UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE QUARTERLY PERIOD ENDED
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
COMMISSION FILE NUMBER
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of | (I.R.S. Employer |
(Address of registrant’s principal executive offices)
(
Registrant’s telephone number, including area code
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
| Trading Symbol |
| Name of Each Exchange on Which Registered |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
☒ | Smaller reporting company | |||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
The number of outstanding shares of the registrant’s common stock as of July 26, 2021 was:
ANNOVIS BIO, INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2021
2
PART I
FINANCIAL INFORMATION
Item 1. Financial Statements
Annovis Bio, Inc.
Balance Sheets
| June 30, | December 31, | |||||
| 2021 |
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(unaudited) | |||||||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | |||
Prepaid expenses and other current assets |
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Total current assets |
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Total assets | $ | | $ | | |||
Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | |||
Accrued expenses |
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Total current liabilities |
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Total liabilities |
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Commitments and contingencies (Note 8) |
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Stockholders’ equity: |
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Preferred stock - $ | |||||||
Common stock - $ |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
See accompanying notes to financial statements.
3
Annovis Bio, Inc.
Statements of Operations
(unaudited)
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2021 |
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Operating expenses: |
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Research and development | $ | | $ | | $ | | $ | | |||||
General and administrative |
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Total operating expenses |
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Operating loss |
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Other income (expense): |
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Change in fair value of derivative liability |
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Interest income (expense), net |
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Grant income |
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Total other income (expense) |
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Loss before income taxes |
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Income tax expense (benefit) |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Basic and diluted loss per common share | $ | ( | $ | ( | $ | ( | $ | ( | |||||
Weighted average number of common shares outstanding, basic and diluted |
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See accompanying notes to financial statements.
4
Annovis Bio, Inc.
Statements of Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(unaudited)
| Redeemable Convertible Preferred Stock |
| Stockholders’ Equity (Deficit) | ||||||||||||||||||||||
Total | |||||||||||||||||||||||||
Additional | Stockholders’ | ||||||||||||||||||||||||
Series A | Series A-1 | Common Stock | Paid-In | Accumulated | Equity | ||||||||||||||||||||
| Shares |
| Amount |
| Shares | Amount |
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| Shares |
| Amount |
| Capital |
| Deficit |
| (Deficit) | ||||||||
Three and Six Months Ended June 30, 2021 | |||||||||||||||||||||||||
Balance, December 31, 2020 |
| — | $ | — |
| — | $ | — |
| | $ | | $ | | $ | ( | $ | | |||||||
Exercise of stock options |
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Exercise of warrants |
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Share-based compensation expense | — |
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Net loss |
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Balance, March 31, 2021 |
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Issuance of common stock, net of issuance costs | — | — | — | — | | | | — | | ||||||||||||||||
Exercise of stock options | — |
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Exercise of warrants |
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Share-based compensation expense | — |
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Net loss | — |
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Balance, June 30, 2021 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | ||||||||||
Three and Six Months Ended June 30, 2020 | |||||||||||||||||||||||||
Balance, December 31, 2019 | | $ | |
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Conversion of redeemable convertible preferred stock to common stock upon completion of initial public offering |
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Conversion of convertible promissory notes, including embedded derivative, to common stock upon completion of initial public offering |
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Issuance of common stock in initial public offering, net of issuance costs | — |
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Exercise of stock options |
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Net loss |
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Balance, March 31, 2020 |
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Exercise of stock options | — |
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Share-based compensation expense | — |
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Net loss | — |
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Balance, June 30, 2020 | — | $ | — | — | $ | — | | $ | | $ | | $ | ( | $ | | ||||||||||
See accompanying notes to financial statements.
5
Annovis Bio, Inc.
Statements of Cash Flows
(unaudited)
Six Months Ended June 30, | ||||||
2021 | 2020 | |||||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Amortization of deferred financing fees |
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Amortization of debt discount |
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Share-based compensation expense, including stock issued to consultants and advisors |
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Change in fair value of derivative liability |
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Changes in operating assets and liabilities: |
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Grant receivable |
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Prepaid expenses and other current assets |
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Accounts payable |
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Accrued expenses |
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Net cash used in operating activities |
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Cash flows from financing activities: |
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Proceeds from issuance of common stock, net of issuance costs |
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Proceeds from exercise of stock options |
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Net cash provided by financing activities |
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Net increase in cash |
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Cash and cash equivalents, beginning of period |
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Cash and cash equivalents, end of period | $ | | $ | | ||
Supplemental disclosure of non-cash financing activities: |
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Common stock issuance costs in accounts payable and accrued expenses | $ | | $ | — | ||
Conversion of redeemable convertible preferred stock to common stock | $ | — | $ | | ||
Conversion of convertible promissory notes, including embedded derivative, to common stock | $ | — | $ | |
See accompanying notes to financial statements.
6
(1) Nature of Business and Liquidity
Annovis Bio, Inc. (the “Company” or “Annovis”) was incorporated on April 29, 2008, under the laws of the State of Delaware. Annovis is 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. The Company’s lead compound, ANVS401, is a small molecule administered orally that attacks neurodegeneration by entering the brain and inhibiting the translation of multiple neurotoxic proteins thereby impeding the toxic cascade.
Since its founding, the Company has been engaged in organizational activities, including raising capital, and research and development activities. The Company has
generated substantial revenues and has not yet achieved profitable operations, nor has it ever generated positive cash flows from operations. There is no assurance that profitable operations, if achieved, could be sustained on a continuing basis. The Company is subject to those risks associated with any clinical stage pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants. Further, the Company’s future operations are dependent on the success of the Company’s efforts to raise additional capital.The Company has a history of incurring net losses and had an accumulated deficit of $
The Company closed its initial public offering (the “IPO”) on January 31, 2020, pursuant to which it sold a total of
On May 26, 2021, the Company closed an underwritten public offering of
As of the date these financial statements are issued, management believes that the current cash and cash equivalents are sufficient to fund operations and capital requirements for at least the next 12 months, including the completion of its Phase 2a clinical trial in AD and PD (the “AD/PD Trial”) in the third quarter of 2021 and a potential Phase 3 trial in DS-AD. In order to fund additional planned Phase 3 trials in AD and PD, however, the Company will need to raise additional capital. There is no assurance that such financing will be available when needed or on acceptable terms.
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(2) Summary of Significant Accounting Policies
(a) Basis of Presentation of Interim Unaudited Financial Statements
The interim financial statements included herein are unaudited. In the opinion of management, these statements include all adjustments, consisting of normal, recurring adjustments, necessary for a fair presentation of the financial position of Annovis at June 30, 2021, and its results of operations and its cash flows for the three and six months ended June 30, 2021 and 2020. The interim results of operations are not necessarily indicative of the results to be expected for a full year. These interim unaudited financial statements should be read in conjunction with the audited financial statements for the year ended December 31, 2020 and notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The accompanying financial statements have been prepared in conformity with U.S. generally accepted accounting principles (“U.S. GAAP”) and the rules and regulations of the Securities and Exchange Commission (“SEC”). Any reference in these notes to applicable guidance is meant to refer to U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Certain information and note disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to such rules and regulations relating to interim financial statements.
(b) Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, including disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the financial statements, actual results may materially vary from these estimates.
Significant items subject to such estimates and assumptions include share-based compensation expense, the valuation of the derivative liability and contingent liabilities. Future events and their effects cannot be predicted with certainty; accordingly, accounting estimates require the exercise of judgment. Accounting estimates used in the preparation of these financial statements change as new events occur, as more experience is acquired, as additional information is obtained and as the operating environment changes.
(c) Basic and Diluted Net Income (Loss) per Share
Basic net income (loss) per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net income (loss) per share includes the effect, if any, from the potential exercise or conversion of securities, such as redeemable convertible preferred stock, convertible promissory notes, warrants and stock options, which would result in the issuance of incremental shares of common stock. The computation of diluted net income (loss) per shares does not include the conversion of securities that would have an anti-dilutive effect.
(d) Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less to be cash equivalents. At times, the Company’s cash balances may exceed the current insured amounts under the Federal Deposit Insurance Corporation.
(e) Issuance Costs Associated with Equity Issuances
Issuance costs incurred in connection with the Company’s equity issuances, which primarily consisted of direct incremental legal, printing, listing and accounting fees, are offset against proceeds received in the issuances and charged to additional paid-in capital in the period the equity issuance is completed.
8
(f) Fair Value of Financial Instruments
The Company’s financial instruments include cash and cash equivalents, accounts payable and accrued expenses. Cash and cash equivalents are reported at fair value. The recorded carrying amounts of accounts payable and accrued expenses reflect their fair value due to their short-term nature.
(g) Research and Development
Research and development costs are expensed as incurred and are primarily comprised of personnel-related expenses and external research and development expenses incurred under arrangements with third parties, such as contract research organizations and consultants. At the end of each reporting period, the Company compares the payments made to each service provider to the estimated progress towards completion of the related project. Factors that the Company considers in preparing these estimates include the number of patients enrolled in studies, milestones achieved, and other criteria related to the efforts of its vendors. These estimates will be subject to change as additional information becomes available. Depending on the timing of payments to vendors and estimated services provided, the Company will record net prepaid or accrued expenses related to these costs.
(h) Grant Income
Grants received are recognized as grant income in the statements of operations as and when they are earned for the specific research and development projects for which these grants are designated. Grant payments received in excess of grant income earned are recognized as deferred grant on the balance sheets, and grant income earned in excess of grant payments received is recognized as grant receivable on the balance sheets.
(i) Share-Based Compensation
Share-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period, which is generally the vesting period. Forfeitures are recognized in compensation expense in the period when they occur.
Determining the appropriate fair value of share-based awards requires the use of subjective assumptions including, in the case of stock options, the expected life of the option and expected share price volatility. The expected life of options was estimated using the simplified method, as the Company has limited historical information to develop reasonable expectations about future exercise patterns and post-vesting employment.
The Company uses the Black-Scholes option pricing model to value its option awards. The assumptions used in calculating the fair value of share-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and management uses different assumptions, share-based compensation expense could be materially different for future awards.
Upon exercise of stock options, the Company issues shares first from treasury stock, if available, then from authorized but unissued shares.
(j) Income Taxes
The Company provides for income taxes using the asset and liability approach. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. Deferred tax assets are reduced by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. As of June 30, 2021 and December 31, 2020, the Company has recorded a full valuation allowance against its deferred tax assets.
The Company is subject to the provisions of ASC 740, Income Taxes, which prescribes a more likely-than-not threshold for the financial statement recognition of uncertain tax positions. ASC 740 clarifies the accounting for income
9
taxes by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. There are currently no open federal or state tax audits. The Company has not recorded any liability for uncertain tax positions at June 30, 2021 or December 31, 2020.
(k) Recent Accounting Pronouncements
In December 2019, the FASB issued ASU No. 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in ASU 2019-12 simplify the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and clarifying and amending existing guidance. The new standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020, with early adoption permitted. The adoption of this standard did not have an impact on the Company’s financial statements.
(3) Fair Value Measurements
The Company measures certain assets and liabilities at fair value in accordance with ASC 820, Fair Value Measurements and Disclosures. ASC 820 defines fair value as the price that would be received to sell an asset or paid to transfer a liability (the exit price) in an orderly transaction between market participants at the measurement date. The guidance in ASC 820 outlines a valuation framework and creates a fair value hierarchy that serves to increase the consistency and comparability of fair value measurements and the related disclosures. In determining fair value, the Company maximizes the use of quoted prices and observable inputs. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from independent sources. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.
Level 3—Valuations based on unobservable inputs and models that are supported by little or no market activity.
The following table provides the carrying value and fair value of certain financial assets and liabilities of the Company measured at fair value on a recurring basis as of June 30, 2021 and December 31, 2020:
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| Fair Value Measurement at | ||||||||||
June 30, 2021 | ||||||||||||
Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||
Cash and cash equivalents | $ | | $ | | $ | — | $ | — |
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December 31, 2020 | ||||||||||||
Carrying Value | Level 1 | Level 2 | Level 3 | |||||||||
Cash and cash equivalents | $ | | $ | | $ | — | $ | — | ||||
(4) Grant Receivable
In September 2019, as modified in September 2020, the Company received a Notice of Award for a $
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long-term chronic toxicology studies of ANVS401 in rats and dogs. The Company began the long-term chronic toxicology studies in November 2019. The Company recognized grant income of $
(5) Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
| June 30, | December 31, | |||||
2021 | 2020 | ||||||
Prepaid insurance | $ | | $ | | |||
Prepaid expenses |
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Security deposit |
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$ | | $ | |
(6) Accrued Expenses
Accrued expenses consisted of the following:
| June 30, | December 31, | |||||
2021 | 2020 | ||||||
Payroll and related benefits | $ | | $ | | |||
Accrued professional and clinical fees |
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Accrued license payments |
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$ | | $ | |
See Note 8 for further detail on the accrued license payments.
(7) Convertible Promissory Notes
In March 2019, the Company issued convertible promissory notes (the “Notes”) to various investors in the aggregate principal amount of $
11
(8) Commitments and Contingencies
(a) Leases
The Company leases its office facilities under a month-to-month operating lease. Total rental expense was $
(b) License Agreement
The Company licenses the rights to certain chemical compounds, know-how and intellectual property rights that may be suitable for the development of human therapeutics from a subsidiary of Horizon Therapeutics, PLC (the “Licensor”). Under the license agreement, the Company pays a minimum annual commitment of $
In July 2021, the Company gave notice to the Licensor of its termination of the license agreement.
(c) Employment Agreements
The maximum aggregate severance payments under the Company’s employment agreements with its executive officers are approximately $
(d) Litigation
The Company is subject, from time to time, to claims by third parties under various legal disputes. The defense of such claims, or any adverse outcome relating to any such claims, could have a material adverse effect on the Company’s liquidity, financial condition and cash flows. At June 30, 2021 and December 31, 2020, the Company did not have any pending legal actions.
(e) Risks and Uncertainties
The extent to which the COVID-19 pandemic could have a material impact on the Company’s 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. Management continues to evaluate the potential impact. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
(9) Redeemable Convertible Preferred Stock and Stockholders’ Equity
(a) Overview
In connection with the closing of the Company’s IPO on January 31, 2020, the then-outstanding
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The Company’s Amended and Restated Certificate of Incorporation was adopted on January 31, 2020 to authorize the issuance of
(b) Common Stock
1. Dividends
Subject to the rights of holders of all classes of Company stock outstanding having rights that are senior to or equivalent to holders of common stock, the holders of the common stock are entitled to receive dividends when and as declared by the Board.
2. Liquidation
Subject to the rights of holders of all classes of stock outstanding having rights that are senior to or equivalent to holders of common stock as to liquidation, upon the liquidation, dissolution or winding up of the Company, the assets of the Company will be distributed to the holders of common stock.
3. Voting
The holders of common stock are entitled to
(c) Preferred Stock
Preferred stock may be issued from time to time by the Board in one or more series. There was
(d) Warrants
In conjunction with the IPO, the Company granted the underwriters
(10) Share-Based Compensation
Effective upon the closing of the Company’s IPO on January 31, 2020, the Company’s 2019 Equity Incentive Plan (the “2019 Plan”) became effective, succeeding the Company’s previous plan (see Note 1). As of the effective date of the 2019 Plan, the previous plan had
There were
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(11) Net Loss Per Share
The following table sets forth the computation of basic and diluted net loss per share:
| Three Months Ended | Six Months Ended | ||||||||||
June 30, | June 30, | |||||||||||
| 2021 |
| 2020 |
| 2021 |
| 2020 | |||||
Numerator: |
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Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Denominator: |
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Weighted-average common shares outstanding, basic and diluted |
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Net loss per share, basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( |
The Company reported a net loss for the three and six months ended June 30, 2021 and 2020, therefore, the basic and diluted net loss per share are the same in the respective period because the inclusion of potential common shares would have an anti-dilutive effect. Potential shares of common stock that are excluded from the computation of diluted weighted-average shares outstanding are as follows:
June 30, | ||||
| 2021 |
| 2020 | |
Stock options | | | ||
Warrants |
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In addition, common shares issuable upon the conversion of the Notes were excluded for all periods in which the Notes were outstanding.
(12) Income Taxes
The Company’s income tax benefit (expense) was $
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted in response to the COVID-19 pandemic. The CARES Act, among other things, permits NOL carryovers and carrybacks to offset 100% of taxable income for taxable years beginning before 2021. Previously, NOLs generated after December 31, 2017 were limited to 80% of taxable income in future years. In addition, the CARES Act allows NOLs incurred in 2018, 2019 and 2020 to be carried back to each of the five preceding taxable years to generate a refund of previously paid income taxes. The NOL carryback provision of the CARES Act had no impact on the Company due to its tax losses generated during all prior years.
Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. The Company has completed financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code or could result in a change in control in the future.
As of June 30, 2021, and December 31, 2020, the Company had not recorded any liability for uncertain tax positions, accrued interest or penalties thereon, and no amounts have been recognized in the Company’s statements of operations.
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(13) Related-Party Transactions
As discussed in Note 7, in March 2019 the Company issued Notes in the aggregate principal amount of $
(14) Subsequent Events
On July 7, 2021, the Company granted options to purchase an aggregate of
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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/Aβ (“APP”), tau/phospho-tau (“tau”) and α-Synuclein (“αSYN”)—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 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 began treating patients in August 2020. 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 June 30, 2021 was $19,963.4 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 | 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 June 30, 2021 and 2020
Research and Development Expenses
Research and development expenses increased by $968.0 thousand for the three months ended June 30, 2021 compared to the prior year period. The increase was primarily the result of an increase of $975.9 thousand in expenses related to our AD/PD Trial. 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 decreased by $977.6 thousand for the three months ended June 30, 2021 compared to the prior year period. The decrease was primarily the result of a decrease in share-based compensation expense of $1,103.3 thousand, partially offset by 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.
Interest Income (Expense), Net
Interest income (expense), net decreased $23.8 thousand for the three months ended June 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 $200.9 thousand for the three months ended June 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.
Six Months Ended June 30, 2021 and 2020
Research and Development Expenses
Research and development expenses increased by $3,291.2 thousand for the six months ended June 30, 2021 compared to the prior year period. The increase was primarily the result of an increase of $2,918.1 thousand in expenses related to our AD/PD Trial and an increase of $276.6 thousand in personnel expenses. 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 $654.6 thousand for the six months ended June 30, 2021 compared to the prior year period. The decrease was primarily the result of a decrease in share-based compensation expense of $1,079.3 thousand, partially offset by an increase of $360.0 thousand in accrued incentive compensation expense 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 (Expense), Net
Interest income (expense), net decreased $34.2 thousand for the six months ended June 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 $328.9 thousand for the six months ended June 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 June 30, 2021, our principal source of liquidity was our cash, which totaled $49,224.2 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 three months ended March 31, 2020.
We closed an equity offering on May 26, 2021, raising gross proceeds of $50,000.0 thousand and net proceeds of $46,668.4 thousand, after deducting underwriting discounts and commissions and issuance costs paid or payable by us, in the three months ended June 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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Cash Flows
The following table summarizes our cash flows from operating, investing and financing activities.
Six Months Ended | |||||||
June 30, | |||||||
| 2021 |
| 2020 | ||||
(in thousands) | |||||||
Statement of Cash Flows Data: |
|
|
|
| |||
Total net cash provided by (used in): |
|
|
|
| |||
Operating activities | $ | (5,619.4) | $ | (2,282.2) | |||
Financing activities |
| 46,768.9 |
| 12,043.6 | |||
Increase in cash and cash equivalents | $ | 41,149.5 | $ | 9,761.4 |
Operating Activities
For the six months ended June 30, 2021, cash used in operations increased $3,337.2 thousand compared to the same period in the prior year. The increase in cash used in operations was primarily the result of the ongoing costs of our AD/PD Trial.
We expect cash used in operating activities to increase in 2021 as compared to 2020 due to an expected increase in our operating losses associated with ongoing development of our product candidates, including our AD/PD Trial.
Financing Activities
Cash provided by financing activities was $46,768.9 thousand during the six months ended June 30, 2021, attributable to net proceeds from our equity offering of approximately $46,673.9 thousand and $95.1 thousand proceeds from the exercise of stock options.
Cash provided by financing activities was $12,043.6 thousand during the six months ended June 30, 2020, attributable to net proceeds from our IPO of $12,034.4 thousand, and $9.2 thousand proceeds from the exercise of stock options.
Funding Requirements
We expect that current cash and cash equivalents will be sufficient to fund our operations and capital requirements for at least the next 12 months. We believe that these available funds will be sufficient to complete our Phase 2a clinical trials for ANVS401 and to complete a Phase 3 study in DS-AD patients for this product candidate. However, it is difficult to predict our spending for our product candidates prior to obtaining FDA approval. Moreover, changing circumstances may cause us to expend cash significantly faster than we currently anticipate, and we may need to spend more cash than currently expected because of circumstances beyond our control.
To the extent that our capital resources are insufficient to meet our future operating and capital requirements, we will need to finance our cash needs through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. We have no committed external sources of funds. Additional equity or debt financing or collaboration and licensing arrangements may not be available on acceptable terms, if at all.
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Contractual Obligations and Other Commitments
This item is not required for smaller reporting companies.
Factors that May Affect Future Results
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 affect our future results.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements, as defined by applicable SEC regulations.
Discussion of Critical Accounting Policies and Significant Judgments and Estimates
The preparation of financial statements in conformity with GAAP requires us to use judgment in making certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in our financial statements and accompanying notes. Critical accounting policies are those that are most important to the portrayal of our financial condition and results of operations and require difficult, subjective and complex judgments by management in order to make estimates about the effect of matters that are inherently uncertain. During the three months ended June 30, 2021, there were no significant changes to our critical accounting policies from those described in our annual financial statements for the year ended December 31, 2020, which we included in our Annual Report on Form 10-K for the year ended December 31, 2020.
Item 3. Quantitative and Qualitative Disclosure About Market Risk
This item is not required for smaller reporting companies.
Item 4. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as the end of the period covered by this Quarterly Report on Form 10-Q. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective to ensure that the information required to be disclosed in our reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that information required to be disclosed in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.
(b) Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting identified in connection with the evaluation required by Rule 13a-15(f) and 15d-15(f) of the Exchange Act that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II
OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceedings against us that we believe could have a material adverse effect on our business, operating results or financial condition.
Item 1A. Risk Factors
This item is not required for smaller reporting companies.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
None.
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Item 6. Exhibits
Exhibit |
| Description of Exhibit |
| ||
1.1 | Underwriting Agreement, dated as of May 23, 2021, between Annovis Bio, Inc. and ThinkEqutiy, a division of Fordham Financial Management, Inc. (Incorporated by reference to Exhibit 1.1 to Form 8-K filed May 24, 2021.) | |
3.1 | Amended and Restated Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to Form 8-K filed February 6, 2020.) | |
| ||
3.2 | Amended and Restated Bylaws of the Registrant. (Incorporated by reference to Exhibit 3.2 to Form 8-K filed February 6, 2020.) | |
31.1 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| ||
31.2 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
| ||
32.1 | Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
| ||
32.2 | Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS | XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. | |
101.SCH | XBRL Taxonomy Extension Schema Document | |
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File – the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Signature |
| Title |
| Date |
|
|
| ||
/s/ MARIA MACCECCHINI | President and Chief Executive Officer (principal | July 28, 2021 | ||
Maria Maccecchini | executive officer) | |||
|
|
| ||
/s/ JEFFREY MCGROARTY | Chief Financial Officer (principal financial and | July 28, 2021 | ||
Jeffrey McGroarty | accounting officer) |
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