DALLAS, TX -- November 18th, 2025 -- Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners updates their coverage on Cingulate Inc. (NASDAQ: CING). 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. 

Company Updates:

NDA Submission and FDA Approval Pathway: In 3Q25, Cingulate advanced CTx-1301 along a defined regulatory path. The NDA was accepted by the FDA under the 505(b)(2) pathway with a PDUFA target action date of May 31, 2026. The filing includes adult and pediatric Phase 3 data plus required clinical and CMC elements, demonstrating rapid onset, full-day symptom control, and a safety profile in line with long-acting methylphenidate products. Cingulate also received a small-business PDUFA fee waiver, preserving capital as it prepares for approval and launch.

Pipeline Update: Cingulate’s pipeline is led by CTx-1301, which uses the PTR platform to deliver three timed releases of dexmethylphenidate in a once-daily tablet designed for rapid onset and full active-day coverage. The Company is advancing CTx-1302 toward development for patients who respond better to amphetamine-based stimulants and progressing CTx-2103 for anxiety disorders. These programs highlight the scalability of PTR across large neuropsychc indications and support a broader strategy.

Balance Sheet, Cash Flows, and Financing Strategy: As of 3Q25, CING had $6.1M in cash and cash equivalents and ~$1.6M in working capital, reflecting continued investment in late-stage development and launch readiness. 3Q25 R&D rose to $2.8M from $1.4M y/y, and G&A increased to $3.1M from $1.9M, driven by Phase 3, NDA-support, and commercial planning costs. Net loss widened to $7.3M versus $4.1M in 3Q24, with $13.6M of net cash used in operations over the first nine months of 2025. Post quarter-end, a $6.0M unsecured promissory note extended the cash runway into 2Q26, as management continues to evaluate additional equity, debt, and partnership options to fund launch and early commercialization.

Management Update: Cingulate further strengthened its leadership as it enters the pre-launch phase for CTx-1301. Jennifer Callahan continues as Interim CEO and CFO alongside Executive Chairman Jay Roberts, providing continuity through FDA review, while industry veteran Bryan Downey has been appointed Chief Commercial Officer to lead launch preparation and go-to-market strategy. With more than 25 years of commercial experience, Downey will oversee execution of the Indegene partnership, including market access, omnichannel engagement, and field deployment ahead of a potential 2026 approval and launch.

Valuation: We use a Discounted Cahs Flow Model when valuing CING. Our model returns a valuation range of $15.29 to $31.44 with a mid-point of $21.86.

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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