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Sana Biotechnology Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates Plans to present data at multiple scientific conferences in 2022 Expects to file INDs for leading CAR T ex vivo program,

Key Takeaway: Sana Biotechnology Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates Plans to present data at multiple scientific conferences in 2022 Expects to file INDs for leading CAR T ex vivo program, SC291, and in vivo program, SG295, in 2022 2021 year-end

Full Press Release Details

Sana Biotechnology Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates
Plans to present data at multiple scientific conferences in 2022
Expects to file INDs for leading CAR T ex vivo program, SC291, and in vivo program, SG295, in 2022
2021 year-end cash position of $746.9 million
SEATTLE - March 16, 2022 - 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, 2021.
"We are pleased with the progress we are making in our pipeline and in building capabilities to execute our vision of exploiting the potential of engineered cells to treat a number of diseases that don't have effective treatments today," said Steve Harr, Sana's President and Chief Executive Officer. "In 2021, we meaningfully strengthened our balance sheet, advanced our pipeline giving us the potential for two investigational new drug applications (INDs) in 2022 and multiple INDs per year going forward, built out our supply chain, including commercial access to gene-editing reagents and pluripotent stem cells, and commenced the build-out of our own manufacturing facility. Most importantly, we successfully attracted talent in key business areas, which, combined with the people already inside of the company, give us the capabilities, insights, focus, and dedication to reach our mission for patients."
Recent Corporate Highlights
Demonstrating forward progress in moving toward clinical trials for Sana's multiple platforms including Sana's ex vivo hypoimmune allogeneic CAR T, in vivo fusogen CAR T, and stem cell-derived programs:
Strengthened balance sheet and Board leadership; signed lease to add internal manufacturing capability
Fourth Quarter 2021 Financial Results
A discussion of non-GAAP measures, including a reconciliation of GAAP and non-GAAP measures, is presented below under "Non-GAAP Financial Measures."
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 more than 380 people working together to create an enduring company that changes how the world treats disease. Sana has operations in Seattle, Cambridge, and South San Francisco.
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 pre-clinical, clinical and regulatory development plans and timing expectations; the potential use and utility of licensed technologies for Sana's programs; the potential ability to make hypoimmune-modified iPSCs that survive and evade the immune system without immunosuppression; the potential ability to make hypoimmune allogeneic CAR T cells that evade the immune system; the potential efficacy of CD19-targeted hypoimmune CAR T cells; the potential efficacy of a CD8 targeted fusosome containing a CD20-targeted CAR and of Sana's SG295 program; the potential efficacy of the NIH's CAR construct; the potential benefits of targeting both CD19 and CD22 with an "off-the-shelf" product, including in combination with Sana's hypoimmune or fusogen platform; the ability to make stem cell-derived pancreatic islet cells and hypoimmune pancreatic islet cells, and the function and efficacy of such cells; and the potential ability to eliminate engraftment arrythmias in hypoimmune-modified pluripotent cell-derived cardiomyocytes. 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 the economic, market and social disruptions due to the ongoing COVID-19 public health crisis. 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 SEC reports, including but not limited to its Annual Report on Form 10-K dated March 16, 2022. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
Investor Relations & Media:
Sana Biotechnology, Inc.
Unaudited Selected Consolidated Balance Sheet Data
December 31, 2021 December 31, 2020
(in thousands)
Cash, cash equivalents, and marketable securities $ 746,877 $ 411,995
Total assets 1,129,407 730,296
Contingent consideration 153,743 121,901
Success payment liabilities 102,525 76,494
Total liabilities 400,905 298,583
Convertible preferred stock - 852,897
Total stockholders' equity (deficit) 728,502 (421,184 )
Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
Three Months Ended December 31, Twelve Months Ended December 31,
2021 2020 2021 2020
(in thousands, except per share data)
Operating expenses:
Research and development $ 108,505 $ 36,491 $ 248,626 $ 132,944
Research and development related success payments and contingent consideration (9,905 ) 67,626 57,873 124,935
General and administrative 12,679 9,207 50,410 28,270
Total operating expenses 111,279 113,324 356,909 286,149
Loss from operations (111,279 ) (113,324 ) (356,909 ) (286,149 )
Interest income, net 267 125 676 747
Other income, net 281 29 305 97
Net loss $ (110,731 ) $ (113,170 ) $ (355,928 ) $ (285,305 )
Net loss per common share - basic and diluted $ (0.60 ) $ (7.40 ) $ (2.14 ) $ (21.92 )
Weighted-average number of common shares - basic and diluted 183,987 15,293 166,433 13,014
Sana Biotechnology, Inc.
Changes in the Estimated Fair Value of Success Payments and Contingent Consideration
Success Payment Liability (1) Contingent Consideration (2) Total Success Payment Liability and Contingent Consideration
(in thousands)
Liability balance as of December 31, 2020 $ 76,494 $ 121,901 $ 198,395
Changes in fair value - expense (gain) 115,657 11,393 127,050
Liability balance as of March 31, 2021 192,151 133,294 325,445
Changes in fair value - expense (gain) (83,188 ) 7,163 (76,025 )
Liability balance as of June 30, 2021 108,963 140,457 249,420
Changes in fair value - expense (gain) 25,229 (8,476 ) 16,753
Liability balance as of September 30, 2021 134,192 131,981 266,173
Changes in fair value - expense (gain) (31,667 ) 21,762 (9,905 )
Liability balance as of December 31, 2021 $ 102,525 $ 153,743 $ 256,268
Total change in fair value for the twelve months ended December 31, 2021 $ 26,031 $ 31,842 $ 57,873
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 ongoing actual 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
Twelve Months Ended December 31,
2021 2020
(in thousands)
Beginning cash, cash equivalents, and marketable securities $ 411,995 $ 138,982
Ending cash, cash equivalents, and marketable securities 746,877 411,995
Change in cash, cash equivalents, and marketable securities 334,882 273,013
Cash paid to purchase property and equipment 29,862 23,872
Change in cash, cash equivalents, and marketable securities, excluding capital expenditures 364,744 296,885
Adjustments:
Cash paid to acquire technology (1) 52,096 7,650
Cash paid to satisfy contingent liability (2) - 6,000
Net proceeds received from the initial public offering of common stock (626,405 ) -
Net cash received from the sale of convertible preferred stock - (435,538 )
Operating cash burn - Non-GAAP $ (209,565 ) $ (125,003 )
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expense
Three Months Ended December 31, Twelve Months Ended December 31,
2021 2020 2021 2020
(in thousands)
Research and development expense - GAAP $ 108,505 $ 36,491 $ 248,626 $ 132,944
Adjustments:
Costs to acquire technology (1) - - - (8,500 )
Change in the estimated fair value of contingent liability (2) - - - (1,443 )
Research and development expense - Non-GAAP $ 108,505 $ 36,491 $ 248,626 $ 123,001
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share
Three Months Ended December 31, Twelve Months Ended December 31,
2021 2020 2021 2020
(in thousands, except per share data)
Net loss - GAAP $ (110,731 ) $ (113,170 ) $ (355,928 ) $ (285,305 )
Adjustments:
Costs to acquire technology (1) - - - 8,500
Change in the estimated fair value of the success payment liabilities (2) (31,667 ) 31,505 26,031 72,142
Change in the estimated fair value of contingent consideration (3) 21,762 36,121 31,842 52,793
Change in the estimated fair value of contingent liability (4) - - - 1,443
Net loss - Non-GAAP $ (120,636 ) $ (45,544 ) $ (298,055 ) $ (150,427 )
Net loss per share - GAAP $ (0.60 ) $ (7.40 ) $ (2.14 ) $ (21.92 )
Adjustments:
Costs to acquire technology (1) - - - 0.65
Change in the estimated fair value of the success payment liabilities (2) (0.17 ) 2.06 0.16 5.54
Change in the estimated fair value of contingent consideration (3) 0.12 2.36 0.19 4.06
Change in the estimated fair value of contingent liability (4) - - - 0.11
Net loss per share - Non-GAAP $ (0.65 ) $ (2.98 ) $ (1.79 ) $ (11.56 )
Weighted-average shares outstanding - basic 183,987 15,293 166,433 13,014
Last updated: Mar 16, 2022