SOUTH SAN FRANCISCO, Calif., Nov. 12, 2015 (GLOBE NEWSWIRE) -- Global Blood Therapeutics, Inc. (GBT) (NASDAQ:GBT), a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet needs, today reported business progress and financial results for the quarter ended September 30, 2015.
“With the proceeds from our IPO, we are well positioned to increase the momentum across our proprietary product portfolio aimed at revolutionizing the treatment of grievous blood-based conditions,” said Ted W. Love, M.D., chief executive officer of GBT. “Specifically in 2016, we plan to complete our ongoing GBT440 Phase 1/2 study, initiate a pivotal study in adult patients with sickle cell disease, initiate a study in pediatric patients with sickle cell disease, study the effect of GBT440 on patients with idiopathic pulmonary fibrosis, and advance our hereditary angioedema program.”
Recent Business Progress
Corporate
• Completed our initial public offering (IPO), raising $126.2 million in net proceeds.
• Appointed Philip A. Pizzo, M.D., founding director of the Stanford Distinguished Careers Institute and former Dean of Stanford University School of Medicine, to the Company’s Board of Directors.
Sickle Cell Disease (SCD)
• Received Fast Track designation for GBT440 for the treatment of SCD from the U.S. Food and Drug Administration (FDA).
• Announced new data from the ongoing Phase 1/2 GBT440-001 study of GBT440 will be presented at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition including an oral presentation of clinical data from additional cohorts of SCD patients beyond those described in the abstract, as well as a poster presentation of pharmacokinetic data.
Idiopathic Pulmonary Fibrosis (IPF)
• Announced new preclinical data supporting the development of GBT440 for the treatment of hypoxemic pulmonary disorders, including IPF, were presented at the American Heart Association (AHA) Scientific Sessions and will be presented later today at the Pulmonary Fibrosis Foundation (PFF) Summit 2015.
Hereditary Angioedema (HAE)
• Nominated a novel, orally available kallikrein inhibitor candidate for Investigational New Drug (IND)-enabling toxicology studies.
Financial Results for the Three Months and Nine Months Ended September 30, 2015
Cash and cash equivalents totaled $158.5 million at September 30, 2015 compared with $52.1 million at December 31, 2014, reflecting the $126.2 million of net proceeds from our initial public offering in August 2015.
Net loss and comprehensive loss for the three months ended September 30, 2015 was $14.8 million compared with $5.2 million for the same period in 2014. Net loss and comprehensive loss for the nine months ended September 30, 2015 was $30.8 million compared with $15.5 million for the same period in 2014. Basic and diluted net loss per share attributable to common stockholders for the three months ended September 30, 2015 was $0.90 compared with $3.53 for the same period in 2014. Basic and diluted net loss per share attributable to common stockholders for the nine months ended September 30, 2015 was $4.83 compared with $10.99 for the same period in 2014.
Research and development (R&D) expenses for the three months ended September 30, 2015 were $12.1 million compared with $4.1 million for the same period in 2014. R&D expenses for the nine months ended September 30, 2015 were $25.3 million compared with $12.3 million for the same period in 2014. The increase in R&D expenses for both comparative periods is primarily attributable to increased expenses related to the Company’s development of GBT440 for the treatment of SCD, including the ongoing Phase 1/2 clinical trial, and to the licensing of related intellectual property. General and administrative (G&A) expenses for the three months ended September 30, 2015 were $2.7 million compared with $1.1 million for the same period in 2014. G&A expenses for the nine months ended September 30, 2015 were $5.5 million compared with $2.9 million for the same period in 2014. The increase in G&A expenses for both comparative periods is primarily attributable to higher employee-related costs associated with the growth of the Company’s operations and additional professional and consulting services related to being a public company.
About Global Blood Therapeutics
Global Blood Therapeutics, Inc. (GBT) is a clinical stage biopharmaceutical company dedicated to discovering, developing and commercializing novel therapeutics to treat grievous blood-based disorders with significant unmet need. GBT is developing its initial product candidate, GBT440, as an oral, once-daily therapy for sickle cell disease (SCD) and is currently evaluating GBT440 in both healthy subjects and SCD patients in a randomized, placebo-controlled, double-blind Phase 1/2 clinical trial. In addition to GBT440 for the treatment of SCD, GBT is engaged in research and development activities targeted toward hypoxemic pulmonary disorders, including idiopathic pulmonary fibrosis (IPF) and hereditary angioedema (HAE). To learn more, please visit: www.globalbloodtx.com.
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