BERWYN,
Pa., Aug. 8, 2022 /PRNewswire/ -- Annovis Bio,
Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a
clinical-stage drug platform company addressing neurodegenerative
diseases, today 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.
About Annovis Bio, Inc.
Headquartered in Berwyn,
Pennsylvania, Annovis Bio, Inc. (Annovis) is a
clinical-stage, drug platform company addressing neurodegeneration,
such as Alzheimer's disease (AD), Parkinson's disease (PD), and
other chronic neurodegenerative diseases, including Alzheimer's in
Down Syndrome (AD-DS). We believe that we are the only company
developing a drug for AD, PD, and AD-DS that inhibits more than one
neurotoxic protein and, thereby, improves the information highway
of the nerve cell, known as axonal transport. When this information
flow is impaired, the nerve cell gets sick and dies. Annovis
conducted two Phase 2 studies: one in AD patients and one in both
AD and PD patients. In the AD/PD study buntanetap showed
improvements in cognition and memory in AD as well as body and
brain function in PD patients.
For more information on Annovis Bio, please visit the Company's
website www.annovisbio.com and follow us
on LinkedIn and Twitter.
Forward-Looking Statements
Statements in this press release contain "forward-looking
statements" that are subject to substantial risks and
uncertainties. Forward-looking statements contained in this press
release may be identified by the use of words such as "anticipate,"
"expect," "believe," "will," "may," "should," "estimate,"
"project," "outlook," "forecast" or other similar words, and
include, without limitation, statements regarding the timing,
effectiveness, and anticipated results of buntanetap clinical
trials. Forward-looking statements are based on Annovis Bio, Inc.'s
current expectations and are subject to inherent uncertainties,
risks and assumptions that are difficult to predict. Further,
certain forward-looking statements are based on assumptions as to
future events that may not prove to be accurate. These and other
risks and uncertainties are described more fully in the section
titled "Risk Factors" in the Annual Report on Form 10-K for the
year ended December 31, 2021, filed
with the Securities and Exchange Commission. Forward-looking
statements contained in this announcement are made as of this date,
and Annovis Bio, Inc. undertakes no duty to update such information
except as required under applicable law.
Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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SOURCE Annovis Bio