RedHill Biopharma Files 6-K on Coronavirus Update

TL;DR

RHBP filed a 6-K on 9/30/24 about a new US coronavirus announcement.

AI Summary

RedHill Biopharma Ltd. filed a Form 6-K on September 30, 2024, reporting on a press release titled "RedHill Announces New U.S. Coronavirus". The filing is for a foreign private issuer and indicates the company files annual reports under Form 20-F. The company's principal executive offices are located at 21 Ha'arba'a Street, Tel Aviv, Israel.

Why It Matters

This filing provides an update on RedHill Biopharma's activities related to coronavirus, which could be significant for investors tracking the company's progress in this area.

Risk Assessment

Risk Level: medium — The filing is a routine report for a foreign private issuer and doesn't contain specific financial or operational disclosures that would immediately indicate high risk, but the nature of biopharma can involve inherent risks.

Key Players & Entities

• RedHill Biopharma Ltd. (company) — Registrant
• 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel (location) — Principal executive offices
• September 2024 (date) — Reporting period
• 001-35773 (other) — SEC File Number

FAQ

Filing Documents

• zk2432079.htm (6-K) — 34KB
• image00001.jpg (GRAPHIC) — 308KB
• 0001178913-24-003164.txt ( ) — 459KB

SIGNATURES

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. REDHILL BIOPHARMA LTD. (the "Registrant") Date: September 30, 2024 By: /s/ Dror Ben-Asher Name: Dror Ben-Asher Title: Chief Executive Officer Press Release RedHill Announces New U.S. Coronavirus Patent for Opaganib, Valid Through 2041 New U.S. patent issued covering the identification of a novel biomarker of coronavirus pneumonia (60% fraction of inspired oxygen (FiO 2 )) prognostic for potential opaganib efficacy in treating COVID-19, valid through 2041 -- Published post-hoc data from opaganib's Phase2/3 study showed that patients with 60% FiO 2 levels had better outcomes after 14 days' opaganib treatment (n=117) compared to placebo (n=134), including: increased number of patients no longer requiring supplemental oxygen by day 14 of opaganib treatment (76.9% vs. 63.4%; p-value =0.033), a 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012) and a clinically meaningful 62% reduction in mortality (5.98% vs. 16.7%; p-value=0.019) by day 42 1 -- With multiple U.S. government collaborations for medical countermeasure and pandemic preparedness, opaganib is a novel, host-directed, potentially broad acting, orally administered small molecule drug with demonstrated safety & efficacy profiles, being developed for various oncology, viral infections, inflammatory diseases and nuclear/radioprotection indications TEL-AVIV, Israel / RALEIGH, NC, September 30, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the issue of a new U.S. patent for identification of a novel biomarker of coronavirus pneumonia (60% fraction of inspired oxygen (FiO 2 )) prognostic for potential opaganib 1 efficacy in treating COVID-19, valid throu

Forward-Looking Statements

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 effects of opaganib in the treatment of COVID-19. 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 devel

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View this 6-K filing on SEC EDGAR