31
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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
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Securities registered or to be 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.
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Large accelerated filer |
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Accelerated filer |
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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. ☐
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As of May 8, 2023, the number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was
CATALYST BIOSCIENCES, INC.
TABLE OF CONTENTS
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Item 1. |
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Condensed Consolidated Balance Sheets as of March 31, 2023 (unaudited) and December 31, 2022 |
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Notes to the Unaudited Interim Condensed Consolidated Financial Statements |
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Item 2. |
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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28 |
PART I. FINANCIAL INFORMATION
ITEM 1. |
FINANCIAL STATEMENTS |
Catalyst Biosciences, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
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March 31, 2023 |
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December 31, 2022 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Accounts and other receivables |
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Prepaid and other current assets |
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Total current assets |
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Long-term receivable from GCBP |
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— |
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Other assets, noncurrent |
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Right-of-use assets |
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Property and equipment, net |
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Total assets |
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$ |
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$ |
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Liabilities, redeemable convertible preferred stock and stockholders’ deficit |
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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 compensation |
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Other accrued liabilities |
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Dividends payable |
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— |
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CVR derivative liability |
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Operating lease liability |
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— |
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Total current liabilities |
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CVR derivative liability, noncurrent |
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— |
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Total liabilities |
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Commitments and Contingencies (Note 9) |
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Redeemable convertible preferred stock, $ |
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Stockholders’ deficit: |
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Common stock, $ respectively |
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Additional paid-in capital |
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Accumulated deficit |
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Total stockholders’ deficit |
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Total liabilities, redeemable convertible preferred stock and stockholders’ deficit |
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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
3
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Revenue: |
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Collaboration |
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$ |
— |
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$ |
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Operating expenses (income): |
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Cost of collaboration |
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— |
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Research and development |
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General and administrative |
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Gain on disposal of assets, net |
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— |
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Total operating expenses (income) |
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Income (loss) from operations |
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Interest and other income, net |
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Income (loss) before income taxes |
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Income tax expenses |
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— |
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Net income (loss) |
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$ |
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$ |
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Net income (loss) per share attributable to common stockholders, basic |
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$ |
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$ |
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Net income (loss) per share attributable to common stockholders, diluted |
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$ |
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$ |
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Shares used to compute net income (loss) per share attributable to common stockholders, basic |
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Shares used to compute net income (loss) per share attributable to common stockholders, diluted |
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Cash dividends paid per common share |
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$ |
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$ |
— |
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CVR cash dividends paid per common share |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
4
Catalyst Biosciences, 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 |
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Total Stockholders' |
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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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Deficit |
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Deficit |
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Balance at 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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Stock-based compensation expense |
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— |
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— |
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— |
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— |
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— |
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Issuance of common stock from stock grants |
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— |
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— |
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— |
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— |
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CVR cash dividends paid related to GCBP Agreement ($ |
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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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CVR derivative liability |
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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 |
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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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Redeemable Convertible Preferred Stock |
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Common Stock |
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Additional Paid-In |
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Accumulated |
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Total Stockholders’ |
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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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Deficit |
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Equity |
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Balance at December 31, 2021 |
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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 expense |
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— |
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— |
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— |
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— |
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Issuance of common stock from stock grants |
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— |
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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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— |
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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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$ |
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$ |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
5
Catalyst Biosciences, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
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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 income (loss) |
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$ |
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$ |
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Adjustments to reconcile net income (loss) to net cash used in operating activities: |
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Stock-based compensation expense |
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Depreciation and amortization |
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Change in fair value of long-term receivables |
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— |
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Change in fair value of derivative liabilities |
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— |
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Bad debt expense |
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— |
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Net gain on disposal of assets |
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— |
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Changes in operating assets and liabilities: |
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Accounts and other receivables |
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— |
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Prepaid and other current assets |
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Accounts payable |
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Accrued compensation and other accrued liabilities |
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Operating lease liability and right-of-use asset |
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Deferred revenue |
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— |
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Net cash flows used in operating activities |
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Investing Activities |
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Proceeds from maturities of short-term investments |
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— |
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Proceeds from the sale of legacy rare bleeding disorder program to GCBP |
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— |
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Payment of transaction costs in connection with the sale of legacy rare bleeding disorder program to GCBP |
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— |
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Net cash flows provided by investing activities |
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Financing Activities |
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Payment of dividends |
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Issuance of common stock from stock grants |
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Net cash flows (used in) provided by financing activities |
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Net decrease in cash and cash equivalents |
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Cash and cash equivalents at beginning of the period |
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Cash and cash equivalents at end of the period |
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$ |
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$ |
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Supplemental Disclosure on Non-Cash Investing and Financing Activities: |
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CVR derivative liability |
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$ |
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$ |
— |
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Accrued transaction costs related to GCBP asset sale |
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$ |
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$ |
— |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
6
Catalyst Biosciences, Inc.
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. |
Nature of Operations and Liquidity |
Catalyst Biosciences, Inc. and its subsidiary (the “Company” or “Catalyst”) was a biopharmaceutical company with expertise in protease engineering. Prior to ceasing research and development activities in March 2022, the Company had several protease assets that were designed to address unmet medical needs in disorders of the complement or coagulation systems. As discussed further below, the Company recently completed a purchase agreement to acquire a clinical-stage drug candidate for the treatment of NASH (nonalcoholic steatohepatitis, a severe form of nonalcoholic fatty liver disease). Concurrent with this purchase agreement, the Company entered into a separate business combination agreement to acquire an indirect controlling interest in a China-based pharmaceutical company. The Company will continue to evaluate the impact of the novel coronavirus disease (“COVID-19”) pandemic on its business, operations, and cash requirements. The Company is located in South San Francisco, California and operates in
On May 19, 2022, Catalyst entered into and closed on an asset purchase agreement with Vertex Pharmaceuticals Inc. (“Vertex”), pursuant to which Vertex acquired Catalyst’s complement portfolio, including CB 2782-PEG and CB 4332, as well as its complement-related intellectual property including the ProTUNETM and ImmunoTUNETM platforms. See Note 11, Restructuring.
On February 27, 2023, Catalyst entered into and closed on an asset purchase agreement with GC Biopharma Corp. (“GCBP”), pursuant to which GCBP acquired Catalyst’s legacy rare bleeding disorder program, including the coagulation related assets marzeptacog alfa (activated) (“MarzAA”), dalcinonacog alfa (“DalcA”), and CB-2679d-GT. See Note 11, Restructuring.
F351 Asset Acquisition
On December 26, 2022, the Company executed and closed an Asset Purchase Agreement, which was amended on
Business Combination Agreement
Concurrent with the F351 Asset acquisition, the Company signed a definitive agreement, as amended on
Contingent Value Rights Agreement
Pursuant to the Business Combination Agreement, on December 26, 2022, Catalyst and the Rights Agent (as defined therein) executed a contingent value rights agreement, as amended on
Liquidity
On
7
On March 8, 2023, the Company distributed the net cash proceeds received from the GCBP asset sale of $
The Company had net income of $
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2. |
Summary of Significant Accounting Policies |
Basis of Presentation
The Company’s condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and following the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. These financial statements have been prepared on the same basis as the Company’s annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s financial information. These interim results and cash flows for any interim period are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period.
The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the consolidated financial statements filed with the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 (the “Annual Report”).
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to revenue recognition, allowance of doubtful accounts, long-term receivable, contingent value rights, operating lease right-of-use assets and liabilities, accrued expenses, income taxes and stock-based compensation. The Company bases its estimates on various assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from those estimates.
Accounting Pronouncements Recently Adopted
In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments. The main objective of ASU 2016-13 is to provide financial statement users with more decision-useful information about an entity's expected credit losses on financial instruments and other commitments to extend credit at each reporting date. To achieve this objective, the amendments in this update replace the incurred loss impairment methodology currently used today with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to develop credit loss estimates. ASU 2016-13 is effective for the Company for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years, using a modified retrospective approach. The Company adopted ASU 2016-13 and related updates as of
Long-Term Receivable
The Company determined that the hold-back from the GCBP asset sale in February 2023 qualified as a long-term receivable. The receivable is considered a loan held for investment since the Company has the intent and ability to hold to maturity. Catalyst has
8
elected to account for the receivable under the fair value option method of accounting and any changes in fair value are recorded in interest and other income, net on the condensed consolidated statement of operations. Refer to Note 4, Fair Value Measurements and Note 11, Restructuring, for additional information regarding the long-term receivable and GCBP asset sale.
Net Income (Loss) per Share Attributable to Common Stockholders
The Company calculates basic and diluted net income (loss) per share attributable to common stockholders in conformity with the two-class method required for participating securities. The Catalyst Convertible Preferred Stock contractually entitles the holders of such shares to participate in dividends but such participation is contingent upon the completion of the merger with GNI. As a result, the Catalyst Convertible Preferred Stock is excluded from the basic EPS calculation, as these shares are not participating securities until the merger with GNI closes. As such, net income for the periods presented was not allocated to these securities. During periods of loss, the Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company.
Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. Participating securities are excluded from the basic weighted average common shares outstanding.
Diluted net income (loss) per share attributable to common stockholders is based on the weighted average number of common shares outstanding during the period, including potential dilutive common shares. For purposes of this calculation, outstanding stock options and warrants are considered potential dilutive common shares. The calculation of diluted EPS does not consider the effect of the Catalyst Convertible Preferred Stock since conversion is contingent upon the occurrence of a specified future event.
3. |
F351 Asset Acquisition |
On December 26, 2022, the Company acquired the F351 Assets from GNI in accordance with the terms of the F351 Agreement as discussed in Note 1, Nature of Operations and Liquidity. Under the terms of the F351 Agreement, the Company issued
The Company concluded that the F351 acquisition was not the acquisition of a business, as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, the intellectual property rights (outside of China) to a clinical stage drug candidate for the treatment of liver fibrosis, or the F351 Assets.
Subject to stockholder approval, each share of Catalyst Convertible Preferred Stock issued under the F351 Agreement is convertible into
In March 2023, the Company amended the F351 Agreement and the Catalyst Convertible Preferred Stock Certificate of Designation to extend the deadline for the cash settlement of the Catalyst Convertible Preferred Stock from June 26, 2023 to September 30, 2023. Under the amended terms, if the Company’s stockholders do not approve the conversion of the Catalyst Convertible Preferred Stock by September 30, 2023, then the Catalyst Convertible Preferred Stock would be redeemable at the option of the holders for cash equal to the closing price of the common stock on the last trading day prior to the holder’s redemption request. Using the closing price on May 8, 2023 of $
9
4. |
Fair Value Measurements |
For a description of the fair value hierarchy and the Company’s fair value methodology, see “Part II - Item 8 - Financial Statements and Supplementary Data - Note 3 – Summary of Significant Accounting Policies” in the Company’s Annual Report. There were no significant changes in these methodologies during the three months ended March 31, 2023.
The following tables present the fair value hierarchy for assets and liabilities measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 (in thousands):
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March 31, 2023 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Financial assets: |
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|
|
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|
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|
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Money market funds(1) |
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$ |
|
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|
$ |
— |
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|
$ |
— |
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|
$ |
|
|
Long-term receivable from GCBP |
|
|
— |
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|
|
— |
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|
|
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Total financial assets |
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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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Financial liabilities: |
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CVR derivative liability |
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$ |
— |
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$ |
— |
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$ |
|
|
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$ |
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|
CVR derivative liability, noncurrent |
|
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— |
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|
|
— |
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|
|
|
|
|
|
|
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Total financial liabilities |
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$ |
— |
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$ |
— |
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$ |
|
|
|
$ |
|
|
|
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December 31, 2022 |
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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Financial assets: |
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|
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Money market funds(1) |
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$ |
|
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|
$ |
— |
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|
$ |
— |
|
|
$ |
|
|
Total financial assets |
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$ |
|
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|
$ |
— |
|
|
$ |
— |
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$ |
|
|
|
|
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|
|
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Financial liabilities: |
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|
|
|
|
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|
|
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|
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CVR derivative liability |
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$ |
— |
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$ |
— |
|
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$ |
|
|
|
$ |
|
|
Total financial liabilities |
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$ |
— |
|
|
$ |
— |
|
|
$ |
|
|
|
$ |
|
|
|
(1) |
|
The carrying amounts of accounts and other receivables, accounts payable, and accrued liabilities approximate their fair values due to the short-term maturity of these instruments.
Derivative Liabilities and Long-term Receivables
The CVR derivative liability relates to the CVR Agreement executed in connection with the Business Combination Agreement. The fair value of this derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the CVR liability was determined based on the anticipated amount and timing of projected cash flows to be received from Vertex pursuant to the Vertex asset purchase agreement. As of March 31, 2023, the Company expects to receive a $
The long-term receivable and the corresponding CVR derivative liability, noncurrent relate to the asset purchase agreement with GCBP. The fair value of this long-term receivable and derivative liability is based on significant unobservable inputs, which represent Level 3 measurements within the fair value hierarchy. The estimated fair value of the long-term receivable and CVR derivative liability, noncurrent was determined based on the anticipated amount and timing of projected cash flows to be received from GCBP pursuant to the GCBP asset purchase agreement discounted to their present values using an estimated discount rate of
10
The following table sets forth the changes in the estimated fair value of the Company’s Level 3 financial assets and liabilities (in thousands):
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Long-term receivable |
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CVR derivative |
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from GCBP |
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liability, noncurrent |
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Balance at December 31, 2022 |
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$ |
— |
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$ |
— |
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Additions in the period |
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Changes in fair value |
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Balance at March 31, 2023 |
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$ |
|
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$ |
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5. |
Lease |
Operating lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term. In calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original lease term and not the remaining lease term. The lease includes non-lease components (e.g., common area maintenance) that are paid separately from rent based on actual costs incurred and, therefore, were not included in the right-of-use asset and lease liability but are reflected as an expense in the period incurred.
The Company leases office space for its corporate headquarters, located in South San Francisco, CA. The lease term is through
In March 2022, the Company entered into a sublease agreement for its leased facility that commenced in
For the three months ended March 31, 2023 and 2022, the Company’s operating lease expense was $
The Company has historically prepaid one month’s worth of rent expense, therefore as of March 31, 2023, the Company does not have any remaining lease payments under its current lease agreement.
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March 31, 2023 |
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December 31, 2022 |
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Weighted-average remaining lease term |
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Weighted-average discount rate |
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% |
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% |
Supplemental cash flow information related to operating leases was as follows (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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Cash paid for amounts included in the measurement of lease liabilities |
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$ |
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$ |
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6. |
Stock Based Compensation |
2018 Omnibus Incentive Plan
In June 2018, stockholders of the Company approved the Company’s 2018 Omnibus Incentive Plan (the “2018 Plan”). The 2018 Plan had previously been approved by the Company’s Board of Directors (the “Board”) and the Compensation Committee (the “Committee”) of the Board, subject to stockholder approval. The 2018 Plan became effective on June 13, 2018. On June 9, 2021, the stockholders of the Company approved an amendment previously approved by the Board to increase the number of shares of common stock reserved for issuance under the 2018 Plan by
11
Performance-Based Stock Option Grants
In June 2022, the Committee approved the issuance of an option grant to purchase
Special Cash Dividend
On
The following table summarizes stock option activity under the Company’s 2018 Plan and related information:
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Number of Shares Underlying Outstanding Options |
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Weighted- Average Exercise Price |
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Weighted- Average Remaining Contractual Term (Years) |
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Outstanding — December 31, 2022 |
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$ |
|
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Options granted (1) |
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$ |
|
|
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Options forfeited and cancelled (1) |
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( |
) |
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$ |
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Options expired |
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( |
) |
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$ |
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Outstanding — March 31, 2023 |
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$ |
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Exercisable — March 31, 2023 |
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$ |
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(1) |
|
Valuation Assumptions
The Company estimated the fair value of stock options granted using the Black-Scholes option-pricing formula and a single option award approach. Due to its limited relevant historical data, the Company estimated its volatility considering a number of factors including the use of the volatility of comparable public companies. The expected term of options granted under the Plan, all of which qualify as “plain vanilla” per SEC Staff Accounting Bulletin 107, is determined based on the simplified method due to the Company’s limited relevant history. The risk-free rate is based on the yield of a U.S. Treasury security with a term consistent with the option. This fair value is being amortized ratably over the requisite service periods of the awards, which is generally the vesting period.
The only options granted during the quarter ended March 31, 2023 were as a result of the option modification. Since
The fair value of employee stock options was estimated using the following weighted-average assumptions:
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Three Months Ended March 31, |
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2023 |
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2022 |
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Employee Stock Options: |
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Risk-free interest rate |
|
|
— |
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% |
Expected term (in years) |
|
|
— |
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Dividend yield |
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