Date: 2014-07-31
Type of information: Loan
Company: Fate Therapeutics (USA - CA)
Investors: Silicon Valley Bank (USA - CA)
Amount: up to $20 million
Funding type: long-term debt financing
Planned used: Proceeds from the transaction will be used for general working capital purposes including the expansion of the Company\'s research on therapeutic applications of human induced pluripotent stem cell (iPSC)-derived hematopoietic cells and myogenic progenitor cells. Fate Therapeutics is currently enrolling patients in its Phase 2 PUMA study, a randomized, controlled clinical trial that is designed to assess the efficacy and safety of PROHEMA® (16, 16-dimethyl prostaglandin E2, or dmPGE2, modulated cord blood) in adult patients undergoing hematopoietic stem cell transplantation (HSCT) for the treatment of hematologic malignancies. Safety reviews are planned after six and 12 subjects, respectively, have been treated with PROHEMA® in the PUMA study. The PUMA study is a 60-patient, Phase 2 clinical trial designed to assess the efficacy and safety of PROHEMA in adult patients undergoing double umbilical cord blood transplantation for the treatment of hematologic malignancies. The first data review of the phase 2 PUMA study supports continuation of enrollment. A total of 10 patients, including seven patients that received PROHEMA® plus an unmanipulated cord blood unit and three control patients that received two unmanipulated cord blood units, were included in the first interim review, which assessed safety, time to engraftment, rates of graft failure, early mortality, infection, and graft versus host disease (GvHD). The iDMC did not identify any safety signals and, based on its consideration of the data available on the first ten patients, supported continuation of the PUMA study. A second data review by the iDMC is scheduled after the first 12 patients have been treated with PROHEMA, and the Company intends to provide a clinical update following the completion of this review, which is expected in the second half of 2014. Full data on the primary efficacy endpoint are anticipated to be available in mid-2015. In addition, Fate Therapeutics has received clearance from the FDA to conduct two clinical trials of PROHEMA® in pediatric patients undergoing HSCT. Both the Phase 1b PROMPT study for the treatment of hematologic malignancies and the Phase 1b PROVIDE study for the treatment of inherited metabolic disorders are expected to commence enrollment in the second half of 2014. In April 2014, the FDA cleared the Company\'s Investigational New Drug Application (IND) amendment to evaluate PROHEMA® in pediatric patients undergoing single umbilical cord blood transplantation for the treatment of hematologic malignancies. The Phase 1b PROMPT study is designed to enroll up to 18 patients, between the ages of 1 and 18, at three leading U.S. pediatric transplant centers. The primary endpoint of the PROMPT study is safety as assessed by neutrophil engraftment. The study will also evaluate various parameters of efficacy, including additional measures of neutrophil engraftment, platelet engraftment, rates of graft failure, GvHD and serious infection, and disease-free and overall survival. In July 2014, the FDA cleared the Company\'s IND to initiate its clinical investigation of PROHEMA® in pediatric patients undergoing single umbilical cord blood transplantation for the treatment of inherited metabolic disorders (IMDs), where cellular enzyme replacement through unrelated donor cord blood transplantation has emerged as a potentially transformative therapeutic intervention. The Phase 1b PROVIDE study is designed to enroll up to 12 patients with various forms of IMDs, between the ages of 1 and 18, at up to three leading U.S. pediatric transplant centers. The study inclusion criteria allow for the enrollment of patients with different types of lysosomal and peroxisomal storage diseases such as Hurler and Hunter syndromes, Krabbe disease and various other leukodystrophies, among others. The primary endpoint of the PROVIDE study is safety as assessed by neutrophil engraftment. Fate Therapeutics has also recently initiated a new program focused on the development of an induced pluripotent stem cell (iPSC)-derived myogenic progenitor cell therapeutic (iMPC), which is the first investigational cell therapeutic to emerge from the Company\'s proprietary iPSC platform. The Company is currently optimizing the generation of iMPCs and assessing their therapeutic potential in models of degenerative muscle disease. In addition, the company continues to advance its two lead Wnt7a protein analogs for muscle regeneration through preclinical assessment and cell line development in order to inform its selection of a single lead product form for continued preclinical development.
Others: * On July 31, 2014, Fate Therapeutics, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced that it has completed a long-term debt financing of up to $20 million with Silicon Valley Bank. The Company has drawn down $10 million, at a fixed interest rate of 6.9%, under the first tranche of the debt facility. Subject to the achievement of a specified clinical milestone relating to the PUMA study, the Company has the option to access a second tranche of up to $10 million through the end of the fourth quarter of 2014. There is no warrant coverage under the first tranche of the debt facility, and 2% warrant coverage on the debt facility in the event the Company elects to access the second tranche. Assuming the full amount of the second tranche is accessed, the total cost of capital of the debt financing is approximately 11.8%, including the cost of the warrants, based on current market valuations.
Therapeutic area: Rare diseases
