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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 (Nasdaq: RDHL) presented new analyses of Movantik® at Digestive Disease Week 2021, showcasing its rapid onset and sustained efficacy in treating opioid-induced constipation (OIC). The studies pooled data from 891 patients, indicating significant symptom relief compared to 546 in placebo groups. Prof. William D. Chey highlighted the importance of early relief for OIC sufferers, which affects 40-80% of chronic opioid users. Movantik is crucial for pain management, countering one of the main side effects of opioid therapy.
RedHill Biopharma (Nasdaq: RDHL) presented a new Travelers' Diarrhea (TD) severity classification tool at Digestive Disease Week 2021, developed with the University of Texas School of Public Health. This tool aims to enhance clinical practice by providing clear separation of TD severity categories. The efficacy of Aemcolo (rifamycin) was confirmed through this tool, showing high effectiveness in moderate to severe TD cases. Aemcolo is noteworthy for its non-systemic delivery, resulting in limited side effects. This advancement could boost demand as travel resumes post-COVID.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will announce its first quarter 2021 financial results and operational highlights on May 27, 2021. A live webcast is scheduled for 8:30 a.m. EDT on the same day, allowing stakeholders to access key information, including performance metrics. RedHill focuses on gastrointestinal and infectious diseases, with products like Movantik, Talicia, and Aemcolo. Its ongoing clinical programs include RHB-204 for pulmonary NTM disease and opaganib for COVID-19 treatment.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a positive fourth review from the independent Data Safety Monitoring Board (DSMB) regarding its Phase 2/3 study of opaganib (Yeliva®) in hospitalized COVID-19 patients. The recommendation was based on safety data from 255 patients, enlarging the safety database to 380. The study is over 75% enrolled across 40 sites. Positive earlier Phase 2 data showed opaganib's effectiveness in reducing oxygen requirements without significant safety differences compared to placebo. Top-line results from the study are anticipated soon.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced a settlement with MSN Pharmaceuticals regarding patent litigation for Movantik® (naloxegol). The agreement prohibits MSN from marketing a generic version in the U.S. until October 1, 2030, unless conditions allow earlier entry. RedHill acquired Movantik rights in April 2020 and aims to protect its interests in ongoing litigation against other ANDA filers. This settlement may impact RedHill's market position as it retains exclusivity for Movantik until the settlement date.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the compassionate use treatment of opaganib for COVID-19 pneumonia patients in Switzerland. This oral sphingosine kinase-2 inhibitor has shown anti-inflammatory and antiviral properties. The company recently reported positive Phase 2 data in the U.S. and is two-thirds enrolled in a global Phase 2/3 study involving 464 patients. Opaganib, which has shown potential against SARS-CoV-2, aims to address severe COVID-19 cases as well as other oncology and inflammatory conditions.
RedHill Biopharma reported 2020 financial results with net revenues of approximately $64 million, marking a significant increase of $58 million from 2019, driven by Movantik and Talicia sales. Gross profit stood at $27.5 million. Despite strong growth, the company faced an operating loss of approximately $64 million and a net loss of about $76 million. The company's cash balance was solid at $100 million as of March 2021. RedHill is progressing in COVID-19 therapeutics with two Phase 2/3 studies for Opaganib and RHB-107, expecting to achieve commercial operational breakeven by the end of 2021.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, during a conference call at 8:30 a.m. EDT. Highlights will include the company's full-year financial performance and ongoing clinical studies, particularly for COVID-19 treatments opaganib and RHB-107, as well as a Phase 3 study for RHB-204 targeting pulmonary nontuberculous mycobacteria disease.
The webcast will be available live on the company's website.
RedHill Biopharma Ltd. (Nasdaq: RDHL) will report its fourth quarter and full year 2020 financial results on March 18, 2021, at 8:30 a.m. EDT.
The company will detail 2020 financial performance, commercial activities, and updates on ongoing clinical studies for COVID-19 treatments (opaganib and RHB-107) and a Phase 3 study of RHB-204 for pulmonary nontuberculous mycobacteria.
The webcast will be available live on the company’s website and for replay for 30 days.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announces its participation in several virtual conferences throughout March 2021. Key events include:
- Sachs Spring Life Sciences Week (March 8-11) featuring Guy Goldberg, Chief Business Officer.
- Barclays Global Healthcare Conference (March 9-11) with CEO Dror Ben-Asher on March 11.
- H.C. Wainwright Global Life Sciences Conference (March 9-10) also with Guy Goldberg.
- 33rd Annual Roth Conference (March 15-17), presentation by Guy Goldberg.
- BIO-Europe Spring Digital Conference (March 22-25) with Adi Frish.
Webcasts will be available on RedHill's website for 30 days.
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