RHB-105 - A combination therapy for Helicobacter pylori infection, with successful top-line results from a first Phase III study.
RHB-104 – A combination therapy for the treatment of Crohn’s disease, with a phase III clinical study underway, and for multiple sclerosis, with a Phase IIa proof of concept study underway.
BEKINDA™ (RHB-102) – A once-daily oral pill formulation of ondansetron, with a Phase III study underway in the U.S. for acute gastroenteritis and gastritis and a European marketing application for chemotherapy and radiotherapy-induced nausea and vomiting submitted to the UK MHRA in December 2014.
RHB-106 – An encapsulated formulation for bowel preparation licensed to Salix Pharmaceuticals Ltd.
ABC294640 – A Phase II-stage orally-administered SK2 inhibitor targeting multiple inflammatory-GI diseases and related oncology indications
MESUPRON® – A Phase II uPA inhibitor, administered by oral capsule, targeting gastrointestinal and other solid tumor cancers.
RP101 – A Phase II-stage Hsp27 inhibitor, administered by oral tablet, targeting pancreatic and other gastrointestinal cancers, currently subject to an option-to-acquire by RedHill.
RIZAPORT™ (RHB-103) – An oral thin film formulation of rizatriptan, for the treatment of acute migraines, with a U.S. NDA under review by the FDA and a European marketing application submitted to the German BfArM in October 2014.
Our key research and development milestones for 2015/2016 are the following:
Final clinical study report (CSR) from the first Phase III study of RHB-105 (Q3)
Planned meeting with FDA to discuss design for pivotal study, clinical and regulatory path towards approval in the U.S. (Q3-Q4)
First patient enrolled in the Phase I/II study with ABC294640 for refractory/relapsed diffuse large B cell lymphoma
Top-line interim results from Phase IIa study for multiple sclerosis (Q4/15-Q1/16)
BEKINDA™ (formerly RHB-102):
Top-line results from Phase III study in gastroenteritis and gastritis (Q4/15-Q1/16)
Feedback from UK MHRA regarding European marketing application for oncology support (H1/2016)
Initiation of Phase IIa study for new undisclosed indication (H2/15)
RIZAPORT™ (formerly RHB-103):
Feedback from Germany’s BfArM regarding the European marketing application for migraines (Q3-Q4/2015)
A new PDUFA date expected from the FDA for previously filed NDA
While we have not finalized our full financial results for the six month period ending June 30, 2015, we had approximately $27 million of cash, cash equivalents and short-term investments as of June 30, 2015. Our current cash resources are not sufficient to complete the research and development of all of our therapeutic candidates.
Investors in the offering included Broadfin Capital LLC, Visium Asset Management, Special Situations Funds, funds managed by Sabby Management LLC, Longwood Capital Partners LLC, Menora Mivtachim and others.