Annovis Bio Announces Second Quarter 2023 Financial Results and Provides Corporate Update
15 August 2023 - 9:20PM
Business Wire
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
- 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)
- Cash and cash equivalents were $15.7 million. Research and
development expenses for the quarter were $8.2 million, compared to
$4.0 million for the same period in 2022. The increase was
primarily the result of an increase of $4.2 million in clinical
expenses, as Annovis incurred costs related to its phase III study
in early Parkinson’s Disease (PD) and its phase II/III Alzheimer's
Disease (AD) study.
- General and administrative expenses for the second quarter were
$1.5 million, compared to $1.9 million for the same period in 2022.
The decrease was primarily the result of a decrease of $0.5 million
in stock-based compensation expense, partially offset by an
increase in salaries and professional fees of $0.1 million.
- Annovis reported a net loss of $9.5 million for the quarter,
compared to a net loss of $5.9 million for the same period in
2022.
Staff News
New Employees
- In May, Annovis hired Sarah MacCallum as senior clinical
project manager, bringing the total employee count to 10.
Annovis scientists spoke at events featuring novel approaches in
neurodegenerative diseases with other leaders in the life sciences
and pharmaceutical industries:
Message from Dr. Maria
It is tremendously rewarding and important that our drug is
safe, well-tolerated, and easily administered as a once-a-day pill.
The two FDA-approved drugs for Alzheimer’s Disease require I.V.
infusions and repeated brain imaging, and have well-documented,
serious side effects that manifest as brain swelling or brain
bleeding. As buntanetap continues to show significant progress
through clinical trials, we remain on course and anticipate having
topline data with good news to share before the end of the
year.
The positive momentum we’re building with this drug is reflected
in the more than 200% annual growth rate of our company over the
last two years. The crystalline form of buntanetap will allow us to
have a new 20-year patent protection for Annovis Bio to continue to
move forward. There’s growing interest and excitement in the
scientific and investment communities about our drug’s very real
potential to not just alleviate devastating neurodegenerative
disease symptoms but ultimately change the course of the diseases
themselves.
–Maria L. Maccecchini, Ph.D., Annovis
Founder, President, and CEO
About Buntanetap
Buntanetap (previously known as ANVS401 or posiphen) is an oral
translational inhibitor of neurotoxic aggregating proteins
(TINAPs), whose mode of action leads to a lower level of neurotoxic
proteins and consequently less toxicity in the brain. In a Phase
I/II clinical trial in AD and PD patients, buntanetap was shown to
be well-tolerated and its pharmacokinetics were found to be in line
with levels measured earlier in humans, meeting both the primary
and secondary endpoints. Additionally, exploratory endpoints were
also met, as treatment with buntanetap resulted in statistically
significant improvement in motor function in PD patients and
cognition in AD patients. Presently buntanetap is being studied in
a phase III study in early PD patients and in a Phase II/III study
in mild to moderate AD patients.
About Annovis Bio, Inc.
Headquartered in Berwyn, Pennsylvania, Annovis Bio, Inc. is a
clinical-stage, drug platform company addressing neurodegeneration,
such as Alzheimer’s Disease (AD), Parkinson’s Disease (PD), and
other chronic neurodegenerative diseases. It is believed to be the
only company developing a drug for both AD and PD designed to
inhibit more than one neurotoxic protein to restore axonal and
synaptic activity. By improving brain function, the company’s goal
is to treat memory loss and dementia associated with AD as well as
body and brain dysfunction associated with PD. Annovis conducted
two phase I/II studies: one in AD patients and one in both AD and
PD patients. In the AD/PD study buntanetap showed improvements in
cognition in AD as well as movement and function in PD patients.
For more information on Annovis Bio, please visit the Company's
website www.annovisbio.com and follow us on LinkedIn, Facebook,
Twitter and Threads.
Forward-Looking Statements
This press release contains "forward-looking" statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. All statements other than statements of historical fact
are statements that could be deemed forward-looking statements. The
Company advises caution in reliance on forward-looking statements.
Forward-looking statements include, without limitation, the
Company's plans related to clinical trials. These statements
involve known and unknown risks, uncertainties and other factors
that may cause actual results to differ materially from those
implied by forward-looking statements, including regarding patient
enrollment, the effectiveness of buntanetap and the timing,
effectiveness, and anticipated results of the Company's clinical
trials evaluating the efficacy, safety and tolerability of
buntanetap. See also additional risk factors set forth in the
Company's periodic filings with the SEC, including, but not limited
to, those risks and uncertainties listed in the section entitled
"Risk Factors," in the Company's Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q filed with the SEC. All
forward-looking statements in this press release are based on
information available to the Company as of the date of this filing.
The Company expressly disclaims any obligation to update or alter
its forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
applicable law.
SOURCE: Annovis Bio
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Investor Contact: Laura Feragen Jacobson Strategic Health
267-262-4309 laura@jacobsonstrategic.com
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