- Cost reduction plan. Cash balance 1 at the end of 2017 is expected to be approximately $45 million, with no debt. A cost reduction plan is in place to gradually reduce the average quarterly cash burn rate in 2018 to approximately $8.5 million.
- Increasing resource optimization and focus on GI, including termination of RIZAPORT® license. Given the Company's increasing focus on gastrointestinal (GI) diseases and in particular its two key Phase III GI programs with near-term data points and blockbuster potential for Crohn's disease and H. pylori infection, a notice has been provided to IntelGenx Corp. (TSXV: IGX; OTCQX: IGXT) that RedHill will terminate, effective January 6, 2018, its co-development and commercialization agreement for the non-core migraine drug product candidate, RIZAPORT®, for which a recent Incomplete Response Letter has been received from the FDA.
- Top-line results from the ongoing Phase III study with RHB-104 for Crohn's disease expected mid-2018. Enrollment of all 331 subjects in the MAP US study has been completed and the last patient to reach the primary endpoint assessment (remission at week 26) is expected by May 2018.
- Top-line results from the ongoing confirmatory Phase III study with TALICIA™ (RHB-105) 2 for H. pylori infection are expected in H2/2018. To date, 136 patients out of a planned total of 444 subjects have been enrolled. TALICIA™ was previously granted QIDP fast track designation from FDA.
- A pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections is expected to be initiated in H1/2018, subject to additional input from the FDA. RHB-104 will be assessed as a first-line treatment of pulmonary NTM disease caused by mycobacterium avium complex (MAC) infection, for which QIDP fast-track designation was previously granted by the FDA.
- A single-arm Phase IIa study with YELIVA® (ABC294640) 3 for the treatment of cholangiocarcinoma (bile duct cancer) is expected to be initiated in the coming weeks at Mayo Clinic and MD Anderson. YELIVA® was granted Orphan Drug designation by the FDA for the treatment of cholangiocarcinoma.
- Managed Markets Activity. RedHill is expanding U.S. managed care access and coverage to its commercial products by securing multiple agreements with top managed care organizations.
|Company contact:Adi FrishSenior VP Business Development & Licensing RedHill Biopharma+972-54-6543-112 firstname.lastname@example.org||IR contact (U.S.): Marcy NanusSenior Vice President The Trout Group+1-646-378-2927 Mnanus@troutgroup.com|