Cingulate Inc. Reports Second Quarter 2025 Financial Results and Provides Recent Highlights

Submitted New Drug Application (NDA) to the FDA for lead asset CTx-1301
Anticipate FDA Decision in Q4 2025 regarding NDA Acceptance with Potential PDUFA Date in Mid-2026

KANSAS CITY, Kan., Aug. 19, 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 quarter ended June 30, 2025, and provided recent highlights.

Recent Highlights:

On July 31, 2025, Cingulate submitted its NDA to the FDA for CTx-1301, a novel, extended-release tablet formulation of dexmethylphenidate designed to deliver a fast onset, entire active-day efficacy, and a smooth pharmacokinetic profile with a single dose, addressing major limitations of current ADHD therapies. The FDA guides that a decision is often made regarding acceptance of the NDA within 60 days. Submission of the NDA came after the following second quarter activities:

• Pre-NDA meeting with the FDA;
• Announcement of positive top-line results from the high dose (50mg) fed/fast study of CTx-1301, demonstrating that CTx-1301 can be taken with or without food; and
• Announcement of results of Phase 3 pediatric study of CTx-1301, demonstrating marked improvement of ADHD symptoms at week five, illustrating the potential benefits of the product and the value of the Precision Timed Release Platform.

In addition, on July 21, 2025, Cingulate entered into a purchase agreement with Lincoln Park Capital, pursuant to which Lincoln Park agreed to purchase from the Company from time to time, over the 36-month term of the agreement and at the Company’s sole discretion, up to an aggregate of $25.0 million of common stock (subject to certain limitations and satisfaction of the conditions set forth in the purchase agreement).

Jay Roberts, Executive Chairman of Cingulate’s Board of Directors, stated, “Submission of the NDA to the FDA for lead asset CTx-1301 marked a pivotal moment in Cingulate’s progression, reflecting years of dedication to developing a truly differentiated ADHD treatment through the Precision Timed Release platform. In addition, the recently executed agreement with Lincoln Park Capital allows management to be opportunistic in its capital needs as we prioritize pre-commercial activities in anticipation of the launch of lead asset CTx-1301 in mid-2026, pending FDA approval.”

SECOND QUARTER RESULTS

Cash and Working Capital: As of June 30, 2025, Cingulate had approximately $8.9 million in cash and cash equivalents, a $3.3 million decrease from December 31, 2024.  The Company expects its cash will satisfy its capital needs into late 2025 under the current business plan. To advance the commercialization efforts for CTx-1301 into early 2026, the Company will need to raise approximately $1.5 million of additional capital. As of June 30, 2025, Cingulate had approximately $3.5 million in working capital, a decrease of $4.2 million as compared to $7.7 million as of December 31, 2024.

R&D Expenses:  Research and development expenses were $2.7 million for the three months ended June 30, 2025, an increase of $0.8 million or 43.6% from the three months ended June 30, 2024. This change was the result of an increase in both clinical and regulatory costs due to activities which occurred in the preparation of the NDA submission of CTx-1301, including data analysis costs and regulatory consulting costs, partially offset by a decrease in manufacturing costs.

G&A Expenses:  G&A expenses were $1.9 million for the three months ended June 30, 2025, an increase of $0.6 million or 47.1% from the three months ended June 30, 2024. This is primarily the result of an increase in legal and financial advisory fees.

Net Loss: Net loss was $4.8 million for the three months ended June 30, 2025, compared to $3.2 million for the three months ended June 30, 2024. The increase in the net loss primarily relates to increased research and development costs as described above.