Cingulate Is Maintained at Buy by Ascendiant Capital

Dallas, Texas--(Newsfile Corp. - November 18, 2025) - Cingulate Inc. : Stonegate Capital Partners updates their coverage on Cingulate Inc. . Cingulate's 3Q25 results reflect continued progress toward transforming CTx-1301 into a commercial ADHD franchise. Recently the Company achieved several key milestones, including FDA acceptance of the CTx-1301 NDA with a May 31, 2026 PDUFA date, presentation of positive pediatric Phase 3 data demonstrating rapid onset and entire active-day symptom control, and execution of an exclusive commercial supply agreement with Bend Bio Sciences to secure U.S. manufacturing capacity ahead of launch. Together with its PTR platform and focused commercial strategy, Cingulate is positioning CTx-1301 to address unmet needs in the large U.S. ADHD market as it prepares for a potential 2026 launch, subject to FDA approval.

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Key Takeaways:

• NDA for CTx-1301 accepted with a PDUFA date set for May 31, 2026 supporting a potential 2026 launch pending approval.
• Quarter end cash was ~$6.1M and a $6M financing post quarter extended runway into 2Q26.
• Commercial build advancing with Bryan Downey named Chief Commercial Officer plus Indegene partnership and Bend Bio Sciences supply to secure U.S. manufacturing.

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About StonegateStonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.

Contacts:

Stonegate Capital Partners

(214) 987-4121

info@stonegateinc.com

Source: Stonegate, Inc.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275080

Q3 2025 saw a net loss of $7.3M, driven by higher R&D and G&A expenses, with cash reserves of $6.1M. The NDA for the lead ADHD candidate was accepted by the FDA, but additional capital is needed to fund operations through the PDUFA date in mid-2026.

Original document: Cingulate Inc. [CING] SEC 10-Q Quarterly Report — Nov. 13 2025

FDA accepted the NDA for CTx-1301 with a May 2026 PDUFA date, following positive Phase 3 results. Q3 net loss widened to $7.3 million due to higher R&D and G&A expenses, and $6 million in new financing was secured to support commercialization efforts.

Original document: Cingulate Inc. [CING] SEC 8-K Current Report — Nov. 13 2025