Annovis Bio Announces Second Quarter 2023 Financial Results and Provides Corporate Update - Seite 2

• It showed improvements in both body and motor function.
• It is easily administered as a once daily pill.
• It is safe and well-tolerated.

• The study is expected to conclude in November with top-line assessment data available by the end of the year.

• Annovis announced on June 20 the positive safety review by the Data and Safety Monitoring Board (DSMB) for its phase III trial of buntanetap for PD. The DSMB recommended that Annovis continue the trial as originally designed.

• The feedback from the DSMB included:

• There were no drug-related SAEs (serious adverse events).
• Each AE (adverse event) was less than 2 percent.
• The dropout rate was 6 percent – significantly below expectations.
• Patients enrolled well ahead of the expected timeline: 9 months to enroll 523 patients.

The planned enrollment has been achieved and based on this DSMB endorsement, Annovis expects topline results by the end of 2023.

Patents

• Annovis announced on June 27, 2023, the creation of a novel crystalline form of buntanetap (ANVS402) and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office. (ANVS402 is covered by a composition of matter claim as well as multiple claims for chronic and acute neurodegenerative diseases and for neuropsychiatric indications.)

• This composition of matter patent is a trailblazing patent for any pharmaceutical company developing a new drug; ANVS402 is the same essential drug as the previous form but offers structural advantages, including:
  • better stability
  • higher purity
  • longer half-life, improving buntanetap’s effectiveness.

• Approval of this patent will come with protection of ANVS402 and all its uses for a 20-year patent term. This significant time frame will enable Annovis to continue working on its robust pipeline, moving forward expeditiously toward developing novel drug therapies for many neurodegenerative diseases.

Financial Results (for the quarter ending June 30, 2023)