Cingulate Reports Q2 Loss of $4.8 Million, NDA Submission for ADHD Drug CTx-1301

Cingulate, a biopharmaceutical company focused on ADHD and anxiety, reported a net loss of $4.8 million in Q2 2025 due to increased operating expenses. The company submitted its NDA for CTx-1301 to the FDA, targeting the ADHD market, with an NDA acceptance decision expected in late 2025. Cingulate's cash reserves reduced to $8.9 million, and management indicated a need for at least $1.5 million in additional capital to sustain operations into early 2026.

Biopharmaceutical company Cingulate Inc. (NASDAQ: CING) has reported its financial results for the second quarter of 2025, highlighting a net loss of $4.8 million and the submission of its New Drug Application (NDA) for CTx-1301, an ADHD treatment, to the U.S. Food and Drug Administration (FDA).

The company's operating expenses increased significantly, leading to a net loss that was $1.6 million deeper than the previous year's loss. General and administrative expenses rose by 47.1% to $1.9 million, largely due to higher legal and advisory fees related to the NDA process and public company requirements. Research and development (R&D) expenses also increased by 43.6% to $2.7 million, driven by costs associated with NDA preparation and ongoing clinical data analysis.

Cingulate's cash reserves stood at $8.9 million at the end of Q2 2025, a 27% decrease from the end of 2024. The company has indicated that the current cash will support operations into late 2025 under the existing plan, but an additional $1.5 million in capital is needed to sustain commercialization efforts for CTx-1301 into early 2026.

In a significant milestone, Cingulate submitted its NDA for CTx-1301 to the FDA on July 31, 2025. The company expects an NDA acceptance decision in the fourth quarter of 2025, with a potential Prescription Drug User Fee Act (PDUFA) date in mid-2026. If approved, CTx-1301 could be commercially launched in mid-2026.

Cingulate has also secured a $25 million purchase agreement with Lincoln Park Capital over a 36-month period to support pre-commercial activities. This agreement provides a potential funding mechanism but may come at the cost of dilution.

Overall, while Cingulate has made regulatory progress with the submission of its NDA for CTx-1301, its financial position remains a concern with a significant net loss and dwindling cash reserves. The company will need to navigate the FDA review process successfully while managing its cash position to reach potential commercialization.

References:
[1] https://www.nasdaq.com/articles/cingulate-posts-wider-loss-q2
[2] https://www.stocktitan.net/news/CINGW/cingulate-inc-reports-second-quarter-2025-financial-results-and-63a7j0n3vb5b.html