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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 partnered with Cosmo Pharmaceuticals to expand manufacturing capacity for opaganib (Yeliva®), targeting increased demand following potential global emergency use authorizations. Opaganib is a novel SK2 inhibitor aimed at treating COVID-19 pneumonia and has demonstrated efficacy against viral strains. An interim analysis of a Phase 2/3 study is imminent, with promising preliminary safety and efficacy data reported from an earlier Phase 2 trial. The drug holds Orphan Drug designation from the FDA for cholangiocarcinoma.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced the closing of a $25 million underwritten offering of 3,188,776 American Depositary Shares (ADSs) at $7.84 each. The offering was managed by H.C. Wainwright & Co., with a 30-day option for the underwriter to purchase an additional 478,316 ADSs. Proceeds will be utilized for clinical development, commercialization activities, acquisitions, and general corporate purposes. The securities were registered under a prior shelf registration statement with the SEC.
RedHill Biopharma (Nasdaq: RDHL) has expanded its previously announced offering, purchasing 3,188,776 American Depositary Shares (ADSs) at $7.84 each, totaling approximately $25 million in gross proceeds. The closing is anticipated by January 14, 2021, subject to standard conditions. Additionally, the underwriter holds a 30-day option for purchasing up to 478,316 more ADSs. Proceeds will be allocated to clinical development, commercialization, acquisitions, and general corporate purposes, enhancing the company's financial position in the biopharmaceutical sector.
RedHill Biopharma (Nasdaq: RDHL) announced a firm commitment underwriting agreement with H.C. Wainwright & Co. for 1,275,510 American Depositary Shares (ADSs) at $7.84 per ADS, expecting gross proceeds of approximately $10 million. The offering is projected to close around January 14, 2021, subject to customary conditions. Additionally, the underwriter holds a 30-day option for 191,326 additional ADSs. Proceeds will be allocated to clinical development, commercialization activities, and general corporate purposes.
RedHill Biopharma Ltd. (Nasdaq: RDHL) announced that its partner, Cosmo Pharmaceuticals, successfully completed a Phase 2 study of Rifamycin SV-MMX 600mg for diarrhea-predominant irritable bowel syndrome (IBS-D). The trial showed statistically significant results in reducing pain and diarrhea, as well as improving IBS-related symptoms. RedHill holds specific rights regarding the product in the U.S. under a 2019 licensing agreement. The outcome suggests that Rifamycin SV-MMX may be a promising treatment option for IBS-D if it receives regulatory approval.
RedHill Biopharma (Nasdaq: RDHL) announced that RHB-204 received Fast Track designation from the FDA for treating pulmonary nontuberculous mycobacteria (NTM) disease, caused by Mycobacterium avium Complex. This designation aims to expedite the development and review of essential therapies for serious diseases without approved treatments. RHB-204 has also been granted Orphan Drug designation, potentially extending market exclusivity to 12 years. A Phase 3 study is underway, evaluating RHB-204 across 40 U.S. sites.
RedHill Biopharma (Nasdaq: RDHL) reported positive top-line data from its U.S. Phase 2 study of opaganib, an oral treatment for COVID-19 pneumonia. The study involved 40 patients requiring oxygen support and showed no significant safety differences compared to placebo. Key findings included a higher percentage of patients no longer needing oxygen support (52.6% vs. 22.2%), as well as improved discharge rates and oxygen requirement reductions. Further analyses are forthcoming, and a global Phase 2/3 study is ongoing, with expected results in Q1 2021.
RedHill Biopharma (Nasdaq: RDHL) announced a unanimous recommendation from the Data Safety Monitoring Board (DSMB) to continue its global Phase 2/3 study of opaganib in severe COVID-19 pneumonia after safety data analysis from 155 patients. Enrollment is over 60% complete, with top-line data expected in Q1 2021. The Phase 2 U.S. study has completed 40 subject enrollments, focusing on safety. Opaganib is a novel oral SK2 selective inhibitor that targets the viral replication process and has shown potential in treating multiple conditions, including cholangiocarcinoma and prostate cancer.
RedHill Biopharma (Nasdaq: RDHL) announced preliminary results from a preclinical study indicating that opaganib, a novel SK2 selective inhibitor, significantly reduces thrombosis in an ARDS model. Administered at 250 mg/kg, opaganib demonstrated a reduction in blood clot length and weight, potentially benefiting COVID-19 patients at risk of ARDS-induced thrombosis. The company anticipates topline data from a U.S. Phase 2 study soon, following the completion of patient dosing on November 26, 2020. A larger global Phase 2/3 study is 60% enrolled, focusing on efficacy.
RedHill Biopharma Ltd. (Nasdaq: RDHL) has been added to the NASDAQ Biotechnology Index, effective December 21, 2020. This index selection reflects the company's commitment to meeting specific eligibility criteria, including market capitalization and trading volume. The NASDAQ Biotechnology Index is significant as it underpins investment portfolios and evaluates biotech companies' performance. RedHill focuses on gastrointestinal and infectious diseases, with key products like Movantik® and Talicia®. More details can be found on their website.
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