Business description of FATE-THERAPEUTICS-INC from last 10-k form

FORWARD-LOOKING STATEMENTS

        This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). Such forward-looking statements, which represent our intent, belief or current expectations, involve risks and uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "expect," "anticipate," "estimate," "intend," "plan," "predict," "potential," "believe," "should" and similar expressions. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:

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    our projected timing of initiation, rate of enrollment and duration of our clinical trials for our product candidates;

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    our plans to resume enrollment in our Phase 2 clinical trial, or to commence other clinical trials, of ProHema;

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    our ability and our timing to incorporate the use of, and our ability to continue to use once incorporated, our nutrient-rich media, or NRM, formulation in our Phase 2 clinical trial of ProHema in adults undergoing double umbilical cord blood transplant, or UCBT, and in any subsequent clinical trials of ProHema;

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    any review comments, or additional requirements, by FDA based upon our submission of ProHema manufacturing and product data generated using our NRM formulation with materials intended for clinical use;

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    our expectations of safety and improved potency and efficacy of ProHema, arising from the use of our NRM formulation in the product's manufacture, in our Phase 2 clinical trial of ProHema in adults undergoing double UCBT, and in any subsequent clinical trials of ProHema;

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    our plans to complete the preclinical development of, and to submit an Investigational New Drug, or IND, application for, and to conduct and generate data from the first clinical trials of, our Wnt7a analogs, and the timing of these activities;

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    our ability to satisfy regulatory requirements with respect to ProHema and our other product candidates, many of which are new and still evolving;

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    the ability of cell processing facilities operated by transplant centers to consistently manufacture ProHema under the proper conditions;

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    the performance of third-party service providers and independent contractors, upon whom we rely to conduct our preclinical studies and clinical trials and to manufacture our product candidates and certain components of our product candidates;

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    our ability to discover, develop and commercialize innovative therapeutics using our proprietary platforms;

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    our ability to develop sales and marketing capabilities or to enter into strategic partnerships to develop and commercialize ProHema or any of our other product candidates;

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    the timing and success of the commercialization of ProHema or any of our other product candidates;

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    the potential price and degree of market acceptance of stem cell-based therapeutics in general and our product candidates in particular;
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    the size and growth of the potential markets for our product candidates and our ability to serve those markets;

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    regulatory developments and approval pathways in the United States and foreign countries for stem cell-based therapeutics in general and our product candidates in particular;

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    our ability to obtain, maintain, defend and enforce intellectual property rights protecting our product candidates, and our ability to develop and commercialize our product candidates without infringing the proprietary rights of third parties;

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    the accuracy of our estimates regarding revenues, expenses and capital requirements; and

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    the additional risks and other factors described under the caption "Risk Factors" under Item 1A of this Annual Report on Form 10-K.

        In this Annual Report on Form 10-K, unless the context requires otherwise, "Fate Therapeutics," "Company," "we," "our," and "us" means Fate Therapeutics, Inc. and its subsidiaries.


 PART I

ITEM 1.    Business

General Development of Our Business

        Fate Therapeutics, Inc., incorporated under the laws of the State of Delaware in April 2007, is a clinical-stage biopharmaceutical company engaged in the discovery and development of pharmacologic modulators of adult stem cells. Based on our understanding of key biological mechanisms that guide the fate of adult stem cells, we have built two platforms that optimize the activity and enhance the therapeutic potential of adult stem cells: our hematopoietic stem cell, or HSC, modulation platform and our muscle satellite stem cell, or Satellite Cell, modulation platform.

        We believe that the product candidates generated by our stem cell modulation platforms have significant potential as life-changing or curative therapeutics across a broad range of orphan indications. We are pursuing the development of pharmacologically optimized HSC therapeutics for the treatment of hematologic malignancies and certain lysosomal storage disorders, or LSDs. In addition, we are pursuing the pharmacologic activation of muscle satellite stem cells using Wnt7a-based protein analogs, and we are initially focused on developing Wnt7a-based protein analogs for the treatment of muscular dystrophies. The following table summarizes key information about our platforms and our product candidates:

Product Candidate
(1)
We have been granted orphan designation in the United States for human allogeneic HSCs ex vivo modulated with 16, 16-dimethyl prostaglandin E2, which we refer to as FT1050, for the enhancement of stem cell engraftment and in the European Union for ProHema for the treatment of acute myelogenous leukemia through the ex vivo modulation of allogeneic umbilical cord blood cells.

        We plan to continue the validation of our two platforms by demonstrating the clinical benefit of our initial product candidates over the next two years in three orphan disease settings: hematologic malignancies, LSDs and muscular dystrophy. Our lead product candidate from our HSC modulation platform, ProHema, is presently undergoing Phase 2 clinical development for the treatment of adult patients with hematologic malignancies. We expect to generate full data on the primary and major secondary endpoints from this trial in mid-2015. We are also pursuing the development of ProHema for the treatment of pediatric patients with hematologic malignancies and certain demyelinating LSDs, and we plan to initiate our first clinical trials of ProHema in these clinical settings in 2014 with the goal of generating data from these trials in 2015. Our most advanced product candidates from our Satellite Cell modulation platform are Wnt7a protein analogs, which are presently undergoing IND-enabling development. We plan to initiate a Phase 1 clinical trial of an injectable analog of a Wnt7a-based recombinant human protein in 2015 with the goal of generating data from this clinical trial in 2015.