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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
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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. |
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Fate Therapeutics Inc's Definitive Proxy Statement (Form DEF 14A) filed after their 2019 10-K Annual Report includes:
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These costs are expensed as incurred and include: salaries and employee-related costs, including stock-based compensation; costs incurred under clinical trial agreements with investigative sites; costs to acquire, develop and manufacture preclinical study and clinical trial materials, including our product candidates; costs associated with conducting our preclinical, process development, manufacturing, clinical and regulatory activities, including fees paid to third-party professional consultants, service providers and suppliers; costs incurred under our collaboration agreements; costs for research, laboratory and manufacturing materials and supplies; costs incurred to license and maintain intellectual property; and facilities, depreciation and other expenses including allocated expenses for rent and maintenance of facilities.
We may encounter difficulties, complications, delays and other unknown factors and unforeseen expenses in the course of our research and development activities, any of which may significantly increase our capital requirements and could adversely affect our liquidity.
In connection with the SVB Loan Amendment, the Company issued to the Bank on the First Amendment Effective Date a warrant to purchase up to an aggregate of 91,463 shares of the Companys common stock, subject to adjustment, at an exercise price equal to $3.28 per share.
To be considered a contract, (i) the contract must be approved (in writing, orally, or in accordance with other customary business practices), (ii) each partys rights regarding the product or the service to be transferred can be identified, (iii) the payment terms for the product or the service to be transferred can be identified, (iv) the contract must have commercial substance (that is, the risk, timing or amount of future cash flows is expected to change as a result of the contract), and (v) it is probable that we will collect substantially all of the consideration to which we are entitled to receive in exchange for the transfer of the product or the service.
A product or a service is distinct if both (i) the customer can benefit from the product or the service either on its own or together with other resources that are readily available to the customer and (ii) our promise to transfer the product or the service to the customer is separately identifiable from other promises in the contract.
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Financial Statements, Disclosures and Schedules
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Fate Therapeutics Inc provided additional information to their SEC Filing as exhibits
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