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
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 March 17, 2025, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2024. 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 March 17, 2025 |
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: March 17, 2025 |
By: |
/s/ Susan Wyrick |
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Susan Wyrick |
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Acting Chief Financial Officer |
Exhibit 99.1
Sana Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results and Business Updates
Announced positive preliminary 12-week clinical results, building on already released 4-week results,
of ongoing type 1 diabetes study showing that hypoimmune-modified pancreatic islet cells transplanted without immunosuppression overcome autoimmune and allogeneic immune recognition, function, and persist with stable C-peptide production post-transplant
Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases and VIVID trial for SC262 in relapsed/refractory B-cell malignancies; expect to report clinical data from both studies in 2025
Presented preclinical data in non-human primates showing safety and deep B cell depletion using a surrogate for SG299, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR
Expect to file investigational new drug applications (INDs) for SC451 in type 1 diabetes and for SG299 in B-cell related diseases as early as 2026
Q4 2024 cash position of $152.5 million and expected cash runway into 2026
SEATTLE — March 17, 2025 — Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today reported financial results and business highlights for the fourth quarter and year ended December 31, 2024.
“The updated preliminary 12-week clinical data for UP421, showing stable C-peptide production and a positive mixed meal tolerance test over time, build upon the earlier reported 4-week data and increase our confidence that we can successfully transplant hypoimmune-modified pancreatic islets into a type 1 diabetes patient without any immunosuppression, a result we view as transformational for the company and the field,” said Steve Harr, Sana’s President and Chief Executive Officer. “With these data and our progress in manufacturing, we are increasingly optimistic about the potential for SC451 – a gene-modified, stem cell-derived pancreatic islet cell therapy with a goal of single treatment that leads to normal blood glucose with no more insulin injections or immunosuppression, and we look forward to presenting more data from our type 1 diabetes program in 2025 and to filing an IND as early as 2026. We expect to share clinical data later this year from two clinical-stage programs, SC291 and SC262, and we are making meaningful progress in moving forward SG299 (in vivo CAR T cell, with no lymphodepleting chemotherapy, for the treatment of B-cell mediated autoimmune diseases and B-cell cancers) with an expected IND filing as early as 2026. Overall, our investments in research across the hypoimmune platform, stem cell biology, and in vivo delivery continue to strengthen our ability to make potentially transformative medicines, and we look optimistically to our future.”
Recent Corporate Highlights
Announced positive initial results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.
Advancing our pipeline across multiple indications and modalities:
Published preclinical data in Cell Stem Cell demonstrating that HIP-modified allogeneic islet cells provided lasting endocrine function in a fully immunocompetent non-human primate with type 1 diabetes, enabling the achievement of exogenous insulin independence without immunosuppression:
Strengthened leadership with the appointment of new Chief Scientific Officer and Chief People Officer
Fourth Quarter 2024 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, South San Francisco, CA, and Bothell, WA.
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 and potential indications for its product candidates; the potential ability to successfully transplant hypoimmune-modified pancreatic islets into a type 1 diabetes patient without any immunosuppression and of SC451 to provide a single treatment that leads to normal blood glucose without insulin injections or immunosuppression; expectations regarding the timing, substance, significance, and impact of data from preclinical studies and clinical trials of the Company’s product candidates and technologies and an IST using HIP-modified primary islet cells in patients with type 1 diabetes, including expectations for reporting of additional data from the IST in publications and/or at scientific conferences; the potential ability of SC291 to be safely dosed and demonstrate deep B-cell depletion and to translate into clinical benefit for patients with B-cell mediated autoimmune diseases; and expectations regarding the Company’s cash runway. 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 March 17, 2025. 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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December 31, 2024 |
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December 31, 2023 |
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(in thousands) |
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Cash, cash equivalents, and marketable securities |
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$ |
152,497 |
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$ |
205,195 |
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Total assets |
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501,020 |
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565,299 |
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Contingent consideration |
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108,968 |
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109,606 |
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Success payment liabilities |
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4,556 |
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12,799 |
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Total liabilities |
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250,516 |
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277,793 |
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Total stockholders' equity |
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250,504 |
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287,506 |
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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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2024 |
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2023 |
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2024 |
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2023 |
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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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$ |
47,036 |
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$ |
63,000 |
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$ |
217,564 |
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$ |
268,823 |
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Research and development related success payments and contingent consideration |
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(13,447 |
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6,835 |
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(8,881 |
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(48,981 |
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General and administrative |
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17,277 |
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20,784 |
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64,040 |
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73,299 |
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Total operating expenses |
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50,866 |
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90,619 |
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272,723 |
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293,141 |
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Loss from operations |
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(50,866 |
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(90,619 |
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(272,723 |
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(293,141 |
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Interest income, net |
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1,656 |
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2,726 |
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10,471 |
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9,938 |
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Other income (expense), net |
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141 |
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(224 |
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(4,507 |
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(52 |
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Net loss |
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$ |
(49,069 |
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$ |
(88,117 |
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$ |
(266,759 |
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$ |
(283,255 |
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Net loss per common share – basic and diluted |
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$ |
(0.21 |
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$ |
(0.45 |
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$ |
(1.16 |
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$ |
(1.46 |
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Weighted-average number of common shares – basic and diluted |
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236,299 |
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197,317 |
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230,891 |
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194,541 |
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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, 2023 |
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$ |
12,799 |
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$ |
109,606 |
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$ |
122,405 |
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Changes in fair value – expense |
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32,623 |
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5,384 |
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38,007 |
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Liability balance as of March 31, 2024 |
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45,422 |
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114,990 |
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160,412 |
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Changes in fair value – gain |
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(24,575 |
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(3,369 |
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(27,944 |
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Liability balance as of June 30, 2024 |
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20,847 |
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111,621 |
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132,468 |
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Changes in fair value – expense (gain) |
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(5,732 |
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235 |
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(5,497 |
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Liability balance as of September 30, 2024 |
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15,115 |
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111,856 |
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126,971 |
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Changes in fair value – gain |
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(10,559 |
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(2,888 |
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(13,447 |
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Liability balance as of December 31, 2024 |
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$ |
4,556 |
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$ |
108,968 |
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$ |
113,524 |
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Total change in fair value for the twelve months ended December 31, 2024 |
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$ |
(8,243 |
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$ |
(638 |
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$ |
(8,881 |
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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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2024 |
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2023 |
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(in thousands) |
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Beginning cash, cash equivalents, and marketable securities |
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$ |
205,195 |
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$ |
434,014 |
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Ending cash, cash equivalents, and marketable securities |
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152,497 |
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205,195 |
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Change in cash, cash equivalents, and marketable securities |
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(52,698 |
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(228,819 |
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Cash paid to purchase property and equipment |
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33,430 |
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20,032 |
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Change in cash, cash equivalents, and marketable securities, excluding capital expenditures |
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(19,268 |
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(208,787 |
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Adjustments: |
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Net proceeds from issuance of common stock |
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(181,000 |
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(27,020 |
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Cash paid for personnel-related costs incurred in connection with portfolio prioritizations |
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5,158 |
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5,454 |
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Cash paid in connection with the termination of the Fremont lease |
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- |
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4,423 |
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Cash received in connection with the CARES Act |
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- |
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(7,063 |
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Operating cash burn – Non-GAAP |
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$ |
(195,110 |
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$ |
(232,993 |
) |
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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2024 |
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2023 |
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2024 |
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2023 |
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(in thousands) |
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Research and development expense – GAAP |
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$ |
47,036 |
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$ |
63,000 |
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$ |
217,564 |
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$ |
268,823 |
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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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(1,891 |
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(7,014 |
) |
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(1,891 |
) |
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(7,014 |
) |
Research and development expense – Non-GAAP |
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$ |
45,145 |
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$ |
55,986 |
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$ |
215,673 |
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$ |
261,809 |
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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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2024 |
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2023 |
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2024 |
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2023 |
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(in thousands) |
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General and administrative – GAAP |
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$ |
17,277 |
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$ |
20,784 |
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$ |
64,040 |
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$ |
73,299 |
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Adjustments: |
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Personnel-related costs incurred in connection with portfolio prioritizations |
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(5,840 |
) |
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(5,203 |
) |
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(5,840 |
) |
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(5,203 |
) |
Loss on termination of Fremont lease(1) |
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- |
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- |
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- |
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(2,668 |
) |
General and administrative – Non-GAAP |
|
$ |
11,437 |
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$ |
15,581 |
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$ |
58,200 |
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$ |
65,428 |
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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 December 31, |
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Twelve Months Ended December 31, |
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2024 |
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2023 |
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2024 |
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2023 |
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(in thousands, except per share data) |
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Net income (loss) – GAAP |
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$ |
(49,069 |
) |
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$ |
(88,117 |
) |
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$ |
(266,759 |
) |
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$ |
(283,255 |
) |
Adjustments: |
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Change in the estimated fair value of the success payment liabilities(1) |
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(10,559 |
) |
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|
385 |
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(8,243 |
) |
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(8,208 |
) |
Change in the estimated fair value of contingent consideration(2) |
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(2,888 |
) |
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6,450 |
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(638 |
) |
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(40,773 |
) |
Personnel-related costs incurred in connection with portfolio prioritizations |
|
|
5,840 |
|
|
|
5,203 |
|
|
|
5,840 |
|
|
|
5,203 |
|
Loss on termination of Fremont lease(3) |
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- |
|
|
|
- |
|
|
|
- |
|
|
|
2,668 |
|
Expense related to the impairment of certain lab equipment and leasehold improvements (4) |
|
|
1,891 |
|
|
|
7,014 |
|
|
|
1,891 |
|
|
|
7,014 |
|
Impairment of other assets |
|
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- |
|
|
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- |
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4,832 |
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|
|
- |
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Net loss – Non-GAAP |
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$ |
(54,785 |
) |
|
$ |
(69,065 |
) |
|
$ |
(263,077 |
) |
|
$ |
(317,351 |
) |
Net income (loss) per share – GAAP |
|
$ |
(0.21 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.16 |
) |
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$ |
(1.46 |
) |
Adjustments: |
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|
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Change in the estimated fair value of the success payment liabilities(1) |
|
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(0.04 |
) |
|
|
- |
|
|
|
(0.04 |
) |
|
|
(0.04 |
) |
Change in the estimated fair value of contingent consideration(2) |
|
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(0.01 |
) |
|
|
0.03 |
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|
|
- |
|
|
|
(0.21 |
) |
Personnel-related costs incurred in connection with portfolio prioritizations |
|
|
0.02 |
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|
|
0.03 |
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|
0.03 |
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|
0.03 |
|
Loss on termination of Fremont lease(3) |
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- |
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- |
|
|
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- |
|
|
|
0.01 |
|
Expense related to the impairment of certain lab equipment and leasehold improvements (4) |
|
|
0.01 |
|
|
|
0.04 |
|
|
|
0.01 |
|
|
|
0.04 |
|
Impairment of other assets |
|
|
- |
|
|
|
- |
|
|
|
0.02 |
|
|
|
- |
|
Net loss per share – Non-GAAP |
|
$ |
(0.23 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.14 |
) |
|
$ |
(1.63 |
) |
Weighted-average shares outstanding – basic and diluted |
|
|
236,299 |
|
|
|
197,317 |
|
|
|
230,891 |
|
|
|
194,541 |
|