Dallas, Texas--(Newsfile Corp. - April 6, 2026) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate's 4Q25 update continues to position CTx-1301 toward a potential commercial ADHD launch, with the regulatory focus now centered on manufacturing (CMC) rather than clinical performance. The NDA remains under FDA review under the 505(b)(2) pathway, and recent financing, IP progress, and commercial buildout efforts remain supportive of the broader investment thesis. Importantly, following the $12M PIPE completed in February 2026, the Company has a pro forma cash balance of approximately ~$23M, which we estimate provides runway into late 2026. Combined with ongoing access to capital through its ATM and ELOC facilities, we believe Cingulate is positioned to fund ongoing regulatory and manufacturing activities as it works toward resolution of remaining CMC items.

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Key Takeaways:

• FDA feedback limited to manufacturing/CMC; no safety or efficacy concerns, positioning remaining work as addressable process validation rather than clinical risk.
• Regulatory timing may shift, but approval remains likely; delay driven by manufacturing validation, not fundamental issues with product profile.
• Large ADHD market opportunity: ~1% share implies ~$250M revenue potential for CTx-1301, primarily targeting the booster-dose segment, as disclosed by the Company.

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About Stonegate
Stonegate 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.

Source: Stonegate, Inc.

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