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Dec 30, 2024
Annovis Bio Q4 2024 Earnings Report
Annovis Bio reported its financial results for the fourth quarter and full fiscal year ended December 31, 2024.
Key Takeaways
Annovis Bio made significant progress in 2024, advancing its buntanetap program with successful completion of two clinical trials and FDA clearance for a pivotal Phase 3 trial in early AD. The company reported a net loss of $5.86 million for Q4 2024, an improvement from the previous year, and ended the year with increased cash and cash equivalents.
Successfully completed two clinical trials (Phase 2/3 AD and Phase 3 PD) for buntanetap, showing promising results.
Received FDA clearance to proceed with a pivotal Phase 3 trial for early AD, launched in early 2025.
Reported a net loss of $5.86 million for Q4 2024, an improvement from a $22.21 million net loss in Q4 2023.
Cash and cash equivalents increased to $10.6 million as of December 31, 2024, up from $5.8 million as of December 31, 2023.
Annovis Bio
Annovis Bio
Forward Guidance
Annovis Bio expects its current cash and cash equivalents, including proceeds from a recent $21.0 million stock offering, to fund operations into the fourth quarter of 2025. The company is focused on generating robust data for buntanetap and advancing its path to patients.
Positive Outlook
- Pivotal Phase 3 AD study launched in early 2025.
- Symptomatic data from Phase 3 AD study anticipated in mid-2026.
- Disease-modifying data from Phase 3 AD study anticipated in mid-2027.
- Both symptomatic and disease-modifying data expected to support respective New Drug Applications (NDAs).
- Current cash and cash equivalents, including recent stock offering proceeds, are expected to fund operations into Q4 2025.
Challenges Ahead
- No specific negative forward guidance was provided in the report.
- The company continues to operate at a net loss.
- Future funding beyond Q4 2025 will be required.
- Clinical trial outcomes are inherently uncertain.
- Regulatory approvals are not guaranteed.