Stonegate Capital Partners has initiated coverage on Cingulate Inc. (NASDAQ: CING), drawing attention to the company's promising lead asset, CTx-1301, for ADHD treatment. This development is significant as CTx-1301, leveraging Cingulate's proprietary Precision Timed Release™ (PTR™) platform, aims to offer a once-daily stimulant therapy with rapid onset and sustained efficacy, addressing the limitations of existing treatments that often require additional booster doses.
The coverage comes on the heels of Cingulate's announcement of positive efficacy results from its FDA-required Phase 3 fixed-dose pediatric trial of CTx-1301. The trial demonstrated statistically significant improvements across all dose levels, with robust effect sizes, marking a pivotal step towards the drug's potential FDA approval and subsequent commercial launch. The ability of CTx-1301 to be taken with or without food, as confirmed by recent studies, further underscores its potential to enhance patient adherence and flexibility in treatment.
Cingulate is preparing to submit a New Drug Application (NDA) for CTx-1301 in mid-2025, incorporating data from nine clinical trials. The drug's strong safety profile and the absence of serious treatment-emergent adverse events position it as a potentially groundbreaking option in the estimated $22 billion U.S. ADHD market. If approved, CTx-1301 could redefine ADHD treatment paradigms by offering the first true once-daily stimulant with full-day efficacy.
Financially, Cingulate reported a net loss of $3.8 million for the first quarter of 2025, with an operating cash burn of $4.6 million. The company is exploring strategic financing options to support its NDA filing and pre-launch activities, highlighting the critical role of upcoming regulatory milestones and financial strategies in its path to commercialization.
The initiation of coverage by Stonegate Capital Partners not only underscores the potential of CTx-1301 to fill unmet needs in ADHD treatment but also reflects the broader implications for the healthcare industry and patients seeking more effective and convenient treatment options. With the ADHD market's significant size and the limitations of current therapies, Cingulate's progress represents a noteworthy development in the pursuit of innovative healthcare solutions.
