Cingulate Inc. Reports Full Year 2024, Fourth Quarter Results, and Provides Development Update on Major Milestones Achieved
In-Person FDA Meeting Scheduled for April 2; New Drug Application Submission Targeted for Mid-2025$17.5 million increase in Working Capital; Cash Runway Extending into Q4, Well Beyond Target Date for NDA Submission
KANSAS CITY, Kan., March 26, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the twelve months ended December 31, 2024, and provided a clinical and business update. Highlights include the announcement of safety results from Cingulate's final Phase 3 trials for lead ADHD asset CTx-1301 (dexmethylphenidate), and confirmation of a scheduled in-person Pre-NDA meeting with the FDA.
"The capital raised over the past year has allowed us to strengthen our balance sheet and complete all required clinical trials for NDA submission for CTx-1301. We look forward to meeting with the FDA next week, submitting our new drug application this summer, and, assuming approval by the FDA, bringing to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day," said Cingulate Chairman and CEO Shane J Schaffer.
LEAD ASSET CTx-1301 HIGHLIGHTS
Cingulate is on-target for the NDA submission in mid-2025, following an in-person, pre-NDA meeting scheduled for April 2, 2025.
March 2025 - Cingulate released safety data from two Phase 3 pediatric and adolescent studies, a fixed dose study and a dose optimization study as well as its high-dose food effect study, noting no serious treatment emergent adverse events and confirming that the safety profile of CTx-1301 has remained remarkably consistent and unprecedented over the course of nine clinical trials. A final analysis that combines both adult and pediatric safety data will be prepared and included in the NDA submission.
January 2025 - Cingulate completed its final FDA-required study, a food effect study utilizing a single 50-mg dose of CTx-1301, the highest dosage being studied. The medical findings are consistent with the previous study performed with the 25mg dose which showed that CTx-1301 could be taken with or without food.
August 2024 - European patent for CTx-1301 issued. The patent application was granted on August 14, 2024, as EP Patent No. 3261625, and includes up to 30 European territories, including the United Kingdom. Cingulate holds additional patents in Australia, Canada and Israel. Patents are pending in Hong Kong, the Republic of Korea, and the United States.
July 2024 - Cingulate commissioned a managed care payor study in 2024 evaluating CTx-1301. The participants in the study represented over 121 million covered lives in the United States. The study reviewed current coverage and reimbursement status for ADHD treatments, assessed unmet medical needs and expectations for management of the category in the future, and tested the product profile to explore payer's perceptions and expectations, including perceived value, differentiation, and expected pricing, reimbursement and contracting potential. Key findings showed CTx-1301 to be the most valuable ADHD prospective treatment and is likely to gain coverage through the contracting process.
Cingulate continues to explore licensing agreements both inside and outside the United States.
BUSINESS UPDATE
Cingulate has increased its working capital by $17.5 million as compared to December 31, 2023, extending its cash runway into 4Q 2025, which is beyond the targeted NDA submission.
In 2024, Cingulate sold shares of common stock under its At-the-Market Offering Agreement with H.C. Wainwright & Co., LLC for net proceeds of $9.4 million and under its Purchase Agreement with Lincoln Park Capital for gross proceeds of $8 million.
In December 2024, Cingulate executed a $5.5 million non-convertible, unsecured promissory note with an accredited investor which provided net proceeds of $5 million.
On July 1, 2024, Cingulate closed a warrant inducement transaction for net proceeds of $1.6 million pursuant to which holders of certain of its existing warrants from the February 2024 public offering, agreed to exercise their warrants at a reduced exercise price. In consideration for the exercise of these warrants, the holders received new Series C and Series D common stock purchase warrants.
In February 2024, Cingulate closed a $7.5 million public offering of its common stock (or pre-funded warrants in lieu thereof) and Series A and Series B warrants to purchase shares of common stock.In January 2024, Werth Family Investment Associates, LLC (WFIA), the manager of which is Peter J. Werth, a member of the Cingulate board of directors, converted at a 10 percent premium to market the remaining $3.3 million of outstanding debt plus accrued interest into pre-funded warrants to purchase shares of common stock, demonstrating his continued support of the Company.
FULL YEAR AND FOURTH QUARTER RESULTS
Cash Position: As of December 31, 2024, Cingulate had approximately $12.2 million in cash and cash equivalents, a $12.1 million increase from December 31, 2023, providing the Company with an extended cash runway into the fourth quarter of 2025, beyond its targeted submission of the NDA for CTx-1301.
Working Capital (current assets less current liabilities): As of December 31, 2024, Cingulate had approximately $7.5 million in working capital, an increase of $17.2 million from December 31, 2023. This increase in working capital is reflective of a significant strengthening of the Company's balance sheet resulting from capital raised in 2024. Cingulate believes working capital is meaningful to investors as a measure of short-term financial health.
R&D Expenses: Research and development expenses were $9.4 million for the year ended December 31, 2024, compared to $15.5 million for the year ended December 31, 2023. Research and development expenses were $4.3 million for the three months ended December 31, 2024, compared to $5.0 million for the same period in 2023. This change was primarily the result of completed clinical activity in 2024 as compared to 2023. During 2023, two Phase 3 trials were initiated for CTx-1301, the fixed-dose pediatric and adolescent safety and efficacy study in addition to the pediatric dose optimization and duration study. Enrollment in these two trials was closed in early 2024 and the final data analysis will be included in the NDA submission for CTx-1301 which is targeted for mid-2025. Personnel costs also decreased in 2024 as the result of lower headcount and cost containment measures, which were implemented in late 2023 in order to conserve cash, including salary reductions ranging from 5-55% for all employees. 2023 base salaries were reinstated in September 2024.
G&A Expenses: General and administrative expenses were $6.2 million for the year ended December 31, 2024, compared to $7.3 million for the year ended December 31, 2023. General and administrative expenses remained consistent in the three months ended December 31, 2024, as compared to the three months ended December 31, 2023. The year over year decrease was primarily the result of a decrease in the personnel expenses, a decrease in the renewal premium for directors' and officers' insurance, offset with an increase in professional fees, including legal and investor relations related to our financing and shareholder communications.
Net Loss: Net loss was $15.5 million for the year ended December 31, 2024, compared to $23.5 million for the year ended December 31, 2023. Net loss was $6.1 million for the three months ended December 31, 2024, compared to $6.9 million for the same period in 2023. The decrease in the net loss relates to the completion in development activity over these periods as well as a decrease in personnel costs.
Cingulate Inc.
Consolidated Balance Sheet Data
December 31,
December 31,
2024
2023
Cash and cash equivalents
$
12,211,321
$
52,416
Total assets
$
14,864,489
$
3,491,436
Working capital
