Redhill Biopharma

RDHL

Market cap $3.96M

TEL-AVIV, Israel and RALEIGH, N.C. , Dec. 1, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.

RALEIGH, N.C. and TEL-AVIV, Israel , Nov. 4, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.

On October 16, 2025, the Company received a Staff Determination notification from The Nasdaq Stock Market LLC regarding continued non-compliance with the minimum stockholders' equity requirements for continued listing, pursuant to Listing Rule 5550(b)(1)  Following RedHill's transaction with Cumberland Pharmaceuticals Inc., announced October 20, 2025, the Company believes that its stockholders' equity now exceeds the minimum $2.5 million requirement and that it is well positioned to maintain compliance  The Company intends to appeal Staff's determination to a Hearings Panel, pursuant to the Nasdaq Listing Rule 5800 Series and present its case. The Panel has the authority to determine whether the Company has regained compliance or to grant up to a 180-day extension to regain compliance  Submission of a hearing request will stay any delisting or suspension action of the Company's American Depositary Shares, and RedHill remains listed and traded on the Nasdaq Capital Market, pending the hearing  There can be no assurance that the Panel will grant an extension of the compliance period or that the outcome of the hearing will be favorable to the Company TEL AVIV, Israel and RALEIGH, N.C.

Cumberland to expand its gastroenterology offerings with the market-leading Helicobacter pylori therapy NASHVILLE, Tenn. , Oct. 20, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company focused on delivering high-quality products to improve patient care, announced strategic arrangements with RedHill Biopharma Ltd.

The deal aims to accelerate Talicia's entry into new Middle East markets  Under the terms of the agreement RedHill will receive $500,000 in guaranteed payments, including a $250,000 upfront payment and $250,000 in fixed payments due within 18 months, plus a minimum of $1.3 million in near-term potential milestone payments, as well as tiered royalties up to mid-teens percent on Talicia net sales  Talicia is the only FDA-approved all-in-one, low-dose rifabutin-based therapy to address H. pylori antibiotic resistance.

The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses (including 9% statutory interest accrual) RALEIGH, N.C., and TEL AVIV, Israel , Sept.

Extensive strategic, financial and operational overhaul has reshaped and refocused our business; Strong progress on multiple fronts Commercial and R&D Highlights: Recruitment initiated in the Bayer-supported Phase 2 combination study of opaganib and darolutamide in advanced prostate cancer Positive U.S. Food and Drug Administration (FDA) feedback on pathway to approval for RedHill's next-generation Crohn's disease program with RHB-204 - planned to be the first ever clinical study in a defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Increased Talicia net revenues and units sold as compared to first half 2024 - achieved with significantly reduced resources Talicia U.S. formulary wins securing 8 million additional covered lives, taking the total to more than 204 million lives UK Marketing Authorization Application (MAA) for Talicia® submission imminent and expected to be in time for potential approval this year Ex-U.S. Talicia: cash inflows from first sales milestone and from royalties, majority received post–balance sheet date Up to $60 million global (ex-North America) RHB-102 out-licensing deal signed with Hyloris Pharmaceuticals Corporate and financial highlights: Gross profit doubled compared to first half 2024 59% increase in net revenues in first half of 2025 to $ 4.1  million, up from $2.6 million in first half of 2024 Enhanced financial stability with up to approximately $13.5 million available to the Company through At-the-Market ("ATM") and Any Market Purchase agreements  Cash balance of $3 million as of June 30, 2025 1 Further 19% reduction in cash burn following the previous year's 74% reduction Net cash used in operations in first half of 2025 dropped to $5 million from $6.2 million in first half of 2024  Following RedHill's approximately $8.25 million including interest New York Supreme Court summary judgment win against Kukbo (appeal to be heard this month), the Court also awarded RedHill approximately $1.82 million including interest in legal costs and expenses. RedHill also won an attachment grant in the Korean courts, preventing Kukbo asset disposal prior to enforcement TEL AVIV, Israel and RALEIGH, N.C.

The New York Supreme Court has awarded RedHill approximately $1.82 million in legal costs and expenses following, and in addition to, the Court's prior summary judgment of approximately $8.25 million in favor of RedHill in its action against Kukbo Co. Ltd's ("Kukbo"); the $8.25 million and $1.82 million awards include 9% ongoing statutory interest accrual RALEIGH, N.C. and TEL-AVIV, Israel , Aug. 20, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.

RedHill has received its first Talicia sales milestone payment as well as royalties and other payments, totaling $1.1 million, following the first ex-U.S. commercial launch of Talicia in 2024 Talicia is the first FDA-approved rifabutin-based product specifically designed to treat Helicobacter pylori (H. pylori), a bacterial infection with high and rising resistance rates that affects over 50% of the world's adult population [1] and is the strongest risk factor for gastric cancer and peptic ulcer disease Talicia is the leading branded first-line therapy prescribed by U.S. gastroenterologists [2] for treatment of H.

The positive FDA feedback allows for: A novel Phase 2 RHB-204[1] study, planned to be the first ever clinical study in a specifically defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn's disease (CD) patient population Groundbreaking approach testing MAP as a root cause of CD, supporting RHB-204 as a potential paradigm-shifting therapy treating both the suspected cause of Crohn's disease and its symptoms  RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection diagnostics – the lack of which has previously been a major barrier to advancing the Company's novel anti-MAP Crohn's disease program Innovative design enables a smaller sample size allowing for lower study costs and faster time to completion Funding for this ground-breaking program expected to be non-dilutive; Grant application submitted and discussions ongoing for additional non-dilutive financing Patent protected through 2041, orally-administered RHB-204, a next-generation optimized formulation of RedHill's RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104[2] Phase 3 safety and efficacy results, which delivered a statistically significant 64% improvement in efficacy[3] Expected transferal of pediatric orphan drug designation to RHB-204 as well as potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher The multibillion-dollar Crohn's disease market is expected to expand significantly, with sales in the key markets growing from $13.6 billion in 2024 to over $19 billion in 2033[4], presenting significant commercial potential for new, paradigm changing, FDA-approved therapies RALEIGH, N.C. and TEL AVIV, Israel , July 21, 2025 /PRNewswire/ -- RedHill Biopharma Ltd.