Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights Cingulate (NASDAQ: CING) reported Q4 and full-year 2025 results and operational milestones on March 18, 2026, including a U.S. Notice of Allowance and a European patent for CTx-1301, acceptance of the NDA with a PDUFA date of May 31, 2026, and a closed $12M at-the-market PIPE.Financials show approximately $11.0M cash as of Dec 31, 2025, a $22.4M net loss for 2025, and working capital of $1.7M; the company expects cash to fund operations into late Q4 2026 under its current plan.

#CING #CINGW Cingulate Inc. Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

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#CING #CINGW Cingulate Inc. Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301 Cingulate (NASDAQ: CING) appointed Bryan Downey as Chief Commercial Officer and announced FDA acceptance of its New Drug Application for CTx-1301 with a PDUFA date of May 31, 2026. The company completed a $6.0 million financing via a $6,570,000 unsecured promissory note carrying 9% interest and maturing in 18 months, which the company says extends cash runway into Q2 2026. Downey received 30,000 inducement stock options at a $3.80 exercise price, vesting over four years. Cingulate is preparing commercial infrastructure with partner Indegene, pending FDA approval.

#CING #CINGW Cingulate Names Industry Veteran Bryan Downey Chief Commercial Officer to Lead Launch Preparation for CTx-1301

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Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company developing and advancing a pipeline of

#CING #CINGW Cingulate Presents Positive Phase 3 Results for CTx-1301 Demonstrating Statistically Significant Efficacy and Entire Active-Day Symptom Control

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Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting Cingulate (NASDAQ: CING) announced that Phase 3 data for its lead ADHD candidate CTx-1301 (dexmethylphenidate HCl) was selected for a podium presentation at the AACAP Annual Meeting in Chicago.Dr. Ann Childress will present “Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD” on October 24, 2025. The session will be livestreamed and results will be summarized in a follow-up company announcement after the conference.

#CING #CINGW Cingulate’s Lead ADHD Candidate CTx-1301 Selected for Podium Presentation at AACAP Annual Meeting

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FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company

#CING #CINGW FDA Accepts Cingulate’s New Drug Application for CTx-1301 in Attention-Deficit/Hyperactivity Disorder (ADHD) and sets a May 31, 2026 PDUFA Date

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Next-Gen ADHD Treatment: Cingulate Locks Exclusive Manufacturing Deal Through 2028 for CTx-1301 Biotech firm Cingulate secures exclusive US manufacturing partnership with Bend Bio Sciences for CTx-1301, its novel ADHD treatment, following July 2025 NDA submission. Deal runs through 2028.

#CINGW #CING Cingulate Secures Exclusive Manufacturing Partnership with Bend Bio Sciences to Support Future Commercialization of Next Generation ADHD Treatment

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Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights Cingulate (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment asset utilizing Precision Timed Release™ technology. The company expects an FDA decision on NDA acceptance in Q4 2025, with a potential PDUFA date in mid-2026.Key Q2 2025 financial results show cash position of $8.9 million, expected to last into late 2025. The company needs an additional $1.5 million for commercialization efforts. Q2 net loss widened to $4.8 million from $3.2 million year-over-year, with R&D expenses increasing 43.6% to $2.7 million. Cingulate secured a $25 million purchase agreement with Lincoln Park Capital over 36 months to support pre-commercial activities.

#CINGW #CING Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

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Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301 Cingulate Inc. (NASDAQ: CING) has submitted a New Drug Application (NDA) to the FDA for CTx-1301, its lead ADHD treatment candidate. The drug, utilizing Cingulate's proprietary Precision Timed Release™ (PTR™) platform, is designed to provide once-daily dosing with fast onset and entire active-day efficacy.CTx-1301 is a novel extended-release formulation of dexmethylphenidate HCl that aims to address major limitations of current ADHD therapies. The company expects to receive notification of NDA acceptance within 60 days of its July 31 submission. The drug targets the $23 billion U.S. ADHD market and represents the first regulatory application of Cingulate's PTR™ platform technology.

#CINGW #CING Cingulate Submits New Drug Application to FDA for Lead ADHD Asset CTx-1301

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Cingulate Saves $4.3M on ADHD Drug Application as FDA Waiver Boosts Commercialization Plans FDA waives $4.3M PDUFA fee for Cingulate's novel ADHD treatment CTx-1301. NDA submission expected within days. See commercialization timeline.

#CINGW #CING Cingulate Receives $4.3M Waiver from FDA Ahead of Imminent Filing for Marketing Approval of Lead ADHD Asset CTx-1301

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Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD Cingulate (NASDAQ: CING) announced positive Phase 3 clinical trial results for CTx-1301 (dexmethylphenidate) in treating ADHD in pediatric patients aged 6-17. The study demonstrated statistically significant improvements in ADHD symptoms across all fixed doses (18.75-mg, 25-mg, and 37.5-mg), achieving effect sizes of 0.737 to 1.185 within 5 weeks. The drug, utilizing Cingulate's proprietary Precision Timed Release™ platform, showed promising results in the randomized, double-blind, placebo-controlled trial. A recent food effect study confirmed CTx-1301 can be taken with or without food, and previous Phase 3 safety data showed consistent safety profiles across eight clinical trials. The company plans to submit a New Drug Application (NDA) this summer, with expectations to launch CTx-1301 in eight dosage strengths, six targeting patients under 18.

#CINGW #CING Efficacy Results Announced from Cingulate’s Phase 3 Pediatric Study of CTx-1301 (dexmethylphenidate) for ADHD

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FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301 Cingulate Inc. (NASDAQ: CING) has received formal pre-New Drug Application (NDA) meeting minutes from the FDA for CTx-1301, its lead ADHD treatment asset. The company plans to submit the NDA this summer following positive feedback from the April 2, 2025 meeting. CTx-1301, a dexmethylphenidate-based medication, is positioned as the first true once-daily stimulant for full-day ADHD treatment.Key FDA agreements include: post-NDA approval commitment for additional stability data on 6 intermediate dose strengths, expected 24-month shelf-life at launch, adequacy of nonclinical safety data, ability to rely on Focalin XR's efficacy and safety data, and acceptance of the company's approach to integrated safety and efficacy summaries.

#CINGW #CING FDA and Cingulate Aligned with Filing Requirements for New Drug Application for Lead ADHD Asset CTx-1301

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Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets Cingulate Inc. (NASDAQ: CING) reported its Q1 2025 financial results and provided key updates on its drug development pipeline. The company completed a Pre-NDA meeting with the FDA for its lead ADHD asset CTx-1301 on April 2, 2025, maintaining its timeline for NDA submission in mid-2025. Recent Phase 3 safety data and food effect studies showed positive results for CTx-1301.The company received a $3 million non-dilutive grant to accelerate the development of CTx-2103 (buspirone) for anxiety treatment, to be paid in three $1 million installments. As of March 31, 2025, Cingulate had $9.5 million in cash, providing runway into Q4 2025. The company reported a Q1 2025 net loss of $3.8 million, up from $3.0 million in Q1 2024, with R&D expenses at $2.2 million and G&A expenses at $1.5 million.

#CINGW #CING Cingulate Inc. Reports First Quarter 2025 Financial Results and Provides an Updated Timeline of Key Developments for its lead ADHD and Anxiety Assets

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Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed

#CINGW #CING Cingulate Announces Positive Top-Line Results from High-Dose (50mg) Fed/Fast Study of Lead Asset CTx-1301 for ADHD

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Revolutionary Once-Daily Anxiety Drug Gets $3M Boost: Targeting $5.5B Market New grant accelerates development of first once-daily buspirone for anxiety disorders. Targeting $5.5B US market with innovative time-release technology. Full analysis inside.

#CINGW #CING Cingulate Receives $3 Million Grant from Private Foundation to Accelerate Development of Anxiety Asset CTx-2103 (buspirone)

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Breakthrough ADHD Treatment Clears Critical FDA Hurdle: Once-Daily Drug Shows Promise Novel ADHD treatment CTx-1301 progresses toward NDA submission with positive Phase 3 safety data. First-ever once-daily stimulant medication shows promise. Full analysis inside.

#CINGW #CING Cingulate Completes Pre-NDA Meeting with FDA to Discuss New Drug Application for lead ADHD Asset CTx-1301

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Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved Cingulate reported its full year 2024 and Q4 results, highlighting significant progress towards NDA submission for its ADHD treatment CTx-1301. The company secured a $17.5 million increase in working capital, extending cash runway into Q4 2025. Key developments include:- Scheduled FDA Pre-NDA meeting for April 2, 2025- Completed safety data from Phase 3 pediatric and adolescent studies with no serious adverse events- Finished final FDA-required food effect study- Secured European patent for CTx-1301Financial highlights:- Cash position: $12.2 million as of December 31, 2024- Working capital: $7.5 million- R&D expenses decreased to $9.4 million from $15.5 million in 2023- Net loss reduced to $15.5 million from $23.5 million in 2023

#CINGW #CING Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved

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Could This ADHD Drug Breakthrough End Multiple Daily Dosing? Cingulate's Phase 3 Results Point to Yes Cingulate reports no serious adverse events in final Phase 3 trials for once-daily ADHD treatment. FDA approval filing on track for mid-2025.

#CINGW #CING Cingulate Reports Safety Results from Final Phase 3 Trials for Lead ADHD Asset CTx-1301: On Track to File for FDA Approval Mid-2025

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Cingulate Completes Final FDA Study for Once-Daily ADHD Drug CTx-1301 with Zero Safety Issues Cingulate's breakthrough ADHD treatment CTx-1301 clears final FDA-required food effect study. Data readout expected Q2 2025, with NDA submission targeted for mid-2025.

#CINGW #CING Final Study Completed for Cingulate’s Lead Asset CTx-1301

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Cingulate Secures $5M Financing Deal to Advance CTx-1301 Drug Development Through 2025 Biotech firm Cingulate raises $5M through promissory note, extending cash runway to Q4 2025 and supporting planned NDA submission for CTx-1301 drug candidate.

#CINGW #CING Cingulate Completes Financing Transaction for Net Proceeds of $5,000,000

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