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Sana Biotechnology Reports First Quarter 2023 Financial Results and Business Updates IND cleared and enrolling patients in SC291 Phase 1 clinical trial in B-cell malignancies with initial data expected later this year SC

Key Takeaway: Sana Biotechnology reported its first quarter 2023 results, highlighting the progress of its SC291 Phase 1 trial for B-cell malignancies, which has received FDA Fast Track Designation. The company expects initial clinical data later in the year and plans to submit Investigational New Drug applications for two additional product candidates by year-end. Sana's financial position remains robust with $355 million in cash, sufficient to support multiple readouts through 2025. The firm has also strengthened its R&D leadership, aiming to enhance its research capabilities and outcomes.

Market Sentiment Analysis

POSITIVE FACTORS

  • SC291 has received Fast Track Designation from the FDA for treatment of specific lymphomas.
  • Significant cash position of $355 million to support ongoing projects until at least 2025.
  • Recent scientific publications validate the potential of Sana's hypoimmune technology.
  • Strong leadership appointments signal confidence in R&D direction and progress.

Full Press Release Details

Sana Biotechnology Reports First Quarter 2023 Financial Results and Business Updates
IND cleared and enrolling patients in SC291 Phase 1 clinical trial in B-cell malignancies with initial data expected later this year
SC291 granted Fast Track Designation by the FDA for the treatment of relapsed/refractory large B-cell lymphoma and relapsed/refractory chronic lymphocytic leukemia
Expect data later this year from investigator-sponsored trial with hypoimmune-modified primary human islet cells
Goal to submit INDs this year for both SC262 and SG299 in hematologic cancers
Strengthened R&D leadership with addition of Dr. Doug Williams as President of Research and Development and Dr. Gary Meininger as Chief Medical Officer
Publication in Nature Communications demonstrates immune evasion, persistence, and anti-tumor activity of hypoimmune-modified CD19-directed CAR T cells in allogeneic humanized mouse model
Publication in Science Translational Medicine highlights multiple preclinical datasets for hypoimmune-modified islet cells
demonstrating potential for allogeneic immune evasion, autoimmune evasion, and control of type 1 diabetes
Publication in Nature Biotechnology shows that hypoimmune-modified allogeneic cells survive and escape immune detection while remaining fully functional across several species, including non-human primates with normal immune systems
Presented multiple abstracts from hypoimmune and fusogen platforms at 2023 AACR meeting
Cash position of $355 million expected to support activities through multiple data readouts and last into 2025
SEATTLE - May 8, 2023 - 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
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 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:
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 15,667 155,839 171,506
Total change in fair value for the three months ended March 31, 2023 $ (5,340 ) $ 5,460 $ 120
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 )
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

Frequently Asked Questions

What is the purpose of SC291 clinical trial?

SC291 aims to treat B-cell malignancies and is currently enrolling patients.

What designations has SC291 received?

SC291 has been granted Fast Track Designation by the FDA.

What are the financial highlights for Q1 2023?

Sana Biotechnology reported a cash position of $355 million to support ongoing activities.

Who joined Sana's R&D leadership recently?

Dr. Doug Williams and Dr. Gary Meininger joined as President and CMO, respectively.

When does Sana expect key data readouts?

Sana expects initial clinical data from two studies later this year.

Last updated: May 8, 2023