Cingulate Q2 2024 Financial Results and Development Milestones Update

Cingulate Inc. (NASDAQ: CING), a biopharmaceutical firm specializing in developing next-generation pharmaceutical products using its proprietary Precision Timed Release™ (PTR™) platform technology, reported its financial results for the quarter ending June 30, 2024, and provided updates on its clinical and business progress.

CEO Shane Schaffer highlighted key achievements for the second quarter of 2024, particularly concerning Cingulate's lead product candidate, CTx-1301, aimed at treating ADHD. Significant milestones included receiving clearance from the FDA to file for marketing approval and completing the registration batches, positioning the company for a New Drug Application (NDA) submission in the first half of 2025. Schaffer also mentioned ongoing licensing explorations for CTx-1301, both domestically and internationally.

Regarding CTx-1301's development, Cingulate confirmed the FDA's clinical requirements for the NDA filing. The company is advancing with these requirements, including completing a Food Effect Study for the 50mg dose and analyzing data from the Phase 3 adult dose optimization study and the Phase 3 fixed dose pediatric and adolescent safety and efficacy study. Plans are underway for a pre-NDA meeting, with a targeted NDA submission in early 2025. Additionally, twelve registration batches necessary for the NDA have been manufactured, adhering to the FDA's commercial criteria.

Cingulate is actively pursuing additional licensing opportunities for CTx-1301. The company commissioned a payer study to assess coverage, reimbursement status, and policies for ADHD treatments. Ten payers representing over 121 million covered lives participated in the study. The findings suggest that CTx-1301 would likely gain coverage through the contracting process, given its perceived value and differentiation as a prospective ADHD treatment.

Financially, Cingulate raised $1.6 million through a warrant inducement, allowing holders of existing warrants to exercise at a reduced price in exchange for new common stock purchase warrants. The net proceeds were received on July 1, 2024.

In terms of Nasdaq listing compliance, Cingulate received an exception from the Nasdaq Hearings Panel to meet the $1.00 minimum bid price requirement by August 23, 2024. To comply, the company executed a one-for-twelve reverse stock split on August 9, 2024.

The company's financial position as of June 30, 2024, included $0.4 million in cash and cash equivalents, with an additional $1.6 million from the warrant inducement. Total liabilities stood at $2.0 million, a substantial decrease from $10.3 million at the end of 2023, including the conversion of a related party note payable. Stockholders' equity was $3.1 million, marking a $10.0 million increase from December 2023.

For the second quarter of 2024, R&D expenses were $1.9 million, a decrease of $2.6 million from the same period in 2023, due to reduced clinical activity and manufacturing costs. G&A expenses were $1.3 million, down by $0.6 million from the previous year, attributed to lower personnel and insurance expenses. Consequently, the net loss for the quarter was $3.2 million, a significant improvement from the $6.6 million loss in the second quarter of 2023.

Cingulate Inc. continues to focus on advancing its PTR™ technology platform and pipeline, initially targeting ADHD and potentially expanding into other therapeutic areas such as anxiety disorders. The company is headquartered in Kansas City, Kansas.