Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements, within
the meaning of the
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
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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
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.
We are presently conducting two Phase 2a clinical trials. 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
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
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Operating expenses and other income (expense) were comprised of the following:
Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 (in thousands) (in thousands) Operating expenses: Research and development$ 1,824.5 $ 856.5 $ 4,214.1 $ 922.9 General and administrative 709.6 1,687.2 1,549.3 2,203.9 Other income (expense): Change in fair value of derivative liability - - - (26.5) Interest income (expense), net 2.1 25.9 2.3 36.5 Grant income 7.4 208.3 36.8 365.7
Three Months Ended
Research and Development Expenses
Research and development expenses increased by
General and Administrative Expenses
General and administrative expenses decreased by
Interest Income (Expense), Net
Interest income (expense), net decreased
Grant Income
Grant income decreased
Six Months Ended
Research and Development Expenses
Research and development expenses increased by
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General and Administrative Expenses
General and administrative expenses decreased by
Change in Fair Value of Derivative Liability
The derivative liability represents an embedded derivative in our convertible
promissory notes which were issued in
Interest Income (Expense), Net
Interest income (expense), net decreased
Grant Income
Grant income decreased
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
Equity Financings
We closed our IPO on
We closed an equity offering on
Debt Financings
In
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