UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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 FOR THE TRANSITION PERIOD FROM _____________________ TO _____________________ |
Commission File Number
(Exact name of Registrant as specified in its Charter)
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Securities registered pursuant to Section 12(b) of the Act:
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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, 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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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 ☐ No
The number of shares of Registrant’s common stock outstanding as of May 1, 2023 was
Table of Contents
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Page |
PART I |
FINANCIAL INFORMATION |
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Item 1. |
1 |
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Condensed Balance Sheets as of March 31, 2023 (unaudited) and December 31, 2022 |
1 |
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2 |
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3 |
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Condensed Statements of Cash Flows for the three months ended March 31, 2023 and 2022 (unaudited) |
4 |
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5 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
11 |
Item 3. |
16 |
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Item 4. |
17 |
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PART II |
18 |
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Item 1. |
18 |
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Item 1A. |
18 |
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Item 2. |
23 |
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Item 3. |
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Item 4. |
23 |
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Item 5. |
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Item 6. |
25 |
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26 |
i
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act). Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions, or strategies regarding the future, including those relating to the statements described below. In addition, any statements that refer to projections, forecasts, or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
Forward-looking statements relating to us in this Quarterly Report on Form 10-Q include, but are not limited to, statements about:
The forward-looking statements in this Quarterly Report on Form 10-Q are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting us will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements.
In addition, statements that we “believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this Quarterly Report on Form 10-Q, and while we believe that such information forms a reasonable basis for such statements, such information may be limited or incomplete, and these statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements.
The risks and uncertainties include, but are not limited to, those factors described under the headings “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 14, 2023. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. There may be additional risks that we currently consider immaterial or which are unknown. It is not possible to predict or identify all such risks. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
ii
PART I—FINANCIAL INFORMATION
Item 1. Condensed Financial Statements.
PARDES BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
(in thousands, except share and par value data)
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March 31, |
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December 31, |
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2023 |
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2022 |
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(unaudited) |
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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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Prepaid expenses and other current assets |
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Total current assets |
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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 expenses |
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Total current liabilities |
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Total liabilities |
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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 other comprehensive loss |
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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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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
1
PARDES BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(in thousands, except share and per share data)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Other income (expense): |
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Interest and other income (expense), net |
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Net loss |
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$ |
( |
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$ |
( |
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Net loss per share, basic and diluted |
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$ |
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$ |
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Weighted-average number of common shares used in computing net loss per share, basic and diluted |
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Unrealized gain on available-for-sale securities |
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$ |
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$ |
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Comprehensive loss |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
2
PARDES BIOSCIENCES, INC.
CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
(in thousands, except share amounts)
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For the Three Months Ended March 31, 2023 |
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Common Stock |
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Number of |
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$0.0001 |
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Additional Paid-In Capital |
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Accumulated Other Comprehensive Loss |
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Accumulated |
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Total |
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Balance as of December 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Vesting of restricted stock |
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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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Other comprehensive income |
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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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( |
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( |
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Balance at March 31, 2023 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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For the Three Months Ended March 31, 2022 |
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Common Stock |
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Number of |
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$0.0001 |
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Additional Paid-In Capital |
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Accumulated |
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Total |
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Balance as of December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
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Vesting of restricted stock |
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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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Net loss |
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— |
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— |
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— |
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( |
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Balance at March 31, 2022 |
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$ |
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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 condensed financial statements.
3
PARDES BIOSCIENCES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(in thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Operating activities: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Net accretion of discounts on available-for-sale securities |
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( |
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Stock-based compensation expense |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
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( |
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Interest receivable |
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Accounts payable |
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( |
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Accrued expenses |
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( |
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( |
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Other assets |
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Net cash used in operating activities |
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( |
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Investing activities: |
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Purchases of available-for-sale securities |
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Proceeds on sale of available-for-sale securities |
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Maturities of available-for-sale securities |
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Net cash provided by investing activities |
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Financing activities: |
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Cash paid for deferred offering costs |
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( |
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Net cash used in financing activities |
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( |
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Decrease in cash and cash equivalents |
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( |
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( |
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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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$ |
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$ |
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The accompanying notes are an integral part of these condensed financial statements.
4
PARDES BIOSCIENCES, INC.
Notes to Unaudited Condensed Financial Statements
Note 1. Description of Business
Description of Business
Pardes Biosciences, Inc., a Delaware corporation, is a biopharmaceutical company that has been focused on discovering, developing and commercializing novel oral-antiviral therapeutics to improve the lives of patients suffering from life-threatening disease. Unless the context otherwise requires, references in these notes to “Pardes,” “the Company,” “we,” “us,” “our” and any related terms are intended to mean Pardes Biosciences, Inc.
On April 3, 2023, we announced topline results from our Phase 2 clinical trial to evaluate pomotrelvir (formerly known as PBI-0451) for the treatment of mild-to-moderate COVID-19 in test-positive, symptomatic, otherwise healthy, vaccinated adults without risk factors for developing severe disease. COVID-19 is caused by infection with the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Pomotrelvir did not achieve the primary endpoint as measured by the proportion of participants below the limit of detection for infectious SARS-CoV-2 by infectious virus assay (IVA) on day three of treatment with pomotrelvir versus with placebo. Pomotrelvir did not demonstrate meaningful improvement over placebo in reduction from baseline of SARS-CoV-2 infectious virus titer by IVA or in the reduction from baseline or proportion achieving undetectable viral load by quantitative reverse transcriptase polymerase chain reaction measured from mid-turbinate swabs.
Based upon the topline results from the Phase 2 clinical trial, the Company decided to suspend further clinical development of pomotrelvir and the Board of the Directors of the Company (the Board) has initiated a review of a range of strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, or other transaction. There can be no assurance that this review process will result in the Company pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company does not intend to comment further unless or until the Board has approved a definitive course of action, the review process is concluded, or it is determined that other disclosure is appropriate.
Business Combination
On December 23, 2021 (Closing Date), Pardes Biosciences, Inc., a private company (Old Pardes) and FS Development Corp. II (FSDC II) completed the transactions contemplated by the Agreement and Plan of Merger, dated as of June 29, 2021, as amended on November 7, 2021 (Merger Agreement), by and among Old Pardes, Shareholder Representative Services LLC, a Colorado limited liability company solely in its capacity as the representative, agent and attorney-in-fact of the Company Securityholders (as defined in the Merger Agreement), FSDC II and Orchard Merger Sub Inc., a Delaware corporation and a wholly-owned subsidiary of FSDC II (Merger Sub). FSDC II was formed in August 2020 for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses. Pursuant to the Merger Agreement, on the Closing Date, FSDC II changed its name to “Pardes Biosciences, Inc.”
In connection with the transactions contemplated under the Merger Agreement and described above (collectively, the Business Combination) certain investors purchased an aggregate of $
For additional information on the Business Combination, please refer to Note 5, Business Combination, to the consolidated financial statements included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the Securities and Exchange Commission (SEC) on March 14, 2023 (2022 Form 10-K).
Liquidity
Through March 31, 2023, we have funded our operations primarily with proceeds from the sale of preferred stock, the Business Combination and the PIPE Investment. On January 12, 2023, we filed a shelf registration statement on Form S-3, which was declared effective by the U.S. Securities and Exchange Commission on January 20, 2023 (2023 Shelf). In connection with the 2023 Shelf, we entered into a Sales Agreement, dated January 11, 2023, with SVB Securities LLC (Sales Agent), pursuant to which we may offer and sell up to $
We have cash deposits with regulated financial institutions, which may from time to time exceed insurance provided on such deposits.
5
Note 2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed financial statements should be read in conjunction with the audited financial statements and notes thereto in our 2022 Form 10-K, from which we derived our balance sheet as of December 31, 2022. The accompanying unaudited condensed financial statements have been prepared in accordance with United States (U.S.) generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, that are, in the opinion of our management, necessary to a fair statement of the results for the interim periods presented. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results to be expected for the year ending December 31, 2023 or for any other future annual or interim period.
Use of Estimates
The preparation of the unaudited condensed financial statements in accordance with GAAP requires our management to make estimates and assumptions that affect the amounts reported on our unaudited condensed financial statements and accompanying notes. The amounts reported could differ under different estimates and assumptions. On an ongoing basis, we evaluate our estimates and judgments, which are based on historical and anticipated results and trends and on various other assumptions that management believes to be reasonable under the circumstances. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from management’s estimates.
Significant Accounting Policies
The accounting policies we follow are set forth in our audited financial statements for the fiscal year ended December 31, 2022. For further information, please refer to the audited financial statements and footnotes thereto included in Part II, Item 8 of our 2022 Form 10-K. There have been no material changes to these accounting policies.
Net Loss Per Share
Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury-stock method. Common stock equivalents are only included in the calculation of diluted earnings per common share when net income is reported and their effect is dilutive. For the periods presented, there is no difference in the number of shares used to calculate basic and diluted shares outstanding due to our net loss position. Basic and diluted net loss attributable to common stockholders per share is presented in conformity with the two-class method required for participating securities as shares of unvested restricted stock are considered participating securities. Our participating securities do not have a contractual obligation to share in our losses. As such, the net loss was attributed entirely to common stockholders for all periods presented.
The following outstanding shares of potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods presented because including them would be anti-dilutive (in common stock equivalent shares):
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March 31, 2023 |
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March 31, 2022 |
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Outstanding stock options |
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Restricted common stock subject to repurchase or forfeiture |
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Total |
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New Accounting Pronouncements Adopted and Not Yet Adopted
The Company has not adopted any significant accounting policies since December 31, 2022. Upon evaluation of recently issued accounting pronouncements, the Company does not believe any will have a material impact on its unaudited condensed financial statements or related financial statement disclosures.
Note 3. Investments
Available-for-sale securities consisted of U.S. Treasury securities, U.S. Agency bonds, commercial paper, corporate debt securities and asset-backed securities.
6
Our cash equivalents consisted of the following (in thousands):
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March 31, 2023 |
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December 31, 2022 |
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Cash equivalents |
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Money market fund |
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$ |
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$ |
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U.S. government and government agencies |
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Commercial paper |
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Corporate debt securities |
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Total cash equivalents |
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$ |
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$ |
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Short-term investments are classified as available-for-sale, which reflects management’s intention to use proceeds from sales of these securities to fund our operations as necessary and, as such, are carried at fair value.
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March 31, 2023 |
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Maturities |
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Estimated |
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Short-term investments |
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U.S. government and government agencies |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Commercial paper |
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( |
) |
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Asset-backed securities |
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Total short-term investments |
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$ |
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$ |
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$ |
( |
) |
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$ |
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December 31, 2022 |
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Maturities |
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Amortized Cost |
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Unrealized Gains |
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Unrealized Losses |
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Estimated |
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Short-term investments |
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U.S. government and government agencies |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Commercial paper |
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Asset-backed securities |
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Total short-term investments |
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$ |
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$ |
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$ |
( |
) |
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$ |
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The amortized cost and the fair value of short-term investments were $
Note 4. Fair Value Measurements
Fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the accounting guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows:
Level 1 — Observable inputs such as quoted prices in active markets;
Level 2 — Inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities, quoted prices in markets with insufficient volume or infrequent transactions (less active markets), or model-driven valuations in which all significant inputs are observable or can be derived principally from, or corroborated with, observable market data; and
7
Level 3 — Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.
Below are summaries of our cash equivalents and short-term investments that were measured at fair value on a recurring basis and are categorized using the fair value hierarchy (in thousands):
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March 31, 2023 |
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December 31, 2022 |
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Level 1 |
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Level 2 |
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Estimated Fair Value |
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Level 1 |
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Level 2 |
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Estimated Fair Value |
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Cash equivalents |
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Money market fund |
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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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U.S. government and government agencies |
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— |
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— |
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Commercial paper |
|
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— |
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|
— |
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|
|
— |
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|
|
— |
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Corporate debt securities |
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— |
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|
— |
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|
— |
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— |
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Total cash equivalents |
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$ |
|
|
$ |
|
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$ |
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$ |
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$ |
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|
$ |
|
|
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March 31, 2023 |
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December 31, 2022 |
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Level 2 |
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Estimated Fair Value |
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Level 2 |
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Estimated Fair Value |
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Short-term investments |
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U.S. government and government agencies |
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$ |
|
|
$ |
|
|
$ |
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|
$ |
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Commercial paper |
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Asset-backed securities |
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Total short-term investments |
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$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
Note 5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
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March 31, 2023 |
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December 31, 2022 |
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Prepaid insurance |
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$ |
|
|
$ |
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||
Prepaid research and development costs |
|
|
|
|
|
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Other prepaid expenses and current assets |
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Total |
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$ |
|
|
$ |
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Note 6. Accrued Expenses
Accrued expenses consisted of the following (in thousands):
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March 31, 2023 |
|
|
December 31, 2022 |
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Research and development accruals |
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$ |
|
|
$ |
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||
Accrued compensation |
|
|
|
|
|
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Other accrued expenses |
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|
|
|
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Total |
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$ |
|
|
$ |
|
Note 7. Stockholders’ Equity
Preferred Stock
Pursuant to the terms of the Second Amended and Restated Certificate of Incorporation dated December 23, 2021 (Certificate of Incorporation), we authorized
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Common Stock
Pursuant to the Certificate of Incorporation, as of March 31, 2023 and December 31, 2022, there were
Note 8. Stock-Based Compensation
The following table summarizes stock-based compensation expense for all stock-based compensation arrangements (in thousands):
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Three Months Ended March 31, |
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2023 |
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2022 |
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Research and development |
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$ |
|
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$ |
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General and administrative |
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