New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$27m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Negative equity (-US$4.3m). Shareholders have been substantially diluted in the past year (118% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Market cap is less than US$100m (US$78.7m market cap). Announcement • Jul 07
Annovis Bio Reaches Full Enrollment in Pivotal Phase 3 Trial of Buntanetap for Early Alzheimer’S Disease Annovis Bio announced full enrollment of its pivotal Phase 3 trial (NCT06709014) evaluating buntanetap in patients with early Alzheimer’s disease. The trial enrolled 850 patients with pTau217-confirmed Alzheimer’s disease pathology across 83 clinical sites in the US. The pivotal Phase 3 Alzheimer’s disease study is a randomized, placebo-controlled, double-blind dual clinical trial designed with two pre-specified readouts: a 6-month analysis of symptomatic effects and an 18-month analysis of disease-modifying effects of daily oral buntanetap (30mg). The trial has recruited patients diagnosed with early Alzheimer’s disease (MMSE 20-28) who are positive for blood biomarker pTau217, which indicates Alzheimer's pathology in the brain. The primary endpoints will assess changes in cognition (ADAS-Cog13) and function (ADCS-iADL). This dual design will produce two distinct data readouts, each intended to support a separate regulatory submission for a New Drug Application. With the last patient expected to complete the 6-month treatment period in January 2027, followed by data cleaning and analysis, Annovis anticipates the following near-term milestones: First Quarter 2027: 6-month symptomatic top-line data readout; First Quarter 2028: 18-month disease-modifying top-line data readout. Regulatory submissions: The Company has already begun preparations for New Drug Application submissions to the U.S. Food and Drug Administration, building on guidance received during prior FDA interactions, to position Annovis for submission shortly after each respective readout. Announcement • Jul 02
Annovis Bio, Inc. Promotes Cheng Fang as Chief Scientific Officer Annovis Bio, Inc. announced the promotion of Cheng Fang, Ph.D., to Chief Scientific Officer, effective July 01, 2026. Dr. Fang joined Annovis in 2021 and most recently served as Senior Vice President, Research and Development. Dr. Fang will lead scientific strategy and research operations across the Company's Alzheimer's disease and Parkinson's disease programs, including translational science, clinical development, biomarker strategy, and regulatory interactions. Dr. Fang has held multiple senior leadership and academic roles spanning translational research, clinical development, and regulatory strategy, with a sustained focus on understanding and treating neurodegenerative diseases. She earned her Ph.D. in Neuroscience from The Pennsylvania State University and her B.S. in Biopharmaceutical Sciences from Nanjing University. 
