BERWYN,
Penn., Nov. 8, 2022 /PRNewswire/ -- Annovis Bio,
Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a
clinical-stage drug platform company addressing neurodegenerative
diseases, today announced third quarter financial results for the
quarter ended September 30, 2022, and
reviewed recent accomplishments.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of
Annovis, commented: "This quarter, we have made significant
advances in the clinical development of buntanetap as we began to
dose patients in our Phase 3 trial for early Parkinson's Disease
and received FDA authorization to proceed with a Phase 2/3 trial in
moderate Alzheimer's Disease. Additionally, we have seen that
buntanetap works in numerous acute and chronic neurodegenerative
conditions through its ability to inhibit multiple neurotoxic
proteins, improve axonal transport and preserve nerve cell function
in various neurodegenerative conditions. As a result, we have
pursued and made significant strides this quarter in expanding our
intellectual property portfolio as it relates to buntanetap and
additional neurodegenerative conditions."
Third Quarter Highlights and New Developments
- Receipt of Positive U.S. Food and Drug Administration (FDA)
Notice for Buntanetap Phase 3 Clinical Trial in Parkinson's Disease
(PD): The Company received notice from the FDA that the
Phase 3 clinical study in early PD 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. The Phase 3 trial is a randomized, double-blind,
placebo-controlled trial investigating the efficacy, safety, and
tolerability of buntanetap. The trial will enroll a total of 450
early PD patients to be treated with 10mg buntanetap, 20mg
buntanetap or a placebo, on top of their standard of care, for six
months. Movement Disorder Society-Sponsored Revision of the Unified
Parkinson's Disease Rating Scale (MDS-UPDRS) Part II and III will
be used as primary endpoints, while total MDS-UPDRS and Participant
Global Impression of Change will be secondary endpoints. In
addition, Wechsler Adult Intelligence Scale, plasma biomarkers and
Mini-Mental State Examination will be evaluated as exploratory
endpoints.
- Dosed First Patient for the Phase 3 Trial in Patients with
Early Parkinson's Disease: Annovis announced that the
first patient in the Phase 3 clinical trial evaluating buntanetap
in early PD has been dosed.
- Receipt of FDA Authorization to Proceed with Phase 2/3 Trial
for Buntanetap in Alzheimer's Disease (AD): The Company
announced that the FDA authorized the Phase 2/3 clinical study of
buntanetap in moderate AD. The Phase 2/3 study is a randomized,
double-blind, placebo-controlled trial investigating the efficacy,
safety, and tolerability of buntanetap in moderate AD patients. The
trial will enroll a total of 320 AD patients to be treated with
7.5mg buntanetap, 15mg buntanetap, 30mg buntanetap or a placebo, on
top of their standard of care, for three months.
- Publication of Phase 2a Clinical Data in The Journal of
Prevention of Alzheimer's Disease: The published study,
titled 'Buntanetap, a Novel Translational Inhibitor of Multiple
Neurotoxic Proteins, Proves to Be Safe and Promising in Both
Alzheimer's and Parkinson's Patients', evaluated safety,
pharmacokinetics, biomarkers, and efficacy of buntanetap in
treating early AD and PD patients. The study demonstrated that
buntanetap was well tolerated, safe and significantly improved
cognition in AD patients and motor function in PD patients.
- Appointment of Henry Hagopian
III as Chief Financial Officer: Mr. Hagopian
comes to Annovis with 30 years of finance and accounting
experience, including 15 years at Organogenesis, a leading publicly
traded regenerative medicine company. Mr. Hagopian has an extensive
background in corporate accounting, financial reporting, treasury
operations, financial planning & analysis, and investor
relations.
- Publication of Patents Covering the Treatment of Amyloid
Lateral Sclerosis, Huntington's Disease and Prion
Diseases: Annovis announced the publication of three
granted US patents – US11400075, US11376238, and US11382893. The
patents cover methods of treating amyloid lateral sclerosis,
Huntington's disease, and prion diseases by administering
buntanetap. The patents provide intellectual property protection
through 2031 and strengthen and expand the Company's intellectual
property portfolio. The Company now has issued patents covering a
wide range of neurodegenerative diseases, including AD,
alpha-synucleopathies, such as PD, tauopathies, such as
frontotemporal dementia, chronic traumatic encephalopathy and acute
injuries, such as stroke and traumatic brain injury.
- Presented at the Alzheimer's Association International
Conference: Maria Maccecchini, Ph.D., Founder,
President, and CEO of Annovis, participated on the Systems Biology
of Alzheimer's Disease Panel at the Alzheimer's Association
International Conference. The panel was moderated by Jeffrey Cummings, MD, ScD, and Krista Lanctôt,
Ph.D. The discussion focused on the need and underpinning rationale
for advancing novel therapeutic approaches for AD and featured a
panel of industry thought leaders and experts.
Financial Results for the Third Quarter of 2022
Cash, cash equivalents, and marketable securities were
$32.0 million as of September 30, 2022. Research and development
expenses for the quarter ended September 30,
2022 were $5.3 million,
compared to $1.4 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 Phase 3
study in early PD patients, an increase of $1.0 million for the cost of materials and an
increase of $0.4 million in
stock-based compensation expense. General and administrative
expenses for the quarter ended September 30,
2022 were $2.4 million,
compared to $1.5 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 September 30,
2022, Annovis reported a net loss of $7.6 million, compared to a net loss of
$2.9 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 expected
effectiveness of buntanetap and 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 Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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SOURCE Annovis Bio
