Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates First patient treated with FT819 off-the-shelf CAR T-cell product candidate following fludarabine-free conditioning for severe lupus ne

Fate Therapeutics Reports Second Quarter 2025 Financial Results and Business Updates

First patient treated with FT819 off-the-shelf CAR T-cell product candidate following fludarabine-free conditioning for severe lupus nephritis demonstrated durability of response with drug-free definition of remission in systemic lupus erythematosus (DORIS) at 12-month follow-up

Held initial discussion with FDA under

FT819 RMAT designation to seek feedback on registrational pathway in moderate-to-severe Systemic Lupus Erythematosus (SLE) and refractory Lupus Nephritis (LN)

First extrarenal SLE patient treated with FT819 in the absence of conditioning, and as add-on to standard-of-care maintenance therapy, achieved Low Lupus Disease Activity State (LLDAS) at 3- and

IND application allowed by FDA

for FT836 MICA/B-targeted off-the-shelf CAR T cell with Sword and ShieldTM

technology for conditioning-free treatment of broad array of solid tumors

Projected operating runway extended through YE27 to

enable achievement of key clinical and collaboration milestones with $249 million in cash, cash equivalents, and investments

August 12, 2025 - Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of

induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today reported business highlights and financial results for the second

quarter ended June 30, 2025.

"We begin the second half of the year with meaningful progress across our clinical programs as we continue our

mission to make cell therapies accessible to all. Our priority remains focused on driving patient enrollment to demonstrate both the therapeutic differentiation and unique on-demand availability of FT819 in

autoimmune diseases. We remain encouraged by the promising FT819 data in SLE and LN we reported this past quarter, showing significant disease improvement with less-intensive or no conditioning, and have made strides in expanding our trial sites and

accelerating enrollment. Building on this momentum, we are also working closely with the FDA under our RMAT designation with the goal of commencing our registrational study for FT819 in SLE and LN in 2026," said Bob Valamehr, Ph.D., MBA,

President and Chief Executive Officer of Fate Therapeutics. "Additionally, we continue to strengthen our broader pipeline programs with an extended partnership with Ono Pharmaceuticals, and advancements in bringing our next-generation, off-the-shelf CAR T cells with Sword and ShieldTM technology toward the clinic. Operationally, we have taken proactive

steps to optimize our resource allocation and extend our cash runway, positioning us well to continue executing across our pipeline, working to bring transformative

off-the-shelf cellular immunotherapies to patients with unmet needs."

off-the-shelf CAR T-cell program in autoimmune disease

FT825 / ONO-8250 iPSC-derived

off-the-shelf CAR T-cell Program in Solid Tumors

Next-generation iPSC-derived off-the-shelf CAR T-cell Programs with Novel Sword & ShieldTM Technology

Designed to Reduce or Eliminate the Need for Conditioning Chemotherapy

Other Corporate Updates

Second Quarter 2025 Financial Results

About Fate Therapeutics iPSC Product Platform

Human induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell

types of the body. The Company s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce

biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in

inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the

Company s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 500

issued patents and 500 pending patent applications.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived

cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company s pipeline includes iPSC-derived T-cell and natural killer (NK) cell

product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more

information, please visit www.fatetherapeutics.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 including statements

regarding the Company s results of operations, financial condition, anticipated operating expenses and cash runway, and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and

plans related to the Company s product candidates, clinical studies and preclinical research and development programs, the Company s progress, plans and timelines for the clinical investigation of its product candidates, including the

Company s plans to complete IND-enabling studies and to submit IND applications for its product candidates, the initiation and continuation of enrollment in the Company s clinical trials, the

initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company s product candidates, the availability of data from the Company s clinical trials and the

Company s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company s research and development programs and product candidates, the Company s clinical and product development strategy, and

the Company s expectations regarding progress and timelines, the objectives, plans and goals of its collaboration with Ono, and the Company s expectations regarding the receipt of funding under the collaboration and

the expected effects of the Company s pipeline prioritization plan and reduction in force. These and any other forward-looking statements in this release are based on management s

current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and

uncertainties include, but are not limited to, the risk that the Company s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety,

efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company s product candidates, including preclinical studies and clinical trials, will not be

observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company s product candidates or in the initiation and conduct of, or enrollment of patients in, any

clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or

conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory

approval, difficulties or delays in patient enrollment and continuation in the Company s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company s product candidates for clinical testing, failure to

demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk

that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, the risk that the Company may not comply with its obligations under and otherwise maintain its collaboration agreement with Ono, the

risk that research funding and milestone payments received by the Company under its collaboration may be less than expected, and the risk that the Company may incur operating expenses in amounts greater than anticipated. For a discussion of other

risks and uncertainties, and other important factors, any of which could cause the Company s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company s

periodic filings with the Securities and Exchange Commission, including but not limited to the Company s most recently filed periodic report, and from time to time in the Company s press releases and other investor communications. Fate

Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share data)

Condensed Consolidated Balance Sheets