Cingulate Posts Wider Loss in Q2

Key Points

• Cingulate submitted its New Drug Application (NDA) for CTx-1301 to the FDA, targeting the ADHD market, with an NDA acceptance decision expected in late 2025.

• Operating expenses increased for the three months ended June 30, 2025, resulting in a net loss of $4.8 million (GAAP) for Q2 2025 and reducing cash reserves to $8.9 million.

• Management indicated the need for at least $1.5 million in additional capital to sustain operations into early 2026.

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Cingulate (NASDAQ:CING), a biopharmaceutical company focused initially on ADHD and anxiety, released its second-quarter results on August 19, 2025. The company’s most noteworthy milestone was the submission of its NDA to the U.S. Food and Drug Administration for CTx-1301, a once-daily, extended-release medication for attention deficit/hyperactivity disorder (ADHD). Cingulate reported a net loss of $4.8 million (GAAP) as operating expenses spiked, and the reported net loss was deeper than last year’s. Overall, the quarter marked regulatory momentum but underlined the company’s need for new capital as cash reserves continued to decline.

Source: Analyst estimates for the quarter provided by FactSet.

Business Overview and Strategic Focus

Cingulate is an early-stage biopharmaceutical company that develops therapies for central nervous system disorders. Its main product candidate is CTx-1301, designed as an extended-release tablet for ADHD, targeting both pediatric and adult populations. The company leverages its Precision Timed Release (PTR) drug delivery platform, engineered to combine speed of action with all-day efficacy from a single daily dose.

The recent business focus has been on completing clinical trials and preparing regulatory submissions for CTx-1301. Achieving regulatory approval for this product is considered critical, as it would allow commercial entry into a U.S. ADHD market that numbers over 20 million diagnosed patients. Other key success factors include executing commercialization partnerships and expanding the PTR platform pipeline to diversify future revenue streams, including indications such as anxiety and insomnia.

Quarterly Performance: Financials, Product Progress, and Strategic Activity

In Q2 2025, Cingulate submitted its NDA for CTx-1301 to the FDA. The company highlighted top-line data from a high-dose study indicating that CTx-1301 can be taken with or without food. A positive phase 3 pediatric trial also showed strong symptom improvement by week five, reinforcing the clinical profile of CTx-1301.

The NDA submission on July 31, 2025, marks a pivotal regulatory step, with the company expecting an acceptance decision in the fourth quarter. If accepted, the Prescription Drug User Fee Act (PDUFA) date, the deadline by which the FDA must respond, would likely fall in mid-2026. FDA approval at that stage could enable a commercial launch in mid-2026.

This is expected for a company at this clinical stage. R&D expenses surged 43.6% year over year to $2.7 million. The company attributed these higher costs to work surrounding the NDA preparation, regulatory support, and ongoing clinical data analysis. General and administrative costs also grew 47.1% to $1.9 million, mainly on higher legal and advisory fees linked to the NDA process and public company requirements. These spending increases widened the operating loss and drove net loss (GAAP) to $4.8 million, up from $3.2 million in the same quarter of 2024.

Outside of drug development, Cingulate entered a capital agreement with Lincoln Park Capital. This agreement enables the company to sell up to $25.0 million in stock as needed over a 36-month term. The company noted that this arrangement gives it more flexibility in funding, especially as it approaches commercialization activities for CTx-1301. It did not announce any new marketing or licensing partnerships for its lead product or its PTR platform.

Product Pipeline and Technology Platform

Cingulate’s primary focus remains CTx-1301, an extended-release stimulant for ADHD formulated as a tablet using the PTR platform. This drug is designed to address common complaints about existing ADHD medications, such as the need for multiple daily doses, midday drops in effectiveness, or late-day rebounds in symptoms. The platform technology is built to precisely time the release of active drug, which could simplify dosing and improve daily control of symptoms.

The company’s intellectual property strategy continues to focus on defending its PTR delivery technology, which it says will be crucial in differentiating its products, maintaining market position, and extending patent protection as far as 2043.

Financial Position, Capital Needs, and Outlook

Cingulate ended Q2 2025 with $8.9 million in cash and cash equivalents, a 27% decrease from $12.2 million at the end of 2024, as of June 30, 2025. Working capital also declined, reflecting ongoing spending to advance CTx-1301 through the regulatory process. Management has stated that current cash will support operations into late 2025 under the existing plan, and about $1.5 million of additional funding is needed to sustain commercialization efforts through early 2026. The recently completed Lincoln Park Capital equity facility offers another potential source of funds, but accessing it would require additional share issuance and investor dilution.

Looking forward, Cingulate did not provide quantitative financial guidance for the coming quarters or for fiscal 2025. The only forward-looking disclosure concerns timing for the NDA acceptance (expected in the fourth quarter) and the projected PDUFA decision in mid-2026. The company indicated that cash management, potential fundraising, and progress on regulatory milestones will remain top priorities. CING does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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