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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

 


 

FORM 10-Q

 


 

(Mark One)

QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2023

 

TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from __________ to ___________

 

Commission file number:   000-55462

 

GB SCIENCES, INC.

(Exact name of registrant as specified in its charter)

 

Nevada

(State or other Jurisdiction of Incorporation or organization)

 

59-3733133

(IRS Employer I.D. No.)

 

9205 W. Russell Road, Suite 240

Las Vegas, Nevada 89148

Phone: (866) 721-0297

(Address and telephone number of

principal executive offices)

 

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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

 

Title of each Class

Trading Symbol(s)

Name of exchange on which registered

None

N/A

N/A

 

Indicate by check mark whether registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  ☒  Yes     ☐  No

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).   ☒  Yes     ☐  No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. 

 

Large accelerated filer ☐   

Accelerated filer ☐       

Non-accelerated filer

Smaller reporting company  

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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Act).    Yes     ☒  No  

 

There were 381,872,561 shares of common stock, par value $0.0001 per share, outstanding as of August 14, 2023.  

 

 

 
 

PART I. FINANCIAL INFORMATION

 

ITEM 1. Financial Statements (Unaudited)

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

 

 

  

As of June 30,

  

As of March 31,

 
  

2023

  

2023

 

CURRENT ASSETS:

 

(unaudited)

     

Cash and cash equivalents

 $29,611  $109,912 

Prepaid expenses and other current assets

  199,592   199,592 

TOTAL CURRENT ASSETS

  229,203   309,504 

Intangible assets, net of accumulated amortization and impairment of $2,433,116 and $2,390,297 at June 30, 2023 and March 31, 2023, respectively

  -   42,819 

TOTAL ASSETS

 $229,203  $352,323 

CURRENT LIABILITIES:

        

Accounts payable

 $1,946,026  $1,861,829 

Accounts payable related party

  120,911   120,911 

Accrued interest

  372,535   346,806 

Accrued liabilities

  75,628   75,628 

Notes and convertible notes payable and line of credit, net of unamortized discount of $26,155 and $41,230 at June 30, 2023 and March 31, 2023, respectively

  1,411,152   1,396,077 

Income taxes payable

  958,455   958,455 

TOTAL CURRENT LIABILITIES

  4,884,707   4,759,706 
Long-term convertible notes payable  25,000   - 

TOTAL LIABILITIES

  4,909,707   4,759,706 

Commitments and contingencies (Note 5)

          

STOCKHOLDERS' DEFICIT:

        

Common Stock, $0.0001 par value, 950,000,000 shares authorized, 381,872,561 and 381,872,561 outstanding at June 30, 2023 and March 31, 2023, respectively

  38,187   38,187 

Additional paid-in capital

  104,259,745   104,259,745 

Accumulated deficit

  (108,978,436

)

  (108,705,315

)

TOTAL STOCKHOLDERS' DEFICIT

  (4,680,504

)

  (4,407,383

)

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

 $229,203  $352,323 

 

The accompanying unaudited condensed notes are an integral part of these unaudited consolidated financial statements

 

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

 

   

For the Three Months Ended June 30,

 
                 
   

2023

   

2022

 
                 

Sales revenue

  $ -     $ -  

Cost of goods sold

    -       -  

Gross profit

    -       -  

General and administrative expenses

    265,122       459,517  

LOSS FROM OPERATIONS

    (265,122

)

    (459,517

)

OTHER INCOME (EXPENSE)

               

Interest expense

    (40,804

)

    (38,572

)

Loss on impairment of capitalized patent and trademark costs

    (42,195

)

    -  

Other income

    75,000       -  

Total other expense

    (7,999

)

    (38,572

)

LOSS BEFORE INCOME TAXES

    (273,121

)

    (498,089

)

Income tax expense

    -       -  

NET LOSS

  $ (273,121

)

  $ (498,089

)

                 

 

               
Net loss per common share basic and diluted   $ (0.00

)

  $ (0.00

)

                 

Weighted average common shares outstanding – basic and diluted

    381,872,561       325,743,436  

 

The accompanying unaudited condensed notes are an integral part of these unaudited consolidated financial statements

 

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

   

Three Months Ended June 30,

 
   

2023

   

2022

 

OPERATING ACTIVITIES:

               

Net loss

  $ (273,121

)

  $ (498,089

)

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation and amortization

    624       20,086  

Stock-based compensation

    -       6,500  

Amortization of debt discount and beneficial conversion feature

    15,075       15,976  

Loss on impairment of capitalized patent and trademark costs

    42,195       -  

Changes in operating assets and liabilities:

               

Prepaid expenses and other current assets

    -       37,520  

Accounts payable

    84,197       66,334  

Accrued liabilities

    -       39,145  

Accrued interest

    25,729       20,485  

Net cash used in operating activities

  $ (105,301

)

  $ (292,043

)

FINANCING ACTIVITIES:

               

Gross proceeds from convertible notes payable

    25,000       -  

Gross proceeds from issuing common stock

    -       125,000  

Principal payment on notes and convertible notes payable

    -       (12,890

)

Net cash provided by financing activities

  $ 25,000     $ 112,110  

Net change in cash and cash equivalents

    (80,301

)

    (179,933

)

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

    109,912       233,893  

CASH AND CASH EQUIVALENTS AT END OF PERIOD

  $ 29,611     $ 53,960  

 

The accompanying unaudited condensed notes are an integral part of these unaudited consolidated financial statements

 

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION

(unaudited)

 

   

Three Months Ended June 30,

 
   

2023

   

2022

 

Cash paid for interest

  $ -     $ 2,111  

Cash paid for income tax

  $ -     $ -  
                 

Non-cash investing and financing transactions:

               

Patent drafting and filing costs capitalized in intangible assets

  $ -     $ 28,234  

Accrued brokerage fees for common stock issuances and warrant exercises

  $ -     $ 16,250  

 

The accompanying unaudited condensed notes are an integral part of these unaudited consolidated financial statements

 

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' DEFICIT

For the Three Months Ended June 30, 2023 and June 30, 2022

(unaudited)

 

   

Shares

   

Amount

   

Additional

Paid-In

Capital

   

Accumulated

Deficit

   

Total

 

Balance at March 31, 2022

    325,037,557     $ 32,504     $ 102,764,746     $ (104,580,122

)

  $ (1,782,872

)

                                         

Stock issued for cash, net of offering costs

    4,168,334       417       108,333       -       108,750  

Share based compensation expense

    -       -       6,500       -       6,500  

Net loss

    -       -       -       (498,089

)

    (498,089

)

Balance at June 30, 2022

    329,205,891     $ 32,921     $ 102,879,579     $ (105,078,211

)

  $ (2,165,711

)

 

 

   

Shares

   

Amount

   

Additional

Paid-In

Capital

   

Accumulated

Deficit

   

Total

 

Balance at March 31, 2023

    381,872,561     $ 38,187     $ 104,259,745     $ (108,705,315

)

  $ (4,407,383

)

                                         

Net loss

    -       -       -       (273,121

)

    (273,121

)

Balance at June 30, 2023

    381,872,561     $ 38,187     $ 104,259,745     $ (108,978,436

)

  $ (4,680,504

)

 

The accompanying unaudited condensed notes are an integral part of these unaudited consolidated financial statements

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

 

Note 1 – Background and Significant Accounting Policies 

 

GB Sciences, Inc. (“the Company”, “GB Sciences”, “GBLX”, “we”, “us”, or “our”) is a plant-inspired, biopharmaceutical research and development company creating patented, disease-targeted formulations of cannabis- and other plant-inspired therapeutic mixtures for the prescription drug market through its wholly owned Canadian subsidiary, GbS Global Biopharma, Inc. (“GBSGB”).

 

Through GBSGB, the Company is engaged in the research and development of plant-inspired medicines, with virtual operations in North America and Europe. GBSGB’s assets include a portfolio of intellectual property containing both proprietary plant-inspired formulations and our AI-enabled drug discovery platform, as well as critical research contracts and key supplier arrangements. The Company’s intellectual property portfolio, which is held by GBSGB, contains six U.S. and eight foreign patents issued, one US and three foreign patents allowed, as well as 18 U.S. and 55 foreign patent-pending applications.

 

On February 3, 2023, GB Sciences’ first foreign patent protecting its proprietary cannabinoid-based formulations for Parkinson’s disease was issued in China. China is an increasingly important pharmaceutical market with cultural acceptance of plant-based formulations, which is a good fit for GB Sciences’ drug candidates. The global market for treatments of Parkinson’s disease is projected to grow to $8.8 billion by the year 2026, and new therapies to address Parkinson’s disease symptoms are greatly needed. GB Sciences’ first foreign patent also confirms that the Company’s intellectual property strategy can work globally and validates both our plant-inspired drug discovery process and intellectual property strategy, which involves defining and protecting Minimum Essential Mixtures. GBLX/GBSGB starts its drug discovery process with plant-based therapies that are working anecdotally or in traditional medical systems, then the Company systematically reduces the number of compounds to reveal Minimum Essential Mixtures. The Company’s novel Minimum Essential Mixtures retain the increased efficacy of whole plant medicines, but they are easier to manufacture with precision at scale like single ingredient drugs. These Minimum Essential Mixtures are a viable alternative to standard single ingredient drugs or traditional whole plant medicines. The Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease.

 

Several more of GBLX/GBSGB’s foreign patents for plant-based treatments of serious disorders were allowed in different countries, expanding our patent protections as follows. On December 1, 2022, the Israeli (IL) Patent was allowed, protecting our Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. On December 15, 2022, the Australian (AU) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). Additionally, on March 9, 2023, the Notice of Allowance was received for the Company’s U.S. Patent Application No. 16/878,295. This Notice of Allowance protects the use of the Company’s Myrcene-Containing Complex Mixtures in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. On April 25, 2023, the Japanese patent was also issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease.

 

GBSGB’s intellectual property covers a range of over 65 medical conditions, from which five drug development programs are in the preclinical stage of drug development including our formulations for Parkinson’s disease ("PD"), chronic pain, COVID-related cytokine release syndrome, depression/anxiety, and cardiovascular therapeutic programs. The Company’s primary focus is on preparing its lead program for the treatment of the motor symptoms of Parkinson's disease for a first-in-human clinical trial. Depending on the results of ongoing preclinical studies, the Company intends to move forward with clinical trials for its chronic pain and COVID-related cytokine release syndrome therapies after PD. The Company’s formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council of Canada. The Company recently received proof-of-concept data supporting its kava-inspired anxiety formulations. The Company also has positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Proof-of-concept studies in animals that support our heart disease formulations have been successfully completed at the University of Hawaii. The Company runs a lean drug development program through GBSGB and takes effort to minimize expenses, including personnel, overhead, and fixed capital expenses through strategic partnerships with Universities and Contract Research Organizations (“CROs”). Our productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. 

 

 

8

 

Basis of Presentation

 

The accompanying unaudited interim condensed consolidated financial statements of GB Sciences, Inc. have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the year ending March 31, 2024. The balance sheet at  March 31, 2023 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended March 31, 2023.

 

Principles of Consolidation

 

We prepare our consolidated financial statements in accordance with generally accepted accounting principles (GAAP) for the United States of America. Our consolidated financial statements include all operating divisions and majority-owned subsidiaries, reported as a single operating segment, for which we maintain controlling interests. Intercompany accounts and transactions have been eliminated in consolidation. All subsidiaries were wholly owned by the Company for the periods presented.

 

9

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Use of Estimates

 

The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company regularly evaluates estimates and assumptions related to allowances for doubtful accounts, inventory valuation and standard cost allocations, valuation of initial right-of-use assets and corresponding lease liabilities, valuation of beneficial conversion features in convertible debt, valuation of the assets and liabilities of discontinued operations, stock-based compensation expense, purchased intangible asset valuations, deferred income tax asset valuation allowances, uncertain tax positions, litigation, other loss contingencies, and impairment of long lived assets.  These estimates and assumptions are based on current facts, historical experience and various other factors that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of costs and expenses that are not readily apparent from other sources. The actual results the Company experiences may differ materially and adversely from these estimates.

 

Indefinite and Definite-Lived Intangible Assets

 

Capitalized costs related to our indefinite-lived intangible assets consisted primarily of the value of our patents pending and includes the costs paid to draft and file patent applications. Upon issuance of the patents, the indefinite-lived intangible assets will have finite lives. Intangible assets also historically included the acquisition cost of a cannabis production license with an indefinite life.

 

We historically amortized our finite-lived intangible assets, which consisted of granted patents, over their estimated useful lives using the straight-line method, and we periodically evaluate the remaining useful lives of our finite-lived intangible assets to determine whether events or circumstances warrant a revision to the remaining period of amortization.

 

We review all of our intangible assets for impairment indicators throughout the year. Impairment testing for indefinite-lived intangible assets is performed at least annually and we perform testing for definite-lived intangible assets whenever impairment indicators are present. If we determine that the fair value is less than the carrying value of these assets during testing, we record impairment losses equal to the difference between the carrying value of the asset and the fair market value of the asset.

 

As of March 31, 2023, we recorded a loss on impairment related to the capitalized patent costs of $2,374,261. The Company recorded an impairment of its capitalized patent costs based on the relevant facts and circumstances that existed as of March 31, 2023 in accordance with ASC 350-30-35.

 

At June 30, 2023, the Company had six patents that have been granted in the United States, including two licensed patents and four patents assigned to the Company's subsidiary, GBS Global Biopharma, Inc. The patents owned by the Company expire between January 2038 and May 2039. Amortization expense for the three months ended June 30, 2023 and 2022, was $624 and $20,086, respectively.

 

There were 10 United States patent applications that are pending as of June 30, 2023, and the corresponding patent assets are treated as indefinite-lived intangible assets. There were 35 international patents pending at June 30, 2023. The carrying amount of the indefinite-lived patent assets was $0 at June 30, 2023.

 

Included in Intangible assets at June 30, 2023, are capitalized license costs and trademarks with a carrying amount of $0, after impairment of $42,195 recorded during the three months ended June 30, 2023.

 

10

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Equity-Based Compensation

 

The Company accounts for equity instruments issued to employees in accordance with the provisions of ASC 718 Stock Compensation (ASC 718) and Equity-Based Payments to Non-employees pursuant to ASC 505-50 (ASC 505-50). The computation of the expense associated with stock-based compensation requires the use of a valuation model. The FASB-issued accounting guidance requires significant judgment and the use of estimates, particularly surrounding Black-Scholes assumptions such as stock price volatility, expected option lives, and expected option forfeiture rates, to value equity-based compensation. We currently use a Black-Scholes option pricing model to calculate the fair value of our stock options. We primarily use historical data to determine the assumptions to be used in the Black-Scholes model and have no reason to believe that future data is likely to differ materially from historical data. However, changes in the assumptions to reflect future stock price volatility and future stock award exercise experience could result in a change in the assumptions used to value awards in the future and may result in a material change to the fair value calculation of stock-based awards. This accounting guidance requires the recognition of the fair value of stock compensation in net income. Although every effort is made to ensure the accuracy of our estimates and assumptions, significant unanticipated changes in those estimates, interpretations and assumptions may result in recording stock option expense that may materially impact our financial statements for each respective reporting period.

 

Revenue Recognition

 

The FASB issued Accounting Standards Codification (“ASC”) 606 as guidance on the recognition of revenue from contracts with customers. Revenue recognition depicts the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The guidance also requires disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. The guidance permits two methods of adoption: retrospectively to each prior reporting period presented, or retrospectively with the cumulative effect of initially applying the guidance recognized at the date of initial application (the cumulative catch-up transition method). The Company adopted the guidance on April 1, 2018 and applied the cumulative catch-up transition method.

 

The Company’s only material revenue source was part of discontinued operations prior to the sale of the Nevada Subsidiaries (Note 7), and was derived from sales of distinct physical goods. Under ASC 606, the Company is required to separately identify each performance obligation resulting from its contracts from customers, which may be a good or a service. A contract may contain one or more performance obligations. All of the Company’s contracts with customers contained only a single performance obligation, the delivery of distinct physical goods. Because fulfillment of the company’s performance obligation to the customer under ASC 606 results in the same timing of revenue recognition as under the previous guidance (i.e. revenue is recognized upon delivery of physical goods), the Company did not record any material adjustment to report the cumulative effect of initial application of the guidance.

 

Income Taxes

 

The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in financial statements or tax returns. Deferred tax items are reflected at the enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. Due to the uncertainty regarding the success of future operations, management has valued the deferred tax asset allowance at 100% of the related deferred tax assets.

 

Because the Company previously operated in the State-licensed cannabis industry through its now-deconsolidated Nevada Subsidiaries, gross profits from those subsidiaries has is subject to the limitations of Internal Revenue Code Section 280E (“280E”) for U.S. income tax purposes. Under 280E, the Company is allowed to deduct expenses that are directly related to the production of its products, i.e. cost of goods sold, but is allowed no further deductions for ordinary and necessary business expenses from its gross profit. The Company believes that the deductions disallowed include the deduction of net operating loss carryforwards ("NOLs"). The unused NOLs will continue to carry-forward and may be used by the Company to offset future taxable income that is not subject to the limitations of 280E.

 

11

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Loss per Share 

 

The Company’s basic loss per share has been calculated using the weighted average number of common shares outstanding during the period. The Company had 162,611,301 and 123,013,087 potentially dilutive common shares, related to convertible debt, warrants, and stock options, at  June 30, 2023 and June 30, 2022, respectively, however, those shares were not included in the computation of diluted net loss per share for the three months ended June 30, 2023 and 2022, as their inclusion would have been antidilutive.

 

Recent Accounting Pronouncements

 

Standards Recently Adopted

 

In May 2021, the FASB issued ASU No. 2021-04, Issuer's Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This guidance clarifies and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options due to a lack of explicit guidance in the FASB Codification. The ASU 2021-04 is effective for The Company's fiscal year beginning April 1, 2022. The Company adopted the standard on April 1, 2022 and it did not have a material impact on its financial statements.

 

On June 16, 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments. The standard requires the use of an “expected loss” model on certain types of financial instruments. The standard also amends the impairment model for available-for-sale debt securities and requires estimated credit losses to be recorded as allowances instead of reductions to amortized cost of the securities. The amendments in this ASU are effective for the Company's fiscal year beginning April 1, 2023. The Company adopted ASU 2016-13 on April 1, 2023, and it did not have a material impact on its financial statements.

 

In June 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. The guidance simplifies the current guidance for convertible instruments and the derivatives scope exception for contracts in an entity’s own equity. Additionally, the amendments affect the diluted EPS calculation for instruments that may be settled in cash or shares and for convertible instruments. This ASU will be effective for the Company's fiscal year beginning April 1, 2023. Early adoption is permitted. The amendments in this update must be applied on either full retrospective basis or modified retrospective basis through a cumulative-effect adjustment to retained earnings/(deficit) in the period of adoption. The Company adopted ASU 2020-06 on April 1, 2023, and it did not have a material impact on its financial statements.

 

All other newly issued accounting pronouncements have been deemed either immaterial or not applicable.

 

 

Note 2 – Going Concern

 

The Company’s unaudited consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has sustained net losses since inception, which have caused an accumulated deficit of $108,978,436 at June 30, 2023. The Company had a working capital deficit of $4,655,504 at June 30, 2023, compared to a deficit of $4,450,202 at March 31, 2023. In addition, the Company has consumed cash in its operating activities of $105,301 for the three months ended June 30, 2023, compared to $292,043 used in operating activities for the three months ended June 30, 2022. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

 

Management has been able, thus far, to finance the losses through a public offering, private placements and obtaining operating funds from stockholders. The Company is continuing to seek sources of financing.  There are no assurances that the Company will be successful in achieving its goals.

 

In view of these conditions, the Company’s ability to continue as a going concern is dependent upon its ability to obtain additional financing or capital sources, to meet its financing requirements, and ultimately to achieve profitable operations. Management believes that its current and future plans provide an opportunity to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that may be necessary in the event the Company is unable to continue as a going concern.

 

12

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

 

Note 3 – Notes and Convertible Notes Payable and Line of Credit

 

At June 30, 2023, notes with a carrying amount of $1,436,152 were included in short term notes and convertible notes payable, net of unamortized discounts of $26,155. Interest expense related to the notes was $40,040 for the three months ended June 30, 2023, which includes $15,075 from amortization of the note discounts.

 

As of June 30, 2023 and March 31, 2023 the following notes payable were recorded in the Company’s consolidated balance sheets:

 

 

 

  

As of June 30, 2023

 
  

Face Value

  

Discount

  

Carrying Value

 

6% Convertible promissory notes payable

 $560,000  $-  $560,000 

6% Convertible notes payable due January 18, 2022

  325,000   -   325,000 

6% Convertible note payable due July 1, 2022

  50,000   -   50,000 

6% Convertible promissory notes payable due September 30, 2023

  197,000   (4,859)  192,141 

6% Convertible note payable due December 31, 2023

  250,000   (21,296)  228,704 

0% Note Payable dated October 23, 2017 (as amended)

  55,307   -   55,307 

Total short-term notes and convertible notes payable

 $1,437,307  $(26,155

)

 $1,411,152 
6% Convertible note payable due June 30, 2026  25,000   -   25,000 
Total long-term convertible notes payable  25,000   -   25,000 
Total notes and convertible notes payable $1,462,307  $(26,155) $1,436,152 

 

 

  

As of March 31, 2023

 
  

Face Value

  

Discount

  

Carrying Value

 

6% Convertible promissory notes payable

 $560,000  $-  $560,000 

6% Convertible notes payable due January 18, 2022

  325,000   -   325,000 

6% Convertible note payable due July 1, 2022

  50,000   -   50,000 

6% Convertible promissory notes payable due September 30, 2023

  197,000   (9,475

)

  187,525 

6% Convertible note payable due December 31, 2023

  250,000   (31,755

)

  218,245 

0% Note Payable dated October 23, 2017 (as amended)

  55,307   -   55,307 

Total short-term notes and convertible notes payable

 $1,437,307  $(41,230

)

 $1,396,077 

 

0% Note Payable dated October 23, 2017

 

On October 23, 2017, the Company amended the existing Nevada Medical Marijuana Production License Agreement (“Amended Production License Agreement”). Per the terms of the Amended Production License Agreement, GB Sciences purchased the remaining percentage of the production license resulting in the 100% ownership of the license. GB Sciences also received 100% ownership of the cultivation license included in the original Nevada Medical Marijuana Production License Agreement. In exchange, GB Sciences made one-time payment of $500,000 and issued a 0% Promissory Note in the amount of $700,000 payable in equal monthly payments over a three-year period commencing on January 1, 2018. The present value of the note was $521,067 on the date of its issuance based on an imputed interest rate of 20.3% and the Company recorded a discount on notes payable of $178,933 related to the difference between the face value and present value of the note.

 

On August 10, 2020, the Company entered into the Membership Interest Purchase Agreement ("Nopah MIPA") for the sale of its interest in GB Sciences Nopah, LLC. The Nopah sale was closed December 31, 2021 after successful transfer of the Nevada Medical Marijuana Cultivation Facility Registration Certificate on December 14, 2021. At close, the principal balance of the note was reduced from $369,445 to $190,272 and accounts payable totaling $74,647 to an affiliate of the purchaser were extinguished.

 

On March 4, 2022, the Company entered into the Second Promissory Note Modification Agreement, which reduced the total outstanding balance of principal and interest from $201,532 (at the time of the agreement) to $179,127 and modified the terms of the note to provide that the Company would make an immediate payment of $75,000, with $5,000 monthly payments thereafter until the note is repaid in full. The modification also provided that the note would bear interest at 8.0% per annum. The Company made a $75,000 payment pursuant to the terms of the modification on March 4, 2022.

 

13

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

We evaluated the modification under the guidance in ASC 470-50 and determined that the modification represents an extinguishment because the change in the fair value of the note exceeded 10% of the carrying value of the note immediately prior to the modification. As a result, the Company recorded a gain on extinguishment for the year ended March 31, 2022, of $22,405 equal to the change in the carrying value of the note resulting from the modification.

 

At June 30, 2023, the outstanding balance of the note was $55,307, and accrued interest was $1,454. The company made no payments during the three months ended June 30, 2023.

 

8% Line of Credit dated July 24, 2020

 

On July 24, 2020, the Company entered into the Loan Agreement, 8% Secured Promissory Note, and Security Agreement (together, the "July 24 Note") with AJE Management, LLC, which established a revolving loan of up to $500,000 that the Company may draw on from time to time. The loan was collateralized by the Teco Facility, subject to the pre-existing lien held by CSW Ventures, L.P. in connection with the 8% Senior Secured Convertible Promissory Note dated February 28, 2019. Contemporaneously with the Loan Agreement, the Company and AJE Management entered into the Amendment to the Membership Interest Purchase Agreement with AJE Management. The amendment provides that any balances outstanding under the July 24 Note at the time of the close of the sale of the Teco Facility would be forgiven in exchange for a reduction to the $4,000,000 note receivable that the Company will receive as consideration for the sale of the Teco Facility. The reduction to the note receivable would be equal to 3 times the balance outstanding under the July 24 Note on the date of the close of the sale of the Teco Facility. The balance outstanding under the note plus accrued interest were permitted to be repaid at any time prior to the close of the sale of the Teco facility.

 

On December 29, 2020, the Company entered into the Omnibus Amendment with the purchaser of the Teco Facility. The Omnibus Amendment reduced the amount of the note receivable that the Company was to receive from the sale of the Teco Facility by $975,000 (three times $325,000 in advances made under the July 24 Note) to $3,025,000. Any advances made to the Company under the July 24 Note in excess of $325,000 were to reduce the amount of cash received upon close of the sale of Teco one-for-one, i.e., such advances would be considered advance payments of the $4,000,000 cash purchase price. No interest would accrue after November 30, 2020. The Company also agreed that it would not repay the balances outstanding under the July 24 Note prior to the closing of the Teco sale. As a result of the Omnibus Amendment, the Company accrued a modification expense of $650,000 during the year ended March 31, 2021. Prior to December 31, 2021, the Company received $50,000 in additional advances above $325,000 during the fiscal year ended March 31, 2021, bringing the total balance to $1,025,000, and accrued interest was $12,510. Upon close of the Teco sale on December 31, 2021, the note and accrued interest balances were forgiven and the Company has no further obligations related to the line of credit.

 

March 2017 and July 2017 Convertible Note Offerings

 

In March 2017, the Company entered into a Placement Agent’s Agreement with a third-party brokerage firm to offer units consisting of a $1,000 6% promissory note convertible into 4,000 shares of the Company’s common stock at $0.25 per share and 4,000 warrants to purchase shares of the Company’s’ common stock at an exercise price of $0.60 per share for the period of three years. Between March 2017 and May 2017, the Company issued short-term Promissory Notes (“Notes”) to various holders with combined face value of $2,000,000. The Notes are payable within three years of issuance and are convertible into 8,000,000 shares of the Company’s common stock. The Company also issued 8,000,000 common stock warrants to the Noteholders. The warrants are exercisable at any time and from time to time before maturity at the option of the holder. Each warrant gives the Noteholder the right to purchase one share of common stock of the Company at an exercise price of $0.60 per share for a period of three years. The Company recorded an aggregate discount on convertible notes of $1,933,693, which included $904,690 related to the relative fair value of beneficial conversion features and $1,029,003 for the relative fair value of the warrants issued with each note. The fair value of warrants was derived using the Black-Scholes valuation model.

 

In July 2017, the Company entered into a Placement Agent’s Agreement with a third-party brokerage firm to offer units consisting of a $1,000 6% promissory note convertible into 4,000 shares of the Company’s common stock at $0.25 per share and 4,000 warrants to purchase shares of the Company’s’ common stock at an exercise price of $0.65 per share for the period of three years. Between July 2017 and December 2017, the Company issued short-term Promissory Notes (“Notes”) to various holders with combined face value of $7,201,000. The Notes are payable within three years of issuance and are convertible into 28,804,000 shares of the Company’s common stock. The Company also issued 28,804,000 common stock warrants to the Note holders. The warrants are exercisable at any time and from time to time before maturity at the option of the holder. Each warrant gives the Noteholder the right to purchase one share of common stock of the Company at an exercise price of $0.60 per share for a period of three years. The Company recorded an aggregate discount on convertible notes of $7,092,796, which included $3,142,605 related to the relative fair value of beneficial conversion features and $3,950,191 for the relative fair value of the warrants issued with each note. The fair value of warrants was derived using the Black-Scholes valuation model.

 

14

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

All notes from the March and July 2017 offerings have passed their maturity dates. During the year ended March 31, 2022, the Company agreed to extensions with the holders of a total of $197,000 of the $1,257,000 that remained outstanding at the time. For the $197,000 of extended notes, the Company agreed to reduce the conversion price to $0.10 per share and issued a total of 788,000 additional warrants to the holders of the notes with a term of three years and an exercise price of $0.10 per share. In exchange, the maturity date of the notes was extended to September 30, 2023. Using the Black-Scholes model, the Company valued the warrants at $13,396 and the change in the fair value of the conversion feature at $33,490. Because the change in the fair value of the conversion feature exceeded 10% of the carrying amount of the notes, the Company accounted for the modification of the notes as an extinguishment and recorded a discount on the new convertible notes of $46,886 related to the fair value of the new warrants issued and the change in the fair value of the conversion feature. The Company recorded interest expense of $7,564 on the extended notes during the three months ended June 30, 2023, of which $4,617 represented amortization of the note discounts. Accrued interest on the $197,000 extended notes is $70,919 and the remaining unamortized discount was $4,859 at June 30, 2023.

 

Three convertible notes totaling $1,060,000 were held by the same investor and in default. On January 20, 2022, the Company repaid $500,000 of the principal balances owed to the investor, and one convertible note in the amount of  $560,000 remains outstanding plus accrued interest totaling $206,939. The Company intends to negotiate the terms of an extension of the remaining note and accrued interest with the note holder. The notes do not provide for a default penalty or penalty interest rate. Interest expense for the outstanding note was $11,169 for the three months ended June 30, 2023, and no unamortized discount at June 30, 2023.

 

December 2020 $625,000 6% Convertible Notes

 

On December 18, 2020, the Company began an offering of 6.0% convertible notes for the purpose of funding a pre-clinical study of the Company's patent-pending Cannabinoid-Containing Complex Mixtures for the treatment of Cytokine Release Syndromes, including Acute Respiratory Distress Syndrome, in COVID-19 patients. The Company pledged the related intellectual property as security for the notes. The notes are convertible at a rate of $0.05 per share at the lender's request. The Company previously issued $625,000 in convertible notes under the offering to three investors. $375,000 of the notes mature between January 31, 2021 and July 1, 2022, and $250,000 mature in December 2023. Payment of accrued interest and principal is due at maturity. The Company received cash of $543,750, net of brokerage fees, and recorded discounts on the convertible notes totaling $81,250 related to the issuance costs. Notes totaling $425,000 were issued with in-the-money conversion features, and the Company recorded beneficial conversion feature discounts totaling $347,000 on the related notes. During the year ended March 31, 2022, the Company received an additional $50,000 related to the note offering and recorded a discount on convertible notes payable of $6,500 related to issuance costs.

 

During the three months ended June 30, 2023, the Company received an additional $25,000 related to the note offering with a maturity date of June 29, 2026, and recorded no discount or beneficial conversion features. The Company recorded interest expense of $21,307 on the December 2020 $625,000 6% Convertible Notes, of which $10,458 represented amortization of the note discounts. Accrued interest on these notes is $93,222 and the remaining unamortized discount was $21,296 at June 30, 2023.

 

 

Note 4 Capital Transactions

 

Three Months Ended June 30, 2023

 

Warrants

 

During the three months ended June 30, 2023, the Company recorded no issuance of warrants. During the three months ended June 30, 2023, warrants totaling 3,490,834 expired with an exercise price of $0.10.

 

Employee Option Grants

 

During the three months ended June 30, 2023, the Company recorded no employee option grants. During the three months ended June 30, 2023, option grants totaling 1,150,000 with an exercise price of $0.05, were forfeited.

 

15

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Year Ended March 31, 2023

 

Sale of Common Stock and Warrants

 

On  May 9, 2022 the Company entered into a Placement Agent's Agreement with its brokers for the private placement of up to $565,000 in units at a price of $0.03 per unit. For each unit purchased, the investor will receive one share of the Company's common stock and one warrant to purchase one share of the Company's common stock at a price of $0.10 for a period of five years. On  September 9, 2022, the Company entered into the Amendment to the Placement Agent's Agreement which extended the placement to  November 30, 2022 and increased the amount to $2,000,000, all other terms remaining the same.  During the year ended  March 31, 2023, the Company received $1,483,350 under the private placement, net of brokerage fees of $221,650, and issued 56,835,004 shares of its common stock and 56,835,004 warrants to purchase one share of the Company's common stock at $0.10 for five years.

 

As the result of the units sold to date under the private placement, the Company will issue its brokers 5,416,834 compensation warrants to purchase one share of the Company's common stock at $0.03 per share for a period of five years. The Company valued the compensation warrants at $0.0273 or $147,879 using the Black-Scholes model.

 

Employee Option Grant

 

On  August 25, 2022, the Board of Directors approved a commitment to grant options to a total of seven persons which include the officers and directors of the Company, who will be instrumental in obtaining an up-listing of the common shares of the Company onto the NASDAQ Stock Market.  The Options will be granted to the employees on the effective date of the up-listing (the “Effective Date”), and will equal options sufficient to purchase 13% of the issued and outstanding common shares of the Company on a fully diluted basis, as of the Effective Date.  The exercise price of one Option will equal 80% of the value of one share of common stock on the Effective Date. The options will be accounted for once the performance condition (the up-listing) is probable.

 

 

Note 5 Commitments and Contingencies

 

On April 11, 2022, the Company was served notice of a lawsuit filed in the Eighth Judicial District Court in Clark County, Nevada by an individual who alleges he was shot by a security guard at the Teco Facility in May of 2020. The alleged incident occurred after the claimant broke into the Teco Facility during closing hours. GB Sciences, Inc. and its former subsidiaries GB Sciences Nevada, LLC and GB Sciences Las Vegas, LLC, along with the security provider, Protective Force International, Inc., were named as defendants in the lawsuit. The Company holds a certificate of insurance with the insurer for Protective force International and believes it may have coverage under that policy in the event the Company is found liable for damages, however, the Company denies any liability and intends to vigorously defend the lawsuit. We are unable to make any determination at this time as to the likelihood or amount of damages.

 

From time to time, the Company may become involved in certain legal proceedings and claims which arise in the ordinary course of business. In management’s opinion, based on consultations with outside counsel, the results of any of these ordinary course matters, individually and in the aggregate, are not expected to have a material effect on our results of operations, financial condition, or cash flows. As more information becomes available, if management should determine that an unfavorable outcome is probable on such a claim and that the amount of such probable loss that it will incur on that claim is reasonably estimable, the Company would record a reserve for the claim in question. If and when the Company records such a reserve, it could be material and could adversely impact its results of operations, financial condition, and cash flows.

 

 

Note 6 Related Party Transactions

 

As of  June 30, 2023, $108,816 has been recorded in accounts payable related party, due to an entity controlled by a family member of Mr. John Poss, Chief Executive Officer of the Company.

 

As of  June 30, 2023, $12,095 has been recorded in accounts payable related party, due to Dr. Andrea Small Howard, President and Director, related to amounts owed for expenses incurred in connection with the business operations of the Company.

 

 

Note 7 Sale of Membership Interests in Nevada Subsidiaries

 

On March 24, 2020, the Company entered into the Membership Interest Purchase Agreement ("Teco MIPA") with AJE Management, LLC. Pursuant to the Teco MIPA, the Company agreed to sell 100% of its membership interests in GB Sciences Nevada, LLC, and GB Sciences Las Vegas, LLC (the "Teco Subsidiaries") for approximately $8 million, which amount includes a cash payment at closing, the extinguishment and/or repayments of certain liabilities owed to the purchaser and affiliates of the purchaser, and an 8% promissory note.

 

16

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

On August 10, 2020, the Company entered into the Membership Interest Purchase Agreement ("Nopah MIPA") and Promissory Note Modification Agreement with 483 Management, LLC. Pursuant to the Nopah MIPA, the Company agreed to sell its 100% membership interest in GB Sciences Nopah, LLC ("Nopah"), which holds a Nevada medical marijuana cultivation certificate. As consideration, the Company would receive $312,315 in consideration in the form of a $237,668 reduction to the outstanding principal and accrued interest balances of the 0% Note payable dated October 23, 2017 (Note 3), and extinguishment of accounts payable of $74,647, which were owed to an affiliate of the purchaser.

 

The closing of the Teco and Nopah sales was contingent upon the successful transfer of the Nevada cultivation and production licenses. On December 14, 2021, the Company received approval from the Nevada Cannabis Compliance Board for the transfer of cannabis cultivation and extraction licenses held by its subsidiaries GB Sciences Nevada, LLC, GB Sciences Las Vegas, LLC, and GB Sciences Nopah, LLC (the "Nevada Subsidiaries"). Consequently, all conditions to closing the sales of the 100% membership interests in the Nevada Subsidiaries were satisfied, and the transactions formally closed on December 31, 2021. After the closing date, the Company retains no ownership interest in the Nevada Subsidiaries.

 

Note Receivable from Sale of Teco Subsidiaries

 

The $3,025,000 note receivable from the sale of the Teco Subsidiaries is payable as quarterly, interest only payments of $60,500 for the first year, followed by seven quarterly payments of interest and principal of $201,774 beginning March 31, 2023, with a final payment of principal and interest totaling $2,014,225 on December 31, 2024.

 

The note contains a provision that allows payments of principal and interest due prior to the maturity date to be postponed to the next quarterly payment date if cash flow from the operations of the facility is insufficient to cover the amount of the payment. Several days prior to the first interest payment due date of April 1, 2022, AJE Management, LLC notified the Company that it would be postponing the payment of interest of $60,500 due on April 1, 2022 due to insufficient cash flow to make the payment. AJE Management, LLC was also unable to make the interest payment due July 1, 2022 due to insufficient cash flow. As a result, the Company reevaluated the factors relating to the collectibility of the note and recorded a valuation allowance in the amount of $3,025,000 at March 31, 2022, equal to the full balance of the note, as there is substantial uncertainty around the collectibility of the note, and we are unable to make an appropriate estimate of the amount of payments, if any, the Company will ultimately receive.

 

During the three months ended June 30, 2023, the Company received $75,000 on this Note Receivable and recorded the amount in Other Income on the Statement of Operations.

 

 

Note 8 Subsequent Events

 

Subsequent to  June 30, 2023, the Company raised $50,000 through the issuance of a convertible note payable. The notes bears interest at 6% per annum and is convertible into shares of the Company’s common stock at $0.03 per share, the note matures between  June and  July 2026.

 

Subsequent to  June 30, 2023 the Company received $80,025 related to the exercise of warrants. The exercise of the warrants will result on the issuance of 8,002,500 common shares. The shares have not yet been issued by the Company.

 

17

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

 

ITEM 2.  Managements Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis contains forward-looking statements, as defined in the United States Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terminology such as may, will, should, could, expects, plans, intends, anticipates, believes, estimates, predicts or continue, which list is not meant to be all-inclusive, and other such negative terms and comparable technology. These forward-looking statements, include, without limitation, statements about market opportunity, strategies, competition, expected activities and expenditures as we pursue business our plan, and the adequacy of available cash reserves. Although we believe the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Actual results may differ materially from the predictions discussed in these forward-looking statements. The economic environment within which we operate could materially affect actual results. Additional factors that could materially affect these forward-looking statements and/or predictions include among other things:

 

(i) product demand, market and customer acceptance of any or all of the Companys products, equipment and other goods,

(ii) ability to obtain financing to expand its operations,

(iii) ability to attract and retain qualified personnel,

(iv) the results, cost and timing of our preclinical studies and clinical trials, including any delays to such clinical trials relating to enrollment or site initiation, as well as the number of required trials for regulatory approval and the criteria for success in such trials,

(v) our dependence on third parties in the conduct of our preclinical studies and clinical trials,

(vi) legal and regulatory developments in the United States and foreign countries, including any actions or advice that may affect the design, initiation, timing, continuation, progress or outcome of clinical trials or result in the need for additional clinical trials,

(vii) the results of our preclinical studies and earlier clinical trials of our product candidates may not be predictive of future results and we may not have favorable results in our ongoing or planned clinical trials,

(viii) the difficulties and expenses associated with obtaining and maintaining regulatory approval of our product candidates, and the indication and labeling under any such approval,

(ix) our plans and ability to develop and commercialize our product candidates,

(x) successful development of our commercialization capabilities, including sales and marketing capabilities, whether alone or with potential future collaborators,

(xi) the size and growth of the potential markets for our product candidates, the rate and degree of market acceptance of our product candidates and our ability to serve those markets,

(xii) the success of competing therapies and products that are or become available,

(xiii) our ability to limit our exposure under product liability lawsuits, shareholder class action lawsuits or other litigation,

(xiv) our ability to obtain and maintain intellectual property protection for our product candidates,

(xv) our ability to obtain and maintain third-party manufacturing for our product candidates on commercially reasonable terms,

(xvi) delays, interruptions or failures in the manufacture and supply of our product candidates,

(xvii) the performance of third parties upon which we depend, including third-party contract research organizations, or CROs, contract manufacturing organizations, or CMOs, contractor laboratories and independent contractors,

(xviii) the timing and outcome of current and future legal proceedings,

(xix) our ability to maintain proper functionality and security of our internal computer and information systems and prevent or avoid cyberattacks, malicious intrusion, breakdown, destruction, loss of data privacy or other significant disruption,

(xx) the adequacy of capital reserves and liquidity including, but not limited to, access to additional borrowing capacity,

(xxi) the extent to which health epidemics and other outbreaks of communicable diseases, including the ongoing COVID-19 pandemic, could disrupt our operations or materially and adversely affect our business and financial conditions, and

(xxii) general industry and market conditions and growth rates, unexpected natural disasters, and other factors, which we have little or no control: and any other factors discussed in the Companys filings with the Securities and Exchange Commission (SEC).

 

The Company does not undertake any obligation to update forward-looking statements to reflect events or circumstances occurring after the date of this report.

 

The following discussion highlights the Companys results of operations and the principal factors that have affected our financial condition, as well as our liquidity and capital resources for the periods described and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis is based on the Companys unaudited financial statements contained in this Quarterly Report, which we have prepared in accordance with United States generally accepted accounting principles. You should read this discussion and analysis together with such financial statements and the related notes thereto.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

Overview

 

GB Sciences, Inc. (“the Company”, “GB Sciences”, “we”, “us”, or “our”) is a plant-inspired, biopharmaceutical research and development company creating patented, disease-targeted formulations of cannabis- and other plant-inspired therapeutic mixtures for the prescription drug market through its wholly owned Canadian subsidiary, GbS Global Biopharma, Inc. (“GBSGB”).

 

Through GBSGB, the Company is engaged in the research and development of plant-inspired medicines, with virtual operations in North America and Europe. GBSGB’s assets include a portfolio of intellectual property containing both proprietary plant-inspired formulations and our AI-enabled drug discovery platform, as well as critical research contracts and key supplier arrangements. The Company’s intellectual property portfolio, which is held by GBSGB, contains six U.S. and eight foreign patents issued, one US and three foreign patents allowed, as well as 18 U.S. and 55 foreign patent-pending applications.

 

On February 3, 2023, GB Sciences’ first foreign patent protecting its proprietary cannabinoid-based formulations for Parkinson’s disease was issued in China. China is an increasingly important pharmaceutical market with cultural acceptance of plant-based formulations, which is a good fit for GB Sciences’ drug candidates. The global market for treatments of Parkinson’s disease is projected to grow to $8.8 billion by the year 2026, and new therapies to address Parkinson’s disease symptoms are greatly needed. GB Sciences’ first foreign patent also confirms that the Company’s intellectual property strategy can work globally and validates both our plant-inspired drug discovery process and intellectual property strategy, which involves defining and protecting Minimum Essential Mixtures. GBLX/GBSGB starts its drug discovery process with plant-based therapies that are working anecdotally or in traditional medical systems, then the Company systematically reduces the number of compounds to reveal Minimum Essential Mixtures. The Company’s novel Minimum Essential Mixtures retain the increased efficacy of whole plant medicines, but they are easier to manufacture with precision at scale like single ingredient drugs. These Minimum Essential Mixtures are a viable alternative to standard single ingredient drugs or traditional whole plant medicines. The Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease.

 

Several more of GBLX/GBSGB’s foreign patents for plant-based treatments of serious disorders were allowed in different countries, expanding our patent protections as follows. On December 1, 2022, the Israeli (IL) Patent was allowed, protecting our Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. On December 15, 2022, the Australian (AU) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). Additionally, on March 9, 2023, the Notice of Allowance was received for the Company’s U.S. Patent Application No. 16/878,295. This Notice of Allowance protects the use of the Company’s Myrcene-Containing Complex Mixtures in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. On April 25, 2023, the Japanese patent was also issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease.

 

GBSGB’s intellectual property covers a range of over 65 medical conditions, from which five drug development programs are in the preclinical stage of drug development including our formulations for Parkinson’s disease ("PD"), chronic pain, COVID-related cytokine release syndrome, depression/anxiety, and cardiovascular therapeutic programs. The Company’s primary focus is on preparing its lead program for the treatment of the motor symptoms of Parkinson's disease for a first-in-human clinical trial. Depending on the results of ongoing preclinical studies, the Company intends to move forward with clinical trials for its chronic pain and COVID-related cytokine release syndrome therapies after PD. The Company’s formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council Canada. The Company recently received proof-of-concept data supporting its kava-inspired anxiety formulations. The Company also has positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Proof-of-concept studies in animals that support our heart disease formulations have been successfully completed at the University of Hawaii. The Company runs a lean drug development program through GBSGB and takes effort to minimize expenses, including personnel, overhead, and fixed capital expenses through strategic partnerships with Universities and Contract Research Organizations (“CROs”). Our productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. 

 

We were incorporated in the State of Delaware on April 4, 2001, under the name “Flagstick Venture, Inc.” On March 28, 2008, stockholders owning a majority of our outstanding common stock approved changing our then name “Signature Exploration and Production Corp.” as our business model had changed.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

On April 4, 2014, we changed our name from Signature Exploration and Production Corporation to Growblox Sciences, Inc. Effective December 12, 2016, the Company amended its Certificate of Corporation pursuant to shareholder approval, and the Company’s name was changed from Growblox Sciences, Inc. to GB Sciences, Inc.

 

Effective April 8, 2018, Shareholders of the Company approved the change in corporate domicile from the State of Delaware to the State of Nevada and increase in the number of authorized capital shares from 250,000,000 to 400,000,000. Effective August 15, 2019, Shareholders of the Company approved an increase in authorized capital shares from 400,000,000 to 600,000,000. Effective March 09, 2023, Shareholders of the Company approved an increase in authorized capital shares from 600,000,000 to 950,000,000.

 

Plan of Operation

 

Drug Discovery and Development of Novel Cannabis- and Other Plant-Inspired Therapies 

 

Through its wholly owned Canadian subsidiary, GBS Global Biopharma, Inc. ("GBSGB"), the Company has conducted ground-breaking research embracing the rational design of plant-inspired medicines led by Dr. Andrea Small-Howard, the Company’s President, Chief Science Officer, and Director. In the early days, Small-Howard and Dr. Helen Turner, Vice President of Innovation and Dean of the Natural Sciences and Mathematics Department at Chaminade University, posited that minimum essential mixtures of plant-based ingredients would provide more targeted and effective treatments for specific disease conditions than either single ingredient or whole plant formulations. They started with cannabis-based drug discovery and developed a rapid screening and assaying system that tested thousands of combinations of cannabinoids and terpenes in vitro against cell-based models of disease. This process identified precise mixtures of cannabinoids and terpenes, many of which contained no THC, to treat categories of disease conditions, including neurological disorders, inflammation, heart disease, metabolic syndrome, and chronic neuropathic pain. More recently, a similar approach has been applied to the discovery and validation of therapies informed by plants described in a variety of Traditional Medical Systems. These rich discovery efforts have yielded new preclinical programs; for example, our anxiety and depression formulations that contain minimum essential mixtures of compounds derived from plants in the Piper plant family, such as kava.  

 

Currently, the Company’s drug discovery engine involves both a data analytics/machine learning tool to expedite drug discovery and high throughput screening of cell and animal models of disease. As previously mentioned, the Company initially explored the potential medical uses of specific mixtures derived from cannabis-based raw materials, but our early in silico tools have now been improved, and they are becoming increasingly effective for investigating the medical applications of potential therapeutic mixtures from any plant-derived starting material. In 2014, the Company developed its first rapid screening and assaying system which tested thousands of combinations of cannabinoids and terpenes against cell-based models of diseases. This process has been refined over the years and now has identified precise mixtures of cannabinoids and terpenes, many of which contained no THC, to treat categories of disease conditions, including neurological disorders, inflammation, heart disease, metabolic syndrome, chronic and neuropathic pain. Through GBSGB, the Company has filed for patent protection on these plant-inspired, minimum essential mixtures, and they are validating them in disease-specific animal models in preparation for human trials.

 

The Company’s drug discovery process combines: 1) PhAROS™: Phytomedical Analytics for Research Optimization at Scale for the prediction of minimum essential mixtures from plant-based materials, and 2) HTS: high throughput screening to refine and validate plant-inspired, minimum essential mixtures in well-established cell and animal models of diseases. This combined approach to drug discovery increases research efficiency and accuracy reducing the time from ideation to patenting from 7 years to 1.5 years. The Company now uses its PhAROS™ Drug Discovery Platform to ‘pre-validate’ therapeutic mixtures. PhAROS can both prioritize and eliminate some potential combinations, which reduces time and resources used in the discovery period. PhAROS™ can also be used to identify and predict the efficacy of plant-inspired, minimum essential mixtures for specific diseases in silico, which are then tested by screening in cell and animal models. Screening of plant-inspired mixtures for drug discovery involves the testing of specific combinations of plant chemicals from many naturally occurring plants and the use of live models for these diseases that have been well established by other researchers. The Company refines the potential therapeutic mixtures pre-validated by PhAROS™ to optimize their effectiveness using cell and animal models. Based on data from disease-specific assays, therapeutic formulations are refined during the HTS screening process by removing compounds that do not act synergistically with the others in the mixtures. The goal is to identify minimum essential mixtures (MEM) that retain the efficacy of the whole plant extracts, but with the manufacturing and quality control advantages of single ingredient pharmaceutical products.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

Recently, the Company has received positive preclinical results supporting the efficacy of its proprietary kava-based formulas designed for the treatment of anxiety, which were obtained as a part of its on-going preclinical study of kava-inspired formulations for the treatment of anxiety or depression. The Company is addressing the growing need for anxiety and depression medications with non-psychedelic kava-based formulations. As mental health disorders increasingly impact global populations, Gb Sciences is developing psychotropic but non-psychedelic treatments for anxiety and depression that compete with the emerging billion-dollar psychedelic companies. Gb Sciences’ psychotropic kava-inspired formulas enhance mood, but they do not have potentially unwanted psychedelic side-effects. The National Research Council of Canada (“NRC”) has been testing the Company’s proprietary, psychotropic plant-based formulas for the treatment of depression and anxiety. For these novel psychotropic drug candidates, the Company used their AI-enabled PhAROS™ platform to identify new ingredients to improve upon an initial formulation for anxiety based on traditional medicine. The original plant mixture was derived from the kava plant, but some elements of kava are thought to cause liver toxicity. PhAROS™ identified ingredients from the Piper plant family as a substitute for the functionality of the ingredients in question without the potentially adverse safety profiles of those original ingredients. The Piper plant family includes pepper plants that are used worldwide in traditional medicines. The Company’s novel psychotropic formulations have been tested in preclinical trials at the Zebrafish Toxicology, Genomics and Neurobiology Lab at the NRC, led by Dr. Lee Ellis, Research Officer and Team Lead. The ongoing work between the NRC and the Company has produced strong and applicable data for the evaluation of its therapies, and this trial could provide novel treatment options for patients with depression and anxiety.

 

The U.S. Patent and Trademark Office allows complex mixtures to be claimed as Active Pharmaceutical Ingredients ("APIs"). Through GBSGB, the Company has six issued patents, plus a series of pending patents containing plant-derived complex mixtures and minimum essential mixtures that act as therapeutic agents for specific disease categories, as described below. The Company’s pending patents are protected whether the individual compounds are derived from the cannabis plant, another plant, synthetically produced, or derived from a combination of sources for the individual chemical compounds in these mixtures.

 

On February 3, 2023, GB Sciences’ first foreign patent protecting its proprietary cannabinoid-based formulations for Parkinson’s disease was issued in China. China is an increasingly important pharmaceutical market with cultural acceptance of plant-based formulations, which is a good fit for GB Sciences’ drug candidates. The global market for treatments of Parkinson’s disease is projected to grow to $8.8 billion by the year 2026, and new therapies to address Parkinson’s disease symptoms are greatly needed. The Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease. On April 25, 2023, the Japanese patent was issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease. On June 28th of 2023, GBSGB received a Notice of Allowance for its Israeli patent application. On July 7th, GBSGB received a Notice of Allowance for its European patent application protecting GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease.

 

Several more of GBLX/GBSGB’s foreign patents for plant-based treatments of serious disorders were allowed in different countries, expanding our patent protections as follows. On December 1, 2022, the Israeli (IL) Patent was issued, protecting our Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. On December 15, 2022, the Australian (AU) Patent was issued, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was issued, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On April 24, 2023, GbS received the Notice of Allowance for its European Patent, which also triggers the allowance of its Hong Kong patent protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). Additionally, on March 9, 2023, the Notice of Allowance was received for the Company’s U.S. Patent Application No. 16/878,295. This Notice of Allowance protects the use of the Company’s Myrcene-Containing Complex Mixtures in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. On June 28th of 2023, GBSGB received a Notice of Allowance on its Australian patent application protecting the Company’s Myrcene-Containing Complex Mixtures (MCCM) for use in the treatment of pain related to arthritis, shingles, irritable bowel syndrome, sickle cell disease, and endometriosis.

 

Drug Development Progress

 

The Company has made significant strides in the past year with respect to both its drug discovery research and product development programs. The Company, through GBSGB, has five preclinical phase product development programs and is aggressively preparing its lead formulations for the treatment of Parkinson’s disease for a first-in-human clinical trial. Our lead program in Parkinson’s disease is being prepared for a first-in-human trial through the following essential steps: a) creating clinical prototypes by combining our proprietary Parkinson’s formulas with a convenient oral delivery system; b) performing a dose response study in rodents to establish the correct range of active ingredients for our first-in-human trial; c) performing necessary ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicology) tests on the clinical prototypes; and d) selecting a Contract Research Organization (CRO) to prepare an Investigational New Drug (IND) application to the US FDA to begin our first-in-human trial. In addition to our work in preparing the Parkinson’s formulation for a First-in-Human trial, the Company’s chronic pain, anxiety, and depression formulations are currently in preclinical animal studies with Dr. Lee Ellis of the National Research Council ("NRC") Canada in Halifax, Nova Scotia. Based on our positive preclinical, proof-of-concept data supporting our minimum essential mixtures for the treatment of Cytokine Release Syndrome in COVID-19 (COVID-CRS) and other severe hyperinflammatory conditions, the Company’s lead COVID-CRS candidates will be optimized in late-stage preclinical studies with Dr. Norbert Kaminski at Michigan State University.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

For the Company’s lead program in PD therapeutics, the efficacy of our original formulations has been improved and the Company has filed a new patent application family to protect our defined cannabinoid ratio-minimum essential mixtures (DCR-MEMs) for the treatment of Parkinsonian motor symptoms. The Company had announced previously that it has obtained the statistically significant reduction of Parkinson’s-disease like symptoms using proprietary cannabinoid-containing MEMs in an animal model of Parkinson’s disease ("PD"). These important preclinical results will be included in GBS’ Investigational New Drug ("IND") application with the US FDA to enter human clinical trials as soon as possible. New therapies to address Parkinson’s disease symptoms are needed to help those afflicted with this debilitating disease. The combined direct and indirect costs associated with Parkinson’s disease are estimated at $52 billion in the U.S. alone.

 

This year, we have successfully created clinical prototypes of our top three performing cannabinoid-containing Parkinson’s formulations with Catalent Pharma based on incorporating our proprietary cannabinoid formulations for Parkinson’s disease into Catalent Pharma’s proprietary Zydis® delivery system. Catalent Pharma’s Zydis® delivery system is an Orally Disintegrating Tablet format (“ODT”) that should be ideal for delivering our cannabinoid-ratio controlled formulations to Parkinson’s patients. More than 50% of Parkinson’s patients have trouble swallowing, but the Zydis® format delivers the active ingredients into the mouth by dispersion without needing water or the ability to swallow. To ready the Company’s Parkinson’s disease therapies for a First-in-Human trial, the initial clinical prototypes of our Defined Cannabinoid Ratio (DCR)-MEM have been formulated by Catalent Pharma using Catalent’s Zydis® Orally Disintegrating Tablet technology and they are being evaluated in stability and functional testing. As mentioned above, the ODT format was selected for the PD formulas because it dissolves on the tongues of patients without the need to swallow for ease of use in patients with PD, who often have difficulties with swallowing. Previously, the Company has completed two proof-of-concept studies for its MEM. Now, the Company has completed a Feasibility Study that has produced the clinical prototypes for its DCR-MEM. The Company selected Catalent for the delivery of their PD therapies due to Catalent’s prior experience in working on US FDA-approved, cannabinoid-containing drugs, their Schedule I drug manufacturing facilities, their familiarity with US FDA and international regulatory and manufacturing requirements, their expertise in tackling formulation challenges, and their ability to achieve the stability and dosing necessary for these novel therapeutic mixtures. In addition to its Zydis® technology, Catalent has early drug development services and additional oral drug delivery solutions available for the efficient delivery of the Company's proprietary APIs.

 

Additionally, the Company has successfully completed our required dose response study in a rodent model of Parkinson’s disease, which will help us to establish the correct dosing for our first-in-human trial. The University of Lethbridge completed this study in February of 2023, and the final report has recently been delivered to us for our usage. Prior to filing our IND application, we must conduct ADMET testing on the clinical prototypes of our Parkinson’s medication being formulated for us by Catalent Pharma. The Company has identified a Contract Research Organization that will perform the ADMET testing. In the IND application for our novel Parkinson’s disease therapy, the ADMET testing data will be combined with the Chemistry Manufacturing and Controls (CMC) data prepared by Catalent Pharma and our proof-of-concept data (National Research Council Canada). In the near future, we expect to announce the selection of the Contract Research Organization that will write the IND-application and run the first-in-human trials for our novel treatment for the motor symptoms of Parkinson’s disease.

 

For its lead chronic pain program, the Company is testing its MEM for chronic pain both as encapsulated, time-released nanoparticles, as well as in non-encapsulated forms of these therapeutic mixtures in an animal model at the NRC in Halifax, Nova Scotia. In preparation for human clinical trials, our standard MEM and the time-released MEM are currently being compared in an animal model that demonstrates their potential effectiveness at treating chronic pain. The early results from this preclinical research project look very promising.

 

The Company received positive proof-of-concept data from a human immune cell model supporting the efficacy of their proprietary MEM designed for the suppression of COVID-related, cytokine release syndromes (CRS) while preserving key anti-viral immune responses. Based on this new positive proof-of-concept data, GBSGB converted their provisional patent application entitled, “CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF CYTOKINE RELEASE SYNDROME WHILE PRESERVING KEY ANTI-VIRAL IMMUNE REACTIONS” to a nonprovisional patent application. The best performing MEM will be further developed in preparation for clinical studies to evaluate their anti-inflammatory potential in the treatment of severely ill COVID-19 patients contending with Cytokine Release Syndrome (CRS) and associated hyperinflammatory conditions, such as macrophage activation syndrome (MAS) and acute respiratory distress syndrome (ARDS). CRS, MAS, and ARDS are the leading causes of deaths in COVID-19 patients. The Company’s proof-of-concept study was performed at Michigan State University using a state-of-the-science human immune model. In the Company’s proof-of-concept study, immune cells from human donors were co-cultured together in one of four treatment groups: untreated (no inflammatory stimulus), inflammatory stimulus, control (inflammatory stimulus + vehicle from cannabinoid mixtures), or pre-treatment with the cannabinoid mixture + inflammatory stimulus. Then a panel of cytokines and inflammatory markers was measured from each of these treatment groups from different immune cell types within the co-cultured cells at four time points to determine whether the Company’s MEMs were able to alter the levels of pro-inflammatory cytokines or other inflammatory agents. The Company’s COVID-CRS formulations showed potential for the selective inhibition of pro-inflammatory processes in response to viral- and bacterial-triggered hyperinflammation in a human immune cell model. These positive proof-of-concept results support the potential for some of these mixtures to accomplish our therapeutic goals, but, ultimately, clinical trial results will determine whether they are efficacious. The Company’s plant-based drug discovery platform is advancing biopharmaceutical research at a time when thousands are dying from COVID-19. The next step is to further develop our plant-inspired drugs and eventually bring them to human trials so that the use of well-defined cannabinoid mixtures in clinical practice can become a reality.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

As mentioned above, the Company has announced that our kava-inspired formulas for anxiety have achieved statistically significant efficacy in animal proof-of-concept studies. Gb Sciences is now preparing its non-psychedelic, kava-based anxiety formulations to treat the growing global need for anxiety and depression relief. The NRC of Canada has tested our proprietary, psychotropic plant-based formulas for the treatment of depression and anxiety in preclinical animal studies. The Company has leveraged its patent-pending PhAROS™ (Phytomedical Analytics for Research Optimization at Scale) platform to identify these combinations of plant compounds for novel drug candidates to treat depression and anxiety. These are the company’s first non-cannabis formulations to achieve proof-of-concept efficacy in preclinical studies. For these novel psychotropic drug candidates, the Company used the PhAROS™ platform to identify new ingredients to improve upon an initial formulation for anxiety based on traditional medicine. The original plant mixture was derived from the kava plant, but some elements of kava are thought to cause liver toxicity. PhAROS™ identified ingredients from the Piper plant family as a substitute for the functionality of the ingredients in question without the potentially adverse safety profiles of those original ingredients. The Piper plant family includes pepper plants that are used worldwide in traditional medicines. The Global Anxiety Disorder and Depression Treatment Market size is forecast to reach USD 19.81 Billion by 2028 according to Reports & Data.

 

Favorable Research Updates from our university collaborators reveal the promise in our discovery programs including: 1) Multiple MEM discovery projects using and advancing our proprietary PhAROS™ drug discovery platform in conjunction with Chaminade University, 2) the Company’s Cannabis Metabolomics Project with both Chaminade University of Honolulu, Hawai’i and the University of Athens, Greece, and 3) the Company’s Time-Released Nanoparticles for Delivery of Cannabis-based Ingredients with the University of Seville, Spain and the University of Cadiz, Spain.

 

In the past year GBLX/GBSGB’s foreign patents for plant-based treatments of serious disorders were allowed in different countries, expanding our patent protections as follows. On February 3, 2023, GB Sciences’ first foreign patent protecting its proprietary cannabinoid-based formulations for Parkinson’s disease was issued in China. China is an increasingly important pharmaceutical market with cultural acceptance of plant-based formulations, which is a good fit for GB Sciences’ drug candidates. The global market for treatments of Parkinson’s disease is projected to grow to $8.8 billion by the year 2026, and new therapies to address Parkinson’s disease symptoms are greatly needed. The Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease. On April 25, 2023, the Japanese patent was also issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease. On June 28th of 2023, GBSGB received a Notice of Allowance for its Israeli patent application for its Parkinson’s disease formulas. On July 7th, GBSGB received a Notice of Allowance for its European patent application protecting the Parkinson’s disease formulas. On December 1, 2022, the Israeli (IL) Patent was issued, which protects our Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. On December 15, 2022, the Australian (AU) Patent was issued, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was issued, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On April 24, 2023, GBSGB received the Notice of Allowance for its European Patent, which also triggers the allowance of its HK Patent protecting its Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). Additionally, on March 9, 2023, the Notice of Allowance was received for the Company’s U.S. Patent Application No. 16/878,295, which protects the use of the Company’s Myrcene-Containing Complex Mixtures in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. On June 28th of 2023, GbS received a Notice of Allowance on its Australian patent application, which protects the Company’s Myrcene-Containing Complex Mixtures for use in the treatment of pain related to arthritis, shingles, irritable bowel syndrome, sickle cell disease, and endometriosis.

 

In 2021, our growing intellectual property portfolio was augmented with additional patent-protections for our PhAROS™ drug discovery platform that were filed in July of 2021 and in October of 2021. The Company, through GBSGB, also filed for protection of new PhAROS™ discovered, non-cannabis formulations in July of 2021. In September of 2021, the Company filed a patent application for the Company’s improved DCR-MEM formulations for our PD therapeutic program. These new patent applications expanded upon the solid foundation of intellectual property developed over the past six years. In 2020, the three patents which protect formulations for the Company’s lead therapeutic programs were issued by the USPTO. The issuance of U.S. Patent No. 10,653,640 entitled "Cannabinoid-Containing Complex Mixtures for the Treatment of Neurodegenerative Diseases" on May 19, 2020 protects methods of using GBSGB’s proprietary cannabinoid-containing complex mixtures (CCCM™) for treating Parkinson’s Disease. This was an important milestone in the development of these vitally important therapies and validates GBSGB’s drug discovery platform. In the US alone, the combined direct and indirect costs associated with Parkinson’s disease are estimated at $52 billion, and new therapies to address Parkinson’s disease symptoms are greatly needed. This was also the first time that a US patent has been awarded for a cannabis-based complex mixture defined using this type of drug discovery method. The first US patent for PD therapies validated our drug discovery platform and strengthened our intellectual property portfolio of unique CCCM’s™, each targeting one of up to 60 specific clinical applications.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

The issuance of the Company’s second and third US patents for active pharmaceutical ingredients that are complex mixtures identified by our biotech platform further confirmed that the Company’s pharmaceutical compositions can be patent protected for use as biopharmaceutical and nutraceutical products. The US Patent entitled “Myrcene-Containing Complex Mixtures Targeting TRPV1” protects methods of using our proprietary MEMs for the treatment of pain disorders related to arthritis, shingles, irritable bowel syndrome, sickle cell disease, and endometriosis. In the US alone, chronic pain represents an estimated health burden of between $560 and $650 billion dollars, and an estimated 20.4% of U.S. adults suffer from chronic pain that significantly decreases their quality of life. Despite the widespread rates of addiction and death, opioids remain the standard of care treatment for most people with chronic pain. The Company believes that it is important to create safer, less addictive alternatives to opioids for the treatment of chronic pain disorders, like GBSGB’s myrcene-containing MEMs.

 

The Company's third issued US Patent entitled "Cannabinoid-Containing Complex Mixtures for the Treatment of Mast-Cell-Associated or Basophil-Mediated Inflammatory Disorders" protects methods of using the Company’s proprietary MEMs for treating Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. Receiving this patent for the treatment of MCAS using our MEMs is an important milestone in the development of this urgently needed medicine. There is no single recommended treatment for MCAS patients. Instead, they attempt to manage MCAS symptoms primarily by avoiding ‘triggers’ and using rescue medicines for their severe hyperinflammatory attacks. Therefore, MCAS patients need new therapeutic options to control their mast cell related symptoms, and our MEMs were designed to simultaneously control multiple inflammatory pathways within mast cells as a comprehensive treatment option. The Company is strategically targeting MCAS for two additional reasons. By focusing on a rare disease with no known cure, our company can apply for the U.S. Food and Drug Administration’s expedited approval process, which allows clinically successful treatments to get to market both quicker and more cost effectively. Gaining approval from the US FDA for the entire anti-inflammatory market would be extremely time consuming and cost prohibitive. Demonstrating that our MEMs are safe for the treatment of MCAS would favorably position our Company for clinical testing of these MEMs as potential treatments for other related inflammatory disorders, such as inflammatory bowel disease, thereby widening the target market and drastically shortening the development cycle and costs.

 

The Company’s fourth US Patent was issued on March 1, 2022 for a cannabinoid-containing mixture designed to treat cardiac hypertrophy, often present in advanced heart disease. Gb Sciences’ newly issued patent also covers the use of these receptor-targeted formulations for the treatment of TRPV1-receptor associated hearing loss and urinary cystitis. Despite multiple categories of prescription heart medications on the market, heart disease remains the leading cause of death in the United States for people of most racial and ethnic groups. Alternative therapeutic approaches are still needed, especially for the treatment of advanced heart disease. The market for prescription heart disease medications is predicted to rise to $64 billion dollars in the US by 2026, with future market growth fueled by innovative new therapeutic approaches.

 

Intellectual Property Portfolio

 

GBSGB retained Fenwick & West, a Silicon Valley based law firm focusing on life sciences and high technology companies with a nationally top-ranked intellectual property practice, to develop strategies for the protection of the Company's intellectual property. The status of the intellectual property portfolio is as follows. Unless otherwise indicated, all patents listed below are assigned to the Company's wholly-owned subsidiary, GBS Global Biopharma, Inc.

 

Six USPTO & Eight International Patents Issued; One USPTO & Five International Patents Allowed*

*Notice of Allowances received which confirms patent protection on claim set

 

Title: CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF NEURODEGENERATIVE DISEASES (002 Patent Family)

 

U.S. Patent Number: US10653640B2

Issued: May 19, 2020

Expiration date: October 10, 2037

Inventors: Andrea Small-Howard et al.

Chinese Patent Number: CN109963595B

Issued: Feb 3, 2023

Expiration date: October 10, 2037

Inventors: Andrea Small-Howard et al.

Japanese Patent Number: JP7225103B2

Issued: April 25, 2023

Expiration date: October 10, 2037

Inventors: Andrea Small-Howard et al.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

On May 19, 2020, U.S. Patent protection was granted for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease. On February 3, 2023, the Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease. On April 25, 2023, the Japanese patent was issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease. On June 28th of 2023, GBSGB received a Notice of Allowance for its Israeli patent application. On July 7th, GBSGB received a Notice of Allowance for its European patent application. These patents claim benefit of U.S. Patent Application No. 62/406,764 that was originally filed October 11, 2016.

 

Title: MYRCENE-CONTAINING COMPLEX MIXTURES TARGETING TRPV1 (005 Patent Family)

 

U.S. Patent Number US10709670B2

Issued: July 14, 2020

Expiration date: May 22, 2038

Inventors: Andrea Small-Howard, et al.

US Patent Application: US20200390721A1

Allowed: March 9, 2023

Expiration date: May 22, 2038

Inventors: Andrea Small-Howard et al.

 

As of July 14, 2020, GBSGB’s Myrcene-Containing Complex Mixtures (MCCM) are protected in the US for use in the treatment of pain related to arthritis, shingles, irritable bowel syndrome, sickle cell disease, and endometriosis. On June 28th of 2023, GBSGB received a Notice of Allowance on its Australian patent application. On March 9, 2023, the Notice of Allowance was received for GBSGB’s U.S. Patent Application No. 16/878,295, which was filed as a Continuation of Review of US Patent Application No. 15/986,316 (originally filed on May 22, 2018). The Notice of Allowance on the US Continued Review Application protects the use of GBSGB’s MCCM in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. These patents claim benefit of U.S. Patent Application No. 62/509,546 that was originally filed May 22, 2017.

 

Title: CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF MAST CELL-ASSOCIATED OR BASOPHIL-MEDIATED INFLAMMATORY DISORDERS (003 Patent Family)

 

U.S. Patent Number US10,857,107B2

Issued: December 8, 2020

Expiration date: January 31, 2038

Inventors: Andrea Small-Howard et al.

IL Patent Number: IL268211B

Issued: December 1, 2022

Expiration date: January 31, 2038

Inventors: Andrea Small-Howard et al.

AU Patent Number: AU2018215200B2

Issued: December 15, 2022

Expiration date: January 31, 2038

Inventors: Andrea Small-Howard et al.

JP Patent Number: JP7225104B2

Issued: February 20, 2023

Expiration date: January 31, 2038

Inventors: Andrea Small-Howard et al.

European Patent Application: EP3576724A1 Allowed: April 24, 2023
Expiration date: January 31, 2038    Inventors: Andrea Small-Howard et al.
HK Patent Application: HK62020008641.6 Allowed: August 1, 2023
Expiration date: January 31, 2038    Inventors: Andrea Small-Howard et al.                                   

 

On December 8, 2020, U.S. Patent protection was granted for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On December 1, 2022, the Israeli (IL) Patent was issued, protecting GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On December 15, 2022, the Australian (AU) Patent was issued, protecting GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was issued, protecting GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On April 24, 2023, GbS received the Notice of Allowance for its European Patent, which also triggers the allowance of its HK Patent. These patents claim benefit of U.S. Patent Application No. 62/453,161 originally filed February 1, 2017.

 

Title: TRPV1 ACTIVATION-MODULATING COMPLEX MIXTURES OF CANNABINOIDS AND/OR TERPENES (006 Patent Family)

 

U.S. Patent Number US11260044B2

Issued: May 1, 2022

Expiration date: May 22, 2039

Inventors: Andrea Small-Howard, et al.

 

U.S. Patent coverage was granted for CBGA-containing mixtures used for the treatment of TRPV1-associated heart disease, renal cystitis, and hearing loss. This patent claims benefit of U.S. Patent Application Nos. 62/674,843 filed May 22, 2018; 62/769,743 filed November 20, 2018; and 62/849,719 filed May 17, 2019.

 

Title: METHODS AND COMPOSITIONS FOR PREVENTION AND TREATMENT OF CARDIAC HYPERTROPHY (050 Patent Family)

 

U.S. Patent Number: US9084786B2

Issued: July 21, 2015

U.S. Patent Number: US10137123B2

Issued: November 27, 2018

European Union Patent Number: EP2635281B1

Issued: March 14, 2018

Hong Kong Patent Number: HK14102182.8B1

Issued: March 14, 2018

Inventor: Alexander Stokes

Assignee: University of Hawai’i

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

GBSGB has sublicensed these two issued USPTO patents and two issued international patents for the prevention and treatment of heart failure due to cardiac hypertrophy through therapeutic regulation of TRPV1 from Makai Biotechnology, LLC.

 

Title: METHOD FOR PRODUCING A PHARMACEUTICAL COMPOSITION OF POLYMERIC NANOPARTICLES FOR TREATING NEUROPATHIC PAIN CAUSED BY PERIPHERAL NERVE COMPRESSION (008 Patent Family)

Spanish Patent: ES2582287                                              Issued: September 29, 2017

Expiration: February 9, 2035

Inventors: Martin Banderas, Lucia; Fernandez Arevalo, Mercedes; Berrocoso, Dominguez, Esther; and Mico Segura, Juan Antonio

Assignees: Universidad de Sevilla, Universidad de Cadiz, and Centro de Investigacion Biomedica En Red

Exclusive worldwide license held by GbS Global Biopharma, Inc. Claims benefit of Spanish Patent Application no. P201500129 (Pub. No. ES 2582287).

 

GBSGB holds the exclusive worldwide rights to commercialize the issued Spanish patent-protected, cannabinoid-containing, time-released, oral nanoparticles for the treatment of neuropathic pain.

 

Pending Patents

 

In addition to the issued patents listed above, GBSGB's intellectual property portfolio includes a total of eighteen USPTO and fifty-five international patents pending:

 

Title

 

Jurisdiction

 

Application Number

 

Other

International

Applications

Filed

 

Continuation of

CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF NEURODEGENERATIVE DISEASES

 

US

 

USPTO 16/844,713
PCT/US2017/055989

 

AU, CA, CN, EP, HK, IL, JP

 

US15/729,565

CN202310039015.8A JP2023058599A

MYRCENE-CONTAINING COMPLEX MIXTURES TARGETING TRPV1

 

US

 

USPTO 16/878,295
PCT/US2018/033956

 

AU, CA, CN, EP, HK, IL, JP

 

US15/986,316 US16/878,295

CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF MAST CELL-ASSOCIATED OR BASOPHIL-MEDIATED INFLAMMATORY DISORDERS

 

US

 

USPTO 17/065,400
PCT/US2018/016296

 

AU, CA, CN, EP, HK, IL, JP

 

US15/885,620

TRPV1 ACTIVATION-MODULATING COMPLEX MIXTURES OF CANNABINOIDS AND/OR TERPENES

 

US

 

USPTO 16/420,004 PCT/US2019/033618

 

AU, CA, CN, EP, HK, IL, JP

 

US17/576,485

THERAPEUTIC NANOPARTICLES ENCAPSULATING TERPENOIDS AND/OR CANNABINOIDS

 

US

 

USPTO 16/686,069
PCT/ES2019/070765

 

AU, CA, CN, EP, HK, IL, JP

   

TREATMENT OF PAIN USING ALLOSTERIC MODULATOR OF TRPV1

 

US

 

USPTO 16/914,205
PCT/US2020/039989

 

AU, CA, CN, EP, HK, IL, JP

   

CANNABINOID-CONTAINING COMPLEX MIXTURES FOR THE TREATMENT OF CYTOKINE RELEASE SYNDROME WHILE PRESERVING KEY ANTI-VIRAL IMMUNE REACTIONS

 

US

 

USPTO 17/406,035
PCT/US2021/046584

 

AU, CA, CN, EP, HK, IL, JP

   

IN SILICO META-PHARMACOPEIA ASSEMBLY FROM NON-WESTERN MEDICAL SYSTEMS USING ADVANCED DATA ANALYTIC TECHNIQUES TO IDENTIFY AND DESIGN PHYTOTHERAPEUTIC STRATEGIES

 

US

 

USPTO 17/501,498
PCT/US2021/055056

 

CA, EP, HK, KR 

   

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

METHODS AND COMPOSITIONS FOR PREVENTION AND TREATMENT OF CARDIAC HYPERTROPHY

 

US/EU

 

EPO 3,348,267

 

IN, CN

   

METHOD FOR PRODUCING A PHARMACEUTICAL COMPOSITION OF POLYMERIC NANOPARTICLES FOR TREATING NEUROPATHIC PAIN CAUSED BY PERIPHERAL NERVE COMPRESSION

 

WIPO/PCT

 

WIPO 2016/128591
PCT/ES2016/000016

 

US, EU, CA

   

CANNABINOID-CONTAINING FORMULATIONS FOR PARKINSONIAN MOVEMENT DISORDERS

 

US

 

USPTO 17/501,498 PCT/US2021/055056

       

METHODS AND COMPOSITIONS FOR THE IDENTIFICATION OF NOVEL THERAPEUTIC APPROACHES TO MIGRAINE USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

USPTO 63/221,334
(provisional)

       

METHOD AND COMPOSITIONS FOR THE PHYTOMEDICAL COMPONENT SUPPLY CHAIN DECISION SUPPORT USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

Incorporated into

USPTO 17/501,498
PCT/US2021/055056

       

METHODS AND COMPOSITIONS FOR NOVEL PAIN THERAPIES INCLUDING OPIOID-ALTERNATIVE STRATEGIES IDENTIFIED USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

Incorporated into

USPTO 17/501,498
PCT/US2021/055056

       

METHODS AND COMPOSITIONS FOR NOVEL PAIN THERAPIES TARGETED TO SPECIFIC PAIN SUBTYPES IDENTIFIED USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

Incorporated into

USPTO 17/501,498
PCT/US2021/055056

       

METHODS AND COMPOSITIONS DEVELOPMENT OF NOVEL THERAPEUTICS BASED ON PIPER SPECIE-CONTAINING PHYTOMEDICINES FOR ANXIETY AND ASSOCIATED DISORDERS USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

Incorporated into

USPTO 17/501,498
PCT/US2021/055056

       

METHODS AND COMPOSITIONS FOR DECONVOLUTION OF COMPLEX PHYTOMEDICAL FORMULAE FOR CANCER TO IDENTIFY TARGETED STRATEGIES FOR CANCER PAIN AND CYTOTOXIC THERAPEUTIC CANDIDATES USING THE PHAROS IN SILICO DRUG DISCOVERY PLATFORM

 

US

 

Incorporated into

USPTO 17/501,498
PCT/US2021/055056

       

NANOPARTICLE FORMULATIONS FOR TREATING PAIN

 

US

 

63/374,581 (provisional)

       

FORMULATIONS FOR TREATING CYTOKINE RELEASE SYNDROME

 

US

 

63/374,583 (provisional)

       

FORMULATIONS FOR TREATING ANXIETY

 

US

 

63/374,584 (provisional)

       

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

Partnering Strategy 

 

The Company runs a lean drug development program and minimizes expenses, including personnel, overhead, and fixed capital expenses (such as lab and diagnostic equipment), through strategic partnerships with universities, hospitals, suppliers, Contract Research Organizations (“CROs”), and Contract Manufacturing Organizations (“CMOs”). Through these research and development agreements, the Company has created a virtual pipeline for the further development of novel medicines based on ingredients originally derived from the cannabis plant and other plant-based traditional medicines. The partners bring both expertise and infrastructure at a reasonable cost to the life sciences program. In most instances, the Company has also negotiated with these partners to keep 100% of the ownership of the IP within GBSGB for original patent filings.

 

The Company currently has on-going research agreements with the following institutions covering the indicated areas of research:

 

Chaminade University: Broad-based research program to support the drug discovery platform that has yielded many of the Company’s original patents to date in the areas of neurodegenerative diseases, heart disease, inflammatory diseases, neuropathic and chronic pain. They have also performed the bioassay portion of the Cannabis Metabolomics study performed with the University of Athens, Greece and the Company. Our collaborations with Chaminade also led to the development of our PhAROS™ drug discovery platform.

 

University of Athens: Broad-based metabolomics analysis of over 100 cannabis genotypes including both hemp and THC-producing cannabis varieties, in combination with the Company’s bioassay data linking genotypes and potential disease-remediations. This project has the potential to define active ingredients from plant-derived mixtures beyond the standard cannabinoids and terpenoids. The discovery potential is huge, and novel agents have recently been discovered. Novel ligands have been identified and are being validated. This project will ultimately yield novel patent-protected therapies.

 

Michigan State University: Preclinical work using a cutting-edge, multi-cellular model of the human immune system and a multi-cell model of the brain to validate our MEMs for use in the treatment of COVID-19-related cytokine release syndromes (COVID-CRS). MSU has performed experiments using their novel model of the human-immune system that have allowed GBSGB to prepare cannabis-based formulas for the potential treatment of virally-induced hyperinflammation/cytokine storm syndrome that has led to the majority of COVID-19 deaths. Positive proof-of-concept results have guided the development of these selectively anti-inflammatory MEM.

 

The University of Lethbridge: Our research partners bring expertise in studying neurodegenerative diseases using animal models and “Home Cage Small World” assessments using cameras and Artificial Intelligence-to assess efficacy of our proprietary Minimum Essential Mixtures for the treatment of Parkinson’s disease symptoms. Our colleagues at the University of Lethbridge have recently finished the dose-response study for our Company’s cannabinoid-containing Parkinson’s disease therapies.

 

The University of Seville: Bringing their novel expertise to the development and functional testing of time-released and disease-targeted nanoparticles of cannabis-based minimum essential mixtures for oral administration. These specialized nanoparticles are being used for the precise and time-released delivery of several of our therapies, including the Company’s chronic pain MEMs used in the preclinical animal testing performed at the NRC Canada. The University of Seville has completed functional testing on nanoparticles containing myrcene, nerolidol, and beta-caryophyllene for our chronic pain MEMs. In cell-based assays, the effectiveness and kinetics of the nanoparticle-forms of these terpenes were compared with the “naked” terpenes both individually and in mixtures. In all cases, the effectiveness of the nanoparticles was superior to the naked terpenes, however, the mixtures were dramatically more effective than the individuals. Recently, our partners at the University of Seville have completed the formulation of new cannabis-based ingredients for inclusion into the oral, time-released nanoparticle format for the completion of our maximally effective MEMs for chronic pain. The results from Seville are very promising, and these nanoparticles have entered the animal testing phase at the NRC of Canada in Halifax.

 

The National Research Center (NRC) of Canada, Halifax, Nova Scotia: Three animal-phase studies are being performed by Dr. Lee Ellis’ group at the NRC of Canada. 1) Chronic Pain: The Company has re-started a safety and efficacy study in animals for our Chronic Pain (CP) formulas. The midterm results for these preclinical pain studies were promising, but the study was significantly delayed by the COVID pandemic. 2) Anxiety: We recently announced the positive performance of our plant-inspired formulas in an animal model of anxiety. 3) Depression: Minimum essential mixtures of plant-based ingredients from kava and the related Piper plant family are being evaluated now.

 

The University of Cadiz: Testing the safety and efficacy of the above-mentioned time-released nanoparticles in rodent models of chronic pain. Proof of concept complete for one formulation.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

University of Hawaii: Validating the efficacy of a complex cannabis-based mixture for the treatment of cardiac hypertrophy and cardiac disease in a rodent model. Proof of concept work is complete in rodents, and we are seeking commercialization partners.

 

Path to Market: Drug Development Stages and Proposed Clinical Trials

 

The Company has plant-based therapeutic products in the following stages of drug development: Discovery, Pre-Clinical, and entering the Clinical Phase. It has also licensed therapeutic products that the Company intends to develop through partners, labeled Partner Programs.

 

The completion of discovery, preclinical studies, clinical trials, and the required regulatory submissions required for obtaining US FDA pre-market approvals for pharmaceutical products (and equivalent approvals from other corresponding agencies worldwide) is traditionally a long and expensive process. However, the Company asserts that its proprietary, PhAROS™, AI-enabled, drug discovery engine; plant-inspired formulations; lean development program; novel regulatory strategy; experienced development partners; and aggressive licensing of these products at early clinical stages can mitigate some of the risks. The Company uses a combination of in silico discovery methods and automated screening of cellular and animal models of disease to decrease the time in Discovery prior to filing novel patent applications for disease-specific therapeutics. Through GBSGB, the Company’s original patent applications cover new chemical entities (“NCE”) based on discovery and validation of minimum essential mixtures derived from complex, plant-based therapeutics. The Company plans to use an Exploratory IND/Phase 0 Program that gets the Company to First-in-Human sooner than traditional programs, which reduces translational risks, and includes preliminary efficacy measures for responsible development decisions. In contrast, a traditional phased-development path would not provide any efficacy measures until Phase II. After the completion of our Phase 0 study for PD, which compares the efficacies of multiple related cannabinoid-based formulations, the Company plans to advance the lead PD drug candidate using an adaptive trial design that is more efficient than the traditional phased-development pathway. Through GBSGB, the Company has entered into research contracts, partnerships, and/or joint ventures with several respected, independent contract research organizations, medical schools, universities, and with other scientific consultants to increase developmental efficiencies. If and when one or more of the Company’s drugs, therapies or treatments are approved by the US FDA, the Company will seek to market them under licensing arrangements with major biotechnology or pharmaceutical companies.

 

There can be no assurance that we will ever be able to enter into any joint ventures or other arrangements with third parties to finance our drug development program or that if we are able to do so, that any of our projected therapies will ever be approved by the US FDA. Even if we obtain US FDA approval to market one of our therapies, there can be no assurance that it could be successfully marketed or would not be superseded by another plant-based therapy produced by one or more of our competitors. It also may be anticipated that even if we enter into a joint venture development with a financially stable pharmaceutical or institutional partner, we will still be required to raise significant additional capital in the future to achieve the strategic goals of the Company. There can be no assurance that we will be able to obtain such additional capital on reasonable terms, if at all. If the Company fails to achieve its goal of producing one or more plant-inspired pharmaceuticals or therapies, it would have a material adverse effect on our future financial condition and business prospects.

 

Other Operations

 

On March 24, 2020, the Company entered into the Membership Interest Purchase Agreement ("Teco MIPA") with AJE Management, LLC. Pursuant to the Teco MIPA, the Company agreed to sell 100% of its membership interests in GB Sciences Nevada, LLC, and GB Sciences Las Vegas, LLC (the "Teco Subsidiaries") for approximately $8 million, which amount includes a cash payment at closing, the extinguishment of certain liabilities owed to the purchaser and affiliates of the purchaser, and an 8% promissory note.

 

On August 10, 2020, the Company entered into the Membership Interest Purchase Agreement ("Nopah MIPA") and Promissory Note Modification Agreement with 483 Management, LLC. Pursuant to the Nopah MIPA, the Company agreed to sell its 100% membership interest in GB Sciences Nopah, LLC ("Nopah"), which holds a Nevada medical marijuana cultivation certificate. As consideration, the Company would receive $300,000 as a reduction to the balance of the 0% Note payable dated October 23, 2017 and accounts payable of $74,647, which were owed to an affiliate of the purchaser.

 

The closing of the Teco and Nopah sales was contingent upon the successful transfer of the Nevada cultivation and production licenses. On December 14, 2021, the Company received approval from the Nevada Cannabis Compliance Board for the transfer of cannabis cultivation and extraction licenses held by its subsidiaries GB Sciences Nevada, LLC, GB Sciences Las Vegas, LLC, and GB Sciences Nopah, LLC (the "Nevada Subsidiaries"). Consequently, all conditions to closing the sales of the 100% membership interests in the Nevada Subsidiaries were satisfied, and the transactions formally closed on December 31, 2021. After the closing date, the Company retains no ownership interest in the Nevada Subsidiaries.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

RESULTS OF OPERATIONS

 

The following table sets forth certain of our Statements of Operations data:

 

   

For the Three Months Ended

 
   

June 30,

 
   

2023

   

2022

 
                 

General and administrative expenses

  $ 265,122     $ 459,517  

LOSS FROM OPERATIONS

    (265,122

)

    (459,517

)

OTHER EXPENSE

               

Interest expense

    (40,804

)

    (38,572

)

Loss on impairment of capitalized patent and trademark costs

    (42,195

)

    -  

Other income

    75,000       -  

LOSS BEFORE INCOME TAXES

    (273,121

)

    (498,089

)

Income tax expense

    -       -  

NET LOSS

  $ (273,121

)

  $ (498,089

)

 

Comparison of the Three Months Ended June 30, 2023 and 2022

 

General and Administrative Expenses

 

General and administrative expenses decreased by $194,395 to $265,122 for the three months ended June 30, 2023, compared to $459,517 for the three months ended June 30, 2022. The decrease is attributable in part to the completion of a research contract with Michigan State University. In addition, the Company is continuing its efforts to maintain administrative costs at a minimum and to make the best use of its limited resources in advancing research & development of the Company's intellectual property portfolio.

 

Interest Expense

 

Interest expense increased by $2,232 to $40,804 for the three months ended June 30, 2023, compared to $38,572 in the prior year quarter. The increase is attributable to a slight increase in net note balances.

 

Loss on impairment of capitalized patent and trademark costs

 

During the three months ended June 30, 2023, the Company recorded an impairment of all remaining capitalized patents and trademark costs totaling $42,195. No impairment was recorded during the three months ended June 30, 2022.

 

Other income

 

During the three months ended June 30, 2023, the Company recorded other income of $75,000. The Income in the 2023 period relates to the receipt of $75,000 from the makers of a note receivable in the amount of $2,520,833 due and payable to the Company. The note receivable was fully allowed for as of March 31, 2023 and therefore the receipt of cash from the payor has been classified as other income.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Current Liquidity

 

The Company will need additional capital to implement its strategies. There is no assurance that it will be able to raise the amount of capital needed for future growth plans. Even if financing is available, it may not be on terms that are acceptable. If unable to raise the necessary capital at the times required, the Company may have to materially change the business plan, including delaying implementation of aspects of the business plan or curtailing or abandoning the business plan. The Company represents a speculative investment and investors may lose all of their investment. In order to be able to achieve the strategic goals, the Company needs to further expand its business and financing activities. Based on the Company's cash position, it is necessary to raise additional capital by the end of the next quarter in order to continue to fund current operations. These factors raise substantial doubt about the ability to continue as a going concern.  The Company is pursuing several alternatives to address this situation, including the raising of additional funding through equity or debt financing. In order to finance existing operations and pay current liabilities over the next twelve months, the Company will need to raise additional capital. No assurance can be given that the Company will be able to operate profitably on a consistent basis, or at all, in the future.

 

The principal sources of liquidity to date have been cash generated from sales of debt and equity securities and loans along with the sale of our subsidiaries.

 

At June 30, 2023, cash was $29,611, other current assets excluding cash were $199,592, and our working capital deficit was $4,655,504. Current liabilities were $4,884,707 and consisted principally of $2,066,937 in accounts payable, accrued interest of $372,535, $75,628 in accrued liabilities, $1,411,152 in notes and convertible notes payable, and a federal income tax liability related to the Company's past ownership of the Nevada Subsidiaries of $958,455.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

Managements Discussion and Analysis of Financial Condition and Results of Operations

June 30, 2023

(unaudited)

 

 

At March 31, 2023, cash was $109,912, other current assets excluding cash were $199,592, and our working capital deficit was $4,450,202. Current liabilities were $4,759,706, which consisted principally of $1,982,740 in accounts payable, $346,806 in accrued interest, $75,628 in accrued liabilities, $1,396,077 in notes and convertible notes payable, and an income tax liability related to the Company's past ownership of the Nevada Subsidiaries of $958,455.

 

Sources and Uses of Cash

 

Operating Activities

 

Net cash used in operating activities was $105,301 for the three months ended June 30, 2023, compared to cash used of $292,043 for the three months ended June 30, 2022. We anticipate that cash flows from operations will be insufficient to fund business operations for the next twelve-month period. Accordingly, we will have to generate additional liquidity or cash flow to fund our current and anticipated operations. This will likely require the sale of additional common stock or other securities. There is no assurance that we will be able to realize any significant proceeds from such sales, if at all.

 

Investing Activities

 

During the three months ended June 30, 2023 and June 30, 2022, no cash was provided or used by investing activities.

 

Financing Activities

 

During the three months ended June 30, 2023, cash flows provided by financing activities totaled $25,000, in gross proceeds from a convertible note offering. Cash provided by financing activities for the three months ended June 30, 2022 included $125,000 gross proceeds from sales of the Company’s common stock in a private placement and was offset by $12,890 used in payment of principal on notes payable.

 

Going Concern 

 

The Company’s consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company has sustained net losses since inception, which have caused an accumulated deficit of $108,978,436 at June 30, 2023. The Company had a working capital deficit of $4,655,504 at June 30, 2023, compared to a deficit of $4,450,202 at March 31, 2023. In addition, the Company has consumed cash in its operating activities of $105,301 for the three months ended June 30, 2023, compared to $292,043 used in operating activities for the three months ended June 30, 2022. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.

 

Management has been able, thus far, to finance the losses through a public offering, private placements and obtaining operating funds from stockholders. The Company is continuing to seek sources of financing.  There are no assurances that the Company will be successful in achieving its goals.

 

In view of these conditions, the Company’s ability to continue as a going concern is dependent upon its ability to obtain additional financing or capital sources, to meet its financing requirements, and ultimately to achieve profitable operations. Management believes that its current and future plans provide an opportunity to continue as a going concern. The accompanying financial statements do not include any adjustments relating to the recoverability and classification of recorded assets, or the amounts and classification of liabilities that may be necessary in the event the Company is unable to continue as a going concern.

 

VARIABLES AND TRENDS

 

In the event the Company is able to obtain the necessary financing to progress with its business plan, the Company expects expenses to increase significantly to grow the business. Accordingly, the comparison of the financial data for the periods presented may not be a meaningful indicator of future performance and must be considered in light of these circumstances.

 

CRITICAL ACCOUNTING POLICIES

 

A description of the Company's significant accounting policies is included in Note 3 of its Annual Report on Form 10–K for the fiscal year ended March 31, 2023.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

ITEM 3.  Quantitative and Qualitative Disclosures About Market Risk

 

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.

 

ITEM 4.  Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

The Company  maintains disclosure controls and procedures that are designed to ensure that material information required to be disclosed in the periodic reports filed under the Securities Exchange Act of 1934, as amended, or 1934 Act, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and to ensure that such information is accumulated and communicated to management, including the chief executive officer and chief financial officer as appropriate, to allow timely decisions regarding required disclosure. At the end of the quarter ended June 30, 2023, the Company carried out an evaluation, under the supervision and with the participation of management, including the principal executive officer and the principal financial officer, of the effectiveness of the design and operation of disclosure controls and procedures, as defined in Rule 13(a)-15(e) and Rule 15d-15(e) under the 1934 Act. Based on this evaluation, management concluded that as of June 30, 2023, the disclosure controls and procedures were not effective due to material weaknesses: (1) as no member of our board of directors qualifies as an “audit committee financial expert” as defined in Item 407(d)(5) of Regulation S-K promulgated under the Securities Act; and (2) due to the fact the duties of the principal executive officer and the principal financial officer are consolidated in one person and therefore the Company lacks duel control within the duties of these two positions.

 

Limitations on Effectiveness of Controls and Procedures

 

Management, including the Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), does not expect that disclosure controls and procedures will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

 

Changes in Internal Controls

 

On April 14, 2023, the long-time principal financial officer of the Company resigned his position to accept other employment. On the same day the principal executive officer of the Company was appointed interim principal financial officer. Despite the fact the new interim principal financial officer has both a strong educational and operational background in accounting and financial management, consolidating the positions in one person constitutes a change in the internal controls over financial reporting that have materially affected or are reasonably likely to materially affect the internal controls over financial reporting. 

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

PART II – OTHER INFORMATION

ITEM 1.  Legal Proceedings

 

No new items to disclose.

 

ITEM 1A.  Risk Factors

 

There are no material changes from the risk factors previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2023, as filed with the SEC.

 

ITEM 2.  Unregistered Sales of Equity Securities and Use of Proceeds

 

On June 30, 2023, the Company issued a convertible note payable in the face amount of $25,000. The note bears interest at 6% per annum and is convertible into shares of the Company’s common stock at $0.03 per share. The note was not registered under the Securities Act of 1933 (the “Act”), and was issued in reliance upon the exemption from registration contained in Section 4(2) of the Act since it was a transaction that was not a part of any public offering.

 

ITEM 3. Defaults Upon Senior Securities

 

No new items to disclose.

 

ITEM 4.  Mine Safety Disclosures

 

Not Applicable.

 

ITEM 5.  Other Information

 

None.

 

ITEM 6.  Exhibits

 

In reviewing the agreements included as exhibits to this Form 10-Q, please remember that they are included to provide you with information regarding their terms and are not intended to provide any other factual or disclosure information about the Company or the other parties to the agreements. The agreements may contain representations and warranties by each of the parties to the applicable agreement. These representations and warranties have been made solely for the benefit of the parties to the applicable agreement and:

 

●should not in all instances be treated as categorical statements of fact, but rather as a way of allocating the risk to one of the parties if those statements prove to be inaccurate; 

 

●have been qualified by disclosures that were made to the other party in connection with the negotiation of the applicable agreement, which disclosures are not necessarily reflected in the agreement; 

 

●may apply standards of materiality in a way that is different from what may be viewed as material to you or other investors; and 

 

●were made only as of the date of the applicable agreement or such other date or dates as may be specified in the agreement and are subject to more recent developments. 

 

Accordingly, these representations and warranties may not describe the actual state of affairs as of the date they were made or at any other time. Additional information about the Company may be found elsewhere in this Form 10-Q and the Company’s other public filings, which are available without charge through the SEC’s website at http://www.sec.gov.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

The following exhibits are included as part of this report:

 

Exhibit

Number

 

Description of Exhibit

3.1

 

Articles of Incorporation (Incorporated by reference to an exhibit to Form SB-2 No. 333-82580 filed with the Commission on February 12, 2002)

3.2

 

Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.2 to Form S-1/A No. 333-82580 filed with the Commission on October 6, 2014 and Exhibit 3.2 to the Annual Report on Form 10-K filed with the Commission on June 27, 2014)

3.3

 

Articles of Incorporation (Incorporated by reference to Exhibit 3.3 to the Annual Report on Form 10-K filed with the Commission on August 28, 2020)

3.4

 

Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.3 to the Annual Report on Form 10-K filed with the Commission on August 28, 2020)

3.5

 

Amendment to Articles of Incorporation (Incorporated by reference to Exhibit 3.5 to the Annual Report on Form 10-K filed with the Commission on July 14, 2023)

3.6

 

Bylaws (Incorporated by reference to an exhibit to Form SB-2 No. 333-82580 filed with the Commission on February 12, 2002)

31.1

 

Certification of Principal Executive and Financial Officer and Pursuant to Rule 13a-14

32.1*

 

Chief Executive Officer and Chief Financial Officer Certification Pursuant to Section 906 of the Sarbanes-Oxley Act

101.INS

 

Inline XBRL Instance Document

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.LAB

 

Inline XBRL Taxonomy Extension Labels Linkbase Document

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

* This certification is being furnished and shall not be deemed “filed” with the SEC for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the registrant specifically incorporates it by reference.

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

SIGNATURES

 

 

In accordance with the requirements of the Securities Exchange Act of 1934, the Registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

GB SCIENCES, INC.

   

Date: August 14, 2023

By:

/s/ John Poss

 

John Poss, Chief Executive Officer, Chief Financial Officer

(Principal Executive Officer and Principal Financial Officer)

   

 

35

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE AND FINANCIAL OFFICER 

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, John Poss, certify that:

 

1.I have reviewed this quarterly report on Form 10-Q of GB Sciences, Inc.; 

 

2.Based on my knowledge, the quarterly report does not contain any untrue statement of material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; 

 

3.Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of and for the periods presented in this report; 

 

4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: 

 

(a)Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; 

 

(b)Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; 

 

(c)Evaluated the effectiveness of the registrant’s disclosure controls and procedures; and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and 

 

(d)Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and 

 

5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent function): 

 

(a)All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and 

 

(b)any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls. 

 

Date: August 14, 2023

/s/ John Poss

 

John Poss, Chief Executive Officer and Chief Financial Officer

(Principal Executive Officer and Principal Financial Officer)

 

 

GB SCIENCES, INC. AND SUBSIDIARIES

June 30, 2023

(unaudited)

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

 

AS ADOPTED PURSUANT TO

 

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with the Quarterly Report of GB Sciences, Inc. (the “Company”) on Form 10-Q for the quarter ended June 30, 2023, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, John Poss, Chief Executive Officer and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and 

 

(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. 

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

Date: August 14, 2023

/s/ John Poss

 

John Poss, Chief Executive Officer and Chief Financial Officer

(Principal Executive Officer and Principal Financial Officer)

 

 

 

 
v3.23.2
Document And Entity Information - shares
3 Months Ended
Jun. 30, 2023
Aug. 14, 2023
Document Information [Line Items]    
Entity Central Index Key 0001165320  
Entity Registrant Name GB SCIENCES INC  
Amendment Flag false  
Current Fiscal Year End Date --03-31  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2023  
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2023  
Document Transition Report false  
Entity File Number 000-55462  
Entity Incorporation, State or Country Code NV  
Entity Tax Identification Number 59-3733133  
Entity Address, Address Line One 9205 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  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   381,872,561
v3.23.2
Consolidated Balance Sheets (Current Period Unaudited) - USD ($)
Jun. 30, 2023
Mar. 31, 2023
Cash and cash equivalents $ 29,611 $ 109,912
Prepaid expenses and other current assets 199,592 199,592
TOTAL CURRENT ASSETS 229,203 309,504
Intangible assets, net of accumulated amortization and impairment of $2,433,116 and $2,390,297 at June 30, 2023 and March 31, 2023, respectively 0 42,819
TOTAL ASSETS 229,203 352,323
CURRENT LIABILITIES:    
Accrued interest 372,535 346,806
Accrued liabilities 75,628 75,628
Notes and convertible notes payable and line of credit, net of unamortized discount of $26,155 and $41,230 at June 30, 2023 and March 31, 2023, respectively 1,411,152 1,396,077
Income taxes payable 958,455 958,455
TOTAL CURRENT LIABILITIES 4,884,707 4,759,706
Long-term convertible notes payable 25,000 0
TOTAL LIABILITIES 4,909,707 4,759,706
Commitments and contingencies (Note 5)
STOCKHOLDERS' DEFICIT:    
Common Stock, $0.0001 par value, 950,000,000 shares authorized, 381,872,561 and 381,872,561 outstanding at June 30, 2023 and March 31, 2023, respectively 38,187 38,187
Additional paid-in capital 104,259,745 104,259,745
Accumulated deficit 108,978,436 108,705,315
TOTAL STOCKHOLDERS' DEFICIT (4,680,504) (4,407,383)
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT 229,203 352,323
Nonrelated Party [Member]    
CURRENT LIABILITIES:    
Accounts payable 1,946,026 1,861,829
Related Party [Member]    
CURRENT LIABILITIES:    
Accounts payable $ 120,911 $ 120,911
v3.23.2
Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - USD ($)
Jun. 30, 2023
Mar. 31, 2023
Intangible assets, accumulated amortization $ 2,433,116 $ 2,390,297
Unamortized discount, current $ 26,155 $ 41,230
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 950,000,000 950,000,000
Common stock, shares issued (in shares) 381,872,561 381,872,561
Common stock, shares outstanding (in shares) 381,872,561 381,872,561
v3.23.2
Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Sales revenue $ 0 $ 0
Cost of goods sold 0 0
Gross profit 0 0
General and administrative expenses 265,122 459,517
LOSS FROM OPERATIONS (265,122) (459,517)
OTHER INCOME (EXPENSE)    
Interest expense (40,804) (38,572)
Loss on impairment of capitalized patent and trademark costs (42,195) 0
Other income 75,000 0
Total other expense (7,999) (38,572)
LOSS BEFORE INCOME TAXES (273,121) (498,089)
Income tax expense 0 0
NET LOSS $ (273,121) $ (498,089)
Net loss per common share – basic and diluted    
Weighted average common shares outstanding – basic and diluted (in shares) 381,872,561 325,743,436
v3.23.2
Consolidated Statements of Cash Flows (Unaudited) - USD ($)
3 Months Ended
Jun. 30, 2023
Jun. 30, 2022
OPERATING ACTIVITIES:    
Net loss $ (273,121) $ (498,089)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 624 20,086
Stock-based compensation 0 6,500
Amortization of debt discount and beneficial conversion feature 15,075 15,976
Loss on impairment of capitalized patent and trademark costs 42,195 0
Changes in operating assets and liabilities:    
Prepaid expenses and other current assets 0 37,520
Accounts payable 84,197 66,334
Accrued liabilities 0 39,145
Accrued interest 25,729 20,485
Net cash used in operating activities (105,301) (292,043)
FINANCING ACTIVITIES:    
Gross proceeds from convertible notes payable 25,000 0
Gross proceeds from issuing common stock 0 125,000
Principal payment on notes and convertible notes payable 0 (12,890)
Net cash provided by financing activities 25,000 112,110
Net change in cash and cash equivalents (80,301) (179,933)
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 109,912 233,893
CASH AND CASH EQUIVALENTS AT END OF PERIOD 29,611 53,960
Cash paid for interest 0 2,111
Cash paid for income tax 0 0
Non-cash investing and financing transactions:    
Patent drafting and filing costs capitalized in intangible assets 0 28,234
Accrued brokerage fees for common stock issuances and warrant exercises $ 0 $ 16,250
v3.23.2
Consolidated Statements of Changes in Stockholders' Deficit (Unaudited) - USD ($)
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Balance (in shares) at Mar. 31, 2022 325,037,557      
Balance at Mar. 31, 2022 $ 32,504 $ 102,764,746 $ (104,580,122) $ (1,782,872)
Stock issued for cash, net of offering costs (in shares) 4,168,334      
Stock issued for cash, net of offering costs $ 417 108,333 0 108,750
Share based compensation expense   6,500   6,500
Net income (loss) $ 0 0 (498,089) (498,089)
Balance (in shares) at Jun. 30, 2022 329,205,891      
Balance at Jun. 30, 2022 $ 32,921 102,879,579 (105,078,211) (2,165,711)
Balance (in shares) at Mar. 31, 2023 381,872,561      
Balance at Mar. 31, 2023 $ 38,187 104,259,745 (108,705,315) (4,407,383)
Net income (loss) $ 0 0 (273,121) (273,121)
Balance (in shares) at Jun. 30, 2023 381,872,561      
Balance at Jun. 30, 2023 $ 38,187 $ 104,259,745 $ (108,978,436) $ (4,680,504)
v3.23.2
Note 1 - Background and Significant Accounting Policies
3 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Significant Accounting Policies [Text Block]

Note 1 – Background and Significant Accounting Policies 

 

GB Sciences, Inc. (“the Company”, “GB Sciences”, “GBLX”, “we”, “us”, or “our”) is a plant-inspired, biopharmaceutical research and development company creating patented, disease-targeted formulations of cannabis- and other plant-inspired therapeutic mixtures for the prescription drug market through its wholly owned Canadian subsidiary, GbS Global Biopharma, Inc. (“GBSGB”).

 

Through GBSGB, the Company is engaged in the research and development of plant-inspired medicines, with virtual operations in North America and Europe. GBSGB’s assets include a portfolio of intellectual property containing both proprietary plant-inspired formulations and our AI-enabled drug discovery platform, as well as critical research contracts and key supplier arrangements. The Company’s intellectual property portfolio, which is held by GBSGB, contains six U.S. and eight foreign patents issued, one US and three foreign patents allowed, as well as 18 U.S. and 55 foreign patent-pending applications.

 

On February 3, 2023, GB Sciences’ first foreign patent protecting its proprietary cannabinoid-based formulations for Parkinson’s disease was issued in China. China is an increasingly important pharmaceutical market with cultural acceptance of plant-based formulations, which is a good fit for GB Sciences’ drug candidates. The global market for treatments of Parkinson’s disease is projected to grow to $8.8 billion by the year 2026, and new therapies to address Parkinson’s disease symptoms are greatly needed. GB Sciences’ first foreign patent also confirms that the Company’s intellectual property strategy can work globally and validates both our plant-inspired drug discovery process and intellectual property strategy, which involves defining and protecting Minimum Essential Mixtures. GBLX/GBSGB starts its drug discovery process with plant-based therapies that are working anecdotally or in traditional medical systems, then the Company systematically reduces the number of compounds to reveal Minimum Essential Mixtures. The Company’s novel Minimum Essential Mixtures retain the increased efficacy of whole plant medicines, but they are easier to manufacture with precision at scale like single ingredient drugs. These Minimum Essential Mixtures are a viable alternative to standard single ingredient drugs or traditional whole plant medicines. The Chinese Patent was issued for GBSGB’s Cannabinoid-Containing Complex Mixtures for the treatment of Parkinson’s disease.

 

Several more of GBLX/GBSGB’s foreign patents for plant-based treatments of serious disorders were allowed in different countries, expanding our patent protections as follows. On December 1, 2022, the Israeli (IL) Patent was allowed, protecting our Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). MCAS is a severe immunological condition in which mast cells inappropriately and excessively release inflammatory mediators, resulting in a range of severe chronic hyperinflammatory symptoms and life-threatening anaphylaxis attacks. On December 15, 2022, the Australian (AU) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). On February 20, 2023, the Japanese (JP) Patent was allowed, protecting the Company’s Cannabinoid-Containing Complex Mixtures for the treatment of Mast Cell Activation Syndrome (MCAS). Additionally, on March 9, 2023, the Notice of Allowance was received for the Company’s U.S. Patent Application No. 16/878,295. This Notice of Allowance protects the use of the Company’s Myrcene-Containing Complex Mixtures in the treatment of cardiac hypertrophy, overactive bladder, and refractory chronic cough. On April 25, 2023, the Japanese patent was also issued for the use of GBSGB’s Cannabinoid-Containing Complex Mixtures in the treatment of Parkinson’s disease.

 

GBSGB’s intellectual property covers a range of over 65 medical conditions, from which five drug development programs are in the preclinical stage of drug development including our formulations for Parkinson’s disease ("PD"), chronic pain, COVID-related cytokine release syndrome, depression/anxiety, and cardiovascular therapeutic programs. The Company’s primary focus is on preparing its lead program for the treatment of the motor symptoms of Parkinson's disease for a first-in-human clinical trial. Depending on the results of ongoing preclinical studies, the Company intends to move forward with clinical trials for its chronic pain and COVID-related cytokine release syndrome therapies after PD. The Company’s formulations for chronic pain, anxiety, and depression are currently in preclinical animal studies with researchers at the National Research Council of Canada. The Company recently received proof-of-concept data supporting its kava-inspired anxiety formulations. The Company also has positive preclinical proof-of-concept data supporting its complex mixtures for the treatment of Cytokine Release Syndrome, and its lead candidates will be optimized based on late-stage preclinical studies at Michigan State University. Proof-of-concept studies in animals that support our heart disease formulations have been successfully completed at the University of Hawaii. The Company runs a lean drug development program through GBSGB and takes effort to minimize expenses, including personnel, overhead, and fixed capital expenses through strategic partnerships with Universities and Contract Research Organizations (“CROs”). Our productive research and development network includes distinguished universities, hospitals, and Contract Research Organizations. 

 

 

Basis of Presentation

 

The accompanying unaudited interim condensed consolidated financial statements of GB Sciences, Inc. have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the periods presented are not necessarily indicative of the results that may be expected for the year ending March 31, 2024. The balance sheet at  March 31, 2023 has been derived from the audited financial statements at that date but does not include all of the information and footnotes required by U.S. GAAP for complete financial statements. The unaudited interim condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and footnotes thereto included in the Company’s annual report on Form 10-K for the year ended March 31, 2023.

 

Principles of Consolidation

 

We prepare our consolidated financial statements in accordance with generally accepted accounting principles (GAAP) for the United States of America. Our consolidated financial statements include all operating divisions and majority-owned subsidiaries, reported as a single operating segment, for which we maintain controlling interests. Intercompany accounts and transactions have been eliminated in consolidation. All subsidiaries were wholly owned by the Company for the periods presented.

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Use of Estimates

 

The preparation of the consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. The Company regularly evaluates estimates and assumptions related to allowances for doubtful accounts, inventory valuation and standard cost allocations, valuation of initial right-of-use assets and corresponding lease liabilities, valuation of beneficial conversion features in convertible debt, valuation of the assets and liabilities of discontinued operations, stock-based compensation expense, purchased intangible asset valuations, deferred income tax asset valuation allowances, uncertain tax positions, litigation, other loss contingencies, and impairment of long lived assets.  These estimates and assumptions are based on current facts, historical experience and various other factors that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of costs and expenses that are not readily apparent from other sources. The actual results the Company experiences may differ materially and adversely from these estimates.

 

Indefinite and Definite-Lived Intangible Assets

 

Capitalized costs related to our indefinite-lived intangible assets consisted primarily of the value of our patents pending and includes the costs paid to draft and file patent applications. Upon issuance of the patents, the indefinite-lived intangible assets will have finite lives. Intangible assets also historically included the acquisition cost of a cannabis production license with an indefinite life.

 

We historically amortized our finite-lived intangible assets, which consisted of granted patents, over their estimated useful lives using the straight-line method, and we periodically evaluate the remaining useful lives of our finite-lived intangible assets to determine whether events or circumstances warrant a revision to the remaining period of amortization.

 

We review all of our intangible assets for impairment indicators throughout the year. Impairment testing for indefinite-lived intangible assets is performed at least annually and we perform testing for definite-lived intangible assets whenever impairment indicators are present. If we determine that the fair value is less than the carrying value of these assets during testing, we record impairment losses equal to the difference between the carrying value of the asset and the fair market value of the asset.

 

As of March 31, 2023, we recorded a loss on impairment related to the capitalized patent costs of $2,374,261. The Company recorded an impairment of its capitalized patent costs based on the relevant facts and circumstances that existed as of March 31, 2023 in accordance with ASC 350-30-35.

 

At June 30, 2023, the Company had six patents that have been granted in the United States, including two licensed patents and four patents assigned to the Company's subsidiary, GBS Global Biopharma, Inc. The patents owned by the Company expire between January 2038 and May 2039. Amortization expense for the three months ended June 30, 2023 and 2022, was $624 and $20,086, respectively.

 

There were 10 United States patent applications that are pending as of June 30, 2023, and the corresponding patent assets are treated as indefinite-lived intangible assets. There were 35 international patents pending at June 30, 2023. The carrying amount of the indefinite-lived patent assets was $0 at June 30, 2023.

 

Included in Intangible assets at June 30, 2023, are capitalized license costs and trademarks with a carrying amount of $0, after impairment of $42,195 recorded during the three months ended June 30, 2023.

 

GB SCIENCES, INC. AND SUBSIDIARIES

CONDENSED NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

(unaudited)

 

 

Equity-Based Compensation

 

The Company accounts for equity instruments issued to employees in accordance with the provisions of ASC 718 Stock Compensation (ASC 718) and Equity-Based Payments to Non-employees pursuant