Full Press Release Details
ANNOUNCES FOURTH QUARTER and full year 2022 financial RESULTS AND PROVIDES CORPORATE UPDATE
BERWYN, Penn., April 3, 2023 /PRNewswire/
-- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a clinical-stage drug platform company
addressing neurodegenerative diseases, has announced fourth quarter and full year financial results for the period ended December
31, 2022, and reviewed recent accomplishments.
Fourth Quarter Highlights and New
Maria L. Maccecchini, Ph.D.,
Founder, President, and CEO of Annovis, commented: "The fourth quarter and subsequent announcements in early 2023 highlight continued
execution and productivity across many facets of our business. We are pleased with the pace of enrollment in our ongoing clinical trials.
We expect to report a blinded interim analysis of our Phase 2/3 Alzheimer's study in Fall 2023. We are also building an expansive
intellectual property estate surrounding the use of buntanetap and its analogues across a myriad of neuro-inflammatory diseases and conditions.
As our clinical activities continue to expand, we are also managing this growth through the appointments of key senior-level professionals
who will play a pivotal role as we reach key inflection points in our clinical programs. We believe 2023 promises to be an exciting year
for Annovis driven by our team's continued execution, and the strong therapeutic potential of our lead drug candidate, buntanetap,
to address the unmet medical need in Alzheimer's and Parkinson's disease."
Financial Results for the Fourth
Cash and cash equivalents were $28.4
million as of December 31, 2022. Research and development expenses for the quarter ended December 31, 2022 were $6.2
million, compared to $2.9 million for the same period in 2021. The increase was primarily the result of an increase of $4.3
million in clinical expenses, as the Company incurred costs related to its Phase 3 study in early PD patients and its Phase 2/3
Alzheimer's study, partially offset by a decrease of $1.0 million in stock-based compensation expense. General and administrative
expenses for the quarter ended December 31, 2022 were $1.6 million, compared to $3.0 million for the same period
in 2021. The decrease was primarily the result of a decrease of $1.5 million in stock-based compensation expense.
For the quarter ended December
31, 2022, Annovis reported a net loss of $7.7 million, compared to a net loss of $5.9 million for the same period in 2021.
Financial Results for the Full Year
Research and development expenses for
the year ended December 31, 2022, were $16.5 million, compared to $8.5 million for the same period in 2021.
The increase was primarily the result of an increase of $6.6 million in clinical expenses, as the Company incurred costs related
to its Phase 3 study in early PD patients, its Phase 2/3 Alzheimer's study and an increase of $1.4 million in stock-based
compensation expense. General and administrative expenses for the year ended December 31, 2022 were $9.0 million, compared
to $6.1 million for the same period in 2021. The increase was primarily the result of an increase of $3.1 million in
stock-based compensation expense.
For the full year ended 2022, Annovis
reported a net loss of $25.3 million, compared to a net loss of $14.5 million in 2021.
Buntanetap (previously known as ANVS401
or Posiphen) is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs), which mode of action leads to a lower level
of neurotoxic proteins and consequently less toxicity in the brain. In a Phase 1/2 clinical trial in Alzheimer's disease (AD) and Parkinson's
disease (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 3 study in early PD patients and in a Phase 2/3 study in mild to moderate AD patients.
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. We believe that we are the only company developing a drug for AD and PD that
is designed to inhibit more than one neurotoxic protein, and has a mechanism of action designed to restore nerve cell axonal and synaptic
activity.. By improving brain function, our goal is to treat memory loss and dementia associated with AD as well as body and brain function
associated with PD. Annovis conducted two Phase 1/2 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 body and function in PD patients.
For more information on Annovis
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