SEATTLE, May 08, 2023 (GLOBE NEWSWIRE) -- 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 first quarter 2023.
“Our initial human studies using Sana’s hypoimmune technology remain on track, as we have begun enrolling patients in our SC291 trial and expect to deliver data from two clinical studies in 2023,” said Steve Harr, Sana’s President and Chief Executive Officer. “We are also making progress in our earlier-stage pipeline and are on pace to file two additional INDs later this year and potentially three more in 2024. The quality of our key hires, publications in high quality peer-reviewed journals, and presentations at important scientific conferences are recent validations of the science behind Sana’s programs. Our capital position and people give us the resources for multiple data read-outs with our current balance sheet, and we continue to be optimistic about our future, with the opportunity to see the potential of these medicines in patients starting this year.”
Recent Corporate Highlights
Opportunity for clinical proof of concept for two different first-in-human studies, each with the potential for initial clinical data this year
Published preclinical data in Nature Communications describing immune evasion, persistence, and durable anti-tumor activity of Sana’s hypoimmune-modified CD19-directed CAR T cells
Published preclinical data in Science Translational Medicine demonstrating that Sana’s hypoimmune-modified pseudo-islets control type 1 diabetes
Published preclinical data in Nature Biotechnology demonstrating that Sana’s hypoimmune-modified cells survive allogeneic transplant across several species, including non-human primates (NHPs) with normal immune systems, and remain fully functional
Presented multiple abstracts at the 2023 American Association for Cancer Research (AACR) Annual Meeting highlighting ex vivo hypoimmune-modified allogeneic CAR T cells, as well as in vivo cell-specific delivery of genetic material using Sana’s in vivo fusogen platform
Strengthened Research and Development leadership with the appointment of two seasoned drug developers
First Quarter 2023 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, 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 preclinical, clinical and regulatory development plans and timing expectations, including the expected timing of IND filings and clinical trials 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 type 1 diabetes patients (the “IST”); expectations regarding the IST, including the ability to initiate the IST and the potential of the IST to show cell survival and immune evasion without immunosuppression; the potential ability of SC291 to serve as clinical proof-of-platform for other hypoimmune-modified CAR T cell candidates; expectations with respect to the potential therapeutic benefits and impact of its development programs and platforms, including the potential ability of the hypoimmune platform to overcome immunologic rejection of allogeneic cells and the impact thereof, the potential for hypoimmune-modified islet cells to demonstrate allogeneic immune evasion, autoimmune evasion, and control of type 1 diabetes, and the potential ability to replace missing islet cells without immunosuppression in patients with type 1 diabetes; the potential ability of preclinical data to provide insight for the Company’s development programs and platforms; expectations regarding the Company’s capital position, resources, and balance sheet and the potential impact thereof on the Company’s development programs, including data readouts from such programs; 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 economic, market, and social disruptions, including due to the 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 Quarterly Report on Form 10-Q dated May 8, 2023. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.
Investor Relations & Media:
Nicole Keith
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Sana Biotechnology, Inc. | ||||||||
Unaudited Selected Consolidated Balance Sheet Data | ||||||||
March 31, 2023 | December 31, 2022 | |||||||
(in thousands) | ||||||||
Cash, cash equivalents, and marketable securities | $ | 355,131 | $ | 434,014 | ||||
Total assets | 746,928 | 822,720 | ||||||
Contingent consideration | 155,839 | 150,379 | ||||||
Success payment liabilities | 15,667 | 21,007 | ||||||
Total liabilities | 318,666 | 323,405 | ||||||
Total stockholders' equity | 428,262 | 499,315 |
Sana Biotechnology, Inc. | ||||||||
Unaudited Consolidated Statements of Operations | ||||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
(in thousands, except per share data) | ||||||||
Operating expenses: | ||||||||
Research and development | $ | 67,166 | $ | 72,689 | ||||
Research and development related success payments and contingent consideration | 120 | (55,438 | ) | |||||
General and administrative | 16,766 | 14,434 | ||||||
Total operating expenses | 84,052 | 31,685 | ||||||
Loss from operations | (84,052 | ) | (31,685 | ) | ||||
Interest income, net | 1,976 | 339 | ||||||
Other expense, net | (47 | ) | (102 | ) | ||||
Net loss | $ | (82,123 | ) | $ | (31,448 | ) | ||
Net loss per common share - basic and diluted | $ | (0.43 | ) | $ | (0.17 | ) | ||
Weighted-average number of common shares - basic and diluted | 191,228 | 185,955 |
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, 2022 | $ | 21,007 | $ | 150,379 | $ | 171,386 | ||||||
Changes in fair value – expense (gain) | (5,340 | ) | 5,460 | 120 | ||||||||
Liability balance as of March 31, 2023 | 15,667 | 155,836 | 171,506 | |||||||||
Total change in fair value for the three months ended March 31, 2023 | $ | (5,340 | ) | $ | 5,460 | $ | 120 |
(1) Cobalt Biomedicine, Inc. (Cobalt) and the Presidents of Harvard College (Harvard) are entitled to success payments pursuant to the terms and conditions of their respective agreements. The success payments are recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in research and development related success payments and contingent consideration on the statement of operations.
(2) Cobalt is entitled to contingent consideration upon the achievement of certain milestones pursuant to the terms and conditions of the agreement. Contingent consideration is recorded at fair value and remeasured at each reporting period with changes in the estimated fair value recorded in research and development related success payments and contingent consideration on the statement of operations.
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 | ||||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
(in thousands) | ||||||||
Beginning cash, cash equivalents, and marketable securities | $ | 434,014 | $ | 746,877 | ||||
Ending cash, cash equivalents, and marketable securities | 355,131 | 657,392 | ||||||
Change in cash, cash equivalents, and marketable securities | (78,883 | ) | (89,485 | ) | ||||
Cash paid to purchase property and equipment | 2,176 | 7,533 | ||||||
Change in cash, cash equivalents, and marketable securities, excluding capital expenditures | (76,707 | ) | (81,952 | ) | ||||
Adjustments: | ||||||||
Cash paid for restructuring(1) | 1,881 | - | ||||||
Operating cash burn - Non-GAAP | $ | (74,826 | ) | $ | (81,952 | ) |
(1) The non-GAAP adjustment of $1.9 million for the three months ended March 31, 2023 consisted of cash payments related to the portfolio prioritization and corporate restructuring in the fourth quarter of 2022.
Sana Biotechnology, Inc. | ||||||||
Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share | ||||||||
Three Months Ended March 31, | ||||||||
2023 | 2022 | |||||||
(in thousands, except per share data) | ||||||||
Net loss - GAAP | $ | (82,123 | ) | $ | (31,448 | ) | ||
Adjustments: | ||||||||
Change in the estimated fair value of the success payment liabilities(1) | (5,340 | ) | (54,910 | ) | ||||
Change in the estimated fair value of contingent consideration(2) | 5,460 | (528 | ) | |||||
Net loss - Non-GAAP | $ | (82,003 | ) | $ | (86,886 | ) | ||
Net loss per share - GAAP | $ | (0.43 | ) | $ | (0.17 | ) | ||
Adjustments: | ||||||||
Change in the estimated fair value of the success payment liabilities(1) | (0.03 | ) | (0.30 | ) | ||||
Change in the estimated fair value of contingent consideration(2) | 0.03 | - | ||||||
Net loss per share - Non-GAAP | $ | (0.43 | ) | $ | (0.47 | ) | ||
Weighted-average shares outstanding - basic and diluted | 191,228 | 185,955 |
(1) For the three months ended March 31, 2023, the gains related to the Cobalt and Harvard success payment liabilities were $4.8 million and $0.6 million, respectively, compared to gains of $46.8 million and 8.1 million, respectively, for the same periods in 2022.
(2) The contingent consideration is in connection with the acquisition of Cobalt.
Last Trade: | US$2.69 |
Daily Change: | 0.03 1.13 |
Daily Volume: | 328,611 |
Market Cap: | US$598.440M |
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