Dallas, Texas--(Newsfile Corp. - June 4, 2026) - Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates coverage on Cingulate Inc. (NASDAQ: CING). Cingulate's latest update shifts the near-term CTx-1301 setup from a PDUFA driven approval event to a CMC-driven resubmission process, while leaving the core product thesis intact based on the information disclosed. The FDA issued a Complete Response Letter for the CTx-1301 NDA focused on specific CMC information requests, with no current clinical safety or efficacy concerns identified. In our view, the key read-through is timing rather than product viability, as the path forward now depends on completing the requested CMC work, resubmitting to FDA, and moving through the next review cycle. Importantly, Cingulate disclosed nearly $30M of cash on hand, which management believes is sufficient to address the FDA's requests, execute the resubmission process, and continue pre-commercial activities into 2027.

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Key Takeaways:

• Regulatory risk shifted to execution timing, not clinical viability. The CRL was focused on CMC information requests, with no current clinical safety or efficacy concerns identified, keeping the CTx-1301 product thesis intact while moving the key catalyst to resubmission timing.
• CTx-1301 remains differentiated in a large ADHD stimulant market. Its once-daily, tri-modal PTR design targets morning onset, sustained active-day coverage, and reduced booster use, positioning the product against a U.S. stimulant market Cingulate frames at over 100M prescriptions and approximately $10B.
• Cash runway supports the resubmission and launch-prep bridge. With nearly $30M of cash, management believes Cingulate can complete the FDA response, move through resubmission, and continue pre-commercial work into 2027, supporting potential 2H27 revenue generation.

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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.

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Source: Stonegate, Inc.