TEL-AVIV, Israel and RALEIGH, N.C. – RedHill Biopharma Ltd. (NASDAQ: NASDAQ:RDHL), a specialty biopharmaceutical company, has been selected by the U.S. Biomedical Advanced Research and Development Authority (BARDA) for development funding of opaganib, a potential treatment for Ebola virus disease (EBOV).
The funding is part of a cost-sharing contract to advance opaganib's development under the Animal Rule pathway, which allows for animal model efficacy studies to support U.S. Food and Drug Administration (FDA) approval when human trials are not feasible. Opaganib is a novel, orally administered drug that has demonstrated mutation-resistant antiviral and anti-inflammatory activity.
Opaganib's selection follows recent U.S. Army-funded studies that showed a significant increase in survival in an in vivo EBOV model. The drug represents a host-directed therapeutic strategy, which is a departure from current FDA-approved monoclonal antibody treatments for EBOV that require intravenous administration.
RedHill's Chief Business Officer, Guy Goldberg, highlighted the urgent need for additional effective treatments for EBOV, especially those that are easy to distribute and administer, given the logistical challenges in managing outbreaks.
The development of opaganib is supported by federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA. This collaboration is part of a larger effort to address the need for medical countermeasures for EBOV and other potential biodefense threats.
Opaganib is also being evaluated for multiple other indications, including oncology, viral, inflammatory, and diabetes and obesity-related conditions. Its host-directed action targets multiple pathways in human cells, potentially maintaining efficacy against emerging viral variants.
This initiative comes a decade after the West Africa Ebola epidemic, underscoring the continuous need for effective therapies against EBOV, which has a high fatality rate. The WHO reports that EBOV can be fatal in around half of all cases.
The information in this article is based on a press release statement from RedHill Biopharma Ltd.
In other recent news, RedHill Biopharma Ltd. has made significant strides in multiple areas. The company has renewed its contract with Medi-Cal, ensuring continued access to Talicia, a treatment for H. pylori infection, for approximately 15 million Californians. This development aligns with the new American College of Gastroenterology Clinical Guideline, which recommends Talicia as a first-line treatment.
Notably, RedHill Biopharma has reported encouraging results from in vivo studies for its drug, opaganib, which shows potential in treating obesity and Type 2 diabetes. These studies, conducted by Apogee (NASDAQ:APOG) Biotechnology Corporation, suggest that opaganib could reduce weight gain and improve glucose tolerance. Concurrently, the company has initiated a Phase 2 trial for its oral antiviral drug, RHB-107, as an outpatient treatment for early COVID-19, aiming to enroll 300 patients across multiple countries.
In financial developments, RedHill Biopharma has finalized a Global Termination Agreement, augmenting its cash position by approximately $9.9 million and potentially granting access to an additional $0.74 million. This agreement signifies the conclusion of credit relationships with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC, thereby enhancing RedHill's financial flexibility. These are the recent developments as the company continues to explore additional treatment options for early-stage COVID-19 and enhance pandemic preparedness.
InvestingPro Insights
RedHill Biopharma's selection by BARDA for the development of opaganib as a potential Ebola treatment comes at a critical time for the company. According to InvestingPro data, RedHill's market capitalization stands at a modest $10.26 million, reflecting the company's current position as a small-cap biopharmaceutical player.
The company's financial health presents a mixed picture. An InvestingPro Tip indicates that RedHill holds more cash than debt on its balance sheet, which could provide some financial flexibility as it pursues the development of opaganib. This cash position may be crucial for supporting the cost-sharing contract with BARDA and advancing other pipeline projects.
However, another InvestingPro Tip warns that the company is quickly burning through cash. This is not uncommon for biopharmaceutical companies in the development stage, but it underscores the importance of the BARDA funding and the potential need for additional capital in the future.
The company's revenue for the last twelve months as of Q2 2024 was $3.71 million, with a significant revenue decline of -89.63% over the same period. This decline highlights the importance of developing new products like opaganib to potentially drive future revenue growth.
Despite the current financial challenges, analysts anticipate sales growth in the current year, according to another InvestingPro Tip. This optimism could be linked to the potential of opaganib and other pipeline candidates.
For investors considering RedHill Biopharma, it's worth noting that InvestingPro offers 14 additional tips for this stock, providing a more comprehensive analysis of the company's financial health and market position.
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