SANA 8-K
Sana Biotechnology, Inc. (SANA)
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
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(State or other jurisdiction of incorporation) |
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(Commission File Number)
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(Address of principal executive offices, including Zip Code)
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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:
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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 August 10, 2026, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026. 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 August 10, 2026 |
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: August 10, 2026 |
By: |
/s/ Brian Piper |
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Brian Piper |
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Executive Vice President, Chief Financial Officer |
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Exhibit 99.1
Sana Biotechnology Reports Second Quarter 2026 Financial Results and Business Updates
Continued progress toward starting SC451 Phase 1/2 trial, including GLP toxicology studies, SC451 process transfer to the contract manufacturer, and clinical trial readiness
Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma and generating initial clinical data, including manufacturing and clinical trial readiness
Announced follow-on publication in The New England Journal of Medicine (NEJM) highlighting long-term data and durability of hypoimmune-modified islet cell transplantation with UP421 without immunosuppression in type 1 diabetes
Announced upcoming symposium presentation highlighting UP421 clinical data at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 on October 2
Advancing strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451
Presented SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) 2026 Annual Meeting
Continued progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027
Q2 2026 cash position of $160.5 million; expected cash runway into mid-2027
SEATTLE — August 10, 2026 — 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 second quarter 2026.
“Our team is executing on our goals of beginning clinical studies soon for both SC451 in type 1 diabetes and SG293 in non-Hodgkin lymphoma,” said Steve Harr, President and Chief Executive Officer. “Proof of concept data for these programs, including the recent update for UP421 in The New England Journal of Medicine and for an SG293 surrogate at the ASGCT meeting, are encouraging. If all goes as we anticipate, we expect to gain valuable insight into the clinical profiles and potential of both SC451 and SG293 over the next 6-9 months, and we look forward to sharing our progress.”
Corporate Highlights
Continued progress toward beginning clinical trials for SC451 and SG293
Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.
Announced strategic collaboration with Mayo Clinic to advance development of SC451, a HIP-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.
Advanced preclinical pipeline
Raised aggregate net proceeds of $93.3 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and Mayo Clinic investment in the second quarter; expected cash runway into mid-2027.
Second Quarter 2026 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, WA, Cambridge, MA, and South San Francisco, CA.
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 with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of clinical data, and potential indications for and the potential impact and benefits of its platforms and product candidates; expectations regarding the impact of the Company’s activities on its ability to start clinical studies for SC451 and SG293, including with respect to GLP toxicology studies, manufacturing, including technology transfer, and clinical trial readiness; the potential benefits of, plans for, and activity under the Company’s strategic collaboration with Mayo Clinic; the potential ability for SC451 to be a one-time treatment for patients with type 1 diabetes that achieves long-term normal blood glucose without insulin therapy or immunosuppression; the potential ability for SG293 to minimize potential toxicities related to in vivo CAR T cells; timing and other expectations for, and the potential significance and impact of data from, preclinical studies and clinical trials of the Company’s product candidates and technologies, including future studies and trials, and an IST utilizing HIP-modified primary pancreatic islet cells; expectations for the presentation at the EASD Annual Meeting 2026, including the content of such presentation; expectations regarding the Company’s cash runway; and statements made by the Company’s President and Chief Executive Officer. 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: 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 and preclinical and clinical trials, including that the timing of development activities, including IND submissions and initiation of clinical trials, is subject to change, IND acceptance is subject to the discretion of the U.S. Food and Drug Administration, acceptance of an IND and initiation of a clinical trial are not predictive of clinical trial results or whether the Company will successfully enroll or dose patients, preclinical data may not be predictive of clinical trial results, and clinical results from one product candidate may not be predictive of clinical results from another product candidate; the risk that the collaboration with Mayo Clinic may not achieve its anticipated benefits; and risks associated with economic, market, and social conditions and disruptions, which could cause delays in Sana’s business plans, impede Sana’s access to additional capital, and impede the clinical development of its product candidates, among other things. 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 Quarterly Report on Form 10-Q dated August 10, 2026. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
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Investor Relations & Media:
Nicole Keith
Sana Biotechnology, Inc.
Unaudited Selected Consolidated Balance Sheet Data
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June 30, 2026 |
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December 31, 2025 |
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(in thousands) |
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Cash, cash equivalents, and marketable securities |
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$ |
160,490 |
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$ |
138,382 |
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Total assets |
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431,522 |
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416,890 |
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Contingent consideration |
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150,825 |
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123,718 |
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Success payment liabilities |
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24,477 |
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19,238 |
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Total liabilities |
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276,954 |
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256,006 |
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Total stockholders' equity |
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154,568 |
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160,884 |
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Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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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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$ |
30,729 |
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$ |
29,761 |
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$ |
59,448 |
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$ |
66,950 |
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Research and development related success payments and contingent consideration |
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23,913 |
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10,262 |
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32,346 |
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12,219 |
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General and administrative |
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10,778 |
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10,341 |
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22,240 |
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21,825 |
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Impairment of long-lived assets |
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- |
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44,611 |
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- |
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44,611 |
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Total operating expenses |
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65,420 |
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94,975 |
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114,034 |
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145,605 |
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Loss from operations |
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(65,420 |
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(94,975 |
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(114,034 |
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(145,605 |
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Interest income, net |
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1,129 |
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577 |
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2,080 |
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1,569 |
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Other income, net |
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656 |
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598 |
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1,109 |
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847 |
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Net loss |
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$ |
(63,635 |
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$ |
(93,800 |
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$ |
(110,845 |
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$ |
(143,189 |
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Net loss per common share – basic and diluted |
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$ |
(0.22 |
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$ |
(0.39 |
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$ |
(0.39 |
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$ |
(0.60 |
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Weighted-average number of common shares – basic and diluted |
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295,667 |
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238,409 |
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286,314 |
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237,996 |
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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, 2025 |
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$ |
19,238 |
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$ |
123,718 |
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$ |
142,956 |
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Changes in fair value – expense (gain) |
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(2,312 |
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10,745 |
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8,433 |
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Liability balance as of March 31, 2026 |
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16,926 |
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134,463 |
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151,389 |
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Changes in fair value – expense |
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7,551 |
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16,362 |
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23,913 |
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Liability balance as of June 30, 2026 |
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$ |
24,477 |
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$ |
150,825 |
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$ |
175,302 |
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Total change in fair value for the six months ended June 30, 2026 |
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$ |
5,239 |
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$ |
27,107 |
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$ |
32,346 |
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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, non-GAAP general and administrative 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, provide 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 allow 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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Six Months Ended June 30, |
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2026 |
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2025 |
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(in thousands) |
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Beginning cash, cash equivalents, and marketable securities |
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$ |
138,382 |
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$ |
152,497 |
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Ending cash, cash equivalents, and marketable securities |
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160,490 |
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72,674 |
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Change in cash, cash equivalents, and marketable securities |
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22,108 |
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(79,823 |
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Cash paid to purchase property and equipment |
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1,909 |
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24 |
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Change in cash, cash equivalents, and marketable securities, excluding capital expenditures |
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24,017 |
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(79,799 |
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Adjustments: |
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Net proceeds from issuance of common stock |
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(93,334 |
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(254 |
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Cash paid for personnel-related costs incurred in connection with portfolio prioritization |
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- |
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1,062 |
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Operating cash burn – Non-GAAP |
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$ |
(69,317 |
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$ |
(78,991 |
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Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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(in thousands, except per share data) |
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Net loss – GAAP |
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$ |
(63,635 |
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$ |
(93,800 |
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$ |
(110,845 |
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$ |
(143,189 |
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Adjustments: |
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Change in the estimated fair value of the success payment liabilities(1) |
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7,551 |
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3,962 |
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5,239 |
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4,055 |
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Change in the estimated fair value of contingent consideration(2) |
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16,362 |
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6,300 |
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27,107 |
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8,164 |
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Impairment of long-lived assets |
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- |
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44,611 |
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- |
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44,611 |
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Net loss – Non-GAAP |
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$ |
(39,722 |
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$ |
(38,927 |
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$ |
(78,499 |
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$ |
(86,359 |
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Net loss per share – GAAP |
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$ |
(0.22 |
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$ |
(0.39 |
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$ |
(0.39 |
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$ |
(0.60 |
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Adjustments: |
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Change in the estimated fair value of the success payment liabilities(1) |
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0.03 |
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0.01 |
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0.02 |
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0.02 |
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Change in the estimated fair value of contingent consideration(2) |
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0.06 |
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0.03 |
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0.10 |
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0.03 |
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Impairment of long-lived assets |
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- |
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0.19 |
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- |
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0.19 |
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Net loss per share – Non-GAAP |
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$ |
(0.13 |
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$ |
(0.16 |
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$ |
(0.27 |
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$ |
(0.36 |
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Weighted-average shares outstanding – basic and diluted |
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295,667 |
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238,409 |
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286,314 |
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237,996 |
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