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RedHill Biopharma Ltd. develops and commercializes specialty biopharmaceutical products focused on gastrointestinal diseases, infectious diseases and oncology. Its recurring news includes U.S. commercialization activity for Talicia, an FDA-approved all-in-one rifabutin-based therapy for H. pylori infection, as well as updates on joint commercialization through Talicia Holdings Inc.
Company updates also cover clinical and preclinical development across RedHill’s pipeline, including RHB-204 for MAP-related Crohn’s disease research, RHB-102 (Bekinda) for gastrointestinal and oncology-support indications, and opaganib in oncology models and related clinical research. Additional recurring themes include regulatory disclosures, intellectual property, capital-structure matters, governance actions and operating or financial results for the foreign issuer’s ADSs.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a public offering priced at approximately $8.0 million, consisting of 32 million units of American Depositary Shares (ADS) and associated warrants at a price of $0.25 per ADS. The offering is set to close on December 6, 2022, subject to customary conditions. The net proceeds will be used for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is the book-running manager for this offering, conducted under a shelf registration statement declared effective by the SEC.
RedHill Biopharma (Nasdaq: RDHL) announced a proposed underwritten public offering of American Depositary Shares (ADSs) and warrants to purchase ADSs. The Company plans to use net proceeds for working capital, acquisitions, and general corporate purposes. Aegis Capital Corp. is acting as the sole book-running manager. The offering is subject to market conditions and is detailed in a shelf registration statement declared effective by the SEC.
RedHill Biopharma Ltd. (RDHL) has reached a non-binding agreement to sell Movantik to HCR, eliminating its debt obligations. For Q3 2022, RedHill reported net revenues of $17.6 million, a decrease from the previous quarter, with an operating loss of $7.1 million. Prescription growth for Talicia and Movantik stood at 65% and 6.7% year-to-date, respectively. The company has ongoing discussions about opaganib for nuclear radiation injury and COVID-19, while RHB-204 received EU orphan drug status. Cash balance as of September 30, 2022, was $31.4 million.
RedHill Biopharma announced positive preclinical results for opaganib, demonstrating its potential in protecting hematological and kidney functions post total body irradiation (TBI). These findings align with U.S. government-funded data supporting opaganib as a therapeutic for nuclear radiation injuries. The development plan may leverage the Animal Rule, allowing for potential expedited approval without human efficacy studies. Discussions for governmental support are ongoing, while opaganib's further development for COVID-19 and oncology continues, highlighting its versatile pipeline potential.
RedHill Biopharma (Nasdaq: RDHL) has announced accelerated development for opaganib as a potential therapeutic against nuclear radiation injury and for cancer radiotherapy. Recent studies published in the International Journal of Molecular Sciences indicate opaganib may protect normal tissue from radiation damage and enhance survival in irradiated subjects. The drug is an oral, stable, small molecule with a shelf-life exceeding five years, making it suitable for government stockpiling. Development plans include following the Animal Rule for FDA approval and discussions for government support are already underway.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a non-binding agreement with HCR Collateral Management to transfer its rights in Movantik® (naloxegol) in exchange for cancelling all debt obligations under a Credit Agreement with HCR. RedHill will retain pre-closing liabilities related to Movantik while HCR will assume post-closing liabilities. The definitive agreements are expected to be signed soon, with closing anticipated by year-end, though certainty in completion remains uncertain. The agreement aims to ensure continuity in patient care during the transition.
RedHill Biopharma reported Q2 2022 net revenues of $18.3 million with an operating loss of $9.2 million. As of June 30, 2022, the cash balance stood at $43.2 million. Q3 2022 estimates project revenues between $16.5 million and $18.5 million, with losses between $5.5 million and $7.5 million. Prescription growth continues for Talicia® and Movantik®, with Talicia becoming the most prescribed H. pylori therapy. Ongoing negotiations regarding loan repayments and potential asset sales mark efforts to improve financial standing.
RedHill Biopharma (Nasdaq: RDHL) presented new analyses on Talicia at the Obesity Week Annual Meeting (Nov 1-4, 2022). These analyses indicate that Talicia's efficacy for eradicating H. pylori is not affected by elevated body mass index (BMI) or diabetes. Notably, Talicia achieved an 84% eradication rate compared to 58% for standard therapies. This positions Talicia as a first-line treatment for H. pylori, crucial given that the infection affects ~35% of U.S. adults. Talicia offers a favorable safety profile and demonstrates high intragastric concentrations, supporting its broad applicability in diverse patient populations.
RedHill Biopharma (Nasdaq: RDHL) presented new data analyses for its products Talicia and Movantik at the ACG Annual Meeting on October 21-26, 2022. A PBPK modeling study revealed that Talicia, a leading H. pylori treatment, provides superior intragastric antibiotic exposure with a dosing regimen of 50 mg rifabutin every 8 hours compared to standard rifabutin therapies. Movantik, the top oral PAMORA for opioid-induced constipation, demonstrated significant improvements in patient quality of life and symptom control in pooled analyses of phase 3 studies. RedHill emphasizes Talicia's efficacy in addressing antibiotic resistance issues.
RedHill Biopharma (NASDAQ: RDHL) announced that the United States Patent and Trademark Office granted a new method of use patent for opaganib, aimed at treating COVID-19 pneumonia in patients requiring supplemental oxygen (FiO2 up to 60%). This patent protects findings from a Phase 2/3 study, which revealed a 62% reduction in mortality among treated patients. RedHill continues its development of opaganib, focusing on pivotal Phase 3 trial preparations and potential funding opportunities for pandemic preparedness.