Redhill Biopharm SEC Filings

RedHill Biopharma Ltd. filed a Form 6-K attaching a press release that reports a New York Supreme Court appeal decision upholding a $10 million summary judgment in the company’s favor against Kukbo. The filing reiterates RedHill’s corporate registration details and lists recent and prior registration statements incorporated by reference. The document also summarizes RedHill’s clinical-stage pipeline, including opaganib (ABC294640) (multiple indications including GI-ARS, hospitalized COVID-19, prostate cancer), RHB-204 (planned Phase 2 for Crohn’s disease; Phase 3-stage for pulmonary NTM), RHB-107 (upamostat) (late-stage for non-hospitalized COVID-19 and other indications), and RHB-102 (positive Phase 2/3 results for GI indications; partnered with Hyloris Pharma). The filing contains no financial results or quantified impact of the judgment.

RedHill Biopharma Ltd. announced that the New York Supreme Court awarded the company approximately $1.82 million in legal costs and expenses, in addition to a prior summary judgment award of approximately $8.25 million, with a 9% ongoing statutory interest applicable to both awards. The company also obtained a court-ordered attachment from Korea's Incheon District Court to seize Kukbo Co. Ltd.'s assets pending enforcement. Kukbo appealed the summary judgment on December 4, 2024, and briefing on that appeal is complete with oral argument tentatively scheduled for the September term; Kukbo may also appeal the legal-costs award. The release reiterates RedHill's clinical and commercial programs and includes standard forward-looking risk disclosures.

RedHill Biopharma reported receipt of its first ex-U.S. Talicia sales milestone, royalties and other payments totaling approximately $1.1 million following Talicia's first commercial launch outside the U.S. in 2024. Talicia is an FDA-approved, rifabutin-based therapy for H. pylori, a common infection affecting over 50% of adults worldwide and a major risk factor for gastric cancer and peptic ulcers. The product has QIDP designation providing up to eight years of U.S. exclusivity and patent protection through 2042. RedHill said Talicia showed up to 90% eradication in adherent patients in Phase 3 and contrasted this with lower effectiveness of clarithromycin-based regimens.

RedHill Biopharma disclosed it is not in compliance with Nasdaq Listing Rule 5550(b), which requires minimum stockholders' equity of $2,500,000. Nasdaq notified the Company of the deficiency on April 15, 2025 and on August 8, 2025 granted an extension giving the Company until October 13, 2025 to regain compliance.

The Company has submitted a plan to Nasdaq to restore compliance; if it does not meet the requirement by the extension date it may appeal to a Hearings Panel for additional time. The filing also notes that forward-looking statements about achieving compliance depend on market conditions and the satisfaction and closing of financing arrangements referenced in other filings.

RedHill Biopharma (Nasdaq: RDHL) filed a Form 6-K announcing positive FDA Type C meeting feedback for RHB-204, its next-generation, orally administered triple-antibiotic for Crohn’s disease (CD). The Agency agreed to a first-ever Phase 2 trial in MAP-positive CD patients, with co-primary endpoints of mucosal remission and MAP eradication. Use of rapid MAP diagnostics from two academic partners allows a smaller sample size, meaning lower cost and faster completion.

RHB-204 is protected by patents to 2041 and leverages Phase 3 data from predecessor RHB-104 that showed a 64 % efficacy improvement versus standard of care. Management plans to fund the study through non-dilutive grants/partnerships and pursue additional FDA designations (orphan, breakthrough, fast track) that could confer exclusivity and priority review vouchers. The Crohn’s market is forecast to expand from $13.6 bn in 2024 to $19 bn in 2033, creating significant commercial upside if the program succeeds. Key risks remain: trial execution, securing external funding, and eventual regulatory approval.