Sana Biotechnology (NASDAQ: SANA) shares cell therapy milestones update

Rhea-AI Filing Summary

Sana Biotechnology, Inc. furnished an updated corporate presentation tied to its appearance at the 44th Annual J.P. Morgan Healthcare Conference. The company highlighted progress across its cell therapy platforms, including UP421, a primary pancreatic islet cell therapy using its hypoimmune platform, which at 12 months post-transplant in a type 1 diabetes patient without immunosuppression continued to survive, evade immune detection, and function.

The company also stated it remains on track to file an investigational new drug application and begin a Phase 1 trial for SC451, a hypoimmune-modified, iPSC-derived pancreatic islet cell therapy, as early as this year, and announced a goal of generating initial human data for SG293, an in vivo CD19-directed CAR T cell therapy, as early as this year. The information is furnished under Regulation FD and is not deemed filed or incorporated into other SEC reports unless specifically referenced.

Insights

Biotech clinical and regulatory analyst

Sana highlights 12‑month UP421 data and near‑term IND, data goals.

Sana Biotechnology uses this update to showcase progress across its hypoimmune and in vivo CAR T platforms. UP421, a primary pancreatic islet cell therapy using the hypoimmune platform, is reported to survive, evade immune detection, and function 12 months after transplantation in a type 1 diabetes patient who received no immunosuppression. This emphasizes persistence and immune evasion in a real‑world setting, though no quantitative efficacy or safety details are given.

The company also notes it is on track to file an IND and begin a Phase 1 trial for SC451, an iPSC‑derived, hypoimmune pancreatic islet cell therapy, as early as this year. In parallel, it sets a goal of generating initial human data for SG293, an in vivo CD19‑directed CAR T therapy, in the same timeframe. These statements outline an ambitious near‑term clinical roadmap, but timelines and outcomes remain subject to the usual drug development risks and regulatory review.

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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): January 14, 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 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 7.01 Regulation FD Disclosure.

Sana Biotechnology, Inc. (the “Company” or “Sana”) intends to discuss an updated corporate presentation (the “Corporate Presentation”) at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. A copy of the Corporate Presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference herein. In connection with its discussion of the Corporate Presentation, the Company intends to provide an overview of and updates regarding the Company’s programs and platforms, including the following:

•At 12 months post-transplantation into a patient with type 1 diabetes who received no immunosuppression, UP421, a primary pancreatic islet cell therapy engineered with Sana’s hypoimmune platform (“HIP”) technology, continued to survive, evade immune detection, and function.

•Sana remains on track to file an investigational new drug application (“IND”) and begin a Phase 1 trial for SC451, a HIP-modified, induced pluripotent stem cell (“iPSC”)-derived pancreatic islet cell therapy, as early as this year.

•Sana announced its goal of generating initial human data as early as this year for SG293, an in vivo CD19-directed CAR T cell therapy.

By furnishing the information in this Item 7.01 of this Current Report, including Exhibit 99.1, the Company makes no admission as to the materiality of such information. The information contained herein is intended to be considered in the context of the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Corporate Presentation, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.

In accordance with General Instruction B.2 of Form 8-K, the information furnished with this Current Report, including Exhibit 99.1, shall not be deemed “filed” for 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 other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Cautionary Note Regarding Forward-Looking Statements

This Current Report contains forward-looking statements about the Company within the meaning of the federal securities laws, including those related to the Company’s discussion at the 44th Annual J.P. Morgan Healthcare Conference; the Company’s vision, progress, and business plans; and expectations for its development programs, product candidates, and technology platforms, including its preclinical, clinical, and regulatory development plans and timing expectations, including with respect to the substance and timing of potential INDs, the commencement of clinical trials and generation of clinical data, and potential indications for and the potential impact and benefits of its technologies and product candidates. All statements other than statements of historical facts contained in this Current Report, 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 and preclinical and clinical trials, as well as economic, market, and social disruptions. 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 SEC reports, including but not limited to its Quarterly Report on Form 10-Q dated November 6, 2025. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

See the Exhibit Index below, which is incorporated by reference herein.

1

EXHIBIT INDEX

Exhibit Number		Description
99.1		Corporate Presentation dated January 14, 2026
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

2

SIGNATURES

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

		Sana Biotechnology, Inc.
Date: January 14, 2026		By:	/s/ Aaron M. Grossman
			Aaron M. Grossman
			Executive Vice President, Chief Legal Officer

3

FAQ

What is Sana Biotechnology (SANA) announcing in this 8-K?

Sana Biotechnology is furnishing a corporate presentation tied to its discussion at the 44th Annual J.P. Morgan Healthcare Conference, highlighting updates on several of its cell therapy programs.

What update did Sana Biotechnology provide on UP421 in type 1 diabetes?

The company reported that 12 months after transplantation into a type 1 diabetes patient who received no immunosuppression, UP421, a primary pancreatic islet cell therapy using its hypoimmune platform, continued to survive, evade immune detection, and function.

What are Sana Biotechnology’s plans for its SC451 cell therapy program?

Sana stated it remains on track to file an investigational new drug application and begin a Phase 1 trial for SC451, a hypoimmune-modified, iPSC-derived pancreatic islet cell therapy, as early as this year.

What goal did Sana Biotechnology set for its SG293 CAR T program?

The company announced its goal of generating initial human data as early as this year for SG293, an in vivo CD19-directed CAR T cell therapy.

Is the information in Sana Biotechnology’s corporate presentation considered filed with the SEC?

No. The company specifies that the information furnished, including the corporate presentation, is provided under Regulation FD, is not deemed filed for purposes of Section 18 of the Exchange Act, and is not incorporated by reference into other filings unless expressly stated.

Does Sana Biotechnology provide any financial results in this 8-K filing?

No financial results are described; the filing focuses on program and platform updates and forward-looking statements about development plans and timing.