FAQ: Stonegate Capital Partners' Coverage Update on Cingulate Inc. (CING) Q2 2025

What is the main focus of Stonegate Capital Partners’ update on Cingulate Inc.?

The update focuses on Cingulate’s progress toward the commercial launch of its lead ADHD asset, CTx-1301, including the recent NDA submission to the FDA, pipeline advancements, financial position, and management changes.

Why is the NDA submission for CTx-1301 significant for Cingulate?

The NDA submission represents Cingulate’s first regulatory application of its Precision Timed Release™ (PTR™) platform and could lead to FDA approval with a potential PDUFA date in mid-2026, addressing significant unmet need in ADHD treatment.

How does Cingulate’s PTR™ platform differentiate its ADHD treatments?

The PTR™ platform is designed to enable true once-daily dosing for ADHD treatments, addressing gaps in current therapies by providing full-day coverage through precision timed release technology.

What are the key financial metrics for Cingulate as of Q2 2025?

As of Q2 2025, Cingulate reported $8.9M in cash and cash equivalents, $3.5M in working capital, with R&D expenses of $2.7M (up 44.0% y/y) and a net loss of $4.8M for the quarter.

When is the FDA expected to make a decision on CTx-1301?

The FDA is expected to decide on acceptance of the NDA by Q4 2025, which could set up a potential PDUFA date in mid-2026 for CTx-1301.

What management changes occurred at Cingulate in August 2025?

On August 15, 2025, Jennifer Callahan was appointed Interim CEO while continuing as CFO, and board member Jay Roberts was appointed Executive Chairman to enhance leadership focus during the pre-commercial phase.

What is Stonegate Capital Partners’ valuation range for Cingulate?

Stonegate’s valuation model returns a range of $15.03 to $30.46 with a midpoint of $21.28, using a Discounted Cash Flow Model.

What other products are in Cingulate’s pipeline beyond CTx-1301?

Cingulate is advancing CTx-1302 (dextroamphetamine) with pivotal-stage studies planned and early-stage candidate CTx-2103 for anxiety disorders, demonstrating the scalability of the PTR™ platform.

How is Cingulate funding its commercialization efforts?

Cingulate has a $25 million purchase agreement with Lincoln Park Capital for additional financial flexibility, though current resources are expected to fund operations only into late 2025, requiring additional financing for early 2026 commercialization.