Endovia Health Sciences, formerly Splash Beverage, Achieves First FDA Regulatory Milestone for CannEpil® Veterinary Development Program (Form 8-K)

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

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Endovia Health Sciences

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