Annovis Bio Announces Second Quarter 2023 Financial Results and Provides Corporate Update

Annovis Bio, Inc. (NYSE: ANVS), a late-stage clinical drug platform company developing transformative therapies to treat neurodegenerative diseases, including Alzheimer’s Disease (AD) and Parkinson’s Disease (PD) announced second quarter financial results for the period ended June 30, 2023, and reviewed recent accomplishments.

Second Quarter 2023 Highlights and New Developments

Clinical Updates

AD phase II/III study

• 52 sites have been activated and 201 patients have been screened through June 30: 61 patients have been enrolled to receive either one of three doses of buntanetap or placebo.
• This is a dose ranging trial of buntanetap (formerly known as posiphen or ANV401) in patients with mild to moderate Alzheimer’s Disease with a dosing treatment period of 12 weeks. Its mechanism of action, favorable toxicology profile, and oral mode of administration distinguish buntanetap as superior to other AD drugs. Other drugs attempt to remove just one neurotoxic protein and, at best, have a minor effect. Buntanetap has been shown to effectively stop the synthesis of four neurotoxic proteins -Amyloid Beta, Tau, alpha Synuclein, and TDP43 - the culprits behind nerve cell degeneration and death. Buntanetap’s early trials have shown its ability to reverse the destructive effects that Alzheimer’s Disease has on thinking and memory.

PD phase III study

• On June 3, Annovis announced it had reached full enrollment in the trial in a record nine months. Since the first patient was dosed in late August 2022, over 640 patients were screened and a total of 520 patients enrolled with 67 sites (43 in the United States and 24 in the European Union).
• The phase III trial is a randomized, double-blind, placebo-controlled trial investigating the efficacy, safety, and tolerability of buntanetap for early PD patients on top of their standard of care. By lowering levels of all the neurotoxic proteins, buntanetap improves axonal transport (the nerve cell’s information highway), which has been shown to be the cause of nerve cell degeneration and, ultimately, death.

• The record enrollment and low drop-out rate in this trial are believed to be due to the drug’s benefits demonstrated in the I/II trial: