ProTmune (FT1050+FT4145 programmed mPB) / Fate Therap - LARVOL DELTA

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=89 | Completed | Sponsor: Fate Therapeutics | Active, not recruiting ➔ Completed

Preclinical • Trial completion • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-B • HLA-C • HLA-DRB1

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=80; Active, not recruiting; Sponsor: Fate Therapeutics; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Mar 2020 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Fate Therapeutics Inc (FATE) Q4 2020 Earnings Call Transcript (The Motley Fool) - “Primary and secondary endpoints in our randomized controlled and double blinded Phase 2 protect clinical trial of ProTmune are scheduled to be available in the second quarter of 2021….The primary efficacy endpoint of PROTECT is cumulative incidence of grades two through four acute GvHD by day 100...”

P2 data • Graft versus Host Disease

Fate Therapeutics Announces Pricing of Public Offering of Common Stock and Pre-Funded Warrants (Fate Therapeutics Press Release) - "Fate Therapeutics, Inc....today announced the pricing of an underwritten public offering of 4,421,053 shares of its common stock at a public offering price of $85.50 per share....The proceeds to Fate Therapeutics from this offering are expected to be approximately $376 million...Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies of its product candidates, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes."

Financing • Graft versus Host Disease

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=80; Active, not recruiting; Sponsor: Fate Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • HLA-DRB1

Protmune, a Next-Generation Graft for GvHD Prophylaxis in Allogeneic Hematopoietic Cell Transplantation: 1-Year Safety and Efficacy Phase 1 Data (ASH 2018) - "...Here we report the 1-year safety and efficacy data from the Phase 1 stage of PROTECT, an ongoing Phase 1 open-­label / Phase 2 blinded, randomized and controlled trial of ProTmune in adult subjects with hematologic malignancy undergoing matched unrelated donor HCT following myeloablative conditioning and receiving standard GvHD prophylaxis of methotrexate and tacrolimus...ProTmune was manufactured on-­site on the day of HCT by pharmacologically-modulating a conventional mobilized peripheral blood (mPB) cell graft ex vivo with 16,16-dimethyl prostaglandin E2 and dexamethasone, to enhance the biologic properties and therapeutic function of the graft...The Phase 2 stage of PROTECT is currently enrolling a planned 60 subjects at 15 U.S. centers. Subjects with hematologic malignancies undergoing matched unrelated donor HCT following myeloablative conditioning are randomized 1:1 to receive in a blinded manner, either ProTmune or a conventional matched unrelated..."

Clinical • P1 data • Acute Myelogenous Leukemia • Biosimilar • Cardiovascular • Graft versus Host Disease • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Pain • Transplantation

Fate Therapeutics announces additional clinical data from phase 1 stage of PROTECT clinical trial of ProTmune (Fate Therapeutics Press Release) - P1, N=70; NCT02743351; "Fate Therapeutics...announced today additional clinical data from the Phase 1 stage of its PROTECT clinical trial of ProTmune...data is being featured in a poster presentation at the 44th Annual Meeting of the European Society for Blood and Marrow Transplantation being held in Lisbon...safety profile of ProTmune and suggest that ProTmune has the unique potential to attenuate early, life-threatening events of acute GvHD and promote the curative potential of allogeneic transplant."

P1 data • Graft versus Host Disease • Immunology

ProTmune: Protection of composition-of-matter patents until 2032 (Fate Therapeutics) - Corporate Presentation

Patent • Graft versus Host Disease • Immunology

ProTume: “PROTECT Phase 1 Day 100 Efficacy Data” (Fate Therapeutics) - Corporate Overview

P1 data • Graft versus Host Disease • Immunology

ProTmune: 1-year data from P1 portion of P1/2 PROTECT trial (NCT02743351) for allogeneic hematopoietic cell transplantation in adult patients with hematologic malignancies at ASH (December 1-4, 2018) (Fate Therapeutics) - Q1 2018 Results: Data from P2 portion of P1/2 PROTECT trial in 2019

P1 data • P2 data • Graft versus Host Disease • Immunology

Protmune Reduces the Incidence and Severity of Acute GvHD By Transiently Dampening T-Cell Signaling (BMT 2018) - "These observations provide a rationale for the simultaneously reduced incidence and severity of aGvHD and intact GvL responses previously observed in preclinical animal models. ProTmune is currently undergoing clinical testing in PROTECT, an ongoing Phase 1-2 clinical trial in adult patients with hematologic malignancies."

Biosimilar • Graft versus Host Disease • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • Test

Fate Therapeutics reports second quarter 2017 financial results (Fate Therapeutics Press Release) - "...Fate Therapeutics plans to begin enrolling the randomized, controlled and blinded Phase 2 efficacy stage of PROTECT in adult subjects with hematologic malignancies undergoing matched unrelated donor transplant during the third quarter of 2017."

Enrollment open • Graft versus Host Disease • Immunology

Fate Therapeutics reports third quarter 2019 financial results and highlights operational progress (GlobeNewswire) - "In October, the Company completed enrollment in the randomized, controlled and double-blinded Phase 2 PROTECT study of ProTmune...allogeneic hematopoietic cell graft for the prevention of acute graft-versus-host disease (GvHD) in patients undergoing hematopoietic cell transplantation (HCT) for the treatment of hematologic malignancies."

Enrollment closed

Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=80; Recruiting; Sponsor: Fate Therapeutics; Trial completion date: Jun 2020 ➔ Dec 2020; Trial primary completion date: Sep 2019 ➔ Apr 2020

Clinical • Trial completion date • Trial primary completion date

ProTmune: Completion of enrollment of P2 portion of P1/2 PROTECT trial (NCT02743351) for GVHD in allogeneic hematopoietic cell transplantation in adult patients with hematologic malignancies in mid-2019 (Fate Therapeutics) - Q4 2018 Results

Trial status

ProTmune: Completion of enrollment of P2 portion of P1/2 PROTECT trial (NCT02743351) for GVHD in allogeneic hematopoietic cell transplantation in adult patients with hematologic malignancies in 2019 (Fate Therapeutics) - Corporate Presentation

Trial status

Fate Therapeutics reports fourth quarter and full year 2018 financial results and highlights operational progress (GlobeNewswire) - "The Company expects to complete enrollment of the randomized, controlled and double-blind Phase 2 PROTECT study in 2019, and that data on the primary and secondary endpoints will be available in 2020."

Enrollment status • P2 data