Cingulate Inc. Reports $15.5 Million Net Loss for Fiscal Year 2024, Down from $23.5 Million

Cingulate Inc., a biopharmaceutical company focused on developing innovative treatments for Attention Deficit/Hyperactivity Disorder (ADHD) and anxiety, reported a net loss of $15.5 million for the fiscal year ending December 31, 2024, a decrease from a loss of $23.5 million in the previous year. The company's total operating expenses for 2024 were approximately $15.6 million, down 31.3% from $22.8 million in 2023. This reduction in losses is attributed to decreased research and development costs, which fell by 39% to $9.4 million, primarily due to the completion of significant clinical trials for its lead product candidate, CTx-1301.

Cingulate's financial performance reflects a strategic shift as the company prepares for the anticipated submission of a New Drug Application (NDA) for CTx-1301 in mid-2025. The company has made significant progress in its clinical development pipeline, including the completion of a Phase 3 adult dose-optimization study for CTx-1301, which demonstrated a trend toward efficacy in improving ADHD symptoms. However, the study did not achieve statistical significance on its primary endpoint. The company has also initiated two Phase 3 studies in pediatric and adolescent populations, although enrollment was closed based on FDA guidance, and data consolidation is currently underway.

Operationally, Cingulate has focused on enhancing its manufacturing capabilities through a partnership with Bend Biosciences, which will produce clinical and commercial batches of CTx-1301. The company is also actively seeking strategic partnerships for the commercialization of its products, particularly CTx-1301, to ensure successful market entry upon receiving FDA approval. As of December 31, 2024, Cingulate had 13 employees, a reduction from previous years, as part of cost containment measures implemented to conserve cash.

Looking ahead, Cingulate anticipates continued operating losses as it invests in the development and commercialization of its product candidates. The company has raised approximately $107.3 million since its inception, primarily through public and private capital raises, and expects its current cash reserves to sustain operations into the fourth quarter of 2025. However, additional capital will be necessary to advance its commercialization efforts and support ongoing research and development activities. The company faces significant risks, including the need for further funding, regulatory approval challenges, and competition from established pharmaceutical companies in the ADHD and anxiety treatment markets.