Cingulate Inc. Reports Third Quarter 2026 Financial Results and Provides Regulatory Update on CTx-1301 NDA Resubmission

(NASDAQ:CING) Cingulate Inc. reported financial results for the quarter ended September 30, 2026, and provided an update on the regulatory status of its lead ADHD asset, CTx-1301. The company has substantially completed the manufacturing work required to address the FDA’s chemistry, manufacturing and controls (CMC) information requests for CTx-1301, following a Complete Response Letter (CRL) issued by the FDA on June 1, 2026. Cingulate expects to resubmit the new drug application (NDA) for CTx-1301 between December 2026 and January 2027. The FDA’s CRL did not raise concerns about the clinical safety or efficacy of CTx-1301. After resubmission, the FDA is expected to classify the NDA as a Class 1 or Class 2 resubmission, with review goals of two and six months, respectively. As of September 30, 2026, Cingulate had approximately $23,185,900 in cash and cash equivalents, compared to $10,953,383 as of December 31, 2025. The increase in cash was primarily due to capital raised during the first nine months of 2026, including a $12,000,000 private placement in the first quarter and $22,500,000 of capital raised through an At-the-Market Agreement with AGP and a Purchase Agreement with Lincoln Park Capital, partially offset by $20,400,000 in cash used for operations. Working capital as of September 30, 2026 was $18,832,234, up from $1,695,633 at December 31, 2025. Research and development expenses were $2,910,660 for the three months ended September 30, 2026, up from $2,848,544 for the same period in 2025, and $6,581,803 for the nine months ended September 30, 2026, down from $7,772,109 for the same period in 2025. Selling, general and administrative expenses were $4,580,358 for the three months ended September 30, 2026, compared to $3,147,291 for the same period in 2025, and $14,247,412 for the nine months ended September 30, 2026, compared to $6,579,735 for the same period in 2025. Net loss was $7,731,397 for the three months ended September 30, 2026, compared to $7,341,062 for the same period in 2025, and $22,913,750 for the nine months ended September 30, 2026, compared to $16,177,001 for the same period in 2025. Total assets as of September 30, 2026 were $28,150,677, with total liabilities of $7,383,547 and total stockholders' equity of $20,767,130. The company’s accumulated deficit as of September 30, 2026 was $155,288,781. Cingulate’s commercialization partner is Indegene. The company believes its cash and cash equivalents will be sufficient to fund operations into mid-2027, including costs associated with seeking regulatory approval for CTx-1301 and continuing the build-out of commercial readiness capabilities. CTx-1301 is a once-daily, multi-core tablet utilizing Cingulate’s proprietary Precision Timed Release™ (PTR™) platform, and is being evaluated for the treatment of ADHD under the FDA’s 505(b)(2) pathway. The PTR platform incorporates a proprietary Erosion Barrier Layer (EBL) formulation, Oralogik™, licensed from BDD Pharma.

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