FATE

EX-99.1

2 fate-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Fate Therapeutics Reports First Quarter 2026 Financial Results and Business Updates

RECLAIM – LN, a Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with lupus nephritis, on schedule to initiate in the 2nd half of 2026

FDA selects FT819 into the CDRP (CMC Development and Readiness Pilot) program enabling early and enhanced communication with the FDA to ensure CMC readiness for accelerated clinical timelines

Clinical data presented at Pediatric Rheumatology Symposium 2026 and Congress of Clinical Rheumatology – East 2026 highlights safety and efficacy of single dose of FT819 with reduced conditioning in SLE

Preclinical data presented at the American Association for Cancer Research 2026 demonstrates the unique ability of FT839 for comprehensive targeting of hematological malignancies and autoimmune diseases without the use of conditioning chemotherapy

Operating runway extended into 2028, driven by a 20% reduction in operating expenses in the first quarter of 2026 compared to the first quarter of 2025

San Diego, CA – May 13, 2026 – Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients for broad accessibility, today reported financial results for the first quarter ended March 31, 2026, and provided a business update.

"We are incredibly excited and focused on initiating RECLAIM-LN, our Phase 2 potentially registrational clinical trial of FT819 for the treatment of lupus nephritis to provide eligible trial patients a truly accessible CAR T-cell treatment option," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "Our acceptance into the FDA's highly competitive CDRP Program, combined with our RMAT designation, reflects a recognition of the strength of our initial Phase 1 clinical data and provides a powerful regulatory foundation as we advance FT819 along an accelerated clinical pathway. With planned clinical advancement of FT819 on multiple fronts, next generation CAR T-cell programs entering clinical trials, a strong cash balance supporting our runway into 2028 and a team that continues to execute at the highest level, we believe 2026 will be a defining year for Fate Therapeutics."

Clinical Development & Program Updates

RECLAIM-LN, Phase 2 potentially registrational clinical trial of FT819 in patients with refractory moderate-to-severe SLE with lupus nephritis

The Company anticipates commencing patient dosing in FT819-201, RECLAIM – LN (NCT07570862), a Phase 2 potentially registrational clinical trial of FT819 in patients with

refractory moderate-to-severe SLE with lupus nephritis, in the second half of 2026. The planned open-label, single-arm study was developed during interactions with the FDA under the RMAT designation for FT819, and is expected to enroll approximately 53 patients, evaluating a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with complete renal response (CRR) at six months as the primary endpoint. The conditioning regimen selected for RECLAIM – LN is unique and less-intensive than most CAR T-cell clinical trials that incorporate up to 3 days of co-administration of cyclophosphamide and fludarabine, a combination that was perceived as less desirable to patients and clinicians during the Company’s Phase 1 clinical study. Based on enrollment cadence in the Phase 1 clinical trial and current clinical site engagement, the unique on-demand availability of FT819, and the option for outpatient treatment with reduced conditioning chemotherapy requirements, the Company aims to complete the enrollment of the RECLAIM – LN clinical study approximately 15 months from commencement.

CDRP program selection for FT819 to align CMC plans with the FDA early in the development process

FT819 has been selected for participation in the FDA’s Chemistry, Manufacturing and Controls (CMC) Development and Readiness Pilot (CDRP) Program, a highly selective initiative designed to accelerate development of investigational therapies for serious diseases with unmet medical need through enhanced FDA engagement on CMC-related activities. Participation in the program enables increased interaction with the Agency, including additional CMC-focused Type B meetings with FDA review staff intended to help clarify development strategies, address key manufacturing questions, align CMC readiness and support a more efficient regulatory review process. The Company believes participation in the CDRP Program, in addition to its previously received Regenerative Medicine Advanced Therapy (RMAT) designation, has the potential to accelerate the registration pathway of FT819 in SLE.

FT819-102 Phase 1 clinical trial now enrollin

8-K

0001434316false00014343162026-02-262026-02-26

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): February 26, 2026

FATE THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-36076

65-1311552

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

12278 Scripps Summit Drive

San Diego, California

92131

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 858 875-1800

(Former Name or Former Address, if Changed Since Last Report)

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, $0.001 par value

FATE

Nasdaq Global Market

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 February 26, 2026, Fate Therapeutics, 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 as Exhibit 99.1. The information in this Item 2.02 of this Current Report on Form 8-K, including 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 (“Exchange Act”) or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press release dated February 26, 2026

104

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

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 thereunto duly authorized.

FATE THERAPEUTICS, INC.

Date:

February 26, 2026

By:

/s/ Bahram Valamehr

Bahram Valamehr, Ph.D., MBA President and Chief Executive Officer

8-K

0001434316false00014343162025-11-132025-11-13

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 13, 2025

FATE THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-36076

65-1311552

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification No.)

12278 Scripps Summit Drive

San Diego, California

92131

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 858 875-1800

(Former Name or Former Address, if Changed Since Last Report)

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, $0.001 par value

FATE

Nasdaq Global Market

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 13, 2025, Fate Therapeutics, 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 as Exhibit 99.1. The information in this Item 2.02 of this Current Report on Form 8-K, including 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 (“Exchange Act”) or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press release dated November 13, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

FATE THERAPEUTICS, INC.

Date:

November 13, 2025

By:

/s/ Bahram Valamehr

Bahram Valamehr, Ph.D., MBA President and Chief Executive Officer