UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
Form
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| (Mark One) |
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| OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the Quarterly Period Ended
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| OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from ___________ to ___________ |
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Commission File Number:
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(Exact name of registrant as specified in its charter)
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| incorporation or organization) | Identification Number) |
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(Address, including zip code, of registrant’s principal executive offices and
telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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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. Yes No ¨
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). Yes No ¨
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.
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| Large Accelerated Filer ¨ | Accelerated Filer ¨ |
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| 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). Yes ¨ No
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
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| Common Stock, $0.001 par value |
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| Shares Outstanding as of August 2, 2021 |
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CASSAVA SCIENCES, INC.
TABLE OF CONTENTS
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PART I. | FINANCIAL INFORMATION |
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Item 1. | Financial Statements |
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| Condensed Balance Sheets – June 30, 2021 and December 31, 2020 | 3 | ||
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| Condensed Statements of Operations – Three and Six Months Ended June 30, 2021 and 2020 | 4 | ||
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| Condensed Statements of Cash Flows – Six Months Ended June 30, 2021 and 2020 | 5 | ||
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Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 14 | ||
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Item 3. | 30 | |||
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Item 4. | 31 | |||
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PART II. | OTHER INFORMATION |
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Item 1. | 31 | |||
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Item 1A | 31 | |||
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Item 2. | 31 | |||
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Item 3. | 31 | |||
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Item 4. | 31 | |||
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Item 5. | 31 | |||
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Item 6. | 32 | |||
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33 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
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CASSAVA SCIENCES, INC. | ||||||
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CONDENSED BALANCE SHEETS | ||||||
(Unaudited, in thousands, except share and par value data) | ||||||
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| June 30, 2021 |
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| December 31, 2020 |
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ASSETS | ||||||
Current assets: |
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Cash and cash equivalents | $ | |
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Prepaid expenses and other current assets |
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Total current assets |
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Operating lease right-of-use assets |
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Property and equipment, net |
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Other assets |
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Total assets | $ | |
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LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
Current liabilities: |
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Accounts payable | $ | |
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Accrued development expense |
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Accrued compensation and benefits |
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Operating lease liabilities, current |
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Other current liabilities |
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Total current liabilities |
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Operating lease liabilities, non-current |
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Total liabilities |
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Commitments and contingencies (Notes 6 and 8) |
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Stockholders' equity: |
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Preferred stock, $ |
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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 | $ | |
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See accompanying notes to condensed financial statements.
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CASSAVA SCIENCES, INC. | ||||||||||||
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CONDENSED STATEMENTS OF OPERATIONS | ||||||||||||
(Unaudited, in thousands, except per share data) | ||||||||||||
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Operating expenses: |
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Research and development, net of grant reimbursement |
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General and administrative |
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Gain on sale of property and equipment |
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Total operating expenses |
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Operating loss |
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Interest income |
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Net loss |
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Net loss per share, basic and diluted |
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Shares used in computing net loss per share, basic and diluted |
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See accompanying notes to condensed financial statements.
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CASSAVA SCIENCES, INC. | |||||
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CONDENSED STATEMENTS OF CASH FLOWS | |||||
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| Six months ended June 30, | ||||
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Cash flows from operating activities: |
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Net loss | $ | ( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Depreciation and amortization |
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Gain on sale of property and equipment |
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Changes in operating assets and liabilities: |
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Prepaid and other assets |
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Operating lease right-of-use assets and liabilities |
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Accounts payable |
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Accrued development expense |
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Accrued compensation and benefits |
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Other current liabilities |
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Net cash used in operating activities |
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Cash flows from investing activities: |
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Purchase of property and equipment |
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Proceeds from sale of property and equipment |
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Net cash (used in) provided by investing activities |
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Cash flows from financing activities: |
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Proceeds from exercise of stock options |
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Proceeds from exercise of common stock warrants |
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Proceeds from registered direct offering, net of issuance costs |
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Net cash provided by financing activities |
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Net increase in cash and cash equivalents |
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Cash and cash equivalents at beginning of period |
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Cash and cash equivalents at end of period | $ | |
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See accompanying notes to condensed financial statements.
Cassava Sciences, Inc.
Notes to Condensed Financial Statements
(Unaudited)
Cassava Sciences, Inc. (the “Company”) discovers and develops proprietary pharmaceutical product candidates that may offer significant improvements to patients and healthcare professionals. The Company generally focuses its discovery and product development efforts on disorders of the nervous system.
The accompanying unaudited condensed financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and pursuant to the instructions to the Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. Accordingly, the condensed financial statements do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management of the Company, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation have been included. Operating results for the three and six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for any other interim period or for the year 2021. For further information, refer to the financial statements and footnotes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.
Coronavirus Disease 2019 (COVID-19)
The widespread outbreak of a novel infectious disease called Coronavirus Disease 2019, or COVID-19, has not significantly impacted the Company’s operations or financial condition as of August 4, 2021. However, this pandemic has created a dynamic and uncertain situation in the national economy. The Company continues to closely monitor the latest information to make timely, informed business decisions and public disclosures regarding the potential impact of pandemic on its operations and financial condition. The scope of pandemic is unprecedented and its long-term impact on the Company’s operations and financial condition cannot be reasonably estimated at this time.
Liquidity
The Company has incurred significant net losses and negative cash flows since inception, and as a result has an accumulated deficit of $
The Company makes estimates and assumptions in preparing its condensed financial statements in conformity with GAAP. These estimates and assumptions affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed financial statements and the reported amount of revenue earned and expenses incurred during the reporting period. The Company evaluates its estimates on an ongoing basis, including those estimates related to manufacturing agreements and research collaborations. Actual results could differ from these estimates and assumptions.
The Company invests in cash and cash equivalents. The Company considers highly liquid financial instruments with original maturities of three months or less to be cash equivalents. Highly liquid investments that are considered
cash equivalents include money market accounts and funds, certificates of deposits, and U.S. Treasury securities. The Company maintains its cash and cash equivalents at one financial institution.
The Company recognizes financial instruments in accordance with the authoritative guidance on fair value measurements and disclosures for financial assets and liabilities. This guidance defines fair value, establishes a framework for measuring fair value in accordance with GAAP, and expands disclosures about fair value measurements. The guidance also establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
Level 1 includes quoted prices in active markets.
Level 2 includes significant observable inputs, such as quoted prices for identical or similar securities, or other inputs that are observable and can be corroborated by observable market data for similar securities. The Company uses market pricing and other observable market inputs obtained from third-party providers. It uses the bid price to establish fair value where a bid price is available. The Company does not have any financial instruments where the fair value is based on Level 2 inputs.
Level 3 includes unobservable inputs that are supported by little or no market activity. The Company does not have any financial instruments where the fair value is based on Level 3 inputs.
If a financial instrument uses inputs that fall in different levels of the hierarchy, the instrument will be categorized based upon the lowest level of input that is significant to the fair value calculation. The fair value of cash and cash equivalents was based on Level 1 inputs at June 30, 2021 and December 31, 2020.
During the three months ended June 30, 2021 and 2020, the Company received reimbursements totaling $
The Company recognizes non-cash expense for the fair value of all stock options and other share-based awards. The Company uses the Black-Scholes option valuation model (“Black-Scholes”) to calculate the fair value of stock options, using the single-option award approach and straight-line attribution method. For all options granted, it recognizes the resulting fair value as expense on a straight-line basis over the vesting period of each respective stock option, generally
The Company has granted share-based awards that vest upon achievement of certain performance criteria (“Performance Awards”). The Company multiplies the number of Performance Awards by the fair value of its common stock on the date of grant to calculate the fair value of each award. It estimates an implicit service period for achieving performance criteria for each award. The Company recognizes the resulting fair value as expense over the implicit service period when it concludes that achieving the performance criteria is probable. It periodically reviews and updates as appropriate its estimates of implicit service periods and conclusions on achieving the performance criteria. Performance Awards vest and common stock is issued upon achievement of the performance criteria.
The Company computes basic net loss per share on the basis of the weighted-average number of common shares outstanding for the reporting period. Diluted net loss per share is computed on the basis of the weighted-average number of common shares outstanding plus potential dilutive common shares outstanding using the treasury-stock method. Potential dilutive common shares consist of outstanding common stock options and warrants. There is no difference between the Company’s net loss and comprehensive loss.
The Company included the following in the calculation of basic and diluted net loss per share (in thousands, except per share data):
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| Three months ended |
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| June 30, |
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| 2021 |
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Numerator: |
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Net loss |
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Denominator: |
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Shares used in computing net loss per share, basic and diluted |
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Net loss per share, basic and diluted |
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Dilutive common stock options excluded from net loss per share, diluted |
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Common stock warrants excluded from net loss per share, diluted |
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The Company excluded common stock options and warrants outstanding from the calculation of net loss per share, diluted, because the effect of including options and warrants outstanding would have been anti-dilutive.
Financial instruments include accounts payable and accrued liabilities. The estimated fair value of certain financial instruments may be determined using available market information or other appropriate valuation methodologies. However, considerable judgment is required in interpreting market data to develop estimates of fair value; therefore, the estimates are not necessarily indicative of the amounts that could be realized or would be paid in a current market exchange. The effect of using different market assumptions and/or estimation methodologies may be material to the estimated fair value amounts. The carrying amounts of accounts payable and accrued liabilities are at cost, which approximates fair value due to the short maturity of those instruments.
The Company has entered into various research and development contracts with research institutions and other third-party vendors. These agreements are generally cancelable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from actual costs.
In 2020, the Company established the 2020 Cash Incentive Bonus Plan (the “Plan”) to incentivize Plan participants. Awards under the Plan are accounted for as liability awards under Accounting Standards Codification (ASC) 718 “Stock-based Compensation”. The fair value of each potential Plan award will be determined once a grant date occurs and will be remeasured each reporting period. Compensation expense associated with the Plan will be recognized over the expected achievement period for each Plan award, when a Performance Condition is considered probable of being met. See Note 8 for further discussion of the Plan.
The Company recognizes assets and liabilities that arise from leases. For operating leases, the Company is required to recognize a right-of-use asset and a lease liability, initially measured at the present value of the lease payments during the lease term, in the condensed balance sheets. The Company elected the short-term lease recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company does not recognize right-of-use assets or lease liabilities. As the Company`s leases do not provide an implicit rate, it uses its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax balances are adjusted to reflect tax rates based on currently enacted tax laws, which will be in effect in the years in which the temporary differences are expected to reverse. The Company has accumulated significant deferred tax assets that reflect the tax effects of net operating loss and tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Realization of certain deferred tax assets is dependent upon future earnings. The Company is uncertain about the timing and amount of any future earnings. Accordingly, the Company offsets these deferred tax assets with a valuation allowance.
The Company accounts for uncertain tax positions in accordance with ASC 740, “Income Taxes”, which clarifies the accounting for uncertainty in tax positions. These provisions require recognition of the impact of a tax position in the Company’s condensed financial statements only if that position is more likely than not of being sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected as a component of income tax expense.
Prepaid and other assets at June 30, 2021 and December 31, 2020 consisted of the following (in thousands):
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Prepaid insurance | $ | — |
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Contract research organization deposit |
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Other |
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Total prepaid expenses and other current assets | $ | |
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Contract research organization deposit | $ | |
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Total other assets | $ | |
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Stockholders’ Equity Activity during the Six Months Ended June 30, 2021 and 2020
During the six months ended June 30, 2021 and 2020, the Company’s common stock outstanding and stockholders’ equity changed as follows:
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Balance at December 31, 2019 | |
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Stock-based compensation for: |
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Stock options for employees |
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Stock options for non-employees |
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Proceeds from exercise of common stock warrants | |
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Net loss |
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Balance at March 31, 2020 | |
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Stock-based compensation for: |
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Stock options for employees |
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Stock options for non-employees |
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Proceeds from exercise of common stock warrants | |
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Net loss |
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Balance at June 30, 2020 | |
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Balance at December 31, 2020 | |
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Stock-based compensation for: |
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Stock options for employees |
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Stock options for non-employees |
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Proceeds from exercise of common stock warrants | |
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Exercise of stock options | |
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Proceeds from registered direct offering of common stock | |
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Net loss |
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Balance at March 31, 2021 | |
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Stock-based compensation for: |
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Stock options for employees |
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Stock options for non-employees |
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Exercise of stock options | |
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Net loss |
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Balance at June 30, 2021 | |
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2021 Registered Direct Offering
On February 12, 2021, the Company completed a common stock offering pursuant to which certain investors purchased
At-the-Market Common Stock Offering
In March 2020, the Company established an at-the-market offering program (“ATM”) to sell, from time to time, shares of Company common stock having an aggregate offering price of up to $
There were
Common Stock Warrants
In August 2018, the Company issued warrants to purchase up to an aggregate of
The Company did
During the six months ended June 30, 2021, the Company received proceeds of $
There were
Stock Option and Performance Award Activity in 2021
During the six months ended June 30, 2021, stock options and unvested Performance Awards outstanding under the Company’s stock option plans changed as follows:
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| Stock Options |
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Outstanding as of December 31, 2020 |
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Options granted |
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Options exercised |
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