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 August 2026
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 ☐
INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
RedHill Biopharma Ltd. (the “Company”) today announced the divestment of its Talicia (the “Product”) business
to a subsidiary of Apotex Health Corp. (“Apotex”). Pursuant to a stock purchase agreement between the parties, the Company
sold its 70% interest in Talicia Holdings Inc. (“THI”) to Apotex for an upfront payment of $18 million plus up to an additional
$35 million in potential payments based on worldwide net sales milestones. Apotex previously held the other 30% holdings in THI following
its recent acquisition of the U.S. branded business of Cumberland Pharmaceuticals Inc. (“Cumberland”), which included Cumberland’s
30% interest in THI. In addition, under the stock purchase agreement, the Company agreed to a five-year non-compete covenant in relation
to the Product in the U.S. and its territories covering competing products.
In addition, the Company, through a subsidiary,
entered into a Transition Services Agreement (“TSA”) with Apotex, pursuant to which the Company and its affiliates will provide
certain transition services for an initial period of six (6) months, with an option by Apotex to extend the TSA for an additional period
of three (3) months for limited services.
Attached hereto and incorporated by reference
in this Report on Form 6-K is the following exhibit:
Exhibit 99.1: Press release, dated August 31, 2026, entitled: “RedHill Divests Talicia® to Apotex for $18 Million Cash Upfront Plus Milestones to Fuel Strategic Growth Opportunities.”
This Form 6-K (other than the management comments
in the second paragraph of Exhibit 99.1) 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), on March 25, 2025 (File No.
333-286082) and on January 22, 2026 (File No. 333-292879), 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), October 13, 2023 (File No. 333-274957),
as amended, on August 9, 2024 (File No. 333-281417) and on July 2, 2026 (File No. 333-297223).
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.
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REDHILL BIOPHARMA LTD. |
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(the “Registrant”) |
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| Date: August 31, 2026 |
By: |
/s/ Dror Ben-Asher |
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Name: |
Dror Ben-Asher |
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Title: |
Chief Executive Officer |
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Exhibit 99.1
RedHill Divests
Talicia® to Apotex for $18 Million Cash
Upfront Plus
Milestones to Fuel Strategic Growth Opportunities
Executes a major step in RedHill’s strategic
roadmap to fundamentally reposition the Company’s
commercial business toward new and larger product opportunities, revenue growth
and an
accelerated path toward operational profitability
--
Realizes substantial value from RedHill’s
70% stake in Talicia, currently held within a shared
ownership and economic structure, while immediately creating a stronger liquidity
position and fully
funding the next major steps in RedHill’s transformational commercial expansion
--
Under the terms of the agreement, Apotex will
pay RedHill an upfront payment of $18 million plus
up to an additional $35 million in potential worldwide net sales milestone payments
RALEIGH, N.C., and TEL-AVIV, Israel, August
31, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty
biopharmaceutical company, today announced the divestment of its Talicia business to a subsidiary of Apotex Health Corp. (TSX: APTX)
(“Apotex”) for an upfront payment of $18 million plus up to an additional $35 million in potential payments based on worldwide
net sales milestones.
“This transaction is a pivotal milestone
for RedHill. We are converting our 70% stake in Talicia into immediate capital, significantly stronger liquidity and meaningful potential
upside, while fully funding the next major step in our commercial business expansion. I want to thank the RedHill team for developing
and positioning this important product for success, targeting H. pylori infection, the main cause of gastric cancer and stomach
ulcers,” said Dror Ben-Asher, RedHill’s Chief Executive Officer. “We are confident that given its proven capabilities,
Apotex is the right home to grow Talicia globally. We thank Apotex for their partnership on the successful conclusion of this transaction,
which unlocks the resources needed to scale RedHill’s existing gastrointestinal (GI) commercial franchise into a stronger and larger
one, including new, high-value, FDA-approved product opportunities intended to drive sustained growth and accelerate our path toward
operational profitability.”
Under the terms of the agreement, RedHill received
$18 million in cash and has the potential to receive up to an additional $35 million in payments based on worldwide net sales milestones
from Apotex. In return, Apotex will receive RedHill’s 70% interest in Talicia, following Apotex’s prior acquisition of Cumberland
Pharmaceuticals Inc.’s U.S. branded business, which included Cumberland Pharmaceuticals Inc.’s 30% ownership in Talicia.
RedHill was advised by Morningstar Law Group and
Greenberg Traurig LLP on this transaction.
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'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, metabolic and anticancer activity,
targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure
development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), an ongoing Phase 2 study in
prostate cancer in combination with darolutamide and a Phase 2/3 program for hospitalized COVID-19; (ii) RHB-102 (Bekinda®),
with a planned Phase 2 proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a U.S. Phase
3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for
chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide
development and commercialization outside North America; (iii) 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 (iv) RHB-107 (upamostat),
an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and also targeting
multiple cancer and inflammatory gastrointestinal diseases.
More information about the Company is available
at www.redhillbio.com / X.com/RedHillBio.
About Apotex
Apotex is a Canadian-based global health company.
Apotex improves everyday access to affordable, innovative medicines and health products for millions of people around the world, with
a broad portfolio of generic, biosimilar, and innovative branded pharmaceuticals, and consumer health products. Headquartered in Toronto,
with regional offices globally, including in the United States, Mexico, and India, Apotex is the largest Canadian-based pharmaceutical
company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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, and include,
among others, statements regarding the divestment of Talicia and the potential use of the proceeds of that sale; the Company’s ability
to acquire or develop new products, expected revenue growth, the Company’s anticipated path toward operational profitability, and
the Company’s strategic plans for its commercial business. 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: the risk that the divestment of Talicia does not result in any planned asset
acquisitions, or that any such acquisitions are not commercially successful; the risk that proceeds from the transaction are insufficient
to fund the Company’s strategic plans or that such plans do not achieve the anticipated results; the risk that opaganib is not accepted
into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204
for Crohn’s disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that
opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively
reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company's ability to regain and maintain compliance with
Nasdaq's listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products
or out-licensing transactions will not occur; the risk that the Company will not receive future milestone payments under its existing
agreements, including under the Apotex agreement, or that they will be less than anticipated; 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 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; (v) the Company's ability to establish and maintain corporate collaborations; (vi)
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; (vii) 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; (viii) the implementation
of the Company's business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property
defaulting in their obligations to the Company; (xi) the Company’s ability to collect on its judgement against Kukbo; (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
27, 2026. 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.
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Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
adi@redhillbio.com
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Category: Corporate
