UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
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Accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
As of May 1, 2023, the registrant had
TABLE OF CONTENTS
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PART I. |
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Item 1. |
5 |
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5 |
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6 |
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7 |
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8 |
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9 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
21 |
Item 3. |
31 |
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Item 4. |
32 |
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PART II. |
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Item 1. |
33 |
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Item 1A. |
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Item 2. |
98 |
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Item 3. |
98 |
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Item 4. |
98 |
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Item 5. |
98 |
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Item 6. |
99 |
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100 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report could be deemed forward-looking statements, including those statements highlighted below. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “should,” “would,” or “will,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, include, but are not limited to, statements about:
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our expectations regarding the potential market size and size of the potential patient populations for our product candidates and any future product candidates, if approved for commercial use; |
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our clinical and regulatory development plans; |
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our expectations with regard to the results of our preclinical studies, clinical trials, and research and development programs, including the timing and availability of data from such studies and trials; |
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the timing of commencement of future preclinical studies, clinical trials, and research and development programs; |
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our ability to acquire, discover, and develop product candidates and timely advance them into and through clinical data readouts and successful completion of clinical trials; |
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our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; |
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our intentions with respect to and our ability to establish collaborations or partnerships; |
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the timing or likelihood of regulatory filings and approvals for our product candidates; |
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our commercialization, marketing, and manufacturing expectations, including with respect to the buildout of our manufacturing facility and capabilities and the timing thereof; |
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impact of future regulatory, judicial, and legislative changes or developments in the United States and foreign countries; |
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our intentions with respect to the commercialization of our product candidates; |
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the pricing and reimbursement of our product candidates, if approved; |
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the potential effects of public health crises on our preclinical and clinical programs and business; |
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our expectations regarding the impact of global events and macroeconomic conditions on our business; |
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the implementation of our business model and strategic plans for our business and product candidates, including additional indications which we may pursue; |
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our ability to effectively manage our growth, including our ability to retain and recruit personnel, and maintain our culture; |
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the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates, including the projected terms of patent protection; |
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estimates of our expenses, future revenue, capital requirements, needs for additional financing, and ability to obtain additional capital; |
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our expected use of proceeds from our initial public offering and our existing cash, cash equivalents, and marketable securities; |
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the performance of our third-party suppliers and manufacturers; |
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our future financial performance; |
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our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012 (JOBS Act); and |
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developments and projections relating to our competitors and our industry, including competing products. |
We have based these forward-looking statements largely on our current expectations, estimates, forecasts, and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur in a timely manner or at all. You should refer to the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Other sections of this Quarterly Report may include additional factors that could harm our business and financial performance. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. Except as required by law, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Sana Biotechnology, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except 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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Marketable securities |
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Restricted cash |
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Prepaid expenses and other current assets |
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Total current assets |
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Long-term marketable securities |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Long-term restricted cash |
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Intangible asset |
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Goodwill |
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Other non-current assets |
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TOTAL ASSETS |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued compensation |
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Accrued expenses and other current liabilities |
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Operating lease liabilities |
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Contingent consideration |
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Total current liabilities |
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Operating lease liabilities, net of current portion |
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Contingent consideration, net of current portion |
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Success payment liabilities, net of current portion |
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Total liabilities |
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Commitments and contingencies (Note 9) |
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Stockholders' equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated other comprehensive loss |
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Accumulated deficit |
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( |
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( |
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Total stockholders' equity |
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TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY |
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$ |
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$ |
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See accompanying notes.
5
Sana Biotechnology, Inc.
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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Research and development related success payments and contingent consideration |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Interest income, net |
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Other expense, net |
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( |
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Net loss |
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$ |
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$ |
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Net loss per common share – basic and diluted |
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$ |
( |
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$ |
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Weighted-average number of common shares – basic and diluted |
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See accompanying notes.
6
Sana Biotechnology, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(unaudited)
(in thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive loss, net of tax: |
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Unrealized gain (loss) on marketable securities, net |
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( |
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Total comprehensive loss |
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$ |
( |
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$ |
( |
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See accompanying notes.
7
Sana Biotechnology, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(unaudited)
(in thousands)
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Common Stock |
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Additional Paid-In |
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Accumulated Other Comprehensive |
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Accumulated |
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Total Stockholders' |
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Shares |
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Amount |
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Capital |
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Loss |
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Deficit |
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Equity |
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Balance as of December 31, 2022 |
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$ |
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$ |
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$ |
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$ |
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$ |
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Fees incurred related to issuance of common stock from at the market offering |
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- |
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- |
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( |
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- |
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- |
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Vesting of restricted stock |
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- |
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- |
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- |
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- |
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Exercise of stock options |
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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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Unrealized gain on marketable securities, net |
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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 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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$ |
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Common Stock |
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Additional Paid-In |
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Accumulated Other Comprehensive |
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Accumulated |
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Total Stockholders' |
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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 |
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Balance as of December 31, 2021 |
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$ |
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$ |
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$ |
( |
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$ |
( |
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$ |
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Vesting of restricted stock |
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( |
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- |
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- |
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- |
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Exercise of stock options |
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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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Unrealized loss on marketable securities, net |
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- |
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- |
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- |
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( |
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- |
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( |
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Net loss |
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- |
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- |
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- |
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- |
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( |
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( |
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Balance as of 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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See accompanying notes.
8
Sana Biotechnology, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
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Three Months Ended March 31, |
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2023 |
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2022 |
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OPERATING ACTIVITIES: |
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Net loss |
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$ |
( |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
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Stock-based compensation expense |
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Change in the estimated fair value of contingent consideration |
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( |
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Change in the estimated fair value of success payment liabilities |
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( |
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( |
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Non-cash expense for operating lease right-of-use assets |
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Other non-cash items, net |
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( |
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( |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other assets |
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( |
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( |
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Operating lease right-of-use assets and liabilities |
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( |
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Accounts payable |
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( |
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Accrued expenses and other liabilities |
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( |
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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 marketable securities |
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( |
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( |
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Proceeds from maturities of marketable securities |
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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 investing activities |
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FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock, net |
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Net cash provided by financing activities |
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Net decrease in cash, cash equivalents, and restricted cash |
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( |
) |
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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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SUPPLEMENTAL CASH FLOW INFORMATION: |
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Operating lease right-of-use assets obtained in exchange for lease obligations |
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$ |
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$ |
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Purchases of property and equipment included in accounts payable and accrued liabilities |
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$ |
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$ |
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Cash received for amounts related to tenant improvement allowances |
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$ |
- |
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$ |
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See accompanying notes.
9
Sana Biotechnology, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. Organization
Sana Biotechnology, Inc. (the Company or Sana) is a biotechnology company focusing on utilizing engineered cells as medicines. The Company’s operations to date have included identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, preparing for clinical trials of our product candidates, acquiring technology, organizing and staffing the Company, business planning, establishing and maintaining the Company’s intellectual property portfolio, raising capital, and providing general and administrative support for these operations.
Liquidity and capital resources
The Company is subject to a number of risks and uncertainties similar to other biotechnology companies in the development stage, including, but not limited to, those related to the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, building out internal and external manufacturing capabilities, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, the need to protect the Company’s intellectual property and proprietary technologies, and the need to attract and retain key scientific and management personnel. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations with the proceeds from additional equity or debt financings or capital obtained in connection with strategic collaborations or licensing or other arrangements. In the event that additional financing is required, the Company may not be able to raise it on terms acceptable to it or at all.
In August 2022, the Company entered into a sales agreement with Cowen and Company, LLC (Cowen), acting as sales agent, pursuant to which it may offer and sell through Cowen shares of the Company’s common stock having an aggregate offering price of up to $
The Company has incurred operating losses each year since inception and expects such losses to continue for the foreseeable future. As of March 31, 2023, the Company had cash, cash equivalents, and marketable securities of $
2. Summary of significant accounting policies
Basis of presentation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, and have been prepared in accordance with generally accepted accounting principles in the United States (GAAP). Certain prior period amounts have been reclassified to conform to current period presentation.
The condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (SEC) on March 16, 2023 (2022 Annual Report).
Significant accounting policies
The significant accounting policies used in the preparation of these condensed consolidated financial statements as of March 31, 2023 and for the three months ended March 31, 2023 and 2022 are consistent with those discussed in Note 2 in the 2022 Annual Report.
Use of estimates
The preparation of the financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company evaluates its estimates and assumptions on an ongoing basis using historical experience and other factors and adjusts those estimates and assumptions when facts and circumstances dictate. Actual results could materially differ from those estimates. The most significant estimates in the Company’s condensed consolidated financial statements relate to success payment liabilities, contingent consideration, business combinations, accrued expenses, and operating lease right-of-use assets and liabilities.
10
Recent accounting pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed, the Company does not believe that the adoption of recently issued standards has had or may have a material impact on its condensed consolidated financial statements or disclosures.
3. Acquisitions
Cobalt Biomedicine, Inc.
In February 2019, the Company acquired
As part of the Cobalt acquisition, the Company recorded an intangible asset of $
The Company recognized $
Pursuant to the terms and conditions in the Cobalt acquisition agreement, the Company has an obligation to pay to certain former Cobalt stockholders contingent consideration (Cobalt Contingent Consideration) of up to an aggregate of $
The following table sets forth various thresholds for the Company’s market capitalizations as of the date of a change of control and the resulting potential Cobalt Success Payment and additional potential Cobalt Contingent Consideration:
Sana market capitalization upon a change of control and resulting impact to Cobalt Success payment and additional potential Cobalt Contingent Consideration |
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Cobalt Success Payment |
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Additional potential Cobalt Contingent Consideration |
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(in millions) |
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Equal to or exceeds $ |
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$ |
|
|
|
$ |
- |
|
Equal to or exceeds $ |
|
|
|
|
|
|
|
|
Equal to or exceeds $ |
|
|
|
|
|
|
|
|
Less than $ |
|
|
- |
|
|
|
|
|
The Cobalt Success Payment and Cobalt Contingent Consideration liabilities are carried at fair value, with changes in fair value recognized in research and development related success payments and contingent consideration. As of March 31, 2023 and December 31, 2022, the estimated fair value of the Cobalt Success Payment liability was $
11
As of March 31, 2023, the estimated fair value of the Cobalt Contingent Consideration was $
4. License and collaboration agreements
Beam Therapeutics Inc.
In October 2021, the Company entered into an option and license agreement with Beam Therapeutics Inc. (Beam), pursuant to which the Company was granted a non-exclusive license to use Beam’s proprietary CRISPR Cas12b nuclease editing technology to research, develop, and commercialize engineered cell therapy products that (i) are directed to certain antigen targets, with respect to the Company’s allogeneic T cell programs, or (ii) comprise certain human cell types, with respect to the Company’s stem cell-derived programs. The Company made an upfront payment of $
President and Fellows of Harvard College
In March 2019, the Company entered into an exclusive license agreement with the President and Fellows of Harvard College (Harvard) to access certain intellectual property for the development of hypoimmune-modified cells.
The Company has paid to Harvard aggregate consideration of $
Multiple of Equity Value at Issuance |
|
5x |
|
|
10x |
|
|
20x |
|
|
30x |
|
|
40x |
|
|||||
Per share common stock price required for payment |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Success payment(s) (in millions) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
The Harvard Success Payment liabilities are carried at fair value, with the initial value and changes in fair value recognized in research and development related success payments and contingent consideration. As of March 31, 2023 and 2022, the estimated fair value of the Harvard Success Payment liability was $
12
5. Restricted cash
As of March 31, 2023 and December 31, 2022, the Company maintained
6. Fair value measurements
The following tables summarize the Company’s financial assets and liabilities measured at fair value on a recurring basis based on the three-tier fair value hierarchy:
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|
March 31, 2023 |
|
|||||||||||||
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|
Valuation Hierarchy |
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
|
Gross Unrealized Holding Losses |
|
|
Estimated Fair Value |
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||||
|
|
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|
(in thousands) |
|
|||||||||||||
Financial assets: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Cash equivalents: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
|
Level 1 |
|
$ |
|
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
|
|
U.S. government and agency securities |
|
Level 2 |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
Corporate debt securities |
|
Level 2 |
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
|
Total cash equivalents |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
Short-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency securities |
|
Level 2 |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
Corporate debt securities |
|
Level 2 |
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
|
Total short-term marketable securities |
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
Long-term marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government and agency securities |
|
Level 2 |
|
|
|
|
|
|
- |
|
|
|
( |
) |
|
|
|
|
Total long-term marketable securities |
|
|
|
|
|
|
|