BERWYN, PA — Annovis Bio, Inc. (NYSE: ANVS) recently announced second quarter financial results for the quarter ended June 30, 2022, and reviewed recent accomplishments.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of Annovis, commented: “Because of buntanetap’s unique mode of action, it has the potential to act on a variety of neurodegenerative disorders. As a result, in the second quarter, we have taken significant steps to expand our intellectual property portfolio as it relates to buntanetap. Importantly, the FDA has approved our Phase 3 clinical trial design in early PD patients. This approval affirms the Company’s path to securing approval for buntanetap to treat neurodegenerative diseases, including Parkinson’s and Alzheimer’s diseases, with longer treatment regimens.”
Recent Highlights and New Developments
- Receipt of positive FDA Notice for Buntanetap Phase 3 clinical trial in Parkinson’s Disease: The Company received notice from the FDA that the Phase 3 clinical study in early Parkinson’s patients may proceed. The FDA accepted the final protocol and the clinical development plan, approved the use of the Company’s new large-scale batch of good manufacturing practice material, and found the chronic toxicology in rats and dogs safe and adequate to support long-term human studies lasting decades compared to the previous restriction of one month.
- Submission of an international patent application to cover the treatment of neurological injuries caused by infections: The Company announced the submission of an international patent application under the Patent Cooperation Treaty for its drug platform buntanetap. The patent claims a method of inhibiting, preventing, or treating neurological injuries due to viral, bacterial, fungal, protozoan, or parasitic infections in humans.
- Cooperative Research and Development Agreement with the National Institute on Aging: The Company announced a Cooperative Research and Development Agreement (CRADA) with the National Institute on Aging (NIA), a part of the National Institutes of Health. Under this CRADA, NIA and Annovis are collaborating to develop pharmacodynamic biomarkers for buntanetap, focusing on isolating brain-derived extracellular vesicles (EV) containing potential biomarkers of neuronal function and viability.
Financial Results for the Second quarter of 2022
Cash, cash equivalents, and marketable securities were $36.0 million as of June 30, 2022. Research and development expenses for the quarter ended June 30, 2022, were $6.8 million, compared to $1.8 million for the same period in 2021. The increase was primarily the result of an increase of $2.4 million in clinical expenses as the Company incurred costs related to its upcoming Phase 3 study in early PD patients, an increase of $1.8 million for the cost of materials and an increase of $0.7 million in stock-based compensation expense. General and administrative expenses for the quarter ended June 30, 2022, were $1.9 million, compared to $0.7 million for the same period in 2021. The increase was primarily the result of an increase of $1.2 million in stock-based compensation expense.
For the quarter ended June 30, 2022, Annovis reported a net loss of $8.7 million, compared to a net loss of $2.5 million for the same period in 2021.
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