UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation) |
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(Commission File Number)
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(IRS Employer Identification Number) |
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Name of each exchange on which registered |
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The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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.
Item 2.02 Results of Operations and Financial Condition.
On February 29, 2024, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2023. A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press release of Sana Biotechnology, Inc. dated February 29, 2024 |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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SANA BIOTECHNOLOGY, INC. |
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Date: February 29, 2024 |
By: |
/s/ Nathan Hardy |
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Nathan Hardy |
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Executive Vice President and Chief Financial Officer |
Exhibit 99.1
Sana Biotechnology Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
Goal to treat 40-60 patients in 2024 in four trials across seven indications in oncology, B-cell mediated autoimmune diseases, and type 1 diabetes
Early SC291 data from ongoing ARDENT trial in relapsed/refractory NHL and CLL suggest ability to dose safely, demonstrate the desired immune evasion profile, and early clinical efficacy using hypoimmune technology
Announced SC291 IND clearance for B-cell mediated autoimmune diseases with goal to report initial clinical data in 2024
Announced SC262 IND clearance for relapsed/refractory B-cell malignancies with goal to report initial clinical data in 2024
Announced CTA authorization for investigator-sponsored trial with hypoimmune-modified primary islet cells with potential clinical data in 1H2024
Publication in Cell Stem Cell demonstrates transplanted allogeneic hypoimmune-modified islet cells evade rejection and control glucose without immunosuppression or insulin treatment in non-human primate diabetes study
Q4 2023 cash position of $205.2 million and expected 2024 operating cash burn below $200 million
Recent financing of $189.8 million in gross proceed combined with existing cash position supports activities through multiple data readouts
SEATTLE — February 29, 2024 — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2023.
“2023 was an important year for the company, setting a strong foundation in three therapeutic areas with significant unmet needs – blood cancers, B-cell mediated autoimmune diseases, and type 1 diabetes. With the ongoing trials in these areas – ARDENT, GLEAM, VIVID, and the primary islet cell investigator-sponsored trial – we expect to treat 40-60 patients across multiple indications in 2024 and report data from each study,” said Steve Harr, Sana’s President and Chief Executive Officer. “By year-end 2024, our goal is to demonstrate that we are able to transplant allogeneic cells in patients in multiple settings without immune detection or rejection, delivering potentially transformative therapies across multiple therapeutic areas. With the recent financing, we were able to strengthen the balance sheet, allowing us to continue to invest appropriately in moving our clinical pipeline forward.”
Recent Corporate Highlights
Advancing four clinical programs across seven indications, including an allogeneic CAR T program targeting CD19+ cancers, an allogeneic CAR T program for B-cell mediated autoimmune diseases, an allogeneic CAR T program targeting CD22+ cancers, and a primary islet cell therapy in type 1 diabetes:
Published preclinical data in Cell Stem Cell demonstrating that HIP-modified islet cells provided lasting endocrine function in a fully immunocompetent non-human primate, enabling the achievement of exogenous insulin independence without immunosuppression for six-month study duration:
Published preclinical data in Nature Communications, Science Translational Medicine, and Nature Biotechnology describing immune evasion, persistence, and durable anti-tumor activity of HIP-modified CD19-directed CAR T cells and HIP-modified pseudo-islets control type 1 diabetes in preclinical models:
Advanced Sana’s HIP ex vivo platform with presentations at AACR, ADA, ISSCR, and ASH:
Completed financing with gross proceeds of approximately $189.8 million to further support activities to enable multiple data readouts and announced key corporate updates:
Fourth Quarter 2023 Financial Results
GAAP Results
Non-GAAP Measures
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under “Non-GAAP Financial Measures.”
About Sana
Sana Biotechnology, Inc. is focused on creating and delivering engineered cells as medicines for patients. We share a vision of repairing and controlling genes, replacing missing or damaged cells, and making our therapies broadly available to patients. We are a passionate group of people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, South San Francisco, and Rochester.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the company’s vision, progress, and business plans; expectations for its development programs, product candidates and technology platforms, including its preclinical, clinical and regulatory development plans and timing expectations, including the expected timing of IND filings and clinical trials for the Company’s product candidates and indications for which such INDs will be filed; expectations regarding the number of patients to be treated and the indications to be evaluated in its clinical trials in 2024; expectations regarding the timing, substance, significance, and impact of data from clinical trials of the Company’s product candidates and an IST utilizing HIP-modified primary islet cells in patients with type 1 diabetes patients; the potential ability to use hypoimmune technology to dose safely and achieve efficacy in certain indications; expectations regarding the Company’s 2024 operating cash burn; expectations regarding the potential of the gross proceeds from the recent financing along with the Company’s existing cash position to support activities through multiple data readouts; and the ability to demonstrate by year-end 2024 that the Company’s is able to transplant allogeneic cells in patients in multiple settings without immune detection or rejection. All statements other than statements of historical facts contained in this press release, including, among others, statements regarding the Company’s strategy, expectations, cash runway and future financial condition, future operations, and prospects, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its 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. These statements are subject to risks and uncertainties that could cause the actual results to vary materially, including, among others, the risks inherent in drug development such as those associated with the initiation, cost, timing, progress and results of the Company’s current and future research and development programs, preclinical and clinical trials, as well as economic, market, and social disruptions. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated February 29, 2024. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
###
Investor Relations & Media:
Nicole Keith
investor.relations@sana.com
media@sana.com
Sana Biotechnology, Inc.
Unaudited Selected Consolidated Balance Sheet Data
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December 31, 2023 |
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December 31, 2022 |
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(in thousands) |
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Cash, cash equivalents, and marketable securities |
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$ |
205,195 |
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$ |
434,014 |
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Total assets |
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565,299 |
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822,720 |
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Contingent consideration |
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109,606 |
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150,379 |
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Success payment liabilities |
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12,799 |
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21,007 |
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Total liabilities |
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277,793 |
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323,405 |
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Total stockholders' equity |
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287,506 |
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499,315 |
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Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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(in thousands, except per share data) |
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Operating expenses: |
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Research and development |
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$ |
63,000 |
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$ |
63,921 |
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$ |
268,823 |
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$ |
285,885 |
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Research and development related success payments and contingent consideration |
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6,835 |
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(5,454 |
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(48,981 |
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(84,882 |
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General and administrative |
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20,784 |
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23,321 |
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73,299 |
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71,561 |
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Total operating expenses |
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90,619 |
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81,788 |
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293,141 |
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272,564 |
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Loss from operations |
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(90,619 |
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(81,788 |
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(293,141 |
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(272,564 |
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Interest income, net |
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2,726 |
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1,613 |
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9,938 |
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3,762 |
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Other expense, net |
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(224 |
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(268 |
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(52 |
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(674 |
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Net loss |
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$ |
(88,117 |
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$ |
(80,443 |
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$ |
(283,255 |
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$ |
(269,476 |
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Net loss per common share – basic and diluted |
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$ |
(0.45 |
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$ |
(0.42 |
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$ |
(1.46 |
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$ |
(1.43 |
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Weighted-average number of common shares – basic and diluted |
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197,317 |
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190,420 |
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194,541 |
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188,344 |
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Sana Biotechnology, Inc.
Changes in the Estimated Fair Value of Success Payments and Contingent Consideration
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Success Payment |
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Contingent |
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Total Success Payment Liability and Contingent Consideration |
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(in thousands) |
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Liability balance as of December 31, 2022 |
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$ |
21,007 |
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$ |
150,379 |
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$ |
171,386 |
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Changes in fair value – expense (gain) |
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(5,340 |
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5,460 |
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120 |
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Liability balance as of March 31, 2023 |
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15,667 |
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155,839 |
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171,506 |
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Changes in fair value – expense |
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20,784 |
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5,895 |
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26,679 |
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Liability balance as of June 30, 2023 |
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36,451 |
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161,734 |
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198,185 |
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Changes in fair value – gain |
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(24,037 |
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(58,578 |
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(82,615 |
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Liability balance as of September 30, 2023 |
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12,414 |
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103,156 |
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115,570 |
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Changes in fair value – expense |
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385 |
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6,450 |
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6,835 |
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Liability balance as of December 31, 2023 |
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$ |
12,799 |
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$ |
109,606 |
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$ |
122,405 |
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Total change in fair value for the twelve months ended December 31, 2023 |
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$ |
(8,208 |
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$ |
(40,773 |
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$ |
(48,981 |
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Non-GAAP Financial Measures
To supplement the financial results presented in accordance with generally accepted accounting principles in the United States (GAAP), Sana uses certain non-GAAP financial measures to evaluate its business. Sana’s management believes that these non-GAAP financial measures are helpful in understanding Sana’s financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sana’s management utilizes non-GAAP operating cash burn, non-GAAP research and development expense and non-GAAP net loss and net loss per share. Sana believes the presentation of these non-GAAP measures provides management and investors greater visibility into the company’s actual ongoing costs to operate its business, including actual research and development costs unaffected by non-cash valuation changes and certain one-time expenses for acquiring technology, as well as facilitating a more meaningful comparison of period-to-period activity. Sana excludes these items because they are highly variable from period to period and, in respect of the non-cash expenses, provides investors with insight into the actual cash investment in the development of its therapeutic programs and platform technologies.
These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Sana’s financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. Sana’s management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sana’s business and make operating decisions. In addition, Sana’s management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sana’s results from period to period and allows for greater transparency with respect to key financial metrics Sana uses in making operating decisions. The following are reconciliations of GAAP to non-GAAP financial measures:
Sana Biotechnology, Inc.
Unaudited Reconciliation of Change in Cash, Cash Equivalents, and Marketable Securities to
Non-GAAP Operating Cash Burn
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Twelve Months Ended December 31, |
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2023 |
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2022 |
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(in thousands) |
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Beginning cash, cash equivalents, and marketable securities |
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$ |
434,014 |
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$ |
746,877 |
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Ending cash, cash equivalents, and marketable securities |
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205,195 |
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434,014 |
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Change in cash, cash equivalents, and marketable securities |
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(228,819 |
) |
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(312,863 |
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Cash paid to purchase property and equipment |
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20,032 |
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20,876 |
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Change in cash, cash equivalents, and marketable securities, excluding capital expenditures |
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(208,787 |
) |
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(291,987 |
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Adjustments: |
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Net proceeds from issuance of common stock (1) |
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(27,020 |
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(601 |
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Cash paid in connection with the termination of the Fremont lease |
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4,423 |
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- |
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Cash paid for personnel-related costs related to portfolio prioritizations |
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5,454 |
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4,333 |
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Cash received in connection with the Coronavirus Aid, Relief, and Economic Security Act |
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(7,063 |
) |
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- |
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Operating cash burn – Non-GAAP |
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$ |
(232,993 |
) |
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$ |
(288,255 |
) |
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expense
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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(in thousands) |
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Research and development expense – GAAP |
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$ |
63,000 |
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$ |
63,921 |
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$ |
268,823 |
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$ |
285,885 |
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Adjustments: |
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Expense related to the impairment of certain lab equipment and leasehold improvements (1) |
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(7,014 |
) |
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- |
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(7,014 |
) |
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- |
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Research and development expense – Non-GAAP |
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$ |
55,986 |
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$ |
63,921 |
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$ |
261,809 |
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$ |
285,885 |
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Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expense
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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(in thousands) |
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General and administrative – GAAP |
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$ |
20,784 |
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$ |
23,321 |
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$ |
73,299 |
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$ |
71,561 |
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Adjustments: |
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Costs incurred in connection with portfolio prioritizations |
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(5,203 |
) |
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(8,704 |
) |
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(5,203 |
) |
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(8,704 |
) |
Loss on termination of Fremont lease (1) |
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- |
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- |
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(2,668 |
) |
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- |
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Write-off of construction in progress costs incurred in connection with the Fremont facility |
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- |
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- |
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- |
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(4,474 |
) |
General and administrative – Non-GAAP |
|
$ |
15,581 |
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$ |
14,617 |
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$ |
65,428 |
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$ |
58,383 |
|
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share
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Three Months Ended December 31, |
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Twelve Months Ended December 31, |
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||||||||||
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2023 |
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2022 |
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2023 |
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2022 |
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(in thousands, except per share data) |
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Net loss – GAAP |
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$ |
(88,117 |
) |
|
$ |
(80,443 |
) |
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$ |
(283,255 |
) |
|
$ |
(269,476 |
) |
Adjustments: |
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|
|
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|
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Change in the estimated fair value of the success payment liabilities(1) |
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|
385 |
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|
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(14,703 |
) |
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|
(8,208 |
) |
|
|
(81,518 |
) |
Change in the estimated fair value of contingent consideration(2) |
|
|
6,450 |
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|
|
9,249 |
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|
|
(40,773 |
) |
|
|
(3,364 |
) |
Costs incurred in connection with portfolio prioritizations |
|
|
5,203 |
|
|
|
8,704 |
|
|
|
5,203 |
|
|
|
8,704 |
|
Loss on termination of Fremont lease (3) |
|
|
- |
|
|
|
- |
|
|
|
2,668 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection with the Fremont facility |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,474 |
|
Expense related to the impairment of certain lab equipment and leasehold improvements (4) |
|
|
7,014 |
|
|
|
- |
|
|
|
7,014 |
|
|
|
- |
|
Net loss – Non-GAAP |
|
$ |
(69,065 |
) |
|
$ |
(77,193 |
) |
|
$ |
(317,351 |
) |
|
$ |
(341,180 |
) |
Net loss per share – GAAP |
|
$ |
(0.45 |
) |
|
$ |
(0.42 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.43 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Change in the estimated fair value of the success payment liabilities(1) |
|
|
- |
|
|
|
(0.08 |
) |
|
|
(0.04 |
) |
|
|
(0.43 |
) |
Change in the estimated fair value of contingent consideration(2) |
|
|
0.03 |
|
|
|
0.05 |
|
|
|
(0.21 |
) |
|
|
(0.02 |
) |
Costs incurred in connection with portfolio prioritizations |
|
|
0.03 |
|
|
|
0.05 |
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|
|
0.03 |
|
|
|
0.05 |
|
Loss on termination of Fremont lease (3) |
|
|
- |
|
|
|
- |
|
|
|
0.01 |
|
|
|
- |
|
Write-off of construction in progress costs incurred in connection with the Fremont facility |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.02 |
|
Expense related to the impairment of certain lab equipment and leasehold improvements(4) |
|
|
0.04 |
|
|
|
- |
|
|
|
0.04 |
|
|
|
- |
|
Net loss per share – Non-GAAP |
|
$ |
(0.35 |
) |
|
$ |
(0.40 |
) |
|
$ |
(1.63 |
) |
|
$ |
(1.81 |
) |
Weighted-average shares outstanding – basic and diluted |
|
|
197,317 |
|
|
|
190,420 |
|
|
|
194,541 |
|
|
|
188,344 |
|