Stonegate Capital Partners has updated its coverage on Cingulate Inc. (NASDAQ: CING), highlighting the company's third-quarter 2025 results and continued progress in transforming its lead candidate, CTx-1301, into a commercial franchise for attention-deficit/hyperactivity disorder. The update follows several key milestones that position Cingulate for a potential 2026 launch, subject to regulatory approval.
The U.S. Food and Drug Administration has accepted the New Drug Application for CTx-1301 under the 505(b)(2) pathway, setting a Prescription Drug User Fee Act target action date of May 31, 2026. The filing includes positive Phase 3 data from both adult and pediatric studies demonstrating rapid onset and full-day symptom control, alongside required clinical and chemistry, manufacturing, and controls elements. The company also received a small-business PDUFA fee waiver, preserving capital as it prepares for approval and commercialization.
CTx-1301 utilizes Cingulate's proprietary Precision Timed Release platform to deliver three timed releases of dexmethylphenidate in a once-daily tablet designed to address unmet needs in the large U.S. ADHD market. The company recently presented positive pediatric Phase 3 data and executed an exclusive commercial supply agreement with Bend Bio Sciences to secure U.S. manufacturing capacity ahead of launch. Further details on the company's pipeline and strategy can be found in the Stonegate Capital Partners research update.
Cingulate's pipeline extends beyond CTx-1301, with CTx-1302 advancing toward development for patients who respond better to amphetamine-based stimulants and CTx-2103 progressing for anxiety disorders. These programs demonstrate the scalability of the PTR platform across large neuropsychiatric indications and support a broader corporate strategy.
Financially, the company reported $6.1 million in cash and cash equivalents and approximately $1.6 million in working capital as of the third quarter of 2025. Research and development expenses increased to $2.8 million from $1.4 million year-over-year, while general and administrative expenses rose to $3.1 million from $1.9 million, driven by Phase 3 activities, NDA support, and commercial planning costs. The net loss widened to $7.3 million compared to $4.1 million in the third quarter of 2024. Following the quarter's end, a $6.0 million unsecured promissory note extended the company's cash runway into the second quarter of 2026.
Management has been strengthened as the company enters the pre-launch phase. Jennifer Callahan continues as Interim CEO and CFO alongside Executive Chairman Jay Roberts, providing continuity through the FDA review process. Industry veteran Bryan Downey, with more than 25 years of commercial experience, has been appointed Chief Commercial Officer to lead launch preparation and go-to-market strategy. Downey will oversee execution of the partnership with Indegene, focusing on market access, omnichannel engagement, and field deployment.
The implications of Cingulate's progress are significant for the ADHD treatment landscape. If approved, CTx-1301 could offer a new therapeutic option with a profile of rapid onset and sustained, full-day symptom control. For business and technology leaders monitoring the intersection of healthcare innovation and commercial strategy, Cingulate's journey illustrates the capital requirements, regulatory hurdles, and strategic partnerships necessary to bring a novel drug from late-stage development to market. The company's current positioning, with a defined regulatory path and commercial preparations underway, marks a critical inflection point as it approaches a potential 2026 launch.
