GlobeNewswire·Nov 13, 2026, 4:45 PM ET

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

Cingulate Inc. (NASDAQ: CING) announced it has substantially completed manufacturing work to address FDA CMC information requests for its lead asset CTx-1301.
The company expects to resubmit the new drug application (NDA) for CTx-1301 between December 2026 and January 2027.
The FDA's June 2026 Complete Response Letter requested additional CMC data but raised no concerns regarding the clinical safety or efficacy of CTx-1301.
Following resubmission, the FDA is expected to classify the application as a Class 1 or Class 2 resubmission with review goals of two or six months.
As of September 30, 2026, Cingulate held approximately $23.2 million in cash and cash equivalents, an increase from $11.0 million in December 2025.
Working capital stood at approximately $18.8 million as of September 30, 2026, up from $1.7 million in December 2025.
The company estimates its current cash runway is sufficient to fund operations into mid-2027.
R&D expenses for the three months ended September 30, 2026, were $2.9 million, driven by higher manufacturing costs to address FDA requests.
SG&A expenses for the three months ended September 30, 2026, rose to $4.6 million due to the build-out of commercial readiness capabilities.
Net loss for the three months ended September 30, 2026, was $7.7 million, while the nine-month net loss was $22.9 million.
CTx-1301 is a once-daily, multi-core tablet utilizing the proprietary Precision Timed Release™ platform for the treatment of ADHD.

Company: Cingulate Inc.
Keywords: Nasdaq:CINGW, Cingulate Inc., Cingulate, CING, CTx-1301, NDA resubmission, ADHD, Precision Timed Release™, PTR™