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Cingulate (CING) investor relations material
Cingulate Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary19 Aug, 2025
Executive summary
NDA for lead candidate CTx-1301, a novel extended-release ADHD treatment, submitted to FDA on July 31, 2025; FDA decision on acceptance expected in Q4 2025 and potential PDUFA date in mid-2026; PDUFA fee waiver received.
Positive Phase 3 pediatric and high-dose fed/fast study results for CTx-1301 support efficacy and flexible dosing.
No product candidates approved or revenue generated as of June 30, 2025; operations funded by $113.5M in capital raised since inception.
Recent management changes: CEO placed on leave due to legal proceedings, CFO appointed interim CEO, and new Executive Chairman named.
Entered a $25M equity purchase agreement with Lincoln Park Capital in July 2025 to support pre-commercial activities.
Financial highlights
Net loss for Q2 2025 was $4.8M, up 49.2% year-over-year, driven by higher R&D and G&A expenses; six-month net loss was $8.6M, up 39% year-over-year.
Cash and cash equivalents were $8.9M as of June 30, 2025, down $3.3M from December 31, 2024.
Working capital stood at $3.5M, a decrease of $4.2M from year-end 2024.
Operating expenses for Q2 2025: R&D $2.7M (up 43.6%), G&A $1.9M (up 47.1%).
Accumulated deficit reached $117.1M as of June 30, 2025.
Outlook and guidance
Cash expected to fund operations into late 2025; $1.5M additional capital needed to advance CTx-1301 commercialization into early 2026.
Additional capital required for further development of pipeline assets.
Anticipates FDA decision on NDA acceptance in Q4 2025 and potential product launch in mid-2026, pending approval.
Ongoing evaluation of equity, debt, and strategic transactions for funding.
Explain the intended release profile of CTx-1301.
Assess the impact of Lincoln Park agreement.
When will Cingulate need to raise more capital?
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Q3 20256 Nov, 2025
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Frequently asked questions
Cingulate Inc. is a biopharmaceutical company focused on developing treatments for central nervous system disorders. The company specializes in precision drug delivery technology to enhance the efficacy and control of medications. Its primary research targets attention-deficit/hyperactivity disorder (ADHD) and other cognitive and psychiatric conditions. Cingulate leverages its proprietary Precision Timed Release (PTR) platform to develop extended-release formulations for improved patient outcomes. The company is headquartered in Kansas City, Kansas, and its shares are listed on the NASDAQ.
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