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 ...

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 ...

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 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 ...

Core Viewpoint - RedHill Biopharma has signed a Global Termination Agreement that enhances its cash position and eliminates previous encumbrances, allowing the company to focus on its R&D and commercial activities, marking a new chapter for the company [4][8]. Financial Impact - The Agreement resulted in RedHill receiving approximately $9.9 million in cash and gaining control over an additional $0.74 million, leading to a total increase of approximately $12.2 million in liabilities, but a net balance sheet reduction of about $2.3 million [4]. Business Operations - The Agreement ends all existing credit ties with the involved parties, removes the lien against Talicia®, and restores control over cash collections back to RedHill [4]. - RedHill is primarily focused on gastrointestinal and infectious diseases, promoting drugs such as Talicia® for H. pylori infection and Aemcolo® for travelers' diarrhea [8]. Development Programs - Key clinical late-stage development programs include: - Opaganib, targeting multiple indications with a collaboration for Acute Radiation Syndrome and a Phase 2/3 program for hospitalized COVID-19 [8]. - RHB-107, in late-stage development for non-hospitalized symptomatic COVID-19, with external funding covering its Phase 2 trial [8]. - RHB-102, RHB-104, and RHB-204, which are in various stages of development for gastrointestinal diseases and Crohn's disease [8].

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].

New Chinese patent notice of allowance issued covering opaganib in combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response[1]. Provides protection for opaganib's potential use in combination with a range of approved and in-development (ICIs) across a growing range of indications[2] through 2040 ICIs have become a cornerstone in cancer treatment, having been hailed as a major breakthrough by oncologists, with the global ICI market expected to exceed $100 bi ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April 2024 Commission File No.:001-35773 REDHILL BIOPHARMA LTD. (Translation of registrant's name into English) 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or For ...

Financial Position and Capital Needs - As of December 31, 2023, the company had a cash balance of approximately $6.5 million, including $0.8 million of restricted cash held in an escrow account[30]. - The net cash used in operating activities for the year ended December 31, 2023, was $35.8 million, raising substantial doubt about the company's ability to continue as a going concern[30]. - The company needs to raise significant additional capital to finance its operations and achieve strategic objectives, particularly after losing revenue from Movantik®[40]. - The company may need to raise additional capital due to insufficient revenues from current and future commercial products to cover operating expenses[42]. - The company must secure additional funding if resource consumption exceeds current expectations, potentially leading to earlier funding needs[1]. Revenue and Business Operations - Following the sale of Movantik®, the company lost its primary revenue source, significantly impacting its ability to operate as a financially viable commercial business[34]. - The company has downsized its commercial operations due to the loss of economies of scale following the sale of Movantik®, which has adversely affected its ability to sell commercial products[34]. - The company plans to fund future operations through the commercialization of Talicia® and Aemcolo®, as well as through equity or debt financing[40]. - The company reported a net income of approximately $23.9 million for the twelve months ended December 31, 2023, compared to a net loss of $71.7 million for the same period in 2022 and a net loss of $97.7 million for 2021[58]. - As of December 31, 2023, the company had an accumulated deficit of approximately $407.7 million[58]. Regulatory and Compliance Challenges - Internal control over financial reporting was deemed ineffective as of December 31, 2023, which could harm investor confidence and the company's financial reporting[48]. - The company is subject to various regulatory requirements that could impact its marketing and promotional activities, including compliance with FDA and FTC regulations[64][66]. - The company must obtain and maintain regulatory approvals for its products; failure to do so could prevent commercialization of its therapeutic candidates[131]. - Regulatory compliance failures could lead to sanctions, including fines, product recalls, or withdrawal of marketing approvals[155]. - The company is subject to ongoing regulatory review, and failure to comply could result in loss of approvals and adverse effects on operations[149]. Clinical Development and Trials - The company is required to complete two additional postmarketing studies for Aemcolo® in pediatric populations, with deadlines extended to January 2025 for completion and December 2025 for final report submissions due to COVID-19 impacts[74][76]. - The company faces challenges in recruiting patients for clinical trials, particularly in pediatric and oncology studies, which may affect the completion of these studies[1]. - Clinical trials are lengthy and expensive, with uncertain outcomes, and prior results may not predict future trial success[159]. - The company relies on third parties for clinical trials, which may not perform satisfactorily, leading to delays and increased costs[166]. Market Competition and Product Commercialization - The company faces competition from larger pharmaceutical companies with greater financial capabilities and marketing resources[101]. - Talicia® competes with several branded and generic therapies for H. pylori treatment, and Aemcolo® faces competition from both branded drugs and generic antibiotics[192]. - The pharmaceutical and biotechnology industry is highly competitive, with significant competition from various companies developing similar therapeutic candidates[189]. - The market for current commercial products and therapeutic candidates is rapidly changing, with new drug delivery technologies potentially rendering existing products noncompetitive[188]. Strategic Transactions and Partnerships - The company is actively pursuing strategic business transactions, including potential divestment of certain assets, to raise additional capital[40]. - The company has acquired rights to Talicia®, Aemcolo®, and five clinical-stage therapeutic candidates, indicating a strategy focused on in-licensing and acquisitions for commercial success[117]. - The company relies on third-party collaborators for manufacturing and commercialization, which exposes it to risks related to compliance and operational difficulties[81][82]. - The company may need to alter or abandon its development and commercialization plans if it fails to establish collaborations or raise substantial additional capital[116]. Financial and Market Risks - The healthcare industry faced a challenging market during 2023, impacting the company's ability to raise capital and secure partners for development or commercialization[42]. - The company may incur higher than expected costs in the commercialization of its products, which could adversely affect its financial condition[96]. - Unexpected product safety or efficacy concerns could lead to product recalls or declining sales, adversely affecting market acceptance[199]. - The company faces uncertainty regarding future healthcare regulations and their potential adverse effects on product approval and commercialization[211]. Legislative and Regulatory Environment - The financial impact of U.S. healthcare reform legislation will depend on various factors, including changes in sales volumes for therapeutics affected by the legislation[206]. - The American Rescue Plan Act of 2021 eliminates the statutory Medicaid drug rebate cap for single source drugs and innovator multiple source drugs, effective January 1, 2024[209]. - The Inflation Reduction Act of 2022 requires manufacturers of certain drugs to engage in price negotiations with Medicare starting in 2026 and imposes rebates under Medicare Part B and Part D for price increases that exceed inflation, first due in 2023[210]. - Heightened scrutiny over drug pricing practices has led to proposed legislation aimed at increasing transparency and controlling pharmaceutical pricing[222].

As filed with the Securities and Exchange Commission on February 9, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 REDHILL BIOPHARMA LTD. (Exact name of registrant as specified in its charter) Israel (State or other jurisdiction of incorporation or organization) RedHill Biopharma Inc. 8045 Arco Corporate Drive, Suite 200 Raleigh, NC 27617 (984) 444-7010 (Name, address, including zip code, and ...