📄 What This Document Is 📰

This filing is a Form 6-K, a document required by the U.S. Securities and Exchange Commission (SEC) for foreign private issuers like RedHill Biopharma Ltd. 🌍. Essentially, it acts like a mandatory update to keep U.S. investors informed about the company's activities.

The primary content is a press release attached to the 6-K, detailing new preclinical data presented by RedHill at the 2026 American Association for Cancer Research (AACR) Annual Meeting. This means the headline finding centers on the potential use of RedHill's key drug, Opaganib, for specific cancers.

👉 Why it matters: This document is highly focused on early-stage scientific breakthroughs, providing potential investors with insight into the company's most advanced research and development efforts.

🧬 What RedHill Biopharma Does 🧪

RedHill Biopharma is a specialty biopharmaceutical company headquartered in Israel (Tel Aviv, 🇮🇱). In simple terms, the company develops, tests, and seeks to commercialize drugs to treat severe conditions, focusing heavily on oncology (cancer), gastrointestinal diseases, and infectious diseases.

Its business model is highly research-intensive, revolving around several proprietary drugs in various stages of development. The entire company has its operations spanning both Raleigh, N.C., and Tel Aviv, Israel.

👉 The Core Focus: The company’s primary pillar is a drug called Opaganib, a novel, oral, small molecule drug, which acts as a selective inhibitor of Sphingosine Kinase-2 (SPHK2). This mechanism allows it to potentially target multiple diseases—not just cancer—including viral and metabolic conditions.

🎗️ Opaganib: Breakthrough Cancer Data 🚀

The main highlight of this 6-K is the presentation of new, encouraging preclinical data for Opaganib, which was presented via two separate posters at the AACR 2026 Annual Meeting. These data suggest Opaganib could function as a valuable add-on therapy for two challenging types of cancer: neuroblastoma (NB) and triple-negative breast cancer (TNBC).

Neuroblastoma (NB) Findings

The positive NB data came from studies conducted by Penn State University’s Jeremy Hengst and Apogee Biotechnology, funded by the Beat Childhood Cancer Foundation and Four Diamonds. The findings suggest that Opaganib can enhance the existing treatment plan for high-risk NB.

• Mechanism: Opaganib was found to directly destabilize n-Myc, which is a key driver of neuroblastoma and other solid tumors.
• Impact: This destabilization works by increasing ceremide production, which ultimately boosts apoptosis (programmed cell death) in cancer cells.
• Context: Neuroblastoma is particularly concerning because it is the most common cancer in infancy, accounting for 10% of childhood cancers and 15% of pediatric cancer-related deaths in the U.S.

Triple-Negative Breast Cancer (TNBC) Findings

The second set of data, presented by University of Kansas’ Colette Worcester, focused on TNBC, a breast cancer subtype known for having one of the poorest prognoses.

• Study Model: The in vitro model showed that pre-treating the cancer with Opaganib, followed by a low dose of diABZI treatment, had a potent effect.
• Immunity Boost: This pre-treatment appeared to augment the downstream STING-mediated effects, potentially improving the body’s overall anti-tumor immunity.

👉 Why it matters: These results add significant academic credibility to Opaganib, suggesting it has a multi-faceted mechanism of action (targeting cell proliferation, apoptosis, and immune function) that could benefit patients with aggressive or hard-to-treat cancers.

💊 Opaganib's Scientific Profile and Development 💡

Opaganib (known as ABC294640) is described as a first-in-class, orally administered drug that selectively inhibits SPHK2. Its mechanism is broad, allowing it to address multiple issues across oncology, viral infections, and metabolism.

• Mechanism Breadth: Beyond cancer, Opaganib is noted for its ability to inhibit three specific sphingolipid-metabolizing enzymes (SPHK2, DES1, and GCS). This simultaneous action allows it to work on multiple pathways implicated in insulin resistance, inflammation, and viral replication.
• FDA Status: Opaganib has already received FDA Orphan Drug designation for both neuroblastoma and cholangiocarcinoma, which are rare cancers, and also holds the potential for a Rare Pediatric Disease Priority Review Voucher (“PRV”).
• Current Clinical Activity:
  • A large, ongoing Phase 2/3 study is testing Opaganib in hospitalized patients with moderate to severe COVID-19.
  • A Bayer-supported Phase 2 study is underway to test Opaganib combined with darolutamide in men with metastatic castrate-resistant prostate cancer (mCRPC).
  • The company also has a Phase 1 chemoradiotherapy study protocol ready for potential FDA-IND submission.

🔬 Other Key Pipeline Assets 🧬

RedHill’s pipeline is diverse, covering several other promising compounds beyond Opaganib. These assets demonstrate the company's broad platform approach to drug discovery.

• RHB-102: This drug is being developed as an agonist for the GLP-1/GIP receptor. It shows positive results in multiple areas, including:
  • Acute gastroenteritis and gastritis (from a U.S. Phase 3 study).
  • Irritable Bowel Syndrome with diarrhea (IBS-D) (from a U.S. Phase 2 study).
  • Potential submission for chemotherapy and radiotherapy induced nausea and vomiting.
  • (Note: RHB-102 is partnered with Hyloris Pharmaceuticals for worldwide development outside North America.)
• RHB-204: This is a next-generation, optimized formulation of an earlier drug (RHB-104). It is planned for a Phase 2 study for Crohn's disease, building on positive Phase 3 results of the predecessor drug.
• RHB-107 (Upamostat): This is an oral, broad-acting, host-directed serine protease inhibitor. Due to its nature, it has potential for pandemic preparedness and is being explored for multiple cancer and inflammatory gastrointestinal diseases, including COVID-19.

💲 Commercial and Partnership Updates 💰

While RedHill is heavily weighted toward R&D, the company maintains a commercial revenue stream through one key drug.

• Talicia®: RedHill promotes Talicia®, which is an FDA-approved drug used to treat Helicobacter pylori (H. pylori) infection in adults.
• Co-commercialization: The company has a recent U.S. co-commercialization agreement for Talicia® with Cumberland Pharmaceuticals (Nasdaq: CPIX).

👨‍🔬 Management Commentary and Strategy 🗣️

Management remains highly optimistic about Opaganib's potential, particularly regarding its use in combination therapies. Dr. Mark Levitt, the company’s Chief Scientific Officer, provided strong commentary on the findings.

In his statement, Dr. Mark Levitt noted that: "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."

He also pointed to the current prostate cancer study, stating that: "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.”

👉 Why it matters: These quotes do not just report data; they contextualize the findings, signaling that management views Opaganib as a highly adaptable platform drug, capable of multiple "paradigm-shifting" applications.

☎️ Company Information and Resources 📍

For readers who want to follow up on the company’s activities, the following contact and resource information was provided:

• Website: www.redhillbio.com
• Social Media: X.com/RedHillBio
• Office Location: 21 Ha'arba'a Street, Tel Aviv, 6473921, Israel

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🧠 The Analogy

Think of RedHill Biopharma like a Swiss Army Knife for medicine. Instead of focusing all its effort on one specific tool (one drug), the company has developed a core mechanism—the Swiss Army Knife blade, called Opaganib. This blade is multi-purpose because it can cut through different problems (cancers, infections, inflammation) using slightly different techniques (inhibiting multiple pathways). The new AACR data is proof that this particular knife blade works exceptionally well when combined with other treatments, making it a powerful potential solution across multiple types of surgical needs.

🧩 Final Takeaway

RedHill Biopharma is making significant progress using its core drug, Opaganib, which shows promising preclinical results for difficult cancers like Neuroblastoma and TNBC. The company’s strength lies in its diverse pipeline (including RHB-102 and RHB-204), suggesting it is building a broad platform of potential treatments rather than relying on a single blockbuster drug.