FATE : Fate Therapeutics Stock Analysis and Research Report

2017-11-10 - by Asif, Contributing Analyst

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Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. Fate Therapeutics is developing first-in-class cell therapy product candidates based on a simple notion: the company believe that better cell therapies start with better cells.

To create better cell therapies, the company use a therapeutic approach that the company generally refer to as cell programming. For certain of its cell therapy product candidates, the company use pharmacologic modulators, such as small molecules, to enhance the biological properties and therapeutic function of cells ex vivo before its product candidates are administered to a patient. In other cases, the company use human induced pluripotent stem cells “iPSCs”, generate a master iPSC line having preferred biological properties and direct the fate of the iPSC line to create a clonal population of its cell therapy product candidate. The company believe the use of master pluripotent cell lines may enable the creation of cell therapy product candidates that are well-defined and uniform in composition; that can be reproducibly manufactured at significant scale; and that can be effectively used to treat a large number of patients in an off-the-shelf manner. Utilizing these therapeutic approaches, the company program cells of the immune system, including Natural Killer “NK” cells, T cells and CD34+ cells, and are advancing a pipeline of programmed cellular immunotherapies in the therapeutic areas of immuno-oncology and immuno-regulation.

Fate Therapeutics has entered into a research collaboration and license agreement with the Regents of the University of Minnesota to develop an off-the-shelf, targeted NK cell cancer immunotherapy derived from an engineered iPSC line. Additionally, Fate Therapeutics has entered into a research collaboration and license agreement with Memorial Sloan Kettering Cancer Center to develop off-the-shelf T-cell immunotherapies derived from engineered iPSC lines.

Fate Therapeutics has also entered into a research collaboration and license agreement with Juno Therapeutics, Inc. to identify and apply small molecule modulators to enhance the therapeutic function of genetically-engineered CAR (chimeric antigen receptor) T-cell and TCR (T-cell receptor) immunotherapies.

The company were incorporated in Delaware in 2007, and are headquartered in San Diego, CA. Since its inception in 2007, Fate Therapeutics has devoted substantially all of its resources to its cell programming approach and the research and development of its product candidates, the creation, licensing and protection of related intellectual property, and the provision of general and administrative support for these activities. To date, Fate Therapeutics has funded its operations primarily through the public and private sale of common stock, the private placement of preferred stock and convertible notes, commercial bank debt and revenues from collaboration activities and grants.

Fate Therapeutics has never been profitable and have incurred net losses in each year since inception. Substantially all of its net losses resulted from costs incurred in connection with its research and development programs and from general and administrative costs associated with its operations. The company expect to continue to incur operating losses for at least the foreseeable future. The company's net losses may fluctuate significantly from quarter to quarter and year to year. The company expect its expenses will increase substantially in connection with its ongoing and planned activities as we:

  • conduct its Phase 1/2 clinical trial of ProTmune, and initiate and conduct any additional clinical trials of ProTmune;
  • conduct its clinical trials of FATE-NK100, including under investigator-initiated clinical trial agreements with the University of Minnesota and under its own Investigational New Drug application;
  • conduct preclinical research, process development and development activities to support the clinical translation of its first-in-class product candidates derived from induced pluripotent stem cell lines;
  • continue its research and development activities, including under its research collaboration agreements;
  • continue process development for, and manufacture of, preclinical study and clinical trial materials, including its product candidates;
  • maintain, prosecute, protect, expand and enforce its intellectual property portfolio;
  • engage with regulatory authorities for the development of, and seek regulatory approvals for, its product candidates;
  • hire additional clinical, regulatory, quality control and technical personnel to advance its product candidates;
  • hire additional scientific personnel to advance its research and development efforts; and
  • hire general and administrative personnel to continue operating as a public company and support its operations.

The company do not expect to generate any revenues from sales of any therapeutic products unless and until the company successfully complete development and obtain regulatory approval for one or more of its product candidates, which the company expect will take a number of years. If the company obtain regulatory approval for any of its product candidates, the company expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. Accordingly, the company will seek to fund its operations through public or private equity or debt financings or other sources. However, the company may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. The company's failure to raise capital or enter into such other arrangements when needed would have a negative effect on its financial condition and ability to develop its product candidates.

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