (p < 0.001) with consistent symptom relief up to 12 hours post-dose KANSAS 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 (dexmethylphenidate HCl) in pediatric ADHD, were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing. In the randomized, double-blind, pediatric and adolescent, placebo-controlled study, CTx-1301 delivered rapid onset of effect and sustained efficacy through the evening hours. Safety and tolerability were consistent with the stimulant class, with no unexpected adverse events reported. “In summary, CTx1301 demonstrated dose dependent efficacy in improving ADHD symptoms in children and adolescents. The 37.5mg dose demonstrated the largest effect size in symptom reduction and effect sizes were pretty substantial, considering this was a forced dose and not a dose optimization study,” Dr. Childress stated during the presentation. “The safety profile did not show anything that would be of concern, as it looks like other methylphenidates.” ADHD represents a $23 billion global market, yet most treatments require two or more daily doses. CTx-1301 offers the potential for simpler once-daily management, which could translate to better adherence for patients and families. Cingulate’s commercial partnership with Indegene, a digital-first, life sciences commercialization company, is designed around a variable-cost structure that aligns commercial execution with growth milestones as the company approaches launch. The New Drug Application for CTx-1301 was accepted by the FDA in October 2025, with a target PDUFA date of May 31, 2026. Cingulate also received a waiver of the standard PDUFA filing fee. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic A...

Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301 Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026 KANSAS CITY, Kan., Aug. 19, 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 for the quarter ended June 30, 2025, and provided recent highlights. Recent Highlights: On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities: Pre-NDA meeting with the FDA; Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Precision Timed Release Platform. In addition, on July 21, 2025, Cingulate entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase from the Company from time to time, over the 36-month term of the agreement and at the Company’s sole discretion, up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the purchase agreement). Jay Roberts, Executive Chairman of Cingulate’s Board of Directors, stated, “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment in Cingulate’s progression, reflecting years of dedication to developing a truly differentiated ADHD treatment through the Precision Timed Release platform. In addition, the recently executed agreement with Lincoln Park Capital allows management to be opportunistic in its capital needs as we prioritize pre-commercial activities in anti...

Subjects Demonstrated Marked Improvement of ADHD Symptoms at Week 5New 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 FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics (aged 6-17), for its lead asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The primary efficacy endpoint of the study was change in total score on the ADHD-RS-5 rating scale (a scale which measures aspects of ADHD in pediatrics). The fixed doses used in the study were 18.75-mg; 25-mg and 37.5-mg. Pending approval by the FDA, Cingulate expects to launch CTx-1301 with a total of eight dosage strengths, six of which are expected to treat patients under the age of 18. "In a randomized, double-blind, placebo-controlled Phase 3 trial in pediatric ADHD patients, CTx-1301 demonstrated statistically significant improvements in ADHD symptoms across all fixed doses, achieving robust effect sizes (0.737 to 1.185) within 5 weeks,” said Cingulate Chief Science Officer Raul R. Silva, MD. “These results illustrate that CTx-1301, if approved by the FDA, is positioned to become a potential first-line treatment for providers to overcome the longstanding unmet needs facing the millions of ADHD patients worldwide.” Cingulate Chairman and CEO Shane J. Schaffer stated, “These compelling results once again validate the therapeutic benefits and commercial potential of CTx-1301. Achieving statistically significant outcomes and remarkable effect sizes across all tested dose levels illustrates the potential benefits of our product and the value of our Precision Timed Release ™ Platform. These findings represent a significant value inflection point for Cingulate as we advance toward regulatory submission and commercialization.” Last month Cingulate announced positive top-line results of a high dose (50-mg) food effect study for CTx-1301, with the primary endpoints establishing that it can be taken with or without food....

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 for the quarter ended March 31, 2025, and provided a clinical and business update. Highlights include the completion of the Pre-NDA meeting for CTx-1301 and grant received to accelerate development of CTx-2103. “The first quarter of 2025 has been a very constructive one for Cingulate,” stated Chairman and CEO Shane J. Schaffer. “We held a productive meeting with the FDA last month and remain on target to file an NDA in the middle of the year for our lead ADHD asset CTx-1301. The results announced from a food effect study of 50mg CTx-1301 – our largest dose – were positive and consistent with previous fed/fast data (25mg CTx-1301). We were also pleased to receive a $3 million grant of non-dilutive funding for the development of CTx-2103 for the treatment of anxiety, advancing our pipeline and illustrating the applicability of Cingulate’s PTR™ platform.” Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application (NDA) for lead ADHD Asset CTx-1301 and Remains on Track to Submit the NDA Mid-2025 and Provides additional Clinical Updates On April 2, 2025, Cingulate completed its Pre-NDA meeting with the FDA to discuss the submission of an NDA for CTx-1301, its lead asset for the treatment of ADHD. This important milestone keeps Cingulate on track for a mid-2025 submission of the NDA for CTx-1301. In March 2025, Cingulate released Phase 3 safety data for CTx-1301, showing that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. In late April 2025, Cingulate reported that the primary endpoint of the 50mg food effect study demonstrated that CTx-1301 can be taken with or without food. Cingulate Receives $3 million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone) In April 2025, Cingulate received a $3 million grant to accelerate the development of CTx-2103 (buspi...

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 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 FDA required study, assessing the effect of food on absorption of the highest dose (50mg) of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). The trial demonstrated that 50mg CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicate a favorable tolerability profile. “We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and that offers eight dose strengths so that medical professionals can effectively optimize a patient’s medication. Crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study confirm that we have identified the optimal formulation of 50mg CTx-1301.” CTx-1301 Pharmacokinetics in Both Fed and Fasted StatesThe CTx-1301-013 study enrolled 27 healthy adult subjects, male and female, (age range: 18 to 50 years) who were randomized into one of two sequences to receive a single 50 mg dose of CTx-1301 on two occasions (once with a standard high fat breakfast and once on an empty stomach). Both doses were administered with 8 oz of water and frequent blood samples were obtained for a period of 28 hours after each dose in order to define the absorption and elimination profile of dexmethylphenidate (i.e. the pharmacokinetics or PK). The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorb...

In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025$17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for NDA Submission KANSAS CITY, Kan., March 26, 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 for the twelve months ended December 31, 2024, and provided a clinical and business update. Highlights include the announcement of safety results from Cingulate’s final Phase 3 trials for lead ADHD asset CTx-1301 (dexmethylphenidate), and confirmation of a scheduled in-person Pre-NDA meeting with the FDA. “The capital raised over the past year has allowed us to strengthen our balance sheet and complete all required clinical trials for NDA submission for CTx-1301. We look forward to meeting with the FDA next week, submitting our new drug application this summer, and, assuming approval by the FDA, bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day,” said Cingulate Chairman and CEO Shane J Schaffer. LEAD ASSET CTx-1301 HIGHLIGHTS Cingulate is on-target for the NDA submission in mid-2025, following an in-person, pre-NDA meeting scheduled for April 2, 2025. March 2025 - Cingulate released safety data from two Phase 3 pediatric and adolescent studies – a fixed dose study and a dose optimization study as well as its high-dose food effect study, noting no serious treatment emergent adverse events and confirming that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. A final analysis that combines both adult and pediatric safety data will be prepared and included in the NDA submission. January 2025 - Cingulate completed its final FDA-required study, a food effect study utilizing a single 50-mg dose of CTx-1301, the highest dosage being studied. The medical findings are consistent with the previous study performed with the 25mg dose which showed that CTx-1301 could be taken with or without food. August 2024 - European patent for CTx-1301 issued. The patent application was granted on August 14, 2024, as EP Patent No...