Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements, within
the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that
involve substantial risks and uncertainties. In some cases, you can identify
forward-looking statements by the words "anticipate," "believe," "continue,"
"could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing,"
"plan," "predict," "project," "potential," "should," "will," or "would," and or
the negative of these terms, or other comparable terminology intended to
identify statements about the future. These statements involve known and unknown
risks, uncertainties and other factors that may cause our actual results, levels
of activity, performance or achievements to be materially different from the
information expressed or implied by these forward-looking statements. Although
we believe that we have a reasonable basis for each forward-looking statement
contained in this Quarterly Report on Form 10-Q, we caution you that these
statements are based on a combination of facts and factors currently known by us
and our expectations of the future, about which we cannot be certain.
The forward-looking statements in this Quarterly Report on Form 10-Q include,
among other things, statements about:
? our business strategies;
? the timing of regulatory submissions;
our ability to obtain and maintain regulatory approval of our existing product
? candidates and any other product candidates we may develop, and the labeling
under any approval we may obtain;
? risks relating to the timing and costs of clinical trials and the timing and
costs of other expenses;
? risks related to market acceptance of products;
? risks associated with our reliance on third-party organizations;
? our competitive position;
? assumptions regarding the size of the available market, product pricing and
timing of commercialization of our product candidates;
? our intellectual property position and our ability to maintain and protect our
intellectual property rights;
? our results of operations, financial condition, liquidity, prospects, and
growth strategies;
? our cash needs and financing plans;
? the industry in which we operate; and
? the trends that may affect the industry or us.
You should refer to Part I, Item 1A "Risk Factors" of our Annual Report on
Form 10-K for the year ended December 31, 2020 for a discussion of important
factors that may cause our actual results to differ materially from those
expressed or implied by our forward-looking statements. Those factors are
updated, as applicable, in "Factors that May Affect Future Results" below. As a
result of the risks, uncertainties and assumptions described above and
elsewhere, we cannot assure you that the forward-looking statements in this
Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our
forward-looking statements prove to be inaccurate, the inaccuracy may be
material. In light of the
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significant uncertainties in these forward-looking statements, you should not
regard these statements as a representation or warranty by us or any other
person that we will achieve our objectives and plans in any specified time frame
or at all.
You should not rely upon forward-looking statements as predictions of future
events. Although we believe that the expectations reflected in the
forward-looking statements are reasonable, we cannot guarantee that the future
results, levels of activity, performance, or events and circumstances reflected
in the forward-looking statements will be achieved or occur. We undertake no
obligation to update publicly any forward-looking statements for any reason
after the date of this report to conform these statements to new information,
actual results or changes in our expectations, except as required by law.
The following Management's Discussion and Analysis of Financial Condition and
Results of Operations should be read in conjunction with: (i) the interim
financial statements and related notes thereto which are included in this
Quarterly Report on Form 10-Q; and (ii) our annual financial statements for the
year ended December 31, 2020 which are included in our Annual Report on Form
10-K for the year ended December 31, 2020.
Company Overview
We are a clinical stage, drug platform company addressing neurodegeneration such
as Alzheimer's disease ("AD"), Parkinson's disease ("PD") and Down Syndrome
patients with AD ("DS-AD"). The toxic cascade in neurodegeneration begins with
high levels of neurotoxic proteins which lead to impaired axonal transport,
inflammation, death of nerve cells and loss of cognition and motor function. Our
lead compound, ANVS401, is a small molecule administered orally that attacks
neurodegeneration by entering the brain and inhibiting the translation of
neurotoxic proteins-amyloid precursor protein APP/A? ("APP"), tau/phospho-tau
("tau") and ?-Synuclein ("?SYN")-thereby impeding the toxic cascade. Human
studies in four mildly cognitive impaired patients have shown that ANVS401
lowered the levels of neurotoxic proteins and inflammatory factors. In
preclinical studies, lower neurotoxic protein levels led to improved axonal
transport, reduced inflammation, lower nerve cell death and improved function.
In collaboration with the Alzheimer's Disease Cooperative Study ("ADCS") we are
conducting a trial in 24 early AD patients (the "ADCS Trial"). Under an
agreement with UC San Diego, where ADCS is located, we have contracted to
provide study supplies at our cost but the remaining costs of the ADCS Trial are
paid for by the National Institutes of Health ("NIH"). We are also conducting a
Phase 2a clinical trial in 14 AD and 54 PD patients (the "AD/PD Trial") which
finished treating patients in August 2021. Both clinical trials are
double-blind, placebo-controlled studies.
The extent to which the COVID-19 pandemic could have a material impact on our
current or future clinical trials is dependent on the spread of the disease and
government and healthcare system responses to such spread, which are presently
highly uncertain. We continue to evaluate the potential impact.
We have never been profitable and have incurred net losses since inception. Our
accumulated deficit at September 30, 2021 was $22,811.6 thousand. We expect to
incur losses for the foreseeable future, and we expect these losses to increase
as we continue our development of, and seek regulatory approvals for, our
product candidates. Because of the numerous risks and uncertainties associated
with product development, we are unable to predict the timing or amount of
increased expenses or when, or if, we will be able to achieve or maintain
profitability.
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Results of Operations
Operating expenses and other income (expense) were comprised of the following:
Three Months Ended Nine Months Ended
September 30, September 30,
2021 2020 2021 2020
(in thousands) (in thousands)
Operating expenses:
Research and development $ 1,380.8 $ 718.9 $ 5,594.9 $ 1,641.8
General and administrative 1,473.0 884.9 3,022.2 3,088.7
Other income (expense):
Change in fair value of derivative liability - - - (26.5)
Interest income, net 5.6 10.5 7.9 47.0
Grant income - 586.9 36.8 952.6
Three Months Ended September 30, 2021 and 2020
Research and Development Expenses
Research and development expenses increased by $661.9 thousand for the three
months ended September 30, 2021 compared to the prior year period. The increase
was primarily the result of an increase of $715.8 thousand in expenses related
to our clinical trials. For the year ending December 31, 2021, we expect
research and development expenses to be higher than the prior year as we
complete our AD/PD Trial and commence the planning of a Phase 3 study.
General and Administrative Expenses
General and administrative expenses increased by $588.1 thousand for the three
months ended September 30, 2021 compared to the prior year period. The increase
was primarily the result of an increase in conference expenses, professional
fees and recruiting expenses. We expect general and administrative expenses in
2021 will be higher as compared to 2020 due to increased personnel expenses.
Interest Income, Net
Interest income, net decreased $4.9 thousand for the three months ended
September 30, 2021 compared to the prior year period. The decrease was primarily
the result of lower interest rates compared to the prior year period.
Grant Income
Grant income decreased $586.9 thousand for the three months ended September 30,
2021 compared to the prior year period. The income relates to a grant from the
NIH to reimburse the costs of our long-term toxicology studies in rats and dogs,
which was substantially completed in 2020.
Nine months Ended September 30, 2021 and 2020
Research and Development Expenses
Research and development expenses increased by $3,953.1 thousand for the nine
months ended September 30, 2021 compared to the prior year period. The increase
was primarily the result of an increase of $3,800.6 thousand in expenses related
to our clinical trials and an increase of $540.5 thousand in personnel expenses,
including share-based compensation expense, partially offset by a decrease of
$451.5 thousand in expenses related to our long-term toxicology studies. For the
year ending December 31, 2021, we expect research and development expenses to be
higher than the prior year as we complete our AD/PD Trial and commence the
planning of a Phase 3 study.
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General and Administrative Expenses
General and administrative expenses decreased by $66.5 thousand for the nine
months ended September 30, 2021 compared to the prior year period. The decrease
was primarily the result of a decrease in share-based compensation expense of
$1,119.9 thousand, partially offset by an increase in accrued incentive
compensation expense, conference expenses and an increase in recruiting
expenses. We expect general and administrative expenses in 2021 will be higher
as compared to 2020 due to increased personnel expenses.
Change in Fair Value of Derivative Liability
The derivative liability represents an embedded derivative in our convertible
promissory notes which were issued in March 2019. At each balance sheet date, we
estimated the fair value of the derivative liability and recognized any change
in our statements of operations. The fair value of the derivative liability was
adjusted to $132.5 thousand immediately prior to the closing of the IPO on
January 31, 2020. Effective upon the closing of the IPO, the derivative
liability was eliminated, and the amount was reclassified to additional paid-in
capital on the balance sheet.
Interest Income, Net
Interest income, net decreased $39.1 thousand for the nine months ended
September 30, 2021 compared to the prior year period. The decrease was primarily
the result of lower interest rates compared to the prior year period.
Grant Income
Grant income decreased $915.8 thousand for the nine months ended September 30,
2021 compared to the prior year period. The income relates to a grant from the
NIH to reimburse the costs of our long-term toxicology studies in rats and dogs,
which was substantially completed in 2020.
Liquidity and Capital Resources
Since our inception in 2008, we have devoted most of our cash resources to
research and development and general and administrative activities. We have
financed our operations primarily with the proceeds from the sale of common
stock, redeemable convertible preferred stock, and convertible promissory notes
and funding from research grants. To date, we have not generated any revenues
from the sale of products, and we do not anticipate generating any revenues from
the sales of products for the foreseeable future. We have incurred losses and
generated negative cash flows from operations since inception. As of September
30, 2021, our principal source of liquidity was our cash, which totaled
$47,455.3 thousand.
Equity Financings
We closed our IPO on January 31, 2020, raising gross proceeds of $13,800.0
thousand and net proceeds of $12,034.4 thousand, after deducting underwriting
discounts and commissions and issuance costs paid by us, in the nine months
ended September 30, 2020.
We closed an equity offering on May 26, 2021, raising gross proceeds of
$50,000.0 thousand and net proceeds of $46,648.4 thousand, after deducting
underwriting discounts and commissions and issuance costs paid or payable by us,
in the nine months ended September 30, 2021.
Debt Financings
In March 2019 we issued $530.0 thousand principal amount of convertible
promissory notes. Upon the closing of our IPO on January 31, 2020, the
outstanding convertible promissory notes plus accrued interest converted into
118,470 shares of our common stock at a 20% discount to the public offering
price.
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