UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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( State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer |
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(Address of principal executive offices) |
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, 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 4, 2021, 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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Condensed Consolidated Statements of Comprehensive Income (Loss) |
7 |
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Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
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9 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
10 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
21 |
Item 3. |
29 |
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Item 4. |
30 |
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PART II. |
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Item 1. |
31 |
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Item 1A. |
31 |
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Item 2. |
87 |
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Item 3. |
87 |
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Item 4. |
87 |
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Item 5. |
87 |
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Item 6. |
88 |
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89 |
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, 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 clinical studies, preclinical studies and research and development programs, including the timing and availability of data from such studies; |
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the timing of commencement of future nonclinical studies and clinical trials and research and development programs; |
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our ability to acquire, discover, develop and advance product candidates into, and successfully complete, clinical trials; |
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our intentions and our ability to establish collaborations and/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, including the buildout of our own manufacturing facility, capabilities and expectations; |
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impact from 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, such as the COVID-19 pandemic, on our preclinical and clinical programs and business; |
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our expectations regarding the impact of the COVID-19 pandemic 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 for 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, our needs for additional financing and our 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 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 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 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
3
sections of this 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. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. 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.
4
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, 2021 |
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December 31, 2020 |
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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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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Operating lease right-of-use assets |
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Restricted cash |
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Long-term marketable securities |
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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, CONVERTIBLE PREFERRED STOCK, 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 expenses and other current liabilities |
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Operating lease liabilities |
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Success payment liabilities |
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- |
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Total current liabilities |
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Operating lease liabilities, net of current portion |
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Contingent consideration |
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Success payment liabilities, net of current portion |
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Other non-current liabilities |
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Total liabilities |
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Commitments and contingencies (Note 10) |
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Convertible preferred stock, $ |
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- |
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Stockholders' equity (deficit): |
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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 income |
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Accumulated deficit |
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( |
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Total stockholders' equity (deficit) |
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TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT) |
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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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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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General and administrative |
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Total operating expenses |
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Loss from operations |
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Interest income, net |
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Other income, net |
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Net loss |
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$ |
( |
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$ |
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Net loss per share, basic and diluted |
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$ |
( |
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$ |
( |
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Weighted-average shares outstanding, 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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2021 |
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2020 |
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Net loss |
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$ |
( |
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$ |
( |
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Other comprehensive income (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 Convertible Preferred Stock and Stockholders’ Equity (Deficit)
(unaudited)
(in thousands)
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Convertible Preferred Stock |
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Common Stock |
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Additional Paid-In |
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Accumulated Other Comprehensive |
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Accumulated |
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Total Stockholders' Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Income |
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Deficit |
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(Deficit) |
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Balance as of December 31, 2020 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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Conversion of convertible preferred stock into common stock, upon initial public offering |
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( |
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( |
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- |
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- |
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Issuance of common stock in initial public offering, net of $ offering costs |
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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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- |
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- |
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Exercise of stock options |
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- |
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- |
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- |
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- |
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- |
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Stock-based compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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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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- |
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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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( |
) |
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( |
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Balance as of March 31, 2021 |
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- |
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$ |
- |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Convertible Preferred Stock |
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Common Stock |
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Additional Paid-In |
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Accumulated Other Comprehensive |
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Accumulated |
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Total Stockholders' |
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Shares |
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Amount |
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Shares |
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Amount |
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Capital |
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Income |
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Deficit |
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Deficit |
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Balance as of December 31, 2019 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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Vesting of restricted stock |
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- |
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- |
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- |
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- |
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- |
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- |
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- |
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Exercise of stock options |
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- |
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- |
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- |
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- |
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- |
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Stock-based compensation expense |
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- |
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- |
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- |
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- |
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- |
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- |
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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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- |
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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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( |
) |
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( |
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Balance as of March 31, 2020 |
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$ |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
( |
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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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2021 |
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2020 |
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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 fair value of contingent consideration |
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Change in fair value of success payment liabilities |
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Non-cash expense in connection with license agreement |
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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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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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Accounts payable |
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Accrued expenses and other 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 marketable securities |
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( |
) |
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- |
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Proceeds from sales and 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 initial public offering of common stock, net of offering costs |
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- |
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Proceeds from exercise of stock options |
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Net cash provided by financing activities |
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Net increase in cash, cash equivalents, and restricted cash |
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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 DISCLOSURES: |
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Tenant improvement allowance included in operating lease liabilities |
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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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Right-of-use assets obtained in exchange for operating lease liabilities |
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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
1. Organization
Sana Biotechnology, Inc. (the Company or Sana) was incorporated in Delaware on
Reverse stock split
Initial public offering
In February 2021, the Company successfully completed its initial public offering (IPO) of its common stock. In connection with its IPO, the Company issued
Need for additional capital
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, 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, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, protect the Company’s intellectual property and proprietary technology, 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 from the sale of additional equity or debt financings, or other capital which come in the form of strategic collaborations, 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.
The Company has incurred operating losses each year since inception and expects such losses to continue for the foreseeable future. As of March 31, 2021, the Company had cash, cash equivalents, and marketable securities of $
2. Summary of significant accounting policies
The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 24, 2021 (2020 Form 10-K). The significant accounting policies used in preparation of these condensed consolidated financial statements as of March 31, 2021 and for the three months ended March 31, 2021 and 2020 are consistent with those discussed in Note 2 in the 2020 Form 10-K.
10
Basis of presentation
The accompanying condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. The Company’s condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (GAAP).
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 the valuation of stock options.
Recent accounting pronouncements
Recently adopted
Accounting Standards Updates (ASU) No. 2016-13, Financial Instruments—Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements, ASU No. 2019-05 Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief, ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses
In June 2016, the Financial Accounting Standards Board (FASB) issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 362): Measurement of Credit Losses on Financial Statements (ASU 2016-13). The new standard requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which the carrying value exceeds fair value and also requires the reversal of previously recognized credit losses if fair value increases. The targeted transition relief standard allows companies an option to irrevocably elect the fair value option of ASC 825-10, Financial Instruments-Overall, applied on an instrument-by-instrument basis for eligible instruments. The Company adopted ASU 2016-13 effective
Not yet adopted
ASU No. 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment
In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment (ASU 2017-04). To address concerns over the cost and complexity of the two-step goodwill impairment test, the amendments in this ASU remove the second step of the test. An entity will instead apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit’s carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. The new guidance does not amend the optional qualitative assessment of goodwill impairment. The new standard will be effective beginning January 1, 2023. The adoption of ASU 2017-04 is not expected to have a material impact on the Company’s consolidated financial statements.
3. Acquisitions
Oscine Corp.
In September 2020, the Company entered into a stock purchase agreement to acquire
The primary asset acquired in the acquisition was IPR&D technology related to Oscine’s glial progenitor ex vivo cell engineering programs focused on brain disorders. The Company evaluated the acquisition and determined the screen test, as permitted under ASC 805, Business Combinations, was met as the $
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The Oscine Holdback Amount will be held for 15 months, until December 2021, at which time the remainder of the balance, after payment of any claims, will be released. In addition, the Company is required to make up to an aggregate of $
Cobalt Biomedicine, Inc.
In February 2019, the Company acquired
Pursuant to the terms and conditions in the Cobalt acquisition agreement, the Company agreed to pay contingent consideration of up to an aggregate of $
In addition to an IPO, a valuation measurement date is triggered upon a change of control when at least one company product utilizing technology acquired from Cobalt is the subject of an active research program. If there is a change of control and Company’s market capitalization falls below certain thresholds on the change of control date, the amount of the potential Cobalt Success Payment will decrease, and the amount of potential Cobalt Contingent Consideration will increase.
The following table sets forth the different market capitalizations and resulting potential Cobalt Success Payment and additional potential Cobalt Contingent Consideration if there is a change of control subsequent to the IPO:
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 $ |
|
$ |
|
|
|
$ |
- |
|
Equal to or exceeds $ |
|
|
|
|
|
|
|
|
Equal to or exceeds $ |
|
|
|
|
|
|
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|
Less than $ |
|
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- |
|
|
|
|
|
The Cobalt Success Payment and Cobalt Contingent Consideration liabilities are carried at fair value with changes in fair value recognized in research and development expense. As of March 31, 2021 and December 31, 2020, the estimated fair value of the Cobalt Success Payment liability was $
4. Intangible asset and goodwill
As of March 31, 2021, the Company had an intangible asset of $
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5. License and collaboration agreements
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 hypo-immune cells.
Under the terms of the agreement, the Company may be required to make Harvard Success Payments up to an aggregate 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) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
As of March 31, 2021 and December 31, 2020, the estimated fair value of the Harvard Success Payment liability was $
In connection with this agreement, the Company also paid Harvard a license payment of $
6. Restricted cash
As of March 31, 2021 and December 31, 2020, the Company maintained
13
7. 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, 2021 |
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|
Valuation Hierarchy |
|
Amortized Cost |
|
|
Gross Unrealized Holding Gains |
|
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Gross Unrealized Holding Losses |
|
|
Estimated Fair Value |
|
||||
|
|
|
|
(in thousands) |
|
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Financial assets: |
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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 |
|
|
|
|
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|
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|
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|
Total cash equivalents |
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