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) |
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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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Name of each exchange on which registered |
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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.
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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 October 27, 2022, the registrant had
TABLE OF CONTENTS
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PART I. |
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Item 1. |
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5 |
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6 |
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7 |
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Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity |
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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 |
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Item 3. |
32 |
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Item 4. |
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PART II. |
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Item 1. |
34 |
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Item 1A. |
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Item 2. |
96 |
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Item 3. |
96 |
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Item 4. |
96 |
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Item 5. |
96 |
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Item 6. |
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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, future 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 advance them into, and successfully complete, clinical trials; |
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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, such as the ongoing COVID-19 pandemic, on our preclinical and clinical programs and business; |
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our expectations regarding the impact of the ongoing 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 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 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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September 30, 2022 |
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December 31, 2021 |
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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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- |
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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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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, 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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( |
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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 |
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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 September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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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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$ |
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$ |
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Research and development related success payments and contingent consideration |
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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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( |
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( |
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( |
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( |
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Interest income, net |
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Other income (expense), net |
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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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Net loss per common share - basic and diluted |
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$ |
( |
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$ |
( |
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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 September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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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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Other comprehensive loss, net of tax: |
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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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Total comprehensive loss |
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$ |
( |
) |
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$ |
( |
) |
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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
(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' |
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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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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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$ |
( |
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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 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, 2022 |
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- |
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$ |
- |
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$ |
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$ |
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$ |
( |
) |
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$ |
( |
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$ |
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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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Issuance of common stock related to employee stock purchase plan |
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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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|
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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|
( |
) |
|
Balance as of June 30, 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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|
Issuance of common stock from at the market offering, net of issuance 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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|
- |
|
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|
Vesting of restricted stock |
|
|
- |
|
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|
- |
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|
- |
|
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|
- |
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|
- |
|
|
|
- |
|
|
|
- |
|
|
Exercise of stock options |
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Stock-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
Unrealized loss on marketable securities, net |
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
|
Net loss |
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|
- |
|
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|
- |
|
|
|
|
- |
|
|
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- |
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|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
( |
) |
|
Balance as of September 30, 2022 |
|
|
- |
|
|
$ |
- |
|
|
|
|
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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 (Loss) |
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Deficit |
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Equity |
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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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|
$ |
( |
) |
|
$ |
( |
) |
|
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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