KANSAS CITY, Kan., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ:CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform to build a pipeline of next-generation products, today announced financial results for the quarter ended September 30, 2025, and provided recent corporate highlights.
Recent Highlights (Post-Q3)
FDA Accepts NDA for CTx-1301; PDUFA Date Set for May 31, 2026In October of 2025, the U.S. Food and Drug Administration (FDA) accepted Cingulate's New Drug Application (NDA) for CTx-1301 (dexmethylphenidate HCl), a once-daily, extended-release therapy designed to optimize ADHD treatment. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026, confirming the NDA is complete and ready for review.
Industry Veteran Bryan Downey Named Chief Commercial Officer; $6 Million Financing CompletedOn November 3, 2025, Cingulate appointed Bryan Downey as Chief Commercial Officer, and announced the completion of a $6 million financing transaction, further strengthening its balance sheet as the company prepares for potential commercialization. Downey brings over 25 years of experience in commercial strategy, leadership, and successful pharmaceutical launches, having held senior executive roles at Alfasigma USA, Jubilant Pharma, and Sanofi.
In conjunction with Downey's appointment, Cingulate completed a financing transaction with an accredited investor, providing net proceeds of $6 million. The transaction was structured as a $6,570,000 non-convertible, unsecured promissory note accruing interest at 9% per annum and maturing 18 months from issuance. The note provides the flexibility for Cingulate to begin monthly redemptions on the note subsequent to the CTx-1301 PDUFA date of May 31, 2026, subject to the terms of the note and other conditions. Cingulate intends to use the proceeds for working capital and other general corporate purposes. The summary of the financing terms herein is qualified in its entirety by the definitive agreements filed with the SEC.
Positive Phase 3 Results Presented at Annual AACAP Conference
The positive Phase 3 results from Cingulate's pivotal trial of CTx-1301 were recently presented by Ann Childress, M.D., at the AACAP Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5 (ADHD-RS-5), and Clinical Global Impression-Severity (CGI-S) scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.
"Cingulate has made meaningful progress this quarter toward key value-creating milestones," said Jay Roberts, Executive Chairman of Cingulate. "The FDA's acceptance of our NDA for CTx-1301, the appointment of an experienced commercial leader in Bryan Downey, and the completion of a $6 million financing collectively strengthen our position as we advance toward a potential 2026 launch. We remain focused on disciplined execution, operational efficiency, and creating long-term value for our shareholders."
Third Quarter Activities:
Commercial Supply Agreement Reached with Bend Bio Sciences
Cingulate announced in September that it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301. Under the new agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if approved by the FDA, and Cingulate has committed to purchasing 100% of its overall U.S. commercial supply of CTx-1301 from Bend, following and subject to any FDA approval.
$4.3 Million PDUFA Fee Waiver Granted by FDA
In July Cingulate received a fiscal year 2025 PDUFA (Prescription Drug User Fee Act) fee waiver from the FDA for its NDA for CTx-1301. Granted through the small business waiver provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the waiver will save the Company approximately $4.3 million.
THIRD QUARTER RESULTS
Cash and Working Capital: As of September 30, 2025, Cingulate had approximately $6.1 million in cash and cash equivalents, a $6.1 million decrease from December 31, 2024. The Company expects its cash will satisfy its capital needs into the second quarter of 2026 under the current business plan. To advance the commercialization efforts through the May 31, 2026 PDUFA date for CTx-1301, the Company will need to raise approximately $7.0 million of additional capital. As of September 30, 2025, Cingulate had approximately $1.6 million in working capital, a decrease of $6.1 million as compared to $7.7 million as of December 31, 2024.
R&D Expenses: Research and development expenses were $2.8 million for the three months ended September 30, 2025, an increase of $1.4 million or 99.5% from the three months ended September 30, 2024. This change was the result of an increase in personnel expenses, manufacturing costs and regulatory costs. Personnel expenses increased due to separation costs for an executive in August 2025 as well as costs related to the contingent bonus plan, which were accrued upon the NDA submission of CTx-1301 in the third quarter of 2025. The increase in manufacturing costs was due to more significant manufacturing costs in 2025 related to activity in preparation of the manufacturing of the process validation batches of CTx-1301. Regulatory costs increased due to preparation for the NDA submission.
G&A Expenses: G&A expenses were $3.1 million for the three months ended September 30, 2025, an increase of $1.3 million or 69.7% from the three months ended September 30, 2024. This is primarily the result of an increase personnel and other expenses. The increase in personnel expenses was due to costs related to the contingent bonus plan, which were accrued upon the NDA submission of CTx-1301 in the third quarter of 2025. Other costs increased primarily due to commercial costs incurred in preparation of a potential mid-2026 launch of CTx-1301.
Net Loss: Net loss was $7.3 million for the three months ended September 30, 2025, compared to $4.1 million for the three months ended September 30, 2024. The increase in the net loss primarily relates to increased research and development costs and G&A expenses as described above.
Cingulate Inc.
Consolidated Balance Sheet Data
September 30,
December 31,
2025
2024
Cash and cash equivalents
$
6,118,710
$
12,211,321
Total assets
$
10,518,892
$
14,864,489
Total liabilities
$
7,045,206
$
7,408,984
Working Capital
$
1,551,025
$
7,688,698
Accumulated deficit
$
