[6-K] RedHill Biopharma Ltd. Current Report (Foreign Issuer)

Rhea-AI Filing Summary

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.

Positive

• Appellate court upheld a $10 million summary judgment in RedHill's favor against Kukbo, reducing litigation uncertainty
• Clear pipeline overview showing multiple clinical-stage programs and an active partnership for RHB-102 with Hyloris Pharma
• Multiple registration statements incorporated by reference, indicating maintained compliance for equity offerings and share plans

Negative

• No financial quantification of the $10 million judgment’s expected recoverability, timing, or impact on cash/earnings
• Filing lacks clinical updates or timelines for the listed programs, providing limited information for near-term clinical or commercial milestones

Insights

Corporate Governance Expert

TL;DR: Court win strengthens legal position but filing lacks quantified financial impact.

The Form 6-K communicates a favorable appellate outcome affirming a $10 million summary judgment, which reduces legal uncertainty and may improve the company’s balance sheet prospects depending on collectability and timing. However, the filing does not disclose recoverability, expected cash inflows, counterparty status, or provisions, limiting assessment of near-term financial effects. The repetition of registration statements is administrative and does not alter governance or capital structure.

Biotech Industry Analyst

TL;DR: Legal victory is positive; pipeline description confirms ongoing late-stage programs but no new clinical data.

The notice highlights a material legal outcome and reiterates a diversified clinical portfolio with multiple late-stage and partnered programs—opaganib, RHB-204, RHB-107, and RHB-102—targeting infectious, inflammatory, and oncology indications. These program descriptions signal continued development activity and partnerships (notably Hyloris for RHB-102) but the filing supplies no new trial results, timelines, or financial guidance to change valuation assumptions.

 UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

For the month of September 2025
Commission File No.:001-35773

REDHILL BIOPHARMA LTD.

(Translation of registrant’s name into English)

21 Ha'arba'a Street, Tel Aviv, 6473921, Israel

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.  

Form 20-F ☒        Form 40-F ☐

Attached hereto and incorporated by reference herein are the following:

Attached hereto and incorporated by reference herein is a press release issued by the Registrant entitled: “RedHill Wins New York Supreme Court Appeal, Upholding $10 Million Summary Judgment Against Kukbo”.

This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No. 333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001), on June 20, 2024 (File No. 333-280327) and on March 25, 2025 (File No. 333-286082), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on August 9, 2024 (File No. 333-281417).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	REDHILL BIOPHARMA LTD.
	(the "Registrant")
Date: September 29, 2025	By:	/s/ Dror Ben-Asher
	Name:	Dror Ben-Asher
	Title:	Chief Executive Officer

Press Release

RedHill Wins New York Supreme Court Appeal, Upholding

$10 Million Summary Judgment Against Kukbo

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, September 29, 2025 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that The New York Supreme Court has, on appeal, upheld its original summary judgment ruling and award in favor of RedHill, unequivocally dismissing, once again, the entirety of Kukbo Co. Ltd’s (“Kukbo”) defense, ruling that Kukbo was in breach of both the original subscription agreement and subsequent exclusive license agreements with the Company (the “Agreements”).

In making its appeal judgment, the New York Supreme Court clearly stated that RedHill had properly fulfilled its obligations according to the Agreements, even after Kukbo’s non-payment breach.

RedHill has been granted approximately $10 million in total awards from related court actions, comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses (including 9% ongoing statutory interest accrual). Kukbo has the right to further appeal the Court’s ruling.

In addition, to the New York Supreme Court case, RedHill recently won an attachment grant against Kukbo, from Korea’s Incheon District Court, providing a court-ordered seizure (attachment) of Kukbo’s assets, preventing their disposal prior to judgment enforcement.

About RedHill Biopharma  

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia^®, for the treatment of Helicobacter pylori (H. pylori) infection in adults¹. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn’s disease (based on RHB-104’s positive Phase 3 Crohn’s disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America.

More information about the Company is available at www.redhillbio.com / X.com/RedHillBio.

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Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Category: Corporate

¹ Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: https://www.talicia.com/.

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FAQ

What did RedHill (RDHL) report in the Form 6-K?

The Form 6-K attached a press release stating the New York Supreme Court upheld a $10 million summary judgment in RedHill's favor against Kukbo and summarized the company's clinical pipeline.

Does the filing state how the $10 million judgment will affect RedHill's finances?

No. The filing does not provide any financial quantification, timing, or recoverability details related to the $10 million judgment.

Which development programs does RedHill describe in the filing?

The filing describes opaganib (ABC294640), RHB-204, RHB-107 (upamostat), and RHB-102, including indications and stage notes (e.g., Phase 2/3, Phase 3-stage, partnerships).

Is there new clinical data or trial results included in this 6-K?

No. The document provides program descriptions and past positive study references but does not present new clinical data or trial results.

Who is RedHill's partner for RHB-102?

RHB-102 is partnered with Hyloris Pharma for worldwide development and commercialization outside North America.