RedHill Biopharma Ltd 6-K, filed Oct 28, 2024
RedHill Biopharma Ltd. (RDHL)
6-K
2024-10-28
For: 2024-10-28
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Added on
April 07, 2026
About this 6-K
RedHill Biopharma Ltd filed this 6-K on October 28, 2024.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of October 2024
Commission File No.:001-35773
Commission File No.:001-35773
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)
21 Ha'arba'a Street, Tel Aviv, 6473921, Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form
40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(1): ____
Indicate by check mark if the Registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule
101(b)(7): ____
Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: “RedHill Selected to Present
Opaganib at Conference Organized by U.S. Government’s JPEO-CBRND”.
This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and
Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No.
333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001) and on June 20, 2024 (File No.
333-280327), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on
August 9, 2024 (File No. 333-281417).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
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REDHILL BIOPHARMA LTD.
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(the "Registrant")
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Date: October 28, 2024
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By:
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/s/ Dror Ben-Asher
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Name:
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Dror Ben-Asher
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Title:
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Chief Executive Officer
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Press Release
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RedHill Selected to Present Opaganib at Conference
Organized by U.S. Government’s JPEO-CBRND
RedHill has been
selected to provide a presentation to further elaborate on opaganib’s potential
to U.S. government
representatives at the Joint Program Executive Office for Chemical,
Biological,
Radiological and Nuclear Defense’s (JPEO-CBRND) “Host Directed Therapeutics
Industry Day”
--
Based on reviews, feedback, and discussion, the judges selected for presentation those
therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and
the
treatment of exposure to viruses, bacteria and toxins. The meeting is scheduled to take place
October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA
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The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological,
and nuclear (CBRN) defense equipment and medical countermeasures (MCMs). The JPEO-
CBRND’s mission is to provide integrated, layered, chemical, biological, radiological, and
nuclear defense capabilities to the Joint Force across combined Joint all-domain operations
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With multiple U.S. government collaborations for chemical and MCMs and pandemic
preparedness, opaganib is a novel, host-directed, potentially broad-acting, orally administered
small molecule, clinical-stage drug with demonstrated safety and efficacy profiles, being
developed for various oncology, viral infections, inflammatory diseases, and chemical and
nuclear/radioprotection indications
TEL-AVIV, Israel / RALEIGH, NC,
October 28, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that the Company has been selected to further elaborate on opaganib’s1
potential in a presentation to U.S. government representatives at the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) “Host Directed Therapeutics Industry Day”. The meeting is scheduled to
take place October 29-30, 2024, at the United States Patent and Trademark Office in Alexandria, VA.
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The JPEO-CBRND manages U.S. government investments in chemical, biological, radiological, and nuclear (CBRN) defense equipment and
medical countermeasures (MCMs). The JPEO-CBRND mission is to provide integrated, layered, chemical, biological, radiological, and nuclear defense capabilities to the Joint Force across combined Joint all-domain operations. Based on reviews,
feedback, and discussion, the judges selected for presentation those therapeutics that demonstrated capability in the prophylaxis, post-exposure prophylaxis, and treatment of exposure to viruses, bacteria and toxins.
“Opaganib is already the subject of multiple ongoing collaborations with several U.S. government agencies. However, selection for
presentation at this important governmental investment event provides a significant opportunity to highlight the growing body of evidence in support of opaganib’s potential as an oral, host-directed, broad-acting viral, chemical and nuclear
countermeasure,” said Guy Goldberg, RedHill’s Chief Business Officer.
About Opaganib (ABC294640)
Opaganib, a proprietary investigational host-directed and potentially broad-acting drug, is a first-in-class, orally administered
sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple potential indications, including several cancers, diabetes and obesity-related disorders, gastrointestinal acute
radiation syndrome (GI-ARS), Sulfur Mustard exposure, COVID-19, Ebola and other viruses as part of pandemic preparedness.
Opaganib’s host-directed action 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).
Several U.S. government countermeasures and pandemic preparedness programs have selected opaganib for evaluation for multiple
indications, including Acute Radiation Syndrome (ARS), Ebola virus disease and others. Funding bodies include the Radiation and Nuclear Countermeasures Program (RNCP), led by the National Institute of Allergy and Infectious Diseases (NIAID), part
of the U.S. government Department of Health & Human Services’ National Institutes of Health and the Administration for Strategic Preparedness and Response’s (ASPR) Center for Biomedical Advanced Research and Development Authority (BARDA).
Opaganib has demonstrated antiviral activity against SARS-CoV-2, multiple variants, and several other viruses, such as Influenza A and
Ebola. Opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease. Opaganib also recently demonstrated a distinct synergistic
effect when combined individually with remdesivir (Veklury®, Gilead Sciences Inc.), significantly improving potency while maintaining cell viability, in a U.S. Army-funded and conducted in vitro Ebola virus study.
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Being host-targeted, and based on data accumulated to date, opaganib is expected to maintain effect against emerging viral variants.
In prespecified analyses of Phase 2/3 clinical data in hospitalized patients with moderate to severe COVID-19, oral opaganib demonstrated improved viral RNA clearance, faster time to recovery and significant mortality reduction in key patient
subpopulations versus placebo on top of standard of care. Opaganib has demonstrated its safety and tolerability profile in more than 470 people in multiple clinical studies and expanded access use. Data from the opaganib global Phase 2/3 study was
published in Microorganisms.
Opaganib has received several orphan-drug designations from the FDA in oncology and other diseases and has undergone studies in
advanced cholangiocarcinoma (Phase 2a) and prostate cancer. Opaganib also has a Phase 1 chemoradiotherapy study protocol ready for FDA-IND submission.
Opaganib has also shown positive preclinical results in renal fibrosis, and has the potential to target multiple oncology,
radioprotection, viral, inflammatory, and gastrointestinal indications.
Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the
U.S. government and shall not be used for advertising or product endorsement purposes. Reference herein to any specific commercial products, process, or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its
endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious
diseases. RedHill promotes the gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults2.
RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential
for chemical and medical countermeasure and pandemic preparedness use, targeting multiple indications with a U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a
Phase 2 program in oncology; (ii) RHB-107 (upamostat),
an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19, with non-dilutive external funding covering the entirety
of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2
study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
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More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.
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 of opaganib. 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 Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue
generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline 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 opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA
pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining
alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3
COVID-19 study for RHB-107 may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for
opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, 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 a commercial companion diagnostic for the detection of MAP; (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® and Aemcolo®; (vi) the Company's
ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii)
the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's
business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate
its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future
revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and
technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements
is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. 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.
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Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
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Category: R&D
1Opaganib is an investigational new drug, not available for commercial distribution.
2Talicia® (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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