Annovis Bio (ANVS) Q4 2025 earnings summary

Executive summary

• Achieved a major milestone with the initiation of a pivotal Phase 3 clinical trial in early Alzheimer's disease (AD), focusing on both symptomatic and disease-modifying effects over 18 months.

• Reported encouraging biomarker data from AD and Parkinson's disease (PD) programs, indicating buntanetap's potential disease-modifying activity.

• Launched an open-label extension (OLE) study in PD and advanced regulatory discussions for a new PD dementia study.

• Expanded management team with new CFO and Director of Biostatistics.

Financial highlights

• Research and development expenses rose to $25.2M for 2025 from $20.0M in 2024.

• General and administrative expenses decreased to $4.5M from $6.7M year-over-year.

• Net loss for 2025 was $28.9M, or $1.40 per basic and diluted share, compared to $24.6M, or $2.02/$2.31 per share in 2024.

• Cash and cash equivalents totaled $19.5M at year-end 2025, up from $10.6M at year-end 2024.

• 27.2M shares of common stock outstanding as of December 31, 2025.

Outlook and guidance

• Current cash and equivalents, including Q4 2025 stock offering proceeds, expected to fund operations into Q3 2026.

• Ongoing pivotal Phase 3 AD trial has enrolled 65% of target participants as of March 2026.

• OLE PD study enrolling patients to evaluate long-term safety and efficacy of buntanetap.