Cingulate Inc. has achieved several critical milestones in advancing CTx-1301 toward potential commercialization as a new treatment option for attention-deficit/hyperactivity disorder. The company's third-quarter 2025 results demonstrate continued progress in transforming CTx-1301 into a commercial ADHD franchise, with the Food and Drug Administration accepting the New Drug Application under the 505(b)(2) pathway and setting a Prescription Drug User Fee Act target action date of May 31, 2026. This regulatory advancement represents a significant step toward bringing a new therapeutic option to the substantial U.S. ADHD market.
The NDA submission includes comprehensive adult and pediatric Phase 3 data demonstrating CTx-1301's rapid onset and full-day symptom control capabilities. Recent presentation of positive pediatric Phase 3 data further validates the medication's profile, showing it provides entire active-day symptom control while maintaining a safety profile consistent with existing long-acting methylphenidate products. The treatment utilizes Cingulate's proprietary Precision Timed Release platform technology to deliver three timed releases of dexmethylphenidate in a single daily tablet, addressing key limitations of current ADHD medications.
Beyond CTx-1301, Cingulate is advancing its broader pipeline, including CTx-1302 for patients who respond better to amphetamine-based stimulants and CTx-2103 for anxiety disorders. These programs highlight the scalability of the PTR platform across multiple neuropsychiatric indications and support the company's broader strategic vision. The technology's potential application across multiple large market indications represents significant long-term value creation opportunity.
Financially, Cingulate reported $6.1 million in cash and cash equivalents and approximately $1.6 million in working capital as of third-quarter 2025. Research and development expenses increased to $2.8 million from $1.4 million year-over-year, while general and administrative costs rose to $3.1 million from $1.9 million, reflecting increased investment in late-stage development and launch preparation activities. The company secured a $6.0 million unsecured promissory note post-quarter-end, extending its cash runway into second-quarter 2026 as management evaluates additional financing options to support potential launch and early commercialization efforts.
Leadership changes further strengthen Cingulate's position as it enters the critical pre-launch phase. Jennifer Callahan continues as interim CEO and CFO alongside Executive Chairman Jay Roberts, providing continuity through the FDA review process. The appointment of industry veteran Bryan Downey as Chief Commercial Officer brings more than 25 years of commercial experience to lead launch preparation and go-to-market strategy execution. Downey will oversee the implementation of the company's partnership with Indegene, including market access initiatives and omnichannel engagement strategies. Additionally, the company has executed an exclusive commercial supply agreement with Bend Bio Sciences to secure U.S. manufacturing capacity ahead of potential product launch, ensuring supply chain readiness should FDA approval be granted.
