Stonegate Capital Partners Initiates Coverage on Cingulate Inc. (CING)

Rhea-AI Summary

Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's progress toward commercializing its lead ADHD treatment, CTx-1301. The drug leverages Cingulate's proprietary Precision Timed Release (PTR) platform to provide once-daily stimulant therapy with rapid onset and sustained efficacy, addressing key limitations in current ADHD treatments. CTx-1301 targets the substantial $22B U.S. ADHD market. The company plans to submit its New Drug Application (NDA) in mid-2025, supported by data from nine clinical trials, including successful pediatric and high-dose studies demonstrating strong efficacy, safety, and flexible dosing. Cingulate is simultaneously preparing for U.S. commercialization while exploring international out-licensing opportunities.

Positive

• Targeting large $22B U.S. ADHD market opportunity
• Successful completion of nine clinical trials showing strong efficacy and safety
• Innovative once-daily dosing solution addressing current treatment limitations
• On track for NDA submission in mid-2025
• Potential for additional revenue through international licensing opportunities

Negative

• None.

Dallas, Texas--(Newsfile Corp. - June 18, 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.

To view the full announcement, including downloadable images, bios, and more, click here.

Key Takeaways:

• Cingulate is on track to submit the NDA for CTx-1301 in mid-2025, including data from nine clinical trials.
• Pediatric and high-dose studies showed strong efficacy, safety, and flexible dosing for CTx-1301.
• The Company is actively preparing for U.S. launch and exploring out-licensing opportunities abroad.

Click image above to view full announcement.

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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.

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/255813

FAQ

What is Cingulate's (CING) main product CTx-1301 and how does it work?

CTx-1301 is an ADHD treatment utilizing Precision Timed Release technology to provide once-daily stimulant therapy with rapid onset and sustained efficacy throughout the day, eliminating the need for booster doses.

When is Cingulate (CING) planning to submit its NDA for CTx-1301?

Cingulate plans to submit the New Drug Application (NDA) for CTx-1301 in mid-2025.

What is the market size for ADHD treatment that Cingulate (CING) is targeting?

Cingulate is targeting an estimated $22 billion U.S. ADHD market.

How many clinical trials has Cingulate (CING) completed for CTx-1301?

Cingulate has completed nine clinical trials for CTx-1301, including pediatric and high-dose studies showing strong efficacy, safety, and flexible dosing.

What are Cingulate's (CING) commercialization plans for CTx-1301?

Cingulate is preparing for U.S. commercialization while simultaneously exploring out-licensing opportunities in international markets.