RedHill Biopharma Reports 2016 Third Quarter Financial Results

  • RedHill maintains a debt-free balance sheet with $40.5 million in cash at the end of the third quarter, allowing the Company to continue to diligently execute its three ongoing Phase III gastrointestinal disease programs and other clinical-stage programs
  • Recent key milestones include:
    • Enhancement of the RHB-104 Phase III Crohn's disease program, including the introduction of an option for early stop for success for overwhelming efficacy, expected in Q2/2017
    • Initiation of Phase II studies with YELIVA for multiple myeloma and hepatocellular carcinoma
    • Signing of an exclusive license agreement with Grupo JUSTE for the commercialization in Spain of RIZAPORT ® oral thin-film migraine drug and filing of a national Marketing Authorization Application in Spain by Grupo JUSTE
    • Signing of a binding term sheet with Pharmatronic Co. for the commercialization of RIZAPORT ® in South Korea 
  • Potential milestones expected in the coming year include:
    • Q4/2016 - Safety-focused independent data and safety monitoring board (DSMB) meeting for the MAP US Phase III study with RHB-104 for Crohn's disease
    • Q4/2016 - Top-line final results from the ongoing Phase IIa CEASE-MS study with RHB-104 for multiple sclerosis
    • Q2/2017 - Independent DSMB evaluation of the MAP US Phase III study with RHB-104 for Crohn's disease, including option for early stop for success for overwhelming efficacy
    • H1/2017 - Initiation of a confirmatory Phase III study with RHB-105 for the treatment of H. pylori infection
    • Mid-2017 - Top-line results from the ongoing Phase III study with BEKINDA ® for gastroenteritis and gastritis in the U.S. (the GUARD study)
    • Mid-2017 - Top-line results from the ongoing Phase II study with BEKINDA ® for diarrhea-predominant irritable bowel syndrome (IBS-D) in the U.S.
    • H1/ 2017 - Re-submission of the RIZAPORT ® U.S. NDA to the FDA                          

TEL-AVIV, Israel, Nov. 14, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today reported its financial results for the quarter ended September 30, 2016.

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