Full Press Release Details
Sana Biotechnology Reports Fourth Quarter and Full Year 2022 Financial Results and Business Updates
Announced SC291 IND clearance with goal to report initial clinical data this year
Expect to initiate investigator-sponsored trial with hypoimmune-modified primary islet cells with potential clinical data this year
Goal to submit two INDs this year for SC262 and SG299
Targeting multiple additional INDs in 2024
Q4 2022 cash position of $434.0 million
Current cash position enables for runway into 2025
SEATTLE - March 16, 2023 - 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, 2022.
"2022 began our transformation from a research focused organization to a clinical-stage company, setting the stage for important clinical data in 2023 and 2024 to better define our product candidates and platforms," said Steve Harr, Sana's President and Chief Executive Officer. "The recent clearance of our first IND - for SC291, a hypoimmune-modified, CD19-targeted allogeneic CAR T therapy for patients with B-cell malignancies - offers the first of several near-term opportunities to understand our hypoimmune technology in patients and its potential to move forward important medicines. We anticipate initial clinical data with this program and hypoimmune islet cells in type 1 diabetic patients in 2023. We also expect to file INDs in oncology for an additional allogeneic CAR T program and our first in vivo fusogen program targeting T cells. Our balance sheet gives us the financial strength to build on our execution in 2022 and push our R&D portfolio forward."
Recent Corporate Highlights
Advancing to the clinic with two opportunities for clinical proof of concept this year for the hypoimmune platform, including ex vivo hypoimmune-modified allogeneic CAR T cells and hypoimmune-modified primary human islet cells:
Building pipeline with potential to deliver multiple clinical data readouts over the next several years across three platforms - ex vivo hypoimmune-modified allogeneic CAR T cells, stem-cell derived cell therapies, and the in vivo fusogen platform:
Advanced Sana's hypoimmune ex vivo platform and in vivo fusogen platform with presentations at AACR, ASGCT, ADA, ISSCR, and ASH:
Announced expected cash runway into 2025 to enable multiple data readouts across the platforms; largest part of cash savings from plans to relocate manufacturing facility to Bothell, Washington
Announced key corporate updates, building on the company's scientific excellence and operational capabilities
Fourth Quarter 2022 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 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 pre-clinical, clinical and regulatory development plans and timing expectations, including the expected timing of IND filings for the Company's product candidates and indications for which such INDs will be filed, and expected timing, substance, and impact of data from clinical trials of its product candidates and an investigator-sponsored trial utilizing hypoimmune-modified primary human islet cells in patients with type 1 diabetes (the IST); expectations regarding the IST, including the Company's ability to initiate the IST and the potential of the IST to provide insight on the performance of the Company's hypoimmune technology and SC451 program, including in patients; the potential to generate a pipeline of allogeneic CAR T therapies using clinically-validated CAR constructs; expectations regarding the Company's expected use of a CD22 chimeric antigen receptor with a fully-human binder in-licensed from the NIH; expectations with respect to the potential therapeutic benefits and impact of its development programs; the potential of the Company's SG299 program to generate CAR T cells in vivo and the potential impact thereof; the potential advantages of the second-generation manufacturing process for the Company's SG299 program; the potential ability of the hypoimmune platform to make genomic modifications to cells to prevent allogeneic transplant rejection and the potential ability of such modifications to prevent both adaptive and innate immune recognition and rejection, and the potential benefits associated therewith; the potential ability of the Company's pipeline of hypoimmune-modified cells to replace damaged or missing cells in the body in various diseases, including cancer, type 1 diabetes, and various neurologic conditions; the Company's expected cash runway and the potential impact thereof on the Company's development programs, including data readouts from such programs; expectations regarding cost savings associated with its decision to move the Company's manufacturing plant from Fremont, California to Bothell, Washington; expectations with respect to the design of the Company's manufacturing plant; the expected outcomes and benefits associated with the Company's portfolio prioritization; expectations regarding the impact of a reduction in the amount of the letter of credit for the Company's Fremont, California facility on the Company's cash balance; and the potential impact of changes in the Company's market capitalization and stock price on its potential success payment and contingent consideration liabilities. 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 Securities and Exchange Commission (SEC) reports, including but not limited to its Annual Report on Form 10-K dated March 16, 2023. 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, 2022 | December 31, 2021 | |||||||
| (in thousands) | ||||||||
| Cash, cash equivalents, and marketable securities | $ | 434,014 | $ | 746,877 | ||||
| Total assets | 822,720 | 1,129,407 | ||||||
| Contingent consideration | 150,379 | 153,743 | ||||||
| Success payment liabilities | 21,007 | 102,525 | ||||||
| Total liabilities | 323,405 | 400,905 | ||||||
| Total stockholders' equity | 499,315 | 728,502 |
Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 63,921 | $ | 108,505 | $ | 285,885 | $ | 248,626 | ||||||||
| Research and development related success payments and contingent consideration | (5,454 | ) | (9,905 | ) | (84,882 | ) | 57,873 | |||||||||
| General and administrative | 23,321 | 12,679 | 71,561 | 50,410 | ||||||||||||
| Total operating expenses | 81,788 | 111,279 | 272,564 | 356,909 | ||||||||||||
| Loss from operations | (81,788 | ) | (111,279 | ) | (272,564 | ) | (356,909 | ) | ||||||||
| Interest income, net | 1,613 | 267 | 3,762 | 676 | ||||||||||||
| Other income (expense), net | (268 | ) | 281 | (674 | ) | 305 | ||||||||||
| Net loss | $ | (80,443 | ) | $ | (110,731 | ) | $ | (269,476 | ) | $ | (355,928 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.42 | ) | $ | (0.60 | ) | $ | (1.43 | ) | $ | (2.14 | ) | ||||
| Weighted-average number of common shares - basic and diluted | 190,420 | 183,987 | 188,344 | 166,433 |
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, 2021 | $ | 102,525 | $ | 153,743 | $ | 256,268 | ||||||
| Changes in fair value - gain | (54,910 | ) | (528 | ) | (55,438 | ) | ||||||
| Liability balance as of March 31, 2022 | 47,615 | 153,215 | 200,830 | |||||||||
| Changes in fair value - gain | (14,098 | ) | (3,830 | ) | (17,928 | ) | ||||||
| Liability balance as of June 30, 2022 | 33,517 | 149,385 | 182,902 | |||||||||
| Changes in fair value - expense (gain) | 2,193 | (8,255 | ) | (6,062 | ) | |||||||
| Liability balance as of September 30, 2022 | 35,710 | 141,130 | 176,840 | |||||||||
| Changes in fair value - expense (gain) | (14,703 | ) | 9,249 | (5,454 | ) | |||||||
| Liability balance as of December 31, 2022 | $ | 21,007 | $ | 150,379 | $ | 171,386 | ||||||
| Total change in fair value for the twelve months ended December 31, 2022 | $ | (81,518 | ) | $ | (3,364 | ) | $ | (84,882 | ) |
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
| Twelve Months Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| (in thousands) | ||||||||
| Beginning cash, cash equivalents, and marketable securities | $ | 746,877 | $ | 411,995 | ||||
| Ending cash, cash equivalents, and marketable securities | 434,014 | 746,877 | ||||||
| Change in cash, cash equivalents, and marketable securities | (312,863 | ) | 334,882 | |||||
| Cash paid to purchase property and equipment | 20,876 | 29,862 | ||||||
| Change in cash, cash equivalents, and marketable securities, excluding capital expenditures | (291,987 | ) | 364,744 | |||||
| Adjustments: | ||||||||
| Cash paid for restructuring ( 1) | 4,333 | - | ||||||
| Cash paid to acquire technology ( 2) | - | 52,096 | ||||||
| Net proceeds from issuance of common stock ( 3) | (601 | ) | (626,405 | ) | ||||
| Operating cash burn - Non-GAAP | $ | (288,255 | ) | $ | (209,565 | ) |
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expense
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands) | ||||||||||||||||
| General and administrative - GAAP | $ | 23,321 | $ | 12,679 | $ | 71,561 | $ | 50,410 | ||||||||
| Adjustments: | ||||||||||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility ( 1) | - | - | (4,474 | ) | - | |||||||||||
| Costs incurred in connection with restructuring ( 2) | (8,704 | ) | - | (8,704 | ) | - | ||||||||||
| General and administrative - Non-GAAP | $ | 14,617 | $ | 12,679 | $ | 58,383 | $ | 50,410 |
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, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Net loss - GAAP | $ | (80,443 | ) | $ | (110,731 | ) | $ | (269,476 | ) | $ | (355,928 | ) | ||||
| Adjustments: | ||||||||||||||||
| Change in the estimated fair value of the success payment liabilities ( 1) | (14,703 | ) | (31,667 | ) | (81,518 | ) | 26,031 | |||||||||
| Change in the estimated fair value of contingent consideration ( 2) | 9,249 | 21,762 | (3,364 | ) | 31,842 | |||||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility 3) | - | - | 4,474 | - | ||||||||||||
| Costs incurred in connection with restructuring ( 4) | 8,704 | - | 8,704 | - | ||||||||||||
| Net loss - Non-GAAP | $ | (77,193 | ) | $ | (120,636 | ) | $ | (341,180 | ) | $ | (298,055 | ) | ||||
| Net loss per share - GAAP | $ | (0.42 | ) | $ | (0.60 | ) | $ | (1.43 | ) | $ | (2.14 | ) | ||||
| Adjustments: | ||||||||||||||||
| Change in the estimated fair value of the success payment liabilities ( 1) | (0.08 | ) | (0.17 | ) | (0.43 | ) | 0.16 | |||||||||
| Change in the estimated fair value of contingent consideration ( 2) | 0.05 | 0.12 | (0.02 | ) | 0.19 | |||||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility ( 3) | - | - | 0.02 | - | ||||||||||||
| Costs incurred in connection with restructuring ( 4) | 0.05 | - | 0.05 | - | ||||||||||||
| Net loss per share - Non-GAAP | $ | (0.40 | ) | $ | (0.65 | ) | $ | (1.81 | ) | $ | (1.79 | ) | ||||
| Weighted-average shares outstanding - basic and diluted | 190,420 | 183,987 | 188,344 | 166,433 |