Accessibility StatementSkip Navigation The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses ( ...

Core Points - The New York Supreme Court awarded RedHill approximately $1.82 million in legal costs and expenses, in addition to a prior summary judgment of approximately $8.25 million in favor of RedHill against Kukbo Co. Ltd [1][2] - Both awards include a 9% ongoing statutory interest accrual [2] - RedHill successfully obtained an attachment grant from Korea's Incheon District Court against Kukbo, allowing for the seizure of Kukbo's assets [2] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [4] - The company promotes the FDA-approved gastrointestinal drug Talicia® for treating Helicobacter pylori infection in adults [4] - Key clinical late-stage development programs include: - Opaganib (ABC294640), targeting multiple indications including COVID-19 and prostate cancer [4] - RHB-204, aimed at Crohn's disease and pulmonary nontuberculous mycobacteria [4] - RHB-107 (upamostat), in late-stage development for non-hospitalized symptomatic COVID-19 and other diseases [4] - RHB-102, with potential applications for chemotherapy-induced nausea and vomiting [4]

Core Insights - RedHill Biopharma has received its first sales milestone payment and royalties totaling approximately $1.1 million for Talicia following its first ex-U.S. commercial launch in 2024 [1] - Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), which affects over 50% of the global adult population and is a significant risk factor for gastric cancer and peptic ulcer disease [1][2] - Talicia is recognized as the leading first-line therapy prescribed by U.S. gastroenterologists for H. pylori infection and has been granted a Qualified Infectious Disease Product (QIDP) designation, providing eight years of U.S. market exclusivity [1][7] Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [16] - The company promotes Talicia for the treatment of H. pylori infection in adults and is engaged in discussions with potential partners to secure additional non-dilutive ex-U.S. licensing revenue streams [2][16] Product Details - Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) [6] - In clinical studies, Talicia demonstrated up to 90% eradication of H. pylori infection in adherent patients, significantly outperforming traditional clarithromycin-based therapies [3][6] - Talicia is patent protected until 2042, with additional patents pending in various territories worldwide [7][8] Market Context - H. pylori infection is classified by the WHO as a Group 1 carcinogen, with over 27,000 Americans diagnosed with gastric cancer annually [4][12] - Current clarithromycin-based therapies show declining effectiveness, with eradication rates dropping to 32% in patients with resistant H. pylori strains [3][4] - The increasing resistance of H. pylori to antibiotics, particularly clarithromycin, highlights the urgent need for effective first-line therapies like Talicia [5][16]

Core Viewpoint - RedHill Biopharma received positive FDA feedback for its RHB-204 Crohn's disease development program, indicating a promising pathway to approval for a potentially groundbreaking therapy targeting the root cause of the disease [1][2]. Company Overview - RedHill Biopharma Ltd. is a specialty biopharmaceutical company focused on developing and commercializing drugs for gastrointestinal diseases, infectious diseases, and oncology [15]. - The company is actively pursuing non-dilutive funding options for its RHB-204 program, including grant applications and discussions with external funding sources [1][10]. Product Development - RHB-204 is a next-generation formulation of RHB-104, designed to enhance tolerability, safety, and patient adherence, with a 40% reduction in pill burden [5][13]. - The drug is patent protected until 2041 and is expected to receive pediatric orphan drug designation, along with potential breakthrough therapy and fast track designations [1][10][14]. - The Phase 2 study of RHB-204 will be the first clinical trial targeting a specific population of Mycobacterium avium subspecies paratuberculosis infected Crohn's disease patients, aiming to address both the cause and symptoms of the disease [2][6]. Clinical Study Insights - The primary endpoints of the Phase 2 study will focus on mucosal remission, which is considered a new gold standard in efficacy evaluation for Crohn's disease, correlated with MAP status and clinical remission [4]. - The study design allows for a smaller sample size, which could lead to lower costs and faster completion times [4][6]. Market Potential - The Crohn's disease market is projected to grow significantly, with sales expected to increase from $13.6 billion in 2024 to over $19 billion by 2033, representing a compound annual growth rate (CAGR) of 3.87% [9]. - Up to 40% of Crohn's disease patients do not respond to existing anti-TNF treatments, highlighting the need for new, effective therapies like RHB-204 [8]. Competitive Landscape - Current FDA-approved therapies for Crohn's disease include Abbvie's Humira, Janssen's Remicade, and others, which are often expensive and have known safety issues [11][8]. - RHB-204 aims to provide a safe and effective oral therapy alternative, potentially transforming treatment options for Crohn's disease patients [7][8].

Core Points - RedHill Biopharma Ltd. has secured a court ruling in its favor against Kukbo Co. Ltd., with a summary judgment amounting to approximately $8.25 million plus legal fees and costs [1][3] - The New York Supreme Court dismissed all counterclaims made by Kukbo, reinforcing RedHill's position in the legal dispute [1] - An attachment petition in South Korea has been granted, preventing Kukbo from disposing of its assets prior to enforcement of the judgment [1][2] Financial Implications - The summary judgment includes approximately $1.75 million in accrued interest at a rate of 9%, due to Kukbo's failure to adhere to the terms of subscription and licensing agreements [3] - Legal fees and costs are also recoverable as per the court's ruling, indicating potential additional financial recovery for RedHill [3] Legal Context - Kukbo has filed a notice of appeal against the judgment, with a six-month window to perfect its appeal, which may be extended [4] - The outcome of the appeal process could impact the enforcement of the judgment and the collection of the awarded amount [4] Company Overview - RedHill Biopharma is focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [5] - The company promotes the FDA-approved drug Talicia® for treating H. pylori infection and has several late-stage clinical development programs targeting various diseases [5]

Core Viewpoint - RedHill Biopharma Ltd. has received a Notification Letter from Nasdaq indicating non-compliance with listing requirements due to a stockholders' deficit of $4,683,000, but this does not immediately affect its listing or operations [1][2][3]. Group 1: Compliance Status - The company is required to maintain a minimum of $2,500,000 in stockholders' equity for continued listing on the Nasdaq Capital Market [2]. - As of the fiscal year ended December 31, 2024, the company reported a stockholders' deficit of $4,683,000, leading to non-compliance with Nasdaq Listing Rule 5550(b)(1) [2]. - The company has 45 days to submit a plan to regain compliance, with a deadline of May 30, 2025, and if accepted, Nasdaq may grant an extension of up to 180 days [3][4]. Group 2: Company Operations and Plans - The company is exploring various options to regain compliance and intends to submit its compliance plan as soon as possible [4]. - There is no assurance that the company's compliance plan will be accepted or that it will successfully regain compliance with the Nasdaq listing requirements [4]. Group 3: Company Overview - RedHill Biopharma is a specialty biopharmaceutical company focused on the development and commercialization of drugs for gastrointestinal diseases, infectious diseases, and oncology [5]. - The company promotes the FDA-approved drug Talicia for treating H. pylori infection and has several late-stage clinical development programs, including opaganib, RHB-204, RHB-104, RHB-107, and RHB-102 [5].

The Notification Letter has no immediate effect on the Company's listing on the Nasdaq Capital Market at this time, nor are the Company's business operations affected by receipt of the Notification LetterTEL AVIV, Israel and RALEIGH, N.C., April 17, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the Company received a written notification (the "Notification Letter") from the Listing Qualifications Departmen ...