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 April 30, 20222023

OR

OR

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

For the transition period from ___________ to ____________

Commission file number 000-56016

KAIVAL BRANDS INNOVATIONS GROUP, INC.

(Exact name of registrant as specified in its charter)

delawareDelaware83-3492907
(State or other jurisdiction of
incorporation or organization)
(I.R.S. Employer
Identification No.)

4460 Old Dixie Highway

GrantGrant-Valkaria, Florida 32949

 (Address of principal executive offices, including zip code)

(833) 452-4825

 (Registrant’s telephone number, including area code)

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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareKAVLThe Nasdaq Stock Market, LLC

Indicate by check mark whether the 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. YESYes NO 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 such shorter period that the registrant was required to submit such files). YESYes NO 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 filerAccelerated filer
Non-accelerated filerSmaller 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 in Rule 12b-2 of the Exchange Act). YES Yes NONo

APPLICABLE ONLY TO CORPORATE ISSUERS:

Indicate the numberAs of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date:

June 14, 2023, there were

31,166,09058,169,090 shares of common stock, $0.001 par value, outstanding as of June 13, 2022outstanding.

KAIVAL BRANDS INNOVATIONS GROUP, INC.

FORM 10-Q

TABLE OF CONTENTS

 ItemPage
Cautionary Note Concerning Forward-Looking Statementsii
PART IFinancial InformationF-1
Item 1.Financial StatementsF-1
Unaudited Consolidated Balance SheetsF-1
Unaudited Consolidated Statements of OperationsF-2
Unaudited Consolidated Statements of Changes in Stockholders’ EquityF-3
Unaudited Consolidated Statements of Cash FlowsF-5
Notes to Unaudited Consolidated Financial StatementsF-6
Item 2Management’s Discussion and Analysis of Financial Condition and Results of Operations1
Liquidity and Capital Resources36
Results of Operations37
Off-Balance Sheet Arrangements
Emerging Growth Company58
Item 3Quantitative and Qualitative Disclosures aboutAbout Market Risk68
Item 4Controls and Procedures69
PART IIOther Information710
Item 1.Legal Proceedings710
Item 1A.Risk Factors710
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds710
Item 3Defaults Upon Senior Securities710
Item 4Mine Safety Disclosures710
Item 5Other Information710
Item 6Exhibits811
Signatures912

i

i

CAUTIONARY NOTE CONCERNINGREGARDING FORWARD-LOOKING STATEMENTS

Certain statements and information included in this Quarterly Report on Form 10-Q for the three and six monthsquarter ended April 30, 2022 (the “Quarterly Report”2023 (this “Report”) contain or may constitutecontain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), Section 21E21 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995. All

We generally use the words “may,” “should,” “believe,” “expect,” “intend,” “plan,” “anticipate,” “likely,” “estimate,” “potential,” “continue,” “will,” and similar expressions to identify forward-looking statements. Forward-looking statements other thanare not statements of historical facts, which address activities, events, or developments that we expect or anticipate will or may occur in the future, including such things as future capital expenditures, business strategy, statements related to the expected effects on our business from the novel coronavirus (“COVID-19”) pandemic, our ability to obtain the products we distribute from Bidi Vapor, LLC (“Bidi”), the timing and outcome of Bidi’s appeal of the U.S. Food and Drug Administration’s (the “FDA”) Premarket Tobacco Product Application (“PMTA”) marketing authorization denials for Bidi’s non-tobacco flavored products, the scope of future FDA enforcement of regulations in the electronic nicotine delivery system (“ENDS”), the FDA’s approach to the regulation and enforcement of synthetic nicotine and our competitors’ use of the substance in their products to avoid the PMTA requirements, the impact of black-market goods on our business, the success of the agreement with Philip Morris Products S.A. (“PMPSA”), a wholly owned affiliate of Philip Morris International Inc. (“PMI”) related to the international distribution of the BIDI® Stick, the demand for the products we distribute, anticipated product performance, market and industry expectations, significant changes in our relationships with our distributors or sub-distributors, changes in government regulation or laws that affect our business, and circumstances or developments that may make us unable to implement or realize the anticipated benefits, or that may increase the costs of our current and planned business initiatives, and other similar matters are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or other comparable terminology. These forward-looking statements are based largely onbut rather reflect our current expectations concerning future events and assumptionsresults, including, without limitation, statements related to:

our substantial reliance on, and efforts to diversify our business from, the business of our affiliate Bidi Vapor, LLC (“Bidi”);

our ability to obtain from, and pay for, the products we distribute for Bidi;

our ability to integrate and ultimately enter into licenses for or create products relating to the intellectual property assets we acquired from GoFire, Inc. in May 2023;

the impact of the August 2022 11th Circuit Court of Appeals decision overturning the U.S. Food and Drug Administration’s (the “FDA”) previous denial of Bidi’s Premarket Tobacco Product Application (“PMTA”) for its non-tobacco flavored BIDI® Stick electronic nicotine delivery system (“ENDS”), which we are permitted to distribute in the U.S. subject to FDA enforcement and maintenance of all state licenses and permits; 

our substantial reliance on QuikfillRx, LLC (now known as Kaival Marketing Services) to provide key sales, marketing and other support services to us;

our relationships with, and reliance on, third parties to broker and distribute our products;

the scope of future FDA enforcement of regulations in the ENDS products generally;

the market perception of the products we distribute and related impacts on our reputation;

the FDA’s approach to the regulation and enforcement of synthetic nicotine and our competitors’ use of the substance in their products to avoid the PMTA requirements;

the impact of black-market goods on our business;

the demand for the products we distribute;

anticipated product performance, and our market and industry expectations;

our relationships with key third party commercial collaborators such as Phillip Morris International;

our ability or plans to diversify our product offerings;

changes in government regulation or laws that affect our business; and

circumstances or developments that may make us unable to implement or realize the anticipated benefits, or that may increase the costs of, our current and planned business initiatives, including matters over which we have little or no control such as the COVID-19 pandemic.

Forward-looking statements, including those concerning our expectations, involve significant risks, uncertainties and are subject to a number of risks and uncertainties, manyother factors, some of which are beyond our control. These statements are subjectcontrol, which may cause our actual results, performance, or achievements, or industry results to many risks, uncertainties,be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. See the “Management’s Discussion and other importantAnalysis of Financial Condition and Results of Operation” section contained in this Report and the section “Risk Factors” in our Annual Report on Form 10-K for the year ended October 31, 2022, for a listing of some of the factors that could cause the results anticipated by our forward-looking statements to differ from actual future results to differ materially from those expressed inresults. Except as required by applicable law, including the forward-looking statements including, but not limited to, the duration and scopesecurities laws of the COVID-19 pandemic and impact on the demand for the productsUnited States, we distribute; our ability to obtain the products from the manufacturer; actions governments, businesses, and individuals take in response to the pandemic, including restrictions on onsite commercial interactions; the impact of the COVID-19 pandemic and action taken in response to the pandemic on global and regional economies and economic activity; the pace of recovery when the COVID-19 pandemic subsides; general economic uncertainty in key global markets and a worsening of global economic conditions or low levels of economic growth; our inability to sustain profitable sales growth; changes in government regulations or laws that affect our business; significant changes in our relationships with our distributor or sub-distributors; and circumstances or developments that may make us unable to implement or realize the anticipated benefits, or that may increase the costs, of our current and planned business initiatives. In light of these risks and uncertainties, all of the forward-looking statements made herein are qualified by these cautionary statements and there can be no assurance that the actual results or developments anticipated by us will be realized. We undertake no obligation to publicly update or revise any of the forward-looking statements, contained herein.whether as a result of new information, future events, or otherwise. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Report.

ii

ii

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements.

Kaival Brands Innovations Group, Inc.

 Consolidated Balance Sheets

 (Unaudited)

                
 April 30,
2022
 October 31,
2021
 April 30, 2023 October 31, 2022
ASSETS                
CURRENT ASSETS:                
Cash $4,661,495  $7,760,228  $1,124,371  $3,685,893 
Restricted Cash  65,542   65,007 
Accounts receivable  1,175,583   1,985,186 
Inventory deposit – related party     2,925,000 
Accounts receivable, net  1,534,236   574,606 
Other receivable – related party – short term  1,448,376   1,539,486 
Inventories  9,214,320   15,326,370   3,646,738   1,239,725 
Prepaid expenses  375,891   319,531   181,921   426,407 
Income tax receivable  1,753,594   1,753,594      1,607,302 
Total current assets  17,246,425   30,134,916   7,935,642   9,073,419 
        
Fixed assets, net  3,190    
Other receivable – related party – net of current portion  1,771,270   2,164,646 
Right of use asset- operating lease  48,299   55,604   1,104,622   1,198,969 
        
TOTAL ASSETS $17,294,724  $30,190,520  $10,814,724  $12,437,034 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
CURRENT LIABILITIES:                
Accounts payable $224,774  $242,829  $163,270  $40,023 
Accounts payable- related party  3,394,759   12,667,769 
Other payable- related party  2,122,452    
Accrued expenses  467,079   579,604   696,876   1,099,157 
Customer deposits  12,099   44,973 
Customer refund due  921,078    
Deferred revenue  129,702   235,274 
Operating lease obligation – short term  13,680   13,020   175,206   166,051 
Customer refund due  2,382   316,800 
Total current liabilities  4,102,674   13,820,022   4,220,683   1,585,478 
                
LONG TERM LIABILITIES                
Operating lease obligation, net of current portion  39,180   46,185   961,593   1,050,776 
                
TOTAL LIABILITIES  4,141,854  13,866,207   5,182,276   2,636,254 
                
STOCKHOLDERS’ EQUITY:                
                
Preferred stock 5,000,000 shares authorized; Series A Convertible Preferred stock ($.001 par value, 3,000,000 shares authorized, 3,000,000 issued and outstanding as of April 30, 2022 and October 31, 2021)  3,000   3,000 
Preferred stock, 5,000,000 shares authorized: Series A Convertible Preferred stock ($0.001 par value, 3,000,000 shares authorized, none issued and outstanding as of April 30, 2023 and October 31, 2022, respectively)      
                
Common stock ($0.001 par value, 1,000,000,000 shares authorized, 31,166,090 and 30,195,312 issued and outstanding as of April 30, 2022 and October 31, 2021, respectively)  31,166   30,195 
Common stock ($0.001 par value, 1,000,000,000 shares authorized, 56,169,090 and 56,169,090 issued and outstanding as of April 30, 2023, and October 31, 2022, respectively)  56,169   56,169 
                
Additional paid-in capital  26,173,669   21,551,959   32,164,512   29,375,787 
                
Accumulated deficit  (13,054,965)  (5,260,841)  (26,588,233)  (19,631,176)
Total Stockholders’ Equity  13,152,870   16,324,313   5,632,448   9,800,780 
TOTAL LIABILITIES & STOCKHOLDERS’ EQUITY $17,294,724  $30,190,520  $10,814,724  $12,437,034 

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

F-1

Kaival Brands Innovations Group, Inc.

Consolidated Statements of Operations

(Unaudited)

            ��    
  For the Three Months   Ended April 30, For the Six Months
Ended April 30,
  2022 2021 2022 2021
Revenues                
Revenues, net
 $3,099,751  $18,752,086  $5,965,506  $56,122,053 
Revenues - related parties     11,245      61,545 
Excise tax on products  (39,727)  (614,252)  (63,599)  (673,000)
Total revenues  3,060,024   18,149,079   5,901,907   55,510,598 
                 
Cost of revenue                
Cost of revenue - related party  2,627,430   11,792,353   6,112,050   44,271,453 
Cost of revenue - other  44,925   70,247   93,097   156,268 
Total cost of revenue  2,672,355   11,862,600   6,205,147   44,427,721 
                 
Gross profit  387,669   6,286,479   (303,240)  11,082,877 
                 
Operating expenses                
 Advertising and Promotion  761,069   800,685   1,353,570   1,761,187 
General & Administrative expenses  4,644,567   9,558,009   6,143,121   12,976,348 
Total operating expenses  5,405,636   10,358,694   7,496,691   14,737,535 
                 
Other Income                
Interest income     46      376 
Total Other Income     46       
                 
Income (loss) before income taxes provision  (5,017,967)  (4,072,169)  (7,799,931)  (3,654,282)
                 
Provision for income taxes  5,807  (186,758)  5,807  (293,144)
                 
Net income (loss) $(5,012,160) $(4,258,927) $(7,794,124) $(3,947,426)
                 
Net income (loss) per common share - basic and diluted $(0.16) $(0.18) $(0.25) $(0.17)
                 
Weighted average number of common shares outstanding - basic and diluted  30,701,393   23,511,959   30,680,701   23,368,691 
                 
  For the Three Months Ended April 30, For the Six Months Ended April 30,
  2023 2022 2023 2022
Revenues                
Revenues, net $3,046,657  $3,092,366  $5,482,492  $5,934,356 
Revenues – related party  3,628   7,385   6,713   31,150 
Royalty revenue        105,572    
Excise tax on products  (29,983)  (39,727)  (48,557)  (63,599)
Total revenues, net  3,020,302   3,060,024   5,546,220   5,901,907 
                 
Cost of revenues                
Cost of revenue – related party  3,145,652   2,627,430   5,131,452   6,112,050 
Cost of revenue – other     44,925      93,097 
Total cost of revenue  3,145,652   2,672,355   5,131,452   6,205,147 
                 
Gross profit (loss)  (125,350)  387,669   414,768   (303,240)
                 
Operating expenses                
Advertising and promotion  660,132   761,069   1,249,042   1,353,570 
General and administrative expenses  3,176,666   4,644,567   6,134,735   6,143,121 
Total operating expenses  3,836,798   5,405,636   7,383,777   7,496,691 
                 
Other income                
Interest income        11,952    
Total other income        11,952    
                 
Loss before income taxes provision  (3,962,148)  (5,017,967)  (6,957,057)  (7,799,931)
                 
Provision for income taxes     5,807      5,807 
                 
Net loss $(3,962,148) $(5,012,160) $(6,957,057) $(7,794,124)
                 
Net loss per common share – basic and diluted $(0.07) $(0.16) $(0.12) $(0.25)
                 
Weighted average number of common shares outstanding – basic and diluted  56,169,090   30,701,393   56,169,090   30,680,701 

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

F-2

Kaival Brands Innovations Group, Inc.

Consolidated StatementsStatement of Changes in Stockholders’ Equity

For the Six Months Ended April 30, 20222023

(Unaudited)

                             
  Convertible Preferred Shares (Series A) Par Value Convertible Preferred Shares (Series A) Common Shares Par Value Common Shares Additional Paid-in Capital Accumulated Deficit Total
               
Balances, October 31, 2021  3,000,000  $3,000   30,195,312  $30,195  $21,551,959  $(5,260,841) $16,324,313 
Stock Issued for Services – RSUs        61,250   61   110,189      110,250 
Common shares settled and cancelled        (19,866)  (20)  (35,739)     (35,759)
Stock Option Expenses              309,700      309,700 
Net income                 (2,781,964)  (2,781,964)
Balances, January, 31, 2022  3,000,000  $3,000   30,236,696  $30,236  $21,936,109  $(8,042,805) $13,926,540 
Stock Issued for Services – RSUs        80,166   80   80,086      80,166 
Common shares settled and cancelled        (24,058)  (24)  (24,034)     (24,058)
Exercise of common stock warrants        873,286   874   1,565,316      1,566,190 
Stock Option Expenses              2,616,192      2,616,192 
Net income                 (5,012,160)  (5,012,160)
Balances, April, 30, 2022  3,000,000  $3,000   31,166,090  $31,166  $26,173,669  $(13,054,965) $13,152,870 
                             
  Convertible Preferred Shares (Series A) Par Value Convertible Preferred Shares (Series A) Common Shares Par Value Common Shares Additional Paid-in Capital Accumulated Deficit Total
               
Balances, October 31, 2022    $   56,169,090  $56,169  $29,375,787  $(19,631,176) $9,800,780 
Stock option expense              1,435,787      1,435,787 
Net loss                 (2,994,909)  (2,994,909)
Balances, January 31, 2023    $   56,169,090  $56,169  $30,811,574  $(22,626,085) $8,241,658 
Stock option expense              1,352,938      1,352,938 
Net loss                 (3,962,148)  (3,962,148)
Balances, April 30, 2023    $   56,169,090  $56,169  $32,164,512  $(26,588,233) $5,632,448 

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

F-3

Kaival Brands Innovations Group, Inc.

Consolidated Statement of Changes in Stockholders’ Equity

For the Six Months Ended April 30, 20212022

(Unaudited)

  Convertible Preferred Shares (Series A) Par Value Convertible Preferred Shares (Series A) Common Shares Par Value Common Shares Additional Paid-in Capital Retained Earnings Total
               
Balances, October 31, 2020  3,000,000  $3,000   23,106,886  $23,107  $618,904  $3,772,597  $4,417,608 
Issuance of common shares for employee compensation        44,583   45   76,655      76,700 
Common shares settled and cancelled        (17,625)  (18)  (30,493)     (30,511)
Issuance of common shares for compensation        172,129   172   1,034,424      1,034,596 
Net income                 311,501   311,501 
Balances, January 31, 2021  3,000,000  $3,000   23,305,973  $23,306  $1,699,490  $4,084,098  $5,809,894 
  Convertible Preferred Shares
(Series A)
 Par Value Convertible Preferred Shares
(Series A)
 Common Shares Par Value Common Shares Additional Paid-in Capital Accumulated Deficit Total
               
Balances, October 31, 2021  3,000,000  $3,000   30,195,312  $30,195  $21,551,959  $(5,260,841) $16,324,313 
Stock issued for services – RSUs        61,250   61   110,189      110,250 
Common shares settled and cancelled        (19,866)  (20)  (35,739)     (35,759)
Stock option expense              309,700      309,700 
Net loss                 (2,781,964)  (2,781,964)
Balances, January 31, 2022  3,000,000  $3,000   30,236,696  $30,236  $21,936,109  $(8,042,805) $13,926,540 
Stock issued for services – RSUs        80,166   80   80,086      80,166 
Common shares settled and cancelled        (24,058)  (24)  (24,034)     (24,058)
Exercise of common stock warrants        873,286   874   1,565,316      1,566,190 
Stock option expense              2,616,192      2,616,192 
Net loss                 (5,012,160)  (5,012,160)
Balances, April 30, 2022  3,000,000  $3,000   31,166,090  $31,166  $26,173,669  $(13,054,965) $13,152,870 

Issuance of common shares for employee compensation        64,583   65   647,396      647,461 
Common shares settled and cancelled        (20,505)  (21)  (47,443)     (47,464)
Issuance of common shares for compensation        216,924   

217

   

6,494,338

      

6,494,555

 
Stock Option Expenses              579,699      579,699 
Net income                 (4,258,927)  (4,258,927)
Balances, April, 30, 2021  3,000,000  $3,000   23,566,975  $23,567  $9,373,480  $(174,829) $9,225,218  

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

F-4

KaivalKaival Brands Innovations Group, Inc.

Consolidated Statements of Cash Flows

 (Unaudited)

        
         For the Six Months Ended For the Six Months Ended
 For the Six Months Ended April 30, 2022 For the Six Months Ended April 30, 2021 April 30, 2023 April 30, 2022
CASH FLOWS FROM OPERATING ACTIVITIES                
Net (loss) income $(7,794,124) $(3,947,426)
Adjustment to reconcile net (loss) income to net cash used in operating activities:        
Net loss $(6,957,057) $(7,794,124)
Adjustments to reconcile net loss to net cash used in operating activities:        
Stock based compensation     190,416 
Depreciation  290    
Stock option expense  2,788,725   2,925,892 
Bad debt expense  4,622    
ROU operating lease expense  94,347   7,305 
Writeoff of inventory  105,057    
                
Stock based compensation  190,416   8,253,312 
Stock option expense  2,925,892   579,699 
ROU operating lease expense  7,305   7,905 
Changes in current assets and liabilities:                
Accounts receivable  809,603   (16,734,585)  (964,252)  809,603 
Accounts receivable – related parties  0   14,595 
Other receivable – related party  484,486    
Prepaid expenses  (56,360)  (30,000)  244,486   (56,360)
Inventory  (2,512,070)  6,112,050 
Inventory deposit – related party   2,925,000          2,925,000 
Inventory  6,112,050   (28,787,767)
Income tax receivable  1,607,302    
Accounts payable  (18,055)  272,509   123,247   (18,055)
Accounts payable – related party  (9,273,010)  36,592,072   2,122,452   (9,273,010)
Accrued expenses  (112,525)  (37,854)  (402,281)  (112,525)
Deferred revenue     (623,096)  (105,572)   
Income tax accrual     (756,078)
Customer refund due  (314,418)   
Customer deposits  (32,874)   
Customer refunds due  921,078   (314,418)
Right of use liabilities – operating lease  (6,345)  (6,345)  (80,028)  (6,345)
Net cash used in operating activities  (4,604,571)  (5,203,059)
Net cash used in Operating Activities  (2,558,042)  (4,604,571)
                
CASH FLOWS FROM FINANCING ACTIVITIES:        
CASH FLOWS FROM INVESTING ACTIVITIES        
Cash paid for equipment  (3,480)   
Net cash used in investing activities  (3,480)   
                
CASH FLOWS FROM FINANCING ACTIVITIES        
Stock warrant exercises  1,566,190         1,566,190 
Settled RSUs with cash  (59,817)  (77,975)
Cash flows provided by (used in) financing activities  1,506,373   (77,975)
Settled RSU shares with cash     (59,817)
Net cash provided by financing activities     1,506,373 
                
Net change in cash and restricted cash  (3,098,198) (5,281,034) $(2,561,522) $(3,098,198)
Beginning cash and restricted cash balance  7,825,235   7,421,701   3,685,893   7,825,235 
Ending cash and restricted cash balance $4,727,037  $2,140,667  $1,124,371  $4,727,037 
                
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:        
        
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:        
Interest paid $  $  $  $ 
Income taxes paid $  $106,385  $  $ 

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

F-5

 


KAIVAL BRANDS INNOVATIONS GROUP, INC.

 Notes to Unaudited Consolidated Financial Statements

Note 1 – Organization and Description of Business

Kaival Brands Innovations Group, Inc. (the “Company,” the “Registrant,” “we,” “us,” “our” or “our”)similar terminology), formerly known as Quick Start Holdings, Inc., was incorporated on September 4, 2018, in the State of Delaware.

As used herein, the term “Common Stock” means the Company’s common stock, par value $0.001 per share.

Description of Business

The Company is focused on growing and incubating innovative and profitable products into mature, dominant brands. In March 2020, the Company commenced business operations as a result of becoming the exclusive distributor of certain ENDSelectronic nicotine delivery system (“ENDS”) and related components (the “Products”) manufactured by Bidi Vapor, LLC (“Bidi”), a related party company that is also owned by Nirajkumar Patel, the Chief ExecutiveScience and Regulatory Officer and a director of the Company. Mr. Patel also controls Kaival Holdings, LLC, a Delaware limited liability company and the Company’s majority stockholder (“Kaival Holdings”).

On March 9, 2020, the Company entered into an exclusive distribution agreement (the “Distribution Agreement”) with Bidi, which Distribution Agreement was amended and restated on May 21, 2020, and again on April 20, 2021 (collectively, the “A&R Distribution Agreement”). Pursuant to the A&R Distribution Agreement, Bidi granted the Company an exclusive worldwide right to distribute the Products for sale and resale to both retail level customers and non-retail level customers. Currently, the Products consist primarilyentirely of the “BIDI® Stick.” The Company ceased all retail/direct-to-consumer sales in February 2021. Subsequent to April 30,On June 10, 2022, and again on November 17, 2022, the Company and Bidi entered into a third amended and restated exclusive distribution agreement (the “Third A&R Distribution Agreement”). For additional information, see Note 8, Subsequent Events. which memorializes the Company’s current business relationship with Bidi.

In connection with the A&R Distribution Agreement, the Company entered into non-exclusive sub-distribution agreements, some of which were subsequently amended and restated by the parties in order to clarify certain provisions (all such agreements, as amended and restated, are collectively referred to as the “A&R Sub-Distribution Agreements”), whereby the Company appointed the counterparties as non-exclusive sub-distributors. Pursuant to the A&R Sub-Distribution Agreements, the sub-distributors agreed to purchase for resale the Products in such quantities as they should need to properly service non-retail customers within the continental United States (the “Territory”).

On August 31, 2020, the Company formed Kaival Labs, Inc., a Delaware corporation (herein referred to as “Kaival(“Kaival Labs”), as a wholly owned subsidiary of the Company. Company, for the purpose of developing Company-branded and white-label products and services. The Company has not yet launched any Kaival-branded products, nor has it begun to provide white label wholesale solutions for other product manufacturers. The Company may also utilize Kaival Labs to acquire or license complimentary businesses or assets. On May 30, 2023, the Company and Kaival Labs entered into an Asset Purchase Agreement (the “GoFire APA”) with GoFire, Inc. (“GoFire”) to purchase certain vaporizer and inhalation-related intellectual property assets of GoFire in exchange for equity securities of the Company and contingent cash consideration. For a detailed description of this asset acquisition, please refer to “Note 8 – Subsequent Events” below .

On March 11, 2022, the Company formed Kaival Brands International, LLC, a Delaware limited liability company (herein referred to as “KBI”), as a wholly owned subsidiary of the Company.Company, for the purpose of entering into an international licensing agreement with Philip Morris Products S.A. (“PMPSA”), a wholly owned affiliate of Philip Morris International Inc. (“PMI”).

On July 16, 2021,Current Product Offerings

Pursuant to the A&R Distribution Agreement with Bidi, the Company filedsells and resells electronic nicotine delivery systems, which it may refer to herein as “ENDS Products”, or “e-cigarettes”, to non-retail level customers. The sole Product the Company resells is the “BIDI® Stick,” a Certificatedisposable, tamper-resistant ENDS product that comes in a variety of Amendmentflavor options for adult cigarette smokers. The Company does not manufacture any of the Products it resells. The BIDI® Stick is manufactured by Bidi. Pursuant to the Restated Certificate of Incorporation, as amended, with the Secretary of Stateterms of the State of DelawareA&R Distribution Agreement, Bidi provides the Company with all branding, logos, and marketing materials to effect a 1-for-12 reverse stock split (the “Reverse Stock Split”) ofbe utilized by the shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”). The Reverse Stock Split was effective as of 12:01 a.m. Eastern time on July 20, 2021. No fractional shares were issuedCompany in connection with the Reverse Stock Split. Any fractional shares of Common Stock that would have otherwise resulted from the Reverse Stock Split were rounded up to the nearest whole number. In connection with the Reverse Stock Split, the Board of Directors (the “Board”) approved appropriateits marketing and proportional adjustments to all outstanding securities or other rights convertible or exercisable into shares of Common Stock, including, without limitation, all preferred stock, warrants, options, and other equity compensation rights. All historical share and per-share amounts reflected throughout our consolidated financial statements and other financial information in this Quarterly Report have been adjusted to reflect the Reverse Stock Split as if the split occurred aspromotion of the earliest period presented. The par value per share of the Common Stock was not affected by the Reverse Stock Split.Products.

Current Product Offerings


COVID-19 Impact

Pursuant to the A&R Distribution Agreement, the Company sells and resells electronic nicotine delivery systems, which it may refer to herein as “ENDS Products”, or “e-cigarettes”, to non-retail level customers. The sole Product the Company resells is the “BIDI® Stick,” a disposable, tamper-resistant ENDS product that comes in a variety of flavor options for adult cigarette smokers. The Company does not manufacture any of the Products it resells. The BIDI® Stick is manufactured by Bidi. Pursuant to the terms of the A&R Distribution Agreement, Bidi provides the Company with all branding, logos, and marketing materials to be utilized by the Company in connection with its marketing and promotion of the Products.

On July 14, 2021, the Company announced plans to launch its first Kaival-branded product, a Hemp CBD product. In addition to its branded formulation, the Company anticipates that it will also provide white label, wholesale solutions for other product manufacturers through its subsidiary, Kaival Labs. The Company has not yet launched any branded product, nor has it begun to provide white label wholesale solutions for other product manufacturers.

 

F-6

COVID-19 Impact

In January 2020, the World Health Organization (the “WHO”) announced a global health emergency becausedue to the emergence of a new strain of coronavirus (“COVID-19”) originatingthat originated in Wuhan, China and theChina. This novel strain of coronavirus posed risks to the international community as the virusit spread globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic based on the rapid increase in global exposure.

TheDuring the Company’s operations have not been directly impacted by COVID-19. However, we have encountered some logistical delays related to product launchesfiscal year 2021 and distribution in international markets. Thethe beginning of fiscal 2022, the Company was also indirectly impacted by supply chain issues and regulatory oversight. No impairments have been recordedoversight arising out of COVID-19. The Company believes that many retailers and no triggering events or changesdistributers relaxed their ENDS compliance standards as an indirect result of COVID-19 for two reasons: (i) government enforcement of regulations was very limited due to imposed social restrictions, resulting in circumstances had occurred.less in-person monitor enforcement by government officials and (ii) retail stores experienced light foot traffic from customers due to COVID-19 restrictions and fears, which resulted in relaxed compliance in an effort to generate additional revenue. While the spreadimpact of COVID-19 has slowed and social restrictions have been largely lifted, the full impact of the COVID-19 pandemic continues to evolve and remains uncertain, particularly as new variants of the virus emerge. As such, the full magnitude of the COVID-19 pandemic, and the resulting impact, if any, ondecreased during the Company’s financial condition, liquidity,fiscal 2022 year and future resultsboth the first and second quarters of operations is uncertain.its fiscal 2023 year, outbreaks of COVID-19 or its variants, either locally, nationally or globally, as well as related supply chain issues, could adversely impact the Company’s business.

Impact of the FDA PMTA Decision and Subsequent Court Actions

As of MarchJanuary 31, 2022, the FDA announced that it has taken actionacted on over 99% of applications and issued Marketing Denial Orders (“MDOs”) for more than 1,167,000 non-tobacco flavored ENDS products, while issuing zero marketing authorizations for such products.

Bidi, along with nearly every other company in the ENDS industry, received a MDO for its non-tobacco flavored ENDS products. With respect to Bidi, the MDO covered all non-tobacco flavored BIDI®BIDI® Sticks, including its Arctic (menthol) BIDI®BIDI® Stick. As a result, beginning in September 2021, Bidi pursued multiple avenues to challenge the MDO. First, on September 21, 2021, separate from the judicial appeal of the MDO in its entirety, Bidi filed a 21 C.F.R. § 10.75 internal FDA supervisory review request specifically of the decision to include the Arctic (menthol) BIDI® BIDI® Stick in the MDO. In May 2022, the FDA issued a determination that it views the Arctic BIDI®BIDI® Stick as a non-tobacco flavored ENDS product, and not strictly a menthol flavored product.

 

On September 29, 2021, Bidi petitioned the U.S. Court of Appeals for the Eleventh Circuit (the “11th Circuit”) to review the FDA’s denial of the comprehensive PMTAs for its non-tobacco flavored BIDI®BIDI® Stick ENDS, arguing that it was arbitrary and capricious under the Administrative Procedure Act (“APA”), as well as ultra vires,, for the FDA not to conduct any scientific review of Bidi’s comprehensive applications, as required by the Tobacco Control Act (“TCA”), to determine whether the BIDI®BIDI® Sticks are “appropriate for the protection of the public health”. Bidi further argued that the FDA violated due process and the APA by failing to provide fair notice of the FDA’s new requirement for ENDS companies to conduct long-term comparative smoking cessation studies for their flavored products.products, and that the FDA should have gone through the notice and comment rulemaking process for this requirement.

Finally, onOn October 14, 2021, Bidi requested that the FDA re-review the MDO and reconsider its position that Bidi did not include certain scientific data in its applications sufficient to allow the PMTAs to proceed to scientific review. In light ofConsidering this request, on October 22, 2021, pursuant to 21 C.F.R. § 10.35(a), the FDA issued an administrative stay of Bidi’s MDO pending its re-review.re-review, permitting the Company to continue sales. Subsequently, the FDA decided not to rescind the MDO and lifted its administrative stay on December 17, 2021. Following the lifting of the FDA’s administrative stay, Bidi filed a renewed motion to stay the MDO with the U.S. Court of Appeals for the Eleventh Circuit, which was granted on February 1, 2022.

11th Circuit. On February 1, 2022, the U.S. Court of Appeals for the Eleventh Circuitappellate court granted Bidi’s motion to stay (i.e.(i.e., put on hold) the MDO, again allowing the Company to continue sales pending the litigation on the merits. The court-ordered stay means that the MDO is not legally in force. Accordingly, we anticipate being able to continue marketing and selling the Products, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challenging the legality of the MDO. The FDA has indicated that it is prioritizing enforcement against companies that have not submitted PMTAs, whose PMTAs have been refused acceptance or filing by the FDA, or whose PMTAs remain subject to MDOs. Oral arguments in the merits-based proceeding were held on May 17, 2022.

In the event thatOn August 23, 2022, the U.S. Court of Appeals for the Eleventh Circuit issues a ruling adverseset aside the MDO issued to Bidi, or ifthe non-tobacco flavored BIDI® Sticks and remanded Bidi’s back to the FDA otherwise chooses to enforcefor further review. Specifically, the Court held that the MDO was “arbitrary and capricious” in violation of the Administrative Procedure Act (“APA”) because the FDA failed to consider the relevant evidence before it, specifically Bidi’s aggressive and comprehensive marketing and sales-access-restrictions plans designed to prevent youth appeal and access.


The 11th Circuit’s opinion further indicated that the FDA did not properly review the data and evidence that it has long made clear are critical to the appropriate for the protection of the public health (“APPH”) standard for PMTAs set forth in the Tobacco Control Act including, in Bidi’s case, “product information, scientific safety testing, literature reviews, consumer insight surveys, and details about the company’s youth access prevention measures, distribution channels, and adult-focused marketing practices,” which “target only existing adult vapor product users, including current adult smokers,” as well as our retailer monitoring program and state-of-the-art anti-counterfeit authentication system. Because a MDO must be based on a consideration of the relevant factors, such as the marketing and sales-access-restrictions plans, the denial order was deemed arbitrary and capricious, and vacated by the FDA.

The FDA did not appeal the 11th Circuit’s decision. The FDA had until October 7, 2022 (45 days from the August 23, 2022 decision) to either request a panel rehearing or a rehearing “en banc” (a review by the entire 11th Circuit, not just the 3-judge panel that issued the decision), and until November 21, 2022 (90 days after the decision) to seek review of the decision by the U.S. Supreme Court. No request for a rehearing was filed, and no petition for a writ of certiorari was made to the Supreme Court. In the meantime, the Company anticipates continued ability to market and sell the non-tobacco flavored BIDI® Sticks, subject to the FDA’s enforcement discretion, for the duration of the PMTA scientific review.

Separately, on or about May 13, 2022, the FDA placed the tobacco-flavored Classic BIDI® Stick into the final Phase III scientific review, and in September 2022 completed a remote regulatory assessment of Bidi and its contract manufacturer in China, SMISS Technology Co. LTD, in relation to the pending PMTA for the Classic BIDI® Stick.

Risks and Uncertainties Regarding FDA Regulation

The FDA has indicated that it is prioritizing enforcement of unauthorized ENDS against companies (1) that never submitted PMTAs, (2) whose PMTAs have been refused acceptance or filing by the FDA, (3) whose PMTAs remain subject to MDOs, and (4) that are continuing to market unauthorized synthetic nicotine products after the July 13, 2022, cutoff. Subject to the FDA’s enforcement discretion, until the scientific review process is complete on each of Bidi’s PMTAs, the Company views the risk of FDA enforcement against Bidi Bidias low. The Company anticipates the FDA will be forced to ceasemove forward with a review of Bidi’s PMTA on remand, as directed by the continued sale of its non-tobacco flavored BIDI® Stick products inCourt; however, the United States, thereby resulting in the Company being unable to distribute such products, and the Company’s business and financial condition would be materially adversely affected. The Company cannot provide any assurances as to the timing or outcomeoutcome.

Moreover, the Company believes that Bidi’s application is particularly comprehensive, and now includes, among other things, a randomized, crossover, clinical study to assess nicotine pharmacokinetics and subjective effects of the merits-based case.BIDI® Stick, several behavioral, perception and intention studies, as well as a nationally-representative population prevalence study. A complete scientific review of the PMTA would require the FDA to review all this information before making an APPH determination, and while the FDA could narrowly interpret the Court’s ruling as an order to review only Bidi’s marketing and sales-access restrictions plans, the 11th Circuit’s opinion, in the Company’s view, makes clear that all “relevant evidence” in an application must be considered. For applications that are in scientific review, the FDA typically issues a deficiency letter identifying its questions before making a marketing authorization decision and gives the applicant at least 90 days to respond. This further solidifies the Company’s belief that the scientific review of Bidi’s non-tobacco flavored applications could take 1-2 years or longer. However, the Company cannot provide any assurances as to the timing or outcome.

Note 2 – Basis of Presentation and Significant Accounting Policies

Principles of Consolidation

The consolidated financial statements include the financial statements of the Company’s wholly-owned subsidiaries, Kaival Labs Inc. and Kaival Brands International, LLC.KBI. Intercompany transactions are eliminated.


Basis of Presentation

The accompanying unaudited interim consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and the rules of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the audited financial statements and notes thereto contained in the Company’s most recent audited financial statements contained within the Company’s Annual Financial StatementsReport on Form 10-K, filed with the SEC on Annual Report on Form 10-K on February 16, 2022January 30, 2023 (the “2021“2022 Annual Report”). In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim period presented have been reflected herein. The results of operations for the interim period are not necessarily indicative of the results to be expected for the full fiscal year. Notes to the consolidated financial statements, which would substantially duplicate the disclosures contained in the audited financial statements for the most recent fiscal period as reported in the 20212022 Annual Report, have been omitted.

F-7

Use of Estimates

The preparation of financial statements in conformity with GAAP 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 financial statements and the reported amounts of revenues and expenses during the reporting period. In the opinion of management, all adjustments necessary in order to make the financial statements not misleading have been included. Actual results could differ from those estimates.

Cash and Restricted Cash Equivalents

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. There were no cash equivalents atand restricted cash as of April 30, 20222023, and October 31, 2021. Cash2022.

The Federal Deposit Insurance Corporation (“FDIC”) insures deposits according to the ownership category in which the funds are insured and restrictedhow the accounts are titled. The standard deposit insurance coverage limit is $250,000 per depositor, per FDIC-insured bank, per ownership category. The Company had uninsured cash atand cash equivalents of $804,971 and $2,912,793 on April 30, 20222023, and October 31, 2021 were $4,727,037 and $7,825,235,2022, respectively.

Restricted cash consists of cash held in short-term escrow as required. As of April 30, 2022, and October 31, 2021, the Company had $65,542 and $65,007 in restricted cash, respectively, for amounts held in escrow.

The following table sets forth a reconciliation of cash, and restricted cash reported in the consolidated balance sheet and the consolidated statements of cash flows that agrees to the total of those amounts presented in the consolidated statements of cash flows.

Restrictions on Cash and Cash Equivalents        
  

April 30,

2022

 October 31, 2021
Cash $4,661,495  $7,760,228 
Restricted cash  65,542   65,007 
Total cash and restricted cash shown in statement of cash flows $4,727,037  $7,825,235 

Advertising and Promotion

All advertising, promotion and marketing expenses, including commissions, are expensed when incurred.


Accounts Receivable and Allowance for Doubtful Accounts

Receivables are stated at cost, net of an allowance for doubtful accounts. The Company establishes an allowance for doubtful accounts based on management’s assessment of the collectability of accounts receivables.receivable. A considerable amount of judgment is required in assessing the amount of the allowance and the Company considers the historical level of credit losses and collection history and applies percentages to aged receivable categories. The Company makes judgments about the creditworthiness of debtors based on ongoing credit evaluations and monitors current economic trends that might impact the level of credit losses in the future. If the financial condition of the debtors were to deteriorate, resulting in their inability to make payments, a larger allowance may be required. As of April 30, 2023, and October 31, 2022, based upon management’s assessment of the accounts receivable aging and the customers’ payment history, the Company has determined that no allowance for doubtful accounts was required. As of October 31, 2021, the Company also determined that 0 allowance for doubtful accounts wasis required.

Inventories

All product inventory is purchased from a related party, Bidi. Inventories are stated at the lower of cost and net realizable value. Cost includes all costs of purchase and other costs incurred in bringing the inventories to their present location and condition. The Company determines cost based on the FIFOfirst-in, first-out (“FIFO”) method. Net realizable value is the estimated selling price in the ordinary course of business less the estimated costs of completion and the estimated costs necessary to make the sale. All inventories (i) were purchased from Bidi, a related party, asAs of April 30, 2023, and October 31, 2021 and April 30, 2022, (ii)the inventories only consisted of finished goods (iii) were significant, and (iv) were located in three storage warehouses: (1)locations: the primary leasedCompany’s main warehouse which is owned bylocated in Florida and two customer warehouses whose service agreements are on a related party, Just Pick, LLC (“Just Pick”), (2) a customer/sub distributor warehouse, which is owned by Favs Business LLC (“Favs Business”), and (3) a third-party logistics services warehouse, which is owned by Ranger Enterprises, LLC (“Ranger”).consignment basis with the Company. Based upon fiscal year 20212022 inventory management procedures, and their results, that have continued throughas well as those inventory management procedures performed during the second fiscal quarter ended April 30, 2022,2023, and their results for both periods of time, the Company has determined that no allowance for the inventory valuation was required at April 30, 2022, nor October 31, 2021.

Inventory deposit related party

In the fourth quarter of fiscal 2021, the Company placed an order for BIDI® Sticks in anticipation of the distribution launch in the United Kingdom. In connection with this order, the Company paid $2,925,000 from its capital financing raise to Bidi, a related party, in advance to have the BIDI® Sticks manufactured in compliance with the regulatory product requirements in the United Kingdom, which differs from the regulatory product requirements in the United States. The parties originally contemplated that delivery of the BIDI® Sticks to the Company would occur by the end of April 2022. On April 29, 2022, the Company and Bidi agreed to cancel the order due to an internal change of approach to international distribution, and Bidi agreed to credit the $2,925,000 against the accounts payable balance owed by the Company to Bidi. Asas of April 30, 2022, the Company has on its balance sheet a zero balance for inventory deposits2023 and inventory deposits related party. October 31, 2022.

F-8

Revenue Recognition

The Company adopted ASC 606, Revenue from Contracts with Customers (Topic 606) (“ASC 606”), in the second quarter of fiscal year 2020, as this was the first quarter that the Company generated revenues. Under ASC 606, the Company recognizes revenue when a customer obtains control of promised goods, in an amount that reflects the consideration that the Company expects to receive in exchange for the goods. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods it transfers to the customer. Under ASC 606, disaggregated revenue from contracts with customers depicts the nature, amount, timing, and uncertainty of revenue and cash flows affected by economic factors. On October 31, 2021, the Company and one of its customers, Favs Business, entered into a Consignment Agreement. As of October 31, 2021, the value of the Products stored at Favs Business under the Consignment Agreement was approximately $2,556,930. As of April 30, 2022, the value of the Products stored at Favs Business under the Consignment Agreement was approximately $1,433,730.

Deferred Revenue

The Company accepts partial payments for orders from wholesale customers, which it holds as deposits or deferred revenue, until the Company has received full payment and orders are shipped to the customer. Revenue for these orders is recognized at the time of shipment to the customer. As of April 30, 2023, and October 31, 2022, the Company had receivedhas $2,38212,099 and $44,973 in deposits from customers, respectively, which is included with the Company’s current liabilities. As of April 30, 2023, and October 31, 2021,2022, the Company had not received any depositshas $129,702 and $235,274 in deferred income from customers.PMI guaranteed royalty revenue prepayments, respectively, which is included with the Company’s current liabilities.

Customer Refunds

The Company infrequently has a need to adjustIn the sizenormal course of an order after it has been shipped, received, and paid for, due to the customer oversizing the order for more product that it can realistically sell at that time. If and when this occurs,business, the Company will ask theissues credits for product returns and certain customer incentives related to return the over allotted Products. Once receivedrebates, discounts and inspected,promotions. When such credits exceed amounts receivable from customers, the Company recognizes such excess amounts as customer refunds which will issue a refund for the Product return.be applied against future product purchases. As of April 30, 20222023, and October 31, 2021,2022, the Company had customer refunds due in the amounts equal to approximately $0921,078 and $316,8000, respectively, which refund was the result of one of the Company’s sub-distributor customers returning Products that had become defective in storage.respectively.


Products Revenue

The Company generates products revenue from the sale of the Products (as defined above) to non-retail customers. The Company recognizes revenue at a point in time based on management’s evaluation of when performance obligations under the terms of a contract with the customer are satisfied and control of the Products has been transferred to the customer. In most situations, transfer of control is considered complete when the Productsproducts have been shipped to the customer. The Company determinesdetermined that a customer obtains control of the Product upon shipment when title of such product and risk of loss transfer to the customer. However, when the Company enters a consignment agreement with a new customer, once it ships and delivers the requested amount of ordered Products to its distribution center for its retail sales locations, the Company retains ownership of the delivered Products until they are delivered to the actual retail stores (as opposed to the Company’s consignment customer). The Company’s shipping and handling costs are fulfillment costs, and such amounts are classified as part of cost of sales. The Company’s sales arrangements for retail sales usually require full prepayment before delivery of the Products. The advance payment is not considered a significant financing component because the period between when the Company transfers a promised good to a customer and when the customer pays for that good is short. The Company offers credit sales arrangements to non-retail (or wholesale) customers and monitors the collectability of each credit sale routinely.

Revenue is measured by the transaction price, which is defined as the amount of consideration expected to be received in exchange for providing goods to customers. The transaction price is adjusted for estimates of known or expected variable consideration, which includes refunds and returns as well as incentive offers and promotional discounts on current orders. Estimates for sales returns are based on, among other things, an assessment of historical trends, information from customers, and anticipated returns related to current sales activity. These estimates are established in the period of sale and reduce revenue in the period of the sale. Variable consideration related to incentive offers and promotional programs are recorded as a reduction to revenue based on amounts the Company expects to collect. Estimates are regularly updated, and the impact of any adjustments are recognized in the period the adjustments are identified. In many cases, key sales terms such as pricing and quantities ordered are established at the time an order is placed and incentives have very short-term durations.

Amounts billed and due from customers are short term in nature and are classified as receivablesreceivable since payments are unconditional and only the passage of time related to credit terms is required before payments are due. The Company does not grant payment financing terms greater than one year. Payments received in advance of revenue recognition are recorded as deferred revenue.revenue, as noted above.

Royalty Revenue

On June 13, 2022, KBI entered into a Deed of Licensing Agreement (the “PMI License Agreement”), by and between KBI and PMPSA, effective as of May 13, 2022 (the “PMI Commencement Date”). Pursuant to the PMI License Agreement, KBI granted PMPSA an exclusive irrevocable license to use its technology, documentation, and intellectual property to make, distribute, and sell disposable nicotine e-cigarette Products based on the intellectual property in certain international markets set forth in the PMI License Agreement (the “PMI Markets”). The Company has the exclusive international distribution rights to the Products and, in order to allow KBI to fulfill its obligations set forth in the PMI License Agreement, has contributed the international distribution rights for the PMI Markets to KBI as set forth in a Capital Contribution Agreement, dated June 10, 2022. The sublicense granted to PMPSA is exclusive in the PMI Markets and neither KBI nor any of its affiliates can sell, promote, use, or distribute any competing products in the PMI Markets for the duration of the term of the PMI License Agreement and any Sell-Out Period (as defined in the PMI License Agreement). PMSPA will be responsible for any regulatory filings necessary to sell the Products in the PMI Markets. Both KBI and PMPSA agree to work together in the registration and maintenance of the Intellectual Property, but KBI will bear all cost and expense to implement the registration strategy. Finally, PMPSA has agreed to potential future development services with KBI in the PMI Markets and has been granted certain rights with respect to potential future products.

The initial term of the PMI License Agreement is five (5) years and automatically renews for an additional five-year period unless PMPSA has failed to meet the agreed upon minimum key performance indicators set forth in the PMI License Agreement, in which case the PMI License Agreement will automatically terminate at the end of the initial license term.

In consideration for the grant of the licensed rights, PMPSA agreed to pay to KBI a royalty equal to a percentage of the base price of the first sale of each unit of Product manufactured. In addition, before the launch of the first product in a market and each anniversary of such launch, PMPSA agrees to pre-pay to KBI a guaranteed minimum royalty based on the estimated royalties payable by PMPSA to KBI in relation to all markets in the twelve (12)-month period following the first launch or each successive anniversary of the first launch, subject to an aggregate maximum guaranteed royalty payment for all markets for each applicable twelve (12)-month period. PMPSA may require modification of certain products to be sold under the PMI Licensing Agreement to be modified for a PMI Market. Pursuant to the PMI Licensing Agreement, PMPSA has absolute discretion over sales, marketing, product branding and packaging pertaining to sales in the PMI Markets, as well as the right to select the specific PMI Markets in which to launch commercialization and determine what product types are to be promoted in each market, subject to sales and marketing plans and annual business plans set by PMPSA and certain expansion criteria agreed between PMPSA and KBI. Royalty revenue earned from the PMI License Agreement is recognized in the period the sales of the Product manufactured occurs.


The PMI License Agreement contains customary representations, warranties, covenants, and indemnification provisions; however, KBI’s liability under the PMI License Agreement is capped at the greater of: (i) Ten Million Dollars ($10,000,000); or (ii) an amount equal to the total of the royalties due to KBI (but not yet paid) plus the royalties (including the guaranteed royalty payment) paid to KBI pursuant to the PMI License Agreement during the immediately preceding twelve (12) consecutive months, provided that such amount shall not exceed Thirty Million Dollars ($30,000,000). These royalties may be initially offset on a limited basis by jointly agreed upon costs such as development costs incurred for entry to specific international markets.

On June 10, 2022, Bidi entered into a License Agreement (the “KBI License Agreement”) with KBI, pursuant to which KBI has the exclusive irrevocable license to use Bidi’s licensed intellectual property to the extent necessary for KBI to fulfill its obligations set forth in the PMI Licensing Agreement. Such irrevocable license includes: (i) the right of KBI to grant sub-licenses to PMPSA under the PMI License Agreement for the express purposes set forth in the PMI License Agreement, but for no other purpose; (ii) the right of KBI to grant to PMPSA the right to grant sub-sub-licenses in the manner set forth in the PMI License Agreement, but for no other purpose; and (iii) certain branding rights to the extent (but only to the extent) necessary to permit KBI to perform its obligations to PMPSA as set forth in the PMI License Agreement.

The KBI License Agreement provides that KBI shall pay Bidi license fees equivalent to 50% of the adjusted earned royalty payments, after any offsets due to jointly agreed costs such development costs incurred for entry to specific international markets. While PMPSA announced the launch of a product (called VEEBA) under the PMI License Agreement in March 2023,   the Company has determined that no license fees are owed to Bidi as of April 30, 2023.

Concentration of Revenues and Accounts Receivable

For the six months ended April 30, 2023, (i) 21% or $1,169,310 of the revenue from the sale of Products, solely consisting of the BIDI® Stick, was generated from FAVS Business (“FAVS”), (ii) 19% or $1,054,646 of the revenue from the sale of the Products was generated from H.T. Hackney Co., (iii) approximately 17% or $914,754 of the revenue from the sale of Products, solely consisting of the BIDI Stick, was generated from GPM Investments, LLC (“GPM”), and (iv) approximately 11% or $596,171 of the revenue from the sales of Products was generated from QuikTrip Corporation.

For the six months ended April 30, 2022, approximately 40%, or $2,366,200, of the revenue from the sale of Products was generated from Favs Business, and approximately 15%, or $877,264, of the revenue from the sale of Products was generated from The H.T. Hackney Company.

Favs Business had an outstanding balance of approximately $305,430, which accounted for approximately 26% of the Company’s total accounts receivable from customers as of April 30, 2022. The H.T. Hackney Company had an outstanding balance of approximately $297,629, which accounted for approximately 25% of the Company’s total accounts receivable from customers as of April 30, 2022.  Grocery Supply Warehouse had an outstanding balance of $163,163, which accounting for approximately 14% of the Company’s total accounts receivable from customers as of April 30, 2022. Finally, MMS Distribution, LLC (“MMS Distro”) had an outstanding balance of approximately $116,444, which accounted for approximately 10% of the Company’s total accounts receivable from customers as of April 30, 2022.     

For the six months ended April 30, 2021, approximately 33%, or $18,129,136, of the revenue from the sale of Products was generated from Favs Business, approximately 16%FAVS, and 15%, or $9,069,455877,264, of the revenue from the sale of Products was generated from MMS Distro, and approximately 12%, or $6,820,132, of the revenue from the sale of Products was generated from C Store Master (“C Store Master”).H.T. Hackney Company.

Favs Business,H.T. Hackney Co, with an outstanding balance of approximately $8,590,200545,215, and GPM Investment, LLC,FAVS, with an outstanding balance of approximately $2,482,553499,200, and KwikTrip with an outstanding balance of $216,000, accounted for approximately 47%36%, 33%, and 14%14% of the total accounts receivable from customers, respectively, as of April 30, 2021.2023. Favs Business with an outstanding balance of $375,425 and QuikTrip Corporation, with an outstanding balance of $85,510, accounted for approximately 65% and 15% of the total accounts receivable from customers, respectively, as of October 31, 2022.

F-9

Share-Based Compensation

The Company measures the cost of services received in exchange for an award of equity instruments (share-based payments, or SBP)referred to herein as “SBP”) based on the grant-date fair value of the award. That cost is recognized over the period during which a recipient is required to provide service in exchange for the SBP award—the requisite service period (vesting period). For SBP awards subject to performance conditions, compensation is not recognized until the performance condition is probable of occurrence. The grant-date fair value of share options is estimated using the Black-Scholes-Merton option-pricing model. Compensation expense for SBP awards granted to nonemployees is remeasured each period asmodel based on certain assumptions which include the underlying options vest.expected term, expected volatility and discount rate.

The fair value of each option granted during the fiscal six-month period ended April 30, 2022 and at October 31, 2021 was estimated on the date of grant using the Black-Scholes-Merton option-pricing model with the weighted average assumptions in the following table:

Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions        
  As of April 30, 2022 As of October 31, 2021
Expected dividend yield  0%  0%
Expected option term (years)  10   10 
Expected volatility  294.55%-301.53%  294.55%-301.53 
Risk-free interest rate  1.19%-1.62%  1.19%-1.62%

The expected term of options granted represents the period of time that options granted are expected to be outstanding. The expected volatility wasis based on the volatility in the trading of the Common Stock.Stock over the expected term of the award. The assumed discount rate wasis the default risk-free ten-year interest rate for U.S. Treasury bills. The Company’s stock option expense for the fiscal three and six months ended April 30, 2022 was $2,616,193 and $2,925,892, respectively.

The Company’s stock-based compensation for the fiscal three and six months ended April 30, 2022 was $110,189 and $190,416, respectively.

Income Tax

Income taxes are provided for the tax effects of transactions reported in the financial statements and consist of taxes currently due plus deferred taxes related primarily to differences between the recorded book basis and the tax basis of assets and liabilities for financial and income tax reporting. Deferred tax assets and liabilities represent the future tax return consequences of those differences, which will either be taxable or deductible when the assets and liabilities are recovered or settled. Deferred taxes are also recognized for operating losses that are available to offset future taxable income and tax credits that are available to offset future federal income taxes. The Company believes that its income tax filing positions and deductions will be sustained on audit and does not anticipate any adjustments that will result in a material adverse effect on the Company’s financial condition, results of operations, or cash flow.

The Company has Federal net operating loss (“NOL”) carryforwards of approximately $4,000,000 and state NOL carryforwards of approximately $1,800,000. With the changes instituted by the CARES Act, the Federal NOLs have an indefinite life and will not expire. The Company’s federal and state tax returns for the 2018 and 2019 tax years generally remain subject to examination by U.S. and various state authorities. A valuation allowance is recorded to reduce the deferred tax asset if, based on the weight of the evidence, it is more likely than not that some portion or all of the deferred tax asset will not be realized. After evaluation of the evidence, management determined that a valuation allowance of approximately $1,256,059 for the year ended on October 31, 2021, and the fiscal six-month period ended April 30, 2022, is necessary to reduce the deferred tax asset to the amount that will more likely than not be realized pursuant to ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.

The Company has completed its federal and state tax returns for the 2020 tax year and intends on filing them shortly. Given the federal and state NOLs, the Company anticipates that its 2020 tax returns will report that it is eligible to apply those NOLs against the federal and state taxes it paid in 2019. The Company anticipates federal and state tax refunds of approximately $1,600,000 and $146,000, respectively, and expects to collect the refunds in the current fiscal year.

 

During the six months ended April 30, 2022, the Company generated no taxable income and, thus, no federal or state income taxes are accrued for fiscal year 2022.

Fair Value of Financial Instruments

The Company’s balance sheet includes certain financial instruments. The carrying amounts of current assets and current liabilities approximate their fair value because of the relatively short period of time between the origination of these instruments and their expected realization.

ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that distinguishes between (1) market participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable inputs). The fair value hierarchy consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are described below:

F-10

Level 1 – Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities.

Level 2 – Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly, including quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability (e.g., interest rates); and inputs that are derived principally from or corroborated by observable market data by correlation or other means.

Level 3 - Inputs that are both significant to the fair value measurement and unobservable.

Fair value estimates discussed herein are based upon certain market assumptions and pertinent information available to management as of April 30, 2022.2023. The respective carrying value of certain on-balance-sheet financial instruments approximated their fair values due to the short-term nature of these instruments. These financial instruments include cash, restricted cash, accounts receivable, inventory, accounts payable and accrued expenses. As of April 30, 2023, and October 31, 2022, the Company did not have any financial assets or liabilities measured and recorded at fair value on a recurring basis.


Recent Accounting Pronouncements

The Company does not believe that any recently issued effective pronouncements, or pronouncements issued but not yet effective, if adopted, would have a material effect on the accompanying financial statements. However, In March 2022, the FASB issued ASU 2022-02, “Financial Instruments-Credit Losses (Topic 326), Troubled Debt Restructurings and Vintage Disclosures.” ASU 2022-02 addresses areas identified by the FASB as part of its post-implementation review of the credit losses standard (ASU 2016-13) that introduced the CECL model. The amendments eliminate the accounting guidance for TDRs by creditors that have adopted the CECL model and enhance the disclosure requirements for certain loan refinancings and restructurings by creditors when a borrower is experiencing financial difficulty. In addition, the amendments require a public business entity to disclose current-period gross write-offs for financing receivables and net investment in leases by year of origination in the vintage disclosures. The amendments in this ASU should be applied prospectively, except for the transition method related to the recognition and measurement of TDRs, where an entity has the option to apply a modified retrospective transition method resulting in a cumulative-effect adjustment to retained earnings in the period of adoption. This is not effective for the Company until November 1, 2023.  

Note 3 – Going Concern

In February 2022, the U.S. Court of Appeals for the Eleventh Circuit granted Bidi a judicial stay of the MDO previously issued by the FDA. The ruling means that the MDO is not legally in force pending the outcome of litigation on the merits of Bidi’s challenge to the MDO. Accordingly, we anticipate being able to continue marketing and selling the Products, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challenging the legality of the MDO. The FDA has indicated that it is prioritizing enforcement against companies that have not submitted PMTAs, whose PMTAs have been refused acceptance or filing by the FDA, or whose PMTAs remain subject to MDOs. Oral arguments in the merits case were held on May 17, 2022.

 

IfThe Company’s financial statements are prepared in accordance with U.S. GAAP applicable to a going concern, which contemplates realization of assets and the U.S. Courtsatisfaction of Appeals for the Eleventh Circuit rules in Bidi’s favorliabilities in the merits case,normal course of business within one year after the Company anticipates thatdate the FDA will be compelled to place the non-tobacco flavored ENDS back into the PMTA scientific review process. If this is the outcome of the merits case, the Company anticipates being able to continue marketing and selling the Products, subject to the FDA’s enforcement discretion, until the scientific review process is complete on each of Bidi’s PMTA for non-tobacco flavored ENDS and the FDA issues its decision on each.consolidated financial statements are issued.

 

If the U.S. CourtIn accordance with Financial Accounting Standards Board (the “FASB”), Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Appeals for the Eleventh Circuit does not ruleFinancial Statements – Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in Bidi’s favor on the merits case, if the FDA re-issues the MDO after completing its scientific review process for each of Bidi’s PMTAs for its non-tobacco flavored ENDS, or if the FDA otherwise chooses to enforce the MDO against Bidi, the Company will be forced to cease sales of the non-tobacco flavored BIDI® Sticks in the United States market, leaving only the Tobacco (Classic) BIDI® Sticks for sale in the United States. If this is the outcome of the merits case, this combined with a negative cash flow from operations, raisesaggregate, that raise substantial doubt onabout our ability to continue as a going concern within one year after the date that the accompanying financial statements are issued. As shown in the accompanying consolidated financial statements, the Company has incurred significant recurring losses and negative cash flow from operations, which raises substantial doubt about the Company’s ability to continue as a going concern.

 

ManagementIn response to the above, the Company assessed its management’s plans to continue similar operationsalleviate that doubt. The Company has positive working capital as of April 30, 2023, of $3,714,959.   The Company considered that its losses were due to various factors such as: (i) uncertainty surrounding the PMTA process with increased marketing,the FDA and (ii) the MDO that was issued to Bidi Vapor on its non-tobacco flavored ENDS products. However, the MDO was set aside and vacated by the 11th Circuit in August 2022, and the ability to appeal such decision has passed, thereby facilitating the continued sales of the non-tobacco flavored BIDI® Sticks for sale in the United States (pending the FDA’s review of the pending PMTAs and subject to FDA enforcement). Concurrently, the PMTA for the tobacco-flavored (Classic) BIDI® Sticks for sale in the United States continues to move through the PMTA scientific review phase. Management’s assessment included the preparation of cash flow forecasts which considered increases in revenues considering the favorable ruling obtained on the MDO as disclosed above.

The Company believes that its available cash and the cash to be provided by future operating activities should enable the Company believes will result in increased revenue and net income. Further,to meet its estimated liquidity needs for the next 12 months after the end ofdate that the three and six months ended April 30, 2022,accompanying financial statements are issued. The Company believes that the above factors alleviate the substantial doubt regarding the Company’s wholly owned subsidiary, KBI, entered into an international licensing agreement with PMPSA, which the Company expects will generate additional revenues. ability to continue as a going concern.

However, there is no assurance that management’s planthe Company’s plans will be successfulable to generate expected or greater amounts of revenues or ever achieve profitability, due to the current economic climate in the United States and globally.

Theseglobally, the regulation and public perception of ENDS products and the various other risks faced by the Company. The accompanying consolidated financial statements do not include any adjustments relating to reflect the possible future effects on the recoverability and classification of recorded assets or the amounts and classification of liabilities that might be necessary inmay result from the event that we cannot continue as a going concern.outcome of these or other risks or uncertainties.

Note 4 – Leases

The Company capitalizes all leased assets pursuant to ASU 2016-02, Leases (Topic 842) (“Topic 842”), which requires lessees to recognize right-of-use (“ROU”) assets and lease liability, initially measured at present value of the lease payments, on its balance sheet for leases with terms longer than 12 months and classified as either financing or operating leases. The Company excludes short-term leases having initial terms of 12 months or less from Topic 842 as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. The Company adopted the standard in the fourth quarter of fiscal year 2020. The adoption of Topic 842 did not have any impact on the Company’s previously reported financial statements in any prior period nor did it result in a cumulative effect adjustment to retained earnings. The Company does not have financing leases and only one operating lease for office space and inventory storage space with Just Pick, LLC (“Just Pick”), a related party.party owned and controlled by Nirajkumar Patel, the Chief Science and Regulatory Officer and a director of the Company, as of April 30, 2023, and October 31, 2022. Certain of the Company’s leases, have and may in the future, include renewal options, which have been and have not beenmight be in the future, included in the calculation of the lease liabilities and right of use assets aswhen the Company is not reasonably certain to exercise the option.


Office Space

On August 1, 2020, the Company began leasing office space for its main corporate office in Grant, Florida. The five-year lease agreement is with a related party, Just Pick. The Company’s Chief Executive Officer is an officer of Just Pick. Prior to this, the Company utilized the home office space and warehouse of its management at no cost through July 31, 2020. The operating lease is for a term of five 5 years, beginning August 1, 2020, with rent of $1,000 payable monthly. As the operating lease does not provide for an implicit interest rate, we estimated a current borrowing rate of 4.5% in determining the present value of the lease.

As of April 30, 2022 and October 31, 2021, the ROU lease asset, net of accumulated amortization, was approximately $48,299 and $55,604, respectively. The initial recognition of the ROU operating lease was approximately $73,749 for both the ROU asset and ROU liability. The amortization expense for ROU asset for the twelve months ended October 31, 2021 was approximately $14,529 and no payments were made on the ROU liability. The amortization expense for the ROU asset for the six months ended April 30, 2022 was approximately $7,305 and resulted in a change in the ROU liability. At October 31, 2021, short-term ROU lease liability was approximately $13,020 and long-term liability was approximately $46,185, totaling approximately $59,205. At April 30, 2022, short-term ROU lease liability was approximately $13,680 and long-term liability was approximately $39,180 totaling approximately $52,860.

Schedule of Future Minimum Rental Payments for Operating Leases                    
  2022 2023 2024 2025 Total
Lease payments $13,400  $15,000  $18,000  $15,000  $61,400 
Less discount imputed interest                  (8,540)
Present value of future payments                  52,860 
Less current obligations                  (13,680)
Long term lease obligations                 $39,180 

F-11

Storage Space

On November 1, 2021, the Company entered into a month-to-month lease agreement with Ranger Enterprises, LLC, located in Seymour, Indiana, to store product inventory at this satellite location. The Company made seven payments on this lease totaling approximately $15,451, duringin the six months ended April 30,amount of $19,959. The lease was terminated in June 2022.

On November 11, 2021, the Company entered into a month-to-month lease agreement with FFE Solutions Group, located in Salt Lake City Utah, to store additional product inventory at this satellite location. The Company made five payments on this lease in the amount of $19,108. This lease was terminated in April 2022.

On June 10, 2022, the Company entered into a Lease Agreement (the “2022 Lease”) with Just Pick for approximately 21,332 rentable square feet combined in the office building and warehouse located at 4460 Old Dixie Highway, Grant-Valkaria, Florida 32949 (the “Premises”), together with all improvements thereon. The Company must pay Just Pick base rent equal to $19,10817,776.67 per month during the first year of the Lease Term with a five-year lease renewal option. Thereafter, the monthly base rent will be increased annually with a monthly base rent of $18,665.50 in the second year, $19,554.33 in the third year, $20,443.17 in the fourth year, $22,220.83 in the fifth year, $23,998.50 in the sixth year, and one twelfth (1/12th) of the market annual rent for the seventh through eleventh years, if applicable. In addition to the base rent, on thisthe Company must pay one hundred percent (100%) of operating expenses, insurance costs, and taxes for each calendar year during the Lease term. For both the ROU asset and ROU liability, the lease duringrenewal option was considered in the calculation with an incremental borrowing rate of 4.5%. The Company had $94,347 and $7,305 in operating lease expense for the six months ended April 30, 2022. 2023, and April 30, 2022, respectively.

Cash flow information related to leases was as follows:

Schedule of cash flow information related to leases        
  April 30, 2023 April 30, 2022
Other Lease Information        
Cash paid for amounts included in the measurement of lease liabilities:        
Operating cash flows from operating leases $(94,347) $(7,305)

The Company terminatedfollowing table summarizes the lease with FFE Solutions Group on April 29, 2022 after returning all inventory previously stored at this location.

For additional information regarding leaseslease-related assets and liabilities recorded in the consolidated balance sheets as of April 30, 2023, and October 31, 2022:

Schedule Of Condensed Balance Sheet        
Lease Position April 30, 2023 October 31, 2022
Operating Leases        
Operating lease right-of-use assets $1,104,622  $1,198,969 
Right of use liability operating lease current portion $175,206  $166,051 
Right of use liability operating lease long term  961,593   1,050,776 
Total operating lease liabilities $1,136,799  $1,216,827 

The following table provides the date these unaudited consolidated financial statements were issued, please see Note 8, Subsequent Events.maturities of lease liabilities at April 30, 2023:

Schedule of Lessee Operating Lease Liability Maturity  
  Operating Leases
Maturity of Lease Liabilities on April 30, 2023     
2023  $110,809 
2024   228,134 
2025   238,800 
2026   253,614 
2027 and thereafter   450,934 
Total future undiscounted lease payments  $1,282,291 
Less: Interest   (145,492)
Present value of lease liabilities  $1,136,799 


At April 30, 2023, the Company had no additional leases which had not yet commenced.

Note 5 – StockholderStockholders’ Equity

Common Stock

No

Additional Paid-In Capital

During the six months ended April 30, 2022, approximately $2,925,892 of stock option expense was recognized and contributed to Additional Paid-In Capital. Also, during the six months ended April 30, 2022, on November 5, 2021 and February 5, 2022, restricted stock units (“RSUs”) previously granted to employees vested and shares of Common Stock were issued which contributed approximately $130,502 to Additional Paid-In Capital. Additionally, during the three and six months ended April 30, 2022, warrants of the Company were exercised for shares of Common Stock resulting in a further contribution to Additional Paid-in Capital of approximately $1,565,316. All of these contributions resulted in a total increase in Additional Paid-In Capital during the six months ended April 30, 2022 of approximately $4,621,710.2023.

Preferred Shares IssuedStock Converted

The authorized preferred stock of the Company consists of 5,000,000 shares with a par value of $0.001 per share, of which 3,000,000 shares were designated as Series A Convertible Preferred Stock (the “Series A Preferred Stock”). Each share of the Series A Preferred Stock was initially convertible into 100 shares of Common Stock; however, as a result of the Reverse Stock Split, the conversion rate was adjusted such that each share of the Series A Preferred Stock is convertible into approximately 8.33 shares of Common StockStock.. All On June 24, 2022, all 3,000,000 shares of Series A Preferred Stock were converted into shares of Common Stock by Kaival Holdings. The conversion of 3,000,000 shares of Series A Preferred Stock, at a conversion rate of 8.33, equaled 25,000,000 shares of Common Stock. As a result, the authorized, preferred stock of the Company consists of 5,000,000 shares with a par value of $0.001 per share, with 0 shares of preferred stock issued andor outstanding as of April 30,October 31, 2022.

Common Shares IssuedStock Options

The Company implemented the Reverse Stock Split, effective prior to the openingSummary of the market on July 20, 2021. The Reverse Stock Split was implemented by the Company in support of its application to list on the Nasdaq Capital Market (“Nasdaq”). As a result of the Reverse Stock Split at a ratio of 1-for-12, every 12 shares of the Common Stock were exchanged for one share of the Common Stock. The Company has retroactively adjusted all share amounts and per share data herein to give effect to the Reverse Stock Split.stock options information is as follows:

Schedule of stock options        
        Weighted
  Aggregate Aggregate Exercise Price Average
  Number Exercise Price Range Exercise Price
Outstanding, October 31, 2022  3,202,265   8,921,419   1.03-28.68   2.79 
Granted  5,275,000   4,714,825   0.61-0.99   0.89 
Exercised            
Cancelled, forfeited, or expired  (75,000)  (154,500)  2.06   2.06 
Outstanding, April 30, 2023  8,402,265  $13,481,744  $0.61-28.69  $1.60 
Exercisable, April 30, 2023  3,477,265  $8,580,894  $0.99-28.69  $2.47 

During the three months ended April 30, 2023, and 2022, stockholders of the Company exercised warrantsrecognized $1,352,938 and $2,616,192, respectively of stock option expense related to purchase approximately 873,286 shares ofoutstanding stock options. During the Company’s Common Stock.

The authorized Common Stock of the Company consists of 1,000,000,000 shares with a par value of $0.001 per share. There were 31,166,090 shares of Common Stock issued and outstanding as of April 30, 2022. There were 30,195,312 shares of the Common Stock issued and outstanding as of October 31, 2021.

Warrants Shares Issued

As part of the Company’s underwritten public offering during fiscal 2021, the Company issued warrants to purchase a total of 4,053,750 shares of Common Stock at an exercise price of $1.90 per share. These warrants expire in 2026. Warrants for 873,326 shares of Common Stock were exercised during the six-month periodsix months ended April 30, 2023, and 2022, the Company recognized $2,788,725 and $2,824,892, respectively of stock option expense related to outstanding stock options. On April 30, 2023, the Company had $3,643,178 of unrecognized expenses related to options. The weighted average remaining contractual life is approximately 9.41 years for net proceeds of $1,566,190.stock options outstanding on April 30, 2023. The aggregate intrinsic value of thethese outstanding Common Stock warrantsoptions as of April 30, 2022 and October 31, 20212023, was $0. The weighted average remaining termCompensation expense related to performance-based options is recognized on a straight-line basis over the requisite service period, provided that it is probable that performance conditions will be achieved, with probability assessed on a quarterly basis and any changes in expectations recognized as an adjustment to earnings in the period of the outstanding Common Stock warrantschange. Compensation cost is 4.50 years as of April 30, 2022.

The followingnot recognized for service- and performance-based awards that do not vest because service or performance conditions are not satisfied, and any previously recognized compensation cost is a summaryreversed. If vesting occurs prior to the end of the stock warrant activity duringrequisite service period, expense is accelerated and fully recognized through the fiscal six months ended April 30, 2022 and the year ended October 31, 2021.vesting date.

Share-based Payment Arrangement, Option, Activity                
  Six Months Ended April 30, 2022 Year Ended October 31, 2021
  Number of Warrants Weighted Average Exercise Price Number of Warrants Weighted Average Exercise Price
 Warrants Outstanding at Beginning of the Period  3,173,922  $1.90     $1.90 
                 
Granted        4,053,750   1.90 
Exercised  (873,286)  1.90   (879,828)  1.90 
                 
Canceled, forfeited, expired           1.90 
                 
 Warrants Outstanding and Exercisable at End of Period  2,300,636  $1.90   3,173,922  $1.90 

F-12

 

Restricted Stock Unit Awards

On November 5, 2021, the Company issued 61,250 shares of Common Stock to 7 employees in accordance with the vesting schedules set forth in RSU agreements previously entered into with such employees, resulting in the recognition of approximately $110,250 of share-based compensation. Of the shares issued to employees, 19,866 shares were withheld by the Company to satisfy tax withholding obligations and/or satisfy cash settlement options to employees, equaling approximately $35,759.

On February 5, 2022, the Company issued 61,250 shares of Common Stock to 7 employees in accordance with the vesting schedules set forth in RSU agreements previously entered into with such employees, resulting in the recognition of approximately $65,538 of share-based compensation. Of the shares issued to employees, 24,058 shares were withheld by the Company to satisfy tax withholding obligations and/or satisfy cash settlement options to employees, equaling approximately $24,058. On March 4, 2022, the Company’s Board approved the termination of the RSU agreements with the consent of the employees. At the time these agreements were terminated, there remained 1,230,833 unvested RSUs with approximately $4,457,875 of related unvested compensation.See Common Stock Compensation Transition Planbelow for additional details.

Additionally, during the three months ended April 30, 2022, the Company issued 18,160 shares of restricted Common Stock to two vendors who provide legal and advertising and promotions services to the Company. Those vendors preferred to be paid in shares of restricted Common Stock instead of cash for the services they performed and billed the Company.

.

Stock Options

During fiscal year 2021, the Company granted options exercisable for up to 150,000 shares of Common Stock of which 15,000 fully vested on March 17, 2021, 7,500 fully vested on June 30, 2021, 41,667 fully vested on December 1, 2021, 68,333 vested on March 17, 2022, 68,333 vest on March 17, 2023, and 17,500 vest over the next 2 years on June 30, 2022 and 2023. The options have exercise prices ranging from $9.12 to $28.68 per share. These options have a weighted average remaining life of 9.43 years as of October 31, 2021 and of 8.92 years as of April 30, 2022. The options expire in the year 2031. On July 19, 2021, two of the stock option agreements, exercisable for an aggregate of 50,000 shares of Common Stock, were modified to accelerate the full vesting period from 3 years to 2 years. As of April 30, 2022, the amortized expense and unamortized expense of these stock options was $1,044,517 and $1,065,217, respectively.

The Company granted new options during the three months ended April 30, 2022. On February 27,9, 2022, non-qualified stock options exercisable for up to 100,000250,000 shares of Common Stock were awarded to two consultantsone supplier of the Company. These stock options have a ten-year term from the grant date, with one-half of the shares vestingfully vested on the grant date and the remaining one-half of the shares vesting on the first anniversary of the grantissue date. The stock options exercisable for an aggregate of up to 200,000 shares of Common Stock had a fair market value of $2.45 per share, which represents the closing price of the Company’s Common Stock on the grant date. The amortization expense and unamortized expense for these stock options for the three months ended April 30, 2022 was $285,832and $204,167.

The aggregate intrinsic value of these outstanding options as of October 31, 2021 and April 30, 2022 was $0.

Common Stock Compensation Transition Plan

During the second quarter of fiscal year 2021 the Board and executive management began cost reduction discussions, including the reduction of non-cash items such as equity compensation awards. Those discussions stalled primarily due to the focus on other corporate events of significant value.

In the first and second fiscal quarters of 2022, the Board resumed serious discussions, assessments, and evaluations regarding the equity compensation awarded to its officers and employees. The Board ultimately approved a stock option program for equity awards granted to its officers and employees. The Compensation Committee spent considerable time, effort, and resources designing this program, which was finalized in February 2022 and approved in March 2022. While evaluating and designing this program, the Compensation Committee did not utilize any aspects of value to the employees or other features. Therefore, the termination of the RSU program and the newly adopted stock option program were developed completely independent of each other and terminated and implemented, respectively, distinctly and simultaneously. Management concluded under ASC 718 these transactions are a cancelation and replacement whereby total compensation cost measured at the date of a cancellation and replacement is the portion of the grant-date fair value of the original award for which the service is expected to be rendered at that date plus the incremental cost resulting from the cancellation and replacement. Incremental cost is measured as the excess of the fair value of the replacement award over the fair value of the cancelled award at the cancellation date in which there was none since the fair value of the replacement award was less than the fair value of the canceled award.

The outcomes of this decision and the transition on March 4, 2022 resulting in: (i) the termination of the RSU program for all executive officers and employees, consisting of 1,230,833 unvested RSUs and (ii) the implementation a new stock option program for executive officers and employees. The stock options granted pursuant to the program will have ten-year terms from the grant date, with one-half of the shares vesting on the grant date and the remaining one-half of the shares vesting on the first anniversary of the grant date. Stock options exercisable for up to an aggregate of 1,385,600 shares of Common Stock were granted to the executive officers and employees with a fair market value of $2.85 per share, which was calculated using the Black Scholes method.

The amortization expense and unamortized expense for these stock options for the three months ended April 30, 2022 was $2,303,533 and $1,645,395. The aggregate intrinsic value of these outstanding options as of October 31, 2021 and April 30, 2022 was $0.

F-13

The fair values of the options on the grant dates, as noted above, were approximately $3,948,948date was $246,747 using a Black-Scholes option pricing model with the following assumptions: stock price $2.85$0.9869 per share (based on the quoted trading price on the date of grant), a computed volatility range of 294.55%275.68%, expected term of 10 years, and a risk-free interest rate range of 1.62%4.12%.


On November 9, 2022, non-qualified stock options exercisable for up to 3,000,000 shares of Common Stock were awarded to one supplier of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting based on the achievement of certain net revenue and profit margin targets up to $180,000,000 in total net revenues over a period of 3 years. The fair value of the options on the grant date was $2,960,968 using a Black-Scholes option pricing model with the following assumptions: stock price $0.9869 per share (based on the quoted trading price on the date of grant), a computed volatility of 275.68%, expected term of 10 years, and a risk-free interest rate of 4.12%. Management determined the performance conditions were deemed probable on the grant date.

On February 6, 2023, non-qualified stock options exercisable for up to 150,000 shares of Common Stock were awarded to five employees of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting on February 6, 2024. The Company is amortizingfair value of the expense overoptions on the grant date was $109,499 using a Black-Scholes option pricing model with the following assumptions: stock price $0.73 per share (based on the quoted trading price on the date of grant), a computed volatility of 270.98%, expected term of 10 years, and a risk-free interest rate of 3.63%.

On February 6, 2023, non-qualified stock options exercisable for up to 1,000,000 shares of Common Stock were awarded to two senior executives of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting termson February 6, 2024. The fair value of each option.the options on the grant date was $729,988 using a Black-Scholes option pricing model with the following assumptions: stock price $0.73 per share (based on the quoted trading price on the date of grant), a computed volatility of 270.98%, expected term of 10 years, and a risk-free interest rate of 3.63%.

On February 6, 2023, non-qualified stock options exercisable for up to 375,000 shares of Common Stock were awarded to three independent board members of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting on February 6, 2024. The totalfair value of the options on the grant date was $273,747 using a Black-Scholes option pricing model with the following assumptions: stock option expenseprice $0.73 per share (based on the quoted trading price on the date of grant), a computed volatility of 270.98%, expected term of 10 years, and a risk-free interest rate of 3.63%.

On February 6, 2023, non-qualified stock options exercisable for up to 200,000 shares of Common Stock were awarded to one consultant acting as a sales broker for the threeCompany. These stock options have a ten-year term from the grant date, with the shares fully vesting based on the achievement of certain net revenue targets up to $100,000,000 in total net revenues over time to be generated from certain customers as listed in the sales broker agreement. The fair value of the options on the grant date was $145,998 using a Black-Scholes option pricing model with the following assumptions: stock price $0.73 per share (based on the quoted trading price on the date of grant), a computed volatility of 270.98%, expected term of 10 years, and six monthsa risk-free interest rate of 3.63%. Management determined the performance conditions were deemed not probable and as such no expense was recognized on these awards for the period ended April 30, 20222023.

On March 3, 2023, non-qualified stock options exercisable for up to 50,000 shares of Common Stock were awarded to one interim senior executive of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting on June 30, 2023. The fair value of the options on the grant date was $30,650 using a Black-Scholes option pricing model with the following assumptions: stock price $0.61 per share (based on the quoted trading price on the date of grant), a computed volatility of 286.91%, expected term of 10 years, and a risk-free interest rate of 3.97%.

On March 19, 2023, non-qualified stock options exercisable for up to 250,000 shares of Common Stock were awarded to two independent board members of the Company. These stock options have a ten-year term from the grant date, with the shares fully vesting on March 19, 2024. The fair value of the options on the grant date was $217,498 using a Black-Scholes option pricing model with the following assumptions: stock price $0.87 per share (based on the quoted trading price on the date of grant), a computed volatility of 286.15%, expected term of 10 years, and a risk-free interest rate of 3.47%.

Warrants

Warrant information as of the periods indicated is as follows:

Schedule of warrant information                
        Weighted
  Aggregate Aggregate Exercise Price Average
  Number Exercise Price Range Exercise Price
Outstanding, October 31, 2022  2,318,317   4,404,802   1.90   1.90 
Granted            
Exercised            
Cancelled, forfeited, or expired            
Outstanding, April 30, 2023  2,318,317  $4,404,802  $1.90  $1.90 
Exercisable, April 30, 2023  2,318,317  $4,404,802  $1.90  $1.90 

The weighted average remaining contractual life is approximately $2,303,533. The fiscal year 2022 unamortized stock option expense at3.42 years for Common Stock warrants outstanding as of April 30, 20222023. As of April 30, 2023, there was approximately $1,645,395.no intrinsic value of outstanding stock warrants.


Note 6 – Related-Party Transactions

In March 2020, the Company commenced business operations as a result of becoming the exclusive distributor of certain ENDS and related components (the “Products”) manufactured by Bidi, a related party company that is also owned by Nirajkumar Patel, the Chief Science and Regulatory Officer and a director of the Company. Mr. Patel also controls Kaival Holdings, the Company’s majority stockholder.

Other Receivable

On August 1, 2022, the Company and Bidi agreed to a price credit for short-coded or expiring inventory against the related-party accounts payable balance due to Bidi. A credit of $2,924,655 was applied on August 1, 2022, resulting in a related-party accounts receivable balance due from Bidi of $2,134,413, to be applied on future orders of Product. On October 31, 2022, the Company and Bidi agreed to a return for short-coded or expiring inventory. An additional credit of $1,543,545 and $108,841 for recycling cost was applied on October 31, 2022, to the related-party receivable balance due from Bidi.

As of April 30, 2023 and October 31, 2022, the Company has a related-party receivable balance due from Bidi of $3,219,646 and $3,704,132, respectively. The receivable balance will be realized though Bidi applying 5% credits on all future orders of product purchased until the entire balance is extinguished.

Revenue and Accounts Receivable

During the six months ended April 30, 2023, the Company recognized revenue of $6,713 from three companies owned by Nirajkumar Patel, the Chief Science and Regulatory Officer and a director of the Company, and/or his wife. There was no accounts receivable balance for these transactions as of April 30, 2023.

During the six months ended April 30, 2022, the Company recognized revenue of approximately $31,150 from four companies owned by Nirajkumar Patel, the Chief ExecutiveScience and Regulatory Officer of the Company, and/or his wife. There was no accounts receivable balance for these transactionsdue as of April 30,October 31, 2022.

Concentration Purchases and Accounts Payable

During the six months ended April 30, 2021,2023, 100% of the Company recognized revenueinventories of approximately $61,545Products, consisting solely of the BIDI® Stick, were purchased from three companies ownedBidi, a related party controlled by Nirajkumar Patel, in the Chief Executive Officeramount of $6,355,234. As of April 30, 2023, the Company and/or his wife. Thehad accounts receivable balance for these transactions waspayable to Bidi of $7652,122,452 and Products valued at $3,646,738 were held in inventory. In addition, as of April 30, 2021.2023, the Company had accrued freight in expense of $202,461. As of October 31, 2022, the Company did not have an accounts payable balance to Bidi.

Concentration Purchases and Accounts Payable

During the six months ended April 30, 2022, the Company did not purchase Products from Bidi, a related party. Sales of Products during the first six months of fiscal year 2022 were drawn from the inventory purchase made on September 6, 2021. As of April 30, 2022, the Company had accounts payable to Bidi of approximately $3,394,759 and Products valued at approximately $9,214,320 were held in inventory.

DuringThe KBI License Agreement provides that KBI shall pay Bidi license fees equivalent to 50% of the six months ended April 30, 2021,adjusted earned royalty payments, after any offsets due to jointly agreed costs such development costs incurred for entry to specific international markets. Consequently, the Company purchased Products of approximately $75,065,602 fromhas determined that no license fees are owed to Bidi a related party. Asas of April 30, 2021, the Company had accounts payable to Bidi of approximately $38,001,633. During the six months ended April 30, 2021, 100% of all Product purchases were made by the Company from Bidi.2023 and October 31, 2022.

Leased Office Space and Storage Space

The Company capitalizes all leased assets pursuant to ASU 2016-02, Leases (Topic 842) (“Topic 842”), which requires lessees to recognize right-of-use (“ROU”) assets and lease liability, initially measured at present value of the lease payments, on its balance sheet for leases with terms longer than 12 months and classified as either financing or operating leases. The Company excludes short-term leases having initial terms of 12 months or less from Topic 842 as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. On August 1, 2020,June 10, 2022, the Company began leasingentered into the 2022 Lease with Just Pick for approximately 21,332 rentable square feet combined in the office space for its main corporate office in Grant, Florida. The five-year lease agreementbuilding and warehouse located at the Premises, together with all improvements thereon. Just Pick is withconsidered a related party Just Pick. Theto the Company because the Company’s Chief ExecutiveScience and Regulatory Officer is an officer ofand director, Mr. Nirajkumar Patel, owns and controls Just Pick. The liability for rent not paid from the beginning of the lease through April 30, 2022 is $21,900.

For additional information regarding leases as of the date these unaudited consolidated financial statements were issued, please see Note 8, Subsequent Events.


Note 7 – Commitments and Contingencies

The Company follows ASC 450-20, LossContingencies,to report accounting for contingencies. Liabilities for loss contingencies arising from claims, assessments, litigation, fines and penalties and other sources are recorded when it is probable that a liability has been incurred and the amount of the assessment can be reasonably estimated. There were no commitments or contingencies as of April 30, 20222023, and April 30, 2021October 31, 2022, other than the below:

Cash and Equity Bonus Awards

On May 28, 2020, the Board approved cash bonus awards to each of the Company’s Chief Executive Officer and its Chief Operating Officer. With respect to the Chief Executive Officer, the Board approved a cash bonus award equal to $30,000 for every $25 million in gross revenues generated by the Company. With respect to the Chief Operating Officer, the Board approved a cash bonus award equal to $20,000 for every $25 million in gross revenues generated by the Company. On May 28, 2020, the Board also approved an equity bonus award for each of the Chief Executive Officer and the Chief Operating Officer. With respect to the Chief Executive Officer, the Board approved an award of 7,500 restricted shares of the Common Stock for every $50 million in accumulated gross revenues generated by the Company. With respect to the Chief Operating Officer, the Board approved an award of 6,250 restricted shares of the Common Stock for every $50 million in accumulated gross revenues generated by the Company. The Company’s accumulated gross revenues will be evaluated on a quarterly basis, beginning with the second quarter of fiscal year 2020. At October 31, 2020, the Company determined that the fair value of the equity bonus shares, or $165,000, should be accrued as it was deemed likely that the $50 million revenue target would be met. The Company issued these shares to the Chief Executive Officer and Chief Operating Office on January 1, 2021. During the quarter ended April 30, 2021, the $75 million and $100 million accumulated revenue targets were both achieved and the Company determined that the fair market value of the 13,750 shares, or approximately $70,785, and the cash bonuses totaling $100,000 should be accrued at April 30, 2021.

During the quarter ended April 30, 2022, the $125 million accumulated revenue targets were achieved and the Company determined that cash bonuses totaling $50,000 should be accrued at April 30, 2022.

On March 4, 2022, the Board terminated all future cash and equity bonus awards for the Company’s Chief Executive Officer and its Chief Operating Officer.

QuikfillRx Service Agreement Amendment

On March 31, 2020,Effective as of November 9, 2022, the Company entered into a service agreement (the “Service Agreement”) with QuikfillRx LLC, a Florida limited liability company (“QuikfillRx”), whereby QuikfillRx provides the Company with certain services and support relating to sales management, website development and design, graphics, content, public communication, social media, management and analytics, and market and other research (collectively, the “Services”). The Services are provided by QuikfillRx as requested from time to time by the Company.

F-14

On June 2, 2020, the Company entered into the First Amendmentits latest amendment to the Service Agreement (the “First Amendment) with QuikfillRx. Effective as of March 16, 2021,QuikfillRx (collectively with prior amendments, the Company entered into the Second Amendment to“Amended Service Agreement (the “Second Amendment”Agreement”) with QuikfillRx. Effective as of September 17, 2021, the Company entered into the Third Amendment. The November 9, 2022 amendment to the Service Agreement (the “Third Agreement” and, collectively withwas captioned as the First Amendment, Second Amendment, and“Fourth Amendment” although it was the fifth amendment to the Service Agreement. Pursuant to the Amended Service Agreement:

(a) the term of the Amended Service Agreement the “Amended Service Agreement”) with QuikfillRx. Pursuantwas extended (unless earlier terminated pursuant to the terms of the Amended Service Agreement) from November 1, 2022 (the “Effective Date”) until October 31, 2025, following which the term shall automatically renew for successive one (1) year periods beginning November 1, 2025;

(b) QuikfillRx agreed to change its “doing business as” name to “Kaival Marketing Services” within thirty (30) days following the Effective Date;

(c) It was provided that either party may terminate the Amended Service Agreement without cause upon not less than ninety (90) days prior written notice to the other party;

(d) QuikfillRx was granted a one-time, fully vested, ten-year non-qualified option award to purchase up to 250,000 shares of Company common stock with an exercise price of $0.9869 per share (the closing price of the Company’s common stock on November 9, 2022)”)., which option grant was memorialized pursuant to a Nonqualified Option Agreement, dated November 9, 2022, between the Company and QuikfillRx; and

(e) the parties agreed to revise the following “General Compensation” payments: compensation for services as follows: (i) for the Services provided in March 2020, the Company paid QuikfillRx an amount equal to $86,000; (ii) for the Services provided in April 2020, the Company paid QuikfillRx an amount equal to $100,000; (iii) each calendar month commencing May 2020 through October 2020, the Company paid QuikfillRx an amount equal topayment of $125,000 per month for the Servicesmonth; (ii) bonus equivalent to be performed during such calendar month; (iv) for each calendar month between November 1, 2020 and October 31, 2021, the Company paid QuikfillRx $125,000 per month for the Services to be performed during such calendar month; (iv) for the period between November 1, 2021 and October 31, 2022, the Company will pay QuikfillRx $150,000 per month for the Services to be performed during such calendar month; and (v) if the parties agree to extend the term0.27% of the Amended Service Agreement beyond October 31, 2022, then for the period between November 1, 2022applicable gross quarterly sales and October 31, 2021, the Company will pay QuikfillRx $150,000 per month for the Services to be performed during such calendar month.On November 1, 2021, the parties agreed to extend the term for an additional one-year period. In addition, the Company will pay the following quarterly bonuses:

An amount equal to 0.9% of the Applicable Gross Quarterly Sales (as defined in the Amended Service Agreement), which amount shall, at the Company’s option be paid in (a) cash or (b) shares of the Company’s common stock, or (c) a combination of cash and Common Stock.
An amount equal to 0.27% of the Applicable Gross Quarterly Sales, which amount must be paid in cash.

On March 17, 2021, the Company entered into(iii) a consulting agreement with Russell Quick, pursuant to which the Company grantedgrant of 3,000,000 nonqualified stock options exercisable forto purchase shares of Company common stock which shall vest based on achievement of certain net revenue and profit margin targets up to 41,667 shares$180,000,000 in total net revenues over a period of the Company’s Common Stock in exchange for consulting services. The shares underlying the stock option fully vested on December 1, 2021. The exercise price per share is $28.68. The Company recognized approximately $190,000 in expense to account for the stock options. Russell Quick is the Chief Executive Officer of QuikfillRx. 3 years.

The Company accrued approximately $35,80335,338 for a quarterly bonus payable to QuikfillRx, based on the Applicable Gross Quarterly Sales results of the three months ended April 30, 2023. The Company accrued $33,871 for a quarterly bonus payable to QuikfillRx, based on the Applicable Gross Quarterly Sales results for the three months ended October 31, 2022.

Effective February 6, 2023, the Company and Futura, LLC (“Broker”) entered into an agreement for the sale of the Company’s BIDI vapor sticks to certain retail customers. The term of the agreement is one year, which shall automatically renew for successive terms of one year each, if only the minimum net sales required for each covered retail customer, as set forth in the sales broker agreement, is met. As compensation, the Company shall pay to the broker a 5% commission on all eligible products sold under the agreement.


Note 8 – Subsequent Events

Third Amended and Restated Distribution Agreement

On June 10, 2022,May 30, 2023 (the “Closing Date”), the Company and Kaival Labs entered into the Third A&R Distribution AgreementGoFire APA with Bidi, which amended and restated the A&R Distribution Agreement (collectively, the “Distribution Agreement”).

The Third A&R Distribution Agreement modifies various terms and provisionsGoFire. Pursuant to reflect the terms of the PMI Licensing Agreement (as defined below) and also modify the terms betweenGoFire APA, the Company and Bidi. Kaival Labs purchased certain intellectual property assets of GoFire consisting of various patents, patent applications and trademarks (the “Purchased Assets”) in exchange for equity securities of the Company and certain contingent cash consideration. The Purchased Assets consist of 12 existing patents and 46 pending patents with novel technologies related to vaporization and inhalation technologies. The patents and patent applications cover the U.S. and several international territories. The Purchased Assets also include four registered and two pending trademarks. The Company has determined that the acquisition of the Purchased Assets does not constitute the acquisition of a “business” (as defined in Rule 11-01(d) of Regulation S-X).

Pursuant to the Third A&R Distribution Agreement, Bidi grantedterms of the GoFire APA, the Company and its designees, an exclusive rightpaid to distribute electronic and non-electronic nicotine delivery systems and related components (other thanGoFire, in addition to certain excluded products) for sale and resale to both retail level customers and non-retail level customers worldwide, subject to a carve-out for, and exclusion,contingent cash consideration described below, consideration in the form of equity securities of the PMI Markets (as defined below). The Third A&R Distribution Agreement has a termCompany consisting of ten years and automatically renews for a successive ten-year term, unless earlier terminated pursuant its terms.

Exercise(i) an aggregate of Stock Warrants

As part of the Company’s underwritten public offering during fiscal 2021, the Company issued warrants to purchase a total of 4,053,7502,000,000 shares of Common Stock at an exercise price(the “APA Shares”); (ii) 900,000 shares of newly-designated Series B Convertible Preferred Stock, par value $1.900.001 per share. These warrants expireshare, (the “Series B Preferred Stock” and the shares of Common Stock underlying the Series B Preferred, the “Series B Conversion Shares”), the rights, preferences and terms of which are set forth in 2026. Warrants fora Certificate of Designation of Rights and Preferences of the Series B Preferred Stock  (the “Certificate of Designation”), and (iii) a common stock purchase warrant to purchase 3,0002,000,000 shares of Common Stock were exercised on June 14, 2022(the “Warrant” and the shares of Common Stock underlying the Warrant, the “Warrant Shares”). As additional consideration for net proceeds of $5,700. The aggregate intrinsic valuethe Purchased Assets, any cannabis-specific (meaning cannabis, hemp or cannabinoid) royalties that are generated by Kaival Labs from or due to the Purchased Assets, from the Closing Date until January 1, 2027, will be subject to a contingent cash payment as described in the GoFire APA and subject to the terms of the outstanding Common Stock warrants as of April 30, 2022GoFire APA.

Pursuant to the GoFire APA, the Company is required to use commercially reasonable efforts to register the APA Shares and October 31, 2021 was $0. The weighted average remaining termWarrant Shares with the SEC for distribution to GoFire’s stockholders and/or public resale by such stockholders within 180 days of the Closing Date. In addition, if any Series B Preferred Stock remains outstanding Common Stock warrants is 4.50 years as of April 30, 2022.

Lease Agreement

On June 10, 2022,nineteen (19) months after the Closing Date, the Company entered intoshall use commercially reasonable efforts to file with the SEC a Lease Agreement (the “2022 Lease”) with Just Pick for approximately 21,332 rentable square feet combined insubsequent registration statement registering the office building and warehouse located at 4460 Old Dixie Highway, Grant Valkaria, Florida 32949 (the “Premises”), together with all improvements thereon. Just Pickdistribution to GoFire’s stockholders and/or public resale Series B Conversion Shares by such stockholders. If such subsequent registration statement is considered a related party torequired, the Company becausewill use its commercially reasonable efforts to obtain effectiveness of such subsequent registration statement within nineteen (19) months of the Closing Date, and if the Company does not so register the Series B Conversion Shares within nineteen (19) months of the Closing Date, the Company will issue to GoFire or its designee an additional ten percent (10%) of all of the Series B Conversion Shares underlying the then-outstanding shares of Series B Preferred Stock.

All of the securities issued as consideration for the Purchased Assets are subject to a lock-up agreement that terminates one hundred eighty (180) days from the Closing Date; provided, however, that it is anticipated that the Company’s Chief Executive Officer and director, Mr. Nirajkumar Patel, owns and controls the Just Pick.

The anticipated commencement datesecurities issued in consideration of the 2022 Lease is June 10, 2022 (the “Commencement Date”). The termpurchase of the LeasePurchased Assets will be assigned by GoFire to a trust for the benefit of GoFire’s stockholders. It is one (1) year (the “Lease Term”), with one automatic renewal period for a five-year term. The Company, in its sole and absolute discretion, hasanticipated that the optionagreement governing such trust would require the trust to extendhold the automatic renewal for an additional five (5) year period immediately following the first renewal term.Company’s securities subject to such lock-up agreement.

The Company must pay Just Pick base rent equal to $17,776.67 per month during the first yearTerms of the Lease Term. Thereafter, the monthly base rent will be increased annually with a monthly base rent of $18,665Series B Convertible Preferred Stock.50 in the second year, $19,554.33 in the third year, $20,443.17 in the fourth year, $22,220.83 in the fifth year, $23,998.50 in the sixth year, and one twelfth (1/12th) of the market annual rent for the seventh through eleventh years, if appliable. In addition to the base rent, the Company must pay one hundred percent (100%) of operating expenses, insurance costs, and taxes for each calendar year during the Lease term.

Any changes, alterations, additions, or improvements to the Premises made by the Company becomes the property of Just Pick unless prior to the 2022 Lease expiration, the Company removes such improvements and restores the Premises to the same condition as existed on the Commencement Date.

The 2022 Lease contains customary representations, warranties, covenants, indemnification provisions, default provisions, and termination provisions.

 

F-15

 

License AgreementThe Series B Convertible Preferred

On June 10, 2022, Bidi entered into a License Agreement (the “License Agreement”)Stock carries no voting rights except: (i) with KBI, pursuant to which KBI has the exclusive irrevocable license to use Bidi’s licensed intellectual propertyrespect to the extentability of the holders of a majority of the then outstanding Series B Preferred Stock (the “Majority Holders”), to nominate a director to the Company’s board of directors, and (ii) that the vote of the Majority Holders is necessary for KBI to fulfill its obligations set forth in the Deed of Licensing Agreement (the “PMI License Agreement”), by and between KBI and PMPSA. Such irrevocable license includes: (i) the right of KBI to grant sub-licenses to PMPSA under the PMI License Agreement for the express purposes set forth in the PMI License Agreement, but for no other purpose; (ii) the right of KBI to grant to PMPSA the right to grant sub-sub-licenses in the manner set forth in the PMI License Agreement, but for no other purpose; and (iii) certain branding rightseffecting any amendment to the extent (but onlyCompany’s Certificate of Incorporation or Certificate of Designation that affects the Series B Preferred Stock. The Series B Convertible PreferredStock is redeemable at the option of the Company at a redemption price of $15 per share, subject to the extent) necessary to permit KBI to perform its obligations to PMPSA as set forth in the PMI License Agreement.

Pursuant to the License Agreement, if at any time, KBI receives any license of PMPSA intellectual property from PMPSA or any of its affiliates in the manner contemplated by the PMI License Agreement, KBI will grant Bidi an irrevocable sub-license of all right, title, and interest of KBI in and to that PMPSA intellectual property. In addition, Bidi and KBI agree that any amount payable and all net royalties payable to KBI under the PMI License Agreement will be apportioned equally among Bidi and KBI in a manner such that each will ultimately receive fifty percent (50%) thereof.

The License Agreement contains customary representations, warranties, covenants, and indemnification provisions.

Deed of Licensing Agreement

On June 13, 2022 KBI entered into the PMI License Agreement with PMPSA, effective as of May 13, 2022 (the “PMI Commencement Date”). Pursuant to the PMI License Agreement, KBI granted PMPSA an exclusive irrevocable license to use its technology, documentation, and intellectual property to make, distribute, and sell disposable nicotine e-cigarettes Productspotential downward adjustments based on the intellectual property in certain international markets set forthtrading price of the Common Stock. Subject to additional limitations in the PMI License AgreementGoFire APA, the Series B Convertible Preferred Stock holds seniority over the Common Stock and each other class of series of securities now existing or hereafter authorized with respect to dividend rights, the distribution of assets upon liquidation, and dissolution and redemption rights. Upon a liquidation and winding up of the Company, the holders of Series B Convertible Preferred Stock are entitled to a liquidation preference of $15 per share (the “PMI Markets”“Liquidation Preference”)., though this price may be adjusted downward based on the trading price of the Common Stock at the time of liquidation. The Company hasholders of Series B Convertible Preferred Stock are entitled to receive a dividend equal to 2% of the exclusive international distributionLiquidation Preference, accruing from the Closing Date and payable on the eighteen-month anniversary of the Closing Date. No preemptive rights are granted to the Products and, in orderholders of Series B Convertible Preferred Stock.

The Majority Holders have the ability to allow KBI to fulfill its obligations set forth in the PMI License Agreement, has contributed the international distribution rights for the PMI Markets to KBI as set forth incause a Capital Contribution Agreement dated June 10, 2022. The sublicense granted to PMPSA is exclusive in the PMI Markets and neither KBI nor any of its affiliates can sell, promote, use, or distribute any competing products in the PMI Markets for the durationvoluntary conversion of the termSeries B Convertible Preferred Stock into Common Stock at a conversion rate of 8.3333 shares of Common Stock per share of Series B Convertible Preferred Stock. All shares of Series B Convertible Preferred Stock will automatically convert to Common Stock upon the PMI License Agreement and any Sell-Out Periodoccurrence of a Change of Control (as defined in the PMI License Agreement)GoFire APA). PMSPA will be responsible for any regulatory filings necessary to sell the Products in the PMI Markets. Both KBI and PMPSA agree to work together in the registration and maintenance

Terms of the Intellectual Property, but KBI will bear all costWarrant

The Warrant is exercisable for an aggregate of 2,000,000 Warrant Shares for a period of four (4) years from the Closing Date. The exercise price for the Warrant Shares is $3.00, $4.00, $5.00 and expense to implement the registration strategy. Finally, PMPSA has agreed to potential future development services with KBI in the PMI Markets and has been granted certain rights with respect to potential future products.$6.00

per share, respectively, for each of four tranches of five hundred thousand (500,000

) Warrant Shares. The initial termexercise prices of the PMI License AgreementWarrant are subject to customary stock-based (but not price-based) adjustments upon the occurrence of stock splits and the like involving the Common Stock. The Warrant is five (5) years and automatically renews for an additional five-year period unless PMPSA has failed to meetexercisable on a cash basis only, except that the agreed upon minimum key performance indicators set forth in the PMI License Agreement, in which case the PMI License Agreement will automatically terminateWarrant may be exercised on a “cashless basis” if at the endtime of exercise there is not an effective registration statement under the Securities Act of 1933, as amended covering the public resale of the initial license term.Warrant Shares.

In consideration for the grant of the licensed rights, PMPSA agreed to pay to KBI a royalty equal to 2.00% to 3.50% of the base price of the first sale of each unit of Product manufactured. In addition, before the launch of the first product in a market and each anniversary of such launch, PMPSA agrees to pre-pay to KBI a guaranteed minimum royalty equal to twenty percent (20%) of the estimated royalties payable by PMPSA to KBI in relation to all markets in the twelve (12)-month period following the first launch or each successive anniversary of the first launch, subject to an aggregate maximum guaranteed royalty payment of One Million Dollars ($1,000,000) for all markets for each applicable twelve (12)-month period. PMPSA may require modification of certain products to be sold under the PMI Licensing Agreement to be modified for a PMI Market. Pursuant to the PMI Licensing Agreement, PMPSA has absolute discretion over sales, marketing, product branding and packaging pertaining to sales in the PMI Markets, as well as the right to select the specific PMI Markets in which to launch commercialization and determine what product types are to be promoted in each market, subject to sales and marketing plans and annual business plans set by PMPSA and certain expansion criteria agreed between PMPSA and KBI.

The PMI License Agreement contains customary representations, warranties, covenants, and indemnification provisions; however, KBI’s liability under the PMI License Agreement is capped at the greater of: (i) Ten Million Dollars ($10,000,000); or (ii) an amount equal to the total of the royalties due to KBI (but not yet paid) plus the royalties (including the guaranteed royalty payment) paid to KBI pursuant to the PMI License Agreement during the immediately preceding twelve (12) consecutive months, provided that such amount shall not exceed Thirty Million Dollars ($30,000,000).

In connection with the PMI License Agreement, the Company, Bidi, and PMPSA also entered into a deed of letter (“Deed of Letter”) to require specific performance of the duties and obligations set forth in the PMI License Agreement if KBI is unable or fails to sublicense the intellectual property to PMPSA pursuant to the PMI License Agreement and/or is unable or fails to perform certain of its obligations or grant the rights pursuant to the PMI License Agreement. In addition, the Company, Bidi, and PMPSA entered into a guarantee (“Guarantee”), whereby each of the Company and Bidi guarantees to PMPSA up to 50% of all of KBI’s monetary obligations set forth in the PMI License Agreement if KBI fails to perform or discharge certain of its obligations in the PMI License Agreement.

F-16

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsOperations.

This Management’s Discussion and Analysis of Financial Condition and Results of Operations is designed to provide a reader of the financial statements with a narrative report on our financial condition, results of operations, and liquidity. This discussion and analysis should be read in conjunction with the unaudited Financial Statementsfinancial statements and notes thereto for the three and six months ended April 30, 20222023 included under Item 1 – Financial Statements in this Quarterly Report and our audited Financial Statementsfinancial statements and notes thereto for the year ended October 31, 20212022 contained in the 20212022 Annual Report. The following discussion contains forward-looking statements that involve risks and uncertainties, such as statements of our plans, objectives, expectations, and intentions. Our actual results could differ materially from those discussed in the forward-looking statements. Please also see the cautionary language at the beginning of this Quarterly Report regarding forward-looking statements.

ImpactCapitalized terms used but not defined in this discussion have the meanings ascribed to them in the notes to the accompanying unaudited financial statements.

Overview

We are focused on growing and incubating innovative and profitable products into mature, dominant brands, with a current focus on the distribution of COVID-19electronic nicotine delivery systems (“ENDS”), also known as “e-cigarettes.” Our business plan is to seek to diversify into distributing other nicotine and non-nicotine delivery system products (including those related to hemp-derived cannabidiol (known as CBD) products.

Pursuant to the A&R Distribution Agreement, Bidi granted us an exclusive worldwide right to distribute Bidi’s ENDS as well as non-electronic nicotine delivery systems and related components (as more particularly set forth in the A&R Distribution Agreement, the “Products”) for sale and resale to both retail level customers and non-retail level customers. Currently, the Products consist solely of the “BIDI® Stick”, In MarchBidi’s disposable, tamper resistant ENDS product made with medical-grade components, a UL-certified battery and technology designed to deliver a consistent vaping experience for adult smokers 21 and over. We presently distribute Products to wholesalers and retailers of ENDS products, having ceased all direct-to-consumer sales in February 2021. Nirajkumar Patel, our Chief Science and Regulatory Officer and director and an indirect controlling stockholder of our company, owns Bidi.

BIDI® Stick comes in a variety of flavor options for adult cigarette smokers. We do not manufacture any of the Products we resell. The BIDI® Stick is manufactured by Bidi. Pursuant to the terms of the A&R Distribution Agreement, Bidi provides us with all branding, logos, and marketing materials to use with our commercial partners use in connection with our marketing and promotion of the Products.

We process all sales made only to non-retail customers, with all sales to non-retail customers made through Bidi’s age-restricted website, www.wholesale.bidivapor.com. We ceased all direct-to-consumer sales in February 2021 in order to better ensure youth access prevention and to comply with the Prevent All Cigarette Trafficking (“PACT”) Act. We provide all customer service and support at our own expense. We set the minimum prices for all sales made by us. We maintain adequate inventory levels of the Products in order to meet the demands of our non-retail customers, and deliver the Products sold to these customers.

A key third party collaborator of ours is QuikfillRx, LLC, (“QuikfillRx”) a Florida limited liability company which recently began doing business as “Kaival Marketing Services” to better reflect its contributions to our company. QuikfillRx provides us with certain services and support relating to sales management, website development and design, graphics, content, public communication, social media, management and analytics, and market and other research. QuikfillRx provides these services to us pursuant to a Services Agreement, most recently amended on November 9, 2022, which has a current term ending on October 31, 2025 (subject to potential one-year extensions) and pursuant to which QuikfillRx receives monthly cash compensation and was granted certain equity compensation in the form of options.

We have also entered into key international licensing agreements with Philip Morris Products S.A. (“PMPSA”), a wholly owned affiliate of Philip Morris International Inc. (“PMI”).

On August 31, 2020, the WHO declared the outbreak of COVID-19we formed Kaival Labs, Inc., a Delaware corporation (herein referred to as “Kaival Labs”), as a pandemicwholly owned subsidiary for the purpose of developing our own branded and white-label products and services, of which none has commenced as of the date of this Report. On March 11, 2022, we formed Kaival Brands International, LLC, a Delaware limited liability company (herein referred to as “KBI”), as a wholly owned subsidiary for the purpose of entering into an international licensing agreement with PMPSA.


GoFire Asset Acquisition

On May 30, 2023, we and Kaival Labs entered into the GoFire APA with GoFire. Pursuant to the terms of the GoFire APA, we purchased certain intellectual property assets of GoFire consisting of various patents and patent applications (the “Purchased Assets”) in exchange for equity securities of our company and certain contingent cash consideration. The Purchased Assets will be housed in Kaival Labs and consist of 12 existing and 46 pending patents with novel technologies related to vaporization and inhalation technologies. The patents and patent applications cover the U.S. and several international territories. The Purchased Assets also include four registered and two pending trademarks. The goal of this acquisition is to diversify our product offerings and create near and longer term revenue opportunities in the form of potential licenses of the acquired technology and our development of new products based on the rapid increasePurchased Assets. In the near term, we expect to seek third-party licensing opportunities in global exposure. COVID-19 continues to spread throughout the world, including the United States. Our business operations, which commenced during this pandemic, continue to be operational; however, we were indirectly negatively impacted by COVID-19.

We were indirectly impacted by supply chain issuescannabis, hemp/CBD, nicotine and regulatory oversight. First, COVID-19 impacted Bidi’s ability to quality test and develop its new product, the BIDI® Pouch, in line with its targeted release date, which negatively impacted our ability to begin distribution of the BIDI® Pouch. Secondly,nutraceutical markets. Longer term, we believe we can utilize the Purchased Assets to create innovative and market-disruptive products, including patent protected vaporizer devices and related hardware and software applications. No assurances can be given, however, that many retailers and distributers relaxed their compliance standards as an indirect result of COVID-19the Purchased Assets will generate revenue for two reasons: (i) government enforcement of regulations was very limited due to imposed social restrictions, resultingus in less in-person monitor enforcement by government officials and (ii) retail stores experienced light foot traffic from customers due to COVID-19 restrictions and fears, which resulted in relaxed compliance in an effort to generate revenue. We believe this relaxation of standards by certain retailers significantly impactedthe future or otherwise create the value for our revenues.company that we anticipate.

Impact of the FDA PMTA Determinations, 11th Circuit Decision and Impact on Our Business

In September 2021, in connection with the PMTABidi’s Premarket Tobacco Product Application (“PMTA”) process for BIDI® Stick, the FDAU.S. Food and Drug Administration’s (the “FDA”) effectively “banned” non-tobacco flavored ENDS by denying nearly all then-pending PMTAs for such products.products (including Bidi’s). Following the issuance of an MDO,by the FDA of a related Marketing Denial Order (“MDO”) regarding these ENDS products, manufacturers arewere required to stop selling non-tobacco flavored ENDS product. As of March 2022, the FDA announced that it has taken action on over 99% of applications and issued MDOs for more than 1,167,000 non-tobacco flavored ENDS products, while issuing zero marketing authorizations for such products. Bidi, along with nearly every other company in the ENDS industry, received a MDO for its non-tobacco flavored ENDS products. With respect to Bidi, the MDO covered all non-tobacco flavored BIDI®BIDI® Sticks, including its Arctic (menthol) BIDI®BIDI® Stick.

As a result, beginning in September 2021, Bidi pursued multiple avenues to challenge the MDO. First, on September 21, 2021, separate from the judicial appeal of the MDO in its entirety, Bidi filed a 21 C.F.R. § 10.75§10.75 internal FDA supervisory review request specifically of the decision to include the Arctic (menthol) BIDI®BIDI® Stick in the MDO. In May 2022, the FDA issued a determination that it views the Arctic BIDI®BIDI® Stick as a non-tobacco flavored ENDS product, and not strictly a menthol flavored product.

 

On September 29, 2021, Bidi petitioned the U.S. Court of Appeals for the Eleventh Circuit (the “11th Circuit”) to review the FDA’s denial of the PMTAs for its non-tobacco flavored BIDI®BIDI® Stick ENDS (including the Arctic BIDI® Stick), arguing that it was arbitrary and capricious under the APA,Administrative Procedure Act (“APA”), as well as ultra vires,, for the FDA not to conduct any scientific review of the company’sBidi’s comprehensive applications, as required by the TCA,Tobacco Control Act (“TCA”), to determine whether the BIDI®BIDI® Sticks are “appropriate for the protection of the public health”. Bidi further argued that the FDA violated due process and the APA by failing to provide fair notice of the FDA’s new requirement for ENDS companies to conduct long-term comparative smoking cessation studies for their non-tobacco flavored products.

On October 14, 2021, Bidi requestedproducts compared to tobacco-flavored ENDS products, and that the FDA re-reviewshould have gone through the notice and comment rulemaking process for this requirement.

On August 23, 2022, the 11th Circuit set aside (i.e., vacated) the MDO issued to the non-tobacco flavored BIDI® Sticks and reconsider its positionremanded Bidi’s PMTA back to the FDA for further review. Specifically, the 11th Circuit held that Bidithe MDO was “arbitrary and capricious” in violation of the APA because the FDA failed to consider the relevant evidence before it, specifically Bidi’s aggressive and comprehensive marketing and sales-access-restrictions plans designed to prevent youth appeal and access.

The 11th Circuit’s opinion further indicated that the FDA did not include certainproperly review the data and evidence that it has long made clear are critical to the appropriate for the protection of the public health (“APPH”) standard for PMTAs set forth in the Tobacco Control Act including, in Bidi’s case, “product information, scientific data in its applications sufficientsafety testing, literature reviews, consumer insight surveys, and details about the company’s youth access prevention measures, distribution channels, and adult-focused marketing practices,” which “target only existing adult vapor product users, including current adult smokers,” as well as our retailer monitoring program and state-of-the-art anti-counterfeit authentication system. Because a MDO must be based on a consideration of the relevant factors, such as the marketing and sales-access-restrictions plans, the denial order was deemed arbitrary and capricious, and vacated by the FDA.

The FDA did not appeal to allow the PMTAs11th Circuit’s decision. The FDA had until October 7, 2022 (45 days from the August 23, 2022 decision) to proceedeither request a panel rehearing or a rehearing “en banc” (a review by the entire 11th Circuit, not just the 3-judge panel that issued the decision), and until November 21, 2022 (90 days after the decision) to scientific review. seek review of the decision by the U.S. Supreme Court. No request for a rehearing was filed, and no petition for a writ of certiorari was made to the Supreme Court.

In light of this request, on October 22, 2021 pursuant to 21 C.F.R. § 10.35(a), the FDA issued an administrative stay of Bidi’s MDO pending its re-review. Subsequently, the FDA lifted its administrative stay on December 17, 2021. Following the lifting of the FDA’s administrative stay, Bidi filed a renewed motion to stay the MDO with the U.S. Court of Appeals for the Eleventh Circuit.

On February 1, 2022, the U.S. Court of Appeals for the Eleventh11th Circuit granted Bidi’s motion to stay (i.e., put on hold) the MDO, pending the litigation on the merits. The court-ordered stay means that the MDO is not legally in force. Accordingly,decision, we anticipate being ablehaving the continued ability to continue marketingmarket and sellingsell the Products,non-tobacco flavored BIDI® Sticks, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challengingfor the legalityduration of the MDO.PMTA scientific review. The FDA has indicated that it is prioritizing enforcement of unauthorized ENDS against companies (1) that have either notnever submitted PMTAs, (2) whose PMTAs have been refused acceptance or filing by the FDA, or(3) whose PMTAs remain subject to MDOs. Oral arguments inMDOs, and (4) that are continuing to market unauthorized synthetic nicotine products after the merits-based proceeding were held on May 17, 2022.July 13, 2022 cutoff. As none of these scenarios apply to Bidi, we believe the current risk of FDA enforcement is low.

 

InSince the eventPMTA was remanded, Bidi has continued to update its application with the results of new studies, including a nationwide population prevalence study on the BIDI® Stick that is currently undergoing peer review for publication.

Separately, on or about May 13, 2022, the FDA placed the tobacco-flavored Classic BIDI® Stick into the final Phase III scientific review, and in September 2022 completed a remote regulatory assessment of Bidi and its contract manufacturer in China, SMISS Technology Co. LTD, in relation to the pending PMTA for the Classic BIDI® Stick.


Material Items, Trends and Risks Impacting Our Business

We believe that the U.S. Courtfollowing items and trends may be useful in better understanding our results of Appealsoperations.

Dependence on Bidi and Nirajkumar Patel

We are wholly dependent on Bidi to supply the BIDI® Sticks to us for distribution. Accordingly, any supply or other issues that impact Bidi indirectly impact us and our ability to operate our business. Moreover, and while we are seeking to diversify our product offerings, the Eleventh Circuit issuesloss of our relationship with Bidi would substantially harm the viability of our business, which constitutes an on-going risk factor to our business.

Bidi is controlled by Nirajkumar Patel, our Chief Science and Regulatory Officer and a rulingdirector of the Company. Moreover, Kaival Holdings, an entity controlled by Mr. Patel, is our majority stockholder. In addition, our corporate headquarters is leased to us by an affiliate of Mr. Patel. Therefore, Mr. Patel has the power and ability to control or influence our business.

Dependence on QuikfillRx, LLC and Distributors

We are substantially dependent on QuikfillRx, LLC (d/b/a Kaival Marketing Services, or KMS) to provide key marketing, sales and other support services to us. In addition, we rely on third-party brokers and distributors to introduce and place our products into our historic foundation of convenience-stores and more recently into new retail channels, including dollar, grocery and mass-merchandisers. The loss of one or more of these key relationships would have a material adverse effect on our business.

Ability to Bidi, or ifDevelop and Monetize the FDA otherwise chooses to enforceGoFire Intellectual Property

We purchased certain vaporizer and inhalation-related technology from GoFire in May 2023 with the MDO against Bidi, Bidi will be forced to cease the continued salegoal of its non-tobacco flavored BIDI® Sticks in the United States, thereby resulting in us being unable to distribute such Products, anddiversifying our business and financiallessening our dependence on BIDI Vapor. We do not expect that the acquired assets will generate immediate revenue for us, and while we believe this to be a transformative acquisition for us and we are already seeking to develop and monetize the acquired assets, we can give no assurances at this time that either (i) the patent applications we acquired will eventuate in issued patents or (ii) we will be able to enter into successful monetizing arrangements with respect to these assets.

Nature of our Products and Regulation

Competition in the market for e-cigarettes from illicit sources may have an adverse effect on our overall sales volume, restricting our ability to increase selling prices and damaging our brand equity and reputation. Illicit trade and tobacco trafficking in the form of counterfeit products, smuggled genuine products, and locally manufactured products on which applicable taxes or regulatory requirements are evaded, represent a significant and growing threat to the legitimate tobacco industry, including the products we sell.

Although we combat counterfeiting of our Products by engaging in certain tactics, such as requiring all sales force personnel to randomly collect our Products from retailers in order to be tested by our quality control team, maintaining a quality control group that is responsible for identifying counterfeit products and surveillance of retailers we suspect are selling counterfeit Products through our own secret shopper force, no assurance can be given that we will be able to detect or stop sales of all counterfeit products. In addition, while we may bring suits against retailers and distributors that sell certain counterfeit products, no assurance can be given that we will be successful in any such suits or that such suits will be successful in stopping other retailers or distributors from selling counterfeit products.

Our Products (included in this context any products that we may develop from the GoFire Purchased Assets) are and will be heavily regulated by the FDA, which has broad regulatory powers. The market for ENDS products is subject to a great deal of uncertainty and is still evolving. ENDS products, having recently been introduced to market over the past 10 to 15 years, are at a relatively early stage of development, and represent core components of a market that is evolving rapidly, highly regulated, and characterized by a number of market participants. Rapid growth in the use of, and interest in, ENDS products is recent, and may not continue on a lasting basis. With respect to the GoFire Purchase Assets, the underlying technology touches on hemp/cannabis, nutraceutical and healthcare applications in addition to nicotine, all of which are heavily regulated by the FDA and other federal and state agencies. The demand and market acceptance for all of these products is subject to a high level of uncertainty. Therefore, we are subject to all the business risks associated with a new enterprise in an evolving market.

Some of our Product offerings through Bidi are subject to developing and unpredictable regulation. Our Products are sold through our distribution network and may be subject to uncertain and evolving federal, state, and local regulations, including hemp, non-THC cannabidiol (CBD) and other non-tobacco consumable products. Enforcement initiatives by those authorities are therefore unpredictable and impossible to anticipate. We anticipate that all levels of government, which have not already done so, are likely to seek in some way to regulate these products, but the type, timing, and impact of such regulations remains uncertain. With respect to CBD in particular, on January 26, 2023, the FDA announced that it would not initiate rulemaking to regulate CBD as a dietary food ingredient. Rather, after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed and has further indicated that it is prepared to work with Congress to create a new regulatory pathway for CBD through legislation.


In addition to the de facto FDA flavor ban that has resulted from the denial of nearly all PMTAs for flavored ENDS, ENDS products that are non-tobacco flavored continue to face the threat of prohibition at the local level, as many state and local authorities and attorneys general push for bans or request the FDA to deny PMTAs for flavored ENDS. In addition, a number of states and localities have banned the sale of non-tobacco flavored tobacco products. Recently, for example, California passed Proposition 31, which prohibits the sale of non-tobacco flavored tobacco products, including e-cigarettes, in retail locations. Thus, the non-tobacco flavored BIDI® Sticks are not permitted to be sold in California retail locations. We anticipate more states and localities will take this approach. Several other states have banned flavored ENDS, including New York, New Jersey, Rhode Island, and Massachusetts, with several more considering similar bans (e.g., Maryland, and Connecticut).

Ability to Meet Demand for our Products

We believe that the matters described under “FDA PMTA Determinations, 11th Circuit Decision and Impact on Our Business” have increased demand for our Products and has opened new distribution channels for us through which we can sell our Products. However, a sharp increase in demand for the Products will require us to use cash and/or obtain financing in order to purchase Products from Bidi for resale in the marketplace. As a result, we are faced with the risk that such cash or financing will not be available in sufficient amounts or on terms acceptable to us (or at all) to meet the market demand for the Products. Our inability to fulfill this demand will damage our reputation and could materially impact our ability to increase sales of the Products which, in turn, would adversely impact our results of operations. 

Inflation

Consumer purchases of tobacco products are historically affected by economic conditions, such as changes in employment, salary and wage levels, the availability of consumer credit, inflation, interest rates, fuel prices, sales taxes, and the level of consumer confidence in prevailing and future economic conditions. The U.S. has been experiencing an environment of material inflation in recent quarters, and this condition wouldmay impact discretionary consumer purchases, such as the BIDI® Stick. Demand for our Products may also decline during recessionary periods or at other times when disposable income is lower, and taxes may be higher.

Supply Chain

The spread of COVID-19 throughout the world as well as increasing tensions with China over the past several years and Russia’s February 2022 invasion of Ukraine  has created global economic uncertainty, which may cause partners, suppliers, and potential customers to closely monitor their costs and reduce activities. Any of the foregoing could materially adversely affected. We cannot provideaffect the supply chain for Bidi and our Products, and any assurances as tosupply chain distribution for the timing or outcomeProducts could have a materially adverse effect on our results of the merits-based case.operations.

Corporate History

We were incorporated on September 4, 2018, in the State of Delaware. Effective July 12, 2019, we changed our corporate name from Quick Start Holdings, Inc. to Kaival Brands Innovations Group, Inc. The name change was effected through a parent/subsidiary short-form merger of Kaival Brands Innovations Group, Inc., our wholly-owned Delaware subsidiary formed solely for the purpose of the name change, with and into us. We were the surviving entity.

Change of Control

On February 6, 2019, we entered into a Share Purchase Agreement (the “Share Purchase Agreement”), by and among us, GMRZ Holdings LLC, a Nevada limited liability company (“GMRZ”), our then-controlling stockholder, and Kaival Holdings, LLC, a Delaware limited liability company (“KH”), pursuant to which, on February 20, 2019, GMRZ sold 504,000,000 shares of our restricted common stock, representing approximately 88.06 percent88.06% of our then issued and outstanding shares of common stock, to KH,Kaival Holdings, and KHKaival Holdings paid GMRZ consideration in the amount set forth in the Share Purchase Agreement. The consummation of the transactions contemplated by the Share Purchase Agreement resulted in a change in control, with KHKaival Holdings becoming our largest controllingmajority stockholder. Nirajkumar Patel and Eric Mosser are the sole voting members of KH.Kaival Holdings, and Mr. Patel controls Kaival Holdings.

1

Description of Business

We are focused on growing and incubating innovative and profitable products into mature, dominant brands. Pursuant to the Distribution Agreement, Bidi granted us an exclusive worldwide right to distribute the Products for sale and resale to both retail level customers and non-retail level customers. We ceased all retail/direct-to-consumer sales in February 2021. Pursuant to the terms of the Distribution Agreement, Bidi provides us with all the branding, logos, and marketing materials to be utilized by us in connection with our marking and promotion of the Products. We do not manufacture any of the Products we resell. Currently, the Products consist of the “BIDI® Stick,” a disposable, tamper-resistant ENDS Product. In June 2022, we entered into the Third A&R Distribution Agreement, which, among other items, modifies various terms and provisions to reflect the terms of the PMI Licensing Agreement. Pursuant to the Third A&R Distribution Agreement, the exclusive right to distribute the Products is subject to a carve-out for, and exclusion, of the PMI Markets.

 

In connection with the Distribution Agreement, we entered into Sub-Distribution Agreements, whereby we appointed the counterparties as non-exclusive sub-distributors. Pursuant to the Sub-Distribution Agreements, the sub-distributors agreed to purchase for resale the Products in such quantities as they should need to properly service non-retail customers within the Territory

We process all sales made only to non-retail customers in the United States, with all sales to non-retail customers made through Bidi’s age-restricted website, www.wholesale.bidivapor.com. We ceased all retail/direct-to-consumer sales in February 2021 in order to better ensure youth access prevention and to comply with the Prevent All Cigarette Trafficking (“PACT”) Act. We provide all customer service and support at our own expense. Bidi sets the minimum prices for all sales made by us. We maintain adequate inventory levels of the Products in order to meet the demands of our non-retail customers, and deliver the Products sold to these customers.


Current Product Offerings

 

Pursuant to the A&R Distribution Agreement, we sellThe Company sells and resell ENDS Products, also referredresells electronic nicotine delivery systems, which it may refer to herein as (“e-cigarettes”)“ENDS Products”, or “e-cigarettes”, to non-retail level customers. Our primaryThe sole Product we resellthe Company resells is the “BIDI®“BIDI® Stick,” a disposable, tamper-resistant ENDS product that comes in a variety of flavor options for adult cigarette smokers. The court-ordered stay means thatCompany does not manufacture any of the MDOProducts it resells. The BIDI® Stick is not legallymanufactured by Bidi. Pursuant to the terms of the A&R Distribution Agreement, Bidi provides the Company with all branding, logos, and marketing materials to be utilized by the Company in force. Accordingly, we anticipate being able to continueconnection with its marketing and selling the Products, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challenging the legalitypromotion of the MDO. The FDA has indicated that it is prioritizing enforcement against companies that have either not submitted PMTAs, whose PMTAs have been refused acceptance or filing by the FDA, or whose PMTAs remain subject to MDOs. We are wholly dependent on Bidi to supply the BIDI® Sticks to us for distribution. Accordingly, any supply or other issues that impact Bidi, indirectly impacts us and our ability to operate our business.Products.

Other Potential Product Offerings

 

In addition to the BIDI®BIDI® Stick, we originally anticipated launching the distribution of the “BIDI® Pouch”“BIDI® Pouch,” initially outside of the United States. The initial planned February 2021 roll-out of the BIDI®BIDI® Pouch was delayed due to COVID-19 based manufacturing and supply chain constraints. Due to these complications, and in an effort to prevent future bottlenecks, Bidi decided to move manufacturing in-house. In 2021, Bidi modified the planned formulation of the BIDI®BIDI® Pouch. The original BIDI® BIDI® Pouch formulation (which never came to market) intended to utilize a tobacco-free (synthetic) nicotine formulation, along with natural fibers and a chew-base filler in six different flavors. However, production of the BIDI®BIDI® Pouch product was placed on temporary hold domestically in anticipationdue to concerns about the safety of synthetic nicotine and the likelihood of the FDA’sFDA enforcement of synthetic nicotine products either as eitherunapproved drugs or unauthorized drugs under Section 201(g)tobacco products. Subsequently, the Consolidated Appropriations Act of the Food, Drug and Cosmetic Act (“FDCA”) or as tobacco products under new FDA authority. On2022, signed by President Biden on March 15, 2022, the FDA Center for Tobacco Products (“CTP”) was given the authority to regulate products containing non-tobacco derived synthetic nicotine after President Biden signed the Omnibus Budget Bill (H.R. 2741). Pursuant to the new legislation, which included a rider amendingamended the definition of a “tobacco product” in the FDCAFood, Drug and Cosmetic Act and gave the FDA authority to includeregulate products containing nicotine from any source, including synthetic nicotine. The legislation also gave manufacturers of synthetic nicotine products became60 days to prepare and submit PMTAs by May 14, 2022. Synthetic nicotine products subject to timely submitted PMTAs were allowed to remain on the TCA requirementsmarket without the threat of enforcement for tobaccoanother 60 days, until July 13, 2022. After July 13, 2022, all synthetic nicotine products, includingregardless of PMTA status, are illegal and subject to FDA enforcement (unless the requirement for premarket authorization. Given these developments, Bidiproduct has decided notbeen authorized and is subject to launch the synthetic-nicotine BIDI® Pouch at this time, but will instead seek a PMTA marketing authorization from the FDA for the BIDI® Pouch made with tobacco-derived nicotine.Marketing Grant Order).

 

OnAlso, on July 14, 2021, we announced plans to launch ourits first Kaival-branded product, a Hemphemp CBD vaping product. In addition to our branded formulation, we anticipate that we will also provide white label, wholesale solutions for other product manufacturers through ourits subsidiary, Kaival Labs. However, as of the date of this Quarterly Report, weWe have not yet launched any Kaival-branded products,branded product, nor has have we begun to offerprovide white label wholesale solutions tofor other product manufacturers.  manufacturers, but the diversification of the types of products we distribute is an important part of our growth strategy.

Assuming we launch a hemp CBD product, of which there can be no assurances, we intend that all CBD products will be produced and distributed strictly in compliance under the Agriculture Improvement Act of 2018 (known as the 2018 Farm Bill), which defines hemp as the plant cannabis sativa and any part of the plant with a delta-9 THC concentration of not more than 0.3 percent by dry weight. According to the 2018 Farm Bill, hemp-derived products can be offered for retail sale in many forms: smoke, pouch, tinctures, topicals, capsules, vape oil and gummies/edibles. We plan to utilize Bidi’s patented BIDI® Stick delivery mechanism in order to provide a similar, premium experience in the initial CBD product line. We expect our industrial-grade hemp CBD formula to provide greater bioavailability than many market peers, resulting in a better consumer experience in less usage. On January 26, 2023, the FDA announced that it would not initiate rulemaking to regulate CBD as a dietary food ingredient. Rather, after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The FDA further indicated that it is prepared to work with Congress on this matter.

In addition, in May 2023 we acquired 12 existing and 46 pending patents with novel technologies related to vaporization and inhalation technologies from GoFire and related trademarks and trademark applications. As described above, we hope to generate revenue from this acquired intellectual property via licensing and product development activities. However, there can be no assurance that we will be able to implement this strategy.

 

PMI Licensing Agreement and International Distribution

On June 13, 2022, we, through our wholly owned subsidiary, KBI, entered into the PMI License Agreement with PMPSA, a wholly owned affiliate of PMI, for the development and distribution of ENDS products in certain markets outside of the United States, subject to market (or regulatory assessment). The PMI License Agreement grants to PMPSA a license of certain intellectual property rights relating to Bidi’s ENDS device, known as the BIDI® Stick in the United States, as well as potentially newly developed devices, to permit PMPSA to manufacture, promote, sell, and distribute such ENDS device and newly developed devices, in international markets, outside of the United StatesStates.

 

On July 25, 2022, we announced the launch of PMPSA’s custom-branded self-contained e-vapor product, pursuant to the licensing agreement. The product, a self-contained e-vapor device, VEEBA, has been custom developed and is now being distributed in Canada. VEEBA was then commercially launched by PMPSA in Europe in February 2023 and we expect to generate royalty revenues pursuant to the licensing agreement beginning in our fiscal fourth quarter of 2023 (quarter ending October 31, 2023), with additional market launches planned this year.

Going Concern

Our financial statements are prepared in accordance with U.S. GAAP applicable to a going concern, which contemplates realization of assets and the satisfaction of liabilities in the normal course of business within one year after the date the consolidated financial statements are issued.

 

In February 2022,accordance with Financial Accounting Standards Board (the “FASB”), Accounting Standards Update (“ASU”) No. 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40), our management evaluates whether there are conditions or events, considered in aggregate, that raise substantial doubt about our ability to continue as a going concern within one year after the U.S. Courtdate that the financial statements are issued. As shown in the accompanying consolidated financial statements, the Company has incurred significant recurring losses, which raises substantial doubt about the Company’s ability to continue as a going concern.

In response to the above, our management assessed our plans to alleviate that doubt. We had positive working capital as of Appeals forApril 30, 2023, of $3,714,959. Management considered that the Eleventh Circuit granted Bidi a judicial stay ofCompany’s losses were due to various factors such as: (i) uncertainty surrounding the PMTA process with the FDA and (ii) the MDO previouslythat was issued by the FDA to Bidi in September 2021. The ruling means that the MDO is not legally in force. Accordingly, we anticipate being able to continue marketing and selling the Products, subject to the FDA’s enforcement discretion, while Bidi continues with its merits case challenging the legality of the MDO. The FDA has indicated that it is prioritizing enforcement against companies that have either not submitted PMTAs, whose PMTAs have been refused acceptance or filing by the FDA, or whose PMTAs remain subject to MDOs. Oral arguments in the merits case were heldVapor on May 17, 2022.

If the U.S. Court of Appeals for the Eleventh Circuit rules in favor of Bidi in the merits case, we anticipate that the FDA will be compelled to place the non-tobacco flavored ENDS back into the PMTA scientific review process. If this is the outcome of the merits case, we anticipate being able to continue marketing and selling the Products, subject to the FDA’s enforcement discretion, until the scientific review process is complete on each of Bidi’s PMTA for the non-tobacco flavored ENDS and the FDA issues its decision on each.

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If the U.S. Court of Appeals for the Eleventh Circuit rules against Bidi on the merits case, if the FDA re-issues the MDO after completing its scientific review process for each of Bidi’s PMTAs for its non-tobacco flavored ENDS or if the FDA otherwise chooses to enforceproducts. However, the MDO against Bidi, we will be forcedwas set aside and vacated by the 11th Circuit in August 2022, and the ability to ceaseappeal such decision has passed, thereby facilitating the continued sales onof the non-tobacco flavored BIDI®BIDI® Sticks in the United States market, leaving only the Tobacco (Classic) BIDI® Sticks product for sale in the United States. If this isStates (pending the outcomeFDA’s review of the merits case, this combined with a negativepending PMTAs and subject to FDA enforcement). Concurrently, the PMTA for the tobacco-flavored (Classic) BIDI® Sticks for sale in the United States continues to move through the PMTA scientific review phase (pending the FDA’s review of that PMTA). Management’s assessment included the preparation of cash flow from operations may raiseforecasts which considered increases in revenues considering the favorable ruling obtained on the MDO as disclosed above.


We believe that our available cash and the cash to be provided by future operating activities (including anticipated sales of BIDI® Sticks and royalty revenue under the PMI License Agreement), should enable the Company to meet its estimated liquidity needs for the next 12 months after the date that the financial statements included within this Report are issued. We believe that the above factors alleviate the substantial doubt onregarding our ability to continue as a going concern.

Management plans to continue similar operations with increased marketing, which we believe will result in increased revenue and net income. Further, we believe that the PMI License Agreement will generate additional revenues through royalties paid by PMPSA.

However, there is no assurance that management’s planthe Company’s plans will be successfulable to generate expected or greater amounts of revenues or ever achieve profitability, due to the current economic climate in the United States and globally.

globally, the regulation and public perception of ENDS products and the various other risks faced by the Company. The unaudited consolidated financial statements filed as part ofincluded in this Quarterly Report do not include any adjustments relating to reflect the possible future effects on the recoverability and classification of recorded assets or the amounts and classification of liabilities that might be necessary inmay result from the event that we cannot continue as a going concern.outcome of these or other risks or uncertainties.

Liquidity and Capital Resources

We believe we have sufficient cash on hand as of June 13, 2022. However, we are awaiting the outcomedate of Bidi’s merit-based case pending in the U.S. Court of Appealsthis Report to support our operations for the Eleventh Circuit with respect to the MDO issued by the FDA in September 2021. If the Eleventh Circuit Court of Appeals rules against Bidi, our business and financial condition will be materially adversely affected, including our ability to generate revenues and our liquidity. Other than the ongoing MDO matters, we have no known current demands or commitments and are not aware of any events or uncertainties asat least 12 months. As of April 30, 2022 that will result in or that are reasonably likely to materially increase or decrease our current requirements for cash.

At April 30, 2022,2023, we had working capital of approximately $13.1$3.7 million and total cash of approximately $4.7$1.1 million.

We intend to generally rely on cash from operations and equity and debt offerings to the extent necessary and available, to satisfy our liquidity needs. There are a number of factors that could result in the need to raise additional funds, including a decline in revenue, or a lack of anticipated sales growth, increased costs and increased costs.our potential plan to redeem for cash the shares of our Series B Preferred Stock issued in connection with our GoFire asset purchase in May 2023. Our efforts are directed toward generating positive cash flow and, ultimately, profitability. If these efforts are not successful, we maywill very likely need to raise additional capital. Should capital not be available to us at reasonable terms, other actions may become necessary in addition to cost control measures and continued efforts to increase sales. These actions may include exploring strategic options for the sale of the Company, the creation of joint ventures or strategic alliances under which we will pursue business opportunities, or other alternatives. We believe we have the financial resources to weather any short-term impacts of the FDA’s PMTA process and Bidi’s receipt of a MDO from the FDA; however, an extended impact, or a negative ruling in Bidi’s merits-based litigation case orFDA, which has now been set aside and remanded by the FDA ultimately not approving Bidi’s PMTA if it is re-evaluated could have a material and adverse effect on our sales, earnings, and liquidity.11th Circuit. At this time, we do not foresee the likely need for further strategic financing for the next twelve months, given the financing we completed in September 2021 as indicated below, and our continual sales growth efforts and our operating cash results.

In September 2021, we completed a firm commitment underwritten offering, which offering was made pursuant to our Registration Statement on Form S-3 (File No. 333-258339) (the “Registration Statement”). The SEC declared the Registration Statement effective on August 10, 2021. We sold 4,700,000 shares of our Common Stock and warrants to purchase an additional 3,525,000 shares of our Common Stock. We sold each share of our Common Stock and warrants to purchase 0.75 shares of our Common Stock at a combined public offering price of $1.70. We also granted the underwriter the option to purchase an additional 705,000 shares of our Common Stock and warrants to purchase an additional 528,750 shares of our Common Stock. We received net proceeds from the offering of approximately $8.3 million. We have also received approximately $1.7 million from the exercise of the warrants. We used the proceeds for general corporate purposes.

Cash Flows:

Cash flow used in operations was approximately $(4.6)$(2.6) million for the first six months of fiscal year 2022,2023, compared to $(5.2)$(4.6) million used in operations for the first six months of fiscal year 2021.2022. The decrease in cash flow used inby operations for the first six months of fiscal year 20222023 compared to the first six months of fiscal 20212022 was primarily due to decreasebuild up of planned inventory for anticipated sales, changes in stock-based compensation,related party accounts receivable,payable, and accounts payable.income tax receivable.

Cash flow used in investing activities of approximately $3,400 for the six months of fiscal year 2023, compared to no cash flow used in investing activities for the six months of fiscal year 2022. The cash used in investing activities for the six months of fiscal year 2023 consisted of cash used for the purchase of warehouse equipment.

 

The netCompany had no cash flow from financing activities for the six months of fiscal year 2023, compared to cash flow provided by financing activities wasof approximately $1.5 million for the first six months of fiscal year 2022, compared to2022. The cash flow used in financing activities of approximately $78,000 for the first six months of fiscal year 2021. Cash provided by financing activities during the first six months of fiscal year 2022 resulted from the exercise of warrants by various stockholders. The cash used in financing activities for the first six months of fiscal year of 2022 and fiscal year 2021 consisted of cash usedprovided for the settlementexercise of RSUs issued to employees.stock warrants.


Results of Operations

Three months ended April 30, 2022,2023, compared to three months ended April 30, 20212022

Revenues:Revenues:

Revenues for the second quarter of fiscal year 20222023 were approximately $3.1$3.0 million, compared to approximately $18.1$3.1 million in the same period of the prior fiscal year. In February 2022, Bidi was granted a judicial stay on the MDO previously issued by the FDA prohibiting the marketing and sale of non-tobacco flavored BIDI® Sticks, which had significantly impacted our revenues in previous quarters. As a result of the grant of the judicial stay of the MDO, our revenues increasedRevenues were flat in the second quarter of fiscal 2022, as compared2023, primarily due to first quarter of fiscal 2022.credits/discounts/rebates issued to customers. We expectdo not anticipate this trend to continue as renewed distribution ramps up and sales of non-tobacco flavored BIDI® Sticks increase, subjectand even more so now that the MDO has been vacated, which allows us to continue marketing and selling the court ruling in Bidi’s favor in the pending merits-based case, andProducts, subject to the FDA’s enforcement discretion.

 

With respect to synthetic nicotine vaping products, on March 15, 2022, the FDA was given the authority to regulate products containing non-tobacco derived synthetic nicotine after President Biden signed the Omnibus Budget Bill (H.R. 2741). Pursuant to the new legislation, which amended the definition of a “tobacco product” in the FDCA to include products containing nicotine from any source, manufacturers of all currently marketed synthetic nicotine products were required to submit a PMTA by May 14, 2022 to remain on the market. Products that do not receive PMTA authorization (i.e., a Marketing Grant Order or “MGO”) within 60 days (i.e., by July 13, 2022) and that remain on the market thereafter will be in violation of the statute and subject to FDA enforcement. We anticipate that if the FDA begins enforcement against illegally-marketed or synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products, such as the BIDI® Stick.

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Cost of Revenue, netNet and Gross Profit (Loss):

Gross (loss) profit in the second quarter of fiscal year 20222023 was approximately $387,700,($0.1) million, or approximately 12.7%,(4.2%) of revenues, net, compared to approximately $6.3$0.4 million gross profit or approximately 34.6%12.7%, of revenues, net, for the second quarter of fiscal year 2021.2022. Total cost of revenue, net was approximately $2.7$3.1 million, or approximately 87.3%,104.2% of revenue, net for the second quarter of fiscal year 2022,2023, compared to approximately $11.9$2.7 million, or approximately 65.4%,87.3% of revenue, net for the second quarter of fiscal year 2021.2022. The decrease in gross profit is primarily driven by the decrease in overall sales and the recognition of accumulated year-to-date credits/discounts/rebates givenissued to customers, totaling approximately $499,000, resulting in an offset to revenue, net,$1.4 million, during the second quarter of fiscal year 2022.2023.

 

Operating Expenses:

Total operating expenses were approximately $3.8 million for the second quarter of fiscal year 2023, compared to approximately $5.4 million for the second quarter of fiscal year 2022, compared to approximately $10.4 million for the second quarter of fiscal year 2021.2022. For the second quarter of fiscal year 2022,2023, operating expenses consisted primarily of advertising and promotion fees of approximately $761,000, stock-based compensation$0.7 million, stock option expense of approximately $2.5$1.4 million, professional fees of approximately $163,000,$0.8 million, and all other general and administrative expenses of approximately $2.0 $1.0 million. General and administrative expenses in the second quarter of fiscal year 20222023 consisted primarily of salaries and wages, stock option expense, insurance, lease expense, project expenses, banking fees, business fees and state and franchise taxes. For the second quarter of fiscal year 2021,2022, operating expenses were approximately $10.4$5.4 million, consisting primarily of advertising and promotion fees of approximately $801,000,$0.8 million, stock option expense of 2.5 million, professional fees totaling approximately $7.3$0.2 million, and all other general and administrative expenses of approximately $2.3$1.9 million. General and administrative expenses consisted primarily of salaries and wages, insurance, banking fees, business fees, and other service fees. We expect future operating expenses to increase while we increase the footprint of our business and generate increased sales growth.

Income Taxes:

During the three months ended April 30, 2023, we did not accrue a tax provision for income taxes, due to the pre-tax loss of approximately ($4.0) million, similarly we did not accrue a tax provision for income taxes, due to the pre-tax loss of approximately ($5.0) million for the three months ended April 30, 2022.

Net Loss:

As a result of the items noted above, the net loss for the second quarter of fiscal year 2023 was approximately $4.0 million, or $0.07 basic and diluted net loss per share, compared to a net loss of approximately $5.0 million, or $0.16 basic and diluted net loss per share, for the second quarter of fiscal year 2022. The decrease in the net loss for the second quarter of fiscal year 2023, as compared to the second quarter of fiscal year 2022, is primarily attributable to the increase revenues and decrease in customer credits/discounts/rebates, as noted above.

Six months ended April 30, 2023, compared to six months ended April 30, 2022

Revenues:

Revenues for the six months of fiscal year 2023 were approximately $5.5 million, compared to $6.0 million in the same period of the prior fiscal year.

Revenues decreased in the six months of fiscal year 2023 compared to fiscal year 2022, generally do to credits/discounts/rebates issued to customers. We do not anticipate this trend to continue as renewed distribution ramps up and sales of non-tobacco flavored BIDI® Sticks increase, and even more so now that the MDO has been vacated, which allows us to continue marketing and selling the Products, subject to the FDA’s enforcement discretion.

Cost of Revenue and Gross Profit (Loss):

Gross profit in the six months of fiscal year 2023 was approximately $0.4 million, compared to gross loss of approximately ($0.3) million for the six months of fiscal year 2022. Total cost of revenue was approximately $5.1 million for the six months of fiscal year 2023, compared to $6.2 million for the six months of fiscal year 2022. Therefore, the increase in gross profit of approximately $0.7 million for the six-month periods of fiscal years 2023 and 2022 is primarily driven by the decrease in overall sales of approximately $0.4 million   and the decrease in the cost of revenue, totaling approximately $1.1 million, resulting in an increase in gross profit of approximately $0.7 million during the six months ended April 30, 2023.

Operating Expenses:

Total operating expenses were approximately $7.4 million for the first six months of fiscal year 2023, compared to approximately $7.5 million for the first six months of fiscal year 2022. For the first six months of fiscal year 2023, operating expenses consisted of advertising and promotion fees of approximately $1.2 million, stock option expense of approximately $2.8 million, professional fees of approximately $1.4 million, and all other general and administrative expenses of approximately $2.0 million. General and administrative expenses in the second quarter of fiscal year 20212023 consisted primarily of salaries and wages, stock option expense, insurance, lease expense, project expenses, banking fees, business fees and state and franchise taxes. For the first six months of fiscal year 2022, operating expenses were approximately $7.5 million, consisting primarily of advertising and promotion fees of approximately $1.4 million, stock option expense of $2.8 million, professional fees totaling approximately $1.4 million, and all other general and administrative expenses of approximately $1.9 million. General and administrative expenses consisted primarily of salaries and wages, insurance, banking fees, business fees, and other service fees. We expect future operating expenses to increase while we increase the footprint of our business and generate increased sales growth.

 


Income Taxes:

 

During the second quarter of fiscal year 2022,six months ended April 30, 2023, we did not accrue a tax provision for income taxes, due to the pre-tax loss of approximately ($5.1)7.0) million, compared tosimilarly we did not accrue a tax provision of approximately $187,000 for the second quarter of fiscal year 2021, due to the amount of pre-tax income for that three-month period. However, we did report a tax benefit of approximately $5,800 during fiscal year 2022. The reduction from the second quarter of fiscal year 2021 wastaxes, due to the pre-tax operating loss recognized during the second quarter of fiscal year 2022.

Net Loss:

As a result of the items noted above, the net loss for the second quarter of fiscal year 2022 was approximately ($5.0) million, or ($0.16) basic and diluted loss per share, compared to a net loss of approximately ($4.3)7.8) million or ($0.18) basic and diluted earnings per share, for the second quarter of fiscal year 2021. The increase in the net loss for the second quarter of fiscal year 2022, as compared to the second quarter of fiscal year 2021, is primarily attributable to the decreased revenues and increase in customer credits/discounts/rebates, as noted above.

Six months ended April 30, 2022, compared to six months ended April 30, 2021

Revenues:

Revenues for the first six months of fiscal year 2022 were approximately $6.0 million, compared to $55.5 million in the same period of the prior fiscal year. Revenues decreased in the first six months of fiscal year 2022 compared to fiscal year 2021, generally due to (i) Bidi’s receipt of the MDO, which limited our ability during the first six months of fiscal year 2022 to sell flavored BIDI® Sticks in the United States and (ii) increased competition. A recent court ruling in favor of Bidi granted a judicial stay on the MDO previously issued by the FDA banning the marketing and sale of flavored BIDI® Sticks, amongst banning these flavored sticks with other industry competitors. As a result of the judicial stay of Bidi’s MDO, we have begun to experience an upward trajectory of revenues as renewed distribution ramps up and sales of flavored BIDI® Sticks products increase, which sales remain subject to FDA’s enforcement discretion (and assuming that Bidi is successful in its currently pending merits-based case). We also anticipate that if the FDA begins enforcement against illegally-marketed or synthetic-nicotine vaping products, there may be an increased demand for compliant and legal vaping products, such as the BIDI® Stick.     

Cost of Revenue and Gross Profit (Loss):

Gross loss in the first six months of fiscal year 2022 was approximately ($303,000), compared to gross profit of approximately $11.1 million profit for the first six months of fiscal year 2021. Total cost of revenue was approximately $6.2 million for the first six months of fiscal year 2022, compared to $44.4 million for the first six months of fiscal year 2021. The decrease in gross profit is primarily driven by the decrease in overall sales and the recognition of accumulated year-to-date credits, discounts, and rebates given to customers, totaling approximately $1.4 million, resulting in an offset to revenue, net, during the six months ended April 30, 2022.

 

Operating Expenses:

Total operating expenses were approximately $7.5 million for the first six months of fiscal year 2022, compared to approximately $14.7 million for the first six months of fiscal year 2021. For the first six months of fiscal year 2022, operating expenses consisted of commissions paid pursuant to the Amended Service Agreement of approximately $1.4 million and general and administrative expense consisting of amortized stock option expense of approximately $2.8 million, professional fees of approximately $1.4 million, salaries and wages of approximately $939,000, and all other general and administrative expenses of approximately $1.0 million. General and administrative expenses in the first six months of fiscal year 2022 consisted primarily of legal fees, salaries, other professional fees, merchant fees, and other service fees. Total operating expenses for the first six months of fiscal year 2021 were approximately $14.7 million. These operating expenses consisted primarily of advertising and promotion fees of approximately $1.8 million; professional fees of approximately $9.7 million; salary, wages, commissions, and bonuses of approximately $1.8 million; stock-based compensation expense of approximately $580,000; professional fees of approximately $163,000; and general and administrative expenses of approximately $820,000, which consisted primarily of insurance, banking fees, merchant fees, business fess and other service fees.

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Income Taxes:

During the first six months of fiscal year 2022, we did not accrue a tax provision for income taxes, due to the pre-tax loss of approximately ($7.8) million. However, we did report a tax benefit of approximately $5,800 during fiscal year 2022. During the first six months of fiscal year 2021, we accrued a tax provision of approximately $293,100 related to tax liabilities for fiscal year 2020.

Net Income (Loss):

Net loss for the first six months of fiscal year 20222023 was approximately ($7.8)$7.0 million, or $(0.25)$0.12 basic and diluted earnings per share, compared to net loss for the first six months of fiscal year 2021,2022, which was approximately ($3.9)$7.8 million, or $(0.17)$0.25 basic and diluted earnings per share. The increasedecrease in the net loss for the first six months of fiscal year 2022,2023, as compared to the first six months of fiscal year 2021,2022, is primarily attributable to the decreased revenues and increasethe decrease in customer credits/discounts/rebates.cost of sales.

 

Weighted-average shares of Common Stock outstanding were 23,511,959 and 23,368,691 for the first six months of fiscal year 2022 and 2021, respectively.

Critical Accounting Policies and Estimates

 

Other than the policy changes disclosed in Note 2, Basis of Presentation and Significant Accounting Policies, to the unaudited Consolidated Financial Statements in Item 1 of Part I of this Quarterly Report, thereThere have been no material changes to our critical accounting policies and estimates during the threesix months ended April 30, 20222023 from those disclosed in Item 7, Management’s Discussion and Analysis of Financial Condition and Results of Operations, of our 20212022 Annual Report for the year ended October 31, 2021.2022.

Emerging Growth Company

We are an “emerging growth company,” that is exempt from certain financial disclosure and governance requirements for up to five years as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). The JOBS Act eases restrictions on the sale of securities and increases the number of stockholders a company must have before becoming subject to the SEC’s reporting and disclosure rules. We have not elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(2) of the JOBS Act, that allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies.

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Item 3. Quantitative and Qualitative Disclosures About Market RiskRisk.

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


Item 4. Controls and ProceduresProcedures.

Evaluation of Disclosure Controls and Procedures

OurDisclosure controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act, is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitations, controls and procedures designed to ensure that information required to be disclosed in our reports filed under the Exchange Act is accumulated and communicated to our management, is responsible for establishingincluding our principal executive officer and maintaining adequate internal control over our principal financial reportingofficer, to allow timely decisions regarding required disclosure.

Under the supervision and with the participation of our management, including our President and Chief Operating Officer and Interim Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(f)13a-15(e) under the Exchange Act). Internal control over financial reporting is a process, including policies as of April 30, 2023, the end of the period covered by this Quarterly Report. Based on that evaluation, the President and procedures, designed to provide reasonable assurance regarding the reliabilityChief Operating Officer and Interim Chief Financial Officer concluded that because of financial reporting and the preparation of financial statements for external reporting purposesmaterial weaknesses in accordance with U.S. generally accepted accounting principles. Our management assessed our internal control over financial reporting, using the criteria in Internal Control – Integrated Framework (2013 Framework), issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). A system of internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reportingour disclosure controls and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting mayprocedures were not prevent or detect misstatements.

Based on our evaluation under the framework in COSO, our management concluded that our internal control over financial reporting remained ineffectiveeffective as of April 30, 2022 based on such criteria. Material weaknesses existed in the design or operation2023. Some of certain of ourthose internal controls over financial reporting that adversely affect our internal controls. A material weakness is a significant deficiency, or combinationinclude multiple levels of deficiencies, in internal control over financial reporting that results in more than a remote likelihood that a material misstatementreview of the annual or interim financial statements may not be prevented or detected. Management determined that there was aaccounting and reporting procedures and processes, lack of resources to provideproper segregation of duties, consistent with control objectives, the lack of sufficient and consistent real time remote communications, as well as certain accounting and reporting issues.

Remediation of Material Weaknesses

We are committed to maintaining a strong internal control environment and implementing measures designed to help ensure that all material weaknesses are remediated as soon as possible. Management will continue to work to improve its disclosure controls and procedures during fiscal 2023 with the lackgoal of a fully developed formal review process that includesimprovement in the effectiveness of its systems in our internal controls during the next 12 months. We intend to hire additional staff and to take such other actions as may be necessary to address its material weaknesses. The Company did add additional financial and accounting personnel during its fiscal year ended October 31, 2022, and as such, we believe we have made progress in the implementation of certain internal controls, such as multiple levels of review over financial disclosureand analysis of the accounting and reporting processes.procedures and processes, and of journal entries and general ledger account reconciliations.

The weaknesses and the related risks are not uncommon in a company of our size because of the limitations in the location, size and number of our staff. To address these material weaknesses, and subject to the receipt of additional financing or cash flows, we have undertaken certain remediation measures to date to address the material weaknesses described in this Quarterly Report, including implementing procedures pursuant to which we can ensure segregation of duties and hire additional resources to ensure appropriate review and oversight, as well as more timely formal communications processes, more diligent review and approval of all disbursements and more timely review of all banking transactions sales orders and inventory management.

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 under all potential conditions, regardless of how remote, and may not prevent or detect all errors and all fraud. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of a simple error or mistake. Our internal control over financial reporting is designed 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

Changes in Internal Control over Financial Reporting

There have beenDue to the identification of certain material weaknesseswe continue to work on strengthening our internal control structure. We made no other changes in our internal control over financial reporting, (as that term isas defined in Rules 13(a)-15(f)13a-15(f) and 15(d)-15(f) of15d-15(f) under the Exchange Act) that have occurredAct, during the fiscal three monthsquarter ended April 30, 20222023, that have materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.

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PART II OTHER INFORMATION

Item 1. Legal ProceedingsProceedings.

There are no material pending legal proceedings as defined by Item 103 of Regulation S-K, to which we are a party or of which any of our property is the subject, other than ordinary routine litigation incidental to the Company’s business.

Item 1A. Risk FactorsFactors.

Our business, operations, and financial condition are subject to various risks and uncertainties. The risk factors described in Part I, “Item 1A. Risk Factors” in the 20212022 Annual Report, for the year ended October 31, 2021,2022, should be carefully considered, together with the other information contained or incorporated by reference in this Quarterly Report and in our other filings with the SEC in connection with evaluating us, our business, and the forward-looking statements contained in this Quarterly Report. DuringOther than as disclosed under Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations in this Report, during the quartersix months ended April 30, 2022,2023, there have been no material changes from the risk factors previously disclosed under Part I, “Item 1A. Risk Factors” in the 20212022 Annual Report, for the year ended October 31, 2021.2022.

Item 2. Unregistered Sales of Equity Securities and Use of ProceedsProceeds.

Share-based CompensationNone.

During the three months ended April 30, 2022, we issued the following securities as compensation to certain of our employees and consultants:

On February 4, 2022, the Company entered into a Consulting Agreement with Oakhill Europe Ltd (“Oakhill Europe”), pursuant to which the Company engaged Oakhill Europe to provide strategic advising and negotiation assistance for potential international distribution agreements (collectively, the “Oakhill Services”), in exchange for a cash monthly retainer, incentive compensation bonuses, and an incentive compensation bonus value of $75,000 paid in fully-vested non-qualified stock options, upon the achievement of certain events.

On February 5, 2022, the Company issued 61,250 shares of Common Stock to 7 employees in accordance with the vesting schedules set forth in RSU agreements previously entered into with such employees. The RSUs were a portion of the compensation paid to such employees for their services to us. Of the shares issued to employees, 24,058 shares were withheld by the Company to satisfy tax withholding obligations and/or satisfy cash settlement options to employees, equaling approximately $23,336. The issuances were exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) by virtue of Section 4(a) (2) thereof as a transaction not involving a public offering.

On February 27, 2022, the Company granted a stock option award to Mark Thoenes, Interim Chief Financial Officer, to acquire up to 100,000 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan, as partial compensation for Mr. Thoenes’ services. The option shares are exercisable at a price of $2.45 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

On February 27, 2022, the Company granted a stock option award to Russell Quick, as an independent consultant providing strategic advising and negotiation assistance for potential international distribution agreements, to acquire up to 100,000 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan. The option shares are exercisable at a price of $2.45 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

On March 5, 2022, the Company granted a stock option award to Nirajkumar Patel, Chief Executive Officer, to acquire up to 600,000 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan, as partial compensation for Mr. Patel’s services as Chief Executive Officer. The option shares are exercisable at a price of $2.85 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

On March 5, 2022, the Company granted stock option awards to Eric Mosser, Chief Operating Officer, to acquire up to 500,000 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan, as partial compensation for Mr. Patel’s services as Chief Operating Officer. The option shares are exercisable at a price of $2.85 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

On March 5, 2022, the Committee and the Board approved the grant of stock option awards to 5 employees, to acquire up to 285,600 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan. The option shares are exercisable at a price of $2.85 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

On February 28, 2022 and on March 3, 2022 the Company issued 10,000 shares and 2,963 shares, respectively, of the Company’s Common Stock to Mr. Rudy Singh as payment for the EDGAR filing services performed for the filing of the Company’s Annual Report on Form 10-K for the year ended October 31, 2021. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

Following the end of the three months ended April 30, 2022, we issued the following securities as compensation:

On May 18, 2022, the Company granted a stock option award to Russell Quick, pursuant to a previously executed independent consultant agreement that renewed on December 1, 2022, to acquire up to 500,000 shares of Common Stock under the Company’s 2020 Stock and Incentive Compensation Plan. The option shares are exercisable at a price of $1.03 per share, which equaled the closing price of the Common Stock as of the date immediately prior to the grant date. The issuances were exempt from the registration requirements of the Securities Act by virtue of Section 4(a)(2) thereof as a transaction not involving a public offering.

Item 3. Defaults Upon Senior SecuritiesSecurities.

None.

Item 4. Mine Safety DisclosuresDisclosures.

None.Not applicable.

Item 5. Other InformationInformation.

None.

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Item 6. Exhibits

The following exhibits are filed herewith as a part of this Quarterly Report.

Exhibit NumberDescription
3.1Restated Certificate of Incorporation, which was filed as Exhibit 3.1 to our Registration Statement on Form 10-12G filed with the Securities and Exchange Commission on March 25, 2019, and is incorporated herein by reference thereto.
3.2Bylaws, which were filed as Exhibit 3.2 to our Registration Statement on Form 10-12G filed with the Securities and Exchange Commission on February 19, 2019, and is incorporated herein by reference thereto.
3.3Certificate of Ownership and Merger, as filed with the Secretary of State of the State of Delaware on June 20, 2019, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 15, 2019, and is incorporated herein by reference thereto.
3.4Certificate of Correction, as filed with the Secretary of State of the State of Delaware on July 15, 2019, which was filed as Exhibit 3.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 15, 2019, and is incorporated herein by reference thereto.
3.5Certificate of Designation of the Preferences, Rights and Limitations of the Series AB Convertible Preferred Stock, as filed with the Secretary of State of the State of Delaware on August 19, 2020, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on August 21, 2020, and is incorporated herein by reference thereto.
3.6Certificate of Amendment to the Amended and Restated Certificate of Incorporation of Kaival Brands Innovations Group, Inc., effective July 20, 2021, which was filed as Exhibit 3.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 20, 2021, and is incorporated herein by reference thereto.
10.1Exclusive Distribution Agreement by and between Kaival Brands Innovations Group, Inc. and Bidi Vapor LLC, dated March 9, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 9, 2020, and is incorporated herein by reference thereto. (1)
10.2Service Agreement by and between Kaival Brands Innovations Group, Inc. and QuikfillRx LLC, dated March 31, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on April 1, 2020, and is incorporated herein by reference thereto.
10.3First Amendment to Service Agreement by and between Kaival Brands Innovations Group, Inc. and QuikfillRx LLC, dated June 2, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on June 3, 2020, and is incorporated herein by reference thereto.
10.4Non-Exclusive Sub-Distribution Agreement by and between Kaival Brands Innovations Group, Inc. and Favs Business, LLC, dated April 3, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2020, and is incorporated herein by reference thereto. (1)

10.5Non-Exclusive Sub-Distribution Agreement by and between Kaival Brands Innovations Group, Inc. and Colonial Wholesale Distributing Inc., dated April 11, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on April 13, 2020, and is incorporated herein by reference thereto. (1)
10.6Amended and Restated Exclusive Distribution Agreement by and between Kaival Brands Innovations Group, Inc. and Bidi Vapor LLC, dated May 21, 2020, which was filed as Exhibit 10.5 to our Form 10-Q filed with the Securities and Exchange Commission on May 27, 2020, and is incorporated herein by reference thereto. (1)30, 2023*
10.7Amended and Restated Non-Exclusive Sub-Distribution Agreement by and between Kaival Brands Innovations Group, Inc. and Favs Business, LLC, dated May 21, 2020, which was filed as Exhibit 10.6 to our Form 10-Q filed with the Securities and Exchange Commission on May 27, 2020, and is incorporated herein by reference thereto. (1)
   
10.84.1Common Stock Purchase Warrant issued to GoFire, Inc on May 30, 2023*
10.1Amended and Restated Non-Exclusive Sub-DistributionAsset Purchase Agreement by and between Kaival Brands Innovations Group, Inc. and Colonial Wholesale Distributing Inc., dated May 25, 2020, which was filed as Exhibit 10.7 to our Form 10-Q filed with the Securities and Exchange Commission on May 27, 2020, and is incorporated herein by reference thereto. (1)
10.9Share Cancellation and Exchange Agreement, by and between the Company and Kaival Holdings, LLC, dated August 19, 2020, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on August 21, 2020, and is incorporated herein by reference thereto.
10.102020 Stock and Incentive Compensation Plan, which was filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on June 3, 2020, and is incorporated herein by reference thereto.

8

10.11Lease Agreement by and betweenamong Kaival Brands Innovations Group, Inc., Kaival Labs, Inc., and Just Pick, LLC,GoFire, Inc., dated July 15, 2020, filed as Exhibit 10.14 to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on September 14, 2020, and is incorporated herein by reference thereto.
 10.12Second Amended and Restated Exclusive Distribution Agreement, by and between Kaival Brands Innovations Group, Inc. and Bidi Vapor, LLC, dated April 20, 2021, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on April 21, 2021, and is incorporated herein by reference thereto. (1)
10.13Consulting Agreement, by and between Kaival Brands Innovations Group, Inc. and Russell Quick, dated March 16, 2021, which was filed as Exhibit 10.18 to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 21, 2021, and is incorporated herein by reference thereto.
10.14Second Amendment to Service Agreement, by and between Kaival Brands Innovations Group, Inc. and QuikfillRx LLC, effective as of March 16, 2021, which was filed as Exhibit 10.19 to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on June 21, 2021, and is incorporated herein by reference thereto.
10.15Independent Director Agreement, dated JuneMay 30, 2021, by and between the Company and George Chuang, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2021, and is incorporated herein by reference thereto.
10.16Consulting Agreement, dated June 14, 2021, by and between the Company and Mark Thoenes, which was filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 1, 2021, and is incorporated herein by reference thereto.
10.17Amended and Restated Independent Director Agreement, dated March 29, 2021, by and between the Company and Roger Brooks, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 23, 2021, and is incorporated herein by reference thereto.
10.18Amended and Restated Independent Direct Agreement, dated March 29, 2021, by and between the Company and Paul Reuter, which was filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on July 23, 2021, and is incorporated herein by reference thereto.
10.19Amendment to Amended and Restated Independent Director Agreement, dated July 19, 2021, by and between the Company and Roger Brooks, which was filed as Exhibit 10.3 to our Current Report on Form 8-K filed with Securities and Exchange Commission on July 23, 2021, and is incorporated herein by reference thereto.
10.20Amendment to Amended and Restated Independent Director Agreement, dated July 19, 2021, by and between the Company and Paul Reuter, which was filed as Exhibit 10.4 to our Current Report on Form 8-K filed with Securities and Exchange Commission on July 23, 2021, and is incorporated herein by reference thereto.
10.21Form of Non-Qualified Stock Option, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 10, 2022, and is incorporated herein by reference thereto.
10.22Amended and Restated 2020 Stock and Incentive Compensation Plan, which was filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on May 26, 2022, and is incorporated herein by reference thereto.
10.23Third Amended and Restated Distribution Agreement by and between the Company and Bidi Vapor, LLC, dated June 10, 2022.(1)*2023*+
 
10.24Lease Agreement by and between the Company and Just Pick, LLC, dated June 10, 2022.*
10.25License Agreement by and between the Company and Bidi Vapor, LLC, dated June 10, 2022.(1)*
10.26Deed of Licensing Agreement by and between Kaival Brands International, LLC and Philip Morris Products S.A., dated as of June 13, 2022.(1)*
31.1Certification of Chief Executive Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934*
31.2Certification of Chief Financial Officer pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934*
32.1Chief Executive Officer pursuant to 18 U.S.C. Section 1350 of Chapter 63 of Title 18 of the United States Code*
32.2Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350 of Chapter 63 of Title 18 of the United States Code*

101.INSInline XBRL Instance Document*
101.SCHInline XBRL Taxonomy Extension Schema Document*
101.CALInline XBRL Taxonomy Extension Calculation Linkbase Document*
101.DEFInline XBRL Taxonomy Extension Definition Linkbase Document*
101.LABInline XBRL Taxonomy Extension Label Linkbase Document*
101.PREInline XBRL Taxonomy Presentation Linkbase Document*
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)*

(1)Schedules and Exhibits omitted pursuant to Item 601(b) (10) (iv) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted schedule to the Securities and Exchange Commission upon request; provided, however, that the Company may request confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended, for any Schedule or Exhibit so furnished

*filed herewith

+ Schedules omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to supplementally furnish to the staff of the Securities and Exchange Commission a copy of any omitted schedule or exhibit upon request. 

9

SIGNATURES

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

KAIVAL BRANDS INNOVATIONS GROUP, INC.
Date: June 21, 202214, 2023By:A/s/ Nirajkumar PatelEric Mosser
Nirajkumar PatelEric Mosser
President and Chief ExecutiveOperating Officer

Date: June 21, 202214, 2023By:/s/ Mark Thoenes
Mark Thoenes
Interim Chief Financial Officer

1012