Redhill Biopharma Ltd (RDHL)

Two things that shocked me.

1. Somebody is still willing to give them money.
2. The stock in not trading in the 60 cent range.

potential strategic product acquisition
Lots of potential indeed. Promises-promises.

The Company intends to use a portion of the net proceeds to support a potential strategic product acquisition and the balance for working capital, research and development and general corporate purposes.
No definitive acquisition agreement has been executed, and any such transaction would remain subject to completion of definitive documentation, financing and other customary conditions. There can be no assurance that any such transaction will be completed.

RedHill Biopharma Announces Up To $19.4 Million Private PlacementJune 18, 2026 8:00 AM
PR Newswire (US) $6 million upfront with up to approximately $13.4 million of potential aggregate gross proceeds upon the exercise in full of warrantsTEL AVIV, Israel & RALEIGH, N.C., June 18, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 8,571,429 American Depositary Shares ("ADSs") (or ADS equivalents in lieu thereof), each ADS representing ten thousand (10,000) ordinary shares of the Company, series A-1 warrants to purchase up to an aggregate of 8,571,429 ADSs and series A-2 warrants to purchase up to an aggregate of 8,571,429 ADSs, at a combined purchase price of $0.70 per ADS (or ADS equivalent in lieu thereof) and accompanying warrants in a private placement. The Series A-1 warrants have an exercise price of $0.86 per ADS, are exercisable immediately and have a term of five years following the Effectiveness Date (as defined below), and the Series A-2 warrants have an exercise price of $0.70 per ADS, are exercisable immediately and have a term of 18 months following the Effectiveness Date. The private placement is expected to close on June 22, 2026, subject to the satisfaction of customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.The gross proceeds to the Company from this offering are expected to be approximately $6 million, before deducting the placement agent's fees and other offering expenses payable by the Company. The potential additional gross proceeds to the Company from the series A-1 warrants and the series A-2 warrants, if fully exercised on a cash basis, will be approximately $13.4 million. No assurance can be given that any of the series warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the series warrants.The Company intends to use a portion of the net proceeds to support a potential strategic product acquisition and the balance for working capital, research and development and general corporate purposes.No definitive acquisition agreement has been executed, and any such transaction would remain subject to completion of definitive documentation, financing and other customary conditions. There can be no assurance that any such transaction will be completed.The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the ordinary shares of the Company represented by ADSs underlying the warrants, have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities issued in the private placement and ordinary shares of the Company represented by ADSs underlying the warrants may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. Pursuant to a registration rights agreement with the investors, the Company has agreed to file a resale registration statement covering the securities described above (such date of effectiveness of the resale registration statement, the "Effectiveness Date").This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.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 adults[1], with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-102 (Bekinda®), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.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, stock analysis, financial performance, investor relations, and market trends. 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, among others, the consummation of the offering and the satisfaction of customary closing conditions related to the offering, the use of proceeds therefrom, the potential exercise of the series warrants and potential proceeds therefrom, potential acquisition of strategic products, 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. 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, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions, the risk that the MAA submission for Talicia may not be approved; the risk that the Company will not succeed in its enforcement action against Kukbo, and if successful may not recover all or any of awards granted by the New York Supreme Court; the risk that opaganib does not receive a priority review voucher, marketing exclusivity or accelerated development and review times; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, 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) the Company's ability to collect on its judgment against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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, whether as a result of new information, future events or otherwise unless required by law.Category: Financials[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/1334141/5268648/RedHill_Biopharma_Logo.jpgCompany contact:Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
adi@redhillbio.com  View original content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-up-to-19-4-million-private-placement-302804327.htmlSOURCE RedHill Biopharma Ltd. Original: RedHill Biopharma Announces Up To $19.4 Million Private Placement

There is nothing to discuss its a dilute and put out fluff PR company and nothing more. Not one thing has changed in six years.If They ever have a legit pr you might be lucky enough to get a big bounce but you better sell fast because they will dilute it down again days later. I am amazed this are still operating honestly.

"Ditto!"

I came to the sad conclusion that discussing
RDHL is a sheer waste of time!

Dilute, dilute, dilute

They did not regain compliance so that is why they are doing fulff pr's
RedHill Biopharma (NASDAQ: RDHL) is currently in a 180-day compliance period to regain its minimum bid price of $1.00 per share. The company was notified by Nasdaq on April 8, 2026, that its shares traded below the required threshold for 30 consecutive business days. RedHill has until October 5, 2026, to fix the deficiency

If they did regain compliance they never did a PR on it so my guess is they did not.

It is comical at this point that they actually think fluff pr after fluff pr still works. Shows what they really have which is basically nothing.

As i previously wrote:
RDHL- a shlimazal company.

Put out another fluff PR and dilute like crazy. Never have even mentioned if they got compliance back or not. Amazing they claim to cure every disease in the world yet never make it past a fluff pr.

Crazy company!

My guess is they are diluting on the pr and that was the plan. They drove it down hard.

RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug DesignationJune 9, 2026 7:00 AM
PR Newswire (US) The U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation to opaganib1 for the treatment of neuroblastoma, a type of cancer most commonly affecting babies and young children--Rare pediatric disease designation provides for a Priority Review Voucher (PRV) subject to certain conditions --This new designation is in addition to opaganib's current neuroblastoma orphan drug designation, providing for potential benefits such as accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers, tax credits and seven-years' marketing exclusivity, if approved--New preclinical data, presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, showed positive effects of opaganib as a potential add-on therapy in models of neuroblastoma and triple-negative breast cancer (TNBC)2--The neuroblastoma market is expected to be valued at approximately $3.5 billion in 20323--Opaganib is a novel, potentially broad acting, oral, small molecule drug with demonstrated safety & efficacy profiles4. It is in development for multiple oncology, viral (including Ebola virus disease (EVD)), inflammatory and diabetes and obesity-related indicationsRALEIGH, N.C. and TEL-AVIV, Israel, June 9, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease (RPD) designation to opaganib for treatment of neuroblastoma (NB).  "Receiving a cancer diagnosis is always distressing, but when it involves your child, it becomes profoundly devastating. There is an ongoing necessity to explore new alternatives that can augment treatment and enhance results for neuroblastoma, the most prevalent cancer in infants. In data from models of high-risk NB (HRNB), presented at AACR 2026, we saw positive effects of opaganib as a potential add-on to chemotherapy, showing an ability to directly destabilize a key oncogenic driver of neuroblastoma and other solid tumors, n-Myc, through increased ceremide production enhancing programmed cancer cell death (apoptosis)," said Dr. Mark Levitt, Chief Scientific Officer at RedHill. "This rare pediatric disease designation, supported by data from NB and other preclinical oncology models, along with a clinically demonstrated safety and tolerability profile adds to our belief that opaganib holds promise for improving outcomes in treating pediatric NB. We aim to further advance development following ongoing discussions with Penn State University and the Beat Childhood Cancer consortium."The FDA grant of rare pediatric disease designation to opaganib provides for a Priority Review Voucher (PRV), subject to certain conditions, and with opaganib's current neuroblastoma orphan drug designation also allows for the potential for seven years' marketing exclusivity, if approved, accelerated development and review times, FDA Prescription Drug User Fee Act (PDUFA) application fee waivers and tax credits. The neuroblastoma market is expected to be valued at approximately $3.5 billion in 2032.Opaganib is a novel, potentially broad acting, oral, small molecule sphingosine kinase-2 (SPHK2) selective inhibitor drug with demonstrated safety & efficacy profiles. It is in development for multiple oncology, viral (including Ebola virus disease (EVD), inflammatory and diabetes and obesity-related indications.About NeuroblastomaNeuroblastoma is a type of cancer most commonly affecting babies and young children. While rare, neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6. Around 750 children in the United States are diagnosed with neuroblastoma each year7. Approximately half of all neuroblastoma patients have high risk (HRNB) disease which has an overall five-year survival of ~50%8.Neuroblastoma originates from immature nerve cells (neuroblasts), and most often forms in the adrenal glands - small organs that sit on top of the kidneys - but can also start in nerve cells in the abdomen, chest, neck, or pelvis. The exact cause of neuroblastoma is not well understood, but genetic mutations and abnormalities are known to play a role. Some cases may be linked to genetic syndromes or family history, although most occur sporadically without a clear inherited pattern.About Opaganib (ABC294640) Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral (including Ebola virus disease), inflammatory, metabolic (diabetes and obesity) and additional indications.Opaganib's suggested mechanism of action, published in the journal Drug Design, Development and Therapy, is host-directed and potentially broad-acting and is expected to maintain its effect against emerging viral variants. Opaganib is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing 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 prognosis9. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms.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 adults10, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations intended for medical countermeasure development including for Ebola virus disease, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-102 (Bekinda®), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.Visit www.redhillbio.com / X.com/RedHillBio for more information about the CompanyForward 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, stock analysis, financial performance, investor relations, and market trends. 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, among others, statements regarding the potential for the Company to succeed in its enforcement action against Kukbo and recovery any or all of the awards granted by the New York Supreme Court. 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, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company will not succeed in its enforcement action against Kukbo, and if successful may not recover all or any of awards granted by the New York Supreme Court; the risk that opaganib does not receive a priority review voucher, marketing exclusivity or accelerated development and review times; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, 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) the Company's ability to collect on its judgment against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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, whether as a result of new information, future events or otherwise unless required by law.Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
adi@redhillbio.com Category: R&D1Opaganib is an investigational new drug, not available for commercial distribution.
2Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879
3Evaluate Ltd
4Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi.org/10.3390/microorganisms12091767
5https://www.ncbi.nlm.nih.gov/books/NBK448111/#:~:text=Neuroblastoma%20is%20the%20most%20common,of%20pediatric%20cancer%2Drelated%20deaths
6Yan P, Qi F, Bian L, et al. Comparison of Incidence and Outcomes of Neuroblastoma in Children, Adolescents, and Adults in the United States: A Surveillance, Epidemiology, and End Results (SEER) Program Population Study. Med Sci Monit. 2020;26:e927218. Published 2020 Nov 29. doi:10.12659/MSM.927218.
7https://together.stjude.org/en-us/conditions/cancers/neuroblastoma.html
8Flaadt T, Rehm J, Simon T, Hero B, Ladenstein RL, Lode HN, Grabow D, Nolte S, Crazzolara R, Greil J, Ebinger M, Abele M, Holzer U, Döring M, Schulte JH, Bader P, Schlegel PG, Eyrich M, Lang P, Klingebiel T, Handgretinger R. Long-Term Outcomes and Quality of Life of High-Risk Neuroblastoma Patients Treated with a Multimodal Treatment Including Anti-GD2 Immunotherapy: A Retrospective Cohort Study. Cancers (Basel). 2025 Jan 5;17(1):149. doi: 10.3390/cancers17010149. PMID: 39796776; PMCID: PMC11720496.
9https://www.redhillbio.com/news/news-details/2025/RedHill-Announces-Initiation-of-Phase-2-Study-of-Opaganib-and-Darolutamide-in-Advanced-Prostate-Cancer/default.aspx
10Talicia® (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 View original content:https://www.prnewswire.com/news-releases/redhills-opaganib-receives-fda-rare-pediatric-disease-designation-for-neuroblastoma-in-addition-to-current-orphan-drug-designation-302795146.htmlSOURCE RedHill Biopharma Ltd. Original: RedHill's Opaganib Receives FDA Rare Pediatric Disease Designation for Neuroblastoma in Addition to Current Orphan Drug Designation

How very true, however RDHL has
something to PR every few months.
$RDHL - A shlimazal company.

They may never recover any of these and if they do it likely will not be for years

Recognition and enforcement efforts are ongoing. Following service of the complaint in Korea, the Company now awaits Kukbo's response in the Korean proceeding and the further scheduling of the matter by the Korean court. No assurances can be provided regarding the timing of any recovery or the amount that may be recovered, including whether the Company will recover all or any portion of the awarded amounts.

RedHill Launches Enforcement of $11 Million New York Supreme Court Final Judgment Against KukboJune 8, 2026 7:00 AM
PR Newswire (US) RALEIGH, N.C. and TEL-AVIV, Israel, June 8, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has commenced recognition and enforcement proceedings in Korea in respect of the New York Supreme Court's final judgment in favor of RedHill against Kukbo Co. Ltd ("Kukbo"), totaling approximately $10.9 million, and that Kukbo has now been served in those proceedings. In November 2025, the New York Supreme Court judgment on the principal award became final and eligible for enforcement and foreign recognition. The award to RedHill of legal fees and expenses is now also final following Kukbo's failure to perfect its appeal by the applicable deadline in March 2026. No further appeals are permissible with respect to either judgment.The Court awarded approximately $10.9 million in total to RedHill, comprised of the main judgment of approximately $8.9 million, and the award for legal fees and expenses of approximately $1.95 million, each including the principal amounts and accrued 9% statutory interest to date, which continues to accrue.RedHill had also previously secured a Korean court attachment grant against Kukbo aimed at preventing Kukbo from disposing of assets prior to judgment enforcement.Recognition and enforcement efforts are ongoing. Following service of the complaint in Korea, the Company now awaits Kukbo's response in the Korean proceeding and the further scheduling of the matter by the Korean court. No assurances can be provided regarding the timing of any recovery or the amount that may be recovered, including whether the Company will recover all or any portion of the awarded amounts.About RedHill BiopharmaRedHill 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 adults[1], with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations intended for medical countermeasure development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-102 (Bekinda®), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.Visit www.redhillbio.com / X.com/RedHillBio for more information about the CompanyForward-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, stock analysis, financial performance, investor relations, and market trends. 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, among others, statements regarding the potential for the Company to succeed in its enforcement action against Kukbo and recovery any or all of the awards granted by the New York Supreme Court. 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, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company will not succeed in its enforcement action against Kukbo, and if successful may not recover all or any of awards granted by the New York Supreme Court; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including  the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, 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) the Company's ability to collect on its judgment against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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, whether as a result of new information, future events or otherwise unless required by law. Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharmaadi@redhillbio.com 
Category: Corporate[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  View original content:https://www.prnewswire.com/news-releases/redhill-launches-enforcement-of-11-million-new-york-supreme-court-final-judgment-against-kukbo-302793864.htmlSOURCE RedHill Biopharma Ltd. Original: RedHill Launches Enforcement of $11 Million New York Supreme Court Final Judgment Against Kukbo

RedHill Biopharma Advancing Opaganib Options For Ebola Virus Disease OutbreakJune 3, 2026 12:04 PM
PR Newswire (US) Amid the rapidly evolving Ebola virus disease (EVD) outbreak involving the rare Bundibugyo ebolavirus sub-type, for which there are no approved medications or vaccines, RedHill Biopharma is actively discussing potential collaborations for clinical advancement of opaganib1, including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform Opaganib EVD rationale (analogous to EVD treatment pathway):Phase 3 clinical antiviral activity (severe COVID-19) showing2:  70.2% mortality reduction with opaganib given as add-on to best available standard of care (remdesivir + corticosteroids): 6.98% (n=3/43) opaganib + SoC vs. 23.4% (n=11/47) placebo + SoC (p=0.034))Improved median time to viral RNA clearance by ≥4 days in opaganib-treated patients (median 10 days vs. not reached by Day 14 in placebo, HR 1.34, p=0.043)Demonstrated safety and tolerability profile in 470 clinical trial participantsPreclinical EVD activity in USAMRIID-funded studies showed3:
Opaganib inhibition of EVD in human macrophagesIncreased survival for opaganib group (one of two animal models)4Synergistic effect when opaganib combined with Gilead Sciences' remdesivir (Veklury®)Opaganib's potential dual mechanism of action against EVD and filovirus-class activity5:   Opaganib's therapeutic target—SPHK2 inhibition—disrupts host-cell components essential for filovirus entry and replication that are conserved across FiloviridaePI3K/Akt pathway inhibition (required for filovirus entry and membrane trafficking)NLRP3 and IL-6/TNFa inflammasome suppression and S1P-mediated vascular permeability reduction (addressing immune dysregulation and vascular leak in viral hemorrhagic fever)Published literature explicitly validates sphingosine kinases as targets for filovirus inhibition6Opaganib, an investigational SPHK2 inhibitor drug, offers a novel potential approach to strengthen global infectious disease preparedness and biodefense:Host-directed therapeutic (HDT) – providing for a possible two-pronged approach to viral defense with potential for co-administration with direct-acting EVD-focused antivirals (i.e. Gilead's remdesivir and obeldesivir, Regeneron's maftivimab, and Mapp's MBP134) with minimal expected drug-drug interactionsOral administration, ease of storage and distribution supporting clinical evaluation and possible stockpiling requirements The Company has provided available supply readiness, safety and efficacy data to aid rapid discussions to enable clinical exploration of the potential synergies of opaganib host-directed therapy in addressing a growing global public health threatTEL AVIV, Israel and RALEIGH, N.C., June 3, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat EVD, which can be fatal in approximately half of all cases7, including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform and pharma collaborations. Gilead Raday, Chief Operating Officer and Head of R&D at RedHill said: "Opaganib sits in a distinct category as a host-directed agent which can be added to direct-acting antivirals, representing an opportunity to enhance global infectious disease preparedness and biodefense infrastructure against EVD, while also being preferentially suited to the logistical challenges found on the ground during these tragic outbreaks."Peer-reviewed published data shows opaganib's host-direction action stems from its ability to simultaneously inhibit three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), altering the cellular lipid balance and enabling inhibition of replication of viruses like SARS-CoV-2 and Ebola. In EVD specifically, opaganib offers a potential dual mechanism of action; blocking the PI3K/Akt pathway critical for filovirus entry and suppressing NLRP3 inflammasome and reducing IL-6/TNFa and S1P-mediated vascular permeability (addressing immune dysregulation and vascular leak).Proactively, and upon request, the Company has provided information to relevant government, industry and other organizations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions.Opaganib has demonstrated its safety and tolerability profile in more than 470 participants in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms2. Opaganib is an investigational new drug. It has not been approved by any regulatory authority and is not available for commercial distribution. Inclusion in the WHO CORE platform cannot be guaranteed. About RedHill BiopharmaRedHill 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. Visit www.redhillbio.com / X.com/RedHillBio for more information about the CompanyForward-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, stock analysis, financial performance, investor relations, and market trends. 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, among others, statements regarding the potential for opaganib to be accepted into Ebola virus disease control programs or, if accepted, the ability to demonstrate its efficacy. 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, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn's disease may not be completed, or if completed may not be approved or may not achieve commercial success;  the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including  the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, 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) the Company's ability to collect on its judgement against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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, whether as a result of new information, future events or otherwise unless required by law.Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
adi@redhillbio.comCategory: R&D1 Opaganib is an investigational new drug, not available for commercial distribution.2 Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi.org/10.3390/microorganisms120917673 Antiviral Activity of Opaganib, a First-in-class Sphingolipid Modulator. Rekha G. Panchal1*, Raina Kumar1, Eric Nguyen1#, LTC Jeffrey Kugelman1, Janet Skerry1, Xiaoli Chi1, Ashley Mcaleese1#, Aura R. Garrison, Mark Levitt, Gilead Raday, Patricia Anderson, Sara Johnston, Reza Fathi, LTC Robert Haupt United States Army Medical Research Institute of Infectious Diseases4 Repeat study showed 20% vehicle survival vs. 10% opaganib; mixed results across the two animal models (including the vehicle only group inter study variability) underscore model variability.5 Sphingosine Kinases Promote Ebola Virus Infection and Can Be Targeted to Inhibit Filoviruses, Coronaviruses, and Arenaviruses Using Late Endocytic Trafficking to Enter Cells. Corina M. Stewart, Yuxia Bo, Kathy Fu, Mable Chan, Robert Kozak, Kim Yang-Ping Apperley, Geneviève Laroche, Redaet Daniel, André M. Beauchemin, Gary Kobinger, Darwyn Kobasa, and Marceline Côté. ACS Infectious Diseases 2023 9 (5), 1064-1077. DOI: 10.1021/acsinfecdis.2c004166 Sphingosine Kinases Promote Ebola Virus Infection and Can Be Targeted to Inhibit Filoviruses, Coronaviruses, and Arenaviruses Using Late Endocytic Trafficking to Enter Cells. Corina M. Stewart, Yuxia Bo, Kathy Fu, Mable Chan, Robert Kozak, Kim Yang-Ping Apperley, Geneviève Laroche, Redaet Daniel, André M. Beauchemin, Gary Kobinger, Darwyn Kobasa, and Marceline Côté. ACS Infectious Diseases 2023 9 (5), 1064-1077. DOI: 10.1021/acsinfecdis.2c004167 https://www.who.int/health-topics/ebola#tab=tab_1Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg View original content:https://www.prnewswire.co.uk/news-releases/redhill-biopharma-advancing-opaganib-options-for-ebola-virus-disease-outbreak-302790437.html Original: RedHill Biopharma Advancing Opaganib Options For Ebola Virus Disease Outbreak

RedHill Biopharma Advancing Opaganib Options for Novel Dual Host Directed and Direct Acting Antiviral Approach for Ebola Outbreak Biodefense Platforms

Amid the rapidly evolving Ebola virus disease (EVD) outbreak involving the rare Bundibugyo ebolavirus sub-type, for which there are no approved medications or vaccines, RedHill Biopharma is actively discussing potential collaborations for clinical advancement of opaganib1, including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform

Opaganib EVD rationale (analogous to EVD treatment pathway):

Phase 3 clinical antiviral activity (severe COVID-19) showing2:

70.2% mortality reduction with opaganib given as add-on to best available standard of care (remdesivir + corticosteroids): 6.98% (n=3/43) opaganib + SoC vs. 23.4% (n=11/47) placebo + SoC (p=0.034))

Improved median time to viral RNA clearance by =4 days in opaganib-treated patients (median 10 days vs. not reached by Day 14 in placebo, HR 1.34, p=0.043)

Demonstrated safety and tolerability profile in 470 clinical trial participants

Preclinical EVD activity (United States Army Medical Research Institute of Infectious Diseases (USAMRIID)-funded studies showed3:

Opaganib inhibition of EVD in human macrophages

Increased survival for opaganib group (one of two animal models)4

Synergistic effect when opaganib combined with Gilead Sciences' remdesivir (Veklury®)

Opaganib's potential dual mechanism of action against EVD and filovirus-class activity5:

Opaganib's therapeutic target—SPHK2 inhibition—disrupts host-cell components essential for filovirus entry and replication that are conserved across Filoviridae

PI3K/Akt pathway inhibition (required for filovirus entry and membrane trafficking)

NLRP3 and IL-6/TNFa inflammasome suppression and S1P-mediated vascular permeability reduction (addressing immune dysregulation and vascular leak in viral hemorrhagic fever)

Published literature explicitly validates sphingosine kinases as targets for filovirus inhibition6

Opaganib, an investigational SPHK2 inhibitor drug, offers a novel potential approach to strengthen global infectious disease preparedness and biodefense:

Host-directed therapeutic (HDT) – providing for a possible two-pronged approach to viral defense with potential for co-administration with direct-acting EVD-focused antivirals (i.e. Gilead's remdesivir and obeldesivir, Regeneron's maftivimab, and Mapp's MBP134) with minimal expected drug-drug interactions

Oral administration, ease of storage and distribution supporting clinical evaluation and possible stockpiling requirements

With the WHO suggesting the current outbreak was outpacing response efforts7, the Company has provided available supply readiness, safety and efficacy data to aid rapid discussions to enable clinical exploration of the potential synergies of opaganib host-directed therapy in addressing a growing global public health threat

TEL AVIV, Israel and RALEIGH, N.C. , June 2, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it is actively discussing potential collaborations for advancement of its investigational oral drug, opaganib, to combat EVD, which can be fatal in approximately half of all cases8, including the World Health Organization's (WHO) SOLIDARITY CORE clinical trial platform and pharma collaborations. Opaganib is an easily stored, distributed and orally administered, host-directed, small molecule SPHK2 inhibitor with demonstrated antiviral properties in advanced clinical stage.

"Recent remarks from the WHO, and health authorities worldwide, point to the urgent need for options to combat the current Ebola outbreak, involving the rare Bundibugyo ebolavirus sub-type - which appears to be outpacing response efforts. Opaganib has shown a potential dual mechanism of action against EVD and filovirus-class activity, EVD-specific preclinical activity, showing inhibition of EVD, increased survival, and synergistic effects with directing acting antiviral therapy, significantly improving potency while maintaining cell viability, and clinical antiviral evidence of a 70.2% mortality reduction as add-on therapy to the remdesivir + corticosteroids subgroup in our Phase 3 severe COVID-19 trial. This along with its demonstrated clinical safety profile and ability to be easily stored, distributed and administered without the need for complex cold store distribution chains strongly supports the need for clinical evaluation of opaganib in light of the deadly current outbreak," said Gilead Raday, Chief Operating Officer and Head of R&D at RedHill. "Opaganib sits in a distinct category as a host-directed agent which can be added to direct-acting antivirals, representing an opportunity to enhance global infectious disease preparedness and biodefense infrastructure against EVD, while also being preferentially suited to the logistical challenges found on the ground during these tragic outbreaks."

Peer-reviewed published data shows opaganib's host-direction action stems from its ability to simultaneously inhibit three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS), altering the cellular lipid balance and enabling inhibition of replication of viruses like SARS-CoV-2 and Ebola. In EVD specifically, opaganib offers a potential dual mechanism of action; blocking the PI3K/Akt pathway critical for filovirus entry and suppressing NLRP3 inflammasome and reducing IL-6/TNFa and S1P-mediated vascular permeability (addressing immune dysregulation and vascular leak).

Proactively, and upon request, the Company has provided information to relevant government, industry and other organizations, regarding supply readiness and all available clinical and preclinical safety and efficacy data to aid rapid clinical and regulatory discussions.

Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications. Opaganib is an investigational new drug. It has not been approved by any regulatory authority and is not available for commercial distribution. Inclusion in the WHO CORE platform cannot be guaranteed.

About Ebola virus disease:

According to the Centers for Disease Control and Prevention (CDC), Ebola disease is a rare and often deadly illness, caused by infection by one of a group of four viruses, known as ebolaviruses. Transmission of the disease is mostly through contact with an infected animal (bat or nonhuman primate) or a sick or dead person infected with an ebolavirus. The course of the illness typically progresses from "dry" symptoms initially (such as fever, aches and pains, and fatigue) and then progresses to "wet" symptoms (such as diarrhea, vomiting and unexplained hemorrhaging, bleeding or bruising) as the person becomes sicker. Currently only Inmazeb™ (atoltivimab, maftivimab, and odesivimab-ebgn, Regeneron Pharmaceuticals, Inc.), a combination of three monoclonal antibodies and Ebanga™ (ansuvimab-zykl, Ridgeback Biotherapeutics, LP), a single monoclonal antibody, are FDA-approved to treat EVD. Both are intravenously administered, direct acting, monoclonal antibody antivirals that bind to glycoproteins on the Ebola virus's surface to prevent the virus from entering a person's cells. There is an urgent need for host-directed small molecule therapies that may be effective against multiple strains of ebolavirus, less likely to be impacted by viral mutation, and that are easy to store, distribute and administer, especially in areas where healthcare services and infrastructures may be sub-optimal.

Form 6-K

On May 7, 2026, RedHill Biopharma Ltd. (the “Company”) filed a prospectus supplement to increase the maximum aggregate offering amount of the American Depositary Shares, each representing ten thousand (10,000) of its ordinary shares, par value NIS 0.01 per share, that may be issued and sold from time to time under the At The Market Offering Agreement that the Company entered into with H.C. Wainwright & Co., LLC on February 3, 2025.

RedHill and U.S. Army Announce Opaganib and RHB-107 Combinations with Remdesivir Show Distinct Synergistic Effect Against Ebola

https://www.prnewswire.com/news-releases/redhill-and-us-army-announce-opaganib-and-rhb-107-combinations-with-remdesivir-show-distinct-synergistic-effect-against-ebola-302020104.html

In appropos Elbola outbreak in Congo

RedHill Biopharma : Corporate Presentation

https://www.marketscreener.com/news/redhill-biopharma-corporate-presentation-ce7f5bd3d18ff024

Published on 05/17/2026 at 07:21 am EDT

Corporate Presentation May 2026

Corporate Highlights
Emerging U.S. specialty biopharmaceutical company (Nasdaq: RDHL), primarily focused on U.S. commercialization and development of drugs for gastrointestinal (GI) diseases, infectious diseases and oncology

Strong U.S. Commercial Footprint and Robust Development Pipeline

Net Revenues FY 2025

$7.8M*

Late-Clinical-Stage Pipeline

Multiple de-risked programs and successfully completed Phase 3 studies

Strengthened

U.S. Commercial

Organization

Partnered with Cumberland Pharma for the co-commercialization of Talicia®

* Includes continuing and discontinued operations.

#1 branded H. pylori Rx among U.S. Gastroenterologists

Emerging U.S. Specialty Pharma: Select Programsi
Commercial Productii

Talicia® (H. pylori infection in adults) | U.S. Co-Commercialization Partnership with Cumberland Pharma.|

Development Pipeline

Preclinical Phase 1/2

Phase 3 NDA

Opaganib

(ABC294640)

Anticancer

Antiviral

Anti-inflammatory

Metabolic

disorders

Oncology

Virus-induced ARDS* Ebola virus

Diabetes and obesity

Phase 2 oncology programs

Phase 2/3 COVID-19 (ARDS)

Preclinical stage Preclinical stage

Includes the DARO LIPID Trial | ongoing Phase 2 combination study with Bayer's darolutamide in prostate cancer

GI-ARS† (Radioprotection)

Preclinical stage

Pursuing FDA Animal Rule pathway

RHB-102

(Bekinda®)iii

GLP-1/GIP-associated GI Intolerance

Gastroenteritis IBS-D

Oncology support

Planned Phase 2 proof-of-concept

Positive results from a first U.S. Phase 3 study Positive results from U.S. Phase 2 study

UK MAA‡ planned

In partnership with Hyloris Pharma. (ex-North America)

RHB-204

RHB-107

(upamostat)

Antiviral

Crohn's disease

Pulmonary NTM§ disease

COVID-19, Oncology/GI

Phase 2-stage Phase 3-stage

Phase 2 COVID-19, GI & oncology indications

* ARDS: Acute respiratory distress syndrome;

4

† GI-ARS: Gastrointestinal acute radiation syndrome; ‡ MAA: Marketing Authorisation Application; § NTM: Nontuberculous mycobacteria. i Estimated timeline/indication in the pipeline is subject to changes in development plans and regulatory requirements/clarifications, including complementary /additional studies; ii For full Talicia® prescribing information, see: www.talicia.com; iii Bekinda® (RHB-102) is the proposed tradename which is subject to FDA review and approval at the time of NDA filing.

Financial Highlightsi
RedHill Biopharma Ltd.

Nasdaq: RDHL

Market Cap (approx.)i $5.2 million American Depositary Shares (ADSs) (approx.) 5.2 million FY 2025 (Fiscal Year Ended Dec 31, 2025):

Cash Balanceii $4.1 million

Net Revenuesiii $7.8 million

Gross Marginiii 74.6%

Equity Financing Capacityiv $31.7 million

i Financial information as of May 8, 2026, unless otherwise noted. ii Including cash, cash equivalents, short-term bank deposits and restricted cash. iii Includes continuing and discontinued operations. iv "Any Market Purchase Agreement", announced in June 2025; SEPA (Standby Equity Purchase Agreement), announced

in December 2025. 5

Highly Experienced Senior Leadership
Dror Ben-Asher, Chief Executive Officer

P.C.M.I. Ltd.

Razi Ingber, Chief Financial Officer

PwC

Adi Frish, Chief Corporate & Business Development Officer

Y. Ben-Dror, MediGus

Gilead Raday, MSc, Mphil, Chief Operating Officer

Sepal Pharma, Charles Street Securities LLP

Rick D. Scruggs, President, RedHill Biopharma Inc. & Chief Commercial Officer

Salix, Watson, Oclassen

Guy Goldberg, Chief Business Officer

Eagle Pharma, ProQuest, McKinsey

Mark L. Levitt, MD, PhD, Chief Scientific Officer

NCI, Teva, Inotek, Immune Pharma

Reza Fathi, PhD, Senior VP R&D

XTL, PharmaGenics, Harvard Inst. of Chem. & Cell Biology

Patricia Anderson, Senior VP Regulatory Affairs

MAPI Group, OptumInsight, Bayer, Novopharm

6

Board of Directors*
Dror Ben-Asher, CEO

P.C.M.I. Ltd.

Kenneth Reed, MD

Dermatologist; Director Minerva Biotechnologies

Dr. Roni Mamluk, PhD

Ayala Pharmaceuticals, Chiasma

Shmuel Cabilly, PhD

Scientist, Director in several life-science companies

Rick D. Scruggs

Salix, Watson, Oclassen

Ofer Tsimchi

Danbar, Polysack, Director in several companies

* Includes select past positions

7

Significantly Strengthened U.S. Commercial Operations in Partnership with Cumberland Pharmaceuticals*†
U.S. Co-Commercialization Partnership Designed to:

Accelerate Talicia sales growth

Leverage Cumberland's expanded national GI sales promotion and marketing support

Deliver significant efficiencies through shared operational responsibility

"A strong growth opportunity for both companies"

A.J. Kazimi, CEO

Combined U.S. commercial operations focused on commercialization to thousands of gastroenterologists (GIs), advanced practice providers (APPs), and primary care providers (PCPs)

Indicated for the treatment of Helicobacter

pylori (H. pylori) infection in adults

U.S. launch in Q1/20

Leading Branded H. pylori Therapy among U.S.

Gastroenterologistsi

*RedHill announced on Oct 20, 2025, a strategic partnership with Cumberland Pharmaceuticals Inc., incl. $4 million strategic investment for a 30% ownership stake in RedHill's global Talicia business and co-commercialization agreement for Talicia (See PR here); Restructuring of the commercial operations is currently ongoing. † On April 23, 2026, Cumberland and Apotex, a Canadian-based global health company, announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex.

i IQVIA XPonent Plantrak 12 months ending September 2025 8

Indicated for the treatment of Helicobacter pylori infection in adults

Approved for Marketing by U.S. FDA Following Two Phase 3 Studies Launched in the U.S. and the United Arab Emirates (UAE)

Listed as First-Line Option for Treatment of H. pylori Infection in the 2024 American

College of Gastroenterology (ACG) Guideline*

*Chey WD, et al. ACG Clinical Guideline: Treatment of Helicobacter Pylori Infection. American Journal of Gastroenterology. 2024; 119(9): 1730-1753. 9

Talicia®- FDA-Approved for Treatment of H. pylori Infection in Adults
Approved Indication

Drug

Regulatory Status

Key Attributes

Market Exclusivity

Market Size

Treatment of H. pylori infection in adults

Omeprazole magnesium, amoxicillin and rifabutin 10.3 mg/ 250 mg/ 12.5 mg delayed-release capsulesi

- U.S. FDA approved (2019); United Arab Emirates (UAE) approved (2024); UK MAA* planned

High rates of H. pylori eradication (>90%) achieved in confirmed adherent populationi

Zero to minimal H. pylori resistance to rifabutin and amoxicillin reportedii

Simple regimen (all-in-one oral capsule) with a single prescription

Flexible dosing schedule (4 capsules TID at least 4 hours apart for 14 days)

Generic rifabutin is commercially available only as 150 mg capsules in the U.S. and is not therapeutically equivalent to the low-dose formulation of rifabutin found in Talicia (50 mg, TID)iii

- U.S. patent protection until 2042

- FDA QIDP designation granted, providing 8 years of market exclusivity (initially 3 years, extended by 5 under QIDP) through 2027

- Affects over 50% of the world populationiv, with ~1.6 million U.S. patients treated annuallyv

- High levels of government (7/10 lives) and commercial (6/10 lives) coverage

.i Each delayed-release capsule contains omeprazole 10 mg (equivalent to 10.3 mg omeprazole magnesium), amoxicillin 250 mg, and rifabutin 12.5 mg. ii Confirmed adherent population included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at Visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. ii Resistance rates as determined by in vitro testing of 345 H. pylori isolates collected at baseline from patients enrolled in the Talicia pivotal trial. iii Talicia 50 mg, three times daily (TID), had higher intragastric exposure times than 150 mg once daily or twice daily, or 300 mg once daily generic rifabutin; Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology & Therapeutics. 2023;58(2):159-167. iv Hooi JKY et

al. Global Prevalence of Helicobacter pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology 2017; 153:420-429. v IQVIA Custom Study for RedHill Biopharma, 2021. 10



H. pylori Overview and

Increasing Global Burden
FDA recognizes

IARC*/(WHO)

H. pylori is listed as a

WHO identifies antimicrobial

H. pylori as a potential

classifies H. pylori as

human carcinogen in the

resistance (AMR) as one of the

serious public health

a Group 1

HHS NTP 2021 HHS

top global public health and

threati

carcinogen

Report on Carcinogens

development threatsii

H. pylori is a gram-negative bacterium that colonizes gastric mucosa

Infection with H. pylori is the most common chronic bacterial infection in humansiii:

It affects over 50% of the global population; In the U.S., approx. 35% of the population are affectediv, with around 1.6 million patients treated annuallyv

Chronic H. pylori infection is the strongest known risk factor for gastric cancer, the 5th leading cause of cancer related deaths worldwide, accounting for almost 1 million new cases and over 1.3 million deaths in 2022vi

Confirmed eradication of H. pylori leads to a ~75% decreased risk of gastric cancervii

Infection is also associated with other conditions, including dyspepsia, peptic ulcer disease, primary gastric B-cell lymphoma, vitamin B12 deficiency, iron deficiency anemia and mucosa-associated lymphoid tissue (MALT) lymphomaviii

Commonly used therapies fail in approx. 25% to 40% of patients due to growing antimicrobial resistance of

H. pylori to regimens containing antibiotics such as clarithromycin and metronidazoleix

IARS: International Agency for Research on Cancer, the specialized cancer research agency of the World Health Organization (WHO). i FDA, Department of Health and Human Services. 21 CFR Part 317: Qualifying Pathogens That Have the Potential To Pose a Serious Threat to Public Health. eCFR. Available at: https://www.ecfr.gov/current/title-21/part-317. Accessed March 2025. ii World Health Organization. Antimicrobial Resistance. Fact Sheet, 21 Nov. 2023. World Health Organization, WHO, 2023. iii Chey WD, et al. ACG Clinical Guideline: Treatment of Helicobacter Pylori Infection. American Journal of Gastroenterology. 2024; 119(9): 1730-1753. iv Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420-429. v IQVIA Custom Study for RedHill Biopharma, 2021. vi World Cancer Research Fund. Stomach Cancer Statistics. WCRF, accessed 3 Dec. 2025. vii Kumar S, et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology. 2020;158(3).viiiVakil N, et al. Physiologically Based Pharmacokinetic Modeling and Simulation to Support a Change in the FDA-Labeled Dosing Frequency of RHB-105 Low-Dose Rifabutin Triple Therapy for Helicobacter pylori Eradication. J Clin Pharmacol. 2025; Malfertheiner et al. Nat Rev Dis Primers. 2024; National Toxicology Program. Report on Carcinogens, 15th ed. U.S. Dep. of Health and Human Services. 2021. Helicobacter pylori (Chronic Infection). ix Malfertheiner P. et al. Management of Helicobacter pylori infection - the Maastricht IV/ Florence Consensus Report. Gut. 2012;61(5):646-664; O'Connor A, et al. Treatment of Helicobacter Pylori Infection 2015. Helicobacter. 2015;20(S1):54-61; Venerito M, et al. Meta-Analysis of Bismuth

Quadruple Therapy versus Clarithromycin Triple Therapy for Empiric Primary Treatment of Helicobacter Pylori Infection. Digestion. 2013;88(1):33-45. 11



Talicia® - A Rational and Effective Choice for H. pylori Therapy

Recommended as

first-line treatment of

H. pylori in American College of

Gastroenterology

(ACG) Guideline

Only

all-in-one formulation with simplified dosing

Generically substituted rifabutin-triple therapy is not bioequivalent to Talicia®i

>90% H. pylori eradication in confirmed adherent population regardless of obesity/BMI or type 2 diabetes statusii

Safe and well-tolerated

in two U.S.

Phase 3 Trials

Addressing diminishing efficacy of SoC therapies due to growing

H. pylori

resistance

i Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology & Therapeutics. 2023;58(2):159-167. ii Kao, JY et al. Helicobacter Pylori Eradication by Low-dose Rifabutin Triple Therapy (RHB-105) Is Unaffected by High

Body Mass Index. GastroHep, 2021, 3(7), 426-434. 12







1st Line Use of Talicia® in Peer-Reviewed Literature and 2024 ACG Guidelinei
Talicia®: Listed as empiric first-line option by >15 peer-reviewed publications including the 2024 American College of Gastroenterology (ACG)

H. pylori Treatment Guideline



Furthermore, the 2024 ACG Guideline recommends against the use of clarithromycin as part of any treatment regimen without prior susceptibility testingi

Since Talicia® does not contain clarithromycin, there is no risk of possible clarithromycin resistance, eliminating the need for antimicrobial sensitivity testing prior to treatment

i Chey WO, Howden CW, Moss SF, et al. ACG Clinical Guideline: treatment of Helicobacter pylori infection. Am) Gastroenterol. 2024;1 12(9): 1730 -1753. 13



Talicia® Continues to Have Broad U.S. Managed Care Coverage
Talicia Access: More than 200 Million American Lives have Formulary Coveragei

Talicia Lives Covered • Talicia is Preferred on Aetna,

OptumRx, and Express Scripts

Commercial Formularies

7 out of

10 lives 6 out of

10 lives

Government Commercial

Talicia is covered on Medi-Cal, California's Medicaid Program, with no PA/ST or restrictions and a $0 copay

Talicia is now covered on Humana's Medicare Part D Formulary, the VA National Formulary, and Preferred on TennCare

i Estimated coverage based on Clarivate® Fingertip Formulary as of April 1, 2026.

14





ERADICATE Hp 2 Study: Positive Results
The ERADICATE Hp2 study met its primary endpoint with a high degree of statistical significance (p<0.0001)



Primary endpoint: ¹³C UBT at 43-71 days post treatment ITT analysis

Number of subjects: 455 in the U.S.

Eradication rate of 83.8% in the ITT population receiving Talicia vs. 57.5% with active comparator (?26.1%); p-value<0.0001

90% eradication based on adherence analysis (confirmed adherent population*) using protocol-defined population with evidence of drug ); p-value<0.0001

No safety signals reported

No AEs related to myelotoxicity

Well tolerated

n=228 n=227

ITT Population

n=207 n=184

Confirmed Adherent Population

IIT population included all randomized patients who received at least one dose of study drug; Confirmed adherent population included those subjects in the ITT population who had demonstrated

presence of any component of investigational drug at Visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose.

15





Resistance Patterns in Pivotal Study Demonstrate Zero to Negligible Resistance For Component Antibiotics in Talicia®i
across 20 U.S. states and tested for antibiotic resistance

Results confirmed high resistance of H. pylori to antibiotics com other therapies vs. zero to negligible resistance for the compon Talicia®:

monly used in ent antibiotics in

Antibiotics Commonly Used in Other Therapies

Antibiotics Contai

ned in Talicia®

Antibiotic

H. Pylori Resistance Rate

Antibiotic

H.

Pylori Resistance Rate

Clarithromycin

(n=345)

60 (17.4%)

Rifabutin (n=345)

0 (0%)

Metronidazole (n=344)

150 (43.6%)

Amoxicillin (n=345)

22 (6.4%)

345 H. pylori isolates were collected at baseline from treatment naïve patients

i Hulten, K. G., et al. National and regional US antibiotic resistance to Helicobacter pylori: Lessons from a clinical trial. Gastroenterology.

2021.161(1), 342-344.e1. 16





Positive Supportive First Phase 3 Study
A Randomized Placebo-Controlled Phase 3 Study (ERADICATE Hp) to Assess the Safety and Efficacy of Talicia® in the Treatment of Confirmed H. pylori Infection in Dyspepsia Patients, Regardless of Ulcer Status

Number of Subjects Treatment Duration

118 in the U.S. 14 days

Primary Endpoints

The occurrence of H. pylori eradication as confirmed via 13C UBT testing 28-35 days after completion of treatment

Greater eradication of H. pylori infection over historical standard of care efficacy levels of 70% effectiveness

Positive Phase 3 Results

Study met protocol-defined primary endpoint - demonstrating 89.4% efficacy in eradicating H. pylori infection (p< 0.001) in the mITT populationi

63% eradication rate demonstrated in open-label treatment of treatment naïve placebo-arm patients with physician choice therapy (mostly clarithromycin triple therapy) for persistent H. pylori infection

No serious adverse events related to the drug were noted in the study

i mITT Population included those subjects who completed the study and returned for a follow-up test of cure. 17





IP - Strong Protection from Competition and Substitution
Talicia® is covered by a portfolio of U.S. patents, including those for its unique 'all-in-one' capsule formulation and distinct PK profile, among others, with the latest patent set to expire in 2042; Additional patents have been granted and more applications are pending in various territories worldwide

FDA QIDP designation granted, providing 8 years of market exclusivity

(initially 3 years, extended by 5 under QIDP) through 2027

Generically substituted rifabutin-triple therapy is not bioequivalent to Talicia®i

- Unique low-dose (50 mg TID) rifabutin formulation is not commercially

available and cannot be replicated by prescribers

Indication allowing unique labeling, marketing and promotional opportunity

'All-in-one' easy to use regimen with single co-pay preferred over more cumbersome regimens

i Howden CW, et al. Physiologically-based Pharmacokinetic Modelling to Predict Intragastric Rifabutin Concentrations in the Treatment of Helicobacter Pylori Infection. Alimentary Pharmacology &

Therapeutics. 2023;58(2):159-167. 18



Talicia® (omeprazole magnesium, amoxicillin and rifabutin) -

Important Safety Information

Talicia® contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity to any of these medications, any other components of the formulation, any other beta-lactams or any other rifamycins.

Talicia® is contraindicated in patients receiving delavirdine, voriconazole or rilpivirine-containing products.

Serious and occasionally fatal hypersensitivity reactions have been reported with the components of Talicia®: omeprazole, amoxicillin and rifabutin.

Severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) and toxic epidermal

necrolysis (TEN) have been reported with the components of Talicia®: rifabutin, amoxicillin, and omeprazole. Drug-induced enterocolitis syndrome (DIES) has been reported with use of amoxicillin, a component of Talicia. Acute Tubulointerstitial Nephritis has been observed in patients taking PPIs and penicillins.

Clostridioides difficile - associated diarrhea has been reported with use of nearly all antibacterial agents and may range from mild diarrhea to fatal colitis.

Talicia® may cause fetal harm and is not recommended for use in pregnancy. It may also reduce the efficacy of hormonal contraceptives. An additional non-hormonal method of contraception is recommended when taking Talicia®.

Talicia® should not be used in patients with hepatic impairment or severe renal impairment.

Cutaneous lupus erythematosus and systemic lupus erythematosus have been reported in patients taking PPIs.

These events have occurred as both new onset and exacerbation of existing autoimmune disease.

The most common adverse reactions (=1%) were diarrhea, headache, nausea, abdominal pain, chromaturia, rash, dyspepsia, oropharyngeal pain, vomiting, and vulvovaginal candidiasis.

Please also see complete Prescribing Information 19



RHB-102 (Bekinda®) - In partnership with Hyloris Pharma (ex-North America)

GLP-1/GIP-associated GI Intolerance

Planned Phase 2 proof-of-concept (PoC) study

Gastroenteritis & gastritis

First U.S. Phase 3 study successfully completedii

Irritable bowel syndrome with diarrhea (IBS-D)

U.S. Phase 2 study successfully

completed; Phase 3 ready

Oncology support

UK MAA* planned

Opaganib (ABC294640)

Prostate cancer

Ongoing Phase 2 study evaluating opaganib

in combination with Bayer's darolutamide

Cholangiocarcinoma

Phase 2a study completed

Neuroblastoma and chronic lymphocytic leukemia

Preclinical data support potential as an add on therapy; neuroblastoma: Phase 2 ready

Virus-induced ARDS† (incl. COVID-19 & influenza)

Phase 2/3 readyiii; Phase 2/3 study in hospitalized COVID-19 patients completed

Ebola virus disease and other viral infections

Preclinical stage

Additional preclinical evaluation ongoing with NIAID for various antiviral indications

Metabolic disorders (diabetes and obesity)

Preclinical stage

GI-ARS‡

Preclinical stage, with development under FDA Animal Rule

Inflammatory bowel disease

Phase 2 ready

RHB-107 (upamostat)

COVID-19 (symptomatic outpatients)

Phase 2a study successfully completed

Included in a separate U.S. Gov.-supported Phase 2 platform trial for early COVID-19 outpatient treatment (PROTECT study) - study terminated

Influenza

Preclinical stage

Pancreatic & breast cancer

Phase 2 PoC study completed

R&D Pipeline Overviewi
RHB-204

Crohn's disease

Phase 2 study planned

Pulmonary nontuberculous mycobacterial (NTM) disease

Phase 3-stage

*MAA: Marketing Authorisation Application. † ARDS: Acute respiratory distress syndrome; ‡ GI-ARS: Gastrointestinal acute radiation syndrome.

i Additional elaborated information can be found in this presentation and RedHill's ongoing public filings. ii Confirmatory Phase 3 study is required and planned to support a potential NDA for RHB-102 (24 mg) for acute gastroenteritis

and gastritis. iiiData obtained from the Phase 2/3 COVID-19 study to support the potential Phase 2/3 study ARDS. 20



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Redhill Biopharma Ltd. published this content on May 17, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 17, 2026 at 11:20 UTC.

© Publicnow - 2026

Seems the short attacked failed,
RDHL still above $1.
Hurray

Big short attack today to make sure she does not regain compliance. Just typical.

Here is yet another day with sp
above $1

Well, at least another day with sp of over $1

I do not even read these anymore as they are usually just fluff. I look at the stock price and if it has not jumped 30% I know the news was just another fluff PR.

Perhaps this news piece will keep the boost momentum going?

RedHill's RHB-204 Demonstrates Comparable MAP Killing Efficacy to RHB-104 - Important Step in RHB-204 Development for MAP-related Crohn's Disease

https://finance.yahoo.com/sectors/healthcare/articles/redhills-rhb-204-demonstrates-comparable-110000165.html

RHB-2041 is a next-generation optimized formulation of RedHill's oral RHB-1042, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD)

In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048)3

New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1044. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects

Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease. With discussions ongoing and grant application submitted, funding for this program is planned to be non-dilutive

Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC5

The multibillion-dollar CD market is expected to grow from $13.6 billion in 2024 to over $19 billion in 2033 in key markets,6 presenting a significant opportunity for new FDA-approved therapies

RALEIGH, N.C. and TEL AVIV, Israel, April 30, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking MAP-targeted therapeutic approach to the treatment of Crohn's disease (CD).

The comparability results were achieved in both spot and phage assays of several different MAP strains. Importantly, the MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of the potential for reduced toxicity and side effects.

"As published in the peer-reviewed journal, Antibiotics3, RedHill's RHB-104 had previously delivered positive Phase 3 results showing a statistically significant 64% improvement in efficacy in treating CD using this potentially transformative MAP-targeted approach, achieving the primary endpoint of induction of clinical remission at week 26 (p = 0.0048). The demonstration of RHB-204's comparability to RHB-104 is an important step forward in the ongoing development of RHB-204 for MAP-related CD, following the pathway to approval guided by the FDA at our positive meeting," said Reza Fathi, PhD, Senior VP, R&D at RedHill. "Up to 40% of CD patients fail to respond to anti-TNF treatment, and over time a similar number of responders lose response and have disease flare-ups7. Many existing treatment options are both expensive and intravenously administered, further increasing the cost burden. Moreover, several of these existing therapies have known safety issues, including Black Box Warnings. A safe and effective orally administered therapy would provide a welcome alternative approach."

A planned Phase 2 study of RHB-204 in CD is expected to be the first clinical study in a specifically defined MAP-positive CD patient population. There is a significant body of peer reviewed published research supporting the scientific rationale that MAP may be a root cause of CD8, however, a major hurdle in previous clinical studies for new therapies directed at MAP has been the ability to rapidly and accurately detect MAP – one of the slowest growing and hard to detect bacteria on the planet. This study, along with RedHill's collaborations with two leading European academic centers for the provision of cutting-edge MAP detection diagnostics, which support the study's novel design and the potential future commercial application of RHB-204, represents a groundbreaking approach that could potentially make RHB-204, if approved, an exciting new therapy treating both the suspected cause of the disease and its symptoms.

RedHill is actively pursuing partnerships and collaborations for this program, including via an innovation development grant application, which has already been submitted. In addition, RedHill is engaging in ongoing discussions with non-dilutive external funding sources.


The development of RHB-204 is supported by a strong foundation of published clinical efficacy and safety data from the randomized, double-blind, placebo-controlled 331-patient Phase 3 study of RHB-104 in active CD, which successfully met its primary and secondary endpoints, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, achieving clinical CD remission at week 26 (the primary endpoint) in 36.7% of the RHB-104-treated group compared to 22.4% in the placebo (standard of care only) group3. The Phase 3 study also demonstrated the safety and efficacy of concomitant use of RHB-104 with anti-TNFs, immunomodulators and steroids, suggesting that RHB-204 could be a transformative safe and effective, stand-alone or combination, oral therapy3.

The CD market is expected to expand significantly through 2033, with sales in the United States, Japan, and five major European markets, growing from $13.6 billion to $19.1 billion at a compound annual growth rate (CAGR) of 3.87%5.


About RHB-204

RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease.

Patent protected until at least 2041, and with an expected pediatric orphan designation (subject to the U.S. Food and Drug Administration (FDA) approval to transfer from RHB-104), RHB-204 is a next-generation formulation of RHB-104 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, and with an optimized dosing profile, 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.

Originally developed for the treatment of pulmonary non-tuberculous mycobacteria (NTM) disease caused by Mycobacterium avium complex (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), extending U.S. post-approval U.S. 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. Where applicable, 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.

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, severe diarrhea, fatigue, weight loss and malnutrition. 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. It is estimated that 1 million Americans9 and approximately 6-8 million people globally have Crohn's disease10.

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).

A few more days over $1 and RDHL
regains Naz compliance.

Something is holding it up so far just not sure what

Seems to me that the financial report
looks slightly ever, hence a possible
explanation the sp holds.

They are likely trying to keep it over a buck to regain compliance and then they will go hard with the dilution. Rinse and repeat.

RedHill Biopharma Announces Full-Year 2025 Financial Results and Operational Highlights

Mon, April 27, 2026 at 3:00 PM GMT+3 26 min read

2025 was a year of tenacity, strategic transactions and building traction for RedHill
Talicia® business transformed:

Formation of Talicia Holdings Inc. (THI) and the U.S. co-commercialization partnership with Cumberland Pharmaceuticals ("Cumberland") (Nasdaq: CPIX), including Cumberland's $4 million investment for a 30% equity interest in THI planned to drive Talicia growth, and potentially additional revenue generating products. Cumberland and Apotex1, Canadian-based global health company, have since announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex

Added eight million lives with coverage by Humana®'s Part D Plan and published new data supporting Talicia's FDA-approved label change to a more convenient three-times daily Talicia dosing routine

Expanded Talicia activities in the Middle East, which included licensing for new Middle East markets, generated revenue of approximately $1.9 million in 2025 within discontinued operations

Targeting Talicia global market expansion in the UK with submission of fast-track Marketing Authorisation Application (MAA) imminent

R&D pipeline focus and progress:

RHB-204 for Crohn's disease (CD) advancing in accordance with FDA feedback on its pathway to approval as well as two new lab collaborations signed with work ongoing for MAP killing preclinical testing and development of rapid and accurate detection diagnostics

Opaganib's potential as a key add-on therapy in oncology progressing with a Phase 2 combination study of opaganib and darolutamide (Bayer' fast growing blockbuster drug) in advanced prostate cancer (mCRPC), with expanded sites and ongoing recruitment; Additionally, new preclinical data supporting opaganib potential as add-on therapy in Chronic Lymphocytic Leukemia (CLL)2, neuroblastoma3 and Triple Negative Breast Cancer4 therapy was reported

Discussions for further development of opaganib in neuroblastoma ongoing with Penn State University, Beat Childhood Cancer and Apogee, with potential for priority review voucher

RHB-102 (Bekinda®) being advanced as a late-stage potential therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects (e.g., nausea, vomiting and diarrhea)


Corporate opportunity unlocked:

RHB-102 (Bekinda) licensed to Hyloris (excluding North America) for up to $60 million in potential milestone payments plus royalties

$10 million line of credit agreed with Alumni Capital LP providing the right to sell up to $10,000,000 of American Depositary Shares (ADSs) to Alumni as part of the Any Market Purchase Agreement

More than $10.5 million awarded to RedHill in Kukbo Co. Ltd. New York Supreme Court rulings, which are now final and eligible for enforcement, with collection remaining subject to future realization

2025 ended with positive equity of $4.3 million, compared to a capital deficiency of $4.7 million at year end 2024

Cash balance of $4.1 million as of December 31, 20255

TEL AVIV, Israel and RALEIGH, N.C., April 27, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full-year 2025 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2025.

RedHill Biopharma Logo
RedHill Biopharma Logo
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "2025 was not an easy year in our industry, but for RedHill it was a year that demonstrates our business tenacity, the strategic transactions that we successfully accomplished and the traction we have achieved in progressing key commercial, R&D and financial objectives. Through the partnership with Cumberland, we have transformed the Talicia business creating a strong new partnership powered to drive increased sales, strengthen our balance sheet and provide a platform for future growth and market expansion."


Mr. Ben-Asher continued: "We have carefully and intentionally focused our R&D pipeline: demonstrating opaganib's potential to augment current standard of care therapies across multiple oncology indications; taking major steps in a ground-breaking new approach to Crohn's disease, with the FDA providing positive feedback on RHB-204's pathway to approval and signing breakthrough collaborations in MAP detection diagnostics; and driving the emergence of RHB-102 (Bekinda) as a potential answer to GLP-1/GIP-related nausea, vomiting and diarrhea - one of the biggest growth restrictors in the $100 billion GLP-1 market."

In summarizing 2025, Mr. Ben-Asher added: "We have unlocked significant opportunity for the Company through strategic transactions like the Cumberland partnership and the ex-North America licensing of RHB-102 (Bekinda) to Hyloris for up to $60 million in potential milestone payments plus royalties. We demonstrated our tenacity and clear adherence to our agreements in successfully winning and defending the New York Supreme Court's more than $10.5 million ruling against Kukbo, making it now final and eligible for enforcement, though collection remains subject to future realization. We have ended the year better positioned than we started. Having reshaped the Talicia business, improved our balance sheet, transitioned to a leaner and optimized operational footprint and sharply focused our R&D efforts, we are now on stronger footing for further growth."

Financial results for the 12 months ended December 31, 20256

Following the Cumberland transaction in October 2025, RedHill's direct Talicia commercial operations were transferred to Talicia Holdings Inc. ("THI"), a 70%-owned jointly controlled venture. As a result, those operations are presented as "discontinued operations" in RedHill's 2025 financial statements for accounting purposes. The year-over-year comparison below is therefore presented on a continuing operations basis, which reflects RedHill's non-Talicia activities only. RedHill's ongoing economic participation in the Talicia franchise going forward is reflected separately as its share of results of the joint venture. Prior period results have been recast accordingly.

Revenues for the year ended December 31, 2025, were $0.3 million, generated from the Hyloris license for RHB-102 (Bekinda), compared to no revenues for the year ended December 31, 2024.

Research and Development Expenses for the year ended December 31, 2025, were $2.0 million, as compared to $1.6 million for the year ended December 31, 2024. The increase was mainly driven by costs related to clinical activities.

General, Administrative and Business Development Expenses for the year ended December 31, 2025, were $6.2 million, compared to $4.9 million for the year ended December 31, 2024. The increase was primarily attributable to legal expenses related to the Kukbo litigation.

Share of loss of joint venture for the year ended December 31, 2025, was $33 thousand, representing RedHill's 70% share of the net loss of THI, the joint venture formed in September 2025 with Cumberland Pharmaceuticals. This reflects less than three months of THI's activity post-closing. Under the joint commercialization agreement, THI is entitled to 50% of Cumberland's net revenues from Talicia sales in the U.S., and RedHill participates in that economic activity through its 70% interest in THI.

Operating Loss for the year ended December 31, 2025, was $7.9 million, compared to Operating Loss of $6.5 million for the year ended December 31, 2024. The difference is primarily attributable to an increase in operating expenses, as detailed above.

Financial Expenses, net for the year ended December 31, 2025, were $0.1 million, compared to Financial Income, net of $6.8 million for the year ended December 31, 2024. The income recognized in the year ended December 31, 2024, was primarily driven by the revaluation of financial instruments, partially offset by other financing expenses.

Net loss from continuing operations was $8.1 million for the year ended December 31, 2025, compared to net income from continuing operations of $0.4 million for the year ended December 31, 2024. The change was primarily attributable to the absence of significant financial income recognized in 2024 from the revaluation of financial instruments, together with higher operating expenses in 2025.

Net income from discontinued operations was $7.7 million for the year ended December 31, 2025, compared to net loss from discontinued operations of $8.6 million for the year ended December 31, 2024. The change was primarily attributable to the gain recognized upon loss of control of THI in 2025, and a decrease in other operating expenses.

Total assets as of December 31, 2025, were $25.3 million, compared to $18.0 million as of December 31, 2024. The increase was primarily attributable to the Company's investment in a joint venture as part of the Talicia Holdings transaction.

Total liabilities as of December 31, 2025, were $21.1 million, compared to $22.7 million as of December 31, 2024. The decrease was primarily attributable to a reduction in allowance for deductions from revenues and a decrease in derivative financial instrument liabilities, partially offset by an increase in lease liabilities.

Net Cash Used in Operating Activities for the year ended December 31, 2025, was $9.7 million, compared to $9.4 million for the year ended December 31, 2024. The cash used in operating activities was primarily directed toward settling pre-closing liabilities related to Movantik® and other operational activities.

Net Cash Provided by Investing Activities for the year ended December 31, 2025, was $1.7 million, primarily related to the proceeds from the investment in a joint venture, compared to an immaterial amount used in investing activities for the year ended December 31, 2024.

Net Cash Provided by Financing Activities for the year ended December 31, 2025, was $7.3 million, primarily generated through equity offerings and exercise of certain warrants. Net Cash Provided by Financing Activities for the year ended December 31, 2024, was $8.4 million, primarily generated through equity offerings.

Cash Balance as of December 31, 2025, was $4.1 million5.

2025 Corporate, Commercial and R&D Highlights:

Corporate – opportunity unlocked:

In 2025, RedHill successfully completed several important strategic transactions and won a significant court case against Kukbo, unlocking significant opportunity across our business:

In October 2025 the Company announced it had secured a $4 million strategic investment and U.S. co-commercialization partnership deal with Cumberland Pharmaceuticals for Talicia. The $4 million investment, to acquire a 30% ownership stake in RedHill's global Talicia business, is payable in two equal tranches, $2 million of which was paid at closing and $2 million to be paid within 12 months of execution of the definitive agreements. RedHill and Cumberland have also entered into an Exclusive Joint Commercialization Agreement for Talicia in the United States with an equal sharing of the product's net revenues. Subsequent to this, in February 2026, the Company announced the full sales and operational launch of Talicia, by Talicia Holdings Inc. ("THI"), a RedHill and Cumberland jointly controlled operating entity with a 70/30 RedHill/Cumberland ownership, supporting accelerated market penetration and expanded reach. Cumberland and Apotex have since announced their planned strategic transaction to integrate Cumberland's U.S branded business into Apotex.

Earlier, in February 2025, the Company announced another transaction, licensing RHB-102 (Bekinda) for commercialization worldwide, excluding North America, to Hyloris Pharmaceuticals for up to $60 million in potential milestone payments plus royalties. Under the terms of the deal, Hyloris paid RedHill an upfront payment and will pay up to $60 million in potential milestone payments, plus up to mid-20s percent royalties on revenues, contingent upon achieving specified commercial targets, in return for exclusive rights to develop and commercialize RHB-102 (Bekinda) across all indications and territories outside the United States, Canada and Mexico.

A third deal was signed in October 2025, amending the existing Middle East licensing agreement to expand Talicia's entry into additional Middle East markets. Under the terms of the amendment, RedHill will receive $500,000 in guaranteed payments, including a $250,000 upfront payment and $250,000 in fixed payments due within 18 months, plus a minimum of $1.3 million in near-term potential milestone payments, as well as tiered royalties up to mid-teens percent on Talicia net sales. In August 2025, the Company had also announced receipt of licensing payments from the original Middle East agreement totaling $1.1 million.

In June 2025, the Company entered into an Any Market Purchase Agreement (the "Purchase Agreement") with Alumni Capital LP, a Delaware limited partnership (the "Purchaser"). Pursuant to the Purchase Agreement, the Company has the right, but not the obligation, to sell to the Purchaser, from time to time, up to $10,000,000 of American Depositary Shares ("ADSs"), each representing 10,000 ordinary shares ("Ordinary Shares"), par value NIS 0.01 per share, of the Company, subject to the terms and conditions set forth in the Purchase Agreement.

In November 2025, the Company also announced that the New York Supreme Court's approximately $10.5 million summary judgment in favor of RedHill against Kukbo is now final and eligible for enforcement and foreign recognition, with no further appeal permissible following expiry of the appeal period. Collection of the award and associated legal fees and costs, which were also awarded to RedHill, remain subject to future realization, and no related receivable has been recognized in the financial statements.

Commercial – a transformed Talicia business:

Following the transaction with Cumberland, at the Talicia business level, which is distinct from RedHill's 2025 continuing operations, Talicia generated net revenues of approximately $8.9 million in the U.S. in 2025 (including Cumberland's post-closing net revenues), and approximately $1.9 million in ex-U.S. licensing, product supply and royalties. This included revenues under our October 2025 amendment to the Middle East licensing agreement, a deal worth potentially $1.8 million plus sales royalty payments.

In January 2025, eight million lives were covered with Humana's addition of Talicia to its Medicare Part D Formulary. New data describing the foundations for Talicia's FDA-approved label change to a more convenient three-times daily (TID) "breakfast, lunch, and dinner" dosing routine, supporting patient adherence, were published in the Journal of Clinical Pharmacology. Talicia remains the leading U.S. gastroenterologist-prescribed branded H. pylori therapy.

RedHill continues to pursue acquisition of additional commercial products through licensing or promotion transactions, asset purchases, joint ventures, acquisitions, mergers or other business combinations involving companies with rights to commercial GI and other relevant assets. The Company intends to pursue such opportunities in the United States and, if available, in other jurisdictions.

R&D - focused on new opportunities:

With multiple externally funded Government and non-governmental collaborations, RedHill's pipeline provides new and exciting opportunities in major indications, with multiple oncological indications alongside Crohn's disease, diabetes and obesity-related disorders, viral and other gastrointestinal uses:

Opaganib7:

A potentially broad acting, novel, oral, host-directed small molecule drug, with a demonstrated safety and efficacy profile, advancing in largely externally funded programs directed at multiple underserved oncology, viral, inflammatory and diabetes and obesity-related indications, with sizeable multi-billion-dollar markets:

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, causing almost 400,000 deaths8. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them.

In February 2025, 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. In July 2025, the Company further announced initiation of recruitment and an expansion of recruiting sites.

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).

Additional opaganib oncology and other updates include:

In April 2026 two posters outlining data showing opaganib enhances efficacy of neuroblastoma chemotherapy combination and augments anti-tumor immunity in triple-negative breast cancer in preclinical studies were presented at the American Association of Cancer Research (AACR) annual meeting. Orphan drug designation for opaganib was previously granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology)

Discussions for further development of opaganib in neuroblastoma ongoing with Penn State University, Beat Childhood Cancer and Apogee, with potential for priority review voucher

In December 2025, RedHill reported additional preclinical data that opaganib reduces venetoclax resistant cells in chronic lymphocytic leukemia (CLL)

Positive in vivo study results supporting the potential of opaganib therapy in diabetes and obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade - were published in the journal Diabetes, Metabolic Syndrome and Obesity in an article entitled "Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance"9.

Pre-clinical testing of opaganib in metabolic disease (Obesity, T2D and Fatty Liver Disease) following prior publication of promising results continues

Programs in Ebola, acute respiratory distress syndrome (ARDS, COVID-19 and Influenza continue to seek to address important markets worth multiple hundreds of millions of dollars

RHB-20410:

RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, 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).

Patent protected until at least 2041, 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, and with an optimized dosing profile, 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 Crohn's disease treatment approach

In March 2025, 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. In July 2025, the Company further updated that it had received positive FDA feedback on the pathway to approval of RHB-204 for CD and had initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP killing detection diagnostics - the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program.

The planned innovative Phase 2 study of RHB-204 is expected to be the first clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population. The study intends to utilize 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.

RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment.

RHB-102 (Bekinda)11 update:

RHB-102 (Bekinda) is a proprietary, advanced clinical-stage, once-daily, bimodal extended-release, oral tablet formulation of 5-HT3 antagonist, ondansetron, targeting oncology support, acute gastroenteritis and gastritis, IBS-D and GLP-1/GIP-associated gastrointestinal (GI) side effects.

Largely de-risked, RHB-102 (Bekinda) development is supported by published positive U.S. Phase 3 & 2 results in gastroenteritis/gastritis and diarrhea-predominant irritable bowel syndrome (IBS-D) respectively, a positive comparative PK clinical study as part of the oncology support (CINV/RINV) program12, plus decades of ondansetron clinical use (>22 million annual U.S. ER prescriptions)13

RHB-102 (Bekinda) is clinically aligned, if approved, to improve titration success and reduce the #1 cause of discontinuing diabetes & weight loss therapies like Mounjaro®/Zepbound® & Ozempic®/Wegovy®

Development is being planned under the accelerated FDA 505(b)(2) route of RHB-102 (Bekinda) as a once-daily oral therapy for GLP-1/GIP receptor agonist therapy-associated GI side effects.

>2% of Americans take GLP-1 receptor agonist drugs14 but estimates suggest up to 50% discontinue within 3 months[15], potentially costing an estimated $35 billion in lost market value by 203016.

RHB-10717 (upamostat) update:

RHB-107 was included in the U.S. Government-supported PROTECT study, which was a Phase 2 adaptive, randomized, double-blind, placebo-controlled platform trial to evaluate the safety and efficacy of RHB-107 for early outpatient COVID-19 treatment. The study was conducted as part of a master protocol evaluating promising investigational products for safety and efficacy as early outpatient treatment and post-exposure prophylaxis for COVID-19. RHB-107 was the first and only drug to enter the platform and was evaluated in the early treatment arm of the study. The study was planned for a duration of approximately 18 months, but due to challenges to enrollment and U.S. Government funding limitations, enrollment was discontinued after a total of only 92 of the planned 300 participants were enrolled. While a benefit in time to resolution of symptoms and time to viral clearance were observed regarding the efficacy of RHB-107 in this study it did not reach statistical significance. Whether the lack of significant results were due to true lack of efficacy or accrual of fewer than one third of the planned number of patients is unknown.

Annual Report:

A copy of the Company's annual report on Form 20-F for the year ended December 31, 2025, has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ and posted on the Company's investor relations website at:
https://www.redhillbio.com/investors/financial-filings/quarterly-reports/default.aspx.

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:
investors@redhillbio.com.

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 adults18, with a U.S. co-commercialization agreement with Cumberland Pharmaceuticals (Nasdaq: CPIX). RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for medical countermeasures including radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting multiple cancer and inflammatory gastrointestinal diseases.

Visit www.redhillbio.com / X.com/RedHillBio for more information about the Company

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. 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, among others, statements regarding the potential success of any transactions, commercial programs or development activities and the payment of future milestone payments. 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, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, 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 that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, 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) the Company's ability to collect on its judgement against Kukbo; (xiii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiv) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xv) competition from other companies and technologies within the Company's industry; and (xvi) 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 27, 2026. 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, whether as a result of new information, future events or otherwise unless required by law.

Company contact:

Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
adi@redhillbio.com

Category: Financials

REDHILL BIOPHARMA LTD.



CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)















Year Ended December 31,



2025



2024



2023



U.S. dollars in thousands

REVENUES

286



—



—

RESEARCH AND DEVELOPMENT EXPENSES

2,023



1,588



3,529

GENERAL, ADMINISTRATIVE, BUSINESS AND

DEVELOPMENT EXPENSES

6,172



4,887



6,019

SHARE OF LOSS OF JOINT VENTURE

33



—



—

OPERATING LOSS

(7,942)



(6,475)



(9,548)

FINANCIAL INCOME

1,318



8,347



301

FINANCIAL EXPENSES

1,456



1,512



9,251

FINANCIAL INCOME (EXPENSES), net

(138)



6,835



(8,950)

INCOME (LOSS) FROM CONTINUING OPERATIONS

(8,080)



360



(18,498)

INCOME(LOSS) FROM DISCONTINUED OPERATIONS

7,651



(8,628)



42,414

INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS)

FOR THE YEAR

(429)



(8,268)



23,916

LOSS PER ORDINARY SHARE FROM CONTINUING

OPERATION, basic and diluted (U.S. dollars)

(0.00)



(0.00)



(0.01)

EARNINGS (LOSS) PER ORDINARY SHARE FROM

DISCONTINUED OPERATION, basic and diluted (U.S. dollars)

0.00



(0.00)



0.02

EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted

(U.S. dollars)

(0.00)



(0.00)



0.01



The accompanying notes are an integral part of these consolidated financial statements.



REDHILL BIOPHARMA LTD.



CONSOLIDATED STATEMENTS OF FINANCIAL POSITION















December 31,



December 31,





2025



2024





U.S. dollars in thousands

CURRENT ASSETS:









Cash and cash equivalents



3,971



4,617

Trade receivables



79



2,539

Prepaid expenses and other receivables



2,478



1,104

Inventory



—



3,651





6,528



11,911

NON-CURRENT ASSETS:









Restricted cash



169



148

Trade receivables



201



—

Fixed assets



49



135

Right-of-use assets



1,057



302

Intangible assets



5,291



5,547

Investment in a joint venture



12,050



—





18,817



6,132

TOTAL ASSETS



25,345



18,043











CURRENT LIABILITIES:









Account payable



731



1,168

Lease liabilities



170



353

Allowance for deductions from revenue



6,304



9,288

Derivative financial instruments



—



1,421

Accrued expenses and other current liabilities



12,016



9,993





19,221



22,223











NON-CURRENT LIABILITIES:









Lease liabilities



900



3

Accrued expenses and other non-current liabilities



456



—

Royalty obligation



500



500





1,856



503

TOTAL LIABILITIES



21,077



22,726











EQUITY (CAPITAL DEFICIENCY):









Ordinary shares



147,641



35,036

Additional paid-in capital



270,382



375,082

Accumulated deficit



(413,755)



(414,801)

TOTAL EQUITY (CAPITAL DEFICIENCY)



4,268



(4,683)

TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY)



25,345



18,043



The accompanying notes are an integral part of these consolidated financial statements.



REDHILL BIOPHARMA LTD.



CONSOLIDATED STATEMENTS OF CASH FLOWS

















Year Ended December 31,





2025



2024



2023





U.S. dollars in thousands

OPERATING ACTIVITIES:













Income (loss)

(429)



(8,268)



23,916



Adjustments in respect of income and expenses not involving cash flow:













Share-based compensation to employees and service providers

457



665



1,647



Depreciation

384



588



1,445



Amortization of intangible assets

25



31



545



Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, see below

—



—



(56,082)



Gains from early termination of leases, and impairment of fixed assets, net

—



(22)



(543)



Gain on loss of control (presented as part of a discontinued operation)

(7,983)



—



—



Share from loss of joint venture

33



—



—



Loss from global termination agreement, see below

—



2,359



—



Fair value (gains) losses on derivative financial instruments, recognition of day 1 loss and changes in royalty
obligation

(1,280)



(8,268)



5,359



Loss from modification of warrants terms as part of a new issuance

—



—



1,459



Issuance costs in respect of warrants and equity line of credit

1,018



1,497



2,034



Exchange differences and revaluation of bank deposits

93



(4)



19





(7,253)



(3,154)



(44,117)



Changes in assets and liability items:













Decrease in trade receivables

2,259



52



31,930



Decrease (increase) in prepaid expenses and other receivables

(2,911)



1,697



1,586



Decrease (increase) in inventories (excluding THI transaction)

(375)



738



2,387



Decrease in accounts payable

(437)



(2,110)



(952)



Increase (decrease) in accrued expenses and other liabilities

2,479



3,042



(13,354)



Decrease in allowance for deductions from revenue

(2,984)



(1,366)



(37,216)





(1,969)



2,053



(15,619)



Net cash used in operating activities

(9,651)



(9,369)



(35,820)



Net cash used in operating activities from discontinued operation

(2,460)



(434)



(18,998)



Net cash used in operating activities from continuing operation

(7,191)



(8,935)



(16,822)



INVESTING ACTIVITIES:













Purchase of fixed assets

(5)



(9)



(11)



Proceeds from investment in joint venture (see below)

2,000



—



—



Reconciliation related to receivable from joint venture

(304)



—



—



Change in investment in current bank deposits

—



—



15



Net cash provided by (used in) investing activities

1,691



(9)



4



Net cash provided by investing activities from discontinued operation (see loss of control appendix below)

1,696



—



—



Net cash (used in) provided by investing activities from continuing operation

(5)



(9)



4



FINANCING ACTIVITIES:













Proceeds from issuance of ordinary shares and warrants, net of issuance costs

7,764



8,263



13,959



Repayment of payable in respect of intangible asset purchase

—



—



(6,555)



Decrease in restricted cash

—



790



15,210



Payment of principal with respect to lease liabilities

(447)



(636)



(1,175)



Net cash provided by financing activities

7,317



8,417



21,439



Net cash provided by financing activities from discontinued operation

—



474



7,815



Net cash provided by financing activities from continuing operation

7,317



7,943



13,624



DECREASE IN CASH AND CASH EQUIVALENTS

(644)



(961)



(14,377)



EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS

(2)



9



(22)



BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF YEAR

4,617



5,569



19,968



BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF YEAR

3,971



4,617



5,569



SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH

60



131



138



SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH

18



55



367



SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:













Acquisition of right-of-use assets by means of lease liabilities

1,048



—



270



Decrease in lease liability (with corresponding decrease in right of use asset: none during 2025 and amount of $166 in 2024)

—



188



5,413



Loss of control of Talicia Holdings Inc.:













Derecognition of assets

(1,538)











Derecognition of intangible assets

(232)











Derecognition of inventory

(4,026)











Recognition of investment in joint venture

13,779











Gain on loss of control

(7,983)











Proceeds from investment in joint venture

2,000











Transfer of rights in Movantik® and extinguishment of debt obligations:













Decrease in Intangible asset









(59,503)



Decrease in Inventories









(4,233)



Decrease in Payable in respect of Intangible asset









4,602



Decrease in Borrowing









115,216



Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations









56,082





The accompanying notes are an integral part of these consolidated financial statements.



1 https://www.apotex.com/global/home
2 https://www.redhillbio.com/news/news-details/2025/RedHill-Biopharmas-Positive-Opaganib-Results-Indicate-Reduction-in-Venetoclax-Resistant-Cells/default.aspx
3 Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879
4 Abstract 4323: The SPHK2 inhibitor opaganib potentiates tumor-intrinsic STING activation in triple-negative breast cancer in vitro. Colette R. Worcester, Amrita Mitra, Harsh B. Pathak, Shane R. Stecklein. Cancer Res (2026) 86 (7_Supplement): 4323. https://doi.org/10.1158/1538-7445.AM2026-4323 Published: 03 April 2026
5 Including cash, cash equivalents, short-term bank deposits and restricted cash.
6 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
7 Opaganib is an investigational new drug, not available for commercial distribution.
8 Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
9 Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983
https://doi.org/10.2147/DMSO.S514548
10 RHB-204 is an investigational new drug, not available for commercial distribution
11 RHB-102 is an investigational new drug, not available for commercial distribution
12 Data on file
13 Cairns C, Kang K. National Hospital Ambulatory Medical Care Survey: 2021 emergency department summary tables. Available from: https://ftp.cdc.gov/pub/Health_Statistics/NCHS/Dataset_Documentation/NHAMCS/doc21-ed-508.pdf.
14 FAIR Health. Obesity and GLP-1 Drugs: A Claims-Based Analysis. FAIR Health White Paper; May 27, 2025.
15 Issue Brief (Real-World Trends in GLP-1 Treatment Persistence and Prescribing for Weight Management, May 2024)
16 https://www.goldmansachs.com/insights/articles/the-anti-obesity-drug-market-may-prove-smaller-than-expected
17 RHB-107 is an investigational new drug, not available for commercial distribution
18 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.

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Price holds! It's a miracle!!!

Nice pleasant surprise, now what i need
is + 2700% to just break even.

Must be an offering coming they got someone to pump it up so the dump will likely happen next week.

what a shock bring on like the 5th rs and mor offerings.

It cures everything yet it cures nothing. Do they honestly think people still fall for these worthless PR's that are always pre clinical every single time and never go anywhere. Rinse and repeat to do more offerings and pay more bonuses. The only thing the company has is talicia but the sales stink. Everything else they have is complete bs and a scam.

New preclinical data
And yet another totaly worthless PR

RedHill’s Opaganib Enhances Efficacy of Neuroblastoma
Chemo Combination and Augment Anti-Tumor Immunity
in Triple-Negative Breast Cancer in Preclinical Studies –
New Data Presented at AACR 2026

https://finance.yahoo.com/sectors/healthcare/articles/redhills-opaganib-enhances-efficacy-neuroblastoma-120000828.html

New preclinical data, independently presented in two posters at the 2026 American Association for
Cancer Research (AACR) Annual Meeting, show positive effects of opaganib1 as potential add-on
therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC)
--
The positive NB data from studies undertaken by Penn State University’s Jeremy Hengst and Apogee
Biotechnology, and funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate
that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX)
chemotherapy combination in high-risk NB by directly destabilizing n-Myc, a key oncogenic driver
of neuroblastoma and other solid tumors, through increased ceremide production enhancing
programmed cell death (apoptosis) in cancer cells2
--
A second poster from University of Kansas’ Colette Worcester describes in vitro model data showing
that pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the
downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the
poorest prognosis of the breast cancer subtypes3
--
Opaganib, a novel, potentially broad acting, oral, small molecule drug with demonstrated safety &
efficacy profiles4, is in development for multiple oncology, viral, inflammatory and diabetes and
obesity-related indications

RALEIGH, N.C., and TEL-AVIV, Israel, April 22, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the independent presentation of new preclinical data at the 2026 American Association for Cancer Research (AACR) Annual Meeting, showing positive effects of opaganib as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC).

The positive NB data, from studies undertaken by Penn State University’s Jeremy Hengst, PhD, and Apogee Biotechnology funded by the Beat Childhood Cancer Foundation and Four Diamonds, indicate that opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX) chemotherapy combination in high-risk NB. The data showed that opaganib directly destabilized n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, regulating cell proliferation, differentiation, and apoptosis during embryonic development, a critical factor driving poor outcomes.

A second poster from the University of Kansas’ Colette Worcester describes in vitro model data showing that pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes.

Dr. Mark Levitt, Chief Scientific Officer at RedHill said: “These data represent exciting findings that could hold promise for improving outcomes in treating pediatric NB and TNBC, providing additional encouragement for further exploration. Opaganib has previously shown potential as add-on therapy in several preclinical oncology models in combination with chemotherapy. Moreover, the ongoing Phase 2 clinical study of opaganib in combination with darolutamide in advanced prostate cancer could potentially provide paradigm-shifting clinical data in support of the additive use of opaganib in a cancer setting.”

Neuroblastoma is the most common infancy cancer with ~5,500 global pediatric cases per year in children aged 0–14. It accounts for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.5,6 Opaganib received FDA Orphan Drug and Rare Pediatric Disease designations for the treatment of neuroblastoma, a rare pediatric cancer, with potential for a Rare Pediatric Disease Priority Review Voucher (“PRV”). Development discussions for this indication are ongoing with Penn State University and the Beat Childhood Cancer consortium.

About Opaganib (ABC294640)

Opaganib is a proprietary first-in-class investigational, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor drug. Potentially broad-acting, it is in development for multiple oncology, viral, inflammatory, metabolic (diabetes and obesity) and additional indications.

Peer-reviewed data, published in the journal Diabetes, Metabolic Syndrome and Obesity7, provides evidence that opaganib uniquely works through the inhibition of multiple pathways implicated in insulin resistance, ß-cell disruption, adipocyte function, inflammation / immune regulation, vascular complications, energy metabolism, induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS).

Opaganib has received Orphan Drug designation from the FDA for the treatment of neuroblastoma and cholangiocarcinoma. A Bayer-supported 80-patient placebo-controlled randomized Phase 2 study is ongoing 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 prognosis8. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.

Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use, including a large global Phase 2/3 study in hospitalized patients with moderate to severe COVID-19, published in Microorganisms.

RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that on April 8, 2026, it received a letter from the Listings Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days from February 20, 2026 to April 2, 2026, the bid price for the American Depositary Shares (“ADSs”) representing the Company’s ordinary shares had closed below the minimum $1.00 per share requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

No Big Surprise!
R/S Expected!!!

As it seems - real soon!
Ugh

when is the next reverse split?

Nope the more you buy the the lower it goes I learned that lesson long ago. I think most of the stuff they peddle is just bs. The only legit thing they have is talicia but the sales stink. All the studies I think are just fluff to try and pump

Shame on me for not only did i not cut
losses, but i even added shares thinking
this time something will work out!
Sigh

I should have cut my losses long ago on this complete turd. Nothing has changed they simply operate to pay themselves and lie about how great these studies are. Heck it appears they even ran out of things to do pump and dump with now. Soon it will be out of compliance once again they will have to RS for like the fifth time. It is nothing but a scam

It is only myself to blame for having
invested in this stock and not getting
rid of it a very long time ago.