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RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company centered on gastrointestinal and infectious diseases. The company is headquartered in Israel and operates internationally, with teams in the U.S., Canada, and Europe. RedHill's primary focus is the development and commercialization of late-stage clinical therapeutics and patented reformulations of existing drugs.
Core Business and Products
RedHill's flagship commercial products in the U.S. include Talicia® (omeprazole, amoxicillin, and rifabutin) for treating Helicobacter pylori (H. pylori) infection in adults, and Aemcolo® (rifamycin) for treating travelers' diarrhea. Talicia® is unique as the only FDA-approved rifabutin-containing therapy optimized for H. pylori eradication, addressing the rising concern of antibiotic resistance.
Key Development Programs
- Opaganib (ABC294640): A first-in-class oral SPHK2 inhibitor with applications in pandemic preparedness, oncology, and radioprotection. It is undergoing trials for multiple indications including Acute Radiation Syndrome (ARS) and COVID-19, and has shown promising results in pre-clinical studies against Ebola.
- RHB-107 (upamostat): An oral broad-acting, host-directed serine protease inhibitor targeting non-hospitalized symptomatic COVID-19, supported by U.S. Department of Defense funding in a 300-patient Phase 2 trial. It also shows potential for cancer and inflammatory gastrointestinal diseases.
- RHB-102: A novel therapy for chemotherapy and radiotherapy-induced nausea and vomiting, with positive Phase 3 results for acute gastroenteritis.
- RHB-104: Demonstrated efficacy in a Phase 3 study for Crohn's disease.
- RHB-204: In Phase 3 development for pulmonary nontuberculous mycobacteria (NTM) disease.
Recent Achievements
Recent publications highlight Opaganib's efficacy in enhancing long-term survival in radiation exposure models, and its selection by the U.S. NIH for the Radiation and Nuclear Countermeasures Program. Additionally, the company secured a new U.S. patent for Talicia®, extending its protection until 2034, and obtained a new Chinese patent for Opaganib in combination with immune checkpoint inhibitors, valid through 2040.
Financial Performance
For the year ending December 31, 2023, RedHill reported net revenues of $6.5 million, primarily from Talicia®, with a gross profit of $3.1 million. The company has reduced its liabilities significantly following the divestiture of Movantik, and its financial health is bolstered by ongoing U.S. government funding for key R&D programs.
Strategic Direction
RedHill is focused on leveraging its solid pipeline and partnerships to address unmet medical needs in gastrointestinal and infectious diseases. The company is strategically positioned to benefit from growing geopolitical and health threats, aiming to provide innovative solutions in challenging healthcare environments.
RedHill Biopharma (RDHL) is accelerating its COVID-19 clinical programs for opaganib and RHB-107, showcasing their efficacy against the Omicron variant. A Phase 2/3 analysis revealed a 62% mortality reduction in moderately severe patients treated with opaganib. The company reported Q3 2021 net revenues of $21.6 million, with a gross margin increase to 57%. New strategic investments and a $15.5 million public offering bolster its financial position, while Talicia and Movantik continue to see prescription growth, with Talicia's revenue up 117% compared to Q3 2020.
RedHill Biopharma (Nasdaq: RDHL) will announce its Q3 2021 financial results and operational highlights on November 30, 2021. A webcast is scheduled for 8:30 a.m. EST, where key highlights will be presented. The webcast will be available for replay for 30 days. RedHill focuses on gastrointestinal and infectious diseases, promoting drugs like Movantik, Talicia, and Aemcolo. Ongoing clinical developments include RHB-204 for NTM disease and opaganib targeting COVID-19.
On November 23, 2021, RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the closing of an underwritten public offering of approximately 4.7 million American Depositary Shares (ADSs), raising about $15.5 million in gross proceeds. Each ADS represents ten ordinary shares and was offered by RedHill, which has granted a 30-day option to purchase approximately 0.7 million additional ADSs. The funds will support commercialization activities, clinical development programs, and general corporate purposes.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has priced an underwritten public offering of 4.7 million American Depositary Shares (ADSs) for gross proceeds of $15.5 million. The offering is set to close around November 23, 2021, pending customary conditions. Each ADS represents ten ordinary shares, and the underwriter, Cantor Fitzgerald & Co., has a 30-day option to purchase up to an additional 0.7 million ADSs. Funds will support commercialization activities, clinical development, acquisitions, and general corporate purposes.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced an underwritten public offering of American Depositary Shares (ADSs), with each ADS representing ten ordinary shares. The offering includes a 30-day option for the underwriter to purchase up to 15% additional ADSs. Proceeds will fund commercialization, clinical development, acquisitions, and general corporate purposes. The offering is conducted under a shelf registration statement effective since August 8, 2019, and will not constitute an offer to sell or solicit any offer to buy securities.
RedHill Biopharma has completed the last patient enrollment in Part A of its Phase 2/3 study evaluating RHB-107 (upamostat) for non-hospitalized patients with symptomatic COVID-19. This study is being conducted in the U.S. and South Africa, with top-line results expected in Q1 2022. RHB-107 is a novel antiviral designed to be effective against emerging viral variants. In parallel, data for another candidate, opaganib, has been submitted for regulatory reviews. RedHill focuses on gastrointestinal and infectious diseases, promoting treatments like Movantik and Talicia.
RedHill Biopharma (RDHL) has completed enrollment for Part A of its Phase 2/3 study of RHB-107 (upamostat), a once-daily oral treatment for symptomatic COVID-19 patients not requiring hospitalization. The study, conducted in the U.S. and South Africa, aims to evaluate safety, tolerability, and dose selection. Top-line results are expected in Q1 2022. RHB-107 targets human cell factors and aims to be effective against emerging variants. Concurrently, data packages for another COVID-19 drug, opaganib, have been submitted for regulatory review.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that Chief Business Officer Guy Goldberg will present at two upcoming virtual conferences: the H.C. Wainwright 7th Annual Israel Conference on November 15, 2021, and the German Equity Forum from November 22-24, 2021. The presentations will cover the company's biopharmaceutical focus on gastrointestinal and infectious diseases, including ongoing clinical trials for various therapies. Webcasts of both presentations will be available for 30 days post-event. More details can be found on RedHill's investor relations page.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has entered a strategic agreement with South Korea's Kukbo Co. Ltd. for a $10 million private placement, sold in two tranches. The first tranche of $5 million has been completed, issuing 827,586 American Depositary Shares (ADSs) at $6.04 each, a 20% premium. Kukbo will have a six-month option for licensing RedHill's late-stage clinical assets in select Asian territories. This investment aims to support the advancement of RedHill's COVID-19 therapeutic, opaganib, among others.
RedHill Biopharma (NASDAQ:RDHL) recently presented new analyses of Talicia® and Movantik® at the ACG 2021 Annual Scientific Meeting. The findings support Talicia's recommendation as a first-line therapy for H. pylori eradication due to low resistance rates. Talicia's studies indicate that unique dosing achieves high eradication rates. Movantik demonstrated rapid symptom relief for extreme opioid-induced constipation in pivotal trials, with a favorable safety profile. Both products address significant healthcare challenges, with Talicia highlighting the clinical detriments of clarithromycin use.
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