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Cingulate (CING) investor relations material
Cingulate Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Focused on developing once-daily, multi-dose therapies for ADHD and anxiety using proprietary drug delivery technology, with lead candidate CTx-1301 submitted for FDA review and a PDUFA date set for May 31, 2026.
No product revenue to date; operations funded by equity and debt, with cumulative capital raised of $116.1 million as of September 30, 2025.
Net loss for Q3 2025 was $7.3 million, up from $4.1 million in Q3 2024; accumulated deficit reached $126.1 million.
Management changes included the hiring of a new Chief Commercial Officer and interim CEO appointment following legal proceedings involving the former CEO.
Positive Phase 3 results for CTx-1301 were presented, showing dose-dependent improvements in ADHD symptoms and supporting once-daily dosing.
Financial highlights
Q3 2025 research and development expenses rose 99.5% year-over-year to $2.8 million, driven by personnel, manufacturing, and regulatory costs.
General and administrative expenses increased 69.7% year-over-year to $3.1 million, mainly due to personnel and commercial costs.
Net loss for Q3 2025 was $7.3 million, a 77.9% increase from Q3 2024; net loss for the nine months ended September 30, 2025 was $16.2 million, up 56.6% year-over-year.
Cash and cash equivalents were $6.1 million as of September 30, 2025, down $6.1 million from December 31, 2024.
Working capital was $1.6 million at quarter-end, a decrease from $7.7 million at the end of 2024.
Outlook and guidance
Cash on hand, including $6 million from a November 2025 debt issuance, is expected to fund operations into Q2 2026; an additional $7–9 million will be needed to advance commercialization through the PDUFA date.
Plans to continue seeking additional capital through equity, debt, or strategic transactions.
Focus remains on disciplined execution, operational efficiency, and long-term value creation.
Capital plan for $7M needed through PDUFA
CTx-1301 market differentiation strategy
Strategic implications of exclusive supply agreement?
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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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