RedHill Biopharma (RDHL) Provides R&D Update

RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the termination of RHB-204's^[1] U.S. Phase 3 study for Non-tuberculosis Mycobacteria (NTM) disease due to a very low accrual rate, and the shifting of the Company's resources to advance once-daily, oral RHB-107's^[2] late-stage development for outpatient treatment of COVID-19. This decision is intended to enable the Company to better focus its resources on key pipeline catalysts and revenue-generating product acquisition, while searching for out-licensing partners for RHB-204.

"RHB-204 is an innovative potential treatment for a difficult to treat disease with strong unmet medical need and no current stand-alone first-line therapies. We are hugely grateful to the RHB-204 development team, including the Clinical Research Organizations and trial sites, who have designed and implemented a very smart Phase 3 clinical trial, in addition to securing Qualified Infectious Disease Product and orphan drug designations in both the U.S. and EU, along with solid intellectual property coverage for RHB-204," said Gilead Raday, RedHill's Chief Operating Officer, and Head of R&D. "However, due to the very slow enrolment in NTM and given the current state of the financial markets and the negative biotech sector sentiment, we must focus our limited resources where we believe most value can be generated for our shareholders in the short to medium term and, as such, we are prioritizing RHB-107 for non-hospitalized COVID-19 patients and opaganib for Acute Radiation Syndrome."

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