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RedHill Biopharma(RDHL) - 2024 Q2 - Quarterly Report
2024-08-29 11:07
Table of Contents Exhibit 99.2 REDHILL BIOPHARMA LTD. CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION (UNAUDITED) June 30, 2024 1 Table of Contents REDHILL BIOPHARMA LTD. CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION (UNAUDITED) June 30, 2024 TABLE OF CONTENTS | UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF JUNE 30, | Page | | --- | --- | | 2024, IN U.S. DOLLARS: | | | Condensed consolidated interim statements of comprehensive income (loss) | 3 | | Condensed consolidated in ...
RedHill Biopharma Announces First Half 2024 Business Highlights
Prnewswire· 2024-08-29 11:00
A transformed RedHill: Numerous potential catalysts Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline via U.S. government and other collaborations Addressing substantial and underserved indicatio ...
RedHill's Opaganib Granted Orphan Drug Designation by the FDA for Childhood Cancer, Neuroblastoma
Prnewswire· 2024-08-26 11:00
Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths[1],[2] Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times, potential grant funding and possible tax credits The neuroblastoma market i ...
Talicia® Launched in the United Arab Emirates
Prnewswire· 2024-08-21 11:00
Core Viewpoint - RedHill Biopharma has launched Talicia, the first approved low-dose rifabutin-containing all-in-one combination treatment for H. pylori infection, in the UAE, which opens up eligibility for additional milestone payments and royalties for the company [1][2]. Group 1: Product Launch and Market Impact - Talicia is now available by prescription in the UAE for adults with H. pylori infection, which affects 41% of the UAE population and over 50% of the global adult population [1][3]. - The launch of Talicia triggers RedHill's eligibility for potential milestone payments, minimum sales payments, and tiered royalties up to mid-teens on net sales [1][2]. - Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori treatment [1]. Group 2: Medical Need and Efficacy - H. pylori is a significant public health concern, being a major risk factor for gastric cancer, with traditional clarithromycin-based therapies showing declining effectiveness [2][4]. - A 2021 study indicated only 68.5% eradication with clarithromycin-based therapy, which dropped to 32% in patients with resistant H. pylori [2][3]. - Talicia demonstrated an 84% eradication rate in a pivotal Phase 3 study, significantly higher than the 58% rate in the active comparator arm [5][6]. Group 3: Product Composition and Resistance - Talicia is a fixed-dose combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), specifically designed to combat high resistance rates of H. pylori to other antibiotics [4][5]. - Minimal to zero resistance to rifabutin was detected in the pivotal Phase 3 study, highlighting its effectiveness [5][6]. Group 4: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, promoting Talicia for H. pylori and Aemcolo for travelers' diarrhea [9]. - The company is engaged in various late-stage development programs targeting multiple indications, including COVID-19 and oncology [9].
RedHill Announces Positive Obesity and Diabetes Results with Opaganib
Prnewswire· 2024-08-19 11:00
The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034[1] – largely driven by Glucagon-like peptide-1 (GLP-1) inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity® and Mounjaro® and sodium glucose cotransporter-2 (SGLT2) inhibitors such as Boehringer Ingelheim's Jardiance® -- Positive results from multiple in vivo studies show the impact of sphingosine kinase-2 (SPHK2) inhibition in various models of metabolic disease, supporting the potential ...
RedHill Biopharma Announces Plan to Implement ADS Ratio Change
Prnewswire· 2024-08-16 11:00
TEL AVIV, Israel and RALEIGH, N.C., Aug. 16, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it plans to implement a ratio change of the Company's American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing four hundred (400) ordinary shares to a new ratio of one (1) ADS representing ten thousand (10,000) ordinary shares. The anticipated first date o ...
Why Is RedHill Biopharma (RDHL) Stock Up 75% Today?
Investor Place· 2024-08-01 18:11
One of today's biggest movers in the biotech sector is RedHill Biopharma (NASDAQ:RDHL), a little-known specialty player in the space focusing on gastrointestinal and infectious diseases. Today, RDHL stock is up more than 75% in early afternoon trading on an announcement from the company that it has seen positive results for a key Phase 3 study. This study focused on patients suffering from Chron's disease, assessing how its RHB-104 treatment would compare to the current standards of care in the industry. Im ...
Newly Published Positive Phase 3 Data Demonstrates 64% Increased Efficacy with RedHill's RHB-104 in Crohn's Disease
Prnewswire· 2024-08-01 11:00
Newly published in the peer-reviewed journal Antibiotics, the 331-patient Phase 3 Crohn's disease study data shows the primary endpoint of clinical remission at week 26 was achieved, with high statistical significance, in 36.7% (61/166) of orally administered RHB-104 plus standard of care (SoC) patients, compared to 22.4% (37/165) of placebo plus SoC patients (p=0.0048); Safety profile similar to placebo. Study conducted across more than 100 sites The advanced stage clinical data demonstrating the potential ...
RedHill Biopharma Strengthens Cash Balance, Settles Obligations and Removes Talicia® Lien
Prnewswire· 2024-07-22 11:00
About RedHill Biopharma Forward Looking Statements [1] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com. TEL-AVIV, Israel and RALEIGH, NC, July 22, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the signing of a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma ...
RedHill Biopharma Terminates License Agreement for Aemcolo®
Prnewswire· 2024-07-09 12:00
Core Viewpoint - RedHill Biopharma Ltd. has mutually decided with Cosmo Technologies Ltd. to terminate their exclusive U.S. license agreement for Aemcolo, a treatment for traveler's diarrhea, effective October 8, 2024 [3][6][11]. Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, promoting drugs such as Talicia® for H. pylori infection and Aemcolo® for traveler's diarrhea [11]. - The company is engaged in late-stage development programs including opaganib for multiple indications and RHB-107 for symptomatic COVID-19, with external funding covering the RHB-107 arm of a Phase 2 trial [11]. License Agreement Details - The License Agreement for Aemcolo was initially dated October 17, 2019, and will officially terminate on October 8, 2024, after which all rights will revert to Cosmo [3][6]. - RedHill will cease any commercialization efforts for Aemcolo immediately upon termination of the License Agreement [6]. Future Development Plans - RedHill's key clinical programs include: - Opaganib, a first-in-class oral SPHK2 selective inhibitor, targeting indications such as Acute Radiation Syndrome and COVID-19 [11]. - RHB-107, an oral serine protease inhibitor in late-stage development for non-hospitalized symptomatic COVID-19 [11]. - Other programs targeting gastrointestinal diseases and oncology [11].