Form 8-K - Current report

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 26, 2024

GB Sciences, Inc.

(Exact name of Registrant as specified in its charter)

Nevada

(State or other Jurisdiction of
Incorporation or organization)

000-55462

(Commission File Number)

59-3733133

(IRS Employer I.D. No.)

205 W. Russell Road, Suite 240

Las Vegas,Nevada89148

(Address of Principal Executive Offices) (Zip Code)

(866) 721-0297

Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

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 (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule l 4a- l 2 under the Exchange Act ( 17 CFR 240. l 4a- l 2)

☐	Pre-commencement communications pursuant to Rule l 4d-2(b) under the Exchange Act (17 CFR 240. l 4d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. l 3e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
None	N/A	N/A

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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. ☐

Item 1.01 Entry into a Material Definitive Agreement.

Effective September 26, 2024, the Company entered into a license agreement (the “Agreement”) with EndoPure Life Sciences, LLC (“EndoPure”), a company with experience in regulatory approvals, manufacturing, and the distribution of cannabinoid-based treatments in Brazil and throughout South America. Pursuant to the Agreement, the Company granted EndoPure an exclusive license to their cannabinoid-based treatment for Parkinson’s disease, as a part of a suite of cannabinoid-based treatments for neurological disorders. In addition to other consideration, the Agreement secures a 5% top line royalty for the Company on gross sales of its products by EndoPure in Brazil and South America. The Agreement also provides the capital and expertise to advance the Company’s products through first-in-human clinical trials in this region. The human data from these clinical trials in Brazil and South America can be used by the Company to supplement its efforts for U.S. FDA approvals and its other global regulatory approval efforts.

Item 9.01 Financial Statements and Exhibits.

Exhibits

No.	Description

99.1	Press release regarding Material Definitive Agreement

104	Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirement of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

		GB Sciences, Inc.
		a Nevada corporation
Dated: October 15, 2024	By:	/s/ Dr. Andrea Small-Howard
		Dr. Andrea Small-Howard
		Chief Executive Officer

Exhibit 99.1

GB Sciences Signs Licensing Deal with EndoPure Life Sciences for 5% Gross Sales Royalty & Sponsorship of First-in-Human Trial for their Cannabinoid-based Parkinson’s Drug

As a part of their Exclusive Licensing Deal, EndoPure Life Sciences will finance and sponsor first-in-human clinical trials, which help to advance GB Sciences’ cannabinoid-based products globally.

Las Vegas, NV/ ACCESSWIRE/ Tuesday, October 15th, 2024/ GB Sciences, Inc. (OTCQB:GBLX), a leading data-driven, plant-inspired biopharmaceutical development company, has signed an exclusive licensing deal with EndoPure Life Sciences, LLC, a company with experience in regulatory approvals, manufacturing, and the distribution of cannabinoid-based treatments in Brazil and throughout South America. GB Sciences has granted EndoPure Life Sciences an exclusive license to their cannabinoid-based treatment for Parkinson’s disease; as a part of a suite of cannabinoid-based treatments for neurological disorders. Aging populations have led to an increased global demand for effective treatments of neurological disorders, such as Parkinson’s disease, Alzheimer’s disease, dementia, multiple sclerosis, and epilepsy. The global market for treatments of neurological disorders is growing and is projected to hit $94.3 billion USD by 2032. Novel, validated products that address this important market are urgently needed.

“GB Sciences’ novel cannabinoid-based therapies for neurological disorders will be marketed under our brand name in Brazil and South America, where we have a strong track record of providing trusted cannabinoid-based medicines,” said Allen Voigt, CEO and Founder of EndoPure Life Sciences. “GB Sciences provides scientific validation for their patented cannabinoid-based formulas; as well as expertise in developing products utilizing patient-friendly delivery methods. Our first licensed cannabinoid-based product from GB Sciences will be delivered in Oral Dissolving Tablets that are perfect for Parkinson’s patients that have trouble swallowing medicines but like the convenience of taking their medicine by mouth.”

“This licensing deal not only secures a 5% top line royalty for GB Sciences on gross sales of its novel cannabinoid-based neurological products by EndoPure Life Sciences in Brazil and South America, but also provides the capital and expertise to advance GB Sciences’ products through first-in-human clinical trials in this region,” said Dr. Andrea Small-Howard, CEO, CSO and Chairman of the Board at GB Sciences. “The human data from these clinical trials in Brazil and South America can be used to supplement GB Sciences’ efforts for U.S. FDA approvals. Also, the expedited regulatory pathways in Brazil and South America allow for valuable post-market data gathering, which further benefits GB Sciences’ global regulatory approval efforts.”

About EndoPure Life Sciences, LLC

EndoPure Life Sciences researches, develops, manufacturers, and distributes some of the purest and most cost-effective natural cannabinoid Active Pharmaceutical Ingredients (API) and products, produced under stringent cGMP pharmaceutical quality standards, to deliver a premium quality natural cannabinoid solution. Distributing cannabinoid-based products to 30 countries, EndoPure Life Sciences has been in the pharmaceutical business in Brazil for over 8 years, being one of the pioneers and a prominent player in the South American market. For more information, visit www.endopureusa.com .

About GB Sciences, Inc. and GbS Global Biopharma, Inc.

GB Sciences, Inc. (OTCQB:GBLX) is a data-driven, plant-inspired drug development company that leverages machine learning and high-throughput biology, which transform plant-based drug development and target novel treatments for multi-billion-dollar biopharmaceutical markets, together with its wholly-owned Canadian subsidiary, GbS Global Biopharma, Inc.. PhAROS™, the Company’s proprietary AI-powered drug discovery platform, predicts novel, simple, plant-based mixtures that address critical unmet medical needs. PhAROS™ leverages demonstrated healing from within twelve global Traditional Medical Systems; pre-validates novel, simple, plant-based mixtures to address multi-billion-dollar markets; and goes beyond looking at what has worked within plant-based medicines in the past to predicting the efficacies of entirely new formulations.

GB Sciences’ novel AI-powered drug discovery platform has facilitated an intellectual property portfolio containing 8 US & 14 global patents that are issued and protect 28 unique formulas for the treatment of serious human health disorders. The Company has 15 US and 41 global patents-pending that cover an additional 25 unique formulas for the treatment of human health disorders. The Company has 5 late preclinical programs with cell & animal data supporting novel treatments for Parkinson’s disease, chronic pain, stress & anxiety, cytokine syndromes, and heart failure. Our lead Parkinson’s disease therapeutic program is being prepared for a First-in-Human clinical trial. GB Sciences’ productive research and development network includes industry leading biopharmaceutical CMOs, service providers, universities, hospitals, and global clinical CROs. To learn more, visit www.gbsciences.com.

Forward Looking Statements

This press release may contain statements relating to future results or events, which are forward-looking statements. Words such as "expects," "intends," "plans," "may," "could," "should," "anticipates," "likely," "believes" and words of similar import may identify forward-looking statements. These statements are not historical facts, but instead represent only the Company's belief regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control. It is possible that the Company's actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further, information concerning the Company and its business, including factors that potentially could materially affect the Company's business and financial and other results, are contained in the Company's filings with the Securities and Exchange Commission, available at www.sec.gov. All forward-looking statements included in this press release are made only as of the date of this press release, and we do not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Document And Entity Information	Sep. 26, 2024
Document Information [Line Items]
Entity, Registrant Name	GB Sciences, Inc.
Document, Type	8-K
Document, Period End Date	Sep. 26, 2024
Entity, Incorporation, State or Country Code	NV
Entity, File Number	000-55462
Entity, Tax Identification Number	59-3733133
Entity, Address, Address Line One	205 W. Russell Road, Suite 240
Entity, Address, City or Town	Las Vegas
Entity, Address, State or Province	NV
Entity, Address, Postal Zip Code	89148
City Area Code	866
Local Phone Number	721-0297
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity, Emerging Growth Company	false
Amendment Flag	false
Entity, Central Index Key	0001165320