Cognition Therapeutics (CGTX) Q4 2025 earnings summary

Executive summary

• Focus shifted to developing zervimesine (CT-1812) for dementia with Lewy bodies (DLB) psychosis, following strong phase II results and regulatory feedback.

• Phase II SHIMMER study showed zervimesine slowed progression of neuropsychiatric symptoms in DLB by 86% versus placebo, especially for psychosis (hallucinations and delusions).

• Completed enrollment in the 545-patient Phase II START trial for early Alzheimer's disease; top-line results expected in 2027.

• Expanded access program (EAP) for DLB patients filled quickly, with consistent positive anecdotal feedback from patients and families.

• Published positive Phase II SHIMMER study results in DLB, showing strong therapeutic responses.

Financial highlights

• Cash, cash equivalents, and restricted cash at year-end 2025 totaled $37 million.

• Remaining NIA grant funds were $35.7 million.

• R&D expenses for 2025 were $37.2 million, down from $41.7 million in 2024.

• G&A expenses for 2025 were $10.6 million, down from $12.3 million in 2024.

• Net loss for 2025 was $23.5 million ($0.32 per share), improved from $34 million ($0.86 per share) in 2024.

Outlook and guidance

• Sufficient cash runway to fund operations and capital expenditures through Q2 2027.

• Awaiting FDA Division of Psychiatry meeting mid-2026 to finalize registrational trial design for DLB psychosis.

• Decision on registrational program in Alzheimer's disease to follow START study results in 2027.

• EAP program for DLB funded for another 9–12 months.

• Plans to seek EMA alignment for global DLB psychosis trial after FDA feedback.