On September 30, 2026 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported operational highlights and financial results for the six months ended June 30, 2026.
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Commercial portfolio update:
$12 million upfront payment to Ferring for the acquisition of commercialization rights to Rebyota and Clenpiq, fully funded by the $18 million received upfront for the Talicia divestment
Transactions strengthen liquidity, provide potential growth and expansion opportunities and enable addition of complementary revenue-generating products
RedHill’s lean commercial infrastructure supports delivery of significant synergies with capacity for further portfolio extension
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: "We have executed on two major transactions that unlock significant value and fuel our capacity for growth. The acquisition of commercial rights to Rebyota and Clenpiq, funded by sale of Talicia, improves our liquidity position and provides us with control to drive increased revenues, identify additional complementary revenue-generating products and support ongoing development of our assets. We are now focused on the rapid and smooth transition of Rebyota and Clenpiq into RedHill, utilizing our lean and efficient commercial team, which is already well positioned and deeply embedded in the U.S. GI market."
Mr. Ben-Ashercontinued: "Looking forward to the second half of 2026 and beyond, we also aim to progress our R&D development projects, which provide compelling opportunities in areas of significant unmet need, including multiple oncology indications, Crohn’s disease and other GI-associated conditions and Ebola virus disease (EBOV). In oncology, opaganib has been granted the U.S. Food and Drug Administration’s rare pediatric disease designation for neuroblastoma, with potential to receive an accompanying Priority Review Voucher. Furthermore, new preclinical data supportive of opaganib add-on therapy in neuroblastoma and triple negative breast cancer was presented at AACR (Free AACR Whitepaper), while recruitment continues into the Bayer-supported Phase 2 study of opaganib and darolutamide in advanced castrate resistant prostate cancer. Progress has also been made on key aspects of our Phase 2-ready Crohn’s program with RHB-204, potentially the first ever in a wholly MAP-positive population, with in vitro assay data demonstrating RHB-204’s comparable MAP killing to RHB-104. Meanwhile, RHB-102 continues its late-stage development for oncology support and GI indications including GLP-1/GIP-associated GI intolerance."
Commercial focus:
Following the divestment of RedHill’s 70% stake in Talicia for $18 million in upfront cash, plus up to $35 million in potential worldwide net sales milestone payments, the Company has acquired for an upfront cash payment of $12 million, plus future milestones and tiered royalties, the exclusive global and U.S. commercialization rights to Rebyota and Clenpiq, respectively, two synergistic, revenue-generating, FDA-approved GI drugs that together generated approximately $37.5 million in 2025 net sales under Ferring.
With a growing medical need, the potential for expanded indications and territories, and an experienced and efficient commercial infrastructure that is highly established within the GI market, these two new assets provide RedHill with a stronger commercial engine for revenue growth, in both the U.S. and other new territories, with potential for further added value through acquisition of additional complementary revenue-generating products.
Rebyota:
Rebyota is a proprietary, first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT) for prevention of recurrent Clostridioides difficile (C. diff) infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and established customer base.
C. diff(CDI) infection is a distressing and life-threatening condition, being the most common cause of healthcare-associated (HA) diarrhea in developed countries1. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. 30,000 Americans die every year due to CDI2, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings1. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences3, indicating the need for use of prevention strategies.
Rebyota’s one-time administration, which requires no fasting, bowel prep or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI4. An aging population and accompanying increasing hospital-acquired vulnerabilities will likely increase this need. A streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage including 43% with coverage after 1st recurrence5.
Rebyota, which was granted, Breakthrough Therapy and Orphan Drug designations, with exclusivities and other patent protections that could run to 2036, provides multiple growth opportunities, including recent approval in Canada. The existing approvals also provide the potential for additional approvals in other territories.
Clenpiq:
Clenpiq is a ready-to-drink, low-volume bowel preparation on the U.S. market. In 2025, it delivered $20.6 million in net sales, with minimal promotion under Ferring. Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually6. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy.
Bowel preparation quality drives outcomes and cost, but it is not a pleasant process and is often poorly performed – driving the need for repeated procedures. As such the benefits of a simplified, ready-to-drink, low-volume bowel preparation are evident. Clenpiq has broad commercial and government payer coverage making its benefits readily accessible to patients: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. 23 million lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12 million (21%) lives with preferred position5.
Focused and advanced R&D pipeline – first half of 2026 highlights:
Opaganib granted U.S. Food and Drug Administration (FDA) rare pediatric disease designation for neuroblastoma, the most prevalent cancer in infants, providing potential for an accompanying Priority Review Voucher (PRV)
New preclinical data showed positive effects of opaganib as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC). Two sets of data presented at the 2026 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting indicate that:
– Opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX) chemotherapy combination in high-risk NB by directly destabilizing n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, through increased ceremide production enhancing programmed cell death (apoptosis) in cancer cells7
– Pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes8
– Opaganib Ebola (Bundibugyo, BDBV) development next steps and potential partnership discussions ongoing with African Medicines Agency, Ugandan Ministry of Health and Mbarara University of Science and Technology (MUST), alongside liaison with the Democratic Republic of Congo (DRC) Scientific Advisory Committee
In Crohn’s disease, new RHB-204in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1049. RHB-204 achieved these results with lower doses of key active ingredients enhancing potential for reduced toxicity and side effects, supporting an innovative FDA-aligned Phase 2-ready study design allowing for a smaller sample size, lower study costs and faster time to completion
Financial results for the six months ended June 30, 2026 (Unaudited) 10
Following the transfer of the Talicia commercial operations to Talicia Holding Inc. ("THI") in October 2025, Talicia’s operations are presented as "discontinued operations" in RedHill’s financial statements. The comparison below is therefore presented on a continuing operations basis, with first half of 2025 comparative figures re-presented on the same basis. RedHill’s ongoing economic participation in the Talicia franchise during the period is reflected separately as its share of loss of the joint venture. RedHill sold its entire 70% interest in THI to Apotex in August 2026.
Net Revenues: No revenues were recognized in the first half of 2026, compared to $0.3 million in the first half of 2025, which was generated from the Hyloris license agreement for RHB-102 (Bekinda).
Research and Development Expenses for the first half of 2026 were $1.0 million, unchanged from the first half of 2025. During the first half of 2026, the Company continued preclinical work related to RHB-204 and opaganib in Ebola.
General, Administrative and Business Development Expenses for the first half of 2026 were $2.5 million, compared to $2.7 million for the first half of 2025. The decrease was primarily attributable to lower professional services expenses and the allocation of certain costs to THI following the transfer of Talicia commercial operations.
Share of Loss of Joint Venture for the first half of 2026 was $0.7 million, representing RedHill’s share of THI’s net loss for the period. THI recorded net revenues of $1.3 million and a net loss of $1.0 million for the first half of 2026.
Operating Loss for the first half of 2026 was $4.1 million, compared to $3.4 million for the first half of 2025. The increase was mainly attributable to the share of THI’s loss and the absence of license revenues in the first half of 2026, partially offset by lower general, administrative and business development expenses.
Financial Expenses, net for the first half of 2026 were $1.6 million, compared to Financial Income, net of $0.5 million for the first half of 2025. Financial expenses in the first half of 2026 mainly reflected warrant-related issuance costs and fair value adjustments on derivative financial instruments.
Net Loss from Continuing Operations for the first half of 2026 was $5.7 million, compared to $2.9 million for the first half of 2025. The increase was mainly attributable to the share of THI’s loss and higher net financial expenses, partially offset by lower general, administrative and business development expenses.
Net Loss from Discontinued Operations for the first half of 2026 was $0.4 million, compared to $1.2 million for the first half of 2025. The decrease was primarily attributable to the transfer of the Talicia commercial operations to THI.
Net Loss for the first half of 2026 was $6.1 million, compared to $4.1 million for the first half of 2025.
Total Assets as of June 30, 2026, were $26.3 million, compared to $25.3 million as of December 31, 2025. The increase was mainly attributable to higher cash and other receivables, partially offset by a decrease in the investment in THI.
Total Liabilities as of June 30, 2026, were $27.4 million, compared to $21.1 million as of December 31, 2025. The increase primarily reflected derivative liabilities associated with the June 2026 private placement and higher accrued expenses and other liabilities.
Net Cash Used in Operating Activities for the first half of 2026 was $4.6 million, compared to $5.0 million for the first half of 2025.
Net Cash Provided by Financing Activities for the first half of 2026 was $5.4 million, primarily reflecting net proceeds from the June 2026 private placement, compared to $3.3 million for the first half of 2025, primarily generated through the Company’s equity offerings11.
Cash Balance as of June 30, 2026, was $5.3 million.
(Press release, RedHill Biopharma, SEP 30, 2026, View Source [SID1234671193])