Redhill Biopharm - RDHL STOCK NEWS

RedHill Biopharma (Nasdaq: RDHL) has been selected to present its drug opaganib at the JPEO-CBRND's 'Host Directed Therapeutics Industry Day' on October 29-30, 2024, in Alexandria, VA. The selection was based on the drug's demonstrated capabilities in prophylaxis and treatment of exposure to viruses, bacteria, and toxins.

The JPEO-CBRND, which manages U.S. government investments in chemical, biological, radiological, and nuclear defense equipment and medical countermeasures, will host the presentation. Opaganib, a novel host-directed oral drug, is being developed for various applications including oncology, viral infections, inflammatory diseases, and chemical/nuclear protection, with multiple ongoing U.S. government collaborations.

RedHill Biopharma (Nasdaq: RDHL) has announced a collaboration with Duke University School of Medicine to develop opaganib as a potential countermeasure against phosgene inhalation injury. The research aims to advance opaganib into U.S. government-sponsored development under the FDA's Animal Rule pathway to approval.

Phosgene, a toxic chemical used in industrial processes, poses a significant risk to public safety. The EPA has identified 123 sites in the U.S. that could potentially expose millions to phosgene. Currently, there is no approved antidote for phosgene inhalation injury, which can cause severe respiratory damage.

Opaganib, RedHill's novel, host-directed drug, is being developed for various indications, including chemical and nuclear/radioprotection. The collaboration with Duke University aims to determine if opaganib can provide protection against phosgene-induced damage and potentially be stockpiled for emergency use.

RedHill Biopharma has secured U.S. government funding through BARDA to advance opaganib for Ebola treatment. The funding will support the development of opaganib as a medical countermeasure (MCM) for Ebola virus disease (EBOV). Recent U.S. Army-funded studies showed that opaganib significantly increased survival in an EBOV model. Opaganib is a novel, potentially broad-acting drug with mutation-resistant antiviral and anti-inflammatory activity.

The development comes as there is an urgent need for effective and usable therapies for EBOV, which has a fatality rate of around 50% according to WHO. Opaganib represents an alternative host-directed therapeutic strategy for biodefense and global health preparedness. The drug is also being developed for other indications, including COVID-19, ARDS, and radiological and chemical protection.

RedHill Biopharma (Nasdaq: RDHL) has renewed its contract with Medi-Cal, California's Medicaid healthcare program, to maintain Talicia's first-line position on the Medi-Cal Fee-For-Service (FFS) Contract Drug List with no prior authorization and a $0 copay. This renewal, effective October 1, 2024, benefits approximately 15 million Californian Medi-Cal patients.

The agreement follows the new American College of Gastroenterology (ACG) Clinical Guideline for H. pylori infection, which lists Talicia as an empirically prescribed first-line option. Talicia's all-in-one three-times daily formulation offers a simplified patient experience, supporting high rates of H. pylori eradication without requiring prior resistance testing. It remains the most prescribed branded H. pylori therapy by U.S. gastroenterologists.

RedHill Biopharma (Nasdaq: RDHL) has announced the issuance of a new U.S. patent for opaganib, valid through 2041. The patent covers the identification of a novel biomarker of coronavirus pneumonia (≤60% fraction of inspired oxygen (FiO2)) prognostic for potential opaganib efficacy in treating COVID-19.

Post-hoc data from opaganib's Phase 2/3 study showed that patients with ≤60% FiO2 levels had better outcomes after 14 days of treatment compared to placebo, including:

• Increased number of patients no longer requiring supplemental oxygen (76.9% vs. 63.4%; p-value=0.033)
• 62.6% reduction in intubation/mechanical ventilation (6.84% vs. 17.91%; p-value=0.012)
• 62% reduction in mortality by day 42 (5.98% vs. 16.7%; p-value=0.019)

Opaganib is being developed for various indications, including oncology, viral infections, inflammatory diseases, and nuclear/radioprotection.

RedHill Biopharma (Nasdaq: RDHL) announced that its product Talicia® has been listed as a first-line choice for treating H. pylori infection in the new American College of Gastroenterology (ACG) Clinical Guideline. This is significant as it's the first update since Talicia's approval. Talicia offers a convenient all-in-one formulation taken three times daily, supporting high eradication rates without prior resistance testing.

Talicia is currently the leading branded first-line therapy prescribed by U.S. gastroenterologists for H. pylori, which affects about 35% of U.S. adults. Globally, H. pylori infects around 66% of the population and is classified as a Group 1 carcinogen by the WHO, being the strongest known risk factor for gastric cancer.

RedHill Biopharma (Nasdaq: RDHL) has successfully regained compliance with Nasdaq's minimum bid price requirement. The company received confirmation from the Nasdaq Listings Qualifications Department that it has met the necessary criteria for continued listing on The Nasdaq Capital Market. To achieve compliance, RedHill was required to maintain a minimum closing bid price of $1.00 per share for its American Depositary Shares (ADSs) for at least 10 consecutive business days. This milestone was reached on September 3, 2024, ensuring RedHill's continued presence on the Nasdaq exchange.

RedHill Biopharma (Nasdaq: RDHL) has announced the publication of data from a post-hoc analysis of its phase 2/3 study of opaganib in COVID-19 pneumonia. The analysis, published in the journal Microorganisms, showed a 62% reduction in mortality and a 21% improvement in time to room air in a subgroup of 251 hospitalized patients requiring FiO2 ≤60%. The study also suggests that FiO2 >60% may represent a threshold for disease severity and could potentially serve as a patient selection biomarker. With 30,000 Americans dead due to COVID-19 so far this year, RedHill emphasizes the continued need for effective and safe therapies. Opaganib, an orally administered drug, has demonstrated safety and efficacy profiles in various indications, including viral infections and inflammatory diseases.

RedHill Biopharma (Nasdaq: RDHL) reported its first half 2024 financial results and operational highlights. The company has transformed with a strengthened cash balance, streamlined operations, and a focus on U.S. government collaborations for developing its pipeline. Key highlights include:

- Cash balance of $8.2 million as of June 30, 2024

- Net revenues of $2.6 million for H1 2024

- Talicia maintained leadership position as the top prescribed branded H. pylori therapy in the U.S.

- Advancing opaganib and RHB-107 in U.S. government-supported programs for various indications including Ebola, COVID-19, and radiation protection

- Cost reduction measures resulted in improved operating loss and net loss compared to H1 2023

- Post-balance sheet, RedHill signed a Global Termination Agreement, receiving $9.9 million in cash and reducing net liabilities by approximately $2.3 million