Cingulate(CING) - 2025 Q2 - Quarterly Results

Overview and Recent Highlights Key Developments Cingulate submitted an NDA for CTx-1301, anticipating Q4 2025 FDA acceptance and mid-2026 approval, supported by $25 million equity financing - Submitted a New Drug Application (NDA) to the FDA for its lead asset CTx-1301 for ADHD on July 31, 2025[1][2] - Anticipates an FDA decision on NDA acceptance in Q4 2025, with a potential Prescription Drug User Fee Act (PDUFA) date in mid-2026[1] - Entered into a 36-month purchase agreement with Lincoln Park Capital for up to $25.0 million of common stock, providing opportunistic access to capital[2][3] Clinical Trial Updates Positive Q2 CTx-1301 clinical results from fed/fast and Phase 3 pediatric studies supported the NDA submission - Announced positive top-line results from a high-dose (50mg) fed/fast study, demonstrating that CTx-1301 can be administered with or without food[4] - Results from the Phase 3 pediatric study showed a marked improvement of ADHD symptoms at week five, highlighting the product's potential benefits[4] Financial Performance Second Quarter 2025 Financial Results Cingulate's Q2 2025 net loss increased to $4.8 million due to higher NDA-related expenses, with $8.9 million cash covering operations into late 2025 - Cash and cash equivalents stood at $8.9 million as of June 30, 2025. The company projects this will satisfy capital needs into late 2025 and will need to raise an additional $1.5 million to advance commercialization efforts into early 2026[5] Quarterly Expense Analysis | Expense Category | Q2 2025 (USD) | Q2 2024 (USD) | Change (%) | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $2.7 million | $1.9 million | +43.6% | Increased clinical and regulatory costs for NDA submission | | G&A Expenses | $1.9 million | $1.3 million | +47.1% | Increase in legal and financial advisory fees | | Net Loss | $4.8 million | $3.2 million | +50.0% | Primarily due to increased R&D costs | Consolidated Financial Statements Consolidated financials show declining position and worsening operating results, with Q2 2025 operating loss increasing to $4.6 million due to higher expenses Consolidated Balance Sheet Consolidated Balance Sheet Data | Account | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Cash and cash equivalents | $8,900,183 | $12,211,321 | | Total assets | $13,468,208 | $14,864,489 | | Total liabilities | $7,956,334 | $7,408,984 | | Working Capital | $3,489,921 | $7,688,698 | | Total stockholders' equity | $5,511,874 | $7,455,505 | Consolidated Statements of Operations Consolidated Statements of Operations Data | Account | Three Months Ended June 30, 2025 (USD) | Three Months Ended June 30, 2024 (USD) | | :--- | :--- | :--- | | Research and development | $2,700,939 | $1,881,093 | | General and administrative | $1,949,035 | $1,325,087 | | Operating loss | ($4,649,974) | ($3,206,180) | | Net loss | ($4,788,735) | ($3,209,677) | Corporate and Product Information About CTx-1301 and PTR™ Platform CTx-1301, an ADHD drug on Cingulate's PTR™ platform, provides once-daily dosing with three timed releases for full-day efficacy - CTx-1301 is a multi-core formulation of dexmethylphenidate designed to deliver three releases of medication at predefined times to provide rapid onset and entire active-day efficacy from a single tablet[13] - The PTR™ drug delivery platform uses a proprietary Erosion Barrier Layer (EBL) to control drug release at precise, pre-defined intervals[14] About ADHD Market The ADHD market offers significant opportunity with over 20 million U.S. patients, led by the larger, faster-growing adult segment - ADHD affects over 20 million diagnosed patients in the U.S., with 12 million adults and over 8 million under the age of 17[12] - Market trends show the adult ADHD segment is larger and growing faster than the child and adolescent segments combined[12] Company Overview Cingulate Inc. is a biopharmaceutical company leveraging its PTR™ platform to develop next-gen products, initially focusing on ADHD with plans for anxiety disorders - Cingulate is a biopharmaceutical company using its proprietary PTR™ platform to develop products designed to improve the lives of patients with conditions requiring complex daily dosing[15] - The company's initial focus is on ADHD, with plans to evaluate additional therapeutic areas like anxiety disorders for future product candidates[15]