RedHill supports an independent medical education grant that includes a new two-part H Pylori Continuing Medical Education (CME) program developed by Medscape aimed at advancing clinical knowledge and improving patient outcomes pylori is classified by the World Health Organization (WHO) as a Group 1 carcinogen being the strongest known risk factor for gastric cancer[1] and a major risk factor for peptic ulcer disease[2] With almost half the global population infected by H its treatment represents a billion-dollar market opportunity[4] Listed by the American College of Gastroenterology (ACG) Clinical Guideline[5] as a first-line option low-dose rifabutin-based therapy designed to address H RALEIGH, N.C., May 2, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company") today announced its support of an independent medical education grant that includes a new two-part H developed by Medscape and designed to advance clinical knowledge and improve patient outcomes a livestreamed event entitled "Let's Get Social About H will take place on May 6 during a major gastroenterology meeting RedHill also announces that it will be attending Digestive Diseases Week (DDW) in San Diego and will be available at booth 5312 said: "We are proud to announce that RedHill is supporting a Medscape CME educational program to help meet the need for healthcare professional education on H RedHill believes in the critical need to effectively treat H pylori at the first attempt amid increasing global concern of rising antibiotic resistance particularly within the macrolide class of anti-infectives pylori is estimated to be carried by around 50% of the global population and it is the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease This CME program is targeted to help thousands of specialists by providing education on guideline-driven H designed to advance clinical knowledge and improve patient outcomes in H The 2-part Medscape CME program consists of: Overview: A 30-minute expert panel livestream (0.5 CME Credits) on Medscape's social media channels (YouTube The event will remain available on-demand post-livestream to support those gastroenterology professionals unable to attend the live event Part 2: Expert Roundtable: Overcoming Challenges in H pylori Diagnosis and TreatmentFaculty: Colin Howden MPHDate/Time: June 2025 (TBD)Overview: A 30-minute interactive case-based online discussion (0.5 CME Credits) in order to help clinicians translate key guideline updates into clinical practice pylori infection affects around 50% of the global adult population and is classified as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases)[6] and a major risk factor for peptic ulcer disease (causing 90% of cases)[7] gastroenterologists and is listed by ACG Clinical Guideline as an empiric first-line option Talicia is also launched in the United Arab Emirates (UAE) and the Company recently announced its plan to submit a Marketing Authorisation Application (MAA) for Talicia in the UK which if approved may be accepted by some additional countries as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia pylori          H pylori is a bacterial infection that affects approximately 35% of the U.S with an estimated two million patients treated annually which is classified by the World Health Organization (WHO) as a Group 1 carcinogen It remains the strongest known risk factor for gastric cancer and a major risk factor for peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[9] More than 27,000 Americans are diagnosed with gastric cancer annually[10] pylori is becoming increasingly difficult with current therapies failing in approximately 25-40% of patients who remain H pylori-positive due to high resistance of H pylori to antibiotics – especially clarithromycin – which is still commonly used in standard combination therapies[11] About TaliciaApproved by the FDA for the treatment of H pylori infection in adults in November 2019 all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole) market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide  Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health and was launched there by Ghassan Aboud Group (GAG) in August 2024 TALICIA: INDICATION AND IMPORTANT SAFETY INFORMATIONTalicia is a three-drug combination of omeprazole indicated for the treatment of Helicobacter pylori infection in adults.         To reduce the development of drug-resistant bacteria and maintain the effectiveness of Talicia and other antibacterial drugs Talicia should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.  About RedHill Biopharma   RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640) orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer targeting multiple indications with U.S Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS) a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204 combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104 with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat) host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102 with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.  This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties many of which are beyond the Company's control and cannot be predicted or quantified actual results may differ materially from those expressed or implied by such forward-looking statements without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S government research and development funding and that the U.S such studies and results may not be sufficient for regulatory applications including emergency use or marketing applications and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation progress and results of the Company's research and other therapeutic candidate development efforts and the timing of other regulatory filings approvals and feedback; (iv) the manufacturing and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC) including the Company's Annual Report on Form 20-F filed with the SEC on April 10 All forward-looking statements included in this press release are made only as of the date of this press release The Company assumes no obligation to update any written or oral forward-looking statement future events or otherwise unless required by law Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected] Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg (Nasdaq: RDHL) ("RedHill" or the "Company") today announced that the Company received.. Medical Pharmaceuticals Biotechnology Education Health Care & Hospitals Do not sell or share my personal information: Jersey Bulls' only losses have come at home to Redhill and fellow title chasers Whyteleafe Redhill knocked Jersey Bulls off the top of Combined Counties Premier South as the islanders lost 2-1 at home to their title rivals Having drawn 1-1 in Surrey last week the pair met at Springfield knowing a win for the islanders would put them three points clear with two games to play But two goals in as many second-half minutes saw the English side become just the second team to beat the islanders in the league this season Bulls had the better of the opening exchanges as Lorne Bickley had a penalty claim turned down before Adam McKay and Toby Ritzema headed wide from Miguel Carvalho crosses But the hosts went ahead in the 28th minute as Adam Trotter finished well after Joe Kilshaw had broken up the play Bulls could have gone into the break 2-0 up but Bickley hit the bar shortly after the opener It was a miss they would regret as Redhill levelled when Timmy Obisanya poked the ball home from a goalmouth scramble following a floated 57th-minute free kick from the edge of the box And almost straight away Redhill were in front when substitute Elliott York blasted in from 12 yards after Euan van der Vliet had saved Nathan Hogan's shot James Queree had a header palmed wide while Kurtis Guthrie had a penalty appeal waved away inside the final 10 minutes as the island side pushed unsuccessfully for an equaliser "We pressed the self-destruct button for five minutes and it cost us three points which would have probably sealed it so disappointed," Bulls manager Elliot Powell told BBC Radio Jersey The result leaves Redhill three points clear of Bulls with a game against mid-table Guildford City to play Jersey Bulls would likely still win the title should they win their final two games thanks to their goal difference They travel to mid-table Abbey Rangers on Tuesday night before hosting relegation-threatened Sandhurst Town at Springfield next week Champions League updates: Calafiori back training for Arsenal before PSG semi-final Stunning stats and 'Ronaldo behaviour' - is Yamal cut out to rival Messi Real seek to sign Alexander-Arnold for Club World Cup A gritty crime saga set in Liverpool starring Sean Bean Stacey Dooley explores Britain’s shoplifting epidemic Who has made Troy's Premier League team of the week Is the risk that Mercedes took with Antonelli paying off Trailblazer Zhao set to take snooker to 'another level' in China 'Calamity keeper' or 'human wall' - which Donnarumma will Arsenal face Zhao beats Williams in historic final - highlights VideoZhao beats Williams in historic final - highlights Alexander-Arnold leaves as modern Liverpool great - but fans will feel hurt 'Scheffler and DeChambeau wins further raise US PGA excitement levels' Match-fixing scandal to Crucible champion - fall and rise of Zhao 'We need to take a look at ourselves' - Arsenal stalling at wrong time Europa League 'papering over cracks' for Man Utd - Rooney VideoEuropa League 'papering over cracks' for Man Utd - Rooney Ask Me Anything the new BBC Sport service designed to serve you Bayern's 'James Bond' - how Kane clinched his first trophy Nine bolters with a shot of making the Lions squad How 'absolutely outstanding' Palmer 'destroyed' Liverpool VideoHow 'absolutely outstanding' Palmer 'destroyed' Liverpool Solskjaer on Besiktas Saints 'punch' favourites Leinster in game for the ages VideoVardy the best £1m ever spent - Shearer Poppy's tears Elton John & Happy Gilmore - McIlroy on Jimmy Fallon show Copyright © 2025 BBC. The BBC is not responsible for the content of external sites. Read about our approach to external linking. Jersey Bulls had topped the table on goal difference Jersey Bulls have failed in their appeal against a points deduction that cost them the Combined Counties Premier South title The islanders were docked three points after played a suspended player in their 4-0 win over Tooting and Mitcham in late March The club had appealed to the Football Association (FA) to try and overturn the points deduction The Combined Counties League is assessing a number of other cases of ineligible players, and as yet no dates for the play-offs have been announced. As it stands Bulls will drop to third place in the league table although it is understood rivals Redhill are also facing a similar charge and would fall to third with Whyteleafe winning the title Jersey Bulls end season with win after title disappointment Jersey Bulls title hopes in balance after points deduction Play-offs postponed as Bulls appeal points deduction In a statement Jersey Bulls say the FA's judgement read: League Rule 6.9 directs that the Club shall have any points gained from the match in question deducted "The Appeal Board concluded that there were no exceptional circumstances in this case and that the process that had been followed was fair." The case centred on midfielder Toby Ritzema who received 10 bookings - one coming in the FA Vase Bulls mistakenly counted that booking as counting towards the 10 and therefore he served a two-match ban in the league when he did not need to He subsequently passed the 10-booking threshold in league games and should have been suspended for the Tooting and Mitcham win on 29 March Strong Use of Composition-of-Matter Coverage: Patent protects the molecular structure of RHB-107 providing market exclusivity beyond method-of-use claims COVID-19 Therapeutic Use: Includes coverage for treatment of SARS-CoV-2 This patent grant enhances RedHill's strategic positioning in the global COVID-19 therapeutic space a market still expected to be worth more than $3 billion in 2025[1] RHB-107 successfully met the primary endpoint of safety and tolerability delivering promising reduction in hospitalization efficacy results in a U.S Additional clinical data expected from the externally non-dilutive funded PROTECT study host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations[3] RALEIGH, N.C. and TEL-AVIV, Israel, April 28, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company") today announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat) a potential oral treatment for COVID-19 (patent application No "This newly allowed Chinese patent application is a significant success enhancing RedHill's strategic positioning in the global COVID-19 therapeutic space – a market still expected to be worth more than three billion dollars in 2025 It provides broad and robust protection of the use of RHB-107 including its structure in oral formulations targeting SARS-CoV-2 infections including both wild-type and naturally occurring variants and expanding its patent footprint in Asia a key pharmaceutical market," said Guy Goldberg "It underscores the uniqueness of our antiviral candidate and further strengthens our global intellectual property portfolio as we advance development of a much-needed oral candidate for early community-based (non-hospitalized) treatment of COVID-19 which still represents a considerable threat to vulnerable patients host-directed antiviral that is expected to act independently of viral spike protein mutations could provide a much-needed additional option for use in the early COVID-19 treatment space Data from RHB-107's U.S. Phase 2 study, published in the International Journal of Infectious Diseases showed a 100% reduction in hospitalization due to COVID-19 with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317) The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation with new severe COVID-19 symptoms reported by only 2.4% of the RHB-107 treated group (1/41) compared to 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036) Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with RHB-107 compared to 8 days with placebo Additional clinical data is expected from the externally non-dilutive funded PROTECT study once-daily orally administered investigational antiviral that targets human serine proteases involved in preparing the spike protein for viral entry into target cells RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein RHB-107 is well tolerated; in the initial COVID-19 study among 41 patients only one reported a drug-related adverse reaction (a mild RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease RHB-107 has undergone several Phase 1 studies and two Phase 2 studies demonstrating its clinical safety profile in approximately 200 patients[4] RedHill acquired the exclusive worldwide rights to RHB-107 from Germany's Heidelberg Pharma AG (FSE: HPHA) (formerly WILEX AG) for all indications RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204 combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104 More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected] Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg STEM (Science, Tech, Engineering, Math) advanced development pipeline and multiple upcoming catalysts TEL AVIV, Israel and RALEIGH, N.C., April 10, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company") today reported its full-year 2024 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31 said: "We have undergone an extensive overhaul reshaping ourselves financially have resulted in new and clearer opportunities to deliver maximum value from both our commercial and R&D assets The potential $60 million ex-North America global license of RHB-102 to Hyloris lays the groundwork for the ongoing development and commercialization in the large gastroenteritis oncology support and IBS-D markets while enabling RedHill to maintain control of the key North American markets The approximately $8 million plus legal costs New York Supreme Court summary judgment was a resounding win for RedHill and we are fully committed to pursuing the collection of this award Last year's recommendation by the latest ACG Clinical Guideline for Talicia as a first-line therapeutic option for H we expect further enhanced Talicia's product profile as the leading branded U.S winning additional formulary successes securing 25 million covered lives Talicia is also poised for a potential UK Marketing Authorisation Application (MAA) mid-year presenting a promising pathway for Talicia's entry into additional markets globally." Ben-Asher continued: "Having successfully completed the Hyloris RHB-102 out-license deal we are now advancing our next-generation candidate supported by RHB-104's positive Phase 3 clinical data opaganib continues to show its broad-acting potential and we are very excited to have initiated the innovative Bayer-supported Phase 2 study in combination with darolutamide which may bring vital new hope to men with metastatic castrate resistant prostate cancer Progress was also made with opaganib as a treatment for GI-ARS following positive results from new in vivo studies government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract further confirming opaganib's radioprotective activity in models of GI-ARS Discussions are ongoing regarding advanced development Government-supported work in Ebola continues following our previously announced BARDA grant We have started 2025 as we mean to go on – aggressively pursuing our business goals and aiming to deliver on our catalysts in a meaningful way." Financial results for the 12 months ended December 31 Net Revenues for the year ended December 31 compared to $6.5 million for the year ended December 31 Talicia net revenues for the year ended December 31 increased to $9.0 million from $8.8 million for the year ended December 31 driven by approximately $1.0 million of revenues generated from the UAE partnership with Gaelan Medical Net revenues for the years ended December 31 2023 included Movantik contra-revenues of $0.9 million and $2.6 million for Movantik Cost of Revenues for the year ended December 31 compared to $3.5 million for the year ended December 31 The decrease was primarily due to lower inventory write-downs which totaled $0.2 million in 2024 compared to $1.3 million in 2023.   Gross Profit for the year ended December 31 compared to $3.1 million for the year ended December 31 reflecting the increase in net revenues and the lower level of inventory write-downs in 2024 Research and Development Expenses for the year ended December 31 as compared to $3.5 million for the year ended December 31 The decrease was attributable to the costs from closing the RHB-204 clinical trial as well as ongoing cost-reduction measures and General and Administrative Expenses for the year ended December 31 as compared to $31.0 million for the year ended December 31 The reduction was primarily attributable to ongoing cost-reduction measures and the divestment of Movantik in 2023 which led to workforce downsizing and other related expense reductions Other Expenses for the year ended December 31 recognized as part of the Global Termination Agreement3 as compared to Other Income of $44.1 million for the year ended December 31 The Other Income in 2023 was comprised of (i) $35.5 million from the divestiture of Movantik calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services provided to the buyer of Movantik Operating Loss for the year ended December 31 compared to Operating Income of $12.6 million for the year ended December 31 Both periods include items related to the Movantik divestiture as described under Other Expenses - a $2.3 million loss in 2024 and $44.1 million income in 2023 the year-over-year change reflects improved operating performance driven by cost-cutting measures net of $11.3 million for the year ended December 31 The income recognized for the year ended December 31 was primarily driven by the revaluation of financial instruments partially offset by other financing expenses The income recognized in the year ended December 31 was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCRM debt in exchange for the transfer of rights to Movantik calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred partially offset by financial expenses related to the financial instruments and other financial expenses as compared to Net Income of $23.9 million for the year ended December 31 Both periods include impacts from the Movantik divestiture as detailed under Other Expenses and Financial Income - a $2.3 million loss in 2024 and $64.7 million in income in 2023 the year-over-year change reflects improved performance driven by cost cutting measures.  as compared to $23.0 million as of December 31 The decrease was primarily attributable to the decrease in cash balance reduced inventory and a decline in prepaid expenses and other receivables consistent with the Company's scaled-down operations as well as impact of balances settled as part of the Global Terminations Agreement and a reduction in right-of-use assets following the termination of vehicle leases during 2024 as compared to $21.0 million as of December 31 The increase primarily reflects the impact of the Global Termination Agreement under which the Company incurred liabilities related to Movantik that were allocatable to HCRM and its affiliates under their agreements with the Company offset by payments made toward these liabilities during the period there was an increase in derivative financial instruments associated with warrant liabilities from offerings made during 2024 This was partially offset by a decrease in accounts payable and allowance from deductions from revenues as well as a reduction in lease liabilities due to the termination of car leases Net Cash Used in Operating Activities for the year ended December 31 compared to $35.8 million for the year ended December 31 The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities This was partially offset by proceeds received from the Global Termination Agreement net of payments made to settle obligations arising from this agreement Net Cash Provided by Financing Activities for the year ended December 31 primarily generated through equity offerings Net Cash Provided by Financing Activities for the year ended December 31 comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023 partially offset by repayment of payables in respect of intangible asset purchases Commercial - streamlined and revenue-generating: With a significantly streamlined commercial operation Talicia has generated net revenues of $9.0 million supported by approximately $1.0 million of new revenues from the UAE partnership with Gaelan Medical Significant effort has resulted in important accomplishments with Talicia such as the inclusion as first-line option for treatment of H pylori infection in the recently updated 2024 American College of Gastroenterology (ACG) Clinical Guideline the securing of 25 million covered lives following the Medi-Cal renewal and Humana formulary win a successful launch in the UAE and the potential for opening up new markets with the recently announced plan for a Talicia UK MAA Talicia has now surpassed the 100,000 prescriptions milestone and our innovative warranty program Government and non-governmental collaborations RedHill's pipeline provides new and exciting opportunities in major indications: Crohn's disease Ebola and other viral and pandemic preparedness indications as well as for gastrointestinal-acute radiation syndrome (GI-ARS) and other medical/chemical countermeasure uses: with a demonstrated safety and efficacy profile directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval Opaganib is in development for multiple oncology inflammatory and diabetes and obesity-related indications acute respiratory distress syndrome (ARDS) and radio/chemical protection A new approach in the $12 billion prostate cancer market: Prostate cancer (PC) is the second most diagnosed cancer in the world with around 1.5 million new cases per year People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them the Company announced the initiation of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC evaluating the potentially enhancing effect of opaganib in patients with poor prognosis The study will utilize a companion lipid biomarker test (PCPro) to select mCRPC patients who have a poor prognosis due to standard of care (SoC) treatment and who may benefit from an opaganib + darolutamide combination treatment approach The primary endpoint will be improved 12-month radiographic progression-free survival (rPFS) fixed-dose oral capsule containing a combination of clarithromycin at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease (CD) Unlike existing therapies that focus on symptom relief RHB-204 is intended to target the possible root cause of Crohn's disease which is hypothesized to be caused by Mycobacterium avium subspecies paratuberculosis (MAP) RHB-204 is a next-generation formulation of RHB-104 which successfully completed a Phase 3 study in Crohn's disease with an optimized formulation for the treatment of CD It contains the same three antimicrobial agents with potent intracellular anti-mycobacterial and anti-inflammatory properties RHB-204 provides the potential for enhanced tolerability safety and compliance with a 40% pill burden reduction RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD with its potential further demonstrated using mucosal healing imaging considered to be the gold standard for efficacy evaluation in CD Paradigm shift in MAP-positive CD treatment approach the Company announced its plans to advance its potentially groundbreaking late-stage RHB-204 Crohn's disease program building on statistically significant positive RHB-104 Phase 3 results FDA guidance on pathway to approval is anticipated in the coming weeks RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment The planned innovative Phase 2 study of RHB-204 is planned to be the first ever clinical study in CD patients who are all MAP-positive and will evaluate mucosal healing a new gold standard in assessing efficacy in Crohn's disease and MAP eradication utilizing novel and decisive endpoints and imaging allowing for a study design with a relatively small sample size RHB-204 builds upon RHB-104's successful Phase 3 study which successfully met its Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus standard of care It also showed compelling mucosal healing data in CD patients who underwent colonoscopy The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes we were notified that funding from the U.S Government Department of Defense's Joint Program Executive Office for Chemical Radiological and Nuclear Defense (JPEO-CBRND) for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination requiring the study to cease enrollment on Feb 28 93 patients have been enrolled out of a fully enrolled target patient population of 300 Due to the reduced number of patients enrolled in this study the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial Army-funded Ebola development program remains ongoing with RHB-107 having demonstrated a robust synergistic effect in vitro when combined with remdesivir Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at:[email protected] RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.  Adi FrishChief Corporate and Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected] CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE YEAR The accompanying notes are an integral part of these consolidated financial statements CONSOLIDATED STATEMENTS OF FINANCIAL POSITION  U.S. dollars in thousands Accrued expenses and other current liabilities TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) Adjustments in respect of income and expenses not involving cash flow: Share-based compensation to employees and service providers Gains from the transfer of rights in Movantik® and extinguishment of debt obligations Non-cash expenses related to borrowing and payable in respect of intangible assets purchase Fair value (gains) losses on derivative financial instruments recognition of day 1 loss and changes in royalty obligation Loss from modification of warrants terms as part of a new issuance Exchange differences and revaluation of bank deposits Decrease in prepaid expenses and other receivables Decrease in accrued expenses and other liabilities Increase (decrease) in allowance for deductions from revenue Change in investment in current bank deposits Net cash provided by (used in) investing activities Proceeds from issuance of ordinary shares and warrants Repayment of payable in respect of intangible asset purchase Payment of principal with respect to lease liabilities EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF PERIOD BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: Acquisition of right-of-use assets by means of lease liabilities Decrease in lease liability (with corresponding decrease in right of use asset in amount of $166 in 2024 and $4,697 in 2023) resulting from early termination of lease Transfer of rights in Movantik® and extinguishment of debt obligations: Decrease in Payable in respect of Intangible asset Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations Pharmaceuticals GLP-1 comparable efficacy: Opaganib's positive results demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models formulation and administration: Opaganib is a differentiated oral non-peptide therapeutic that targets sphingosine kinase-2 (SPHK2) potentially avoiding common Glucagon-like peptide-1 (GLP-1) inhibitor side effects and administration burdens Market disruptor potential: The rapidly growing global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034[1] – largely driven by GLP-1 inhibitors like Novo Nordisk's Ozempic® and Wegovy® and Eli Lilly's Trulicity® Potential high value and de-risked development pathway: Existing human safety and tolerability data from over 470 subjects may help expedite the FDA pathway to approval; new obesity and diabetes indications add strategic expansion and value to existing development programs in oncology TEL AVIV, Israel and RALEIGH, N.C., April 16, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the new publication[2] of positive in vivo data in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet (HFD)-Induced Obesity and Glucose Intolerance" The data indicates that opaganib[3] effectively suppresses the loss of metabolic control in mice on a HFD is associated with improved glucose tolerance weight loss and the prevention of weight gain rebound after removal of semaglutide said: "Sphingolipid metabolism is implicated in insulin resistance vascular complications and energy metabolism – all significant components of obesity diabetes and their associated complications The studies showed that treatment with opaganib markedly suppressed weight gain in mice fed the HFD but not in mice given the control diet (CD) mice on the HFD demonstrated poor glucose tolerance at 8 consistent with the progression of obesity opaganib treatment of the HFD-fed mice abolished this developing glucose intolerance at all times of measurement Opaganib treatment also reduced the elevation of hemoglobin A1c and the deposition of inguinal fat in HFD-fed mice Opaganib and semaglutide were equally effective in promoting body weight loss and improving glucose tolerance in obese mice Opaganib's ability to modulate multiple signaling pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells – the first known clinical drug to do so - provides a strong rationale for evaluation of opaganib in obesity-related disorders – and opaganib could potentially represent a game-changing opportunity in the multi-billion-dollar obesity and diabetes market." The global obesity-diabetes drugs market is projected to be worth around $100 billion by 2034 – largely driven by GLP-1 inhibitors like Novo Nordisk's Ozempic and Wegovy (semaglutide) and Eli Lilly's Trulicity (dulaglutide) and Mounjaro / Zepbound (tirzepatide) a proprietary investigational host-directed and potentially broad-acting drug orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer gastrointestinal acute radiation syndrome (GI-ARS) Ebola and other viruses as part of pandemic preparedness Opaganib's host-directed action is thought to work through the inhibition of multiple pathways through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2 government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple indications Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP) led by the National Institute of Allergy and Infectious Diseases (NIAID) government Department of Health & Human Services' National Institutes of Health and the Administration for Strategic Preparedness and Response's (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA) A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study has also been initiated to evaluate the efficacy of opaganib in combination with Bayer's darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC) testing the potentially enhancing effect of opaganib in patients with a poor prognosis Opaganib has demonstrated antiviral activity against SARS-CoV-2 Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study making it the first host-directed molecule to show activity in Ebola virus disease Opaganib also recently demonstrated a distinct synergistic effect when combined individually with remdesivir (Veklury® significantly improving potency while maintaining cell viability Army-funded and conducted in vitro Ebola virus study Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in solid tumors (Phase 1) advanced cholangiocarcinoma (Phase 2a) and prostate cancer Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission Opaganib has also shown positive preclinical results in renal fibrosis and has the potential to target multiple oncology gastrointestinal and diabetes/obesity-related indications More information about the Company is available at www.redhillbio.com / X.com/RedHillBio Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding the potential effects of opaganib on obesity- and diabetes-related conditions Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected]  Text description provided by the architects. A reworking of a 1910 Queenslander worker's cottage in Red Hill, Brisbane to accommodate the architects' own home and architecture studio. The project is notable for its balancing of family life and work, and the interfaces between public, private, street, interior and garden. © Clinton WeaverThe project seeks to make a delightful and intimate set of spaces for living and working are repositioned as an enfilade of rooms running the length of the northern edge Compact sleeping spaces now comfortably occupy the darker southern edge the rear wall of the cottage slides away and brings the garden prominently into view The single bathroom is broken into distinct functions distributed along the length of the book-lined stair leading to the garden You'll now receive updates based on what you follow Personalize your stream and start following your favorite authors If you have done all of this and still can't find the email RedHill will obtain an upfront payment from Hyloris and may receive up to $60m in milestone payments RedHill Biopharma has signed an exclusive licensing agreement with Hyloris Pharmaceuticals for the global development and commercialisation of RHB-102 (Bekinda) plus royalties on revenues for exclusive rights to RHB-102 outside Canada RedHill plans to progress the drug’s development for approval from the US Food and Drug Administration Hyloris will be accountable for overseeing all aspects of development regulatory processes and commercialisation efforts associated with the drug within its designated territories RedHill Biopharma CEO Dror Ben-Asher stated: “This agreement follows the recent initiation of the Bayer-funded Phase II study of opaganib and darolutamide in advanced prostate cancer and is a further demonstration of the potential of RedHill’s research and development pipeline RHB-102 will provide the opportunity to deliver 24-hour relief from nausea and vomiting in a single pill for outpatient use by cancer patients undergoing chemotherapy or radiotherapy gastritis or diarrhoea-predominant irritable bowel syndrome (IBS-D).” Don’t let policy changes catch you off guard Stay proactive with real-time data and expert analysis The one-time-a-day bimodal extended-release oral tablet formulation of ondansetron RHB-102 comes in 12mg and 24mg dose strengths and is being developed for indications such as acute gastroenteritis and gastritis The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has provided positive advice for the tablet paving the way for a marketing authorisation application This could lead to RHB-102 being the first oral 24-hour extended-release ondansetron antiemetic drug for chemotherapy/radiotherapy-induced nausea and vomiting treatment A US Phase III study of the tablet was completed by the company for treating acute gastroenteritis and gastritis as well as a Phase II study for IBS-D In July 2023, the company received additional funds of $1.7m from the US government to further develop opaganib as a medical countermeasure for gastrointestinal acute radiation syndrome Give your business an edge with our leading industry insights View all newsletters from across the GlobalData Media network 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 Letter TEL AVIV, Israel and RALEIGH, N.C., April 17, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company") today announced that the Company received a written notification (the "Notification Letter") from the Listing Qualifications Department of the Nasdaq Stock Market LLC ("Nasdaq") dated April 15 notifying the Company that it is no longer in compliance with Nasdaq Listing Rule 5550(b)(1) (the "Rule") The Rule requires companies listed on the Nasdaq Capital Market to maintain a minimum of $2,500,000 in stockholders' equity for continued listing based on the Company's Annual Report on Form 20-F for the fiscal year ended December 31 the Company reported a stockholders' deficit of $4,683,000 and does not meet the alternatives of market value of listed securities or net income from continuing operations In accordance with the Nasdaq Listing Rules Nasdaq can grant an extension of up to 180 calendar days from receipt of the Notification Letter to evidence compliance The Company is looking into various options available to regain compliance and maintain its continued listing on the Nasdaq Capital Market The Company intends to submit the compliance plan as soon as practicable There can be no assurance that the Company's plan will be accepted or the Company will be able to regain compliance with the Rule Adi FrishChief Corporate and Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected] [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 Logo - https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg The planned innovative Phase 2 study of RHB-2041 will be the first ever clinical study in Crohn's Disease (CD) patients who are all MAP-positive and will correlate mucosal healing with MAP2 infection eradication utilizing novel endpoints and imaging pending Type C discussions on path to FDA approval RHB-204 is a next generation anti-MAP therapy derivative of RHB-1043 which successfully met its groundbreaking Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus SoC and showed compelling mucosal healing data in CD patients who underwent colonoscopy Based on insights from RHB-104's statistically significant positive Phase 3 study results the improved formulation RHB-204 is designed to reduce pill burden and further enhance tolerability and along with the uniquely defined patient population (MAP-positive) allows for a study design with a small sample size and decisive endpoints entailing lower study costs and expedited timeframe supports a paradigm-shifting new therapeutic approach for CD – focused on addressing the actual cause of the disease The multibillion-dollar Crohn's disease market is expected to expand significantly with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033 presenting significant commercial potential for a new FDA approved therapy RALEIGH, N.C. and TEL-AVIV, Israel, March 12, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company") today announced plans to advance its groundbreaking late-stage program for Crohn's disease (CD) with initiation of an innovative Phase 2 study of RHB-204 in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) moderate to severe CD utilizing novel endpoints and the new gold standard in imaging techniques pending Type C discussions on path to FDA approval with guidance from FDA anticipated next quarter and with an expected pediatric orphan designation (subject to FDA approval to transfer from RHB-104) is a novel next generation improved formulation of Phase 3-stage RHB-104 In its groundbreaking positive Phase 3 study which met primary and secondary endpoints RHB-104 demonstrated a 64% increase in efficacy versus SoC improving further at week 26 and continuing through week 52 and also showed compelling mucosal healing data in those patients who underwent colonoscopy The Phase 2 study is expected to have primary endpoints of mucosal healing (considered a new gold standard in efficacy evaluation in Crohn's disease) per FDA guidance following the positive Phase 3 CD study results with RHB-104 The RHB-204 study will be the first ever clinical trial in CD patients who are all MAP-positive and will correlate mucosal healing with MAP eradication Based on the successful RHB-104 Phase 3 study insights and specified endpoints it is expected that the RHB-204 study could be efficiently conducted with a clearly defined and relatively small patient population and an expedited timeframe (with early efficacy indications potentially at just 16 weeks) reducing substantially the anticipated program costs Clinical study material has already been manufactured and is in place ready for study implementation The CD market is expected to expand significantly over the 2024–2033 forecast period growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%4 With significant numbers of treatment failures and approximately 1.6 million diagnosed prevalent cases of CD diagnosed globally last year4 there is a strong need for effective new CD therapies the Company intends to explore the potential for additional regulatory process designations such as breakthrough therapy designation and fast track designations that may provide additional exclusivity or potential for priority review vouchers Professor of Medicine and Molecular Virology and Microbiology at Baylor College of Medicine said: "Up to 40% of patients fail to respond to anti-TNF treatment and over time up to 50% of responders lose response and have disease flare-ups In addition to the unmet medical need for alternative therapeutic approaches most of the existing drugs for CD are both expensive and are intravenously administered further adding to the treatment cost burden several of these existing therapies have known safety issues so we believe a safe and effective orally administered therapy would be a very convenient and welcome addition Based on the safety and efficacy data with concomitant anti-TNFs immunomodulators and steroids demonstrated in RedHill's initial RHB-104 Phase 3 U.S the development of RHB-204 may provide an expedited route to a safe "Advances in diagnostic technology have led to increasingly higher identification of MAP in Crohn's diseases patients5," said Gilead Raday Chief Operating Officer and Head of R&D at RedHill "Utilizing gold standard imaging technology to provide clear and unambiguous efficacy results the study is designed to include only MAP positive CD patients and is expected to increase the study's power potentially allowing to demonstrate the benefits of RHB-204 anti-MAP therapy in a relatively small sample size over and above the promising efficacy observed in the positive Phase 3 study results of RHB-104's in all-comer CD patients RedHill is actively pursuing partnering and collaborations for this program including ongoing discussions with non-dilutive external funding sources which may pave the way to a much-needed new therapeutic modality for CD focused on addressing a suspected cause of the disease The randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active Crohn's disease met its primary and secondary endpoints, showing RHB-104 standard of care (SoC) to be 64% more effective than SoC alone, was published in the peer-reviewed journal, Antibiotics6 a total of 166 patients were randomized to receive RHB-104 plus SoC and 165 to placebo plus SoC that 36.7% (61/166) of RHB-104 patients achieved clinical remission at week 26 vs 22.4% (37/165) of placebo patients (p = 0.0048) In the secondary endpoint of mucosal healing endoscopy was performed in a group of 35 patients who volunteered to undergo colonoscopy with results showing meaningful improvement in endoscopic healing (Simple Endoscopic Score for Crohn's Disease (SES-CD)) at week 26 (statistically significant at 25% decrease with similar trend at 50% decrease) Further corroborating these results was the statistically significantly marked and continuous decline of inflammatory marker fecal calprotectin (FCP) - an accepted surrogate for mucosal healing - in the RHB-104 active arm from baseline through week 52 in patients with high calprotectin at baseline RHB-104 was found to be generally safe and well tolerated with adverse event reporting similar to placebo Full results are available in the publication About Crohn's Disease:   Crohn's disease (CD) is a form of Inflammatory Bowel Disease (IBD) causing inflammation of digestive tract tissue that can lead to abdominal pain CD can be highly debilitating and remains a serious burden for both patients and healthcare systems: destroying quality of life and even leading to life-threatening complications There is no known cure for Crohn's disease experts estimate that more than three-quarters of a million Americans and approximately 6-8 million people globally have Crohn's disease Commonly used FDA approved therapies in the treatment of CD include: Abbvie's Humira® (adalimumab) Janssen's Remicade® (infliximab) and Stelara® (Ustekinumab) BMS's Zeposia® (ozanimod) and Pfizer's Xeljanz® (tofacitinib) at specific doses designed to safely and effectively treat MAP+-related Crohn's disease RHB-204 is a next-generation formulation of RHB-104 with an optimized formulation for the treatment of CD Originally developed for the treatment of pulmonary NTM disease caused by MAC RHB-204 was granted FDA Fast Track and Orphan Drug Designation in addition to QIDP Designation under the Generating Antibiotic Incentives Now Act (GAIN Act) market exclusivity to a potential total of 12 years RHB-204 has additionally been granted EU Orphan Designation providing eligibility for 10 years EU post-approval market exclusivity and its use in treating pulmonary MAC disease About RedHill Biopharma RedHill Biopharma Ltd (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H pylori) infection in adults7. RedHill's key clinical late-stage development programs include: (i) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) RHB-104 with positive results from a first Phase 3 study for Crohn's disease; (iii) opaganib (ABC294640) government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS) a Phase 2/3 program for hospitalized COVID-19 and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (iv) RHB-107 (upamostat) is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and  (v) RHB-102 More information about the Company is available at www.redhillbio.com / X.com/RedHillBio Forward Looking StatementsThis press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities statements regarding the potential development of RHB-204 for Crohn's disease without limitation: the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S including the Company's Annual Report on Form 20-F filed with the SEC on April 8 Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected]  The trial is being financially backed by Bayer and the Ramsay Hospital Research Foundation Israeli pharmaceutical company RedHill Biopharma has initiated a placebo-controlled Phase II trial to assess the combination of opaganib and darolutamide in treating metastatic castrate-resistant prostate cancer (mCRPC) The study involves 80 male subjects and aims to determine if opaganib can enhance the effects of standard androgen receptor pathway inhibition (ARPI) treatments The randomised trial uses a companion lipid biomarker test to identify mCRPC patients with a poor prognosis who may benefit from the combination 200 eligible subjects will be screened using a 5ml plasma sample for the PCPro test with treatment due to begin within seven days of randomisation Improvement in 12-month radiographic progression-free survival is the trial’s primary endpoint with various secondary and exploratory endpoints also under evaluation The study was designed and is being led by Prof Lisa Horvath a prostate cancer researcher at the Chris O’Brien Lifehouse in Australia as well as the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) It is being financially supported by German pharmaceutical company Bayer alongside the Ramsay Hospital Research Foundation RedHill chief scientific officer Dr Mark Levitt said: “Men with mCRPC have few treatment options available to them and those positive for the PCPro marker of ARPI resistance seem to have a particularly poor prognosis “Darolutamide is establishing itself as a key therapy in the treatment of prostate cancer a market worth approximately $12bn in 2023 “If the addition of opaganib can reduce the resistance to darolutamide therapy this could represent a significant breakthrough in improving the ability to manage advanced treatment-resistant mCRPC for improved outcomes.” Opaganib is an investigational therapy with potential applications for several conditions RedHill Biopharma previously published positive outcomes from a Phase II trial of its antiviral RHB-107 (upamostat) in non-hospitalised Covid-19 patients View all newsletters from across the GlobalData Media network. Redhill and Jersey Bulls were only separated by goal difference before kick-off Jersey Bulls were denied the chance to go three points clear at the top of Combined Counties Premier South after drawing 1-1 at second-placed Redhill in a fiery encounter The hosts played the second half with 10 men and levelled moments after Luke Campbell had put the islanders in front late on In a tight first-half Miguel Carvalho fired into the side netting after 26 minutes for Bulls before Euan van der Vliet pulled off a superb save soon after as Redhill tried to go ahead Tensions had been strained for much of the first half and threatened to boil over shortly before half-time as Bulls striker Lorne Bickley was brought down and players from both sides came together The hosts had early substitute Sean Swift sent off for a second booking in the fourth of 17 minutes of first-half stoppage time after a foul on Fraser Barlow before the islanders had an effort deflected wide soon after With the extra man Bulls created more chances as Luke Watson had a header saved by Luke Roberts before the Redhill keeper superbly kept out a Joe Kilshaw effort with seven minutes to go But two minutes later an unmarked Campbell put the islanders in front with a back post header from a corner Seb Tauta-Caballero then equalised in the first minute of stoppage time as he reacted quickest to tap in after Van der Vliet could not hold a Redhill shot The result leaves the two sides tied on 90 points although Bulls have a game in hand with third-placed Whyteleafe four points off them Redhill travel to Jersey in a week's time for a game which could prove decisive in where the title will end up because obviously a point in terms of the league table is a really positive result," Jersey Bulls manager Elliot Powell told BBC Radio Jersey "But it's just a bit of a sickener not to have won it "I thought we did the running in the second half obviously they're down to 10 and they were going to tire but when we went 1-0 up it was disappointing that we haven't seen that game out "It was a great save from Euan and it's just fallen straight back to his feet and he's slammed it in but in the grand scheme of things it's a decent point and sets us up well for next week." - Hyloris will pay RedHill an upfront payment and up to $60 million in potential milestone payments plus up to mid-20s percent royalties on revenues in return for exclusive rights to develop and commercialize RHB-102 (Bekinda®) across all indications and territories outside the United States - Recent positive UK MHRA advice provided a clear pathway for a UK Marketing Authorization Application (MAA) RHB-102 could be the first oral 24-hour extended-release ondansetron for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV) - RedHill intends to continue development of RHB-102 for FDA approval in the U.S. Hyloris will be responsible for all development regulatory and commercialization activities related to RHB-102 in its territories  - The global antiemetics drugs market size was valued at approximately $7.5 billion in 2023 and is expected to grow at a CAGR of approximately 6% from 2024 to 2030  - Positive results from the successful U.S Phase 2 IBS-D study (RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24 mg) were published in The American Journal of Gastroenterology and JAMA Network Open TEL AVIV, Israel and RALEIGH, N.C., Feb. 25, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company") today announced that it has entered into an exclusive worldwide development and commercialization licensing agreement with Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) ("Hyloris") for RedHill's RHB-102 (Bekinda®) Hyloris will pay RedHill an upfront payment in addition to up to $60 million in potential milestone payments contingent upon achieving specified commercial targets in return for exclusive rights to RHB-102 across all indications and territories outside the United States RedHill intends to continue development of RHB-102 for FDA approval in the U.S. regulatory and commercialization activities related to RHB-102 in its territories bimodal extended-release oral tablet formulation of ondansetron a 5-HT3 antagonist in advanced development for oncology support and diarrhea-predominant irritable bowel syndrome (IBS-D) at two dose strengths: 12mg and 24mg "Ondansetron ER will be a valuable addition to supportive care in oncology and post-surgical settings where sustained relief from nausea is essential," said Thomas Jacobsen "We are committed to delivering innovative solutions that enhance patient comfort and streamline therapy especially in areas where reducing treatment burden can make a meaningful impact We look forward to collaborating with RedHill to bring this product to patients." "Our new partners at Hyloris share our vision of RHB-102's significant potential and we look forward to working with them to bring RHB-102 to patients worldwide," said Dror Ben-Asher "This agreement follows the recent initiation of the Bayer-funded Phase 2 study of opaganib and darolutamide in advanced prostate cancer and is further demonstration of the potential of RedHill's R&D pipeline Recent positive advice from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) provided a clear pathway for a UK Marketing Authorization Application (MAA) for RHB-102 (24 mg) for oncology support (CINV and RINV) in the UK subject to completion of certain manufacturing activities RHB-102 could be the first oral 24-hour extended-release ondansetron antiemetic drug for the treatment of chemotherapy/radiotherapy-induced nausea and vomiting (CINV/RINV) The global antiemetics drugs market size was valued at approximately $7.5 billion in 2023 and is expected to grow at a CAGR of approximately 6% from 2024 to 2030[2] Phase 3 study with RHB-102 for acute gastroenteritis & gastritis (24 mg) and a U.S There is also additional potential for use in post-operative nausea and vomiting (PONV) and IBS-D at two dose strengths: 12mg and 24mg Positive results from the successful U.S. Phase 2 IBS-D study (RHB-102 12 mg) and Phase 3 GUARD gastroenteritis study (RHB-102 24 mg) were published in The American Journal of Gastroenterology[3] and JAMA Network Open[4] Hyloris (EBR: HYL) is a specialty biopharma company focused on innovating and optimizing existing medications to address important healthcare needs and deliver relevant improvements for patients Hyloris is based in Liège, Belgium. For more information, visit www.hyloris.com or LinkedIn infectious diseases and oncology. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H pylori) infection in adults[5]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640) and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-107 (upamostat) is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102 positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104 with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease statements regarding the potential arrangement and relationship with Hyloris without limitation: the risk that the Company will not benefit from the agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected]  RedHill plans to submit UK MAA1 for Talicia for H using MHRA's2 new fast-track approval process Listed by ACG3 Clinical Guideline as a first-line option gastroenterologists and the only FDA-approved all-in-one Talicia is also approved and launched in the UAE4 and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes pylori infection is a billion-dollar market opportunity affecting approximately 40% of the UK adult population,5 a third of the U.S adult population and over 50% of the global adult population6 RALEIGH, N.C., March 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company") today announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP) a fast-track regulatory process for UK drug approvals based on a recognized reference approval Food and Drug Administration (FDA) approval of Talicia as reference potential UK approval could be received as early as the fourth quarter of 2025 pylori resistance to other antibiotics commonly used in H is listed in the American College of Gastroenterology (ACG) Guideline as a first-line treatment option and is the number one branded H Some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia pylori infection affects approximately 35% of the U.S adult population and over 50% of the global adult population7 as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases) and a major risk factor for peptic ulcer disease (causing 90% of cases)8 said: "The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H pylori treatment regimen without prior susceptibility testing Resistance to both clarithromycin and levofloxacin has been rising significantly and is linked to high H pylori treatment failure rates – with more than one in three patients failing on standard proton pump inhibitor-clarithromycin triple therapy when used in the face of known clarithromycin resistance9 Talicia is now the leading prescribed branded H with the ACG Guideline listing it as first-line treatment option for H based on Talicia's proven superior efficacy – up to 90% effective - and safety and its convenient FDA-approved three-times daily (TID) 'breakfast providing for easier adherence.10,11,12 Almost 40% of the UK population are infected by H 14 and 18 people are diagnosed with gastric cancer in the UK every day15 pylori infection leading to a 75% decreased risk of gastric cancer.16 We are committed to expanding the global access and sales of Talicia following approvals in the U.S and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market." Approved by the FDA for the treatment of H pylori) infection in adults17. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640) and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-104 statements regarding the potential submission of Talicia® for UK Marketing Authorisation and any approval thereof and statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected]  Campaign’s PR Faces to Watch 2025 – Zeina Ghanem I am driven by a passion for storytelling that creates meaningful connections between brands and audiences and executing campaigns that amplify brand visibility I have collaborated on projects that secured extensive media coverage and forged strong client relationships With a sharp eye for evolving trends and a results-oriented mindset I am committed to delivering creative PR solutions that resonate and inspire and collaboration shape my professional approach I believe that strong relationships and compelling narratives are at the heart of effective PR I aim to deliver work that not only meets objectives but also leaves a lasting impact I’ve always been drawn to the power of storytelling and human connections After years of studying international law in Egypt I made the bold move to Riyadh to carve out a new path in communications I now find joy in their companionship—proof that fears can turn into love Passionate about travel and meeting new people I thrive on new experiences that expand my worldview and enrich both my personal and professional journey Go back to main article: Campaign’s PR Faces to Watch 2025 Companies take over former Digital Realty site A data center campus outside London has been sold As reported by Green Street News, Building UK private real estate investor Castleforge has acquired the Redhill Data Centre Campus in Redhill Located in the Foxboro Business Park in Surrey the 7.8-acre campus totals more than 160,000 sq ft (14,865 sqm) across three buildings and offers 26MW in total The site reportedly has a development value of £100 million ($124.9m) The campus reportedly has 26 tenants in place The companies plan to increase the capacity of the data center in the future; a brochure on Galaxy’s site suggests a 15MW expansion is in the works the site was previously operated by Digital Realty as its LGW10 facility The data center is no longer listed on the company’s website A spokesperson confirmed to DCD it was Digital's site that has been sold but didn't provide any further details or comment Castleforge invests in real estate located in and around select UK and European cities This is seemingly the company’s first data center investment Castleforge partner Adam MacLeod said: “Data centers have been an attractive prospect that we have been monitoring for some time but with advancements in AI and cloud computing accelerating demand we have been eager to find the right opportunity in which to invest.” Part of investment firm Galaxy Capital Partners Galaxy Data Centers is a global data center operator and advisory provider founded in 2016 Galaxy Capital describes itself as an owner strategically located across North America is fully equipped to meet customers’ immediate needs we are exploring a 10-15MW build-to-suit expansion to ensure we can deliver the scale and enterprise customer needs of tomorrow in this rapidly evolving digital landscape.” The deal was brokered by CBRE. Paul Mortlock, senior director and head of European data center capital markets at CBRE, said on LinkedIn his team was "pleased" to conclude the deal and added that it "has value-added characteristics a 6.7MW turnkey facility" and "two powered shells.” Digital said it sold its site in Redhill for £64 million ($80m) Data Centre Dynamics Ltd (DCD), 32-38 Saffron Hill, London, EC1N 8FH Email. [email protected]DCD is a subsidiary of InfraXmedia TEL AVIV, Israel and RALEIGH, N.C., Aug. 29, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company") today reported its first half 2024 financial results and operational highlights "The first six months of this year have realized significant accomplishments laying the groundwork for numerous potential upcoming catalysts RedHill is now in possession of a promising advancing and largely financially de-risked development pipeline designed to address substantial and underserved indications in oncology nuclear/radioprotection and diabetes and obesity-related disorders," said Dror Ben-Asher "There is no doubt that the last four years have been a challenge primarily as a result of the pandemic's negative impact on our commercial launches in the United States in the first half of 2020 we have been turning the ship around and I am immensely proud of our team that works tirelessly to create opportunities deliver on plans and create value in the lab and in the clinic through new studies generating additional patents and publications identifying important new indications and forging the right partnerships for our assets while maintaining a market leadership position with Talicia We are executing on our plans to ensure a clear value-driven focus operational efficiency and financial streamlining with a low cost-base as well as a strengthened cash balance and solid control over all elements of our business." Financial results for the six months ended June 30 Net Revenues for the first half of 2024 were $2.6 million compared to $5.4 million for the first half of 2023 Talicia net revenues were $3.5 million for the six months ended June 30 compared to $5.1 million for the six months ended June 30 mainly due to a 26% decrease in gross revenues and a 9% increase in Gross-to-Net deductions $0.5 million of net revenues came from sales in the UAE in the first half of 2024 were down by approximately 12% mainly due to reduced promotion and marketing following employee terminations and other cost-cutting measures in the United States These measures had a significant positive impact on reducing expenses Movantik had negative net revenues of $0.9 million in the first half of 2024 compared to negative net revenues of $0.1 million in the first half of 2023 mainly due to returns related to sales in the second and third quarters of 2020 Gross Profit for the first half of 2024 was $1.2 million compared to $3 million for the first half of 2023 in line with the decrease in Net Revenues as explained above and primarily attributable to the reduction in Talicia prescriptions following employee terminations and other cost-cutting measures Research and Development Expenses for the first half of 2024 were $0.7 million as compared to $2.3 million for the first half of 2023 The decrease is mainly attributable to the costs from closing the RHB-204 clinical trial which were recognized in the first half of 2023 and General and Administrative Expenses for the first half of 2024 were $9 million compared to $19 million for the first half of 2023 This decrease was primarily due to downsizing the U.S workforce following the Movantik divestiture leading to lower payroll and related expenses Other Income – There was no other income for the first half of 2024 as compared to $43 million of other income for the first half of 2023 The other income recognized in the first half of 2023 was comprised of (i) $35.5 million from the divestiture of Movantik and (ii) $7.5 million from transitional services fees provided to the buyer of Movantik Operating Loss for the first half of 2024 was $8.4 million compared to operating income of $24.7 million for the first half of 2023 The difference is primarily attributable to the changes resulting from the divestiture of Movantik the previous year Excluding the other income from the Movantik transaction in 2023 the operating loss decreased by approximately $9.9 million from an operating loss of $18.3 million for the first half of 2023 reflecting the positive operating impact of the cost-cutting measures net for the first half of 2024 was $5.4 million compared to $26.3 million for the first half of 2023 the income recognized was mainly attributable to warrants' revaluation the income recognized was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC debt in exchange for the transfer of rights to Movantik.  Net Loss was $3.1 million for the first half of 2024 compared to net income of $51 million for the first half of 2023 This change was primarily attributable to the effects resulting from the sale of Movantik and ongoing cost-reduction measures Excluding the other income and financial income from the Movantik transaction in 2023 the net loss decreased by approximately $9.5 million from a net loss of $12.6 million for the first half of 2023 reflecting the positive net impact of the cost-cutting measures as compared to $23 million as of December 31 The decrease was primarily attributable to a reduction in the inventory balance due to sales as well as a reduction in right-of-use assets due to termination of car leases in the six months ended June 30 as compared to $21 million as of December 31 The increase is mainly due to higher allowance from deductions from revenues and increased warrant-related derivative liabilities partially offset by lower accounts payable accrued expenses and lease liabilities (due to the car leases' termination) Net Cash Used in Operating Activities for the six months ended June 30 compared to $17.8 million for the same period in 2023 The decrease in cash used was primarily due to settling pre-closing liabilities associated with Movantik and other operational activities in the six months ended June 30 this reduction is attributable to the cost-cutting measures mentioned above Net Cash Provided by Financing Activities for the six months ended June 30 comprised primarily of the net proceeds from securities offerings in the six months ended June 30 Net Cash Provided by Financing Activities was $4.8 million partially offset by the repayment of payables related to the purchase of intangible assets RedHill's pipeline is centered around opaganib[3] & RHB-107[4] host-directed small molecule drugs with demonstrated safety and efficacy profiles Both candidates are advancing in predominantly U.S they are in development for multiple oncology acute respiratory distress syndrome (ARDS) and radio/chemical protection (Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure) Being (i) easy to administer and distribute and (ii) viral mutation-resistant they are ideally suited for stockpiling strategies in the event of nuclear/chemical incidents and viral pandemic scenarios RHB-104[7]: Newly published positive Phase 3 data demonstrated 64% increased efficacy with RHB-104 in Crohn's disease RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases RedHill promotes the gastrointestinal drugs Talicia for the treatment of Helicobacter pylori (H for the treatment of travelers' diarrhea in adults[9] RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640) host-directed SPHK2 selective inhibitor with potential for pandemic preparedness government collaboration for development for Acute Radiation Syndrome (ARS) and a Phase 2 program in oncology; (ii) RHB-107 (upamostat) serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102 positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104 with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease statements regarding the progress of the research and development activities for opaganib and RHB-107 including (i) timing of opaganib's development for Acute Radiation Syndrome (ii) the potential market opportunity for opaganib and RHB-107 (iii) delays in the research and development activities for opaganib or RHB-107 including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment (iv) the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios and (v) non-dilutive development funding from RHB-107 and its inclusion in a key platform study that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study and that the Phase 2/3 COVID-19 study for RHB-107 may not be successful and and that additional COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation and market acceptance of the Company's therapeutic candidates and Talicia; (v) the Company's ability to successfully commercialize and promote Talicia and Aemcolo; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S Company contact: Adi FrishChief Corporate and Business Development OfficerRedHill Biopharma+972-54-6543-112[email protected] REDHILL BIOPHARMA LTD.CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)(Unaudited) INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) The accompanying notes are an integral part of these condensed consolidated financial statements REDHILL BIOPHARMA LTD.CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION(Unaudited) REDHILL BIOPHARMA LTD.CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS(Unaudited) Fair value gains on derivative financial instruments Decrease (increase) in prepaid expenses and other receivables INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD Decrease in lease liability (with corresponding decrease in right of use asset in amount of $170 in the six months ended June 30 and $4,117 in the six months ended June 30 2023) resulting from early termination of lease By: Charlie Sternberg RedHill Biopharma Ltd., a specialty biopharmaceutical company, has entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America, with Hyloris Pharmaceuticals SA for RedHill’s RHB-102 (Bekinda) “Ondansetron ER will be a valuable addition to supportive care in oncology and post-surgical settings where sustained relief from nausea is essential,” said Thomas Jacobsen “We are committed to delivering innovative solutions that enhance patient comfort and streamline therapy We look forward to collaborating with RedHill to bring this product to patients.” “Our new partners at Hyloris share our vision of RHB-102’s significant potential and we look forward to working with them to bring RHB-102 to patients worldwide,” said Dror Ben-Asher “This agreement follows the recent initiation of the Bayer-funded Phase 2 study of opaganib and darolutamide in advanced prostate cancer and is further demonstration of the potential of RedHill’s R&D pipeline Recent positive advice from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) provided a clear pathway for a UK Marketing Authorization Application (MAA) for RHB-102 (24 mg) for oncology support (CINV and RINV) in the UK Phase 3 and 2 studies for acute gastroenteritis & gastritis (24 mg) and IBS-D (12 mg) RHB-102 may also be used for post-operative nausea and vomiting (PONV) Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced except with the prior written permission of Rodman Media