UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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.
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, 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 |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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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
As of October 8, 2021, the Registrant had
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact, including statements concerning our business strategy and plans, future operating results and financial position, as well as our objectives and expectations for our future operations, are forward-looking statements.
In some cases, you can identify forward-looking statements by such terminology as “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements about:
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the timing of our planned investigational new drug application (IND) submissions for our lead drug candidates and other drug candidates; |
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the timing and conduct of our clinical trial programs for our lead drug candidates NX-2127, NX-1607, NX-5948, DeTIL-0255 and other drug candidates, including statements regarding the timing of initiation of the clinical trials; |
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the timing of, and our ability to obtain, marketing approvals for our lead drug candidates NX-2127, NX-1607, NX-5948, DeTIL-0255 and other drug candidates; |
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our plans to pursue research and development of other drug candidates; |
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the potential advantages of our DELigase platform and our drug candidates; |
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the extent to which our scientific approach and DELigase platform may potentially address a broad range of diseases; |
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the potential benefits of our arrangements with Sanofi S.A. and Gilead Sciences, Inc.; |
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the timing of and our ability to obtain and maintain regulatory approvals for our drug candidates; |
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the potential receipt of revenue from future sales of our drug candidates; |
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the rate and degree of market acceptance and clinical utility of our drug candidates; |
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our estimates regarding the potential market opportunity for our drug candidates; |
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our sales, marketing and distribution capabilities and strategy; |
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our ability to establish and maintain arrangements for the manufacturing of our drug candidates; |
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the impact of the ongoing coronavirus (COVID-19) pandemic, including the resurgence of cases relating to the spread of the Delta variant, on our business, clinical trials, financial condition, liquidity and results of operations; |
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the potential achievement of milestones and receipt of royalty payments under our collaborations; |
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our ability to enter into additional collaborations with third parties; |
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our intellectual property position; |
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our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; |
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the impact of government laws and regulations; and |
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our competitive position. |
We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We disclaim any intention or obligation to publicly update or revise any forward-looking statements for any reason or to conform such statements to actual results or revised expectations, except as required by law.
TABLE OF CONTENTS
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PART I. |
1 |
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Item 1. |
1 |
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1 |
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2 |
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3 |
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4 |
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6 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
22 |
Item 3. |
32 |
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Item 4. |
32 |
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PART II. |
33 |
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Item 1. |
33 |
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Item 1A. |
33 |
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Item 2. |
82 |
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Item 3. |
82 |
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Item 4. |
82 |
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Item 5. |
82 |
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Item 6. |
83 |
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84 |
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(unaudited)
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August 31, |
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November 30, |
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2021 |
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2020 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Short-term investments |
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Contract assets |
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Income tax receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Long-term investments |
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Property and equipment, net |
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Restricted cash |
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Other assets |
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Total assets |
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$ |
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$ |
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Liabilities and stockholders' equity |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued and other current liabilities |
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Deferred revenue, current |
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Total current liabilities |
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Deferred revenue, net of current portion |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note 6) |
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Stockholders’ equity: |
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Preferred stock, $ authorized as of August 31, 2021 and November 30, 2020; as of August 31, 2021 and November 30, 2020 |
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Common stock, $ authorized as of August 31, 2021 and November 30, 2020; issued and outstanding as of August 31, 2021 and November 30, 2020, respectively |
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Additional paid-in-capital |
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Accumulated other comprehensive income (loss) |
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( |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended August 31, |
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Nine Months Ended August 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Collaboration revenue |
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$ |
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$ |
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$ |
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$ |
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Operating expenses: |
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Research and development |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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( |
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( |
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( |
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Interest and other income, net |
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Loss before income taxes |
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( |
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( |
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( |
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( |
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Provision (benefit) for income taxes |
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( |
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— |
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( |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Weighted-average number of shares outstanding, basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands)
(unaudited)
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Three Months Ended August 31, |
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Nine Months Ended August 31, |
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2021 |
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2020 |
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2021 |
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2020 |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive income (loss): |
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Unrealized gain (loss) on available-for-sale investments |
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( |
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( |
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( |
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Total comprehensive loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
NURIX THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(in thousands, except share amounts)
(unaudited)
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Redeemable convertible preferred stock |
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders’ equity |
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Shares |
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Amount |
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Shares |
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Amount |
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capital |
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income (loss) |
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deficit |
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(deficit) |
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Balance as of November 30, 2019 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
( |
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Exercise of stock options |
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— |
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— |
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— |
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— |
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— |
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Repurchase of unvested early exercised stock options |
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— |
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— |
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( |
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— |
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— |
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— |
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— |
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— |
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Vesting of early-exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized gain (loss) on available-for-sale investments |
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— |
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— |
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— |
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— |
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— |
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— |
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Net income (loss) |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance as of February 29, 2020 |
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( |
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( |
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Issuance of Series D redeemable convertible preferred stock at $ issuance costs of $ |
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— |
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— |
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— |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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— |
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— |
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Vesting of early-exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized gain (loss) on available-for-sale investments |
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— |
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— |
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— |
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— |
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— |
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— |
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Net income (loss) |
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— |
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— |
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— |
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— |
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— |
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— |
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Balance as of May 31, 2020 |
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( |
) |
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( |
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Conversion of redeemable convertible preferred stock into common stock |
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( |
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( |
) |
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— |
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— |
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Issuance of common stock upon initial public offering, net of offering costs of $ |
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— |
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— |
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— |
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— |
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Exercise of stock options |
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— |
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— |
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— |
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— |
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— |
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Repurchase of unvested early exercised stock options |
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— |
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— |
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( |
) |
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— |
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— |
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— |
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— |
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— |
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Vesting of early-exercised stock options |
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— |
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— |
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— |
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— |
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— |
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— |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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— |
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— |
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Unrealized gain (loss) on available-for-sale investments |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net income (loss) |
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— |
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— |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Balance as of August 31, 2020 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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4
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Redeemable convertible preferred stock |
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Common stock |
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Additional paid-in |
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Accumulated other comprehensive |
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Accumulated |
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Total stockholders’ equity |
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Shares |
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Amount |
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Shares |
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Amount |
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capital |
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income (loss) |
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deficit |
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(deficit) |
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Balance as of November 30, 2020 |
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— |
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$ |
— |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Exercise of stock options |
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— |
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— |
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— |
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— |
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— |
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Repurchase of unvested early exercised stock options |
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— |
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— |
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( |
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— |
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— |
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— |
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— |
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— |
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Vesting of early-exercised stock options |
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— |
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— |
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|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Issuance under employee stock purchase plan |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Unrealized gain (loss) on available-for-sale investments |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
Net income (loss) |
|
|
— |
|
|
|
— |
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance as of February 28, 2021 |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
Issuance of common stock in connection with equity offering, net of offering costs of $ |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
|
|
|
|
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|