FATE

EX-99.1

2 fate-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Fate Therapeutics Reports Second Quarter 2026 Financial Results and Business Updates

First lupus nephritis patient dosed in RECLAIM-LN, a Phase 2 potentially registrational trial utilizing FT819, an iPSC-derived, off-the-shelf CAR T-cell therapy; patient was treated as an outpatient with same-day discharge

FDA clearance of the FT839 IND application advances the Company’s novel dual CD19/CD38 targeting off-the-shelf CAR T-cell product candidate into a Phase 1/2 basket trial in autoimmune disease

Preliminary clinical data in SSc presented at the ISSCR 2026 Annual Meeting demonstrate rCRISS25 or greater responses and improvement in mRSS in all four treated patients, with no CRS, ICANS, GvHD, or hypogammaglobulinemia reported

Appointment of Laura Hamill to the Board, bringing strong commercial expertise as the Company advances its pipeline toward later-stage development and prepares for its transition to a commercial-stage organization

Quarterly change in cash, cash equivalents, and investments is a decrease of $21 million; cash runway expected into 2028

San Diego, CA – August 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 second quarter ended June 30, 2026, and provided a business update.

"Dosing of the first patient in RECLAIM-LN, our Phase 2 potentially registrational trial, is an exciting milestone as we work to address significant unmet medical needs in patients with lupus nephritis using our FT819 off-the-shelf CAR T-cell treatment," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “The use of a clonally engineered master cell bank provided us the unique advantage of producing a FT819 pivotal CAR T-cell drug product batch that is uniform in composition and consistent with previously manufactured batches, a level of manufacturing consistency that can be challenging to achieve with patient- and donor-sourced CAR T-cell therapies. The clinical development of the FT819 franchise is further strengthened through its FDA RMAT designation and CDRP program inclusion. With our first patient treated, multiple clinical sites activated, and pivotal drug product inventory in distribution depots ready to be shipped to clinical sites on demand, we are building momentum to accelerate the clinical development of RECLAIM-LN. In addition to FT819, our next generation CAR T-cell programs include FT839, a novel 13-point edited CAR T-cell product candidate co-targeting CD19 and CD38, which is advancing to first patient treatment in rheumatoid arthritis and other autoimmune diseases, as well as FT836, CAR T-cell product candidate targeting the stress ligands MICA/B for pan-tumor treatment which is showing early anti-tumor activity in colorectal cancer without conditioning chemotherapy. With these advancements and a strong cash position, we believe Fate is positioned for strong execution across our portfolio.”

Clinical Development & Program Updates

RECLAIM-LN, FT819 Phase 2 Potentially Registrational Trial in Lupus Nephritis

Lupus nephritis (LN) is among the most serious manifestations of systemic lupus erythematosus (SLE). Approximately 100,000 U.S. patients have refractory moderate-to-severe LN, a subset of LN not previously evaluated with currently available therapies. Of these patients, only approximately 10-20% are expected to

achieve a complete renal response (CRR), underscoring the substantial unmet need that RECLAIM-LN is designed to address.

The RECLAIM-LN trial is an open-label, single-arm study developed following interactions with the FDA under the Company’s Regenerative Medicine Advanced Therapy (RMAT) designation. The Phase 2 potentially registrational clinical trial is expected to enroll approximately 53 patients and evaluate a single dose of FT819 administered at 900 million cells following bendamustine conditioning, with CRR at Week 26 as the primary endpoint. The conditioning regimen selected for RECLAIM-LN is less-intensive than other CAR T-cell clinical trials, which typically incorporate up to three days of co-administration of cyclophosphamide and fludarabine, a combination that was observed as less desirable to patients and clinicians during the Company's Phase 1 clinical study, in part because of the potential increase in adverse events.

To date, the Company has achieved the following operational milestones in RECLAIM-LN:

• First patient dosed in RECLAIM-LN. To the Company's knowledge, this represents the first patient treated with an iPSC-derived off-the-shelf CAR T-cell therapy in a potentially registrational clinical trial in an autoimmune disease.

• Notably, the patient was treated in an outpatient setting with same-day discharge an

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