DALLAS, TX -- June 17th, 2025 -- Cingulate Inc. (NASDAQ: CING): Stonegate Capital Partners initiates their coverage on Cingulate Inc. (NASDAQ: CING). Cingulate reported 1Q25 results that highlight continued progress toward the commercial launch of its lead ADHD asset, CTx-1301. The Company remains focused on leveraging its proprietary Precision Timed Release™ (PTR™) platform to address long-standing gaps in ADHD treatment. CTx- 1301 is uniquely designed to provide once-daily stimulant therapy with rapid onset and sustained efficacy through the entire active day, addressing limitations of existing therapies that often require booster doses. With a differentiated profile targeting an estimated $22B U.S. ADHD market, CING is actively preparing for commercialization while pursuing potential out-licensing opportunities outside the U.S. and initiating scale-up plans for a targeted product launch upon FDA approval. 

Company Updates:

Phase 3 Pediatric Study and High-Dose Results: In May 2025, Cingulate announced positive efficacy results from its FDA-required Phase 3 fixed-dose pediatric trial of CTx-1301. All dose levels (18.75 mg, 25 mg, 37.5 mg) demonstrated statistically significant improvements on the ADHD-RS-5 scale within five weeks, with robust effect sizes ranging from 0.737 to 1.185. The Clinical Global Impression scale (CGI-I) also confirmed clinical improvements across doses compared to placebo. These findings follow April’s positive topline results from the high-dose (50mg) food effect study, which confirmed that CTx-1301 can be taken with or without food— supporting flexibility and adherence in real-world use.

NDA Submission and FDA Approval Pathway: Cingulate is on track to submit a New Drug Application (NDA) for CTx-1301 in mid-2025. The NDA will incorporate safety and efficacy data from nine clinical trials, including recent pediatric and adult studies. In March 2025, the Company submitted final Phase 3 safety results to the FDA and held a pre-NDA meeting in April. The safety profile of CTx-1301 remains strong, with no serious treatment-emergent adverse events and a favorable tolerability profile compared to existing extended-release stimulants. If approved, CTx-1301 would be the first true once-daily stimulant to offer rapid onset and full-day efficacy, potentially redefining the ADHD treatment paradigm.

Balance Sheet, Cash Flows, and Financing Strategy: As of 1Q25, Cingulate reported cash and cash equivalents of $9.5M and a total accumulated deficit of $112.3M. Net loss for the quarter was $3.8M, and operating cash burn totaled $4.6M for the quarter. The Company continues to actively evaluate strategic financing options, including equity raises, debt issuance, and partnerships—to support NDA filing, pre-launch activities, and clinical operations. In December 2024, Cingulate secured $5M in gross proceeds via an unsecured promissory note from Streeterville Capital, with initial monthly redemptions scheduled for July 2025. While current resources provide limited runway, successful financing and regulatory milestones will be critical in maintaining operational momentum through potential FDA approval.

Valuation: We use a Discounted Cash Flow Model when valuing CING. Our valuation model returns a range of $13.96 to $26.96 with a midpoint of $19.09. More details can be found on the Valuation page.

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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