On March 5, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the fourth quarter ended December 31, 2017 (Press release, Fate Therapeutics, MAR 5, 2018, View Source [SID1234524391]).
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"Initial clinical observations from the investigation of our first-in-class product candidates have established Fate Therapeutics as a leading innovator in the development of next-generation cellular immunotherapies. We look forward to sharing additional clinical data from three ongoing studies of FATE-NK100 and the PROTECT Phase 1 study of ProTmune at upcoming scientific conferences throughout 2018," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "In addition, we are now poised to advance FT500, our first iPSC-derived NK cell cancer immunotherapy, to a landmark IND filing in the first half of 2018. We believe our proprietary iPSC product platform, which we are applying to consistently produce large quantities of uniform, well-characterized NK cells and T cells from clonal master iPSC lines, can transform cell therapy from a single-dose, patient-restricted process to a multi-dose, off-the-shelf product paradigm. Upon clearance of this first IND from our iPSC product platform, we are well positioned to rapidly advance multiple off-the-shelf cancer immunotherapies, including our engineered NK cell and universal CAR T-cell products, into clinical development."
Clinical Programs – Highlights & Updates
Anti-Leukemia Activity of FATE-NK100 Observed in VOYAGE Study. In November 2017, initial clinical data of FATE-NK100, a first-in-class adaptive memory natural killer (NK) cell product, from the ongoing VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia (AML) were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. At two weeks following a single intravenous infusion of FATE-NK100, the subject in the first dose cohort showed nearly a 50% reduction in leukemic blasts and the subject in the second dose cohort achieved a morphologic leukemia-free state based on bone marrow biopsy.No dose limiting toxicities were reported.
Advanced FATE-NK100 through First Two Dose Cohorts of APOLLO Study. In December 2017, the APOLLO study of FATE-NK100 was initiated for the treatment of women with ovarian cancer that is resistant to, or recurrent on, platinum-based treatment. FATE-NK100 has advanced through the first two dose cohorts with no reports of dose limiting toxicities. The Company expects to release initial clinical data from the ongoing APOLLO study at the 3rd Innate Killer Summit (March 27-29, San Diego).
Reported Day 100 Clinical Data from Phase 1 Stage of PROTECT Study of ProTmune. In December 2017, initial clinical data of ProTmune, a next-generation hematopoietic cell graft, were presented at the 59thAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. During the first 100 days following hematopoietic cell transplantation (HCT), all seven subjects receiving ProTmune in the Phase 1 stage of the PROTECT study for the treatment of hematologic malignancies remained alive and relapse-free. Three subjects experienced acute graft-versus-host disease (GvHD) during the first 100 days following HCT, all of whom responded to standard-of-care steroid treatment. There were no ProTmune-related serious adverse events reported by investigators.
Preclinical Programs – Highlights & Updates
Initiated IND-enabling Manufacture of FT500 iPSC-derived NK Cell Cancer Immunotherapy. Clinical-scale production of FT500, a first-of-kind, off-the-shelf NK cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, commenced at Molecular and Cellular Therapeutics, a state-of-the-art, FDA-registered Good Manufacturing Practice (GMP) facility. The Company is currently preparing an Investigational New Drug (IND) application for FT500 for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2018. The Company plans to clinically investigate multiple dosing cycles of FT500 in combination with FDA-approved checkpoint inhibitor therapy for the treatment of advanced solid tumors.
Presented Preclinical Data for FT819 iPSC-derived CAR19 T-Cell Cancer Immunotherapy. In December 2017, scientists from the laboratories of Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, and Fate Therapeutics presented at ASH (Free ASH Whitepaper) the generation of iPSC-derived, anti-CD19 chimeric antigen receptor (CAR)-targeted, TCR-null CD8αβ+ T cells. The universal T cells were derived from a single iPSC engineered to completely eliminate T-cell receptor (TCR) expression and to insert a CAR targeting CD19 into the T-cell receptor α constant (TRAC) locus. The groundbreaking development enables the renewable production of large quantities of CAR T cells, from a clonal master iPSC line, that are uniformly engineered and are not patient-restricted. In preclinical studies, the collaborators demonstrated that the universal CAR T cells displayed target-specificity and potent anti-tumor activity. Fate Therapeutics is currently advancing FT819, an off-the-shelf CAR19 T-cell product candidate derived from a clonal master iPSC line engineered with complete TCR elimination and TRAC-regulated CAR expression.
Launched Collaboration with UCSD for Development of iPSC-derived CAR NK Cell Cancer Immunotherapies. The multi-year research collaboration with the University of California, San Diego (UCSD) is being led by Dan S. Kaufman, M.D., Ph.D., Professor of Medicine in the Division of Regenerative Medicine and Director of Cell Therapy. Dr. Kaufman and Fate Therapeutics have developed a novel CAR construct specifically designed to enhance NK cell activation and persistence that is comprised of a NKG2D transmembrane domain, a 2B4 co-stimulatory domain and a CD3ζ signaling domain. Preclinical data presented at ASH (Free ASH Whitepaper) demonstrated that a single dose of these iPSC-derived CAR NK cells markedly inhibited tumor growth and significantly enhanced survival as compared to iPSC-derived CAR NK cells containing a construct commonly used in T cells.
Fourth Quarter 2017 Financial Results
Cash & Short-term Investment Position: Cash, cash equivalents and short-term investments as of December 31, 2017 were $100.9 million compared to $92.1 million as of December 31, 2016. The increase was primarily driven by $43.2 million in net cash proceeds received by the Company from its December 2017 public offering of common stock and $7.5 million in net cash proceeds received by the Company in July 2017 in connection with the amendment of its loan agreement with Silicon Valley Bank. These proceeds were offset by the Company’s use of cash to fund operating activities and to service principal and interest obligations under its loan agreement with Silicon Valley Bank.
Total Revenue: Revenue was $1.0 million for the fourth quarter of 2017 as well as for the comparable period in 2016. All revenue was derived from the Company’s research collaboration and license agreement with Juno Therapeutics.
Total Operating Expenses: Total operating expenses were $13.3 million for the fourth quarter of 2017 compared to $8.7 million for the comparable period in 2016. Operating expenses for the fourth quarter of 2017 included $0.9 million of stock compensation expense compared to $0.8 million for the comparable period in 2016.
R&D Expenses: Research and development expenses were $9.9 million for the fourth quarter of 2017 compared to $6.2 million for the comparable period in 2016. The increase in R&D expenses was attributable to an increase in third-party service provider fees for the manufacture and clinical development of ProTmune and FATE-NK100 and for FT500 IND-enabling activities, as well as an increase in equipment and materials associated with the advancement of the Company’s iPSC-derived cancer immunotherapy programs, employee compensation and benefits expense, and facilities costs associated with the expansion of the Company’s laboratory space.
G&A Expenses: General and administrative expenses were $3.4 million for the fourth quarter of 2017 compared to $2.5 million for the comparable period in 2016. The increase in G&A expenses was attributable to an increase in intellectual property-related expenses and licensing costs.
Shares Outstanding: Common shares outstanding were 52.6 million as of December 31, 2017 and 41.4 million as of December 31, 2016. Preferred shares outstanding as of December 31, 2017 and December 31, 2016 were 2.82 million, each of which is convertible into five shares of common stock. All preferred shares outstanding are from the Company’s sale and issuance of non-voting Class A convertible preferred stock to Redmile Group, LLC in November 2016.
Today’s Conference Call and Webcast
The Company will conduct a conference call today, Monday, March 5, 2018 at 5:00 p.m. ET to review financial and operating results for the quarter ended December 31, 2017. In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 7589759. The live webcast can be accessed under "Events & Presentations" in the Investors & Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.