Cingulate Inc. 8K

Cingulate Inc. announced Q2 2026 results, reported cash runway into mid-2027, detailed progress toward resubmitting the CTx-1301 NDA after an FDA CMC-focused Complete Response Letter, obtained new U.S. patent protection for CTx-1301, and advanced key commercial readiness partnerships and activities.

On August 13, 2026, Cingulate Inc. reported its second quarter 2026 financial results, highlighted by $28.4 million in cash and cash equivalents as of June 30, 2026 providing expected operating runway into mid-2027, and provided a corporate update on its lead ADHD product candidate CTx-1301, including continued CMC work toward resubmission of its NDA following a June 1, 2026 FDA Complete Response Letter limited to CMC issues, issuance of a new U.S. patent protecting CTx-1301 through December 2042, and multiple commercial readiness steps such as an exclusive distribution agreement with Prasco, manufacturing activities with Bend Bioscience, commercialization support under a master services agreement with Indegene, and planned field deployment with IQVIA, while also disclosing higher SG&A expenses related to commercialization build-out and a net loss of $5.9 million for the quarter.

Filing Facts

CIK

1862150

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-037605

Alert Tier

6