Full Press Release Details
Sana Biotechnology Reports Third Quarter 2022 Financial Results and Business Updates
Expect to file IND this year for SC291 with potential clinical data in 2023
Followed by expected INDs for SG295 and SC276 in 2023 and SC451 in 2024 with potential clinical data in 2024
Q3 2022 cash position of $511.6 million
Expect cash runway into 2025
SEATTLE - November 2, 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 third quarter 2022.
"Our team is executing well, and 2023 is shaping up to be an important year for the company as we look forward to generating our first data in patients," said Steve Harr, Sana's President and Chief Executive Officer. "For SC291, we expect to generate tumor response data and CAR T cell persistence data, which have the potential to highlight differentiation from current CAR T programs and provide generalizable insights on how preclinical results for our hypoimmune platform (HIP) will translate into patients. For SG295, our scientists have developed a second-generation process that is many times more potent and has the potential to lead to better efficacy, safety, and manufacturability. Given the promise and potential of this program, we will take more time to implement these changes and now expect to file the IND in 2023. Our team continues to make meaningful progress across our pipeline and platforms while maintaining a strong balance sheet to fund our lead programs through early clinical development."
Select Program Updates
Third 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 with respect to the expected timing of IND filings for the Company's product candidates; the Company's expectations with respect to the potential therapeutic benefits and impact of its development programs; the Company's expectations regarding the timing, substance, and impact of the data from its clinical trials; the Company's expected cash runway; potential ability of the Company's HIP platform to make genomic modifications to allogeneic cells to hide them from immune detection and the potential benefits associated therewith; the potential capabilities of the Company's manufacturing process for its SC291 program; the potential of the Company's SG295 program to generate CAR T cells in vivo; the potential advantages of the second-generation manufacturing process for the Company's SG295 program; the potential ability of the Company's SC276 program to treat patients with B cell malignancies who have either failed previous CAR T therapies or are na ve to CAR T therapy; and the potential ability of the Company's HIP platform to make genetic modifications to islet cells to allow them to evade both allogeneic and autoimmune rejection in type 1 diabetes. 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 Quarterly Report on Form 10-Q dated November 2, 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
| September 30, 2022 | December 31, 2021 | |||||||
| (in thousands) | ||||||||
| Cash, cash equivalents, and marketable securities | $ | 511,573 | $ | 746,877 | ||||
| Total assets | 898,102 | 1,129,407 | ||||||
| Contingent consideration | 141,130 | 153,743 | ||||||
| Success payment liabilities | 35,710 | 102,525 | ||||||
| Total liabilities | 332,083 | 400,905 | ||||||
| Total stockholders' equity | 566,019 | 728,502 |
Sana Biotechnology, Inc.
Unaudited Consolidated Statements of Operations
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 76,735 | $ | 53,245 | $ | 221,964 | $ | 140,121 | ||||||||
| Research and development related success payments and contingent consideration | (6,062 | ) | 16,753 | (79,428 | ) | 67,778 | ||||||||||
| General and administrative | 15,514 | 13,433 | 48,240 | 37,731 | ||||||||||||
| Total operating expenses | 86,187 | 83,431 | 190,776 | 245,630 | ||||||||||||
| Loss from operations | (86,187 | ) | (83,431 | ) | (190,776 | ) | (245,630 | ) | ||||||||
| Interest income, net | 1,173 | 158 | 2,149 | 409 | ||||||||||||
| Other income (expense), net | (106 | ) | 10 | (406 | ) | 24 | ||||||||||
| Net loss | $ | (85,120 | ) | $ | (83,263 | ) | $ | (189,033 | ) | $ | (245,197 | ) | ||||
| Net loss per common share - basic and diluted | $ | (0.45 | ) | $ | (0.46 | ) | $ | (1.01 | ) | $ | (1.53 | ) | ||||
| Weighted-average number of common shares - basic and diluted | 189,303 | 181,827 | 187,645 | 160,515 |
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 | ||||||
| Total change in fair value for the nine months ended September 30, 2022 | $ | (66,815 | ) | $ | (12,613 | ) | $ | (79,428 | ) |
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
| Nine Months Ended September 30, | ||||||||
| 2022 | 2021 | |||||||
| (in thousands) | ||||||||
| Beginning cash, cash equivalents, and marketable securities | $ | 746,877 | $ | 411,995 | ||||
| Ending cash, cash equivalents, and marketable securities | 511,573 | 866,112 | ||||||
| Change in cash, cash equivalents, and marketable securities | (235,304 | ) | 454,117 | |||||
| Cash paid to purchase property and equipment | 16,274 | 24,660 | ||||||
| Change in cash, cash equivalents, and marketable securities, excluding capital expenditures | (219,030 | ) | 478,777 | |||||
| Adjustments: | ||||||||
| Cash paid to acquire technology ( 1) | - | 1,246 | ||||||
| Net proceeds from issuance of common stock ( 2) | (724 | ) | (626,405 | ) | ||||
| Operating cash burn - Non-GAAP | $ | (219,754 | ) | $ | (146,382 | ) |
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP General and Administrative Expense
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands) | ||||||||||||||||
| General and administrative - GAAP | $ | 15,514 | $ | 13,433 | $ | 48,240 | $ | 37,731 | ||||||||
| Adjustments: | ||||||||||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility ( 1) | - | - | (4,474 | ) | - | |||||||||||
| General and administrative - Non-GAAP | $ | 15,514 | $ | 13,433 | $ | 43,766 | $ | 37,731 |
Sana Biotechnology, Inc.
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (in thousands, except per share data) | ||||||||||||||||
| Net loss - GAAP | $ | (85,120 | ) | $ | (83,263 | ) | $ | (189,033 | ) | $ | (245,197 | ) | ||||
| Adjustments: | ||||||||||||||||
| Change in the estimated fair value of the success payment liabilities (1) | 2,193 | 25,229 | (66,815 | ) | 57,698 | |||||||||||
| Change in the estimated fair value of contingent consideration (2) | (8,255 | ) | (8,476 | ) | (12,613 | ) | 10,080 | |||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility 3) | - | - | 4,474 | - | ||||||||||||
| Net loss - Non-GAAP | $ | (91,182 | ) | $ | (66,510 | ) | $ | (263,987 | ) | $ | (177,419 | ) | ||||
| Net loss per share - GAAP | $ | (0.45 | ) | $ | (0.46 | ) | $ | (1.01 | ) | $ | (1.64 | ) | ||||
| Adjustments: | ||||||||||||||||
| Change in the estimated fair value of the success payment liabilities (1) | 0.01 | 0.14 | (0.36 | ) | 0.39 | |||||||||||
| Change in the estimated fair value of contingent consideration (2) | (0.04 | ) | (0.05 | ) | (0.07 | ) | 0.07 | |||||||||
| Write-off of construction in progress costs incurred in connection with the previously planned Fremont facility (3) | - | - | 0.02 | - | ||||||||||||
| Net loss per share - Non-GAAP | $ | (0.48 | ) | $ | (0.37 | ) | $ | (1.42 | ) | $ | (1.18 | ) | ||||
| Weighted-average shares outstanding - basic and diluted | 189,303 | 179,899 | 187,645 | 149,683 |