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 (GLOBE NEWSWIRE) -- 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 dont have effective treatments today, said Steve Harr, Sanas 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 Sanas multiple platforms including Sanas 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

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 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 companys 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 Sanas 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 Sanas SG295 program; the potential efficacy of the NIHs CAR construct; the potential benefits of targeting both CD19 and CD22 with an off-the-shelf product, including in combination with Sanas 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 Companys 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 Companys 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 Companys actual results, please refer to the risk factors identified in the Companys 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: Nicole Keith investor.relations@sana.com media@sana.com

Sana Biotechnology, Inc. Unaudited Selected Consolidated Balance Sheet Data

Sana Biotechnology, Inc. Unaudited Consolidated Statements of Operations

Sana Biotechnology, Inc. Changes in the Estimated Fair Value of Success Payments and Contingent Consideration

(1) Cobalt Biomedicine, Inc. (Cobalt) and the Presidents of Harvard College (Harvard) are entitled to success payments pursuant to the terms of their 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 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. Sanas management believes that these non-GAAP financial measures are helpful in understanding Sanas financial performance and potential future results, as well as providing comparability to peer companies and period over period. In particular, Sanas 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 Companys 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 Sanas 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. Sanas management uses these supplemental non-GAAP financial measures internally to understand, manage, and evaluate Sanas business and make operating decisions. In addition, Sanas management believes that the presentation of these non-GAAP financial measures is useful to investors because they enhance the ability of investors to compare Sanas 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

(1) The non-GAAP adjustment of $52.1 million for the twelve months ended December 31, 2021 consisted of the one-time upfront payment of $50.0 million to Beam to license its genome editing technology and holdback payments of $2.1 million related to the acquisitions of Cytocardia, Inc. in 2019 and Oscine Corp. in 2020. The non-GAAP adjustment of $7.7 million for the twelve months ended December 31, 2020 was the upfront payment related to the acquisition of Oscine Corp. in 2020. (2) The non-GAAP adjustment of $6.0 million for the twelve months ended December 31, 2020 was the payment of a contingent liability due to Harvard in connection with the closing of the Series B convertible preferred stock financing.

Sana Biotechnology, Inc. Unaudited Reconciliation of GAAP to Non-GAAP Research and Development Expense

(1) The non-GAAP adjustment of $8.5 million for the twelve months ended December 31, 2020 was the upfront expense recorded in connection with the acquisition of Oscine Corp. in 2020. (2) The contingent liability was recorded in connection with the Harvard license agreement and paid in June 2020.

Sana Biotechnology, Inc. Unaudited Reconciliation of GAAP to Non-GAAP Net Loss and Net Loss Per Share

(1) The non-GAAP adjustment of $8.5 million for the twelve months ended December 31, 2020 was the upfront expense recorded in connection with the acquisition of Oscine Corp. in 2020. (2) For the three and twelve months ended December 31, 2021, we recorded a gain related to the Cobalt success payment liability of $23.3 million and an expense of $23.6 million, respectively. For the three and twelve months ended December 31, 2020, we recorded expenses related to the Cobalt success payment liability of $27.1 million and $62.3 million, respectively. For the three and twelve months ended December 31, 2021, we recorded a gain related to the Harvard success payment liability of $8.4 million and an expense of $2.4 million, respectively. For the three and twelve months ended December 31, 2020, we recorded expenses related to the Harvard success payment liability of $4.4 million and $9.9 million, respectively. The expense and gain recorded in each period are due to changes in our market capitalization and common stock price during the relative periods. (3) The contingent consideration was recorded in connection with the acquisition of Cobalt. The change in value of the contingent consideration was primarily due to scientific progress toward the achievement of milestones during the relative periods. (4) The contingent liability was recorded in connection with the Harvard license agreement and paid in June 2020.

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Sana Biotechnology Reports Fourth Quarter and Full Year 2021 Financial Results and Business Updates - BioSpace