1. Organization

Sana Biotechnology, Inc. (the Company or Sana) is a biotechnology company focusing on utilizing engineered cells as medicines. The Company’s operations to date have included identifying and developing potential product candidates, executing preclinical studies, establishing manufacturing capabilities, preparing for and executing clinical trials of its product candidates and supporting clinical trials of product candidates developed using its technologies, acquiring technologies, staffing the Company, business planning, establishing and maintaining the Company’s intellectual property portfolio, raising capital, and providing general and administrative support for these operations.

Liquidity and capital resources

The Company is subject to a number of risks and uncertainties similar to other biotechnology companies in the development stage, including, but not limited to, those related to the need to obtain adequate additional funding, possible failure of preclinical testing or clinical trials, the need to obtain marketing approval for its product candidates, building out manufacturing capabilities, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s products, the need to protect the Company’s intellectual property and proprietary technologies, and the need to attract and retain key scientific and management personnel. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. Until such time as the Company can generate significant revenue from product sales, if ever, it expects to finance its operations with the proceeds from additional equity or debt financings or capital obtained in connection with strategic collaborations or licensing or other arrangements. In the event that additional financing is required, the Company may not be able to raise capital on terms acceptable to it or at all.

In August 2025, the Company completed an underwritten public offering (the Offering) pursuant to which it sold 20.9 million shares of its common stock and pre-funded warrants to purchase 1.5 million shares of its common stock for net proceeds of approximately $70.0 million, after deducting underwriting discounts and commissions and estimated offering expenses.

In May 2025, the Company entered into a sales agreement (the Sales Agreement) with TD Securities (USA) LLC (TD Cowen), acting as sales agent, pursuant to which it may offer and sell through TD Cowen up to $119.0 million of shares of the Company’s common stock from time to time in a series of one or more at the market equity offerings (collectively, the ATM facility). Concurrently with entering into the Sales Agreement, the Company terminated its prior sales agreement with TD Cowen (as successor to Cowen and Company, LLC) entered into in August 2022 (the Prior Sales Agreement). As of June 30, 2025, the Company had sold an aggregate of 0.2 million shares of the Company's common stock under the Sales Agreement. The Company received gross proceeds of $0.5 million from sales of common stock under the Sales Agreement during the quarter ended June 30, 2025, and did not sell any common stock under the Prior Sales Agreement during the quarter ended June 30, 2025.

In February 2024, the Company completed an underwritten public offering pursuant to which it sold 21.8 million shares of its common stock, including 4.5 million shares pursuant to the full exercise of the underwriters' option to purchase additional shares, and pre-funded warrants to purchase 12.7 million shares of its common stock for net proceeds of approximately $180.0 million, after deducting underwriting discounts and commissions and offering expenses.

The Company has incurred operating losses each year since inception and expects such losses to continue for the foreseeable future. As of June 30, 2025, the Company had cash, cash equivalents, and marketable securities of $72.7 million, and an accumulated deficit of $1.7 billion, which includes cumulative non-cash charges related to the revaluation of the success payment liabilities and contingent consideration of $6.2 million and $65.9 million, respectively. As described above, in August 2025, the Company completed the Offering, generating net proceeds of approximately $70.0 million, after deducting underwriting discounts and commissions and estimated offering expenses. In addition, from July 1, 2025 through the date of this Quarterly Report, the Company raised $28.6 million in net proceeds under the Sales Agreement. In assessing its ability to continue as a going concern, the Company carefully evaluated the conditions and events that may raise substantial doubt about its ability to continue operations for one year from the filing of this Quarterly Report. This evaluation considered several factors, including the Company’s current financial condition and available liquidity resources, which now include the proceeds from the Offering and the ATM facility. Based on the Company’s current operating plan, the Company believes that its existing cash, cash equivalents, and marketable securities as of June 30, 2025, together with the net proceeds received from the Offering and the ATM facility, will be sufficient to fund its planned operations for at least one year from the filing of this Quarterly Report and there is no longer substantial doubt about its ability to continue as a going concern as of the date of this Quarterly Report.