Form 8-K

8-K — Endovia Health Sciences, Inc.

Accession: 0001731122-26-001271

Filed: 2026-09-22

Period: 2026-09-22

CIK: 0001553788

SIC: 2080 (BEVERAGES)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — e7964_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (e7964_ex99-1.htm)

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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):

September 22, 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 September 22, 2026, Endovia Health Sciences, Inc.

(the “Company”) issued a press release announcing certain developments. 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 September 22, 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: September 22, 2026

By:

/s/ Brady Cobb

Name:

Brady Cobb

Title:

Interim Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: e7964_ex99-1.htm · Sequence: 2

EXHIBIT 99.1

Endovia Health Sciences Closes Initial $500,000 Financing

to Accelerate CannEpil® Development Amid Growing Federal Support for Botanical Drug Pathways

Initial funding represents first tranche of previously

announced $1 million C/M Capital commitment supporting CannEpil® development and commercialization

Financing comes as FDA and Congress increase focus

on advancing and incentivizing regulated development of botanical and plant-derived medicines

FORT LAUDERDALE, Fla. — September 22, 2026

— Endovia Health Sciences, Inc. (NYSE American: EDVA) (“Endovia” or the “Company”), a cannabinoid health

sciences company, today announced that it has closed $500,000 of initial secured convertible debt funding from C/M Capital Master Fund,

LP (“C/M Capital”), representing the first tranche of the aggregate $1 million investment commitment previously announced

in connection with the Company’s exclusive global licensing agreement for CannEpil® with Argent BioPharma Limited.

The financing provides additional capital to advance

the development and commercialization of CannEpil®, including Endovia’s U.S. FDA-regulated veterinary development program and

international commercialization initiatives.

C/M Capital’s commitment to the $1 million investment

was previously announced in connection with Endovia’s acquisition of exclusive worldwide rights to CannEpil®. C/M Capital committed

capital to support regulatory advancement, clinical development planning and commercialization of the product.

“When we acquired the global rights to CannEpil,

we laid out a clear strategy: secure a differentiated pharmaceutical cannabinoid asset, capitalize the program, advance it through established

regulatory pathways and build a broader cannabinoid health sciences platform around it,” said Brady Cobb, Interim Chief Executive

Officer of Endovia Health Sciences. “With this initial funding now closed, we are putting capital directly behind that strategy

at what we believe is an increasingly important time for cannabinoid science and federal regulatory policy.”

Advancing CannEpil® Through Established FDA Pathways

The financing follows a series of milestones for Endovia’s

CannEpil® development program.

The U.S. Food and Drug Administration’s Center

for Veterinary Medicine previously established Investigational New Animal Drug (“INAD”) File No. 14145 for the CannEpil®

veterinary development program, formally initiating the FDA regulatory process for development of CannEpil® as an investigational

veterinary pharmaceutical.

Endovia is initially pursuing CannEpil® for the

management of cancer-related pain in companion animals, beginning with canine oncology, and is working with Lupvindol Biosciences Ltd.,

its veterinary development partner, to advance the program through the applicable FDA regulatory process.

The Company also continues to pursue international

commercialization opportunities for CannEpil® and evaluate additional cannabinoid formulations and intellectual property for potential

licensing, acquisition or strategic collaboration.

Federal Momentum Toward Botanical Drug Development

Endovia believes its investment in cannabinoid pharmaceutical

development is occurring against an increasingly constructive federal backdrop for the scientific development of botanical and plant-derived

medicines.

The FDA recently launched an initiative seeking public

input on opportunities to advance botanical drug development in the United States, including regulatory challenges facing botanical drug

developers, innovative approaches to accelerate development, potential updates to FDA guidance and resources, quality standards and clinical

study design. The initiative builds upon the FDA’s existing botanical drug regulatory framework, under which plant-derived products

may be developed through established FDA drug-approval pathways. FDA materials addressing drug development from the cannabis plant have

also identified the Agency’s botanical drug guidance as applicable to the use of botanicals, including cannabis, as sources for

drug development.

Congress is also considering new incentives intended

to encourage investment in FDA-regulated botanical medicines. On August 27, 2026, Representatives Lauren Boebert and Derrick Van Orden

introduced H.R. 10150, the Advancing Botanical Drug Development Act of 2026, which was referred to the House Committee on Energy

and Commerce. The proposed legislation would amend Section 505 of the Federal Food, Drug, and Cosmetic Act to provide qualifying botanical

drugs approved through the FDA’s Section 505(b)(1) pathway with a 12-year period of market exclusivity, during which certain

subsequent applications relying upon the approved botanical drug could not become effective.

In its findings, H.R. 10150 recognizes both the scientific

potential and unique development challenges associated with botanical medicines and states that existing intellectual-property and regulatory-exclusivity

frameworks may provide insufficient incentives for private investment in botanical drug research and development. The legislation expressly

seeks to encourage the development and approval of evidence-based, FDA-regulated botanical drugs while maintaining the safety and effectiveness

standards applicable to other FDA-regulated drugs.

“We

believe these developments are significant for the broader cannabinoid sciences industry,”

Cobb said. “The FDA already has an established regulatory framework for botanical

drug development, and cannabis has been recognized within the Agency’s botanical

drug development materials. We are now seeing renewed attention from both FDA and Congress around how sophisticated plant-derived medicines

can be developed, evaluated and ultimately brought to market through rigorous, science-based regulatory pathways.”

Cobb continued, “The proposed 12-year exclusivity

period is particularly noteworthy because access to capital and protection of the substantial investment required for pharmaceutical

development are critical to building viable programs around complex plant-derived medicines. While H.R. 10150 remains proposed legislation,

we believe its introduction, together with FDA’s renewed focus on botanical drug development, reflects meaningful federal attention

to creating an environment capable of supporting greater scientific and private-sector investment in this area.”

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.

Forward-Looking Statements

This press release contains “forward-looking

statements” within the meaning of applicable federal securities laws, including statements regarding the development and commercialization

of CannEpil®; the intended use and anticipated benefits of financing proceeds; future funding; FDA and other regulatory activities;

potential changes in federal laws, regulations and policies affecting botanical drugs, cannabis and cannabinoids; plans and expectations

for commercialization efforts including for veterinary uses and U.S. and international commercialization; potential licensing and acquisition

opportunities; and the Company’s strategy to develop and expand its cannabinoid health sciences platform.

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. These

risks include the Company’s ability to obtain additional financing; successfully develop, obtain regulatory authorization for and

commercialize CannEpil® or other products; maintain its rights under applicable license agreements; the enactment, implementation

or impact of proposed legislation or regulatory initiatives; the occurrence of greater scientific and private-sector investment in botanical

drug pathways, our ability to identify and consummate licensing, acquisition or strategic transactions; comply with NYSE American continued

listing standards; and successfully execute our business strategy, our ability to complete required studies, establish product safety

and efficacy, obtain and maintain regulatory authorizations, the risk that competitors market the same or similar products, our ability

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, 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.

There can be no assurance that additional funding

will be received, H.R. 10150 or other proposed legislation will be enacted in its current form or at all, regulatory policies will change,

regulatory or commercialization milestones will be achieved, or any product or initiative will ultimately generate revenue. Additional

risks are described in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company’s Annual

Report on Form 10-K for the year ended December 31, 2025, the Form S-1 filed on August 7, 2026, as amended, 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

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