Sign in

You're signed outSign in or to get full access.

FATE THERAPEUTICS (FATE)

--

Earnings summaries and quarterly performance for FATE THERAPEUTICS.

Recent press releases and 8-K filings for FATE.

Fate Therapeutics Updates on CAR iT Pipeline and Cash Runway
FATE
Product Launch
New Projects/Investments
Guidance Update
  • Fate Therapeutics is advancing its iPSC-derived CAR iT cell therapy platform, with a strategic focus on T cells for improved disease elimination.
  • The lead candidate, FT819 (CD19 CAR iT), demonstrates promising safety and efficacy in lupus, with a pivotal registration study planned for 2026 in Systemic Lupus Erythematosus (SLE).
  • FT819's manufacturing process allows for 50,000 doses per year at a cost of goods near $3,000 per dose, facilitating broad accessibility and potential outpatient treatment.
  • In oncology, the company has dosed the first patient for FT836, a MICA/MICB CAR-T cell therapy targeting stress antigens, with initial outcomes anticipated in the first half of 2026.
  • Fate Therapeutics has extended its cash runway through year-end 2027 by implementing cost savings, supporting its ongoing clinical programs.
Dec 2, 2025, 2:00 PM
Fate Therapeutics Provides Update on iPSC-Derived Cell Therapies and Financial Runway
FATE
New Projects/Investments
Guidance Update
  • Fate Therapeutics has extended its cash runway through year-end 2027, an additional year, achieved through precise cost savings measures and strategic focus.
  • The company is advancing its FT819 CD19 CAR iT program for lupus, with plans to move into a pivotal registration study in 2026 for lupus nephritis and extra-renal lupus.
  • Fate's iPSC platform enables the manufacturing of approximately 50,000 doses per year of its cell therapies at a cost of goods close to $3,000 per dose, facilitating an "off-the-shelf" approach and potential for outpatient, same-day infusion.
  • The pipeline includes next-generation therapies like FT839 for autoimmune and malignancies, and FT836 for oncology, which has dosed its first patient.
Dec 2, 2025, 2:00 PM
Fate Therapeutics Provides Update on iPSC-Derived Cell Therapies and Extends Cash Runway
FATE
Product Launch
Guidance Update
New Projects/Investments
  • Fate Therapeutics is prioritizing its FT819 (CD19 CAR iT) program for lupus and other autoimmune diseases, with a goal to initiate a pivotal registration study in 2026 for Systemic Lupus Erythematosus (SLE). The company highlights its ability to manufacture 50,000 doses per year at a cost of approximately $3,000 per dose, aiming for an accessible, off-the-shelf CAR-T therapy.
  • The company reported a cash position of $226 million at the end of Q3 and has extended its cash runway through year-end 2027, an additional year from its previous estimate, due to cost savings and strategic focus.
  • Fate Therapeutics has cleared the IND and dosed the first patient for its FT836 (MICA/MICB CAR-T) oncology program, designed to target stress antigens on cancer cells, with initial outcomes anticipated in the first half of next year.
Dec 2, 2025, 2:00 PM
Fate Therapeutics Reports Q3 2025 Financial Results, Pipeline Advancements, and CFO Appointment
FATE
Earnings
CFO Change
New Projects/Investments
  • Fate Therapeutics reported $1.7 million in total revenue and a net loss of $(32.250) million for the third quarter ended September 30, 2025.
  • As of September 30, 2025, the company held $225.7 million in cash, cash equivalents, and investments, projecting an operating runway through Year-End 2027.
  • The company received authorization from UK and EU authorities to activate ex-US clinical trial sites for FT819 and treated the first systemic sclerosis patient in its Phase 1 study.
  • Fate Therapeutics also treated the first patient with FT836 for solid tumors and commenced Investigational New Drug (IND) application enabling activities for FT839.
  • Kamal Adawi has been appointed as the new Chief Financial Officer.
Nov 13, 2025, 1:32 PM
Fate Therapeutics Announces Positive Clinical Data for FT819 in SLE
FATE
New Projects/Investments
  • Fate Therapeutics, Inc. presented new clinical data for FT819, its off-the-shelf CAR T-cell therapy, in 10 patients with moderate-to-severe Systemic Lupus Erythematosus (SLE) at ACR Convergence 2025, based on a September 25, 2025, data cut-off.
  • All five patients who surpassed the 3-month post-treatment mark showed significant reductions in SLE Disease Activity Index (SLEDAI-2K) score and Physician’s Global Assessment (PGA). Two lupus nephritis patients achieved complete renal response (CRR) at 6 months, with one remaining in drug-free remission at 15 months.
  • The therapy demonstrated a favorable safety profile with no dose-limiting toxicities, no ICANS, no GvHD, and only low-grade cytokine release syndrome (CRS) in three patients, supporting potential for same-day discharge.
  • The company plans to accelerate patient enrollment for the Phase 1 trial and aims to initiate a pivotal study in 2026 under its Regenerative Medicine Advanced Therapy (RMAT) designation with the FDA. Fate Therapeutics has also initiated dose-expansion cohorts for FT819 in other autoimmune diseases including AAV, IIM, and SSc.
Oct 27, 2025, 11:00 AM
Fate Therapeutics Presents Positive FT819 Clinical Data for SLE and Plans for Pivotal Study
FATE
New Projects/Investments
  • Fate Therapeutics announced new clinical data for FT819, its off-the-shelf CAR T-cell therapy, showing favorable safety and meaningful clinical activity in 10 patients with moderate-to-severe Systemic Lupus Erythematosus (SLE) from a Phase 1 trial, as of a September 25, 2025 data cut-off.
  • All 5 patients surpassing a 3-month post-treatment time point demonstrated significant reductions in SLEDAI-2K score and Physician’s Global Assessment (PGA), with 2 lupus nephritis patients achieving complete renal response (CRR) at 6 months.
  • The observed favorable safety profile with no dose-limiting toxicities supports plans for same-day discharge post-treatment.
  • The company plans to accelerate patient enrollment to promptly complete the Phase 1 trial and aims to initiate a pivotal study in 2026 under its RMAT designation with the FDA.
  • Fate Therapeutics has also initiated dose-expansion cohorts for FT819 in anti-neutrophilic cytoplasmic antibody-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc).
Oct 26, 2025, 3:30 PM
FATE Therapeutics Discusses Emerging Solid Tumor Pipeline and Clinical Data
FATE
New Projects/Investments
Product Launch
  • Fate Therapeutics presented its proprietary iPSC product platform, highlighting its unique features for developing multiplexed engineered cell therapies for solid tumors.
  • The company reported positive clinical data from its FT500 and FT516 pilot programs, demonstrating a favorable safety profile, feasibility of multi-dose, multi-cycle treatment, and anti-tumor responses in heavily pretreated, checkpoint-resistant patients with classical Hodgkin lymphoma, non-small cell lung cancer, and melanoma.
  • Enrollment has commenced for the Phase I study of FT538, a multiplex engineered iPSC-derived NK cell product candidate, in combination with monoclonal antibodies for various solid tumor indications.
  • Fate Therapeutics is also advancing other wholly-owned multiplex engineered product candidates, FT536 and FT573, and is collaborating with Janssen and Ono on additional CAR NK and CAR T cell product candidates for solid tumors, with IND submissions expected over the next eighteen months.
Nov 15, 2021, 9:30 PM
FATE Reports Early Clinical Data for FT516 and FT596 Cell Therapies
FATE
New Projects/Investments
  • FATE Therapeutics reported compelling interim clinical data for FT516, with four of eleven patients maintaining a complete response (CR) between 4.6 and 9.5 months as of July 7, 2021. The therapy is being explored for patients who failed autologous CAR T-cell therapy and can be administered in an outpatient setting.
  • For FT596, clinical data as of June 25, 2021, showed that ten of fourteen patients (71%) achieved an objective response and seven patients (50%) achieved a complete response in dose cohorts two and three (90 million and 300 million cells).
  • FT596 demonstrated dose-dependent activity, with 83% objective response at the 300 million cell dose. Retreatment with a second cycle was well tolerated, and four patients maintained CR after the second cycle. The FDA has recommended allowing retreatment without prior consent.
  • Both FT516 and FT596 exhibited a highly favorable safety and tolerability profile, with no evidence of host immune cell rejection.
Aug 19, 2021, 8:30 PM
Fate Therapeutics Presents Interim Phase I Clinical Data for FT516 and FT538
FATE
  • Fate Therapeutics presented interim Phase I clinical data for its off-the-shelf iPS derived NK cell programs, FT516 and FT538, in relapsed/refractory acute myeloid leukemia (AML) as of April 16, 2021.
  • Out of 12 patients (9 treated with FT516, 3 with FT538), five patients achieved an objective response with complete leukemic blast clearance in the bone marrow, including four patients achieving complete remission with incomplete hematologic recovery (CRI) and one patient achieving morphologic leukemia-free state (MLFS).
  • Both FT516 and FT538 were well tolerated, with no dose-limiting toxicities, cytokine release syndrome, immune effector cell associated neurotoxicity syndrome, or graft versus host disease observed in either study.
  • The company plans to initiate a Phase I clinical trial for FT538 in combination with daratumumab in relapsed/refractory AML before the end of Q2 2021.
May 13, 2021, 9:00 PM