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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities
Exchange Act of 1934
Date of Report (Date of earliest event reported):
August 24, 2026
ENDOVIA
HEALTH SCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Nevada |
|
001-40471 |
|
34-1720075 |
|
(State or other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
|
1112 N. Flagler Drive
Fort Lauderdale, Florida |
|
33304 |
| (Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including area
code: (954) 648-7238
Registrant’s Former Name: Splash Beverage
Group, Inc.
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ |
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange
Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Securities registered pursuant to Section 12(b) of
the Act:
| Title of Each Class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, $0.001 par value |
|
EDVA |
|
NYSE American LLC |
Item 7.01 Regulation FD Disclosure
On August 25, 2026, Endovia Health Sciences, Inc. formerly known as Splash
Beverage Group, Inc. (the “Company”) issued a press release announcing that it achieved the first FDA Regulatory Milestone
for its CannEpil® veterinary development program under its previously announced collaboration agreement with Lupvindal Biosciences
Ltd., formally initiating the regulatory process for the development of CannEpil® as an investigational veterinary pharmaceutical.
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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit |
|
Description |
| 99.1 |
|
Press Release dated August 25, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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 hereunto
duly authorized.
| |
SPLASH BEVERAGE GROUP, INC. |
| |
|
|
| Date: August 25, 2026 |
By: |
/s/ Brady Cobb |
| |
Name: |
Brady Cobb |
| |
Title: |
Interim Chief Executive Officer |
EXHIBIT 99.1
Endovia Health Sciences, formerly Splash Beverage, Achieves First FDA
Regulatory Milestone for CannEpil® Veterinary Development Program
FDA establishes Investigational New Animal Drug (INAD) File No. 14145,
advancing the Company’s companion-animal oncology program and marking first milestone under Lupvindol collaboration
FORT LAUDERDALE, Fla., August 25, 2026 — Endovia Health Sciences,
Inc. (NYSE American: EDVA), formerly Splash Beverage Group, Inc. (NYSE American: SBEV) (“Endovia Health” or the “Company”)
announced that the U.S. Food and Drug Administration’s Center for Veterinary Medicine has established Investigational New Animal
Drug (INAD) File No. 14145 for the Company’s CannEpil® veterinary development program.
The establishment of the INAD file represents the first regulatory milestone
under the Company’s previously announced development and collaboration agreement with Lupvindol Biosciences Ltd. and formally initiates
the FDA regulatory process for the development of CannEpil® as an investigational veterinary pharmaceutical.
Endovia Health is initially pursuing the development of CannEpil® for
the management of cancer-related pain in companion animals, beginning with canine oncology.
Cancer remains the leading cause of death in older dogs, yet there are
currently no FDA-approved therapies specifically indicated for the treatment of cancer-related pain.[1][2]
Veterinarians often rely on off-label treatment approaches that may be limited by gastrointestinal or renal toxicity, sedation, controlled-substance
restrictions or limited clinical evidence. The Company believes this represents a significant unmet medical need within companion-animal
medicine.
The Company intends to pursue development under the FDA’s Minor Use
/ Minor Species (MUMS) designation and Conditional Approval pathway, which is intended to encourage the development of therapies addressing
important unmet veterinary needs.
“This achievement represents much more than an administrative milestone—it
demonstrates our ability to execute,” said Brady Cobb, Chief Executive Officer of Endovia Health Sciences. “When we announced
our collaboration with Lupvindol, we committed to advancing CannEpil through a disciplined, milestone-driven FDA development program.
Receiving our INAD file on schedule validates both our development strategy and the strength of our partnership.”
“In our view, cancer remains one of the greatest unmet medical needs
in companion-animal health. We believe CannEpil has the potential to become an important new therapeutic option, and today’s milestone
officially begins our regulatory engagement with the FDA. Our focus now shifts to finalizing our product development plan, advancing the
required studies and continuing to build a differentiated veterinary pharmaceutical platform.”
Hunter Land, Ph.D., Chief Executive Officer of Lupvindol Biosciences Ltd.,
added:
“Opening the INAD file is the first formal regulatory milestone in
the development process and establishes the framework for our ongoing interactions with the FDA Center for Veterinary Medicine. Our team
has successfully advanced cannabinoid-based medicines through regulated development programs before, and we look forward to applying that
same scientific rigor and regulatory discipline to the CannEpil program as we pursue FDA Conditional Approval.”
[1]
https://en.wikipedia.org/wiki/Cancer_in_dogs
[2]
https://pmc.ncbi.nlm.nih.gov/articles/PMC10352038/
The INAD establishes the regulatory foundation for future FDA interactions,
including development planning, preclinical and clinical studies, manufacturing activities and regulatory submissions supporting potential
Conditional Approval.
The Company expects to provide additional updates as future regulatory
and development milestones are achieved.
About CannEpil®
CannEpil® is a proprietary pharmaceutical-grade cannabinoid formulation
comprised of cannabidiol (CBD) and tetrahydrocannabinol (THC) isolates in an oral liquid formulation manufactured under European Union
Good Manufacturing Practice (EU-GMP) standards. Splash holds the exclusive global rights to develop and commercialize CannEpil® across
licensed fields of use, including veterinary therapeutics.
About Endovia Health Sciences
The Company has rebranded as Endovia Health Sciences (NYSE American:
EDVA), with a corporate name change and ticker symbol change effective on the NYSE American on August 24, 2026. The rebranding reflects
the Company’s evolution into a diversified cannabinoid-based health sciences platform focused on pharmaceutical commercialization,
FDA-regulated human and veterinary therapeutics, and cannabinoid-based consumer wellness and beverage opportunities across pharmaceutical,
veterinary and consumer wellness markets.
Where Science Meets Cannabinoid Innovation
More Information
Endovia Health Sciences: endoviasciences.com
Contact Information
Endovia Health Sciences
investors@endoviasciences.com
Media Contact
Angela Gorman
AMWPR
angela@amwpr.com
917-348-0083
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning
of applicable federal securities laws, including statements regarding the Company’s new strategic focus and corporate name change,
efforts towards the development and commercialization of pharmaceutical products for humans and animals, FDA regulatory activities, international
expansion and future business opportunities. anticipated needs, trends and expectations for the Company’s business and industry
and goals and expectations with respect to the Company’s new business strategy.
Forward-looking statements are based on current expectations and assumptions
and involve risks and uncertainties that could cause actual results to differ materially. These risks include the Company’s ability
to raise the necessary capital to finance the its operations and business and product development plan, satisfy its contractual obligations
including our ability to maintain the license under the license agreement for the CannEpil® product on which the Company’s initial
focus depends and related agreements in connection therewith, our ability to complete required studies, establish product safety and efficacy,
obtain and maintain regulatory authorizations, protect intellectual property and the risk that competitors market the same or similar
products, our ability to execute commercialization or strategic-partnering arrangements, 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, our ability to meet our debt obligations
and the negative financial and operational consequences of failing to do so, our ability to comply with NYSE American’s continued
listing standards and the risk that we may be delisted, the possibility that our expectations and perceived benefits with respect to our
business and product development plan and strategic transactions we may pursue prove to be incorrect, and risks with respect to our ability
to negotiate and execute definitive agreements, satisfy closing conditions, obtain required approvals with respect to any such strategic
transaction. There can be no assurance that the Company’s goals and milestones will be achieved, that the Company or its collaborators
will receive or maintain necessary regulatory authorizations or that any initiative will ultimately generate revenue.
Additional risks are described in the Company’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 Form S-1/A filed
on August 20, 2026. The Company undertakes no obligation to update forward-looking statements except as required by law.
