RedHill Biopharma (Nasdaq: RDHL) today reported its financial results and operational highlights for the third quarter ended September 30, 2021 and acceleration of its two advanced COVID-19 pill clinical programs in light of their potential against Omicron.
• Acting independently of spike protein mutation, opaganib and RHB-107’s unique host-targeted mechanisms of action hold potential versus Omicron and other variants
• Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality in moderately severe hospitalized patients; Data packages submitted in the U.S., EU (EMA has provided expedited evaluation process timelines), UK and other territories, ahead of regulatory advice
• Top-line data from Part A of the COVID-19 Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients in the U.S. and South Africa expected in Q1/2022
• Second consecutive quarter of record net revenues with $21.6 million for Q3/2021 and an increase in gross margin and steep reduction in operating and net loss; Cash balance of $51.5 million as of September 30, 2021
• Strategic investment in RedHill by South Korea’s Kukbo Co. of up to $10 million as well as a $15.5 million underwritten public offering in November
• Another record quarter for Talicia® revenues, with new prescription volume up 15%, reflecting 117% growth vs. Q3/2020; Movantik® continues to rise with an increase in quarterly new prescriptions of 1.1%
• Continued prescription volume growth seen into the fourth quarter to date for both Talicia and Movantik, with coverage increase on both commercial and government formularies
• Management to host webcast today, at 8:30 a.m. EST
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million despite the continuously challenging pandemic environment. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. In addition, gross margin increased from 51% in the second quarter to 57% in the third quarter. The Company has successfully attracted a strategic investment from South Korea’s Kukbo and continues to demonstrate responsible financial discipline across the entire business as we strive to achieve our long-term growth aims.”
Mr. Ben-Asher added: “Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107’s host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19. This quarter saw significant focus on our opaganib Phase 2/3 COVID-19 study. The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience. Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib’s effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries.”
“In parallel, we continue to progress our Phase 2/3 study in the U.S. and South Africa with our other novel, once-daily, oral COVID-19 antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with top-line results expected in the first quarter of 2022. Our Phase 3 study of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to enroll patients in the U.S. and progress with Phase 3-stage RHB-104 for Crohn’s disease is expected to speed up thanks to a recent, much-awaited, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection research .”
“With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe RedHill is well positioned for short, medium and long-term success.”
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