UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number
(Exact Name of Registrant as Specified in its Charter)
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(I.R.S. Employer Identification No.) |
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Registrant’s Telephone Number, Including Area Code: (
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.
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 ☐ No
The number of outstanding shares of the Registrant’s Common Stock as of May 2, 2024 was
ATARA BIOTHERAPEUTICS, INC.
INDEX
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PART I. |
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FINANCIAL INFORMATION |
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Item 1. |
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Financial Statements (Unaudited) |
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6 |
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Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) |
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7 |
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Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit) |
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8 |
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9 |
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10 |
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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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24 |
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Item 3. |
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35 |
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Item 4. |
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35 |
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PART II. |
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36 |
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Item 1. |
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36 |
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Item 1A. |
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36 |
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Item 5. |
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83 |
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Item 6. |
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84 |
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85 |
2
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements, which represent our intent, belief or current expectations, involve risks and uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. In some cases, you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “predict,” “plan,” “expect” or the negative or plural of these words or similar expressions. The forward-looking statements include, but are not limited to, statements about:
3
These statements are only current predictions and are subject to known and unknown risks, uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; the sufficiency of our cash resources and need for additional capital; and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this report in greater detail under the heading “1A. Risk Factors” and elsewhere in this report. You should not rely upon forward-looking statements as predictions of future events. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risks and uncertainties.
In this Quarterly Report on Form 10-Q, unless the context requires otherwise, “Atara,” “Atara Biotherapeutics,” “Company,” “we,” “our,” and “us” means Atara Biotherapeutics, Inc. and, where appropriate, its subsidiaries.
Summary Risk Factors
Our business is subject to numerous risks and uncertainties that may have a material adverse effect on our business, financial condition or results of operations. These risks are more fully described under the heading “1A. Risk Factors” and elsewhere in this report and include, among others:
4
5
Atara Biotherapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands, except per share amounts)
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March 31, |
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December 31, |
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2024 |
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2023 |
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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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Restricted cash |
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Accounts receivable |
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Inventories |
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Other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease 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 (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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Accrued research and development expenses |
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Deferred revenue |
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Other current liabilities |
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Total current liabilities |
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Deferred revenue – long-term |
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Operating lease liabilities – long-term |
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Liability related to the sale of future revenues – long-term |
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Other long-term liabilities |
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Total liabilities |
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Stockholders’ equity (deficit): |
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Common stock—$ |
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Additional paid-in capital |
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Accumulated other comprehensive (loss) income |
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( |
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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 (deficit) |
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( |
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( |
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Total liabilities and stockholders’ equity (deficit) |
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$ |
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$ |
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See accompanying notes to the condensed consolidated financial statements.
6
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(Unaudited)
(In thousands, except per share amounts)
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Three Months Ended March 31, |
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2024 |
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2023 |
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Commercialization revenue |
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$ |
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$ |
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License and collaboration revenue |
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Total revenue |
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Costs and operating expenses: |
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Cost of commercialization revenue |
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Research and development expenses |
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General and administrative expenses |
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Total costs and operating expenses |
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Loss from operations |
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( |
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( |
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Other income (expense), net: |
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Interest income |
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Interest expense |
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( |
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( |
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Other income (expense), net |
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( |
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Total other income (expense), net |
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( |
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Loss before provision for (benefit from) income taxes |
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( |
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( |
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Provision for (benefit from) income taxes |
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Net income (loss) |
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$ |
( |
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$ |
( |
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Other comprehensive gain (loss): |
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Unrealized gain (loss) on available-for-sale securities |
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Comprehensive income (loss) |
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$ |
( |
) |
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$ |
( |
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Basic and diluted net loss per common share |
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$ |
( |
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$ |
( |
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Basic and diluted weighted-average shares outstanding |
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See accompanying notes to the condensed consolidated financial statements.
7
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
(Unaudited)
(In thousands)
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Accumulated |
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Common |
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Additional |
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Other |
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Total |
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Stock |
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Paid-in |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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For the Three Months Ended March 31, 2024 |
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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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Equity (Deficit) |
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Balance as of January 1, 2024 |
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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 pre-funded warrants to purchase common stock through a registered direct 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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— |
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Issuance of common stock through ATM facilities, net of commissions and offering costs of $ |
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— |
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— |
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RSU settlements, net of shares withheld |
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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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Net (loss) 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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( |
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Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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Balance as of March 31, 2024 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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Accumulated |
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Common |
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Additional |
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Other |
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Total |
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Stock |
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Paid-in |
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Comprehensive |
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Accumulated |
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Stockholders’ |
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For the Three Months Ended March 31, 2023 |
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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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Equity (Deficit) |
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Balance as of January 1, 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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Issuance of common stock through ATM facilities, net of commissions and offering costs of $ |
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— |
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— |
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— |
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RSU settlements, net of shares withheld |
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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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Net (loss) 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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( |
) |
Unrealized gain (loss) on available-for-sale securities |
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— |
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— |
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— |
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— |
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Balance as of March 31, 2023 |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
) |
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$ |
|
See accompanying notes to the condensed consolidated financial statements.
8
Atara Biotherapeutics, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(In thousands)
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Three Months Ended March 31, |
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2024 |
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2023 |
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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 expense |
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Accretion of liability related to sale of future revenues |
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Amortization (accretion) of investment premiums (discounts) |
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( |
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Non-cash operating lease expense |
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Other non-cash items, net |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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( |
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Inventories |
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( |
) |
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( |
) |
Other current assets |
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( |
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( |
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Other assets |
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( |
) |
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Accounts payable |
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( |
) |
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( |
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Accrued compensation |
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( |
) |
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( |
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Accrued research and development expenses |
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( |
) |
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( |
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Other current liabilities |
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( |
) |
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( |
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Deferred revenue |
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Operating lease liabilities |
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( |
) |
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( |
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Other long-term liabilities |
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( |
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Net cash used in operating activities |
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( |
) |
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( |
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Investing activities |
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Purchases of short-term investments |
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( |
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Proceeds from maturities and sales of short-term investments |
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Purchases of property and equipment |
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( |
) |
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( |
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Net cash provided by (used in) investing activities |
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( |
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Financing activities |
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Proceeds from sale of pre-funded warrants to purchase common stock in a registered direct offering, net |
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Proceeds from issuance of common stock through ATM facilities, net |
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Proceeds from employee stock awards |
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Taxes paid related to net share settlement of restricted stock units |
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( |
) |
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( |
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Principal payments on finance lease obligations |
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( |
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( |
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Net cash provided by financing activities |
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Increase (decrease) in cash, cash equivalents and restricted cash |
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( |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period |
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$ |
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$ |
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Non-cash investing and financing activities |
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Property and equipment purchases included in accounts payable and other accrued liabilities |
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$ |
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$ |
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Accrued costs related to underwritten public offering |
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$ |
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$ |
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Accrued costs related to ATM facility |
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$ |
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$ |
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Supplemental cash flow disclosure |
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Cash paid for interest |
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$ |
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$ |
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Cash paid for income taxes |
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$ |
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$ |
|
See accompanying notes to the condensed consolidated financial statements.
9
Atara Biotherapeutics, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Atara Biotherapeutics, Inc. (Atara, we, our or the Company) was incorporated in in
We have several T-cell immunotherapies in clinical development and are progressing multiple next-generation allogeneic chimeric antigen receptor T-cell (CAR T) programs. Our most advanced T-cell immunotherapy program, tab-cel® (tabelecleucel), has received marketing authorization approval under the proprietary name Ebvallo by the European Commission (EC) for commercial sale and use in the European Union (EU) and by the Medicines and Healthcare products Regulatory Agency (MHRA) for commercial sale and use in the United Kingdom (UK). Tab-cel is currently in Phase 3 development in the US. In October 2021, we entered into a commercialization agreement (Pierre Fabre Commercialization Agreement) with Pierre Fabre Medicament (Pierre Fabre), as amended in September 2022, pursuant to which we granted to Pierre Fabre an exclusive, field-limited license to commercialize and distribute Ebvallo in Europe and select emerging markets in the Middle East, Africa, Eastern Europe and Central Asia (the Initial Territory), following regulatory approval. In October 2023, we amended and restated the Pierre Fabre Commercialization Agreement (A&R Commercialization Agreement). Pursuant to the A&R Commercialization Agreement, Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel (Ebvallo) were expanded to include all other countries in the world (Additional Territory) in addition to the Initial Territory (Initial Territory and Additional Territory together, the Territory), subject to our performance of certain obligations. See Note 5 for further information. In December 2022, we sold a portion of our right to receive royalties and certain milestones in Ebvallo under the Pierre Fabre Commercialization Agreement to HCR Molag Fund L.P. (HCRx) for a total investment amount of $
We have licensed rights to T-cell product candidates from Memorial Sloan Kettering Cancer Center (MSK), rights related to our next-generation CAR T programs from MSK, and rights to know-how and technology from the Council of the Queensland Institute of Medical Research (QIMR Berghofer). See Note 8 for further information.
We and FUJIFILM Diosynth Biotechnologies California, Inc. (FDB) entered into a Master Services and Supply Agreement and related Statements of Work (collectively, the Fujifilm MSA), which became effective in April 2022 and could extend for up to ten years. Pursuant to the Fujifilm MSA, FDB will supply us with specified quantities of our cell therapy product candidates and any products approved by regulatory authorities, manufactured in accordance with cGMP standards. See Note 8 for further information.
Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements include the accounts of Atara and its wholly owned subsidiaries and have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) and the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited interim condensed consolidated financial statements should therefore be read in conjunction with the audited consolidated financial statements and notes for the year ended December 31, 2023, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 28, 2024. In the opinion of management, the condensed consolidated financial statements reflect all adjustments, consisting only of normal recurring adjustments, which are necessary for a fair presentation of the Company’s condensed consolidated financial statements. The results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or any other future period. The condensed consolidated balance sheet as of December 31, 2023 has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete consolidated financial statements.
10
Liquidity Risk
We have incurred significant operating losses since inception and have relied primarily on public and private equity financings and receipts from commercialization and license and collaboration agreements to fund our operations. As we continue to incur losses, our transition to profitability will depend on the successful development, approval and commercialization of product candidates and on the achievement of sufficient revenues to support our cost structure. We may never achieve sustained operating cash inflows or profitability.
Going Concern
We have incurred operating losses since inception and we expect that existing cash, cash equivalents and short-term investments as of March 31, 2024, will not be sufficient to fund our planned operations for at least 12 months from the date of issuance of these condensed consolidated financial statements. Although we anticipate the receipt of certain payments from the amended and restated Pierre Fabre Commercialization Agreement in 2024 and 2025, such payments are contingent upon the successful filing and approval of the tab-cel BLA, as well as the completing of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time.
To alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, we plan to secure additional capital, potentially through a combination of public or private security offerings; use of our ATM facility as described in Note 9; and/or strategic transactions. We may also need to raise additional funding as required based on the status of our development programs and our projected cash flows. Although we have been successful in raising capital in the past, and expect to continue to raise capital as required, there is no assurance that we will be successful in obtaining sufficient funding on terms acceptable to us to fund continuing operations, if at all, or identify and enter into any strategic transactions that will provide the capital that we will require. If we are unable to obtain sufficient funding on acceptable terms, we could be forced to delay, limit, reduce or terminate preclinical studies, clinical studies or other development activities for one or more of our product candidates, which could have a material adverse effect on our business, results of operations, and financial condition. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern for at least 12 months after the issuance of the accompanying condensed consolidated financial statements. The condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, assumptions and judgments that affect the amounts reported in the financial statements and accompanying notes. Significant estimates relied upon in preparing these financial statements include estimates related to revenue recognition, accrued research and development expenses, stock-based compensation expense, income taxes and the liability related to the sale of future revenues. Actual results could differ materially from those estimates.
Recent Accounting Pronouncements
We consider the applicability and impact of any recent Accounting Standards Update (ASU) issued by the Financial Accounting Standards Board (FASB). Other than the ASUs listed below, all other ASUs were assessed and determined to be either not applicable to Atara or are expected to have minimal impact on our condensed consolidated financial statements.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The amendment requires disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Additionally, all disclosure requirements under the guidance are also required for public entities with a single reportable segment. We will adopt the amendments effective for the fiscal year ending December 31, 2024, and for interim periods within fiscal years beginning January 1, 2025. We are currently evaluating this ASU to determine its impact on our disclosures.
In December 2023, the FASB issued ASU No. 2023-09 Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires enhancements to certain income tax disclosures, most notably the income tax rate reconciliation and income taxes paid. The amendments are effective for fiscal years beginning after December 15, 2024. Early adoption is permitted. We do not expect the adoption of this standard will have a material impact on our disclosures.
11
Basic net loss per common share is calculated by dividing net loss by the weighted-average number of shares of common stock and pre-funded warrants outstanding during the period, without consideration of common share equivalents. Diluted net loss per common share is computed by dividing net loss by the weighted-average number of shares of common stock, pre-funded warrants and common share equivalents outstanding for the period. The pre-funded warrants are included in the computation of basic and diluted net loss per common share as the exercise price is negligible and the pre-funded warrants are fully vested and exercisable. Common share equivalents are only included in the calculation of diluted net loss per common share when their effect is dilutive.
Potential dilutive securities, which include unvested restricted stock units (RSUs), unvested performance-based RSUs and performance-based options to purchase common stock for which established performance criteria have been achieved as of the end of the respective periods, vested and unvested options to purchase common stock and shares to be issued under our employee stock purchase plan (ESPP), have been excluded from the computation of diluted net loss per common share as the effect is antidilutive. Therefore, the denominator used to calculate both basic and diluted net loss per common share is the same in all periods presented.
The following table represents the potential common shares issuable pursuant to outstanding securities as of the related period end dates that were excluded from the computation of diluted net loss per common share, as their inclusion would have an antidilutive effect:
|
|
|
|
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|
||
|
As of March 31, |
|
|||||
|
2024 |
|
|
2023 |
|
||
Unvested RSUs |
|
|
|
|
|
||
Vested and unvested options |
|
|
|
|
|
||
ESPP share purchase rights |
|
|
|
|
|
||
Total |
|
|
|
|
|
Our financial assets are measured at fair value on a recurring basis using the following hierarchy to prioritize valuation inputs, in accordance with applicable U.S. GAAP:
Level 1: Quoted prices in active markets for identical assets or liabilities that we have the ability to access
Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data such as quoted prices, interest rates and yield curves
Level 3: Inputs that are unobservable data points that are not corroborated by market data
We review the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels of certain securities within the fair value hierarchy. We recognize transfers into and out of levels within the fair value hierarchy in the period in which the actual event or change in circumstances that caused the transfer occurs. There have been no transfers between Level 1, Level 2 and Level 3 in any periods presented.
Financial assets and liabilities are considered Level 2 when their fair values are determined using inputs that are observable in the market or can be derived principally from or corroborated by observable market data such as pricing for similar securities, recently executed transactions, cash flow models with yield curves, and benchmark securities. In addition, Level 2 financial instruments are valued using comparisons to like-kind financial instruments and models that use readily observable market data as their basis. U.S. Treasury, government agency and corporate debt obligations, commercial paper and asset-backed securities are valued primarily using market prices of comparable securities, bid/ask quotes, interest rate yields and prepayment spreads and are included in Level 2.
Financial assets and liabilities are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies, or similar techniques, and at least one significant model assumption or input is unobservable. We have no Level 3 financial assets or liabilities.
12
The following tables summarize the estimated fair value and related valuation input hierarchy of our available-for-sale securities as of each period end:
|
|
|
|
Total |
|
|
Total |
|
|
Total |
|
|
Total |
|
||||
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
As of March 31, 2024: |
|
Input Level |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Fair Value |
|
||||
|
|
|
|
(in thousands) |
|
|||||||||||||
Money market funds |
|
Level 1 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Corporate debt obligations |
|
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
$ |
|
|||
Total available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Less: amounts classified as cash equivalents |
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
||
Amounts classified as short-term investments |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
|
|
Total |
|
|
Total |
|
|
Total |
|
|
Total |
|
||||
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Estimated |
|
||||
As of December 31, 2023: |
|
Input Level |
|
Cost |
|
|
Gain |
|
|
Loss |
|
|
Fair Value |
|
||||
|
|
|
|
(in thousands) |
|
|||||||||||||
Money market funds |
|
Level 1 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
U.S. Treasury obligations |
|
Level 2 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Corporate debt obligations |
|
Level 2 |
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Total available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|||
Less: amounts classified as cash equivalents |
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
( |
) |
|
Amounts classified as short-term investments |
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
The amortized cost and fair value of our available-for-sale securities by contractual maturity were as follows:
|
As of March 31, 2024 |
|
|
As of December 31, 2023 |
|
||||||||||
|
Amortized |
|
|
Estimated |
|
|
Amortized |
|
|
Estimated |
|
||||
|
Cost |
|
|
Fair Value |
|
|
Cost |
|
|
Fair Value |
|
||||
|
(in thousands) |
|
|
(in thousands) |
|
||||||||||
Maturing within one year |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
Maturing in one to five years |
|
|
|
|
|
|
|
|
|
|
|
||||
Total available-for-sale securities |
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
We considered the current and expected future global economic and market conditions, including, but not limited to, the wars in Ukraine and the Middle East and increased tensions between the U.S. and China, and determined that our investments have not been significantly impacted. As of March 31, 2024, no significant facts or circumstances were present to indicate a deterioration in the creditworthiness of the issuers of the available-for-sale securities we hold, and we have no requirement or intention to sell these securities before maturity or recovery of their amortized cost basis. For all securities with a fair value less than its amortized cost basis, we determined the decline in fair value below amortized cost basis to be non-credit related and no allowance for losses has been recorded. During the three months ended March 31, 2024 and 2023, we did not recognize any impairment losses on our investments.
We have elected the practical expedient to exclude the applicable accrued interest from both the fair value and the amortized cost basis of our available-for-sale securities for purposes of identifying and measuring an impairment. We present accrued interest receivable related to our available-for-sale securities in other current assets, separate from short-term investments, on our condensed consolidated balance sheet. As of March 31, 2024 and December 31, 2023, accrued interest receivable was $
In addition, restricted cash collateralized by money market funds is a financial asset measured at fair value and is a Level 1 financial instrument under the fair value hierarchy.
The following table provides a reconciliation of cash, cash equivalents and restricted cash within the condensed consolidated balance sheets that sum to the total of the same such amounts in the condensed consolidated statement of cash flows:
|
|
March 31, |
|
|
December 31, |
|
||
|
|
2024 |
|
|
2023 |
|
||
|
|
(in thousands) |
|
|||||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash – short term |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
13
Pierre Fabre Agreements
In October 2021, we entered into the Pierre Fabre Commercialization Agreement, pursuant to which, we granted to Pierre Fabre an exclusive, field-limited license to commercialize and distribute Ebvallo in Europe and select emerging markets in the Initial Territory following regulatory approval. In September 2022, we entered into Amendment No. 1 to the Pierre Fabre Commercialization Agreement (the PF Amendment). Under the terms of the PF Amendment, following EC approval of Ebvallo for EBV+ PTLD and subsequent filing of the Marketing Authorization Application (MAA) transfer to Pierre Fabre, we received an additional $
In October 2023, we entered into the A&R Commercialization Agreement with Pierre Fabre. Pursuant to the A&R Commercialization Agreement, Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel were expanded to include the Additional Territory in addition to the Initial Territory, subject to our performance of certain obligations as described below.
Pierre Fabre paid us an upfront cash payment of $
We have entered into a separate manufacturing and supply agreement with Pierre Fabre for us to manufacture Ebvallo for Pierre Fabre to use in the Initial Territory based on a fixed price through December 31, 2023 and at a price equal to cost plus a margin for orders placed after December 31, 2023, subject to a maximum annual increase. Pierre Fabre will assume the responsibility and cost for the manufacture and supply of tab-cel (Ebvallo) in the Territory upon the Manufacturing Transition Date, which is defined as the earlier of: i) all activities relating to the transfer of tab-cel manufacturing, pursuant to the A&R Commercialization Agreement, from Atara to Pierre Fabre have been completed to the reasonable satisfaction of both parties, or ii) December 31, 2025, through the remainder of the term of the A&R Commercialization Agreement. Pierre Fabre and we are to use commercially reasonable efforts to achieve this prior to the earlier transfer date from Atara to Pierre Fabre of the first marketing authorization in the Additional Territory or the first BLA (PF Transfer Date). Prior to the Manufacturing Transition Date, we are responsible for manufacturing and supplying tab-cel (Ebvallo) to Pierre Fabre in the Territory. Without transfer of the manufacturing technology, no other party can manufacture tab-cel (Ebvallo).
Cell selection is the process of identifying the appropriate cell line from available tab-cel inventory to be used for a patient. We are responsible for the performance of cell selection services in the Initial Territory at our cost through the earlier of the PF Transfer Date, June 30, 2025 or a date otherwise agreed to by Pierre Fabre and us. To the extent that the transfer of cell selection technology occurs subsequent to June 30, 2025, we will be responsible for the performance of cell selection services in the Initial Territory at Pierre Fabre’s cost until cell selection technology is transferred to Pierre Fabre. Without transfer of the cell selection technology, no other party can provide such services. We are responsible for the performance of cell selection services in the Additional Territory through the earlier of the PF Transfer Date or a date otherwise agreed to by Pierre Fabre and us, at the sole expense of Pierre Fabre.
14
As part of the Pierre Fabre Commercialization Agreement, we formed a joint steering committee (JSC) with Pierre Fabre that provides oversight, decision making and implementation guidance regarding the commercialization activities, the responsibilities of which has been expanded to cover the incremental scope of the A&R Commercialization Agreement.
During the applicable period specified in the A&R Commercialization Agreement, we are responsible for various development, safety, process science, and regulatory activities, including obtaining regulatory approval in the United States for tab-cel for EBV-associated post-transplant lymphoproliferative disease. Pierre Fabre will pay us for these services in accordance with the A&R Commercialization Agreement. Pierre Fabre will be responsible, at its cost, for obtaining and maintaining all other required regulatory approvals and for commercialization and distribution of tab-cel in the Additional Territory, including conducting any other clinical study required. We will own any intellectual property rights developed solely by us under the A&R Commercialization Agreement.
Accounting Analysis
Identification of the Contract
We assessed this arrangement in accordance with ASC 606 and concluded that the promises in the A&R Commercialization Agreement represent transactions with a customer.
Identification of the Promises and Performance Obligations
We identified four performance obligations under the A&R Commercialization Agreement, consisting of the following material promises:
Determination of the Transaction Price
Under the Pierre Fabre Commercialization Agreement, we determined that the $
Upon the effective date of the A&R Commercialization Agreement, the $
15
with the Intermediate Inventory Obligation was excluded from the transaction price as the amount was fully constrained based on uncertainty surrounding available inventory on the Manufacturing Transition Date.
Allocation of the Transaction Price to Performance Obligations
The transaction price was allocated to each performance obligation based on their relative standalone selling price. We developed the estimated standalone selling price for each of the A&R Commercialization Agreement performance obligations with the objective of determining the price at which we would sell such an item if it were to be sold regularly on a standalone basis.
Recognition of Revenue
Commercialization revenue associated with the Initial Territory Obligation is recognized over the period during which the material right exists, which would end upon the Manufacturing Transition Date. Based on these considerations and our forecast of the timing and associated costs of the purchases related to the manufacture and supply of Ebvallo and estimated timing of technology transfer, we estimate the material right in the Initial Territory will exist for approximately one year. We reassess this evaluation each reporting period. Commercialization revenue associated with sales of Ebvallo to Pierre Fabre under the Initial Territory Obligation is deferred until we have performed the associated cell selection services, or once cell selection technology transfer to Pierre Fabre has been completed. At that point, Pierre Fabre would be able to utilize the Ebvallo it had purchased from us on its own.
Commercialization revenue associated with the Additional Territory Obligation and the Process Sciences Obligation is recognized using a cost-based input method based on the amount of actual costs incurred relative to the total budgeted costs expected to be incurred for the respective performance obligations. A cost-based input method of revenue recognition requires us to make estimates of costs to complete our performance obligation. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete our performance obligation will be recorded in the period in which changes are identified and amounts can be reasonably estimated. We expect to recognize the remaining deferred revenue associated with the Additional Territory Obligation and the Process Sciences Obligation over a period of approximately one year and two years, respectively. We reassess this evaluation each reporting period. The transfer of control occurs over the respective time period and, in our judgment, is the best measure of progress towards satisfying the performance obligation. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods. We expect to recognize revenue associated with the Intermediate Inventory Obligation at a point in time on the Manufacturing Transition Date, which is when title and risk of loss, and thus, control, of the intermediate inventory transfers to Pierre Fabre.
Deferred revenue activity related to commercialization revenue for the three months ended March 31, 2024 was as follows:
|
|
(in thousands) |
|
|
Deferred revenue, January 1, 2024 |
|
$ |
|
|
Additions |
|
|
|
|
Recognized into commercialization revenue |
|
|
( |
) |
Deferred revenue March 31, 2024 |
|
|
|
|
Less: deferred revenue – current portion |
|
|
( |
) |
Deferred revenue – long-term, March 31, 2024 |
|
$ |
|
During the three months ended March 31, 2024, we recognized $
Costs incurred relating to performing the services within the Additional Territory Obligation and Process Sciences Obligation consist of third party expenses and for time incurred by our employees to satisfy requirements set forth by the A&R Commercialization Agreement. These costs are included in research and development expenses in the condensed consolidated statements of operations and comprehensive income (loss) during the three months ended March 31, 2024. Such costs were approximately $
In December 2022, we entered into a Purchase and Sale Agreement (the HCRx Agreement) with HCR Molag Fund, L.P., a Delaware limited partnership, (HCRx). In exchange for a payment of $
16
Under the HCRx Agreement, HCRx is entitled to receive tiered royalties on net sales of Ebvallo in the Initial Territory in amounts ranging from the mid-single digits to double digits based on annual net sales. HCRx is also entitled to certain milestone payments due to Atara from Pierre Fabre. The total royalties and milestones payable to HCRx are capped between
The gross proceeds of the Investment Amount of $
To determine the amortization of the recorded liability, we are required to estimate the total amount of future payments to be received by HCRx. The sum of these amounts less the $
The following table presents the changes in the liability related to the sale of future revenues under the HCRx Agreement for the three months ended March 31, 2023:
|
|
(in thousands) |
|
|
Liability related to sale of future revenues as of January 1, 2024 |
|
$ |
|
|
Accretion of interest expense on liability related to sale of future revenues |
|
|
|
|
Amortization of debt discount and debt issuance costs |
|
|
|
|
Repayment of the liability |
|
|
( |
) |
Liability related to the sale of future revenues as of March 31, 2024 |
|
|
|
|
Less: current portion classified within other accrued liabilities |
|
|
( |
) |
Liability related to sale of future revenues - long-term |
|
$ |
|
In November 2023, we announced a strategic reduction in workforce of approximately
In January 2024, we announced a strategic reduction in workforce of approximately
The following is a summary of restructuring charges associated with the reductions in force for the periods presented:
|
|
Three Months Ended March 31, |
|
|||||
|
|
2024 |
|
|
2023 |
|
||
|
|
(in thousands) |
|
|
(in thousands) |
|
||
Research and development expense |
|
$ |
|
|
$ |
|
||
General and administrative expense |
|
|
|
|
|
|
||
Total restructuring charges |
|
$ |
|
|
$ |
|
17
The following restructuring liability activity was recorded in connection with the reductions in force for the three months ended March 31, 2024:
|
|
(in thousands) |
|
|
Liability balance, January 1, 2024 |
|
$ |
|
|
Restructuring charges |
|
|
|
|
Cash payments |
|
|
( |
) |
Non-cash settlements/adjustments |
|
$ |
( |
) |
Liability balance, March 31, 2024 |
|
$ |
|
The liability balance as of March 31, 2024 and December 31, 2023 is recorded within other current liabilities on the accompanying condensed consolidated balance sheet.
MSK In-license Agreements
In June 2015, we entered into an exclusive license agreement with MSK for three clinical stage T-cell therapies. We are required to make payments to MSK based on achievement of specified regulatory and sales-related milestones, as well as mid-single-digit percentage tiered royalty payments based on future sales of products resulting from the development of the licensed product candidates, if any. In addition, under certain circumstances, we are required to make certain minimum annual royalty payments to MSK, which are creditable against earned royalties owed for the same annual period. We are also required to pay a low double-digit percentage of any consideration we receive for sublicensing the licensed rights. The license agreement expires on a product-by-product and country-by-country basis on the latest of: (i) expiration of the last licensed patent rights related to each licensed product, (ii) expiration of any market exclusivity period granted by law with respect to each licensed product, and (iii) a specified number of years after the first commercial sale of the licensed product in each country. Upon expiration of the license agreement, we will retain non-exclusive rights to the licensed products.
In May and December 2018, we licensed additional technology from MSK. We are obligated to make additional milestone payments based on achievement of specified development, regulatory and sales-related milestones, as well as mid-single-digit percentage tiered royalty payments based on future sales of products resulting from the development of the licensed product candidates, if any.
In March 2021, we amended and restated our license agreement with MSK to terminate our license to certain rights and license additional know-how rights not otherwise covered by our existing agreements.
In March 2024, we terminated our license agreements with MSK to the ATA2271 and ATA3271 programs targeting mesothelin.
QIMR Berghofer In-license Agreements
In October 2015, we entered into an exclusive license agreement and a research and development collaboration agreement with QIMR Berghofer. Under the terms of the license agreement, we obtained an exclusive, worldwide license to develop and commercialize allogeneic T-cell therapy programs utilizing technology and know-how developed by QIMR Berghofer. In September 2016, the exclusive license agreement and research and development collaboration agreement were amended and restated. Under the amended and restated agreements, we obtained an exclusive, worldwide license to develop and commercialize additional T-cell programs, as well as the option to license additional technology that we exercised in June 2018. We further amended and restated our license agreement and research and development collaboration agreements with QIMR Berghofer in August 2019, August 2020 and December 2021, in each case, to terminate our license to certain rights. Our current license agreement also provides for various milestone and royalty payments to QIMR Berghofer based on future product sales, if any. Under the terms of our current research and development collaboration agreement, we are also required to reimburse the cost of agreed-upon development activities related to programs developed under the collaboration. These payments are expensed on a straight-line basis over the related development periods. The agreement also provides for various milestone payments to QIMR Berghofer based on achievement of certain developmental and regulatory milestones.
Other In-license and Collaboration Agreements
From time to time, we have entered into other license and collaboration agreements with other parties. For example, we licensed rights related to our MSK-partnered next-generation CAR T programs from the National Institutes of Health in December 2018.
18
Milestones and royalties under each of the above agreements are contingent upon future events and will be recorded as expense when the underlying milestones are achieved or royalties are earned. Sales related milestone and royalty costs related to Ebvallo are recorded in cost of commercialization revenue, whereas regulatory milestone costs are recorded in research and development expense. As of March 31, 2024 and December 31, 2023, there were
CRL Manufacturing Agreement
In December 2019, we entered into a Commercial Manufacturing Services Agreement (the CRL MSA) with Cognate BioServices, Inc., which was acquired by Charles River Laboratories Inc. (CRL) in March 2021.
Pursuant to the CRL MSA, CRL provides manufacturing services for our product and certain of our product candidates. We further amended the CRL MSA to extend the term until the earlier of April 30, 2024 or upon receipt of certain batches of our product and product candidates. We are currently in negotiations with CRL for an amendment to further extend the term of the CRL MSA and new commercial drug product supply agreement to be effective upon the expiration of the CRL MSA. However, there can be no assurance that we will be able to further extend the CRL MSA or enter into a new commercial drug product supply agreement with CRL on terms favorable or acceptable to us, or at all. If we are unable to enter into a new commercial drug product supply agreement or extend the CRL MSA, we may need to identify alternative sources of drug product supply.
Fujifilm Master Services and Supply Agreement
In January 2022, we entered into the Fujifilm MSA, which became effective upon the closing of the sale of the ATOM Facility on April 4, 2022 and could extend for up to
Other Research, Development and Manufacturing Agreements
We may enter into other contracts in the normal course of business with clinical research organizations for clinical trials, with CMOs for product, product candidates and clinical supplies, and with other vendors for preclinical studies, supplies and other services for our operating purposes. These contracts generally provide for termination on notice. As of March 31, 2024 and December 31, 2023, there were
Minimum Commitments
We have non-cancellable minimum commitments for products and services, subject to agreements with a term of greater than one year with clinical research organizations and CMOs.
We have incurred $
Indemnification Agreements
In the normal course of business, we enter into contracts and agreements that contain a variety of representations and warranties and provide for indemnification for certain liabilities. The exposure under these agreements is unknown because it involves claims that may be made against us in the future but have not yet been made. To date, we have not paid any claims or been required to defend any action related to our indemnification obligations. However, we may record charges in the future as a result of these indemnification obligations. We also have indemnification obligations to our directors and executive officers for specified events or occurrences, subject to some limits, while they are serving at our request in such capacities. There have been no claims to date and we consider the fair value of these indemnification agreements to be minimal. Accordingly, we did
Contingencies
From time to time, we may be involved in legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business or otherwise. The ultimate outcome of any litigation is uncertain and unfavorable outcomes could have a negative impact on our results of operations and financial condition. Regardless of outcome, litigation can have an adverse impact on us because of the defense costs, diversion of management resources and other factors. We are not currently involved in any material legal proceedings.
19
Our authorized capital stock consists of
Equity Offerings
As part of our July 2019 underwritten public offering, we issued and sold pre-funded warrants to purchase
Each pre-funded warrant entitles the holder to purchase
As part of the May 2020 underwritten public offering, we issued and sold pre-funded warrants to purchase
The terms of the pre-funded warrants issued and sold as part of the 2020 public offerings were similar to those issued and sold in 2019. No May 2020 or December 2020 pre-funded warrants were exercised during the three months ended March 31, 2024. As of March 31, 2024,
In January 2024, we issued and sold pre-funded warrants to purchase
Each of the January 2024 pre-funded warrants issued entitles the holder to purchase
No January 2024 pre-funded warrants were exercised during the three months ended March 31, 2024 and all
ATM Facilities
In the past three years, we have entered into two separate sales agreements with Cowen and Company, LLC (Cowen): in November 2021 (the 2021 ATM Facility) and in November 2023 (the 2023 ATM Facility). Each ATM facility provides or provided for the sale, in our sole discretion, of shares of our common stock having an aggregate offering price of up to $
During the three months ended March 31, 2023, we sold an aggregate of
20
During the three months ended March 31, 2024, we sold an aggregate of
As of March 31, 2024, $
Equity Incentive Plans
Under the terms of the 2014 Equity Incentive Plan, as amended (the 2014 EIP), we may grant stock options, restricted stock awards (RSAs) and RSUs to employees, directors, consultants and other service providers.
RSUs generally vest over two to
Stock options are granted at prices no less than
As of March 31, 2024, a total of
In February 2018, we adopted the 2018 Inducement Plan (the Inducement Plan), under which we may grant options, stock appreciation rights, RSAs and RSUs to new employees. In November 2020, September 2021 and June 2022 we amended the Inducement Plan to reserve an additional
As of March 31, 2024,
Restricted Stock Units
The following is a summary of RSU activity under our 2014 EIP and Inducement Plan:
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RSUs |
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Shares |
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Weighted |
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Balance as of December 31, 2023 |
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$ |
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Granted |
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$ |
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Forfeited |
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( |
) |
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$ |
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Vested |
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( |
) |
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$ |
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|
Balance as of March 31, 2024 |
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$ |
|
As of March 31, 2024, there was $
21
Stock Options
The following is a summary of stock option activity under our 2014 EIP and Inducement Plan:
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Shares |
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Weighted Average |
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Weighted Average |
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Aggregate Intrinsic |
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Balance as of December 31, 2023 |
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$ |
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