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On August 5, 2026, the Company issued a press release
announcing its entry into the Collaboration Agreement with Lupvindol Biosciences Ltd. for the development and advancement of CannEpil®
for veterinary uses. A copy of the press release is furnished as Exhibit 99.1 of this Current Report on Form 8-K.
The information in this Item 7.01 (including Exhibit
99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”)
or otherwise subject to the liabilities under such section, and shall not be deemed to be incorporated by reference into any filing of
the Company under the Securities Act of 1933 or the Exchange Act.
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 hereunto
duly authorized.
EXHIBIT 99.1
SPLASH BEVERAGE GROUP PARTNERS WITH VETERAN CANNABINOID DRUG-DEVELOPMENT
TEAM TO ADVANCE CANNEPIL® THROUGH FDA VETERINARY PATHWAY
Collaboration with Lupvindol Biosciences will initially target companion-animal
oncology and chronic pain management
Splash retains ownership of resulting data, intellectual property and commercialization
rights
FORT LAUDERDALE, Fla., August 5, 2026 — Splash Beverage Group, Inc.
(NYSE American: SBEV) (“Splash” or the “Company”) today announced that it has entered into a strategic development
and collaboration agreement with Lupvindol Biosciences Ltd. to advance CannEpil® as a potential FDA-regulated veterinary pharmaceutical
product for companion-animal oncology and chronic pain management.
The milestone-driven program is designed to advance CannEpil through the
U.S. Food and Drug Administration’s Center for Veterinary Medicine, beginning with the Investigational New Animal Drug (“INAD”)
process and progressing toward potential conditional approval pursuant to Section 571 of the Federal Food, Drug, and Cosmetic Act (“Conditional
Approval”). Canine applications are expected to represent the initial development focus.
Lupvindol will lead the scientific, product-development and FDA regulatory
activities, including preparation of the INAD submission, development of an FDA-acceptable product development plan, study design and
oversight, regulatory correspondence and preparation of a potential Conditional Approval submission.
Splash will provide milestone-based funding and lead commercialization
strategy, strategic partnering and capital-markets activities. Importantly, Splash will own the medical technology, study data, regulatory
submissions and foreground intellectual property generated through the collaboration and will retain control over future licensing and
commercialization decisions.
“This collaboration converts our expanded CannEpil rights into a
defined and capital-efficient FDA development program,” said Brady Cobb, Interim Chief Executive Officer of Splash Beverage Group.
“Our objective is to build a differentiated cannabinoid health sciences platform by pairing high-quality intellectual property with
experienced scientific leadership, disciplined regulatory execution and global commercial capabilities.”
“The Lupvindol team has helped advance cannabinoid medicines from
development through FDA approval and commercialization. By combining that experience with Splash’s exclusive global CannEpil rights,
we believe we have assembled the assets and leadership necessary to pursue a significant opportunity in companion-animal health while
preserving Splash’s ownership of the value created through the program.”
EXPERIENCED CANNABINOID PHARMACEUTICAL LEADERSHIP
The program will be led by Hunter Land, Ph.D., Chief Executive Officer
of Lupvindol Biosciences, a pharmaceutical research and development executive with more than two decades of experience across multiple
therapeutic areas.
Dr. Land was GW Pharmaceuticals’ first full-time U.S. research and
development employee and played an important role in the development of Epidiolex®, the first FDA-approved plant-derived cannabinoid
medicine, as well as Sativex®. His experience includes cannabinoid pharmaceutical development, clinical protocol design, regulatory
strategy and commercialization planning.
The broader Lupvindol team brings experience in FDA regulatory pathways,
cannabinoid science, preclinical and clinical study design, product development and commercialization.
“Having participated in the development of Epidiolex®, I have
seen firsthand how rigorous science, disciplined execution and thoughtful regulatory engagement can transform cannabinoid research into
approved pharmaceutical products,” said Dr. Land.
“CannEpil represents a differentiated pharmaceutical cannabinoid
platform that we believe warrants evaluation through the FDA’s veterinary regulatory framework. Our team looks forward to working
with Splash to generate the scientific and clinical evidence required to support potential approval and commercialization in companion-animal
oncology and chronic pain management.”
CAPITAL-EFFICIENT DEVELOPMENT MODEL
The agreement aligns Splash’s investment with measurable regulatory
progress through an initial payment followed by milestone payments tied to opening the INAD, completing the product development plan,
advancing FDA submissions and achieving Conditional Approval or an earlier licensing transaction.
Lupvindol will absorb the annual FDA sponsor fee through Conditional Approval,
unless the parties agree to transfer sponsorship. Splash will fund any FDA-required pilot study subject to an agreed development plan
and contractual funding cap.
Following a designated FDA submission milestone, Splash will evaluate regulatory
feedback, remaining development requirements and interest from potential animal-health pharmaceutical partners before determining the
next phase of the program.
Splash will retain lead responsibility for commercialization and may elect
to partner with an established animal-health pharmaceutical company or pursue direct commercialization based on the regulatory and commercial
data available at that time.
For additional information regarding the collaboration agreement, including
an overview of material terms and a copy of the agreement as an exhibit, investors should review the Company’s Current Report on
Form 8-K filed with the Securities and Exchange Commission on August 4, 2026.
The Company licenses CannEpil from Argent Biopharma Limited pursuant to
an Exclusive License Agreement dated July 6, 2026, as amended on July 27, 2026.
COMPANION-ANIMAL HEALTH OPPORTUNITY
The global veterinary pain-management market was valued at approximately
$2.6 billion in 2024 and is projected to reach approximately $3.8 billion by 2030. Companion-animal oncology also represents a significant
unmet need. The Veterinary Cancer Society estimates that one in four dogs will develop cancer, while the National Cancer Institute estimates
approximately six million new canine cancer diagnoses annually in the United States.
“Splash is executing a disciplined strategy to build a diversified
cannabinoid health sciences platform by commercializing existing international pharmaceutical assets, advancing FDA-regulated veterinary
and human therapeutics, and developing innovative cannabinoid consumer wellness and beverage brands for global markets,” Cobb said.
“We have secured the asset, expanded its licensed field and now engaged
an experienced cannabinoid drug-development team to execute the veterinary program. Our focus is achieving measurable regulatory and commercial
milestones.”
CannEpil has not been approved by the FDA for veterinary use. The indications,
study designs, regulatory requirements, costs and development timeline will be determined through engagement with the FDA. There can be
no assurance that CannEpil will receive Conditional Approval, full approval or any other regulatory authorization.
About Lupvindol Biosciences Ltd.
Lupvindol Biosciences Ltd. is a pharmaceutical and bioscience development
company with expertise in cannabinoid-based therapeutics and U.S. FDA regulatory pathways. The company is led by Hunter Land, Ph.D., whose
experience includes participation in the development of Epidiolex® and Sativex® at GW Pharmaceuticals.
About CannEpil®
CannEpil® is a proprietary pharmaceutical-grade formulation comprising
cannabidiol and tetrahydrocannabinol isolates in a liquid solution manufactured under European Union Good Manufacturing Practice standards.
CannEpil was originally developed for drug-resistant epilepsy in humans and has previously been made accessible through certain physician-directed
and special-access pathways outside the United States.
About Splash Beverage Group, Inc.
About Splash Beverage Group, Inc.
Splash Beverage Group, Inc. (NYSE American: SBEV) is a publicly traded
company headquartered in Fort Lauderdale, Florida. The Company is pursuing a strategic transformation toward becoming a cannabinoid health,
wellness, and biopharmaceutical platform through disciplined capital allocation, strategic investments, acquisitions, and other platform-building
initiatives.
More Information
Splash Beverage Group
Contact Information
Splash Beverage Group
Info@SplashBeverageGroup.com
Media Contact
Angela Gorman
AMWPR
angela@amwpr.com
917-348-0083
Forward-Looking Statements
This press release contains forward-looking statements, including statements
regarding CannEpil’s veterinary development; potential oncology and chronic pain indications; the INAD and Conditional Approval
processes; anticipated studies, FDA interactions and regulatory submissions; potential licensing and commercialization arrangements; and
Splash’s broader business strategy.
Forward-looking statements involve risks and uncertainties that could cause
actual results to differ materially, including Splash’s ability to raise the necessary capital to finance the program, satisfy its
contractual obligations including our ability to maintain the license under the license agreement for the CannEpil product on which the
collaboration described herein depends, complete required studies, establish product safety and efficacy, obtain regulatory authorization,
protect intellectual property and the risk that competitors market the same or similar products, and execute commercialization or strategic-partnering
arrangements, and the risk that that the market or demand for any resulting product we seek to commercialize in the future could be less
than expected or projected. There can be no assurance that an INAD will be opened, any development milestone will be achieved, CannEpil
will receive regulatory approval or any initiative will generate revenue.
Additional risks are described in Splash’s filings with the Securities
and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2025 and the Final Prospectus on Form
424B3 filed on June 26, 2026. Splash undertakes no obligation to update forward-looking statements except as required by law.
