Cingulate published a fourth-quarter and full-year 2025 earnings release, reporting a Q4 net loss of USD 6.27 million and a FY net loss of USD 22.45 million. FY general and administrative expense rose 64% to USD 10.16 million, driven by higher pre-commercialization costs, personnel expenses and legal and professional fees. As of Dec. 31, cash and cash equivalents were USD 10.95 million and working capital was USD 1.7 million. The company said current cash on hand is expected to fund operations into late Q4 2026 under its current plan focused on regulatory approval and pre-commercialization for CTx-1301. Management said the FDA accepted the CTx-1301 NDA under the 505(b)(2) pathway with a PDUFA target action date of May 31, 2026, and that recent FDA information requests relate to manufacturing and CMC rather than clinical safety or efficacy.

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