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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):
October 5, 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
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 |
|
SBEV |
|
NYSE American LLC |
Item 7.01 Regulation FD Disclosure
On October 5, 2026, Endovia Health Sciences, Inc.
(the “Company”) issued a press release announcing the U.S. Food and Drug Administration’s determination that CannEpil®
qualifies as a minor use for canine bone cancer pain. 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 October 5, 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.
| |
ENDOVIA HEALTH SCIENCES, INC. |
| |
|
|
| Date: October 5, 2026 |
By: |
/s/ Brady Cobb |
| |
Name: |
Brady Cobb |
| |
Title: |
Interim Chief Executive Officer |
EXHIBIT 99.1
Endovia and Lupvindol BioSciences Announce FDA Determination
that CannEpil® for Canine Bone Cancer Pain Qualifies as a Minor Use, Establishing Eligibility for Conditional Approval Pathway
Companies to Meet Formally with FDA’s Center
for Veterinary Medicine on November 19th for Pre-Submission Conference; U.S. Manufacturing Strategy Underway to Support Potential 2027
Veterinary Product Launch
FORT LAUDERDALE, Fla. — October 5, 2026 — Endovia Health Sciences,
Inc. (“Endovia” or the “Company”) (NYSE American: EDVA), in association with Lupvindol BioSciences (“Lupvindol”),
today announced that the U.S. Food and Drug Administration’s (“FDA”) Center for Veterinary Medicine has determined that
the proposed use of CannEpil®, an investigational cannabidiol (“CBD”) and tetrahydrocannabinol (“THC”) oral
solution, for the control of pain associated with bone cancer in dogs qualifies as a “minor use” under the Minor Use and Minor
Species (“MUMS”) program.
The FDA determination establishes CannEpil’s eligibility to pursue
the conditional approval pathway for this proposed indication. The FDA further determined that the minor-use status will be maintained
through approval of the applicable New Animal Drug Application (“NADA”).
Under the MUMS framework, qualifying new animal drugs may be eligible for
conditional approval which is a regulatory pathway designed to facilitate earlier availability of therapies for uncommon diseases and
conditions in animals. Conditional approval requires satisfaction of applicable FDA requirements, including safety and manufacturing standards
and a reasonable expectation of effectiveness, while allowing additional effectiveness data required for full approval to be collected
following conditional approval.
Endovia and Lupvindol are scheduled to meet formally with the FDA on November
19, 2026, for a Pre-Submission Conference to discuss and align with the FDA on the proposed CannEpil® development program,
including the studies, manufacturing requirements and regulatory submissions necessary to pursue conditional approval.
In parallel with the regulatory program, Endovia and Lupvindol are actively
sourcing and finalizing U.S.-based manufacturing capabilities for CannEpil®. This work is intended to establish a scalable,
FDA-compliant domestic supply chain capable of supporting the clinical and regulatory program and, subject to receipt of the necessary
regulatory approvals, a potential commercial launch for veterinary use in 2027.
“This determination represents an important regulatory milestone
for CannEpil® and provides greater clarity around the pathway we are pursuing with the FDA,” said Brady Cobb, Interim
Chief Executive Officer of Endovia Health Sciences. “Importantly, we are not waiting to begin preparing for commercialization. Alongside
Lupvindol, we are advancing our FDA development program while simultaneously working to establish U.S. manufacturing and supply capabilities
that can support a potential veterinary launch in 2027, subject to regulatory approval.”
Cobb continued, “We believe CannEpil has the potential to demonstrate
what a science-driven, federally regulated cannabinoid medicine can look like in the United States. Our veterinary program gives us an
opportunity to address a serious unmet need for dogs suffering from cancer-related pain while building the regulatory, manufacturing and
scientific infrastructure that we believe can support the broader development of CannEpil.”
The MUMS conditional approval pathway was established to encourage development
of new animal drugs for uncommon conditions affecting relatively small populations. Following conditional approval, a sponsor may legally
market a qualifying animal drug while continuing to collect the additional effectiveness data necessary to support full FDA approval,
subject to applicable statutory and regulatory requirements and annual FDA renewal.
CannEpil® remains an investigational new animal drug and
has not been approved or conditionally approved by the FDA. The Company’s anticipated development timelines, including a potential
2027 commercial launch, remain subject to FDA review, successful completion of applicable regulatory requirements, manufacturing readiness
and other factors.
About CannEpil®
CannEpil® is a proprietary cannabinoid-based oral formulation containing
cannabidiol (CBD) and tetrahydrocannabinol (THC). Endovia and Lupvindol BioSciences are advancing CannEpil through the FDA’s Center
for Veterinary Medicine for the proposed control of pain associated with bone cancer in dogs.
The veterinary development program is part of Endovia’s broader strategy
to develop cannabinoid-based therapeutics through established federal regulatory pathways and to build a platform capable of supporting
additional veterinary and human therapeutic applications, subject to applicable statutory and regulatory requirements.
About Endovia Health Sciences
Endovia Health Sciences, Inc. (NYSE American: EDVA) is a cannabinoid health
sciences company focused on building a diversified platform across pharmaceutical development, FDA-regulated human and veterinary therapeutics,
international pharmaceutical commercialization and cannabinoid-based wellness products.
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.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform act of 1995 including statements regarding the development and commercialization
of CannEpil®; obtaining a manufacturing source, and a potential commercial veterinary launch in 2027.
Forward-looking statements are based on current expectations, estimates,
projections and assumptions and involve risks and uncertainties that could cause actual results to differ materially. Some or all of these
risks may not occur. These risks include the Company’s ability to obtain additional financing; the development of and obtaining
regulatory authorization for and commercialize CannEpil® for veterinary use, the results of any clinical trials, the availability
of raw materials, the ability to obtain a manufacturer to meet our needs on a financially viable basis, ; maintaining its rights under
applicable license agreements; the enactment, implementation or impact of proposed legislation or regulatory initiatives; ability to meet
competition from both CBD and conventional pharmaceuticals products ,our ability to successfully 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.
Additional risks are described in the Company’s filings with the
Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and
the final prospectus filed pursuant to Rule 424(b)(3) on August 28, 2026.
Forward-looking statements speak only as of the date of this press release,
and the Company undertakes no obligation to update or revise any such statements whether as a result of new information, future events
or otherwise, except as required by applicable law.
Investor Contact
Endovia Health Sciences
investors@endoviasciences.com
Media Contact
Angela Gorman
AMWPR
angela@amwpr.com
917-348-0083
