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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) has announced a significant financial restructuring through a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, , and HCR Redhill SPV, This agreement has resulted in:
1. A $9.9 million cash influx
2. Full control over an additional $0.74 million in a restricted account
3. An increase of $12.2 million in liabilities
4. A net balance sheet reduction of $2.3 million
5. Removal of the existing lien against Talicia®
6. Restoration of control over cash collections to RedHill
This restructuring aims to strengthen RedHill's cash position, enhance cash management, and allow the company to focus on R&D and commercial activities for future growth.
RedHill Biopharma (Nasdaq: RDHL) and Cosmo Technologies have mutually agreed to terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea. The initial agreement, established on October 17, 2019, will end on October 8, 2024. RedHill will cease all commercialization efforts for Aemcolo upon termination, with all rights reverting to Cosmo. Rick Scruggs, Chief Commercial Officer of RedHill, expressed gratitude for the collaboration with Cosmo.
RedHill Biopharma announced a new Chinese patent that covers the use of opaganib in combination with immune checkpoint inhibitors (ICIs) to induce an anti-cancer immune response, valid until 2040. This patent, issued by the Chinese National Intellectual Property Administration, reinforces opaganib's potential across various approved and in-development ICIs for a growing number of indications. ICIs, pivotal in cancer treatment, are projected to contribute to a global market exceeding $100 billion by 2028. Opaganib, an oral small molecule with proven safety and efficacy, is also in development for COVID-19, Ebola, and other conditions.
RedHill Biopharma announced a new Chinese patent for opaganib as a therapy for inhibition of single-stranded RNA virus replication, specifically against Ebola Virus, valid through 2035. The patent strengthens opaganib's global intellectual property portfolio, with studies indicating its effectiveness in treating Ebola and potential synergistic effects in combination with remdesivir. Opaganib, a twice-daily oral small molecule, is being developed for multiple indications, including COVID-19, acute respiratory distress syndrome, oncology, and U.S. government-sponsored countermeasures programs. It has shown safety, efficacy, resistance to viral mutations, and ease of administration, positioning it well for various scenarios including viral pandemics.
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