SANA

EX-99.1

2 sana-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Sana Biotechnology Reports First Quarter 2026 Financial Results and Business Updates

Announced strategic collaboration with Mayo Clinic, focused on improving care in type 1 diabetes and accelerating development of SC451

Continued progress toward starting SC451 Phase 1 trial later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation

Announced positive clinical results at 14 months from ongoing clinical trial transplanting UP421 without any immunosuppression into a patient with type 1 diabetes, showing ongoing survival and function

Continued progress toward starting clinical study for SG293 in non-Hodgkin lymphoma later this year, including manufacturing readiness, non-clinical testing, and clinical trial preparation

Will present SG293 surrogate preclinical data demonstrating specificity and potency in non-human primates at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting on May 12

Progress with SG227, a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make BCMA-directed CAR T cells, as a potential treatment for patients with multiple myeloma; expect to begin clinical study as early as mid-2027

Q1 2026 cash position of $101.1 million and pro forma cash position of $128.9 million, including approximately $25.0 million equity investment from Mayo Clinic collaboration and recent at the market offering facility (ATM) activity; expected cash runway into 2027

SEATTLE — May 11, 2026 — 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 first quarter 2026.

“We remain focused on execution in 2026 and are on track with both SC451 and SG293,” said Steve Harr, President and Chief Executive Officer. “We are working to file our IND and begin a Phase 1 trial later this year for SC451, our gene-modified, stem cell-derived pancreatic islet cell product candidate designed for patients with type 1 diabetes with the goal of a single treatment leading to long-term normal blood glucose without the need for any insulin therapy or immunosuppression. We are pleased to have recently entered into a strategic collaboration with Mayo Clinic, whose multidisciplinary expertise we expect will help accelerate the development, standardization of delivery for, and access to SC451. We also continue to advance SG293, our in vivo CAR T cell product candidate, which has the potential to offer a one‑time, off‑the‑shelf treatment without conditioning chemotherapy to patients with blood cancers or B cell-mediated autoimmune disorders. We are making meaningful progress toward our goal of beginning clinical testing later this year. We are also preparing to begin a clinical trial for SG227, an in vivo BCMA-targeted CAR T cell therapy, by as early as mid-2027 assuming positive early safety and efficacy data for SG293. This near-term operational focus has the potential to generate meaningful proof of concept data across multiple programs over the coming 12-18 months, and we look forward to building on this momentum.”

Corporate Highlights

Announced strategic collaboration with Mayo Clinic to advance development of SC451, a hypoimmune (HIP)-modified, induced pluripotent stem cell (iPSC)-derived pancreatic islet cell therapy for type 1 diabetes.

• The collaboration will draw on Mayo Clinic’s multidisciplinary expertise to accelerate the development, validation, and standardization of protocols and processes for SC451, supporting safe, scalable, and consistent delivery across diverse clinical environments.

• In connection with the collaboration, Mayo Clinic made an approximately $25.0 million equity investment in the company, reflecting a shared commitment to advancing innovative approaches aimed at improving care for patients with type 1 diabetes. The organization also has the option to make an additional approximately $25.0 million equity investment.

Shared updated, positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with HIP technology, into a patient with type 1 diabetes without the use of any immunosuppression.

• UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into a type 1 diabetes patient without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.

• Results of the study through 14 months after cell transplantation demonstrate the survival and function of pancreati

8-K

false000177012100017701212026-03-032026-03-03

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 3, 2026

SANA BIOTECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-39941

83-1381173

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

188 East Blaine Street, Suite 350 Seattle, Washington 98102 (Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (206) 701-7914

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

SANA

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On March 3, 2026, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. Item 8.01 Other Events. On March 3, 2026, the Company entered into an amended and restated sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC (“TD Cowen”) to sell shares of the Company’s common stock, $0.0001 par value per share (“Common Stock”), from time to time, through an “at the market offering” program under which TD Cowen will act as sales agent. The Sales Agreement amends and restates the prior sales agreement, dated May 8, 2025, between the Company and TD Cowen (the “Prior Sales Agreement”). As of the entry into the Sales Agreement, the Company had sold an aggregate of approximately 11.3 million shares of Common Stock under the Prior Sales Agreement for net proceeds of approximately $45.8 million, resulting in an unsold aggregate offering price of approximately $71.6 million. Following the entry into the Sales Agreement, the Company may not offer or sell any additional shares of Common Stock under the Prior Sales Agreement or the related prospectus supplement, dated May 8, 2025. Under the Sales Agreement, the Company will set the parameters for the sale of shares of Common Stock, including the number or dollar amount of shares to be issued, the time period during which sales are requested to be made, any limitation on the number or dollar amount of shares that may be sold in any one trading day, and any minimum price below which sales may not be made. Subject to the terms and conditions of the Sales Agreement, TD Cowen may sell the shares in negotiated transactions, including block trades or block sales, or by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including without limitation sales made through the Nasdaq Global Select Market or any other trading market for the Common Stock, or by any method permitted by law. TD Cowen has agreed to use commercially reasonable efforts in conducting such sales activities consistent with its normal trading and sales practices, applicable state and federal laws, rules, and regulations, and the rules of The Nasdaq Stock Market, Inc. As specified in the Sales Agreement, the Sa

8-K

0001770121false00017701212025-11-062025-11-06

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 6, 2025

SANA BIOTECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-39941

83-1381173

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

188 East Blaine Street, Suite 400 Seattle, Washington 98102 (Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (206) 701-7914

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

SANA

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On November 6, 2025, Sana Biotechnology, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1. The information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits

Exhibit No.

Description

99.1

Press release of Sana Biotechnology, Inc. dated November 6, 2025

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

SANA BIOTECHNOLOGY, INC.

Date: November 6, 2025

By:

/s/ Susan Wyrick

Susan Wyrick

Acting Chief Financial Officer

(Principal Accounting Officer)