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Fate Therapeutics Inc (FATE) SEC Filing 10-K Annual report for the fiscal year ending Monday, December 31, 2018

Fate Therapeutics Inc

CIK: 1434316 Ticker: FATE

Exhibit 99.1

Fate Therapeutics Reports Fourth Quarter and Full Year 2018 Financial Results and Highlights Operational Progress

First Patient Treated with FT500 Off-the-Shelf NK Cell Cancer Immunotherapy in Landmark Clinical Trial

Marks First-ever Human Administration of iPSC-derived Cell Therapy in the United States

$201 Million in Cash & Short-term Investments as of December 31, 2018

 

San Diego, CA March 5, 2019 – Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2018.

 

“We achieved an unprecedented milestone in treating the first patient with FT500, which is the first-ever administration of an iPSC-derived cell therapy to a patient in the U.S. In 2018, we made great strides toward our vision of using master iPSC lines to produce universal, off-the-shelf cell-based cancer immunotherapies that are available ‘on demand’ and deliver transformational change in patient outcomes,” said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. “The year was also highlighted by strong clinical execution and encouraging patient data for our ongoing allogeneic cell therapy programs, ProTmune and FATE-NK100. Additionally, our industry-leading iPSC product platform delivered multiple highly differentiated, off-the-shelf NK cell and T-cell product candidates, which we expect to move into the clinic in 2019.”

 

Clinical Programs

 

First-ever iPSC-derived Cell Product FT500 Administered to a Patient in the U.S. In November 2018, the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for FT500, a universal, off-the-shelf natural killer (NK) cell product candidate derived from a clonal master induced pluripotent stem cell (iPSC) line. The landmark clinical trial is intended to assess the safety and efficacy of multiple doses of FT500 over multiple dosing cycles for the treatment of advanced solid tumors as a monotherapy and as a combination with nivolumab, pembrolizumab or atezolizumab in patients that failed to respond to, or progressed on, checkpoint inhibitor therapy. The first subject was treated with FT500 in February 2019.

 

Anti-Tumor Activity of FATE-NK100 Observed Across Three Phase 1 Studies. In November 2018, the Company reported initial dose-escalation clinical data of FATE-NK100 from fifteen subjects across three Phase 1 clinical trials for the treatment of relapsed / refractory acute myelogenous leukemia, recurrent ovarian cancer and advanced solid tumors. As of an October 22, 2018 data cutoff, no FATE-NK100-related dose limiting toxicities were reported, and anti-tumor activity was

 


The following information was filed by Fate Therapeutics Inc (FATE) on Tuesday, March 5, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Fate Therapeutics Inc's 10-K Annual Report:

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California Institute For Regenerative Medicine Award
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Organization And Summary Of Significant Accounting Policies
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Ticker: FATE
CIK: 1434316
Form Type: 10-K Annual Report
Accession Number: 0001564590-19-006258
Submitted to the SEC: Tue Mar 05 2019 11:04:48 AM EST
Accepted by the SEC: Tue Mar 05 2019
Period: Monday, December 31, 2018
Industry: Biological Products No Disgnostic Substances

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